Federal Register Vol. 82, No.12,

Federal Register Volume 82, Issue 12 (January 19, 2017)

Page Range6167-7630
FR Document

82_FR_12
Current View
Page and SubjectPDF
82 FR 7629 - Providing an Order of Succession Within the Federal Mediation and Conciliation ServicePDF
82 FR 7627 - Providing an Order of Succession Within the Council on Environmental QualityPDF
82 FR 7625 - Designation of Officers or Employees of the Office of Science and Technology Policy To Act as DirectorPDF
82 FR 7623 - Continuing To Expand Opportunity for All Young PeoplePDF
82 FR 7621 - Providing an Order of Succession Within the Environmental Protection AgencyPDF
82 FR 7619 - Providing an Order of Succession Within the Department of JusticePDF
82 FR 7617 - Religious Freedom Day, 2017PDF
82 FR 7615 - Martin Luther King, Jr., Federal Holiday, 2017PDF
82 FR 6550 - Sunshine Act MeetingPDF
82 FR 6179 - Promoting Diversity and Inclusion in Our National Parks, National Forests, and Other Public Lands and WatersPDF
82 FR 6195 - Continuation of the National Emergency With Respect to ZimbabwePDF
82 FR 6193 - Continuation of the National Emergency With Respect to VenezuelaPDF
82 FR 6191 - Continuation of the National Emergency With Respect to UkrainePDF
82 FR 6189 - Continuation of the National Emergency With Respect to LibyaPDF
82 FR 6187 - Continuation of the National Emergency With Respect to IranPDF
82 FR 6185 - Continuation of the National Emergency With Respect to Cuba and of the Emergency Authority Relating to the Regulation of the Anchorage and Movement of VesselsPDF
82 FR 6235 - Application of Modified Carryover Basis to General Basis RulesPDF
82 FR 6167 - Establishment of the Reconstruction Era National MonumentPDF
82 FR 6339 - Performance Appraisal System CertificationPDF
82 FR 7336 - Proposed Best Interest Contract Exemption for Insurance IntermediariesPDF
82 FR 6602 - Changes in Flood Hazard DeterminationsPDF
82 FR 6608 - Homeland Security Science and Technology Advisory CommitteePDF
82 FR 6653 - Order of Succession to the Secretary of Labor in Periods of Vacancy, Continuity of Executive Direction, Repositioning and Devolution of Departmental Governance, and Emergency Planning Under Circumstances of Extreme DisruptionPDF
82 FR 6595 - Agency Information Collection Activities: Proposed Collection; Comment Request; Emergency Management Institute (EMI) Independent Study Course Enrollment Application and Test Answer SheetPDF
82 FR 6688 - Controlled Substances and Alcohol Use and Testing: J.B. Hunt Transport, Inc., Schneider National Carriers, Inc., Werner Enterprises, Inc., Knight Transportation, Inc., Dupre Logistics, Inc. and Maveric Transportation, LLC Application for ExemptionPDF
82 FR 6627 - Marine Mammals; Incidental Take During Specified Activities; Proposed Incidental Harassment AuthorizationPDF
82 FR 6482 - Addition of Moldova to the List of Regions Affected by African Swine FeverPDF
82 FR 6483 - Notice of Decision To Authorize the Importation of Fresh Star Apple Fruit From Vietnam Into the Continental United StatesPDF
82 FR 6607 - Proposed Flood Hazard DeterminationsPDF
82 FR 6689 - Parts and Accessories Necessary for Safe Operation; Application for an Exemption From Hino Motors Manufacturing U.S.A., Inc.PDF
82 FR 6601 - Proposed Flood Hazard DeterminationsPDF
82 FR 6597 - Changes in Flood Hazard DeterminationsPDF
82 FR 6500 - California State Nonroad Engine Pollution Control Standards; Commercial Harbor Craft Regulations; Notice of DecisionPDF
82 FR 6610 - HUD Approval of Requests for Transfers of Multifamily Housing Project-Based Rental Assistance, HUD-Held or Insured Debt, and Income-Based Use RestrictionsPDF
82 FR 6540 - California State Nonroad Engine Pollution Control Standards; Evaporative Emission Standards and Test Procedures for Off-Highway Recreational Vehicles (OHRVs); Notice of DecisionPDF
82 FR 6625 - Announcement of the Housing Counseling Federal Advisory Committee Notice of Public MeetingPDF
82 FR 6617 - Federal Property Suitable as Facilities To Assist the HomelessPDF
82 FR 6615 - Rental Assistance Demonstration: Revised Program NoticePDF
82 FR 6621 - Consolidated Delegations of Authority for the Office of Community Planning and DevelopmentPDF
82 FR 6611 - Redelegation of Authority to the Deputy Assistant Secretaries in the Office of Community Planning and DevelopmentPDF
82 FR 6551 - Notice of Agreements FiledPDF
82 FR 6493 - Whaling Provisions; Aboriginal Subsistence Whaling QuotasPDF
82 FR 6451 - Hazardous Materials: FAST Act Requirements for Real-Time Train Consist Information by RailPDF
82 FR 6618 - Redelegation of Authority to Directors and Deputy Directors of Community Planning and Development in Field OfficesPDF
82 FR 6545 - Risk Evaluation Scoping Efforts Under TSCA for Ten Chemical Substances; Notice of Public MeetingPDF
82 FR 6522 - Statutory Requirements for Substantiation of Confidential Business Information (CBI) Claims Under the Toxic Substances Control Act (TSCA)PDF
82 FR 6660 - Texas A&M UniversityPDF
82 FR 6534 - Final National Pollutant Discharge Elimination System (NPDES) General Permit for Stormwater Discharges From Construction ActivitiesPDF
82 FR 6498 - Revision to the PAG Manual: Protective Action Guide (PAG) for Drinking Water After a Radiological IncidentPDF
82 FR 7432 - Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing Under TSCA Section 6(a)PDF
82 FR 6546 - Request for Nominations for Peer Reviewers and for Public Comment on Peer Review Materials To Inform the Derivation of a Water Concentration Value for Lead in Drinking WaterPDF
82 FR 6549 - Acumen CommunicationsPDF
82 FR 6525 - California State Nonroad Engine Pollution Control Standards; In-Use Diesel-Fueled Transport Refrigeration Units (TRUs) and TRU Generator Sets and Facilities Where TRUs Operate; Notice of DecisionPDF
82 FR 7562 - Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control ActPDF
82 FR 6686 - Additional Designation of Syrian Entity Pursuant to E.O. 13382PDF
82 FR 7464 - Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a)PDF
82 FR 6610 - Agency Information Collection Activities: Petition by Entrepreneur To Remove Conditions on Permanent Resident Status, Form I-829; Revision of a Currently Approved CollectionPDF
82 FR 6578 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Ryan White HIV/AIDS Program: Allocation and Expenditure FormsPDF
82 FR 6490 - Foreign-Trade Zone 168; Application Requesting Expansion/Reorganization; Dallas/Fort Worth, Texas AreaPDF
82 FR 6581 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Ryan White HIV/AIDS Program Part F Dental Services ReportPDF
82 FR 6646 - Kraft Heinz Foods Company, a Subsidiary of the Kraft Heinz Company, Including On-Site Leased Workers From Kelly Services, U.S. Securities, West Side Hammer Electric, and Goodwill Keystone Area, Allentown, Pennsylvania; Amended Certification Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
82 FR 6648 - Notice of Determinations Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
82 FR 6646 - Northern Industrial Erectors, Inc., Grand Rapids, Minnesota; Notice of Affirmative Determination Regarding Application for ReconsiderationPDF
82 FR 6489 - Foreign-Trade Zone (FTZ) 158-Vicksburg/Jackson, Mississippi; Authorization of Limited Production Activity; MTD Consumer Group, Inc. (Lawn and Garden Equipment); Verona, MississippiPDF
82 FR 6647 - REC Silicon LLC, a Wholly Owned Subsidiary of Renewable Energy Corporation ASA, Including Workers Whose Wages Were Reported Under REC Solar Grade Silicon LLC, Including On-Site Leased Workers From Express Employment Professionals, Moses Lake, Washington; REC Silicon ASA, a Wholly Owned Subsidiary of REC Solar Grade Silicon LLC, Including Workers Whose Wages Were Reported Under REC Advanced Silicon Materials, Silver Bow, Montana; Nemo IT Solutions, Working On-Site at REC Silicon LLC, a Wholly Owned Subsidiary of Renewable Energy Corporation ASA, Moses Lake, Washington; Spherion Staffing LLC, Working On-Site at REC Silicon ASA, a Wholly Owned Subsidiary of REC Solar Grade Silicon LLC, Silver Bow, Montana; Notice of Revised Determination on ReconsiderationPDF
82 FR 6648 - Huntington Alloys Corporation, Special Metals Division, a Subsidiary of Special Metals Corporation, Including On-Site Leased Workers From Kelly Services, Huntington, West Virginia; Huntington Alloys Corporation, Special Metals Division, a Subsidiary of Special Metals Corporation, Burnaugh, Kentucky; Amended Certification Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
82 FR 6652 - Investigations Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
82 FR 6490 - Foreign-Trade Zone (FTZ) 20-Norfolk, Virginia; Notification of Proposed Production Activity; STIHL Incorporated (Outdoor Power Products Manufacturing); Virginia Beach, VirginiaPDF
82 FR 6489 - Foreign-Trade Zone (FTZ) 177-Evansville, Indiana; Authorization of Production Activity; Best Chairs, Inc. d/b/a Best Home Furnishings (Upholstered Furniture); Ferdinand, Cannelton and Paoli, IndianaPDF
82 FR 6579 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Evaluation of the Maternal and Child Health Bureau's Autism CARES Act InitiativePDF
82 FR 6559 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
82 FR 6558 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
82 FR 6636 - Notice of Realty Action: Application for Conveyance of Federally Owned Mineral Interests in Maricopa County, AZPDF
82 FR 6639 - Notice of Application for Withdrawal and Notification of Public Meeting; MinnesotaPDF
82 FR 6640 - Notice of Application for a Recordable Disclaimer of Interest: Dimmit County, TexasPDF
82 FR 6551 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
82 FR 6634 - BLM Director's Response to the Alaska Governor's Appeal of the BLM Alaska State Director's Governor's Consistency Review Determination for the Eastern Interior Proposed Resource Management Plan and Final Environmental Impact StatementPDF
82 FR 6580 - Meeting of the Advisory Committee on Heritable Disorders in Newborns and ChildrenPDF
82 FR 6662 - Income Tax ReviewPDF
82 FR 6687 - SMS Rail Lines of New York, LLC-Acquisition and Operation Exemption-Rail Line of WCC, LLC, in Hudson Falls, NYPDF
82 FR 6692 - FTA Fiscal Year 2017 Apportionments, Allocations, Program Information and Interim GuidancePDF
82 FR 6487 - Coconino and Tonto National Forests; Arizona; Fossil Creek Wild and Scenic River Comprehensive River Management Plan and Environmental Impact StatementPDF
82 FR 6494 - Combined Notice of FilingsPDF
82 FR 6566 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network)PDF
82 FR 6556 - National Center for Health Statistics (NCHS) Confidentiality Pledge Revision NoticePDF
82 FR 6554 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
82 FR 6687 - Projects Approved for Consumptive Uses of WaterPDF
82 FR 6583 - Agency Information Collection Request. 60-Day Public Comment Request, Grants.govPDF
82 FR 6583 - Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-October Through December 2016PDF
82 FR 6590 - Protecting Our Infants Act Report to CongressPDF
82 FR 6657 - Notice of Intent To Grant a Partially Exclusive LicensePDF
82 FR 6625 - Notice of Intent To Prepare a Draft Environmental Impact Statement for a Proposed Habitat Conservation Plan for the Endangered American Burying Beetle for American Electric Power in Oklahoma, Arkansas, and TexasPDF
82 FR 6552 - Privacy Act of 1974; Notice of a New System of RecordsPDF
82 FR 6482 - Notice of Intent To Grant Exclusive LicensePDF
82 FR 6691 - Notice of Establishment of Emergency Relief Docket for Calendar Year 2017PDF
82 FR 6716 - FY 2017 Competitive Funding Opportunity: Public Transportation on Indian Reservations Program; Tribal Transit ProgramPDF
82 FR 6564 - Psychopharmacologic Drugs Advisory Committee; CancellationPDF
82 FR 6490 - Certain Oil Country Tubular Goods From the People's Republic of China: Notice of Court Decision Not in Harmony With Final Scope Ruling and Notice of Amended Final Scope Ruling Pursuant to Court DecisionPDF
82 FR 6687 - Chesapeake Western Railway-Discontinuance of Service Exemption-in Rockingham and Shenandoah Counties, VA.PDF
82 FR 6726 - Proposed Collection; Comment Request for Form 8874-APDF
82 FR 6726 - Proposed Collection; Comment Request for Revenue Procedure 98-32PDF
82 FR 6727 - Proposed Collection; Comment Request for Regulation ProjectPDF
82 FR 6492 - Proposed Information Collection; Comment Request; Information Collection for Self-Certification to the Swiss-U.S. Privacy Shield FrameworkPDF
82 FR 6659 - Advisory Committee on the Presidential Library-Foundation PartnershipsPDF
82 FR 6673 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change, as Modified by Amendment No. 1, To Amend CBOE Rule 6.53CPDF
82 FR 6667 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Cabinet Trading Pilot ProgramPDF
82 FR 6669 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change in Connection With the Proposed Transaction Involving CHX Holdings, Inc. and North America Casin Holdings, Inc.PDF
82 FR 6674 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Notice of Filing of Proposed Amended Plan for the Allocation of Regulatory Responsibilities Among the Financial Industry Regulatory Authority, Inc., Miami International Securities Exchange, LLC, and MIAX PEARL, LLCPDF
82 FR 6662 - Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange Rule 510 To Extend the Penny Pilot ProgramPDF
82 FR 6678 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Fees for Use of the Exchange's Equity Options PlatformPDF
82 FR 6356 - RecordkeepingPDF
82 FR 6729 - Proposed Information Collection Activity: (Authorization To Disclose Personal Information to a Third Party (VA Form 29-0975))PDF
82 FR 6728 - Agency Information Collection Activity: (Record Keeping at Flight Schools)PDF
82 FR 6729 - Agency Information Collection Activity: (Employment Information in Connection With Claim for Disability Benefits (VA Form 21-4192))PDF
82 FR 6728 - Information Collection Activity: (Presidential Memorial Certificate Form)PDF
82 FR 6644 - Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof; Commission Determination to Review In-Part a Final Initial Determination on Remand, and on Remand To Affirm With Modification; Vacatur of Suspended Remedial Orders; and Termination of the InvestigationPDF
82 FR 6664 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Amendment No. 2 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 2, Relating to Continued Listing Requirements for Exchange-Traded ProductsPDF
82 FR 6497 - Hydro Kennebec, LLC; Notice of Application To Extend Interim Species Protection Plan for Three Years and Soliciting Comments, Motions To Intervene and ProtestsPDF
82 FR 6496 - Alcoa Corporation; Notice of Petition for Declaratory OrderPDF
82 FR 6496 - City of West Memphis, Arkansas; Conway Corporation; Notice of FilingPDF
82 FR 6495 - Texas Eastern Transmission, LP; Notice of Amendment to ApplicationPDF
82 FR 6496 - Combined Notice of Filings #1PDF
82 FR 6489 - Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment AssistancePDF
82 FR 6646 - Notice of Lodging Proposed Consent DecreePDF
82 FR 6658 - Records Schedules; Availability and Request for CommentsPDF
82 FR 6658 - Advisory Committee on the Presidential Library-Foundation PartnershipsPDF
82 FR 6488 - Agenda and Notice of Public Meeting of the Connecticut Advisory CommitteePDF
82 FR 6642 - Notice of March 13, 2017, Meeting for Cape Cod National Seashore Advisory CommissionPDF
82 FR 6657 - Senior Executive Service Performance Review Board MembershipPDF
82 FR 6643 - Notice of the 2017 Meeting Schedule for Cedar Creek and Belle Grove National Historical Park Advisory CommissionPDF
82 FR 6641 - Notice of the 2017 Meeting Schedule for Gettysburg National Military Park Advisory CommissionPDF
82 FR 6642 - Notice of an Open Public Meeting for the Lake Clark National Park Subsistence Resource CommissionPDF
82 FR 6588 - National Institute of Neurological Disorders and Stroke; Notice of Closed MeetingPDF
82 FR 6586 - National Institute of Mental Health; Notice of Closed MeetingPDF
82 FR 6585 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed MeetingPDF
82 FR 6586 - National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed MeetingPDF
82 FR 6584 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed MeetingPDF
82 FR 6585 - National Heart, Lung, and Blood Institute Amended; Notice of MeetingPDF
82 FR 6587 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
82 FR 6585 - National Human Genome Research Institute; Notice of Closed MeetingPDF
82 FR 6585 - National Cancer Institute; Notice of Closed MeetingsPDF
82 FR 6587 - Center for Scientific Review; Notice of Closed MeetingsPDF
82 FR 6558 - Designation of a Class of Employees for Addition to the Special Exposure CohortPDF
82 FR 6556 - Designation of a Class of Employees for Addition to the Special Exposure CohortPDF
82 FR 6485 - Codex Alimentarius Commission: Meeting of the Codex Committee on Food AdditivesPDF
82 FR 6582 - Agency Information Collection Activities; Proposed Collection; Public Comment RequestPDF
82 FR 6551 - Notice of Annual Adjustment of the Cap on Average Total Assets That Defines Community Financial InstitutionsPDF
82 FR 6645 - Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.PDF
82 FR 6506 - Inquiry To Learn Whether Businesses Assert Business Confidentiality Claims Regarding Waste Import and ExportPDF
82 FR 6596 - Proposed Flood Hazard DeterminationsPDF
82 FR 6532 - Proposed Settlement Agreement, Clean Air Act Petition for ReviewPDF
82 FR 6591 - Changes in Flood Hazard DeterminationsPDF
82 FR 6509 - Response to December 9, 2013, Clean Air Act Section 176A Petition From Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New York, Pennsylvania, Rhode Island and VermontPDF
82 FR 6591 - Virginia; Amendment No. 4 to Notice of a Major Disaster DeclarationPDF
82 FR 6602 - North Carolina; Amendment No. 16 to Notice of a Major Disaster DeclarationPDF
82 FR 6725 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel SAIL BE HAPPY; Invitation for Public CommentsPDF
82 FR 6724 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel GRAVITY; Invitation for Public CommentsPDF
82 FR 6725 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel HAVORN; Invitation for Public CommentsPDF
82 FR 6413 - Air Plan Approval; Washington: General Regulations for Air Pollution Sources, Southwest Clean Air Agency JurisdictionPDF
82 FR 6722 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel MAJESTIK; Invitation for Public CommentsPDF
82 FR 6722 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel SHAUN T; Invitation for Public CommentsPDF
82 FR 6684 - 60-Day Notice of Proposed Information Collection: Passport Demand Forecasting SurveyPDF
82 FR 6724 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel SERENITY; Invitation for Public CommentsPDF
82 FR 6721 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel MIRA MAR; Invitation for Public CommentsPDF
82 FR 6723 - Agency Requests for Renewal of a Previously Approved Information Collection(s): Application for Conveyance of Port Facility PropertyPDF
82 FR 6533 - Proposed Reissuance of the NPDES General Permit for Facilities Related to Oil and Gas Extraction in the Territorial Seas of TexasPDF
82 FR 6641 - Harriet Tubman National Historical ParkPDF
82 FR 6609 - Agency Information Collection Activities: Application for Waiver of Grounds of Inadmissibility, Form I-601; Revision of a Currently Approved Collection.PDF
82 FR 6685 - 60-Day Notice of Proposed Information Collection: Evacuee Manifest and Promissory NotePDF
82 FR 6571 - Advice About Eating Fish, From the Environmental Protection Agency and Food and Drug Administration; Revised Fish Advice; AvailabilityPDF
82 FR 6484 - Information Collection Request; Guaranteed Farm Loan ProgramPDF
82 FR 6484 - Information Collection Request; Direct Loan Servicing-RegularPDF
82 FR 6651 - Office of Career, Technical, and Adult Education; Rehabilitation Services Administration; Agency Information Collection Activities; Comment Request; Workforce Innovation and Opportunity Act (WIOA) Common Performance ReportingPDF
82 FR 6250 - Safety Zone; Pleasure Beach Bridge, Bridgeport, CTPDF
82 FR 6492 - United States Travel and Tourism Advisory Board: Meeting of the United States Travel and Tourism Advisory BoardPDF
82 FR 7149 - Federal Policy for the Protection of Human SubjectsPDF
82 FR 6388 - Amendment of Regulations Implementing Section 504 of the Rehabilitation Act of 1973-Nondiscrimination Based on Disability in Federally Assisted Programs or ActivitiesPDF
82 FR 6370 - Definition of DependentPDF
82 FR 7582 - Transfers of Certain Property by U.S. Persons to Partnerships With Related Foreign PartnersPDF
82 FR 6368 - Transfers of Certain Property by U.S. Persons to Partnerships With Related Foreign PartnersPDF
82 FR 7094 - Federal Housing Administration: Strengthening the Home Equity Conversion Mortgage ProgramPDF
82 FR 6560 - Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-March 22, 2017PDF
82 FR 6244 - Regulations Governing Retirement Savings BondsPDF
82 FR 6212 - Amendment of Multiple Air Traffic Service (ATS) Routes; North Central United StatesPDF
82 FR 6353 - Proposed Modification and Establishment of Air Traffic Service (ATS) Routes; Northcentral United StatesPDF
82 FR 6353 - Irish Potatoes Grown in Washington; Continuance ReferendumPDF
82 FR 6212 - Importation of Beef From a Region in ArgentinaPDF
82 FR 6367 - Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Availability of Memorandum; Reopening of the Comment PeriodPDF
82 FR 6575 - Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling-Questions and Answers; Draft Guidance for Industry; AvailabilityPDF
82 FR 6568 - Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Draft Guidance for Industry and Review Staff; AvailabilityPDF
82 FR 6253 - Student Assistance General ProvisionsPDF
82 FR 6252 - Family Educational Rights and Privacy ActPDF
82 FR 6265 - Recognition of Tribal Organizations for Representation of VA ClaimantsPDF
82 FR 6277 - Significant New Use Rules on Certain Chemical Substances; WithdrawalPDF
82 FR 7376 - Open Licensing Requirement for Competitive Grant ProgramsPDF
82 FR 7536 - Transparency of Airline Ancillary Service FeesPDF
82 FR 6307 - Civil Penalties; 2017 Inflation Adjustments for Civil Monetary PenaltiesPDF
82 FR 7042 - National Organic Program (NOP); Organic Livestock and Poultry PracticesPDF
82 FR 6643 - Record of Decision for the 2017-2022 Outer Continental Shelf Oil and Gas Leasing Program Final Programmatic Environmental Impact Statement; MMAA104000PDF
82 FR 6623 - Federal Property Suitable as Facilities To Assist the HomelessPDF
82 FR 7008 - Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered OrganismsPDF
82 FR 6197 - Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin RegulationsPDF
82 FR 6564 - Genome Editing in New Plant Varieties Used for Foods; Request for CommentsPDF
82 FR 6561 - Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; AvailabilityPDF
82 FR 6574 - Regulation of Mosquito-Related Products; Draft Guidance for Industry; AvailabilityPDF
82 FR 6429 - Homeland Security Acquisition Regulation (HSAR); Safeguarding of Controlled Unclassified Information (HSAR Case 2015-001)PDF
82 FR 6446 - Homeland Security Acquisition Regulation (HSAR); Information Technology Security Awareness Training (HSAR Case 2015-002)PDF
82 FR 6425 - Homeland Security Acquisition Regulation (HSAR); Privacy Training (HSAR Case 2015-003)PDF
82 FR 6305 - Onshore Oil and Gas Operations-Annual Civil Penalties Inflation AdjustmentsPDF
82 FR 6278 - Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety RequirementsPDF
82 FR 6294 - National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury TablePDF
82 FR 6423 - National Vaccine Injury Compensation Program: Statement of Reasons for Not Conducting a Rulemaking ProceedingPDF
82 FR 6309 - Endangered and Threatened Wildlife and Plants; Final Rule To List Two Guitarfishes as Threatened Under the Endangered Species ActPDF
82 FR 6456 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Space Vehicle and Missile Launch Operations at Pacific Spaceport Complex Alaska, Kodiak Island, AlaskaPDF
82 FR 6248 - Civil Monetary Penalty Inflation AdjustmentPDF
82 FR 6890 - Control of Communicable DiseasesPDF
82 FR 6210 - Almonds Grown in California; Change in Quality Control RequirementsPDF
82 FR 6197 - Prevailing Rate Systems; Definition of Kent County, Michigan, and Cameron County, Texas, to Nonappropriated Fund Federal Wage System Wage AreasPDF
82 FR 7400 - Health and Environmental Protection Standards for Uranium and Thorium Mill TailingsPDF
82 FR 6980 - Plant Pest Regulations; Update of ProvisionsPDF
82 FR 6472 - Fisheries of the Northeastern United States; Atlantic Sea Scallop Fishery; Framework Adjustment 28PDF
82 FR 6826 - Energy Conservation Program: Energy Conservation Standards for Ceiling FansPDF
82 FR 6243 - Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Paying BenefitsPDF
82 FR 6548 - FY2017 Supplemental Funding for Brownfields Revolving Loan Fund (RLF) GranteesPDF
82 FR 6216 - Support Document Requirements With Respect to Hong KongPDF
82 FR 6218 - Amendments to the Export Administration Regulations Implementing an Additional Phase of India-U.S. Export Control CooperationPDF
82 FR 6317 - Standardized Bycatch Reporting MethodologyPDF
82 FR 6221 - International Affairs; Antarctic Marine Living Resources Convention ActPDF
82 FR 6259 - Changes in Requirements for Affidavits or Declarations of Use, Continued Use, or Excusable Nonuse in Trademark CasesPDF
82 FR 6588 - Office of Refugee Resettlement; Statement of Organization, Functions, and Delegations of AuthorityPDF
82 FR 6273 - Fertility Counseling and Treatment for Certain Veterans and SpousesPDF
82 FR 6276 - Inspection Service Authority; Civil Monetary Penalty Inflation AdjustmentPDF
82 FR 7276 - Energy Conservation Program: Energy Conservation Standards for General Service LampsPDF
82 FR 7322 - Energy Conservation Program: Energy Conservation Standards for General Service LampsPDF
82 FR 6732 - Revision of the Nutrition Facts Labels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily ConsumedPDF

Issue

82 12 Thursday, January 19, 2017 Contents Agency Agency for International Development RULES Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058 Agricultural Marketing Agricultural Marketing Service RULES Almonds Grown in California: Quality and Handling Requirements, 6210-6212 2017-00589 National Organic Program: Organic Livestock and Poultry Practices, 7042-7092 2017-00888 PROPOSED RULES Irish Potatoes Grown in Washington: Continuance Referendum, 6353 2017-01022 Agricultural Research Agricultural Research Service NOTICES Intent To Grant Exclusive Licenses, 6482 2017-01173 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Agricultural Research Service

See

Animal and Plant Health Inspection Service

See

Farm Service Agency

See

Food Safety and Inspection Service

See

Forest Service

RULES Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058
Animal Animal and Plant Health Inspection Service RULES Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of Select Agent and Toxin List: Amendments To Select Agent and Toxin Regulations, 6197-6210 2017-00857 Importation of Beef From Region in Argentina, 6212 2017-01019 PROPOSED RULES Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms, 7008-7039 2017-00858 Plant Pest Regulations, 6980-7005 2017-00532 NOTICES Addition of Moldova to List of Regions Affected by African Swine Fever, 6482 2017-01270 Imports: Fresh Star Apple Fruit From Vietnam, 6483 2017-01267 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 6554-6556 2017-01185 Confidentiality Pledge; Revisions: National Center for Health Statistics, 6556-6558 2017-01186 Designations of Classes of Employees for Additions to Special Exposure Cohort, 6556, 6558 2017-01109 2017-01110 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 6558-6560 2017-01204 2017-01205 Meetings: Medicare Evidence Development and Coverage Advisory Committee, 6560-6561 2017-01043 Civil Rights Civil Rights Commission NOTICES Meetings: Connecticut Advisory Committee, 6488-6489 2017-01127 Coast Guard Coast Guard RULES Safety Zones: Pleasure Beach Bridge, Bridgeport, CT, 6250-6252 2017-01068 Commerce Commerce Department See

Economic Development Administration

See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

Patent and Trademark Office

RULES Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058
Commodity Futures Commodity Futures Trading Commission PROPOSED RULES Recordkeeping, 6356-6367 2017-01148 Defense Department Defense Department RULES Civil Monetary Penalty Inflation Adjustments, 6248-6250 2017-00619 Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058 Drug Drug Enforcement Administration NOTICES Manufacturers of Controlled Substances; Applications: Noramco, Inc., 6645 2017-01103 Economic Development Economic Development Administration NOTICES Trade Adjustment Assistance Eligibility; Petitions, 6489 2017-01134 Education Department Education Department RULES Family Educational Rights and Privacy Act, 6252-6253 2017-00958 Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058 Open Licensing Requirements for Competitive Grant Programs, 7376-7397 2017-00910 Student Assistance General Provisions, 6253-6259 2017-00972 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Workforce Innovation and Opportunity Act Common Performance Reporting, 6651-6652 2017-01069 Employee Benefits Employee Benefits Security Administration PROPOSED RULES Best Interest Contract Exemption for Insurance Intermediaries, 7336-7374 2017-01316 Employment and Training Employment and Training Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Workforce Innovation and Opportunity Act Common Performance Reporting, 6651-6652 2017-01069 Worker Adjustment Assistance Eligibility; Amended Certifications: Huntington Alloys Corp., et al.; Huntington, WV and Burnaugh, KY, 6648 2017-01211 Worker Adjustment Assistance Eligibility; Determinations, 6648-6651 2017-01215 Worker Adjustment Assistance Eligibility; Determinations: Kraft Heinz Foods Co., Allentown, PA, 6646 2017-01216 Northern Industrial Erectors, Inc., Grand Rapids, MN, 6646-6647 2017-01214 REC Silicon LLC, REC Silicon ASA, Nemo IT Solutions, Spherion Staffing, LLC, et al.; Moses Lake, Moses Lake, WA and Silver Bow, MT, 6647 2017-01212 Worker Adjustment Assistance Eligibility; Investigations, 6652-6653 2017-01210 Energy Department Energy Department See

Federal Energy Regulatory Commission

RULES Energy Conservation Programs: Energy Conservation Standards for Ceiling Fans, 6826-6887 2017-00474 Energy Conservation Standards for General Service Lamps, 7276-7333 2016-32012 2016-32013 Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058
Environmental Protection Environmental Protection Agency RULES Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058 Significant New Use Rules on Certain Chemical Substances; Withdrawal, 6277-6278 2017-00938 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Washington; General Regulations for Air Pollution Sources, Southwest Clean Air Agency Jurisdiction, 6413-6423 2017-01090 Health and Environmental Protection Standards for Uranium and Thorium Mill Tailings, 7400-7430 2017-00573 Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act, 7562-7580 2017-01224 Regulation of Certain Uses under Toxic Substances Control Act: Methylene Chloride and N-Methylpyrrolidone, 7464-7533 2017-01222 Trichloroethylene; Vapor Degreasing, 7432-7461 2017-01229 NOTICES California State Nonroad Engine Pollution Control Standards: Commercial Harbor Craft Regulations, 6500-6506 2017-01261 Evaporative Emission Standards and Test Procedures for Off-Highway Recreational Vehicles, 6540-6544 2017-01259 In-Use Diesel-Fueled Transport Refrigeration Units (TRUs) and TRU Generator Sets and Facilities where TRUs Operate, 6525-6532 2017-01225 FY2017 Supplemental Funding for Brownfields Revolving Loan Fund Grantees, 6548-6549 2017-00448 Guidance: Protective Action Guide for Drinking Water After Radiological Incident, 6498-6500 2017-01230 Meetings: Risk Evaluation Scoping Efforts Under Toxic Substances Control Act for Ten Chemical Substances, 6545-6546 2017-01236 Permits: Final National Pollutant Discharge Elimination System General Permit for Stormwater Discharges From Construction Activities, 6534-6540 2017-01231 Petitions: Response to Clean Air Act Petition From Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New York, Pennsylvania, Rhode Island and Vermont, 6509-6522 2017-01097 Proposed Reissuance of NPDES General Permit for Facilities Related to Oil and Gas Extraction in Territorial Seas of Texas, 6533-6534 2017-01082 Proposed Settlement Agreements Under Clean Air Act, 6532-6533 2017-01099 Requests for Comments: Inquiry To Learn Whether Businesses Assert Business Confidentiality Claims Regarding Waste Import and Export, 6506-6509 2017-01101 Requests for Nominations: Peer Reviewers and for Public Comment on Peer Review Materials To Inform Derivation of Water Concentration Value for Lead in Drinking Water, 6546-6548 2017-01228 Statutory Requirements for Substantiation of Confidential Business Information Claims Under Toxic Substances Control Act, 6522-6525 2017-01235 Farm Service Farm Service Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Direct Loan Servicing—Regular, 6484 2017-01071 Guaranteed Farm Loan Program, 6484-6485 2017-01072 Federal Aviation Federal Aviation Administration RULES Amendment of Multiple Air Traffic Service Routes: North Central United States, 6212-6215 2017-01036 PROPOSED RULES Modification and Establishment of Air Traffic Service Routes; Northcentral United States, 6353-6356 2017-01034 Federal Communications Federal Communications Commission NOTICES Acumen Communications, 6549-6550 2017-01226 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 6550-6551 2017-01428 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Emergency Management Institute Independent Study Course Enrollment Application and Test Answer Sheet, 6595-6596 2017-01283 Changes in Flood Hazard Determinations, 6597-6607 2017-01262 2017-01302 Flood Hazard Determinations; Changes, 6591-6595 2017-01098 Flood Hazard Determinations; Proposals, 6596-6597 2017-01100 Major Disaster Declarations: North Carolina; Amendment No. 16, 6602 2017-01095 Virginia; Amendment No. 4, 6591 2017-01096 Proposed Flood Hazard Determinations, 6601-6602, 6607-6608 2017-01264 2017-01266 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Texas Eastern Transmission, LP, 6495-6496 2017-01136 Combined Filings, 6494-6496 2017-01132 2017-01135 2017-01190 Filings: City of West Memphis, AK; Conway Corp., 6496 2017-01137 Hydroelectric Applications: Hydro Kennebec, LLC, 6497-6498 2017-01140 Petitions for Declaratory Orders: Alcoa Corp., 6496-6497 2017-01139 Federal Housing Finance Agency Federal Housing Finance Agency NOTICES Annual Adjustments: Cap on Average Total Assets That Defines Community Financial Institutions, 6551 2017-01104 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 6551 2017-01242 Federal Motor Federal Motor Carrier Safety Administration NOTICES Controlled Substances and Alcohol Use and Testing; Exemption Applications: J.B. Hunt Transport, Inc.; Schneider National Carriers, Inc.; Werner Enterprises, Inc.; Knight Transportation, Inc.; Dupre Logistics, Inc.; and Maveric Transportation, LLC, 6688-6689 2017-01278 Parts and Accessories Necessary for Safe Operation; Exemption Applications: Hino Motors Manufacturing USA, Inc., 6689-6691 2017-01265 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 6551-6552 2017-01200 Federal Transit Federal Transit Administration NOTICES Emergency Relief Docket for Calendar Year 2017, 6691-6692 2017-01172 Fiscal Year 2017 Apportionments, Allocations, Program Information and Interim Guidance, 6692-6716 2017-01194 Funding Opportunities: Public Transportation on Indian Reservations Program; Tribal Transit Program, 6716-6721 2017-01171 Fiscal Fiscal Service RULES Retirement Savings Bonds, 6244-6248 2017-01038 Fish Fish and Wildlife Service RULES Civil Penalties: 2017 Inflation Adjustments for Civil Monetary Penalties, 6307-6309 2017-00889 NOTICES Environmental Impact Statements; Availability, etc.: Habitat Conservation Plan for Endangered American Burying Beetle for American Electric Power in Oklahoma, Arkansas, and Texas, 6625-6627 2017-01176 Incidental Takes of Marine Mammals during Specified Activities: Minhoto-Hester Marsh Restoration Project, Elkhorn Slough, Monterey County, CA, 6627-6634 2017-01271 Food and Drug Food and Drug Administration PROPOSED RULES Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products, 6367-6368 2017-01013 NOTICES Advice About Eating Fish, 6571-6574 2017-01073 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Adverse Event Program for Medical Devices (Medical Product Safety Network), 6566-6568 2017-01187 Guidance: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities: Questions and Answers, 6568-6571 2017-01011 Genome Editing in New Plant Varieties Used For Foods, 6564-6566 2017-00840 Medical Product Communications Consistent with Required Labeling: Questions and Answers, 6575-6578 2017-01012 Regulation of Intentionally Altered Genomic DNA in Animals, 6561-6564 2017-00839 Regulation of Mosquito-Related Products, 6574-6575 2017-00838 Meetings: Psychopharmacologic Drugs Advisory Committee, 6564 2017-01170 Food Safety Food Safety and Inspection Service PROPOSED RULES Revision of Nutrition Facts Labels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed, 6732-6823 2016-29272 NOTICES Meetings: Codex Alimentarius Commission Committee on Food Additives, 6485-6487 2017-01108 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities; Authorizations: Foreign-Trade Zone 158, Vicksburg/Jackson, MS; MTD Consumer Group, Inc. (Lawn and Garden Equipment) Verona, MS, 6489 2017-01213 Foreign-Trade Zone 177, Evansville, IN; Best Chairs, Inc. d/b/a Best Home Furnishings (Upholstered Furniture) Ferdinand, Cannelton and Paoli, IN, 6489-6490 2017-01207 Proposed Production Activities: Foreign-Trade Zone 20, Norfolk, VA; STIHL Inc. (Outdoor Power Products Manufacturing) Virginia Beach, VA, 6490 2017-01209 Subzone Expansions; Applications: Foreign-Trade Zone 168; Dallas/Fort Worth, TX Area: Expansion/Reorganization, 6490 2017-01219 Forest Forest Service NOTICES Environmental Impact Statements; Availability, etc.: Coconino and Tonto National Forests; Arizona; Fossil Creek Wild and Scenic River Comprehensive River Management Plan, 6487-6488 2017-01191 General Services General Services Administration NOTICES Privacy Act; Systems of Records, 6552-6554 2017-01174 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

See

Refugee Resettlement Office

See

Substance Abuse and Mental Health Services Administration

RULES Control of Communicable Diseases, 6890-6978 2017-00615 Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058 National Vaccine Injury Compensation Program: Vaccine Injury Table Revisions, 6294-6305 2017-00701 Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements, 6278-6294 2017-00726 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 6582 2017-01106 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Grants.gov, 6583 2017-01182 Medicare Program: Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances: October through December 2016, 6583-6584 2017-01181
Health Resources Health Resources and Services Administration PROPOSED RULES National Vaccine Injury Compensation Program: Statement of Reasons for Not Conducting Rulemaking Proceeding, 6423-6425 2017-00700 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Evaluation of Maternal and Child Health Bureau's Autism CARES Act Initiative, 6579-6580 2017-01206 Ryan White HIV/AIDS Program Part F Dental Services Report, 6581-6582 2017-01218 Ryan White HIV/AIDS Program: Allocation and Expenditure Forms, 6578-6579 2017-01220 Meetings: Advisory Committee on Heritable Disorders in Newborns and Children, 6580-6581 2017-01198 Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

See

U.S. Citizenship and Immigration Services

RULES Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058 PROPOSED RULES Homeland Security Acquisition Regulations: Information Technology Security Awareness Training, 6446-6451 2017-00754 Privacy Training, 6425-6429 2017-00752 Safeguarding of Controlled Unclassified Information, 6429-6446 2017-00758 NOTICES Meetings: Homeland Security Science and Technology Advisory Committee, 6608-6609 2017-01290
Housing Housing and Urban Development Department RULES Federal Housing Administration: Strengthening Home Equity Conversion Mortgage Program, 7094-7146 2017-01044 Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058 NOTICES Consolidated Delegations of Authority for Office of Community Planning and Development, 6621-6623 2017-01245 Federal Properties Suitable as Facilities to Assist Homeless, 6617-6618 2017-01247 Federal Properties Suitable as Facilities to Assist Homeless; Correction, 6623-6625 2017-00885 Meetings: Housing Counseling Federal Advisory Committee, 6625 2017-01248 Multifamily Housing Project-Based Rental Assistance, HUD-Held or Insured Debt, and Income-Based Use Restrictions: Requests for Transfers; Approval, 6610-6611 2017-01260 Redelegations of Authority: Deputy Assistant Secretaries in Office of Community Planning and Development, 6611-6615 2017-01244 Directors and Deputy Directors of Community Planning and Development in Field Offices, 6618-6621 2017-01238 Rental Assistance Demonstration: Revised Program, 6615-6617 2017-01246 Industry Industry and Security Bureau RULES Export Administration Regulations: Amendments Implementing Additional Phase of India-U.S. Export Control Cooperation, 6218-6221 2017-00439 Support Document Requirements with Respect to Hong Kong, 6216-6218 2017-00446 Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

See

National Park Service

See

Ocean Energy Management Bureau

Internal Revenue Internal Revenue Service RULES Application of Modified Carryover Basis to General Basis Rules, 6235-6243 2017-01365 Transfers of Certain Property by U.S. Persons to Partnerships with Related Foreign Partners, 7582-7611 2017-01049 PROPOSED RULES Definition of Dependent, 6370-6388 2017-01056 Transfers of Certain Property by U.S. Persons to Partnerships with Related Foreign Partners, 6368-6370 2017-01048 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 6726-6728 2017-01158 2017-01160 2017-01162 International Trade Adm International Trade Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Self-Certification to Swiss-US Privacy Shield Framework, 6492-6493 2017-01156 Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Oil Country Tubular Goods From People's Republic of China, 6490-6491 2017-01166 Meetings: United States Travel and Tourism Advisory Board, 6492 2017-01062 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof, 6644-6645 2017-01143 Justice Department Justice Department See

Drug Enforcement Administration

PROPOSED RULES Nondiscrimination Based on Disability in Federally Assisted Programs or Activities, 6388-6413 2017-01057 NOTICES Proposed Consent Decrees Under Clean Water Act, 6646 2017-01133
Labor Department Labor Department See

Employee Benefits Security Administration

See

Employment and Training Administration

See

Occupational Safety and Health Administration

RULES Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058 NOTICES Order of Succession to Secretary of Labor, 6653-6657 2017-01289
Land Land Management Bureau RULES Onshore Oil and Gas Operations: Annual Civil Penalties Inflation Adjustments, 6305-6307 2017-00727 NOTICES Applications for Recordable Disclaimer of Interest for Lands Owned: Dimmit County, TX, 6640-6641 2017-01201 Eastern Interior Proposed Resource Management Plan: BLM Director's Response to Alaska Governor's Appeal:, 6634-6636 2017-01199 Land Withdrawals; Applications: Minnesota; Public Meeting, 6639-6640 2017-01202 Realty Actions: Application for Conveyance of Federally Owned Mineral Interests in Maricopa County, AZ, 6636-6639 2017-01203 Management Management and Budget Office PROPOSED RULES Performance Appraisal System Certification, 6339-6353 2017-01326 Maritime Maritime Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Conveyance of Port Facility Property, 6723 2017-01084 Requests for Administrative Waivers of Coastwise Trade Laws: Vessel GRAVITY, 6724 2017-01092 Vessel HAVORN, 6725-6726 2017-01091 Vessel MAJESTIK, 6722-6723 2017-01089 Vessel MIRA MAR, 6721-6722 2017-01085 Vessel SAIL BE HAPPY, 6725 2017-01093 Vessel SERENITY, 6724-6725 2017-01086 Vessel SHAUN T, 6722 2017-01088 NASA National Aeronautics and Space Administration RULES Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058 NOTICES Intents to Grant Partially Exclusive Licenses, 6657-6658 2017-01179 National Archives National Archives and Records Administration NOTICES Meetings: Advisory Committee on Presidential Library-Foundation Partnerships, 6658 2017-01129 Advisory Committee on Presidential Library-Foundation Partnerships; Correction, 6659-6660 2017-01155 Records Schedules; Availability, 6658-6659 2017-01130 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 6587-6588 2017-01111 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6585 2017-01118 National Cancer Institute, 6585-6586 2017-01112 National Heart, Lung, and Blood Institute, 6587 2017-01114 National Heart, Lung, and Blood Institute; Amendment, 6585 2017-01115 National Human Genome Research Institute, 6585 2017-01113 National Institute of Arthritis and Musculoskeletal and Skin Diseases, 6586 2017-01117 National Institute of Mental Health, 6586-6587 2017-01119 National Institute of Neurological Disorders and Stroke, 6588 2017-01120 National Institute on Alcohol Abuse and Alcoholism, 6584-6585 2017-01116 National Oceanic National Oceanic and Atmospheric Administration RULES Endangered and Threatened Species: Listing of Two Guitarfishes as Threatened under Endangered Species Act, 6309-6317 2017-00680 International Affairs: Antarctic Marine Living Resources Convention Act, 6221-6234 2017-00401 Standardized Bycatch Reporting Methodology, 6317-6338 2017-00405 PROPOSED RULES Fisheries of Northeastern United States: Atlantic Sea Scallop Fishery; Framework Adjustment 28, 6472-6481 2017-00517 Takes of Marine Mammals: Incidental to Space Vehicle and Missile Launch Operations at Pacific Spaceport Complex Alaska, Kodiak Island, AK, 6456-6472 2017-00621 NOTICES Whaling Provisions; Aboriginal Subsistence Whaling Quotas, 6493-6494 2017-01241 National Park National Park Service NOTICES Establishment of Harriet Tubman National Historical Park, 6641 2017-01081 Meetings: Cape Cod National Seashore Advisory Commission, 6642-6643 2017-01126 Cedar Creek and Belle Grove National Historical Park Advisory Commission, 6643 2017-01123 Gettysburg National Military Park Advisory Commission, 6641-6642 2017-01122 Lake Clark National Park Subsistence Resource Commission, 6642 2017-01121 National Science National Science Foundation RULES Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Environmental Assessments; Availability, etc.: Texas A and M University, 6660-6662 2017-01233 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Senior Executive Service Performance Review Board Membership, 6657 2017-01124 Ocean Energy Management Ocean Energy Management Bureau NOTICES Environmental Assessments; Availability, etc.: 2017-2022 Outer Continental Shelf Oil and Gas Leasing Program; Record of Decision, 6643-6644 2017-00886 Patent Patent and Trademark Office RULES Changes in Requirements for Affidavits or Declarations of Use, Continued Use, or Excusable Nonuse in Trademark Cases, 6259-6265 2017-00317 Pension Benefit Pension Benefit Guaranty Corporation RULES Benefits Payable in Terminated Single-Employer Plans: Interest Assumptions for Paying Benefits, 6243-6244 2017-00461 Personnel Personnel Management Office RULES Prevailing Rate Systems: Definition of Kent County, MI, and Cameron County, TX, to Nonappropriated Fund Federal Wage System Wage Areas, 6197 2017-00574 PROPOSED RULES Performance Appraisal System Certification, 6339-6353 2017-01326 Pipeline Pipeline and Hazardous Materials Safety Administration PROPOSED RULES Hazardous Materials: FAST Act Requirements for Real-Time Train Consist Information by Rail, 6451-6456 2017-01240 Postal Regulatory Postal Regulatory Commission NOTICES Income Tax Review, 6662 2017-01196 Postal Service Postal Service RULES Inspection Service Authority; Civil Monetary Penalty Inflation Adjustment, 6276-6277 2017-00204 Presidential Documents Presidential Documents PROCLAMATIONS Reconstruction Era National Monument; Establishment (Proc. 9567), 6167-6177 2017-01363 Special Observances: Martin Luther King, Jr., Federal Holiday (Proc. 9568), 7613-7616 2017-01484 Religious Freedom Day (Proc. 9569), 7617-7618 2017-01485 EXECUTIVE ORDERS Government Agencies and Employees: Department of Justice; Providing an Order of Succession (EO 13762), 7619-7620 2017-01487 Environmental Protection Agency; Providing an Order of Succession (EO 13763), 7621-7622 2017-01489 ADMINISTRATIVE ORDERS Cuba; Continuation of National Emergency and Emergency Authority Relating to the Regulation of the Anchorage and Movement of Vessels (Notice of January 13, 2017), 6185 2017-01366 Government Agencies and Employees: Environmental Quality, Council on; Providing an Order of Succession (Memorandum of January 13, 2017), 7627-7628 2017-01500 Federal Mediation and Conciliation Service; Providing an Order of Succession (Memorandum of January 13, 2017), 7629-7630 2017-01503 Science and Technology Policy, Office of; Designation of Officers or Employees To Act as Director (Memorandum of January 13, 2017), 7625-7626 2017-01493 Iran; Continuation of National Emergency (Notice of January 13, 2017), 6187-6188 2017-01367 Libya; Continuation of National Emergency (Notice of January 13, 2017), 6189 2017-01368 National Parks, National Forests, and Other Public Lands and Waters; Promoting Diversity and Inclusion (Memorandum of January 12, 2017), 6179-6184 2017-01383 Ukraine; Continuation of National Emergency (Notice of January 13, 2017), 6191-6192 2017-01369 Venezuela; Continuation of National Emergency (Notice of January 13, 2017), 6193 2017-01370 Young People, Opportunity for All; Expansion Efforts (Memorandum of January 13, 2017), 7623-7624 2017-01492 Zimbabwe; Continuation of National Emergency (Notice of January 13, 2017), 6195-6196 2017-01371 Refugee Refugee Resettlement Office NOTICES Statements of Organization, Functions, and Delegations of Authority, 6588-6590 2017-00301 Securities Securities and Exchange Commission NOTICES Filings and Orders: Proposed Amended Plan for Allocation of Regulatory Responsibilities Among Financial Industry Regulatory Authority, Inc.; Miami International Securities Exchange, LLC; and MIAX PEARL, LLC, 6674-6678 2017-01151 Self-Regulatory Organizations; Proposed Rule Changes: Bats BZX Exchange, Inc., 6678-6684 2017-01149 Chicago Board Options Exchange, Inc., 6673 2017-01154 Chicago Stock Exchange, Inc., 6669-6673 2017-01152 MIAX PEARL, LLC, 6662-6664 2017-01150 NASDAQ PHLX, LLC, 6667-6669 2017-01153 NASDAQ Stock Market, LLC, 6664-6667 2017-01141 Social Social Security Administration RULES Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Evacuee Manifest and Promissory Note, 6685-6686 2017-01079 Passport Demand Forecasting Survey, 6684-6685 2017-01087 Blocking or Unblocking of Persons and Properties, 6686-6687 2017-01223 Substance Substance Abuse and Mental Health Services Administration NOTICES Requests for Information: Protecting Our Infants Act Report to Congress, 6590-6591 2017-01180 Surface Transportation Surface Transportation Board NOTICES Acquisitions and Operation Exemptions: SMS Rail Lines of New York, LLC; Rail Line of WCC, LLC, in Hudson Falls, NY, 6687 2017-01195 Discontinuance of Service Exemptions: Chesapeake Western Railway in Rockingham and Shenandoah Counties, VA, 6687 2017-01165 Susquehanna Susquehanna River Basin Commission NOTICES Projects Approved for Consumptive Uses of Water, 6687-6688 2017-01184 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

See

Federal Transit Administration

See

Maritime Administration

See

Pipeline and Hazardous Materials Safety Administration

RULES Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058 PROPOSED RULES Transparency of Airline Ancillary Service Fees, 7536-7560 2017-00904
Treasury Treasury Department See

Fiscal Service

See

Internal Revenue Service

U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Waiver of Grounds of Inadmissibility, 6609 2017-01080 Petition by Entrepreneur To Remove Conditions on Permanent Resident Status, 6610 2017-01221 Veteran Affairs Veterans Affairs Department RULES Federal Policy for Protection of Human Subjects, 7149-7274 2017-01058 Fertility Counseling and Treatment for Certain Veterans and Spouses, 6273-6276 2017-00280 Recognition of Tribal Organizations for Representation of VA Claimants, 6265-6272 2017-00947 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Authorization To Disclose Personal Information to Third Party, 6729-6730 2017-01147 Employment Information in Connection with Claim for Disability Benefits, 6729 2017-01145 Presidential Memorial Certificate Form, 6728 2017-01144 Record Keeping at Flight Schools, 6728-6729 2017-01146 Separate Parts In This Issue Part II Agriculture Department, Food Safety and Inspection Service, 6732-6823 2016-29272 Part III Energy Department, 6826-6887 2017-00474 Part IV Health and Human Services Department, 6890-6978 2017-00615 Part V Agriculture Department, Animal and Plant Health Inspection Service, 6980-7005 2017-00532 Part VI Agriculture Department, Animal and Plant Health Inspection Service, 7008-7039 2017-00858 Part VII Agriculture Department, Agricultural Marketing Service, 7042-7092 2017-00888 Part VIII Housing and Urban Development Department, 7094-7146 2017-01044 Part IX Agency for International Development, 7149-7274 2017-01058 Agriculture Department, 7149-7274 2017-01058 Commerce Department, 7149-7274 2017-01058 Defense Department, 7149-7274 2017-01058 Education Department, 7149-7274 2017-01058 Energy Department, 7149-7274 2017-01058 Environmental Protection Agency, 7149-7274 2017-01058 Health and Human Services Department, 7149-7274 2017-01058 Homeland Security Department, 7149-7274 2017-01058 Housing and Urban Development Department, 7149-7274 2017-01058 Labor Department, 7149-7274 2017-01058 National Aeronautics and Space Administration, 7149-7274 2017-01058 National Science Foundation, 7149-7274 2017-01058 Social Security Administration, 7149-7274 2017-01058 Transportation Department, 7149-7274 2017-01058 Veterans Affairs Department, 7149-7274 2017-01058 Part X Energy Department, 7276-7333 2016-32012 2016-32013 Part XI Labor Department, Employee Benefits Security Administration, 7336-7374 2017-01316 Part XII Education Department, 7376-7397 2017-00910 Part XIII Environmental Protection Agency, 7400-7430 2017-00573 Part XIV Environmental Protection Agency, 7432-7461 2017-01229 Part XV Environmental Protection Agency, 7464-7533 2017-01222 Part XVI Transportation Department, 7536-7560 2017-00904 Part XVII Environmental Protection Agency, 7562-7580 2017-01224 Part XVIII Treasury Department, Internal Revenue Service, 7582-7611 2017-01049 Part XIX Presidential Documents, 7613-7618, 7619-7630 2017-01484 2017-01485 2017-01487 2017-01489 2017-01500 2017-01503 2017-01493 2017-01492 Reader Aids

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

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82 12 Thursday, January 19, 2017 Rules and Regulations OFFICE OF PERSONNEL MANAGEMENT 5 CFR Part 532 RIN 3206-AN40 Prevailing Rate Systems; Definition of Kent County, Michigan, and Cameron County, Texas, to Nonappropriated Fund Federal Wage System Wage Areas AGENCY:

U.S. Office of Personnel Management.

ACTION:

Final rule.

SUMMARY:

This rule amends the geographic boundaries of two nonappropriated fund (NAF) Federal Wage System (FWS) wage areas. Based on recommendations of the Federal Prevailing Rate Advisory Committee (FPRAC), the U.S. Office of Personnel Management (OPM) is defining Kent County, Michigan, as an area of application county to the Macomb, MI, NAF FWS wage area and Cameron County, Texas, as an area of application county to the Nueces, TX, NAF FWS wage area. These changes are necessary due to NAF FWS employees working in Kent and Cameron Counties, and the counties are not currently defined to NAF wage areas.

DATES:

Effective date: This regulation is effective on January 19, 2017.

Applicability date: This change applies on the first day of the first applicable pay period beginning on or after February 21, 2017.

FOR FURTHER INFORMATION CONTACT:

Madeline Gonzalez, by telephone at (202) 606-2858 or by email at [email protected]

SUPPLEMENTARY INFORMATION:

On August 24, 2016, OPM issued a proposed rule (81 FR 57809) to define Kent County, Michigan, as an area of application county to the Macomb, MI, NAF FWS wage area and Cameron County, Texas, as an area of application county to the Nueces, TX, NAF FWS wage area.

FPRAC, the national labor-management committee responsible for advising OPM on matters concerning the pay of FWS employees, reviewed and recommended this change by consensus.

The proposed rule had a 30-day comment period, during which OPM received no comments.

Regulatory Flexibility Act

I certify that these regulations will not have a significant economic impact on a substantial number of small entities because they will affect only Federal agencies and employees.

List of Subjects in 5 CFR Part 532

Administrative practice and procedure, Freedom of information, Government employees, Reporting and recordkeeping requirements, Wages.

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

Accordingly, OPM is amending 5 CFR part 532 as follows:

PART 532—PREVAILING RATE SYSTEMS 1. The authority citation for part 532 continues to read as follows: Authority:

5 U.S.C. 5343, 5346; § 532.707 also issued under 5 U.S.C. 552.

2. The table in appendix D to subpart B is amended by revising the wage area listing for the Macomb, MI, and Nueces, TX, wage areas to read as follows: Appendix D to Subpart B of Part 532—Nonappropriated Fund Wage and Survey Areas Definitions of Wage Areas and Wage Area Survey Areas *    *    *    *    * MICHIGAN Macomb Survey Area Michigan: Macomb Area of Application. Survey area plus: Michigan: Alpena Calhoun Crawford Grand Traverse Huron Iosco Kent Leelanau Ottawa Saginaw Washtenaw Wayne Ohio: Ottawa *    *    *    *    * TEXAS *    *    *    *    * Nueces Survey Area Texas: Nueces Area of Application. Survey area plus: Texas: Bee Calhoun Cameron Kleberg San Patricio Webb *    *    *    *    *
[FR Doc. 2017-00574 Filed 1-18-17; 8:45 a.m.] BILLING CODE 6325-39-P
DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 331 9 CFR Part 121 [Docket No. APHIS-2014-0095] RIN 0579-AE08 Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin Regulations AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Final rule.

SUMMARY:

In accordance with the Agricultural Bioterrorism Protection Act of 2002, we are amending and republishing the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Act requires the biennial review and republication of the list of select agents and toxins and the revision of the list as necessary. This action will amend the regulations in several ways, including the addition of provisions to address the inactivation of select agents, provisions addressing biocontainment and biosafety, and clarification of regulatory language concerning security, training, incident response, and records. These changes will increase the usability of the select agent regulations as well as providing for enhanced program oversight. After carefully considering the technical input of subject matter experts and recommendations from Federal advisory groups, we have decided not to finalize the proposed changes to the contents of the list of select agents and toxins at this time. In a companion document published in this issue of the Federal Register, the Centers for Disease Control and Prevention has made parallel regulatory changes.

DATES:

Effective February 21, 2017.

FOR FURTHER INFORMATION CONTACT:

Dr. Freeda Isaac, National Director, Agriculture Select Agent Services, APHIS, 4700 River Road, Unit 2, Riverdale, MD 20737-1231; (301) 851-3300, Option 3.

SUPPLEMENTARY INFORMATION:

Background

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (referred to below as the Bioterrorism Response Act) provides for the regulation of certain biological agents that have the potential to pose a severe threat to both human and animal health, to animal health, to plant health, or to animal plant health, or to animal and plant products. The Animal and Plant Health Inspection Service (APHIS) has the primary responsibility for implementing the provisions of the Act within the United States Department of Agriculture (USDA). Veterinary Services (VS) select agents and toxins are those that have been determined to have the potential to pose a severe threat to animal health or animal products. Plant Protection and Quarantine (PPQ) select agents and toxins are those that have the potential to pose a severe threat to plant health or plant products. Overlap select agents and toxins are those that have been determined to pose a severe threat to both human and animal health or to human health and animal products. Overlap select agents are subject to regulation by both APHIS and the Centers for Disease Control and Prevention (CDC), which has the primary responsibility for implementing the provisions of the Bioterrorism Response Act for the Department of Health and Human Services (HHS).

Subtitle B (which is cited as the “Agricultural Bioterrorism Protection Act of 2002” and referred to below as the Act), section 212(a), provides, in part, that the Secretary of Agriculture (the Secretary) must establish by regulation a list of each biological agent and each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products. Paragraph (a)(2) of section 212 requires the Secretary to review and republish the list every 2 years and to revise the list as necessary. In this document, we are amending and republishing the list of select agents and toxins based on the findings of our fourth biennial review of the list.

In determining whether to include an agent or toxin on the list, the Act requires that the following criteria be considered:

• The effect of exposure to the agent or the toxin on animal and plant health, and on the production and marketability of animal or plant products;

• The pathogenicity of the agent or the toxin and the methods by which the agent or toxin is transferred to animals or plants;

• The availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin; and

• Any other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products.

We use the term “select agents and toxins” throughout the preamble of this rule. Unless otherwise specified, the term “select agents and toxins” will refer to all agents or toxins listed by APHIS. When it is necessary to specify the type of select agent or toxin, we will use the following terms: “PPQ select agents and toxins” (for the plant agents and toxins listed in 7 CFR 331.3), “VS select agents and toxins” (for the animal agents and toxins listed in 9 CFR 121.3), or “overlap select agents and toxins” (for the overlap agents and toxins listed in both 9 CFR 121.4 and 42 CFR 73.4).

On January 19, 2016, we published in the Federal Register (81 FR 2762-2774, Docket No. APHIS-2014-0095) a proposal 1 to amend and republish the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products, and amend the regulations in order to add definitions and clarify language concerning security, training, biosafety, biocontainment, and incident response.

1 To view the proposed rule and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0095.

We solicited comments concerning our proposal for 60 days ending March 21, 2016. We received 24 comments by that date. They were from researchers, scientific organizations, industry groups, laboratories, and universities. Eighteen were supportive of the proposed action. The remaining six comments are discussed below by topic.

Removal of Select Agents and Toxins

We proposed to amend the list of PPQ select agents and toxins listed in 7 CFR 331.3 by removing three PPQ select agents and toxins from the list: Peronosclerospora philippinensis (Peronosclerospora sacchari), Sclerophthora rayssiae, and Phoma glycinicola (formerly Pyrenochaeta glycines).

We also proposed to remove three overlap select agents and toxins from the list set out in 9 CFR 121.4(b): Bacillus anthracis (Pasteur strain), Brucella abortus and Brucella suis.

After carefully considering the technical input of subject matter experts and recommendations from Federal advisory groups, we have decided not to finalize the proposed changes to the list of select agents and toxins at this time.

Definitions

In 7 CFR 331.1 and 9 CFR 121.1, we proposed to add definitions for inactivation and kill curve to clarify terms contained within the proposed inactivation provisions. As detailed later in this final rule, we have removed the requirement for generation of a kill curve. We are therefore not including the definition in the regulations.

One commenter suggested that we specify that a “validated method” was used for inactivation. The commenter said that the addition of the word “validated” would ensure that tested and appropriate methods of inactivation would be utilized.

We are eliminating the definition for inactivation and instead adding a definition of validated inactivation procedure to the regulations. This definition encompasses the prior definition of inactivation as well as providing further detail which we believe will be useful for regulated entities. Validated inactivation procedure is defined as a procedure, whose efficacy is confirmed by data generated from a viability testing protocol, to render a select agent non-viable but allows the select agent to retain characteristics of interest for future use; or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use. While the commenter suggested we use the term “method,” we have decided to use the term “procedure” in response to comments received on the CDC docket.

The same commenter suggested that we add definitions of validated sterility test and safety margin as these terms were both proposed for use in the biocontainment and biosafety sections and could prove confusing or be subject to misinterpretation.

Given that we are adding a definition of validated inactivation procedure as described previously, we are not adding a definition of validated sterility test. We are not adding a definition of safety margin since that term will not be in the regulations.

While we did not receive any further comments regarding definitions, in response to comments received by CDC and in the interests of maintaining parity between the APHIS and CDC regulations, we are adding a definition for viability testing protocol. That term, which is now used in §§ 331.3, 121.3, and 121.4, is defined as, “a protocol to confirm the validated inactivation procedure by demonstrating the inability of a select agent to replicate.”

Exclusions and Inactivation

We proposed to amend 7 CFR 331.3(d)(2), 9 CFR 121.3(d)(2), and 9 CFR 121.4(d)(2), which exclude nonviable select agents or nonfunctional toxins from the requirements of the regulations, in order to clarify our policy that an entity must use a validated procedure to render a select agent nonviable or regulated nucleic acids non-infectious for future use. This means that the method must be scientifically sound and that it will produce consistent results each time it is used.

One commenter stated that we need to consistently address toxins throughout the regulations and suggested adding language specifying that required methods would also render a select toxin as nonfunctional.

We did not include language concerning toxins because, unlike select agents, toxins do not replicate. An inactivation failure with a toxin therefore represents a lower level of risk and thus does not justify the potential additional recordkeeping and reporting burden for registered entities at this time. We may revisit this issue in the future.

We proposed that inactivation include the use of one of the following: The exact conditions of a commonly accepted method that has been validated as applied (e.g., autoclaving), a published method with adherence to the exact published conditions (i.e., extrapolations or deductions are to be avoided), or in-house methods, only if validation testing includes the specific conditions used and appropriate controls.

The same commenter also suggested that we require that the inactivation process be repeatable.

We agree with the commenter that the inactivation process has to be validated so that the results are repeatable. The definition of validated inactivation procedure states that the procedure must be supported by data generated from viability testing. A process that is not repeatable would never be validated.

We also proposed that the entity develop a site-specific kill curve in order to define the conditions of inactivation for each select agent or regulated nucleic acid. If there are strain-to-strain variations in the resistance of a select agent to the inactivation procedure, then a specific kill curve would have to be developed for each strain that undergoes the inactivation procedure. A new kill curve would have to be created upon any change in procedure or inactivation equipment. In addition, a validated sterility testing protocol would have to be conducted in order to ensure that the inactivation method has rendered a select agent nonviable or regulated nucleic acids non-infectious.

Several commenters raised objections regarding development and use of the kill curve. We have considered these comments and determined that the kill curve and safety margin requirements are not applicable to all inactivation procedures and should therefore not be included in the regulations. We are instead requiring that registered entities develop a validated inactivation procedure by establishing parameters for quantities of starting material and measures of uncertainty for repeated successful inactivation. This is a broad performance standard that will allow for flexibility given the variety of select agents and toxins under regulation.2 In addition, for the sake of clarity and efficiency, we have removed the requirements specific to extracts of select agents, instead including them within the overall performance standard for select agents and toxins as a whole.

2 Additional guidance regarding this performance standard has been developed and is available on the Internet at www.selectagents.gov.

One commenter said that, without more specific direction, the subjectivity of individual inspectors would be the principal factor in determining acceptable inactivation verification.

We will not review or approve inactivation protocols. We believe this activity should be approved at the entity, which will allow for researchers to continue to develop new inactivation procedures. However, inspectors will verify that the entity has developed a validated inactivation procedure and will review viability testing results during the entity's inspection.

Another commenter asked that we provide minimum requirements for the sterility testing protocol and specify whether or not this must be site-specific or if validated methods of sterility testing given in published journal articles may be followed.

We recognize that the limits of detection of the viability testing procedures and expected variation from run to run, even when following an inactivation procedure precisely precludes demonstrating full sterility of an inactivated sample. These sources of error must be considered when the entity establishes performance parameters for inactivation procedures. While complete sterility is not a feasible goal for material that is intended for further use, we expect that the risk of live agent in materials that are removed from containment and are thus no longer subject to select agent requirements will be as low as realistically possible from both a safety and security perspective. We will be addressing the need for onsite validation of both inactivation protocols and viability testing in guidance.

The same commenter cited the guidance document entitled “Non-viable Select Agents and Nonfunctional Select Toxins and Rendering Samples Free of Select Agents and Toxins,” 3 which states that, “this guidance does not apply to inactivation for waste disposal.” The commenter urged us to clearly and accurately describe what is intended regarding verification of non-viability in the regulations, stating that they had received comments from some inspectors indicating confusion between inactivation validation requirements for moving materials to a lower containment level and inactivation validation requirements for waste disposal.

3 You may view this guidance document on the Internet at http://www.selectagents.gov/guidance-nonviable.html.

We have modified the reporting requirements to require the responsible official to investigate any viability of material that was subjected to a validated inactivation protocol to determine the reason of the inactivation failure. If the responsible official is unable to determine the reason for this failure, he or she must report the inactivation failure to CDC or APHIS. Our intention is to require registered entities to create an environment where inactivation failures are investigated to determine the root source of the errors instead of re-subjecting the material to an inactivation method that may be flawed or faulty. The revised language only requires reporting of inactivation failures to CDC or APHIS when the responsible official cannot determine the reason for the inactivation failure. We are also clarifying that these provisions apply only to those select agents inactivated for future use as non-select agents and not those intended for waste disposal.

Two commenters asked about the minimum percentage of samples required to be tested to constitute a “representative sample.” Another commenter suggested that inactivated lots be stored with documentation that demonstrates that the lot has met the established standard, but added that it is impractical to conduct validated sterility testing on every sample that is inactivated. The commenter claimed that implementing such a requirement would waste specimens where limited volumes are available, be costly in terms of technical time and resources, and is scientifically unjustified.

Successful implementation of the required validated inactivation procedure and the subsequent data derived from viability testing using that procedure will determine the extent of sampling required. We have removed the sterility testing requirement to allow entities flexibility in establishing and utilizing individualized, validated inactivation procedures.

We also proposed to require that an entity conduct an annual review of their site-specific standard operating procedures to ensure that select agents or regulated nucleic acids that can produce infectious forms of any select agent virus are inactivated by a safety margin and revise as necessary.

Two commenters questioned our use of the term “safety margin.” The commenters requested that we remove or define the term, as its meaning is unclear. The commenters further stated that the need for including a safety margin is unclear and appears superfluous if the intent of the requirement is to define the conditions that achieve conditions that render 100 percent of the select agent non-viable or noninfectious.

We are not defining “safety margin” as the proposed regulatory text using this term will not be incorporated into the final rule.

Finally, we proposed that written records be kept for any select agent that has been rendered nonviable or regulated nucleic acids that have been rendered non-infectious.

Two commenters asked for clarification of the actions constituting review, including description of any documentation that will be expected to demonstrate compliance with the requirement. The commenters wanted to know if it was our expectation that the kill curve and sterility testing be repeated and verified annually, or if this is a review of data and written procedures.

In response, we have modified the language regarding review of site-specific standard operating inactivation procedures to clarify that the entity should review these procedures to determine if they are being adhered to by staff. The annual review requirement does not necessarily involve revalidating inactivation procedures. This review may simply take the form of an evaluation of the site-specific standard operating inactivation procedures to ensure the inactivation conditions used and upper agent limits found in validation data are consistent and that the entity staff are following the site-specific standard operating inactivation procedures. At times an entity may need to revalidate inactivation procedures during the annual review. For example, review may be needed if the entity finds that staff are not adhering to standard operating procedures or if the entity wants to deviate from the established, validated inactivation procedure.

While we did not receive any further comments on this issue, in response to comments received by CDC and in the interests of maintaining parity between the APHIS and CDC regulations, we have made the following changes:

• Establishing that surrogate strains that are known to possess properties equivalent to select agents may be used to validate the required inactivation procedures under certain conditions;

• Replacing the term “extract” with “material containing a select agent” to clarify that the inactivation requirements apply to such materials as serums or liquid cultures from which select agents are typically removed via filtration without first undergoing inactivation. This is intended to more accurately describe an element of a two-step process: An inactivation step to destroy the select agent and a second step intended to remove any remaining, viable select agent; and

• Clarification of when an entity may submit a waiver request to the Administrator as well as the procedure for such determinations.

Finally, in 7 CFR 331.3(d)(2), 9 CFR 121.3(d)(2), and 9 CFR 121.4(d)(2), we are replacing the term “nonfunctional toxin” with “nontoxic toxin.” We have determined that the term “nonfunctional” is overbroad and has caused confusion. Our intent was to exclude toxins that can no longer exert their toxic effect and cause disease. For example, Botulinum neurotoxin has three functional domains: Binding domain, translocation domain, and catalytic domain. Each functional domain may be solely manipulated such that the toxin is no longer toxic and does not cause disease even though the other two domains may remain functional. Note that the example provided is for a CDC toxin due to the fact that APHIS does not currently regulate any select toxins.

Exemptions for Select Agents and Toxins

The provisions of 7 CFR 331.5, 9 CFR 121.5, and 9 CFR 121.6 concern conditions under which entities may be exempted from the requirements of the regulations. We proposed to add language to paragraph (a) in 7 CFR 331.5, 9 CFR 121.5, and 9 CFR 121.6 that specifies that entities may be required to report identification of agents or toxins to other appropriate authorities when required by Federal, State, or local law. Specifically, we proposed to add provisions that state that we do not regulate material containing select agents or toxins when it is in a patient care setting and is not being collected or otherwise tested or retained, nor do we regulate waste generated during delivery of patient care. However, once delivery of patient care for the select agent or toxin infection has concluded, waste would become subject to the requirements of the regulations. If an entity cannot meet these requirements, then the material may be transferred to another entity according to the select agent regulations or destroyed using an approved method. The decision to retain, transfer, or destroy any specimens must be made within 7 calendar days of the conclusion of patient care.

One commenter disagreed with adding such a provision to 9 CFR 121.5. The commenter said that VS should have authority to regulate waste and carcasses from animals (i.e., veterinary patients) naturally infected with select agents to ensure that infection does not spread to other livestock or poultry. The commenter asked that we alter the wording of the proposed section in order to specify that the requirement refers to human patients only.

The provisions the commenter refers to relate to the care of human patients only. However, it should be noted that any waste or carcasses from animals infected with a select agent, provided the select agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source, are already listed as excluded in §§ 121.3(d)(1) and 121.4(d)(1) of the regulations.

While we did not receive any further comments on this issue, in response to comments received by CDC and in the interests of maintaining parity between the APHIS and CDC regulations, we are amending the text to clarify the following:

• That patient care refers to actions by health care professionals;

• To clarify that destruction and transfer requirements apply solely to waste generated in the course of patient care and not specimens or samples taken from the patient; and

• That specimens taken from a patient are not subject to the regulations during the period in which they are directly associated with the diagnosis, but all specimens taken and kept more than 7 days after the conclusion of patient care are subject to the regulations.

Security, Biocontainment/Biosafety, and Incident Response Plans

The regulations require registered entities to develop and implement a number of plans in order to ensure the safety and security of the select agents they handle. These are:

• A security plan, as described by the regulations in 7 CFR 331.11 and 9 CFR 121.11, that provides for measures sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release;

• A biocontainment plan, in the case of PPQ select agents, or a biosafety plan, in the case of VS and overlap select agents, as described in the regulations in 7 CFR 331.12 and 9 CFR 121.12, that provides for measures sufficient to contain the select agent or toxin (e.g., physical structure and features of the entity, and operational and procedural safeguards); and

• An incident response plan, as described in the regulations in 7 CFR 331.14 and 9 CFR 121.14, that provides for measures that the registered entity will implement in the event of theft, loss, or release of a select agent or toxin; inventory discrepancies; security breaches (including information systems); severe weather and other natural disasters; workplace violence; bomb threats and suspicious packages; and emergencies such as fire, gas leak, explosion, power outage, etc. The response procedures must account for hazards associated with the select agent or toxin and appropriate actions to contain such agent or toxin.

All of these plans require annual review and revision as necessary. Drills or exercises must also be conducted at least annually to test and evaluate the effectiveness of the plans. The plans must be reviewed and revised, as necessary, after any drill or exercise and after any incident. We proposed to require that these drills or exercises be documented to include how the drill or exercise tested and evaluated the plan, any problems identified, any corrective action taken, and the names of the individuals who participated in the drill or exercise. This will provide a more thorough accounting of required activities as well as increasing the efficacy of the plans via testing and entity-directed improvements. We proposed to add these requirements to 7 CFR 331.11(h), 331.12(e), 331.14(f), 9 CFR 121.11(h), 121.12(e), and 121.14(f).

One commenter stated that the requirement to record the names of the individuals who participated in a given drill or exercise should be limited to registered entity personnel and not include first responders or others who participate. The commenter suggested that a list of the participating external agencies (e.g., emergency management, emergency medical services, fire department, etc.) could be included.

We agree with the commenter's suggestion and have updated the regulations in order to clarify that only the names of individuals at the registered entity are required to be listed. The entity may choose to list the names of external agencies (e.g., fire department, police department, etc.) that participated in the drill or exercise.

Comments on more specific proposed changes to these plans may be found below.

Biocontainment/Biosafety Plan

Paragraph (a) of 7 CFR 331.12 and 9 CFR 121.12 requires that the biocontainment or biosafety plan contain sufficient information and documentation to describe the biosafety and containment procedures for each select agent or toxin that the registered entity will possess. The plan must also include a description of the biosafety and containment procedures for any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent. We proposed to additionally require that laboratory-specific biocontainment and/or biosafety manuals must be accessible to individuals working in those laboratories. This change will help to foster an enhanced culture of responsibility by ensuring that appropriate biocontainment and/or biosafety resources are available to all staff with access to select agents and toxins within a select agent laboratory.

One commenter suggested that the specific practice of making manuals accessible is already employed by registered entities. The commenter therefore questioned the need for a separate requirement.

We agree with the commenter and have removed the requirement.

Two commenters urged that, “a description of the biosafety and containment procedures for any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent” should clearly refer not only to animals within the laboratory but also wildlife, domestic, and stray animals outside of the buildings if they are potentially exposed via accidental release. The commenter added that there should be a system in place to detect such incidents if they occur.

The term “any animals” includes both laboratory animals as well as the wild, domestic, and stray animals described by the commenters. We will, however, add specific clarification to the guidance documents associated with the biocontainment and biosafety plans.

One commenter requested clarification regarding the term “laboratory.” The commenter wanted to know whether the term refers to a single room, a building, or to a group of rooms (e.g., laboratory, animal room, and necropsy) used by a principal investigator for a research project. The commenter also requested clarification regarding the phrase, “must be available to each individual working in the laboratory,” asking if this would require creation of a specific biocontainment or biosafety manual for each room.

We have clarified the language to state that “biosafety and containment procedures specific to use of the select agent or toxin by the principal investigator must be available to each individual involved with that project.” This more appropriately ties the creation and distribution of biocontainment and biosafety manuals to specific projects, select agents, and people.

We also proposed to add specific provisions to the biocontainment and biosafety plans that would require completion of a written risk assessment for each procedure.

Two commenters stated that these requirements are unnecessary and would prove excessively burdensome to researchers and the responsible official and should be removed. The commenters said that the new requirements regarding validation of inactivation procedures would serve the same security function. The commenters added that APHIS already has opportunity to review and require amendment of an entity's biocontainment or biosafety plan as a condition of registration or as a result of inspection.

We agree with the commenter that this level of detail would prove unnecessarily burdensome. We have instead added language to 7 CFR 331.12(a)(1) and 9 CFR 331.12(a)(1) to explicitly require that the biocontainment and biosafety plans include a description of the hazardous characteristics of each agent or toxin listed on the entity's registration and the biosecurity or biosafety risk associated with laboratory procedures related to the select agent or toxin.

One commenter asked that we define “risk assessment,” given that it is a very broad term and therefore open to interpretation. This commenter and another requested that we provide basic templates for these new required sections and indicate where registered entities and entities seeking registration may find these templates.

We have revised and condensed the proposed language as a result of this and other comments. It no longer includes the term “risk assessment.”

Training

We proposed to amend the regulations in 7 CFR 331.15 and 9 CFR 121.15, which concern provision of mandatory training for staff and visitors who work in or visit areas where select agents or toxins are handled or stored. We proposed to require that all individuals who have received approval to have access to select agents and toxins must undergo training regardless of whether they have access to those select agents or toxins. The training would have to be completed within a year of that individual's approval or prior to entry into an area where select agents and toxins are used or stored, whichever occurs first.

Two commenters objected to the proposed addition, stating that we should include a description of the level of training necessary for personnel in varying positions with highly disparate job duties and responsibilities. The commenters requested that we clarify that required training will be conducted at a level appropriate to the registered person's role and level of access to select agents.

We agree with the commenters' point and have altered the required training language to clearly delineate the types of training required for individuals with varying access levels.

One commenter asked that we clearly specify the requirements for both initial and annual training. The commenter also asked that we consider making training a prerequisite for access to select agents and toxins.

While we made no changes to our regulatory language based on this comment, the document entitled, “Guidance for Meeting the Training Requirements of the Select Agent Regulations” 4 will be updated to provide further detail and assistance regarding the content of initial and annual training. The regulations in 7 CFR 331.15(a)(1) and 9 CFR 121.15(a)(1) already require that each approved individual receive information and training on biosecurity/biosafety, security (including security awareness), and incident response before that individual has access to any select agents and toxins.

4 You may view this document on the Internet at http://www.selectagents.gov/guidance-training.html.

Records

The regulations in 7 CFR 331.17 and 9 CFR 121.17 concern required recordkeeping procedures for regulated entities as those records relate to select agents and toxins. Paragraph (a)(3)(x) requires that registered entities record the destruction of any toxins by specifically noting the quantity of toxin destroyed, the date of such action, and by whom. However, there is not an equivalent requirement regarding the destruction of select agents. We proposed to add this requirement in order to ensure consistency with the toxin provisions and ensure proper tracking of select agents from acquisition to destruction.

While we did not receive any comments on this issue, in response to comments received by CDC and in the interests of maintaining parity between the APHIS and CDC regulations, we are amending the text to stipulate that registered entities must maintain a record of the select agent used, purpose of use, and, when applicable, final disposition (including destruction) for each select agent held in long-term storage.

We also proposed to state that any records created that contain information related to an entity's registration or its select agents and toxins must be provided promptly upon request. We proposed to specify that such records may include, but are not limited to, biocontainment certifications, laboratory notebooks, institutional biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs.

One commenter expressed concern regarding the requirement to keep laboratory notebooks for inspection purposes. The commenter stated that items may include proprietary intellectual property and requested clarification regarding the information needed from the notebooks. The commenter asked that we amend the regulatory language in order to protect intellectual property interests and specify if any information would be required from laboratory notebooks apart from that collected for inventory purposes.

We agree with the commenter and we have clarified that only information related to the requirements of the regulations must be produced upon request. Such information may be found in biocontainment certifications, laboratory notebooks, institutional biosecurity/biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs. Accordingly, we will only be reviewing relevant portions of any laboratory notebooks or documents and only if they contain information related to any requirements of the regulations.

To ensure the accuracy of handwritten records, we also proposed to specify that such records must be legible.

Another commenter suggested that we require that records be written in ink and not pencil and should be signed and dated when appropriate.

We acknowledge this suggestion as good practice. However, in the interests of not being overly prescriptive, we are leaving the interpretation of “legible” up to individual registered entities.

Records for Select Agents in Long-Term Storage

Paragraph (a)(1) in both 7 CFR 331.17 and 9 CFR 121.17 requires entities to maintain an accurate, current inventory for each select agent (including viral genetic elements, recombinant and/or synthetic nucleic acids, and organisms containing recombinant and/or synthetic nucleic acids) held in long-term storage. We continue to receive comments critical of that portion of the regulations. Criticism is typically focused on the belief that a container-based inventory requirement is not a useful mechanism to track inventory of biological agents, since small amounts could be stolen without detection and used to grow larger quantities.

However, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 obliges APHIS and CDC to include a requirement for “the prompt notification of the Secretary, and appropriate Federal, State, and local law enforcement agencies, of the theft or loss of listed agents and toxins” in the regulations. We therefore solicited comment regarding what regulatory requirement or requirements should be implemented such that a registered entity could quickly determine whether a select agent had been lost or stolen from long-term storage without that registered entity first having an accurate, current inventory for each select agent held in long-term storage. Additionally, we solicited ideas concerning ways in which the current regulations could be amended to address the possibility of theft of a select agent from a container held in long-term storage.

One commenter stated that, while they understand the need for such inventory and notification requirements, an enormous amount of time and effort is spent during inspections validating that inventories are accurate. The commenter said that this has resulted in the loss of valuable virus isolates due to unintentional thawing, failure of ultralow temperature freezers due to repeated opening and the resulting loss of ultralow temperature, and inefficient use of employee time. The commenter said that measuring the volumes of stored vials of bacteria and viruses in the manner that toxins or other non-replicative select agents are inventoried is illogical. The commenter acknowledged that it is important to indicate the nature of the pathogens stored and the numbers of vials in freezer stocks, but even the most fastidious recordkeeping could not demonstrate that vials of replicative organisms had not been accessed. The commenter stated that current select agent practices allow for these stocks to be maintained in tamper-evident stocks (e.g., security ties on freezer boxes) so that vials are not individually removed, thawed, and measured. The commenter concluded that requiring the use of tools of this nature in the case of replicative organisms is a logical step that would not eliminate the need to inventory, but which also would not degrade samples and allow for detection of samples that may have disappeared.

We appreciate this comment and will continue to consider how the recognition of theft and loss might be addressed through alternative approaches.

Miscellaneous Changes

We are also adding a definition of principal investigator to the regulations in 7 CFR 331.1 and 9 CFR 121.1 as it is used but not defined in the APHIS regulations. The addition also serves to maintain parity with the CDC regulations. Our definition is identical to that used by CDC.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule with the changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

This final rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.

In accordance with 5 U.S.C. 604, we have performed a final regulatory flexibility analysis, which is summarized below, regarding the economic effects of this rule on small entities. Copies of the full analysis are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

Sections 201 and 212(a)(2) of the Act require a biennial review and republication of the select agent and toxin list, with revisions as appropriate in accordance with this law. This final rule will implement the recommendations of the fourth biennial review of select agent regulations and has finalized changes that will increase their usability as well as provide for enhanced program oversight. These amendments include new provisions regarding the inactivation of select agents, specific biosafety and toxin requirements and clarification of regulatory language concerning security, training, and records. The final rule will require that entities develop a validated inactivation procedure by establishing parameters for quantities of starting material and measures of uncertainty for repeated successful inactivation. This is a broad performance standard that will allow for flexibility given the variety of select agents and toxins under regulation to define conditions of inactivation for each select agent or regulated infectious nucleic acid and maintain written records of having done so. Costs of complying with this amendment are expected to be modest.

Currently, there are 291 entities registered with APHIS and CDC. Of these entities, there are 240 registered to possess Tier 1 select agents and toxins, including 78 academic, 29 commercial, 80 State government, 37 Federal government, and 16 private (non-profit) institutions, most of which are considered to be small entities. Based on current recordkeeping and reporting requirements, an additional 10 to 20 hours per year may be required for maintaining records associated with select agents or material containing select agents or regulated nucleic acids that can produce infectious forms of any select agent virus that have been subjected to a validated inactivation procedure or a procedure for removal of viable select agents. At an imputed cost of $33.40 per hour (GS-12, step 2), this additional time requirement per entity will cost between $334 and $668 per year, or in total for all registered entities between $80,000 and $160,000. Assuming that costs of the rule could be considered to be significant if they exceeded 1 percent of revenue earned by the affected entities, revenues would need to average less than $33,400 to $66,800 for this to be the case. While the vast majority of the entities in industries potentially affected by this rule, other than post-secondary institutions, can be considered small, average annual revenues are well above this range.

Due to the reasons summarized here and explained in the analysis accompanying this rule, the Administrator certifies that this action will not have a significant economic impact on a substantial number of small entities.

Executive Order 12988

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

Executive Order 13175

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

The Animal and Plant Health Inspection Service has assessed the impact of this rule on Indian tribes and determined that this rule does not, to our knowledge, have tribal implications that require tribal consultation under E.O. 13175. If a Tribe requests consultation, the Animal and Plant Health Inspection Service will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified herein are not expressly mandated by Congress.

Paperwork Reduction Act

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the reporting, recordkeeping, and third-party disclosure requirements included this rule are in the process of being reinstated by the Office of Management and Budget under 0579-0213.

E-Government Act Compliance

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at 301-851-2483.

List of Subjects 7 CFR Part 331

Agricultural research, Laboratories, Plant diseases and pests, Reporting and recordkeeping requirements.

9 CFR Part 121

Agricultural research, Animal diseases, Laboratories, Medical research, Reporting and recordkeeping requirements.

Accordingly, 7 CFR part 331 and 9 CFR part 121 are amended as follows:

Title 7—Agriculture PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS 1. The authority citation for part 331 continues to read as follows: Authority:

7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.3.

2. Section 331.1 is amended by adding, in alphabetical order, definitions of principal investigator, validated inactivation procedure, and viability testing protocol to read as follows:
§ 331.1 Definitions.

Principal investigator. The one individual who is designated by the entity to direct a project or program and who is responsible to the entity for the scientific and technical direction of that project or program.

Validated inactivation procedure. A procedure, whose efficacy is confirmed by data generated from a viability testing protocol, to render a select agent non-viable but allows the select agent to retain characteristics of interest for future use; or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.

Viability testing protocol. A protocol to confirm the validated inactivation procedure by demonstrating the material is free of all viable select agent.

3. Section 331.3 is amended as follows: a. By revising paragraph (d)(2). b. By redesignating paragraph (d)(3) as paragraph (d)(9) c. By adding paragraphs (d)(3) through (8) and (e)(3).

The additions and revision read as follows:

§ 331.3 PPQ select agents and toxins.

(d) * * *

(2) Nonviable select agents or nontoxic toxins.

(3) A select agent or toxin that has been subjected to decontamination or a destruction procedure when intended for waste disposal.

(4) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation procedure that is confirmed through a viability testing protocol. Surrogate strains that are known to possess equivalent properties with respect to inactivation can be used to validate an inactivation procedure; however, if there are known strain-to-strain variations in the resistance of a select agent to an inactivation procedure, then an inactivation procedure validated on a lesser resistant strain must also be validated on the more resistant strains.

(5) Material containing a select agent that is subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is subjected to a viability testing protocol to ensure that the removal method has rendered the material free of all viable select agent.

(6) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus not subjected to a validated inactivation procedure or material containing a select agent not subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is determined by the Administrator to be effectively inactivated or effectively removed. To apply for a determination an individual or entity must submit a written request and supporting scientific information to APHIS. A written decision granting or denying the request will be issued.

(7) A PPQ select toxin identified in an original food sample or clinical sample.

(8) Waste generated during the delivery of patient care by health care professionals from a patient diagnosed with an illness or condition associated with a select agent, where that waste is decontaminated or transferred for destruction by complying with State and Federal regulations within 7 calendar days of the conclusion of patient care.

(e) * * *

(3) An individual or entity may make a written request to the Administrator for reconsideration of a decision denying an application for the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.

4. Section 331.5 is amended as follows: a. By revising paragraph (a)(1). b. In paragraph (a)(2), by removing “; and” and adding a period in its place. c. By revising paragraph (a)(3).

The revisions read as follows:

§ 331.5 Exemptions.

(a) * * *

(1) Unless directed otherwise by the Administrator, within 7 calendar days after identification of the select agent or toxin, the select agent or toxin is transferred in accordance with § 331.16 or destroyed on-site by a recognized sterilization or inactivation process.

(3) The identification of the agent or toxin is reported to APHIS or CDC, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law by telephone, facsimile, or email. This report must be followed by submission of APHIS/CDC Form 4 to APHIS or CDC within 7 calendar days after identification.

5. Section 331.7 is amended as follows: a. By redesignating paragraphs (b) through (k) as paragraphs (c) through (l), respectively. b. By adding a new paragraph (b).

The addition reads as follows:

§ 331.7 Registration and related security risk assessments.

(b) As a condition of registration, each entity is required to be in compliance with the requirements of this part for select agents and toxins listed on the registration regardless of whether the entity is in actual possession of the select agent or toxin. With regard to toxins, the entity registered for possession, use, or transfer of a toxin must be in compliance with the requirements of this part regardless of the amount of toxins currently in its possession.

6. Section 331.9 is amended as follows: a. By removing the semicolons at the ends of paragraphs (a)(1) through (4) and “; and” at the end of paragraph (a)(5) and adding periods in their place. b. In paragraph (a)(6), by removing the word “laboratory” and adding the words “registered space” in its place and by adding the words “and the corrections documented” at the end of the second sentence after the words “must be corrected”. c. By adding paragraphs (a)(7), (8), and (9).

The additions read as follows:

§ 331.9 Responsible official.

(a) * * *

(7) Ensure that individuals are provided the contact information for the USDA Office of Inspector General Hotline and the HHS Office of Inspector General Hotline so that they may anonymously report any biosafety/biocontainment or security concerns related to select agents and toxins.

(8) Investigate to determine the reason for any failure of a validated inactivation procedure or any failure to remove viable select agent from material. If the responsible official is unable to determine the cause of a deviation from a validated inactivation procedure or a viable select agent removal method; or receives any report of any inactivation failure after the movement of material to another location, the responsible official must report immediately by telephone or email the inactivation or viable agent removal method failure to APHIS or CDC.

(9) Review, and revise as necessary, each of the entity's validated inactivation procedures or viable select agent removal methods. The review must be conducted annually or after any change in principal investigator, change in the validated inactivation procedure or viable select agent removal method, or failure of the validated inactivation procedure or viable select agent removal method. The review must be documented and training must be conducted if there are any changes to the validated inactivation procedure, viable select agent removal method, or viability testing protocol.

7. In § 331.10, paragraph (e) is amended by adding a sentence at the end of the paragraph to read as follows:
§ 331.10 Restricting access to select agents and toxins; security risk assessments.

(e) * * * A responsible official must immediately notify the responsible official of the visiting entity if the person's access to select agents or toxins has been terminated.

8. Section 331.11 is amended as follows: a. In paragraph (c)(5), by adding the word “keycards,” after the word “keys,” and by removing the word “numbers” and adding the word “permissions” in its place. b. In paragraph (d)(7)(iv), by removing the word “and”. c. By adding paragraph (d)(7)(vi). d. By adding a sentence at the end of paragraph (h).

The additions read as follows:

§ 331.11 Security.

(d) * * *

(7) * * *

(vi) Any loss of computer, hard drive or other data storage device containing information that can be used to gain access to select agents or toxins; and

(h) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants.

9. Section 331.12 is amended as follows: a. By revising paragraph (a). b. By adding a sentence at the end of paragraph (e).

The addition and revision read as follows:

§ 331.12 Biocontainment.

(a) An individual or entity required to register under this part must develop and implement a written biocontainment plan that is commensurate with the risk of the select agent or toxin, given its intended use.4 The biocontainment plan must contain sufficient information and documentation to describe the biocontainment procedures for the select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent. The current biocontainment plan must be submitted for initial registration, renewal of registration, or when requested. The biocontainment plan must include the following provisions:

4 Technical assistance and guidance may be obtained by contacting APHIS.

(1) The hazardous characteristics of each agent or toxin listed on the entity's registration and the biocontainment risk associated with laboratory procedures related to the select agent or toxin;

(2) Safeguards in place with associated work practices to protect entity personnel, the public, and the environment from exposure to the select agent or toxin including, but not limited to: Personal protective equipment and other safety equipment; containment equipment including, but not limited to, biological safety cabinets, animal caging systems, and centrifuge safety containers; and engineering controls and other facility safeguards;

(3) Written procedures for each validated method used for disinfection, decontamination, or destruction, as appropriate, of all contaminated or presumptively contaminated materials including, but not limited to: Cultures and other materials related to the propagation of select agents or toxins, items related to the analysis of select agents and toxins, personal protective equipment, arthropod containment systems, extracted plant and/or arthropod tissues, laboratory surfaces and equipment, and effluent material; and

(4) Procedures for the handling of select agents and toxins in the same spaces with non-select agents and toxins to prevent unintentional contamination.

(e) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants.

10. Section 331.14 is amended as follows: a. By adding a sentence at the end of paragraph (a). b. By adding a sentence at the end of paragraph (f).

The additions read as follows:

§ 331.14 Incident response.5

5 Nothing in this section is meant to supersede or preempt incident response requirements imposed by other statutes or regulations.

(a) * * * The current incident response plan must be submitted for initial registration, renewal of registration, or when requested.

(f) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants.

11. Section 331.15 is amended as follows: a. By revising paragraph (a). b. By adding paragraph (e).

The addition and revision read as follows:

§ 331.15 Training.

(a) An individual or entity required to register under this part must provide information and training on biocontainment, biosafety, security (including security awareness), and incident response to:

(1) Each individual with access approval from the Administrator or HHS Secretary. The training must address the particular needs of the individual, the work they will do, and the risks posed by the select agents or toxins. The training must be accomplished prior to the individual's entry into an area where a select agent is handled or stored, or within 12 months of the date the individual was approved by the Administrator or the HHS Secretary for access, whichever is earlier.

(2) Each individual not approved for access to select agents and toxins by the Administrator or HHS Secretary before that individual enters areas under escort where select agents or toxins are handled or stored (e.g., laboratories, growth chambers, animal rooms, greenhouses, storage areas, shipping/receiving areas, production facilities, etc.). Training for escorted personnel must be based on the risk associated with accessing areas where select agents and toxins are used and/or stored. The training must be accomplished prior to the individual's entry into where select agents or toxins are handled or stored (e.g., laboratories, growth chambers, animal rooms, greenhouses, storage areas, shipping/receiving areas, production facilities, etc.).

(e) The responsible official must ensure and document that individuals are provided the contact information of the USDA Office of Inspector General Hotline and the HHS Office of Inspector General Hotline so that they may anonymously report any safety or security concerns related to select agents and toxins.

12. In § 331.16, paragraph (b) introductory text is revised to read as follows:
§ 331.16 Transfers.

(b) A transfer may be authorized if:

13. Section 331.17 is amended as follows: a. In paragraph (a)(1)(iii), by adding the words “or other storage container” after the word “freezer”. b. By revising paragraph (a)(1)(v). c. In paragraph (a)(3)(v), by adding the words “or other storage container” after the word “freezer”. d. By removing the word “and” at the end of paragraph (a)(6) and removing the period at the end of paragraph (a)(7) and adding “; and” in its place. e. By adding paragraph (a)(8). f. By revising paragraphs (b) and (c).

The addition and revisions read as follows:

§ 331.17 Records.

(a) * * *

(1) * * *

(v) The select agent used, purpose of use, and, when applicable, final disposition;

(8) For select agents or material containing select agents or regulated nucleic acids that can produce infectious forms of any select agent virus that have been subjected to a validated inactivation procedure or a procedure for removal of viable select agent:

(i) A written description of the validated inactivation procedure or viable select agent removal method used, including validation data;

(ii) A written description of the viability testing protocol used;

(iii) A written description of the investigation conducted by the entity responsible official involving an inactivation or viable select agent removal failure and the corrective actions taken;

(iv) The name of each individual performing the validated inactivation or viable select agent removal method;

(v) The date(s) the validated inactivation or viable select agent removal method was completed;

(vi) The location where the validated inactivation or viable select agent removal method was performed; and

(vii) A certificate, signed by the principal investigator, that includes the date of inactivation or viable select agent removal, the validated inactivation or viable select agent removal method used, and the name of the principal investigator. A copy of the certificate must accompany any transfer of inactivated or select agent removed material.

(b) The individual or entity must implement a system to ensure that all records and databases created under this part are accurate and legible, have controlled access, and that their authenticity may be verified.

(c) The individual or entity must promptly produce upon request any information that is related to the requirements of this part but is not otherwise contained in a record required to be kept by this section. The location of such information may include, but is not limited to, biocontainment certifications, laboratory notebooks, institutional biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs. All records created under this part must be maintained for 3 years.

Title 9—Animals and Animal Products PART 121—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS 14. The authority citation for part 121 continues to read as follows: Authority:

7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.

15. Section 121.1 is amended by adding, in alphabetical order, definitions of principal investigator, validated inactivation procedure, and viability testing protocol to read as follows:
§ 121.1 Definitions.

Principal investigator. The one individual who is designated by the entity to direct a project or program and who is responsible to the entity for the scientific and technical direction of that project or program.

Validated inactivation procedure. A procedure, whose efficacy is confirmed by data generated from a viability testing protocol, to render a select agent non-viable but allows the select agent to retain characteristics of interest for future use; or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.

Viability testing protocol. A protocol to confirm the validated inactivation procedure by demonstrating the material is free of all viable select agent.

16. Section 121.3 is amended as follows: a. By revising paragraph (d)(2). b. By redesignating paragraph (d)(3) as paragraph (d)(4). c. By adding a new paragraph (d)(3). d. By revising newly redesignated paragraph (d)(4). e. By adding paragraphs (d)(5) through (9) and (e)(3).

The additions and revisions read as follows:

§ 121.3 VS select agents and toxins.

(d) * * *

(2) Nonviable VS select agents or nontoxic VS toxins.3

3 However, the importation and interstate movement of these nonviable select agents may be subject to the permit requirements under part 122 of this subchapter.

(3) A select agent or toxin that has been subjected to decontamination or a destruction procedure when intended for waste disposal.

(4) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation procedure that is confirmed through a viability testing protocol. Surrogate strains that are known to possess equivalent properties with respect to inactivation can be used to validate an inactivation procedure; however, if there are known strain-to-strain variations in the resistance of a select agent to an inactivation procedure, then an inactivation procedure validated on a lesser resistant strain must also be validated on the more resistant strains.

(5) Material containing a select agent that is subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is subjected to a viability testing protocol to ensure that the removal method has rendered the material free of all viable select agent.

(6) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus not subjected to a validated inactivation procedure or material containing a select agent not subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is determined by the Administrator to be effectively inactivated or effectively removed. To apply for a determination an individual or entity must submit a written request and supporting scientific information to APHIS. A written decision granting or denying the request will be issued.

(7) A VS select toxin identified in an original food sample or clinical sample.

(8) Waste generated during the delivery of patient care by health care professionals from a patient diagnosed with an illness or condition associated with a select agent, where that waste is decontaminated or transferred for destruction by complying with State and Federal regulations within 7 calendar days of the conclusion of patient care.

(9) Any low pathogenic strains of avian influenza virus, avian paramyxovirus serotype-1 (APMV-1) viruses which do not meet the criteria for Newcastle disease virus,4 including those identified as pigeon paramyxovirus-12 5 isolated from a non-poultry species, all subspecies Mycoplasma capricolum except subspecies capripneumoniae (contagious caprine pleuropneumonia), and all subspecies Mycoplasma mycoides except subspecies mycoides small colony (Mmm SC) (contagious bovine pleuropneumonia), provided that the individual or entity can identify that the agent is within the exclusion category.

4 An APMV-1 virus isolated from poultry which has an intracerebral pathogenicity index in day‐old chicks (Gallus gallus) of 0.7 or greater or has an amino acid sequence at the fusion (F) protein cleavage site that is consistent with virulent strains of Newcastle disease virus. A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a virulent virus.

5 Pigeon paramyxovirus (PPMV-1) is a species-adapted APMV-1 virus which is endemic in pigeons and doves in the United States and can be identified through monoclonal antibody testing and demonstration of their characteristic amino acid signature at the fusion gene cleavage site.

(e) * * *

(3) An individual or entity may make a written request to the Administrator for reconsideration of a decision denying an application for the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.

17. Section 121.4 is amended as follows: a. In paragraph (c)(1), by redesignating footnote 4 as footnote 6. b. In paragraph (c)(2) introductory text, by removing the word “functional” and adding in its place the word “toxic”. c. By revising paragraph (d)(2). d. By redesignating paragraph (d)(3) as paragraph (d)(9). e. By adding paragraphs (d)(3) through (8) and (e)(3).

The additions and revision read as follows:

§ 121.4 Overlap select agents and toxins.

(d) * * *

(2) Nonviable overlap select agents or nontoxic overlap toxins.7

7 However, the importation and interstate movement of these nonviable overlap select agents may be subject to the permit requirements under part 122 of this subchapter.

(3) A select agent or toxin that has been subjected to decontamination or a destruction procedure when intended for waste disposal.

(4) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation procedure that is confirmed through a viability testing protocol. Surrogate strains that are known to possess equivalent properties with respect to inactivation can be used to validate an inactivation procedure; however, if there are known strain-to-strain variations in the resistance of a select agent to an inactivation procedure, then an inactivation procedure validated on a lesser resistant strain must also be validated on the more resistant strains.

(5) Material containing a select agent that is subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is subjected to a viability testing protocol to ensure that the removal method has rendered the material free of all viable select agent.

(6) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus not subjected to a validated inactivation procedure or material containing a select agent not subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is determined by the Administrator or HHS Secretary to be effectively inactivated or effectively removed. To apply for a determination an individual or entity must submit a written request and supporting scientific information to APHIS or CDC. A written decision granting or denying the request will be issued.

(7) An overlap select toxin identified in an original food sample or clinical sample.

(8) Waste generated during the delivery of patient care by health care professionals from a patient diagnosed with an illness or condition associated with a select agent, where that waste is decontaminated or transferred for destruction by complying with State and Federal regulations within 7 calendar days of the conclusion of patient care.

(e) * * *

(3) An individual or entity may make a written request to the Administrator or HHS Secretary for reconsideration of a decision denying an application for the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator or HHS Secretary will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.

18. In § 121.5, paragraph (a) is revised as follows:
§ 121.5 Exemptions for VS select agents and toxins.

(a) Diagnostic laboratories and other entities that possess, use, or transfer a VS select agent or toxin that is contained in a specimen presented for diagnosis or verification will be exempt from the requirements of this part for such agent or toxin contained in the specimen, provided that:

(1) Unless directed otherwise by the Administrator, within 7 calendar days after identification of the select agent or toxin, the select agent or toxin is transferred in accordance with § 121.16 or destroyed on-site by a recognized sterilization or inactivation process;

(2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported;

(3) Unless otherwise directed by the Administrator, the clinical or diagnostic specimens collected from a patient infected with a select agent are transferred in accordance with § 121.16 or destroyed on-site by a recognized sterilization or inactivation process within 7 calendar days after delivery of patient care by heath care professionals has concluded; and

(4) The identification of the agent or toxin is reported to APHIS or CDC, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law by telephone, facsimile, or email. This report must be followed by submission of APHIS/CDC Form 4 to APHIS or CDC within 7 calendar days after identification.

19. Section 121.6 is amended as follows: a. By revising paragraph (a)(1). b. In paragraph (a)(2), by removing the word “and” at the end of the paragraph. c. By redesignating paragraph (a)(3) as paragraph (a)(4). d. By adding new paragraph (a)(3). e. By revising newly redesignated paragraph (a)(4).

The addition and revisions read as follows:

§ 121.6 Exemptions for overlap select agents and toxins.

(a) * * *

(1) Unless directed otherwise by the Administrator, within 7 calendar days after identification of the select agent or toxin, the select agent or toxin is transferred in accordance with § 121.16 or destroyed on-site by a recognized sterilization or inactivation process;

(3) Unless otherwise directed by the Administrator or HHS Secretary, the clinical or diagnostic specimens collected from a patient infected with a select agent are transferred in accordance with § 121.16 or destroyed on-site by a recognized sterilization or inactivation process within 7 calendar days after delivery of patient care by heath care professionals has concluded; and

(4) The identification of the agent or toxin is reported to APHIS or CDC, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law by telephone, facsimile, or email. This report must be followed by submission of APHIS/CDC Form 4 to APHIS or CDC within 7 calendar days after identification.

20. Section 121.7 is amended as follows: a. By redesignating paragraphs (b) through (k) as paragraphs (c) through (l), respectively. b. By adding a new paragraph (b). c. In newly redesignated paragraph (d)(3) introductory text, by redesignating footnote 6 as footnote 8. d. In newly redesignated paragraph (i)(1), by redesignating footnote 7 as footnote 9.

The addition reads as follows:

§ 121.7 Registration and related security risk assessments.

(b) As a condition of registration, each entity is required to be in compliance with the requirements of this part for select agents and toxins listed on the registration regardless of whether the entity is in actual possession of the select agent or toxin. With regard to toxins, the entity registered for possession, use, or transfer of a toxin must be in compliance with the requirements of this part regardless of the amount of toxins currently in its possession.

§ 121.8 [Amended]
21. In § 121.8, footnote 8 is redesignated as footnote 10. 22. Section 121.9 is amended as follows: a. By removing the semicolons at the ends of paragraphs (a)(1) through (4) and “; and” at the end of paragraph (a)(5) an adding periods in their place. b. In paragraph (a)(6), by removing the word “laboratory” and adding the words “registered space” in its place and by adding the words “and the corrections documented” at the end of the second sentence after the words “must be corrected”. c. By adding paragraphs (a)(7), (8), and (9).

The additions read as follows:

§ 121.9 Responsible official.

(a) * * *

(7) Ensure that individuals are provided the contact information for the USDA Office of Inspector General Hotline and the HHS Office of Inspector General Hotline so that they may anonymously report any biosafety/biocontainment or security concerns related to select agents and toxins.

(8) Investigate to determine the reason for any failure of a validated inactivation procedure or any failure to remove viable select agent from material. If the responsible official is unable to determine the cause of a deviation from a validated inactivation procedure or a viable select agent removal method; or receives any report of any inactivation failure after the movement of material to another location, the responsible official must report immediately by telephone or email the inactivation or viable agent removal method failure to APHIS or CDC.

(9) Review, and revise as necessary, each of the entity's validated inactivation procedures or viable select agent removal methods. The review must be conducted annually or after any change in principal investigator, change in the validated inactivation procedure or viable select agent removal method, or failure of the validated inactivation procedure or viable select agent removal method. The review must be documented and training must be conducted if there are any changes to the validated inactivation procedure, viable select agent removal method, or viability testing protocol.

23. In § 121.10, paragraph (e) is amended by adding a sentence at the end of the paragraph to read as follows:
§ 121.10 Restricting access to select agents and toxins; security risk assessments.

(e) * * * A responsible official must immediately notify the responsible official of the visited entity if the person's access to select agents and toxins has been terminated.

24. Section 121.11 is amended as follows: a. In paragraph (c)(5), by adding the word “keycards,” after the word “keys,” and by removing the word “numbers” and adding the word “permissions” in its place. b. In paragraph (d)(7)(iv), by removing the word “and”. c. By adding paragraph (d)(7)(vi). d. By adding a sentence at the end of paragraph (h).

The additions read as follows:

§ 121.11 Security.

(d) * * *

(7) * * *

(vi) Any loss of computer, hard drive or other data storage device containing information that could be used to gain access to select agents or toxins; and

(h) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants.

25. Section 121.12 is amended as follows: a. By revising paragraph (a). b. By removing paragraph (c)(2). c. By redesignating paragraph (c)(3) as paragraph (c)(2), and in newly redesignated paragraph (c)(2), removing the words “NIH Guidelines for Research Involving Recombinant DNA Molecules” and adding in their place the words “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules”. d. By adding a sentence at the end of paragraph (e).

The addition and revision read as follows:

§ 121.12 Biosafety.

(a) An individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of the select agent or toxin, given its intended use.11 The biosafety plan must contain sufficient information and documentation to describe the biosafety and containment procedures for the select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent. The current biosafety plan must be submitted for initial registration, renewal of registration, or when requested. The biosafety plan must include the following provisions:

11 Technical assistance and guidance may be obtained by contacting APHIS.

(1) The hazardous characteristics of each agent or toxin listed on the entity's registration and the biosafety risk associated with laboratory procedures related to the select agent or toxin;

(2) Safeguards in place with associated work practices to protect entity personnel, the public, and the environment from exposure to the select agent or toxin including, but not limited to: Personal protective equipment and other safety equipment; containment equipment including, but not limited to, biological safety cabinets, animal caging systems, and centrifuge safety containers; and engineering controls and other facility safeguards;

(3) Written procedures for each validated method used for disinfection, decontamination, or destruction, as appropriate, of all contaminated or presumptively contaminated materials including, but not limited to: Cultures and other materials related to the propagation of select agents or toxins, items related to the analysis of select agents and toxins, personal protective equipment, animal caging systems and bedding (if applicable), animal carcasses or extracted tissues and fluids (if applicable), laboratory surfaces and equipment, and effluent material; and

(4) Procedures for the handling of select agents and toxins in the same spaces with non-select agents and toxins to prevent unintentional contamination.

(e) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants.

26. Section 121.14 is amended as follows: a. In the section heading, by redesignating footnote 10 as footnote 12. b. In paragraph (a), by redesignating footnote 11 as footnote 13, and by adding a sentence at the end of the paragraph. c. In paragraph (f), by adding a sentence at the end of the paragraph.

The additions read as follows:

§ 121.14 Incident response.12

12 Nothing in this section is meant to supersede or preempt incident response requirements imposed by other statutes or regulations.

(a) * * * The current incident response plan must be submitted for initial registration, renewal of registration, or when requested.

(f) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants.

27. Section 121.15 is amended as follows: a. By revising paragraph (a). e. By adding paragraph (e).

The addition and revision read as follows:

§ 121.15 Training.

(a) An individual or entity required to register under this part must provide information and training on biocontainment, biosafety, security (including security awareness), and incident response to:

(1) Each individual with access approval from the Administrator or HHS Secretary. The training must address the particular needs of the individual, the work they will do, and the risks posed by the select agents or toxins. The training must be accomplished prior to the individual's entry into an area where a select agent is handled or stored, or within 12 months of the date the individual was approved by the Administrator or the HHS Secretary for access, whichever is earlier.

(2) Each individual not approved for access to select agents and toxins by the Administrator or HHS Secretary before that individual enters areas under escort where select agents or toxins are handled or stored (e.g., laboratories, growth chambers, animal rooms, greenhouses, storage areas, shipping/receiving areas, production facilities, etc.). Training for escorted personnel must be based on the risk associated with accessing areas where select agents and toxins are used and/or stored. The training must be accomplished prior to the individual's entry into where select agents or toxins are handled or stored (e.g., laboratories, growth chambers, animal rooms, greenhouses, storage areas, shipping/receiving areas, production facilities, etc.).

(e) The responsible official must ensure and document that individuals are provided the contact information of the USDA Office of Inspector General Hotline and the HHS Office of Inspector General Hotline so that they may anonymously report any safety or security concerns related to select agents and toxins.

28. Section § 121.16 is amended as follows: a. In paragraph (a), by redesignating footnote 12 as footnote 14. b. By revising paragraph (b) introductory text. c. By adding paragraph (l).

The addition and revision read as follows:

§ 121.16 Transfers.

(b) A transfer may be authorized if:

(l) Transfer the amounts only after the transferor uses due diligence and documents that the recipient has a legitimate need (e.g., prophylactic, protective, bona fide research, or other peaceful purpose) to handle or use such toxins. Information to be documented includes, but is not limited, to the recipient information, toxin and amount transferred, and declaration that the recipient has legitimate purpose to store and use such toxins.

29. Section 121.17 is amended as follows: a. In paragraph (a)(1)(iii), by adding the words “or other storage container” after the word “freezer”. b. By revising paragraph (a)(1)(v). c. In paragraph (a)(3)(v), by adding the words “or other storage container” after the word “freezer”. d. By removing the word “and” at the end of paragraph (a)(6) and removing the period at the end of paragraph (a)(7) and adding the word “; and” in its place. e. By adding paragraph (a)(8). f. By revising paragraphs (b) and (c).

The addition and revisions read as follows:

§ 121.17 Records.

(a) * * *

(1) * * *

(v) The select agent used, purpose of use, and, when applicable, final disposition;

(8) For select agents or material containing select agents or regulated nucleic acids that can produce infectious forms of any select agent virus that have been subjected to a validated inactivation procedure or a procedure for removal of viable select agent:

(i) A written description of the validated inactivation procedure or viable select agent removal method used, including validation data;

(ii) A written description of the viability testing protocol used;

(iii) A written description of the investigation conducted by the entity responsible official involving an inactivation or viable select agent removal failure and the corrective actions taken;

(iv) The name of each individual performing the validated inactivation or viable select agent removal method;

(v) The date(s) the validated inactivation or viable select agent removal method was completed;

(vi) The location where the validated inactivation or viable select agent removal method was performed; and

(vii) A certificate, signed by the principal investigator, that includes the date of inactivation or viable select agent removal, the validated inactivation or viable select agent removal method used, and the name of the principal investigator. A copy of the certificate must accompany any transfer of inactivated or select agent removed material.

(b) The individual or entity must implement a system to ensure that all records and databases created under this part are accurate and legible, have controlled access, and that their authenticity may be verified.

(c) The individual or entity must promptly produce upon request any information that is related to the requirements of this part but is not otherwise contained in a record required to be kept by this section. The location of such information may include, but is not limited to, biocontainment certifications, laboratory notebooks, institutional biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs. All records created under this part must be maintained for 3 years.

Done in Washington, DC, this 10th day of January 2017. Elvis S. Cordova, Acting Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2017-00857 Filed 1-18-17; 8:45 am] BILLING CODE 3410-34-P
DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 981 [Doc. No. AMS-SC-16-0047; SC16-981-3 FIR] Almonds Grown in California; Change in Quality Control Requirements AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Affirmation of interim rule as final rule.

SUMMARY:

The Department of Agriculture (USDA) is adopting, as a final rule, without change, an interim rule implementing a recommendation from the Almond Board of California (Board) that relaxed the quality control requirements prescribed under the California almond marketing order (order). The Board locally administers the order and is comprised of growers and handlers operating within California. The interim rule relaxed incoming quality requirements by increasing the inedible kernel tolerance from 0.50 percent to 2 percent. This relaxation decreases California almond handlers' disposition obligation. This change also allows handlers more flexibility in their operations while continuing to maintain quality control and ensuring compliance with the order's requirements.

DATES:

Effective January 20, 2017.

FOR FURTHER INFORMATION CONTACT:

Andrea Ricci, Marketing Specialist or Jeffrey Smutny, Regional Director, California Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (559) 487-5901, Fax: (559) 487-5906, or Email: [email protected] or [email protected]

Small businesses may obtain information on complying with this and other marketing order regulations by viewing a guide at the following Web site: http://www.ams.usda.gov/rules-regulations/moa/small-businesses; or by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected]

SUPPLEMENTARY INFORMATION:

This rule is issued under Marketing Order No. 981, as amended (7 CFR part 981), regulating the handling of almonds grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175.

Section 981.442 of the order regulates almond quality, including the percentage of inedible (low quality) kernels required to be disposed of by handlers. Previously, the weight of inedible kernels in excess of 0.50 percent of kernel weight of almonds received by each handler constituted the handler's disposition obligation. Handlers must satisfy their obligation by disposing of the inedible kernels in Board-accepted, non-human outlets such as animal feed or oil.

In the past several years, total inedible kernel percentages have been trending lower. This is partially due to good agricultural practices used by growers and better technologies in handler facilities. At the same time, the market value of almonds has increased significantly. As a result, some of the Board-accepted outlets have started to clean and repurpose almonds disposed under the obligation causing concern that product is being sold for human consumption without following the order's outgoing quality requirements. Increasing the inedible kernel tolerance to 2 percent provides handlers more control over low quality product, helping ensure any product destined for human consumption is compliant with the order's outgoing quality requirements. In an interim rule published in the Federal Register on August 17, 2016, and effective on August 18, 2016, (81 FR 54719, Doc. No. AMS-SC-16-0047, SC16-981-3 IR), § 981.442(a)(4)(i) was amended by changing the disposition obligation from 0.5 percent to 2 percent. This rule continues in effect that action.

Final Regulatory Flexibility Analysis

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 6,800 almond growers in the production area and approximately 100 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

The National Agricultural Statistics Service (NASS) reported in its 2012 Agricultural Census that there were 6,841 almond farms in the production area (California), of which 6,204 had bearing acres. The following computation provides an estimate of the proportion of producers (farms) and agricultural service firms (handlers) that would be considered small under the SBA definitions.

The NASS Census data indicates that out of the 6,204 California farms with bearing acres of almonds, 4,471 (72 percent) have fewer than 100 bearing acres.

For the almond industry's most recently reported crop year (2015), NASS reported an average yield of 2,130 pounds per acre, and a season average grower price of $2.84 per pound. A 100-acre farm with an average yield of 2,130 pounds per acre would produce about 213,000 pounds of almonds. At $2.84 per pound, that farm's production would be valued at $604,920. Since Census of Agriculture indicates that the majority of California's almond farms are smaller than 100 acres, it could be concluded that the majority of growers had annual receipts from the sale of almonds in 2015 of less than $604,920, which is below the SBA threshold of $750,000. Thus, over 70 percent of California's almond growers would be considered small growers according to SBA's definition.

According to information supplied by the Board, approximately 30 percent of California's almond handlers shipped almonds valued under $7,500,000 during the 2014-15 crop year, and would, therefore, be considered small handlers according to the SBA definition.

This rule continues in effect the revision of § 981.442(a)(4)(i), which relaxed incoming quality requirements by increasing the inedible kernel tolerance from 0.50 percent to 2 percent. This relaxation decreases California almond handlers' disposition obligation, and also allows handlers more flexibility in their operations while continuing to maintain quality control and ensuring compliance with the order's requirements. Authority for this action is provided in § 981.42(a) of the order.

Regarding the impact of this action on affected entities, increasing the inedible kernel tolerance reduces disposition obligation on handlers and provides handlers with more flexibility and control over the low quality product. This rule is not expected to change handler inspection costs, as handlers currently are required to have all lots inspected to determine the percentage of inedible kernels.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0178 (Vegetable and Specialty Crops.) No changes are necessary in those requirements as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.

This rule will not impose any additional reporting or recordkeeping requirements on either small or large almond handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. In addition, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

Further, the Board's meeting was widely publicized throughout the almond industry and all interested persons were invited to attend the meeting and participate in Board deliberations. Like all Board meetings, the April 12, 2016, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue.

Comments on the interim rule were required to be received on or before October 17, 2016. Two comments were received. One commenter stated that this change will allow almond handlers to have more flexibility with their operations. The other commenter stated the increase in tolerance should lead to a decrease in price. Marketing orders do not regulate price. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule, without change.

To view the interim rule, go to: https://www.regulations.gov/docket?D=AMS-SC-16-0047.

This action also affirms information contained in the interim rule concerning Executive Orders 12866, 12988, 13175, and 13563; the Paperwork Reduction Act (44 U.S.C. Chapter 35); and the E-Gov Act (44 U.S.C. 101).

After consideration of all relevant material presented, it is found that finalizing the interim rule, without change, as published in the Federal Register (81 FR 54719) will tend to effectuate the declared policy of the Act.

List of Subjects in 7 CFR Part 981

Almonds, Marketing agreements, Nuts, Reporting and recordkeeping requirements.

PART 981—ALMONDS GROWN IN CALIFORNIA Accordingly, the interim rule that amended 7 CFR part 981 and that was published 81 FR 54719 on August 17, 2016, is adopted as a final rule, without change. Dated: January 9, 2017. Bruce Summers, Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2017-00589 Filed 1-18-17; 8:45 am] BILLING CODE 3410-02-P
DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 94 [Docket No. APHIS-2014-0032] RIN 0579-AD92 Importation of Beef From a Region in Argentina AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Final rule; technical amendment.

SUMMARY:

In a final rule published in the Federal Register on July 2, 2015, and effective on September 1, 2015, we amended the regulations governing the importation of certain animals, meat, and other animal products to allow, under certain conditions, the importation of fresh (chilled or frozen) beef from a region in Argentina located north of Patagonia South and Patagonia North B, referred to as Northern Argentina. However, we inadvertently limited the requirement for the maturation of carcasses to meat derived from bovines. Therefore, we are amending the paragraph to remove the limitation.

DATES:

Effective January 19, 2017.

FOR FURTHER INFORMATION CONTACT:

Dr. Roberta Morales, Import Risk Analyst, Regional Evaluation Services, National Import Export Services, VS, APHIS, 920 Main Campus Drive, Suite 200, Raleigh, NC; (919) 855-7735; [email protected]

SUPPLEMENTARY INFORMATION:

In a final rule 1 that was published in the Federal Register on July 2, 2015 (80 FR 37935-37953, Docket No. APHIS-2014-0032), and effective on September 1, 2015, we amended the regulations governing the importation of certain animals, meat, and other animal products to allow, under certain conditions, the importation of fresh (chilled or frozen) beef from a region in Argentina located north of Patagonia South and Patagonia North B, referred to as Northern Argentina. These requirements appear in 9 CFR 94.29, which provides for the importation of fresh beef and ovine meat from certain regions. However, when we added the requirements, we inadvertently limited the requirements in paragraph (i), which provides the requirements for the maturation of carcasses, to meat derived from bovines. Therefore, we are amending the paragraph to remove the limitation.

1 To view the final rule and supporting documents, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0032.

Lists of Subjects in 9 CFR Part 94

Animal diseases, Imports, Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping requirements.

Accordingly, we are amending 9 CFR part 94 as follows:

PART 94—RINDERPEST, FOOT-AND-MOUTH DISEASE, NEWCASTLE DISEASE, HIGHLY PATHOGENIC AVIAN INFLUENZA, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, SWINE VESICULAR DISEASE, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS 1. The authority citation for part 94 continues to read as follows: Authority:

7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

§ 94.29 [Amended]
2. In § 94.29, paragraph (i) is amended by removing the word “bovine”.
Done in Washington, DC, this 12th day of January 2017. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-01019 Filed 1-18-17; 8:45 am] BILLING CODE 3410-34-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2016-9319; Airspace Docket No. 16-AGL-24] RIN 2120-AA66 Amendment of Multiple Air Traffic Service (ATS) Routes; North Central United States AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule, technical amendment.

SUMMARY:

The FAA is amending seven high altitude Area Navigation (RNAV) Q-routes (Q-140, Q-816, Q-818, Q-822, Q-824, Q-917, and Q-935) that cross the United States (U.S.)/Canada border in the north central U.S. to update the geographic latitude/longitude coordinates for five Canadian waypoints listed in the Q-route descriptions contained in the FAA and Canadian aeronautical databases.

DATES:

Effective date 0901 UTC, April 27, 2017. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES:

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

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

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

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

History

On September 26, 2014, the FAA published in the Federal Register a final rule (79 FR 57758), Docket No. FAA-2014-0295, that amended, removed, and established multiple ATS routes in the north central U.S. to reflect and accommodate route changes being made in Canadian airspace as part of a Canadian airspace redesign project. On December 5, 2014, the FAA published in the Federal Register a final rule, technical amendment (79 FR 72135), Docket No. FAA-2014-0986, that further amended a number of the routes to reflect changes made by NAV CANADA as part of their airspace redesign effort after publication of the original final rule. During a recent aeronautical review, the FAA identified waypoint coordinate updates for the Canadian waypoints OMRAK, PEPLA, TAGUM, TANKO, and VIGLO.

This rule makes the corrections to be in concert with FAA and Canadian aeronautical databases.

Availability and Summary of Documents for Incorporation by Reference

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

The Rule

The FAA is amending Title 14, Code of Federal Regulations (14 CFR) part 71 by modifying RNAV routes Q-140, Q-816, Q-818, Q-822, Q-824, Q-917, and Q-935. The route modifications correct the OMRAK, PEPLA, TAGUM, TANKO, and VIGLO waypoint geographic coordinates used in the routes to match the FAA and Canadian aeronautical database information. The amendments ensure safe and efficient across border connectivity.

The RNAV route modifications accomplished by this action are outlined below.

Q-140: Change the PEPLA waypoint geographic coordinates from “lat. 43°47′51.00″ N., long. 080°01′02.00″ W.” to read “lat. 43°47′50.98″ N., long. 080°00′53.56″ W.”

Q-816: Change the OMRAK waypoint geographic coordinates from “lat. 43°16′06.00″ N., long. 082°16′25.00″ W.” to read “lat. 43°16′15.45″ N., long. 082°15′52.31″ W.”

Q-818: Change the TANKO waypoint geographic coordinates from “lat. 43°01′32.00″ N., long. 082°22′43.00″ W.” to read “lat. 43°01′32.48″ N., long. 082°23′02.38″ W.”

Q-822: Change the TANKO waypoint geographic coordinates from “lat. 43°01′32.00″ N., long. 082°22′43.00″ W.” to read “lat. 43°01′32.48″ N., long. 082°23′02.38″ W.”

Q-824: Change the TAGUM waypoint geographic coordinates from “lat. 43°28′47.00″ N., long. 082°10′37.00″ W.” to read “lat. 43°28′54.05″ N., long. 082°09′46.39″ W.”

Q-917: Change the VIGLO waypoint geographic coordinates from “lat. 45°23′28.00″ N., long. 082°25′11.00″ W.” to read “lat. 45°23′48.00″ N., long. 082°25′11.00″ W.”, and the PEPLA waypoint geographic coordinates from “lat. 43°47′51.00″ N., long. 080°01′02.00″ W.” to read “lat. 43°47′50.98″ N., long. 080°00′53.56″ W.”

Q-935: Change the OMRAK waypoint geographic coordinates from “lat. 43°16′06.00″ N., long. 082°16′25.00″ W.” to read “lat. 43°16′15.45″ N., long. 082°15′52.31″ W.”

High altitude United States RNAV Q-routes are published in paragraph 2006 and high altitude Canadian RNAV Q-routes are published in paragraph 2007 of FAA Order 7400.11A dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The high altitude United States and Canadian RNAV Q-routes listed in this rule will be subsequently published in the Order.

Regulatory Notices and Analyses

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

Environmental Review

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

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016, is amended as follows: Paragraph 2006 United States Area Navigation Routes. Q-140 WOBED, WA to YODAA, NY [Amended] WOBED, WA WP (Lat. 48°36′01.07″ N., long. 122°49′46.52″ W.) GETNG, WA WP (Lat. 48°25′30.57″ N., long. 119°31′38.98″ W.) CORDU, ID FIX (Lat. 48°10′46.41″ N., long. 116°40′21.84″ W.) PETIY, MT WP (Lat. 47°58′46.55″ N., long. 114°36′20.31″ W.) CHOTE, MT FIX (Lat. 47°39′56.68″ N., long. 112°09′38.13″ W.) LEWIT, MT WP (Lat. 47°23′00.21″ N., long. 110°08′44.78″ W.) SAYOR, MT FIX (Lat. 47°13′58.34″ N., long. 104°58′39.28″ W.) WILTN, ND FIX (Lat. 47°04′58.09″ N., long. 100°47′43.84″ W.) TTAIL, MN WP (Lat. 46°41′28.00″ N., long. 096°41′09.00″ W.) CESNA, WI WP (Lat. 45°52′14.00″ N., long. 092°10′59.00″ W.) WISCN, WI WP (Lat. 45°18′19.45″ N., long. 089°27′53.91″ W.) EEGEE, WI WP (Lat. 45°08′53.00″ N., long. 088°45′58.00″ W.) DAYYY, MI WP (Lat. 44°10′10.00″ N., long. 084°22′23.00″ W.) RUBKI, Canada WP (Lat. 44°14′56.00″ N., long. 082°15′25.99″ W.) PEPLA, Canada WP (Lat. 43°47′50.98″ N., long. 080°00′53.56″ W.) SIKBO, Canada WP (Lat. 43°39′13.00″ N., long. 079°20′57.00″ W.) MEDAV, Canada WP (Lat. 43°29′19.00″ N., long. 078°45′46.00″ W.) AHPAH, NY WP (Lat. 43°18′19.00″ N., long. 078°07′35.11″ W.) HANKK, NY FIX (Lat. 42°53′41.82″ N., long. 077°09′15.21″ W.) BEEPS, NY FIX (Lat. 42°49′13.26″ N., long. 076°59′04.84″ W.) EXTOL, NY FIX (Lat. 42°39′27.69″ N., long. 076°37′06.10″ W.) MEMMS, NY FIX (Lat. 42°30′59.71″ N., long. 076°18′15.43″ W.) KODEY, NY FIX (Lat. 42°16′47.53″ N., long. 075°47′04.00″ W.) ARKKK, NY WP (Lat. 42°03′48.52″ N., long. 075°19′00.41″ W.) RODYY, NY WP (Lat. 41°52′25.85″ N., long. 074°35′49.39″ W.) YODAA, NY FIX (Lat. 41°43′21.19″ N., long. 074°01′52.76″ W.) Excluding the airspace within Canada. Paragraph 2007 Canadian Area Navigation Routes. Q-816 HOCKE, MI to HANAA, NY [Amended] HOCKE, MI WP (Lat. 43°15′43.38″ N., long. 082°42′38.27″ W.) OMRAK, Canada WP (Lat. 43°16′15.45″ N., long. 082°15′52.31″ W.) AGDOX, Canada WP (Lat. 43°17′01.71″ N., long. 079°05′29.29″ W.) KELTI, NY WP (Lat. 43°16′57.00″ N., long. 078°56′00.00″ W.) AHPAH, NY WP (Lat. 43°18′19.00″ N., long. 078°07′35.11″ W.) GOATR, NY WP (Lat. 43°17′26.08″ N., long. 076°39′07.75″ W.) ARNII, NY WP (Lat. 43°14′59.92″ N., long. 074°20′00.14″ W.) HANAA, NY WP (Lat. 43°11′52.06″ N., long. 073°36′46.17″ W.) Excluding the airspace within Canada. Q-818 Flint, MI (FNT) to GAYEL, NY [Amended] Flint, MI (FNT) VORTAC (Lat. 42°58′00.38″ N., long. 083°44′49.08″ W.) TANKO, Canada WP (Lat. 43°01′32.48″ N., long. 082°23′02.38″ W.) KITOK, Canada WP (Lat. 43°02′30.00″ N., long. 081°55′34.00″ W.) DERLO, Canada WP (Lat. 43°03′59.00″ N., long. 081°05′43.00″ W.) IKNAV, Canada WP (Lat. 42°57′43.00″ N., long. 078°59′04.00″ W.) WOZEE, NY WP (Lat. 42°56′01.65″ N., long. 078°44′19.64″ W.) KELIE, NY FIX (Lat. 42°39′37.32″ N., long. 077°44′41.05″ W.) VIEEW, NY FIX (Lat. 42°26′22.07″ N., long. 077°01′33.30″ W.) Binghampton, NY (CFB) VORTAC (Lat. 42°09′26.96″ N., long. 076°08′11.30″ W.) BUFFY, PA FIX (Lat. 41°56′27.98″ N., long. 075°36′45.35″ W.) STOMP, NY WP (Lat. 41°35′46.78″ N., long. 074°47′47.79″ W.) MSLIN, NY FIX (Lat. 41°29′30.82″ N., long. 074°33′14.28″ W.) GAYEL, NY FIX (Lat. 41°24′24.09″ N., long. 074°21′25.75″ W.) Excluding the airspace within Canada. Q-822 Flint, MI (FNT) to SINVI, Canada [Amended] Flint, MI (FNT) VORTAC (Lat. 42°58′00.38″ N., long. 083°44′49.08″ W.) TANKO, Canada WP (Lat. 43°01′32.48″ N., long. 082°23′02.38″ W.) KITOK, Canada WP (Lat. 43°02′30.00″ N., long. 081°55′34.00″ W.) DERLO, Canada WP (Lat. 43°03′59.00″ N., long. 081°05′43.00″ W.) HOZIR, NY WP (Lat. 43°06′03.59″ N., long. 079°02′05.27″ W.) GONZZ, NY WP (Lat. 43°05′22.00″ N., long. 076°41′12.00″ W.) PUPPY, NY WP (Lat. 43°03′26.46″ N., long. 075°17′39.29″ W.) PAYGE, NY FIX (Lat. 43°00′50.48″ N., long. 074°15′12.76″ W.) Cambridge, NY (CAM) VOR/DME (Lat. 42°59′39.44″ N., long. 073°20′38.47″ W.) Kennebunk, ME (ENE) VOR/DME (Lat. 43°25′32.42″ N., long. 070°36′48.69″ W.) AJJAY, ME WP (Lat. 43°43′40.55″ N., long. 069°36′08.22″ W.) ALLEX, ME WP (Lat. 44°25′00.00″ N., long. 067°00′00.00″ W.) SINVI, Canada WP (Lat. 44°48′15.00″ N., long. 064°19′27.00″ W.) Excluding the airspace within Canada. Q824 Flint, MI (FNT) to TAGUM, Canada [Amended] Flint, MI (FNT) VORTAC (Lat. 42°58′00.38″ N., long. 083°44′49.08″ W.) HOCKE, MI WP (Lat. 43°15′43.38″ N., long. 082°42′38.27″ W.) TAGUM, Canada WP (Lat. 43°28′54.05″ N., long. 082°09′46.39″ W.) Excluding the airspace within Canada. Q-917 Sault Ste Marie, MI (SSM) to WOZEE, NY [Amended] Sault Ste Marie, MI (SSM) VOR/DME (Lat. 46°24′43.60″ N., long. 084°18′53.54″ W.) ULUTO, Canada WP (Lat. 46°18′16.00″ N., long. 084°05′41.00″ W.) VIGLO, Canada WP (Lat. 45°23′48.00″ N., long. 082°25′11.00″ W.) SASUT, Canada WP (Lat. 44°39′59.00″ N., long. 081°17′47.00″ W.) PEPLA, Canada WP (Lat. 43°47′50.98″ N., long. 080°00′53.56″ W.) HOZIR, NY WP (Lat. 43°06′03.59″ N., long. 079°02′05.27″ W.) WOZEE, NY WP (Lat. 42°56′01.65″ N., long. 078°44′19.64″ W.) Excluding the airspace within Canada. Q-935 MONEE, MI to Boston, MA (BOS) [Amended] MONEE, MI FIX (Lat. 43°14′25.80″ N., long. 084°27′50.95″ W.) HOCKE, MI WP (Lat. 43°15′43.38″ N., long. 082°42′38.27″ W.) OMRAK, Canada WP (Lat. 43°16′15.45″ N., long. 082°15′52.31″ W.) DERLO, Canada WP (Lat. 43°03′59.00″ N., long. 081°05′43.00″ W.) IKNAV, Canada WP (Lat. 42°57′43.00″ N., long. 078°59′04.00″ W.) WOZEE, NY WP (Lat. 42°56′01.65″ N., long. 078°44′19.64″ W.) HANKK, NY FIX (Lat. 42°53′41.82″ N., long. 077°09′15.21″ W.) JOSSY, NY WP (Lat, 42°53′29.93″ N., long. 077°02′36.80″ W.) AUDIL, NY FIX (Lat. 42°52′18.74″ N., long. 076°26′35.07″ W.) FABEN, NY WP (Lat. 42°51′12.04″ N., long. 075°57′07.91″ W.) PONCT, NY WP (Lat. 42°44′48.83″ N., long. 073°48′48.07″ W.) Gardner, MA (GDM) VOR/DME (Lat. 42°32′45.32″ N., long. 072°03′29.48″ W.) Boston, MA (BOS) VOR/DME (Lat. 42°21′26.82″ N., long. 070°59′22.37″ W.) Excluding the airspace within Canada. Issued in Washington, DC, on January 10, 2017. Leslie M. Swann, Acting Manager, Airspace Policy Group.
[FR Doc. 2017-01036 Filed 1-18-17; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Parts 740, 748, and 762 [Docket No. 161230999-7013-01] RIN 0694-AH11 Support Document Requirements With Respect to Hong Kong AGENCY:

Bureau of Industry and Security, Commerce.

ACTION:

Final rule.

SUMMARY:

This rule requires persons intending to export or reexport to Hong Kong any item subject to the Export Administration Regulations (EAR) and controlled on the Commerce Control List (CCL) for national security (NS), missile technology (MT), nuclear nonproliferation (NP column 1), or chemical and biological weapons (CB) reasons to obtain, prior to such export or reexport, a copy of a Hong Kong import license or a written statement from the Hong Kong government that such a license is not required.

This rule also requires persons intending to reexport from Hong Kong any item subject to the EAR and controlled for NS, MT, NP column 1, or CB reasons to obtain a Hong Kong export license or a statement from the Hong Kong government that such a license is not required.

DATES:

The rule is effective April 19, 2017.

FOR FURTHER INFORMATION CONTACT:

Tracey Patts, Foreign Policy Division, Bureau of Industry and Security, Phone: (202) 482-4252.

SUPPLEMENTARY INFORMATION: Background

The government of the Hong Kong Special Administrative Region maintains an import and export control system. The “Import and Export (Strategic Commodities) Regulations” are an integral part of that system. Schedules in those regulations identify articles that may not be imported or exported without a license from Hong Kong's Director-General of Trade and Industry. Those schedules and much of the CCL are based on the control lists published by four multilateral export control regimes. Export control classification number (ECCN) entries on the CCL identify one or more reason(s) for which listed items are controlled. Four of these reasons for control are based on the four multilateral export control regimes, as follows: The Wassenaar Arrangement on Export Controls for Conventional Arms and Dual-Use Goods and Technologies (NS on the CCL), the Missile Technology Control Regime (MT on the CCL), the Nuclear Suppliers Group (NP column 1 on the CCL), and the Australia Group (CB on the CCL). Because the Hong Kong schedules and most of the CCL are developed from these same four sources, large portions of both sets of documents cover the same items.

The government of the Hong Kong Special Administrative Region uses information from the import licenses that it issues to identify articles that require an export license. This rule imposes new support documentation requirements affecting items subject to the EAR that are exported or reexported to Hong Kong or are reexported from Hong Kong. BIS is taking this action to provide greater assurance that U.S. origin items that are subject to the multilateral control regimes noted above will be properly authorized by the United States to their final destination, even when those items first pass through Hong Kong. This rule does not impose any new license requirements.

Exports and Reexports to Hong Kong

This rule requires exporters and reexporters using a BIS license or a license exception to export or reexport to Hong Kong items controlled for NS, MT, NP column 1, or CB reasons to obtain certain documents that verify the items' status under the Hong Kong Import and Export (Strategic Commodities) Regulations. The exporter or reexporter must obtain from its client or consignee a copy of a valid import license issued to the Hong Kong importer by the Hong Kong government authorizing import of the item(s) to be shipped to Hong Kong, or a copy of a written statement issued by the Hong Kong government stating that no import license is required to import the item(s) into Hong Kong. The exporter or reexporter must have the copies in its possession, and any Hong Kong import license must not have expired at the time of the export or reexport to Hong Kong. For purposes of this requirement, a written statement issued by the Hong Kong government includes either a written communication to a license applicant informing the applicant that the item does not require a license or a statement available to the general public (including a statement on a Web site by the Hong Kong government) that a license is not required for the item.

Reexports From Hong Kong

This rule also requires reexporters in Hong Kong intending to reexport from Hong Kong items subject to the EAR that are controlled for NS, MT, NP column 1, or CB reasons to obtain from the Hong Kong government a license authorizing export from Hong Kong of the items, or a copy of a written statement issued by the Hong Kong government stating that no export license is required from Hong Kong to export the items. If a Hong Kong license is issued, the reexport must be in accordance with the terms of that license and must be completed during the validity period of the Hong Kong-issued export license. For purposes of this requirement, a written statement issued by the Hong Kong government includes a written communication to a license applicant informing the applicant that the item does not require a license or a statement available to the general public (including a statement on a Web site by the Hong Kong government) that a license is not required for the item.

Export Administration Act

Since August 21, 2001, the Export Administration Act of 1979, as amended, has been in lapse. However, 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 EAR 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). 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 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 includes an expansion of an existing collection of information approved under OMB control number 0694-0093—Import Certificate and End-User Certificate, for which the current burden estimates are 5,872 responses and 1,618 hours annually. BIS expects that this rule will increase the number of transactions for which exporters and reexporters will have to acquire support documentation by about 12,000 transactions annually, with a corresponding increase in the number of burden hours. Send comments regarding this burden estimate or any other aspect of this collections of information, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget, by email at [email protected] or by fax to (202) 395-7285 and to Hillary Hess, BIS, at [email protected]

3. This rule does not contain policies with Federalism implications as that term is defined under 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 30-day delay in effective date, are inapplicable because this regulation involves a military and foreign affairs function of the United States (5 U.S.C. 553(a)(1)). Therefore, we are issuing this action as a final rule. This action will foster effective administration of and compliance with the export control regulations of the Hong Kong Special Administrative Region with respect to U.S.-origin items. Those regulations apply to items that are listed on the control lists of multilateral export control regimes of which the United States is a member. Effective control over such items imported into Hong Kong by the government of the Hong Kong Special Administrative Region serves the United States' national security and foreign policy interests directly, because many of these items are controlled due to their national security significance or their potential to be used in activities that would promote proliferation of weapons of mass destruction or in regional destabilizing activities.

This rule also enhances the effectiveness of the multilateral control regimes, which serves United States interests in two ways. First, widespread consistent implementation of those regime-based export controls promotes peace and stability throughout the world generally. Second, this rule signals to other nations, regime member states and non-members alike, the United States' determination that distribution of U.S. origin items throughout the world will be in accordance with its regime commitments.

Moreover, BIS expects that in nearly all instances, this rule requires only that a party in Hong Kong obtain a license that is already required under Hong Kong law. In those instances, no new action is required by persons reexporting from Hong Kong and the only new action with respect to exports and reexports to Hong Kong is for the person in Hong Kong to send a copy of the license to its supplier. In the limited instances where the CCL covers items with one or more of the reasons for control noted above that are not listed on the Hong Kong control, such as when the Hong Kong Government and the United States Government update their control lists in response the changes in the multilateral export control regime lists at different times, the party in Hong Kong will have to obtain a written statement from the Hong Kong Government that a Hong Kong license is not required. However, the rule gives the party in Hong Kong several options for providing the required information. Various documents, including the Hong Kong government's specific response to a license application informing the applicant that a license is not required and more general statements downloaded from a Hong Kong Government Web site, will be adequate to fulfill this requirement. One document may be used for multiple shipments as long as the document remains accurate.

Despite the importance of prompt publication and effectiveness to our foreign policy goals as noted above, BIS recognizes that some exporters and reexporters will need time to obtain the required documentation from their customers for all transactions subject to this rule. Therefore, the effective date of this final rule is ninety days after publication.

List of Subjects 15 CFR Parts 740 and 748

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

15 CFR Part 762

Administrative practice and procedure, Business and industry, Confidential business information, Exports, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, parts 740, 742, and 762 of the Export Administration Regulations (15 CFR parts 730 through 774) are amended as follows:

PART 740—LICENSE EXCEPTIONS 1. The authority citation for part 740 is revised 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).

2. In § 740.2, add paragraphs (a)(19) and (20) to read as follows:
§ 740.2 Restrictions on all License Exceptions.

(a) * * *

(19) The exporter or reexporter to Hong Kong of any item subject to the EAR and controlled on the CCL for NS, MT, NP Column 1, or CB reasons has not received one of the following with respect to the item:

(i) A copy of an import license issued to the Hong Kong importer by the Government of the Hong Kong Special Administrative Region, pursuant to the Hong Kong Import and Export (Strategic Commodities) Regulations, that covers all items to be exported or reexported pursuant to that license exception for which a Hong Kong import license is required and that is valid on the date of the export or reexport that is subject to the EAR; or

(ii) A copy of a written statement issued by the Government of the Hong Kong Special Administrative Region that no import license is required to import into Hong Kong the item(s) to be exported or reexported. The statement may have been issued directly to the Hong Kong importer or it may be a written statement available to the general public. The statement may be used for more than one export or reexport to Hong Kong so long as it remains an accurate statement of Hong Kong law.

(20) The reexporter from Hong Kong of any item subject to the EAR controlled on the CCL for NS, MT, NP column 1, or CB reasons has not received one of the following with respect to the item:

(i) An export license issued by the Government of the Hong Kong Special Administrative Region, pursuant to the Hong Kong Import and Export (Strategic Commodities) Regulations, that covers all items to be reexported pursuant to that license exception for which a Hong Kong export license is required and that is valid on the date of the reexport that is subject to the EAR; or

(ii) A copy of a written statement issued by the Government of the Hong Kong Special Administrative Region that no Hong Kong export license is required for the item(s) to be rexported. The statement may have been issued directly to the Hong Kong reexporter or it may be a written statement available to the general public. The statement may be used for more than one reexport from Hong Kong so long as it remains an accurate statement of Hong Kong law.

PART 748—APPLICATIONS (CLASSIFICATION, ADVISORY, AND LICENSE) AND DOCUMENTATION 3. The authority citation for part 748 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 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).

4. 748.9(b) is amended by revising the section heading, revising paragraph (b) and all notes to paragraph (b), and adding two sentences to the end paragraph of (e)(1), to read as follows:
§ 748.9 Support documents for evaluation of foreign parties in license applications and/or for promoting compliance with license requirements.

(b) Requirements to obtain support documents for license applications. Unless an exception in paragraph (c) of this section applies, a support document is required for certain license applications for:

(1) The People's Republic of China (PRC) other than the Hong Kong Special Administrative Region (see §§ 748.10 and 748.11(a)(2));

(2) “600 Series Major Defense Equipment” (see § 748.11);

(3) Firearms and related commodities to member countries of the Organization of American States (see § 748.12); and

(4) The Hong Kong Special Administrative Region of the People's Republic of China (see § 748.13).

Note 1 to Paragraph (b):

On a case-by-case basis, BIS may require license applicants to obtain a support document for any license application.

Note 2 to Paragraph (b):

For End-Use Certificate requirements under the Chemical Weapons Convention, see § 745.2 of the EAR.

(e) * * *

(1) * * * The documents issued by the Government of the Hong Kong Special Administrative region that are required pursuant to § 748.13 are not used to evaluate license applications. They must be obtained before shipment and need not be obtained before submitting a license application.

5. Redesignate § 748.13 as § 748.14 and add new § 748.13 to read as follows:
§ 748.13 Hong Kong import and export licenses.

(a) Requirement to obtain the document—(1) Exports and reexports to Hong Kong. An exporter or reexporter must obtain the documents described in paragraph (a)(1)(i) or (a)(1)(ii) of this section before using a license issued by BIS to export or reexport to Hong Kong any item subject to the EAR and controlled on the CCL for NS, MT, NP column 1, or CB reasons. Collectively, the documents issued by Hong Kong must cover all of the items to be exported or reexported pursuant to a license.

(i) A copy of an import license issued to the Hong Kong importer by the Government of the Hong Kong Special Administrative Region, pursuant to the Hong Kong Import and Export (Strategic Commodities) Regulations, that covers the items to be exported or reexported pursuant to that BIS license for which a Hong Kong import license is required and that is valid on the date of the export or reexport that is subject to the EAR; or

(ii) A copy of a written statement issued by the Government of the Hong Kong Special Administrative Region that no import license is required to import into Hong Kong the item(s) to be exported or reexported to Hong Kong. The statement may have been issued directly to the Hong Kong importer or it may be a written statement available to the general public. The statement may be used for more than one export or reexport to Hong Kong so long as it remains an accurate statement of Hong Kong law.

(2) Reexports from Hong Kong. No license issued by BIS may be used to reexport from Hong Kong any item subject to the EAR controlled on the CCL for NS, MT, NP column 1, and/or CB reasons unless the reexporter has received either:

(i) An export license issued by the Government of the Hong Kong Special Administrative Region, pursuant to the Hong Kong Import and Export (Strategic Commodities) Regulations, that covers all items to be rexported pursuant to that BIS license for which a Hong Kong export license is required and that is valid on the date of the reexport that is subject to the EAR; or

(ii) A copy of a written statement issued by the Government of the Hong Kong Special Administrative Region that no export license is required from Hong Kong for the item(s) to be reexported. The statement may have been issued directly to the Hong Kong reexporter or it may be a written statement available to the general public. The statement may be used for more than one reexport from Hong Kong so long as it remains an accurate statement of Hong Kong law.

(b) Recordkeeping. The documents required to be obtained by paragraph (a) of this section must be retained and made available to the U.S. Government upon request in accordance with part 762 of the EAR.

PART 762—RECORDKEEPING 6. The authority citation for part 762 continues to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

7. In § 762.2 remove the word “and” from the end of paragraph (b)(52); remove the period from the end of paragraph (b)(53) and add in its place a semicolon followed by the word “and”; add paragraph (b)(54) to read as follows:
§ 762.2 Records to be retained.

(b) * * *

(54) § 748.13, Certain Hong Kong import and export licenses.

Dated: January 6, 2017. Kevin J. Wolf, Assistant Secretary for Export Admiration.
[FR Doc. 2017-00446 Filed 1-18-17; 8:45 am] BILLING CODE 3510-33-P
DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Parts 742 and 748 [Docket No. 170104015-7015-01] RIN 0694-AH26 Amendments to the Export Administration Regulations Implementing an Additional Phase of India-U.S. Export Control Cooperation AGENCY:

Bureau of Industry and Security, Commerce.

ACTION:

Final rule.

SUMMARY:

In this final rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) to implement the India-U.S. Joint Statement of June 7, 2016 (June Statement), which recognized the United States and India as Major Defense Partners. This rule amends the EAR by establishing a licensing policy of general approval for exports or reexports to or transfers within India of items subject to the EAR and controlled only for National Security or Regional Stability reasons. In addition, BIS amends the end use and end user provisions of the Validated End User (VEU) authorization to state that items obtained under authorization VEU in India may be used for either civil or military end uses other than those that are for use in nuclear, “missile,” or chemical or biological weapons activities.

DATES:

This rule is effective January 19, 2017.

FOR FURTHER INFORMATION CONTACT:

Alexander Lopes, Director, Office of Nonproliferation Controls and Treaty Compliance, Bureau of Industry and Security, Phone: (202) 482-3825.

SUPPLEMENTARY INFORMATION:

Background

As announced by President Obama and India's Prime Minister Singh in a U.S.-India Joint Statement on November 8, 2010, the United States and India formally committed to work together to strengthen the global nonproliferation and export control framework and further transform bilateral export control cooperation to realize the full potential of the global strategic partnership between the two countries. The leaders agreed to take mutual steps to expand cooperation in civil space, defense, and other high-technology sectors. The steps agreed to by the United States included the removal of Indian defense and space-related entities from the Entity List (Supplement No. 4 to part 744 of the EAR) and the realignment of India in U.S. export control regulations. Additionally, the 2010 Joint Statement announced that the United States “intend[ed] to support India's full membership in the four multilateral export control regimes (Nuclear Suppliers Group, Missile Technology Control Regime, Australia Group, and Wassenaar Arrangement) in a phased manner, and to consult with regime members to encourage the evolution of regime membership criteria,” while maintaining these regimes' core principles, “as the Government of India took steps towards the full adoption of the regimes' export control requirements to reflect its prospective membership, with both processes moving forward together.”

To date, BIS has published two rules implementing the President's and Prime Minister's commitments. The first rule, published on January 25, 2011 (76 FR 4228), revised certain export and reexport controls for India, including the removal of nine Indian entities from the Entity List. In addition, BIS amended the EAR to remove India from Country Groups D:2, D:3 and D:4, and added India to Country Group A:2.

In the second rule, published January 23, 2015 (80 FR 3463), BIS amended the EAR, in furtherance of the United States' commitment to the bilateral understanding, by removing India from Crime Control (CC) columns 1 and 3 and from Regional Stability (RS) column 2 on the Commerce Country Chart in Supplement No. 1 to Part 738 of the EAR, because the Government of India had taken appropriate steps to ensure that U.S.-origin items controlled for CC and RS reasons are not reexported from India without a license. Although the second rule removed the license requirement for the majority of items controlled for CC or RS reasons and destined for India, a license requirement remained for items controlled under export control classification numbers (ECCNs) 6A003.b.4.b and 9A515.e for RS column 2 reasons when destined to India.

In addition, BIS published on August 17, 2016, a third rule (81 FR 54721) that was not specific to the bilateral understanding but nonetheless removed a related requirement to include a destination control statement on shipping documents for items controlled for CC columns 1 and 3, and RS column 2 reasons when the items are exported to India.

New Amendments

In this rule, BIS implements an additional step in furtherance of the U.S.-India bilateral understanding and global strategic partnership. On June 7, 2016, the United States and India issued a Joint Statement entitled, “The United States and India: Enduring Global Partners in the 21st Century.” Specifically, in this rule, BIS implements the understanding between the United States and India expressed in the June Statement regarding U.S. export control policy toward India by establishing a new paragraph (b)(8) in § 742.4 (National Security) and a new paragraph (b)(5) in § 742.6 (Regional Stability). These new provisions establish licensing policies of general approval for exports or reexports to or transfers within India of items subject to the EAR, including “600 series” military items, for civil or military end uses in India or for the ultimate end use by the Government of India, for reexport to a Country Group A:5 country, or for return to the United States, so long as such items are not for use in nuclear, “missile,” or chemical or biological weapons activities. This rule does not amend any other licensing policies in part 742 such as those with respect to Missile Technology items. The rule also does not amend any licensing policies pertaining to naval nuclear propulsion. The Country Group A:5 countries are listed in Supplement Number 1 to part 740 and are often informally referred to as the “STA-36” countries because they are the list of countries to which exports under License Exception Strategic Trade Authorization are authorized pursuant to the conditions and limitations of section 740.20(b)(3).

In addition, BIS amends the end user and end use provisions of the Validated End User (VEU) authorization in § 748.15 (Authorization Validated End-User (VEU)), paragraphs (a) (eligible end user provision) and (d) (end-use restrictions), to allow that items obtained under authorization VEU in India may be used for civil or military end uses other than those that involve items controlled for MT reasons, or if for use in nuclear, “missile,” or chemical or biological weapons activities. Section 748.15(c) does not change the January 23, 2015 (80 FR 3463), amendment to the EAR regarding the export and reexport of Crime Control (CC) columns 1 and 3 items to India. Conforming changes are made to paragraph (7)(ii) in Supplement No. 8 to Part 748 (Information Required in Requests for Validated End-User (VEU) Authorization). No other material changes are made in this rule to the VEU program, such as the process for approving a VEU, VEU compliance obligations, the rules pertaining to VEUs in China, or the process of identifying approved VEUs and eligible items and facilities in Supplement No. 7 to Part 748.

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 most recently by the Notice of August 4, 2016, 81 FR 52587 (August 8, 2016), has continued the EAR 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 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 involves a collection of information approved under OMB control number 0694-0088—Simplified Network Application Process—Redesign System (SNAP-R) and the Multipurpose Export License Application, which carries an annual estimated burden of 31,833 hours. BIS believes that this rule will not have a material impact on that burden because this rule does not increase or decrease BIS's existing licensing requirements. To the extent that it has any impact, BIS believes that the benefits of this rule justify any additional (and likely minimal) additional burden it might create. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget, by email at [email protected] or by fax to (202) 395-7285.

3. This rule does not contain policies with Federalism implications as that term is defined under Executive Order 13132.

4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking and 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 (see 5 U.S.C. 553(a)(1)). This rule advances essential foreign policy, national security, and nonproliferation goals of the United States and a critical strategic partner, India. Subsequent agency deliberations following the June Statement culminated in this framework for regulatory implementation of the Statement. Delay in implementing this rule to obtain public comment or for any other reason would undermine the good faith timeliness in which the United States signed, and now implements, the Statement and, therefore, would undermine the foreign policy objectives that the rule is intended to serve. Further, no other law requires that a notice of proposed rulemaking or 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 for this rule under 5 U.S.C. 553, or by any other law, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable.

List of Subjects 15 CFR Part 742

Exports, Terrorism.

15 CFR Part 748

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

Accordingly, 15 CFR parts 742 and 748 of the EAR (15 CFR parts 730 through 774) are amended as follows:

PART 742—CONTROL POLICY—CCL BASED CONTROLS 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 742.4 is amended by adding paragraph (b)(8) to read as follows:
§ 742.4 National security.

(b) * * *

(8) For India, there is a general policy of approval for license applications to export, reexport, or transfer items, including “600 series” items, for civil or military end uses in India, for ultimate end use by the Government of India, for reexport to countries in Country Group A:5, or for return to the United States, so long as such items are not for use in nuclear, “missile,” or chemical or biological weapons activities.

3. Section 742.6 is amended by adding paragraph (b)(7) to read as follows:
§ 742.6 Regional Stability.

(b) * * *

(7) For India, there is a general policy of approval for license applications to export, reexport, or transfer items, including “600 series” items, for civil or military end uses in India, for ultimate end use by the Government of India, for reexport to countries in Country Group A:5, or for return to the United States, so long as such items are not for use in nuclear, “missile,” or chemical or biological weapons activities.

PART 748—APPLICATIONS (CLASSIFICATION, ADVISORY, AND LICENSE) AND DOCUMENTATION 4. The authority citation for 15 CFR part 748 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).

5. Section 748.15 is amended by revising paragraphs (a)(2) and (d) introductory text to read as follows:
§ 748.15 Authorization Validated End-User (VEU).

(a) * * *

(2) In evaluating an end user for eligibility under authorization VEU, the ERC will consider a range of information, including such factors as: The entity's record of exclusive engagement in appropriate end-use activities; the entity's compliance with U.S. export controls; the need for an on-site review prior to approval; the entity's capability of complying with the requirements of authorization VEU; the entity's agreement to on-site reviews by representatives of the U.S. Government to ensure adherence to the conditions of the VEU authorization; and the entity's relationships with U.S. and foreign companies. In addition, when evaluating the eligibility of an end user, the ERC will consider the status of export controls and the support and adherence to multilateral export control regimes of the government of the eligible destination.

(d) End-use restrictions. Items obtained under authorization VEU in China may be used only for civil end uses and may not be used for any activities described in part 744 of the EAR. Items obtained under authorization VEU in India may be used for either civil or military end uses and may not be used for any activities described in part 744 of the EAR. Exports, reexports, or transfers made under authorization VEU may be made to an end user listed in Supplement No. 7 to this part only if the items will be consigned to and for use by the validated end user. Eligible end-users who obtain items under VEU may only:

6. Paragraph (7)(ii) of the section titled Required Information for Validated End-User Authorization Requests in Supplement No. 8 to part 748 is revised to read as follows: Supplement No. 8 to Part 748—Information Required in Requests for Validated End-User (VEU) Authorization Required Information for Validated End-User Authorization Requests

(7) * * *

(ii) Understands and will abide by all authorization VEU end-use restrictions, including the requirement that items received under authorization VEU will only be used for authorized end-uses and may not be used for any activities described in part 744 of the EAR;

Dated: January 6, 2017. Kevin J. Wolf, Assistant Secretary for Export Administration.
[FR Doc. 2017-00439 Filed 1-18-17; 8:45 am] BILLING CODE 3510-33-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 15 CFR Part 902 50 CFR Part 300 [Docket No. 120201087-6641-02] RIN 0648-BB86 International Affairs; Antarctic Marine Living Resources Convention Act AGENCY:

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

ACTION:

Final rule.

SUMMARY:

This final rule sets forth changes to the regulations that implement conservation measures adopted by the Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR or Commission). This final rule streamlines and clarifies the regulations for Antarctic marine living resources, shifts deadlines for advance notice of intended fishing activities, distinguishes between first receivers and dealers of Antarctic marine living resources (AMLR), reduces the time for advance notice of imports of Dissostichus species, and adds transshipment notification requirements. The sections of these regulations are reorganized to group requirements related to the trade of Antarctic marine living resources and those that apply to fishing activities. Additionally, this action updates the regulations to reflect Commission-adopted revisions to existing conservation measures and changes made to the Antarctic Marine Living Resources Convention Act through the Illegal, Unreported, and Unregulated Fishing Enforcement Act of 2015.

DATES:

This rule is effective February 21, 2017.

FOR FURTHER INFORMATION CONTACT:

Mi Ae Kim, Office of International Affairs and Seafood Inspection, NMFS (phone 301-427-8365, or email [email protected]).

SUPPLEMENTARY INFORMATION:

Background

The United States is a Contracting Party to the Convention on the Conservation of Antarctic Marine Living Resources (Convention). Under Article VII of the Convention, contracting parties established and agreed to maintain the Commission to give effect to the Convention's objective—conservation of AMLR. The United States, along with 23 other countries and the European Union, are members of the Commission and meet annually to formulate, adopt and revise conservation measures. Article IX(6) of the Convention requires the Commission to notify conservation measures to all members and, 180 days thereafter, such measures become binding. If a member objects to a measure within 90 days of notification, the measure is not binding on that member and, should that occur, Article IX(6)(d) of the Convention includes a procedure that allows other members to notify that they can no longer accept that measure.

The Antarctic Marine Living Resources Convention Act of 1984 (AMLRCA), codified at 16 U.S.C. 2431, et seq., provides the statutory authority for the United States to carry out its obligations under the Convention, including implementation of Commission-adopted conservation measures. AMLRCA section 305(a)(1) authorizes the Secretary of State, with the concurrence of the Secretary of Commerce and the Director of the National Science Foundation, to decide whether the United States is unable to accept or can no longer accept a Commission-adopted conservation measure (16 U.S.C. 2434(a)(1)). AMLRCA also gives the Secretary of Commerce authority to promulgate regulations as necessary and appropriate to implement the Act. This authority has been delegated to the Assistant Administrator for Fisheries (Assistant Administrator), who has implemented Commission-adopted conservation measures that are binding on the United States under Article IX of the Convention through regulations at 50 CFR part 300, subpart G (AMLR regulations).

Through the “Illegal, Unreported, and Unregulated Fishing Enforcement Act” (IUU Fishing Enforcement Act), Public Law 114-81 (2015), Congress amended AMLRCA section 306, 16 U.S.C. 2435, which specifies unlawful activities; section 307, 16 U.S.C. 2436, which provides the Secretary of Commerce authority to promulgate regulations that are necessary and appropriate to implement AMLRCA; and section 308(a), 16 U.S.C. 2437(a), which specifies the penalties available for violations of the Act. Public Law 114-81 (2015), Title I, 106(1)-(2).

At each annual meeting, the Commission may adopt new conservation measures or revise existing measures. While all conservation measures are subject to revision at the annual meeting, some (particularly those in the fishery regulation category) expire after one or two fishing seasons and so must be revised annually or biennially, to reflect management or monitoring needs identified during Commission deliberations, changes in catch limits or bycatch limits, or other considerations.

Through this action, NMFS reorganizes, streamlines, and updates the regulations that implement AMLRCA and Commission-adopted conservation measures. These revisions incorporate regulatory changes that were finalized on August 3, 2016 (80 FR 51126) regarding the collection of trade documentation within the government-wide International Trade Data System and required electronic information collection. Certain sections are rearranged so that regulations applicable to the trade of AMLR are grouped together while other sections that are obsolete are removed. This action removes sections that implement annual measures which will be implemented through vessel permits if applicable to the permitted fishing activities.

On July 21, 2016, NMFS published a notice of proposed rulemaking for this action (81 FR 47325) to reorganize and update the regulations implementing U.S. obligations under the Convention. The preamble of the proposed rule (81 FR 47325) provides a detailed description of the changes to these regulations as well as NMFS's implementation of annual or biennial measures as conditions to vessel permits instead of through regulations. Responses to public comments received on the proposed rule are set forth below.

Changes From the Proposed Rule

With the exception of minor, non-substantive editorial corrections, this final rule includes no changes to the regulatory text that was published in the proposed rule.

Responses to Public Comments

NMFS received two public comments on the proposed rule which are addressed below.

CCAMLR Ecosystem Monitoring Program Sites

Comment 1: A commenter expressed concern over the removal of the list of CCAMLR Ecosystem Monitoring Program (CEMP) sites from the regulations.

Response: This final rule removes the list of CEMP sites because these sites (Seal Islands, South Shetland Islands and Cape Shirreff and the San Telmo Islands) are no longer protected under CCAMLR conservation measures. The Scientific Committee advised during the 2007 meeting of the Commission that: “because research on the Seal Island CEMP site was no longer undertaken, Conservation Measure 91-03 should be discontinued.” As a result, the Commission discontinued Conservation Measure 91-03 (Report of the Twenty-Sixth Meeting of the Commission: Paragraphs 7.1 and 7.2). Similarly, during the 2009 meeting of the Commission, upon advice from the Scientific Committee, the Commission rescinded Conservation Measure 91-02 (Protection of the Cape Shirreff CEMP site) to avoid duplication of effort on the part of researchers, national governments and the secretariats of CCAMLR and Antarctic Treaty System and noting that the site would continue to be protected under the management plan of an Antarctic Specially Protected Area (ASPA) (Report of the Twenty-Eighth Meeting of the Commission: Paragraph 12.5). ASPAs, as well as Antarctic Specially Managed Areas (ASMAs) are designated and managed under the Antarctic Treaty, and CCAMLR cooperates in implementing these designations and management plans by having Contracting Parties ensure that their fishing vessels are aware of the location and relevant management plan of all designated ASPAs and ASMAs.

Regulatory Structure

Comment 2: NMFS received a comment from United States Seafoods, LLC suggesting that NMFS consider its experience on managing fisheries under the Magnuson-Stevens Fishery Conservation and Management Act (MSA) to establish a stable regulatory environment for U.S. vessels that intend to fish in the CCAMLR Convention Area.

Response: U.S. fishing vessels have not operated within the Convention Area for over a decade. For U.S. vessels interested in fishing in the Convention Area, NMFS established procedures and requirements under the AMLR regulations and, through this rulemaking, makes improvements to that regulatory framework. One improvement is that, under this rule, NMFS may implement annual and biennial measures adopted by CCAMLR as conditions to vessel permits instead of through regulations. Given the short time period between the adoption of new measures by CCAMLR in the fall and the start of the fishing season on December 1, this approach will make the regulatory process more efficient for U.S. vessels and NMFS.

Section 300.101 of the rule defines “annual or biennial measure” as a conservation measure that: (1) Applies to the operation of the Convention's commercial or exploratory fisheries such as gear, catch, and effort restrictions and time and area closures; (2) generally expires after one or two fishing season(s); and (3) does not require the development of policy options or a regulatory framework. This approach will apply only to conservation measures that do not require the development of policy options or a regulatory framework. NMFS will provide for notice-and-comment rulemaking when implementation of a conservation measure implicates other requirements of domestic law or when NMFS needs to interpret or expand upon a conservation measure.

Under this final rule, an application for a vessel permit must be submitted by April 1 for the fishing season that will commence on or after December 1 of that year. Therefore, as part of the vessel permit application process and through the permit itself once issued by NMFS, the applicant would have notice of applicable measures in advance of the start of the fishing season. Moreover, annual and biennial measures, along with all CCAMLR conservation measures currently in force are updated every year following the Commission's annual meeting and made available on the Commission's Web site, www.ccamlr.org and are, therefore, available to all interested members of the public, including prospective participants in CCAMLR fisheries. NMFS may reconsider its approach to implementation of annual and biennial measures if participation by U.S. fishing vessels in CCAMLR fisheries increases.

Classification

This rule is published under the authority of Antarctic Marine Living Resources Convention Act, codified at 16 U.S.C. 2431 et seq.

Regulatory Flexibility Act (RFA)

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) at the proposed rule stage that this rule is not expected to have a significant economic impact on a substantial number of small entities (81 FR 47330, July 21, 2016). The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis is not required and none has been prepared.

Paperwork Reduction Act

This rule contains a Paperwork Reduction Act (PRA) collection-of-information approved by the Office of Management and Budget (OMB) under control number 0648-0194. The table appearing at 15 CFR part 902 is updated to reflect the reorganization of regulations under this final rule. The current, approved collection of information includes permit applications (CEMP, vessel permit, dealer permit, and pre-approval of toothfish imports), vessel and gear marking requirements, installation of and reporting through a vessel monitoring unit, import tickets, and other items.

This rule also contains a new PRA collection-of-information that requires advance notification of transshipments of AMLRs, bait, fuel, or other goods and materials to the CCAMLR Secretariat and submission of a confirmation of the notification to NMFS Headquarters, including information on the vessels involved in the transshipment and the details of the materials being transshipped. The new information collection requirements have been approved by OMB under control number 0648-0742.

Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to 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.

List of Subjects 15 CFR Part 902

Reporting and recordkeeping requirements.

50 CFR Part 300

Antarctica, Antarctic marine living resources, Catch documentation scheme, Fisheries, Fishing, Intergovernmental relations, Reporting and recordkeeping requirements.

Dated: January 5, 2017. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

For the reasons set out in the preamble, NMFS amends 15 CFR part 902 and 50 CFR part 300 as follows:

TITLE 15: COMMERCE AND FOREIGN TRADE PART 902—NOAA INFORMATION COLLECTION REQUIREMENTS UNDER THE PAPERWORK REDUCTION ACT: OMB CONTROL NUMBERS 1. The authority citation for part 902 continues to read as follows: Authority:

44 U.S.C. 3501 et seq.

2. In § 902.1, the table in paragraph (b) under “50 CFR” is amended by removing the entries for 300.103(a), 300.104(d), 300.104(e), 300.105(c), 300.106(e), 300.107, 300.108(a), 300.108(a), 300.108(c), 300.112, and 300.113 and adding entries in numeric order to read as follows:
§ 902.1 OMB control numbers assigned pursuant to the Paperwork Reduction Act.

(b) * * *

CFR part or section where
  • the information collection
  • requirement is located
  • Current OMB
  • control number
  • (all numbers
  • begin with
  • 0648-)
  • *     *     *     *     *     50 CFR: *    *    *    *    *     300.103(b) and (c) -0194 300.104 -0194 300.105 -0194 300.106 -0194 300.107(c) and (l) -0194 300.107(k) -0724 300.108 -0194 300.109(c) -0194 300.110(e) -0194 300.111 -0194 300.112 -0194 300.113(a) -0194 *    *    *    *    *    
    Title 50: Wildlife and Fisheries PART 300—INTERNATIONAL FISHERIES REGULATIONS 3. The authority citation for part 300 continues to read as follows: Authority:

    16 U.S.C. 951 et seq., 16 U.S.C. 1801 et seq., 16 U.S.C. 5501 et seq., 16 U.S.C. 2431 et seq., 31 U.S.C. 9701 et seq.

    4. Revise subpart G to read as follows: Subpart G—Antarctic Marine Living Resources Sec. 300.100 Purpose and scope. 300.101 Definitions. 300.102 Relationship to other treaties, conventions, laws, and regulations. 300.103 Scientific research. 300.104 International Fisheries Trade Permits and AMLR first receiver permits. 300.105 Preapproval for importation of frozen Dissostichus species. 300.106 Catch Documentation Scheme (CDS) documentation and other requirements. 300.107 Vessel permits and requirements. 300.108 Vessel and gear identification. 300.109 Initiating a new fishery. 300.110 Exploratory fisheries. 300.111 Scientific observers. 300.112 Vessel monitoring system. 300.113 CCAMLR Ecosystem Monitoring Program sites. 300.114 Prohibitions. 300.115 Facilitation of enforcement and inspection. 300.116 Penalties. Subpart G—Antarctic Marine Living Resources Authority:

    16 U.S.C. 2431 et seq., 31 U.S.C. 9701 et seq.

    § 300.100 Purpose and scope.

    (a) This subpart implements the Antarctic Marine Living Resources Convention Act of 1984 (AMLRCA or Act), 16 U.S.C. 2431 et seq.

    (b) This subpart regulates—

    (1) The harvesting of Antarctic marine living resources and other associated activities by any person subject to the jurisdiction of the United States or by any vessel of the United States.

    (2) The import, export, and re-export into the United States of any Antarctic marine living resource.

    § 300.101 Definitions.

    In addition to the terms defined in § 300.2, in the Act, and in the Convention on the Conservation of Antarctic Marine Living Resources, done at Canberra, Australia, May 7, 1980 (Convention) the terms used in this subpart have the following meanings for purposes of this subpart. If a term is defined differently in § 300.2, than in the Act, or Convention, the definition in this section shall apply.

    ACA means the Antarctic Conservation Act of 1978 (16 U.S.C. 2401, et seq.).

    Annual or biennial measure means a conservation measure that:

    (1) Applies to the operation of the Convention's commercial or exploratory fisheries such as gear, catch, and effort restrictions and time and area closures;

    (2) Generally expires after one or two fishing season(s); and

    (3) Does not require the development of policy options or a regulatory framework.

    Antarctic convergence means a line joining the following points along the parallels of latitude and meridians of longitude:

    Lat. Long. 50° S 0. 50° S 30° E. 45° S 30° E. 45° S 80° E. 55° S 80° E. 55° S 150° E. 60° S 150° E. 60° S 50° W. 50° S 50° W. 50° S 0.

    Antarctic marine living resources or AMLR(s) means:

    (1) The populations of finfish, mollusks, crustaceans, and all other species of living organisms, including birds, found south of the Antarctic Convergence;

    (2) All parts or products of those populations and species set forth in paragraph (1) of this definition.

    Centralized Vessel Monitoring System (C-VMS) means the system operated by the Secretariat of CCAMLR that receives reports of positional and other information from satellite-linked mobile transceiver units located on vessels that are submitted to the CCAMLR Secretariat, either directly from the vessel or through the relevant flag State.

    Commission or CCAMLR means the Commission for the Conservation of Antarctic Marine Living Resources established under Article VII of the Convention.

    Convention Area means all waters south of the Antarctic Convergence.

    Dealer means a person who imports AMLRs into, or exports or re-exports AMLRs from, the United States.

    Dissostichus catch document (DCD) is a document generated through CCAMLR's electronic catch documentation scheme (CDS), containing information relating to the harvest, landing, and transshipment of Dissostichus species.

    Dissostichus export document (DED) is a document generated through the CCAMLR's electronic CDS, containing information relating to the export of Dissostichus spp.

    Dissostichus re-export document (DRED) is a document generated through CCAMLR's electronic CDS, containing information relating to the re-export of Dissostichus spp.

    Dissostichus species or Dissostichus spp. means Patagonian toothfish and Antarctic toothfish, and any parts or products therefrom.

    Enhanced mobile transceiver unit or EMTU means a transceiver or communication device, including all hardware and software, carried and operated on a vessel as part of a vessel monitoring system.

    Export means any movement of fish or fish product from a territory under the control of the State or free trade zone of landing, or, where that State or free trade zone forms part of a customs union, any other Member State of that customs union.

    First receiver means the person who first receives AMLRs landed from a vessel licensed under 50 CFR 300.107 at a U.S. port.

    Fish means finfish, mollusks, and crustaceans.

    Fishery means:

    (1) One or more stocks of fish that are treated as a unit for purposes of conservation and management and that are identified on the basis of geographical, scientific, technical, recreational, and economic characteristics.

    (2) Any fishing for such stocks.

    Harvesting vessel means any vessel of the United States (including any boat, ship, or other craft), that is used for, equipped to be used for, or of a type that is normally used for harvesting.

    Import means the physical entering or bringing of a fish or fish product into any part of the geographical territory under the control of a State, except where the catch is landed or transshipped within the definitions of landing or transshipment.

    Individual permit means a National Science Foundation (NSF) permit issued under 45 CFR part 670; or an NSF award letter (demonstrating that the individual has received an award from NSF to do research in the Antarctic); or a marine mammal permit issued under § 216.31 of this chapter; or an endangered species permit issued under § 222.21 of this chapter.

    Inspection vessel means a vessel carrying a CCAMLR inspector and displaying the pennant approved by CCAMLR to identify such vessel.

    International observer means a scientific observer operating in accordance with the CCAMLR Scheme of International Scientific Observation and the terms of a bilateral arrangement concluded between the United States and another member of CCAMLR for the placement of a U.S. national onboard a vessel flagged by another member of CCAMLR or for the placement of the national of another member of CCAMLR onboard a vessel of the United States.

    Land or Landing means to begin offloading any fish, to arrive in port with the intention of offloading any fish, or to cause any fish to be offloaded. However, for purposes of catch documentation as provided for in § 300.106, land or landing means the initial unloading or transfer of Dissostichus spp. in any form from a vessel to dockside even if such fish are subsequently transferred to a container or to another vessel in a port or free trade zone.

    National observer means a U.S. national placed and operating onboard a vessel of the United States as a scientific observer in accordance with § 300.111.

    National Seafood Inspection Laboratory means the NMFS laboratory located at 3209 Frederic Street, Pascagoula, MS 39567, telephone (228) 769-8964, email [email protected]

    Office of Law Enforcement (OLE) refers to the NOAA Office of Law Enforcement.

    Port-to-port means from the time the vessel leaves port to the time that the vessel returns to port and at all points in between.

    Real-time means as soon as possible, but at least every hour with no more than a 1-hour delay.

    Recreational fishing means fishing with hook and line for personal use and not for sale.

    Re-export means any movement of a fish or fish product from a territory under the control of a State, free trade zone, or Member State of a customs union of import unless that State, free trade zone, or any Member State of that customs union is the first place of landing, in which case the movement is an export within the definition of export.

    Seal excluder device means a barrier within the body of a trawl comprised of a metal frame, nylon mesh, or any material that results in an obstruction to seals between the mouth opening and the cod end of the trawl. The body of the trawl net forward of the barrier must include an escape opening through which seals entering the trawl can escape.

    Specially Validated Dissostichus Catch Document (SVDCD) means a Dissostichus catch document that has been specially issued by a State to accompany seized or confiscated Dissostichus spp. offered for sale or otherwise disposed of by the State.

    Transship or transshipment means the transfer of fish or fish products, other AMLRs, or any other goods or materials directly from one vessel to another. However, for purposes of catch documentation as provided for in § 300.106, transship or transshipment means the transfer of Dissostichus spp. that has not been previously landed, from one vessel directly to another, either at sea or in port.

    Vessel Monitoring System (VMS) means a system that uses satellite-linked EMTUs installed on vessels to allow a flag State or other entity to receive automatic transmission of positional and other information related to vessel activity.

    § 300.102 Relationship to other treaties, conventions, laws, and regulations.

    (a) Other conventions and treaties to which the United States is a party and other Federal statutes and implementing regulations may impose additional restrictions on the harvesting and importation into the United States of AMLRs.

    (b) The ACA implements the Antarctic Treaty Agreed Measures for the Conservation of Antarctic Fauna and Flora (12 U.S.T. 794). The ACA and its implementing regulations (45 CFR part 670) apply to certain defined activities of U.S. citizens south of 60° S. lat.

    (c) The Marine Mammal Protection Act of 1972 (16 U.S.C. 1361 et seq.), the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.), the Migratory Bird Treaty Act (16 U.S.C. 701 et seq.), and their implementing regulations also apply to the harvesting and importation of AMLRs.

    (d) Rule making exceptions. When implementing conservation measures adopted and notified by CCAMLR, NMFS may apply the following exceptions to Administrative Procedure Act (APA) rulemaking requirements at 5 U.S.C. 553(b)-(d):

    (1) The foreign affairs function exception of the APA, 5 U.S.C. 553(a)(1); or

    (2) The exception under subsection 307(b) of AMLRCA, 16 U.S.C. 2436(b), that provides that, notwithstanding 5 U.S.C. 553(b)-(d), NMFS may publish in the Federal Register a final regulation to implement any CCAMLR-adopted conservation measure—

    (i) That has been in effect for 12 months or less, beginning on the date that the Commission notifies the United States of the conservation measure under Article IX of the Convention; and

    (ii) With respect to which the Secretary of State does not notify the Commission in accordance with section 305(a)(1) of AMLRCA within the time period allotted for objections under Article IX of the Convention.

    (e) Annual or biennial measures. NMFS may implement annual or biennial measures adopted by CCAMLR as conditions to vessel permits issued under section 300.107, instead of through rulemaking.

    § 300.103 Scientific research.

    (a) This section applies to any person, using a vessel for research purposes, who intends to catch more than 1 tonne of finfish or krill or use gear other than longline, trawl, or pot to catch Dissostichus spp.

    (b) Any person planning to use a vessel for research purposes, when the estimated research catch is expected to be less than 50 tonnes of finfish in a season, and no more than the amounts specified in Table 1, must notify the Assistant Administrator at least 2 months in advance of the planned research using the CCAMLR Format for Notification of Research Vessel Activity, Format 1. A copy of the format is available from NMFS Headquarters. The format requires:

    (1) Name and registration number of vessel;

    (2) Division and subarea in which research is to be carried out;

    (3) Estimated dates of entering and leaving the Convention Area;

    (4) Purposes of research; and

    (5) Fishing equipment to be used (bottom trawl, midwater trawl, longline, crab pots, other).

    Table 1—Taxa-Specific Thresholds for Notification of Research Vessel Activity Taxon Gear type Expected catch Thresholds for finfish taxa: Dissostichus spp Longline 5 tonnes. Trawl 5 tonnes. Pot 5 tonnes. Other 0 tonnes. Champsocephalus gunnari All 10 tonnes. Thresholds for non-finfish taxa: Krill All 0.1 percent of the catch limit for a given area. Squid Crabs

    (c) Any person planning to use any vessel for research purposes, when the estimated research catch is expected to be more than 50 tonnes or greater than the amounts specified in Table 1 must report the details of the research plan to NMFS using CCAMLR Format 2 for Notification of Research Vessel Activity. The format must be submitted to Assistant Administrator at least 7 months in advance of the planned start date for the research. A copy of the format is available from NMFS Headquarters. The format requires:

    (1) Description of the main objective of the research;

    (2) Description of the fishery operations;

    (3) Description of the survey design, data collection, and analysis;

    (4) Proposed catch limit;

    (5) Description of the research capability; and

    (6) Description of the reporting for evaluation and review.

    (d) Where the expected catch is more than 50 tonnes of fish or greater than the amounts specified in Table 1, the planned fishing for research purposes shall not proceed until the Assistant Administrator authorizes the person in writing that he or she may proceed. Such authorization may be provided after completion of review of the scientific research plan by the CCAMLR Scientific Committee and Commission.

    (e) A summary of the results of any research subject to these provisions must be provided to the Assistant Administrator within 150 days of the completion of the research and a full report must be provided within 11 months.

    (f) Catch, effort, and biological data resulting from the research must be reported using the reporting format for research vessels in accordance with relevant conservation measures, with a copy to NMFS Headquarters.

    § 300.104 International Fisheries Trade Permits and AMLR first receiver permits.

    (a) General. (1) A person may import, export, or re-export AMLR into the United States only under a NMFS-issued International Fisheries Trade Permit (IFTP). For AMLRs to be released for entry into the United States, the product must be accompanied by a vessel permit, individual permit, AMLR first receiver permit, or IFTP.

    (2) All shipments of Dissostichus spp. must also be accompanied by accurate, complete and valid CDS documentation (including all required validations and DEDs/DREDs) as described in § 300.106, and, in the case of shipments of frozen Dissostichus species, a preapproval certificate issued under § 300.105, as well as verifiable information that the harvesting vessel was reporting to C-VMS from port-to-port, regardless of where the fish were harvested. For purposes of entry of Dissostichus spp. into the United States, NMFS will only accept electronic CDS documents described in § 300.106.

    (3) Imports of fresh or frozen Dissostichus spp. accompanied by an SVDCD are prohibited.

    (b) International Fisheries Trade Permit. A person intending to import, export, or re-export AMLR must possess a valid IFTP issued under § 300.322 and file required data sets electronically with Customs and Border Protection (CBP) at the time, or in advance, of importation, exportation or re-exportation. “Required data set” has the same meaning as § 300.321 (see definition of “Documentation and data sets required”). See § 300.322 for IFTP application procedures and permit regulations. The IFTP holder may only conduct those specific activities stipulated by the IFTP.

    (c) AMLR First Receiver Permits. (1) General. First receivers of AMLR catch landed from a vessel permitted under § 300.107 at a U.S. port of landing must possess an AMLR first receiver permit and may only conduct those activities described in the permit. A person issued, or required to have been issued a first receiver permit under this subpart may only receive fish from a U.S. vessel that has a valid vessel permit issued under § 300.107 as well as a valid High Seas Fishing Permit issued under 50 CFR part 300, subpart R.

    (2) Application. Applications for the AMLR first receiver permit are available from NMFS Headquarters.

    (3) Issuance. NMFS may issue an AMLR first receiver permit if the permit application is complete and NMFS determines that the activity proposed by the first receiver meets the requirements of the Act. First receivers of AMLR required to have a first receiver permit may only receive AMLR that were harvested in a manner consistent with CCAMLR conservation measures and this subpart.

    (4) Duration. Unless revoked or suspended, an AMLR first receiver permit is valid from its date of issuance to its date of expiration.

    (5) Prohibition on transfer or assignment. AMLR first receiver permits are valid only for the person to whom NMFS issued the permit and may not be transferred or assigned.

    (6) Changes in information submitted by permit applicants or permit holders:

    (i) Changes in pending applications. Applicants for an AMLR first receiver permit must report any change in the information contained in the application to the Assistant Administrator in writing as soon as possible.

    (ii) Changes occurring after permit issuance. An AMLR first receiver permit holder must report any change to information previously submitted to the Assistant Administrator in writing within 15 days of the change. Based on such information, the Assistant Administrator may revise the permit effective upon notification to the permit holder.

    (7) Fees. NMFS may charge a fee to recover the administrative expenses of permit issuance. NMFS will determine the fee in accordance with the procedures in the NOAA finance handbook, available from NMFS, for calculating administrative costs of special products and services.

    (8) Reporting and recordkeeping requirements. First receivers of AMLRs who have been issued, or are required to have, a first receiver permit under this subpart must:

    (i) Accurately maintain all reports and records required by their first receiver permit and this subpart at their place of business;

    (ii) Maintain the original permit at their place of business;

    (iii) Make their permit, and all required reports and records, available for inspection upon the request of an authorized officer; and

    (iv) Within the time specified in the permit, submit a copy of such reports and records to NMFS at an address designated by NMFS.

    (d) Revision, suspension, or revocation. NMFS may revise, suspend, or revoke an IFTP, or first receiver permit, issued under this section based upon a violation of the permit, the Act, or this subpart.

    (e) A person may not import a marine mammal into the United States unless authorized and accompanied by an import permit issued under the Marine Mammal Protection Act and/or the Endangered Species Act.

    § 300.105 Preapproval for importation of frozen Dissostichus species

    (a) A NMFS-issued preapproval certificate is required to import each shipment of frozen Dissostichus species.

    (b) Application. Application forms for a preapproval certificate are available from NMFS Headquarters and the National Seafood Inspection Laboratory. With the exception of the U.S. Customs 7501 entry number, a complete and accurate application must be received by NMFS for each preapproval certificate at least 10 working days before the anticipated date of the importation. Dealers must supply the U.S. Customs 7501 entry number at least three working days prior to the expected arrival of a shipment of frozen Dissostichus species at a U.S. port.

    (c) Fees. A person must include the processing fee with each preapproval certificate application. NMFS will determine the fee under the NOAA finance handbook procedures for calculating administrative costs of special products and services and user fees collected for administrative expenses associated with processing applications for preapproval certificates.

    (d) Issuance. NMFS may issue a preapproval certificate for importation of a shipment of frozen Dissostichus species if the preapproval application form is complete and NMFS determines that the activity proposed by the applicant meets the requirements of the Act and that the resources were not harvested in violation of any CCAMLR conservation measure or in violation of any regulation in this subpart. No preapproval will be issued for Dissostichus species without verifiable documentation that the harvesting vessel reported to C-VMS continuously and in real-time from port-to-port, regardless of where such Dissostichus species were harvested.

    (e) Duration. A preapproval certificate is valid until the Dissostichus product specified in the preapproval application is imported.

    (f) Transfer. A person may not transfer or assign a preapproval certificate.

    (g) Changes in information—(1) For pending preapproval certificates, applicants must report in writing to NMFS any changes in the information submitted in their preapproval certificate applications. NMFS may extend the processing period for the application as necessary to review and consider any changes.

    (2) Issued preapprovals. For issued preapproval certificates, the certificate holder must report in writing to NMFS any changes to information included in the preapproval certificate application. Any changes related to fish being imported, such as harvesting vessel or country of origin, type and quantity of the fish to be imported or Convention statistical subarea from which the resource was harvested, will void the preapproval certificate and the shipment may not be imported unless authorized by NMFS through issuance of a revised or new preapproval certificate.

    (3) The provision of false information in a preapproval application, or the failure to report a change in the information contained in a preapproval application, voids the application or preapproval as applicable.

    (h) NMFS will not issue a preapproval certificate for any shipment of Dissostichus species:

    (1) Identified as originating from a high seas area designated by the Food and Agriculture Organization of the United Nations as Statistical Area 51 or Statistical Area 57 in the eastern and western Indian Ocean outside and north of the Convention Area;

    (2) Determined to have been harvested or transshipped in contravention of any CCAMLR Conservation Measure in force at the time of harvest or transshipment;

    (3) Determined to have been harvested or transshipped by a vessel identified by CCAMLR as having engaged in illegal, unreported and unregulated (IUU) fishing; or

    (3) Accompanied by inaccurate, incomplete, invalid, or improperly validated CDS documentation or by a SVDCD.

    § 300.106 Catch Documentation Scheme (CDS): Documentation and other requirements.

    (a) General. (1) CCAMLR CDS document(s) must accompany all shipments of Dissostichus species as required in this section.

    (2) No shipment of Dissostichus species shall be released for entry into the United States unless accompanied by an accurate, complete, valid and validated CCAMLR CDS document.

    (3) Dissostichus species shall not be released for entry into the United States unless all of the applicable requirements of the CCAMLR Conservation Measures and U.S. regulations have been met.

    (b) Harvesting vessels. (1) A U.S. vessel harvesting or attempting to harvest Dissostichus species, whether within or outside of the Convention Area, must possess a valid vessel permit issued under § 300.107, a valid High Seas Fishing Permit issued under 50 CFR part 300, subpart R, as well as DCD issued by NMFS, which is non-transferable. The master of the harvesting vessel must ensure that catch and other information specified on the DCD are accurately recorded.

    (2) Prior to offloading Dissostichus species, the master of the harvesting vessel must:

    (i) Electronically convey, by the most rapid means possible, catch and other information to NMFS and record on the DCD a confirmation number received from NMFS;

    (ii) Obtain on the DCD (or copies thereof) the signature(s) of the following persons: If catch is offloaded for transshipment, the master of the vessel(s) to which the catch is transferred; or if catch is offloaded for landing, the signature of both the responsible official(s) designated by NMFS in the vessel permit and the recipient of the catch at the port(s) of landing; and

    (iii) Sign the DCD (or copies thereof), electronically convey by the most rapid means possible each copy to NMFS and provide a copy to each recipient of the catch.

    (3) The master of the harvesting vessel must submit the original DCD (and all copies thereof with original signatures) to NMFS no later than 30 days after the end of the fishing season for which the vessel permit was issued and retain copies of the DCD for a period of 2 years.

    (c) Transshipment vessels. (1) A U.S. vessel transshipping or attempting to transship Dissostichus species, whether within or outside of the Convention Area, must possess a valid vessel permit issued under § 300.107 and a valid High Seas Fishing Permit issued under subpart R of this part. The master of a U.S. vessel receiving Dissostichus species by transshipment must, upon receipt of Dissostichus species, sign each DCD provided by the master of the vessel that offloads Dissostichus species.

    (2) Prior to landing Dissostichus species, the master of the transshipping vessel must:

    (i) Obtain on each DCD (or copies thereof) the signature(s) of both the responsible official(s) designated by NMFS in the vessel permit and the recipient of the catch at the port(s) of landing; and

    (ii) Sign each DCD (or copies thereof), and electronically convey by the most rapid means possible each copy to NMFS and to the flag state(s) of the offloading vessel(s) and provide a copy to each recipient of Dissostichus species.

    (3) The master of the transshipping vessel must submit all DCDs with original signatures to NMFS no later than 30 days after offloading and retain copies for a period of 2 years.

    (d) First receivers. Any person who receives Dissostichus species landed by a vessel at a U.S. port must hold an AMLR first receiver permit issued under § 300.104 and must sign the DCD(s) provided by the master of the vessel and retain copies at their place of business for a period of 2 years. A person issued, or required to have been issued, a first receiver permit under this subpart may only receive fish from a U.S. vessel that has a valid vessel permit issued under § 300.107 as well as a valid High Seas Fishing Permit issued under 50 CFR part 300, subpart R.

    (e) Import. (1) A person who imports fresh Dissostichus species must hold an IFTP issued under § 300.322. To import frozen Dissostichus species into the United States, a person must:

    (i) Obtain a preapproval certificate issued under § 300.105 for each shipment. Among the information required on the application, applicants must provide the document number and export reference number on the DED or DRED corresponding to the intended import shipment and, if requested by NMFS, additional information for NMFS to verify that the harvesting vessel reported to the C-VMS continuously and in real-time, from port-to-port, regardless of where the fish were harvested;

    (ii) Ensure that the quantity of toothfish listed on the DED (or the Dissostichus re-export document if product is a re-export) matches the quantity listed on the preapproval application within a variance of 10 percent; and

    (iii) Provide copies of the DED or DRED as needed to persons who re-export Dissostichus species.

    (2) Imports of fresh Dissostichus species do not require a preapproval certificate. If the amount or value of the fresh Dissostichus species to be imported is below thresholds that trigger the requirement to file entry documentation with U.S. Customs and Border Protection via the Automated Commercial Environment (see definition in § 300.321), the importer must complete a report of each shipment and submit the report to NMFS within 24 hours following importation. Verification of the harvesting vessel's reporting to C-VMS from port-to-port is not required for imports of fresh Dissostichus species.

    (f) Re-export. (1) To re-export Dissostichus species, a person must hold an IFTP issued under § 300.322 and:

    (i) Submit to NMFS a complete and accurate application for a NMFS Dissostichus re-export document, and

    (ii) Obtain validation by a responsible official(s) designated by NMFS and receive an electronically-generated DRED.

    (2) When applying for a re-export approval, a person must reference or include the approval number issued by NOAA, for the original validated Dissostichus import document.

    (g) Export. (1) To export U.S.-harvested Dissostichus species, the person must possess an IFTP issued under § 300.322 and:

    (i) Submit to NMFS a complete and accurate NMFS application for a DED; and

    (ii) Obtain validation by a responsible official(s) designated by NMFS and receive an electronically-generated DED.

    (2) Any person who exports Dissostichus species must include the original validated DED with the export shipment.

    (h) Recordkeeping. Any person who imports, exports or re-exports Dissostichus spp. must:

    (1) Retain a copy of all CDS documents at the person's place of business for a period of 2 years from the date on the documents and provide copies as needed to NMFS; and

    (2) Make the IFTP and all CDS documents and other records and reports required by this subpart available for inspection upon request of an authorized officer.

    § 300.107 Vessel permits and requirements.

    (a) General. In addition to the High Seas Fishing Permit requirements at 50 CFR part 300, subpart R:

    (1) Every vessel of the United States that attempts to harvest or harvests any AMLR must have a vessel permit authorizing the harvest issued under this subpart, unless the attempt or harvest occurs during recreational fishing or is covered by an individual permit. Boats launched from a vessel issued a vessel permit do not require a separate permit, but are covered by the permit issued to the launching vessel. Any enforcement action that results from the activities of a launched boat will be taken against the owner and operator of the launching vessel.

    (2) Any vessel of the United States that receives or attempts to receive any harvested AMLR from another vessel at sea, regardless of whether such transshipment occurs in the Convention Area or that receives, or attempts to receive any other goods or materials from another vessel in the Convention Area, must have a vessel permit authorizing transshipment issued under this subpart. Transshipment vessels must comply with the permitting provisions of this section. This requirement does not apply to scientific research vessels or to transshipments covered under an individual permit.

    (3) Permits issued under this section do not authorize vessels or persons subject to the jurisdiction of the United States to harass, capture, harm, kill, harvest, or import marine mammals. No marine mammals may be taken in the course of commercial fishing operations unless the taking is authorized under the Marine Mammal Protection Act and/or the Endangered Species Act pursuant to an exemption or permit granted by the appropriate agency.

    (b) Responsibility of owners and operators. (1) The owners and operators of vessels permitted, or required to be permitted, under this subpart are jointly and severally responsible for compliance with the Act, this subpart, and any permit issued under the Act and this subpart.

    (2) The owners and operators of each such vessel are responsible for the acts of their employees and agents constituting violations, regardless of whether the specific acts were authorized or forbidden by the owners or operators, and regardless of knowledge concerning their occurrence.

    (3) The owner of a vessel issued a vessel permit under this subpart must report any sale, change in ownership, or other disposition of the vessel to the Assistant Administrator as soon as possible but no later than 15 days after the change.

    (4) The owner and operator of a harvesting vessel issued a permit to fish for krill in the Convention Area using trawl gear must install a seal excluder device and may not possess onboard or deploy trawl gear without a seal excluder device installed.

    (c) Application. Application forms for vessel permits are available from NMFS Headquarters.

    (1) A separate, fully completed and accurate application is required for each vessel for which a permit is requested.

    (2) NMFS must receive applications for vessel permits no later than April 1 for the fishing season that will commence on or after December 1 of that year.

    (3) Applications for a permit to harvest krill must, to the extent possible, identify the products to be derived from the anticipated krill catch.

    (4) NMFS will only accept permit applications for vessels that have been issued an International Maritime Organization (IMO) number.

    (5) NMFS may charge a fee to recover the administrative expense of permit issuance. NMFS will determine the fee in accordance with procedures in the NOAA finance handbook, available from NMFS, for calculating administrative costs of special products and services and user fees.

    (d) Issuance. The Assistant Administrator may issue a vessel permit if the Assistant Administrator determines that the harvesting or transshipment activities described in the application will meet the requirements of the Act and will not:

    (1) Decrease the size of any harvested population to levels below those that ensure its stable recruitment. For this purpose, the Convention provides that its size should not be allowed to fall below a level close to that which ensures the greatest net annual increment.

    (2) Upset the ecological relationships between harvested, dependent, and related populations of AMLRs and the restoration of depleted populations to levels that will ensure stable recruitment.

    (3) Cause changes or increase the risk of changes in the marine ecosystem that are not potentially reversible over 2 or 3 decades, taking into account the state of available knowledge of the direct and indirect impact of harvesting, the effects of the introduction of alien species, the effects of associated activities on the marine ecosystem and the effects of environmental changes, with the aim of making possible the sustained conservation of AMLRs.

    (4) Violate the Convention or any conservation measures in force with respect to the United States under the Convention. The Convention and the schedule of conservation measures in force can be found on the CCAMLR Web site: www.ccamlr.org.

    (e) Duration. A vessel permit is valid from its date of issuance to its date of expiration unless it is revoked or suspended.

    (f) Transfer. Permits are not transferable or assignable. A permit is valid only for the vessel to which it is issued.

    (g) Display. Each vessel must have on board, at all times, a valid vessel permit and the vessel operator must produce it for inspection upon the request of an authorized officer or CCAMLR inspector.

    (h) Changes in information submitted by permit applicants or holders—(1) Changes in pending applications. Applicants for a vessel permit must report to the Assistant Administrator in writing any change in the information contained in the application. The processing period for the application will be extended as necessary to review the change.

    (2) Changes occurring after permit issuance—(i) Requested changes in the location, manner, or amount of harvesting. Any changes in the location, manner or amount of harvesting must be proposed in writing to the Assistant Administrator and may not be undertaken unless authorized by the Assistant Administrator through a permit revision or issuance of a new permit. If the Assistant Administrator determines that the requested change in the location, manner, or amount of harvesting could significantly affect the status of any Antarctic marine living resource, the Assistant Administrator will treat the requested change as an application for a new permit and so notify the holder.

    (ii) Changes other than in the location, manner or amount of harvesting. For changes other than those addressed in paragraph (h)(2)(i) of this section, the owner or operator of a vessel that has been issued a vessel permit must report to the Assistant Administrator in writing any change in previously submitted information as soon as possible but no later than within 15 days after the change. Based on such reported information, the Assistant Administrator may revise the permit and any revised permit would be effective upon notification to the permit holder.

    (i) Conditions and restrictions. The vessel permit will contain conditions and restrictions that the Assistant Administrator deems necessary for implementation of conservation measures that apply to the harvesting or transshipment activities. The Assistant Administrator may revise the vessel permit to include additional conditions and restrictions on the harvesting vessel as necessary to implement conservation measures in force with respect to the United States or to achieve the purposes of the Convention or the Act. Any additional conditions or restrictions will be effective upon notification to the permit holder.

    (j) Revision, suspension, or revocation for violations. A vessel permit may be revised, suspended, or revoked if the harvesting vessel is involved in the commission of any violation of its permit, the Act, or this subpart. The Assistant Administrator may deny a vessel permit if the applicant or harvesting vessel was previously involved in the commission of any violation of its permit, the Act, or this subpart. Failure to report a change in the information contained in an application within 15 days of the change is a violation of this subpart and voids the application or permit, as applicable. If a change in vessel ownership is not reported, the violation is chargeable to the previous owner.

    (k) Transshipment notification. The vessel operator must notify the CCAMLR Secretariat of transshipments of AMLRs, bait, or fuel, and submit a confirmation of the notification to NMFS Headquarters, no later than 72 hours before the transshipment will take place. The vessel operator must notify the CCAMLR Secretariat of transfers of all other goods, and submit a confirmation of the notification to NMFS Headquarters, no later than 2 hours before the transshipment will take place. Notifications of intended transshipments shall include the following information, for all vessels involved:

    (1) Names, registration numbers, and IMO numbers;

    (2) International radio call signs;

    (3) Flag State;

    (4) Type of vessels, length, gross registered tonnage and carrying capacity;

    (5) Proposed time and position, in latitude and longitude, of transshipment; and

    (6) Details of the type and amount of catches and/or other goods, such as food stores and fuel, involved in the transshipment.

    (l) Reporting and recordkeeping requirements. The operator of any vessel required to have a vessel permit under this subpart must:

    (1) Accurately maintain on board the vessel all CCAMLR reports and records required by its permit.

    (2) Make such reports and records available for inspection upon the request of an authorized officer or CCAMLR inspector.

    (3) Within the time specified in the vessel permit, submit a copy of such reports and records to NMFS.

    (4) Install a NMFS-approved EMTU on board U.S. flagged vessels harvesting AMLR for use in real-time C-VMS port-to-port reporting to a NMFS-designated land-based fisheries monitoring center or centers. The requirements for the installation and operation of the VMS are set forth in § 300.112.

    (5) Provide advance notice of the vessel's entry into port using the CCAMLR Port Inspection Report, including the written declaration that the vessel has not engaged in or supported illegal, unreported and unregulated (IUU) fishing in the Convention Area and has complied with relevant CCAMLR requirements. The CCAMLR Port Inspection Report, and instructions for its submission, is available from NMFS Headquarters.

    § 300.108 Vessel and gear identification.

    (a) Vessel identification. (1) A vessel issued a permit under this subpart must be marked with the vessel's name and its International Radio Call Sign (IRCS) amidships on both the port and starboard sides of the superstructure or hull, so that it is visible at all times from an enforcement or inspection vessel. Fixtures inclined at an angle to the vessel's side or superstructure would be considered as suitable provided that the angle of inclination would not prevent sighting of the IRCS from another vessel or from the air. The vessel's IRCS shall also be marked on the deck. Should an awning or other temporary cover be placed so as to obscure the mark on the deck, the awning or cover shall also be marked with the IRCS. The marks should be placed athwartship with the top of the numbers or letters towards the bow.

    (2) Boats, skiffs and craft carried by the vessel for fishing operations shall bear the same mark as the vessel, except that a numerical suffix specific for the boat, skiff, or craft must follow the IRCS.

    (3) The vessel identification must be in a color in contrast to the background and must be permanently affixed to the vessel in block Roman alphabet letters and Arabic numerals using good quality marine paints. The letters and numbers shall be: At least 1 meter in height (h) for the IRCS placed on the hull, superstructure and/or inclined surfaces and at least 0.3 meter for marks placed on deck. The length of the hyphen shall be half the height of the letters and numbers. The width of the stroke for all letters, numbers and the hyphen shall be h/6. The space between letters and/or numbers shall not exceed h/4 nor be less than h/6. The space between adjacent letters having sloping sides (e.g., A and V) shall not exceed h/8 nor be less than h/10. If a contrasting color is used for the background of the marks, it shall extend to provide a border around the mark of at least h/6.

    (4) The marks and the background shall be maintained in good condition at all times.

    (b) Navigational lights and shapes. Each vessel issued a vessel permit must display the lights and shapes prescribed by the International Regulations for Preventing Collisions at Sea, 1972 (TIAS 8587, and 1981 amendment TIAS 10672), for the activity in which the harvesting vessel is engaged (as described at 33 CFR part 81).

    (c) Gear identification. (1) The operator of each fishing vessel must ensure that all deployed fishing gear is clearly marked at all times at the surface with a buoy displaying the vessel identification of the harvesting vessel (see paragraph (a) of this section) to which the gear belongs, a light visible for 2 miles at night in good visibility, and a radio buoy.

    (2) The operator of each harvesting vessel must ensure that deployed longlines and strings of traps or pots, and gillnets are clearly marked at all times at the surface at each terminal end with a buoy displaying the vessel identification of the harvesting vessel to which the gear belongs (see paragraph (a) of this section), a light visible for 2 miles at night in good visibility, and a radio buoy.

    (3) Unmarked or incorrectly identified fishing gear may be considered abandoned and may be disposed of in accordance with applicable CCAMLR Conservation Measures in force with respect to the United States by any authorized officer or CCAMLR inspector.

    (d) Maintenance. The operator of each vessel issued a vessel permit must:

    (1) Keep the vessel and gear identification clearly legible and in good condition at all times;

    (2) Ensure that nothing on the vessel obstructs the view of the markings from an enforcement or inspection vessel or aircraft; and

    (3) Ensure that the proper navigational lights and shapes are displayed for the vessel's activity and are properly functioning.

    § 300.109 Initiating a new fishery.

    (a) A new fishery, for purposes of this section, is a fishery that uses bottom trawls on the high seas of the Convention Area or a fishery for a species, using a particular method, in a statistical subarea or division for which:

    (1) Information on distribution, abundance, demography, potential yield and stock identity from comprehensive research/surveys or exploratory fishing has not been submitted to CCAMLR;

    (2) Catch and effort data have never been submitted to CCAMLR; or

    (3) Catch and effort data from the two most recent seasons in which fishing occurred have not been submitted to CCAMLR.

    (b) Persons intending to develop a new fishery shall notify the Assistant Administrator no later than April 1 for the fishing season that will commence on or after December 1 and shall not initiate the fishery pending NMFS and CCAMLR review or until a vessel permit has been used under this subpart.

    (c) The notification shall be accompanied by a complete vessel permit application required under § 300.107 and information on:

    (1) The nature of the proposed fishery, including target species, methods of fishing, proposed region and maximum catch levels proposed for the forthcoming season;

    (2) Biological information on the target species from comprehensive research/survey cruises, such as distribution, abundance, demographic data and information on stock identity;

    (3) Details of dependent and related species and the likelihood of them being affected by the proposed fishery;

    (4) Information from other fisheries in the region or similar fisheries elsewhere that may assist in the evaluation of potential yield; and

    (5) If the proposed fishery will be undertaken using bottom trawl gear, the known and anticipated impacts of this gear on vulnerable marine ecosystems, including benthos and benthic communities.

    § 300.110 Exploratory fisheries.

    (a) An exploratory fishery, for purposes of this section, is a fishery that was previously defined as a new fishery under § 300.109.

    (b) A fishery continues to be classified by CCAMLR as an exploratory fishery until sufficient information is available to:

    (1) Evaluate the distribution, abundance, and demography of the target species, leading to an estimate of the fishery's potential yield;

    (2) Review the fishery's potential impacts on dependent and related species; and

    (3) Allow the CCAMLR Scientific Committee to formulate and provide advice to the Commission on appropriate harvest catch levels and fishing gear.

    (c) The operator of any vessel engaging in an exploratory fishery must submit, by the date specified in the vessel permit issued under § 300.107, catch, effort, and related biological, ecological, and environmental data as required by a data collection plan for the fishery formulated by the CCAMLR Scientific Committee.

    (d) In addition to the requirements in § 300.107, any person planning to enter an exploratory fishery must notify the Assistant Administrator no later than April 1 for the fishing season that will commence on or after December 1 and shall not enter the fishery pending NMFS and CCAMLR review or until a vessel permit has been used under this subpart. The Assistant Administrator will not issue a permit to enter an exploratory fishery until after the requirements of § 300.107 have been met and CCAMLR has considered the notification.

    (e) The notification shall be accompanied by a complete vessel permit application required under § 300.107 and information on:

    (1) The nature of the exploratory fishery, including target species, methods of fishing, proposed region and maximum catch levels proposed for the forthcoming season;

    (2) Specification and full description of the types of fishing gear to be used;

    (3) Biological information on the target species from comprehensive research/survey cruises, such as distribution, abundance, demographic data and information on stock identity; details of dependent and related species and the likelihood of their being affected by the proposed fishery;

    (4) Information from other fisheries in the region or similar fisheries elsewhere that may assist in the evaluation of potential yield;

    (5) If the proposed fishery will be undertaken using bottom trawl gear, information on the known and anticipated impacts of this gear on vulnerable marine ecosystems, including benthos and benthic communities; and

    (6) Any other information the Assistant Administrator requires to fully implement the relevant conservation measures.

    § 300.111 Scientific observers.

    (a) Except as otherwise specified, this section applies to both national observers and international observers, as well as to vessels of the United States carrying, or required to carry, such observers.

    (b) All vessels of the United States fishing in the Convention Area must carry one or more scientific observers as required by CCAMLR conservation measures or as specified in a vessel permit issued under this subpart.

    (c) All vessels of the United States conducting longline sink rate testing outside the Convention Area and pursuant to CCAMLR protocols must carry one or more scientific observers as specified in the vessel permit issued under this subpart.

    (d) Procurement of observers by vessel. Owners of vessels required to carry scientific observers under this section must arrange for observer services in coordination with the NMFS Southwest Fisheries Science Center Antarctic Ecosystem Research Division. The vessel owner is required to pay for observer services through an observer service provider who has provided observer services to the Federal government within the past year. In situations where no qualified observer is available through a qualified observer provider, the Secretary may authorize a vessel owner to arrange for an observer by alternative methods. An observer may not be paid directly by the vessel owner.

    (e) Vessel responsibilities. An operator of a vessel required to carry one or more scientific observers must:

    (1) Accommodations and food. Provide, at no cost to the observers or the United States, accommodations and food on the vessel for the observer or observers that are equivalent to those provided for officers of the vessel; and

    (2) Safe conditions. Maintain safe conditions on the vessel for the protection of observers including adherence to all U.S. Coast Guard and other applicable rules, regulations, or statutes pertaining to safe operation of the vessel and have on board:

    (i) A valid Commercial Fishing Vessel Safety Decal issued within the past 2 years that certifies compliance with regulations found in 33 CFR chapter I and 46 CFR chapter I;

    (ii) A certificate of compliance issued pursuant to 46 CFR 28.710; or

    (iii) A valid certificate of inspection pursuant to 46 U.S.C. 3311.

    (3) Health and safety regulations. Comply with the observer health and safety regulations at part 600 of this title.

    (4) Transmission of data. Facilitate transmission of observer data by allowing observers, on request, to use the vessel's communications equipment and personnel for the confidential entry, transmission, and receipt of work-related messages.

    (5) Vessel position. Allow observers access to, and the use of, the vessel's navigation equipment and personnel, on request, to determine the vessel's position, course and speed.

    (6) Access. Allow observers free and unobstructed access to the vessel's bridge, trawl or working decks, holding bins, processing areas, freezer spaces, weight scales, cargo holds, and any other space that may be used to hold, process, weigh, or store fish or fish products at any time.

    (7) Prior notification. Notify observers at least 15 minutes before fish are brought on board, or fish and fish products are transferred from the vessel, to allow sampling the catch or observing the transfer, unless the observers specifically request not to be notified.

    (8) Records. Allow observers to inspect and copy the vessel's DCD, product transfer forms, any other logbook or document required by regulations or CCAMLR conservation measures, printouts or tallies of scale weights, scale calibration records, bin sensor readouts, and production records.

    (9) Assistance. Provide all other reasonable assistance to enable observers to carry out their duties, including, but not limited to:

    (i) Measuring decks, codends, and holding bins;

    (ii) Providing the observers with a safe work area adjacent to the sample collection site;

    (iii) Collecting bycatch when requested by the observers;

    (iv) Collecting and carrying baskets of fish when requested by observers; and

    (v) Allowing observers to determine the sex of fish when this procedure will not decrease the value of a significant portion of the catch.

    (10) Transfer at sea. (i) Ensure that transfers of observers at sea via small boat or raft are carried out during daylight hours, under safe conditions, and with the agreement of observers involved.

    (ii) Notify observers at least 3 hours before observers are transferred, such that the observers can collect personal belongings, equipment, and scientific samples.

    (iii) Provide a safe pilot ladder and conduct the transfer to ensure the safety of observers during transfers.

    (iv) Provide an experienced crew member to assist observers in the small boat or raft in which any transfer is made.

    (f) Insurance. The observer service provider or vessel owner must provide insurance for national observers that provides compensation in the event of an injury or death during the entire deployment, from the point of hire location to return, equivalent to the standards of the North Pacific Groundfish Observer Program set forth in § 679.50 of this title.

    (g) Educational requirements. National observer candidates must:

    (1) Have a Bachelor's degree or higher from an accredited college or university with a major in one of the natural sciences; or

    (2) Have successfully completed a minimum of 30 semester hours or equivalent in applicable biological sciences with extensive use of dichotomous keys in at least one course.

    (h) Health requirements. National observers, and U.S. observers deployed as international observers, must have a signed and dated statement from a licensed physician that he or she has physically examined the observer. The statement must confirm that, based upon the physical examination, the observer does not have any health problems or conditions that would jeopardize that individual's safety or the safety of others while deployed, or prevent the observer from performing his or her duties satisfactorily. The statement must declare that, prior to the examination, the physician was made aware of the duties of an observer and the dangerous, remote and rigorous nature of the work. The physician's statement must be submitted to the NMFS Southwest Fisheries Science Center Antarctic Ecosystem Research Division program office prior to approval of an observer. The physical exam must have occurred during the 12 months prior to the observer's deployment. The physician's statement will expire 12 months after the physical exam occurred. A new physical exam must be performed, and accompanying statement submitted, prior to any deployment occurring after the expiration of the statement.

    (i) Standards of observer conduct. (1) Observers: (i) Must not have a direct financial interest in the fishery being observed, including but not limited to:

    (A) Any ownership, mortgage holder, or other secured interest in a vessel, shoreside or floating stationary processor facility involved in the catching, taking, harvesting or processing of fish;

    (B) Any business involved with selling supplies or services to any vessel, shoreside or floating stationary processing facility; or

    (C) Any business involved with purchasing raw or processed products from any vessel, shoreside or floating stationary processing facilities.

    (ii) Must not solicit or accept, directly or indirectly, any gratuity, gift, favor, entertainment, loan, or anything of monetary value from anyone who either conducts activities that are regulated by NMFS or has interests that may be substantially affected by the performance or nonperformance of the observers' official duties.

    (iii) Must not serve as observers on any vessel or at any shoreside or floating stationary processing facility owned or operated by a person who previously employed the observers.

    (iv) Must not solicit or accept employment as a crew member or an employee of a vessel, shoreside processor, or stationary floating processor while employed by an observer provider.

    (2) Provisions for remuneration of observers under this section do not constitute a conflict of interest.

    (j) Standards of observer behavior. Observers must: (1) Avoid any behavior that could adversely affect the confidence of the public in the integrity of the CCAMLR Scheme of International Scientific Observation or of the government, including but not limited to the following:

    (2) Perform their assigned duties as described in the CCAMLR Scientific Observers Manual and must complete the CCAMLR Scientific Observer Logbooks and submit them to the CCAMLR Data Manager at the intervals specified by the Data Manager.

    (3) Accurately record their sampling data, write complete reports, and report accurately any observations of suspected violations of regulations relevant to conservation of marine resources or their environment.

    (4) Not disclose collected data and observations made on board the vessel or in the processing facility to any person, except the owner or operator of the observed vessel or processing facility or NMFS.

    (5) Refrain from engaging in any illegal actions or any other activities that would reflect negatively on their image as professional scientists, on other observers, or on the CCAMLR Scheme of International Scientific Observation as a whole. This includes, but is not limited to:

    (i) Refrain from engaging in the use, possession, or distribution of illegal drugs; or

    (ii) Refrain from engaging in physical sexual contact with personnel of the vessel or processing facility to which the observer is assigned, or with any vessel or processing plant personnel who may be substantially affected by the performance or non-performance of the observer's official duties.

    (k) Sampling station—(1) Minimum work space aboard at sea processing vessels. The observer must have a working area of 4.5 square meters, including the observer's sampling table, for sampling and storage of fish to be sampled. The observer must be able to stand upright and have a work area at least 0.9 meter (m) deep in the area in front of the table and scale.

    (2) Table aboard at-sea processing vessels. The observer sampling station must include a table at least 0.6 m deep, 1.2 m wide and 0.9 m high and no more than 1.1 m high. The entire surface area of the table must be available for use by the observer. Any area for the observer sampling scale is in addition to the minimum space requirements for the table. The observer's sampling table must be secured to the floor or wall.

    (3) Other requirement for at-sea processing vessels. The sampling station must be in a well-drained area that includes floor grating (or other material that prevents slipping), lighting adequate for day or night sampling, and a hose that supplies fresh or sea water to the observer.

    § 300.112 Vessel monitoring system.

    (a) Requirement for use. Within 30 days after NMFS publishes in the Federal Register a list of approved EMTUs and associated communications service providers for the AMLR fishery, an owner or operator of a vessel that has been issued a vessel permit under § 300.107 must ensure that such vessel has a NMFS-type-approved, operating EMTU installed and continuously operating for the duration of any fishing trip involving the harvesting of AMLR.

    (b) Installing and activating the EMTU. Only EMTUs that have been approved by NMFS for use in the AMLR fishery may be used. The vessel owner or operator shall obtain and have installed on the fishing vessel, by a qualified marine electrician and in accordance with any instructions provided by the VMS Helpdesk or OLE, a NMFS type-approved EMTU.

    (c) Interference with the EMTU. No person may interfere with, tamper with, alter, damage, disable, or impede the operation of the EMTU, or attempt any of the same.

    (d) Interruption of operation of the VMS. When a vessel's EMTU is not operating properly, the owner or operator must immediately contact OLE, and follow instructions from that office. If notified by NMFS that a vessel's EMTU is not operating properly, the owner and operator must follow instructions from that office. In either event, such instructions may include, but are not limited to, manually communicating to a location designated by NMFS the vessel's positions or returning to port until the EMTU is operable.

    (e) Access to data. OLE is authorized to receive and relay transmissions from the EMTU. OLE will share a vessel's position data obtained from the EMTU, if requested, with other NMFS offices, the USCG, and their authorized officers and designees.

    (f) Installation and operation of the VMS. NMFS has authority over the installation and operation of the EMTU. NMFS may authorize the connection or order the disconnection of additional equipment, including a computer, to any EMTU when deemed appropriate by NMFS.

    § 300.113 CCAMLR Ecosystem Monitoring Program sites.

    (a) General. (1) Any person subject to the jurisdiction of the United States must apply for and be granted an entry permit authorizing specific activities prior to entering a CCAMLR Ecosystem Monitoring Program (CEMP) site designated in accordance with the CCAMLR conservation measure describing the procedure for according protection for CEMP sites.

    (2) If a CEMP site is also a site specially protected under the Antarctic Treaty (or the Protocol on Environmental Protection to the Antarctic Treaty and its Annexes, such as the sites listed in 45 CFR 670.29), an applicant seeking to enter such site must apply to the Director of the NSF for a permit under applicable provisions of the ACA or any superseding legislation. The permit granted by NSF shall constitute a joint CEMP/ACA Protected Site permit and any person holding such a permit must comply with the appropriate CEMP site management plan. In all other cases, an applicant seeking a permit to enter a CEMP site must apply to the Assistant Administrator for a CEMP permit in accordance with the provisions of this section.

    (b) Responsibility of CEMP permit holders and persons designated as agents under a CEMP permit. (1) The CEMP permit holder and person designated as agents under a CEMP permit are jointly and severally responsible for compliance with the Act, this subpart, and any permit issued under this subpart.

    (2) The CEMP permit holder and agents designated under a CEMP permit are responsible for the acts of their employees and agents constituting violations, regardless of whether the specific acts were authorized or forbidden by the CEMP permit holder or agents, and regardless of knowledge concerning their occurrence.

    (c) Prohibitions regarding the Antarctic Treaty System and other applicable treaties and statutes. Holders of permits to enter CEMP Protected Sites are not authorized to undertake any activities within a CEMP Protected Site that are not in compliance with the conditions of the CEMP permit and the provisions of:

    (1) The Antarctic Treaty, including the Agreed Measures for the Conservation of Antarctic Fauna and Flora (including the Protocol on the Environmental Protection to the Antarctic Treaty and its Annexes), as implemented by the ACA and any superseding legislation. (Persons interested in conducting activities subject to the Antarctic Treaty or the Protocol should contact the Office of Polar Programs, NSF).

    (2) The Convention for the Conservation of Antarctic Seals.

    (3) The Convention and its Conservation Measures in force, implemented under the Act.

    (d) Prohibitions on takings. Permits issued under this section do not authorize any takings as defined in the applicable statutes and implementing regulations governing the activities of persons in Antarctica.

    (e) Issuance criteria. Permits designated in this section may be issued by the Assistant Administrator upon a determination that:

    (1) The specific activities meet the requirements of the Act;

    (2) There is sufficient reason, established in the CEMP permit application, that the scientific purpose for the intended entry cannot be served elsewhere; and

    (3) The actions permitted will not violate any provisions or prohibitions of the site's management plan submitted in compliance with the CCAMLR Conservation Measure describing the procedure for according protection to CEMP sites.

    (f) Application process. An applicant seeking a CEMP permit from the Assistant Administrator to enter a CEMP site shall include the following in the application.

    (1) A detailed justification that the scientific objectives of the applicant cannot be accomplished elsewhere and a description of how said objectives will be accomplished within the terms of the site's management plan.

    (2) A statement signed by the applicant that the applicant has read and fully understands the provisions and prohibitions of the site's management plan. Prospective applicants may obtain copies of the relevant management plans and the CCAMLR Conservation Measure describing the procedure for according protection to CEMP sites by requesting them from NMFS Headquarters.

    (g) Conditions. CEMP permits issued under this section will contain special and general conditions including a condition that the permit holder shall submit a report describing the activities conducted under the permit within 30 days of the expiration of the CEMP permit.

    (h) Transfer. CEMP permits are not transferable or assignable. A CEMP permit is valid only for the person to whom it is issued.

    (i) Additional conditions and restrictions. The Assistant Administrator may revise the CEMP permit effective upon notification of the permit holder, to impose additional conditions and restrictions as necessary to achieve the purposes of the Convention, the Act and the CEMP Management Plan. The CEMP permit holder must, as soon as possible, notify any and all agents operating under the permit of any and all revisions or modifications to the permit.

    (j) Revocation or suspension. CEMP permits may be revoked or suspended based upon information received by the Assistant Administrator and such revocation or suspension shall be effective upon notification to the permit holder.

    (1) A CEMP permit may be revoked or suspended based on a violation of the permit, the Act, or this subpart.

    (2) Failure to report a change in the information submitted in a CEMP permit application within 10 days of the change is a violation of this subpart and voids the application or permit, as applicable. Title 15 CFR part 904 governs permit sanctions under this subpart.

    (k) Exceptions. Entry into a CEMP site is lawful if committed under emergency conditions to prevent the loss of human life, avoid compromising human safety, prevent the loss of vessels or aircraft, or to prevent environmental damage.

    (l) Protected sites. Sites protected by the Antarctic Treaty and regulated under the ACA are listed at 45 CFR part 670 subpart F.

    § 300.114 Prohibitions.

    In addition to the prohibitions in § 300.4, it is unlawful for any person to:

    (a) Harvest any AMLR without a permit for such activity as required by § 300.107.

    (b) Import into, or export or re-export from, the United States any AMLR: Taken by a vessel of the United States without a permit issued under this subpart or by a foreign-flagged vessel without valid authorization from the applicable flag state to harvest those resources; without accurate, complete, valid and properly validated CDS documentation as required by § 300.106; without an IFTP as required by § 300.104; or in violation of the terms and conditions for such import, export or re-export as specified on the IFTP.

    (c) Engage in or benefit from harvesting or other associated activities in violation of the provisions of the Convention or in violation of a conservation measure in force with respect to the United States under Article IX of the Convention.

    (d) Ship, transport, offer for sale, sell, purchase, import, export, re-export or have custody, control or possession of, any AMLR that was harvested in violation of a conservation measure in force with respect to the United States under Article IX of the Convention or in violation of any regulation promulgated under the Act, without regard to the citizenship of the person that harvested, or vessel that was used in the harvesting of, the AMLR.

    (e) Refuse to allow any CCAMLR inspector or authorized officer to board a vessel of the United States or a vessel subject to the jurisdiction of the United States for the purpose of conducting any search, investigation, or inspection authorized by the Act, this subpart, or any permit issued under the Act.

    (f) Refuse to provide appropriate assistance, including access as necessary to communications equipment, to any CCAMLR inspector or authorized officer.

    (g) Refuse to sign a written notification of alleged violations of CCAMLR conservation measures in force prepared by a CCAMLR inspector.

    (h) Assault, resist, oppose, impede, intimidate, or interfere with a CCAMLR inspector or authorized officer in the conduct of any boarding, search, investigation, or inspection authorized by the Act, this subpart, or any permit issued under the Act.

    (i) Use any vessel to engage in harvesting, or receive, import, export or re-export, AMLRs after the revocation, or during the period of suspension, of an applicable permit issued under the Act.

    (j) Fail to identify, falsely identify, fail to properly maintain, or obscure the identification of a harvesting vessel or its gear as required by this subpart.

    (k) Fish in an area where fishing is prohibited by the Commission, other than for scientific research purposes in accordance with § 300.103.

    (l) Violate or attempt to violate any provision of this subpart, the Act, any other regulation promulgated under the Act or the conditions of any permit issued under the Act.

    (m) Provide incomplete or inaccurate information about the harvest, transshipment, landing, import, export, or re-export of applicable species on any document required under this subpart.

    (n) Receive AMLR from a vessel, without holding an AMLR first receiver permit as required under § 300.104, or receive AMLR from a fishing vessel that does not hold a valid vessel permit issued under § 300.107.

    (o) Import, export or re-export Dissostichus spp. harvested or transshipped by a vessel identified by CCAMLR as having engaged in illegal, unreported and unregulated (IUU) fishing, originating from a high seas area designated by the Food and Agriculture Organization of the United Nations as Statistical Area 51 or Statistical Area 57 or accompanied by inaccurate, incomplete, invalid, or improperly validated CDS documentation or import or re-export Dissostichus spp. accompanied by a SVDCD.

    (p) Import shipments of frozen Dissostichus spp. without a preapproval issued under § 300.105.

    (q) Observers. (1) Assault, resist, oppose, impede, intimidate, harass, bribe, or interfere with an observer.

    (2) Interfere with or bias the sampling procedure employed by an observer, including physical, mechanical, or other sorting or discarding of catch before sampling.

    (3) Tamper with, destroy, or discard an observer's collected samples, equipment, records, photographic film, papers, or personal effects without the express consent of the observer.

    (4) Prohibit or bar by command, impediment, threat, coercion, or by refusal of reasonable assistance, an observer from collecting samples, conducting product recovery rate determinations, making observations, or otherwise performing the observer's duties.

    (5) Harass an observer by conduct that has sexual connotations, has the purpose or effect of interfering with the observer's work performance, or otherwise creates an intimidating, hostile, or offensive environment.

    (6) Fish for or process fish without observer coverage required under § 300.111.

    (7) Require, pressure, coerce, or threaten an observer to perform duties normally performed by crew members, including, but not limited to, cooking, washing dishes, standing watch, vessel maintenance, assisting with the setting or retrieval of gear, or any duties associated with the processing of fish, from sorting the catch to the storage of the finished product.

    (8) Refuse to provide appropriate assistance, including access as necessary to communications equipment, to an observer.

    (r) Vessel monitoring systems. (1) Use any vessel of the United States issued, or required to be issued, an AMLR vessel permit to conduct fishing operations unless that vessel carries a NMFS-type-approved EMTU and complies with the requirements described in this subpart.

    (2) Fail to install, activate, repair or replace an EMTU prior to leaving port as specified in this subpart.

    (3) Fail to operate and maintain an EMTU on board the vessel at all times as specified in this subpart.

    (4) Tamper with, damage, destroy, alter, or in any way distort, render useless, inoperative, ineffective, or inaccurate the EMTU required to be installed on a vessel or the EMTU position reports transmitted by a vessel as specified in this subpart.

    (5) Fail to contact OLE or follow OLE instructions when automatic position reporting has been interrupted as specified in this subpart.

    (6) Register an EMTU to more than one vessel at the same time.

    (7) Connect, or leave connected, additional equipment to an EMTU without the prior approval of the OLE.

    (8) Make a false statement, oral or written, to an authorized officer regarding the installation, use, operation, or maintenance of an EMTU or communication service provider.

    (9) Fail to report to NMFS and to CCAMLR's C-VMS from port-to-port on any trip during which AMLR are, or are expected to be, harvested regardless of whether the vessel operates, or is expected to operate, inside the Convention Area.

    (s) Trawl for krill in Convention Area fisheries without a seal excluder device or possess trawl gear without a seal excluder device installed onboard a vessel permitted, or required to be permitted, under this subpart to harvest krill with trawl gear.

    (t) Harvest any AMLR in the Convention Area without a vessel permit required by this subpart.

    (u) Ship, transport, offer for sale, sell, purchase, import, export, re-export or have custody, control, or possession of, any frozen Dissostichus species without verifiable documentation that the harvesting vessel reported to CCAMLR's C-VMS continuously and in real-time, from port-to-port, regardless of where such Dissostichus species were harvested.

    § 300.115 Facilitation of enforcement and inspection.

    In addition to the facilitation of enforcement provisions of § 300.5, the following requirements apply to this subpart.

    (a) Access and records. (1) The owners and operator of each harvesting vessel must provide authorized officers and CCAMLR inspectors access to all spaces where work is conducted or business papers and records are prepared or stored, including but not limited to personal quarters and areas within personal quarters. If inspection of a particular area would interfere with specific on-going scientific research, and if the operator of the harvesting vessel makes such assertion and produces an individual permit that covers that specific research, the authorized officer or CCAMLR inspector will not disturb the area, but will record the information pertaining to the denial of access.

    (2) The owner and operator of each harvesting vessel must provide to authorized officers and CCAMLR inspectors all records and documents pertaining to the harvesting activities of the vessel, including but not limited to production records, fishing logs, navigation logs, transfer records, product receipts, cargo stowage plans or records, draft or displacement calculations, customs documents or records, and an accurate hold plan reflecting the current structure of the vessel's storage and factory spaces.

    (3) Before leaving vessels that have been inspected, the CCAMLR inspector will give the master of the vessel a Certificate of Inspection and a written notification of any alleged violations of CCAMLR conservation measures in effect and will afford the master the opportunity to comment on it. The ship's master must sign the notification to acknowledge receipt and the opportunity to comment on it.

    (4) Any person issued a first receiver permit under this subpart, or an IFTP under § 300.322, must as a condition of that permit, allow an authorized officer access to any facility from which they engage in the first receipt, import, export or re-export of AMLR for the purpose of inspecting the facility and any fish, equipment or records therein.

    (b) Reports by non-inspectors. All scientists, fishermen, and other non-inspectors present in the Convention Area and subject to the jurisdiction of the United States are encouraged to report any violation of CCAMLR conservation measures observed in the Convention Area to the Office of Ocean and Polar Affairs (CCAMLR Violations), Department of State, Room 5801, Washington, DC 20520.

    (c) Storage of AMLR. The operator of each harvesting vessel storing AMLR in a storage space on board a vessel must ensure that non-resource items are neither stowed beneath nor covered by resource items, unless required to maintain the stability and safety of the vessel. Non-resource items include, but are not limited to, portable conveyors, exhaust fans, ladders, nets, fuel bladders, extra bin boards, or other moveable non-resource items. These non-resource items may be in a resource storage space when necessary for the safety of the vessel or crew or for the storage of the items. Lumber, bin boards, or other dunnage may be used for shoring or bracing of product to ensure the safety of crew and to prevent shifting of cargo within the space.

    § 300.116 Penalties.

    Any person or harvesting vessel found to be in violation of the Act, this subpart, or any permit issued under this subpart will be subject to the civil and criminal penalty provisions and forfeiture provisions prescribed in the Act, 15 CFR part 904, and other applicable laws.

    [FR Doc. 2017-00401 Filed 1-18-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9811] RIN 1545-BK09 Application of Modified Carryover Basis to General Basis Rules AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Final regulations.

    SUMMARY:

    This document contains final regulations regarding the application of the modified carryover basis rules of section 1022 of the Internal Revenue Code (Code). Specifically, the final regulations modify provisions of the Treasury Regulations involving basis rules by including a reference to section 1022 where appropriate. The regulations will affect property transferred from certain decedents who died in 2010. The regulations reflect changes to the law made by the Economic Growth and Tax Relief Reconciliation Act of 2001 and the Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010.

    DATES:

    Effective Date: The regulations are effective on January 19, 2017.

    Applicability Date: The regulations are applicable on January 19, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Mayer R. Samuels at (202) 317-6859 (not a toll-free number).

    SUPPLEMENTARY INFORMATION:

    Background

    This document contains amendments to 26 CFR part 1 under various provisions of the Code in response to statutory changes made by the Economic Growth and Tax Relief Reconciliation Act of 2001, Public Law 107-16 (EGTRRA) and the Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010, Public Law 111-312 (TRUIRJCA).

    Section 501(a) of EGTRRA enacted section 2210 of the Code, which made chapter 11 (the estate tax) inapplicable to the estate of any decedent who died after 2009. Section 542 of EGTRRA also enacted section 1022. While section 1014 generally provides that the recipient's basis in property passing from a decedent is the fair market value of the property on the decedent's date of death, section 1022 sets forth a modified carryover basis system applicable after 2009 generally providing that the recipient's basis in property acquired from a decedent is the lesser of the decedent's adjusted basis in the property or the fair market value of the property on the decedent's date of death. Section 901(a) of EGTRRA, known as the “sunset clause”, provided that all provisions of and amendments made by EGTRRA do not apply to estates of decedents dying, gifts made, or generation-skipping transfers after December 31, 2010. The sunset clause effectively limited the application of sections 501(a) and 542 of EGTRRA to 2010.

    Section 301(a) of TRUIRJCA, which became law on December 17, 2010, retroactively reinstated the estate tax and repealed section 1022 with respect to the estates of decedents who died in 2010. However, section 301(c) of TRUIRJCA allowed the executor of the estate of a decedent who died in 2010 to elect to apply the Code and regulations thereunder as though section 301(a) of TRUIRJCA did not apply with respect to chapter 11 and with respect to property acquired or passing from the decedent (within the meaning of section 1014(b) of the Code). Thus, section 301(c) of TRUIRJCA allowed the executor of the estate of a decedent who died in 2010 to elect not to have the provisions of chapter 11 apply to the decedent's estate, but rather to have the provisions of section 1022 apply (a Section 1022 Election).

    To provide executors with guidance regarding the making of a Section 1022 Election and certain other collateral issues arising from the determination of basis under section 1022, on August 29, 2011, the Treasury Department and the IRS issued Notice 2011-66 (2011-35 IRB 184) and Revenue Procedure 2011-41 (2011-35 IRB 188). Although section 1022 was applicable only to decedents dying in calendar year 2010, basis determined pursuant to that section will continue to be relevant until all of the property whose basis is determined under that section has been sold or otherwise disposed of in a transaction in which gain or loss is recognized. Accordingly, on May 11, 2015, the Treasury Department and the IRS published in the Federal Register (80 FR 26873) a notice of proposed rulemaking (REG-107595-11, 2015-21 IRB 986) proposing amendments to existing regulations under various sections of the Code to take into account the application of the modified carryover basis rules of section 1022. The IRS received written comments responding to the notice of proposed rulemaking. No public hearing was requested or held.

    After consideration of the comments received on the proposed regulations, this Treasury decision adopts the proposed regulations without modification as final regulations. However, the final regulations adopt certain nonsubstantive, clarifying changes. The comments received on the proposed regulations are discussed in the remainder of this preamble.

    Summary of Comments

    One commenter noted that the proposed regulations proposed to amend § 1.742-1 to provide that the basis of a partnership interest acquired from a decedent is determined under section 1022 if the decedent died in 2010 and the decedent's executor made a Section 1022 Election with respect to the decedent's estate. The commenter noted that there was no similar amendment proposed to be made to § 1.1367-1(j), relating to the basis of stock of an S corporation where a portion of the value of the stock is attributable to items constituting income in respect of a decedent (IRD). The commenter recommended that the final regulations amend § 1.1367-1(j) with language referencing section 1022.

    After considering this comment, the Treasury Department and the IRS have determined that no change is necessary. Section 1.1367-1(j) states, “[t]he basis determined under section 1014 of any stock in an S corporation is reduced by the portion of the value of the stock that is attributable to items constituting income in respect of a decedent.” This regulation section, with its required basis adjustment for IRD, is limited to situations in which section 1014 applies. Section 1.1367-1(j) does not apply when a Section 1022 Election is made because there is no basis adjustment under section 1022 to the date of death value of S corporation stock. Without an adjustment to date of death value, no further adjustment to the basis of S corporation stock is required to account for IRD. Therefore, the final regulations do not adopt this comment.

    A commenter noted that the proposed regulations only propose amendments to finalized regulations, and not to proposed regulations or temporary regulations. That commenter specifically requested guidance with respect to proposed regulation § 1.465-69(a) (which provides that a successor to a decedent's amount at risk in an activity is increased by the amount by which the successor's basis in the activity is increased under section 1014) and temporary regulation § 16A.1255-2(b)(2) (which provides that if, as of the date a person acquires section 126 property from a decedent, the basis of the property is determined under section 1014, then on that date the aggregate of excludable portions under section 126 in the hands of such transferee is zero). This Treasury decision cannot modify provisions of the proposed or temporary regulations referenced by the commenter without adopting those provisions as final or temporary regulations. The Treasury Department and the IRS continue to study these areas, and therefore are not prepared to adopt modifications to the proposed or temporary regulations referenced by the commenter at this time. Accordingly, the final regulations do not adopt this comment. However, the Treasury Department and the IRS expect that, if those proposed or temporary regulations are adopted as final or temporary regulations in the future, such regulations will be updated as appropriate to account for the existence of section 1022.

    Another commenter asked why the preamble to the proposed regulations omitted any discussion of the revisions made to regulations under six particular sections of the Code, and requested an explanation as to why changes to those regulatory provisions were considered less significant than the changes for which an explanation was given. Generally, the Treasury Department and the IRS included descriptions of the proposed changes in that preamble that involved more than a mere insertion of a reference to section 1022 in addition to an existing reference to section 1014. In such cases, it was determined that an explanation or clarification of the substance or effect of the proposed revision would be helpful. In the case of the proposed amendments to regulations under the six Code sections mentioned by the commenter, the only change proposed was the mere insertion of references to section 1022 in addition to existing references to section 1014. Accordingly, the Treasury Department and the IRS determined that no further explanation of those changes was necessary.

    A commenter also asked why the proposed regulations did not incorporate the treatment of items under the various Code sections addressed in Revenue Procedure 2011-41, 2011-35 IRB 188. That revenue procedure provides a safe harbor that determines the effect on the application of various Code sections of a Section 1022 Election. The provisions relating to that safe harbor are available only if the executor of the estate makes a Section 1022 Election and takes no position contrary to a provision in that revenue procedure. Nothing in these final regulations changes or invalidates the provisions of Revenue Procedure 2011-41, so the safe harbor will remain available to qualifying taxpayers. Consequently, it is unnecessary to incorporate the revenue procedure into these regulations.

    Special Analyses

    Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. The Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply to these final regulations because the final regulations do not impose a collection of information requirement on small entities. Therefore, a Regulatory Flexibility Analysis is not required. Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking preceding this regulation has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business, and no comments were received.

    Drafting Information

    The principal author of these final regulations is Mayer R. Samuels, Office of the Associate Chief Counsel (Passthroughs and Special Industries). Other personnel from the Treasury Department and the IRS participated in their development.

    List of Subjects in 26 CFR Part 1

    Income taxes, Reporting and recordkeeping requirements.

    Adoption of Amendments to the Regulations

    Accordingly, 26 CFR part 1 is amended as follows:

    PART 1—INCOME TAXES

    Paragraph 1. The authority citation for part 1 continues to read in part as follows:

    Authority:

    26 U.S.C. 7805 * * *

    Par. 2. Section 1.48-12 is amended by revising the last sentence of paragraph (b)(2)(vii)(B) and adding paragraph (g) to read as follows:
    § 1.48-12 Qualified rehabilitated building; expenditures incurred after December 31, 1981.

    (b) * * *

    (2) * * *

    (vii) * * *

    (B) * * * If a transferee's basis is determined under section 1014 or section 1022, any expenditures incurred by the decedent within the measuring period that are treated as having been incurred by the transferee under paragraph (c)(3)(ii) of this section shall decrease the transferee's basis for purposes of the substantial rehabilitation test.

    (g) Effective/applicability date. This section applies on and after January 19, 2017. For rules before January 19, 2017, see § 1.48-12 as contained in 26 CFR part 1 revised as of April 1, 2016.

    Par. 3. Section 1.83-4 is amended by revising the last sentence of paragraph (b)(1) and adding paragraph (d) to read as follows:
    § 1.83-4 Special rules.

    (b) * * *

    (1) * * * Such basis shall also reflect any adjustments to basis provided under sections 1015, 1016, and 1022.

    (d) Effective/applicability date. The provisions in this section are applicable for taxable years beginning on or after July 21, 1978. The provisions of paragraph (b)(1) of this section relating to section 1022 are effective on and after January 19, 2017.

    Par. 4. Section 1.179-4 is amended by revising the first sentence of paragraph (c)(1)(iv) to read as follows:
    § 1.179-4 Definitions.

    (c) * * *

    (1) * * *

    (iv) The property is not acquired by purchase if the basis of the property in the hands of the person acquiring it is determined in whole or in part by reference to the adjusted basis of such property in the hands of the person from whom acquired, is determined under section 1014(a), relating to property acquired from a decedent, or is determined under section 1022, relating to property acquired from certain decedents who died in 2010. * * *

    Par. 5. Section 1.179-6 is amended by: 1. Revising the section heading and the first sentence of paragraph (a). 2. Adding paragraph (d).

    The revision and addition read as follows:

    § 1.179-6 Effective/applicability dates.

    (a) * * * Except as provided in paragraphs (b), (c), and (d) of this section, the provisions of §§ 1.179-1 through 1.179-5 apply for property placed in service by the taxpayer in taxable years ending after January 25, 1993. * * *

    (d) Application of § 1.179-4(c)(1)(iv). The provisions of § 1.179-4(c)(1)(iv) relating to section 1022 are effective on and after January 19, 2017.

    Par. 6. Section 1.197-2 is amended by revising paragraphs (h)(5)(i) and (h)(12)(viii) and adding paragraph (l)(5) to read as follows:
    § 1.197-2 Amortization of goodwill and certain other intangibles.

    (h) * * *

    (5) * * *

    (i) The acquisition of a section 197(f)(9) intangible if the acquiring taxpayer's basis in the intangible is determined under section 1014(a) or 1022; or

    (12) * * *

    (viii) Operating rule for transfers upon death. For purposes of this paragraph (h)(12), if the basis of a partner's interest in a partnership is determined under section 1014(a) or 1022, such partner is treated as acquiring such interest from a person who is not related to such partner, and such interest is treated as having previously been held by a person who is not related to such partner.

    (l) * * *

    (5) Application of section 1022. The provisions of § 1.197-2(h)(5)(i) and (h)(12)(viii) relating to section 1022 are effective on and after January 19, 2017.

    Par. 7. Section 1.267(d)-1 is amended by revising paragraph (a)(3) to read as follows:
    § 1.267(d)-1 Amount of gain where loss previously disallowed.

    (a) * * *

    (3) The benefit of the general rule is available only to the original transferee but does not apply to any original transferee (for example, a donee or a person acquiring property from a decedent where the basis of property is determined under section 1014 or 1022) who acquired the property in any manner other than by purchase or exchange.

    Par. 8. Section 1.267(d)-2 is amended by revising the section heading and adding a sentence to the end of the paragraph to read as follows:
    § 1.267(d)-2 Effective/applicability dates.

    * * * The provisions of § 1.267(d)-1(a)(3) relating to section 1022 are effective on and after January 19, 2017.

    Par. 9. Section 1.273-1 is revised to read as follows:
    § 1.273-1 Life or terminable interests.

    (a) In general. Amounts paid as income to the holder of a life or a terminable interest acquired by gift, bequest, or inheritance shall not be subject to any deduction for shrinkage (whether called by depreciation or any other name) in the value of such interest due to the lapse of time. In other words, the holder of such an interest so acquired may not set up the value of the expected future payments as corpus or principal and claim deduction for shrinkage or exhaustion thereof due to the passage of time. For the treatment generally of distributions to beneficiaries of an estate or trust, see Subparts A, B, C, and D (section 641 and following), Subchapter J, Chapter 1 of the Code, and the regulations thereunder. For basis of property acquired from a decedent and by gifts and transfers in trust, see sections 1014, 1015, and 1022, and the regulations thereunder.

    (b) Effective/applicability date. The provisions in this section are applicable for taxable years beginning on or after September 16, 1958. The provisions of this section relating to section 1022 are effective on and after January 19, 2017.

    Par. 10. Section 1.306-3 is amended by removing the last sentence of paragraph (e) and adding two sentences in its place to read as follows:
    § 1.306-3 Section 306 stock defined.

    (e) * * * Section 306 stock ceases to be so classified if the basis of such stock is determined by reference to its fair market value on the date of the decedent-stockholder's death under section 1014 or the optional valuation date under section 2032. Section 306 stock continues to be so classified if the basis of such stock is determined under section 1022.

    Par. 11. Section 1.306-4 is added to read as follows:
    § 1.306-4 Effective/applicability date.

    The provisions of §§ 1.306-1 through 1.306-3 are applicable on or after June 22, 1954. The provisions of § 1.306-3 relating to section 1022 are effective on and after January 19, 2017.

    Par. 12. Section 1.336-1 is amended by revising paragraph (b)(5)(i)(A) to read as follows:
    § 1.336-1 General principles, nomenclature, and definitions for a section 336(e) election.

    (b) * * *

    (5) * * *

    (i) * * *

    (A) The basis of the stock in the hands of the purchaser is not determined in whole or in part by reference to the adjusted basis of such stock in the hands of the person from whom the stock is acquired, is not determined under section 1014(a) (relating to property acquired from a decedent), or is not determined under section 1022 (relating to the basis of property acquired from certain decedents who died in 2010);

    Par. 13. Section 1.336-5 is amended by revising the section heading and adding a sentence to the end of the paragraph to read as follows:
    § 1.336-5 Effective/applicability dates.

    * * * The provisions of § 1.336-1(b)(5)(i)(A) relating to section 1022 are effective on and after January 19, 2017.

    Par. 14. Section 1.355-6 is amended by revising paragraphs (d)(1)(i)(A)(2) and (g) to read as follows:
    § 1.355-6 Recognition of gain on certain distributions of stock or securities in controlled corporation.

    (d) * * *

    (1) * * *

    (i) * * *

    (A) * * *

    (2) Under section 1014(a) or 1022; and

    (g) Effective/applicability dates. This section applies to distributions occurring after December 20, 2000, except that they do not apply to any distributions occurring pursuant to a written agreement that is (subject to customary conditions) binding on December 20, 2000, and at all later times. The provisions of paragraph (d)(1)(i)(A)(2) of this section relating to section 1022 are effective on and after January 19, 2017.

    Par. 15. Section 1.382-1 is amended by revising the entry for § 1.382-9(d)(6) to read as follows:
    § 1.382-9 Special rules under section 382 for corporations under the jurisdiction of a court in a title 11 or similar case.

    (d) * * *

    (6) Effective/applicability date.

    Par. 16. Section 1.382-9 is amended by revising paragraphs (d)(5)(ii)(D) and (d)(6)(i) to read as follows:
    § 1.382-9 Special rules under section 382 for corporations under the jurisdiction of a court in a title 11 or similar case.

    (d) * * *

    (5) * * *

    (ii) * * *

    (D) The transferee's basis in the indebtedness is determined under section 1014, 1015, or 1022 or with reference to the transferor's basis in the indebtedness;

    (6) Effective/applicability date—(i) In general. This paragraph (d) applies to ownership changes occurring on or after March 17, 1994. The provisions of paragraph (d)(5)(ii)(D) of this section relating to section 1022 are effective on and after January 19, 2017.

    Par. 17. Section 1.421-2 is amended by: 1. Revising paragraphs (c)(4)(i)(a) and (c)(4)(ii). 2. Revising the heading of paragraph (f) and adding paragraph (f)(3).

    The revisions and addition read as follows:

    § 1.421-2 General rules.

    (c) * * *

    (4)(i)(a) In the case of the death of an optionee, the basis of any share of stock acquired by the exercise of an option under this paragraph (c), determined under section 1011, shall be increased by an amount equal to the portion of the basis of the option attributable to such share. For example, if a statutory option to acquire 10 shares of stock has a basis of $100, the basis of one share acquired by a partial exercise of the option, determined under section 1011, would be increased by 1/10th of $100, or $10. The option acquires a basis, determined under section 1014(a) or under section 1022, if applicable, only if the transfer of the share pursuant to the exercise of such option qualifies for the special tax treatment provided by section 421(a). To the extent the option is so exercised, in whole or in part, it will acquire a basis equal to its fair market value (or the basis as determined under section 1022, if applicable) at the date of the employee's death or, if an election is made under section 2032, its value at its applicable valuation date. In certain cases, the basis of the share is subject to the adjustments provided by paragraphs (c)(4)(i)(b) and (c) of this section, but such adjustments are only applicable in the case of an option that is subject to section 423(c).

    (ii) If a statutory option is not exercised by the estate of the individual to whom the option was granted, or by the person who acquired such option by bequest or inheritance or by reason of the death of such individual, the option shall be considered to be property that constitutes a right to receive an item of income in respect of a decedent to which the rules of sections 691 and 1014(c) (or section 1022(f), if applicable) apply.

    (f) Effective/applicability date. * * *

    (3) Application of section 1022. The provisions of paragraph (c) of this section relating to section 1022 are effective on and after January 19, 2017.

    Par. 18. Section 1.423-2 is amended by: 1. Revising the third sentence of paragraph (k)(2). 2. Adding a sentence to the end of paragraph (l).

    The revision and addition read as follows:

    § 1.423-2 Employee stock purchase plan defined.

    (k) * * *

    (2) * * * If the special rules provided in this paragraph (k) are applicable to a share of stock upon the death of an employee, then the basis of the share in the hands of the estate or the person receiving the stock by bequest or inheritance shall be determined under section 1014 or under section 1022, if applicable, and shall not be increased by reason of the inclusion upon the decedent's death of any amount in the decedent's gross income under this paragraph (k). * * *

    (l) * * * The provisions of this section relating to section 1022 are effective on and after January 19, 2017.

    Par. 19. Section 1.424-1 is amended by revising the last sentence of paragraph (c)(2) and adding paragraph (g)(3) to read as follows:
    § 1.424-1 Definitions and special rules applicable to statutory options.

    (c) * * *

    (2) * * * For determination of basis in the hands of the survivor where joint ownership is terminated by the death of one of the owners, see section 1014 or section 1022, if applicable.

    (g) * * *

    (3) Application of section 1022. The provisions of paragraph (c)(2) of this section relating to section 1022 are effective on and after January 19, 2017.

    Par. 20. Section 1.467-7 is amended by revising paragraph (c)(2) and revising the first sentence of paragraph (c)(4) to read as follows:
    § 1.467-7 Section 467 recapture and other rules relating to dispositions and modifications.

    (c) * * *

    (2) Dispositions at death. Paragraph (a) of this section does not apply to a disposition if the basis of the property in the hands of the transferee is determined under section 1014(a) or section 1022. However, see paragraph (c)(4) of this section for dispositions of property subject to section 1022 by transferees. This paragraph (c)(2) does not apply to property that constitutes a right to receive an item of income in respect of a decedent. See sections 691, 1014(c), and 1022(f).

    (4) * * * If the recapture amount with respect to a disposition of property (the first disposition) is limited under paragraph (c)(1) or (c)(3) of this section, or under paragraph (c)(2) of this section because the basis of the property in the hands of the transferee is determined under section 1022, and the transferee subsequently disposes of the property in a transaction to which paragraph (a) of this section applies, the prior understated inclusion determined under paragraph (b)(2) of this section is computed by taking into account the amounts attributable to the period of the transferor's ownership of the property prior to the first disposition. * * *

    Par. 21. Section 1.467-9 is amended by revising the section heading and adding paragraph (f) to read as follows:
    § 1.467-9 Effective/applicability dates and automatic method changes for certain agreements.

    (f) Application of section 1022. The provisions of § 1.467-7(c)(2) and (4) relating to section 1022 are effective on and after January 19, 2017.

    Par. 22. Section 1.617-3 is amended by revising paragraph (d)(5)(ii)(b) to read as follows:
    § 1.617-3 Recapture of exploration expenditures.

    (d) * * *

    (5) * * *

    (ii) * * *

    (b) The transactions referred to in paragraph (d)(5)(ii)(a) of this section are:

    (1) A disposition that is in part a sale or exchange and in part a gift;

    (2) A disposition that is described in section 617(d) through the incorporation by reference of the provisions of section 1245(b)(3) (relating to certain tax free transactions); or

    (3) A transfer at death where basis of property in the hands of the transferee is determined under section 1022.

    Par. 23. Section 1.617-4 is amended by revising the second sentence of paragraph (c)(1)(i) to read as follows:
    § 1.617-4 Treatment of gain from disposition of certain mining property.

    (c) * * *

    (1)(i) * * * For purposes of this paragraph (c), the term gift means, except to the extent that paragraph (c)(1)(ii) of this section applies, a transfer of mining property that, in the hands of the transferee, has a basis determined under the provisions of section 1015(a) or 1015(d) (relating to basis of property acquired by gift) or section 1022 (relating to the basis of property acquired from certain decedents who died in 2010). * * *

    Par. 24. Section 1.617-5 is added to read as follows:
    § 1.617-5 Effective/applicability date.

    Sections 1.617-3 and 1.617-4 apply on and after January 19, 2017. For rules before January 19, 2017, see §§ 1.617-3 and 1.617-4 as contained in 26 CFR part 1 revised as of April 1, 2016.

    Par. 25. Section 1.684-3 is amended by revising paragraph (c) to read as follows:
    § 1.684-3 Exceptions to general rule of gain recognition.

    (c) Certain transfers at death—(1) Section 1014 basis. The general rule of gain recognition under § 1.684-1 shall not apply to any transfer of property to a foreign trust or foreign estate or, in the case of a transfer of property by a U.S. transferor decedent dying in 2010, to a foreign trust, foreign estate, or a nonresident alien, by reason of death of the U.S. transferor, if the basis of the property in the hands of the transferee is determined under section 1014(a).

    (2) Section 1022 basis election. For U.S. transferor decedents dying in 2010, the general rule of gain recognition under § 1.684-1 shall apply to any transfer of property by reason of death of the U.S. transferor if the basis of the property in the hands of the foreign trust, foreign estate, or the nonresident alien individual is determined under section 1022. The gain on the transfer shall be calculated as set out under § 1.684-1(a), except that adjusted basis will reflect any increases allocated to such property under section 1022.

    Par. 26. Section 1.684-5 is revised to read as follows:
    § 1.684-5 Effective/applicability dates.

    (a) Sections 1.684-1 through 1.684-4 apply to transfers of property to foreign trusts and foreign estates after August 7, 2000, except as provided in paragraph (b) of this section.

    (b) In the case a U.S. transferor decedent dying in 2010, § 1.684-3(c) applies to transfers of property to foreign trusts, foreign estates, and nonresident aliens after December 31, 2009, and before January 1, 2011.

    Par. 27. Section 1.691(a)-3 is amended by revising the last two sentences of paragraph (a) and adding paragraph (c) to read as follows:
    § 1.691(a)-3 Character of gross income.

    (a) * * * The provisions of section 1014(a), relating to the basis of property acquired from a decedent, and section 1022, relating to the basis of property acquired from certain decedents who died in 2010, do not apply to these amounts in the hands of the estate and such persons. See sections 1014(c) and 1022(f).

    (c) Effective/applicability dates. The last two sentences of paragraph (a) of this section apply on and after January 19, 2017. For rules before January 19, 2017, see § 1.691(a)-3 as contained in 26 CFR part 1 revised as of April 1, 2016.

    Par. 28. Section 1.742-1 is revised to read as follows:
    § 1.742-1 Basis of transferee partner's interest.

    (a) In general. The basis to a transferee partner of an interest in a partnership shall be determined under the general basis rules for property provided by part II (section 1011 and following), Subchapter O, Chapter 1 of the Internal Revenue Code. Thus, the basis of a purchased interest will be its cost. Generally, the basis of a partnership interest acquired from a decedent is the fair market value of the interest at the date of his death or at the alternate valuation date, increased by his estate's or other successor's share of partnership liabilities, if any, on that date, and reduced to the extent that such value is attributable to items constituting income in respect of a decedent (see section 753 and §§ 1.706-1(c)(3)(v) and 1.753-1(b)) under section 691. See section 1014(c). However, the basis of a partnership interest acquired from a decedent is determined under section 1022 if the decedent died in 2010 and the decedent's executor elected to have section 1022 apply to the decedent's estate. For basis of contributing partner's interest, see section 722. The basis so determined is then subject to the adjustments provided in section 705.

    (b) Effective/applicability date. This section applies on and after January 19, 2017. For rules before January 19, 2017, see § 1.742-1 as contained in 26 CFR part 1 revised as of April 1, 2016.

    Par. 29. Section 1.743-1 is amended by revising paragraphs (k)(2)(ii) and (l) to read as follows:
    § 1.743-1 Optional adjustment to basis of partnership property.

    (k) * * *

    (2) * * *

    (ii) Special rule. A transferee that acquires, on the death of a partner, an interest in a partnership with an election under section 754 in effect for the taxable year of the transfer, must notify the partnership, in writing, within one year of the death of the deceased partner. The written notice to the partnership must be signed under penalties of perjury and must include the names and addresses of the deceased partner and the transferee, the taxpayer identification numbers of the deceased partner and the transferee, the relationship (if any) between the transferee and the transferor, the deceased partner's date of death, the date on which the transferee became the owner of the partnership interest, the fair market value of the partnership interest on the applicable date of valuation set forth in section 1014 or section 1022, the manner in which the fair market value of the partnership interest was determined, and the carryover basis as adjusted under section 1022 (if applicable).

    (l) Effective/applicability date. The provisions in this section apply to transfers of partnership interests that occur on or after December 15, 1999. The provisions of this section relating to section 1022 are effective on and after January 19, 2017.

    Par. 30. Section 1.755-1 is amended by: 1. Revising paragraphs (a)(4)(i)(C) and the first sentence of (b)(4)(i). 2. Revising the heading of paragraph (e) and paragraph (e)(2).

    The revisions read as follows:

    § 1.755-1 Rules for allocation of basis.

    (a) * * *

    (4) * * *

    (i) * * *

    (C) Income in respect of a decedent. Solely for the purpose of determining partnership gross value under this paragraph (a)(4)(i), where a partnership interest is transferred as a result of the death of a partner, the transferee's basis in its partnership interest is determined without regard to section 1014(c) or section 1022(f), and is deemed to be adjusted for that portion of the interest, if any, that is attributable to items representing income in respect of a decedent under section 691.

    (b) * * *

    (4) * * *

    (i) * * * Where a partnership interest is transferred as a result of the death of a partner, under section 1014(c) or section 1022(f), the transferee's basis in its partnership interest is not adjusted for that portion of the interest, if any, that is attributable to items representing income in respect of a decedent under section 691. * * *

    (e) Effective/applicability dates. * * *

    (2) Special rules. Paragraphs (a) and (b)(3)(iii) of this section apply to transfers of partnership interests and distributions of property from a partnership that occur on or after June 9, 2003. The provisions of paragraphs (a)(4)(i)(C) and (b)(4)(i) of this section relating to section 1022 are effective on and after the date January 19, 2017.

    Par. 31. Section 1.995-4 is amended by revising the first sentence of paragraph (d)(2) and adding paragraph (f) to read as follows:
    § 1.995-4 Gain on disposition of stock in a DISC.

    (d) * * *

    (2) * * * For purposes of this section, the period during which a shareholder has held stock includes the period he is considered to have held it by reason of the application of section 1223 and, if his basis is determined in whole or in part under the provisions of section 1014(d) (relating to special rule for DISC stock acquired from decedent) or section 1022 (relating to property acquired from certain decedents who died in 2010), the holding period of the decedent. * * *

    (f) Effective/applicability date. This section applies on and after January 19, 2017. For rules before January 19, 2017, see § 1.995-4 as contained in 26 CFR part 1 revised as of April 1, 2016.

    Par. 32. Section 1.1001-1 is amended by revising the last sentence of paragraph (a), revising paragraph (f)(1), and adding paragraph (i) to read as follows:
    § 1.1001-1 Computation of gain or loss.

    (a) * * * Section 1001(e) and paragraph (f) of this section prescribe the method of computing gain or loss upon the sale or other disposition of a term interest in property the adjusted basis (or a portion) of which is determined pursuant, or by reference, to section 1014 (relating to the basis of property acquired from a decedent), section 1015 (relating to the basis of property acquired by gift or by a transfer in trust), or section 1022 (relating to the basis of property acquired from certain decedents who died in 2010).

    (f) * * *

    (1) General rule. Except as otherwise provided in paragraph (f)(3) of this section, for purposes of determining gain or loss from the sale or other disposition after October 9, 1969, of a term interest in property (as defined in paragraph (f)(2) of this section), a taxpayer shall not take into account that portion of the adjusted basis of such interest that is determined pursuant, or by reference, to section 1014 (relating to the basis of property acquired from a decedent), section 1015 (relating to the basis of property acquired by gift or by a transfer in trust), or section 1022 (relating to the basis of property acquired from certain decedents who died in 2010) to the extent that such adjusted basis is a portion of the adjusted uniform basis of the entire property (as defined in § 1.1014-5). Where a term interest in property is transferred to a corporation in connection with a transaction to which section 351 applies and the adjusted basis of the term interest:

    (i) Is determined pursuant to sections 1014, 1015, or 1022; and

    (ii) Is also a portion of the adjusted uniform basis of the entire property, a subsequent sale or other disposition of such term interest by the corporation will be subject to the provisions of section 1001(e) and this paragraph (f) to the extent that the basis of the term interest so sold or otherwise disposed of is determined by reference to its basis in the hands of the transferor as provided by section 362(a). See paragraph (f)(2) of this section for rules relating to the characterization of stock received by the transferor of a term interest in property in connection with a transaction to which section 351 applies. That portion of the adjusted uniform basis of the entire property that is assignable to such interest at the time of its sale or other disposition shall be determined under the rules provided in § 1.1014-5. Thus, gain or loss realized from a sale or other disposition of a term interest in property shall be determined by comparing the amount of the proceeds of such sale with that part of the adjusted basis of such interest that is not a portion of the adjusted uniform basis of the entire property.

    (i) Effective/applicability date. Except as provided in paragraphs (g) and (h) of this section, this section applies on and after January 19, 2017. For rules before January 19, 2017, see § 1.1001-1 as contained in 26 CFR part 1 revised as of April 1, 2016.

    Par. 33. Section 1.1014-1 is amended by revising paragraph (a) and adding paragraph (d) to read as follows:
    § 1.1014-1 Basis of property acquired from a decedent.

    (a) General rule. The purpose of section 1014 is, in general, to provide a basis for property acquired from a decedent that is equal to the value placed upon such property for purposes of the federal estate tax. Accordingly, the general rule is that the basis of property acquired from a decedent is the fair market value of such property at the date of the decedent's death, or, if the decedent's executor so elects, at the alternate valuation date prescribed in section 2032, or in section 811(j) of the Internal Revenue Code (Code) of 1939. However, the basis of property acquired from certain decedents who died in 2010 is determined under section 1022, if the decedent's executor made an election under section 301(c) of the Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010, Public Law 111-312 (124 Stat. 3296, 3300 (2010)). See section 1022. Property acquired from a decedent includes, principally, property acquired by bequest, devise, or inheritance, and, in the case of decedents dying after December 31, 1953, property required to be included in determining the value of the decedent's gross estate under any provision of the Code of 1954 or the Code of 1939. The general rule governing basis of property acquired from a decedent, as well as other rules prescribed elsewhere in this section, shall have no application if the property is sold, exchanged, or otherwise disposed of before the decedent's death by the person who acquired the property from the decedent. For general rules on the applicable valuation date where the executor of a decedent's estate elects under section 2032, or under section 811(j) of the Code of 1939, to value the decedent's gross estate at the alternate valuation date prescribed in such sections, see § 1.1014-3(e).

    (d) Effective/applicability date. This section applies on and after January 19, 2017. For rules before January 19, 2017, see § 1.1014-1 as contained in 26 CFR part 1 revised as of April 1, 2016.

    Par. 34. Section 1.1014-4 is amended by revising the first sentence of paragraph (a)(1), revising the second sentence of paragraph (a)(2), and adding paragraph (d) to read as follows:
    § 1.1014-4 Uniformity of basis; adjustment to basis.

    (a) * * *

    (1) The basis of property acquired from a decedent, as determined under section 1014(a) or section 1022, is uniform in the hands of every person having possession or enjoyment of the property at any time under the will or other instrument or under the laws of descent and distribution. * * *

    (2) * * * Accordingly, there is a common acquisition date for all titles to property acquired from a decedent within the meaning of section 1014 or section 1022, and, for this reason, a common or uniform basis for all such interests. * * *

    (d) Effective/applicability date. This section applies on and after January 19, 2017. For rules before January 19, 2017, see § 1.1014-4 as contained in 26 CFR part 1 revised as of April 1, 2016.

    Par. 35. Section 1.1014-5 is amended by revising paragraph (b) to read as follows:
    § 1.1014-5 Gain or loss.

    (b) Sale or other disposition of certain term interests—(1) In general. In determining gain or loss from the sale or other disposition after October 9, 1969, of a term interest in property (as defined in § 1.1001-1(f)(2)) the adjusted basis of which is determined pursuant, or by reference, to section 1014 (relating to the basis of property acquired from a decedent), section 1015 (relating to the basis of property acquired by gift or by a transfer in trust), or section 1022 (relating to the basis of property acquired from certain decedents who died in 2010), that part of the adjusted uniform basis assignable under the rules of paragraph (a) of this section to the interest sold or otherwise disposed of shall be disregarded to the extent and in the manner provided by section 1001(e) and § 1.1001-1(f).

    (2) Effective/applicability date. The provisions of paragraph (b)(1) of this section relating to section 1022 are effective on and after January 19, 2017. For rules before January 19, 2017, see § 1.1014-5 as contained in 26 CFR part 1 revised as of April 1, 2016.

    Par. 36. Section 1.1223-1 is amended by adding a sentence to the end of paragraph (b) and adding paragraph (l) to read as follows:
    § 1.1223-1 Determination of period for which capital assets are held.

    (b) * * * Similarly, the period for which property acquired from a decedent who died in 2010 was held by the decedent must be included in determining the period during which the property was held by the recipient, if the recipient's basis in the property is determined under section 1022.

    (l) Effective/applicability date. This section applies January 19, 2017. For rules before January 19, 2017, see § 1.1223-1 as contained in 26 CFR part 1 revised as of April 1, 2016.

    Par. 37. Section 1.1245-2 is amended by revising paragraph (c)(2)(ii) and adding paragraph (d) to read as follows:
    § 1.1245-2 Definition of recomputed basis.

    (c) * * *

    (2) * * *

    (ii) The transactions referred to in paragraph (c)(2)(i) of this section are:

    (A) A disposition that is in part a sale or exchange and in part a gift (see § 1.1245-4(a)(3));

    (B) A disposition (other than a disposition to which section 1245(b)(6)(A) applies) that is described in section 1245(b)(3) (relating to certain tax-free transactions);

    (C) An exchange described in § 1.1245-4(e)(2) (relating to transfers described in section 1081(d)(1)(A)); or

    (D) A transfer at death where the basis of property in the hands of the transferee is determined under section 1022.

    (d) Effective/applicability date. This section applies on and after January 19, 2017. For rules before January 19, 2017, see § 1.1245-2 as contained in 26 CFR part 1 revised as of April 1, 2016.

    Par. 38. Section 1.1245-3 is amended by revising paragraph (a)(3) and adding paragraph (d) to read as follows:
    § 1.1245-3 Definition of section 1245 property.

    (a) * * *

    (3) Even though property may not be of a character subject to the allowance for depreciation in the hands of the taxpayer, such property may nevertheless be section 1245 property if the taxpayer's basis for the property is determined by reference to its basis in the hands of a prior owner of the property and such property was of a character subject to the allowance for depreciation in the hands of such prior owner, or if the taxpayer's basis for the property is determined by reference to the basis of other property that in the hands of the taxpayer was property of a character subject to the allowance for depreciation, or if the taxpayer's basis for the property is determined under section 1022 and such property was of a character subject to the allowance for depreciation in the hands of the decedent. Thus, for example, if a father uses an automobile in his trade or business during a period after December 31, 1961, and then gives the automobile to his son as a gift for the son's personal use, the automobile is section 1245 property in the hands of the son.

    (d) Effective/applicability date. This section applies on and after January 19, 2017. For rules before January 19, 2017, see § 1.1245-3 as contained in 26 CFR part 1 revised as of April 1, 2016.

    Par. 39. Section 1.1245-4 is amended by revising the second sentence of paragraph (a)(1) and adding paragraph (i) to read as follows:
    § 1.1245-4 Exceptions and Limitations.

    (a) * * *

    (1) * * * For purposes of this paragraph (a), the term gift means, except to the extent that paragraph (a)(3) of this section applies, a transfer of property that, in the hands of the transferee, has a basis determined under the provisions of section 1015(a) or 1015(d) (relating to basis of property acquired by gifts) or section 1022 (relating to basis of property acquired from certain decedents who died in 2010). * * *

    (i) Effective/applicability date. This section applies on and after January 19, 2017. For rules before January 19, 2017, see § 1.1245-4 as contained in 26 CFR part 1 revised as of April 1, 2016.

    Par. 40. Section 1.1250-4 is amended by adding paragraphs (c)(5) and (h) to read as follows:
    § 1.1250-4 Holding period.

    (c) * * *

    (5) A transfer at death where the basis of the property in the hands of the transferee is determined under section 1022.

    (h) Effective/applicability date. This section applies on and after January 19, 2017. For rules before January 19, 2017, see § 1.1250-4 as contained in 26 CFR part 1 revised as of April 1, 2016.

    Par. 41. Section 1.1254-2 is amended by revising the second sentence of paragraph (a)(1) to read as follows:
    § 1.1254-2 Exceptions and limitations.

    (a) * * *

    (1) * * * For purposes of this paragraph (a), the term gift means, except to the extent that paragraph (a)(2) of this section applies, a transfer of natural resource recapture property that, in the hands of the transferee, has a basis determined under the provisions of section 1015(a) or 1015(d) (relating to basis of property acquired by gift) or section 1022 (relating to the basis of property acquired from certain decedents who died in 2010). * * *

    Par. 42. Section 1.1254-3 is amended by revising paragraphs (b)(2)(ii) and (iii) and adding paragraph (b)(2)(iv) to read as follows:
    § 1.1254-3 Section 1254 costs immediately after certain acquisitions.

    (b) * * *

    (2) * * *

    (ii) A transaction described in section 1041(a);

    (iii) A disposition described in § 1.1254-2(c)(3) (relating to certain tax-free transactions); or

    (iv) A transfer at death where basis of property in the hands of the transferee is determined under section 1022.

    Par. 43. Section 1.1254-4 is amended by revising paragraph (e)(4) introductory text to read as follows:
    § 1.1254-4 Special rules for S corporations and their shareholders.

    (e) * * *

    (4) * * * If stock is acquired in a transfer that is a gift, in a transfer that is a part sale or exchange and part gift, in a transfer that is described in section 1041(a), or in a transfer at death where the basis of property in the hands of the transferee is determined under section 1022, the amount of section 1254 costs with respect to the property held by the corporation in the acquiring shareholder's hands immediately after the transfer is an amount equal to—

    Par. 44. Section 1.1254-5 is amended by revising paragraph (c)(2)(iv) introductory text to read as follows:
    § 1.1254-5 Special rules for partnerships and their partners.

    (c) * * *

    (2) * * *

    (iv) * * * If an interest in a partnership is transferred in a transfer that is a gift, in a transfer that is a part sale or exchange and part gift, in a transfer that is described in section 1041(a), or in a transfer at death where the basis of property in the hands of the transferee is determined under section 1022, the amount of the transferee partner's section 1254 costs with respect to property held by the partnership immediately after the transfer is an amount equal to—

    Par. 45. Section 1.1254-6 is revised to read as follows:
    § 1.1254-6 Effective/applicability date.

    (a) Sections 1.1254-1 through 1.1254-3 and 1.1254-5 are effective with respect to any disposition of natural resource recapture property occurring after March 13, 1995. The rule in § 1.1254-1(b)(2)(iv)(A)(2), relating to a nonoperating mineral interest carved out of an operating mineral interest with respect to which an expenditure has been deducted, is effective with respect to any disposition occurring after March 13, 1995, of property (within the meaning of section 614) that is placed in service by the taxpayer after December 31, 1986. Section 1.1254-4 applies to dispositions of natural resource recapture property by an S corporation (and a corporation that was formerly an S corporation) and dispositions of S corporation stock occurring on or after October 10, 1996. Sections 1.1254-2(d)(1)(ii) and 1.1254-3(b)(1)(i), (b)(1)(ii), (d)(1)(i), and (d)(1)(ii) are effective for dispositions of property occurring on or after October 10, 1996.

    (b) The provisions of §§ 1.1254-2(a)(1), 1.1254-3(b)(2), 1.1254-4(e)(4), and 1.1254-5(c)(2)(iv) that relate to section 1022 are effective on and after January 19, 2017.

    Par. 46. Section 1.1296-1 is amended by revising paragraphs (d)(4) and (j) to read as follows:
    § 1.1296-1 Mark to market election for marketable stock.

    (d) * * *

    (4) Stock acquired from a decedent. In the case of stock of a PFIC that is acquired by bequest, devise, or inheritance (or by the decedent's estate) and with respect to which a section 1296 election was in effect as of the date of the decedent's death, notwithstanding section 1014 or section 1022, the basis of such stock in the hands of the person so acquiring it shall be the adjusted basis of such stock in the hands of the decedent immediately before his death (or, if lesser, the basis that would have been determined under section 1014 or section 1022 without regard to this paragraph (d)).

    (j) Effective/applicability date. The provisions in this section are applicable for taxable years beginning on or after May 3, 2004. The provisions of paragraph (d)(4) of this section relating to section 1022 are effective on and after January 19, 2017.

    Par. 47. Section 1.1312-7 is amended by revising paragraph (b) and adding paragraph (d) to read as follows:
    § 1.1312-7 Basis of property after erroneous treatment of a prior transaction.

    (b)(1) For this section to apply, the taxpayer with respect to whom the erroneous treatment occurred must be:

    (i) The taxpayer with respect to whom the determination is made; or

    (ii) A taxpayer who acquired title to the property in the erroneously treated transaction and from whom, mediately or immediately, the taxpayer with respect to whom the determination is made derived title in such a manner that he will have a basis ascertained by reference to the basis in the hands of the taxpayer who acquired title to the property in the erroneously treated transaction; or

    (iii) A taxpayer who had title to the property at the time of the erroneously treated transaction and from whom, mediately or immediately, the taxpayer with respect to whom the determination is made derived title, if the basis of the property in the hands of the taxpayer with respect to whom the determination is made is determined under section 1015(a) (relating to the basis of property acquired by gift) or section 1022 (relating to the basis of property acquired from certain decedents who died in 2010).

    (2) No adjustment is authorized with respect to the transferor of the property in a transaction upon which the basis of the property depends, when the determination is with respect to the original transferee or a subsequent transferee of the original transferee.

    (d) Effective/applicability date. This section applies on and after January 19, 2017. For rules before January 19, 2017, see § 1.1312-7 as contained in 26 CFR part 1 revised as of April 1, 2016.

    John Dalrymple, Deputy Commissioner for Services and Enforcement. Approved: November 11, 2016. Mark J. Mazur, Assistant Secretary of the Treasury (Tax Policy).
    [FR Doc. 2017-01365 Filed 1-18-17; 8:45 am] BILLING CODE 4830-01-P
    PENSION BENEFIT GUARANTY CORPORATION 29 CFR Part 4022 Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Paying Benefits AGENCY:

    Pension Benefit Guaranty Corporation.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule amends the Pension Benefit Guaranty Corporation's regulation on Benefits Payable in Terminated Single-Employer Plans to prescribe interest assumptions under the regulation for valuation dates in February 2017. The interest assumptions are used for paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC.

    DATES:

    Effective February 1, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Deborah C. Murphy ([email protected]), Assistant General Counsel for Regulatory Affairs, Pension Benefit Guaranty Corporation, 1200 K Street NW., Washington, DC 20005, 202-326-4400 ext. 3451. (TTY/TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4400 ext. 3451.)

    SUPPLEMENTARY INFORMATION:

    PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribes actuarial assumptions—including interest assumptions—for paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulation are also published on PBGC's Web site (http://www.pbgc.gov).

    PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.

    The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for February 2017.1

    1 Appendix B to PBGC's regulation on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) prescribes interest assumptions for valuing benefits under terminating covered single-employer plans for purposes of allocation of assets under ERISA section 4044. Those assumptions are updated quarterly.

    The February 2017 interest assumptions under the benefit payments regulation will be 1.25 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for January 2017, these interest assumptions are unchanged.

    PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

    Because of the need to provide immediate guidance for the payment of benefits under plans with valuation dates during February 2017, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

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

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

    List of Subjects in 29 CFR Part 4022

    Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements.

    In consideration of the foregoing, 29 CFR part 4022 is amended as follows:

    PART 4022—BENEFITS PAYABLE IN TERMINATED SINGLE-EMPLOYER PLANS 1. The authority citation for part 4022 continues to read as follows: Authority:

    29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344.

    2. In appendix B to part 4022, Rate Set 280, as set forth below, is added to the table. Appendix B to Part 4022—Lump Sum Interest Rates For PBGC Payments Rate set For plans with a valuation date On or after Before Immediate
  • annuity rate
  • (percent)
  • Deferred annuities
  • (percent)
  • i 1 i 2 i 3 n 1 n 2
    *         *         *         *         *         *         * 280 2-1-17 3-1-17 1.25 4.00 4.00 4.00 7 8
    3. In appendix C to part 4022, Rate Set 280, as set forth below, is added to the table. Appendix C to Part 4022—Lump Sum Interest Rates for Private-Sector Payments Rate set For plans with a valuation date On or after Before Immediate
  • annuity rate
  • (percent)
  • Deferred annuities
  • (percent)
  • i 1 i 2 i 3 n 1 n 2
    *         *         *         *         *         *         * 280 2-1-17 3-1-17 1.25 4.00 4.00 4.00 7 8

    Issued in Washington, DC.

    Deborah Chase Murphy, Assistant General Counsel for Regulatory Affairs, Pension Benefit Guaranty Corporation.
    [FR Doc. 2017-00461 Filed 1-18-17; 8:45 am] BILLING CODE 7709-02-P
    DEPARTMENT OF THE TREASURY Fiscal Service 31 CFR Part 347 RIN 1530-AA13 Regulations Governing Retirement Savings Bonds AGENCY:

    Bureau of the Fiscal Service, Fiscal Service, Treasury.

    ACTION:

    Final rule.

    SUMMARY:

    Currently, the Bureau of the Fiscal Service (Fiscal Service) of the United States Department of the Treasury (Treasury), issues nonmarketable, electronic retirement savings bonds to an individual retirement account (IRA) custodian designated by Fiscal Service to act as a custodian for Roth IRAs under Treasury's myRA® program. In this Final Rule, Treasury offers nonmarketable, electronic retirement savings bonds for certain retirement savings programs established by states or certain of their political subdivisions (states). The bonds will be issued to a trustee or custodian (custodian) of a Roth IRA or traditional IRA designated by a state under its retirement savings program (whether or not the program provides for automatic enrollment). Interest will be earned at a rate available to federal employees invested in the Government Securities Investment Fund (G Fund) of the federal Thrift Savings Plan.

    This offering does not affect the terms of retirement savings bonds issued to the custodian of Treasury's retirement savings program, myRA®, which are held in participants' Roth IRAs. More information on myRA® is available at www.myra.gov.

    DATES:

    This Final Rule is effective January 19, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Technical information: Gregory Till, myRA Bureau Director, at (202) 622-6970 or [email protected]

    Legal information: Elizabeth Spears, Senior Counsel, at (304) 480-8647 or [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    Approximately one third of private-sector employees in the United States lack access to a retirement savings plan through their employers.1 To fill this gap, several states are establishing or considering establishing programs that will encourage employees to save for their retirement, including through individual retirement accounts into which employees are automatically enrolled and through other approaches (collectively referred to here as Auto-IRAs, whether or not they use automatic enrollment).2 Under an Auto-IRA program, employee contributions are deposited into an IRA and invested in accordance with the design of the Auto-IRA program and the wishes of the participant. Generally, it is expected that an Auto-IRA program will offer a safe and low-cost investment option as an alternative to a risk-bearing diversified investment, such as a target date fund. In order to assist states in offering savers the option of a principal-protected investment, Fiscal Service will offer retirement savings bonds to state Auto-IRA programs. Fiscal Service reserves the right, however, to decline to issue retirement savings bonds to state Auto-IRA programs on a case-by-case basis, based on considerations such as the structure and reasonableness of associated fees, plans to control fees and expenses, whether participants have reasonable access to their funds, and oversight of providers designated to operate state Auto-IRA programs.

    1National Compensation Survey, Bureau of Labor Statistics (July 2016), Employee Benefits in the United States—March 2016 (http://www.bls.gov/news.release/pdf/ebs2.pdf). These data show that 66 percent of 114 million private-sector workers have access to a retirement plan through their employers. By extension, approximately 34 percent of the 114 million private-sector workers (39 million) do not have access to a retirement plan through work.

    2 The Department of Labor has published regulations relating to state payroll deduction savings programs. 81 FR 59464 (Aug. 30, 2016) and 81 FR 92639 (Dec. 20, 2016).

    II. Section-by-Section Analysis Subpart A—General Information

    Section 347.0 Offering of securities. This section is amended to offer retirement savings bonds to Auto-IRA custodians for certain state retirement savings programs.

    Section 347.1 Applicability. This section is amended to include the Auto-IRA custodians for state retirement savings programs under this part.

    Section 347.2 Official agencies. This section clarifies that Fiscal Service is responsible for issuing retirement savings bonds to the Auto-IRA custodians and that states are responsible for administering their own Auto-IRA retirement savings programs.

    Section 347.3 Definitions. Several new definitions, including “Auto-IRA,” “state Auto-IRA program,” “IRA,” “Custodian,” “State,” and “Auto-IRA custodian” have been added for ease of reference in Subpart C—Auto-IRA Programs and minor changes have been made to some existing definitions.

    Subpart B—Treasury's Retirement Savings Program

    Miscellaneous changes have been made to the sections pertaining to retirement savings bonds issued to the custodian of Treasury's retirement savings program, myRA®, which are held in participants' Roth IRAs. These changes, which were made to accommodate revised definitions and other minor or technical revisions, do not affect the terms of these bonds. See, e.g., §§ 347.10 through 347.16.

    Subpart C—Auto-IRA Programs

    Section 347.30 Plan requirements for State Auto-IRA programs. Subsection (a) of this new section specifies that retirement savings bonds will be issued to Auto-IRA custodians for certain state Auto-IRA programs, and that no other registrations under Subpart C are permitted. As defined in § 347.3, an Auto-IRA custodian is “an entity designated by a state (including, for the purpose of these regulations, certain political subdivisions of states) to act as the trustee or custodian for Auto-IRAs, in the form of Roth IRAs or traditional IRAs, for or opened on behalf of participants in a state Auto-IRA program.” Subsection (b) lists topics that must be addressed by documentation that programs are required to provide and certify to Fiscal Service annually. The documentation must address: (1) Administration of retirement savings bonds, (2) account monitoring, (3) ability to transfer proceeds, (4) IRA withdrawals, (5) consumer protection, (6) state Auto-IRA program costs of administration, (7) oversight of Auto-IRA custodian, (8) pooling prohibitions, (9) default investments, and (10) consumer education. The Commissioner of the Fiscal Service may use the documentation, among other purposes, in exercising any of the rights reserved under § 347.37, which includes the right to require information addressing additional topics. Subsection (c) provides for a successor Auto-IRA custodian, if needed.

    Section 347.31 Crediting of retirement savings bond. This new section requires each bond issued to an Auto-IRA custodian to be credited to an individual's IRA under a state Auto-IRA program.

    Section 347.32 Annual additions to retirement savings bond. This new section provides that the initial contribution and additions to a bond on behalf of a participant are subject to the annual contribution limits provided under the Internal Revenue Code and regulations, and that the total value of a retirement savings bond held by an Auto-IRA custodian in an IRA on behalf of any participant cannot exceed $15,000.00.

    Section 347.33 Individual additions to retirement savings bond. This new section authorizes Fiscal Service to establish minimum amounts for initial and additional contributions to a retirement savings bond.

    Section 347.34 Payment (redemption). Under this new section, an Auto-IRA custodian is responsible for making certain certifications as a condition of the issuance and redemption of a retirement savings bond. Subsection (a) explains how the Auto-IRA custodian will request that Fiscal Service make payment on matured retirement savings bonds as well as those that have been fully or partially redeemed. Under subsection (b), Fiscal Service will make payment on any bonds that it calls for redemption without the Auto-IRA custodian having to make a request. Under § 347.37(4), the Commissioner of the Fiscal Service may exercise discretion to call the bonds for redemption. This might occur for a variety of reasons, including, for example, in the event that a state Auto-IRA program changed significantly such that ongoing use of retirement savings bonds is no longer consistent with these regulations, or in the event that a state Auto-IRA program might have failed to comply with program instructions identified by Fiscal Service or might have failed to provide or comply with documentation required pursuant to § 347.30. Subsection (b) clarifies how bonds called for redemption will be paid, which is in the same manner as bonds submitted for redemption under subsection (a).

    Section 347.35 Computation of interest. This new section provides that the interest rate on the retirement savings bonds will track the annual percentage rate on securities in the Government Securities Investment Fund (G Fund) in the Thrift Savings Plan for federal employees and that interest will cease at maturity or call.

    Section 347.36 Maturity. This new section provides that the maturity dates for the retirement savings bonds may differ for each bond. The longest possible maturity is 30 years (an original maturity period of 20 years and an extended maturity period of 10 years). A bond will mature at the earlier of 30 years from the date the bond is first issued to the Auto-IRA custodian on behalf of the participant or when its value reaches $15,000.00.

    Section 347.37 Reservation of rights. Under this new section, the Commissioner of the Fiscal Service reserves certain rights, including: (1) The right to require a senior official to certify program information to Fiscal Service before the retirement savings bonds are issued to an Auto-IRA custodian; (2) the right to refuse to issue retirement savings bonds to an Auto-IRA custodian in any particular case or class of cases; (3) the right to suspend or cease offering retirement savings bonds to an Auto-IRA custodian; (4) the right to call for redemption of any outstanding retirement savings bond (this might occur for a variety of reasons, including, for example, if a state Auto-IRA program has changed significantly such that ongoing use of retirement savings bonds is no longer consistent with these regulations, or if a state has failed to provide or comply with documentation required pursuant to § 347.30); or (5) the right to determine any appropriate remedy under this subpart.

    Subpart D—Miscellaneous Provisions for Retirement Savings Bonds

    Subpart D contains miscellaneous provisions (§§ 347.40 through 347.42) that apply to retirement savings bonds issued to the custodians, on behalf of participants, in Treasury's and the states' programs.

    III. Procedural Requirements A. Administrative Procedure Act

    Because this rule relates to United States securities, which are contracts between Treasury and the owners of the securities, this rule falls within the contract exception to the Administrative Procedures Act (APA) at 5 U.S.C. 553(a)(2). As a result, the notice, public comment, and delayed effective date provisions of the APA are inapplicable to this rule.

    B. Congressional Review Act

    This rule is not a major rule pursuant to the Congressional Review Act (CRA), 5 U.S.C. 801 et seq.

    C. Paperwork Reduction Act

    This final rule contains a new collection of information that is subject to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. Under the PRA, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The collection of information contained in this final rulemaking has been submitted to the Office of Management and Budget for review in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)).

    D. Regulatory Flexibility Act

    The provisions of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., do not apply to this rule because, pursuant to 5 U.S.C. 553(a)(2), it is not required to be issued with notice and opportunity for public comment.

    E. Executive Order 12866

    This rule is not a significant regulatory action pursuant to Executive Order 12866.

    List of Subjects in 31 CFR Part 347

    Government securities, Savings bonds.

    For the reasons set forth in the preamble, we amend 31 CFR part 347 as follows:

    PART 347—REGULATIONS GOVERNING RETIREMENT SAVINGS BONDS 1. The authority citation for part 347 continues to read as follows: Authority:

    5 U.S.C. 301; 12 U.S.C. 90; 31 U.S.C. 3105.

    2. Revise § 347.0 to read as follows:
    § 347.0 Offering of securities.

    The Secretary of the Treasury (the Secretary), under the authority of Title 31, Chapter 31, offers retirement savings bonds to the IRA custodian for Treasury's retirement savings program and to the Auto-IRA custodians for certain state Auto-IRA programs. The nonmarketable bonds are issued to and held by the custodians, on behalf of participants, in Treasury's program and state programs. This offering will continue until terminated by the Secretary or the Secretary's designee. Treasury's Fiscal Assistant Secretary is authorized to act on behalf of the Secretary on all matters contained in these regulations. The Commissioner of the Fiscal Service, as designee of the Secretary, is delegated the responsibility to administer this part through the Bureau of the Fiscal Service (Fiscal Service).

    3. Revise § 347.1 to read as follows:
    § 347.1 Applicability.

    The regulations in this part apply to retirement savings bonds issued, on behalf of participants, to the IRA custodian for Treasury's retirement savings program and to the Auto-IRA custodians for state Auto-IRA programs.

    4. Revise § 347.2 to read as follows:
    § 347.2 Official agencies.

    (a) Fiscal Service is responsible for administering Treasury's retirement savings program and for issuing the retirement savings bonds to the IRA custodian for Treasury's retirement savings program and to the Auto-IRA custodians for certain state Auto-IRA programs. The states are responsible for administering their Auto-IRA retirement savings programs, including the designation of Auto-IRA custodians to perform all operational responsibilities associated with the retirement savings bonds issued by Fiscal Service.

    (b) Communications concerning transactions relating to an individual's IRA should be addressed to the appropriate custodian.

    5. In § 347.3: a. Redesignate paragraphs (a) through (g) as paragraphs (g) through (m); b. Add new paragraphs (a) through (f); and c. Revise newly redesignated paragraphs (g) through (j).

    The additions and revisions read as follows:

    § 347.3 Definitions.

    (a) Auto-IRA means an individual retirement account for or opened on behalf of a participant in a state retirement savings program (whether or not the program provides for automatic enrollment).

    (b) State Auto-IRA program means a state Auto-IRA retirement savings program.

    (c) IRA means an individual retirement account.

    (d) Custodian means a trustee or custodian of a Roth IRA or traditional IRA.

    (e) State means any of the 50 states, the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Virgin Islands, American Samoa, the Commonwealth of the Northern Mariana Islands, or certain of their political subdivisions.

    (f) Auto-IRA custodian means an entity designated by a state (including, for the purpose of these regulations, political subdivisions of states) to act as the trustee or custodian for Auto-IRAs, in the form of Roth IRAs or traditional IRAs, for or opened on behalf of participants in a state Auto-IRA program.

    (g) Retirement savings bond, as used in this part, means an interest-bearing electronic United States savings bond issued to an Auto-IRA or IRA custodian.

    (h) IRA custodian means an entity designated by Fiscal Service to act as a custodian for Roth IRAs opened by or on behalf of participants in Treasury's retirement savings program.

    (i) Individual means a person eligible to have an IRA in Treasury's retirement savings program or in a state Auto-IRA program.

    (j) Participant means an individual who has an IRA in Treasury's retirement savings program or in a state Auto-IRA program.

    6. Revise the heading of subpart B to read as follows: Subpart B—Treasury's Retirement Savings Program 7. Revise §§ 347.10 and 347.11 to read as follows:
    § 347.10 Authorized form of registration.

    (a) Retirement savings bonds are issued to the IRA custodian for Treasury's retirement savings program. No other registrations under this subpart are permitted.

    (b) In the event Fiscal Service designates a successor IRA custodian, Fiscal Service may reissue retirement savings bonds held by the predecessor custodian to the successor custodian.

    § 347.11 Crediting of retirement savings bond.

    Each retirement savings bond issued to the IRA custodian must be credited to a single Roth IRA established through Treasury's retirement savings program with the custodian.

    8. Remove the headings for subparts C, D, and E and transfer §§ 347.20, 347.21, 347.30, 347.40, and 347.41 to subpart B, and redesignate them as §§ 347.12 through 347.16, respectively. 9. Revise newly redesignated §§ 347.12 through 347.16 to read as follows:
    § 347.12 Annual additions to retirement savings bond.

    The amount that initially may be contributed or added to a retirement savings bond in a calendar year by the IRA custodian on behalf of any participant is limited by the applicable annual contribution limits provided under the Internal Revenue Code and regulations. The total value of a retirement savings bond that may be held by the IRA custodian in an IRA on behalf of any participant shall not exceed $15,000.

    § 347.13 Individual additions to retirement savings bond.

    Fiscal Service is authorized to establish minimum amounts for initial and additional contributions to a retirement savings bond under this subpart.

    § 347.14 Payment (redemption).

    Payment of retirement savings bonds will be made to the IRA custodian upon the custodian's submission of a request for redemption to Fiscal Service. The custodian shall request the redemption of all retirement savings bonds at their respective maturity. The custodian shall request the full or partial redemption of a bond held on behalf of a participant upon the request of the participant or other authorized person entitled to amounts in the IRA. Retirement savings bond redemptions will be rounded to the nearest one cent.

    § 347.15 Computation of interest.

    Retirement savings bonds under this subpart earn interest at the same annual percentage rate as securities issued to the Government Securities Investment Fund (G Fund) in the Thrift Savings Plan for federal employees. The Secretary calculates the G Fund interest rate pursuant to 5 U.S.C. 8438(e)(2). The retirement savings bond interest rate compounds daily at 1/360 of the annual percentage rate. Retirement savings bonds will cease to accrue interest on the date of their maturity.

    § 347.16 Maturity.

    The maturity date for retirement savings bonds is indeterminate and may be different for each bond issued, but shall not exceed the sum of an original maturity period of 20 years and an extended maturity period of 10 years. A retirement savings bond purchased by the IRA custodian on behalf of a participant will mature at the earlier of 30 years from the date the bond is first issued to the custodian on behalf of the participant or when its value reaches $15,000.

    10. Add a new subpart C to read as follows: Subpart C—Auto-IRA Programs Sec. 347.30 Plan requirements for State Auto-IRA programs. 347.31 Crediting of retirement savings bond. 347.32 Annual additions to retirement savings bond. 347.33 Individual additions to retirement savings bond. 347.34 Payment (redemption). 347.35 Computation of interest. 347.36 Maturity. 347.37 Reservation of rights. Subpart C—Auto-IRA Programs
    § 347.30 Plan requirements for State Auto-IRA programs.

    (a) Authorized form of registration. Retirement savings bonds are issued to Auto-IRA custodians for state Auto-IRA programs. No other registrations under this subpart are permitted.

    (b) Documentation. A state Auto-IRA program must provide documentation to Fiscal Service annually, in a form and manner acceptable to Fiscal Service, addressing the following topics:

    (1) Administration—servicing of the retirement savings bonds, such as account maintenance, recordkeeping, and establishment of procedures for automatic payroll direct deposit contributions (or other funding means permitted under state Auto-IRA programs);

    (2) Account monitoring—tracking and, when applicable, redeeming and reallocating retirement savings bond holdings (which may include investment diversification strategies) no later than when a retirement savings bond that may be held by the Auto-IRA custodian on behalf of a participant in a state Auto-IRA program reaches the $15,000 maximum dollar threshold or 30 years, whichever occurs first;

    (3) Ability to transfer—addressing how the state Auto-IRA program enables participants, at their discretion, to redeem their retirement savings bonds prior to maturity and transfer their retirement savings bond proceeds to another investment available in the State Auto-IRA program or to another provider, without imposing unreasonable restrictions on voluntary investment diversification (which might occur through a transfer within or outside of a state Auto-IRA program);

    (4) Withdrawals—addressing how the state Auto-IRA program enables participants, at their discretion, to make reasonable withdrawals from their Auto-IRAs;

    (5) Consumer protection—addressing consumer protections in the program, including disclosures provided to participants;

    (6) Costs of administration—describing any fees or other costs or expenses passed on to or otherwise borne by participants under the state Auto-IRA program (e.g., no more than reasonable administrative, custodial, asset management, or other fees, costs, or expenses);

    (7) Oversight—addressing state Auto-IRA program oversight of Auto-IRA custodians and describing any protections in place for participants' funds invested in retirement savings bonds, including information relating to the protection of participants' funds in the event that the Auto-IRA custodian files for bankruptcy or otherwise experiences financial stress;

    (8) Pooling—prohibiting the inclusion of retirement savings bonds as a component of another investment or asset category (such as a mutual fund or target-date fund);

    (9) Default investment—obtaining, if applicable, Fiscal Service's further consent before any use of retirement savings bonds as a default, sole, or mandatory investment, even if temporary;

    (10) Consumer education—describing plans to provide financial education to participants; and

    (11) Certification—requiring a statement signed by an authorized senior official certifying that the documentation provided to Fiscal Service is accurate and complete, and that procedures are in place to timely notify Fiscal Service of any material changes in the future.

    (c) Successor custodian. In the event a state Auto-IRA program designates a successor Auto-IRA custodian, that program may request that Fiscal Service reissue the retirement savings bonds held by the predecessor custodian to the successor custodian.

    § 347.31 Crediting of retirement savings bond.

    Each retirement savings bond issued to an Auto-IRA custodian must be credited to an IRA under the state Auto-IRA program with the custodian.

    § 347.32 Annual additions to retirement savings bond.

    The amount that initially may be contributed or added to a retirement savings bond in a calendar year by an Auto-IRA custodian on behalf of any participant is limited by the applicable annual contribution limits provided under the Internal Revenue Code and regulations. The total value of a retirement savings bond that may be held by an Auto-IRA custodian in an IRA on behalf of any participant shall not exceed $15,000 for each state Auto-IRA program.

    § 347.33 Individual additions to retirement savings bond.

    Fiscal Service is authorized to establish minimum amounts for initial and additional contributions to a retirement savings bond under this subpart.

    § 347.34 Payment (redemption).

    The issuance and redemption of a retirement savings bond is conditioned on an Auto-IRA custodian certifying compliance with these regulations and with any additional program instructions identified by Fiscal Service that pertain to that bond.

    (a) Payment upon maturity. Payment of retirement savings bonds will be made to an Auto-IRA custodian upon the custodian's submission of a request for redemption to Fiscal Service. The custodian shall request the redemption of all retirement savings bonds at their respective maturity. The custodian shall request the full or partial redemption of a bond held on behalf of a participant upon the request of the participant or other authorized person entitled to amounts in the IRA. Retirement savings bond redemptions will be rounded to the nearest one cent.

    (b) Payment upon call. Final interest on any called bonds will be paid with the principal (amount contributed minus withdrawals taken) at redemption and rounded to the nearest one cent.

    § 347.35 Computation of interest.

    Retirement savings bonds under this subpart earn interest at the same annual percentage rate as securities issued to the Government Securities Investment Fund (G Fund) in the Thrift Savings Plan for federal employees. The Secretary calculates the G Fund interest rate pursuant to 5 U.S.C. 8438(e)(2). The retirement savings bond interest rate compounds daily at 1/360 of the annual percentage rate. Retirement savings bonds will cease to accrue interest on the date of their maturity or call.

    § 347.36 Maturity.

    The maturity date for retirement savings bonds is indeterminate and may be different for each bond issued, but shall not exceed the sum of an original maturity period of 20 years and an extended maturity period of 10 years. A retirement savings bond purchased by the Auto-IRA custodian on behalf of a participant will mature at the earlier of 30 years from the date the bond is first issued to the custodian on behalf of the participant or when its value reaches $15,000.

    § 347.37 Reservation of rights.

    The Commissioner of the Fiscal Service may decide, in his or her sole discretion, to take any of the following actions with respect to the retirement savings bonds offered under this subpart. Such actions are final. Specifically, the Commissioner reserves the right under this subpart:

    (a) As a condition of Fiscal Service's issuance of retirement savings bonds to an Auto-IRA custodian under a state Auto-IRA program, to require a state Auto-IRA program to provide information to Fiscal Service concerning the state Auto-IRA program and retirement savings bonds offered under this subpart, including a certification by a senior official to the completeness and accuracy of the information requested;

    (b) To refuse to issue retirement savings bonds to an Auto-IRA custodian in any particular case or class of cases;

    (c) To suspend or cease offering retirement savings bonds to an Auto-IRA custodian;

    (d) To call for redemption of any outstanding retirement savings bond; or

    (e) To determine any appropriate remedy under this subpart.

    11. Redesignate subpart F (consisting of §§ 347.50, 347.51, and 347.52) as subpart D (consisting of §§ 347.40 through 347.42) and revise newly redesignated subpart D to read as follows: Subpart D—Miscellaneous Provisions for Retirement Savings Bonds Sec. 347.40 Waiver of regulations. 347.41 Additional requirements; bond of indemnity. 347.42 Supplements, amendments, or revisions. Subpart D—Miscellaneous Provisions for Retirement Savings Bonds
    § 347.40 Waiver of regulations.

    The Commissioner of the Fiscal Service may waive or modify any provision or provisions of the regulations in this part. He or she may do so in any particular case or class of cases for the convenience of the United States or in order to relieve any person or persons of unnecessary hardship:

    (a) If such action would not be inconsistent with law or equity;

    (b) If it does not impair any material existing rights; and

    (c) If he or she is satisfied that such action would not subject the United States to any substantial expense or liability.

    § 347.41 Additional requirements; bond of indemnity.

    The Commissioner of the Fiscal Service may require:

    (a) Such additional evidence to support a requested action as he or she may consider necessary or advisable; or

    (b) A bond of indemnity, with or without surety, in any case in which he or she may consider such a bond necessary for the protection of the interests of the United States.

    § 347.42 Supplements, amendments, or revisions.

    The Secretary may at any time, or from time to time, prescribe additional, supplemental, amendatory, or revised rules and regulations governing retirement savings bonds.

    David A. Lebryk, Fiscal Assistant Secretary.
    [FR Doc. 2017-01038 Filed 1-18-17; 8:45 am] BILLING CODE 4810-AS-P
    DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 269 [Docket ID: DOD-2016-OS-0045] RIN 0790-ZA12 Civil Monetary Penalty Inflation Adjustment AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    This final rule is being issued to adjust for inflation each civil monetary penalty (CMP) provided by law within the jurisdiction of the United States Department of Defense (Department of Defense). The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), requires the head of each agency to adjust for inflation its CMP levels in effect as of November 2, 2015, under a revised methodology that was effective for 2016 and for each year thereafter.

    DATES:

    This rule is effective January 19, 2017 and is applicable beginning on January 13, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Brian Banal, 703-571-1652.

    SUPPLEMENTARY INFORMATION: Background Information

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

    The initial catch up adjustments for inflation to the Department of Defense's CMPs were published as an interim final rule in the Federal Register on May 26, 2016 (81 FR 33389-33391) and became effective on that date. The interim final rule was published as a final rule without change on September 12, 2016 (81 FR 62629-62631), effective that date. The revised methodology for agencies for 2017 and each year thereafter provides for the improvement of the effectiveness of CMPs and to maintain their deterrent effect. Effective 2017, agencies' annual adjustments for inflation to CMPs shall take effect not later than January 15. The Department of Defense is adjusting the level of all civil monetary penalties under its jurisdiction by the Office of Management and Budget (OMB) directed cost-of-living adjustment multiplier for 2017 of 1.01636 prescribed in OMB Memorandum M-17-11, “Implementation of the 2017 annual adjustment pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015,” dated December 16, 2016. The Department of Defense's 2017 adjustments for inflation to CMPs apply only to those CMPs, including those whose associated violation predated such adjustment, which are assessed by the Department of Defense after the effective date of the new CMP level.

    Statement of Authority and Costs and Benefits

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

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

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

    Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” because it does not: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a section of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive Orders.

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

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

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

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

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

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

    Executive Order 13132, “Federalism”

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

    List of Subjects in 32 CFR Part 269

    Administrative practice and procedure, Penalties.

    Accordingly, 32 CFR part 269 is amended as follows.

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

    28 U.S.C. 2461 note.

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

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

    United States Code Civil Monetary Penalty
  • Description
  • Maximum Penalty Amount as of 05/26/16 New Adjusted Maximum Penalty Amount
    National Defense Authorization Act for FY 2005, 10 U.S.C 113, note Unauthorized Activities Directed at or Possession of Sunken Military Craft $124,588 126,626 10 U.S.C. 1094(c)(1) Unlawful Provision of Health Care 10,940 11,119 10 U.S.C. 1102(k) Wrongful Disclosure—Medical Records First Offense 6,469 6,575 Subsequent Offense 43,126 43,832 10 U.S.C. 2674(c)(2) Violation of the Pentagon Reservation Operation and Parking of Motor Vehicles Rules and Regulations 1,782 1,811 31 U.S.C. 3802(a)(1) Violation Involving False Claim 10,781 10,957 31 U.S.C. 3802(a)(2) Violation Involving False Statement 10,781 10,957
    Dated: January 9, 2017. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2017-00619 Filed 1-18-17; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2015-1088] RIN 1625-AA00 Safety Zone; Pleasure Beach Bridge, Bridgeport, CT AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone on the navigable waters of Pleasure Beach, Bridgeport, CT for Pleasure Beach Bridge. This temporary final rule is necessary to provide for the safety of life on navigable waters. Entry into, transit through, mooring, or anchoring within the safety zone is prohibited unless authorized by Captain of the Port (COTP), Sector Long Island Sound.

    DATES:

    This rule is effective without actual notice from January 19, 2017 until June 30, 2017. For the purposes of enforcement, actual notice will be used from January 1, 2017 until January 19, 2017.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2015-1088 and USCG-2015-1123 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, contact Petty Officer Jay TerVeen, Prevention Department, U.S. Coast Guard Sector Long Island Sound, telephone (203) 468-4446, email [email protected].

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register LIS Long Island Sound NPRM Notice of Proposed Rulemaking NAD 83 North American Datum 1983 II. Background Information and Regulatory History

    This rulemaking establishes a safety zone for the waters around Pleasure Beach Bridge, Bridgeport, CT. Corresponding regulatory history is discussed below.

    The Coast Guard was made aware on December 9, 2015, of damage to Pleasure Beach Bridge, the result of which created a hazard to navigation. On December 22, 2015, the Coast Guard published a temporary final rule entitled, “Safety Zone; Pleasure Beach Bridge, Bridgeport, CT” in the Federal Register (80 FR 79480). On June 23, 2016, the Coast Guard published a second temporary final rule entitled, “Safety Zone; Pleasure Beach Bridge, Bridgeport, CT” in the Federal Register (81 FR 40814). On July 25, 2016, the Coast Guard published a third temporary final rule entitled, “Safety Zone; Pleasure Beach Bridge, Bridgeport, CT” in the Federal Register (81 FR 48329). The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM with respect to this rule because doing so would be impracticable and contrary to the public interest. A solution to remedy the safety hazards associated with this bridge was initially projected to be completed prior to the expiration of the current safety zone, but has been delayed. It would be impracticable and contrary to the public interest to delay promulgating this rule, as it is necessary to protect the safety of waterway users.

    We are issuing this rule, and under 5 U.S.C. 553(d)(3), and for the same reasons stated in the preceding paragraph, the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register.

    III. Legal Authority and Need for Rule

    The legal basis for this temporary rule is 33 U.S.C. 1231.

    On December 09, 2015, the Coast Guard was made aware of damage sustained to Pleasure Beach Bridge, Bridgeport, CT that has created a hazard to navigation. After further analysis of the bridge structure, the Coast Guard concluded that the overall condition of the structure created a continued hazard to navigation. The COTP Sector LIS has determined that the safety zone established by this temporary final rule is necessary to provide for the safety of life on navigable waterways.

    IV. Discussion of the Rule

    The safety zone established by this rule will cover all navigable waters of the entrance channel to Johnsons Creek in the vicinity of Pleasure Beach Bridge, Bridgeport, CT. This safety zone will be bound inside an area that starts at a point on land at position 41-10.2 N., 073-10.7 W. and then east along the shoreline to a point on land at position 41-9.57 N., 073-9.54 W. and then south across the channel to a point on land at position 41-9.52 N., 073-9.58 W. and then west along the shoreline to a point on land at position 41-9.52 N., 073-10.5 W. and then north across the channel back to the point of origin.

    This rule prohibits vessels from entering, transiting, mooring, or anchoring within the area specifically designated as a safety zone during the period of enforcement unless authorized by the COTP or designated representative.

    The Coast Guard will notify the public and local mariners of this safety zone through appropriate means, which may include, but are not limited to, publication in the Federal Register, the Local Notice to Mariners, and Broadcast Notice to Mariners.

    V. Regulatory Analyses

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

    A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget. The Coast Guard determined that this rulemaking is not a significant regulatory action for the following reasons: (1) Persons or vessels desiring to enter the safety zone may do so with permission from the COTP Sector LIS or a designated representative; and (2) the Coast Guard will notify the public of the enforcement of this rule via appropriate means, such as via Local Notice to Mariners and Broadcast Notice to Mariners to increase public awareness of this safety zone.

    B. Impact on Small Entities

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

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This temporary rule involves the establishment of a safety zone. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination, a Categorical Exclusion Determination, and EA Checklist, will be in the docket for review. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 165

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

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

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

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

    2. Add § 165.T01-1088 to read as follows:
    § 165.T01-1088 Safety Zone; Pleasure Beach Bridge, Bridgeport, CT.

    (a) Location. The following area is a safety zone: All navigable waters of the entrance channel to Johnsons Creek in the vicinity of Pleasure Beach Bridge, Bridgeport, CT bound inside an area that starts at a point on land at position 41°10′02.964″ N., 073°10′08.148″ W. and then east along the shoreline to a point on land at position 41°09′57.996″ N., 073°09′54.324″ W. and then south across the channel to a point on land at position 41°09′52.524″ N., 073°09′58.861″ W. and then west along the shoreline to a point on land at position 41°09′52.776″ N., 073°10′04.944″ W. and then north across the channel back to the point of origin.

    (b) Enforcement Period. This section will be enforced from 12:00 a.m. on January 1, 2017 to 12:00 a.m. June 30, 2017.

    (c) Definitions. The following definitions apply to this section: A “designated representative” is any commissioned, warrant, or petty officer of the U.S. Coast Guard who has been designated by the Captain of the Port (COTP), Sector Long Island Sound, to act on his or her behalf. The designated representative may be on an official patrol vessel or may be on shore and will communicate with vessels via VHF-FM radio or loudhailer. “Official patrol vessels” may consist of any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement vessels assigned or approved by the COTP Sector Long Island Sound. In addition, members of the Coast Guard Auxiliary may be present to inform vessel operators of this regulation.

    (d) Regulations. (1) The general regulations contained in 33 CFR 165.23 apply.

    (2) In accordance with the general regulations in 33 CFR 165.23, entry into or movement within this zone is prohibited unless authorized by the COTP, Long Island Sound.

    (3) Operators desiring to enter or operate within the safety zone should contact the COTP Sector Long Island Sound at 203-468-4401 (Sector Sector Long Island Sound Command Center) or the designated representative via VHF channel 16 to obtain permission to do so.

    (4) Any vessel given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP Sector Long Island Sound, or the designated on-scene representative.

    (5) Upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light or other means, the operator of the vessel shall proceed as directed.

    Dated: December 29, 2016. A.E. Tucci, Captain, U.S. Coast Guard, Captain of the Port Sector Long Island Sound.
    [FR Doc. 2017-01068 Filed 1-18-17; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF EDUCATION 34 CFR Part 99 Family Educational Rights and Privacy Act AGENCY:

    Office of the Chief Privacy Officer, Office of Management, Department of Education.

    ACTION:

    Final rule.

    SUMMARY:

    The Secretary amends the Family Educational Rights and Privacy Act (FERPA) regulations to change the name of the office designated enforcement functions by the Secretary from the Family Policy Compliance Office to the Office of the Chief Privacy Officer. The purpose of this amendment is to reflect additional resources committed to protecting student privacy and to increase internal efficiency.

    DATES:

    These regulations are effective February 21, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Kathleen Styles, U.S. Department of Education, 400 Maryland Avenue SW., Room 2E315, Washington, DC 20202. Telephone: (855) 249-3072 or via email: [email protected]

    If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION:

    FERPA, 20 U.S.C. 1232g(g), requires the Secretary to establish or designate an office within the Department of Education (Department) for the purpose of investigating, processing, reviewing, and adjudicating violations and complaints. As part of an expansion of student privacy operations at the Department, the designated office will change from the Family Policy Compliance Office to the Office of the Chief Privacy Officer. This change will not directly impact the public. This change is being made:

    1. To allow the Department to more effectively make use of new resources dedicated to student privacy;

    2. To permit efficiencies relating to specialization of work; and

    3. To clarify responsibilities within the Department.

    Executive Orders 12866 and 13563 Regulatory Impact Analysis

    Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

    (1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);

    (2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

    (3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

    (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.

    This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

    We have also reviewed these regulations under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

    (1) Propose or adopt regulations only on a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

    (2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

    (3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

    (4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

    (5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

    Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

    We are issuing these final regulations only on a reasoned determination that their benefits justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that these final regulations are consistent with the principles in Executive Order 13563.

    We also have determined that this regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

    In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs associated with this regulatory action are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

    Upon review of the cost, we have determined there is no financial or resource burden associated with these changes.

    Waiver of Proposed Rulemaking

    Under the Administrative Procedure Act (5 U.S.C. 553), the Department generally offers interested parties the opportunity to comment on proposed regulations. However, these amendments merely reflect changes in internal organization and procedure. The changes do not establish or affect substantive policy. Therefore, under 5 U.S.C. 553(b)(B), the Secretary has determined that proposed regulations are unnecessary and contrary to the public interest.

    Regulatory Flexibility Act Certification

    The Secretary certifies that these regulations will not have a significant economic impact on a substantial number of small entities. These regulations contain technical changes to current regulations. The changes will not have a significant economic impact on any of the entities affected because the regulations do not impose excessive burdens or require unnecessary Federal supervision.

    Paperwork Reduction Act of 1995

    These regulations do not contain any information collection requirements.

    Intergovernmental Review

    This program is not subject to Executive Order 12372 and the regulations in 34 CFR part 79.

    Accessible Format: Individuals with disabilities may obtain this document in an alternative format (e.g., braille, large print, audiotape, or compact disc) on request to the contact person listed under FOR FURTHER INFORMATION CONTACT.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    List of Subjects in 34 CFR Part 99

    Administrative practice and procedure, Privacy, Reporting and recordkeeping requirements, Students.

    Denise L. Carter, Acting Assistant Secretary for Management.

    For the reasons discussed in the preamble, the Secretary amends title 34 of the Code of Federal Regulations as follows:

    PART 99—FAMILY EDUCATIONAL RIGHTS AND PRIVACY ACT 1. The authority citation for part 99 continues to read as follows: Authority:

    20 U.S.C. 1232g, unless otherwise noted.

    2. Amend § 99.60 paragraph (a) by removing “Family Policy Compliance Office” and adding, in its place, “Office of the Chief Privacy Officer”.
    [FR Doc. 2017-00958 Filed 1-18-17; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION 34 CFR Part 668 RIN 1840-AD22 [Docket ID ED-2015-OPE-0103] Student Assistance General Provisions AGENCY:

    Office of Postsecondary Education, Department of Education.

    ACTION:

    Final rule with request for comments.

    SUMMARY:

    The Secretary amends the Student Assistance General Provisions regulations governing participation in the student financial assistance programs authorized under Title IV of the Higher Education Act of 1965, as amended (title IV, HEA programs). The amended regulations update the Department's hearing procedures for actions to establish liability against an institution of higher education, and establish procedural rules governing recovery proceedings under the Department's borrower defense regulations.

    DATES:

    Effective date: These regulations are effective January 19, 2017.

    Comment due date: We will accept comments on or before March 20, 2017. We may consider the comments received and may conduct additional rulemaking based on the comments.

    ADDRESSES:

    Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.

    If you are submitting comments electronically, we strongly encourage you to submit any comments or attachments in Microsoft Word format. If you must submit a comment in Portable Document Format (PDF), we strongly encourage you to convert the PDF to print-to-PDF format or to use some other commonly used searchable text format. Please do not submit the PDF in a scanned format. Using a print-to-PDF format allows the U.S. Department of Education (the Department) to electronically search and copy certain portions of your submissions.

    Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on using Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under “Help.”

    Postal Mail, Commercial Delivery, or Hand Delivery: The Department strongly encourages commenters to submit their comments electronically. However, if you mail or deliver your comments about these regulations, address them to Jean-Didier Gaina, U.S. Department of Education, 400 Maryland Ave. SW., Room 6W232B, Washington, DC 20202.

    Privacy Note:

    The Department's policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available.

    FOR FURTHER INFORMATION CONTACT:

    Annmarie Weisman, U.S. Department of Education, 400 Maryland Avenue SW., Room 6W425, Washington, DC 20202-6244. Telephone: (202) 453-6712 or by email: [email protected].

    If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION:

    Invitation To Comment

    As discussed below, these regulations do not establish substantive policy, but instead establish procedures that must be followed. As procedural regulations, there is no requirement for a comment period. Although these regulations are final regulations, we are interested in whether you think we should make any changes in these regulations and thus we are inviting your comments. We will consider these comments in determining whether to revise the regulations. To ensure that your comments have maximum effect, we urge you to identify clearly the specific section or sections of the regulations that each of your comments addresses and to arrange your comments in the same order as the regulations. See ADDRESSES for instructions on how to submit comments.

    We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirements of reducing regulatory burden that might result from these regulations. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the Department's programs and activities.

    During and after the comment period, you may inspect all public comments about these regulations by accessing Regulations.gov. You may also inspect the comments in person in room 6W245, 400 Maryland Avenue SW., Washington, DC, between the hours of 8:30 a.m. and 4:00 p.m., Eastern time, Monday through Friday of each week except Federal holidays. If you want to schedule time to inspect comments, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Assistance to Individuals With Disabilities in Reviewing the Rulemaking Record

    On request, we will supply an appropriate accommodation or auxiliary aid to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for these regulations. If you want to schedule an appointment for this type of accommodation or auxiliary aid, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Background

    On November 1, 2016, the Department of Education promulgated new regulations governing the William D. Ford Federal Direct Loan Program to establish a new Federal standard and a process for determining whether a borrower has a defense to repayment on a loan based on an act or omission of a school (the borrower defense regulations). If the Department determines that a borrower is eligible for relief under the borrower defense regulations, it has the authority to recover losses stemming from such borrower relief from the institution whose conduct gave rise to the borrower defense. These regulations establish the procedural rules that would govern such borrower defense and institutional recovery proceedings, and are designed to ensure that institutions are afforded a full and fair opportunity to defend themselves in such proceedings.

    These regulations amend the Department's existing regulations governing proceedings to assess a fine, limitation, suspension, or termination against an institution by adding procedures for a recovery proceeding under the borrower defense regulations. Such a proceeding may be used when pursuing an action under either the Department's new borrower defense regulation at 34 CFR 685.222 or its precursor at 34 CFR 685.206. These regulations are designed to balance important interests by ensuring that institutions are protected by due process of law prior to the imposition of any monetary liability under the borrower defense regulations, while also ensuring that determinations of the validity of borrower defense claims asserted against institutions are resolved fairly, efficiently, and expeditiously for all parties. In addition, these regulations clarify and update the procedural provisions more broadly applicable to fine, limitation, suspension, and termination proceedings.

    Under the borrower defense regulations at 34 CFR 685.222, effective July 1, 2017, the applicable process for filing and reviewing claims will depend on whether a borrower's application is considered by the Department as an individual claim or if the Department identifies the application as factually similar to other applications such that the Department identifies a group of borrowers (potentially including borrowers who have not submitted applications) with similar claims. The process will also depend on whether the relevant institution is “open” or “closed”, as those terms are described in the regulations. See 34 CFR 685.222(g)through(h).

    The Department has the authority to pursue claims for recovery for losses that the Department has already incurred in granting individual borrower relief, either as stand-alone actions or in combination with group proceedings where those individual claims presented the same facts and circumstances as the group claims. In those instances, the determination of the validity of the individual's discharge claim does not depend on the hearing official's decision, and the Department does not rescind a discharge already granted to an individual if the Department does not succeed in proving the validity of that claim in this proceeding.

    Beginning July 1, 2017, the Department will use these procedural regulations both to determine the validity of borrower claims the Department asserts on behalf of borrowers in group claims against “open” institutions, and to hold the institutions liable for losses on those claims in accordance with 34 CFR 685.222(h). In these instances, the hearing official determines the validity of the borrower claims and, correspondingly, whether relief will be granted to these group borrowers. Borrowers may opt out of the group process. When the Department seeks to recover for losses for claims approved under current authority and before July 1, 2017, the Department will use the procedures in these regulations to pursue recovery from the institution. As with any other proceedings to recover on claims already approved, the outcome of a proceeding brought to recover for claims already approved prior to July 1, 2017 will not affect relief already granted to borrowers, but only the accountability of the institution. At its discretion, the Department may also use these regulations to bring actions against “closed” institutions, as defined in 34 CFR 685.222(g), in order to establish an institution's liability for damages due to the Department as a result of individual or group borrower defense relief.

    The Department bears the burden of proof in any recovery action against an institution for all claims the Department asserts. The Department must therefore prove the merit of the claims it asserts for members of the group. A hearing official will determine the merit of the claims, the relief for members of the group, and the liability of the institution. The Department must also prove in the hearing process the merit of claims it asserts for losses on discharges it has already approved as individual claims, although, as previously indicated, individual discharges already granted by the Department will not be affected if the Department is not successful in proving the claim in this proceeding against the institution.

    These regulations are only applicable to actions initiated by the Department to fine an institution, to limit, suspend, or terminate the eligibility of an institution or servicer, or to recover from an institution for losses from borrower defense claims, and do not encompass the process by which the Department evaluates individual borrower claims or claims for which the Department does not seek to obtain a recovery. That process is set forth in the borrower defense regulations at 34 CFR 685.222(e). In addition, the Department plans to issue a borrower guide before the borrower defense regulations go into effect to ensure borrowers understand the application process and criteria for seeking debt relief.

    Waiver of Proposed Rulemaking, Negotiated Rulemaking, and Delayed Effective Date

    Under the Administrative Procedure Act (5 U.S.C. 553), the Department generally offers interested parties the opportunity to comment on proposed regulations. These regulations only govern the procedures for initiating an action against an institution and the hearing rules applicable to such a proceeding. As such, these regulations make procedural changes only and do not establish substantive policy. The regulations are therefore rules of agency practice and procedure, and exempt from notice and comment rulemaking under 5 U.S.C. 553(b)(A). However, the Department is providing a 60-day comment period and invites interested persons to participate in this rulemaking by submitting written comments. The Department may consider the comments received and may conduct additional rulemaking based on the comments.

    The APA also generally requires that regulations be published at least 30 days before their effective date, unless the agency has good cause to implement its regulations sooner (5 U.S.C. 553(d)(3)). Again, because these final regulations are merely rules of agency practice and procedure, there is good cause to make them effective on the day they are published. For the same reasons, the Secretary has determined, under section 492(b)(2) of the HEA, 20 U.S.C. 1098a(b)(2), that these regulations should not be subject to negotiated rulemaking.

    Executive Orders 12866 and 13563 Regulatory Impact Analysis

    Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

    (1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);

    (2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

    (3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

    (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.

    This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

    We have also reviewed these regulations under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

    (1) Propose or adopt regulations only on a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

    (2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

    (3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

    (4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

    (5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

    Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

    We are issuing these final regulations only on a reasoned determination that their benefits justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that these final regulations are consistent with the principles in Executive Order 13563.

    We also have determined that this regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

    In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs associated with this regulatory action are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities. There are no costs additional to those described under Regulatory Impact Analysis in the notice of final regulations for the borrower defense regulations published in the Federal Register on November 1, 2016 (81 FR 75926). These regulations will benefit institutions by ensuring that, in any action to fine an institution, to limit, suspend, or terminate the eligibility of an institution to participate in the title IV, HEA programs, or to determine the validity of claims against the institution, there are established procedures that provide both due process as well as an efficient process for the timely resolution of claims.

    Clarity of the Regulations

    Executive Order 12866 and the Presidential memorandum “Plain Language in Government Writing” require each agency to write regulations that are easy to understand.

    The Secretary invites comments on how to make these regulations easier to understand, including answers to questions such as the following:

    • Are the requirements in the regulations clearly stated?

    • Do the regulations contain technical terms or other wording that interferes with their clarity?

    • Does the format of the regulations (grouping and order of sections, use of headings, paragraphing, etc.) aid or reduce their clarity?

    • Would the regulations be easier to understand if we divided them into more (but shorter) sections? (A “section” is preceded by the symbol “§ ” and a numbered heading; for example, § 668.81.)

    • Could the description of the regulations in the SUPPLEMENTARY INFORMATION section of this preamble be more helpful in making the regulations easier to understand? If so, how?

    • What else could we do to make the regulations easier to understand?

    To send any comments that concern how the Department could make these regulations easier to understand, see the instructions in the ADDRESSES section.

    Regulatory Flexibility Act Certification

    The Secretary certifies that these regulations will not have a significant economic impact on a substantial number of small entities. The small entities that are affected by these regulations are small postsecondary institutions. These regulations do not have a significant economic impact on these entities because all substantive rules that govern determinations of liability have already been established in the Department's borrower defense regulations promulgated November 1, 2016.

    Paperwork Reduction Act of 1995

    The Paperwork Reduction Act of 1995 does not require you to respond to a collection of information unless it displays a valid OMB control number. We display the valid OMB control number assigned to a collection of information in final regulations at the end of the affected section of the regulations.

    Intergovernmental Review

    This program is not subject to Executive Order 12372 and the regulations in 34 CFR part 79.

    Assessment of Educational Impact

    The Secretary particularly requests comments on whether these regulations require transmission of information that any other agency or authority of the United States gathers or makes available.

    Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or PDF. To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    (Catalog of Federal Domestic Assistance Number: 84.268, Federal Direct Student Loans) List of Subjects in 34 CFR Part 668

    Administrative practice and procedure, Aliens, Colleges and universities, Consumer protection, Grant programs—education, Loan programs—education, Reporting and recordkeeping requirements, Selective Service System, Student aid, Vocational education.

    Dated: January 11, 2017. John B. King, Jr., Secretary of Education.

    For the reasons discussed, the Secretary amends part 668 of title 34 of the Code of Federal Regulations as follows:

    PART 668—STUDENT ASSISTANCE GENERAL PROVISIONS 1. The authority citation for part 668 continues to read as follows: Authority:

    20 U.S.C. 1001-1003, 1070a, 1070g, 1085, 1087b, 1087d, 1087e, 1088, 1091, 1092, 1094, 1099c, 1099c-1, 1221e-3, and 3474, unless otherwise noted.

    2. Section 668.81 is amended by: A. Adding paragraph (a)(5). B. Adding paragraphs (e) through (g). C. Revising the authority citation.

    The additions and revision read as follows:

    § 668.81 Scope and special definitions.

    (a) * * *

    (5) The determination of—

    (i) Borrower defense to repayment claims that are brought by the Department against an institution under § 685.206 or § 685.222; and

    (ii) Liability of an institution to the Secretary for losses to the Secretary arising from these claims.

    (e) The proceedings described in this subpart provide the institution's sole opportunity for a hearing on the existence and amount of the debt that is required by applicable law prior to the Department collecting the debt from any available funds, including but not limited to offsetting the debt or any liability against funds to be provided to an institution pursuant to any Title IV, HEA program in which that institution participates.

    (f) Nothing contained in this subpart limits the right of the Department to gather information, including by subpoena, or conduct any examination, audit, program review, investigation, or other review authorized by other applicable law.

    (g) Unless directed by a court of competent jurisdiction, the hearing official, or the Secretary for good cause, if a collateral attack is brought in any court concerning all or any part of any proceeding under this subpart, the challenged proceeding shall continue without regard to the pendency of that court proceeding. No default or other failure to timely act as directed in a proceeding authorized by this subpart shall be excused based on the pendency of such court proceeding.

    (Authority: 20 U.S.C. 1094)
    § 668.83 [Amended]
    3. In § 668.83(f)(1), remove “§ 668.90(c)” and add, in its place, “§ 668.91(c)”. 4. In § 668.84 revise paragraphs (b)(3) and (b)(4) to read as follows:
    § 668.84 Fine proceedings.

    (b) * * *

    (3) If the institution or servicer requests a hearing by the time specified in paragraph (b)(1)(iii) of this section, the designated department official transmits the request for hearing and response to the Office of Hearings and Appeals, which sets the date and the place. The date is at least 15 days after the designated department official receives the request.

    (4) A hearing official conducts a hearing in accordance with § 668.89.

    5. Section 668.85 is amended by: A. In paragraph (b)(1)(iii), removing “§ 668.90(b)(2)” and adding, in its place, “§ 668.91(b)(2)”. B. Revising paragraph (b)(3). C. In paragraph (b)(4), removing “§ 668.88” and adding, in its place, “§ 668.89”.

    The revision reads as follows:

    § 668.85 Suspension proceedings.

    (b) * * *

    (3) If the institution or servicer requests a hearing by the time specified in paragraph (b)(1)(iii) of this section, the designated department official transmits the request for hearing and response to the Office of Hearings and Appeals, which sets the date and the place. The date is at least 15 days after the designated department official receives the request. The suspension does not take place until the requested hearing is held.

    6. Section 668.86 is amended by: A. In paragraph (a)(3), removing “§§ 668.93 and 668.94” and adding, in its place, “§§ 668.94 and 668.95”. B. Revising paragraphs (b)(3) and (b)(4).

    The revisions read as follows:

    § 668.86 Limitation or termination proceedings.

    (b) * * *

    (3) If the institution or servicer requests a hearing by the time specified in paragraph (b)(1)(iii) of this section, the designated department official transmits the request for hearing and response to the Office of Hearings and Appeals, which sets the date and place. The date is at least 15 days after the designated department official receives the request. The limitation or termination does not take place until after the requested hearing is held.

    (4) A hearing official conducts a hearing in accordance with § 668.89.

    §§ 668.87 through 668.98 [Redesignated as §§ 668.88 through 668.99]
    7. Redesignate §§ 668.87 through 668.98 as §§ 668.88 through 668.99. 8. Add § 668.87 to read as follows:
    § 668.87 Borrower defense and recovery proceedings.

    (a) Procedures. (1) A designated department official begins a borrower defense and recovery proceeding against an institution by sending the institution a notice by certified mail, return receipt requested. This notice—

    (i) Informs the institution of the Secretary's intent—

    (A) To determine the validity of borrower defense claims on behalf of a group under § 685.222(h), to demonstrate the validity of borrower defense claims already approved, or both, as applicable; and

    (B) To recover from the institution by offset, by claim on a letter of credit or other protection provided by the institution, or otherwise, for losses on account of borrower defense claims asserted on behalf of the group and borrower defense claims already approved, as applicable;

    (ii) Includes a statement of facts and law sufficient to show that the Department is entitled to grant any borrower defense relief asserted within the statement, and recover for the amount of losses to the Secretary caused by the granting of such relief;

    (iii) Specifies the date on which the Secretary intends to take action to recover the amount of losses arising from the granting of such relief, which date will be at least 20 days from mailing of the notice of intent and informs the institution that the Secretary will not take action to recover the amount of such loss on the date specified if the designated department official receives, by that date, a written response from the institution indicating why the Secretary should not recover. The notice shall also inform the institution that if it wishes to request a hearing pursuant to this subpart, the institution must include such a request with its written response; and

    (iv) Informs the institution whether the designated Department official intends to proceed with—

    (A) A single action; or

    (B) An action in two phases—

    (1) The determination whether the institution's act or omission gave rise to valid borrower defense claims; and

    (2) The determination of the amount of borrower defense relief.

    (2) Although the hearing official shall have the discretion to bifurcate proceedings with, or without, a motion of either party, any decision by the designated department official to bifurcate the proceeding in accordance with paragraph (a)(1)(iv)(B) of this section may only be modified on motion with good cause shown.

    (3) A hearing official conducts a hearing in accordance with § 668.89.

    (b) Effect of a response by the institution. (1) If the institution submits a written response, but does not therein request a hearing, the designated department official, after considering that material, notifies the institution whether the Secretary will take the proposed recovery action for borrower defense claims and, if so, the date of such action and the amount of losses.

    (2) If the institution submits a response and requests a hearing by the time specified in the notice under paragraph (a)(1)(iii) of this section, the designated department official may, in that official's sole discretion, withdraw the notice or transmit the response and request for hearing to the Office of Hearings and Appeals, which sets the date and the place for the hearing. The date of the hearing is at least 15 days after the designated department official receives the request. No liability shall be imposed on the institution prior to the hearing.

    (c) Limitations on participation. The parties in any borrower defense and recovery proceeding are the Department and the institution(s) against which the Department seeks to recover losses caused to the Department as a result of borrower defense relief. Borrowers are not permitted to intervene or appear in this proceeding, either on their own behalf or on behalf of any purported group, except as witnesses put forth by either party. However, nothing in this section limits the rights available to borrowers under other regulations, including 34 CFR 685.206 and 685.222.

    (d) Effect on the borrower. No proceeding under this subpart imposes liability on any borrower who has already obtained a discharge in an individual proceeding under 34 CFR 685.206(c) or 34 CFR 685.222(e). A borrower defense and recovery proceeding may determine whether and how much relief is due to, and whether and how much of a loan remains owing by, a borrower participating in a group process proceeding as defined in 34 CFR 685.222(f) through (h).

    (Authority: 20 U.S.C. 1087a et seq., 1094)
    9. Revise newly redesignated § 668.88 to read as follows:
    § 668.88 Prehearing conference and motion practice.

    (a) A hearing official may convene a prehearing conference if he or she thinks that the conference would be useful, or if the conference is requested by—

    (1) The designated department official who brought a proceeding against an institution or third-party servicer under this subpart; or

    (2) The institution or servicer, as applicable.

    (b) The purpose of a prehearing conference is to allow the parties to settle or narrow the dispute.

    (c) If the hearing official, the designated department official, and the institution, or servicer, as applicable, agree, a prehearing conference may consist of—

    (1) A conference telephone call;

    (2) An informal meeting; or

    (3) The submission and exchange of written material.

    (d) A non-dispositive motion shall be made, if at all, consistent with any procedures set forth by the hearing official. In the absence of such procedures, non-dispositive motions shall be permitted, and responses to such motions shall be permitted though not required.

    (e)(1) A party may make a motion for summary disposition asserting that the undisputed facts, admissions, affidavits, stipulations, documentary evidence, matters as to which official notice may be taken, and any other evidentiary materials properly submitted in connection with a motion for summary disposition establish that—

    (i) There is no genuine issue as to any material fact; and

    (ii) The moving party is entitled to a decision in its favor as a matter of law.

    (2) A motion for summary disposition must be accompanied by a statement of the material facts as to which the moving party contends there is no genuine issue. Such motion must be supported by evidence that the moving party contends support his or her position. The motion must be accompanied by a brief containing the points and authorities supporting the motion.

    Any party may oppose such a motion by filing a response setting forth those material facts as to which he or she contends a genuine dispute exists. Such response must be supported by evidence of the same type as may be submitted in support of a motion for summary disposition and a brief containing the points and authorities in support of the contention that summary disposition would be inappropriate.

    (f) A motion under consideration by the Secretary or the hearing official shall not stay proceedings before the hearing official unless the Secretary or the hearing official, as appropriate, so orders.

    (Authority: 20 U.S.C. 1094)
    10. Revise newly redesignated § 668.89 to read as follows:
    § 668.89 Hearing.

    (a) A hearing is an orderly presentation of arguments and evidence conducted by a hearing official. At the discretion of the hearing official, any right to a hearing may be satisfied by one or more of the following: Summary disposition pursuant to § 668.88(e), with or without oral argument; an oral evidentiary hearing conducted in person, by telephone, by video conference, or any combination thereof; or a review limited to written evidence.

    (b)(1) Notwithstanding any provision to the contrary, the hearing official sets the procedures to be used in the hearing, and may take steps to expedite the proceeding as appropriate.

    (2) The formal rules of evidence and procedures applicable to proceedings in a court of law are not applicable. However, discussions of settlement between the parties or the terms of settlement offers are not admissible to prove the validity or invalidity of any claim or defense.

    (3)(i) The proponent of any factual proposition has the burden of proof with respect thereto.

    (ii) The designated department official has the burden of persuasion in any fine, suspension, limitation, or termination proceeding under this subpart.

    (iii) The designated department official has the burden of persuasion in a borrower defense and recovery action; however, for a borrower defense claim based on a substantial misrepresentation under § 682.222(d), the designated department official has the burden of persuasion regarding the substantial misrepresentation, and the institution has the burden of persuasion in establishing any offsetting value of the education under § 685.222(i)(2)(i).

    (4) Discovery, as provided for under the Federal Rules of Civil Procedure, is not permitted.

    (5) The hearing official accepts only evidence that is relevant and material to the proceeding and is not unduly repetitious.

    (6) The hearing official may restrict the number of witnesses or exclude witnesses to avoid undue delay or presentation of cumulative evidence. Any witness permitted to appear may do so via telephonic, video, or other means, with the approval of the hearing official.

    (7) Either party may call qualified expert witnesses. Each party will be limited to calling three expert witnesses, as a matter of right, including any rebuttal or surrebuttal witnesses. Additional expert witnesses shall be allowed only by order of the hearing official, granted only upon a showing of good cause.

    (i) At a date set by the hearing official, each party shall serve the other with any report prepared by each of its expert witnesses. Each party shall serve the other party with a list of any rebuttal expert witnesses and a rebuttal report prepared by each such witness not later than 60 days after the deadline for service of expert reports, unless another date is set by the hearing official. A rebuttal report shall be limited to rebuttal of matters set forth in the expert report for which it is offered in rebuttal. If material outside the scope of fair rebuttal is presented, a party may file a motion not later than five days after the deadline for service of rebuttal reports, seeking appropriate relief with the hearing official, including striking all or part of the report, leave to submit a surrebuttal report by the party's own experts, or leave to call a surrebuttal witness and to submit a surrebuttal report by that witness.

    (ii) No party may call an expert witness at the hearing unless the party has listed the expert and has provided reports as required by this section.

    (iii) Each report shall be signed by the expert and contain a complete statement of all opinions to be expressed and the basis and reasons therefor; the data, materials, or other information considered by the witness in forming the opinions; any exhibits to be used as a summary of or support for the opinions; the qualifications of the witness, including a list of all publications authored or co-authored by the witness within the preceding ten years; the compensation to be paid for the study and testimony; and a listing of any other cases in which the witness has testified or sought to testify as an expert at trial or hearing, or by deposition, within the preceding four years. A rebuttal or surrebuttal report need not include any information already included in the initial report of the witness.

    (8)(i) Except as provided in paragraph (b)(8)(ii) of this section, if an institution has been required through compulsory process under section 490A of the HEA or other applicable law to submit to the United States or to the Department material regarding an express or an implied representation, the institution cannot thereafter, in any proceeding under this subpart in which it is alleged that the representation was false, erroneous, or misleading, and for any purpose relating to the defense of such allegation, introduce into the record, either directly or indirectly through references contained in documents or oral testimony, any material of any type that was required to be but was not timely submitted in response to that compulsory process.

    (ii) The hearing official shall, upon motion at any stage, exclude all material that was required to be but was not timely submitted in response to a compulsory process described in paragraph (b)(8)(i) of this section, or any reference to such material, unless the institution demonstrates, and the hearing official finds, that by the exercise of due diligence the material could not have been timely submitted in response to the compulsory process, and the institution notified the Department or such other party that issued the order to produce, of the existence of the material immediately upon its discovery. The hearing official shall specify with particularity the evidence relied upon.

    (9) When issues not raised in the notice of proposed action are tried without objection at the hearing, they will be treated in all respects as if they had been raised in the notice of proposed action, and no formal amendments are required.

    (c) The hearing official makes a transcribed record of the proceeding and makes a copy of the record available to the designated Department official and to the institution or servicer.

    (Authority: 20 U.S.C. 1094)
    11. Newly redesignated § 668.91 is amended by: A. Redesignating paragraph (a)(2) as paragraph (a)(2)(i). B. In newly redesignated paragraph (a)(2)(i) adding “or recovery” after “fine, limitation, suspension, or termination”. C. Adding paragraph (a)(2)(ii). D. Removing the second sentence in paragraph (a)(4). E. Adding paragraph (c)(2)(x).

    The additions read as follows:

    § 668.91 Initial and final decisions.

    (a) * * *

    (2)(i) * * *

    (ii) In a borrower defense and recovery proceeding conducted in two phases under § 668.87(a)(1)(iv)(B), the hearing official's initial decision determines whether the institution is liable for the act or omission described in the notice of intent to recover, and the hearing official issues an initial decision on liability only.

    (c) * * *

    (2) * * *

    (x) In a borrower defense and recovery proceeding conducted in two phases under § 668.87(a)(1)(iv)(B), if a party appeals an initial decision of the hearing official in the first phase, the Secretary may affirm, modify, or reverse the initial decision, or may remand the case to the hearing official for further proceedings consistent with the Secretary's decision.

    § 668.96 [Amended]
    12. Newly redesignated §  668.96 is amended by: A. In paragraph (a) removing the word “The” and adding, in its place, the words “In an action to fine an institution or servicer, or to limit, suspend, or terminate the participation of an institution or the eligibility of a servicer, the”. B. In paragraph (b), after the words “The corrective action”, adding the words “under paragraph (a) of this section”. C. In paragraph (c), after the word “decision”, adding the words “in any action under this subpart”.
    § 668.99 [Amended]
    13. In newly redesignated paragraph (c) of § 668.99, remove “§ 668.91(a)(4)” and add, in its place, “§ 668.92(a)(4)”.
    [FR Doc. 2017-00972 Filed 1-18-17; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF COMMERCE United States Patent and Trademark Office 37 CFR Parts 2 and 7 [Docket No. PTO-T-2016-0002] RIN 0651-AD07 Changes in Requirements for Affidavits or Declarations of Use, Continued Use, or Excusable Nonuse in Trademark Cases AGENCY:

    United States Patent and Trademark Office, Commerce.

    ACTION:

    Final rule.

    SUMMARY:

    In order to assess and promote the accuracy and integrity of the trademark register, the United States Patent and Trademark Office (USPTO or Office) amends its rules concerning the examination of affidavits or declarations of continued use or excusable nonuse filed pursuant to section 8 of the Trademark Act, or affidavits or declarations of use in commerce or excusable nonuse filed pursuant to section 71 of the Act. Specifically, under the regulations enacted herein, the USPTO may require the submission of information, exhibits, affidavits or declarations, and such additional specimens of use as may be reasonably necessary for the USPTO to ensure that the register accurately reflects marks that are in use in commerce in the United States for all the goods/services identified in the registrations, unless excusable nonuse is claimed in whole or in part. A register that does not accurately reflect marks in use in commerce in the United States for the goods/services identified in registrations imposes costs and burdens on the public. The amended rules will allow the USPTO to require additional proof of use to verify the accuracy of claims that a trademark is in use in commerce in connection with particular goods/services identified in the registration.

    DATES:

    This rule is effective on February 17, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Catherine Cain, Office of the Deputy Commissioner for Trademark Examination Policy, by email at [email protected], or by telephone at (571) 272-8946.

    SUPPLEMENTARY INFORMATION:

    Purpose: The USPTO revises the rules in parts 2 and 7 of title 37 of the Code of Federal Regulations to allow the USPTO, during the examination of affidavits or declarations of continued use or excusable nonuse filed pursuant to section 8 of the Trademark Act, 15 U.S.C. 1058, or affidavits or declarations of use in commerce or excusable nonuse filed pursuant to section 71 of the Trademark Act, 15 U.S.C. 1141k (section 8 or section 71 affidavits), to require the submission of such information, exhibits, affidavits or declarations, and such additional specimens of use as may be reasonably necessary for the USPTO to verify the accuracy of claims that a trademark is in use in commerce in connection with the goods/services listed in the registration.

    This will benefit the public because it will facilitate the USPTO's ability to assess and promote the integrity of the trademark register by encouraging accuracy in the identification of goods/services for which use in commerce or continued use is claimed. The accuracy of the trademark register as a reflection of marks that are actually in use in commerce in the United States for the goods/services identified in the registrations listed therein serves an important purpose for the public. The public relies on the register to determine whether a chosen mark is available for use or registration. Where a party's search of the register discloses a potentially confusingly similar mark, that party may incur a variety of resulting costs and burdens, such as those associated with investigating the actual use of the disclosed mark to assess any conflict, proceedings to cancel the registration or oppose the application of the disclosed mark, civil litigation to resolve a dispute over the mark, or changing plans to avoid use of the party's chosen mark. If a registered mark is not actually in use in commerce in the United States, or is not in use in commerce in connection with all the goods/services identified in the registration, these costs and burdens may be incurred unnecessarily. An accurate and reliable trademark register helps avoid such needless costs and burdens.

    The amended rules also facilitate the cancellation of registrations for marks that were never in use in commerce or are no longer in use, and for which acceptable claims of excusable nonuse were not submitted, in connection with the identified goods/services. The statutory requirements in sections 8 and 71 exist to enable the USPTO to clear the register of deadwood by cancelling, in whole or in part, registrations for marks that are not in use in commerce for all or some of the goods/services identified in the registration. The rules enacted herein further this statutory purpose.

    Background

    Post Registration Proof-of-Use Pilot Program: A final rule was published in the Federal Register on May 22, 2012 (77 FR 30197), in which the USPTO announced a two-year pilot program to assess and promote the accuracy and integrity of the trademark register. The USPTO randomly selected 500 registrations for which section 8 and section 71 affidavits were filed to participate in the pilot program to determine the actual use in commerce of the marks in connection with the goods/services identified in the registrations. As part of the pilot program, the selected trademark owners were required to submit proof of use of their marks for additional goods/services per class, in addition to the one specimen per class submitted with their affidavits, and to verify use of the additional goods/services during the statutory filing period.

    In 51% of the registrations selected for the pilot, the trademark owners failed to supply additional verified proof of use on specific goods/services for which use in commerce was initially claimed. Of this 51%, in 35% of the registrations, the owner requested that some goods/services that were initially claimed to be in use in commerce be deleted, and the remaining 16% of the registrations were cancelled because the trademark owners failed to respond to the requirements for additional proof or to other issues raised during examination of the section 8 or section 71 affidavit. Ultimately, the section 8 and section 71 affidavits were accepted for 84.4%, or 422 registrations, which included acceptances issued after goods/services queried under the pilot were deleted.

    The status reports issued throughout the course of the pilot all supported the need for ongoing efforts aimed at ensuring the accuracy and integrity of the trademark register as to the actual use in commerce of marks in connection with the goods/services identified in the registrations. To that end, the USPTO held a roundtable discussion on December 12, 2014, for various stakeholder groups, requested written comments from interested parties to further explore the topic, and discussed the topic at several other outreach sessions. During the roundtable discussion and outreach sessions, one suggestion that received widespread support was to establish a permanent program similar to the proof-of-use pilot. The USPTO considered this recommendation in proposing the permanent program set forth in the notice of proposed rulemaking published in the Federal Register on June 22, 2016, at 81 FR 40589. As discussed below, the Office considered all public comments received during the comment period in the development of this final rule.

    Proposed Rule: Comments and Responses

    The USPTO published a proposed rule on June 22, 2016, soliciting comments on the proposed amendments. In response, the USPTO received comments from six organizations and eight individual commenters representing law firms, corporations, and individuals. The Office received comments both generally supporting and objecting to the proposed requirements. The commenters who supported the goal of promoting the integrity of the register by encouraging accuracy in the listing of goods/services for which use in commerce is claimed agreed that the rules will facilitate the cancellation of registrations of marks that were never in use in commerce or are no longer in use. In addition, several of those commenters expressed suggestions or concerns regarding the audit program. Similar comments have been grouped together and summarized below, followed by the USPTO's responses. All comments are posted on the USPTO's Web site at https://www.uspto.gov/trademark/trademark-updates-and-announcements/comments-changes-requirements-affidavits-or.

    Comment 1: One commenter suggested that costs imposed on trademark owners will likely be minimal because owners will only be randomly selected and not routinely or repeatedly subject to audits and another commenter noted that the information sought is within the knowledge of the trademark owner and should be simple to produce if there is indeed use. Another commenter stated that the proposed procedure would add an additional cost in terms of time and legal expense, but that the cost is generally offset by the public-policy benefit.

    Response: The USPTO appreciates the commenters' support of the rule changes and concurs that the rule changes create minimal burdens on trademark owners. The USPTO also notes that as trademark owners are already required to ascertain whether a mark is currently in use in commerce with all the goods/services in connection with the filing of a section 8 or section 71 affidavit, any additional requirement to provide proof of such use with select goods/services should not be unduly burdensome or costly. Although approximately one-third of section 8 and section 71 affidavits are filed pro se, the USPTO assumes that an attorney is representing the registrant, and estimates it will take approximately one hour to comply.

    Comment 2: One commenter noted that the proposed rule did not address the issue of the “abuse” encouraged by the Madrid Protocol system where there is no pre-registration use requirement for Madrid Protocol applications. Another commenter suggested that the proposed changes could be a model for changes to the process for affidavits or declarations of incontestability under section 15 of the Trademark Act, 15 U.S.C. 1065, by expanding the audit procedure to a percentage of section 15 affidavits. The commenter expressed concern that the cost of a faulty section 15 affidavit is high, given the ability of a registrant to use incontestability as leverage in disputes.

    Response: The USPTO appreciates the commenters' concerns, but notes that the Madrid Protocol is an international treaty that became effective in the United States on November 2, 2003. Addressing any concerns related to the Madrid Protocol or its regulations is beyond the scope of this rulemaking, as is any expansion in the audit procedure to a percentage of section 15 affidavits.

    Comment 3: One commenter requested that the USPTO consider some form of concession for registrants who are audited and successfully comply with audit requirements, such as an immediate fee reduction in the cost of a section 8 or section 71 affidavit or a future fee offset. Another commenter suggested that the USPTO offer registrants the option to elect out of the random audit by checking a box on the electronic form and voluntarily providing evidence of use for each good/service in a class. A third commenter recommended that the USPTO address abusive practices by: requiring specimens for all goods/services; requiring automatic audits of lengthy identifications of goods and services; allowing applicants whose mark is the subject of a likelihood-of-confusion refusal to petition the Office to audit a registration; providing an item-by-item checklist of all goods/services claimed and requiring registrants to specifically declare use for each good/service; shortening the initial period for filing a section 8 or section 71 affidavit; implementing a penalty system to incentivize renewal only for goods/services that are actually being used; and making more data available to the public concerning the marks on the register, the number of applications and renewals filed, and the number of refusals and amendments filed.

    Response: The USPTO notes that although registrants are required to submit only one specimen of use in commerce per class with a section 8 or section 71 affidavit, they are not prevented from voluntarily providing evidence of use in commerce for each good/service listed in the registration. If a registrant does so, it would diminish the likelihood that additional proof of use would be required if the registration is selected for audit. However, any proposal to reduce the fees for section 8 or section 71 affidavits, to create a tiered fee structure, to implement a monetary penalty, to require specimens for all goods/services, or to allow a third party to petition the Office to audit a registration would require separate rulemakings. Moreover, shortening the initial filing period for a section 8 or section 71 affidavit would require Congressional action to amend the Trademark Act. Even if the statute was amended, such proposals would also require substantial changes to the Trademark electronic filing system, as would modifying the forms to require, or allow the owner to elect to provide, proof of use for each good/service listed on the registration. Regarding the request to make data available to the public, the USPTO notes that information about application filings, active registrations, and new registrations by fiscal year is available on the USPTO Web site at https://www.uspto.gov/dashboards/trademarks/main.dashxml. The USPTO will consider making the other requested data available at a future date.

    Comment 4: One commenter stated that cancelling the entire registration for failure to respond to an Office action is overly harsh if the specimen(s) originally submitted with the section 8 or section 71 affidavit are acceptable. In such cases, the commenter recommends that the USPTO cancel only those goods/services that are not supported by the specimen(s) submitted with the relevant affidavit.

    Response: As in the pilot program, owners of the registrations selected will be afforded the usual post-registration response period to the Office action requiring additional information and are subject to the same consequences for failure to respond. In general, Office actions issued in relation to section 8 and section 71 affidavits are governed by the Trademark Act and rules. 15 U.S.C. 1058(c), (e), 1141k(c), (e); 37 CFR 2.163, 7.39. A response to a post-registration Office action must be filed within six months of the date of issuance of the Office action, or before the end of the filing period set forth in section 8(a) or section 71(a) of the Act, whichever is later. 37 CFR 2.163(b), 7.39(a). Failure to respond within the prescribed time periods results in cancellation of the registration, unless time remains in the grace period for filing a new affidavit. 37 CFR 2.163(c), 7.39(b). If no time remains in the grace period, trademark owners may file a petition to the Director under 37 CFR 2.146(a)(5) and 2.148 to waive 37 CFR 2.163(b) so that a late response to the Office action may be accepted. However, the Director will waive a rule only in an extraordinary situation, where justice requires, and no other party is injured. 37 CFR 2.146(a)(5), 2.148.

    Comment 5: One commenter expressed concern that the proposed amendments were vague, unnecessarily open ended, and insufficiently described to properly assess the likely impact and effectiveness of the audit program. Another commenter requested that the USPTO have further discussions with stakeholder groups prior to implementation of the program.

    Response: The USPTO appreciates the commenters' concerns and notes that the expected impact and effectiveness of the audit program can be initially assessed in relation to the results of the pilot program, which supported the need for ongoing efforts aimed at ensuring the accuracy and integrity of the trademark register as to the actual use in commerce of marks in connection with the goods/services identified in the registrations. In addition, the widespread support among stakeholders to establish a permanent program is attributable to the results of the pilot program. An overview of the audit program enacted herein, which is similar to the pilot, is described in the section entitled Overview of the Audit Program of this final rule. As noted in that section, section 8 and section 71 affidavits in which the mark is registered for more than one good or service per class are subject to audit. The additional information or specimens required will be reviewed according to the generally accepted standards for use in commerce. The USPTO notes that there is a uniform standard for determining what constitutes an acceptable specimen both prior to and post registration and finds no basis to establish a different standard for use of the mark in commerce in the context of the audit program. The USPTO believes such a distinction would be a disservice to the public. Not only would a new standard for determining what constitutes acceptable use in commerce increase public confusion, but it would also call into question whether a mark is actually used with particular goods or services. The USPTO also intends to discuss with stakeholder groups the procedures that it will employ to carry out the program to obtain feedback regarding the procedures. These procedures will ultimately be available to the public and internal and external customers in the Trademark Manual of Examining Procedure.

    Comment 6: Two commenters objected to any changes, as they believed the current rule is clear and the present practice is appropriate. One suggested that the existing rule is less susceptible to discriminatory application and that the proposed rule is not capable of being applied equally to all “applicants.” The other commenter stated that it is not the role of the Office to police registrations and if a registrant is not using a mark in connection with all goods/services in the registration, the registration may be challenged in a cancellation proceeding before the Trademark Trial and Appeal Board (TTAB).

    Response: The USPTO appreciates the commenters' concerns regarding equal application of the rules, and notes that registrants, rather than applicants, would be subject to any requirements under the rules. The USPTO does not anticipate that the final rule will have a disproportionate impact upon any particular class of registrant and has determined that its objective of ensuring the accuracy and integrity of the register can be fairly reached by randomly selecting the registrations subject to audit based on the procedures discussed below. Any entity that has a registered trademark in which the mark is registered for more than one good or service per class could potentially be impacted by the rules.

    The USPTO agrees that cancellation proceedings before the TTAB provide an avenue for third parties to seek removal of registrations for marks that are not in use in commerce for some or all of the goods/services identified in the registration. However, as discussed above, the accuracy of the trademark register as a reflection of marks that are actually in use in commerce in the United States for the goods/services identified in the registrations listed therein serves an important purpose for the public, which relies on the register to determine whether a chosen mark is available for use or registration. For example, when a party's search of the register discloses a potentially confusingly similar mark, that party may incur a variety of resulting costs and burdens, such as those associated with proceedings to cancel the registration. If a registered mark is not actually in use in commerce in the United States, or is not in use in commerce in connection with all the goods/services identified in the registration, the cost of undertaking a cancellation proceeding may be incurred unnecessarily. In addition, the results of the pilot audit program supported the need for ongoing efforts aimed at ensuring the accuracy and integrity of the trademark register as to the actual use in commerce of marks in connection with the goods/services identified in live registrations. Further, outreach to stakeholder groups and interested parties in the aftermath of the pilot yielded widespread support for establishing a permanent proof-of-use program similar to the pilot. Therefore, the USPTO believes that establishing a permanent program for auditing registrations that include multiple goods/services furthers the public policy of ensuring the accuracy of the trademark register.

    Overview of the Audit Program

    The USPTO herein enacts a permanent audit program whereby it will conduct random audits of the combined total of section 8 and section 71 affidavits filed each year in which the mark is registered for more than one good or service per class. The USPTO anticipates that upon initial implementation it would conduct random audits of up to approximately 10% of such affidavits and may increase the percentage going forward, depending on results and as resources allow. As part of the review of the selected affidavits, in addition to the one specimen of use per class currently required, owners will be required to provide additional proof of use in the nature of information, exhibits, affidavits or declarations, and specimens showing use in commerce.

    In a selected case, the USPTO will issue an Office action specifying the goods/services for which additional proof of use is required. Upon implementation, the USPTO anticipates requesting proof of use for two additional goods/services per class in the initial Office action. Thereafter, the owner may be required to submit proof of use in commerce for additional goods/services. If there is only one good/service in a class, additional proof of use will be required if the specimen submitted with the section 8 or section 71 affidavit would not also be acceptable to show actual use in commerce. The Office action will also advise trademark owners to delete those goods/services for which they are unable to provide the requested proof of use. It will further advise owners to delete all goods/services not in use in commerce because the Office may issue subsequent actions requiring proof of use on some, or all, remaining goods/services.

    As in the pilot program, trademark owners will be afforded the usual response period to the Office action, that is, a response would be due within six months of the issuance date of the Office action, or before the end of the statutory filing period for the section 8 or section 71 affidavit, whichever is later. 37 CFR 2.163(b), 7.39(a). If the trademark owner responds, but is ultimately unable to provide the requested information, exhibits, affidavits or declarations, and specimens, the USPTO would deem the section 8 or section 71 affidavit unacceptable as to the goods/services to which the requirement pertained and will cancel such goods/services from the registration. If no response to the Office action is filed within six months of the issuance date of the Office action, or before the end of the statutory filing period for the section 8 or section 71 affidavit, whichever is later, the USPTO will cancel the entire registration, unless time remains in the grace period under section 8(a)(3) or section 71(a)(3) of the Act. 15 U.S.C. 1058(a)(3), 1141k(a)(3); 37 CFR 2.163, 7.39. If time remains in the grace period, the owner may file a complete new section 8 or section 71 affidavit, with a new fee and grace-period surcharge. 37 CFR 2.161(d)(2), 7.36(b)(3). The USPTO further clarifies that trademark owners may also file a petition to the Director under 37 CFR 2.146(a)(5) and 2.148 to waive 37 CFR 2.163(b) so that a late response to an Office action may be accepted. However, the Director will waive a rule only in an extraordinary situation, where justice requires, and no other party is injured. 37 CFR 2.146(a)(5), 2.148.

    Costs and Benefits: This rulemaking is not considered to be economically significant under Executive Order 12866 (Sept. 30, 1993).

    Discussion of Proposed Regulatory Changes

    The USPTO amends 37 CFR 2.161 and 7.37 to provide that the USPTO may require such information, exhibits, affidavits or declarations, and such additional specimens of use as may be reasonably necessary for the USPTO to assess and promote the accuracy and integrity of the register. The current rules mandate the submission of only one specimen per class in connection with a section 8 or section 71 affidavit unless additional information, exhibits, affidavits or declarations, or specimens are necessary for proper examination of the affidavit itself. 37 CFR 2.161(g), (h), 7.37(g), (h). This final rule will allow the USPTO to require additional proof of use of a mark not only to facilitate proper examination of a section 8 or section 71 affidavit, but also to verify the accuracy of claims that a trademark is in use on or in connection with the goods/services identified in the registration

    The USPTO revises § 2.161(h) to add the phrase “or for the Office to assess and promote the accuracy and integrity of the register” at the end of the paragraph.

    The USPTO revises § 7.37(h) to add the phrase “or for the Office to assess and promote the accuracy and integrity of the register” at the end of the paragraph.

    Rulemaking Requirements

    Administrative Procedure Act: The changes in this rulemaking involve rules of agency practice and procedure, and/or interpretive rules. See Perez v. Mortg. Bankers Ass'n, 135 S. Ct. 1199, 1204 (2015) (interpretive rules “advise the public of the agency's construction of the statutes and rules which it administers”) (citation and internal quotation marks omitted); Nat'l Org. of Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (rule that clarifies interpretation of a statute is interpretive); Bachow Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (rules governing an application process are procedural under the Administrative Procedure Act); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001) (rules for handling appeals were procedural where they did not change the substantive standard for reviewing claims).

    Accordingly, prior notice and opportunity for public comment for the changes in this rulemaking are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law. See Perez, 135 S. Ct. at 1206 (notice-and-comment procedures are required neither when an agency “issue[s] an initial interpretive rule” nor “when it amends or repeals that interpretive rule”); Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), does not require notice and comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice,” quoting 5 U.S.C. 553(b)(A)). However, the USPTO has chosen to seek public comment before implementing the rule.

    Final Regulatory Flexibility Analysis

    The USPTO publishes this Final Regulatory Flexibility Analysis (FRFA) as required by the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) to examine the impact of the Office's post-registration audit program on small entities. Under the RFA, whenever an agency is required by 5 U.S.C. 553 (or any other law) to publish a notice of proposed rulemaking (NPRM), the agency must prepare and make available for public comment a FRFA, unless the agency certifies under 5 U.S.C. 605(b) that the proposed rule, if implemented, will not have a significant economic impact on a substantial number of small entities. 5 U.S.C. 603, 605. The USPTO published an Initial Flexibility Analysis (IRFA), along with the NPRM, on June 22, 2016 (81 FR 40589). The USPTO received no comments from the public directly applicable to the IFRA, as stated below in Item 2.

    Items 1-6 below discuss the six items specified in 5 U.S.C. 604(a)(1)-(6) to be addressed in a FRFA. Item 6 below discusses alternatives considered by the Office.

    1. Succinct Statement of the Need for, and Objectives of, the Rule

    The USPTO amends its rules to require any information, exhibits, affidavits or declarations, and such additional specimens deemed reasonably necessary to assess and promote the accuracy and integrity of the trademark register in connection with the examination of a section 8 or section 71 affidavit. Post registration affidavits under section 8 or section 71, and their accompanying specimens of use, demonstrate a registration owner's continued use of its mark in commerce for the goods/services identified in the registration. The revisions enacted herein will facilitate the USPTO's ability to ensure that the register accurately reflects marks that are in use in commerce that may be regulated by the U.S. Congress for the goods/services identified therein.

    The objective of the rulemaking is to allow the USPTO to assess and promote the integrity of the trademark register. The Trademark Act gives the Director discretion regarding the number of specimens to require. 15 U.S.C. 1051(a)(1), (d)(1), 1058(b)(1)(C), 1141k(b)(1)(C). The current rules mandate the submission of only one specimen per class in connection with a section 8 or section 71 affidavit unless additional information, exhibits, affidavits or declarations, or specimens are necessary for proper examination of the affidavit itself. 37 CFR 2.161(g), (h), 7.37(g), (h). However, these rules do not currently allow the Office to require additional specimens or other information or exhibits in order to verify that the mark is in use on additional goods/services listed in the registration. The final rule will allow the USPTO to properly examine the nature and veracity of allegations of use made in connection with the submission of a section 8 or section 71 affidavit, and thereby assess and promote the integrity of the register by verifying that the register accurately reflects the goods/services for which use is claimed for a given registered mark.

    2. A Statement of the Significant Issues Raised by the Public Comments in Response to the Initial Regulatory Flexibility Analysis, a Statement of the Assessment of the Agency of Such Issues, and a Statement of any Changes Made in the Proposed Rule as a Result of Such Comments

    The USPTO did not receive any public comments in response to the IRFA. However, the Office received comments about the audit program in general, which are further discussed in the preamble.

    3. The Response of the Agency to any Comments Filed by the Chief Counsel for Advocacy of the Small Business Administration in Response to the Proposed Rule, and a Detailed Statement of any Change Made to the Proposed Rule in the Final Rule as a Result of the Comments

    The USPTO did not receive any comments filed by the Chief Counsel for Advocacy of the Small Business Administration in response to the proposed rule.

    4. Description of and an Estimate of the Number of Small Entities to Which the Rule Will Apply or an Explanation of Why No Such Estimate Is Available

    The USPTO does not collect or maintain statistics in trademark cases on small- versus large-entity registrants, and this information would be required in order to estimate the number of small entities that would be affected by the final rule. However, the USPTO believes that the overall impact of the regulations enacted herein on registrants will be relatively minimal.

    After registration, trademark owners must make periodic filings with the USPTO to maintain their registrations. A section 8 or section 71 affidavit is a sworn statement in which the registrant specifies the goods/services/collective membership organization for which the mark is in use in commerce and/or the goods/services/collective membership organization for which excusable nonuse is claimed. 15 U.S.C. 1058, 1141k. The purpose of the section 8 and section 71 affidavits is to facilitate the cancellation, by the Director, of registrations of marks no longer in use in connection with the goods/services/collective membership organization identified in the registrations. The final rule applies to any entity filing a section 8 or section 71 affidavit, but only a subset of trademark owners would be required to provide more than one specimen or additional information, exhibits, or specimens in connection with the audit. The USPTO is unable to estimate the subset of trademark owners who are small entities that are impacted by the proposed rules. In Fiscal Year 2016, approximately 150,000 section 8 affidavits and 9,100 section 71 affidavits were filed.

    5. Description of the Reporting, Recordkeeping, and Other Compliance Requirements of the Final Rule, Including an Estimate of the Classes of Small Entities Which Will Be Subject to the Requirement and the Type of Professional Skills Necessary for Preparation of the Report or Record

    The final rule imposes no new recordkeeping requirements on trademark registrants.

    Regarding compliance with this final rule, as an initial matter, the USPTO does not anticipate the rules to have a disproportionate impact upon any particular class of small or large entities. Any entity that has a registered trademark in which the mark is registered for more than one good or service per class could potentially be impacted by the final rule.

    The USPTO enacts herein a permanent program where it would conduct random audits of section 8 and section 71 affidavits that are filed in which the mark is registered for more than one good or service per class. The USPTO anticipates that upon initial implementation it would conduct random audits of up to approximately 10% of such affidavits and may increase the percentage going forward, depending on results and as resources allow. In those post registration cases where an initial requirement for additional information, exhibits, affidavits or declarations, and specimens is issued in an Office action, although approximately one-third of section 8 and section 71 affidavits are filed pro se, the USPTO assumes that an attorney is representing the registrant, and estimates it will take approximately one hour to comply. To that end, the USPTO provides an online electronic form for responding to Office actions.

    Similar to the submission necessary for the statutorily required section 8 and section 71 affidavits, a response to an Office action issued in connection with these affidavits will generally necessitate gathering and submitting one or more specimens of use and an accompanying declaration. Therefore, under the final rule, the type of fact gathering and review of the nature and extent of the use of the mark that underlies a section 8 or section 71 affidavit will already have occurred. Compliance with the requirements enacted herein will only necessitate gathering and submitting the additional evidence to demonstrate and support what has previously been assessed.

    Assuming the mark is in use as claimed, the compliance time involves the length of time to secure additional information, exhibits, affidavits or declarations, or specimens and accompanying declaration, plus any time it takes an attorney to communicate with the client in order to obtain what is required and make the necessary filing with the USPTO. As noted above, approximately one-third of section 8 and section 71 affidavits are filed pro se. Trademark owners selected for review are likely to have a shorter compliance time than what the USPTO has estimated, which assumes the involvement of an attorney. The final rule does not mandate the use of legal counsel.

    6. Description of the Steps the Agency Has Taken To Minimize the Significant Economic Impact on Small Entities Consistent With the Stated Objectives of Applicable Statutes, Including a Statement of the Factual, Policy, and Legal Reasons for Selecting the Alternative Adopted in the Rinal Rule and Why Each One of the Other Significant Alternatives to the Rule Considered by the Agency Which Affect the Impact on Small Entities Was Rejected

    The USPTO has considered whether and how it is appropriate to reduce any burden on small businesses through increased flexibility. The following alternatives were considered, but rejected, by the USPTO.

    The USPTO considered an alternative where it would not require additional information, exhibits, affidavits or declarations, and specimens in connection with section 8 or section 71 affidavits, or where it would exempt small entities from such requirements. This alternative would have a lesser economic impact on small entities, but was rejected because it would not accomplish the stated objective of assessing and promoting the integrity of the trademark register by verifying that marks are in use for the goods/services identified in the registration. As noted above, the results of the post registration proof-of-use pilot supported the need for ongoing efforts aimed at assessing and promoting the accuracy and integrity of the register as to the actual use of marks in connection with the goods/services identified in the registrations. Subsequent outreach efforts revealed widespread support for continuing the pilot program on a permanent basis. Exempting small entities would prevent consideration of all section 8 and section 71 affidavits and not achieve the stated objective of assessing and promoting the accuracy and integrity of the register.

    The stated objective of the final rule also facilitates the cancellation of registrations for marks that are no longer in use or that were never used, and for which acceptable claims of excusable nonuse were not submitted, in connection with the identified goods/services. The statutory requirements in sections 8 and 71 exist to enable the USPTO to clear the register of deadwood by cancelling, in whole or in part, registrations for marks that are not in use for all or some of the goods/services identified in the registration. The final rule furthers this statutory purpose. Exempting small entities from possible scrutiny regarding use allegations would fail to address marks not used by them, thereby not achieving the objective.

    The USPTO considered a second alternative that would extend the time period for compliance by small entities. However, this was rejected because there appears to be no reason that meeting the requirements of the final rule would be more time consuming for small entities. The USPTO's standard six-month time period for responding to Office actions allows sufficient time regardless of small-entity status.

    Finally, the USPTO considered an alternative that would streamline or simplify the compliance mechanism for small entities, but it was deemed unnecessary given the ease of responding electronically to Office actions using the Trademark Electronic Application System Response to Post Registration Office Action form. Thus, under the final rule, compliance will be as streamlined and simplified as possible for all affected entities. Moreover, where the objective is to verify the accuracy of a claim of use in a section 8 or section 71 affidavit, the requirements for additional information, exhibits, affidavits or declarations, and specimens demonstrating the manner of use of the mark in connection with the specified goods/services are the least burdensome and most efficient means of achieving the objective of assessing and promoting the accuracy and integrity of the register by verifying allegations of use.

    Use of performance rather than design standards is not applicable to the final rulemaking because the USPTO is not issuing any sort of standard. This final rule will require registrants to furnish evidence of use, rather than comply with a performance or design standard.

    Executive Order 12866 (Regulatory Planning and Review): This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993).

    Executive Order 13563 (Improving Regulation and Regulatory Review): The USPTO has complied with Executive Order 13563 (Jan. 18, 2011). Specifically, the USPTO has, to the extent feasible and applicable: (1) Made a reasoned determination that the benefits justify the costs of the rule changes; (2) tailored the rules to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) provided the public with a meaningful opportunity to participate in the regulatory process, including soliciting the views of those likely affected prior to issuing a notice of proposed rulemaking, and provided on-line access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes, to the extent applicable.

    Executive Order 13132 (Federalism): This rulemaking does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).

    Congressional Review Act: Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), prior to issuing any final rule, the USPTO will submit a report containing the final rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this notice are not expected to result in an annual effect on the economy of 100 million dollars or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this notice is not expected to result in a “major rule” as defined in 5 U.S.C. 804(2).

    Unfunded Mandates Reform Act of 1995: The changes set forth in this rulemaking do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of 100 million dollars (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of 100 million dollars (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.

    Paperwork Reduction Act: This rulemaking involves information collection requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The collection of information involved in this rulemaking has been reviewed and previously approved by OMB under control numbers 0651-0051 and 0651-0055.

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

    List of Subjects 37 CFR Part 2

    Administrative practice and procedure, Trademarks.

    37 CFR Part 7

    Administrative practice and procedure, Trademarks, International registration.

    For the reasons stated in the preamble and under the authority contained in 15 U.S.C. 1123 and 35 U.S.C. 2, as amended, the USPTO amends parts 2 and 7 of title 37 as follows:

    PART 2—RULES OF PRACTICE IN TRADEMARK CASES 1. The authority citation for 37 CFR part 2 continues to read as follows: Authority:

    15 U.S.C. 1113, 15 U.S.C. 1123, 35 U.S.C. 2, Section 10 of Pub. L. 112-29, unless otherwise noted.

    2. Amend § 2.161 by revising paragraph (h) to read as follows:
    § 2.161 Requirements for a complete affidavit or declaration of continued use or excusable nonuse.

    (h) The Office may require the owner to furnish such information, exhibits, affidavits or declarations, and such additional specimens as may be reasonably necessary to the proper examination of the affidavit or declaration under section 8 of the Act or for the Office to assess and promote the accuracy and integrity of the register.

    PART 7—RULES OF PRACTICE IN FILINGS PURSUANT TO THE PROTOCOL RELATING TO THE MADRID AGREEMENT CONCERNING THE INTERNATIONAL REGISTRATION OF MARKS 3. The authority citation for 37 CFR part 7 continues to read as follows: Authority:

    15 U.S.C. 1123, 35 U.S.C. 2, unless otherwise noted.

    4. Amend § 7.37 by revising paragraph (h) to read as follows:
    § 7.37 Requirements for a complete affidavit or declaration of use in commerce or excusable nonuse.

    (h) The Office may require the holder to furnish such information, exhibits, affidavits or declarations, and such additional specimens as may be reasonably necessary to the proper examination of the affidavit or declaration under section 71 of the Act or for the Office to assess and promote the accuracy and integrity of the register.

    Dated: January 5, 2017. Russell Slifer, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office.
    [FR Doc. 2017-00317 Filed 1-18-17; 8:45 am] BILLING CODE 3510-16-P
    DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 14 RIN 2900-AP51 Recognition of Tribal Organizations for Representation of VA Claimants AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Final rule.

    SUMMARY:

    The Department of Veterans Affairs (VA) is amending its regulations concerning recognition of certain national, State, and regional or local organizations for purposes of VA claims representation. Specifically, this rulemaking allows the Secretary to recognize tribal organizations in a similar manner as the Secretary recognizes State organizations. The final rule allows a tribal organization that is established and funded by one or more tribal governments to be recognized for the purpose of providing assistance on VA benefit claims. In addition, the final rule allows an employee of a tribal government to become accredited through a recognized State organization in a similar manner as a County Veterans' Service Officer (CVSO) may become accredited through a recognized State organization. The effect of this action is to address the needs of Native American populations who are geographically isolated from existing recognized Veterans Service Organizations (VSOs) or who may not be utilizing other recognized VSOs due to cultural barriers or lack of familiarity with those organizations.

    DATES:

    Effective Date: This rule is effective February 21, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Dana Raffaelli, Staff Attorney, Benefits Law Group, Office of the General Counsel (022D), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-7699. (This is not a toll free number.)

    SUPPLEMENTARY INFORMATION:

    On July 20, 2016, VA issued a proposed rule to amend part 14 of title 38, Code of Federal Regulations, to provide for the recognition of tribal organizations that are established and funded by tribal governments so that representatives of the organizations may assist Native American veterans and their families in the preparation, presentation, and prosecution of their VA benefit claims. 81 FR 47087-47094. VA proposed to allow a tribal organization that is established and funded by one or more tribal governments to be recognized for the purpose of providing assistance on VA benefit claims. Id. In addition, VA proposed to allow an employee of a tribal government to become accredited through a recognized State organization in a similar manner as a CVSO may become accredited through a recognized State organization and to extend office space opportunities already granted to certain employees of State organizations to employees of tribal organizations. Id.

    VA received 17 comments on the proposed rule. Overall, the comments were supportive of the proposed rule. A couple of commenters stated that they currently meet or will be able to meet the accreditation requirements for recognition as a tribal organization. The actual requests for recognition of specific tribal organizations are outside the scope of this rulemaking. However, VA invites all interested organizations or applicants to consider requesting recognition after this rulemaking takes effect. Please see VA's accreditation Web site for more information on how to request recognition of an organization and how to apply to become accredited as a representative through a recognized organization or as an attorney or agent, http://www.va.gov/ogc/accreditation.asp. No change is warranted to this rulemaking based on these comments.

    A few commenters misinterpreted the proposed rule as meaning that VA intended to propose that VA's recognition of a tribal organization would be tied to VA's recognition of the corresponding State organization. VA is not tying VA recognition of a tribal organization to a State. Recognition of a tribal organization will stand on its own. After a tribal organization becomes recognized by VA, that organization will be able to request to have its own representatives accredited under 38 CFR 14.629. Therefore, VA declines to make any changes based on these comments.

    One commenter stated that there is no need to restrict a tribal government employee to being accredited by either a tribal organization or State organization. Although in the proposed rule, we focused much of our discussion on how a tribal government employee may be accredited through a tribal organization or a State organization, we do not intend for this rulemaking to limit the availability of other avenues to achieve VA accreditation. There are several ways that individuals, including tribal members, tribal government employees, and others who work within and serve tribal or Native American communities, may be accredited by VA to represent claimants. If an individual does not wish to be accredited through a tribal or State organization, the individual may seek accreditation through a National or Regional or Local organization or seek accreditation in his or her individual capacity as either an agent or an attorney under the standards set forth in § 14.629(b). Therefore, VA declines to make any changes based on this comment.

    One commenter asked whether a tribal veterans' service representative who worked in multiple states would be required to get approval from all of the States in which they work. If the representative is accredited through the tribal organization and representing claimants on behalf of that organization, then the representative would not need to seek any additional accreditation through a State organization. If the representative is a tribal veterans service officer (TVSO) and the representative's sole accreditation status is through a State organization, the representative should confer with that State organization to see if the State has placed any geographical limits on its accredited representatives. VA does not place any geographical or residency restrictions or limitations on State or tribal organizations as to who may be served by the organization. Therefore, no change is warranted to this rulemaking based on this comment.

    A couple of commenters recommended that a tribal organization should have the ability to accredit representatives of State organizations through the tribal organization as well. A VA-recognized tribal organization is welcome to put forth any representatives of its choosing for VA accreditation so long as the organization is able to certify that the potential representative is of good character and reputation, has demonstrated an ability to represent claimants, and is a paid employee working no less than 1,000 hours annually. A recognized tribal organization may also recommend a potential representative for accreditation through the tribal organization by certifying that the individual is accredited and functioning as a representative of another recognized organization, this is commonly referred to as “cross-accreditation.” See 38 CFR 14.627(j) and 14.629(a). Because we do not view this rulemaking as prohibiting State organization representatives from being accredited through a tribal organization as well, we do not believe that a change is warranted to this rulemaking based on these comments.

    One commenter asked if it would be possible for a tribal government to have their employees accredited by a tribal organization and State organization concurrently. VA does not limit an accredited representative to one method of accreditation. Therefore, no change is warranted to this rulemaking based on this comment.

    Several commenters appeared to interpret the proposed rule as limiting tribal organizations to representation of only veterans who are Native American and not their dependents or survivors who may not be Native American. It is not VA's intention to limit the type of claimants for VA benefits that any accredited organization, attorney, or agent may represent. The requirements for accreditation require an applying organization to state the number of veterans, survivors, and dependents that will be served by the organization. 38 CFR 14.628(d)(1)(ii)(D). VA makes no changes based on these comments.

    Several commenters also expressed concern over the requirements for recognition in § 14.628(d). Specifically, the commenters expressed concern that many tribal organizations may not be able to satisfy the requirement of having a primary purpose of serving veterans, the requirement of a substantial service commitment to veterans as shown either by a sizable organizational membership or by performance of veterans' services to a sizable number of veterans, or requirements concerning funding and training, to include providing the required supporting documentation. As stated in the proposed rule, VA must ensure that VA accredited organizations can provide long-term, competent representation and has found that the § 14.628(d) requirements further that objective. These requirements apply to all organizations seeking VA recognition. Exempting tribal organizations from meeting the § 14.628(d) requirements would not be consistent with the purpose of VA recognition to ensure that veterans are receiving qualified, competent representation on their VA benefit claims. VA has provided additional means to achieve VA recognition or accreditation for those tribal governments that may have difficulty establishing a tribal organization capable of meeting the § 14.628(d) requirements, to include the ability for one or more tribal governments to establish and fund a tribal organization and the ability of an employee of a tribal government to become accredited as a tribal veterans' service officer through a recognized State organization. Therefore, VA makes no changes based on these comments.

    Several commenters requested that VA further define or quantify what would constitute adequate funding and a substantial service commitment to veterans either by showing a sizeable organizational membership or by showing performance of veterans' services to a sizeable number of veterans. VA's purpose is to ensure that VA claimants have responsible, qualified representation and the above noted requirements serve as an indicator that the organization is stable. VA makes these determinations on a case-by-case basis taking into consideration all of the evidence of record. VA's goal is to ensure that VA claimants have access to the representation that they may need, and in order to provide such access, VA needs flexibility to make accreditation determinations based on the totality of the circumstances. Therefore, VA declines to make any changes based on these comments.

    Several commenters requested that funding be made available to establish tribal organizations. Section 5902, of title 38, United State Code, which is the law that authorizes VA to recognize organizations for the purpose of providing assistance on VA benefit claims, does not provide for the funding of such organizations to train and maintain representatives. Pursuant to § 14.628(d)(iii)(B), organizations are not precluded from seeking and receiving other sources of State and Federal grant funding so long as the organization's funding is not subject to limitations imposed under any Federal grant or law which would prevent it from representing claimants before VA. Therefore, VA declines to make any changes based on these comments.

    Several commenters suggested further outreach and collaboration. On March 3 and 10, 2016, respectively, VA issued letters to tribal leaders and a Federal Register notice, 81 FR 12626, seeking comment on VA's consideration of issuing a proposed rule that would amend part 14 of title 38, Code of Federal Regulations, to expressly provide for the recognition of tribal organizations so that representatives of the organizations may assist Native American claimants in the preparation, presentation, and prosecution of their VA benefit claims. Those interested in providing comment were given 30 days to respond. Based on requests from commenters, VA expanded the comment period an additional 15 days to April 26, 2016. VA received comments from 36 commenters. In the proposed rule, VA addressed the comments received from the tribal consultation and provided an additional 60-day comment period. 81 FR 47091-47093, July 20, 2016. Therefore, VA finds that it has complied with the notice and consultation requirements of the governing Executive Orders. See Exec. Order No. 13175, 65 FR 67249-67252, Nov. 9, 2000; Exec. Order 12866 sec. 6(a), 58 FR 51735, Sept. 30, 1993; Exec. Order 13563 sec. 2(b), 76 FR 3821, 3821-22, Jan. 18, 2011.

    One commenter asked VA to include the veterans departments within the tribal governments as eligible for VA recognition. A Veterans Affairs office or department that is established and funded by a tribal government is included in the definition of tribal organization and may apply for recognition under the rule. Another commenter requested that tribal government be included in the definition of tribal organization. A tribal government would not fit the definition of a tribal organization because the primary purpose of a tribal government is generally much broader than serving the needs of Native American veterans. However, the definition of tribal organization allows for a tribal government to establish such an organization that will be for that specific purpose. In this same way, VA recognizes State organizations rather than the State governments themselves. Therefore, no change to this rulemaking is warranted based on these comments.

    Another commenter stated that, due to the geographic size of their tribal government, it would make sense for it to become its own regional council. If the commenter is asserting its intention to apply to become a VA accredited organization, VA welcomes all organizations to apply once this rulemaking becomes effective. No change is warranted to this rulemaking based on this comment.

    One commenter recommended that, regarding tribal government approval for tribal organization representation, the approval be recognized with a single resolution or other document on behalf of member tribal nations. The commenter stated that obtaining resolutions from each nation would be administratively burdensome. Pursuant to § 14.628, the organization requesting VA accreditation must certify to VA that the organization meets the § 14.628(d) requirements for recognition. As long as VA receives certification from each tribal government approving the tribal organization, VA has no objection to the format of the certification being contained in a single resolution or document. An example may be that the establishment of the tribal organization is contained in one resolution and that resolution is signed, or certified, by all of the appropriate officials. VA makes no changes based on this comment.

    One commenter asked that VA provide recognition for urban Indian organizations or urban Indian health programs. The comment is unclear on whether such an organization would be able to apply for VA recognition as a tribal organization. VA declines to add an additional organization category at this time. In addition to the amendments discussed in this rulemaking, an organization may still utilize other avenues to apply for VA recognition such as requesting VA recognition as a regional or local organization. To be recognized as a regional or local organization, an organization must meet the requirements of § 14.628(c) and (d).

    The same commenter asked that employees of urban Indian organizations or urban Indian health programs be recognized as accredited representatives. An individual may apply for accreditation as a representative through a VA-recognized organization under standards set forth in § 14.629(a). Alternatively, an individual may also seek accreditation in an individual capacity as either an agent or an attorney under the standards set forth in § 14.629(b). The commenter also asked that the requirement for tribal veterans' service officers to work 1,000 hours annually be eliminated or lowered. The same hour requirements apply to county veterans' service officers being recommended for accreditation by a State and will, under this rule, apply to tribal veterans' service officers being accredited by a State. As explained in the proposed rule, VA prescribed these criteria in order to ensure adequate training and fitness to serve as a VA accredited representative. VA declines to make any changes based on these comments.

    One commenter asked VA to require culturally sensitive training for TVSOs. Section 14.628(d)(1)(v)(B) requires that a request for recognition of an organization include a plan for recruiting and training the organization's representatives. In addition, with regard to TVSOs, the organization's certifying official must certify that the TVSO is a paid employee of the tribal government working no less than 1,000 hours annually, has successfully completed a course of training and examination approved by VA, and that the TVSO will receive regular supervision or annual training to assure the TVSO continues to be qualified to represent claimants. 38 CFR 14.629(a)(2)(i)-(iii). The testing or training for TVSOs may include topics such as cultural sensitivity training at the discretion of the organization. VA declines to add a cultural sensitivity training requirement as we believe each organization would be the best judge of the need for cultural sensitivity training for its own representatives. In addition, such an addition would not be a logical outgrowth of the proposed rule. Therefore, VA makes no changes based on this comment.

    One commenter stated that, with regard to the Paperwork Reduction Act (PRA) requirements, VA had underestimated the number of applicants/respondents that would apply to become an accredited tribal organization. However, the commenter did not provide a number of how many applicants/respondents they thought VA would receive. VA notified the Office of Management and Budget (OMB) of the commenter's concern and amended its PRA submission to double the number of applicants/respondents from 5 to 10 per year.

    One commenter asked to what extent OMB was involved in the formulation of this rule. Executive Order 12866, 58 FR 51735, requires that OMB, specifically the Office of Information and Regulatory Affairs, review regulations before they are submitted for publication in the Federal Register. VA submitted the proposed rule and required supporting documents prior to the publication of the proposed rule and will comply with the requirements of the Executive Order in issuing this final rule. No change to this rulemaking is warranted based on this comment.

    One commenter asked to what extent VA believes that all States would support this rulemaking. VA has not received any adverse comments from States on this rulemaking. As previously stated, recognition of a tribal organization is not tied to a State organization. No change to this rulemaking is warranted based on this comment.

    One commenter asked what support VA could provide to tribes that do not have enough veterans per capita to participate in the process outlined to coordinate their activities with States or county veterans' service organizations while respecting a tribe's sovereign authority. It is unclear whether the commenter is requesting that VA waive certain accreditation requirements. As previously discussed, VA cannot waive the requirements for accreditation for any organization. A tribe that is unable to establish an organization that is capable of meeting the requirements to be recognized as a tribal organization may be able to have its members apply to become accredited in their individual capacity as claims agents or attorneys or as representatives through another VA-recognized organization. VA makes no changes based on this comment.

    One commenter said that educational benefits should be allowed to be used at tribal colleges and universities. This comment is outside the scope of this rulemaking. Therefore, no change is warranted based on this comment.

    Finally, VA is correcting a grammatical error in proposed § 14.628(b)(2). In the third sentence, VA mistakenly referred to “tgovernment” when the correct reference should have been to “tribal government.” VA is correcting this error in this rulemaking.

    Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (at 44 U.S.C. 3507) requires that VA consider the impact of paperwork and other information collection burdens imposed on the public. Under 44 U.S.C. 3507(a), an agency may not collect or sponsor the collection of information, nor may it impose an information collection requirement unless it displays a currently valid OMB control number. See also 5 CFR 1320.8(b)(3)(vi).

    This final rule will impose the following new information collection requirements. The collection of information in 38 CFR 14.628 requires organizations seeking VA accreditation under § 14.628 to submit certain documentation to certify that the organization meets the requirements for VA accreditation. Pursuant to § 14.628(d), an organization requesting recognition must have as a primary purpose serving veterans. In establishing that it meets this requirement, an organization requesting recognition shall submit a statement establishing the purpose of the organization and that veterans would benefit by recognition of the organization.

    The organization must also demonstrate a substantial service commitment to veterans either by showing a sizable organizational membership or by showing performance of veterans' services to a sizable number of veterans. In establishing that it meets this requirement, an organization requesting recognition shall submit: The number of members and number of posts, chapters, or offices and their addresses; a copy of the articles of incorporation, constitution, charter, and bylaws of the organization, as appropriate; a description of the services performed or to be performed in connection with programs administered by VA, with an approximation of the number of veterans, survivors, and dependents served or to be served by the organization in each type of service designated; and a description of the type of services, if any, performed in connection with other Federal and State programs which are designed to assist former Armed Forces personnel and their dependents, with an approximation of the number of veterans, survivors, and dependents served by the organization under each program designated.

    An organization requesting recognition must commit a significant portion of its assets to veterans' services and have adequate funding to properly perform those services. In establishing that it meets this requirement, an organization requesting recognition shall submit: A copy of the last financial statement of the organization indicating the amount of funds allocated for conducting particular veterans' services (VA may, in cases where it deems necessary, require an audited financial statement); and a statement indicating that use of the organization's funding is not subject to limitations imposed under any Federal grant or law which would prevent it from representing claimants before VA.

    An organization requesting recognition must maintain a policy and capability of providing complete claims service to each claimant requesting representation or give written notice of any limitation in its claims service with advice concerning the availability of alternative sources of claims service. In establishing that it meets this requirement, an organization requesting recognition shall submit evidence of its capability to represent claimants before VA regional offices and before the Board of Veterans' Appeals. If an organization does not intend to represent claimants before the Board of Veterans' Appeals, the organization shall submit evidence of an association or agreement with a recognized service organization for the purpose of representation before the Board of Veterans' Appeals, or the proposed method of informing claimants of the limitations in service that can be provided, with advice concerning the availability of alternative sources of claims service. If an organization does not intend to represent each claimant requesting assistance, the organization shall submit a statement of its policy concerning the selection of claimants and the proposed method of informing claimants of this policy, with advice concerning the availability of alternative sources of claims service.

    An organization requesting recognition must take affirmative action, including training and monitoring of accredited representatives, to ensure proper handling of claims. In establishing that it meets this requirement, an organization requesting recognition shall submit: A statement of the skills, training, and other qualifications of current paid or volunteer staff personnel for handling veterans' claims; and a plan for recruiting and training qualified claim representatives, including the number of hours of formal classroom instruction, the subjects to be taught, the period of on-the-job training, a schedule or timetable for training, the projected number of trainees for the first year, and the name(s) and qualifications of the individual(s) primarily responsible for the training.

    In addition, the organization requesting recognition shall supply: A statement that neither the organization nor its accredited representatives will charge or accept a fee or gratuity for service to a claimant and that the organization will not represent to the public that VA recognition of the organization is for any purpose other than claimant representation; and the names, titles, and addresses of officers and the official(s) authorized to certify representatives.

    As required by the Paperwork Reduction Act of 1995 (at 44 U.S.C. 3507(d)), VA has submitted this information collection to OMB for its review. OMB approved these new information collection requirements associated with the final rule and assigned OMB control number 2900-0850.

    Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. It does not require any action on the part of any entity but merely provides a new opportunity for tribal organizations to become recognized by VA for the purpose of assisting VA claimants in the preparation, presentation, and prosecution of claims for VA benefits. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the final regulatory flexibility analysis requirements of section 604.

    Executive Order 13175

    Executive Order 13175 provides that Federal agencies may not issue a regulation that has tribal implications, that imposes substantial direct compliance costs on tribal governments, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments or the Federal agency consults with tribal officials early in the process of developing the proposed regulation, develops and publishes in the Federal Register a tribal summary impact statement, and provides to the Director of OMB any written communications submitted to the agency by the tribal officials.

    On March 3 and 10, 2016, respectively, VA issued letters to tribal leaders and a Federal Register notice, 81 FR 12626, seeking comment on VA's consideration of issuing a proposed rule that would amend part 14 of title 38, Code of Federal Regulations, to expressly provide for the recognition of tribal organizations so that representatives of the organizations may assist Native American claimants in the preparation, presentation, and prosecution of their VA benefit claims. Those interested in providing comment were given 30-days to respond. Based on requests from commenters, VA expanded the comment period an additional 15 days to April 26, 2016. VA received comments from a total of 37 commenters. VA addressed 36 of those comments in the proposed rule. 81 FR 47087, 47091-47093. During the drafting of the final rule, VA discovered one additional comment submitted in response to the tribal consultation. Therefore, VA is addressing the additional comment and republishing VA's responses to the other comments in this final rule.

    One commenter asked if tribal organizations, since they are sovereign nations, would work with their local VA regional offices to include submitting claims through their respective regional offices. VA-recognized tribal organizations will be responsible for providing representation on behalf of their clients in the same manner as all other VA-recognized organizations, which often includes filing claims and evidence in support of their client's claims with the appropriate regional office. For TVSO's whose sole accreditation is through a State organization, VA defers to the State organization on their procedures for submitting claims and evidence to VA. No change is warranted to this rulemaking based on this comment.

    The same commenter asked if tribal organizations will “commit to annual/routine training [for their] veterans service officers.” Part of the § 14.628(d) requirements is that an organization seeking accreditation must “[t]ake affirmative action, including training and monitoring of accredited representatives, to ensure proper handling of claims.” 38 CFR 14.628(d)(1)(v). When an organization applies for VA accreditation, the organization must include a plan for recruiting and training the organization's representatives. 38 CFR 14.628(d)(1)(v)(B). No change is warranted to this rulemaking based on this comment.

    One commenter wrote that, currently, their tribal representatives are being accredited through their State as well as other national organizations and was curious as to the “road blocks” other tribal organizations were facing. This commenter did not provide any suggestions, and therefore, no change to this rulemaking is warranted.

    Several commenters noted that currently Native American veterans face many roadblocks to obtaining representation. One commenter noted that geography, economic, and culture barriers prevent Native American veterans from utilizing currently available representation. These comments were offered in support of the rulemaking, and therefore, no change is warranted.

    A few commenters misinterpreted the language provided in the consultation and notice as meaning that VA intended that VA's recognition of a tribal organization would be tied to VA's recognition of the corresponding State organization. One commenter stated that VA should recognize a tribal organization as “equal to” a State organization. VA is not tying VA recognition of a tribal organization to a State and is choosing not to make value judgements as to the importance of the recognition granted to State organizations and Tribal organizations. Recognition of a tribal organization will stand on its own. VA has chosen to use the term similar rather than the term equal in this rule because there are some differences in the requirements for VA recognition of a tribal organization and the requirements for State organizations. Specifically, the rule will allow a single tribal government, or multiple tribal governments to join together to establish and fund a tribal organization, but such allowance is not permitted for State governments.

    A few commenters misinterpreted the language provided in the consultation and notice as limiting recognition of a tribal veterans' service officer through a State. One commenter asked for clarification on what type of employees would be eligible to become accredited by VA. The commenter stated that employees of a tribal nation as well as a tribal organization should be eligible. We agree, and the final rule allows for both avenues to attain VA accreditation depending on the tribal government's size, relationships with other tribal governments, relationships with States, and the needs of Native American veterans in their area. After a tribal organization becomes recognized by VA, that organization will be able to request to have its own representatives accredited under 38 CFR 14.629. In addition to recognizing tribal organizations and accredit their representatives, VA provides an additional means by which VA may recognize an employee of a tribal government as a tribal veterans' service officer through a State organization. This accreditation is akin to accreditation given to county veterans' service officers through State organizations and is only meant to provide an additional path to VA accreditation. The requirements for a tribal veterans' service officer to become accredited as a representative through a State organization be the same as the requirements for a county veterans' service officer. Therefore, VA makes no changes based on these comments.

    One commenter asked what happens to the accreditation of a tribal organization if the Director is relinquished. It seems this comment stems from the misinterpretation previously discussed regarding the accreditation of a tribal organization and the corresponding State organization. The commenter also asked what happens if the State refuses to sponsor the replacement officer. As discussed above, once a tribal organization becomes recognized by VA, that organization can request to have its own representatives accredited under § 14.629. The tribal organization can file with VA to have a replacement officer accredited. Therefore, VA makes no changes based on this comment.

    Several commenters also expressed concern over the requirements for recognition in § 14.628(d). Specifically, the commenters expressed concern that many tribal organizations may not be able to satisfy the primary purpose, size, funding, and training requirements, to include providing the required, supporting documentation. One commenter suggested that VA provide the funding for tribes “to engage in this work.” Another commenter suggested including Indian Health Services for funding assistance. A few commenters expressed concern about the requirement that the organization must maintain a policy of either providing complete claims representation or provide “written notice of any limitation in its claims service with advice concerning the availability of alternative sources of claims service.” 38 CFR 14.628(d)(1)(iv). One commenter seemed to believe VA was questioning the level of competence of tribal representatives. VA must ensure that VA accredited organizations can provide long-term, competent representation and has found that the § 14.628(d) requirements are protective of that mission. These requirements apply to all organizations seeking VA recognition. Exempting tribal organizations from meeting the § 14.628(d) requirements is not consistent with the purpose of VA recognition to ensure that veterans are receiving qualified, competent representation on their VA benefit claims. As previously discussed, VA has provided additional means to achieve VA recognition or accreditation for those tribal governments that may have difficulty establishing a tribal organization capable of meeting the § 14.628(d) requirements, to include the ability for one or more tribal governments to establish and fund a tribal organization and the ability of an employee of a tribal government to become accredited as a tribal veterans' service officer through a recognized State organization. Therefore, VA makes no changes based on these comments.

    One commenter suggested that VA grant accreditation to tribes through a Memorandum of Understanding and included their tribe's Memorandum of Understanding with their State. The commenter also questioned the role of VA in the accreditation and monitoring process. The laws governing VA accreditation are set out at 38 U.S.C. 5902 and 5904 and 38 CFR 14.626-14.637. These laws apply to all organizations, agents, and attorneys seeking VA accreditation. Pursuant to § 14.628, the organization requesting VA accreditation must certify to VA that the organization meets the § 14.628(d) requirements for recognition. Therefore, a Memorandum of Understanding between VA and a tribe is not sufficient for applying for VA accreditation. Furthermore, VA does monitor its accredited organizations, agents, and attorneys and handles disciplinary matters as they arise. Therefore, VA makes no changes based on this comment.

    One commenter suggested that VA engage in additional consultation with Tribes that would be “interested in becoming recognized veterans['] service organizations, but are unable to meet the requirements.” In this rule, VA offers alternative avenues for VA recognition and accreditation for tribal governments that may not be capable of establishing an organization that can meet the VA recognition requirements in the rule on their own. VA declines to make any changes based on this comment.

    One commenter also recommended that “VA enter into Memorandums of Understanding with [F]ederally-recognized tribes and tribal organizations for [v]eterans' [s]ervice [o]fficer training and service reimbursement, on individual bases.” Another commenter objected to the fact that there was “no mention of funding to train and maintain such a position.” Section 5902, of title 38, United State Code, which is the law that authorizes VA to recognize organizations for the purpose of providing assistance on VA benefit claims, does not provide for the funding of such organizations to train and maintain representatives. Pursuant to § 14.628(d)(iii)(B), organizations are not precluded from seeking and receiving other sources of State and Federal grant funding so long as the organization's funding is not subject to limitations imposed under any Federal grant or law which would prevent it from representing claimants before VA. Therefore, VA declines to make any changes based on these comments.

    One commenter wrote that VA “. . . should include [F]ederally-recognized tribes, not just tribal organizations funded by tribal governments, as an entity from which applications will be considered to be recognized for . . .” VA accreditation. Another commenter suggested adding “[F]ederally recognized tribes” or “[F]ederally recognized tribal governments” as part of the definition for tribal organizations. Another commenter suggested adding tribal communities. For the purposes of the regulations pertaining to the representation of VA claimants, VA defines a tribal government to mean “the Federally recognized governing body of any Indian tribe, band, nation, or other organized group or community. . .”. VA finds this definition to be inclusive of the comments, and therefore, no change is warranted.

    One commenter suggested a legislative amendment to the definition of State in 38 U.S.C. 101(20) to include “[F]ederally recognized tribal governments.” Amending the statutory language is something that only Congress can accomplish. Since VA is defining the term “tribal government” in regulation and providing an avenue for VA recognition of a tribal organization separate from a State organization, VA does not find such a legislative amendment necessary. Therefore, no change is warranted based on this comment.

    Several commenters wrote that “[s]pecial attention must be paid to what specifically is meant by a `[t]ribal [o]rganization' ” and that VA should offer a clear definition of the term. The commenters did not offer any suggestions for such definition. As previously discussed, VA is defining this term for the purposes of this rulemaking. Therefore, VA does not make any changes based on this comment.

    Several commenters asked VA to clarify whether tribal governments, including veterans departments within these governments, would be eligible for VA recognition. A Department of Veterans Affairs or a Veterans Affairs office that is established and funded by a tribal government is included in the definition of tribal organization. Therefore, no change to this rulemaking is warranted based on these comments.

    One commenter asked that VA provide recognition for urban Indian organizations. The comment is unclear on whether such an organization would be able to apply for VA recognition as a tribal organization. VA declines to add an additional organization category at this time. In addition to the amendments discussed in this rulemaking, an organization may still utilize other avenues to apply for VA recognition such as requesting VA recognition as a regional or local organization. To be recognized as a regional or local organization, an organization must meet the requirements of § 14.628(c) and (d).

    Further, there are several ways that individuals, including tribal members, tribal government employees, and others who work within and serve tribal or Native American communities, may be accredited by VA to represent claimants. An individual may apply for accreditation as a representative through an existing VA-recognized organization under standards set forth in § 14.629(a). Alternatively, an individual may also seek accreditation in an individual capacity as either an agent or an attorney under the standards set forth in § 14.629(b). Therefore, VA declines to make any changes based on this comment.

    A couple of commenters submitted statements certifying that their organization would meet the requirements for accreditation for a tribal organization. Applications for accreditation are outside the scope of this rulemaking. Therefore, no change is warranted based on these comments.

    One commenter asked whether accredited tribal representatives would be granted access to software programs containing a veteran's claims file information and whether that access would be on tribal grounds. This issue is outside the scope of this rulemaking. Therefore, no change is warranted based on this comment.

    One commenter expressed support for VA recognizing tribal organizations in an equal manner as VA recognizes State organizations but suggested that VA authorize a field office close to tribal administration locations and fund one or two veterans service officer positions. The tribal consultation and this rulemaking are limited in scope to recognition for purposes of VA claims representation. The commenter's suggestion of adding a field office is beyond the scope, and therefore, VA declines to make any changes based on this comment. VA also declines to make any changes to the commenter's suggestion of funding job positions for veterans service officers. Part of the § 14.628(d) requirements is that an organization seeking accreditation must commit a significant portion of its assets to veterans' services and have adequate funding to properly perform those services. 38 CFR 14.628(d)(1)(iii).

    A few commenters expressed concern that the rulemaking is limiting VA recognition for the preparation, presentation, and prosecution of claims for VA benefits. One commenter seemed to think VA is depriving veterans from other title 38 benefits. The commenters did not specify what other accreditation they are seeking. As previously discussed, the relevant regulations in 38 CFR part 14 are to recognizing organizations and accrediting individuals to assist in the preparation, presentation, and prosecution of VA benefit claims. Pursuant to section 5902, VA accreditation may not be granted for any other purpose. This rulemaking in no way deprives any veteran of any title 38 benefits. Therefore, no change is warranted based on these comments.

    One commenter suggested that office space opportunities should be available to tribal governments and organizations in the same manner as they are available to State organizations. As previously discussed, this rule will, under § 14.635, allow the Secretary to furnish office space and facilities, when available, to both State and tribal organization employees who are also accredited to national organizations for the purpose of assisting claimants in the preparation, presentation, and prosecution of claims for benefits. VA will be furnishing office space to tribal organizations in the same manner as it furnishes such space to State organizations. Therefore, no change is warranted based on this comment.

    One commenter noted that VA should allow a tribal government employee to become accredited through an accredited body of their choice. VA in no way is limiting how a particular individual may apply to become an accredited VA representative. As previously discussed, VA is merely providing additional paths to VA accreditation than currently exist. Therefore, VA declines to make any changes to this rulemaking based on this comment.

    Several commenters suggested further outreach and collaboration. One commenter suggested that VA form a tribal workgroup to allow representatives from tribal organizations to collaborate on implementing the new program. One commenter provided VA with their tribal consultation policy. Other commenters suggested that VA engage in additional consultation with experts in Indian law and hold an all-tribes call to gather additional input for this rulemaking. VA appreciates this information. As previously noted, VA extended the comment period for an additional 15 days to ensure that all interested parties had an appropriate time to provide input. Therefore, VA finds that it has complied with the requirements of Executive Order 13175. VA also provided an additional 60-day comment period for the proposed rule.

    One commenter asked for the projected implementation date of this rulemaking. The dates section of this final rule contains the effective date of the rulemaking.

    Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action” requiring review by OMB, unless OMB waives such review, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations or recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

    The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of this rulemaking and its impact analysis are available on VA's Web site at http://www.va.gov/orpm/, by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year to Date.”

    Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.

    Catalog of Federal Domestic Assistance

    There are no Catalog of Federal Domestic Assistance programs numbers and titles associated with this final rule.

    List of Subjects in 38 CFR Part 14

    Administrative practice and procedure, Claims, Courts, Foreign relations, Government employees, Lawyers, Legal services, Organization and functions (Government agencies), Reporting and recordkeeping requirements, Surety bonds, Trusts and trustees, Veterans.

    For the reasons set out in the preamble, the Department of Veterans Affairs amends 38 CFR part 14 as follows:

    PART 14—LEGAL SERVICES, GENERAL COUNSEL, AND MISCELLANEOUS CLAIMS 1. The authority citation for part 14 continues to read as follows: Authority:

    5 U.S.C. 301; 28 U.S.C. 2671-2680; 38 U.S.C. 501(a), 512, 515, 5502, 5901-5905; 28 CFR part 14, appendix to part 14, unless otherwise noted.

    2. Amend § 14.627 by adding paragraph (r) to read as follows:
    § 14.627 Definitions.

    (r) Tribal government means the Federally recognized governing body of any Indian tribe, band, nation, or other organized group or community, including any Alaska Native village or Regional or Village Corporation as defined in or established pursuant to the Alaska Native Claims Settlement Act, which is recognized as eligible for the special programs and services provided by the United States to Indians because of their status as Indians.

    3. Amend § 14.628 by: a. Designating paragraph (b) as paragraph (b)(1) and adding paragraph (b)(2); and b. In the OMB approval parenthetical at the end of the section, removing “2900-0439” and adding, in its place, “2900-0850”.

    The addition reads as follows:

    § 14.628 Recognition of organizations.

    (b) * * *

    (2) Tribal organization. For the purposes of 38 CFR 14.626 through 14.637, an organization that is a legally established organization that is primarily funded and controlled, sanctioned, or chartered by one or more tribal governments and that has a primary purpose of serving the needs of Native American veterans. Only one tribal organization may be recognized for each tribal government. If a tribal organization is created and funded by more than one tribal government, the approval of each tribal government must be obtained prior to applying for VA recognition. If one of the supporting tribal governments withdraws from the tribal organization, the tribal organization must notify VA of the withdrawal and certify that the tribal organization continues to meet the recognition requirements in paragraph (d) of this section.

    § 14.629 [Amended]
    4. Amend § 14.629 by: a. In paragraph (a)(2) introductory text, removing “county veteran's service officer” and adding in its place “county veterans' service officer”; b. In paragraph (a)(2) introductory text, adding “or tribal veterans' service officer” immediately following “county veterans' service officer”; and c. In paragraph (a)(2)(i), adding “or tribal government” immediately following “county”.
    § 14.635 [Amended]
    5. Amend § 14.635 by adding, in the introductory paragraph, “or tribal” immediately following “State”. Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on January 11, 2017, for publication.

    Dated: January 11, 2017. Jeffrey Martin, Office Program Manager, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.
    [FR Doc. 2017-00947 Filed 1-18-17; 8:45 am] BILLING CODE 8320-01-P
    DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 17 RIN 2900-AP94 Fertility Counseling and Treatment for Certain Veterans and Spouses AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Interim final rule.

    SUMMARY:

    The Department of Veterans Affairs (VA) amends its regulation regarding fertility counseling and treatment available to certain veterans and spouses. VA currently provides certain infertility services other than in vitro fertilization (IVF) to veterans as part of the medical benefits package. IVF is the process of fertilization by manually fertilizing an egg, and then transferring the embryo to the uterus. This interim final rulemaking adds a new section authorizing IVF for a veteran with a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment. In addition, we add a new section stating that VA may provide fertility counseling and treatment using assisted reproductive technologies (ART), including IVF, to a spouse of a veteran with a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment. VA will provide ART treatment, including IVF, to these veterans and spouses as specified in the Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act to the extent such services are consistent with the services available to enrolled veterans under the medical benefits package.

    DATES:

    Effective Date: This rule is effective on January 19, 2017.

    Comment date: Comments must be received on or before March 20, 2017.

    ADDRESSES:

    Written comments may be submitted by email through http://www.regulations.gov; by mail or hand-delivery to Director, Regulation Policy and Management (00REG), Department of Veterans Affairs, 810 Vermont Avenue NW., Room 1068, Washington, DC 20420; or by fax to (202) 273-9026. (This is not a toll-free number.) Comments should indicate that they are submitted in response to “RIN 2900AP94—Fertility Counseling and Treatment for Certain Veterans and Spouses.” Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1068, between the hours of 8:00 a.m. and 4:30 p.m. Monday through Friday (except holidays). Please call (202) 461-4902 for an appointment. (This is not a toll-free number.) In addition, during the comment period, comments may be viewed online through the Federal Docket Management System (FDMS) at http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Patricia M. Hayes, Ph.D., Chief Consultant, Women's Health Services, Patient Care Services, Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Ave. NW., Washington, DC 20420. (202) 461-0373. (This is not a toll-free number.)

    SUPPLEMENTARY INFORMATION:

    Section 260 of the Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act (Public Law 114-223) states that VA may use appropriated funds available to VA for the Medical Services account to provide fertility counseling and treatment using assisted reproductive technology (ART) to a covered veteran or the spouse of a covered veteran, or adoption reimbursement to a covered veteran. This rulemaking expands the types of ART treatment available to certain veterans and makes fertility counseling and treatment including ART treatment available to spouses of those veterans, consistent with this statutory authority. Reimbursement of adoption expenses will be the subject of a separate rulemaking.

    According to this law, Veterans who will receive this benefit are those with a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment. The ART treatments referred to in this law are those relating to reproductive assistance provided to a member of the Armed Forces who incurs a serious injury or illness on active duty pursuant to title 10 of the United States Code (U.S.C.) section 1074(c)(4)(A), as described in a policy memorandum issued by the Assistant Secretary of Defense for Health Affairs on April 3, 2012, titled “Policy for Assisted Reproductive Services for the Benefit of Seriously or Severely Ill/Injured (Category II or III) Active Duty Service Members,” and the guidance issued to implement such policy, including any limitations on the amount of such benefits available to such a member. See Public Law 114-223, section 260(b)(2) and (3). The implementing guidance is contained in a document attached to the policy memorandum. We will refer to the April 3, 2012, policy memorandum and guidance issued by the Department of Defense (DoD) to implement that policy collectively as DoD policy guidance. DoD has established a system for categorizing injured servicemembers for purposes of coordinating care. Those in Category II have a serious injury or illness, are unlikely to return to duty within a time specified by their Military Department, and may be medically separated from the military. Servicemembers in Category III have a severe or catastrophic injury or illness, are highly unlikely to return to duty, and will most likely be medically separated from the military.

    ART is defined at Public Law 114-223, section 260(b)(3) to mean the benefits relating to reproductive assistance in DoD policy guidance, including any limitations on the amount of such benefits in that policy. DoD policy guidance addresses assisted reproductive services available to servicemembers, providing specific guidance on the availability of IVF, as well as a wide range of services that VA considers as fertility treatment. Under this statute, VA is authorized to provide ART benefits, consistent with DoD policy guidance, to a veteran with a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment, as well as the spouse of that veteran. The conference report accompanying this legislation makes clear that the implementing guidance developed by the Secretary shall not be materially different from, and in no way more expansive than, DoD's policy. Joint Explanatory Statement. 162 Congressional Record at S6011 (2016).

    The Veterans' Health Care Eligibility Reform Act of 1996, Public Law 104-262, mandated that VA implement a national enrollment system to manage the delivery of healthcare services. A key component of managing delivery of healthcare services to eligible veterans is identifying the medical services provided by VA. The medical benefits package, defining the medical services provided to all enrolled veterans by VA, is found at 38 CFR 17.38. VA may provide services under the medical benefits package that are determined by appropriate healthcare professionals to be needed to promote, preserve, or restore the health of the individual and to be in accord with generally accepted standards of medical practice.

    As part of the medical benefits package, VA provides many different types of fertility treatments and procedures to veterans. These include infertility counseling, laboratory blood testing, surgical correction of structural pathology, reversal of a vasectomy or tubal ligation, medication, and various other diagnostic studies or treatments and procedures. This list is not all-inclusive. Most of the ART evaluation and treatment modalities offered by VA are consistent with DoD policy guidance. The exception is IVF. DoD offers IVF to servicemembers who have sustained serious or severe illness/injury while on active duty that led to the loss of their natural procreative ability, while IVF is excluded from VA's medical benefits package under § 17.38(c)(2). IVF is the process of fertilization by manually fertilizing an egg, and then transferring the embryo to the uterus. IVF is a common and medically accepted procedure for addressing infertility that cannot be overcome with other types of infertility treatment. Although we are not revising the medical benefits package itself, we are revising paragraph (c)(2) to add a note referencing the benefit available in § 17.380, as discussed below. We believe that this clarification will help veterans better understand the benefits available from VA.

    Pursuant to Public Law 114-223 section 260, VA is adding new § 17.380 which states that IVF may be provided when clinically appropriate to a veteran who has a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment, as well as a spouse of such veteran. Per 38 U.S.C. 101(2), the term veteran means a person who served in the active military, naval, or air service, and who was discharged or released therefrom under conditions other than dishonorable. Under this provision, IVF services available to such veterans are the same as those provided by DoD to a member of the Armed Forces who incurs a serious injury or illness on active duty pursuant to 10 U.S.C. 1074(c)(4)(A), as described in DoD policy guidance, including any limitations on the amount of such benefits available to such a member. For the purposes of this section, “a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment” means, for a male veteran, a service-connected injury or illness that prevents the successful delivery of sperm to an egg; and, for a female veteran with ovarian function and a patent uterine cavity, a service-connected injury or illness that prevents the egg from being successfully fertilized by a sperm. This definition parallels requirements in DoD policy guidance for an active duty service member who is seriously or severely ill/injured (Category II or III) to receive fertility counseling and treatment using ART. Public Law 114-223 provides appropriations for FY 2017. The benefits authorized under section 260 are thereby limited to FY2017. Paragraph (b) of § 17.380 states that the authority to provide IVF to covered veterans under this section expires September 30, 2017. If the authority is extended, we will amend this section accordingly.

    In addition, VA adds a new § 17.412. This new section states that VA may provide fertility counseling and treatment using ART to a spouse of a veteran with a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment to the extent such services are available to enrolled veterans under the medical benefits package. It also states that VA may provide IVF to a spouse of a veteran with a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment. Such health care services may be provided when clinically appropriate and consistent with the benefits relating to reproductive assistance provided to a member of the Armed Forces who incurs a serious injury or illness on active duty as described in DoD policy guidance.

    Paragraph (b) states that authority to provide fertility counseling and treatment including IVF to spouses of covered veterans under this section expires September 30, 2017. If the authority is extended we will amend this section accordingly.

    DoD policy guidance addresses various issues including eligibility for ART, testing to predict fertility potential, infertility testing and treatment (including correction of the physical cause of infertility), provisions on the total number of IVF cycles that may be provided, and required processes and procedures. VA intends to issue policy and develop clinical guidelines consistent with DoD policy guidance.

    Finally, we also revise the center heading immediately preceding § 17.410 to read “Hospital Care and Medical Services for Spouses and Families.” VA provides medical care to certain families of Camp LeJeune veterans under § 17.410, and the center heading referred to those services. The current rulemaking adds a new section immediately following § 17.410, and VA believes the center heading should be revised to avoid any confusion.

    Administrative Procedure Act

    In accordance with U.S.C. 553(b)(B) and (d)(3), the Secretary of Veterans Affairs has concluded that there is good cause to publish this rule as an interim final rule without prior opportunity for public comment and to publish this rule with an immediate effective date. As stated above, this rule makes IVF treatment available to certain veterans, and fertility counseling and treatment using ART to the spouses of those veterans. The Secretary finds that it is impracticable and contrary to the public interest to delay this rule for the purpose of soliciting advance public comment or to have a delayed effective date. This rulemaking will benefit those veterans and spouses most in need of ART services including IVF, and delay might cause a significant hardship for affected veterans and spouses. The Joint Theater Trauma Registry (JTTR) reflects the most common single cause of battle injuries is explosive devices (36.3%). Such trauma frequently results in genitourinary injury. For example, 1 in 5 warriors were evacuated from Operation Enduring Freedom (OEF) combat in October 2011 with a genitourinary injury. This increasingly common trauma can have catastrophic reproductive results. While the JTTR tracks combat trauma only for OEF and Operation Iraqi Freedom, genitourinary or spinal cord injury, or pelvic trauma related to combat injuries was also common in previous combat operations, and these injuries may make it impossible for affected veterans to procreate without the use of fertility treatment. In many cases ART, including IVF, is the only viable option for procreation. Further, since age is a factor in successful fertilization and completion of a pregnancy, rulemaking delay may result in some veterans or spouses losing fertility potential prior to a later effective date. In addition, this rulemaking will ensure that covered veterans leaving service at this time, and their spouses, will experience continuity of care when transferring from health care provided by DoD to that provided by VA, with no difference in the level or types of available ART. For the above reason, the Secretary issues this rule as an interim final rule. VA will consider and address comments that are received within 60 days of the date this interim final rule is published in the Federal Register.

    Effect of Rulemaking

    Title 38 of the Code of Federal Regulations, as revised by this final rulemaking, represents VA's implementation of its legal authority on this subject. Other than future amendments to this regulation or governing statutes, no contrary guidance or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible or, if not possible, such guidance is superseded by this rulemaking.

    Paperwork Reduction Act

    This interim final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

    Regulatory Flexibility Act

    The Secretary hereby certifies that this interim final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This interim final rule will directly affect only individuals and will not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604.

    Executive Order 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), unless OMB waives such review, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

    The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's Web site at http://www.va.gov/orpm/, by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year to Date.”

    Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This interim final rule will have no such effect on State, local, and tribal governments, or on the private sector.

    Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans Dental Care; 64.012, Veterans Prescription Service; 64.013, Veterans Prosthetic Appliances; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 64.022, Veterans Home Based Primary Care; and 64.024, VA Homeless Providers Grant and Per Diem Program.

    List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Government contracts, Grant programs—health, Grant programs—veterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and Dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Reporting and recordkeeping requirements, Travel and transportation expenses, Veterans.

    Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on December 23, 2016, for publication.

    Janet Coleman, Chief, Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.

    For the reasons set out in the preamble, VA amends 38 CFR part 17 as follows:

    PART 17—MEDICAL 1. The authority citation for part 17 is revised to read as follows: Authority:

    38 U.S.C. 501, and as noted in specific sections.

    Section 17.38 also issued under 38 U.S.C. 101, 501, 1701, 1705, 1710, 1710A, 1721, 1722, 1782, and 1786.

    Sections 17.380 and 17.412 are also issued under sec. 260, Pub. L. 114-223, 130 Stat. 857.

    Section 17.415 is also issued under 38 U.S.C. 7301, 7304, 7402, and 7403.

    Sections 17.640 and 17.647 are also issued under sec. 4, Pub. L. 114-2, 129 Stat. 30.

    Sections 17.641 through 17.646 are also issued under 38 U.S.C. 501(a) and sec. 4, Pub. L. 114-2, 129 Stat. 30.

    2. Amend § 17.38 by: a. Revising paragraph (c)(2). b. Removing the sectional authority citation.

    The revision reads as follows:

    § 17.38 Medical benefits package.

    (c) * * *

    (2) In vitro fertilization. Note: See § 17.380.

    3. Add an undesignated center heading and § 17.380 to read as follows: In Vitro Fertilization Treatment
    § 17.380 In vitro fertilization treatment.

    (a)(1) In vitro fertilization may be provided when clinically appropriate to—

    (i) A veteran who has a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment; and,

    (ii) The spouse of such veteran, as provided in § 17.412.

    (2) For the purposes of this section, “a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment” means, for a male veteran, a service-connected injury or illness that prevents the successful delivery of sperm to an egg; and, for a female veteran with ovarian function and a patent uterine cavity, a service-connected injury or illness that prevents the egg from being successfully fertilized by sperm.

    (3) In vitro fertilization treatment will be provided under this section when clinically appropriate and to the same extent such treatment is provided to a member of the Armed Forces who incurs a serious injury or illness on active duty pursuant to 10 U.S.C. 1074(c)(4)(A), as described in the April 3, 2012, memorandum issued by the Assistant Secretary of Defense for Health Affairs on the subject of “Policy for Assisted Reproductive Services for the Benefit of Seriously or Severely Ill/Injured (Category II or III) Active Duty Service Members,” and the guidance issued by the Department of Defense to implement such policy, including any limitations on the amount of such benefits available to such a member.

    (b) Authority to provide in vitro fertilization treatment to covered veterans under this section expires September 30, 2017.

    4. Revise the undesignated center heading immediately preceding § 17.410 to read as follows: Hospital Care and Medical Services for Spouses and Families 5. Add § 17.412 to read as follows:
    § 17.412 Fertility counseling and treatment for certain spouses.

    (a)(1) VA may provide fertility counseling and treatment to a spouse of a veteran described in § 17.380 to the extent such services are available to a veteran under § 17.38, and consistent with the benefits relating to reproductive assistance provided to a member of the Armed Forces who incurs a serious injury or illness on active duty pursuant to 10 U.S.C. 1074(c)(4)(A), as described in the April 3, 2012, memorandum issued by the Assistant Secretary of Defense for Health Affairs on the subject of “Policy for Assisted Reproductive Services for the Benefit of Seriously or Severely Ill/Injured (Category II or III) Active Duty Service Members,” and the guidance issued by the Department of Defense to implement such policy, including any limitations on the amount of such benefits available to such a member.

    (2) VA may provide in vitro fertilization to a spouse of a veteran described in § 17.380 when clinically appropriate and consistent with the benefits relating to reproductive assistance provided to a member of the Armed Forces who incurs a serious injury or illness on active duty pursuant to 10 U.S.C. 1074(c)(4)(A), as described in the April 3, 2012, memorandum issued by the Assistant Secretary of Defense for Health Affairs on the subject of “Policy for Assisted Reproductive Services for the Benefit of Seriously or Severely Ill/Injured (Category II or III) Active Duty Service Members,” and the guidance issued by the Department of Defense to implement such policy, including any limitations on the amount of such benefits available to such a member.

    (b) Authority to provide fertility counseling and treatment, including in vitro fertilization under this section, expires September 30, 2017.

    [FR Doc. 2017-00280 Filed 1-18-17; 8:45 am] BILLING CODE 8320-01-P
    POSTAL SERVICE 39 CFR Part 233 Inspection Service Authority; Civil Monetary Penalty Inflation Adjustment AGENCY:

    Postal Service.

    ACTION:

    Interim final rule.

    SUMMARY:

    This rule updates postal regulations to implement the annual inflation adjustments to civil monetary penalties that may be imposed under consumer protection and mailability provisions enforced by the Postal Service pursuant to the Deceptive Mail Prevention and Enforcement Act and the Postal Accountability and Enhancement Act. These adjustments are required under the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. This notice also includes the statutory civil monetary penalties subject to the 2015 Act.

    DATES:

    Effective date: January 19, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Steven Sultan, (202) 268-7385.

    SUPPLEMENTARY INFORMATION:

    The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Act), Public Law 114-74, 129 Stat. 584, amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (1990 Act), Public Law 101-410, 104 Stat. 890 (28 U.S.C. 2461 note), to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. Section 3 of the 1990 Act specifically includes the Postal Service in the definition of “agency” subject to its provisions.

    Beginning in 2017, the 2015 Act requires the Postal Service to make an annual adjustment for inflation to civil penalties that meet the definition of “civil monetary penalty” under the 1990 Act. The Postal Service must make the annual adjustment for inflation and publish the adjustment in the Federal Register by January 15. Each penalty will be adjusted as instructed by the Office of Management and Budget (OMB) based on the Consumer Price Index (CPI-U) from the most recent October. OMB has furnished detailed instructions regarding the annual adjustment for 2017 in memorandum M-17-11, Implementation of the 2017 Annual Adjustment Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (December 16, 2016), https://www.whitehouse.gov/sites/default/files/omb/memoranda/2017/m-17-11_0.pdf. This year, OMB has advised that an adjustment multiplier of 1.01636 will be used. The new penalty amount must be rounded to the nearest dollar.

    The 2015 Act allows the interim final rule and annual inflation adjustments to be published without prior public notice or opportunity for public comment.

    Adjustments to Postal Service Civil Monetary Penalties

    Civil monetary penalties may be assessed for postal offenses under sections 106 and 108 of the Deceptive Mail Prevention and Enforcement Act, Public Law 106-168, 113 Stat. 1811, 1814 (see, 39 U.S.C. 3012(a), (c)(1), (d), and 3017(g)(2), (h)(1)(A)); and section 1008 of the Postal Accountability and Enhancement Act, Public Law 109-435, 120 Stat. 3259-3261 (see, 39 U.S.C. 3018 (c)(1)(A)). The statutory civil monetary penalties subject to the 2015 Act and the amount of each penalty the annual adjustment for inflation are as follows:

    39 U.S.C. 3012(a)—False Representations and Lottery Orders

    Under 39 U.S.C. 3005(a)(1)-(3), the Postal Service may issue administrative orders prohibiting persons from using the mail to obtain money through false representations or lotteries. Persons who evade, attempt to evade, or fail to comply with an order to stop such prohibited practices may be liable to the United States for a civil penalty under 39 U.S.C. 3012(a). This section currently imposes a $68,345 penalty for each mailing less than 50,000 pieces, $136,689 for each mailing of 50,000 to 100,000 pieces, and $13,669 for each additional 10,000 pieces above 100,000 not to exceed $2,733,780. The new penalties will be as follows: $69,463 for each mailing less than 50,000 pieces, $138,925 for each mailing of 50,000 to 100,000 pieces, and $13,893 for each additional 10,000 pieces above 100,000 not to exceed $2,778,505.

    39 U.S.C. 3012(c)(1)—False Representation and Lottery Penalties in Lieu of or as Part of an Order

    In lieu of or as part of an order issued under 39 U.S.C. 3005(a)(1)-(3), the Postal Service may assess a civil penalty. Currently, the amount of this penalty, set in 39 U.S.C. 3012(c)(1), is $34,172 for each mailing that is less than 50,000 pieces, $68,345 for each mailing of 50,000 to 100,000 pieces, and an additional $6,834 for each additional 10,000 pieces above 100,000 not to exceed $1,366,890. The new penalties will be: $34,731 for each mailing that is less than 50,000 pieces, $69,463 for each mailing of 50,000 to 100,000 pieces, and an additional $6,946 for each additional 10,000 pieces above 100,000 not to exceed $1,389,252.

    39 U.S.C. 3012(d)—Misleading References to the United States Government; Sweepstakes and Deceptive Mailings

    Persons sending certain deceptive mail matter described in 39 U.S.C. 3001((h)-(k), including:

    • Solicitations making false claims of Federal Government connection or approval;

    • Certain solicitations for the purchase of a product or service that may be obtained without cost from the Federal Government;

    • Solicitations containing improperly prepared “facsimile checks”; and

    • Certain solicitations for “skill contests” and “sweepstakes” sent to individuals who, in accordance with 39 U.S.C. 3017(d), have requested that such materials not be mailed to them);

    may be liable to the United States for a civil penalty under 39 U.S.C. 3012(d). Currently, this penalty is not to exceed $13,669 for each mailing. The new penalty will be $13,893. 39 U.S.C. 3017(g)(2)—Commercial Use of Lists of Persons Electing Not To Receive Skill Contest or Sweepstakes Mailings

    Under 39 U.S.C. 3017(g)(2), the Postal Service may impose a civil penalty against a person who provides information for commercial use about individuals who, in accordance with 39 U.S.C. 3017(d), have elected not to receive certain sweepstakes and contest information. Currently, this civil penalty may not exceed $2,733,780 per violation. The new penalty may not exceed $2,778,505 per violation.

    39 U.S.C. 3017(h)(1)(A)—Reckless Mailing of Skill Contest or Sweepstakes Matter

    Currently, under 39 U.S.C. 3017(h)(1)(A), any promoter who recklessly mails nonmailable skill contest or sweepstakes matter may be liable to the United States in the amount of $13,669 per violation for each mailing to an individual. The new penalty is $13,893 per violation.

    39 U.S.C. 3018(c)(1)(A)—Hazardous Material

    Under 39 U.S.C. 3018(c)(1)(A), the Postal Service may impose a civil penalty payable into the Treasury of the United States on a person who knowingly mails nonmailable hazardous materials or fails to follow postal laws on mailing hazardous materials. Currently, this civil penalty is at least $295, but not more than $117,858 for each violation. The new penalty is at least $300, but not more than $119,786 for each violation.

    List of Subjects in 39 CFR Part 233

    Administrative practice and procedure, Banks, Banking, Credit, Crime, Infants and children, Law enforcement, Penalties, Privacy, Seizures and forfeitures.

    For the reasons set out in this document, the Postal Service amends 39 CFR part 233 as follows:

    PART 233—INSPECTION SERVICE AUTHORITY 1. The authority citation for 39 CFR part 233 continues to read as follows: Authority:

    39 U.S.C. 101, 102, 202, 204, 401, 402, 403, 404, 406, 410, 411, 1003, 3005, 3012, 3017, 3018; 12 U.S.C. 3401-3422; 18 U.S.C. 981, 983, 1956, 1957, 2254, 3061; 21 U.S.C. 881; Pub. L. 101-410, 104 Stat. 890; Omnibus Budget Reconciliation Act of 1996, sec. 662 (Pub.L. 104-208, 110 Stat. 3009-378); Pub. L. 106-168, 113 Stat. 1806; Pub. L. 114-74, 129 Stat. 584.

    2. In § 233.12(a), remove “$68,345” and add in its place “$69,463”; remove “$136,689” and add in its place “$138,925”; remove “$13,669” and add in its place “$13,893”; remove “each piece above 100,000” and add in its place “each additional 10,000 pieces above 100,000”; remove “$2,733,780” and add in its place “$2,778,505”. 3. In § 233.12(b), remove “$34,172” and add in its place “$34,731”; remove “$68,345” and add in its place “$69,463”; remove “$6,834” and add in its place “$6,946”; remove “every” and add in its place “each”; remove “$1,366,890” and add in its place “$1,389,252”. 4. In § 233.12(c)(4), remove “$13,669” and add in its place “13,893”. 5. In § 233.12(d), remove “$2,733,780” and add in its place “$2,778,505”. 6. In § 233.12(e), remove “$13,669” and add in its place “$13,893”. 7. In § 233.12(f), remove “$295” and add in its place “$300”; remove “$117,858” and add in its place “$119,786”. Stanley F. Mires, Attorney, Federal Compliance.
    [FR Doc. 2017-00204 Filed 1-18-17; 8:45 am] BILLING CODE 7710-12-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA-HQ-OPPT-2016-0207; FRL-9958-20] RIN 2070-AB27 Significant New Use Rules on Certain Chemical Substances; Withdrawal AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Partial withdrawal of direct final rule.

    SUMMARY:

    EPA is withdrawing significant new use rules (SNURs) promulgated under the Toxic Substances Control Act (TSCA) for two chemical substances, which were the subject of premanufacture notices (PMNs). EPA published these SNURs using direct final rulemaking procedures, which requires EPA to take certain actions if a notice of intent to submit an adverse comment is received. EPA received notices of intent to submit adverse comments regarding the SNURs identified in this document. Therefore, the Agency is withdrawing the direct final rule SNURs identified in this document, as required under the direct final rulemaking procedures.

    DATES:

    This document is effective January 19, 2017.

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2016-0207, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    For technical information contact: Kenneth Moss, Chemical Control Division (7405M) Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: [email protected]

    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave. Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]

    SUPPLEMENTARY INFORMATION: I. Does this action apply to me?

    A list of potentially affected entities is provided in the Federal Register of November 17, 2015 (81 FR 1250) (FRL-9953-41). If you have questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

    II. What direct final SNURs are being withdrawn?

    In the Federal Register of November 17, 2015 (81 FR 1250), EPA issued direct final SNURs for the chemical substances that are identified in this document. These direct final SNURs were issued under the procedures in 40 CFR part 721, subpart D. Because the Agency received notices of intent to submit adverse comments, in accordance with § 721.160(c)(3)(ii), EPA is withdrawing the direct final SNURs issued for the following chemical substances, which were the subject of PMNs: bimodal mixture consisting of multi-walled carbon nanotubes and other classes of carbon nanotubes (generic), (PMN No. P-11-482); and carbon nanotubes (generic), (PMN No. P-15-54). EPA intends to publish proposed SNURs for the chemical substances identified in this document.

    For further information regarding EPA's direct final rulemaking procedures for issuing SNURs, see 40 CFR part 721, subpart D, and the Federal Register of July 27, 1989 (54 FR 31314).

    III. Statutory and Executive Order Reviews

    This action withdraws regulatory requirements that have not gone into effect and which contain no new or amended requirements. As such, the Agency has determined that this action will not have any adverse impacts, economic or otherwise. The statutory and Executive Order review requirements applicable to the direct final rule were discussed in the Federal Register of November 17, 2015 (81 FR 1250) (FRL-9953-41). Those review requirements do not apply to this action because it is a withdrawal and does not contain any new or amended requirements.

    IV. Congressional Review Act (CRA)

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    List of Subjects 40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

    40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.

    Dated: January 9, 2017. Maria J. Doa, Director, Chemical Control Division, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR chapter I is amended as follows:

    PART 9—[AMENDED] 1. The authority citation for part 9 continues to read as follows: Authority:

    7 U.S.C. 135 et seq., 136-136y;15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.

    § 9.1 [Amended]
    2. In the table in § 9.1, under the undesignated center heading “Significant New Uses of Chemical Substances,” remove the entries for §§ 721.10927 and 721.10942. PART 721—[AMENDED] 3. The authority citation for part 721 continues to read as follows: Authority:

    15 U.S.C. 2604, 2607, and 2625(c).

    § 721.10927 [Removed]
    4. Remove § 721.10927.
    § 721.10942 [Removed]
    5. Remove § 721.10942.
    [FR Doc. 2017-00938 Filed 1-18-17; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. CDC-2015-0006] 42 CFR Part 73 RIN 0920-AA59 Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Final rule.

    SUMMARY:

    In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. Following the review, HHS has decided: Not to finalize the proposed changes to the list of select agents and toxins at this time; to finalize provisions to address toxin permissible limits and the inactivation of select agents; to finalize specific provisions to the section of the regulations addressing biosafety; and to clarify regulatory language concerning security, training, incident response, and records. In a companion document published in this issue of the Federal Register, the U.S. Department of Agriculture (USDA) has made parallel regulatory changes.

    DATES:

    Effective February 21, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Samuel S. Edwin, Director, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-A46, Atlanta, Georgia 30329. Telephone: (404) 718-2000.

    SUPPLEMENTARY INFORMATION:

    The preamble to this final rule is organized as follows:

    I. Executive Summary II. Changes to 42 CFR Part 73 A. Modifications to the List of HHS and Overlap Select Agents and Toxins B. Responses to Other Proposed Changes i. Definitions ii. Inactivation of a Select Agent iii. Toxins iv. Exclusion Involving Patient Care v. Exemptions for Select Agents and Toxins vi. Registration vii. Responsible Official viii. Visitor Access to Select Agents and Toxins ix. Security, Biosafety, and Incident Response Plans x. Training xi. Records III. Alternatives Considered IV. Required Regulatory Analyses A. Executive Orders 12866 and 13563 B. The Regulatory Flexibility Act C. Paperwork Reduction Act of 1995 D. E.O. 12988: Civil Justice Reform E. E.O. 13132: Federalism F. Plain Language Act of 2010 V. References I. Executive Summary

    On February 27, 2015 we published an Advance Notice of Proposed Rulemaking (ANPRM) (80 FR 10656) that initiated the required biennial review and republication of the HHS list of select agents and toxins. The ANPRM solicited public comments regarding whether any biological agents and toxins should be added or removed from the HHS list of select agents and toxins based on the following criteria:

    (1) The effect on human health of exposure to the agent or toxin;

    (2) The degree of contagiousness of the agent or toxin, and the methods by which the agent or toxin is transferred to humans;

    (3) The availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or exposure to the toxin; and

    (4) Any other criteria, including the needs of children and other vulnerable populations that the commenter considered appropriate.

    This notice also asked for public comment on whether HHS should remove the following agents from the HHS list of select agents and toxins: Coxiella burnetii, Rickettsia prowazekii, Bacillus anthracis Pasteur, Brucella abortus, B. melitensis, and B. suis.

    On January 19, 2016, we published a Notice of Proposed Rulemaking (NPRM) (81 FR 2805). The NPRM solicited public comments regarding whether any biological agents and toxins should be added or removed from the HHS list of select agents and toxins based on the same criteria used in ANPRM:

    We also invited comments on the following:

    (1) Methods that should be required to validate the rendering of a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus as non-infectious;

    (2) Proposed changes to the aggregate amount of toxin excluded from the requirements of the select agent regulations;

    (3) Removal of Diacetoxyscirpenol (DAS) and T-2 from the list;

    (4) Whether seven calendar days provides a sufficient amount of time for the entity to destroy or transfer a select agent or toxin after identification;

    (5) Specific biosafety measures that should be required to prevent laboratory acquired infections (LAIs) or accidental release of the select agents and toxins from an entity into the community; and

    (6) Alternative regulatory requirements that could be constructed such that a registered entity would know whether it had a theft or loss of a select agent or toxin without that registered entity first having “an accurate, current inventory for each select agent . . . held in long term storage.”

    (7) Whether short, paralytic alpha-conotoxins containing the following amino acid sequence (X1CCX2PACGX3X4X5X6CX7), C. burnetii, R. prowazekii, B. anthracis Pasteur, B. abortus, B. melitensis, and B. suis should be removed from the HHS list of select agents and toxins.

    We received 22 public comments to the ANPRM and 35 public comments to the NPRM that addressed the composition of the HHS list of select agents and toxins. After carefully considering the technical input of subject matter experts, both within the Federal government and from public comments, and recommendations from Federal advisory groups, we have decided not to finalize the proposed changes to the list of select agents and toxins at this time. Upon further consideration, we may decide to finalize changes to the list at a future time.

    This final rule makes the following changes to current regulations:

    1. New provisions regarding the inactivation of select agents, specific biosafety requirements, and toxin requirements;

    2. Other revisions to the regulations to clarify regulatory language concerning security, training, and records.

    3. In addition, when HHS added B. cereus Biovar anthracis to the list of HHS select agents and toxins on September 14, 2016 by an interim final rule (81 FR 63138), we neglected to add the name of the agent to the immediate notification list for Tier 1 agents in sections 5 and 9 of the regulations. We are correcting that error in this final rule.

    Costs of the Rule: The entities affected by this final rule include research and diagnostic facilities; Federal, State, and university laboratories; and private commercial and non-profit enterprises. The current regulations require registering for the possession, use, and transfer of select agents or toxins. In addition, the entity is currently required to ensure that the facility where the agent or toxin is housed has adequate biosafety and containment measures; that the physical security of the premises is adequate to prevent unauthorized access; that all individuals with approved access to select agents or toxins have the appropriate education, training, and/or experience to handle such agents or toxins; and that complete records concerning activities related to the select agents or toxins are maintained.

    The HHS final rule will further reduce or minimize the risk of misuse of select agents and toxins that have the potential to pose a severe threat to human health. HHS recognizes that several of the required measures of the regulations may impose certain operational costs upon affected entities. Specifically, the rule will clarify that an entity must use a validated method to render a select agent non-viable or a regulated infectious nucleic acid sample non-infectious for future use. This means the method must be scientifically sound and produce consistent results each time it is used. Appropriate reporting and record keeping is required in order to mitigate threats to human health. In many cases, however, the affected entities already employ some or all of the required measures. Compliance costs actually incurred will therefore vary from one entity to the next.

    While information on the specific changes that would need to occur at individual sites and the associated costs was not readily available during proposed rulemaking, some general observations regarding the potential costs were presented. These general cost observations can be found in the Regulatory Impact Analysis. Based on the current recordkeeping and reporting requirements, an additional 10 to 20 hours per year may be required by entities. At an imputed cost of $33.40 per hour, this additional time requirement per entity will total between $334 and $668 per year, or in total for all registered entities between $80,000 and $160,000.

    Benefits: The objectives of the HHS final rule are to create a means of ensuring enhanced oversight in the transfer, storage, and use of select agents and toxins; clarify that an entity must use a validated method to render a select agent non-viable or a regulated infectious nucleic acid sample non-infectious for future use; and require that entities in possession of such agents and toxins develop and implement effective means of biosafety, information security, and physical security. The overall benefit of the amended regulatory provisions will be a reduced likelihood of the accidental or intentional release of a select agent or toxin; and the avoidance of human morbidity, mortality and the economic loss associated with such a release. The goal of the amended regulations is to enhance the protection of human health and safety.

    II. Changes to 42 CFR Part 73

    The table below describes the changes to the current regulation.

    Section No. Section title Change 73.0 Applicability and related requirements No changes. 73.1 Definitions Adds definitions: Validated inactivation procedure and viability testing protocol. 73.2 Purpose and scope No changes. 73.3 HHS select agents and toxins Clarifies language to include addition of B. cereus Biovar anthracis and adds new paragraphs. 73.4 Overlap select agents and toxins Clarifies language to include addition of B. cereus Biovar anthracis and adds new paragraphs. 73.5 Exemptions for HHS select agents and toxins Clarifies language; redesignates paragraph; and adds new paragraph. 73.6 Exemptions for overlap select agents and toxins Clarifies language; redesignates paragraph; and adds new paragraph. 73.7 Registration and related security risk assessments Redesignates paragraphs; adds new paragraph. 73.8 Denial, revocation, or suspension of registration No changes. 73.9 Responsible Official Clarifies language to include addition of B. cereus Biovar anthracis and adds new paragraphs. 73.10 Restricting access to select agents and toxins; security risk assessments Clarifies language. 73.11 Security Clarifies language and adds new paragraph. 73.12 Biosafety Clarifies language. 73.13 Restricted experiments No changes. 73.14 Incident response Clarifies language. 73.15 Training Clarifies language and adds new paragraph. 73.16 Transfers Clarifies language. 73.17 Records Clarifies language and adds new paragraph. 73.18 Inspections No changes. 73.19 Notification of theft, loss, or release No changes. 73.20 Administrative review No changes. 73.21 Civil money penalties No changes. A. Modifications to the List of HHS and Overlap Select Agents and Toxins

    We received 22 public comments to the ANPRM and 35 public comments to the NPRM that addressed the composition of the HHS list of select agents and toxins. After carefully considering the technical input of subject matter experts, both within the Federal government and from public comments, and recommendations from Federal advisory groups, we have decided not to finalize the proposed changes to the list of select agents and toxins at this time.

    B. Responses to Other Proposed Changes i. Definitions

    It recently became clear that some inactivation protocols have failed to inactivate B. anthracis spores completely, as evidenced by inactivation failures that led to the inadvertent transfer of potentially live B. anthracis samples by the Department of Defense in 2015. In response to this incident, new requirements were proposed to address the inactivation of select agents. We proposed adding definitions for the terms “inactivation” and “kill curve” to clarify the new inactivation provisions. As discussed below, we have removed the proposed requirement for a “kill curve,” and accordingly, we have also removed the proposed definition of “kill curve.”

    To exclude a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus from the requirements of the select agent regulations, an entity will need to subject the select agent or the nucleic acids to a validated inactivation procedure whose efficacy is confirmed through a viability testing protocol.

    Commenters stated that additional definitions should be provided for “validated inactivation procedure,” “sterility testing protocol,” and “safety margin.” We agree with the commenters and are defining the terms as described below. “Validated inactivation procedure” means “a procedure, whose efficacy is confirmed by data generated from a viability testing protocol, to render a select agent non-viable but allows the select agent to retain characteristics of interest for future use; or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.”

    Further, we have not included a separate definition for “inactivation” as it is now captured in the definition of “validated inactivation procedure.”

    We have changed the proposed phrase “sterility testing protocol” to “viability testing protocol” and defined the latter as “a protocol to confirm the validated inactivation procedure by demonstrating the material is free of all viable select agent.” This change reflects the intent that the validated inactivation procedure, or the procedure for removal of viable select agents from material containing select agents, must render the material non-viable (i.e., unable to replicate). In addition, any nucleic acids that can produce infectious forms of any select agent virus must be rendered non-infectious for future use.

    We are choosing to not define the term “safety margin” and have incorporated the concept of a performance standard instead.

    The new definitions will help clarify the regulatory language found in 42 CFR 73.3, 73.4.

    ii. Inactivation of a Select Agent

    Historical inactivation failures by registered entities required us to focus on ways to increase the certainty that inactivated select agents intended for further use do not contain live agent. This is particularly important when the inactivation methods are tempered in order to avoid disrupting some of the physical characteristics of the agent. We proposed adding specific requirements to the exclusion sections of the regulations (42 CFR 73.3(d), 73.4(d)) to address the requirements for rendering select agents, nucleic acids that can produce infectious forms of any select agent virus, or extracts from select agents non-viable.

    Sections 73.3(d)(2) (HHS select agents and toxins) and 73.4(d)(2) (Overlap select agents and toxins) both provide that a non-viable select agent is excluded from the requirements of the select agent regulations. We proposed that for a select agent to be non-viable or to render nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use, an entity must use a validated inactivation procedure. Commenters stated there is some confusion between inactivation validation requirements for moving materials to a lower containment level and inactivation validation requirements for waste disposal. We are clarifying that these provisions apply to a select agent that is inactivated for future use as a non-select agent and is not intended for material for waste disposal.

    Many commenters stated that the focus on strengthening inactivation requirements was being driven by an incorrect public perception of recent procedural errors that occurred at federally run research laboratories. Without commenting on what is or might be the public's perception with regard to inactivation problems, we disagree with these comments because the focus on inactivation failures with select agents is based on the realization that past inactivation activities have proved to be inadequate.

    We proposed that an entity would be required to develop a site-specific kill curve to identify conditions of inactivation for each select agent. Commenters stated that although the generation of kill curves is appropriate for inactivation procedures using heat, irradiation and filtration, it is not generally applicable to determining infectivity of nucleic acids. Commenters stated that for inactivation procedures where a “kill curve is not applicable, inactivation conditions are selected and then replicated to obtain 100% inactivation within a statistical certainty.”

    We agree with the commenters and are withdrawing the proposal to require a kill curve and safety margin because these would not be applicable to all inactivation procedures. Further, the variety of agents and inactivation procedures makes it likely that prescriptive requirements would have unintended negative consequences on research. We are, nonetheless, finalizing requirements for a validated inactivation procedure and viability testing. We are requiring that for a select agent or regulated nucleic acid that can produce infectious forms of any select agent virus to be excluded from the requirements of the select agent regulations, an entity will be responsible for achieving a certain performance standard that is confirmed through a viability testing protocol. Surrogate strains that are known to possess equivalent properties with respect to inactivation can be used to validate an inactivation procedure. However, if there are known strain-to-strain variations in the resistance of a select agent to an inactivation procedure, then an inactivation procedure validated on a lesser resistant strain must also be validated on the more resistant strains. Additional guidance regarding this performance standard has been developed and is available at www.selectagents.gov.

    Many commenters asked HHS to state clearly if the standard for select agent inactivation is complete sterility (i.e., not a single viable pathogen in the entire volume of an inactivated sample), a log reduction in viable pathogen titer, or the limit of detection of the assay. We agree that it is important to specify the intent of the performance standard. HHS recognizes the limits of detection of the viability testing procedures (related to the detection assay and the sampling of inactivated material) and expected run-to-run variation when following an inactivation procedure precisely precludes demonstrating full sterility of inactivated material. These sources of error must be considered when establishing performance parameters for inactivation procedures. While complete sterility is not a feasible goal for material that is intended for further use, HHS expects that the risk of live agent in inactivated materials will be as low as realistically possible from both a safety and security perspective.

    We proposed that entities subject representative samples of an inactivated select agent to a validated sterility testing protocol to ensure that the inactivation procedure has rendered the select agent non-viable. Commenters stated that it is not always practical to conduct validation on each sample that is inactivated. Often samples are in limited quantities and validation studies will leave very little or no sample for the experimental purpose. Commenters also stated that the requirement to subject representative samples to sterility testing using a validated protocol requires further clarification. Commenters stated that it is reasonable to require this type of testing when the inactivation procedure is first established and if any changes to the inactivation protocol are made. However, commenters stated that it cannot be reasonably done on each sample in laboratory research if the inactivation protocol has not changed. They stated that implementing such a requirement would waste specimens where limited volumes are available, would be costly in terms of technical time and resources, and is scientifically unjustified.

    We agree with the commenters that the varied needs and conditions for inactivation preclude setting a specific standard for viability testing at this time. We have removed the proposed sterility testing requirement for select agents and nucleic acids that can produce infectious forms of any select agent virus and have incorporated this concept into the performance standard. The requirement to develop a validated inactivation procedure and subsequent validation data derived from viability testing will determine the extent of sampling required. This activity will provide the associated measures of uncertainty with the sampling protocol chosen.

    We proposed adding exclusion requirements that extracts from a select agent could not be excluded from the requirements of the select agent regulations until an individual or entity met the following requirements: (1) Any extract is subjected to a process that removes all viable cells, spores, or virus particles; (2) any extract is subjected to a validated sterility testing protocol; (3) any viability of an extract that was subjected to a validated inactivation protocol is reported to the Responsible Official (RO); and (4) any viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus, previously assessed as inactive by their validated sterility testing protocol, is reported to APHIS or CDC.

    Some commenters expressed concern with having to subject every extract from a select agent, such as nucleic acids, to sterility testing. We agree with the commenters and are replacing the term “extract” with “material containing a select agent” to clarify that the requirements apply to material containing a select agent such as serum or liquid culture where select agents are typically removed via filtration without a previous inactivation step. The term “extract” is commonly used in conjunction with nucleic acids extracted from a select agent. We are using the term “extract” in the final rule to reflect the application of two processing steps: An inactivation step to destroy the select agent (e.g., lysis of select agent) and then another step (such as filtration), to remove any remaining viable select agents. Extracts from a select agent (nucleic acids, antigens, lysates) would be subject to the performance standard for select agents in the new sections 3(d)(3) and 4(d)(3) of the select agent regulations that includes viability testing but does not necessarily require viability testing on every sample. The requirement to develop a validated inactivation procedure and subsequent validation data derived from viability testing will determine the extent of sampling required. However, material containing select agents, as opposed to extracts (e.g., nucleic acids, antigens, lysates), that is subjected to a process to remove all viable cells, spores, or virus particles would require viability testing on every sample prior to treating it as a non-select agent. The distinguishing feature between “material containing a select agent” and an extract from a select agent is that in the former the select agent will only be removed and in the latter the select agent will be destroyed before removal. The more stringent requirement for viability testing of all material containing a select agent where the select agent was removed is warranted because of the lack of select agent destruction which increases the risk of viable select agent remaining in the material.

    We proposed that if there are strain-to-strain variations in resistance of a select agent to the inactivation procedure, then a specific kill curve must be developed for each strain that undergoes the inactivation procedure. We received comments asking us to clarify language to specify under what circumstances strain-to-strain differences must be validated. Commenters also stated that this is an unnecessary use of resources especially when agents, based on their morphological characteristics, are susceptible to similar inactivating agents. Commenters suggested at a minimum the language should state that this requirement only applies when there are known strain-to-strain variations in resistance of a select agent to the inactivation procedure.

    We agree with the commenters and added in the term “known” strain-to-strain variation and, as stated previously, have removed the kill curve requirement.

    Commenters also inquired whether surrogate strains can be used to develop inactivation procedures. We agree with the commenters that surrogate strains known to possess equivalent properties with respect to inactivation as a select agent can be used to develop inactivation procedures. We have revised the requirement to include the provision that “Surrogate strains that are known to possess equivalent properties with respect to inactivation can be used to validate an inactivation procedure; however, if there are known strain-to-strain variations in the resistance of a select agent to an inactivation procedure, then an inactivation procedure validated on a lesser resistant strain must also be validated on the more resistant strains.”

    Commenters were concerned about performing viability testing on materials such as a single diagnostic sample that is determined to contain a select agent and where there is a limited amount of material with which to work. For example, consider an entity using a commercially available RNA extraction kit on a diagnostic sample to obtain RNA for sequencing, and the sample is identified to contain highly pathogenic avian influenza (HPAI). In this situation, the entire single sample would be used when trying to demonstrate that the inactivation procedure was effective. We agree with the commenters. As noted above, surrogate select agent strains that are known to possess equivalent properties with respect to inactivation as the select agent can be used to develop validated inactivation procedures. In this example, low pathogenic avian influenza (LPAI) could be used to validate the inactivation procedure for diagnostic samples that are identified as containing HPAI, if LPAI possesses equivalent properties with respect to inactivation as HPAI. In addition, we are clarifying that these provisions do not apply to diagnostic samples until they are identified to contain a select agent and are inactivated for future use as a non-select agent.

    Many commenters asked who would determine the validity of an inactivation protocol. The responsibility for this activity remains with the entity, which will allow for researchers to continue to develop new inactivation procedures. Entities retain the responsibility to evaluate their inactivation procedures, to include consideration of the biosafety and security risks posed by the inactivated material. The Federal Select Agent Program (FSAP) inspectors will verify that the entity has developed a validated inactivation procedure and may review validation data during an entity's inspection. We made no changes based on these comments.

    Many commenters stated that the intent behind the annual review provisions was not clear. We agree with the commenters and modified the provisions to state that an entity “Review, and revise as necessary, each of the entity's validated inactivation procedures or viable agent removal method. The review must be conducted annually or after any change in Principal Investigator, change in the validated inactivation procedure or viable agent removal method, or failure of the validated inactivation procedure or viable agent removal method. The review must be documented and training must be conducted if there are any changes to the validated inactivation procedure, viable agent removal method, or viability testing protocol.” We made these changes because the annual review of an entity's validated inactivation procedures or viable agent removal method is key to a successful inactivation program. The annual review requirement does not necessarily involve revalidating inactivation procedures. This review could simply be the evaluation of the site-specific standard operating procedures for validated inactivation of select agents to ensure the inactivating conditions used and upper agent concentration limits found in validation data are consistent, and that entity staff are following the site-specific standard operating procedures for validated inactivation of select agents.

    However, sometimes an entity will need to revalidate inactivation procedures during the annual review. For example, if the entity identifies that staff are not adhering to standard operating procedures for validated inactivation of select agents, or if the entity wants to deviate from the validated inactivation procedure, the entity will need to revalidate the inactivation procedures during the annual review. Further, in this final rule, we have consolidated the review provisions into one provision, clarified that the reviews must be documented, and moved this provision into the requirements for the RO as they will be the individual responsible for these review activities.

    Many commenters stated that the intent of the inactivation failure reporting requirements was not clear and reporting every inactivation failure to CDC or APHIS was burdensome. We agree with the commenters and have modified reporting requirements to require the RO to “Investigate to determine the reason for any failure of a validated inactivation procedure or any failure to remove viable agent from material. If the Responsible Official is unable to determine the cause of a deviation from a validated inactivation procedure or a viable agent removal method; or receives a report of any inactivation failure after the movement of material to another location, the Responsible Official must report immediately by telephone or email the inactivation failure or viable agent removal method failure to CDC or APHIS.” The intent of this modification is to create an environment at the entity where inactivation or select agent removal failures are investigated to determine the reason for the failure as opposed to merely re-subjecting the material to the inactivation or select agent removal method. It is the position of the FSAP that each failure represents either human error in conducting the validated procedure or an inadequate inactivation method or an inadequate select agent removal method if no human error can be discovered. Both situations demand careful attention by the entity to ensure training and/or reevaluation of the inactivation procedure in order to minimize the likelihood that the situation would reoccur in the future. The revised regulatory language only requires reporting of inactivation or select agent removal failures to FSAP when the RO cannot establish that the failure resulted from human error or when an entity receives a report of any inactivation failure after the movement of material to another location.

    We also proposed that written records be kept for select agents that have been subjected to a procedure to render them non-viable, or regulated nucleic acids that can produce infectious forms of any select agent virus that have been subjected to a procedure to render them incapable of producing infectious forms of any select agent virus. Some commenters stated that the proposal was not clear how long these records must be kept and who is responsible for keeping these records. We made no changes based on these comments as these records are subject to the records retention requirement in section 17 of the select agent regulations and must be kept for three years by a registered individual or entity.

    Some commenters asked about the conditions of submitting a waiver to the inactivation provisions of the select agent regulations. An entity may submit a request to FSAP to apply an alternative inactivation procedure. The entity is to provide justification regarding the alternative procedure including a description of what material is to be waived, the inactivation protocol and viability test to be used, validation data, and any other supporting information/references, such as scientific references. Accordingly, we revised the provision found in sections 3(d)(6) and 4(d)(6) to include information on how to apply for a waiver that reads “. . . To apply for such a determination a registered individual or entity must submit a written request and supporting scientific information to FSAP. A written decision granting or denying the request will be issued.” Additional guidance has been developed and is available at: www.selectagents.gov.

    iii. Toxins

    To ensure the language is consistent with the exclusion language found in 73.3(e) which describes the exclusion of toxins that have been modified to be less potent or toxic, we are making a technical change to the regulation and revising the terms “nonfunctional” toxin to “nontoxic” toxin and “functional form(s) of any of the toxins” to “toxic form(s) of any of the toxins.” This change is being made to clarify the intent of the regulations as the terms “nonfunctional” and “functional” are broad and have led to confusion. The intention behind the original provisions was to exclude toxins that can no longer exert their toxic effect and cause disease and regulate those that can. For example, Botulinum neurotoxin has three functional domains—binding domain, translocation domain and catalytic domain. Each functional domain solely can be manipulated such that the toxin is no longer toxic and does not cause diseases even though the other two domains may be functional.

    Due Diligence

    We are adding a more specific documentation requirement to the toxin exclusion provision found in section 73.3(d)(3)(i) of the select agent regulations to require the transferor of an unregulated amount of a select toxin to document the identity of the recipient and the legitimate need (i.e., prophylactic, protective, bona fide research, or other peaceful purpose) claimed by the recipient. The name of the toxin and the total amount transferred must also be documented. Identity information of the person requesting and using the toxins must include the individual's name, institution name, address, telephone number, and email address. We received one comment requesting to include language for transfers of toxins within an institution. We made no changes based on this comment because intra-entity transfers, where the sender and the recipient are covered by the same certificate of registration, are already addressed in section 17(3)(viii) of the regulations.

    Toxin Permissible Limits

    As proposed, we are increasing the toxin exclusion aggregate amounts. We received 10 comments supporting the increase in the toxin exclusion aggregate amounts. We received three general comments opposing the increase of the exclusion aggregate amounts and two additional comments opposing the increase of the ricin exclusion aggregate amount. One commenter stated that no changes were necessary. Another commenter had concerns regarding whether the risk assessment scenarios were relevant to the goal of reducing any significant harm able to be caused by illegitimate use of any lethal amounts of toxin. We are making no changes based on these comments.

    DHS developed toxin parameters and attack scenarios for potential inhalation and ingestion exposures to select toxins to protect the homeland against the potential release of weaponized biological toxins. The DHS group analyzed a range of release sizes (in mg) for each select toxin in order to estimate the number of people that would be exposed to each toxin amount by ingestion of milk (using published TD[50] or LD[50]) and/or indoor inhalation (using published LD[50]). Revised toxin exclusion aggregate amounts were proposed based on the data generated by the models to expose <10 or <100 people by inhalation or ingestion to the LD[50] or TD[50] levels of toxin. A commenter stated that (1) the scenarios proposed appear to consider a high-consequence event or exposure to a given toxin and that the interpretation of what constitutes a high-consequence event or exposure is impacted not only in the number of people affected but in the attention afforded by news media and the public and (2) a revision of these exclusion limits should also consider amounts that would be sufficient for research purposes. We are making no changes based on these comments because we do not believe the impact the news media may have if an exposure occurs is an appropriate consideration for the listing of a biological agent or toxin. Further, the consideration of amounts sufficient for research purposes is a subjective assessment as smaller academic laboratories have differing needs than an entity that is developing detection assays. The comments specific to ricin raised concerns that the increased exclusion aggregate amounts would increase the risk of (1) exposure to laboratory workers and (2) that individuals would have access to greater amounts of material to use for nefarious purposes. We are making no changes based on these comments. We do not agree that the increased permissible limits will increase the risk of laboratory worker exposure. The new proposed exclusion amount is less than an oral lethal dose for a single person weighing more than 50 kg, based on 20 mg/kg-body weight (Ref. 1), thus a single fatality would require consuming more than all of the ricin in the laboratory. Ricin does display a higher toxicity when administered intravenously or by inhalation, but these two routes of exposure require either injection or manipulation to generate particles capable of reaching the lower respiratory tract, respectively, two processes not likely to occur accidentally. Also, entities that produce ricin typically do so in liquid, as opposed to lyophilized powder formulations, thus decreasing the risk of ingestion or aerosol exposure. Additionally, the increased exclusion aggregate amounts would allow entities to more efficiently produce and store ricin preparations which are typically frozen in aliquots until the need to use the material arises. Finally, while increasing the permissible limits allows individuals with nefarious purposes access to greater amounts of toxin, we do not believe access to the revised amounts poses a severe threat to public health and safety based on the reasons stated above.

    Toxins: Exclusion of an HHS Select Toxin Identified in an Original Food Samples and Clinical Samples

    As proposed, we are excluding from the requirements of the regulations a select toxin identified in an original food sample and clinical samples. Original food samples and clinical samples are those specimens that are submitted to laboratories for diagnosis or verification purposes to identify or verify a biological agent or toxin. For example, an original food sample could be a container of potato salad or juice. An original clinical sample could be serum or stool from a patient. Laboratories that test food and clinical samples for the presence of toxins generally do not know the level of toxin in a sample and do not extract and purify a toxin as part of their studies. Therefore, our proposal to exclude select toxin identified in an original food sample or clinical sample identified is consistent with the rationale for the current exclusion for animals exposed to toxins (42 CFR 73.3(d)(4)). This exclusion was based on recommendations by toxin subject matter experts. We received one comment that supported this exclusion.

    Exclusion of Botulinum Neurotoxin Produced as a Byproduct

    In the NPRM, we proposed to exclude all toxins that are only produced as a byproduct of a study of the toxin producing host organism so long as the toxin had not been intentionally collected, purified, or otherwise extracted, and the material containing the toxin was inactivated and properly disposed of within 30 days of the initiation of the culture. Based on the input from subject matter experts, the final regulatory language narrows the exception to only Botulinum neurotoxin produced as a byproduct in the study of Botulinum neurotoxin producing species of Clostridium. Work with that organism is already regulated, thus providing regulatory oversight of the material during the 30 day time frame, as opposed to an agent like Staphylococcus aureus, the organism that produces Staphylococcal enterotoxins, which is not regulated. One commenter stated that clarification was needed in the “exclusion of toxin produced as a by-product” and inquired whether this provision applies to material held in long term storage or cell lysates or culture supernatants kept for diagnostic or research purposes other than toxin work. Since the situations described by the commenter referred to material held in long term storage (longer than 30 days) this exclusion would not apply.

    iv. Exclusion Involving Patient Care

    To clarify how the select agent regulations apply to activities associated with the diagnosis and care for individuals infected with a select agent, we proposed that waste generated during the delivery of patient care is not considered regulated under the select agent regulations. One commenter recommended that we define patient care as part of the diagnosis definition. Specifically, the commenter suggested we define diagnosis as “the analysis of specimens for the purpose of identifying or confirming the presence or characteristics of a select agent or toxin provided that such analysis is associated with the determination or provision of patient treatment in a patient care setting, or directly related to protecting the public health or safety, animal health or animal products, or plant health or plant products. Clinical or diagnostic specimen retention times as required for patient treatment are included within the determination of the point in time when patient care has concluded.” Another commenter stated “the challenges of differentiating between patient care and experimental research when treating infectious diseases are complex and nuanced and any effort to introduce regulation of medical care involving select agents and toxins has the potential to introduce inconsistencies and confusion.” The proposed exclusion language in the NPRM was “Waste generated during the delivery of patient care from a patient infected with a select agent that is decontaminated with a validated method within seven calendar days of the conclusion of patient care.” We revised the proposed language based on the two comments to state: “Waste generated during the delivery of patient care by health care professionals from a patient diagnosed with an illness or condition associated with a select agent, where such waste is, within seven days of the conclusion of patient care, decontaminated, or transferred for destruction in compliance with state and Federal regulations.”

    We revised the proposed exemption language in 42 CFR 73.5(a)(3), and 42 CFR 73.6(a)(3) to provide that, unless otherwise directed by the HHS Secretary or APHIS Administrator, as appropriate, “the clinical or diagnostic specimens collected from a patient infected with a select agent are transferred in accordance with § 73.16 or destroyed on-site by a recognized sterilization or inactivation process within seven days after delivery of patient care by health care professionals has concluded.”

    For specimens generated from the patient, the specimens are not subject to the select agent regulations for only the period that they are directly associated with the diagnosis. In accordance with sections five and six of the select agent regulations, within seven calendar days after identification, a specimen is subject to the select agent regulations and must be transferred in accordance with section 73.16 or destroyed on-site by a recognized sterilization or inactivation process. Since the material would be excluded from the regulations, there would be no requirement to document the transfer or destructions. A specimen must be secured against theft, loss, or release during the period between identification and transfer or destruction, and any theft, loss, or release of the specimen must be reported. All specimens generated from the patient and kept more than seven days after acute patient care concludes would be subject to the select agent regulations.

    v. Exemptions for Select Agents and Toxins Informing Specimen Provider

    Since a registered or reference laboratory typically confirms the identification of a select agent or toxin for public health and agriculture, we proposed to require that a registered or reference laboratory inform the specimen provider of the identification as a condition for a clinical or diagnostic laboratory to maintain their exemption under 42 CFR 73.5(a), and 42 CFR 73.6(a). Two commenters stated they did not believe basic good practices require regulations. We made no changes based on these comments because this provision will ensure that the reference laboratory notifies the specimen provider of the identification of the select agent or toxin. It is important that the specimen provider is aware that they are in possession of the agent or toxin and must meet the requirements outlined in 42 CFR 73.5, 73.6 (e.g., cannot maintain possession of the select agent or toxin, must destroy or get approval for a transfer, and report a theft, loss, or release).

    Identification of Toxin

    In the current select agent regulations, in order for clinical or diagnostic laboratories to maintain their exemption under 42 CFR 73.5(a), and 42 CFR 73.6(a), the clinical or diagnostic laboratory must, either immediately or within seven calendar days, report the identification of a select agent or toxin to APHIS or CDC unless directed otherwise by HHS Secretary or APHIS Administrator. In the NPRM, we proposed to amend the language in 42 CFR 73.5(a), and 42 CFR 73.6(a) to state: “Unless directed otherwise by the Secretary, within seven calendar days after identification of the select agent or toxin (except for Botulinum neurotoxin (BoNT) and/or Staphylococcal enterotoxins (Subtypes A-E)), or within 30 calendar days after identification of Botulinum neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-E), the select agent or toxin is transferred in accordance with § 73.16 or destroyed on-site by a recognized sterilization or inactivation process.” We sought comments concerning (1) the extension of the exemption time period to 30 days for BoNT and Staphylococcal enterotoxin (Subtypes A-E) to allow clinical and diagnostic laboratories sufficient time to complete their investigations without having to transfer or destroy the sample, and (2) whether seven calendar days provided sufficient amount of time for the entity to destroy or transfer other select agents or toxins after identification. We received one comment to extend the amount of time for other select agents or toxins to 10 calendar days since destruction may not occur on-site, therefore allowing the secure transport to the ultimate site of disposition. We made no changes to adjust the seven calendar day requirement for agents or toxins other than BoNT and Staphylococcal enterotoxin (Subtypes A-E) because the other agents or toxins do not involve the identification of both agent and toxin as part of diagnosis. Therefore, these situations are not as complicated and do not warrant additional time for reporting identification.

    vi. Registration

    We are codifying in regulation the current FSAP policy that an entity is required to meet all of the regulatory requirements for those select agents and toxins listed on an entity's registration regardless of whether the select agent or toxin is in the actual possession of an entity, and without regard to the actual amounts of toxins in the possession of an entity. We received no comments regarding this proposal and have made no changes to the language in the proposed rule.

    vii. Responsible Official

    Section 73.9(a)(6) of the select agent regulations currently states that the RO must ensure that an annual inspection is conducted for each laboratory where select agents and toxins are stored or used. This requirement also provides that the results of each inspection must be documented, and any deficiencies identified during an inspection must be corrected. We proposed adding a requirement that the RO must also document the corrective actions taken by the entity to address any identified deficiencies. We received one comment that supported this proposed requirement and are finalizing the requirement as proposed.

    HHS or USDA Office of the Inspector General Hotline

    In its December 2014 report, the Federal Experts Security Advisory Panel (FESAP) recommended adding a specific regulatory requirement addressing how individuals are informed of the availability of procedures for accessing the HHS or USDA Office of Inspector General Hotlines to anonymously report a safety or security concern. In response to that recommendation, we proposed adding a requirement that the RO must ensure that individuals at their entity are provided the contact information of the HHS Office of Inspector General Hotline and USDA Office of Inspector General Hotline so that an individual is able to anonymously report a biosafety or security concern related to select agents and toxins. We received no comments regarding this proposed addition and are finalizing the requirement as proposed.

    viii. Visitor Access to Select Agents and Toxins

    Section 73.10(e) of the select agent regulations currently provides that a person with a valid approval from the HHS Secretary or APHIS Administrator to have access to select agents and toxins may request, through his or her RO, that the HHS Secretary or APHIS Administrator provide their approved access status to another registered individual or entity for a specified period of time. This allows a person with approved access at a registered entity to have approved access to a select agent at another registered entity. To ensure that the RO of the entity hosting such a visitor is aware if a visiting individual loses access approval to select agents and toxins, we added a requirement that the RO at the home entity must immediately notify the RO of the visiting entity if a person's access to select agents or toxins has been terminated. We received one comment that supported this addition to the regulations and are finalizing the requirement as proposed.

    ix. Security, Biosafety, and Incident Response Plans

    The select agent regulations require a registered entity to develop and implement a number of plans in order to ensure the safety and security of the select agents and toxins they handle. These are:

    • A security plan that provides for measures sufficient to safeguard a select agent or toxin against unauthorized access, theft, loss, or release (42 CFR 73.11);

    • A biosafety plan that provides for measures sufficient to contain a select agent or toxin (42 CFR 73.12); and

    • An incident response plan that provides for measures that the registered entity will implement in the event of theft, loss, or release of a select agent or toxin; inventory discrepancies; security breaches (including information systems); severe weather and other natural disasters; workplace violence; bomb threats and suspicious packages; and emergencies such as fire, gas leak, explosion, power outage, or others. (42 CFR 73.14).

    The select agent regulations require that drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plans, and that the plans must be reviewed and revised, as necessary, after any drill or exercise, and after any incident. We proposed to require that these drills or exercises be documented to include how the drill or exercise tested and evaluated the plan, any problems identified and corrective actions that were taken, and the names of the individuals who participated in the drill or exercise. Three commenters stated that there was no need to codify the documentation of how a drill or exercise evaluated a plan and corrective actions in regulations because they believed this requirement is already being documented. We are making no changes based on the comments because this requirement will provide a more thorough accounting of required activities via testing and entity-directed improvements.

    Another commenter requested clarification regarding the recording of the names of individuals who participate in drills or exercises. The commenter believed the requirement should be limited to registered entity personnel and not include first responders or other non-entity participants, but list only the participating external agencies (e.g., emergency management, emergency medical services, or fire department). We agreed with the commenter and have amended the proposed regulatory language to clarify that an entity only needs to document the names of individuals at the registered entity. An entity may choose to list the external agencies who participated in the drill or exercise.

    Similar to the existing requirement for the security plan, we proposed to add a requirement that the biosafety and incident response plans be submitted for initial registration, renewal of registration, or when requested by FSAP. We received two comments regarding these proposals which supported this requirement. However, one commenter questioned the need for additional requirements as this is already done routinely. While we agreed with the commenter that some, or even most, entities already provide the plans routinely, we are making no changes to the proposed language so that all entities will be required to submit their biosafety and incidence response plans, consistent with the existing requirement for the security plan.

    Security

    We proposed amending the requirement that a security plan contain a description of how the entity authorizes the means of entry into areas where select agents or toxins are stored or used, to add a requirement that the security plan must include a description of centralized access control management systems (e.g., keycards) and/or key management (e.g., mechanical keys). We proposed this requirement because during our inspections of registered entities we have observed that the central access control management system in some instances is controlled, either on- or off-site, by individuals who (1) have not received access approval from HHS Secretary or APHIS Administrator, and (2) have the ability to assign people access or override access controls without the knowledge of the entity's RO. Three commenters suggested that access management processes are sensitive and a greater security risk may result from having too detailed information available in a single document. One commenter recommended we include a definition of what an access control system is and what components need to be included in the security plan. After considering the comments and reconsidering the purpose of the proposed language, we are not finalizing the proposed revision. Our concerns about unauthorized persons either having access or granting access without the knowledge of the entity RO can be addressed by the current provisions found in subsections (c)(1) and (c)(2) of section 11 (security) of the select agent regulations, which make the RO responsible to ensure access controls, irrespective of the type of security system in place.

    Paragraphs (d)(7)(i) through (d)(7)(v) of section 11 (security) of the select agent regulations encompass a list of events that individuals with access approval from the HHS Secretary or the APHIS Administrator must immediately report to the RO. We proposed to add a new requirement that the RO must be notified of any loss of computer, hard drive, or other data storage device containing information that could be used to gain access to select agents or toxins. We received one comment requesting clarification on the time frame for notification. We made no changes based on the comment since the regulations under subsection (d) already provide that notification must be immediate. The notification will facilitate notification of the Federal Bureau of Investigation (FBI) if deemed necessary by the RO as the loss of such equipment may be criminal in nature.

    Biosafety

    We proposed amending the regulatory language in section 73.12 of the select agent regulations to update the name change of the National Institutes of Health (NIH) “Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules” (Ref. 2). We received no comments and are finalizing this change as proposed.

    The biosafety section of the select agent regulations contains a reference to the Occupational Safety and Health Administration (OSHA) regulations found in 29 CFR 1910.1200 and 1910.1450. These sections provide specific requirements for handling hazardous chemicals in the laboratories. These regulations also provide recommendations for safely working with chemicals including toxins and give non-mandatory recommendations for prudent practices in laboratories handling chemical hazards. Since the current edition of the CDC/NIH “Biosafety in Microbiological and Biomedical Laboratories” Appendix I (Ref. 3) now provides guidelines for work with toxins of biological origin, we proposed removal of the reference to these OSHA regulations. We note, however, that regulated entities are still required to meet the OSHA regulatory requirements where applicable. We received no comments and are finalizing this change as proposed.

    In the NPRM, we proposed adding the requirement that “biosafety and containment procedures specific to each registered laboratory must be available to each individual working in that laboratory.” We proposed adding this language to ensure that laboratory personnel working with select agents and toxins have access to relevant biosafety information and are therefore aware of the risks associated with these agents. One commenter requested clarification regarding the term “laboratory” and whether the term referred to a single room or a building or to a group of rooms (e.g., laboratory, animal room, necropsy) used by a Principal Investigator for a research project. The commenter also requested clarification on the language “must be available to each individual working in the laboratory” and whether this implied that there must be a specific biosafety manual for each room. We also received three comments that questioned the need for a new requirement since the commenters believe a laboratory-specific biosafety manual was already accessible to individuals. We are not adding the proposed provision to the regulations because upon further reflection we agree with the commenters that individuals already have access to their biosafety plan.

    In the NPRM, we proposed adding specific provisions to the biosafety section that would require (1) a written risk assessment for each registered select agent or toxin; (2) written safety procedures to protect entity personnel, the public, and the environment from exposure to the select agent or toxin; (3) written decontamination procedures; and (4) written waste management procedures. We received 13 comments that stated that “risk assessments” should be defined and the proposed requirement of having these for each procedure involving a select agent or toxin that addresses the hazards associated with the agent or toxin must be clarified because risk assessments are completed through institutional review committees by collaborative processes with Principal Investigators and biosafety professionals. One commenter stated that a risk assessment was always a requirement. We agree with the commenters that “risk assessment for each procedure” should not be required and agreed that having a risk assessment was already addressed in the regulations as outlined in Section 12(a) that “An individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of the select agent or toxin, given its intended use.” However, we have clarified in the final regulatory language found in section 12(a)(1) of the select agent regulations that the biosafety plan include “the hazardous characteristics of each agent or toxin listed on the entity's registration and the biosafety risk associated with laboratory procedures related to the select agent or toxin.”

    The majority of the commenters stated that the approach outlined in the NPRM discussion of section 12(a) would lead to decreased compliance and an increase in paperwork burden. One commenter stated that many biosafety plans are already upwards of 50 pages, and increasing the length further may greatly decrease the likelihood that researchers will continue to read these plans and use them as a resource. Another commenter stated that regulatory language should be omitted to prevent creating a redundant process such as those provisions already covered under training and incident response. We agree with commenters and have removed the training and incident response language that was noted in the NPRM because these provisions are already covered by other sections in the regulations (i.e., incident response and training sections). We combined other provisions to reduce the seven provisions listed in the NPRM to four provisions in the final rule.

    One commenter stated we should consider requiring the adoption of shared algorithms developed by the American Society for Microbiology (ASM) for use by clinical laboratories. These algorithms are presented as frequently asked questions (FAQs) from ASM to assist laboratories. We made no changes based on this comment because FSAP already provides FAQs to assist entities with meeting the biosafety requirements of the regulations.

    Another commenter recommended that we also offer the suggestion that entities consider implementing programs whereby personnel are required to work with another trained person (i.e., a “buddy” system or dual authentication) as an appropriate and effective proactive method for the prevention of laboratory acquired infections and accidental releases of select agents. We made no changes based on this comment as it is essential for entities to develop their own biosafety initiatives to meet their own needs. The commenter continued that many of these issues come down to the culture of safety in an entity, and adherence to established protocols and training. The commenters wanted the regulatory provisions to reflect an improved safety culture. Two commenters requested that we consider leaving the current provisions in place and develop guidance to assist entities that would include risk assessment, use of safety equipment, personal protective equipment, containment devices, and occupational health consideration. Another commenter stated that the new section appears redundant with the risk assessment(s) performed during review of work registrations by an Institutional Biosafety Committee. We agree with the commenters that the provisions focus on the hazards and risks associated with the select agents and toxins and the safety practices put in place by the entity to protect entity personnel, the public, and the environment. We have revised the proposed language to state that the biosafety plan must include the provisions found in section 12(a) of the select agent regulations (see § 73.12(a)(1)-(4)). To address the commenters' suggestion that FSAP develop a guidance document regarding biosafety, additional guidance has been developed and is available at: http://www.selectagents.gov.

    x. Training

    We proposed to amend section 15 of the select agent regulations to require that training be completed within 12 months of that individual's anniversary of receiving access approval from the HHS Secretary or the APHIS Administrator, or prior to his or her entry into an area where any select agents and toxins are used or stored, whichever occurs first. This change is necessary in order to ensure that individuals at registered entities receive timely training. We received no specific comments regarding this proposed change. However, seven commenters stated that we should include a description of the level of training necessary for personnel in varying positions with highly disparate job duties and responsibilities. The commenters requested that we clarify that the required training will be conducted at a level appropriate to the registered person's role and level of access to select agents. We made no changes based on this comment because the current regulatory language is clear that “the training must address the particular needs of the individual, the work they will do, and the risks posed by the select agents or toxins.” The training for the individuals should be determined by the entity based on at the level of which the individual will have access to select agents or toxins. The training that each person receives should be designed to ensure that they can carry out their responsibilities without causing harm to themselves, or to their fellow co‐workers, or to the public. We did clarify the regulatory language regarding training for an individual who must be escorted to specify that their training must be accomplished prior to the individual's entry into a registered area.

    One commenter also asked that we consider making “training a pre-requisite for access to select agents and toxins, and not a requirement for just being FSAP approved.” The regulations in 42 CFR 73.15(a)(1) already requires that each approved individual receive information and training on biosafety, security (including security awareness), and incident response before that individual has access to any select agents and toxins. The same commenter asked that we clearly specify the requirements for both initial and annual training. While we made no changes to our regulatory language based on this comment, the document, “Guidance for Meeting the Training Requirements of the Select Agent Regulations,” found at http://www.selectagents.gov/guidance-training.html, has been amended to provide further detail and assistance regarding the content of initial and annual training. The same commenter stated that in two instances an employee's annual training deadline occurred in the middle of an extended medical leave during which it was not possible to complete the training, and the entity had to choose to either let the training become overdue, or to remove the individual from the registration and completely start over with the security risk assessment (SRA) approval process once the individual was back to work. The commenter stated that “SRA approved personnel could commonly be on other types of extended leave such as maternity leave, or on sabbatical doing research at another institution but still employed and SRA approved at their home institution.” While we made no changes to our regulatory language based on this comment, we have updated our guidance, “Guidance for Meeting the Training Requirements of the Select Agent Regulations,” which is available at www.selectagents.gov, to include information on how to deal with situations regarding individuals that have extended absences from the laboratory.

    xi. Records

    Based on our inspections of registered entities, we observed that not all entities maintain records of the final disposition of select agents when consumed or destroyed, and this impedes validation of inventory holdings. Section 73.17 of the select agent regulations currently does not include a requirement for documenting the final disposition of a select agent. To ensure the proper tracking of a select agent from acquisition to final disposition, we are adding a requirement for entity records to include the final disposition (including destruction) for each select agent that has been held in long-term storage. One commenter expressed concern that a requirement for a record of destruction of select agents would place an undue burden on investigators and recommended that this requirement be excluded from the final rule. However, the commenter did agree that an entity should be required to maintain a current and accurate inventory of all select agents in their possession and document when an agent is no longer in their possession. We agree with the commenter that final disposition needs to be part of the entity's recordkeeping requirement. We disagree with the commenter that this will place undue burden on investigators because this information can be included with an entity's existing recordkeeping system (e.g., inventory spreadsheet). Therefore, to clarify the regulatory language, we have revised the proposed regulatory language to provide that the record will need to include “the select agent used, purpose of use, and, when applicable, final disposition.”

    Section 73.17 of the select agent regulations currently states that records and databases need to be accurate. To ensure that the accuracy of handwritten records can be verified, we proposed to clarify that a handwritten record must be legible (i.e., capable of being read). We received one comment requesting that we define the term “legible handwritten records.” We made no changes based on this comment because we are using the term “legible” in its ordinary meaning.

    We proposed to expand the scope of records required to be maintained to include any records that contain information related to the requirements of the regulations. We received five comments that expressed concerns about the information being kept in laboratory notes. The commenters stated that the information is “proprietary in nature,” contains intellectual property information and should not be required to be provided to FSAP inspectors. We understand the concerns of the commenters and clarified the language to indicate that it is only information related to requirements of the select agent regulations that must be produced on request. Such information may be found in the biocontainment certifications, laboratory notebooks, institutional biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs. Accordingly, we will only review relevant portions of any laboratory notebooks or documents, and only if they contain information related to any requirements of the regulations under sections 73.5, 73.7, 73.9, 73.11, 73.12, 73.14, 73.15, 73.16, 73.17, and 73.19 of the select agent regulations. Two commenters stated that certain records are “protected under the HIPAA Privacy Rule.” FSAP would expect any information provided to FSAP regarding an individual's health would be provided in accord with the HIPAA Privacy Rule, including the use and disclosure of protected health information to public health authorities authorized by law to collect or receive such information for preventing or controlling disease, injury, or disability.

    Records for Long-Term Storage

    In the NPRM we also solicited information and ideas as to how a regulatory requirement could be constructed such that a registered entity would know whether a select agent or toxin had been lost or stolen, without that registered entity first having “an accurate, current inventory for each select agent . . . held in long-term storage.” In addition, we requested ideas as to how the current regulations could be amended to address the threat of the theft of a select agent from a container held in long-term storage. We received three comments that addressed this request. One commenter suggested that FSAP inspectors review the record of select agents held in long-term storage and accept the attestation of the responsible investigators of their accuracy. Another commenter stated we should continue with FSAP's current select agent practices to allow for these stocks to be maintained in tamper-evident containers (e.g., security ties on freezer boxes) so that vials are not individually removed, thawed, and measured. The third commenter recommended dual authentication coupled with required entity inventory reviews. We appreciate the comments and will continue to consider how the recognition of theft and loss might be addressed through alternative approaches.

    III. Alternatives Considered

    The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires HHS and USDA to review and republish the list of select agents and toxins every two years. In drafting this final rule, we considered the action proposed in the NPRM of removing the six select agents and one toxin where its costs and benefits were discussed. If those policies were adopted, it would result in savings ranging from approximately $15,300 for a small commercial BSL-3 laboratory to approximately $165,000 for a larger university with BSL-2/3 laboratories for laboratories no longer regulated. Based on the review of FSAP database, approximately eleven small entities would no longer be regulated and would not be required to register with FSAP. If the entities withdrew their registration, it would result in an estimated saving of $168,300 annually. On the other hand, this policy could increase the likelihood of entities working with these removed select agents and toxin not having the appropriate biosafety and security provisions in place to prevent an accidental or intentional release of a select agent or toxin. The intentional release could adversely affect the public health and safety. Recent events concerning the accidental transfer of select agents that had not been fully inactivated, leading to the inadvertent release of select agents, caused us to also look at provisions in this regulation. After carefully considering the technical input of subject matter experts, both within the Federal government and from public comments, and recommendations from Federal advisory groups, we have decided not to finalize the proposed changes to the list of select agents and toxins at this time.

    IV. Required Regulatory Analyses A. Executive Orders 12866 and 13563

    Under Executive Order (E.O.) 12866, Regulatory Planning and Review (58 FR 51735, October 4, 1993), CDC is required to determine whether this regulatory action would be “significant” and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Orders (E.O.). E.O. 12866 defines “significant regulatory action” as any regulatory action that is likely to result in a rule that may:

    • Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities;

    • Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

    • Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients; or,

    • Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866.

    E.O. 13563, Improving Regulation and Regulatory Review, (76 FR 3821, January 21, 2011), updates some of the provisions of E.O. 12866 in order to promote more streamlined regulatory actions. This E.O. charges, in part, that, while protecting “public health, welfare, safety, and our environment” that regulations must also “promote predictability and reduce uncertainty” in order to promote economic growth. Further, regulations must be written in plain language and be easy to understand.

    We have prepared an economic analysis for this rule. The economic analysis provides a cost-benefit analysis, as required by E.O. 12866, and a final regulatory flexibility analysis (See Section III.B. of this Preamble) that examines the potential economic effects of this rule on small entities, as required by the Regulatory Flexibility Act. The economic analysis is summarized below. Copies of the full analysis are available in the docket at www.regulations.gov or at www.select agents.gov.

    We have determined that this final rule is significant for the purposes of Executive Order 12866 and, therefore, this final rule has been reviewed by OMB.

    Summary of the Regulatory Impact Analysis

    The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188) provides for the regulation of certain biological agents and toxins that have the potential to pose a severe threat to human, animal, or plant health, or to animal or plant products. APHIS and CDC have primary responsibility for implementing the provisions of the Act within the Department of Agriculture and the Department of Health and Human Services, respectively. Within APHIS, Veterinary Services (VS) select agents and toxins are those that have been determined to have the potential to pose a severe threat to animal health or animal products, and Plant Protection and Quarantine (PPQ) select agents and toxins are those that have been determined to have the potential to pose a severe threat to plant health or plant products. HHS select agents and toxins are those that have been determined to have the potential to pose a severe threat to human health. APHIS and CDC coordinate regulatory activities for overlap select agents and toxins that have been determined to pose a severe threat to human and animal health or products.

    Sections 201 and 212(a)(2) of the Act require a biennial review and republication of the select agent and toxin list, with revisions as appropriate in accordance with this law. These final rules will implement the recommendations of the fourth biennial review of select agent regulations and have finalized changes that will increase their usability as well as provide for enhanced program oversight. These amendments include new provisions regarding the inactivation of select agents, specific biosafety and toxin requirements and clarification of regulatory language concerning security, training, and records.

    The final rule will require that entities develop validated inactivation procedures for select agents or regulated infectious nucleic acid and maintain written records of having done so. Costs of complying with this amendment are expected to be modest.

    Currently, there are 286 entities registered with APHIS and CDC including 91 academic, 53 commercial, 81 State government, 45 Federal government, and 16 private (non-profit) institutions, most of which are considered to be small entities. Based on current record keeping and reporting requirements, an additional 10 to 20 hours per year may be required for maintaining records associated with select agents or material containing select agents or regulated nucleic acids that can produce infectious forms of any select agent virus that have been subjected to a validated inactivation procedure or a procedure for removal of viable select agents. At an imputed cost of $33.40 per hour (GS-12, step 2), this additional time requirement per entity will cost between $334 and $668 per year, or in total for all registered entities between $80,000 and $160,000. The final rule will not have a significant economic impact on a substantial number of small entities. Costs associated with this rule do not include costs related to training, overhead, updates to facilities, etc. We assume in this rule that all costs associated with such factors for entities performing inactivation procedures have already been incurred prior to rulemaking.

    The benefits of strengthened safeguards against the unintentional or deliberate release of a select agent or toxin greatly exceed compliance costs of the rules. As an example of losses that can occur, the October 2001 anthrax attacks caused five fatalities and 17 illnesses, disrupted business and government activities (including $2 billion in lost revenues for the Postal Service), and required more than $23 million to decontaminate one Senate office building and $3 billion to decontaminate postal facilities and procure mail-sanitizing equipment. Deliberate introduction greatly increases the probability of a select agent becoming established and causing wide-ranging and devastating impacts to the economy, other disruptions to society, and diminished confidence in public and private institutions.

    The amended regulations will enhance the protection of human, animal, and plant health and safety. The final rules will reduce likelihood of the accidental or intentional release of a select agent or toxin. Benefits of the rules will derive from the greater probability that a release will be prevented from occurring.

    B. The Regulatory Flexibility Act (RFA), as Amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA)

    We have examined the impacts of the proposed rule under RFA (5 U.S.C. 601-612). Unless we certify that the proposed rule is not expected to have a significant economic impact on a substantial number of small entities, RFA, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), requires agencies to analyze regulatory options that would minimize any significant economic impact of a rule on small entities. We certify that this proposed rule will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA because these registered entities are already required to comply with the select agent regulations. The small entities would only incur some costs if they are performing inactivation procedures and are not maintaining records. The additional costs that may be incurred are small in comparison to the long-term benefits of additional protection against the release of select agents and toxins that would result in devastating effects to the economy.

    This regulatory action is not a major rule as defined by Sec. 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This proposed rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in cost or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

    C. Paperwork Reduction Act of 1995

    In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), CDC has determined that the Paperwork Reduction Act does apply to information collection and recordkeeping requirements included in this rule. We note that the information collection and recordkeeping requirements are already approved by the Office of Management and Budget (OMB) under OMB Control Number 0920-0576 (Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73), Expiration 12/31/2018).

    D. E.O. 12988: Civil Justice Reform

    This rule has been reviewed under E.O. 12988, Civil Justice Reform. Once the final rule is in effect, CDC notes that: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) No retroactive effect will be given to this rule; and (3) Administrative proceedings will not be required before parties may file suit in court challenging this rule.

    E. E.O. 13132: Federalism

    HHS/CDC has reviewed this final rule in accordance with E.O. 13132 regarding Federalism, and has determined that it does not have “federalism implications.” The rule does not “have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

    F. Plain Language Act of 2010

    Under the Plain Language Act of 2010 (Pub. L. 111-274, October 13, 2010), executive Departments and Agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal Government administers or enforces. HHS/CDC has attempted to use plain language in promulgating this rule consistent with the Federal Plain Writing Act guidelines.

    V. References 1. D.R. Franz and N.K. Jaax (1997). Defense Against Toxin Weapons (Chapter 30). In Textbook of Military Medicine: Medical Aspects of Chemical and Biological Warfare, Borden Institute, Walter Reed Army Medical Center, Washington, DC. 631-642. 2. U.S. Department of Health and Human Services, National Institutes of Health. (2013). NIH Guidelines for Research Involving Recombinant Or Synthetic Nucleic Acid Molecules (NIH Guidelines). Retrieved from http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html. 3. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of Health. (2009). Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition. Retrieved from http://www.cdc.gov/biosafety/publications/bmbl5/index.htm. List of Subjects in 42 CFR Part 73

    Biologics, Packaging and containers, Penalties, Reporting and recordkeeping requirements, and Transportation.

    For the reasons discussed in the preamble, we amend 42 CFR part 73 as follows:

    PART 73—SELECT AGENTS AND TOXINS 1. The authority citation for part 73 continues to read as follows: Authority:

    42 U.S.C. 262a; sections 201-2014, 221 and 231 of Title II of Public Law 107-188, 116 Stat 637 (42 U.S.C. 262a).

    2. Section 73.1 is amended by adding in alphabetical order, definitions of validated inactivation procedure and viability testing protocol to read as set forth below.
    § 73.1 Definitions.

    Validated inactivation procedure means a procedure, whose efficacy is confirmed by data generated from a viability testing protocol, to render a select agent non-viable but allows the select agent to retain characteristics of interest for future use; or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.

    Viability testing protocol means a protocol to confirm the validated inactivation procedure by demonstrating the material is free of all viable select agent.

    3. Section 73.3 is amended as follows: a. By revising paragraph (b). b. By removing “functional” and adding in its place “toxic” in paragraph (c)(2). c. By revising paragraph (d)(2). d. By redesignating paragraph (d)(3) as (d)(7) and revising redesignated paragraphs (d)(7) introductory text and (d)(7)(i). e. By redesignating paragraph (d)(4) as paragraph (d)(8). f. By redesignating paragraph (d)(5) as paragraph (d)(12). g. By adding new paragraphs (d)(3), (d)(4), (d)(5), (d)(6), (d)(9), (d)(10) and (d)(11). h. By adding paragraph (e)(3). i. By adding “Bacillus cereus Biovar anthracis,” before “Botulinum neurotoxins” in paragraph (f)(3)(i).

    The additions and revisions read as follows:

    § 73.3 HHS select agents and toxins.

    (b) HHS select agents and toxins:

    Abrin Bacillus cereus Biovar anthracis* Botulinum neurotoxins* Botulinum neurotoxin producing species of Clostridium* Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7) 1

    1 C = Cysteine residues are all present as disulfides, with the 1st and 3rd Cysteine, and the 2nd and 4th Cysteine forming specific disulfide bridges; The consensus sequence includes known toxins α-MI and α-GI (shown above) as well as α-GIA, Ac1.1a, α-CnIA, α-CnIB; X1 = any amino acid(s) or Des-X; X2 = Asparagine or Histidine; P = Proline; A = Alanine; G = Glycine; X3 = Arginine or Lysine; X4 = Asparagine, Histidine, Lysine, Arginine, Tyrosine, Phenylalanine or Tryptophan; X5 = Tyrosine, Phenylalanine, or Tryptophan; X6 = Serine, Threonine, Glutamate, Aspartate, Glutamine, or Asparagine; X7 = Any amino acid(s) or Des X and; “Des X” = “an amino acid does not have to be present at this position.” For example if a peptide sequence were XCCHPA then the related peptide CCHPA would be designated as Des-X.

    Coxiella burnetii Crimean-Congo hemorrhagic fever virus Diacetoxyscirpenol Eastern equine encephalitis virus Ebola virus* Francisella tularensis* Lassa fever virus Lujo virus Marburg virus* Monkeypox virus Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments (Reconstructed 1918 influenza virus) Ricin Rickettsia prowazekii SARS coronavirus (SARS-CoV) Saxitoxin South American hemorrhagic fever viruses: Chapare Guanarito Junin Machupo Sabia Staphylococcal enterotoxins (subtypes A-E) T-2 toxin Tetrodotoxin Tick-borne encephalitis virus Far Eastern subtype Siberian subtype Kyasanur Forest disease virus Omsk haemorrhagic fever virus Variola major virus (Smallpox virus)* Variola minor virus (Alastrim)* Yersinia pestis*

    (d) * * *

    (2) Non-viable HHS select agents or nontoxic HHS toxins.

    (3) A select agent or toxin that has been subjected to decontamination or a destruction procedure when intended for waste disposal.

    (4) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation procedure that is confirmed through a viability testing protocol. Surrogate strains that are known to possess equivalent properties with respect to inactivation can be used to validate an inactivation procedure; however, if there are known strain-to-strain variations in the resistance of a select agent to an inactivation procedure, then an inactivation procedure validated on a lesser resistant strain must also be validated on the more resistant strains.

    (5) Material containing a select agent that is subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is subjected to a viability testing protocol to ensure that the removal method has rendered the material free of all viable select agent.

    (6) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus not subjected to a validated inactivation procedure or material containing a select agent not subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is determined by the HHS Secretary to be effectively inactivated or effectively removed. To apply for a determination an individual or entity must submit a written request and supporting scientific information to CDC. A written decision granting or denying the request will be issued.

    (7) Except as required in § 73.16(l), the aggregate amount of the toxin under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor does not, at any time, exceed the following amounts: 1000 mg of Abrin; 1 mg of Botulinum neurotoxins; 100 mg of Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7); 10,000 mg of Diacetoxyscirpenol; 1000 mg of Ricin; 500 mg of Saxitoxin; 100 mg of Staphylococcal enterotoxins (subtypes A-E); 10,000 mg of T-2 toxin; or 500 mg of Tetrodotoxin. Provided that,

    (i) The toxin is transferred only after the transferor uses due diligence and documents the identification of the recipient and the legitimate need (e.g., prophylactic, protective, bona fide research, or other peaceful purpose) claimed by the recipient to use such toxin. Information to be documented includes, but is not limited to, the recipient identity information, including the recipient's name, institution name, address, telephone number and email address; name of the toxin and the total amount transferred; and the legitimate need claimed by the recipient. Notwithstanding the provisions of paragraph (d) of this section, the HHS Secretary retains the authority to, without prior notification, inspect and copy or request the submission of the due diligence documentation to the CDC.

    (9) An HHS select toxin identified in an original food sample or clinical sample.

    (10) For those laboratories that are not exempt under § 73.5(a) and § 73.6(a), Botulinum neurotoxin that is produced as a byproduct in the study of Botulinum neurotoxin producing species of Clostridium so long as the toxin has not been intentionally cultivated, collected, purified, or otherwise extracted, and the material containing the toxin is rendered non-toxic and disposed of within 30 days of the initiation of the culture.

    (11) Waste generated during the delivery of patient care by health care professionals from a patient diagnosed with an illness or condition associated with a select agent, where that waste is decontaminated or transferred for destruction by complying with state and Federal regulations within seven calendar days of the conclusion of patient care.

    (e) * * *

    (3) An individual or entity may make a written request to the HHS Secretary for reconsideration of a decision denying an application for the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The HHS Secretary will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.

    4. Section 73.4 is amended as follows: a. By revising paragraph (b). b. By removing “functional” and adding in its place “toxic” in paragraph (c)(2). c. By revising paragraph (d)(2). d. By redesignating paragraph (d)(3) as (d)(9). e. By adding new paragraphs (d)(3), (d)(4), (d)(5), (d)(6), (d)(7) and (d)(8). f. By adding paragraph (e)(3).

    The revision and additions read as follows:

    § 73.4 Overlap select agents and toxins.

    (b) Overlap select agents and toxins:

    Bacillus anthracis * Bacillus anthracis Pasteur strain Brucella abortus Brucella melitensis Brucella suis Burkholderia mallei * Burkholderia pseudomallei * Hendra virus Nipah virus Rift Valley fever virus Venezuelan equine encephalitis virus

    (d) * * *

    (2) Non-viable overlap select agents or nontoxic overlap toxins.

    (3) A select agent or toxin that has been subjected to decontamination or a destruction procedure when intended for waste disposal.

    (4) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation procedure that is confirmed through a viability testing protocol. Surrogate strains that are known to possess equivalent properties with respect to inactivation can be used to validate an inactivation procedure; however, if there are known strain-to-strain variations in the resistance of a select agent to an inactivation procedure, then an inactivation procedure validated on a lesser resistant strain must also be validated on the more resistant strains.

    (5) Material containing a select agent that is subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is subjected to a viability testing protocol to ensure that the removal method has rendered the material free of all viable select agent.

    (6) A select agent or regulated nucleic acids that can produce infectious forms of any select agent virus not subjected to a validated inactivation procedure or material containing a select agent not subjected to a procedure that removes all viable select agent cells, spores, or virus particles if the material is determined by the HHS Secretary or Administrator to be effectively inactivated or effectively removed. To apply for a determination an individual or entity must submit a written request and supporting scientific information to CDC or APHIS. A written decision granting or denying the request will be issued.

    (7) An overlap select toxin identified in an original food sample or clinical sample.

    (8) Waste generated during the delivery of patient care by health care professionals from a patient diagnosed with an illness or condition associated with a select agent, where that waste is decontaminated or transferred for destruction by complying with state and Federal regulations within seven calendar days of the conclusion of patient care.

    (e) * * *

    (3) An individual or entity may make a written request to the HHS Secretary or Administrator for reconsideration of a decision denying an application for the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The HHS Secretary or Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.

    5. Section 73.5 is amended as follows: a. By revising paragraph (a)(1). b. By redesignating paragraph (a)(3) as paragraph (a)(4) and revising newly redesignated paragraph (a)(4). c. By adding new paragraph (a)(3). d. By adding “Bacillus cereus Biovar anthracis,” before “Botulinum neurotoxins” in paragraph (a)(3)(i).

    The revisions and addition read as follows:

    § 73.5 Exemptions for HHS select agents and toxins.

    (a) * * *

    (1) Unless directed otherwise by the HHS Secretary, within seven calendar days after identification of the select agent or toxin (except for Botulinum neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-E)), or within 30 calendar days after identification of Botulinum neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-E), the select agent or toxin is transferred in accordance with § 73.16 or destroyed on-site by a recognized sterilization or inactivation process,

    (3) Unless otherwise directed by the HHS Secretary, the clinical or diagnostic specimens collected from a patient infected with a select agent are transferred in accordance with § 73.16 or destroyed on-site by a recognized sterilization or inactivation process within seven calendar days after delivery of patient care by health care professionals has concluded, and

    (4) The identification of the agent or toxin is reported to CDC or APHIS, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law by telephone, facsimile, or email. This report must be followed by submission of APHIS/CDC Form 4 to APHIS or CDC within seven calendar days after identification.

    6. Section 73.6 is amended as follows: a. By redesignating paragraph (a)(3) as paragraph (a)(4) and revising newly redesignated paragraph (a)(4). b. By adding new paragraph (a)(3).

    The revision and addition read as follows:

    § 73.6 Exemptions for overlap select agents and toxins.

    (a) * * *

    (3) Unless otherwise directed by the HHS Secretary or Administrator, the clinical or diagnostic specimens collected from a patient infected with a select agent are transferred in accordance with § 73.16 or destroyed on-site by a recognized sterilization or inactivation process within seven calendar days after delivery of patient care by health care professionals has concluded, and

    (4) The identification of the agent or toxin is reported to CDC or APHIS, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law by telephone, facsimile, or email. This report must be followed by submission of APHIS/CDC Form 4 to APHIS or CDC within seven calendar days after identification.

    7. Section 73.7 is amended as follows: a. By redesignating paragraphs (b) through (k) as paragraphs (c) through (l), respectively. b. By adding a new paragraph (b) to read as follows:
    § 73.7 Registration and related security risk assessments.

    (b) As a condition of registration, each entity is required to be in compliance with the requirements of this part for select agents and toxins listed on the registration regardless of whether the entity is in actual possession of the select agent or toxin. With regard to toxins, the entity registered for possession, use or transfer of a toxin must be in compliance with the requirements of this part regardless of the amount of toxin currently in its possession.

    8. Section 73.9 is amended as follows: a. In paragraph (a)(6) by removing “laboratory” and adding in its place “registered space” and adding “and the corrections documented” after “corrected” at the end of the sentence. b. By adding paragraphs (a)(7), (a)(8) and (a)(9) to read as set forth below. c. By adding “Bacillus cereus Biovar anthracis,” after “Bacillus anthracis,” in paragraph (c)(1).
    § 73.9 Responsible Official.

    (a) * * *

    (7) Ensure that individuals are provided the contact information for the HHS Office of Inspector General Hotline and the USDA Office of Inspector General Hotline so that they may anonymously report any biosafety or security concerns related to select agents and toxins.

    (8) Investigate to determine the reason for any failure of a validated inactivation procedure or any failure to remove viable select agent from material. If the Responsible Official is unable to determine the cause of a deviation from a validated inactivation procedure or a viable select agent removal method; or receives a report of any inactivation failure after the movement of material to another location, the Responsible Official must report immediately by telephone or email the inactivation or viable agent removal method failure to CDC or APHIS.

    (9) Review, and revise as necessary, each of the entity's validated inactivation procedures or viable select agent removal methods. The review must be conducted annually or after any change in Principal Investigator, change in the validated inactivation procedure or viable select agent removal method, or failure of the validated inactivation procedure or viable select agent removal method. The review must be documented and training must be conducted if there are any changes to the validated inactivation procedure, viable select agent removal method, or viability testing protocol.

    9. Section 73.10 is amended as follows: a. By a sentence to the end of paragraph (e) to read as follows:
    § 73.10 Restricting access to select agents and toxins; security risk assessments.

    (e) * * * A Responsible Official must immediately notify the Responsible Official of the visited entity if the person's access to select agents and toxins has been terminated.

    10. Section 73.11 is amended as follows: a. In paragraph (c)(5) by adding “keycards,” between “keys,” and “passwords” and removing “numbers” and adding in its place “permissions”. b. By adding paragraph (d)(7)(vi). c. By adding a sentence to the end of paragraph (h).

    The additions read as follows:

    § 73.11 Security.

    (d) * * *

    (7) * * *

    (vi) Any loss of computer, hard drive or other data storage device containing information that could be used to gain access to select agents or toxins.

    (h) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants.

    11. Section 73.12 is amended as follows: a. By revising paragraph (a). b. By removing paragraph (c)(2), redesignating paragraph (c)(3) as (c)(2), and in newly redesignated paragraph (c)(2), removing “NIH Guidelines for Research Involving Recombinant DNA Molecules” and adding in its place “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules”. c. By adding a new sentence to the end of paragraph (e).

    The revision and addition read as follows:

    § 73.12 Biosafety.

    (a) An individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of the select agent or toxin, given its intended use. The biosafety plan must contain sufficient information and documentation to describe the biosafety and containment procedures for the select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent. The current biosafety plan must be submitted for initial registration, renewal of registration, or when requested. The biosafety plan must include the following provisions:

    (1) The hazardous characteristics of each agent or toxin listed on the entity's registration and the biosafety risk associated with laboratory procedures related to the select agent or toxin;

    (2) Safeguards in place with associated work practices to protect entity personnel, the public, and the environment from exposure to the select agent or toxin including, but not limited to: Personal protective equipment and other safety equipment; containment equipment including, but not limited to, biological safety cabinets, animal caging systems, and centrifuge safety containers; and engineering controls and other facility safeguards;

    (3) Written procedures for each validated method used for disinfection, decontamination or destruction, as appropriate, of all contaminated or presumptively contaminated materials including, but not limited to: Cultures and other materials related to the propagation of select agents or toxins, items related to the analysis of select agents and toxins, personal protective equipment, animal caging systems and bedding (if applicable), animal carcasses or extracted tissues and fluids (if applicable), laboratory surfaces and equipment, and effluent material; and

    (4) Procedures for the handling of select agents and toxins in the same spaces with non-select agents and toxins to prevent unintentional contamination.

    (e) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants.

    12. Section 73.14 is amended as follows: a. By adding a new sentence to the end of paragraph (a). b. By adding a new sentence to the end of paragraph (f).

    The additions read as follows:

    § 73.14 Incident response.

    (a) * * * The current incident response plan must be submitted for initial registration, renewal of registration, or when requested.

    (f) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and the names of registered entity personnel participants.

    13. Section 73.15 is amended as follows: a. Revising paragraph (a) to read as set forth below. b. By adding paragraph (e) to read as set forth below.
    § 73.15 Training.

    (a) An individual or entity required to register under this part must provide information and training on biocontainment, biosafety, security (including security awareness), and incident response to:

    (1) Each individual with access approval from the HHS Secretary or Administrator. The training must address the particular needs of the individual, the work they will do, and the risks posed by the select agents or toxins. The training must be accomplished prior to the individual's entry into an area where a select agent is handled or stored, or within 12 months of the date the individual was approved by the HHS Secretary or the Administrator for access, whichever is earlier.

    (2) Each individual not approved for access to select agents and toxins by the HHS Secretary or Administrator before that individual enters areas under escort where select agents or toxins are handled or stored (e.g., laboratories, growth chambers, animal rooms, greenhouses, storage areas, shipping/receiving areas, production facilities, etc.). Training for escorted personnel must be based on the risk associated with accessing areas where select agents and toxins are used and/or stored. The training must be accomplished prior to the individual's entry into where select agents or toxins are handled or stored (e.g., laboratories, growth chambers, animal rooms, greenhouses, storage areas, shipping/receiving areas, production facilities, etc.).

    (e) The Responsible Official must ensure and document that individuals are provided the contact information of the HHS Office of Inspector General Hotline and the USDA Office of Inspector General Hotline so that they may anonymously report any safety or security concerns related to select agents and toxins.

    14. Section 73.16 is amended by revising paragraph (l)(1) to read as follows:
    § 73.16 Transfers.

    (l) * * *

    (1) Transfer the amounts only after the transferor uses due diligence and documents that the recipient has a legitimate need (e.g., prophylactic, protective, bona fide research, or other peaceful purpose) to handle or use such toxins. Information to be documented includes, but is not limited, to the recipient information, toxin and amount transferred, and declaration that the recipient has legitimate purpose to store and use such toxins.

    15. Section 73.17 is amended as follows: a. In paragraphs (a)(1)(iii) and (a)(3)(v) by adding “or other storage container” after “freezer”. b. By revising paragraph (a)(1)(v). c. By adding paragraph (a)(8). d . By revising paragraph (b). e. By revising paragraph (c).

    The revision and additions read as follows:

    § 73.17 Records.

    (a) * * *

    (1) * * *

    (v) The select agent used, purpose of use, and, when applicable, final disposition,

    (8) For select agents or material containing select agents or regulated nucleic acids that can produce infectious forms of any select agent virus that have been subjected to a validated inactivation procedure or a procedure for removal of viable select agent:

    (i) A written description of the validated inactivation procedure or viable select agent removal method used, including validation data;

    (ii) A written description of the viability testing protocol used;

    (iii) A written description of the investigation conducted by the entity Responsible Official involving an inactivation or viable select agent removal failure and the corrective actions taken;

    (iv) The name of each individual performing the validated inactivation or viable select agent removal method;

    (v) The date(s) the validated inactivation or viable select agent removal method was completed;

    (vi) The location where the validated inactivation or viable select agent removal method was performed; and

    (vii) A certificate, signed by the Principal Investigator, that includes the date of inactivation or viable select agent removal, the validated inactivation or viable select agent removal method used, and the name of the Principal Investigator. A copy of the certificate must accompany any transfer of inactivated or select agent removed material.

    (b) The individual or entity must implement a system to ensure that all records and data bases created under this part are accurate and legible, have controlled access, and authenticity may be verified.

    (c) The individual or entity must promptly produce upon request any information that is related to the requirements of this part but is not otherwise contained in a record required to be kept by this section. The location of such information may include, but is not limited to, biocontainment certifications, laboratory notebooks, institutional biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs. All records created under this part must be maintained for 3 years.

    Dated: January 9, 2017. Sylvia M. Burwell, Secretary.
    [FR Doc. 2017-00726 Filed 1-18-17; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 100 RIN 0906-AB01 National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table AGENCY:

    Health Resources and Services Administration (HRSA), HHS.

    ACTION:

    Final rule.

    SUMMARY:

    On July 29, 2015, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) to amend the regulations governing the National Vaccine Injury Compensation Program (VICP or program) by proposing revisions to the Vaccine Injury Table (Table). The Secretary based the Table revisions primarily on the 2012 Institute of Medicine (IOM) report, “Adverse Effects of Vaccines: Evidence and Causality,” the work of nine HHS workgroups who reviewed the IOM findings, and consideration of the Advisory Commission on Childhood Vaccines' (ACCV) recommendations. The Secretary amends the Table through the changes in this final rule. These changes will apply only to petitions for compensation under the VICP filed after this final rule becomes effective.

    DATE:

    This rule is effective February 21, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Narayan Nair, Acting Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane, Room 8N146B, Rockville, MD 20857, or by telephone (855) 266-2427. This is a toll-free number.

    SUPPLEMENTARY INFORMATION: I. Background

    The National Childhood Vaccine Injury Act of 1986, title III of Public Law 99-660 (42 U.S.C. 300aa-10 et seq.), established the VICP, a Federal compensation program for persons thought to be injured by vaccines. The statute governing the VICP has been amended several times since 1986 and is hereinafter referred to as “the Act.” Petitions for compensation under the VICP are filed in the United States Court of Federal Claims (Court), with a copy served on the Secretary, who is designated as the “Respondent.” The Court, acting through judicial officers called Special Masters, makes decisions as to eligibility for, and the amount of, compensation.

    To gain entitlement to compensation under this program, a petitioner must establish that a vaccine-related injury or death has occurred, either by proving that a vaccine actually caused or significantly aggravated an injury (causation-in-fact) or by demonstrating the occurrence of what is referred to as a “Table Injury.” That is, a petitioner may show that the vaccine recipient suffered an injury of the type enumerated in the regulations at 42 CFR 100.3—the “Vaccine Injury Table”—corresponding to the vaccination in question and that the onset of such injury took place within a time period also specified in the Table. If so, the injury is presumed to have been caused by the vaccination and the petitioner is entitled to compensation (assuming that other requirements are satisfied) unless the Respondent affirmatively shows that the injury was caused by some factor other than the vaccination (see 42 U.S.C. 300aa-11(c)(1)(C)(i), 300aa-13(a)(1)(B)), and 300aa-14(a)).

    In prior Table revisions, the Secretary determined that the appropriate framework for making changes to the Table is to make specific findings as to the illnesses or conditions that can reasonably be determined, in some circumstances, to be caused or significantly aggravated by the vaccines under review and the circumstances under which such causation or aggravation can reasonably be determined to occur. The Secretary continues this approach through the use of the 2012 IOM report, the work of the nine workgroups who reviewed the IOM findings, and consideration of the ACCV's recommendations. After consultation with the ACCV, the Secretary may modify the Table by promulgating regulations, with notice and opportunity for a public hearing and at least 180 days of public comment. See 42 U.S.C. 300aa-14(c) and (d).

    II. Summary of the Final Rule

    After the IOM released its 2012 report, 9 HHS workgroups comprising HRSA and Centers for Disease Control and Prevention (CDC) medical staff reviewed IOM's conclusions for 158 vaccine-adverse events, as well as any newly published scientific literature not contained in the report, and developed a set of proposed changes to the Table and its definitional counterpart, the Qualifications and Aids to Interpretation (QAI). For the vast majority of the vaccine-adverse event pairs reviewed (135), the IOM determined that the evidence was inadequate to accept or reject a causal relationship. Considering the remaining IOM conclusions and the ACCV Guiding Principles, the Secretary in this final rule is adopting certain additions or changes to the Table where the scientific evidence either convincingly supports or favors acceptance of a causal relationship between certain conditions and covered vaccines, which are unchanged from the proposed rule. As required by the Act, the changes in the proposed rule were presented to the ACCV, which reviewed and concurred with the Table changes set forth in this final rule.

    Additionally, the Secretary, following the recommendation of the ACCV, is finalizing the Table change, as proposed, to add the injury of Guillain-Barré Syndrome (GBS) for seasonal influenza vaccinations, which is consistent with the approach taken in the Countermeasures Injury Compensation Program (CICP). Studies have demonstrated a causal association between the monovalent 2009 H1N1 vaccine and the 1976 swine flu vaccine and GBS. These causal associations were the basis of the 2015 decision by the Secretary in the CICP Pandemic Influenza A Countermeasures Injury Table Final Rule (80 FR 47411) to include GBS as an injury associated with the 2009 H1N1 influenza. With respect to that vaccine, the Secretary found that there was compelling, reliable, and valid medical and scientific evidence of an association between the 2009 H1N1 vaccine and GBS, which is required to add an injury to the CICP's Injury Table. To date, the H1N1 antigen has been included in all seasonal influenza vaccines beginning with the 2010-2011 flu season. HHS notes that seasonal influenza vaccine formulations, unlike other vaccines, include multiple antigens that change from year-to-year, and enhanced surveillance activities to detect the incidence of GBS that occurred during the 2009 H1N1 pandemic may not occur with each virus strain change. In light of this information and other information as discussed in the proposed rule, the ACCV recommended that the Secretary add GBS consistent with one of its Guiding Principles: That where there is credible evidence to both support and reject a change to the Table, the change should, whenever possible, be made to the benefit of petitioners.

    In addition, in the final rule, the Secretary adopts the proposed rule's new paragraph (b), Provision that applies to all vaccines listed. To streamline the Table, this paragraph includes any acute complication or sequela, including death, of the illness, disability, injury, or condition listed, as a Table injury (absent an exclusion as set forth under the QAI) rather than adding the provision to every line of the Table. To further streamline the Table, the Secretary deleted redundant wording in the various definitions, particularly with regard to any references to the presumption of causation, and the importance of the entire medical record. These elements have been included in paragraph (b) and are unchanged from the proposed rule. Finally, in this final rule, the Secretary adopts changes in the proposed rule that simplify and expand applicability of a provision that previously applied only to an encephalopathy. This provision, which indicates that idiopathic conditions do not rebut the Table presumption, now applies (through inclusion in paragraph (b)), to all injuries, while continuing to apply to an encephalopathy.

    In this final rule, in addition to the changes described in the proposed rule, the Secretary has made the following non-substantive changes to the proposed rule for purposes of clarity:

    a. Added headings to (c)(2)(ii) and (c)(3)(ii).

    b. Moved text from the end of paragraph (c)(3)(ii)(C) to create a new (c)(3)(ii)(D).

    c. Changed paragraphs (c)(11) and (12) by revising the sentence regarding organs other than the skin by adding “the” before ” disease”, inserting “and” after “organ”, and moving “, not just mildly abnormal laboratory values” to the end of the sentence.

    d. Revised paragraph (c)(15)(i) by changing “nine weeks” to “9 weeks”.

    e. Changed paragraph (e)(1) (“Coverage Provisions”) for purpose of clarity and consistency with 42 U.S.C. 300aa-14(c)(4) by adding “only” before “to petitions for compensation.”

    The modified Table applies only to petitions filed under the VICP after the effective date of this final rule. Also, petitions must be filed within the applicable statute of limitations. The general statute of limitations applicable to petitions filed under the VICP, set forth in 42 U.S.C. 300aa-16(a), continues to apply. However, the statute identifies a specific exception to this statute of limitations that applies when the effect of a revision to the Table makes a previously ineligible person eligible to receive compensation or when an eligible person's likelihood of obtaining compensation significantly increases. Under this exception, an individual who may be eligible to file a petition based on the revised Table may file the petition for compensation not later than 2 years after the effective date of the revision if the alleged injury or death occurred not more than 8 years before the effective date of the revision of the Table (42 U.S.C. 300aa-16(b)). This is true even if such individual previously filed a petition for compensation, and is thus an exception to the “one petition per injury” limitation of 42 U.S.C. 300aa-11(b)(2).

    For any vaccine-adverse event pairs for which future scientific evidence develops to support a finding of a causal relationship, the Secretary will consider future rulemaking to revise the Table accordingly.

    III. Comments and Responses

    The NPRM provided a 180-day comment period that resulted in the receipt of 14 written comments—13 from individuals and one from a national organization. In addition, a public hearing on the proposed rule was held on January 14, 2016, during which a representative from the above mentioned national organization presented comments. The organization's oral comments were an expansion of the organization's previously submitted written comments. The Secretary carefully considered all received comments in the development of this final rule. Below is a summary of the comments and the Secretary's responses:

    Comment: One commenter suggested that vaccines are unsafe, disagreed with the process for predicting vaccine harm to humans, and disagreed with the makeup of the “group assembled to force changes in this Table,” calling it a biased group.

    Response: The United States has a long-standing vaccine safety program that closely monitors the safety of vaccines on an ongoing basis. Before vaccines are approved by the Food and Drug Administration (FDA), they are tested and studied extensively by scientists to help ensure they are safe and effective. After vaccines are approved, a critical part of the vaccine safety program is that the Centers for Disease Control and Prevention (CDC)'s Immunization Safety Office (ISO) and FDA monitor for possible vaccine side effects and conduct studies to determine whether health problems are caused by vaccines. CDC's ISO data show that the current U.S. vaccine supply is the safest in history.1 Also, regulating clinical research and reviewing the safety of vaccines are responsibilities of the FDA, not the VICP, and changes in vaccine research and how vaccines are studied and tested are beyond the scope of this final rule.

    1http://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html

    As previously indicated, the Table revisions were based primarily on the 2012 IOM report which was developed after the IOM committee conducted a comprehensive review of the scientific literature on vaccines and adverse events. The committee charged with undertaking this review consisted of 16 members with expertise in the following fields: Pediatrics, internal medicine, neurology, immunology, immunotoxicology, neurobiology, rheumatology, epidemiology, biostatistics, and law. The members of the review committee were subject to stringent conflict of interest criteria by the IOM. In addition, the proposed Table changes were developed by HHS workgroups and reviewed by the ACCV, the membership of which, by statute, reflects a variety of stakeholders with different perspectives.

    Comment: A commenter suggested that shoulder injury related to vaccine administration (SIRVA) as defined in the QAI is too restrictive because the recipient's pain and reduced range of motion must be limited to the shoulder in which the intramuscular vaccine was administered. The commenter stated that such language was an artificial and unnecessary qualification, and expressed concern that recipients who have other symptoms, such as shoulder pain radiating to the neck or upper back, will not have the benefits of a Table injury. The commenter suggested that the QAI be expanded to include the shoulder and parts of the body attributed to that injury.

    Response: SIRVA is a musculoskeletal condition caused by injection of a vaccine intended for intramuscular administration into the shoulder, and, as its name suggests, the condition is localized to the shoulder in which the vaccine was administered. In other words, pain in the neck or back without an injury to the shoulder in which an individual received a vaccine would not be considered SIRVA. Shoulder injuries that are not caused by injection occur frequently in the population. Thus, it is important to have a definition of SIRVA that is clearly associated with vaccine injection. The portion of the QAI limiting the pain and reduced range of motion to the shoulder in which the vaccine was administered is necessary to accurately reflect the vaccine-associated condition.

    Comment: A commenter recommends revising the statute of limitations for filing complex cases, with additional consideration given to the aggravation of preexisting conditions not active until post vaccine(s).

    Response: Revision of the statute of limitations would require a statutory amendment and thus is not within the scope of this final rule.

    Comment: A commenter stated that there is a problem with the VICP's 3-year statute of limitations for filing a claim and the military's 5-year program titled, Temporary Disabled Retirement Listing (TDRL), where active duty military personnel injured by vaccines are placed. The commenter stated that the rules need to be amended and/or waivers granted to military personnel who are severely injured by vaccines so they can seek compensation for damages.

    Response: Amending the Act's statute of limitations is not within the scope of this final rule.

    Comment: A commenter recommended the addition of SIRVA to the vaccine court [sic]. The commenter also indicated a belief that SIRVA is due to lack of education on proper injection technique. The commenter further stated that the CDC should make SIRVA, which the commenter believes is 100 percent preventable, a priority.

    Response: This final rule will add SIRVA as an injury associated with certain vaccines on the Table. In the VICP, claims are adjudicated by special masters in the Court. SIRVA prevention activities are not within the scope of this final rule.

    Comment: A commenter recommended that the VICP transfer a fraction of its compensation responsibilities to pharmaceutical companies, which would incentivize these companies to develop safer vaccines to avoid claim compensation.

    Response: The source of funding for the VICP is the Vaccine Injury Compensation Trust Fund (Trust Fund). The Trust Fund is funded by an excise tax on each dose of vaccines recommended by the CDC for routine administration to children. To the extent that the commenter is proposing a change to the funding mechanism for the VICP, effectuating such a change is beyond the scope of this final rule.

    Comment: A commenter agreed with the Secretary's proposal that SIRVA injuries be added to the Table for the measles, mumps, and rubella (MMR) and varicella vaccines that are currently administered only by percutaneous injection in case an intramuscular injection is available in the future. The commenter suggested that the Table make clear that SIRVA only pertains to intramuscular injection so there is no confusion with respect to vaccines administered using a different method. The commenter also suggested that syncope be added as an injury for vaccines that are administered by jet injectors. The commenter expressed support for the revision of the Table based on new medical findings and for the organizational changes to paragraph (b) of the Table.

    Response: The Secretary agrees that SIRVA should be an injury listed on the Table for potential future formulations of MMR and varicella vaccines that are administered by intramuscular injection, and, therefore, has added SIRVA to the Table for those vaccines despite the fact that currently there are no MMR or varicella vaccines that are administered by intramuscular injection. As such, if an intramuscular formulation of those vaccines is developed in the future, the Table will not need to be amended to allow petitioners to potentially meet the definition for SIRVA in the QAI with respect to those vaccines. The QAI specifically states that SIRVA is a condition related to “administration of a vaccine intended for intramuscular administration in the upper arm.” Thus, the Secretary believes it is clear that to meet the definition of SIRVA in the QAI, the vaccine administered must be one intended for intramuscular injection in the upper arm.

    The Secretary is not aware of any reliable and persuasive evidence demonstrating that syncope occurs following administration of a vaccine via a needleless jet device. While it may be plausible for syncope to occur with this route of administration, given the lack of evidence of syncope following administration of a vaccine via a needleless jet device, the Secretary will not include syncope as a Table injury for vaccines that are administered by a needleless jet device at this time. However, this does not preclude a claim alleging syncope after the administration of a vaccine via needleless jet device from being filed with the program as a non-Table injury.

    Comment: One commenter opposed the revision of the Vaccine Injury Table's QAI for encephalopathy, stating that it is not based on sound science and that it creates a restrictive and exclusionary guideline that unfairly discriminates against children and adults born with certain genes or pre-existing conditions (which may be triggered or significantly aggravated following vaccination). The commenter further contends that due to lack of knowledge about biological mechanisms and high risk factors for vaccine injury, the proposed changes are without ethical, scientific, or legal justification.

    Response: The Secretary respectfully disagrees with the comment that the revised definition for encephalopathy and the new definition for encephalitis in the QAI are not based on firm science. The previous definition of encephalopathy in the QAI was imprecise and did not include the comprehensive criteria used by medical providers, particularly specialists, to diagnose encephalopathy or encephalitis. In addition, the previous QAI did not include any definition for encephalitis, and, therefore, new and more accurate criteria and definitions were necessary. To develop precise definitions for the QAI, an extensive literature search was conducted for reliable, reputable, evidence-based criteria consistently used by medical specialists in the fields of infectious disease and neurology. The Secretary also evaluated information from organizations and publications to formulate definitions, including those responsible for publishing case definitions for the Vaccine Adverse Event Reporting System (2002) and other significant guidelines.

    The commenter also stated that the proposed revisions create a restrictive and exclusionary guideline, unfairly discriminating against children and adults born with certain genes or pre-existing conditions which may be triggered or significantly aggravated following vaccination. The Secretary understands these concerns and agrees that individuals should not be disqualified from potentially receiving VICP compensation due to biodiversity and individual susceptibilities. Certain individuals may not meet the QAI definition, as it is impossible to develop a scientifically sound definition that allows for inclusion of every circumstance, particularly those that may arise when unique and sometimes complex pre-vaccination medical conditions exist.2 However, individuals who do not meet the Table criteria are not precluded from filing a petition, and may be found entitled to receive compensation if they demonstrate that their condition was caused or significantly aggravated by a covered vaccine.

    2 2012 IOM Report, pp. 52, and 82-84.

    Comment: One commenter also noted that, historically, acute and chronic encephalopathy have been acknowledged as a serious complication of pertussis, measles and measles containing vaccines, and have been reported following receipt of other vaccines.

    Response: With regard to this comment, it is important to note that the initial Table and QAI set forth in the 1986 Act reflected Congress's initial determination of vaccine-related injuries for whole cell diphtheria, tetanus, and pertussis (DTwP) vaccine, which is no longer used. Additionally, modifications to the Table and QAI by the Secretary in 1995 were based on scientific findings—the National Childhood Encephalopathy Study and its 10-year follow-up study—related to DTwP vaccine. The IOM committee's conclusions in both 1991 and 1994 were mixed regarding the statistically significant findings of encephalopathy in these studies. After reviewing the evidence, the National Vaccine Advisory Committee (NVAC) voted to remove encephalopathy from the Table. However, in the end, the Secretary, for both scientific and policy reasons, and with support of the ACCV, retained the condition on the Table, but clarified the definition of encephalopathy to make it more clinically precise.

    While the initial Table and QAI were based on studies using DTwP vaccine, the acellular (aP) diphtheria, tetanus, and pertussis (DTaP) vaccine has been the primary formulation used in the United States since 1997 when it was recommended for routine use in children younger than 7 years of age. Current DTaP vaccines were developed because of concerns of reactogenicity with whole cell pertussis.

    To date, no adequate scientific study has been published that demonstrates a causal relationship between either acellular pertussis vaccines or MMR vaccines and encephalopathy or encephalitis. As a result, in its most recent evaluation of adverse events after vaccines (2012), the IOM found that the evidence was inadequate to accept or reject a causal association between either acellular pertussis containing vaccines or MMR vaccines and encephalopathy or encephalitis. Of the large scale studies that have been conducted on DTaP, none have shown an increased risk of encephalopathy or encephalitis after receiving the DTaP vaccine. Furthermore, these studies have demonstrated a significant reduction in the number of common adverse events with acellular pertussis, such as crying and fevers, and less common ones, such as febrile seizures.

    With regard to the MMR vaccine, because natural infection of measles, mumps and/or rubella virus is thought to lead to neurologic illness by damaging neurons through direct viral infection and/or reactivation, it is theorized that the same mechanisms may be responsible for vaccine-associated encephalopathy and encephalitis. However, of the studies examined and described by the IOM in its 2012 report, none identified causality between the MMR vaccine and encephalopathy or encephalitis. Similarly, the IOM concluded that the mechanistic evidence for an association is weak, based on knowledge about natural infection and only a few case reports. Accordingly, the Secretary does not agree that brain inflammation or acute and chronic encephalopathy have been acknowledged as a serious complication of either the DTaP or MMR vaccines. However, for the reasons discussed in the NPRM, the Secretary chose to retain these conditions in the revisions to the Table and QAI.

    Comment: One commenter, when conveying views on acute encephalopathy as “one of the most serious complications of vaccination . . .” also referenced both encephalitis and encephalomyelitis in the discussion.

    Response: The Secretary would like to clarify that encephalitis and encephalomyelitis (which is referred to as acute disseminated encephalomyelitis or ADEM) are distinct conditions. While they share some clinical characteristics, ADEM is a demyelinating condition with distinct differences from other types of encephalitis, as demonstrated on brain magnetic resonance imaging (MRI). The type of encephalitis that was initially attributed to DTwP was not described as demyelinating. Although early ADEM may have laboratory and clinical characteristics similar to acute encephalitis, findings on an MRI are distinct, with only ADEM displaying evidence of acute demyelination. For scientific accuracy, we have excluded ADEM from the Table definition of encephalitis.

    Comment: One commenter, while applauding the expansion of the Vaccine Injury Table and agreeing with the IOM's recommendations, stated that the Table remains wholly inadequate to properly address “the widespread epidemic of vaccine adverse events.” The commenter stated that the reason for this is that science has been corrupted by commercial interests, by financial ties between industry, regulators, and academic institutions and that health care delivery has been compromised by financial ties between industry, physicians, and their trade publications.

    Response: The Secretary believes that the revisions to the Table and QAI increase clarity and scientific accuracy regarding those injuries that will be afforded the Table's presumption of vaccine causation. As previously indicated, the revisions to the Table and QAI were based primarily on the 2012 IOM report which was developed after the IOM committee conducted a comprehensive review of the scientific literature on vaccines and adverse events. The committee charged with undertaking this review consisted of 16 members with expertise in the following fields: pediatrics, internal medicine, neurology, immunology, immunotoxicology, neurobiology, rheumatology, epidemiology, biostatistics, and law. The members of the review committee were subject to stringent conflict of interest criteria by the IOM. In addition, the proposed Table changes were developed by HHS workgroups and reviewed by the ACCV, the membership of which, by statute, reflects a variety of stakeholders with different perspectives.

    Comment: One commenter stated that the Secretary should not make changes to the Vaccine Injury Table that would make it more difficult for “victims” to be compensated.

    Response: The Secretary believes that the revisions to the Table and QAI set forth in this final rule, such as the addition of injuries, will make it easier for petitioners alleging injuries that meet the criteria in the Table and QAI to receive the Table's presumption of causation (which relieves them of having to prove that the vaccine actually caused or significantly aggravated the injury). This will make it easier for such petitioners to receive compensation under the VICP.

    Comment: One commenter asked that additional consideration be given to the human papillomavirus (HPV) vaccination as a cause of postural orthostatic tachycardia syndrome (POTS), a condition where individuals can experience fainting and lightheadedness. The commenter also stated that the “review period” should be indefinite for the HPV vaccine.

    Response: Like all vaccines used in the United States, HPV vaccines are required to go through years of safety testing before they are approved by the FDA. After they are approved and made available to the public, CDC and FDA continue to evaluate vaccines to ensure their safety. To date, there is no medical or scientific evidence that the HPV vaccine causes POTS and safety monitoring has not shown any other problems. Extending the review period for alleged injuries due to the HPV vaccine would require a statutory amendment to the Act's statute of limitations which is not within the scope of the final rule.

    Comment: A commenter requested that food allergies be added to the Table asserting that food proteins that are present in vaccines cause the development of food allergies. The commenter also requested removal of the time limit that compensation is not provided for injuries or death that occurred more than “8 years before the effective date of the revision of the Table” because the commenter believes that “food proteins in vaccines have been causing injury for decades.”

    Response: The Secretary does not agree that food allergies should be added to the Table as injuries. HHS conducted a literature search of the major medical databases for any articles linking the development of food allergies to vaccinations (81 FR 17423, March 29, 2016). Despite an extensive search, HHS found no published research addressing any linkages or potential causality between vaccinations covered by VICP and the development of food allergies in any population. In addition, revision of the Act's statute of limitations would require a statutory amendment and thus is not within the scope of this final rule.

    Comment: One commenter suggested that autism spectrum disorders be added to the Vaccine Injury Table. The commenter also requested removal of the time limit that compensation not be provided for injuries or death that occurred more than “8 years before the effective date of the revision of the Table” because the commenter believes that “bovine milk contaminated vaccines have been causing injury for decades.”

    Response: The Secretary does not agree that autism spectrum disorders should be added as an injury to the Table. The 2012 IOM report found that the epidemiologic and mechanistic evidence favored rejection of a causal relationship between the MMR vaccine and autism. Moreover, in opinions that were upheld on appeal to the U.S. Court of Appeals for the Federal Circuit, special masters of the U.S. Court of Federal Claims held that the MMR, whether administered alone or in conjunction with thimerosal-containing vaccines, is not a causal factor in the development of autism or autism spectrum disorders. In addition, revision of the Act's statute of limitations would require a statutory amendment and thus is not within the purview of this final rule.

    Comment: One commenter stated that thimerosal (a preservative added to vaccines) causes nerve damage.

    Response: The Secretary disagrees with the comment that thimerosal in vaccines causes nerve damage to immunized individuals. Currently, no childhood vaccines used in the U.S. include thimerosal as a preservative, except for some formulations of influenza vaccine in multi-dose vials. When exposure to thimerosal occurs through vaccination, it is at a very low dose, which is readily eliminated from the body. Thimerosal has been used safely in vaccines since the 1930s. According to the CDC, scientists have been studying the use of thimerosal in vaccines for many years. They have not found any evidence that thimerosal causes any harm. Thimerosal use in medical products has a record of being very safe. Data from many studies show no evidence of harm caused by low doses of thimerosal in vaccines.3

    3 Following are referenced thimerosal studies:

    1. Thimerosal Exposure in Infants and Developmental Disorders: A Retrospective Cohort Study in the United Kingdom Does Not Support a Causal Association by Nick Andrews et al. Pediatrics. September 2004. Vol 114: pp. 584-591. http://pediatrics.aappublications.org/cgi/content/full/114/3/584.

    2. Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links with Immunizations by Eric Frombonne et al. Pediatriacs. July 2006. Vol 118: e139-e150. http://pediatrics.aappublications.org/cgi/content/full/118/1/e139.

    3. Association between Thimerosal-Containing Vaccine and Autism by Anders Hviid et al. Journal of the American Medical Association. October 2003. Vol 290: pp. 1763-1766. http://jama.ama-assn.org/cgi/content/full/290/13/1763.

    4. Immunization Safety Review: Vaccines and Autism. Institute of Medicine. The National Academies Press: 2004. http://www.iom.edu/Reports/2004/Immunization-SafetyReview-Vaccines-and-Autism.aspx.

    5. Prenatal and Infant Exposure to Thimerosal from Vaccines and Immunoglobulins and Risk of Autism by Cristofer Price et al. Pediatrics. September 2010. Vol 126: pp. 656-664, http://pediatrics.aappublications.org/cgi/reprint peds. 20100309v1.

    6. Continuing Increases in Autism Reported to California's Developmental Services System by Robert Schechter et al. Archives of General Psychiatry. January 2008. Vol 65: pp. 19-24. http://archpsyc.ama-assn.org/cgi/content/full/65/1/19.

    7. Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years by William Thompson et al. The New England Journal of Medicine. September 2007. Vol 357: pages 1281-1292. http://www.nejm.org/doi/pdf/10.1056/NEJMoa071434.

    Economic and Regulatory Impact

    Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits (including potential economic, environmental, public health, safety, distributive, and equity effects). In addition, under the Regulatory Flexibility Act, if a rule has a significant economic effect on a substantial number of small entities the Secretary must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule.

    Executive Order 12866 requires that all regulations reflect consideration of alternatives, costs, benefits, incentives, equity, and available information. Regulations must meet certain standards, such as avoiding an unnecessary burden. Regulations that are “significant” because of cost, adverse effects on the economy, inconsistency with other agency actions, effects on the budget, or novel legal or policy issues require special analysis.

    The Secretary has determined that no resources are required to implement the requirements in this rule. Compensation will be made in the same manner. This final rule only lessens the burden of proof for potential petitioners. Therefore, in accordance with the Regulatory Flexibility Act of 1980 (RFA), and the Small Business Regulatory Enforcement Act of 1996, which amended the RFA, the Secretary certifies that this rule will not have a significant impact on a substantial number of small entities.

    The Secretary has also determined that this final rule does not meet the criteria for a major rule as defined by Executive Order 12866 and would have no major effect on the economy or Federal expenditures. We have determined that the final rule is not a “major rule” within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, it will not have effects on State, local, and tribal governments and on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995.

    The provisions of this rule do not, on the basis of family well-being, affect the following family elements: Family safety; family stability; marital commitment; parental rights in the education, nurture and supervision of their children; family functioning; disposable income or poverty; or the behavior and personal responsibility of youth, as determined under section 654(c) of the Treasury and General Government Appropriations Act of 1999.

    This rule is not being treated as a “significant regulatory action” as defined under section 3(f) of Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget.

    As stated above, this final rule will modify the Vaccine Injury Table and its Qualifications and Aids to Interpretation based on legal authority.

    Impact of the New Rule

    This final rule will have the effect of making it easier for future petitioners alleging injuries that meet the criteria in the Vaccine Injury Table to receive the Table's presumption of causation (which relieves them of having to prove that the vaccine actually caused or significantly aggravated the injury).

    Paperwork Reduction Act of 1995

    This final rule has no information collection requirements.

    Dated: January 6, 2017. James Macrae, Acting Administrator, Health Resources and Services Administration. Approved: January 9, 2017. Sylvia M. Burwell, Secretary, Department of Health and Human Services. List of Subjects in 42 CFR Part 100

    Biologics, Health insurance, Immunization.

    National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table

    Therefore, for the reasons stated in the preamble, the Department of Health and Human Services amends 42 CFR part 100 as follows:

    PART 100—VACCINE INJURY COMPENSATION 1. The authority citation for 42 CFR part 100 continues to read as follows: Authority:

    Secs. 312 and 313 of Public Law 99-660 (42 U.S.C. 300aa-1 note); 42 U.S.C. 300aa-10 to 300aa-34; 26 U.S.C. 4132(a); and sec. 13632(a)(3) of Public Law 103-66.

    2. Revise § 100.3 to read as follows:
    § 100.3 Vaccine injury table.

    (a) In accordance with section 312(b) of the National Childhood Vaccine Injury Act of 1986, title III of Public Law 99-660, 100 Stat. 3779 (42 U.S.C. 300aa-1 note) and section 2114(c) of the Public Health Service Act, as amended (PHS Act) (42 U.S.C. 300aa-14(c)), the following is a table of vaccines, the injuries, disabilities, illnesses, conditions, and deaths resulting from the administration of such vaccines, and the time period in which the first symptom or manifestation of onset or of the significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths is to occur after vaccine administration for purposes of receiving compensation under the Program. Paragraph (b) of this section sets forth additional provisions that are not separately listed in this Table but that constitute part of it. Paragraph (c) of this section sets forth the qualifications and aids to interpretation for the terms used in the Table. Conditions and injuries that do not meet the terms of the qualifications and aids to interpretation are not within the Table. Paragraph (d) of this section sets forth a glossary of terms used in paragraph (c).

    Vaccine Injury Table Vaccine Illness, disability, injury or condition covered Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration I. Vaccines containing tetanus toxoid (e.g., DTaP, DTP, DT, Td, or TT) A. Anaphylaxis
  • B. Brachial Neuritis
  • ≤4 hours.
  • 2-28 days (not less than 2 days and not more than 28 days).
  • C. Shoulder Injury Related to Vaccine Administration ≤48 hours. D. Vasovagal syncope ≤1 hour. II. Vaccines containing whole cell pertussis bacteria, extracted or partial cell pertussis bacteria, or specific pertussis antigen(s) (e.g., DTP, DTaP, P, DTP-Hib) A. Anaphylaxis ≤4 hours. B. Encephalopathy or encephalitis ≤72 hours. C. Shoulder Injury Related to Vaccine Administration ≤48 hours. D. Vasovagal syncope ≤1 hour. III. Vaccines containing measles, mumps, and rubella virus or any of its components (e.g., MMR, MM, MMRV) A. Anaphylaxis
  • B. Encephalopathy or encephalitis
  • ≤4 hours.
  • 5-15 days (not less than 5 days and not more than 15 days).
  • C. Shoulder Injury Related to Vaccine Administration ≤48 hours. D. Vasovagal syncope ≤1 hour. IV. Vaccines containing rubella virus (e.g., MMR, MMRV) A. Chronic arthritis 7-42 days (not less than 7 days and not more than 42 days). V. Vaccines containing measles virus (e.g., MMR, MM, MMRV) A. Thrombocytopenic purpura 7-30 days (not less than 7 days and not more than 30 days). B. Vaccine-Strain Measles Viral Disease in an immunodeficient recipient —Vaccine-strain virus identified Not applicable. —If strain determination is not done or if laboratory testing is inconclusive ≤12 months. VI. Vaccines containing polio live virus (OPV) A. Paralytic Polio —in a non-immunodeficient recipient ≤30 days. —in an immunodeficient recipient ≤6 months. —in a vaccine associated community case Not applicable. B. Vaccine-Strain Polio Viral Infection —in a non-immunodeficient recipient ≤30 days. —in an immunodeficient recipient ≤6 months. —in a vaccine associated community case Not applicable. VII. Vaccines containing polio inactivated virus (e.g., IPV) A. Anaphylaxis ≤4 hours. B. Shoulder Injury Related to Vaccine Administration ≤48 hours. C. Vasovagal syncope ≤1 hour. VIII. Hepatitis B vaccines A. Anaphylaxis ≤4 hours. B. Shoulder Injury Related to Vaccine Administration ≤48 hours. C. Vasovagal syncope ≤1 hour. IX. Haemophilus influenzae type b (Hib) vaccines A. Shoulder Injury Related to Vaccine Administration ≤48 hours. B. Vasovagal syncope ≤1 hour. X. Varicella vaccines A. Anaphylaxis ≤4 hours. B. Disseminated varicella vaccine-strain viral disease —Vaccine-strain virus identified Not applicable. —If strain determination is not done or if laboratory testing is inconclusive 7-42 days (not less than 7 days and not more than 42 days). C. Varicella vaccine-strain viral reactivation Not applicable. D. Shoulder Injury Related to Vaccine Administration ≤48 hours. E. Vasovagal syncope ≤1 hour. XI. Rotavirus vaccines A. Intussusception 1-21 days (not less than 1 day and not more than 21 days). XII. Pneumococcal conjugate vaccines A. Shoulder Injury Related to Vaccine Administration ≤48 hours. B. Vasovagal syncope ≤1 hour. XIII. Hepatitis A vaccines A. Shoulder Injury Related to Vaccine Administration ≤48 hours. B. Vasovagal syncope ≤1 hour. XIV. Seasonal influenza vaccines A. Anaphylaxis ≤4 hours. B. Shoulder Injury Related to Vaccine Administration ≤48 hours. C. Vasovagal syncope ≤1 hour. D. Guillain-Barré Syndrome 3-42 days (not less than 3 days and not more than 42 days). XV. Meningococcal vaccines A. Anaphylaxis ≤4 hours. B. Shoulder Injury Related to Vaccine Administration ≤48 hours. C. Vasovagal syncope ≤1 hour. XVI. Human papillomavirus (HPV) vaccines A. Anaphylaxis ≤4 hours. B. Shoulder Injury Related to Vaccine Administration ≤48 hours. C. Vasovagal syncope ≤1 hour. XVII. Any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children, after publication by the Secretary of a notice of coverage A. Shoulder Injury Related to Vaccine Administration ≤48 hours. B. Vasovagal syncope ≤1hour.

    (b) Provisions that apply to all conditions listed. (1) Any acute complication or sequela, including death, of the illness, disability, injury, or condition listed in paragraph (a) of this section (and defined in paragraphs (c) and (d) of this section) qualifies as a Table injury under paragraph (a) except when the definition in paragraph (c) requires exclusion.

    (2) In determining whether or not an injury is a condition set forth in paragraph (a) of this section, the Court shall consider the entire medical record.

    (3) An idiopathic condition that meets the definition of an illness, disability, injury, or condition set forth in paragraph (c) of this section shall be considered to be a condition set forth in paragraph (a) of this section.

    (c) Qualifications and aids to interpretation. The following qualifications and aids to interpretation shall apply to, define and describe the scope of, and be read in conjunction with paragraphs (a), (b), and (d) of this section:

    (1) Anaphylaxis. Anaphylaxis is an acute, severe, and potentially lethal systemic reaction that occurs as a single discrete event with simultaneous involvement of two or more organ systems. Most cases resolve without sequela. Signs and symptoms begin minutes to a few hours after exposure. Death, if it occurs, usually results from airway obstruction caused by laryngeal edema or bronchospasm and may be associated with cardiovascular collapse. Other significant clinical signs and symptoms may include the following: Cyanosis, hypotension, bradycardia, tachycardia, arrhythmia, edema of the pharynx and/or trachea and/or larynx with stridor and dyspnea. There are no specific pathological findings to confirm a diagnosis of anaphylaxis.

    (2) Encephalopathy. A vaccine recipient shall be considered to have suffered an encephalopathy if an injury meeting the description below of an acute encephalopathy occurs within the applicable time period and results in a chronic encephalopathy, as described in paragraph (d) of this section.

    (i) Acute encephalopathy. (A) For children less than 18 months of age who present:

    (1) Without a seizure, an acute encephalopathy is indicated by a significantly decreased level of consciousness that lasts at least 24 hours.

    (2) Following a seizure, an acute encephalopathy is demonstrated by a significantly decreased level of consciousness that lasts at least 24 hours and cannot be attributed to a postictal state—from a seizure or a medication.

    (B) For adults and children 18 months of age or older, an acute encephalopathy is one that persists at least 24 hours and is characterized by at least two of the following:

    (1) A significant change in mental status that is not medication related (such as a confusional state, delirium, or psychosis);

    (2) A significantly decreased level of consciousness which is independent of a seizure and cannot be attributed to the effects of medication; and

    (3) A seizure associated with loss of consciousness.

    (C) The following clinical features in themselves do not demonstrate an acute encephalopathy or a significant change in either mental status or level of consciousness: Sleepiness, irritability (fussiness), high-pitched and unusual screaming, poor feeding, persistent inconsolable crying, bulging fontanelle, or symptoms of dementia.

    (D) Seizures in themselves are not sufficient to constitute a diagnosis of encephalopathy and in the absence of other evidence of an acute encephalopathy seizures shall not be viewed as the first symptom or manifestation of an acute encephalopathy.

    (ii) Exclusionary criteria for encephalopathy. Regardless of whether or not the specific cause of the underlying condition, systemic disease, or acute event (including an infectious organism) is known, an encephalopathy shall not be considered to be a condition set forth in the Table if it is shown that the encephalopathy was caused by:

    (A) An underlying condition or systemic disease shown to be unrelated to the vaccine (such as malignancy, structural lesion, psychiatric illness, dementia, genetic disorder, prenatal or perinatal central nervous system (CNS) injury); or

    (B) An acute event shown to be unrelated to the vaccine such as a head trauma, stroke, transient ischemic attack, complicated migraine, drug use (illicit or prescribed) or an infectious disease.

    (3) Encephalitis. A vaccine recipient shall be considered to have suffered encephalitis if an injury meeting the description below of acute encephalitis occurs within the applicable time period and results in a chronic encephalopathy, as described in paragraph (d) of this section.

    (i) Acute encephalitis. Encephalitis is indicated by evidence of neurologic dysfunction, as described in paragraph (c)(3)(i)(A) of this section, plus evidence of an inflammatory process in the brain, as described in paragraph (c)(3)(i)(B) of this section.

    (A) Evidence of neurologic dysfunction consists of either:

    (1) One of the following neurologic findings referable to the CNS: Focal cortical signs (such as aphasia, alexia, agraphia, cortical blindness); cranial nerve abnormalities; visual field defects; abnormal presence of primitive reflexes (such as Babinski's sign or sucking reflex); or cerebellar dysfunction (such as ataxia, dysmetria, or nystagmus); or

    (2) An acute encephalopathy as set forth in paragraph (c)(2)(i) of this section.

    (B) Evidence of an inflammatory process in the brain (central nervous system or CNS inflammation) must include cerebrospinal fluid (CSF) pleocytosis (>5 white blood cells (WBC)/mm3 in children >2 months of age and adults; >15 WBC/mm3 in children <2 months of age); or at least two of the following:

    (1) Fever (temperature ≥ 100.4 degrees Fahrenheit);

    (2) Electroencephalogram findings consistent with encephalitis, such as diffuse or multifocal nonspecific background slowing and periodic discharges; or

    (3) Neuroimaging findings consistent with encephalitis, which include, but are not limited to brain/spine magnetic resonance imaging (MRI) displaying diffuse or multifocal areas of hyperintense signal on T2-weighted, diffusion-weighted image, or fluid-attenuation inversion recovery sequences.

    (ii) Exclusionary criteria for encephalitis. Regardless of whether or not the specific cause of the underlying condition, systemic disease, or acute event (including an infectious organism) is known, encephalitis shall not be considered to be a condition set forth in the Table if it is shown that the encephalitis was caused by:

    (A) An underlying malignancy that led to a paraneoplastic encephalitis;

    (B) An infectious disease associated with encephalitis, including a bacterial, parasitic, fungal or viral illness (such as herpes viruses, adenovirus, enterovirus, West Nile Virus, or human immunodeficiency virus), which may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing; or

    (C) Acute disseminated encephalomyelitis (ADEM). Although early ADEM may have laboratory and clinical characteristics similar to acute encephalitis, findings on MRI are distinct with ADEM displaying evidence of acute demyelination (scattered, focal, or multifocal areas of inflammation and demyelination within cerebral subcortical and deep cortical white matter; gray matter involvement may also be seen but is a minor component); or

    (D) Other conditions or abnormalities that would explain the vaccine recipient's symptoms.

    (4) Intussusception. (i) For purposes of paragraph (a) of this section, intussusception means the invagination of a segment of intestine into the next segment of intestine, resulting in bowel obstruction, diminished arterial blood supply, and blockage of the venous blood flow. This is characterized by a sudden onset of abdominal pain that may be manifested by anguished crying, irritability, vomiting, abdominal swelling, and/or passing of stools mixed with blood and mucus.

    (ii) For purposes of paragraph (a) of this section, the following shall not be considered to be a Table intussusception:

    (A) Onset that occurs with or after the third dose of a vaccine containing rotavirus;

    (B) Onset within 14 days after an infectious disease associated with intussusception, including viral disease (such as those secondary to non-enteric or enteric adenovirus, or other enteric viruses such as Enterovirus), enteric bacteria (such as Campylobacter jejuni), or enteric parasites (such as Ascaris lumbricoides), which may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing;

    (C) Onset in a person with a preexisting condition identified as the lead point for intussusception such as intestinal masses and cystic structures (such as polyps, tumors, Meckel's diverticulum, lymphoma, or duplication cysts);

    (D) Onset in a person with abnormalities of the bowel, including congenital anatomic abnormalities, anatomic changes after abdominal surgery, and other anatomic bowel abnormalities caused by mucosal hemorrhage, trauma, or abnormal intestinal blood vessels (such as Henoch Scholein purpura, hematoma, or hemangioma); or

    (E) Onset in a person with underlying conditions or systemic diseases associated with intussusception (such as cystic fibrosis, celiac disease, or Kawasaki disease).

    (5) Chronic arthritis. Chronic arthritis is defined as persistent joint swelling with at least two additional manifestations of warmth, tenderness, pain with movement, or limited range of motion, lasting for at least 6 months.

    (i) Chronic arthritis may be found in a person with no history in the 3 years prior to vaccination of arthropathy (joint disease) on the basis of:

    (A) Medical documentation recorded within 30 days after the onset of objective signs of acute arthritis (joint swelling) that occurred between 7 and 42 days after a rubella vaccination; and

    (B) Medical documentation (recorded within 3 years after the onset of acute arthritis) of the persistence of objective signs of intermittent or continuous arthritis for more than 6 months following vaccination; and

    (C) Medical documentation of an antibody response to the rubella virus.

    (ii) The following shall not be considered as chronic arthritis: Musculoskeletal disorders such as diffuse connective tissue diseases (including but not limited to rheumatoid arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis/determatomyositis, fibromyalgia, necrotizing vasculitis and vasculopathies and Sjogren's Syndrome), degenerative joint disease, infectious agents other than rubella (whether by direct invasion or as an immune reaction), metabolic and endocrine diseases, trauma, neoplasms, neuropathic disorders, bone and cartilage disorders, and arthritis associated with ankylosing spondylitis, psoriasis, inflammatory bowel disease, Reiter's Syndrome, blood disorders, or arthralgia (joint pain), or joint stiffness without swelling.

    (6) Brachial neuritis. This term is defined as dysfunction limited to the upper extremity nerve plexus (i.e., its trunks, divisions, or cords). A deep, steady, often severe aching pain in the shoulder and upper arm usually heralds onset of the condition. The pain is typically followed in days or weeks by weakness in the affected upper extremity muscle groups. Sensory loss may accompany the motor deficits, but is generally a less notable clinical feature. Atrophy of the affected muscles may occur. The neuritis, or plexopathy, may be present on the same side or on the side opposite the injection. It is sometimes bilateral, affecting both upper extremities. A vaccine recipient shall be considered to have suffered brachial neuritis as a Table injury if such recipient manifests all of the following:

    (i) Pain in the affected arm and shoulder is a presenting symptom and occurs within the specified time-frame;

    (ii) Weakness;

    (A) Clinical diagnosis in the absence of nerve conduction and electromyographic studies requires weakness in muscles supplied by more than one peripheral nerve.

    (B) Nerve conduction studies (NCS) and electromyographic (EMG) studies localizing the injury to the brachial plexus are required before the diagnosis can be made if weakness is limited to muscles supplied by a single peripheral nerve.

    (iii) Motor, sensory, and reflex findings on physical examination and the results of NCS and EMG studies, if performed, must be consistent in confirming that dysfunction is attributable to the brachial plexus; and

    (iv) No other condition or abnormality is present that would explain the vaccine recipient's symptoms.

    (7) Thrombocytopenic purpura. This term is defined by the presence of clinical manifestations, such as petechiae, significant bruising, or spontaneous bleeding, and by a serum platelet count less than 50,000/mm3 with normal red and white blood cell indices. Thrombocytopenic purpura does not include cases of thrombocytopenia associated with other causes such as hypersplenism, autoimmune disorders (including alloantibodies from previous transfusions) myelodysplasias, lymphoproliferative disorders, congenital thrombocytopenia or hemolytic uremic syndrome. Thrombocytopenic purpura does not include cases of immune (formerly called idiopathic) thrombocytopenic purpura that are mediated, for example, by viral or fungal infections, toxins or drugs. Thrombocytopenic purpura does not include cases of thrombocytopenia associated with disseminated intravascular coagulation, as observed with bacterial and viral infections. Viral infections include, for example, those infections secondary to Epstein Barr virus, cytomegalovirus, hepatitis A and B, human immunodeficiency virus, adenovirus, and dengue virus. An antecedent viral infection may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing. However, if culture or serologic testing is performed, and the viral illness is attributed to the vaccine-strain measles virus, the presumption of causation will remain in effect. Bone marrow examination, if performed, must reveal a normal or an increased number of megakaryocytes in an otherwise normal marrow.

    (8) Vaccine-strain measles viral disease. This term is defined as a measles illness that involves the skin and/or another organ (such as the brain or lungs). Measles virus must be isolated from the affected organ or histopathologic findings characteristic for the disease must be present. Measles viral strain determination may be performed by methods such as polymerase chain reaction test and vaccine-specific monoclonal antibody. If strain determination reveals wild-type measles virus or another, non-vaccine-strain virus, the disease shall not be considered to be a condition set forth in the Table. If strain determination is not done or if the strain cannot be identified, onset of illness in any organ must occur within 12 months after vaccination.

    (9) Vaccine-strain polio viral infection. This term is defined as a disease caused by poliovirus that is isolated from the affected tissue and should be determined to be the vaccine-strain by oligonucleotide or polymerase chain reaction. Isolation of poliovirus from the stool is not sufficient to establish a tissue specific infection or disease caused by vaccine-strain poliovirus.

    (10) Shoulder injury related to vaccine administration (SIRVA). SIRVA manifests as shoulder pain and limited range of motion occurring after the administration of a vaccine intended for intramuscular administration in the upper arm. These symptoms are thought to occur as a result of unintended injection of vaccine antigen or trauma from the needle into and around the underlying bursa of the shoulder resulting in an inflammatory reaction. SIRVA is caused by an injury to the musculoskeletal structures of the shoulder (e.g. tendons, ligaments, bursae, etc.). SIRVA is not a neurological injury and abnormalities on neurological examination or nerve conduction studies (NCS) and/or electromyographic (EMG) studies would not support SIRVA as a diagnosis (even if the condition causing the neurological abnormality is not known). A vaccine recipient shall be considered to have suffered SIRVA if such recipient manifests all of the following:

    (i) No history of pain, inflammation or dysfunction of the affected shoulder prior to intramuscular vaccine administration that would explain the alleged signs, symptoms, examination findings, and/or diagnostic studies occurring after vaccine injection;

    (ii) Pain occurs within the specified time-frame;

    (iii) Pain and reduced range of motion are limited to the shoulder in which the intramuscular vaccine was administered; and

    (iv) No other condition or abnormality is present that would explain the patient's symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis, mononeuropathies, or any other neuropathy).

    (11) Disseminated varicella vaccine-strain viral disease. Disseminated varicella vaccine-strain viral disease is defined as a varicella illness that involves the skin beyond the dermatome in which the vaccination was given and/or disease caused by vaccine-strain varicella in another organ. For organs other than the skin, the disease must be demonstrated in the involved organ and not just through mildly abnormal laboratory values. If there is involvement of an organ beyond the skin, and no virus was identified in that organ, the involvement of all organs must occur as part of the same, discrete illness. If strain determination reveals wild-type varicella virus or another, non-vaccine-strain virus, the viral disease shall not be considered to be a condition set forth in the Table. If strain determination is not done or if the strain cannot be identified, onset of illness in any organ must occur 7- 42 days after vaccination.

    (12) Varicella vaccine-strain viral reactivation disease. Varicella vaccine-strain viral reactivation disease is defined as the presence of the rash of herpes zoster with or without concurrent disease in an organ other than the skin. Zoster, or shingles, is a painful, unilateral, pruritic rash appearing in one or more sensory dermatomes. For organs other than the skin, the disease must be demonstrated in the involved organ and not just through mildly abnormal laboratory values. There must be laboratory confirmation that the vaccine-strain of the varicella virus is present in the skin or in any other involved organ, for example by oligonucleotide or polymerase chain reaction. If strain determination reveals wild-type varicella virus or another, non-vaccine-strain virus, the viral disease shall not be considered to be a condition set forth in the Table.

    (13) Vasovagal syncope. Vasovagal syncope (also sometimes called neurocardiogenic syncope) means loss of consciousness (fainting) and postural tone caused by a transient decrease in blood flow to the brain occurring after the administration of an injected vaccine. Vasovagal syncope is usually a benign condition but may result in falling and injury with significant sequela. Vasovagal syncope may be preceded by symptoms such as nausea, lightheadedness, diaphoresis, and/or pallor. Vasovagal syncope may be associated with transient seizure-like activity, but recovery of orientation and consciousness generally occurs simultaneously with vasovagal syncope. Loss of consciousness resulting from the following conditions will not be considered vasovagal syncope: organic heart disease, cardiac arrhythmias, transient ischemic attacks, hyperventilation, metabolic conditions, neurological conditions, and seizures. Episodes of recurrent syncope occurring after the applicable time period are not considered to be sequela of an episode of syncope meeting the Table requirements.

    (14) Immunodeficient recipient. Immunodeficient recipient is defined as an individual with an identified defect in the immunological system which impairs the body's ability to fight infections. The identified defect may be due to an inherited disorder (such as severe combined immunodeficiency resulting in absent T lymphocytes), or an acquired disorder (such as acquired immunodeficiency syndrome resulting from decreased CD4 cell counts). The identified defect must be demonstrated in the medical records, either preceding or postdating vaccination.

    (15) Guillain-Barré Syndrome (GBS). (i) GBS is an acute monophasic peripheral neuropathy that encompasses a spectrum of four clinicopathological subtypes described below. For each subtype of GBS, the interval between the first appearance of symptoms and the nadir of weakness is between 12 hours and 28 days. This is followed in all subtypes by a clinical plateau with stabilization at the nadir of symptoms, or subsequent improvement without significant relapse. Death may occur without a clinical plateau. Treatment related fluctuations in all subtypes of GBS can occur within 9 weeks of GBS symptom onset and recurrence of symptoms after this time-frame would not be consistent with GBS.

    (ii) The most common subtype in North America and Europe, comprising more than 90 percent of cases, is acute inflammatory demyelinating polyneuropathy (AIDP), which has the pathologic and electrodiagnostic features of focal demyelination of motor and sensory peripheral nerves and nerve roots. Another subtype called acute motor axonal neuropathy (AMAN) is generally seen in other parts of the world and is predominated by axonal damage that primarily affects motor nerves. AMAN lacks features of demyelination. Another less common subtype of GBS includes acute motor and sensory neuropathy (AMSAN), which is an axonal form of GBS that is similar to AMAN, but also affects the sensory nerves and roots. AIDP, AMAN, and AMSAN are typically characterized by symmetric motor flaccid weakness, sensory abnormalities, and/or autonomic dysfunction caused by autoimmune damage to peripheral nerves and nerve roots. The diagnosis of AIDP, AMAN, and AMSAN requires:

    (A) Bilateral flaccid limb weakness and decreased or absent deep tendon reflexes in weak limbs;

    (B) A monophasic illness pattern;

    (C) An interval between onset and nadir of weakness between 12 hours and 28 days;

    (D) Subsequent clinical plateau (the clinical plateau leads to either stabilization at the nadir of symptoms, or subsequent improvement without significant relapse; however, death may occur without a clinical plateau); and,

    (E) The absence of an identified more likely alternative diagnosis.

    (iii) Fisher Syndrome (FS), also known as Miller Fisher Syndrome, is a subtype of GBS characterized by ataxia, areflexia, and ophthalmoplegia, and overlap between FS and AIDP may be seen with limb weakness. The diagnosis of FS requires:

    (A) Bilateral ophthalmoparesis;

    (B) Bilateral reduced or absent tendon reflexes;

    (C) Ataxia;

    (D) The absence of limb weakness (the presence of limb weakness suggests a diagnosis of AIDP, AMAN, or AMSAN);

    (E) A monophasic illness pattern;

    (F) An interval between onset and nadir of weakness between 12 hours and 28 days;

    (G) Subsequent clinical plateau (the clinical plateau leads to either

    stabilization at the nadir of symptoms, or subsequent improvement without significant relapse; however, death may occur without a clinical plateau);

    (H) No alteration in consciousness;

    (I) No corticospinal track signs; and

    (J) The absence of an identified more likely alternative diagnosis.

    (iv) Evidence that is supportive, but not required, of a diagnosis of all subtypes of GBS includes electrophysiologic findings consistent with GBS or an elevation of cerebral spinal fluid (CSF) protein with a total CSF white blood cell count below 50 cells per microliter. Both CSF and electrophysiologic studies are frequently normal in the first week of illness in otherwise typical cases of GBS.

    (v) To qualify as any subtype of GBS, there must not be a more likely alternative diagnosis for the weakness.

    (vi) Exclusionary criteria for the diagnosis of all subtypes of GBS include the ultimate diagnosis of any of the following conditions: chronic immune demyelinating polyradiculopathy (CIDP), carcinomatous meningitis, brain stem encephalitis (other than Bickerstaff brainstem encephalitis), myelitis, spinal cord infarct, spinal cord compression, anterior horn cell diseases such as polio or West Nile virus infection, subacute inflammatory demyelinating polyradiculoneuropathy, multiple sclerosis, cauda equina compression, metabolic conditions such as hypermagnesemia or hypophosphatemia, tick paralysis, heavy metal toxicity (such as arsenic, gold, or thallium), drug-induced neuropathy (such as vincristine, platinum compounds, or nitrofurantoin), porphyria, critical illness neuropathy, vasculitis, diphtheria, myasthenia gravis, organophosphate poisoning, botulism, critical illness myopathy, polymyositis, dermatomyositis, hypokalemia, or hyperkalemia. The above list is not exhaustive.

    (d) Glossary for purposes of paragraph (c) of this section—(1) Chronic encephalopathy. (i) A chronic encephalopathy occurs when a change in mental or neurologic status, first manifested during the applicable Table time period as an acute encephalopathy or encephalitis, persists for at least 6 months from the first symptom or manifestation of onset or of significant aggravation of an acute encephalopathy or encephalitis.

    (ii) Individuals who return to their baseline neurologic state, as confirmed by clinical findings, within less than 6 months from the first symptom or manifestation of onset or of significant aggravation of an acute encephalopathy or encephalitis shall not be presumed to have suffered residual neurologic damage from that event; any subsequent chronic encephalopathy shall not be presumed to be a sequela of the acute encephalopathy or encephalitis.

    (2) Injected refers to the intramuscular, intradermal, or subcutaneous needle administration of a vaccine.

    (3) Sequela means a condition or event which was actually caused by a condition listed in the Vaccine Injury Table.

    (4) Significantly decreased level of consciousness is indicated by the presence of one or more of the following clinical signs:

    (i) Decreased or absent response to environment (responds, if at all, only to loud voice or painful stimuli);

    (ii) Decreased or absent eye contact (does not fix gaze upon family members or other individuals); or

    (iii) Inconsistent or absent responses to external stimuli (does not recognize familiar people or things).

    (5) Seizure includes myoclonic, generalized tonic-clonic (grand mal), and simple and complex partial seizures, but not absence (petit mal), or pseudo seizures. Jerking movements or staring episodes alone are not necessarily an indication of seizure activity.

    (e) Coverage provisions. (1) Except as provided in paragraph (e)(2), (3), (4), (5), (6), (7), or (8) of this section, this section applies only to petitions for compensation under the program filed with the United States Court of Federal Claims on or after February 21, 2017.

    (2) Hepatitis B, Hib, and varicella vaccines (Items VIII, IX, and X of the Table) are included in the Table as of August 6, 1997.

    (3) Rotavirus vaccines (Item XI of the Table) are included in the Table as of October 22, 1998.

    (4) Pneumococcal conjugate vaccines (Item XII of the Table) are included in the Table as of December 18, 1999.

    (5) Hepatitis A vaccines (Item XIII of the Table) are included on the Table as of December 1, 2004.

    (6) Trivalent influenza vaccines (Included in item XIV of the Table) are included on the Table as of July 1, 2005. All other seasonal influenza vaccines (Item XIV of the Table) are included on the Table as of November 12, 2013.

    (7) Meningococcal vaccines and human papillomavirus vaccines (Items XV and XVI of the Table) are included on the Table as of February 1, 2007.

    (8) Other new vaccines (Item XVII of the Table) will be included in the Table as of the effective date of a tax enacted to provide funds for compensation paid with respect to such vaccines. An amendment to this section will be published in the Federal Register to announce the effective date of such a tax.

    [FR Doc. 2017-00701 Filed 1-18-17; 8:45 am] BILLING CODE 4160-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management 43 CFR Part 3160 [17X.LLWO310000.L13100000.PP0000] RIN 1004-AE49 Onshore Oil and Gas Operations—Annual Civil Penalties Inflation Adjustments AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Final rule.

    SUMMARY:

    This rule adjusts the level of civil monetary penalties contained in the Bureau of Land Management's regulations governing onshore oil and gas operations as required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the “Act”). The adjustments made by this final rule constitute the annual inflation adjustments contemplated by the Act, and are consistent with applicable Office of Management and Budget (OMB) guidance.

    DATES:

    This rule is effective on January 19, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Steven Wells, Division Chief, Fluid Minerals Division, 202-912-7143, for information regarding the BLM's Fluid Minerals Program. For questions relating to regulatory process issues, please contact Jennifer Noe, Division of Regulatory Affairs, at 202-912-7442. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339, 24 hours a day, 7 days a week to contact the above individuals.

    SUPPLEMENTARY INFORMATION:

    I. Background II. Calculation of Adjustment III. Procedural Requirements A. Regulatory Planning and Review (E.O. 12866 and 13563) B. Regulatory Flexibility Act C. Small Business Regulatory Enforcement Fairness Act D. Unfunded Mandates Reform Act E. Takings (E.O. 12630) F. Federalism (E.O. 13132) G. Civil Justice Reform (E.O. 12988) H. Consultation with Indian Tribes (E.O. 13175 and Departmental Policy) I. Paperwork Reduction Act J. National Environmental Policy Act K. Effects on the Energy Supply (E.O. 13211) L. Administrative Procedure Act I. Background

    On November 2, 2015, the President signed the Act into law (Sec. 701 of Pub. L. 114-74). The Act requires agencies to:

    1. Adjust the level of civil monetary penalties with an initial “catch-up” adjustment through an interim final rulemaking in 2016;

    2. Make subsequent annual adjustments for inflation beginning in 2017; and

    3. Report annually in Agency Financial Reports on these inflation adjustments.

    In July 2016, the BLM issued an interim final rule that adjusted the level of civil monetary penalties with the initial “catch-up” adjustment, which is reflected in the table below in the “Previous Penalty” column.

    With this final rule, the BLM is adjusting civil monetary penalties for inflation. The adjustments made by this rule are consistent with the requirements of the Act and OMB guidance.

    The purpose of these adjustments is to maintain the deterrent effect of civil penalties found in existing regulations, in order to further the policy goals of the underlying statutes. The BLM has reviewed its existing regulations and determined that only the civil monetary penalties found at 43 CFR 3163.2 are subject to the Act's requirements.

    The adjustments made by this final rule constitute the first annual adjustment contemplated by the Act, and include the following changes to the penalties:

    CFR Citation Description of the penalty Previous
  • penalty
  • Adjusted
  • penalty
  • 43 CFR 3163.2(a) Failure to comply $1,031 $1,048 43 CFR 3163.2(b) If corrective action is not taken 10,314 10,483 43 CFR 3163.2(d) If transporter fails to permit inspection for documentation 1,031 1,048 43 CFR 3163.2(e) Failure to permit inspection, failure to notify 20,628 20,965 43 CFR 3163.2(f) False or inaccurate documents; unlawful transfer or purchase 51,570 52,414 43 CFR 3163.2(g)(1) Initial penalty under 43 CFR 3163.2(a) for a major violation 1,031 1,048 43 CFR 3163.2(g)(1) Maximum penalty under 43 CFR 3163.2(a) for a major violation 2,063 2,097 43 CFR 3163.2(g)(1) Initial penalty under 43 CFR 3163.2(b) for a major violation 10,314 10,483 43 CFR 3163.2(g)(1) Maximum penalty under 43 CFR 3163.2(b) for a major violation 20,628 20,965 43 CFR 3163.2(g)(1) Penalty under 43 CFR 3163.2(d) for a major violation 1,031 1,048 43 CFR 3163.2(g)(1) Penalty under 43 CFR 3163.2(e) for a major violation 20,628 20,965 43 CFR 3163.2(g)(1) Penalty under 43 CFR 3163.2(f) for a major violation 51,570 52,414 43 CFR 3163.2(g)(2)(iii) Initial penalty under 43 CFR 3163.2(a) for a minor violation 103 105 43 CFR 3163.2(g)(2)(iii) Initial penalty under 43 CFR 3163.2(b) for a minor violation 1,031 1,048 43 CFR 3163.2(g)(2)(iii) Maximum penalty under 43 CFR 3163.2(a) for a minor violation 206 209 43 CFR 3163.2(g)(2)(iii) Maximum penalty under 43 CFR 3163.2(b) for a minor violation 2,063 2,097
    II. Calculation of Adjustment

    OMB issued guidance on calculating the annual adjustment for 2017 in accordance with the Act. See December 16, 2016, Memorandum for the Heads of Executive Departments and Agencies, from Shaun Donovan, Director, Office of Management and Budget, re: Implementation of the 2017 annual adjustment pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. Under this guidance, the Department of the Interior has identified applicable civil monetary penalties and calculated the annual adjustment. A civil monetary penalty is any assessment with a dollar amount that is levied for a violation of a Federal civil statute or regulation, and is assessed or enforceable through a civil action in Federal court or an administrative proceeding. A civil monetary penalty does not include a penalty levied for violation of a criminal statute, or fees for services, licenses, permits, or other regulatory review. The calculated annual inflation adjustments are based on the percent change between the October CPI-U preceding the date of the adjustment, and the prior year's October CPI-U. In this case, October 2016 CPI-U (241.729)/October 2015 CPI-U (237.838) = 1.01636.

    III. Procedural Requirements A. Regulatory Planning and Review (E.O. 12866 and 13563)

    Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant. Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science, and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

    B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) requires an agency to prepare a regulatory flexibility analysis for rules unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA applies only to rules for which an agency is required to first publish a proposed rule. See 5 U.S.C. 603(a) and 604(a). The Act requires agencies to adjust civil penalties annually for inflation through a final rule (see § 4(b)(2) of the Act). Because the final rule in this case does not include publication of a proposed rule, the RFA does not apply to this final rule.

    C. Small Business Regulatory Enforcement Fairness Act

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

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

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

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

    This rule will potentially affect individuals and companies who hold leases on Federal or Indian lands. The BLM believes that the vast majority of potentially affected entities will be small businesses as defined by the Small Business Administration. However, the BLM does not believe the rule will pose a significant economic impact on the industry, including any small entities, for two reasons. First, any lessee can avoid being assessed civil penalties by operating in compliance with BLM rules and regulations. Second, payments for penalties adjusted as a result of this rule will be negligible compared with the $23 billion worth of crude oil and natural gas produced from Federal and Indian leases in FY 2015.

    D. Unfunded Mandates Reform Act

    This rule does not impose an unfunded mandate on State, local, or tribal governments, or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq.) is not required.

    E. Takings (E.O. 12630)

    This rule does not effect a taking of private property or otherwise have takings implications under Executive Order 12630. A takings implication assessment is not required.

    F. Federalism (E.O. 13132)

    Under the criteria in section 1 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. A federalism summary impact statement is not required.

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

    This rule complies with the requirements of Executive Order 12988. Specifically, this rule:

    (a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and

    (b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

    H. Consultation With Indian Tribes (E.O. 13175 and Departmental policy)

    The Department of the Interior strives to strengthen its government-to-government relationship with Indian tribes through a commitment to consultation with Indian tribes and recognition of their right to self-governance and tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on federally recognized Indian tribes and that consultation under the Department's tribal consultation policy is not required.

    I. Paperwork Reduction Act

    This rule does not contain information collection requirements, and a submission to OMB under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) is not required. We may not conduct or sponsor, and you are not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    J. National Environmental Policy Act

    A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because the rule is covered by a categorical exclusion. This rule is excluded from the requirement to prepare a detailed statement because it is a regulation of an administrative nature. (For further information see 43 CFR 46.210(i).) We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.

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

    This rule is not a significant energy action under the definition in Executive Order 13211. Therefore, a Statement of Energy Effects is not required.

    L. Administrative Procedure Act

    The BLM is promulgating this rule as a final rule because the Act expressly directs us to do so. In accordance with the Act, agencies must adjust civil monetary penalties notwithstanding Section 553 of the Administrative Procedure Act (APA) (see § 4(b)(2) of the Act). This means that the notice and opportunity to comment procedures of the APA do not apply and are not required for agencies to issue regulations implementing the annual adjustment. In addition, since the Act does not give the BLM any discretion to vary the amount of the annual inflation adjustment for any given penalty to reflect any views or suggestions provided by commenters, it would serve no purpose to provide an opportunity for public comment on this rule.

    List of Subjects 43 CFR Part 3160

    Administrative practice and procedure; Government contracts; Indians-lands; Mineral royalties; Oil and gas exploration; Penalties; Public lands-mineral resources; Reporting and recordkeeping requirements.

    For the reasons given in the preamble, the BLM amends Chapter II of Title 43 of the Code of Federal Regulations as follows:

    PART 3160—ONSHORE OIL AND GAS OPERATIONS 1. The authority citation for part 3160 is revised to read as follows: Authority:

    25 U.S.C. 396d and 2107; 30 U.S.C. 189, 306, 359, and 1751; 43 U.S.C. 1732(b), 1733, 1740; and Sec. 107, Pub. L. 114-74, 129 Stat. 599, unless otherwise noted.

    Subpart 3163—Noncompliance, Assessments, and Penalties
    § 3163.2 [Amended]
    2. In § 3163.2: a. In paragraph (a), remove “$1,031” and add in its place “$1,048”. b. In paragraph (b), remove “$10,314” and add in its place “$10,483”. c. In paragraph (d), remove “$1,031” and add in its place “$1,048”. d. In paragraph (e) introductory text, remove “$20,628” and add in its place “$20,965”. e. In paragraph (f) introductory text, remove “$51,570” and add in its place “$52,414”. f. In paragraph (g)(1), remove “$1,031” each place that it occurs and add in its place “$1,048”; remove “$10,314” and add in its place “$10,483”; remove “$2,063 and add in its place “$2,097”; remove “$20,628”each place that it occurs and add in its place “$20,965”; remove “$51,570” and add in its place “$52,414”. g. In paragraph (g)(2)(iii), remove “$103” and add in its place “$105”; remove “$1,031” and add in its place “$1,048”; remove “$206” and add in its place “$209”; remove “$2,063” and add in its place “$2,097”. Dated: January 10, 2017. Amanda C. Leiter, Acting Assistant Secretary, Land and Minerals Management.
    [FR Doc. 2017-00727 Filed 1-18-17; 8:45 am] BILLING CODE 4310-84-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 11 [Docket No. FWS-HQ-LE-2017-0001; FF09L00200-FX-LE18110900000] RIN 1018-BB97 Civil Penalties; 2017 Inflation Adjustments for Civil Monetary Penalties AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Final rule.

    SUMMARY:

    The U.S. Fish and Wildlife Service (Service or we) is issuing this final rule, in accordance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Inflation Adjustment Act) and Office of Management and Budget (OMB) guidance, to adjust for inflation the statutory civil monetary penalties that may be assessed for violations of Service-administered statutes and their implementing regulations. We are required to adjust civil monetary penalties annually for inflation according to a formula specified in the Inflation Adjustment Act. This rule replaces the previously issued amounts with the updated amounts after using the 2017 inflation adjustment multiplier provided in the OMB guidance.

    DATES:

    This rule is effective January 19, 2017.

    ADDRESSES:

    This rule may be found on the internet at www.regulations.gov in Docket No. FWS-HQ-LE-2017-0001. The previous rulemaking action related to this rule and described below in SUPPLEMENTARY INFORMATION may be found at www.regulations.gov in Docket No. FWS-HQ-LE-2016-0045.

    FOR FURTHER INFORMATION CONTACT:

    Paul Beiriger, Special Agent in Charge, Branch of Investigations, U.S. Fish and Wildlife Service, Office of Law Enforcement, (703) 358-1949.

    SUPPLEMENTARY INFORMATION: Background

    The regulations in title 50 of the Code of Federal Regulations at 50 CFR part 11 provide uniform rules and procedures for the assessment of civil penalties resulting from violations of certain laws and regulations enforced by the Service.

    On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (sec. 701 of Pub. L. 114-74) (Inflation Adjustment Act). The Inflation Adjustment Act requires Federal agencies to adjust the level of civil monetary penalties with an initial “catch up” adjustment through rulemaking and then make subsequent annual adjustments for inflation. The purpose of these adjustments is to maintain the deterrent effect of civil penalties and to further the policy goals of the underlying statutes.

    Under section 4 of the Federal Civil Penalties Inflation Adjustment Act of 1990, 28 U.S.C. 2461 note, as amended by the Inflation Adjustment Act, Pub. L. 114-74, 129 Stat. 584 (2015), each Federal agency is required to issue regulations adjusting for inflation the statutory civil monetary penalties (civil penalties) that can be imposed under the laws administered by that agency. The Inflation Adjustment Act provided for an initial “catch up adjustment” to take effect no later than August 1, 2016, followed by subsequent adjustments to be made no later than January 15 every year thereafter. This final rule adjusts the civil penalty amounts that may be imposed pursuant to each statutory provision beginning on the date specified above in DATES.

    On June 28, 2016, the Service published in the Federal Register an interim rule that revised 50 CFR part 11 (81 FR 41862). We did not receive any comments on the interim rule during the public comment period provided. Therefore, the interim rule became effective on July 28, 2016, as specified in that rule. The Service subsequently published a final rule on December 23, 2016, adopting the interim rule as final (81 FR 94274). The current rule adjusts the civil monetary penalty amounts that were listed in the June 28, 2016, interim rule and subsequently codified in 50 CFR 11.33 by using the inflation multiplier provided to all Federal agencies by OMB (see below).

    OMB issued a memorandum, M-17-11, entitled “Implementation of the 2017 annual adjustment pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015,” which provides the cost-of-living adjustment multiplier for 2017: 1.01636. Therefore, we multiplied each penalty in the table published in the interim rule on June 28, 2016 (81 FR 41862), by 1.01636 to obtain the 2017 annual adjustment. The new amounts are reflected in the table in the rule portion of this document and replace the current amounts in 50 CFR 11.33.

    Required Determinations

    In this final rule, we are affirming our required determinations made in the June 28, 2016, interim rule (81 FR 41862); for descriptions of our actions to ensure compliance with the following statutes and Executive Orders, see that rule:

    National Environmental Policy Act (42 U.S.C. 4321 et seq.); Regulatory Flexibility Act (5 U.S.C. 601 et seq.); Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 804(2)); Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.); Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.); and Executive Orders 12630, 12866, 12988, 13132, 13175, 13211, and 13563. Administrative Procedure Act

    As stated above, under section 4 of the Federal Civil Penalties Inflation Adjustment Act of 1990, 28 U.S.C. 2461 note, as amended by the Inflation Adjustment Act, Pub. L. 114-74, 129 Stat. 584 (2015), each Federal agency is required to issue regulations adjusting for inflation the statutory civil monetary penalties that can be imposed under the laws administered by that agency. The Inflation Adjustment Act provided for an initial “catch up adjustment” to take effect no later than August 1, 2016, followed by subsequent adjustments to be made no later than January 15 every year thereafter. This final rule adjusts the civil penalty amounts that may be imposed pursuant to each statutory provision beginning on the effective date of this rule. To comply with the Inflation Adjustment Act, we are issuing these regulations as a final rule.

    Section 553(b) of the Administrative Procedure Act (5 U.S.C. 551 et seq.) provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for prior public comment. The Service finds that providing for public comment before issuing this rule is unnecessary as this rulemaking is a nondiscretionary action. The Service is required to publish this rule in order to update the civil penalty amounts by the specified formula described above. The Service has no discretion to vary the amount of the adjustment to reflect any views or suggestions provided by commenters. Accordingly, it would serve no purpose to provide an opportunity for public comment prior to publication of this rule. Since this update to the June 28, 2016, interim rule (81 FR 41862) is merely ministerial, we find that pre-publication notice and public comment with respect to the revisions set forth in this rule is unnecessary. We also believe that we have good cause under 5 U.S.C. 553(d) to make this rule effective upon publication to meet the statutory deadline imposed by the Inflation Adjustment Act.

    List of Subjects in 50 CFR Part 11

    Administrative practice and procedure, Exports, Fish, Imports, Penalties, Plants, Transportation, Wildlife.

    Regulation Promulgation

    For the reasons described above, we amend part 11, subchapter B of chapter I, title 50 of the Code of Federal Regulations as set forth below.

    PART 11—CIVIL PROCEDURES 1. The authority citation for part 11 continues to read as follows: Authority:

    16 U.S.C. 470aa-470mm, 470aaa-470aaa-11, 668-668d, 1361-1384, 1401-1407, 1531-1544, 3371-3378, 4201-4245, 4901-4916, 5201-5207, 5301-5306; 18 U.S.C. 42-43; 25 U.S.C. 3001-3013; and Sec. 107, Pub. L. 114-74, 129 Stat. 599, unless otherwise noted.

    2. Revise the table in § 11.33 to read as follows:
    § 11.33 Adjustments to penalties. Law Citation Type of violation Maximum civil monetary penalty (a) African Elephant Conservation Act 16 U.S.C. 4224(b) Any violation $10,055 (b) Bald and Golden Eagle Protection Act 16 U.S.C. 668(b) Any violation 12,705 (c) Endangered Species Act of 1973 16 U.S.C. 1540(a)(1) (1) Knowing violation of section 1538 50,276 (2) Other knowing violation 24,132 (3) Any other violation 1,270 (d) Lacey Act Amendments of 1981 16 U.S.C. 3373(a) (1) Violations referred to in 16 U.S.C. 3373(a)(1) 25,409 (2) Violations referred to in 16 U.S.C. 3373(a)(2) 635 (e) Marine Mammal Protection Act of 1972 16 U.S.C. 1375 Any violation 25,409 (f) Recreational Hunting Safety Act of 1994 16 U.S.C. 5202(b) (1) Violation involving use of force or violence or threatened use of force or violence 16,169 (2) Any other violation 8,084 (g) Rhinoceros and Tiger Conservation Act of 1998 16 U.S.C. 5305a(b)(2) Any violation 17,688 (h) Wild Bird Conservation Act 16 U.S.C. 4912(a)(1) (1) Violation of section 4910(a)(1), section 4910(a)(2), or any permit issued under section 4911 42,618 (2) Violation of section 4910(a)(3) 20,456 (3) Any other violation 853
    Dated: January 10, 2017. Michael J. Bean, Principal Deputy Assistant Secretary for Fish and Wildlife and Parks.
    [FR Doc. 2017-00889 Filed 1-18-17; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 223 [Docket No. 150211138-7024-02] RIN 0648-XD771 Endangered and Threatened Wildlife and Plants; Final Rule To List Two Guitarfishes as Threatened Under the Endangered Species Act AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    We, NMFS, issue a final rule to list two foreign marine guitarfish species under the Endangered Species Act (ESA). We considered comments submitted on the proposed listing rule and have determined that the blackchin guitarfish (Rhinobatos cemiculus) and common guitarfish (Rhinobatos rhinobatos) warrant listing as threatened species. We will not designate critical habitat for either of these species because the geographical areas occupied by these species are entirely outside U.S. jurisdiction, and we have not identified any unoccupied areas within U.S. jurisdiction that are currently essential to the conservation of either of these species.

    DATES:

    This final rule is effective February 21, 2017.

    ADDRESSES:

    Chief, Endangered Species Division, NMFS Office of Protected Resources (F/PR3), 1315 East West Highway, Silver Spring, MD 20910.

    FOR FURTHER INFORMATION CONTACT:

    Brendan Newell or Marta Nammack NMFS, Office of Protected Resources (OPR), (301) 427-8403.

    SUPPLEMENTARY INFORMATION: Background

    On July 15, 2013, we received a petition from WildEarth Guardians to list 81 marine species or subpopulations as threatened or endangered under the ESA. This petition included species from many different taxonomic groups, and we prepared our 90-day findings in batches by taxonomic group. We found that the petitioned actions may be warranted for 24 of the species and 3 of the subpopulations and announced the initiation of status reviews for each of the 24 species and 3 subpopulations (78 FR 63941, October 25, 2013; 78 FR 66675, November 6, 2013; 78 FR 69376, November 19, 2013; 79 FR 9880, February 21, 2014; and 79 FR 10104, February 24, 2014). On September 19, 2016, we published a proposed rule to list the blackchin guitarfish (Rhinobatos cemiculus) and the common guitarfish (Rhinobatos rhinobatos) as threated species (81 FR 64094). We requested public comment on information in the draft status review and proposed rule, and the comment period was open through November 18, 2016. This final rule provides a discussion of the information we received during the public comment period and our final determination on the petition to list the blackchin guitarfish and the common guitarfish under the ESA. The status of the findings and relevant Federal Register notices for the other 22 species and 3 subpopulations can be found on our Web site at www.nmfs.noaa.gov/pr/species/petition81.htm.

    Listing Species Under the Endangered Species Act

    We are responsible for determining whether species are threatened or endangered under the ESA (16 U.S.C. 1531 et seq.). To make this determination, we consider first whether a group of organisms constitutes a “species” under the ESA, then whether the status of the species qualifies it for listing as either threatened or endangered. Section 3 of the ESA defines a “species” to include “any subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature.”

    Section 3 of the ESA defines an endangered species as “any species which is in danger of extinction throughout all or a significant portion of its range” and a threatened species as one “which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” We interpret an “endangered species” to be one that is presently in danger of extinction. A “threatened species,” on the other hand, is not presently in danger of extinction, but is likely to become so in the foreseeable future (that is, at a later time). In other words, the primary statutory difference between a threatened and endangered species is the timing of when a species may be in danger of extinction, either presently (endangered) or in the foreseeable future (threatened).

    When we consider whether a species might qualify as threatened under the ESA, we must consider the meaning of the term “foreseeable future.” It is appropriate to interpret “foreseeable future” as the horizon over which predictions about the conservation status of the species can be reasonably relied upon. The foreseeable future considers the life history of the species, habitat characteristics, availability of data, particular threats, ability to predict threats, and the reliability to forecast the effects of these threats and future events on the status of the species under consideration. Because a species may be susceptible to a variety of threats for which different data are available, or which operate across different time scales, the foreseeable future is not necessarily reducible to a particular number of years.

    Section 4(a)(1) of the ESA requires us to determine whether any species is endangered or threatened due to any of the following factors: The present or threatened destruction, modification, or curtailment of its habitat or range; overutilization for commercial, recreational, scientific, or educational purposes; disease or predation; the inadequacy of existing regulatory mechanisms; or other natural or manmade factors affecting its continued existence. Under section (4)(b)(1)(A), we are also required to make listing determinations based solely on the best scientific and commercial data available, after conducting a review of the species' status and after taking into account efforts being made by any state or foreign nation to protect the species.

    In making a listing determination, we first determine whether a petitioned species meets the ESA definition of a “species.” Next, using the best available information gathered during the status review for the species, we complete a status and extinction risk assessment. In assessing extinction risk for these two guitarfishes, we considered the demographic viability factors developed by McElhany et al. (2000). The approach of considering demographic risk factors to help frame the consideration of extinction risk has been used in many of our status reviews, including for Pacific salmonids, Pacific hake, walleye pollock, Pacific cod, Puget Sound rockfishes, Pacific herring, scalloped hammerhead sharks, and black abalone (see www.nmfs.noaa.gov/pr/species/ for links to these reviews). In this approach, the collective condition of individual populations is considered at the species level according to four viable population descriptors: abundance, growth rate/productivity, spatial structure/connectivity, and diversity. These viable population descriptors reflect concepts that are well-founded in conservation biology and that individually and collectively provide strong indicators of extinction risk (NMFS 2015).

    We then assess efforts being made to protect the species to determine if these conservation efforts are adequate to mitigate the existing threats. Section 4(b)(1)(A) of the ESA requires the Secretary, when making a listing determination for a species, to take into consideration those efforts, if any, being made by any State or foreign nation to protect the species.

    Summary of Comments

    In response to our request for comments on the proposed rule, we received five comment letters. Two comment letters were from foreign governments and clarified information about their relevant regulations. One comment letter was from an environmental nonprofit organization supporting our proposed listing decision. Two comment letters were submitted anonymously, each challenging a number of our statements or conclusions in the status review or proposed rule, generally without providing references or evidence that would allow us to investigate further. One commenter also provided some editorial comments, which were incorporated in the status review as appropriate. Summaries of issues raised by the public comments received and our responses are provided below, with references where appropriate.

    Comment 1: One commenter pointed out that R. cemiculus is also referred to in some of the literature by the taxonomic synonym Glaucostegus cemiculus.

    Response: The fact that Glaucostegus cemiculus is a synonym for R. cemiculus has been added to the Taxonomy and Distinctive Characteristics section of the status review. Although we did not include this synonym in the draft status review this did not impact the development of the status review or proposed rule. We were aware of this synonym and searched for publications related to this species using both Rhinobatos cemiculus and Glaucostegus cemiculus while gathering information for the status review.

    Comment 2: One commenter disagreed with our description of the smallest reported length for a fish in a study as the “minimum total length (TL),” stating that minimum TL is always 0 mm for all animals.

    Response: The word minimum was used while discussing the smallest lengths ever reported for juveniles of each species. We did not intend to imply that the reported lengths were the smallest possible lengths that the animals could be. We have revised the status review to clarify this point.

    Comment 3: One commenter noted that we did not include the k value for R. rhinobatos reported in Ismen et al. (2007) in the discussion about growth rates.

    Response: The k value from Ismen et al. (2007) has been added to the discussion in the Reproduction and Growth section of the status review.

    Comment 4: One commenter claimed our analysis is biased because we discuss “conflict” in the literature regarding conclusions researchers have reached about the two guitarfish species' reproductive potential and growth rates. This commenter stated that these different conclusions reached by researchers are not conflicting conclusions but are evidence of intraspecies variation, which could be evidence of population structure. The same party made multiple other comments about regional variations in morphology and biology indicating population structure. An additional commenter also claimed that there is more evidence for population structuring in these guitarfishes than three ESA-listed species of angelshark, Squatina aculeata, S. oculata, and S. squatina. These three Squatina species were listed as endangered on August 1, 2016 (81 FR 50394). This commenter provided no references to validate this claim.

    Response: We disagree with the commenter's implication that noting conflicting conclusions from different authors about a species' life history implies bias. We acknowledge that variations in biology in different portions of a species' range could imply population structure. However, Lteif (2015) attributed these variations to environmental differences throughout each species' range (e.g., food availability and water temperatures) or the relatively small amount of data on the species and differences in sampling approach. ICES (2010) stated that the relationships between the Mediterranean and Atlantic stocks of R. cemiculus and R. rhinobatos are unclear. We found no other discussions of population structure in the available information. Given the lack of information, we could not reach conclusions about population structure. Our status review presents the best available information and notes where authors have reached different conclusions to accurately represent the available information.

    Comment 5: One commenter asserted that the discussion in the status review of both species' preference for warmer waters is moot because the only temperature data provided in the document is sea surface temperature data, and as both species are demersal, they live below the thermocline. This commenter also asserted that, in our discussion about the threat of climate change in the status review, we failed to address specifically how changing bottom temperatures will affect the species.

    Response: According to the best available scientific information, both of the guitarfishes are demersal species that typically occur up to a maximum depth of 100m and spend at least a portion of their lives in shallow waters. The only information we found regarding how these species interact with water temperature is that both species prefer warmer, subtropical waters (Capape and Zaouali 1994; Corsini-Foka 2009; Edelist 2014). The discussion in the status review is about the role that temperature likely plays in restricting many Mediterranean species to biogeographic ranges. While we consider this information relevant to understanding both guitarfish species' habitat and distribution, we explicitly acknowledged in the draft status review that we found no information on how any particular isotherm affects the distribution and abundance of these guitarfish species. We found no discussion in the scientific literature regarding how these species interact with thermoclines, the depths of which likely vary seasonally and regionally given the wide distribution of these species (Coll et al., 2010). Specifically regarding climate change, Akyol and Capapé (2014) and Rafrafi-Nouira et al. (2015) both attributed shifts in R. cemiculus distribution to warming waters but did not discuss bottom temperatures or thermoclines. No references were provided by the commenter to explain how both species interact with thermoclines or invalidate our interpretation that sea surface and mixed layer temperature is likely relevant to the distribution of these subtropical species.

    Comment 6: One commenter asserted that our assumption that both guitarfish species are likely mirroring the trend of decreasing elasmobranch and batoid (rays, skates, guitarfishes, etc.) landings in southern Tunisia, where the best available information shows that both guitarfish species made up a high proportion of the total elasmobranch catch in the longline and gillnet fisheries over a 2-year period, is flawed, because, “A high percentage of one species in a catch at one time says nothing about the trend of that species over time as different species can be targeted or caught with different methods or have different population structures and sources and sinks.”

    Response: We agree that a high percentage of one species in a catch at one time does not indicate a trend. However, the data in question were collected across two different fisheries (longline and gillnet) and in each case the data were collected over multiple months in both 2007 and 2008 years (Echwikhi et al., 2013; Echwikhi et al.. 2012). Echwikhi et al. (2013) and Echwikhi et al. (2012) discuss their results in the context of the trends in elasmobranch abundance declines in the region. An additional citation (Bradaï et al., 2006) has been added to the status review and provides further indication that both species have been and are commonly targeted and landed in southern Tunisia. Given the high proportion of these guitarfish species in the studied artisanal fisheries catches, and the fact that these species are known to be commonly targeted and landed in southern Tunisia, it is likely that the abundance trends for these species are similar to the overall trend of declining elasmobranch catches in southern Tunisia.

    Comment 7: One commenter made several comments that there is no evidence that R. rhinobatos and R. cemiculus were likely historically rare throughout most of the northwestern Mediterranean relative to other portions of its range (e.g., the southern and eastern Mediterranean). The same commenter challenged our conclusion that both species have likely always been rare in all parts of their Atlantic ranges north of the Strait of Gibraltar. This commenter asserted that we failed to include museum records and anthropological literature, but the commenter did not provide any references.

    Response: Our interpretation of the best available information is that R. rhinobatos and R. cemiculus were present, but likely uncommon or rare throughout most of the northwestern Mediterranean (including the waters off Spain, the seas around Italy, and, in the case of R. rhinobatos, the waters of France), with the exception of the waters around Sicily and the Balearic Islands. This interpretation is consistent with the conclusions reached in the best available scientific literature (Akyol and Capapé 2014; Capapé et al., 2006; Capapé et al., 1975; Dulþiü et al., 2005; Psomadakis et al., 2009). In the parts of their Atlantic ranges north of the Strait of Gibraltar, as stated in the status review, we found information that indicates both species have been rare for at least the last 45 years (ICES 2016), and no information that indicates either species was common at any time in what is known to be the northern extent of their ranges.

    To reach these conclusions we searched for data and publications related to both species, and guitarfishes in general, in all of the countries and seas that are considered part of either species' historical range. In the status review, we considered and incorporated the best available information, which included peer reviewed scientific articles, regional checklists of ichthyofauna, studies of fishers' knowledge, reports from conservation organizations (e.g., IUCN), and museum records. We also used relevant data from long term datasets such as trawl surveys and regional fisheries databases, including the MEDITS survey program (International bottom trawl survey in the Mediterranean) and the International Council for the Exploration of the Sea (ICES) DATRAS (Baino et al., 2001; Bertrand et al., 2000, ICES 2016). The only publications that we found that concluded that both species were common throughout the northwestern Mediterranean were the IUCN assessments of both species (Notarbartolo di Sciara et al., 2007a; Notarbartolo di Sciara et al., 2007b) and ICES (2010). All three of these reports specifically discuss and provide references for both species once being common off the Balearic Islands and Sicily, which make up a small amount of the overall area of the northwestern Mediterranean. No references were cited in these three reports to provide evidence that R. rhinobatos or R. cemiculus were common in the remaining area of the northwestern Mediterranean.

    Comment 8: One commenter noted the lack of explanation about what we mean by “available literature.”

    Response: A summary of how we compiled the information used in the status review was added to the second paragraph of the Scope and Intent of Present Document section of the status review.

    Comment 9: Regarding the Overutilization for Commercial, Recreational, Scientific, or Educational Purposes section of the status review, one commenter stated: “Generally in this section you misunderstand the difference between science and fisheries data. Scientifically gathered data is preferable and you are required to use the best available SCIENCE. Fisheries catch and landing data are not the best possible type of data, are not scientifically gathered and have serious flaws which you ignore entirely.”

    Response: The commenter incorrectly restricts the information we are required to use. ESA Section 4(b)(1)(A) states: “The Secretary shall make determinations required by [Section 4](a)(1) solely on the basis of the best scientific and commercial data available to him . . .” There is a paucity of scientific studies on both species range wide, including the almost complete lack of fisheries independent population data, a fact that is well documented in the status review and proposed rule. We agree that additional scientifically gathered data would greatly enhance our ability to accurately understand the status of both species. However, when analyzing the threat of commercial fisheries to these guitarfishes, fisheries data are relevant and valuable. Therefore, this information must be considered as a source of “best scientific and commercial data available,” regardless of flaws with these data, which are acknowledged and discussed throughout the status review.

    Comment 10: Also regarding the discussion of commercial overutilization in the Overutilization for Commercial, Recreational, Scientific, or Educational Purposes section of the status review, one commenter asks: “why is only bycatch considered?”

    Response: All types of interactions with commercial and artisanal fisheries are considered and described in the status review, including bycatch from industrial and artisanal fishing and targeted fishing of both guitarfish species by artisanal fishers using gillnets, longlines, and beach based lines. The commenter may have missed the information by focusing on only one part of the discussion within the section.

    Comment 11: Regarding the passage in the status review: “At the time of the 2007 publication of the IUCN report Overview of the Conservation Status of Cartilaginous Fishes (Chondrichthyans) in the Mediterranean Sea,” by Cavanagh and Gibson (2007) there were six Mediterranean elasmobranchs affected by target fisheries . . . It is unclear if R. rhinobatos and R. cemiculus were two of the six targeted species referenced in this report”, one commenter asked how it can be unclear if the two Rhinobatos species were not part of the six species referred to in Cavanagh and Gibson (2007).

    Response: Cavanagh and Gibson (2007) did not discuss which elasmobranch species or groups were part of past or present targeted fisheries, except for using angelsharks (Squatina spp.) as an example of species that had become so rare they were no longer targeted. Therefore, it was not possible to determine which six Mediterranean elasmobranch species were considered to be affected by targeted fisheries by Cavanagh and Gibson (2007).

    Comment 12: One commenter stated that the discussion of elasmobranch landing trends in Egyptian fisheries in the status review is contradictory because it claims both increased and decreased landings in Egyptian fisheries.

    Response: In Egypt, an increase in effort across fisheries led to a decrease in overall fisheries landings, but an increase in the landings of, and demand for, elasmobranchs, which had previously been discarded. The commenter appears to have misunderstood the discussion in the status review. Elasmobranch landings increased because the landings of preferred, non-elasmobranch targets were decreasing. Thus, elasmobranchs, which were always caught but previously discarded, have been landed at a higher rate by fishers to offset the decreasing availability of other species.

    Comment 13: Regarding the discussion in the status review of the development of the shark (and other shark-like elasmobranchs) fin industry in the Atlantic, one commenter stated, “you claim a need for increased effort CAUSES a need to maximize profits. This is quite [a] twist on economic theory which usually has causation go from the desire for profit as the starting point causing need for more effort . . .”

    Response: This conclusion was reached by Diop and Dossa (2011) who provide the most comprehensive report on shark fishing in West Africa available. As explained in the status review, as fisheries in easily accessible areas became overexploited, fishers had to travel farther to find fish. This increased effort raised their cost of doing business (e.g., fuel costs). Because storage capacity is limited on fishing vessels, and shark fins are more valuable than other products that would take up more space, shrinking profit margins that resulted from the need to increase effort contributed to the unsustainable shift to retaining a larger percentage of the highest value products (i.e., shark fins from many sharks) rather than utilizing the entire shark or less valuable species.

    Comment 14: One commenter stated that while we noted in the status review that large sharks, such as dusky sharks, are predators of Rhinobatos spp., we failed to discuss how the decline of dusky sharks would impact R. cemiculus and R. rhinobatos.

    Response: Based on our analysis, predation is not posing a threat to either guitarfish species and, with the exception of one sentence in Camhi et al. (2005), we found no additional information regarding predation on guitarfishes by any shark species. Additionally, dusky sharks were an example of a large shark that preys on these species, but not the only shark species to do so.

    Comment 15: One commenter stated that in the Commercial Overutilization in the Atlantic section of the status review “you claim Rhinobatos is found in the highest numbers but you fail to say compared to what or part of what grouping.”

    Response: The sentence the commenter is referring to is a quote provided in a series of quotes of the qualitative descriptions of elasmobranch fisheries in West African nations by Diop and Dossa (2011). In all cases, Diop and Dossa (2011) were discussing landing of guitarfishes relative to other elasmobranchs. Additional text has been added to the Commercial Overutilization in the Atlantic section to clarify this point.

    Comment 16: One commenter pointed out the recent evidence suggesting a decline in the demand for shark fins.

    Response: A paragraph further discussing trends in demand for shark fins and meat, as well as the uncertainty related to how these shifts in demand are impacting both guitarfish species, has been added to the Commercial Overutilization in the Atlantic section of the status review.

    Comment 17: One commenter stated that we are required to consider the interaction of the ESA Section 4 (a)(1) factors but failed to do so.

    Response: The commenter is correct that we are required to consider the interaction between the ESA 4(a)(1) factors, and we did so. We present a discussion of the interactions among the threats and each species' demographic risks in the Extinction Risk Analysis sections of the status review for each species. However, because data on both species and their threats are generally lacking, a more detailed analysis of the interactions among the threat factors was not possible.

    Comment 18: One commenter stated that we incorrectly limited our analysis to present and future threats only and that we should have also considered past threats.

    Response: The ESA and the section 4 regulations require that we list a species if the species is endangered or threatened because of any of the five factors in ESA section 4 (a)(1). Included in our risk analysis is an assessment of the manifestation of past threats that have contributed to the species' current status.

    Comment 19: One commenter stated, “Foreseeable future discussion is confounded and you just assert your timeline, you provide no evidence it is the best available. Assertions really arent [sic] facts.”

    Response: As discussed in Box 2: Defining Foreseeable Future in the status review, the foreseeable future for both guitarfish species (15-20 years) is based on these species' life histories and the main threats each species faces. Given the relatively low productivity of these species, it will likely take more than one generation for these species to recover. 15-20 years corresponds to approximately three generations of R. cemiculus, which likely reproduces at a slower rate than R. rhinobatos. 15-20 years is also a reasonable period of time to project the continued threats of overutilization and inadequacy of existing regulations. Many of the regulations that protect these species have recently been adopted and are inadequately enforced. Given both species' reproductive life history traits, 15-20 years is a reasonable amount of time to foresee continued decline of both species should these regulations continue to be inadequate, which seems likely at this time. The commenter provided no information to invalidate any or all of the justification for our definition.

    Comment 20: One commenter pointed out that in our discussion of the increase in abundance of R. rhinobatos in the Tunis Northern and Southern Lagoon after restoration, we did not discuss the possibility that individuals could be migrating into the area without an increase in the overall population.

    Response: A sentence acknowledging that it is unknown if the increase of R. rhinobatos in the Tunis Lagoons is the result of an increasing population or simply individuals migrating into what has become suitable habitat has been added to the Demographic Risk Analysis section of the status review.

    Comment 21: One commenter stated that we missed the following references: Ali et al. (2008), Ambrose (2004), Bauchot (1987), Faruggia, Feretti, Lloris, and Rucabado (1998), McEachran and Capape (1984), Seck et al. (2004), Valadou (2003), and Whitehead et al. (1984).

    Response: In response to this comment, we conducted a search for the references listed that we were unaware of, which were Ambrose (2004), Valadou (2003), and Faruggia et al. (1998). Only an abstract for Ambrose. (2004) was available online, which contained no information about guitarfishes. Because we were not able to review this publication we have not included it in this analysis. We requested but have not received a copy of Valadou (2003), which is a master's dissertation that we cannot access online. We were also unable to find Faruggia et al. (1998) based on the information provided.

    We were already aware of Seck et al. (2004), Ali et al. (2008), Bauchot (1987), McEachran and Capape (1984), and Whitehead et al. (1984). Seck et al. (2004) was used and cited in our draft status review and proposed rule. Ali et al. (2008) was not available online or through interlibrary loan during the development of the status review, proposed rule, and final rule, and we reached out to one of the authors regarding this and another publication but have not received a response. Because this comment was submitted anonymously, we also could not contact the commenter with a request for a copy of this or other references. Bauchot (1987), McEachran and Capape (1984), and Whitehead et al. (1984) are identification guides that provide basic taxonomic and life history information consistent with information already included in the status review. Thus, these references provided no additional information that would affect our status review.

    Comment 22: One comment letter asserted that our decision to list R. rhinobatos and R. cemiculus as threatened is arbitrary and capricious because the commenter believes that both guitarfish species are “in at least as bad a condition” as three species of angelshark, Squatina aculeata, S. oculata, and S. squatina, which are listed as endangered under the ESA (81 FR 50394). This commenter provided the following reasons for this opinion: (1) These five species are all demersal elasmobranchs that share similar ranges, thus they face similar spatial threats; (2) The maximum depth that the guitarfishes occur in (100m) is shallower than the angelsharks' maximum depth (550m), thus the guitarfishes must be easier for humans to catch, increasing their vulnerability; (3) Guitarfishes have a faster reproductive cycle, smaller litter size, later age at maturity, and likely longer life span than the angelsharks, which makes the guitarfishes less resilient to overexploitation; (4) The guitarfishes, but not the angelsharks, are known to have an inshore migration for reproduction, putting the guitarfishes at a greater risk from human threats; (5) There is more evidence of population structuring for the guitarfishes than the angelsharks, resulting in smaller, isolated, less resilient populations; (6) There is higher commercial demand and fewer conservation efforts for the guitarfishes than the angelsharks; (7) Abundance data, including data from the Canary Islands and the northwest Mediterranean, support a worse status for the guitarfishes than the angelsharks, and; (8) The guitarfishes were likely in demand and serially exploited even earlier than the angelsharks.

    Response: While we acknowledge that all five species share some similarities in biology, ecology, and threats, we do not base decisions on whether or not one species should be listed as threatened or endangered solely on similarities in life history traits or circumstances with other listed species. We assess each species individually based on the best scientific and commercial information available, considering both the demographic risks facing the species as well as current and future threats that may affect the species' status. Data on all five species are lacking, but the best available information shows that all three angelsharks are extremely rare throughout most of their ranges, with evidence of declines in abundance and subsequent extirpations and range curtailment, while both guitarfishes are likely still somewhat abundant in relatively larger portions of their ranges, such as within portions of the southern and eastern Mediterranean and West Africa (Echwikhi et al., 2012; Golani 2006; Ismen et al., 2007, Lteif 2015, M. Ducrocq, Parcs Gabon, pers. comm. to J. Shultz, NMFS, 21 June, 2016; Miller 2016, Saad et al., 2006).

    To specifically address some of the commenter's points about guitarfish, regarding point (6), while both the guitarfish and the angelsharks face threats from commercial fishing, it is not appropriate to directly compare the fishing related threats these species face. For example, the fin trade has contributed to the decline of the guitarfishes but is not a direct threat to the angelsharks, while historical commercial fishing pressure on angelsharks has already made these species so rare that they can no longer support fisheries in most areas. Regarding points (5) and (7), the commenter provided no references to verify the assertions about the two guitarfishes' population structures or abundance throughout their respective ranges or the presence of guitarfish in the Canary Islands, so we are unable to determine the validity of any data upon which the commenter based these assertions. As such, without any new information to consider, we maintain our previous conclusion in the proposed rule that the two guitarfish species are likely to be in danger of extinction in the foreseeable future throughout their ranges and, thus, are threatened species under the ESA.

    Additionally, we also wish to clarify some of the information presented for angelsharks, particularly in response to the commenter's points in (2) and (4). We note that while S. aculeata and S. oculata have maximum depths of up to 500 m and 560 m, respectively, S. aculeata can be found in depths as shallow as 30 m and S. oculata is more commonly found in depths between 50 m and 100 m. Squatina squatina is generally found in shallower water, from inshore areas out to the continental shelf in depths of 5 m to 150 m. This species is also thought to conduct inshore migrations in the summer, with reports of beachgoers being bitten by small (likely juvenile) angelsharks (suggesting inshore migration for reproduction). This information on these species, as well as additional information on the threats and status of the three angelsharks, can be found in the proposed (80 FR 40969; July 14, 2015) and final rules (81 FR 50394; August 1, 2016) listing these species under the ESA, as well as the status review for these three species (Miller 2016), available on our Web site at www.nmfs.noaa.gov/pr/species/petition81.htm.

    Comment 23: The Embassy of Greece, through the Hellenic Ministry of Rural Development and Food, commented that Greece meets its obligations arising from international conventions, such as the Barcelona Convention, and is a party to the General Fisheries Commission of the Mediterranean (GFCM), the regional fisheries management organization whose convention area includes Mediterranean waters and the Black Sea. The measures adopted by the GFCM are incorporated into European Law. The Ministry specifically highlighted GFCM recommendation GFCM/36/3012/3, which prohibits those elasmobranchs on Annex II of the Specially Protected Areas and Biological Diversity (SPA/BD) Protocol to the Barcelona Convention (which includes both guitarfish species) from being retained on board, transhipped, landed, transferred, stored, sold or displayed, or offered for sale. The Ministry noted that the species must be released, as far as possible, unharmed and alive, and that there is an obligation for owners of fishing vessels to record information related to fishing activities, including capture data, incidental catch, and releases and/or discards of species. The Ministry recently adopted and released Circular No. 4531/83795/20-07-2016 to inform all stakeholders of the provisions of the above protection measures.

    Response: We thank the Hellenic Ministry of Rural Development and Food for the comments and have updated the status review accordingly. We note that while these regulations will likely, to some extent, reduce the fishing related mortality to both guitarfish species, it does not appear that either species is common in Greek waters. Therefore we conclude that these regulatory mechanisms are unlikely to significantly decrease both Rhinobatos species' risks of extinction.

    Comment 24: The Lebanese Ministry of Agriculture, through the Embassy of Lebanon, commented that fishing both Rhinobatos species is prohibited in Lebanon by decision number 1045/1 issued on November 25, 2014, based on GFCM recommendation GFCM/36/3012/3. Based on this decision, they welcomed our proposal to list both guitarfishes species as threatened under the ESA.

    Response: We thank the Lebanese Ministry of Agriculture for the comments and have updated the status review accordingly. We note that the information available to us (Lteif 2015) indicates that regulations related to these guitarfish species are not adequately enforced. However, we note that these conclusions were reached based on data that were collected up until approximately the time that decision number 1045/1 was issued, so the enforcement of relevant regulations may now be effective. Given the uncertainty regarding the enforcement of these regulations, and the relatively small portion of both species' ranges that occur in Lebanese waters, we conclude that these regulatory mechanisms are unlikely to significantly decrease both Rhinobatos species' risks of extinction range wide.

    Comment 25: One commenter noted that in the Inadequacy of Existing Regulations section of the status review we did not mention relevant Turkish laws, species specific laws for Rhinobatos species in Banc d'Arguin National Park (Mauritania), and a ban on finning in Nigeria.

    Response: The commenter provided no references regarding any of these regulations. We found no information about Turkish laws relevant to guitarfishes or sharks and rays in general and the General Fisheries Commission for the Mediterranean National Legislation Database (available at: http://nationallegislation.gfcmsecretariat.org) lists no such relevant law. However, some additional information about general fisheries management efforts in Turkey, including vessel registrations, gear restrictions, and seasonal area closures has been added to the Regulatory Mechanisms in the Mediterranean section of the status review. Because these management efforts are not specific to guitarfish, and we have no information on how these efforts affect guitarfish in Turkey, this new information does not change our conclusion that current regulations are inadequate to protect either species.

    As discussed in the status review, fishing for all shark species, including guitarfishes, has been banned since 2003 in Banc d'Arguin National Park. Additional information on regulatory efforts from 1998 to 2003 has been added to the Regulatory Mechanisms in the Atlantic section of the status review. This information provides context for how the current protective regulations were developed in Banc d' Arguin, which are currently adequately protecting both species in this small portion of their ranges, a fact that was acknowledged in the draft status review.

    The fact that Nigeria prohibits the dumping of shark carcasses at sea has also been added to the Regulatory Mechanisms in the Atlantic section. While this information augments our knowledge of regulations that may affect these species, we found no information on how this regulation is enforced and very little information on guitarfish in Nigeria in general. Thus, it does not change our conclusion that current regulations are inadequate to protect either species.

    Comment 26: One commenter strongly supported our proposed rule and encouraged us to finalize the our listing decision in a timely manner, incorporate comments and suggestions submitted during the comment period, and incorporate a full analysis of all the factors under section 4(a)(1) of the ESA.

    Response: We appreciate this comment. We have incorporated all substantive comments received into the status review and this final rule and fully analyzed the ESA section 4(a)(1) factors using the best available scientific and commercial information.

    Summary of Changes From the Proposed Listing Rule

    We reviewed, and incorporated as appropriate, scientific data from references that were not previously included in the draft status review (Newell 2016) and proposed rule (81 FR 64094; September 19, 2016). We included the following references and communications, which, together with previously cited references, represent the best available scientific and commercial data on R. cemiculus and R. rhinobatos: Ambrose et al. (2005), Ateweberhan et al. (2012), Carla Jazzar, Embassy of Lebanon, pers. comm. to D. Wieting, NMFS (7 December, 2016), Caverivière and Andriamirado (1997), Coll (2010), D. Berces, University of Florida, pers. comm. to B. Newell, NMFS, (14 November, 2016), Farrugio et al. (1993), Hellenic Ministry of Rural Development pers. comm. (2016), HSI (2016), ICES (2010), and OECD (undated). However, the information not previously included in the draft status review or proposed rule does not present significant new findings that change either of our proposed listing determinations. The updated status review (Newell 2016) is available at: www.nmfs.noaa.gov/pr/species/petition81.htm.

    Status Review

    The status review for both guitarfish species was conducted by a NMFS biologist in the Office of Protected Resources. In order to complete the status review, we compiled information on the species' biology, ecology, life history, threats, and conservation status from information contained in the petition, our files, a comprehensive literature search, and consultation with experts. Prior to publication of the proposed rule, the status review was subjected to peer review. Peer reviewer comments are available at www.cio.noaa.gov/services_programs/prplans/PRsummaries.html. This status review provides a thorough discussion of the life history, demographic risks, and threats to the two guitarfish species. We considered all identified threats, both individually and cumulatively, to determine whether these guitarfish species respond in a way that causes actual impacts at the species level. The collective condition of individual populations was also considered at the species level, according to the four viable population descriptors discussed above.

    Summary of Factors Affecting the Two Guitarfish Species

    We considered whether any one or a combination of the five threat factors specified in section 4(a)(1) of the ESA contribute to the extinction risk of these species. The comments that we received on the proposed rule and the additional information that became available since the publication of the proposed rule did not change our conclusions regarding any of the section 4(a)(1) factors or their interactions for these species. Therefore, we incorporate herein all information, discussion, and conclusions on the summary of factors affecting the two guitarfish species in the status review (Newell 2016) and proposed rule (81 FR 64094; September 19, 2016).

    Extinction Risk

    None of the information we received from public comment on the proposed rule affected our extinction risk evaluations of these two guitarfish species. Therefore, we incorporate herein all information, discussion, and conclusions, with the minor updates noted above, on the extinction risk of the two guitarfish species in the status review (Newell 2016) and proposed rule (81 FR 64094; September 19, 2016).

    Protective Efforts

    As part of our evaluation of the status of the guitarfishes, we considered conservation efforts to protect each species and evaluated whether these conservation efforts are adequate to mitigate the existing threats to the point where extinction risk is significantly lowered and the species' status is improved. None of the information we received from public comment on the proposed rule affected our conclusions regarding conservation efforts to protect the two guitarfish species. We incorporate herein all information, discussion, and conclusions on the protective efforts for both guitarfish species in the status review (Newell 2016) and proposed rule (81 FR 64094; September 19, 2016).

    Final Determination

    There is significant uncertainty regarding the status of the current populations of both R. rhinobatos and R. cemiculus, but both species may still be relatively common, although very likely below their historical population levels, in Tunisia, Israel, Lebanon, Syria, and southeastern Turkey. Based on this information, and the best available scientific and commercial information, as summarized here, in the proposed rule (81 FR 64094; September 19, 2016), and in Newell (2016), we find that neither Rhinobatos species is currently at high risk of extinction throughout their ranges. However, both species are at moderate risk of extinction. We assessed the ESA section 4(a)(1) factors and conclude that R. rhinobatos and R. cemiculus face ongoing threats of overutilization by fisheries and inadequate existing regulatory mechanisms throughout their ranges. Both species have also suffered a curtailment of a large portion of their historical ranges. These species' natural biological vulnerability to overexploitation and present demographic risks (declining abundance, decreasing size of reproductive individuals, and low productivity) are currently exacerbating the negative effects of these threats. Further, ongoing conservation efforts are not adequate to improve the status of these species. Thus, both species likely to become endangered throughout their ranges in the foreseeable future (15-20 years). Therefore, we are listing both species as threatened under the ESA.

    Effects of Listing

    Conservation measures provided for species listed as threatened under the ESA include recovery actions (16 U.S.C. 1533(f)); Federal agency requirements to consult with NMFS under section 7 of the ESA to ensure their actions do not jeopardize the species or result in adverse modification or destruction of critical habitat should it be designated (16 U.S.C. 1536); designation of critical habitat if prudent and determinable (16 U.S.C. 1533(a)(3)(A)); and prohibitions on taking (16 U.S.C. 1538) through a rule promulgated under section 4(d). In addition, recognition of the species' plight through listing promotes conservation actions by Federal and State agencies, foreign entities, private groups, and individuals.

    Identifying Section 7 Consultation Requirements

    Section 7(a)(2) (16 U.S.C. 1536(a)(2)) of the ESA and NMFS/USFWS regulations require Federal agencies to consult with us to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of listed species or destroy or adversely modify critical habitat. It is unlikely that the listing of these species under the ESA will increase the number of section 7 consultations, because these species occur entirely outside of the United States and are unlikely to be affected by Federal actions.

    Critical Habitat

    Critical habitat is defined in section 3 of the ESA (16 U.S.C. 1532(5)) as: (1) The specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the ESA, on which are found those physical or biological features (a) essential to the conservation of the species and (b) that may require special management considerations or protection; and (2) specific areas outside the geographical area occupied by a species at the time it is listed upon a determination that such areas are essential for the conservation of the species. Section 4(a)(3)(A) of the ESA (16 U.S.C. 1533(a)(3)(A)) requires that, to the extent prudent and determinable, critical habitat be designated concurrently with the listing of a species. However, critical habitat shall not be designated in foreign countries or other areas outside U.S. jurisdiction (50 CFR 424.12 (g)).

    The best available scientific and commercial data as discussed above identify the geographical areas occupied by R. rhinobatos and R. cemiculus as being entirely outside U.S. jurisdiction, so we cannot designate occupied critical habitat for these species. We can designate critical habitat in areas in the United States currently unoccupied by the species if the area(s) are determined by the Secretary to be essential for the conservation of the species. The best available scientific and commercial information on these species does not indicate that U.S. waters provide any specific essential biological function for either of the Rhinobatos species. Therefore, based on the available information, we are not designating critical habitat for R. cemiculus or R. rhinobatos.

    Identification of Those Activities That Would Constitute a Violation of Section 9 of the ESA

    On July 1, 1994, NMFS and FWS published a policy (59 FR 34272) that requires NMFS to identify, to the maximum extent practicable at the time a species is listed, those activities that would or would not constitute a violation of section 9 of the ESA. Because we are listing R. rhinobatos and R. cemiculus as threatened, no prohibitions of section 9(a)(1) of the ESA will apply to these species.

    Protective Regulations Under Section 4(d) of the ESA

    We are listing R. rhinobatos and R. cemiculus as threatened under the ESA. In the case of threatened species, ESA section 4(d) leaves it to the Secretary's discretion whether, and to what extent, to extend the section 9(a) “take” prohibitions to the species, and authorizes us to issue regulations necessary and advisable for the conservation of the species. Thus, we have flexibility under section 4(d) to tailor protective regulations, taking into account the effectiveness of available conservation measures. The section 4(d) protective regulations may prohibit, with respect to threatened species, some or all of the acts which section 9(a) of the ESA prohibits with respect to endangered species. These section 9(a) prohibitions apply to all individuals, organizations, and agencies subject to U.S. jurisdiction. Because neither species has ever occupied U.S. waters, and the United States has no known commercial or management interest in either species, we are not applying any section 9(a) prohibitions to either species at this time.

    References

    A complete list of references used in this final rule is available upon request (see ADDRESSES).

    Classification National Environmental Policy Act

    The 1982 amendments to the ESA, in section 4(b)(1)(A), restrict the information that may be considered when assessing species for listing. Based on this limitation of criteria for a listing decision and the opinion in Pacific Legal Foundation v. Andrus, 675 F. 2d 825 (6th Cir. 1981), we have concluded that ESA listing actions are not subject to the environmental assessment requirements of the National Environmental Policy Act (NEPA).

    Executive Order 12866, Regulatory Flexibility Act, and Paperwork Reduction Act

    As noted in the Conference Report on the 1982 amendments to the ESA, economic impacts cannot be considered when assessing the status of a species. Therefore, the economic analysis requirements of the Regulatory Flexibility Act are not applicable to the listing process. In addition, this final rule is exempt from review under Executive Order 12866. This final rule does not contain a collection-of-information requirement for the purposes of the Paperwork Reduction Act.

    Executive Order 13132, Federalism

    In accordance with E.O. 13132, we determined that this final rule does not have significant federalism effects and that a federalism assessment is not required.

    List of Subjects in 50 CFR Part 223

    Endangered and threatened species, Exports, Imports, Transportation.

    Dated: January 10, 2017. Samuel D. Rauch, III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 223 is amended as follows:

    PART 223—THREATENED MARINE AND ANADROMOUS SPECIES 1. The authority citation for part 223 continues to read as follows: Authority:

    16 U.S.C. 1531-1543; subpart B, § 223.201-202 also issued under 16 U.S.C. 1361 et seq.; 16 U.S.C. 5503(d) for § 223.206(d)(9).

    2. In § 223.102, paragraph (e) add new entries for “Guitarfish, blackchin” and “Guitarfish, common”, in alphabetical order by common name under the “Fishes” table subheading to read as follows:
    § 223.102 Enumeration of threatened marine and anadromous species.

    (e) * * *