Federal Register Vol. 81, No.229,

Federal Register Volume 81, Issue 229 (November 29, 2016)

Page Range85837-86248
FR Document

81_FR_229
Current View
Page and SubjectPDF
81 FR 86048 - Sunshine Act MeetingPDF
81 FR 86001 - Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Redding Rancheria Fee-to-Trust and Casino Project, Shasta County, CaliforniaPDF
81 FR 85997 - 60-Day Notice of Proposed Information Collection: FHA Single Family Model Mortgage DocumentsPDF
81 FR 86002 - Pokagon Band of Potawatomi Indians, Michigan and IndianaPDF
81 FR 86072 - Submission for OMB Review; Comment RequestPDF
81 FR 86071 - Publication of the Tier 2 Tax RatesPDF
81 FR 86068 - Agency Information Collection Activities; New Information Collection Request: National Consumer Complaint DatabasePDF
81 FR 85926 - Proposed Renewal of Information Collection; OMB Control Number 3014-0012, Online Architectural Barriers Act (ABA) Complaint FormPDF
81 FR 85950 - Clean Air Act Operating Permit Program; Petition for Objection to State Operating Permit for Tennessee Valley Authority-Bull Run (Anderson County, Tennessee)PDF
81 FR 85952 - Registration Review; Draft Human Health and/or Ecological Risk Assessments; Notice of AvailabilityPDF
81 FR 85951 - Agency Information Collection Activities; Proposed Renewal of EPA ICR No. 0616.12; Comment RequestPDF
81 FR 85924 - Notice of Solicitation of Applications for the Rural Energy for America Program for Federal Fiscal Year 2017; CorrectionPDF
81 FR 86000 - Endangered and Threatened Wildlife and Plants; Permits; Draft Supplement to Environmental Impact Statement and Amendment to Habitat Conservation Plan for Forest Management in MontanaPDF
81 FR 86016 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Consumer Expenditure Surveys: Quarterly Interview and DiaryPDF
81 FR 86018 - Agency Information Collection Activities; Comment Request; Information Collection-Housing Occupancy Certificates Under the Migrant and Seasonal Agricultural Worker Protection ActPDF
81 FR 85968 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Superimposed Text in Direct-to-Consumer Promotion of Prescription DrugsPDF
81 FR 85973 - Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and BiologicsPDF
81 FR 85935 - Taking and Importing of Marine MammalsPDF
81 FR 85944 - Withdrawal of Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Lower Passaic River Ecosystem Restoration Project, Essex, Hudson, Passaic, and Bergen Counties, NJ: Feasibility PhasePDF
81 FR 85944 - Withdrawal of Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Hackensack Meadowlands Ecosystem Restoration Project, Hackensack Meadowlands District, Bergen and Hudson Counties, NJ: Feasibility PhasePDF
81 FR 85980 - Meeting of the Chronic Fatigue Syndrome Advisory CommitteePDF
81 FR 85985 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0028PDF
81 FR 85985 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0087PDF
81 FR 85986 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0079PDF
81 FR 85991 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0084PDF
81 FR 85987 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-NEWPDF
81 FR 85984 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0086PDF
81 FR 85990 - Information Collection Request[s] to Office of Management and Budget; OMB Control Number: 1625-0093PDF
81 FR 85945 - National Advisory Council on Indian Education Meeting NoticePDF
81 FR 86024 - University of Missouri-Columbia Research ReactorPDF
81 FR 86013 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-3D PDF Consortium, Inc.PDF
81 FR 85937 - Digital Economy Board of Advisors MeetingPDF
81 FR 85958 - Proposed Collection; Comment RequestPDF
81 FR 86015 - Agency Information Collection Activities; Comment Request; Job Corps Application DataPDF
81 FR 85928 - Finished Carbon Steel Flanges From India: Preliminary Affirmative Countervailing Duty DeterminationPDF
81 FR 85930 - Certain Carbon and Alloy Steel Cut-To-Length Plate From the Federal Republic of Germany: Amended Preliminary Determination of Sales at Less Than Fair ValuePDF
81 FR 85927 - Chlorinated Isocyanurates From Spain and the People's Republic of China: Continuation of the Antidumping Duty OrdersPDF
81 FR 85982 - Prospective Grant of Exclusive Patent License: Development and Commercialization of Dopamine D3 Receptor Selective Antagonists/Partial Agonists for the Treatment of Opioid Use Disorder, Schizophrenia Bipolar Disorder and Tetrahydrocannabinol DependencePDF
81 FR 85992 - Agency Information Collection Activities: Foreign Assembler's DeclarationPDF
81 FR 85993 - Agency Information Collection Activities: Application and Approval To Manipulate, Examine, Sample or Transfer GoodsPDF
81 FR 85961 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
81 FR 85873 - Schedules of Controlled Substances: Temporary Placement of Furanyl Fentanyl Into Schedule IPDF
81 FR 85991 - Customs Brokers User Fee Payment for 2017PDF
81 FR 85946 - Final 2025 Salt Lake City Area Integrated Projects Power Marketing PlanPDF
81 FR 85939 - Proposed Collection; Comment RequestPDF
81 FR 86019 - Records Schedules; Availability and Request for CommentsPDF
81 FR 86021 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 86067 - Commercial Driver's License: Oregon Department of Transportation; Application for Exemption, CorrectionPDF
81 FR 85923 - Coconino and Tonto National Forests; Arizona; Fossil Creek Wild and Scenic River Comprehensive River Management Plan and Environmental Impact StatementPDF
81 FR 86067 - Agency Information Collection Activities; Extension of a Currently-Approved Information Collection Request: Transportation of Hazardous Materials, Highway RoutingPDF
81 FR 85906 - Refunding Baggage Fees for Delayed Checked BagsPDF
81 FR 86063 - Qualification of Drivers; Exemption Applications; VisionPDF
81 FR 85957 - Agency Information Collection Activities: Submission for OMB Review; Comment Request (3064-0025, -0057, 0140 & -0176)PDF
81 FR 85964 - Proposed Information Collection Activity; Comment RequestPDF
81 FR 85920 - Submission for OMB Review; Comment RequestPDF
81 FR 85945 - Notice of Intent To Grant Exclusive Patent License; Anasys InstrumentsPDF
81 FR 85943 - Defense Health Board; Notice of Federal Advisory Committee MeetingPDF
81 FR 85907 - Approval and Promulgation of Implementation Plans; Oklahoma; Revisions to Minor New Source Review Permitting ProgramPDF
81 FR 85950 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Information Requirements for New Marine Compression Ignition Engines at or Above 30 Liters per Cylinder (Renewal)PDF
81 FR 85921 - Submission for OMB Review; Comment RequestPDF
81 FR 85983 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
81 FR 86030 - New Postal ProductsPDF
81 FR 85977 - The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Establishing Appropriate Durations of Therapeutic Administration; Extension of Comment PeriodPDF
81 FR 86021 - Agency Information Collection Activities: Recordkeeping and Disclosure Requirements Associated With the Fair Credit Reporting Act (FCRA), 15 U.S.C. 1681 et seq., As Amended by the Fair and Accurate Credit Transactions Act of 2003, Public Law 108-159, 117 Stat. 1952, and as Implemented by Regulation V, 12 CFR 1022, and by 12 CFR 717; Comment RequestPDF
81 FR 85904 - Fisheries of the Northeastern United States; Atlantic Bluefish Fishery; Quota TransfersPDF
81 FR 86022 - Agency Information Collection Activities; Proposed Collection; Comment Request; Management Official InterlocksPDF
81 FR 85972 - Novus International, Inc.; Filing of Food Additive Petition (Animal Use); CorrectionPDF
81 FR 85967 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Abbreviated New Drug Applications and 505(b)(2) ApplicationsPDF
81 FR 85974 - Determination of Regulatory Review Period for Purposes of Patent Extension; NUWIQPDF
81 FR 85965 - Determination of Regulatory Review Period for Purposes of Patent Extension; IXINITYPDF
81 FR 85938 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
81 FR 85956 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
81 FR 85955 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
81 FR 85999 - Proposed Information Collection; Pacific Northwest Coastal Landscape Conservation Design Social Network SurveyPDF
81 FR 86061 - PENNSYLVANIA Disaster #PA-00075PDF
81 FR 86060 - Virginia Disaster Number VA-00065PDF
81 FR 86061 - North Carolina; Disaster Number NC-00081PDF
81 FR 85982 - National Institute of Allergy and Infectious Diseases; Amended Notice of MeetingPDF
81 FR 85963 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 86055 - OWLshares Trust, et al.; Notice of ApplicationPDF
81 FR 86044 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendments No. 1 and No. 2 Thereto, To List and Trade Shares of the iShares iBonds Dec 2023 Term Muni Bond ETF and iShares iBonds Dec 2024 Term Muni Bond ETF of the iShares U.S. ETF Trust Pursuant to BZX Rule 14.11(c)(4)PDF
81 FR 86036 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Change, as Modified by Amendment No. 1, Amending the Co-location Services Offered by the Exchange To Add Certain Access and Connectivity FeesPDF
81 FR 86050 - Self-Regulatory Organizations; NYSE MKT LLC; Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Change, as Modified by Amendment No. 1, Amending the Co-location Services Offered by the Exchange To Add Certain Access and Connectivity FeesPDF
81 FR 86056 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change, as Modified by Amendment No. 1, To List and Trade Certain Exchange-Traded Managed FundsPDF
81 FR 86033 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending NYSE Arca Equities Rule 5.1(c) Regarding the Requirements for the Listing of Securities That Are Issued by the Exchange or Any of Its AffiliatesPDF
81 FR 86048 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to the Finance ProceduresPDF
81 FR 86041 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending NYSE MKT Rule 901NYPDF
81 FR 86031 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Allocation of Directed Complex OrdersPDF
81 FR 85939 - Manual for Courts-Martial; Proposed AmendmentsPDF
81 FR 85961 - Notice of Agreement FiledPDF
81 FR 85917 - Federal Automated Vehicles PolicyPDF
81 FR 85932 - National Cybersecurity Center of Excellence (NCCoE) Mobile Application Single Sign On (SSO) for the Public Safety & First Responder SectorPDF
81 FR 85983 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed MeetingPDF
81 FR 85981 - National Center for Advancing Translational Sciences; Notice of MeetingsPDF
81 FR 85980 - Government-Owned Inventions; Availability for Licensing and CollaborationPDF
81 FR 85981 - Center for Scientific Review Notice of Closed MeetingsPDF
81 FR 86069 - Solicitation of Proposals for Designation of Automated Vehicle Proving Grounds PilotPDF
81 FR 85936 - Notice of Availability of a Draft Environmental Assessment for the Bluefield Holdings, Inc. Site 2 Shoreline Restoration Project Credit PurchasePDF
81 FR 86071 - Open Meeting of the Advisory Committee on Risk-Sharing MechanismsPDF
81 FR 85955 - Notice of Issuance of Annual Report for Fiscal Year 2016 and Three-Year PlanPDF
81 FR 85935 - Western Pacific Fishery Management Council; Public Meeting; CorrectionPDF
81 FR 86061 - 60-Day Notice of Intent To Seek Extension of Approval: Information Collection Activities (Complaints, Petitions for Declaratory Orders, and Petitions for Relief Not Otherwise Specified)PDF
81 FR 85995 - Agency Information Collection Activities: Proposed Collection; Comment Request; State Administrative Plan for the Hazard Mitigation Grant ProgramPDF
81 FR 85921 - Notice of Request To Renew an Approved Information Collection (Specified Risk Materials)PDF
81 FR 85901 - Dispute Resolution Procedures Under the Fixing America's Surface Transportation Act of 2015PDF
81 FR 86013 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Application for Alternate Means of Identification of Firearm(s) (Marking Variance) (ATF Form 3311.4)PDF
81 FR 86014 - Agency Information Collection Activities; Proposed eCollection eComments Requested Extension Without Change, of a Previously Approved Collection Federal Coordination and Compliance Section (FCS), FCS Complaint and Consent Form Civil Rights Division, Department of JusticePDF
81 FR 85873 - New Animal Drugs for Use in Animal Feed; Category Definitions; Confirmation of Effective DatePDF
81 FR 85976 - Providing Postmarketing Periodic Safety Reports in the International Council for Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report); Guidance for Industry; AvailabilityPDF
81 FR 85978 - Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Establishment of a Public Docket; Request for Comments; Notice of MeetingPDF
81 FR 85967 - Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes; Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
81 FR 85906 - Competitive Postal ProductsPDF
81 FR 86014 - Notice of Lodging of Proposed Consent Decree Under the Clean Air ActPDF
81 FR 85934 - Ocean Exploration Advisory Board (OEAB)PDF
81 FR 85996 - Housing Opportunity Through Modernization Act of 2016: Solicitation of Comments on Implementation of Public Housing Income LimitPDF
81 FR 85843 - Update of Overflight Fee RatesPDF
81 FR 85962 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 85897 - Air Plan Approval; MA; Decommissioning of Stage II Vapor Recovery SystemsPDF
81 FR 85854 - Submission of Food and Drug Administration Import Data in the Automated Commercial EnvironmentPDF
81 FR 86017 - National Advisory Committee on Occupational Safety and Health (NACOSH)PDF
81 FR 86073 - Agency Information Collection Activity Under OMB Review (Police Officer Pre-Employment Screening Checklist)PDF
81 FR 86073 - Agency Information Collection Activity Under OMB Review (uSPEQ Consumer Survey Experience (Rehabilitation))PDF
81 FR 86074 - Agency Information Collection Activity Under OMB Review (Statement of Purchaser or Owner Assuming Seller's Loan)PDF
81 FR 86072 - Agency Information Collection Activity Under OMB Review: (Inquiry Routing & Information System (IRIS); Statement of Purchaser or Owner Assuming Seller's Loan; VA Police Officer Pre-Employment Screening Checklist; Universal Stakeholder Participation Questionnaire (uSPEQ))PDF
81 FR 85993 - Changes in Flood Hazard DeterminationsPDF
81 FR 86063 - Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of January 1, 2017, Through December 31, 2017PDF
81 FR 86023 - Notice of MeetingPDF
81 FR 86008 - Information Collection: General and Oil and Gas Production Requirements in the Outer Continental Shelf; Submitted for OMB Review; Comment RequestPDF
81 FR 85914 - Federal Acquisition Regulation: Effective Communication between Government and IndustryPDF
81 FR 85877 - Conforming STOP Violence Against Women Formula Grant Program Regulations to Statutory Change; Definitions and Confidentiality Requirements Applicable to All OVW Grant ProgramsPDF
81 FR 85841 - Airworthiness Directives; Fokker Services B.V. AirplanesPDF
81 FR 85916 - Government Property-USAID Reporting RequirementsPDF
81 FR 85837 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 86076 - Elementary and Secondary Education Act of 1965, as Amended by the Every Student Succeeds Act-Accountability and State PlansPDF

Issue

81 229 Tuesday, November 29, 2016 Contents Agency Agency for International Development PROPOSED RULES Acquisition Regulations: Government Property—Reporting Requirements, 85916-85917 2016-28338 Agriculture Agriculture Department See

Food Safety and Inspection Service

See

Forest Service

See

Rural Business-Cooperative Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 85920-85921 2016-28661 2016-28666 2016-28677
Antitrust Division Antitrust Division NOTICES Changes under the National Cooperative Research and Production Act: 3D PDF Consortium, Inc., 86013 2016-28709 Architectural Architectural and Transportation Barriers Compliance Board NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Online Architectural Barriers Act Complaint Form, 85926-85927 2016-28743 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 85938 2016-28651 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 85962-85964 2016-28588 2016-28641 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Center for States Evaluation Ancillary Data Collection, 85964-85965 2016-28678 Coast Guard Coast Guard NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 85984-85991 2016-28715 2016-28716 2016-28717 2016-28719 2016-28720 2016-28721 2016-28722 Commerce Commerce Department See

International Trade Administration

See

National Institute of Standards and Technology

See

National Oceanic and Atmospheric Administration

See

National Telecommunications and Information Administration

Defense Department Defense Department See

Engineers Corps

See

Navy Department

PROPOSED RULES Federal Acquisition Regulations: Effective Communication between Government and Industry, 85914-85915 2016-28450 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 85939 2016-28688 Manual for Courts-Martial: Proposed Amendments, 85939-85943 2016-28630 Meetings: Defense Health Board, Federal Advisory Committee, 85943-85944 2016-28674
Drug Drug Enforcement Administration RULES Schedules of Controlled Substances: Temporary Placement of Furanyl Fentanyl into Schedule I, 85873-85877 2016-28693 Education Department Education Department RULES Elementary and Secondary Education Act, as Amended by the Every Student Succeeds Act: Accountability and State Plans, 86076-86248 2016-27985 NOTICES Meetings: National Advisory Council on Indian Education, 85945-85946 2016-28713 Employment and Training Employment and Training Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals Job Corps Application Data, 86015-86016 2016-28705 Energy Department Energy Department See

Western Area Power Administration

Engineers Engineers Corps NOTICES Environmental Impact Statements; Availability, etc.: Hackensack Meadowlands Ecosystem Restoration Project, Hackensack Meadowlands District, Bergen and Hudson Counties, NJ: Withdrawal, 85944-85945 2016-28729 Lower Passaic River Ecosystem Restoration Project, Essex, Hudson, Passaic, and Bergen Counties, NJ: Feasibility Phase, 85944 2016-28730 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Massachusetts; Air Plan Approval; Decommissioning of Stage II Vapor Recovery Systems, 85897-85901 2016-28587 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Oklahoma; Revisions to Minor New Source Review Permitting Program, 85907-85914 2016-28673 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 85951-85952 2016-28739 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Information Requirements for New Marine Compression Ignition Engines at or Above 30 Liters per Cylinder, 85950-85951 2016-28672 Clean Air Act Operating Permit Program; Petitions: Objection to State Operating Permit for Tennessee Valley Authority, Bull Run, Anderson County, TN, 85950 2016-28742 Registration Reviews: Human Health and Ecological Risk Assessments Draft, 85952-85955 2016-28740 Federal Accounting Federal Accounting Standards Advisory Board NOTICES Annual Report for Fiscal Year 2016 and Three-Year Plan, 85955 2016-28615 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Airbus Airplanes, 85837-85840 2016-28335 Fokker Services B.V. Airplanes, 85841-85843 2016-28341 Update of Overflight Fee Rates, 85843-85854 2016-28589 NOTICES Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for Period of January 1, 2017, through December 31, 2017, 86063 2016-28555 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 85955-85957 2016-28649 2016-28650 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 85957-85958 2016-28679 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: State Administrative Plan for Hazard Mitigation Grant Program, 85995-85996 2016-28612 Flood Hazard Determinations; Changes, 85993-85995 2016-28567 Federal Housing Finance Agency Federal Housing Finance Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 85958-85961 2016-28707 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 85961 2016-28629 Federal Motor Federal Motor Carrier Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Consumer Complaint Database, 86068-86069 2016-28745 Transportation of Hazardous Materials, Highway Routing, 86067-86068 2016-28682 Commercial Driver's Licenses; Exemption Applications: Oregon Department of Transportation; Correction, 86067 2016-28685 Qualification of Drivers; Exemption Applications: Vision, 86063-86067 2016-28680 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 85961-85962 2016-28694 Fish Fish and Wildlife Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Pacific Northwest Coastal Landscape Conservation Design Social Network Survey, 85999 2016-28648 Environmental Impact Statements; Availability, etc.: Endangered and Threatened Wildlife and Plants; Permits; Amendment to Habitat Conservation Plan for Forest Management in Montana, 86000-86001 2016-28736 Food and Drug Food and Drug Administration RULES New Animal Drugs for Use in Animal Feed; Confirmation of Effective Date, 85873 2016-28607 Submission of Import Data in Automated Commercial Environment, 85854-85873 2016-28582 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Abbreviated New Animal Drug Applications, 85967 2016-28655 Guidance for Industry on Expedited Programs for Serious Conditions: Drugs and Biologics, 85973-85974 2016-28732 Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs, 85968-85972 2016-28733 Determinations of Regulatory Review Periods for Purposes of Patent Extensions: IXINITY, 85965-85966 2016-28653 NUWIQ, 85974-85976 2016-28654 Food Additive Petitions: Novus International, Inc., 85972 2016-28656 Guidance: Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Establishing Appropriate Durations of Therapeutic Administration, 85977-85978 2016-28660 Mitigating Risk of Cross-Contamination from Valves and Accessories Used for Irrigation through Flexible Gastrointestinal Endoscopes, 85967-85968 2016-28604 Providing Postmarketing Periodic Safety Reports in International Council for Harmonisation E2C(R2) Format; Periodic Benefit-Risk Evaluation Report, 85976-85977 2016-28606 Meetings: Pharmaceutical Science and Clinical Pharmacology Advisory Committee, 85978-85980 2016-28605 Food Safety Food Safety and Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 85921-85923 2016-28611 Forest Forest Service NOTICES Environmental Impact Statements; Availability, etc.: Coconino and Tonto National Forests, AZ; Fossil Creek Wild and Scenic River Comprehensive River Management Plan, 85923-85924 2016-28683 General Services General Services Administration PROPOSED RULES Federal Acquisition Regulations: Effective Communication between Government and Industry, 85914-85915 2016-28450 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Children and Families Administration

See

Food and Drug Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

NOTICES Meetings: Chronic Fatigue Syndrome Advisory Committee, 85980 2016-28723
Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

See

U.S. Customs and Border Protection

Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: FHA Single Family Model Mortgage Documents, 85997-85999 2016-28756 Housing Opportunity Through Modernization Act of 2016, 85996-85997 2016-28593 Indian Affairs Indian Affairs Bureau NOTICES Environmental Impact Statements; Availability, etc.: Proposed Redding Rancheria Fee-to-Trust and Casino Project, Shasta County, CA, 86001-86002 2016-28757 Liquor Control Ordinances: Pokagon Band of Potawatomi Indians, Michigan and Indiana, 86002-86008 2016-28749 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

Ocean Energy Management Bureau

Internal Revenue Internal Revenue Service NOTICES Publication of Tier 2 Tax Rates, 86071 2016-28747 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Chlorinated Isocyanurates from Spain and People's Republic of China, 85927-85928 2016-28702 Finished Carbon Steel Flanges from India, 85928-85930 2016-28704 Determinations of Sales at Less than Fair Value: Certain Carbon and Alloy Steel Cut-To-Length Plate from Federal Republic of Germany, 85930-85932 2016-28703 Justice Department Justice Department See

Antitrust Division

See

Drug Enforcement Administration

RULES Conforming STOP Violence Against Women Formula Grant Program: Definitions and Confidentiality Requirements Applicable to All Office on Violence Against Women Grant Programs, 85877-85897 2016-28437 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 86014-86015 2016-28608 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Alternate Means of Identification of Firearm(s); Marking Variance, 86013-86014 2016-28609 Proposed Consent Decrees under the Clean Air Act, 86014 2016-28599
Labor Department Labor Department See

Employment and Training Administration

See

Occupational Safety and Health Administration

See

Wage and Hour Division

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Quarterly Interview and Diary, 86016-86017 2016-28735
NASA National Aeronautics and Space Administration PROPOSED RULES Federal Acquisition Regulations: Effective Communication between Government and Industry, 85914-85915 2016-28450 National Archives National Archives and Records Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 86021 2016-28686 Records Schedules, 86019-86021 2016-28687 National Credit National Credit Union Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 86021-86022 2016-28659 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Management Official Interlocks, 86022-86023 2016-28657 National Highway National Highway Traffic Safety Administration PROPOSED RULES Federal Automated Vehicles Policy: Public Meeting, 85917-85919 2016-28628 National Institute National Institute of Standards and Technology NOTICES National Cybersecurity Center of Excellence Mobile Application Single Sign On for Public Safety and First Responder Sector, 85932-85934 2016-28627 National Institute National Institutes of Health NOTICES Government-Owned Inventions; Availability for Licensing, 85980-85981 2016-28624 Meetings: Center for Scientific Review, 85981 2016-28623 National Center for Advancing Translational Sciences, 85981-85982 2016-28625 National Institute of Allergy and Infectious Diseases, 85982 2016-28643 National Institute on Alcohol Abuse and Alcoholism, 85983 2016-28626 Prospective Grants of Exclusive Patent Licenses: Development and Commercialization of Dopamine D3 Receptor Selective Antagonists/Partial Agonists for Treatment of Opioid Use Disorder, Schizophrenia Bipolar Disorder and Tetrahydrocannabinol Dependence, 85982-85983 2016-28698 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Northeastern United States: Atlantic Bluefish Fishery; Quota Transfers, 85904-85905 2016-28658 NOTICES Environmental Assessments; Availability, etc.: Bluefield Holdings, Inc. Site 2 Shoreline Restoration Project Credit Purchase, 85936-85937 2016-28617 Meetings: Western Pacific Fishery Management Council; Correction, 85935 2016-28614 Requests for Nominations: Ocean Exploration Advisory Board, 85934-85935 2016-28594 Taking and Importing of Marine Mammals, 85935-85936 2016-28731 National Telecommunications National Telecommunications and Information Administration NOTICES Meetings: Digital Economy Board of Advisors, 85937-85938 2016-28708 Navy Navy Department NOTICES Exclusive Patent Licenses: Anasys Instruments, 85945 2016-28676 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Environmental Assessments; Availability, etc.: University of Missouri-Columbia Research Reactor, 86024-86030 2016-28711 Meetings: Advisory Committee on Reactor Safeguards, 86023-86024 2016-28550 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Meetings: National Advisory Committee on Occupational Safety and Health, 86017-86018 2016-28581 Ocean Energy Management Ocean Energy Management Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: General and Oil and Gas Production Requirements in Outer Continental Shelf, 86008-86013 2016-28542 Postal Regulatory Postal Regulatory Commission PROPOSED RULES Competitive Postal Products, 85906-85907 2016-28603 NOTICES New Postal Products, 86030-86031 2016-28662 Rural Business Rural Business-Cooperative Service NOTICES Funding Availability: Rural Energy for America Program for Federal Fiscal Year 2017; Correction, 85924-85926 2016-28737 Securities Securities and Exchange Commission NOTICES Applications: OWLshares Trust, et al., 86055-86056 2016-28640 Meetings; Sunshine Act, 86048 2016-28772 Self-Regulatory Organizations; Proposed Rule Changes: Bats BZX Exchange, Inc., 86044-86048 2016-28639 ICE Clear Europe, Ltd., 86048-86050 2016-28634 NASDAQ PHLX, LLC, 86031-86033 2016-28632 NASDAQ Stock Market, LLC, 86056-86060 2016-28636 NYSE Arca, Inc., 86033-86041 2016-28635 2016-28638 NYSE MKT, LLC, 86041-86044, 86050-86055 2016-28633 2016-28637 Small Business Small Business Administration NOTICES Disaster Declarations: North Carolina, 86061 2016-28645 Pennsylvania, 86061 2016-28647 Virginia, 86060-86061 2016-28646 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 85983-85984 2016-28665 Surface Transportation Surface Transportation Board RULES Dispute Resolution Procedures, 85901-85904 2016-28610 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 86061-86062 2016-28613 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

See

National Highway Traffic Safety Administration

PROPOSED RULES Refunding Baggage Fees: Delayed Checked Bags, 85906 2016-28681 NOTICES Designation of Automated Vehicle Proving Grounds Pilot, 86069-86071 2016-28619
Treasury Treasury Department See

Internal Revenue Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 86072 2016-28748 Meetings: Advisory Committee on Risk-Sharing Mechanisms, 86071-86072 2016-28616
Customs U.S. Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application and Approval to Manipulate, Examine, Sample or Transfer Goods, 85993 2016-28696 Foreign Assembler's Declaration, 85992 2016-28697 Customs Brokers User Fee Payment for 2017, 85991-85992 2016-28692 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Consumer Survey Experience (Rehabilitation), 86073 2016-28579 Inquiry Routing and Information System; Statement of Purchaser or Owner Assuming Seller's Loan; VA Police Officer Pre-Employment Screening Checklist; Universal Stakeholder Participation Questionnaire, 86072 2016-28577 Police Officer Pre-Employment Screening Checklist, 86073-86074 2016-28580 Statement of Purchaser or Owner Assuming Seller's Loan, 86074 2016-28578 Wage Wage and Hour Division NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Housing Occupancy Certificates under Migrant and Seasonal Agricultural Worker Protection Act, 86018-86019 2016-28734 Western Western Area Power Administration NOTICES Salt Lake City Area Integrated Projects Power Marketing Plan; Final 2025, 85946-85950 2016-28690 Separate Parts In This Issue Part II Education Department, 86076-86248 2016-27985 Reader Aids

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81 229 Tuesday, November 29, 2016 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5596; Directorate Identifier 2015-NM-121-AD; Amendment 39-18677; AD 2016-20-11] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

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

ACTION:

Final rule.

SUMMARY:

We are superseding Airworthiness Directive (AD) 2014-12-06 for certain Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes); and Airbus Model A310 series airplanes. AD 2014-12-06 required repetitive ultrasonic or detailed inspections of the external area of the aft cargo door sill beam for cracking, and repair if necessary, and provided an optional one-time high frequency eddy current (HFEC) inspection that would terminate the repetitive inspections. This new AD requires the previously optional terminating HFEC inspection, and requires that it be done repetitively. This AD was prompted by findings of multiple fatigue cracks in the aft cargo door that indicated the need for additional, repetitive, HFEC inspections. We are issuing this AD to address the unsafe condition on these products.

DATES:

This AD is effective January 3, 2017.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of January 3, 2017.

The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of July 2, 2014 (79 FR 34403, June 17, 2014).

ADDRESSES:

For service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email [email protected]; Internet http://www.airbus.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5596.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5596, or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (telephone 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-2125; fax 425-227-1149.

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2014-12-06, Amendment 39-17867 (79 FR 34403, June 17, 2014) (“AD 2014-12-06”). AD 2014-12-06 applied to certain Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes); and Airbus Model A310 series airplanes. AD 2014-12-06 required repetitive ultrasonic or detailed inspections of the external area of the aft cargo door sill beam for cracking, and repair if necessary. AD 2014-12-16 also provided an optional one-time HFEC inspection that would terminate the repetitive inspections. The NPRM published in the Federal Register on April 27, 2016 (81 FR 24745). The NPRM was prompted by findings of multiple fatigue cracks in the aft cargo door that indicated the need for repetitive HFEC inspections. The NPRM proposed to continue to require repetitive ultrasonic or detailed inspections of the external area of the aft cargo door sill beam for cracking, and repair if necessary. The NPRM also proposed to require the previously optional terminating HFEC inspection, and to require that it be done repetitively. We are issuing this AD to detect and correct fatigue cracking of the cargo door sill beam, lock fitting, and torsion box plate. Failure of one or more of these components could result in the loss of the door locking function and, subsequently, complete loss of the cargo door in flight with the risk of rapid decompression.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0150, dated July 23, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes); and Airbus Model A310 series airplanes. The MCAI states:

During accomplishment of Maintenance Review Board Report (MRBR) task 531625-01-1 on an A300-600 aeroplane having accumulated more than 25,000 flight cycles (FC) since aeroplane first flight, multiple fatigue cracks were found on the following parts:

—Aft cargo door sill beam Part Number (P/N) A53973085210. —Lock fitting P/N A53978239002. —Torsion box plate P/N A53973318206.

Prompted by these findings, a stress analysis was performed during which it was discovered that there is no dedicated scheduled maintenance task to inspect the affected area for fatigue damage.

This condition, if not detected and corrected, could lead to failure of multiple lock fittings, possibly resulting in loss of the cargo door in flight and consequent explosive decompression of the aeroplane.

To address this unsafe condition, Airbus issued Alert Operators Transmission (AOT) A53W005-14 providing instructions for inspection of the affected area.

Consequently, EASA issued Emergency AD 2014-0097-E [which corresponded to FAA AD 2014-12-06] to require repetitive ultrasonic (US) inspections or detailed inspections (DET) of the aft cargo door sill beam external area, and/or a one-time High Frequency Eddy Current (HFEC) inspection of the aft cargo door sill beam internal structure and, depending on findings, accomplishment of corrective action(s).

Since that [EASA] AD was issued, the results of further analysis have indicated that repetitive HFEC inspections need to be introduced.

For the reasons described above, this [EASA] AD retains the requirements of EASA AD 2014-0097-E, which is superseded, and requires repetitive HFEC inspections of the concerned areas. The first HFEC inspection terminates the repetitive US/DET inspections.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5596.

Comments

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

Support for the NPRM

The Air Line Pilots Association, International stated that it supports the NPRM.

Request To Rewrite Reporting Requirements

One commenter, Mark Hilborn, requested that we revise the structure of paragraph (i) of the proposed AD for clarity and to change the location where the reports should be sent. He stated that we could rewrite paragraph (i) of the proposed AD to remove the subparagraphs.

We partially agree with the request. We have updated the contact information for submitting the reports. We do not find it necessary, however, to change the remainder of the paragraph since it is restated from AD 2014-12-06, and the compliance times are correct.

Request To Clarify the Terminating Actions

Mark Hilborn requested we revise paragraph (m) of the proposed AD for clarity and to add new subparagraphs to aid in that.

We agree with the request and have changed paragraph (m) of this AD accordingly.

Additional Changes Made in This Final Rule

We have revised this AD to require the current version of the service information identified for the terminating action specified in this AD. This service information was revised to make a small tooling change; no additional work is necessary for airplanes on which the original version of this service information was accomplished. We have also added credit for airplanes on which the original version of this service information was accomplished, and made related changes accordingly.

Conclusion

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

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

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

Related Service Information Under 1 CFR Part 51

Airbus has issued the following service information, which describes procedures for repetitive HFEC inspections of the cargo door sill beam, lock fitting, and torsion box plate. These service bulletins are distinct since they apply to different airplane models.

• Airbus Service Bulletin A300-53-6179, dated December 12, 2014.

• Airbus Service Bulletin A310-53-2139, dated December 12, 2014.

Airbus has also issued AOT A53W005-14, Revision 01, dated April 29, 2014, which describes procedures for doing an ultrasonic inspection or detailed inspection of the aft cargo door sill beam external area for cracking.

Additionally, Airbus has issued the following service information, which describes procedures for reinforcing the aft cargo door sill beam are between FR 60 and FR 63. These service bulletins are distinct since they apply to different airplane models.

• Airbus Service Bulletin A310-53-2141, Revision 01, dated July 2, 2015.

• Airbus Service Bulletin A300-53-6181, Revision 01, dated July 2, 2015.

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

Costs of Compliance

We estimate that this AD affects 75 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

Estimated Costs Action Labor cost Parts cost Cost per product Cost on U.S. operators Inspection 12 work-hours × $85 per hour = $1,020 per inspection cycle N/A $1,020 per inspection cycle $76,500 per inspection cycle. Reporting 1 work-hour × $85 per hour = $85 per inspection cycle N/A $85 $6,375. Paperwork Reduction Act

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to 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 current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.

Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings

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

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

1. Is not a “significant regulatory action” under Executive Order 12866;

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

3. Will not affect intrastate aviation in Alaska; and

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by removing AD 2014-12-06, Amendment 39-17867 (79 FR 34403, June 17, 2014), and adding the following new AD: 2016-20-11 Airbus: Amendment 39-18677; Docket No. FAA-2016-5596; Directorate Identifier 2015-NM-121-AD. (a) Effective Date

This AD is effective January 3, 2017.

(b) Affected ADs

This AD replaces AD 2014-12-06, Amendment 39-17867 (79 FR 34403, June 17, 2014) (“AD 2014-12-06”).

(c) Applicability

This AD applies to the airplanes identified in paragraphs (c)(1), (c)(2), (c)(3), (c)(4), and (c)(5) of this AD, certificated in any category, all manufacturer serial numbers on which Airbus Modification 05438 has been embodied in production, except those on which Airbus Modification 12046 has been embodied in production.

(1) Airbus Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes.

(2) Airbus Model A300 B4-605R and B4-622R airplanes.

(3) Airbus Model A300 F4-605R and F4-622R airplanes.

(4) Airbus Model A300 C4-605R Variant F airplanes.

(5) Airbus Model A310-203, -204, -221, -222, -304, -322, -324, and -325 airplanes.

(d) Subject

Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

This AD was prompted by reports of fatigue cracks on the cargo door sill beam, lock fitting, and torsion box plate. We are issuing this AD to detect and correct fatigue cracking of the cargo door sill beam, lock fitting, and torsion box plate, which could result in the loss of the door locking function and subsequently, complete loss of the cargo door in flight with the risk of rapid decompression.

(f) Compliance

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

(g) Retained Inspection, With Revised Service Information

This paragraph restates the requirements of paragraph (g)(1) of AD 2014-12-06, with revised service information. Within the compliance time identified in paragraph (g)(1), (g)(2), or (g)(3) of this AD, as applicable: Do an ultrasonic inspection or detailed inspection of the aft cargo door sill beam external area for cracking, in accordance with Airbus Alert Operators Transmission (AOT) A53W005-14, dated April 22, 2014; or Airbus AOT A53W005-14, Revision 01, dated April 29, 2014. Repeat the inspection thereafter at intervals not to exceed 275 flight cycles. As of the effective date of this AD, only Airbus AOT A53W005-14, Revision 01, dated April 29, 2014, may be used to comply with the requirements of this paragraph.

(1) For airplanes that have accumulated 30,000 flight cycles or more since the airplane's first flight as of July 2, 2014 (the effective date of AD 2014-12-06): Within 50 flight cycles after July 2, 2014.

(2) For airplanes that have accumulated 18,000 flight cycles or more, but fewer than 30,000 flight cycles since the airplane's first flight as of July 2, 2014 (the effective date of AD 2014-12-06): Within 275 flight cycles after July 2, 2014.

(3) For airplanes that have accumulated fewer than 18,000 flight cycles since the airplane's first flight as of July 2, 2014 (the effective date of AD 2014-12-06): Before exceeding 18,275 flight cycles since the airplane's first flight.

(h) Retained Optional Terminating Action, With Revised Service Information and Specific Delegation Approval Language

This paragraph restates the provisions of paragraph (h) of AD 2014-12-06, with revised service information and specific delegation approval language. Accomplishment of a high frequency eddy current (HFEC) inspection for cracking, in accordance with Airbus AOT A53W005-14, dated April 22, 2014; or Airbus AOT A53W005-14, Revision 01, dated April 29, 2014; terminates the repetitive inspections required by paragraph (g) of this AD for that airplane. If any cracking is found during the HFEC inspection, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).

(i) Retained Reporting Requirement, With Revised Contact Information

This paragraph restates the provisions of paragraph (i) of AD 2014-12-06, with revised contact information. Submit a report of the findings (both positive and negative) of the inspection required by paragraph (g) of this AD to “Airbus Service Bulletin Reporting Online Application” on Airbus World (https://w3.airbus.com/), at the applicable time specified in paragraph (i)(1) or (i)(2) of this AD. The report must include the inspection results, including no findings.

(1) If the inspection was done on or after the effective date of this AD: Submit the report within 30 days after the inspection.

(2) If the inspection was done before the effective date of this AD: Submit the report within 30 days after the effective date of this AD.

(j) Definition of Airplane Groups

Paragraphs (k)(1), (k)(2), and (k)(3) of this AD refer to airplane groups, as identified in paragraphs (j)(1), (j)(2), and (j)(3) of this AD.

(1) Airplanes on which an HFEC inspection was accomplished as specified in Airbus AOT A53W005-14.

(2) Airplanes on which no HFEC inspection was accomplished as specified in Airbus AOT A53W005-14, and that have accumulated more than 18,000 total flight cycles as of the effective date of this AD.

(3) Airplanes on which no HFEC inspection was accomplished as specified in Airbus AOT A53W005-14, that have accumulated 18,000 total flight cycles or fewer as of the effective date of this AD.

(k) New Repetitive HFEC Inspections and Repair

At the applicable time specified in paragraph (k)(1), (k)(2), or (k)(3) of this AD: Do an HFEC inspection for fatigue cracking of the cargo door sill beam, lock fitting, and torsion box plate, in accordance with Airbus Service Bulletin A300-53-6179, dated December 12, 2014; or Airbus Service Bulletin A310-53-2139, dated December 12, 2014; as applicable. Repeat the HFEC inspection thereafter at intervals not to exceed 4,600 flight cycles.

(1) For airplanes identified in paragraph (j)(1) of this AD: Inspect within 4,600 flight cycles after the most recent HFEC inspection specified in Airbus AOT A53W005-14.

(2) For airplanes identified in paragraph (j)(2) of this AD: Inspect within 2,000 flight cycles after the effective date of this AD.

(3) For airplanes identified in paragraph (j)(3) of this AD: Inspect before exceeding 13,000 total flight cycles since the airplane's first flight, or within 2,000 flight cycles after the effective date of this AD, whichever occurs later.

(l) Corrective Action

If any crack is found during any inspection required by paragraph (g) or (k) of this AD: Before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA; or Airbus's EASA DOA.

(m) Terminating Action for Repetitive Inspections

This paragraph identifies the requirements to terminate repetitive inspections mandated by this AD.

(1) For any airplane identified in paragraphs (j)(2) and (j)(3) of this AD, accomplishment of the initial inspection required by paragraph (k) of this AD terminates the repetitive inspections required by paragraph (g) of this AD.

(2) For any airplane identified in paragraphs (c)(1) through (c)(5) of this AD, accomplishment of Airbus Service Bulletin A310-53-2141, Revision 01, dated July 2, 2015; or Airbus Service Bulletin A300-53-6181, Revision 01, dated July 2, 2015; as applicable; terminates the repetitive inspections required by paragraph (k) of this AD.

(n) Credit for Previous Actions

This paragraph provides credit for actions provided in paragraph (m)(2) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A300-53-6181, dated June 26, 2015; or Airbus Service Bulletin A310-53-2141, dated June 26, 2015; as applicable.

(o) Other FAA AD Provisions

The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-2125; fax 425-227-1149. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

(2) Contacting the Manufacturer: As of the effective date of this AD, for any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA; or Airbus's EASA DOA. If approved by the DOA, the approval must include the DOA-authorized signature.

(3) Reporting Requirements: A federal agency may not conduct or sponsor, and a person is not 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 current valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately 5 minutes per response, including the time for reviewing instructions, completing and reviewing the collection of information. All responses to this collection of information are mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn: Information Collection Clearance Officer, AES-200.

(4) Required for Compliance (RC): Except as required by paragraph (l) of this AD: If any service information contains procedures or tests that are identified as RC, those procedures and tests must be done to comply with this AD; any procedures or tests that are not identified as RC are recommended. Those procedures and tests that are not identified as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the procedures and tests identified as RC can be done and the airplane can be put back in an airworthy condition. Any substitutions or changes to procedures or tests identified as RC require approval of an AMOC.

(p) Related Information

(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2015-0150, dated July 23, 2015, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5596.

(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (q)(5) and (q)(6) of this AD.

(q) Material Incorporated by Reference

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

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

(3) The following service information was approved for IBR on January 3, 2017.

(i) Airbus Alert Operators Transmission (AOT) A53W005-14, Revision 01, dated April 29, 2014.

(ii) Airbus Service Bulletin A310-53-2141, Revision 01, dated July 2, 2015.

(iii) Airbus Service Bulletin A300-53-6179, dated December 12, 2014.

(iv) Airbus Service Bulletin A300-53-6181, Revision 01, dated July 2, 2015.

(v) Airbus Service Bulletin A310-53-2139, dated December 12, 2014.

(4) The following service information was approved for IBR on July 2, 2014 (79 FR 34403, June 17, 2014).

(i) Airbus AOT A53W005-14, dated April 22, 2014.

(ii) Reserved.

(5) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email [email protected]; Internet http://www.airbus.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

(6) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

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

Issued in Renton, Washington, on September 28, 2016. Dionne Palermo, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-28335 Filed 11-28-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-6895; Directorate Identifier 2015-NM-068-AD; Amendment 39-18673; AD 2016-20-07] RIN 2120-AA64 Airworthiness Directives; Fokker Services B.V. Airplanes AGENCY:

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

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for certain Fokker Services B.V. Model F28 airplanes. This AD was prompted by reports indicating that the main landing gear (MLG) could not be extended and locked down during approach. This AD requires inspection of the restrictor check valve filter screens to detect any degraded or failed filter screens, and installation of serviceable parts. We are issuing this AD to address the unsafe condition on these products.

DATES:

This AD is effective January 3, 2017.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of January 3, 2017.

ADDRESSES:

For service information identified in this final rule, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email [email protected]; Internet http://www.myfokkerfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6895.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6895; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1149.

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Fokker Services B.V. Model F28 airplanes. The NPRM published in the Federal Register on June 1, 2016 (81 FR 34929) (“the NPRM”). The NPRM was prompted by reports indicating that the MLG could not be extended and locked down during approach. The NPRM proposed to require a detailed inspection of the restrictor check valve filter screens to detect any degraded or failed filter screens, and installation of serviceable parts. We are issuing this AD to detect and correct any degraded or failed filter screens. This condition, if not corrected, could prevent MLG extension and lock-down and result in an emergency landing with consequent injury to occupants and damage to the airplane.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0077, dated May 6, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Fokker Services B.V. Model F28 airplanes. The MCAI states:

Two occurrences were reported concerning two different aeroplanes, where during approach, after selecting landing gear down, one of the main landing gears (MLG) could not be extended and locked down. In both cases, subsequent investigation revealed that the filter screen of the corresponding restrictor check valve (integrated in a hydraulic hose assembly) was broken, and debris inside the restrictor check valve was blocking the return flow from the affected MLG actuator. Additional inspection of the fleet of the operator involved revealed more damaged or failed filter screens.

This condition, if not detected and corrected, could prevent MLG extension and lock-down, possibly resulting in an emergency landing with consequent damage to the aeroplane and injury to occupants.

To address this unsafe condition, Fokker Services published SBF28-32-164 and SBF100-32-166 to provide instructions for removal of the affected hydraulic hoses (including the restrictor check valve) to be inspected in-shop, and for installation of serviceable parts. Fokker Services also published Component SB CSB-32-026 to provide those in-shop inspection instructions to detect any damaged filter screen.

For the reasons described above, this [EASA] AD requires a onetime removal of the landing gear hydraulic hoses for the purpose of an in-shop inspection of the affected restrictor check valves filter screens and, depending on findings, re-installation, or replacement of the affected hose(s) with a serviceable part.

This [EASA] AD is considered to be an interim action to detect any degraded or failed filter screens and remove them from service and to collect additional data; further [EASA] AD action may follow. More information on this subject can be found in Fokker Services All Operators Messages AOF28.041 and AOF100.189#02.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6895.

Comments

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

Conclusion

We reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed, except for minor editorial changes. We have determined that these minor changes:

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

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

Related Service Information Under 1 CFR Part 51

Fokker Services B.V. has issued the following service information, which describes procedures for the replacement of hydraulic hose assemblies. These service bulletins are distinct because they apply to different airplane models.

• Fokker Service Bulletin SBF28-32-164, dated January 14, 2015.

• Fokker Service Bulletin SBF100-32-166, dated January 14, 2015.

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

Costs of Compliance

We estimate that this AD affects 8 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S. operators
    Inspection 1 work-hour × $85 per hour = $85 $3,100 $3,185 $25,480 Reporting 1 work-hour × $85 per hour = $85 0 85 680
    Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to 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 current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.

    Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

    We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

    Regulatory Findings

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

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

    1. Is not a “significant regulatory action” under Executive Order 12866;

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2016-20-07 Fokker Services B.V.: Amendment 39-18673; Docket No. FAA-2016-6895; Directorate Identifier 2015-NM-068-AD. (a) Effective Date

    This AD is effective January 3, 2017.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Fokker Services B.V. airplanes, certificated in any category, as identified in paragraphs (c)(1) and (c)(2) of this AD.

    (1) Model F28 Mark 0070 and Mark 0100 airplanes, all serial numbers (S/Ns).

    (2) Model F28 Mark 1000, 2000, 3000, and 4000 airplanes, S/Ns 11003 through 11110 inclusive and S/N 11992, modified in service as specified in Fokker Service Bulletin SBF28-32-123; and S/Ns 11111 through 11241 inclusive.

    (d) Subject

    Air Transport Association (ATA) of America Code 32, Landing Gear.

    (e) Reason

    This AD was prompted by reports indicating that the main landing gear (MLG) could not be extended and locked down during approach. We are issuing this AD to detect and correct any degraded or failed filter screens. This condition, if not corrected, could prevent MLG extension and lock-down and result in an emergency landing with consequent injury to occupants and damage to the airplane.

    (f) Compliance

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

    (g) Inspection

    Within 18 months after the effective date of this AD, do a detailed inspection of the restrictor check valve filter screens to detect any degraded or failed filter screens including dents and missing wire, and install serviceable parts (hydraulic hose assemblies), in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF28-32-164, dated January 14, 2015 (for Model F28 Mark 1000, 2000, 3000, and 4000 airplanes); or SBF100-32-166, dated January 14, 2015 (for Model F28 Mark 0070 and 0100 airplanes); as applicable. Any affected hydraulic hose assembly must be replaced before further flight after the inspection.

    (h) Serviceable Part

    For the purpose of this AD, a serviceable part is a part number (P/N) 97867-1 or P/N 97867-3 hydraulic hose assembly (including the restrictor check valve) that has not previously been installed on an airplane, or a P/N 97867-1 or P/N 97867-3 hydraulic hose assembly (including the restrictor check valve) that has passed an inspection as specified in Fokker Services Component Service Bulletin CSB-32-026.

    (i) Parts Installation Prohibition

    As of the effective date of this AD, no person may install a replacement P/N 97867-1 or P/N 97867-3 hydraulic hose assembly on an airplane, unless the hydraulic hose assembly is a serviceable part as defined in paragraph (h) of this AD.

    (j) Reporting Requirements

    At the applicable time specified in paragraph (j)(1) or (j)(2) of this AD, submit a report of the results (including no findings) of the inspection required by paragraph (g) of this AD. Send the report to Fokker Services B.V., Technical Services, Service Engineering, P.O. Box 1357, 2130 EL Hoofddorp, The Netherlands, email [email protected] The report must include the type of damage found and airplane flight cycles and also any no findings.

    (1) If the inspection was done on or after the effective date of this AD: Submit the report within 30 days after the inspection.

    (2) If the inspection was done before the effective date of this AD: Submit the report within 30 days after the effective date of this AD.

    (k) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1149. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Fokker B.V. Service's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

    (3) Reporting Requirements: A federal agency may not conduct or sponsor, and a person is not 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 current valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately 5 minutes per response, including the time for reviewing instructions, completing and reviewing the collection of information. All responses to this collection of information are mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn: Information Collection Clearance Officer, AES-200.

    (l) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI) European Aviation Safety Agency (EASA) Airworthiness Directive 2015-0077, dated May 6, 2015, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-6895.

    (m) Material Incorporated by Reference

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

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

    (i) Fokker Service Bulletin SBF28-32-164, dated January 14, 2015.

    (ii) Fokker Service Bulletin SBF100-32-166, dated January 14, 2015.

    (3) For service information identified in this AD, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email [email protected]; Internet http://www.myfokkerfleet.com.

    (4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

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

    Issued in Renton, Washington, on September 15, 2016. Suzanne Masterson, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-28341 Filed 11-28-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 187 [Docket No.: FAA-2015-3597; Amdt. No. 187-36] RIN 2120-AK53 Update of Overflight Fee Rates AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    This final rule updates existing overflight fee rates using Fiscal Year (FY) 2013 FAA cost accounting and air traffic activity data. Overflight fees are charges for aircraft flights that transit U.S.-controlled airspace, but neither land in nor depart from the United States. Overflight fee rates were last updated in 2011. As a result, the FAA is not recovering the full cost of the services it provides. The FAA is increasing the rates for enroute and oceanic overflights based on Fiscal Year (FY) 2013 cost and air traffic activity data. The FAA is phasing in this rate increase over 3 years in equal percentage terms. This is a less burdensome approach than the alternative of phasing in the new rates in equal absolute terms, and is the same methodology used in the previous rulemaking. Finally, the FAA is making several organizational and clarifying revisions to the overflight fee requirements.

    DATES:

    This rule is effective January 1, 2017.

    ADDRESSES:

    For information on where to obtain copies of rulemaking documents and other information related to this final rule, see “How to Obtain Additional Information” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Aleksandra Damsz, Financial Analyst, Office of Financial Analysis, AFA-400, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone (202) 267-8055; email [email protected]

    SUPPLEMENTARY INFORMATION: I. Executive Summary

    On August 28, 2015, the FAA published the notice of proposed rulemaking (NPRM), Update of Overflight Fee Rates (80 FR 52217). This rulemaking updates the existing overflight fees (last updated in a 2011 Final Rule) using more current FAA cost accounting and air traffic activity data.

    The FAA is increasing the rates for enroute and oceanic overflights over three 12-month intervals to bring cost recovery from FY 2008 to FY 2013 recovery. The following table shows the increases:

    Table 1—Rate Increases for Enroute and Oceanic Overflights Revision date Enroute rate
  • (per 100
  • nautical miles)
  • Oceanic rate
  • (per 100
  • nautical miles)
  • Current Rate $56.86 $21.63 January 1, 2017 to January 1, 2018 58.45 23.15 January 1, 2018 to January 1, 2019 60.07 24.77 January 1, 2019 and Beyond 61.75 26.51

    Each fee rate will be effective for a 12-month period. However, the FAA will not make fee adjustments based on fiscal year or calendar year, but rather in 12-month intervals based on the effective date of this final rule.

    The FAA received 74 comments to the NPRM. The Aircraft Owners and Pilots Association (AOPA) and 37 individuals (25 of whom were part of a form letter campaign) raised the issue that the $250 overflight fee billing threshold has not been raised while the fee rate has been raised. As a result, flights that were not getting billed in previous years because they were below the $250 threshold amount are now receiving a bill. Based on the comments received and subsequent analysis, the FAA is increasing the overflight fee billing threshold from $250 to $400.

    The FAA also finalizes several organizational and content revisions to part 187 to clarify the overflight fees requirements.

    Summary of Costs and Benefits of the Final Rule

    The higher overflight rates based on FY 2013 unit costs will allow the FAA to move closer to full cost recovery of air traffic control services already being provided to operators. The present value of the fee increases through the third 12-month interval—when the full increase in rates will have taken place—is $9,560,692 for foreign operators and $141,888 for domestic operators. The increased fees provide greater incentives for foreign and domestic operators to economize on U.S. air traffic control facilities and U.S.-controlled airspace, thus increasing the efficient allocation of resources.

    II. Authority for This Rulemaking

    The FAA's authority to issue rules on 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 Chapter 453, Section 45301, et seq. Under that Chapter, the FAA is charged with prescribing regulations for the collection of fees for air traffic control and related services provided to aircraft, other than military and civilian aircraft of the United States Government or a foreign government, that transit U.S.-controlled airspace, but neither take off from nor land in the United States (“overflights”). This final rule is within the scope of that authority.

    III. Background A. History of Overflight Fees

    The FAA's overflight fees were initially authorized in section 273 of the Federal Aviation Reauthorization Act of 1996. After a series of legal challenges and refinements, overflight fee rates were implemented in their current form in 2001. Since that time the fee rates have been based on cost data from the FAA's Cost Accounting System and air traffic data from the FAA's Traffic Flow Management System (TFMS). They were last updated in 2011. The 2011 final rule updated the existing rates by using cost and activity data for FY 2008. Because the rates had not been updated for 9 years, and the total enroute and oceanic rate increases were significant, the FAA decided to phase in the increases. The 2011 final rule phased in the increases over a 4-year period, with rate increases occurring on October 1 of 2011, 2012, 2013, and 2014. Thus, on October 1, 2014, the FAA was recovering the amounts that would have produced full cost recovery in FY 2008.

    B. Aviation Rulemaking Committee

    The FAA established and chartered an Overflight Fees Aviation Rulemaking Committee (ARC) consisting of foreign air carriers (and trade associations of those carriers) that are subject to the FAA's overflight fees. The ARC was chartered on May 1, 2013, with the task to provide the FAA a report detailing recommendations for tasks moving forward with the process of updating the overflight fee rates.

    The ARC met with the FAA on June 12, 2013, and on January 23, 2014. On February 14, 2014, the ARC submitted several recommendations on future overflight rate updates. For a full discussion of the ARC's recommendations and FAA's responses, see the NPRM published at 80 FR 52218-52219.

    IV. Discussion of the Final Rule

    The FAA received 74 comments to the FAA's notice of proposed rulemaking to update the fee rates. Sixty-eight comments were received from individuals. Of the 68 individual comments received, there were 25 commenters who commented as part of a form letter campaign that focused on the interests of general aviation pilots flying from the U.S. to the Caribbean who make one or more intermediate stops enroute due to the aircraft's limited range or human physiological needs.1 The FAA also received comments from three carriers and three associations: Carriers included British Airways, Lufthansa Airlines and Air Canada, and associations included National Airlines Council of Canada (NACC), International Air Transport Association (IATA) and Aircraft Owners and Pilots Association (AOPA).

    1 The flight leg between the intermediate fuel or rest stop outside of the United States and the destination outside of the United States qualifies as an overflight generating a fee where the flight leg transits U.S.-controlled airspace.

    Commenters raised a total of 17 issues. These issues, as well as FAA's responses, are discussed below.

    A. Overflight Fee Billing Threshold

    AOPA and 37 individuals (25 of whom were part of the form letter campaign) raised the issue that the $250 overflight fee billing threshold should be raised. Their concern was that while the overflight fee rate has increased, the billing threshold has not increased. As a result, flights that were not being billed in previous years because they were below the threshold are now receiving a bill. Commenters also asked that the threshold be increased to $450 and that the amendment should provide for automatic adjustments to correspond with future increases in overflight fees rates.

    FAA concurs that the overflight fee billing threshold should be increased. In consideration of the comments, the FAA has analyzed the minimum threshold for overflight billings and has decided to increase this minimum threshold from $250 to $400 as part of this rulemaking. Overflight fee rates (per 100 nautical miles) in the August 2001 final rule were $33.72 for enroute and $18.94 for oceanic and the rule included a minimum billing threshold of $250. The NPRM proposed the following rates over a 3 year period:

    Table 2—Proposed Enroute and Oceanic Fee Rates Revision date Enroute rate
  • (per 100 nm)
  • Oceanic rate
  • (per 100 nm)
  • Current Rate $56.86 $21.63 October 1, 2015 58.45 23.15 October 1, 2016 60.07 24.77 October 1, 2017 61.75 26.51

    This final rule adopts the rates as proposed. The rates under this final rule are 83% higher for enroute and 40% higher for oceanic as compared with the rates in the 2001 final rule ($33.72 for enroute and $18.94 for oceanic). The minimum billing threshold of $250 has been updated to account for the percentage growth in the fee rates, resulting in a threshold of $457.81 for enroute and $349.92 for oceanic. A weighted average of the two rates is then calculated using actual FY 2014 enroute and oceanic miles to calculate the updated billing threshold of $400.

    B. Excluding General Aviation

    AOPA and 67 individuals (25 of whom were part of a form letter campaign) commented that U.S. general aviation should be exempt from paying overflight fees. These commenters stated that Congress did not intend to impose overflight fees on general aviation when it granted FAA authority to establish overflight fees.

    Commenters also stated that charging general aviation traffic does little to recover air traffic control costs and general aviation traffic should not be burdened with overflight fees since they are an existing active consumer of fuel and other taxes which fund FAA and aviation services.

    Further, commenters stated their view that because the FAA excluded enroute Guam and San Juan costs from total costs in the NPRM, that FAA therefore acknowledged that these fees should not apply to U.S. general aviation traffic.

    The FAA notes that Congress did not differentiate between general aviation and commercial aviation in the overflight fees statute. Title 49 U.S.C. 45301 (a) states that “[t]he Administrator shall establish a schedule of new fees, and a collection process for such fees, for . . . [a]ir traffic control and related services provided to aircraft other than military and civilian aircraft of the United States government or of a foreign government that neither take off from, nor land in, the United States.” Similarly, under the FAA's Fee Regulation, 14 CFR part 187, App. B, any person who conducts a flight through U.S.-controlled airspace that does not include a landing or takeoff in the United States must pay a fee for the FAA's rendering or providing certain services, including but not limited to the following: Air traffic management; communications; navigation; radar surveillance, including separation services; flight information services; procedural control; and emergency services and training.

    Consistent with the statutory and regulatory requirements, the FAA is required to collect overflight fees from any person who transits US airspace and neither takes off or lands in the United States. Neither the statute nor the regulation permit the FAA to exclude general aviation operators or to consider whether one aviation user group utilizes air traffic control services more than another. Additionally, there is no statutory or regulatory exception to the overflight fee requirement when persons covered by the requirement pay fuel or other related aviation taxes.

    With regard to enroute Guam and San Juan costs and miles being excluded, the FAA has determined that the NPRM incorrectly stated that the combined enroute Guam and San Juan control facilities “may handle a mix of general and commercial aviation traffic.” The FAA had intended to state that these control facilities “may handle a mix of terminal and enroute aviation traffic.” This correction does not impact the underlying analysis.

    Overflight fees are assessed on all traffic types with the exceptions noted in the August 28, 2015 NPRM, which stated that “The FAA's costs used for this fee calculation are total costs because the services provided benefit all system users, including overflight users”. 80 FR at 52218. While combined control facilities may handle a mix of Terminal and Enroute aviation traffic, this is not an issue because 49 U.S.C. 45301, as noted above, does not distinguish or exempt general aviation users from the fees.

    C. General Aviation Charged for Same Day Fuel Stops

    AOPA and 32 individuals (25 of whom were part of a form letter campaign) stated that the FAA's proposal would impose overflight fees on U.S. registered general aviation operations that land in or depart from the United States but also make intermediate stops enroute due to the aircraft's limited range or human physiological needs. AOPA provided an example as follows:

    [A]n aircraft departs from an airport in Florida destined for the Dominican Republic in the Caribbean, but stops enroute at Nassau to refuel before continuing on to the Dominican Republic that same day. While overflight fees will not be assessed for the first leg of the flight between Florida and the fuel stop in Nassau, overflight fees under the NPRM will be assessed for the second leg of the flight between the fuel stop and the Dominican Republic. In comparison, a non-stop flight between Florida and the Dominican Republic would not result in any overflight fees.

    The commenters also noted that when general aviation is charged for same-day fuel stops, a significant amount of time is wasted in working with the FAA to get these charges reversed.

    The FAA emphasizes that overflight fees are assessed based on an evaluation of each flight. During the evaluation process, each flight is reviewed to consider whether an intermediate stop for fuel has occurred. A flight is not considered to be an overflight (i.e., triggering an overflight fee) if it departs or lands in the United States and the FAA can determine that an intermediate stop for fuel occurred. In that case, no fee is assessed. The amount of time on the ground at an intermediary location is considered when making the determination.

    D. Compromising Safety

    AOPA and 6 individuals stated that by failing to recognize the limitations of most general aviation aircraft, the proposed rule may encourage non-stop flights to or from U.S. airports in order to avoid overflight fees, even though an intermediate fuel stop would increase the safety of the operation or is otherwise physiologically necessary. Commenters argued that this is not in the best interest of safety. One commenter stated that to avoid the fees “[t]he pilots will not use air traffic services. They will not travel, or travel unsafely, perhaps to the point of turning off transponders. And with this will cause preventable accidents.”

    As previously stated, overflight fees are assessed based on an evaluation of each flight. A flight is not considered to be an overflight if it departs or lands in the United States. This can include intermediate stops for fuel.

    Additionally, as discussed previously, the FAA is raising the minimum billing threshold from $250 to $400 as part of this rulemaking action. This will provide for air traffic control services in many instances without the pilot necessarily incurring any cost.

    Discussion of turning off transponders is an unlikely scenario and an unnecessary action. Use of a transponder in and of itself will not generate user fees. User fees are based on the filing of a flight plan and receiving air traffic control services such as flight following or instrument flight rules separation services. A discrete transponder code would also need to be assigned to the aircraft. One could continue to use the transponder without incurring any cost, such as squawking 1200, indicating a Visual Flight Rules (VFR) operation without necessarily receiving air traffic control services.

    A desire to reduce or minimize the dollar cost associated with any flight does not alleviate a pilot from the duties and responsibilities associated with acting as pilot in command. The pilot in command is the final authority and ultimately responsible for the operational safety of that flight. Pilots avoiding necessary fuel stops and/or turning off transponders to avoid air traffic control services and fees will likely jeopardize the safety of that flight and create unnecessary risk. The overflight fee must be considered part of the planning and associated cost of any flight, where a pilot does not take off or land from an airport located in the United States. Again, intermediate fuel stops that are of a short duration can be considered part of an overall flight that originates or departs from a United States location.

    E. Cost Recovery Rate Increase

    In the NPRM, the FAA asked for comments on whether it should expedite the increase of overflight fee rates to achieve full cost recovery. IATA, NACC, Lufthansa, Air Canada and British Airways opposed an expedited increase to enable cost recovery and suggested that the overflight fee rates be frozen at their present level until the ARC is re-convened and a new proposal for the rate increases is discussed and agreed upon. Air Canada noted that the Air Transport Agreement between Canada and the United States states that user charges must be “just, reasonable, and not unjustly discriminatory.”

    The FAA has reviewed the feedback on expediting the increase in overflight fee rates for cost recovery and has decided to proceed with the rate increases proposed in the NPRM without expediting them. Congress has directed the FAA to establish and maintain overflight fees “reasonably related to the Administration's costs.” To retain the cost-based relationship, that means the FAA must periodically review and revise its overflight fee rates, and that is why the FAA is now proceeding to the final rule to impose the fee rates proposed in the NPRM. The FAA believes that fees “reasonably related to the Administration's costs” would necessarily be “just, reasonable, and not unjustly discriminatory,” under the Transport Agreement. In addition, the overflight fees are not unjustly discriminatory because they are assessed only on aircraft flights that transit U.S.-controlled airspace, but neither land in nor depart from the United States. Both foreign and domestic operators are charged in the same manner. Those aircraft that do not transit U.S.-controlled airspace pay no fee.

    F. Marginal Allocation

    Lufthansa, Air Canada, and IATA commented on the issue of the cost base used for the fee calculation and stated two concerns:

    The first comment on marginal cost allocation stated generally is that costs for services neither used nor required by overflights should be removed from the cost base. The commenters also expressed concern that the level of overflight fees goes beyond that which is reasonably related to costs for providing air traffic control and related services to these operations. Commenters pointed out that the ARC noted that the amount recovered for non-overflight 2 services has remained unchanged, while overflight fees have continued to rise at a steady pace over the same period. IATA stated that insufficient data has been provided to justify FAA's claim that under the ARC proposal, “the FAA would have recovered slightly less than 60% for enroute and 50% for oceanic of the total increase between FY 2015 rates (based on FY 2008 costs) and rates using FY 2013 data.”

    2 “Non-overflight services” refers to services provided by the FAA to aircraft that do land in or takeoff from the United States, and operate in U.S. airspace under the direction of the FAA.

    Second, these commenters asserted that it is difficult to allocate overhead costs in a fair and justifiable manner to the air navigation cost base, specifically to the cost base of overflight charges. They asserted that this is because, contrary to most other air navigation service providers around the world, the FAA does not exclusively provide air traffic control services and hence, according to Air Canada, there is a fundamental problem with the FAA's “organizational structure and complexity and the size of the overhead cost.”

    The FAA notes the cost base concerns raised by Lufthansa, Air Canada, and IATA are not accurate. The methodology for estimating the fee is the same one used in the FY 2011 Final Rule to which the ARC had agreed.

    Since the original issuance of the Final Rule relating to overflight fees in August 2001, the statutory standard for the fees was relaxed by Congress to provide that the fees need to be “reasonably related” to costs. This is in contrast to the previous standard in effect at the time of the issuance of the original Interim Final Rule in August 2000. That standard provided that the fees needed to be “directly” related to the FAA's costs of providing the air traffic control and related services.

    The FAA continues to use the same methodology for calculating the fee rates as was used in the 2011 update. The overflight fee rate is calculated by dividing total ATO costs by the total flight miles. The rate calculation methodology is used separately for both enroute and oceanic cost and mile data to derive the overflight fee rate for enroute and oceanic. ATO costs and flight miles used in this calculation are system totals and not related only to overflights. Therefore, there is no need to exclude any costs from the cost base. The FAA and ARC proposals are both based on FY 13 actual rates. The difference in methodology is that the FAA proposed a 3 year compounded annual growth rate (CAGR) phased-in over 3 years. The ARC proposal is based on a 5 year CAGR that only includes 3 years of phase-in. After year 3 the ARC recommended that a new ARC be re-convened to determine the need for updates after that period. Under the ARC's proposal therefore, the FAA would recover less than the FY13 levels.

    In response to IATA's statement that the FAA has not provided the data to support its claim that “the FAA would have recovered slightly less than 60% for enroute and 50% for oceanic of the total increase between FY 2015 rates (based on FY 2008 costs) and rates using FY 2013 data,” the FAA provides the following details (per 100 nautical miles):

    Table 3—Cost Recovery Comparison Enroute Oceanic FAA Rate—FY 2008 Cost Recovery $56.86 $21.63 FAA Rate—FY 2013 Cost Recovery 61.75 26.51 FAA Increase 4.89 4.88 ARC Final Proposed Rate 59.75 24.09 ARC Increase 2.89 2.46 ARC Proposed Increase as % of FAA Increase 60% 50%

    Inclusion of overhead is a commonly accepted practice in fee setting, is consistent with generally accepted accounting principles, and is a specifically allowable element of cost under Office of Management and Budget (OMB) Circular No. A-25 on User Charges as well as International Civil Aviation Organization's (ICAO'S) Policies on Charges for Airports and Air Navigation Services. In addition, the same Act of Congress that changed the above fee setting standard from “directly” to “reasonably related” also gave the Administrator sole and final discretion in the determination of FAA costs. 49 U.S.C. 45301(b)(1). Again, the methodology used for determining overhead also remains unchanged from the FY2011 Final Rule and is based on FAA's Cost Accounting System.

    G. FAA Costs

    Lufthansa, Air Canada, NACC and IATA commented on the issue of increasing FAA costs. They expressed concern over the steady pace at which FAA operational costs continue to rise and their impact on overflight fees. Industry partners are expected to embark on cost control and cost reduction efforts and the FAA is urged to commit to a cost efficiency target that remains below inflation. Also, IATA expressed disagreement with the NPRM stating that the FAA “believes forecasting based on projected traffic is more appropriate than using arbitrary cost targets” and stated that it has found that unanticipated and untimely economic occurrences can significantly impact forecast-based traffic projections, resulting in inaccurate accounting of traffic demand, business plans, required resources, and funding streams. As an example, over the past several years, the FAA forecast has consistently overestimated the growth projections for operations in the National Airspace System. Lufthansa suggested freezing the overflight fee rates at their current level and “reconsider the whole question of overflight fees.”

    The issue of FAA's operational costs, and the rate at which they may increase, is outside the scope of this rulemaking. Under the statutory requirement, overflight fees must be “reasonably related to the Administration's costs, as determined by the Administrator, of providing the services rendered.” 49 U.S.C. 45301(b)(1). Neither the FAA traffic forecast nor cost targets are used in the fee calculation, but rather fees are calculated based on actual cost and miles.

    H. Overflight Fee Calculation Cost Base

    Lufthansa, IATA and Air Canada commented on the cost base used for the overflight fee rate calculation. Lufthansa and Air Canada both asserted that Air Route Traffic Control Center's (ARTCC's) have staff dedicated to manage, organize and optimize traffic approaching major airports in metropolitan areas. These working positions and all associated costs are included in the cost base for enroute, as the traffic concerned is still hundreds of miles away from the respective TRACON. As part of the enroute cost base, the costs are partly paid for by overflight fees. However, according to the commenters, overflying traffic does not require those services and hence, these costs should be excluded from the cost base used for the rate calculation. IATA also reiterated that the ARC recommended that the costs for services not used by overflights (e.g., flow control into major airports and approach services at airports and airfields not served by a TRACON) be removed from the cost base.

    Lufthansa also commented that it is unacceptable for the FAA to simply qualify services as “de minimis” without providing any details and justification. According to Lufthansa, “[t]he NPRM on overflight fees is about facts and data and transparency of these. The term[] “de minimis” is a qualification, but not a quantification, and is not appropriate or acceptable in this context.”

    The FAA does not agree that costs relating to flow control should be removed from the enroute cost base. The Traffic Management Unit personnel at the enroute centers are responsible for the safe and efficient flow of all traffic, including overflights, in their airspace, and it would be neither reasonable nor practicable for the FAA to attempt to sort out and exclude the portion of such costs solely attributed to overflights.

    Moreover, air traffic flow management is a specifically allowable item for cost recovery under ICAO's Policies on Charges for Airports and Air Navigation Services (ICAO Document 9082).

    While it is true that there are low activity airports and airfields that are not served by a TRACON or an air traffic control tower, and that in these instances the air traffic control services are provided by enroute controllers, the level of such activity is sufficiently low that it does not require increased staffing. See 76 FR 43114-43115 (July 20, 2011).

    I. Failed ARC Process

    British Airways, Air Canada, Lufthansa, IATA and NACC expressed disappointment that the FAA has chosen to dismiss the ARC's recommendations and stated that they viewed the ARC process as failed. They stated concern that the FAA's proposed rule included several new methodologies for which there had not been any consultation with industry and for which prior indication and relevant information required to accurately determine the cost-based charges had not been provided. Had any prior indication or concerns been raised, these ARC members stated that they could have provided guidance to the Agency. Additionally, these ARC members stated that the FAA released its NPRM one month prior to the current rate expiration date, leaving no time for the ARC members to react to it and develop an alternative that could be supported by all parties.

    Under the ARC's May 1, 2013 Charter, the objective of the ARC was to provide “advice and recommendations on the appropriate amounts for future overflight fees.” However, the FAA has no obligation to accept the advice and recommendations; it takes the ARC's report under advisement. The agency also is not required to coordinate with the ARC after the ARC has issued its report. In most cases, the ARC would be terminated after its business has concluded.

    While the FAA considered the ARC's recommendations, it declined to implement the recommendations. Also, FY 2015 enroute and oceanic overflight fee rates do not have a set expiration date and remain in effect until notice of new rates is published and the new rates are effective. Consequently, the NPRM was not released one month prior to the expiration date of these fee rates.

    J. ARC Data Transparency

    Lufthansa, British Airways and IATA commented that the ARC was not provided with relevant information such as staffing levels, labor costs, actual and projected traffic growth, and efficiency measures, to be able to accurately determine the cost-based user fee. They stated that without this information it is impossible to accurately determine cost based charges.

    The FAA does not concur that information relevant to overflight fees was kept from the ARC. The FAA provided detailed responses to ARC questions in 2013. Moreover, during the ARC meetings, the FAA provided the following relevant information to ARC members:

    • Number of airports providing service for approach and departure services • Difference between lower and higher level sectors • IFR flights operating from these airports • Inclusion and exclusion in cost allocation for enroute • Stable and decreasing expenses from 2010 to 2013 • Specific FAA initiatives to improve efficiency • Classification of flight miles for IFR and VFR traffic • Detailed description and breakout of overhead costs, staffing levels, and capital expenditure • Methodology for overflight fee calculation • Results of sequestration on ATO costs • Current rates and collection data for overflight fees • Use of overflight fee collections • Cost Accounting System cost of service documents • Enroute and oceanic flight miles • 2013 President's Budget (budget in effect when the ARC met) • 2013 Senate Appropriations Bill • Detailed summary of FAA budget breakdown • Detailed summary specific to FAA operating budget • Detailed summary specific to FAA capital programs • Detailed summary specific to FAA NextGen programs • Detailed summary specific to FAA NextGen Research, Engineering & Development • Air Traffic Controller Workforce headcount, hires, and attrition • System wide Traffic and Controller Trends

    The data stated above as well as responses to the ARC's questions include the details to accurately determine cost based fee charges.

    K. Guam and San Juan Costs and Miles Exclusion

    Lufthansa noted FAA's proposal in the NPRM to exclude enroute Guam and San Juan costs from total FAA costs. Lufthansa noted that while it did not disagree with the exclusion in principle, it did not see in the NPRM how the exclusion would impact cost base, traffic, and fees. Lufthansa then questioned why this change and others in the NPRM had not been brought to the attention of the ARC.

    The FAA response is as follows:

    As an initial matter, the ARC concluded business on February 14, 2014, when it issued its recommendations. It was not until August 28, 2015, however, that FAA announced in the NPRM that it was proposing to exclude Guam and San Juan costs from total FAA costs. As a result, this change could not have been brought before the ARC, which was terminated 18 months prior to the time that the NPRM was issued.

    Costs:

    Guam and San Juan facilities are being excluded from the enroute costs to be consistent with Honolulu. This determination was made after reviewing the ARC recommendations. As a result, the FAA enroute costs have decreased.

    Traffic Mileage:

    The enroute miles associated with Honolulu and oceanic miles for Guam were double-counted when presented to the ARC as they are also counted as part of the Oakland oceanic airspace. It was determined that the mileage was to be removed for these facilities. As a result, the total flight miles (GCD-nm) for enroute and oceanic were lower.

    Net Impact:

    With the decrease in costs and flight miles for enroute, the per 100nm fee decreased. On the oceanic side, the costs remained un-changed while the flight miles decreased, resulting in an increased per 100 nm fee.

    This change was not brought to the attention of the ARC before the publication of the NPRM because, at the time of the change, the FAA had already received the ARC's recommendations.

    Table 4—Impact of the Guam and San Juan Change Prior to Guam and San Juan change Post Guam and San Juan change Enroute FAA Cost $4,645,629,212 $4,597,808,058 Total Flight Miles (GCD-nm) 7,504,243,185 7,445,668,883 Rate Prior to Change (/100nm) $61.91 $61.75 Oceanic FAA Cost $184,391,603 $184,391,603 Total Flight Miles (GCD-nm) 708,610,831 695,620,413 Rate After Change (/100nm) $26.02 $26.51

    Enroute fees are $61.75 per 100 nautical miles (based on FY13 cost recovery) and oceanic fees are $26.51/100 nautical miles (based on FY13 cost recovery).

    L. Weight-Based Fee Rates

    Thirteen individuals stated that it is not fair that small planes are charged the same fee rate as large commercial planes. They suggested that a tiered rate be charged on only U.S.-registered aircraft with a not-to-exceed amount depending upon the aircraft total gross weight similar to landing fees at larger airports or that the rate be based on the number of seats on the plane.

    The FAA does not concur that the fee rates should be charged based on weight or the number of seats on the aircraft. As noted above, the FAA is required to collect overflight fees from any person who transits US airspace and neither takes off or lands. 49 U.S.C. 45301(a); 14 CFR part 187, App. B. The statutory requirement is that the overflight fees be “reasonably related to the Administration's costs, as determined by the Administrator, of providing the services rendered.” 49 U.S.C. 45301(b). No distinction is made in the law between types of aircraft, aircraft weight, or number of seats. In addition, VFR aircraft utilizing flight following services are provided similar service as IFR traffic. They are both charged overflight fees.

    M. General Aviation Excluded From the Aviation Rulemaking Committee

    One individual stated that general aviation was not represented in the ARC, which was established to examine overflight fees and provide the FAA recommendations on future overflight fee rates.

    The 2013 ARC inadvertently did not include representatives from general aviation because historically, members of this ARC and its predecessors were primarily composed of the parties from the extensive 1997-2003 overflight fees litigation—the Air Transport Association of Canada and seven international air carriers. Representatives from general aviation were not parties to the litigation. Membership of the 2013 ARC appears to have been an outgrowth of the 2008 overflight fees ARC, which appears to have been an outgrowth of the 2004 ARC on overflight fees. According to the August 26, 2009 ARC Report, “[a]s part of the settlement with the litigating carriers, the FAA agreed to the creation of the ARC, which was to consist of FAA and industry representatives working to examine in depth the FAA's methodology for overflight fees and to recommend whether it should be modified.”

    Despite the fact that general aviation was not represented on the ARC, general aviation was provided an opportunity to review and comment on the final rule. Twenty-five of the 74 comments that the FAA received in response to the NPRM were filed by advocates of general aviation. As noted above, the general aviation commenters raised the issue that the $250 overflight fee billing threshold had not been raised while the fee rate had been raised. As a result, flights that were not getting billed in previous years because they were below the $250 threshold amount were now receiving a bill. As noted, the FAA concurred with the general aviation commenters that billing threshold should be increased. In consideration of the comments, the FAA will be increasing the minimum threshold from $250 to $400 as part of this rulemaking.

    N. General Aviation Visual Flight Rules

    Lufthansa, Air Canada, NACC and IATA asked for further clarification on the timeline of VFR flights being included in the calculation of overflight fees. Additionally, three individuals stated that because VFR traffic neither requires nor receives the same level of service as IFR traffic, VFR traffic should be charged less or excluded from the overflight fees requirement.

    VFR traffic utilizing flight following services are already included in the total mileage. Hence, there is no need for a timeline. In order to provide VFR flight following services, air traffic control generates a “flight plan” within FAA systems that is captured in the TFMS. This allows the aircraft call-sign (typically tail number for VFR flights) to be displayed and tracked against the discrete beacon code assigned by air traffic control. Non-discrete beacon codes (e.g., 1200) are not provided by TFMS and therefore not captured in the overflights data. These VFR flights would not be assessed an overflight fee. This is consistent with the recommendation.

    Air traffic control actively monitors and controls VFR flight following aircraft providing them with updates and guidance when necessary. VFR aircraft utilizing flight following are provided similar service as IFR traffic.

    O. Great Circle Distance

    Lufthansa, Air Canada, IATA and NACC commented on the use of great circle distance for calculating the nautical mile distance used in the overflight fee rate calculation. They stated that great circle distance was not part of the ARC agenda, nor was it discussed in terms of calculating overflight fees and stress the importance of ensuring the adoption of great circle distance be revenue neutral to the FAA. Further, they ask that a clearly defined GCD catalogue be published and consulted with airline users before it takes effect and that the FAA provide examples of same-route cost comparisons between great circle distance, as proposed, versus cost data (via the Cost Accounting System) and air traffic data (from TFMS).

    The FAA has not changed the application of great circle distance within overflights. The great circle distance methodology is the same as used in the previous rulemaking (2011 Final Rule) with no change to the way the fees are generated. The formula in the rule was rewritten to enhance clarity and transparency concerning how the fees are assessed. Since the great circle distance use and methodology remains the same, FAA has determined there is not a need to consult with the airline users before taking effect (since it has already been in effect), nor is there a need for a great circle distance catalogue to be published.

    P. Regulatory Costs on Small Entities

    According to IATA, the NPRM indicates that there were 469 domestic operators (mostly small entities) that overflew U.S. controlled airspace in FY 2013. The NPRM provided assurances that the rulemaking would not have a significant economic impact on small entities (estimated at an average increase of $36.50 per operation). In its comments, IATA asked for further detail as to the air traffic control services rendered to these domestic operators: “how much they cost and (most importantly) who is covering those costs.” IATA stated that its members should not be required to cover the costs incurred by these domestic operators.

    The FAA concurs that IATA members are not and will not be assessed costs incurred by domestic operators. Any aircraft that overflies U.S. controlled airspace will be charged the same overflight fee, calculated based on systemwide cost and traffic, regardless if it is a domestic US or foreign operator. Regardless of the level of exception, which is applied to both domestic and foreign carriers, operator origin does not affect overflight fee billings.

    Q. Meaning of $250 Billing Threshold Language

    One individual commented that the NPRM's “wording of Section 187.55(b) changes the wording in the current rules from a prohibition on the FAA sending an invoice when monthly fees are below the threshold to a statement that the FAA will send an invoice when monthly fees are above the threshold.” The commenter further stated that, if strictly interpreted, this would allow the FAA “to send invoices when fees are below the threshold at its discretion” and would require invoices “when fees are above the threshold.” The commenter advised that this would be “opposite to the original meaning,” and recommended that “the prohibition on below-threshold invoices should be restored as this appears unintentional. If intentional, the FAA has offered no justification for the change as would be required by the rulemaking process.”

    The current regulatory provision addressing invoicing of overflight fees includes billing and states that the FAA will send an invoice to each user that is covered by this appendix when fees are owed to the FAA. If the FAA cannot identify the user, then an invoice will be sent to the registered owner. No invoice will be sent unless the monthly (based on Greenwich Mean Time) fees for service equal or exceed $250. Users will be billed at the address of record in the country where the aircraft is registered, unless a billing address is otherwise provided. (14 CFR part 187, appendix B, paragraph (f)(1).)

    Under this provision, if the overflight fee amount owed is less than $250, no invoice will be sent and no billing results. Overflight fees are only assessed when the invoice amount is $250 or more.

    In the NPRM, FAA suggested regulatory text that would replace the language in appendix B relating to invoicing. (The NPRM proposed to remove and reserve appendix B). (80 FR 52217, 52224 (Aug. 28, 2015).)

    The FAA does not agree that the change in wording would permit the agency to issue invoices for fees when the fee amount is below the $250 threshold. The FAA also does not agree with the comment that the change would be “opposite to the original meaning.” As adopted in this final rule, the proposed language in section 187.55 makes no substantive change. It does nothing different than the existing appendix B provision. In both cases, the FAA will send an invoice if fees are owed. In both cases, if the fees equal or exceed $400, as adjusted from $250 based on the comments received, the FAA will send an invoice. If the fees are less than $400, as adjusted from $250 based on the comments received, then the FAA will not send an invoice and no fees will be owed for the services rendered. As indicated in the NPRM, the FAA proposed this change and others as “organizational changes to part 187 to clarify the overflight fee requirements.” 80 FR 52220. The NPRM proposed no substantive changes to the current regulatory provision addressing invoicing of overflight fees found in appendix B, paragraph (f)(1). “The proposed billing and payment procedures in new § 187.55 are unchanged from those in existing Appendix B.” 80 FR 52220.

    V. Summary of Regulatory Text Changes

    The changes to the existing regulatory text made pursuant to this final rule generally reflect “organizational changes to part 187 to clarify the overflight fee requirements.” 80 FR 52220.

    The FAA has revised the authority citation for part 187 to reflect current law.

    In § 187.1, “Scope,” the FAA has removed the duplicate reference to Appendix A, removed the reference to Appendix B because Appendix B is being removed, and added a reference to Appendix C that inadvertently had not been added when Appendix C (computation of fees for production certification-related services performed outside the United States) was added.

    The FAA has added a new § 187.3, “Definitions,” section to the rule, which revises four existing definitions from former Appendix B and adds a new definition for “great circle distance” consistent with the FAA's method used for calculating overflight fees.

    The FAA has added a new § 187.51, “Applicability of overflight fees,” in which subparagraph (a) specifies who must pay an overflight fee. The FAA has added a new subparagraph (d) to address fees for flights through U.S.-controlled airspace covered by an FAA agreement or other binding arrangement. The FAA periodically enters into agreements with foreign states, regional groups of states, or foreign air navigation services providers to set the terms for the FAA's management or control of foreign airspace among other air navigation services provided by the FAA.

    The FAA has added a new § 187.53, “Calculation of overflight fees,” which in subparagraph (a) retains the formula for calculating overflight fees from the former Appendix B but also clarifies the explanation of calculating that fee. Subparagraph (b) addresses how miles flown through each segment of airspace will be calculated, using great circle distance (GCD), from the point of entry into U.S.-controlled airspace to the point of exit from U.S.-controlled airspace. Subparagraph (c) includes a table providing the rate for each 100 nautical miles flown through enroute or oceanic airspace. Subparagraph (d) provides the mathematical formula for the total overflight fee. Subparagraph (e) states that the FAA will review the rates described in this section at least once every 2 years and will adjust them to reflect current costs and volume of services provided.

    In § 187.55, “Overflight fees billing and payment procedures,” are unchanged from those in former Appendix B.

    VI. Regulatory Notices and Analyses A. Regulatory Evaluation

    Changes to Federal regulations must undergo several economic analyses. First, Executive Orders 12866 and 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, this Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this final rule.

    In conducting these analyses, FAA has determined that this final rule: (1) Has benefits that justify its costs, (2) is not an economically “significant regulatory action” as defined in section 3(f) of Executive Order 12866, (3) is not “significant” as defined in DOT's Regulatory Policies and Procedures; (4) will not have a significant economic impact on a substantial number of small entities; (5) will not create unnecessary obstacles to the foreign commerce of the United States; and (6) will not impose an unfunded mandate on state, local, or tribal governments, or on the private sector by exceeding the threshold identified above. These analyses are summarized below.

    DOT Order 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If the expected cost impact is so minimal that a proposed or final rule does not warrant a full evaluation, this order permits that a statement to that effect and the basis for it to be included in the preamble if a full regulatory evaluation of the costs and benefits is not prepared. Such a determination has been made for this final rule. The reasoning for this determination follows.

    This rule will institute a 3-year phase-in of rate increases for oceanic and enroute overflights, with rates per 100 nautical miles increasing in three 12-month intervals to $23.15, $24.77, and $26.51 for oceanic flights, and to $58.45, $60.07, and $61.75 for enroute flights. The final rate of $26.51 for oceanic services, reached at the end of the third 12-month interval, is derived from the FAA's FY 2013 total cost of providing these services ($184,391,603) divided by the total nautical miles (695,620,413 nm) flown by operators (overflights and non-overflights) in oceanic airspace. An analogous calculation is made to obtain the third 12-month interval rate of $61.75 for enroute services ($4,597,808,058/7,445,668,883 nm). These higher rates based on FY 2013 unit costs will allow the FAA to move closer to full cost recovery of air traffic control services already being provided to operators.

    Tables 5 and 6 show estimates of the increase in overflight fees for domestic operators and foreign operators for the three 12-month intervals, using FY 2013 overflight mileage totals, thus assuming no annual growth. As the tables show, the present value (at a 7 percent discount rate) in 2013 dollars of the projected fee increases through the third 12-month interval—when the full increase in rates will have taken place—is $141,888 for domestic operators and $9,560,692 for foreign operators. The updated fee rates will provide greater incentives for foreign and domestic operators to economize on U.S. air traffic control facilities and U.S.-controlled airspace, thus increasing the efficient allocation of resources.

    Table 5—Domestic Operators—Overflight Fees Domestic Operators Current Year 1 Year 2 Year 3 Oceanic Fees (per 100 nm) $21.63 $23.15 $24.77 $26.51 Oceanic Billings w/o Final Rule 528,616 528,616 528,616 528,616 Oceanic Billings w/Final Rule 528,616 565,707 605,400 647,878 Increase in Oceanic Billings 0 37,091 76,784 119,262 Enroute Fees (per 100 nm) 56.86 58.45 60.07 61.75 Enroute Billings w/o Final Rule 634,376 634,376 634,376 634,376 Enroute Billings w/Final Rule 634,376 652,064 670,245 688,933 Increase in Enroute Billings 0 17,688 35,869 54,557 Increase in Overflight Billings 0 54,779 112,653 173,819 PV Increase in Overflight Billings 0 51,195 98,395 141,888 Table 6—Foreign Operators—Overflight Fees Foreign Operators Current Year 1 Year 2 Year 3 Oceanic Fees (per 100 nm) $21.63 $23.15 $24.77 $26.51 Oceanic Billings w/o Final Rule 28,072,427 28,072,427 28,072,427 28,072,427 Oceanic Billings w/Final Rule 28,072,427 30,042,152 32,150,083 34,405,920 Increase in Oceanic Billings 0 1,969,724 4,077,656 6,333,493 Enroute Fees (per 100 nm) 56.86 58.45 60.07 61.75 Enroute Billings w/o Proposed Rule 62,543,288 62,543,288 62,543,288 62,543,288 Enroute Billings w/Proposed Rule 62,543,288 64,287,136 66,079,607 67,922,055 Increase in Enroute Billings 0 1,743,848 3,536,318 5,378,767 Increase in Overflight Billings 0 3,713,572 7,613,974 11,712,259 PV Increase in Overflight Billings 0 3,470,628 6,650,340 9,560,692 Notes: 1. Rates for overflights are per 100 nautical miles. 2. Fees are in U.S. dollars. 3. Values are discounted back to the effective date of the rule at a 7% discount rate.3 4. Fees are slightly overstated in that we do not account for the fact that under the old rule operators incurring a bill of less than $250 were not charged, and under the new rule operators incurring a bill of less than $400 will not be charged. Over the 3-year period, FY2013-FY2015, monthly fees of less than $250 were small, constituting between 0.3% and 0.4% of annual total fees, and monthly fees of between $250 and $400 were smaller, constituting between 0.2% and 0.3% of annual total fees. B. Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354, subsection (b)) (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide-range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.

    3 Office of Management and Budget, Circular A-94, “Guidelines and Discount Rates for Benefit-Cost Analysis of Federal Programs,” October 29, 1992, p. 8.

    Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA.

    However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

    While the FAA did not receive comments on the regulatory flexibility analysis, the FAA did receive comments from 25 individuals and from AOPA, an industry group representing small entities. They commented that the overflight fees should not be applied to general aviation aircraft and that the fees went up but the $250 threshold was not changed. The FAA notes that Congress did not differentiate between general aviation and commercial aviation in the overflight fee statute. AOPA commented that with the fee increase users were now paying fees when they exceeded the $250 threshold. In response, the FAA has raised the threshold to $400 in this final rule.

    We ranked in descending order all 469 domestic operators based on their overflight fees for fiscal year 2013 and found that the 14 top ranked operators accounted for more than 40% of that year's total domestic overflight fees. Of these 14 operators we identified 4 as small entities (using a size standard of 1,500 or fewer employees) and found all of them to have an increase in overflight fees as a percentage of annual revenues to be less than 1 percent. 4 5 We believe this rule does not impose a significant economic impact on those small entities.

    4 Employment and revenue data is from www.Manta.com.

    5 Since our overflight fees by operator include both enroute and oceanic overflights, we first calculate the weighted average percentage increase in fees from the final rule, which we find to be 14.95%. To assess the economic impact on any one U.S. operator, we then multiply the operator's 2013 operating fees by 14.95% to estimate the increase in that operator's fees as a result of the final rule. We then divide this estimate by the operator's annual revenue to assess the impact of the final rule on the operator.

    Therefore, as provided in section 605(b), the head of the FAA certifies that this rulemaking will not result in a significant economic impact on a substantial number of small entities.

    C. International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. ICAO standards allow providers of navigation services to require users of these services to pay their share of the related costs. The FAA has determined that this rule primarily affects foreign commercial operators. The recovery of costs of providing air navigation services is consistent with ICAO standards and international practice. Foreign operators will be charged a fee only if they use U.S.-controlled airspace without taking off or landing in the U.S., and U.S. operators will be charged in the same manner. Accordingly, the FAA does not believe this rule will create an unnecessary obstacle to the foreign commerce of the United States.

    D. Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $155.0 million in lieu of $100 million.

    This rule does not contain such a mandate. Therefore, the requirements of Title II of the Act do not apply.

    E. Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this rule. The information used to track overflights (including the information collection necessary to implement this rule) can be accessed from flight plans filed with the FAA. The collection of information from the Domestic and International Flight Plans is approved under OMB information collection 2120-0026.

    F. International Compatibility and Cooperation

    In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to International Civil Aviation Organization Standards and Recommended Practices to the maximum extent practicable. The FAA has reviewed the corresponding ICAO Standards and Recommended Practices and has identified no differences with these regulations.

    The ICAO guidance document on aviation fees and charges, ICAO Document 9082 (Ninth Edition—2012), ICAO's Policies on Charges for Airports and Air Navigation Services, recommends consultations before imposing fees. In addition, Article 12 of the Air Transport Agreement between the United States of America and the European Union and its Member States (April 30, 2007, as amended June 24, 2010) encourages consultation.

    By convening an ARC, presenting updated cost and traffic data to the ARC, and considering the ARC's recommendations, the FAA consulted with system users prior to proposing the overflight fee update. 80 FR 52217 (August 28, 2015). Additionally, the FAA invited comments on the proposal as part of its rulemaking process, which permitted participation by all interested parties.

    G. Environmental Analysis

    FAA Order 1050.1F identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 5-6.6f and involves no extraordinary circumstances.

    VII. Executive Order Determinations A. Executive Order 13132, Federalism

    The FAA has analyzed this final rule under the principles and criteria of Executive Order 13132, Federalism. The agency has determined that this action will not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, will not have Federalism implications.

    B. Executive Order 13211, Regulations That Significantly Affect Energy Supply, Distribution, or Use

    The FAA analyzed this final rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it will not be a “significant energy action” under the executive order and will not be likely to have a significant adverse effect on the supply, distribution, or use of energy.

    C. Executive Order 13609, Promoting International Regulatory Cooperation

    Executive Order 13609, Promoting International Regulatory Cooperation, (77 FR 26413, May 4, 2012) promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609, and has determined that this action will have no effect on international regulatory cooperation.

    VIII. Additional Information A. Availability of Rulemaking Documents

    An electronic copy of rulemaking documents may be obtained from the Internet by—

    • Searching the Federal eRulemaking Portal (http://www.regulations.gov);

    • Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies or

    • Accessing the Government Publishing Office's Web page at http://www.fdsys.gov

    Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9677. Commenters must identify the docket, notice, or amendment number of this rulemaking.

    All documents the FAA considered in developing this final rule, including economic analyses and technical reports, may be accessed from the Internet through the Federal eRulemaking Portal referenced above.

    B. Comments Submitted to the Docket

    Comments received may be viewed by going to http://www.regulations.gov and following the online instructions to search the docket number for this action. Anyone is able to search the electronic form of all comments received into any of the FAA's dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.).

    C. Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official, or the person listed under the FOR FURTHER INFORMATION CONTACT heading at the beginning of the preamble. To find out more about SBREFA on the Internet, visit http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

    List of Subjects in 14 CFR Part 187

    Administrative practice and procedure, Air transportation.

    The Amendment

    In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations as follows:

    PART 187—FEES 1. Revise the authority citation for part 187 to read as follows: Authority:

    31 U.S.C. 9701; 49 U.S.C. 106(f), 106(g), 106(l)(6), 40104-40105, 40109, 40113-40114, 44702, 45301.

    2. Revise § 187.1 to read as follows:
    § 187.1 Scope.

    This part prescribes fees only for FAA services for which fees are not prescribed in other parts of this chapter or in 49 CFR part 7. The fees for services furnished in connection with making information available to the public are prescribed exclusively in 49 CFR part 7. Appendix A to this part prescribes the methodology for computation of fees for certification services performed outside the United States. Appendix C to this part prescribes the methodology for computation of fees for production certification-related services performed outside the United States.

    3. Add § 187.3 to read as follows:
    § 187.3 Definitions.

    For the purpose of this part:

    Great circle distance means the shortest distance between two points on the surface of the Earth.

    Overflight means a flight through U.S.-controlled airspace that does not include a landing in or takeoff from the United States.

    Overflight through Enroute airspace means an overflight through U.S.-controlled airspace where primarily radar-based air traffic services are provided.

    Overflight through Oceanic airspace means an overflight through U.S.-controlled airspace where primarily procedural air traffic services are provided.

    U.S.-controlled airspace means all airspace over the territory of the United States, extending 12 nautical miles from the coastline of U.S. territory; any airspace delegated to the United States for U.S. control by other countries or under a regional air navigation agreement; or any international airspace, or airspace of undetermined sovereignty, for which the United States has accepted responsibility for providing air traffic control services.

    4. Add new §§ 187.51, 187.53, and 187.55 to read as follows:
    § 187.51 Applicability of overflight fees.

    (a) Except as provided in paragraphs (c) or (d) of this section, any person who conducts an overflight through either Enroute or Oceanic airspace must pay a fee as calculated in § 187.53.

    (b) Services. Persons covered by paragraph (a) of this section must pay a fee for the FAA's rendering or providing of certain services, including but not limited to the following:

    (1) Air traffic management.

    (2) Communications.

    (3) Navigation.

    (4) Radar surveillance, including separation services.

    (5) Flight information services.

    (6) Procedural control.

    (7) Emergency services and training.

    (c) The FAA does not assess a fee for any military or civilian overflight operated by the United States Government or by any foreign government.

    (d) Fees for overflights through U.S.-controlled airspace covered by a written FAA agreement or other binding arrangement are charged according to the terms of that agreement or arrangement unless the terms are silent on fees.

    § 187.53 Calculation of overflight fees.

    (a) The FAA assesses a total fee that is the sum of the Enroute and Oceanic calculated fees.

    (1) Enroute fee. The Enroute fee is calculated by multiplying the Enroute rate in paragraph (c) of this section by the total number of nautical miles flown through each segment of Enroute airspace divided by 100 (because the Enroute rate is expressed per 100 nautical miles).

    (2) Oceanic fee. The Oceanic fee is calculated by multiplying the Oceanic rate in paragraph (c) of this section by the total number of nautical miles flown through each segment of Oceanic airspace divided by 100 (because the Oceanic rate is expressed per 100 nautical miles).

    (b) Distance flown through each segment of Enroute or Oceanic airspace is based on the great circle distance (GCD) from the point of entry into U.S.-controlled airspace to the point of exit from U.S.-controlled airspace based on FAA flight data. Where actual entry and exit points are not available, the FAA will use the best available flight data to calculate the entry and exit points.

    (c) The rate for each 100 nautical miles flown through Enroute or Oceanic airspace is:

    Time period Enroute rate Oceanic rate January 1, 2017 to January 1, 2018 58.45 23.15 January 1,2018 to January 1, 2019 60.07 24.77 January 1, 2019 and Beyond 61.75 26.51

    (d) The formula for the total overflight fee is:

    Rij = E*DEij/100 + O*DOij/100 Where: Rij = the total fee charged to aircraft flying between entry point i and exit point j. DEij = total distance flown through each segment of Enroute airspace between entry point i and exit point j. DOij = total distance flown through each segment of Oceanic airspace between entry point i and exit point j. E and O = the Enroute and Oceanic rates, respectively, set forth in paragraph (c) of this section.

    (e) The FAA will review the rates described in this section at least once every 2 years and will adjust them to reflect the current costs and volume of the services provided.

    § 187.55 Overflight fees billing and payment procedures.

    (a) The FAA will send an invoice to each user when fees are owed to the FAA. If the FAA cannot identify the user, then an invoice will be sent to the registered owner. Users will be billed at the address of record in the country where the aircraft is registered, unless a billing address is otherwise provided.

    (b) The FAA will send an invoice if the monthly (based on Universal Coordinated Time) fees equal or exceed $400.

    (c) Payment must be made by one of the methods described in § 187.15(d).

    Appendix B to Part 187—[Removed and Reserved] 5. Remove and reserve Appendix B to Part 187. Issued under authority provided by 49 U.S.C. 106(f) and 45302, in Washington, DC, on November 7, 2016. Michael P. Huerta, Administrator.
    [FR Doc. 2016-28589 Filed 11-28-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 1005, and 1271 [Docket No. FDA-2016-N-1487] RIN 0910-AH41 Submission of Food and Drug Administration Import Data in the Automated Commercial Environment AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy. FDA is a Partner Government Agency (PGA) for purposes of submission of import data in ACE. As of July 23, 2016, ACE became the sole EDI system authorized by CBP for entry of FDA-regulated articles into the United States. We also updated certain sections of FDA regulations related to imports. This rule will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.

    DATES:

    This rule is effective December 29, 2016.

    ADDRESSES:

    For access to the docket to read background documents or comments received, go to https://www.regulations.gov and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    With regard to the final rule: Ann M. Metayer, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4338, Silver Spring, MD 20993-0002, 301-796-3324, [email protected]

    With regard to the information collection: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]

    SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Final Rule B. Summary of the Major Provisions of the Final Rule C. Legal Authority D. Costs and Benefits II. Table of Abbreviations/Commonly Used Acronyms in This Document III. Background IV. Legal Authority V. Comments on the Proposed Rule and FDA Response A. Introduction B. Description of General Comments and FDA Response C. Specific Comments and FDA Response D. Technical Amendments in the Final Rule VI. Economic Analysis of Impacts A. Introduction B. Summary of Benefits and Costs of the Final Rule VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. Federalism X. Reference I. Executive Summary A. Purpose of the Final Rule

    The rule requires that certain data elements material to our import admissibility review be submitted in ACE or any other CBP-authorized EDI system, at the time of entry. This action will facilitate automated “May Proceed” determinations by us for low-risk FDA-regulated products which, in turn, will allow the Agency to focus our limited resources on products that may be associated with a greater public health risk. We also made technical revisions to certain sections of FDA regulations to make updates and provide clarifications.

    B. Summary of the Major Provisions of the Final Rule

    This rule adds subpart D to part 1 of 21 CFR chapter I (21 CFR part 1) to require that certain data elements be submitted in ACE or any other CBP-authorized EDI system, at the time of entry in order to facilitate admissibility review by the Agency of FDA-regulated products being imported or offered for import into the United States. Submission of these data elements in ACE will help us to more effectively and efficiently make admissibility determinations for FDA-regulated products by increasing the opportunity for automated review by FDA's Operational and Administrative System for Import Support (OASIS). We also added § 1.81 to the final rule to clarify that FDA may reject an import filing for failure to provide the complete and accurate information required in the rule.

    We made technical revisions to certain sections of 21 CFR chapter I to update them. We revised 21 CFR 1.83 and 1005.2 to update the definition of owner or consignee in order to make that definition consistent with Title 19 of the U.S. Code. We also revised § 1.90 to allow FDA to provide notice of sampling directly to an owner or consignee. Additionally, we revised § 1.94 to clarify that written notice can be provided electronically by FDA to owners or consignees of FDA actions to refuse and/or subject certain products to administrative destruction. Under § 1.94, owners or consignees receive notice that FDA intends to take a certain action against an FDA-regulated product that is being imported or offered for import and the owner or consignee will have an opportunity to introduce testimony to the Agency in opposition to such action. We also amended 21 CFR 1271.420 to make clear that, unless otherwise exempt, importers of record of human cells, tissues or cellular or tissue-based products (HCT/Ps) that are regulated solely under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264) and part 1271 (21 CFR part 1271) would be required to submit the applicable data elements included in this rule in ACE.

    The final rule does not include certain aspects of the proposed rule that were opposed by many who submitted comments. For example, the final rule no longer includes FDA Value, FDA Quantity, Entity Contact Information other than for the importer of record, name and address of the ACE filer for tobacco products, and the Investigational New Drug Application Number for device-drug combination products as data elements that must be submitted in ACE at the time of entry. We have also removed, at our own initiative, the Drug Listing Number requirement for those human drugs that are regulated by FDA's Center for Biologics Evaluation and Research (CBER).

    C. Legal Authority

    The legal authority for this rule includes sections 536, 701, and 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360mm, 371, and 381, respectively), and sections 351, 361, and 368 of the PHS Act (42 U.S.C. 262, 264, and 271, respectively).

    D. Costs and Benefits

    The costs of complying with this regulation are between $27 million and $69 million per year (using 3 and 7 percent discount rates). The annualized cost savings to the entire industry cannot be fully quantified because of the lack of certain data currently available to the Agency. Partially quantifiable cost savings are estimated to range from $2.6 million to $43.4 million (using 3 and 7 percent discount rates).

    II. Table of Abbreviations and Acronyms Commonly Used in This Document Abbreviation/acronym What it means ACE Automated Commercial Environment or any other CBP-authorized EDI system. ACE filer The person who is authorized to submit an electronic import entry for an FDA-regulated product in ACE. ACS Automated Commercial System—the predecessor CBP-authorized EDI system to ACE. Agency U.S. Food and Drug Administration. CATAIR Customs and Border Protection and Trade Automated Interface Requirements. CBP U.S. Customs and Border Protection Agency. CBER FDA Center for Biologics Evaluation and Research. CDER FDA Center for Drug Evaluation and Research. CDRH FDA Center for Devices and Radiological Health. CTP FDA Center for Tobacco Products. CVM FDA Center for Veterinary Medicine. EDI Electronic Data Interchange. FDA U.S. Food and Drug Administration. FDASIA Food and Drug Administration Safety and Innovation Act. FD&C Act Federal Food, Drug, and Cosmetic Act. HCT/P Human cells, tissues, or cellular or tissue-based products. ITDS International Trade Data System. OASIS FDA's Operational and Administrative System for Import Support. PGA Partner Government Agency in ACE. PHS Act Public Health Service Act. We, Our, Us U.S. Food and Drug Administration. III. Background

    In the Federal Register of July 1, 2016 (81 FR 43155), FDA proposed a rule to require that certain data elements material to our import admissibility review be submitted in ACE at the time of entry. We also proposed to make technical revisions to certain sections of FDA regulations to make updates and provide clarifications. Interested parties were given 60 days to submit comments on the proposed rule to the public docket.

    We received 13 comment letters on the proposed rule by the close of the comment period, each containing one or more comments on one or more issues. These comments were submitted to the public docket by trade organizations, the trade industry, and the public. The final rule has been revised in response to comments received on the proposed rule. Our responses are discussed in section V. As discussed earlier in this document, we also decided, on our own initiative, to not include one required data element in the final rule. Additionally, the final rule includes several minor editorial revisions. Substantive changes from the proposed rule to the final rule are summarized in table 1.

    Table 1—Substantive Changes From the Proposed Rule to the Final Rule 21 CFR
  • section in
  • final rule
  • Description of change from proposed rule
    1.71 Definitions.
  • • Removed definition of “combination product” because Investigational New Drug Application Number (§ 1.76(h) in the proposed rule) removed.
  • • Removed definition of “import line” because FDA Value (§ 1.72(a)(3) in the proposed rule) removed.
  • 1.72 Data elements that must be submitted in ACE for articles regulated by FDA.
  • • Removed FDA Value (§ 1.72(a)(3) in the proposed rule).
  • • Removed FDA Quantity (§ 1.72(a)(4) in the proposed rule).
  • • Removed Name, telephone, and email address of any one of the persons related to the importation of the product which may include the manufacturer, shipper, importer of record, or Deliver to Party (§ 1.72(b)(1) in the proposed rule).
  • • Added submission of the full intended use code (§ 1.72(a)(3)); not in the proposed rule.
  • 1.73 Food.
  • • Removed requirement to submit FDA Value under § 1.72(a)(3) for food (§ 1.73(a) in the proposed rule).
  • • Removed requirement to provide Food Canning Establishment Number and the Submission Identifier, and can dimensions or volume for low-acid canned foods and acidified foods imported or offered for import for laboratory analysis only, when such foods will not be taste tested or otherwise ingested
  • 1.76 Medical Devices.
  • • Removed requirement to submit Investigational New Drug Application Number (§ 1.76(h) in the proposed rule).
  • 1.78 Biological products, HCT/Ps, and related drugs and medical devices.
  • • Removed requirement to submit Drug Listing Number (removed from § 1.78(d) in the proposed rule).
  • 1.79 Tobacco products.
  • • Excludes products solely intended for further manufacturing and investigational tobacco products from requirement. Requires submission of a commercial name for any such tobacco product that does not have a specific brand name (§ 1.79(a) of the proposed rule).
  • • Removed name and address of the ACE filer for any entry that includes an article that is a tobacco product (§ 1.79(b) of the proposed rule).
  • 1.81 Rejection of Entry Filing.
  • • Clarifies that FDA may reject an entry filing for failure to provide complete and accurate information as required in the final rule; not included in the proposed rule.
  • IV. Legal Authority

    We have the legal authority under the FD&C Act and the PHS Act to regulate foods, cosmetics, drugs, biological products, medical devices, and tobacco products being imported or offered for import into the United States (sections 701 and 801 of the FD&C Act; section 351 of the PHS Act). We also have the legal authority to regulate the importation of radiation-emitting electronic products (section 536 of the FD&C Act).

    Additionally, section 361 of the PHS Act authorizes FDA to make and enforce such regulations as it judges necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States or from State to State. FDA has issued regulations in part 1271 to regulate HCT/Ps. HCT/Ps that do not meet the criteria listed in § 1271.10(a) for them to be regulated solely under section 361 of the PHS Act and the regulations in part 1271 are regulated as drugs, devices, and/or biological products under the FD&C Act and/or section 351 of the PHS Act and must follow applicable regulations, including the applicable regulations in part 1271. FDA has determined that improving the efficiency of admissibility determinations for HCT/Ps, thus improving the allocation of Agency resources, is necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries. We are therefore relying on the authority of section 361 of the PHS Act in the amendments to § 1271.420. Authority for enforcement of section 361 of the PHS Act is provided by section 368 of the PHS Act.

    We are also issuing this rule under authority granted to FDA by section 801(r) of the FD&C Act, added by section 713 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) (FDASIA). Title VII of FDASIA provides FDA with important new authorities to help the Agency better protect the integrity of the drug supply chain. Section 801(r) of the FD&C Act authorizes FDA to require, as a condition of granting admission to a drug imported or offered for import into the United States, that the importer of record electronically submit information demonstrating that the drug complies with the applicable requirements of the FD&C Act. This information may include:

    • Information demonstrating the regulatory status of the drug, such as the new drug application, the abbreviated new drug application, investigational new drug, or drug master file number;

    • facility information, such as proof of registration and the unique facility identifier; and

    • any other information deemed necessary and appropriate by FDA to assess compliance of the article being offered for import.

    Section 701(a) of the FD&C Act authorizes the Agency to issue regulations for the efficient enforcement of the FD&C Act, while section 701(b) of the FD&C Act authorizes FDA and the Department of the Treasury to jointly prescribe regulations for the efficient enforcement of section 801 of the FD&C Act. This rule is being jointly prescribed by FDA and the Department of the Treasury, with the exception of the provisions of the rule related to the importation of HCT/Ps which are regulated solely under section 361 of the PHS Act and part 1271 and the importation of radiation-emitting electronic products which are regulated under section 536 of the FD&C Act; neither of these provisions will be issued for the efficient enforcement of section 801 of the FD&C Act.

    V. Comments on the Proposed Rule and FDA Response A. Introduction

    Sections V.B and V.C contain summaries of the relevant portions of the responsive comments and the Agency's responses to those comments. We have numbered each comment to help distinguish between different comments. We have grouped similar comments together under the same number, and, in some cases, we have separated different issues discussed in the same comment and designated them as distinct comments for purposes of our responses. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's value or importance or the order in which comments were received.

    The Agency also received a number of comments that were not responsive to the content of the proposed rule and therefore were not considered in its final development.

    B. Description of General Comments and FDA Response

    A number of comments made general remarks supporting or opposing the proposed rule without focusing on a particular proposed provision. In the following paragraphs, we discuss and respond to such general comments.

    (Comment 1) We received a comment expressing concern that several of the data elements in the proposed rule appear to require information that is already being provided in ACE pursuant to CBP requirements. We also received comments that many of the required data elements represent information that is already available to the Agency.

    (Response 1) FDA acknowledges that some of the required data elements in this rule may appear similar to CBP data requirements in ACE. The rule, however, only contains those data elements that provide additional information that is material to FDA's initial admissibility review of an FDA-regulated article that is being imported or offered for import. Where information is already being collected by CBP and is acceptable for FDA admissibility review purposes, we did not include those data elements in the rule. For example, CBP collected FDA manufacturer and shipper, and ultimate consignee information in the Automated Commercial System (ACS), the predecessor CBP-authorized EDI system to ACE, to assist FDA in admissibility review of FDA-regulated products. We determined that the information CBP collects in ACE for manufacturer and shipper and Deliver to Party is sufficient for our purposes so we did not include those data elements in this rule.

    We acknowledge that FDA may have access to some of the information which is required by the rule to be submitted by ACE filers at the time of entry. However, ACE filers and importers are in a better position to know the identity and characteristics of the particular article being imported or offered for import. For example, the importer should be aware of what Drug Listing Number is applicable to a particular drug article, what the applicable Food Canning Establishment Registration (FCE) number, Submission Identifier (SID), or can dimensions or volume are applicable to a particular low-acid canned food, or what the brand name is of a particular tobacco product.

    In addition, submission of the required data elements in the final rule will assist FDA in expediting the initial screening and further review of an entry, and can significantly increase the likelihood that an entry line will receive an automated “May Proceed.” Historically, when these data fields are inaccurate or incomplete, these entries must be manually reviewed for an admissibility determination by FDA. Entries are delayed, sometimes significantly, while an FDA-reviewer either searches for that information in our data systems or requests followup documentation from the importer of record. An automated review to determine whether an article “May Proceed” is much faster and less resource intensive for both FDA and the importer.

    (Comment 2) Several commenters requested that FDA make some or all of the required data elements in the proposed rule optional or, in the alternative, allow ACE filers to submit “UNK” representing “unknown” in ACE for those data elements. These commenters stated that the data elements are not always known or available to the ACE filer at the time entry is electronically filed in ACE. They expressed concern that CBP would not process the entry filing in ACE if all the required data elements are not submitted at time of entry. But, if the data is optional or if “UNK” is allowed to be submitted for a required data element, they asserted, CBP would process the entry and transmit the entry data to FDA's OASIS system. These commenters recognized that an FDA “May Proceed” would not issue until the missing data was provided by the ACE filer but that CBP may issue a delivery authorization to allow the goods to move from the port to the importer's premises in the interim. This would, they believe, avoid a backlog of cargo at the port and the cost of storage and demurrage as an ACE filer waited to receive the information from the importer.

    (Response 2) As discussed in Response 6 in this document, we are requiring submission of intended use codes in ACE in the final rule but are allowing ACE filers to submit “UNK” as the intended use code in ACE at the time of entry. We decline, however, to accept “UNK” for any other required data element in the final rule. As stated in the proposed rule, the number of import lines that include FDA-regulated articles continues to grow steadily every year and this is posing challenges to the Agency in enforcing sections 536 and 801 of the FD&C Act and sections 351, 361, and 368 of the PHS Act. The number of import lines in 2015 that included an FDA-regulated article exceeded 35 million. In ACS, where submission of data elements was optional, the number of submissions varied depending on commodity. As stated previously in this document, where certain data was missing or inaccurate, entries had to be manually reviewed for an admissibility determination by FDA and entries were sometimes significantly delayed. In the final rule, we are requiring only certain data elements that we have determined to be material to our import admissibility review be submitted in ACE at the time of entry. The purpose of the rule is to facilitate automated “May Proceed” determinations by us for low-risk FDA-regulated products which, in turn, will allow the Agency to focus our limited resources on products that may be associated with a greater public health risk. An automated review to determine whether an article “May Proceed” is much faster and less resource intensive for FDA and the importer than a manual review. As expected, we have seen a decrease in the FDA processing time for both automated and manual “May Proceed” determinations since ACE became the sole CBP-authorized EDI system in July 2016. The average time for the OASIS system to process an import entry submitted in ACS from August 27 to October 22, 2015, and issue an automated “May Proceed” determination was approximately 7.1 minutes which has been reduced to approximately 2 minutes in ACE from August 27 to October 22, 2016. The average time for an FDA-reviewer to manually review and issue a “May Proceed” determination in ACS from August 27 to October 22, 2015, was about 28 hours and that has been reduced to under 2 hours in ACE from August 27 to October 22, 2016. As a result of a more streamlined import process, the rule is expected to lead to a more effective use of FDA and importer resources, and more efficient enforcement of the FD&C Act and the PHS Act for imported products.

    In addition, we expect that, after the initial adjustment phase, submission of the data elements required by the rule will become incorporated into the business practices of importers and customs brokers. Persons wishing to import FDA-regulated products into the United States are required to file the entry documentation or data required by CBP and FDA at the time of entry in ACE in order to secure the release of an FDA-regulated article from CBP custody (19 CFR 142.3). Entry and entry summary documentation that is filed electronically in ACE must be certified by the importer of record or his/her duly authorized customs broker as being true and correct to the best of his/her knowledge. A certified electronic transmission is binding in the same manner and to the same extent as a signed document (19 CFR 141.61(a)(2)).

    Approximately 98 percent of importers use customs brokers to file their entries containing FDA-regulated products subject to the final rule. Customs brokers are required to exercise due diligence in preparing or assisting in the preparation of records for import entries (19 CFR 111.29). We expect that importers and customs brokers will adapt their business practices to provide the required data elements in ACE at the time of entry in order to secure the release of an FDA-regulated article from CBP custody and submission of these data elements will become routine.

    (Comment 3) Some commenters requested that we use the term “transmission of data elements in ACE” instead of “submission of data elements in ACE” by ACE filers suggesting that FDA distinguish between the importer (as the provider of information) and the customs broker/filer (as the transmitter of the information provided by the importer). One comment suggested that we adopt the distinction between “submitter” and “transmitter” that appears in the Prior Notice of Imported Food regulation (21 CFR part 1, subpart I).

    (Response 3) We decline to make that change. “Submission” is the term used in CBP regulations to characterize the electronic submission to ACE of the entry summary documentation or data for preliminary review or of entry documentation or data for other purposes (19 CFR 141.0a(c)). Further, as stated previously, approximately 98 percent of importers use customs brokers to file their entries containing FDA-regulated products subject to the rule; the other 2 percent file these entries themselves. The obligations of customs brokers extend beyond the mere electronic transmission of data received for transmission to CBP (see definition of “customs business” in 19 CFR 111.1).

    It should also be noted that this rule does not address or impact the current import entry review process for food articles requiring prior notice which has been operationally transitioned from ACS to ACE. The prior notice information required under § 1.281 is currently submitted in ACE or the FDA Prior Notice System Interface (PNSI) before the arrival of a food article in the United States. The different roles of transmitter and submitter for prior notice are tied to the existence of two systems for filing prior notice and the particular roles of filers in that process. We do not see a benefit in applying those concepts to the process of filing entry for FDA-regulated products that are not subject to prior notice.

    (Comment 4) Some commenters expressed doubts that submission of additional data in ACE for FDA-regulated products will result in increased efficiencies in FDA admissibility review particularly an increase in automated “May Proceed” determinations by the Agency.

    (Response 4) Although we do not at this time have statistics on the numbers of automated “May Proceed” determinations that will result from implementation of the rule, we have already seen a substantial decrease in average FDA processing times for both automated and manual “May Proceed” determinations since ACE became the sole CBP-authorized EDI system in July 2016. As we and the trade industry continue to adjust to the new system and various technological issues with ACE that have arisen during the transition to ACE are addressed, we expect these processing times to continue to improve.

    C. Specific Comments and FDA Response

    For some of the proposed data elements and other requirements, FDA either did not receive comments or the comments were generally supportive. Unless otherwise noted, FDA has kept these requirements in the final rule for the reasons given in the proposal.

    1. Approval or Clearance Status of FDA-Regulated Medical Products

    In the Notice of Proposed Rulemaking, we invited comments on the advantages, disadvantages, and feasibility of requiring the submission of data elements related to the approval or clearance status of FDA-regulated medical products. We proposed to require the submission at the time of entry of application numbers for those articles that are the subject of such applications. In particular, we invited comment on whether the submission of these data elements would help us achieve our goals of facilitating admissibility review and focusing our resources on those products that may be associated with a serious public health risk to consumers.

    We received several comments supportive of our position and none of the comments suggested revising the provisions in the proposed rule related to the submission of application numbers. We are finalizing those provisions without change.

    2. Active Pharmaceutical Ingredient Data Elements

    We also invited comments on the advantages, disadvantages, and feasibility of requiring what are now optional active pharmaceutical ingredient (API) data elements for finished human and animal drugs contained in the PGA Message Set (e.g., name of the API, the amount and unit of measure of the API, and the name of the manufacturer of the API in the finished drug) to be submitted in ACE at the time of entry.

    (Comment 5) Several comments asserted that requiring submission of these API data elements in ACE at the time of filing entry would create a significant burden on industry. These commenters urged FDA to leave the API data elements as optional submissions in ACE, so that an ACE filer could choose to transmit the information if available at time of entry. The comments noted that by keeping the API data elements optional, CBP would be able to process the entry for a drug product, even if the API information were not transmitted in ACE at the time of entry. If, however, FDA determines further evaluation is necessary, FDA could then request API information during our review of the entry for admissibility.

    (Response 5) In response to these comments, we have decided to keep the API data elements as optional submissions in ACE at the time of entry. Although these data elements will remain optional, FDA strongly encourages ACE filers to submit the API data elements at the time of entry to facilitate FDA's admissibility review. These API data elements provide us with information that may be material to our admissibility review for drug products. For example, submission of these API data elements would help FDA assess whether a finished dosage form drug that is being imported or offered for import appears to be adulterated and may be subject to refusal of admission under section 801(a) of the FD&C Act. If an API has not been manufactured in compliance with Current Good Manufacturing Practices (CGMP), it is deemed adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act because the methods used in, or the facilities or controls used for, the drug's manufacture, processing, packing or holding did not conform to, or were not operated or administered in conformity with, CGMP requirements. A finished dosage form drug is deemed adulterated if it contains an API that is adulterated. Drugs that appear to be adulterated are subject to detention and refusal under section 801(a) of the FD&C Act. FDA has placed a number of foreign API suppliers on Import Alert 66-40, which may subject their APIs to detention without physical examination, because the firms have not met CGMPs. As a consequence, FDA has refused admission of drug products that have been manufactured using APIs on Import Alert 66-40, under section 801(a)(3) of the FD&C Act.

    In addition, if a foreign-manufactured API was used in a drug product that is the subject of an approved application under section 505 or 512 of the FD&C Act (21 U.S.C. 355 or 360b), the API manufacturer must be an acceptable source listed in the approved NDA or ANDA for human drugs (see, e.g., 21 CFR 314.50(d)(1)(i)) or in the approved NADA or ANADA for animal drugs (see, e.g., 21 CFR 514.1(b)(5)(i)). Submitting the API data elements in ACE for a drug product that is the subject of an approved application would facilitate FDA's assessment of whether the finished dosage form drug complies with section 505 or 512.

    If ACE filers submit the optional API data elements in ACE, it likely will increase the likelihood that the import entry will receive an automated “May Proceed” determination from the Agency. If the API data elements are not submitted in ACE, the entry may receive a manual review and the FDA reviewer may request that the importer provide API information for the finished dosage product.

    3. Intended Use Code and Disclaimer

    FDA invited comments on the advantages, disadvantages, and feasibility of the Agency requiring the submission of the following data elements in ACE at the time of entry: (1) An intended use code for the FDA-regulated article being imported or offered for import and (2) a disclaimer indicating that that the article is not currently regulated by FDA or that FDA does not currently have any requirements for submission of data for importation of that article per Agency guidance.

    a. Intended use code. We received several comments supporting inclusion of intended use codes in the final rule. Historically, FDA derived intended use information for the purposes of FDA's admissibility review from the free text information submitted in the CBP-required product description field in ACS. Intended use codes were developed for ACE in the PGA message set to provide a consistent, systematic approach to collection of certain intended use information about articles that are being imported or offered for import into the United States. These codes standardize the data input for computer processing in ACE. If FDA needs a particular intended use code (IUC) for the ACE system to identify what FDA data elements are needed for a particular FDA-regulated product, the proposed IUC is submitted to CBP for inclusion in Appendix R to the Customs and Border Protection and Trade Automated Interface Requirements (CATAIR).

    We added § 1.72(a)(3) to the final rule to require that a full IUC be submitted in ACE at the time of entry for each FDA-regulated article that is being imported or offered for import into the United States. Appendix R defines a full IUC as consisting of a base code that designates the general use intended for the article and a subcode, if applicable, that designates the specific use intended for the article.

    (Comment 6) One commenter supported mandatory intended use codes and several commenters requested that IUCs be optional data submissions at the time of entry in ACE or, in the alternative, that FDA continue to allow ACE filers to submit “UNK” as the IUC in ACE at the time of entry. These commenters assert that the intended use of an article is often not known at the time of entry and that if FDA needs this information, it can be provided at a later date.

    (Response 6) Because IUCs are such an integral part of the ACE system regarding the identification of those required data elements in the rule applicable to a particular article that must be submitted in ACE at the time of entry, we decline to make IUCs optional. After considering the comments, we have decided, however, to continue to allow submission of the intended use code “UNK” for FDA-regulated articles. “UNK” is currently listed as an IUC in Appendix R of the CATAIR. Operationally, submission of “UNK” will not trigger the ACE system to identify all of the FDA data elements that are required to be submitted for a particular FDA-regulated article whereas submission of the specific IUC applicable to that article will trigger the ACE system to identify the required data fields and reject the filing if the required data is not submitted.

    If “UNK” is submitted as the IUC for the article, the ACE filer is still responsible for submitting the other required data elements in this rule that are applicable to that article, in ACE at the time of entry. If those other data elements are not submitted in ACE at the time of entry, the entry may be transmitted by ACE to OASIS for FDA's admissibility review but FDA may decide to not perform an admissibility review until those data elements have been submitted. We have added § 1.81 to the final rule to make clear that FDA may reject any entry filing that does not contain the complete and accurate information required by the rule without performing an admissibility review. If FDA rejects an entry filing under § 1.81, the ACE filer will need to withdraw the entry in ACE and resubmit the entry with the complete and accurate information required under the rule in order to have FDA perform an admissibility review of that entry. ACE filers also need to be aware that submitting “UNK” as the intended use code will, in most cases, subject the entry to a manual review for admissibility provided the entry filing is not rejected by FDA.

    b. Disclaimer. By submitting a disclaimer in ACE at the time of entry, an ACE filer indicates that the article being imported or offered for import is not currently regulated by FDA or that FDA does not currently have any requirements for submission of data for importation of that article per Agency guidance.

    (Comment 7) Several commenters expressed the opinion that the current disclaimer procedures in ACE should not be changed.

    (Response 7) After consideration of the comments received, we have decided not to include FDA-required disclaimer data elements in the final rule. ACE filers can continue to submit disclaimers in ACE at the time of entry following current procedures.

    4. General Data Elements for FDA-Regulated Commodities

    a. FDA country of production. The FDA Country of Production identifies the country where an FDA-regulated article last underwent any manufacturing or processing but only if such manufacturing or processing was of more than a minor, negligible, or insignificant nature. This differs from the CBP country of origin which uses a substantial transformation test. When an article has undergone a “substantial transformation” in a different country, CBP requires that the country of origin be changed to the country where the substantial transformation has taken place. Substantial transformation occurs in the country where the article acquired the name, character or intended use that matches the article identified in the entry.

    CBP collected FDA Country of Production in ACS to assist FDA in making admissibility decisions for FDA-regulated products.

    (Comment 8) Some commenters requested additional guidance on what FDA considers to be manufacturing or processing of more than a minor, negligible, or insignificant nature. One commenter suggested that FDA consider issuing a “positive” list of manufacturing activities or processes that definitively impart “FDA Country of Production” status or alternatively issue a list of manufacturing or processing activities that are considered by the Agency to be minor, negligible or insignificant.

    (Response 8) Whether the manufacturing or processing of a particular FDA-regulated article is of more than a minor, negligible or insignificant nature is dependent on the facts of each particular case which include the specific manufacturing or processing activities involved as well as the type of commodity that is being affected by those activities. We have provided below some examples to illustrate activities FDA would consider to be more than minor, negligible, or insignificant which would impact the FDA Country of Production.

    For example:

    • If an FDA-regulated article undergoes further manufacturing/processing at a facility, such as encapsulating a drug, the country where the facility that performed the additional manufacturing/processing is located is considered to be the FDA Country of Production.

    • Conversely if an article was not further manufactured/processed by a facility, such as repacking retail packages into a different master carton for shipping, the country where the facility that performed this repacking is located would not be considered to be the FDA Country of Production.

    We will also consider the issuance of additional guidance in the future as resources allow.

    (Comment 9) One comment requested clarification regarding the application of FDA Country of Production to Foreign Trade Zone (FTZ) operations. The Commenter suggested revising the FDA Country of Production data element by adding this sentence: “For articles imported from foreign-trade zones, if the article has undergone manufacturing in the foreign-trade zone, the FDA Country of Production is the United States for FDA import purposes.”

    (Response 9) FDA recognizes that the FDA Country of Production will be the United States if more than minimal, negligible, or insignificant manufacture or processing occurs in an FTZ but we decline to make the suggested revision because it is unnecessary.

    b. The complete FDA product code. CBP also collected the Complete FDA Product Code in ACS to assist FDA in making admissibility decisions for FDA-regulated products.

    (Comment 10) Some commenters supported the requirement for submission of the Complete FDA Product Code but requested clarification regarding the requirement that the code “ . . . must agree with the invoice description of the product. ” They expressed concern that “agreement” could be interpreted in various ways by both FDA-reviewers and industry resulting in unintended and unnecessary detentions or delays for completion of admissibility determinations. For example, “agreement” with the invoice description could be understood as requiring a partial or complete verbatim match between the invoice description and the product code.

    (Response 10) FDA does not intend for the invoice description and the Complete FDA Product Code to be identical. In order to clarify this requirement, we have revised the language in the rule to require that the Complete FDA Product Code be “consistent” with the invoice description.

    c. FDA value. We proposed to require that the total value of an entry as required by CBP or the total value of the article(s) in each import line be submitted at the time of entry in ACE and invited comments on the advantages, disadvantages, and feasibility of allowing the ACE filer to submit the total value of the entry or the total value apportioned to the article(s) in each import line. In particular, we invited comment on whether the submission by an ACE filer of the value apportioned to the article(s) in an import line in ACE at the time of entry would help us achieve our goals of facilitating admissibility review and focusing our resources on those products that may be associated with a serious public health risk to consumers.

    (Comment 11) We received several comments that expressed confusion over the products that would be subject to the proposed FDA Value requirement, as well as the “value” that was required to be submitted in ACE for an entry that includes an FDA-regulated article. The commenters suggested that the Agency accept the total value of an entry required by CBP without the need to break-out the value of each import line. Pro-rating the value to each import line, they assert, can be a cumbersome, time intensive process with no practical value to FDA for typical entries containing FDA-regulated products which may have many separate lines.

    (Response 11) FDA will accept the total value of an entry required by CBP and, therefore, we have decided not to finalize § 1.72(a)(3) in the proposed rule. ACE filers, however, will continue to have the option to submit the total value of the article(s) in each import line.

    d. FDA quantity. FDA proposed to require submission of the quantity of the FDA-regulated article(s) in each import line at the time of entry in ACE. FDA Quantity would include the quantity of each layer/level of packaging of the article(s), the unit of measure which is the description of each type of package, and the volume and/or weight of each of the smallest of the packaging units. The quantity would be required to be submitted in decreasing size of packing unit (starting with the outermost/largest package to the innermost/smallest package). We invited comments on the advantages, disadvantages, and feasibility of requiring an ACE filer to submit the FDA quantity of the article(s) in each import line in ACE at the time of entry. In particular, we invited comment on whether the submission by an ACE filer of the FDA quantity of the article(s) in an import line would help us achieve our goals of facilitating admissibility review and focusing our resources on those products that may be associated with a serious public health risk to consumers.

    (Comment 12) We received several comments that this level of detail for quantity as an “across-the-board” data requirement would entail significant data input on the part of ACE filers and would not enhance admissibility review by FDA.

    (Response 12) In response to the comments we received we have decided not to finalize § 1.72(a)(4) of the proposed rule which would have required FDA Quantity to be submitted in ACE at the time of entry. ACE filers, however, will still have the option of submitting this information.

    e. Entity contact information. In the proposed rule, we proposed to require that the name, telephone, and email address of any one of the persons related to the importation of the article(s) in the entry, which may include the manufacturer, shipper, importer of record, or Deliver to Party, be submitted in ACE at the time of entry. We invited comments on the advantages, disadvantages, and feasibility of requiring an ACE filer to submit the name, telephone, and email address of any one of the persons related to the importation of the article(s) in the entry, in ACE at the time of entry. In particular, we invited comment on whether the submission by an ACE filer of this information would help us achieve our goals of facilitating admissibility review and focusing our resources on those products that may be associated with a serious public health risk to consumers.

    (Comment 13) We received several comments opposing this provision in the proposed rule. One commenter expressed concern that the proposed entity contact information was unnecessarily duplicative of the contact information the Agency was proposing to require for the importer of record. In addition, the commenter suggested that the email and phone of the importer of record should only be required at the header level, not for each import line.

    (Response 13) After review of the comments we have decided to require email address and phone for the importer of record only. The contact information for other parties to the shipment, which may expedite the entry review process, can be provided to the Agency at the option of the ACE filer.

    However, FDA does not determine what information is submitted at the header level, CBP makes those determinations. In addition, the burden to input the same data repeatedly on the same entry may be ameliorated through software programming.

    5. Food

    Low-acid canned food. We proposed that the Food Canning Establishment (FCE) Number, the Submission Identifier (SID), and the can dimensions or volume (e.g., pouches and bottles) be required submissions in ACE at the time of entry.

    (Comment 14) One comment asked us to clarify whether the FCE number, SID, and can dimensions or volume information will be required for LACF products that are imported for research and testing at laboratories, but that are not sold or marketed in the United States and are not intended for consumption in the United States.

    (Response 14) We do not believe we will generally need the FCE number, SID, and can dimensions or volume to effectively identify LACF products that are being imported or offered for import for laboratory analysis only, when such foods will not be consumed by humans or animals. Consequently, we have revised § 1.73(b). Under the final rule, § 1.73(b) provides that for an article of food that is a low-acid canned food, the ACE filer must transmit at the time of filing entry the FCE number, SID, and can dimensions or volume, except that the ACE filer does not need to submit this information if the LACF product is for laboratory analysis only and will not be taste tested or otherwise ingested. Because we also do not believe we will generally need this information to effectively identify acidified food products in similar circumstances, we have made similar revisions to § 1.73(c). Specifically, we have revised § 1.73(c) to provide that for an article of food that is an acidified food, the ACE filer must submit at the time of filing entry the FCE number, SID, and can dimensions or volume, except that the ACE filer does not need to submit this information if the acidified food product is for laboratory analysis only and will not be taste tested or otherwise ingested. We consider LACF and acidified food products to be for laboratory analysis only and not taste tested or otherwise ingested only if the entire article will be used completely in the laboratory analysis, destroyed by the laboratory analysis, or destroyed following a reasonable retention period after the laboratory analysis. No portions of the article can be taste tested or otherwise consumed by humans or animals. Consequently, if an LACF or acidified food product being imported or offered for import will be used for product promotional tasting or other types of research in which the food will be ingested, ACE filers are required to submit the FCE number, SID, and can dimensions or volume information in ACE at the time of entry. In order to allow ACE filers to identify in ACE any LACF or acidified foods that are for laboratory analysis which do not require submission of the FCE number, SID, and can dimension or volume, we intend to create an FDA product code that can be used to identify such foods. When ACE filers use this product code, they will not be required to submit the FCE number, SID, and can dimension or volume information in ACE at the time of entry. ACE filers should be aware that entries submitted in ACE that include this new product code will be subject to manual review for an admissibility determination by FDA.

    6. Human Drugs

    Drug registration number. We proposed to require the submission of the Drug Registration Number in ACE at the time of entry. For purposes of this rule, the Drug Registration Number that would be submitted in ACE is the unique facility identifier (UFI) of the foreign establishment where the drug was manufactured, prepared, propagated, compounded, or processed before being imported or offered for import into the United States.

    (Comment 15) One commenter requested clarification regarding what number was required to be submitted for the Drug Registration Number.

    (Response 15) We published a final rule on August 31, 2016, regarding the requirements for Drug Registration and Listing (81 FR 60170). FDA also provides guidance and instruction on establishment registration on our Web site (see, e.g., http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm078801.htm)

    7. Animal Drugs

    One comment supported inclusion of all of the proposed data elements to be submitted in ACE for importation of animal drugs, noting that all clearly impact admissibility. We are finalizing these provisions without change.

    8. Medical Devices

    a. Registration and Listing. We proposed to require that the applicable Registration and Listing Numbers of the Domestic Manufacturer, Foreign Manufacturer, and/or Foreign Exporter for each medical device identified in the entry, be submitted in ACE at the time of entry.

    (Comment 16) One commenter stated that if there are different medical device registrants involved in the same entry, for example a foreign manufacturer and a foreign exporter, only one medical device registration and listing number should be required and this would be sufficient for FDA to make an admissibility decision.

    (Response 16) As explained in the preamble of the proposed rule, we have determined that the registration numbers of certain parties involved in the importation of a medical device (as well as the device listing number) may be material to our admissibility review. Submission of one party's registration number does not convey the registration information for another party involved in the importation of a medical device. Device foreign exporters can and do vary for medical devices manufactured at a particular firm and thus the information for all parties involved is needed at the time of entry. In addition, the time needed for an FDA reviewer to attempt to ascertain that information from our records or to request that information from the ACE filer or importer during a manual review can result in a lengthy delay in our admissibility determination. As such, we are not amending this requirement.

    b. Device listing number. We proposed to require that the Device Listing Number (LST) required under section 510 of the FD&C Act (21 U.S.C. 360) and part 807 (21 CFR part 807) for each medical device identified in the entry, be submitted in ACE at the time of entry. Providing the LST will allow FDA to review important information during our initial admissibility review as the information for each listed medical device, as enumerated in § 807.25(g), includes the proprietary or brand name(s) under which each medical device is marketed and the activities or processes that are conducted on or done to the medical device at each establishment (e.g., manufacturing, repacking, relabeling, developing specifications, remanufacturing, single-use device reprocessing, contract manufacturing, or contract sterilizing). When the listing process is complete, FDA issues an LST for each medical device associated with a particular registration.

    (Comment 17) Some commenters, while recognizing that the LST is a critical component of our admissibility review, felt that the LST should be made publicly available by FDA to ensure that ACE filers have this information to submit in ACE at the time of entry. The commenters asserted that, if LSTs are not publicly available (and thus potentially not readily available to ACE filers), this will cause unnecessary disruptions and additional caged shipments. They suggest that an alternative to making the LST publicly available is to continue to allow “UNK” to be submitted for the LST.

    (Response 17) We do not agree that FDA should make LSTs publicly available, and decline to make the requested revisions to the requirement to submit the LST (i.e., permit the use of “UNK” instead of the LST).

    As explained in the preamble to the proposed rule, in the device registration and listing process, FDA issues a registration number to the registrant that is publicly available and an LST for each device associated with the registration. Under section 510(f) of the FD&C Act, device listing information “shall be exempt from such inspection unless the Secretary finds that such an exemption would be inconsistent with protection of the public health.” Under § 807.37(b)(2), FDA-assigned LSTs are expressly excluded from public inspection or posting on the FDA Web site. In the Federal Register, FDA provided the following brief explanation for that exclusion: “Listing numbers serve important governmental functions that may be harmed if they were made public” (77 FR 45927 at 45930 (Aug. 2, 2012)).

    The confidentiality of LSTs serves important public health interests and helps to prevent the importation of substandard, mislabeled, and counterfeit medical devices. Some imports, e.g., counterfeit devices, may not be as safe and effective as devices approved or cleared for the U.S. market, may have been inadequately stored or maintained according to standards applicable outside the United States, or may be labeled or bear inadequate instructions for use in foreign markets. All of these issues can impact patient safety. FDA, therefore, will not be making LSTs publicly available as requested by commenters. Moreover, FDA will not be allowing “UNK” to be entered for LST as doing so would also increase the likelihood that counterfeit devices could enter the U.S. market and harm consumers. Although “UNK” cannot be used in lieu of an LST, “UNK” is an option for the intended use code.

    ACE filers and importers in an established transactional or commercial relationship with the registrant will have access to the proprietary LST to submit in ACE at the time of entry.

    c. Investigational devices. We proposed to require that an ACE filer submit in ACE at the time of entry, in the data field for the investigational device exemption (IDE) number in ACE, for an investigational device that is being imported or offered for import: (1) The IDE number for a medical device granted an exemption under section 520(g) of the FD&C Act (21 U.S.C. 360j(g)) or (2) “NSR” for a medical device to be used in a nonsignificant risk or in an exempt study (§ 1.76(b)).

    One comment supportive of this provision in the proposed rule was received and we are finalizing this provision without change.

    d. Impact resistant lens. We proposed to require for impact resistant lenses in eyeglasses and sunglasses an Affirmation of Compliance with the applicable requirements of § 801.410 (21 CFR 801.410) at the time of entry in ACE. This regulation states that importers may have the tests required by § 801.410(d) conducted in the country of origin but they must make the results of the testing available, upon request, to FDA, as soon as practicable (§ 801.410(g)). The current Affirmation of Compliance Code is “IRC.”

    (Comment 18) Two commenters requested that FDA clarify whether impact-resistant lenses imported for personal use require submission of the IRC Affirmation of Compliance Code at the time of entry in ACE and whether an ACE filer must possess or submit the results of the “drop fall” test under § 801.410 in order to submit that Affirmation of Compliance when applicable.

    (Response 18) For further relevant information on the importation of impact-resistant lenses for personal use, please see FDA's Supplemental Guide to the CATAIR (available at https://www.cbp.gov/document/guidance/fda-supplemental-guide-release-16), Chapter 9 of FDA's Regulatory Procedures Manual (available at http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf), and FDA's Impact-Resistant Lenses: Questions and Answers Guidance (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070755.pdf).

    As in the past, an ACE filer submitting “IRC” in ACE at the time of entry may rely on a drop-fall test certificate from the manufacturer or from a third party confirming to the ACE filer that the import satisfies the applicable requirements of § 801.410.

    e. Investigational new drug application number. Proposed § 1.76(h), as explained in section V.C.5.h of the preamble of the Proposed Rule, would require the ACE filer, in the case of a combination product consisting of at least one medical device and one drug intended for human use and subject to an investigational new drug application (IND), to submit in ACE at the time of entry the IND number if FDA has designated the Center for Devices and Radiological Health (CDRH) as the center with primary jurisdiction for the premarket review and regulation of the combination product.

    (Comment 19) We received a comment asserting that a combination product consisting of at least one medical device and one investigational new drug where FDAs CDRH has been designated as the center with primary jurisdiction would rightfully be conducted under an IDE rather than an IND. The commenter expressed the opinion that the final rule should distinguish between a combination product approved under an IDE and a combination product approved under an IND.

    The commenter also observed that the proposed rule only addressed the importation of stand-alone medical devices not associated with a combination product and not the importation of devices that are included in combination products. Although medical device components of combination products may be integrated directly with a drug or biologic (21 CFR 3.2(e)(1)) or co-packaged with a drug or biologic (21 CFR 3.2(e)(2)), the commenter stated, the proposed rule did not appear to discuss the importation of medical device components of drug- or biologic-primary mode of action combination products regulated by CDER or CBER and approved for marketing under a new drug application or a biologics license application.

    (Response 19) In light of this comment and based on further FDA review, FDA is not finalizing proposed § 1.76(h). FDA believes that the other requirements in §§ 1.74, 1.76, and 1.78 of the final rule, regarding products subject to the various types of applications, including investigational use applications, will suffice for combination products. If warranted, FDA will provide additional information on submitting this information for imported combination products in future guidance or other published materials.

    f. Convenience kit. We proposed to require that a medical device that is a convenience kit or part of a convenience kit and is a re-import of a medical device manufactured in the United States or is an import of a medical device manufactured outside the United States be identified as such in ACE at the time of entry using the current Affirmation of Compliance Code “KIT.”

    (Comment 20) One commenter was not sure that this data element will aid FDA in making admissibility decisions.

    (Response 20) The purpose of the convenience kit data element is to facilitate our admissibility review of medical device products approved or cleared for marketing as a kit by FDA, and to identify convenience kits that include recalled or unapproved medical devices. As explained in the preamble to the proposed rule, convenience kits imported or offered for import have been found at times to contain recalled or unapproved medical devices.

    9. Radiation-Emitting Electronic Products

    We received no comments regarding this proposed provision, and we are finalizing it without change.

    10. Biological Products, HCT/Ps, and Related Drugs and Medical Devices

    HCT/P Registration Number and Affirmation of Compliance. Human cells, tissues, or cellular or tissue-based products are articles containing or consisting of human cells or tissues intended for implantation, transplantation, infusion or transfer into a human recipient (§ 1271.3(d)). For HCT/Ps manufactured by establishments required to register under part 1271 and regulated solely under section 361 of the PHS Act and the regulations in part 1271, we proposed to require the submission of that registration number in ACE at the time of entry. The current Affirmation of Compliance Code for the HCT/P Registration Number is “HRN”.

    We also proposed to require for HCT/Ps regulated solely under section 361 of the PHS Act and the regulations in part 1271 being imported or offered for import that are not otherwise exempt, that an Affirmation of Compliance with all applicable requirements of part 1271 be submitted in ACE at the time of entry. The current Affirmation of Compliance Code for HCT/Ps to affirm compliance with part 1271 is “HCT”.

    (Comment 21) One comment agreed with most of the proposed requirements specific to biological products, HCT/Ps, and related drugs and medical devices, because the data clearly impacts admissibility. However, the comment questioned the need for the submission of HCT/P registration number and Affirmation of Compliance, and expressed a belief that this information is not applicable to admissibility.

    (Response 21) We acknowledge and appreciate the supportive comments. We disagree that the HCT/P registration number and Affirmation of Compliance are not applicable to our admissibility review. As noted in the proposed rule, establishments that manufacture HCT/Ps are required to register and list their HCT/Ps in accordance with part 1271, subpart B, unless they are subject to an exception under 21 CFR 1271.15. When an establishment successfully completes the required registration process, CBER assigns a unique registration number to that firm. FDA established these registration requirements, as well as other requirements in part 1271 (e.g., donor eligibility and current good tissue practice requirements) to prevent the introduction, transmission, or spread of communicable diseases by HCT/Ps. Requiring submission of the HCT/P registration number and Affirmation of Compliance helps to ensure compliance with the part 1271 requirements and is necessary to prevent the introduction, transmission, or spread of communicable diseases by HCT/Ps. Accordingly, we have finalized these requirements as proposed.

    11. Tobacco Products

    a. Brand name. We proposed to require that the brand name for a tobacco product be submitted in ACE at the time of entry.

    (Comment 22) Several comments expressed concern that not all tobacco products have brand names.

    (Response 22) FDA recognizes that not all tobacco products have specific brand names. One key example is tobacco products for further manufacturing; another example is rolling papers that may not have a specific brand name, and only bear the manufacturer name. Thus, the final rule allows the ACE filer to submit the commercial name for the brand name in ACE if the product is unbranded. Further, in the final rule, this data element does not apply to products solely intended for further manufacturing or to investigational tobacco products.

    We note that, for purposes of this rule, brand name includes brand and sub-brand, for example: “Acme Silver Box 100s,” or “Acme Little Cigars.”

    b. Name and address of the ACE filer. We proposed to require that the name and address of the ACE filer for import entries that include a tobacco product be submitted in ACE at the time of entry. We invited comments on the advantages, disadvantages, and feasibility of requiring an ACE filer to submit this information in ACE at the time of entry. In particular, we invited comment on whether the submission by an ACE filer of the name and address of the ACE filer for import entries that include a tobacco product would help us achieve our goals of facilitating admissibility review and focusing our resources on those products that may be associated with a serious public health risk to consumers and whether this could be sufficiently accomplished through proposed § 1.72(b) or other means.

    We received a number of comments in opposition to this provision and after consideration of those comments we have decided not to finalize this provision.

    12. Cosmetics

    We received no comment regarding proposed § 1.80, other than the comments regarding § 1.72 which are addressed previously in this document. Under proposed § 1.80, we proposed to require that an ACE filer must submit the data specified in § 1.72 at the time of filing entry in ACE. We are finalizing this provision without change.

    13. Technical Amendments in the Proposed Rule

    a. Revisions to §§ 1.83 and 1005.2. We proposed to revise §§ 1.83 and 1005.2 to update the legal references in those sections in order to bring the definition of “owner and consignee” in section 801 of the FD&C Act back in line with the customs terminology and to make clear that “owner or consignee” continues to mean the person authorized to make entry, now designated under customs law as the “importer of record.”

    (Comment 23) Several comments stated that redefining “owner or consignee” in § 1.83 as “the person eligible to make entry” under the relevant provisions of the Tariff Act of 1930 was confusing because several persons are in fact eligible to become the “importer of record” and therefore to make entry. The commenters suggested that FDA define “owner or consignee” as the “person who makes entry.”

    (Response 23) We agree and have revised the final rule to provide that the “owner or consignee” is defined as the “person who makes entry” under section 484 of the Tariff Act of 1930 (19 U.S.C. 1484). We removed the reference to section 485 of the Tariff Act of 1930 and 19 U.S.C. 1485 as that section relates to the filing of a declaration by the importer of record. We made the same change to § 1005.2.

    (Comment 24) One commenter suggested that we should adopt a definition of “owner or consignee” that is more consistent with the definition of “importer” adopted by FDA in other areas, for example, in our proposed rule on Foreign Supplier Verification Programs (FSVP).

    (Response 24) We decline to revise the rule as suggested in this comment. FDA adopted a definition of “importer” (§ 1.500) in our final FSVP rule published on November 27, 2015, that best serves the specific purposes of the FSVP requirements for importers of food for humans and animals, consistent with the statutory provisions the FSVP regulation must implement (80 FR 74226 at 74239). The purpose of the technical amendments to 21 CFR 1.83 and 1005.2 is to update the definition of “owner or consignee” to take into account revisions to the provisions of the Tariff Act of 1930 that were referenced in those regulations. Since the relevant person for these purposes is the “importer of record,” FDA is defining “owner or consignee” as the “importer of record” as that term is used in the Tariff Act of 1930.

    b. Electronic notification in §§ 1.90 and 1.94. We proposed to revise § 1.90 to allow FDA to provide notice of sampling directly rather than through the “collector of customs” which will normally happen through a secure electronic system. We also proposed to revise § 1.94 to clarify that FDA can provide either written or electronic notification to an owner or consignee when FDA has determined that an article being imported or offered for import may be subject to refusal of admission and/or administrative destruction.

    (Comment 25) One commenter requested clarification regarding whether electronic notification will completely replace written or facsimile communication for these purposes.

    (Response 25) While our intent is to move to an automated, electronic process to expedite the notification process for both the Agency and the trade, FDA will still consider providing a written or facsimile notification if, under the circumstances, that is the most efficient and effective means to provide any such notification.

    (Comment 26) Several commenters supported FDA providing electronic notification of FDA actions but also requested that, in addition to providing notification to the owner or consignee, FDA provide electronic notification to other parties to the import.

    (Response 26) We decline to require that the Agency provide electronic notification under § 1.94 to a person other than the owner or consignee which, pursuant to the revision to § 1.83 in the final rule, is the importer of record. The purpose of § 1.94 is to provide the importer of record of an FDA-regulated article being imported or offered for import into the United States with notice and opportunity to present testimony to the Agency prior to refusal of admission of an FDA-regulated article or prior to administrative destruction of certain refused drugs. There is only one importer of record and only that person has the right to notification and a hearing under § 1.94.

    14. Effective Date

    FDA proposed that the effective date of the final rule would be 30 days after its publication in the Federal Register.

    (Comment 27) FDA received comments expressing concern about an effective date of 30 days after publication of the final rule, stating that this does not provide enough time for the necessary programming integration between ACE, FDA's OASIS system, the ACE filers' and the importers' systems. One comment suggested that the trade industry will resort to manual data entry while the data feeds are being developed. The comments suggested effective dates that ranged from 60 days to 180 days after publication of the final rule. One comment suggested that FDA adopt a gradual and incremental approach to requiring submission of the data elements in the final rule.

    (Response 27) We decline to change the effective date of the final rule. As of July 23, 2016, ACE became the sole CBP-authorized EDI system for electronic entry and entry summary filings for importation of FDA-regulated products. The trade community has already transitioned to ACE and software is available in the marketplace that conforms with the requirements in FDA's Supplemental Guide to the CATAIR. FDA acknowledges that software vendors and the trade community may need to make a small number of alterations to their current programming to be consistent with the requirements in the final rule but 30 days should be sufficient for that purpose. FDA will shortly issue an updated FDA Supplemental Guide to assist software vendors and the trade industry with their programming needs.

    15. Summary of Benefits and Costs

    (Comment 28) Several commenters emphasized that each additional data element that will be mandated by this FDA rulemaking represents real cost added to the entry process.

    (Response 28) We understand that each additional data element that firms will be required to submit in ACE at the time of entry represents added cost to the entry process. FDA has removed some of data elements from the final rule, which should lessen the burden.

    While FDA is requiring ACE filers to submit more data upfront, we believe that this may not necessarily end up being burdensome to the industry over time. The Agency believes that, after the initial adjustment stage, submission of the required data will result in faster processing time and cost savings to the industry and FDA.

    (Comment 29) Some commenters opined that FDA underestimated transition costs.

    (Response 29) In the Preliminary Regulatory Impact Analysis (PRIA) we recognized the uncertainty surrounding our cost estimates for scenario 1, including transition cost estimates in the first year. We requested comments to provide additional data and information to improve these cost estimates. We did not receive any additional information that would help improve our transition cost estimates.

    (Comment 30) Several commenters complained that the PGA message set in ACE often experiences system outages, failures to perform necessary functions, and that the time that FDA takes to process entries has already doubled for some ACE filers. They assert that this causes “down time” and significant added costs to the trade industry.

    (Response 30) System outages and failures to perform necessary functions should be in part attributed to ACE implementation by CBP. In order to address these comments and also Comment 27 about alleging underestimated transition costs, we have revised our ranges for first year estimates and doubled the time necessary for filing entries in ACE for FDA-regulated products during the initial adjustment period.

    (Comment 31) Some commenters said that FDA dismissed additional costs of reprogramming caused by further changes to the CATAIR.

    (Response 31) In the PRIA (page 22), we stated that because the costs of updating the existing software or purchasing a new one would fall under the cost of CBP action of implementing ACE, we do not include these transition costs in our economic impact analysis. FDA expects that software updates occur regularly as a part of ongoing business practice and the price of new off-the-shelf software would incorporate all ACE requirements, including FDA PGA message set requirements. The commenters did not provide any new information that can be used to estimate the share of reprogramming costs that should be attributed only to FDA rulemaking and not the entire CBP action of implementing ACE.

    (Comment 32) One commenter stated that only importers with large budgets can generate, maintain, and provide data electronically.

    (Response 32) FDA acknowledges this viewpoint, but because most importers including small businesses typically hire customs brokers to electronically file entries for them in ACE, FDA expects that reprogramming costs would fall on customs brokers as a part of costs of doing business related to imports. As stated previously, approximately 98 percent of importers use customs brokers to file their entries of FDA-regulated products impacted by the final rule.

    (Comment 33) Some commenters stated that the cost to file FDA entries in ACE increased by 8 minutes (by over 50 percent) and that 40 percent more staffing is required because, compared to ACS, FDA data requirements are different in ACE.

    (Response 33) We incorporated this new information from the industry into our ranges of cost and time estimates for the final rule. That being said, the 50 percent time increase to process an FDA entry in ACE and the estimated 40 percent labor cost increase asserted by commenters could be caused by: (1) The overall switch from ACS to ACE (which should be attributed to the cost of ACE implementation by CBP) and (2) the additional time required for filing FDA data elements that are required in the final rule (which should be attributed to the cost of the FDA rulemaking; that is unless a filer already voluntarily provided these data elements to FDA in ACS on a regular basis). Only the costs caused by (2) should be attributed to FDA rulemaking (see scenario 1 in the PRIA).

    Furthermore, it is not clear from the comment whether the 50 percent time increase and the 40 percent staffing cost increase are the same across the entire industry. In the PRIA, FDA estimated that for each FDA-regulated unique product-manufacturer import line, it would take up to 8 additional minutes to prepare and look up information mandated by the proposed rule and up to 4 additional minutes (5 minutes in the first year) to file that information in ACE, for a total of up to 12 minutes per unique import line (up to 13 minutes in the first year). Therefore, an 8 minute increase (= 24 minutes minus 16 minutes) per import line described by these comments is a possible outcome, especially in the initial adjustment stage, that is consistent with our analysis in the PRIA.

    D. Technical Amendments in the Final Rule

    We made three technical changes to the proposed rule due to our issuance of a final rule on August 31, 2016, regarding the requirements for drug registration and listing (81 FR 60170) that was published after our Notice of Proposed Rulemaking for this rule (published on July 1, 2016 (81 FR 43155)).

    Under §§ 1.74(a), 1.75(a) and 1.78(d) of our proposed rule, an ACE filer would be required to submit the Drug Registration Number and Drug Listing Number in ACE at the time of entry for an article which is a drug if it is from a foreign establishment where the drug was manufactured, prepared, propagated, compounded, or processed before being imported or offered for import into the United States that is required to be registered and the drug to be listed under section 510 of the FD&C Act. The final drug registration and listing rule amended 21 CFR parts 207 and 607 which provide the regulatory requirements for drug registration and listing including who must register their establishments and list their drugs annually with the FDA.

    In this final rule, we have not changed the requirement that ACE filers submit a Drug Registration Number and a Drug Listing Number in ACE at the time of entry except that, as discussed earlier in this document, we have removed the requirement for submission of a drug listing number from § 1.78(d) for CBER-regulated drugs. For purposes of clarity regarding the underlying requirement of who must register and list their drugs with FDA, we have added a reference to part 207 in § 1.74(a) for human drugs, § 1.75(a) for animal drugs, and § 1.78(d) for those drugs regulated by CBER. Because the drugs regulated by CBER include blood and blood products we have also added a reference in § 1.78(d) to part 607, which contains the registration and listing requirements for blood and blood products.

    VI. Economic Analysis of Impacts A. Introduction

    We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.

    The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. By requiring import entry filers to submit data elements mandated by this final rule into ACE and updating certain sections of 21 CFR Chapter I, we intend to streamline our import entry admissibility review and reduce ambiguity about the import process. Small businesses will be affected by this final rule in the same way as non-small businesses. Because the burden of switching from ACS to ACE is already covered by CBP's ACE regulation, for those small business filers that choose to continue filing electronically (and, therefore, must use ACE), we believe that providing several additional data elements to FDA via ACE in exchange for a more streamlined process and potentially receiving an import admissibility decision faster would not cause a significant impact. These small businesses would bear the costs of this rule, but would also enjoy most of the benefits. We therefore certify that the final rule will not have a significant economic impact on a substantial number of small entities.

    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.

    B. Summary of Benefits and Costs of the Final Rule

    FDA is issuing a final rule to establish requirements for the electronic filing of import entries in ACE. The final rule will require that certain data elements material to our admissibility review be submitted to the FDA via ACE as part of an electronic import entry. This final regulation will help streamline FDA's existing admissibility procedures for FDA-regulated commodities imported or offered for import into the United States. For import entries submitted electronically, FDA will require that certain key data be submitted as a part of the import entry filing in ACE. The final regulation also provides further clarifications to the import process by revising sections of 21 CFR Chapter I relating to the definition of owner or consignee; the notice of sampling; and notices of FDA actions related to FDA-regulated products being imported or offered for import into the United States, such as notices of hearing on refusal of admission or administrative destruction, to allow for electronic notification by FDA. The rule also clarifies that importers of record of human cells, tissues, or cellular or tissue-based products (HCT/Ps) that are regulated solely under section 361 of the PHS Act and part 1271, unless exempted, will be required to submit the applicable data elements included in the final rule in ACE at the time of entry.

    The estimated costs of the final rule—and the cost savings—stem from the mandatory information that will be submitted and collected under the ACE system. In the baseline scenario for our estimates of these costs, we assumed that without this final regulation the information would be collected by ACE only if and to the extent that it is voluntarily provided by filers like under the former ACS system (table 2). Annualized over a 20-year horizon, the costs of complying with this final regulation are between $27.7 million and $69.1 million per year with a 3 percent discount rate; these costs are between $26.8 million and $66.7 million per year with a 7 percent discount rate (table 2). The total annualized cost savings to the entire society cannot be fully quantified because of the lack of certain data currently available to the Agency. Partially quantifiable cost savings are estimated to range from $2.6 million to $43.4 million with a 3 percent discount rate; these partially quantifiable benefits are estimated to range from $2.6 million to $43.4 million with a 7 percent discount rate (table 2). These benefits, in terms of cost savings, to both FDA and the industry that we are able to quantify will arise from FDA simplifying the notification process on certain FDA actions taken by the Agency under section 801 of the FD&C Act by allowing electronic notification of the owner or consignee.

    Cost savings to both the industry and FDA that we are unable to quantify will potentially arise from the reduced time of import entry processing and fewer imported products being held, and a shorter timeframe between the time of entry submission and a final admissibility decision by FDA as a result of increased efficiency in FDA's imports admissibility process. Other potential benefits of this final rule that we are unable to quantify will result from compliant FDA-regulated imports reaching U.S. consumers faster and a reduction in the number of non-compliant imports reaching U.S. consumers, thereby making the overall supply of FDA-regulated products on the U.S. market safer. Other potential benefits in the form of cost savings that we are similarly unable to quantify will arise because by revising certain sections of 21 CFR Chapter I the Agency would provide more clarity to the industry about certain aspects of the overall process of import admissibility for FDA-regulated products.

    Table 2—Total Annualized Costs and Benefits of the Final Rule 1 Discount rate
  • (percent)
  • Total annualized costs Total benefits Cost savings Other benefits
  • (not quantified)
  • 3 $46.7 million (range $27.7 million to $69.1 million) $21.0 million (range $2.6 to $43.4 million) Potential time reduction for processing import entry declarations by FDA; potential increase in predictability of the import process; potentially shorter timeframes for imported products being held pending a final admissibility decision; more efficient use of FDA's internal resources; potentially fewer recalls of imported products; reduction of counterfeit and misbranded imports on the U.S. market; increased efficiency of the overall import process due to decreased ambiguity because of a better defined the owner or consignee term, the clarifications related to notice of sampling, and allowing for electronic notice of certain FDA actions related to hearing on refusal of admission of imports and destruction of drugs. 7 $45.1 million (range $26.8 million to $66.7 million) $21.0 million (range $2.6 million to $43.4 million) Potential time reduction for processing import entry declarations by FDA; potential increase in predictability of the import process; potentially shorter timeframes for imported products being held pending a final admissibility decision; more efficient use of FDA's internal resources; potentially fewer recalls of imported products; reduction of counterfeit and misbranded imports on the U.S. market; increased efficiency of the overall import process due to decreased ambiguity because of a better defined the owner or consignee term, the clarifications related to notice of sampling, and allowing for electronic notice of certain FDA actions related to hearing on refusal of admission of imports and destruction of drugs. 1 We generated upper and lower bounds using Monte Carlo simulations.

    The Economic Analysis of Impacts of the final rule performed in accordance with Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of 1995 is available to the public in the docket for this final rule (Docket No. FDA-2016-N-1487) at https://www.regulations.gov and is also available on FDA's Web site at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 1).

    VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    VIII. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering the data needed, and completing and reviewing each collection of information.

    Title: Importer's Entry Notice.

    Description: We are issuing a regulation that requires ACE filers to submit certain information in ACE or any other CBP-authorized EDI system related to FDA-regulated products they are importing or offering for import into the United States. The information collection provisions of the rule, specifically the amendment of 21 CFR part 1 by adding §§ 1.70 through 1.81, will allow us to require ACE filers to submit in ACE at the time of entry important and useful information about FDA-regulated products being imported or offered for import into the United States, beyond the information that was submitted previously. The information collection provisions of this rule will facilitate an effective and efficient admissibility review of FDA-regulated products being imported or offered for import into the United States, and protect public health by allowing us to focus our limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.

    The authority to issue this regulation and to conduct the associated information collection is found in sections 801, 701, and 536 of the FD&C Act, sections 351, 361, and 368 of the PHS Act, and section 713 of FDASIA (which added section 801(r) to the FD&C Act).

    To account for the information collection provisions of the rule, we are amending the information collection currently approved under OMB control number 0910-0046. The information collection approved under OMB control number 0910-0046 has historically accounted for the collection of information from entry filers for FDA-regulated products being imported or offered for import into the United States. The vast majority of this information was submitted by entry filers electronically in ACS. On July 23, 2016, ACE replaced ACS as the sole EDI system authorized by CBP for submission of electronic entry and entry summary information for FDA-regulated products being imported, or offered for import, into the United States. Although much of the information collection pursuant to this rule was previously collected from entry filers for FDA-regulated products being imported or offered for import into the United States, and was approved for collection under OMB control number 0910-0046, this rule requires ACE filers to submit certain information in addition to what entry filers were previously submitting.

    The annual recordkeeping requirements for this collection are accounted for by the “Customs Modernization Act Recordkeeping Requirements” information collection approved by OMB under OMB control number 1651-0076.

    Of note, in addition to accounting for the information collection pursuant to the rule, we are also adjusting the existing estimated burden approved under OMB control number 0910-0046 upwards to account for an increase in FDA-regulated import lines, to account for the submission of intended use information, which had previously been submitted by entry filers but not accounted for under an approved FDA information collection, and to correct for our previous underestimates of the number of FDA-regulated entries. Accordingly, we are adjusting upward the estimated existing burden under OMB control number 0910-0046 (without yet accounting for the information collection of the rule) to 1,186,464 hours.

    The information collection provisions of this rule are in §§ 1.72, 1.73, 1.74, 1.75, 1.76, 1.77, 1.78, 1.79, and 1.80. Section 1.72 requires certain product identifying data elements and certain entity identifying data elements to be submitted in ACE at the time of entry for food contact substances, drugs, biological products, HCT/Ps, medical devices, radiation-emitting electronic products, cosmetics, and tobacco products. Sections 1.73 through 1.80 require certain data elements to be submitted in ACE depending on the type of FDA-regulated article being imported or offered for import into the United States. Sections 1.73, 1.74, 1.75, 1.76, 1.77, 1.78, 1.79, and 1.80 apply, respectively, to certain food products (food contact substances, low-acid canned food, and acidified food); human drugs; animal drugs; medical devices; radiation-emitting electronic products; biological products, HCT/Ps, and related drugs and medical devices regulated by CBER; tobacco products; and cosmetics.

    Although we did not receive any comments specifically relating to the information collection burden pursuant to the information collection provisions of the rule, we did receive comments relating to the rule and the Regulatory Impact Analysis (RIA). We have revised our information collection burden estimates as appropriate to reflect those revisions we made to the rule and the RIA.

    Description of Respondents: The primary respondents to this collection of information are domestic and foreign importers of FDA-regulated articles being imported or offered for import into the United States and ACE filers. An importer of record may be the owner or purchaser of the article being imported or offered for import, or a customs broker licensed by CBP under 19 U.S.C. 1641 who has been designated by the owner, purchaser, or consignee to file the import entry. There is only one importer of record per entry.

    Using the estimates in the RIA for the rule, we estimate there are about 41,703 owners or purchasers of FDA-regulated commodities who seek to import FDA-regulated articles (“importers”) into the United States on an annual basis. We have estimated that 97.7 percent of these importers will use customs brokers to file their import entries in ACE, and the other 2.3 percent will file their import entries themselves. We thereby estimate that there are a total of 3,667 entry filers, which includes the 959 owners or purchasers of the article who will file their own import entry in ACE (= 41,703 importers × (100 − 97.7) percent).

    Reporting Burden: We have used the relevant assumptions and estimates in Option 1 of the RIA for this rule to estimate the annual information collection burden pursuant to the rule. Option 1 of the RIA is the option which reflects the rule.

    Of the data elements that the rule requires ACE filers to submit in ACE at the time of entry, all except for four, were previously collected from entry filers (as either required or optional submissions, depending on the data element) and have been accounted for by the previously approved information collection under OMB control number 0910-0046. One of those four data elements, intended use information, had been collected from entry filers but not accounted for under an OMB approved information collection. Under the rule, intended use information is collected in ACE in the form of an IUC, instead of in the form of a text input into the CBP-required product description field, as it had been collected previously in ACS. The rule provides for the collection of three data elements to be collected in ACE that are new, i.e., we have not previously collected the information from entry filers. One of the three new data elements is required by § 1.72 which applies to food contact substances, drugs, biological products, HCT/Ps, medical devices, radiation-emitting electronic products, cosmetics, and tobacco products, and is the telephone and email address for the importer of record, which will help to facilitate electronic notices provided by FDA under § 1.94 for certain FDA actions. One of the other two new data elements is required by § 1.78, which applies only to biological products, HCT/Ps, and related drugs and medical devices, and is the product name, and the other is required by § 1.79, which applies only to tobacco products, and is the brand name of the tobacco product.

    Although just three data elements collected pursuant to the rule are new, we expect that filers who were not submitting certain previously optional data elements in ACS that the rule now requires ACE filers to submit in ACE will begin submitting those data elements in order to comply with the rule. We expect this to be the primary cause of the increased reporting burden pursuant to the rule. Notably, however, the submission rates of many of these data elements in ACS were quite high, although their submission varied by commodity. For example, in 2015 approximately 98 percent of medical device lines were submitted in ACS with at least one Affirmation of Compliance. Based on 2014 and 2015 data, we estimate that medical device lines will make up approximately seventy percent of all import lines that will be impacted by the rule. On the other hand, for example, in 2015 only 24 percent of animal drug import lines were submitted in ACS with at least one Affirmation of Compliance, although, based on 2014 and 2015 data, we estimate that animal drugs will make up less than 0.5 percent of all import lines that will be affected by the rule.

    Using the estimates in the RIA for the rule, we have estimated that the rule will impact 23,119,465 import lines in the first year. The rule will not impact import lines of foods other than acidified foods, low-acid canned foods, and food contact substances. We have also estimated that 504,768 of affected import lines in the first year represent unique product-manufacturer combinations. We have estimated that the number of impacted import lines will grow at an average rate of about 3.3 percent per year. For the purposes of calculating the additional annual recurring reporting burden of the rule, we have annualized those 3.3 percent per year increases for 3 years.

    Other key assumptions in the RIA (Option 1) for the rule that affect our estimate of the additional annual reporting burden are:

    • Respondents (ACE filers) will have to become aware of the rule's requirements, which will include activities related to reading the rule, understanding the reporting requirements, consulting with specialists if necessary, determining how to best meet these requirements, and communicating these requirements to workers; and this is a one-time event that will require an average of 30 minutes.

    • Respondents (owners or purchasers) will require an administrative worker to locate, gather, and prepare the additional information required by this rule for each unique product-manufacturer import line; and this will require on average about 2.333 minutes (0.03889 hours) per line.

    • Respondents (ACE filers) will require an administrative worker to submit the applicable data elements required in the final rule and Respondents (ACE filers) may also require an owner or manager to check if the information is correct, or alternatively, the administrative worker to quality check their submission using software that is connected to ACE and this will require about 1.166667 minutes (approximately 0.01944 hours) per line on average.

    • It will take respondents about 25 percent more time in the first year for an administrative worker to complete each import line and quality check the information, because the respondent will have to adjust to the new system and data elements.

    We expect the annual recurring reporting burden for the information collection pursuant to this rule to be as follows:

    Table 3—Estimated Additional Annual Recurring Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average burden per response Total hours
    Preparing the required information (applies to unique lines only) 41,703 12.5 521,609 0.03889 (2.333 minutes) 20,285 Quality checks and data submission into ACE 3,667 6,515 23,890,800 0.01944 (1.1667 minutes) 464,543 Total 484,828 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    We expect the additional one-time (i.e., occurring only in the first year) reporting burden for the information collection that will result from this rule to be as follows:

    Table 4—Estimated One Time Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average burden per response Total hours
    Review and familiarization with the rule 3,667 1 3,667 0.5 (30 minutes) 1,834 First year adjusting to new requirements that will result in an average of 25 percent more time for quality checks and submission into ACE 3,667 6,305 23,119,465 0.00486 (0.29 minutes) 112,386 Total 114,220 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Accordingly, we estimate that the additional annual reporting burden under the rule will be 599,048 hours in the first year (484,828 recurring hours + 114,220 one-time hours) and 484,828 hours recurring after the first year.

    Pursuant to our revision of the information collection under OMB control number 0910-0046, which includes adjustment of the existing burden and amendment to account for the information collection provisions of the rule, the total reporting burden is 1,785,712 hours in the first year (= 1,186,464 adjusted existing burden hours + 484,828 recurring hours pursuant to the rule + 114,220 one-time hours pursuant to the rule) and 1,671,292 hours annually after the first year (= 1,186,464 adjusted existing burden hours + 484,828 recurring hours pursuant to the rule).

    The information collection provisions in this final rule have been submitted to OMB for review as required by section 3507(d) of the Paperwork Reduction Act of 1995. FDA will publish a subsequent notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    IX. Federalism

    We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

    X. Reference

    The following reference is on display in the Division of Dockets Management (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    1. Final Regulatory Impact Analysis, Final Regulatory Flexibility Analysis, and Final Unfunded Mandates Reform Act Analysis for Submission of Food and Drug Administration Import Data in the Automated Commercial Environment, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm# List of Subjects 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, Reporting and recordkeeping requirements.

    21 CFR Part 1005

    Administrative practice and procedure, Electronic products, Imports, Radiation protection, Surety bonds.

    21 CFR Part 1271

    Biologics, Drugs, Human cells and tissue-based products, Medical devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 1, 1005, and 1271 are amended as follows:

    PART 1—GENERAL ENFORCEMENT REGULATIONS 1. The authority citation for part 1 is revised to read as follows: Authority:

    15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350e, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 373, 374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Public Law 107-188, 116 Stat. 594, 668-69; Public Law 111-353, 124 Stat. 3885, 3889.

    2. Add subpart D, consisting of §§ 1.70 through 1.81, to read as follows: Subpart D—Electronic Import Entries Sec. 1.70 Scope. 1.71 Definitions. 1.72 Data elements that must be submitted in ACE for articles regulated by FDA. 1.73 Food. 1.74 Human drugs. 1.75 Animal drugs. 1.76 Medical devices. 1.77 Radiation-emitting electronic products. 1.78 Biological products, HCT/Ps, and related drugs and medical devices. 1.79 Tobacco products. 1.80 Cosmetics. 1.81 Rejection of entry. Subpart D—Electronic Import Entries
    § 1.70 Scope.

    This subpart specifies the data elements that are required by the Food and Drug Administration (FDA) to be included in an electronic import entry submitted in the Automated Commercial Environment (ACE) system or any other U.S. Customs and Border Protection (CBP)-authorized electronic data interchange (EDI) system, which contains an article that is being imported or offered for import into the United States and that is regulated by FDA.

    § 1.71 Definitions.

    For purposes of subpart D:

    ACE filer means the person who is authorized to submit an electronic import entry for an FDA-regulated product in the Automated Commercial Environment or any other CBP-authorized EDI system.

    Acidified food means acidified food, as defined in § 114.3(b) of this chapter, and subject to the requirements in parts 108 and 114 of this chapter.

    Automated Commercial Environment or ACE means the automated and electronic system for processing commercial importations that is operated by U.S. Customs and Border Protection in accordance with the National Customs Automation Program established in Subtitle B of Title VI—Customs Modernization, in the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057, 2170, December 8, 1993) (Customs Modernization Act), or any other CBP-authorized EDI system.

    Biological product means a biological product as defined in section 351(i)(1) of the Public Health Service Act.

    Cosmetic means a cosmetic as defined in section 201(i) of the Federal Food, Drug, and Cosmetic Act.

    CBP or U.S. Customs and Border Protection means the Federal Agency that is primarily responsible for maintaining the integrity of the borders and ports of entry of the United States.

    Drug means those articles meeting the definition of a drug in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act.

    FDA or Agency means the U.S. Food and Drug Administration.

    Food means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act.

    Food contact substance means any substance, as defined in section 409(h)(6) of the Federal Food, Drug, and Cosmetic Act, that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.

    HCT/Ps means human cells, tissues, or cellular or tissue-based products, as defined in § 1271.3(d) of this chapter.

    Low-acid canned food means a thermally processed low-acid food (as defined in § 113.3(n) of this chapter) in a hermetically sealed container (as defined in § 113.3(j) of this chapter), and subject to the requirements in parts 108 and 113 of this chapter.

    Medical device means a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, that is intended for use in humans.

    Radiation-emitting electronic product means an electronic product as defined in section 531 of the Federal Food, Drug, and Cosmetic Act.

    Tobacco product means a tobacco product as defined in section 201(rr) of the Federal Food, Drug, and Cosmetic Act.

    § 1.72 Data elements that must be submitted in ACE for articles regulated by FDA.

    General. When filing an entry in ACE, the ACE filer shall submit the following information for food contact substances, drugs, biological products, HCT/Ps, medical devices, radiation-emitting electronic products, cosmetics, and tobacco products.

    (a) Product identifying information for the article that is being imported or offered for import. This consists of:

    (1) FDA Country of Production, which is the country where the article was last manufactured, processed, or grown (including harvested, or collected and readied for shipment to the United States). The FDA Country of Production for an article that has undergone any manufacturing or processing is the country where that activity occurred provided that the manufacturing or processing had more than a minor, negligible, or insignificant effect on the article.

    (2) The Complete FDA Product Code, which must be consistent with the invoice description of the product.

    (3) The Full Intended Use Code.

    (b) Importer of record contact information, which is the telephone and email address of the importer of record.

    § 1.73 Food.

    (a) Food contact substances. An ACE filer must submit the information specified in § 1.72 at the time of filing entry in ACE for food that is a food contact substance.

    (b) Low-acid canned food. For an article of food that is a low-acid canned food, the ACE filer must submit at the time of filing entry the Food Canning Establishment Number and the Submission Identifier, and can dimensions or volume, except that the ACE filer does not need to submit this information in ACE at the time of entry if the article is being imported or offered for import for laboratory analysis only and will not be taste tested or otherwise ingested.

    (c) Acidified food. For an article of food that is an acidified food, the ACE filer must submit at the time of filing entry the Food Canning Establishment Number and the Submission Identifier, and can dimensions or volume, except that the ACE filer does not need to submit this information in ACE at the time of entry if the article is being imported or offered for import for laboratory analysis only and will not be taste tested or otherwise ingested.

    § 1.74 Human drugs.

    In addition to the data required to be submitted in § 1.72, an ACE filer must submit the following information at the time of filing entry in ACE for drugs, including biological products, intended for human use that are regulated by the FDA Center for Drug Evaluation and Research.

    (a) Registration and listing. For a drug intended for human use, the Drug Registration Number and the Drug Listing Number if the foreign establishment where the human drug was manufactured, prepared, propagated, compounded, or processed before being imported or offered for import into the United States is required to register and list the drug under part 207 of this chapter. For the purposes of this section, the Drug Registration Number that must be submitted at the time of entry in ACE is the unique facility identifier of the foreign establishment where the human drug was manufactured, prepared, propagated, compounded, or processed before being imported or offered for import into the United States. The unique facility identifier is the identifier submitted by a registrant in accordance with the system specified under section 510(b) of the Federal Food, Drug, and Cosmetic Act. For the purposes of this section, the Drug Listing Number is the National Drug Code number of the human drug article being imported or offered for import.

    (b) Drug application number. For a drug intended for human use that is the subject of an approved application under section 505(b) or 505(j) of the Federal Food, Drug, and Cosmetic Act, the number of the new drug application or abbreviated new drug application. For a biological product regulated by the FDA Center for Drug Evaluation and Research that is required to have an approved new drug application or an approved biologics license application, the number of the applicable application.

    (c) Investigational new drug application number. For a drug intended for human use that is the subject of an investigational new drug application under section 505(i) of the Federal Food, Drug, and Cosmetic Act, the number of the investigational new drug application.

    § 1.75 Animal drugs.

    In addition to the data required to be submitted in § 1.72, an ACE filer must submit the following information at the time of filing entry in ACE for animal drugs:

    (a) Registration and listing. For a drug intended for animal use, the Drug Registration Number and the Drug Listing Number if the foreign establishment where the drug was manufactured, prepared, propagated, compounded, or processed before being imported or offered for import into the United States is required to register and list the drug under part 207 of this chapter. For the purposes of this section, the Drug Registration Number that must be submitted in ACE is the Unique Facility Identifier of the foreign establishment where the animal drug was manufactured, prepared, propagated, compounded, or processed before being imported or offered for import into the United States. The Unique Facility Identifier is the identifier submitted by a registrant in accordance with the system specified under section 510(b) of the Federal Food, Drug, and Cosmetic Act. For the purposes of this section, the Drug Listing Number is the National Drug Code number of the animal drug article being imported or offered for import.

    (b) New animal drug application number. For a drug intended for animal use that is the subject of an approved application under section 512 of the Federal Food, Drug, and Cosmetic Act, the number of the new animal drug application or abbreviated new animal drug application. For a drug intended for animal use that is the subject of a conditionally approved application under section 571 of the Federal Food, Drug, and Cosmetic Act, the application number for the conditionally approved new animal drug.

    (c) Veterinary minor species index file number. For a drug intended for use in animals that is the subject of an Index listing under section 572 of the Federal Food, Drug, and Cosmetic Act, the Minor Species Index File number of the new animal drug on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.

    (d) Investigational new animal drug number. For a drug intended for animal use that is the subject of an investigational new animal drug or generic investigational new animal drug application under part 511 of this chapter, the number of the investigational new animal drug or generic investigational new animal drug file.

    § 1.76 Medical devices.

    In addition to the data required to be submitted in § 1.72, an ACE filer must submit the following information at the time of filing entry in ACE for medical devices regulated by the FDA Center for Devices and Radiological Health.

    (a) Registration and listing. For a medical device, the Registration Number for Foreign Manufacturers, Foreign Exporters, and/or Domestic Manufacturers, and the Device Listing Number, required under section 510 of the Federal Food, Drug, and Cosmetic Act and part 807 of this chapter.

    (b) Investigational devices. For an investigational medical device that has an investigational device exemption granted under section 520(g) of the Federal Food, Drug, and Cosmetic Act, the Investigational Device Exemption Number. For an investigational medical device being imported or offered for import for use in a nonsignificant risk or exempt study, “NSR” to be entered in the Affirmation of Compliance for the “investigational device exemption” that identifies the device as being used in a nonsignificant risk or exempt study.

    (c) Premarket number. For a medical device that has one, the Premarket Number. This is the Premarket Approval Number for those medical devices that have received premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act; the Product Development Protocol Number for those medical devices for which FDA has declared the product development protocol complete under section 515(f) of the Federal Food, Drug, and Cosmetic Act; the De Novo number for those medical devices granted marketing authorization under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act; the Premarket Notification Number for those medical devices that received premarket clearance under section 510(k) of the Federal Food, Drug, and Cosmetic Act; or the Humanitarian Device Exemption Number for those medical devices for which an exemption has been granted under section 520(m) of the Federal Food, Drug, and Cosmetic Act.

    (d) Component. If applicable for a medical device, an affirmation identifying that the article being imported or offered for import is a component that requires further processing or inclusion into a finished medical device.

    (e) Lead wire/patient cable. For electrode lead wires and patient cables intended for use with a medical device, an Affirmation of Compliance with the applicable performance standard under § 898.12 of this chapter.

    (f) Impact resistant lens. For impact resistant lenses in eyeglasses and sunglasses, an Affirmation of Compliance with the applicable requirements of § 801.410 of this chapter.

    (g) Convenience kit. If applicable for a medical device, an Affirmation of Compliance that the article imported or offered for import is a convenience kit or part of a convenience kit.

    § 1.77 Radiation-emitting electronic products.

    In addition to the data required to be submitted in § 1.72, an ACE filer must submit all of the declarations required in Form FDA 2877 electronically in ACE at the time of filing entry for products subject to the standards under parts 1020-1050 of this chapter.

    § 1.78 Biological products, HCT/Ps, and related drugs and medical devices.

    In addition to the data required to be submitted in § 1.72, an ACE filer must submit the following information at the time of filing entry in ACE for biological products, HCT/Ps, and related drugs and medical devices regulated by the FDA Center for Biologics Evaluation and Research.

    (a) Product name which identifies the article being imported or offered for import by the name commonly associated with that article including the established name, trade name, brand name, proper name, or product description if the article does not have an established name, trade name, brand name, or proper name.

    (b) HCT/P registration and affirmation. (1) For an HCT/P regulated solely under section 361 of the Public Health Service Act and the regulations in part 1271 of this chapter that is manufactured by an establishment that is required to be registered under part 1271 of this chapter, the HCT/P Registration Number; and

    (2) For an HCT/P regulated solely under section 361 of the Public Health Service Act and the regulations in part 1271 of this chapter, an Affirmation of Compliance with the applicable requirements of part 1271 of this chapter.

    (c) Licensed biological products. For a biological product that is the subject of an approved biologics license application under section 351 of the Public Health Service Act, the Submission Tracking Number of the biologics license application and/or the Biologics License Number.

    (d) Drug registration. For a drug intended for human use, the Drug Registration Number if the foreign establishment where the human drug was manufactured, prepared, propagated, compounded, or processed before being imported or offered for import into the United States is required to register the drug under part 207 or part 607 of this chapter as applicable. For the purposes of this section, the Drug Registration Number that must be submitted at the time of entry in ACE is the unique facility identifier of the foreign establishment where the human drug was manufactured, prepared, propagated, compounded, or processed before being imported or offered for import into the United States. The unique facility identifier is the identifier submitted by a registrant in accordance with the system specified under section 510(b) of the Federal Food, Drug, and Cosmetic Act.

    (e) Drug application number. For a drug intended for human use that is the subject of an approved application under section 505(b) or 505(j) of the Federal Food, Drug, and Cosmetic Act, the number of the new drug application or the abbreviated new drug application.

    (f) Investigational new drug application number. For a drug intended for human use that is the subject of an investigational new drug application under section 505(i) of the Federal Food, Drug, and Cosmetic Act, the number of the investigational new drug application.

    (g) Medical device registration and listing. For a medical device subject to the registration and listing procedures contained in part 807 of this chapter, the Registration Number for Foreign Manufacturers, Foreign Exporters, and/or Domestic Manufacturers, and the Device Listing Number, required under section 510 of the Federal Food, Drug, and Cosmetic Act and part 807 of this chapter.

    (h) Investigational devices. For an investigational medical device that has an investigational device exemption granted under section 520(g) of the Federal Food, Drug, and Cosmetic Act, the Investigational Device Exemption Number. For an investigational medical device being imported or offered for import for use in a nonsignificant risk or exempt study, “NSR” to be entered in the Affirmation of Compliance for the “investigational device exemption” that identifies the device as being used in a nonsignificant risk or exempt study.

    (i) Medical device premarket number. For a medical device that has one, the Premarket Number. This is the Premarket Approval Number for those medical devices that have received premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act; the Product Development Protocol Number for those medical devices for which FDA has declared the product development protocol complete under section 515(f) of the Federal Food, Drug, and Cosmetic Act; the De Novo number for those medical devices granted marketing authorization under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act; the Premarket Notification Number for those medical devices that received premarket clearance under section 510(k) of the Federal Food, Drug, and Cosmetic Act; or the Humanitarian Device Exemption Number for those medical devices for which an exemption has been granted under section 520(m) of the Federal Food, Drug, and Cosmetic Act.

    (j) Medical device component. If applicable for a medical device, an affirmation identifying that the article being imported or offered for import is a component that requires further processing or inclusion into a finished medical device.

    § 1.79 Tobacco products.

    In addition to the data required to be submitted in § 1.72, an ACE filer must submit the following information at the time of filing entry in ACE.

    (a) Brand name of an article that is a tobacco product that is being imported or offered for import. If the article does not have a specific brand name, the ACE filer must submit a commercial name for the brand name. This data element is not applicable to those products solely intended either for further manufacturing or as investigational tobacco products.

    (b) [Reserved]

    § 1.80 Cosmetics.

    An ACE filer must submit the data specified in § 1.72 at the time of filing entry in ACE.

    § 1.81 Rejection of entry filing.

    FDA may reject an entry filing for failure to provide complete and accurate information that is required pursuant to this subpart.

    3. In § 1.83, revise paragraph (a) to read as follows:
    § 1.83 Definitions.

    (a) The term owner or consignee means the person who makes entry under the provisions of section 484 of the Tariff Act of 1930, as amended (19 U.S.C. 1484), namely, the “importer of record.”

    4. Revise § 1.90 to read as follows:
    § 1.90 Notice of sampling.

    When a sample of an article offered for import has been requested by the district director, FDA shall provide to the owner or consignee prompt notice of delivery of, or intention to deliver, such sample. Upon receipt of the notice, the owner or consignee shall hold such article and not distribute it until further notice from the district director or U.S. Customs and Border Protection of the results of examination of the sample.

    5. In § 1.94, revise the first sentence of paragraphs (a) and (c) to read as follows:
    § 1.94 Hearing on refusal of admission or destruction.

    (a) If it appears that the article may be subject to refusal of admission, or that the article is a drug that may be subject to destruction under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the district director shall give the owner or consignee a written or electronic notice to that effect, stating the reasons therefor. * * *

    (c) If the article is a drug that may be subject to destruction under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the district director may give the owner or consignee a single written or electronic notice that provides the notice of refusal of admission and the notice of destruction of an article described in paragraph (a) of this section. * * *

    PART 1005—IMPORTATION OF ELECTRONIC PRODUCTS 6. The authority citation for part 1005 continues to read as follows: Authority:

    21 U.S.C. 360ii, 360mm.

    7. Revise § 1005.2 to read as follows:
    § 1005.2 Definitions.

    As used in this part:

    The term owner or consignee means the person who makes entry under the provisions of section 484 of the Tariff Act of 1930, as amended (19 U.S.C. 1484), namely, the “importer of record.”

    PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS 8. The authority citation for part 1271 continues to read as follows: Authority:

    42 U.S.C. 216, 243, 263a, 264, 271.

    9. In § 1271.420, revise paragraph (a) to read as follows:
    § 1271.420 HCT/Ps offered for import.

    (a) Except as provided in paragraphs (c) and (d) of this section, when an HCT/P is offered for import, the importer of record must notify, either before or at the time of importation, the director of the district of the Food and Drug Administration (FDA) having jurisdiction over the port of entry through which the HCT/P is imported or offered for import, or such officer of the district as the director may designate to act in his or her behalf in administering and enforcing this part, and must provide sufficient information, including information submitted in the Automated Commercial Environment (ACE) system or any other electronic data interchange system authorized by the U.S. Customs and Border Protection Agency as required in part 1, subpart D of this chapter, for FDA to make an admissibility decision.

    Dated: November 21, 2016. Leslie Kux, Associate Commissioner for Policy, Food and Drug Administration.

    In concurrence with FDA:

    Dated: November 21, 2016. Timothy E. Skud, Deputy Assistant Secretary (Tax, Trade, and Tariff Policy), Department of the Treasury.
    [FR Doc. 2016-28582 Filed 11-28-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2016-N-1896] New Animal Drugs for Use in Animal Feed; Category Definitions; Confirmation of Effective Date AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Direct final rule; confirmation of effective date.

    SUMMARY:

    The Food and Drug Administration (FDA) is confirming the effective date of December 1, 2016, for the final rule that appeared in the Federal Register of August 24, 2016. The direct final rule amends the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This document confirms the effective date of the direct final rule.

    DATES:

    Effective date of final rule published in the Federal Register of August 24, 2016 (81 FR 57796) confirmed: December 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    David Edwards, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6205.

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of August 24, 2016 (81 FR 57796), FDA solicited comments concerning the direct final rule for a 75-day period ending November 7, 2016. FDA stated that the effective date of the direct final rule would be on December 1, 2016, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments.

    Authority:

    Therefore, under the animal drug provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 354, 360b, 360ccc, 360ccc-1, and 371), and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 558 is amended. Accordingly, the amendments issued thereby are effective.

    Dated: November 22, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-28607 Filed 11-28-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-448] Schedules of Controlled Substances: Temporary Placement of Furanyl Fentanyl Into Schedule I AGENCY:

    Drug Enforcement Administration, Department of Justice.

    ACTION:

    Final order.

    SUMMARY:

    The Administrator of the Drug Enforcement Administration is issuing this final order to temporarily schedule the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide (furanyl fentanyl), and its isomers, esters, ethers, salts and salts of isomers, esters and ethers, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of furanyl fentanyl into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, furanyl fentanyl.

    DATES:

    This final order is effective on November 29, 2016.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION: Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.

    Under the CSA, every controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the drug or other substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of all scheduled substances is published at 21 CFR part 1308.

    Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance into schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if she finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).

    Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1). The Attorney General has delegated her scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

    Background

    Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of his intention to temporarily place a substance into schedule I of the CSA.1 The Administrator transmitted the notice of intent to place furanyl fentanyl into schedule I on a temporary basis to the Assistant Secretary by letter dated June 22, 2016. The Assistant Secretary responded to this notice by letter dated July 8, 2016, and advised that based on review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications or approved new drug applications for furanyl fentanyl. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of furanyl fentanyl into schedule I of the CSA. The DEA has taken into consideration the Assistant Secretary's comments as required by 21 U.S.C. 811(h)(4). Furanyl fentanyl is not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for furanyl fentanyl under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of furanyl fentanyl in schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent to temporarily schedule furanyl fentanyl was published in the Federal Register on September 27, 2016. 81 FR 66224.

    1 As discussed in a memorandum of understanding entered into by the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS in carrying out the Secretary's scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993.

    To find that placing a substance temporarily into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in section 201(c) of the CSA, 21 U.S.C. 811(c): The substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).

    A substance meeting the statutory requirements for temporary scheduling may only be placed into schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1). Available data and information for furanyl fentanyl, summarized below, indicate that this synthetic opioid has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. The DEA's updated three-factor analysis, and the Assistant Secretary's July 8, 2016, letter, are available in their entirety under the tab “Supporting Documents” of the public docket of this action at www.regulations.gov under FDMS Docket ID: DEA-2016-0018 (Docket Number DEA-448).

    Factor 4. History and Current Pattern of Abuse

    The recreational abuse of fentanyl-like substances continues to be a significant concern. These substances are distributed to users with often unpredictable outcomes. Furanyl fentanyl has recently been encountered by law enforcement and public health officials and the adverse health effects and outcomes are documented in the scientific literature. The documented negative effects of furanyl fentanyl are consistent with those of other opioids. On October 1, 2014, the DEA implemented STARLiMS (a Web-based, commercial laboratory information management system) to replace the System to Retrieve Information from Drug Evidence (STRIDE) as its laboratory drug evidence data system of record. DEA laboratory data submitted after September 30, 2014, are reposited in STARLiMS; data from STRIDE and STARLiMS were queried on November 2, 2016. STARLiMS registered 113 reports containing furanyl fentanyl, all reported in 2016, from Alabama, California, Connecticut, Delaware, Florida, Georgia, Illinois, Maryland, Mississippi, Missouri, Montana, New Jersey, New York, North Carolina, North Dakota, Rhode Island, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, and the District of Columbia.

    The National Forensic Laboratory Information System (NFLIS) is a national drug forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by participating Federal, State and local forensic laboratories across the country. According to NFLIS, the first report of furanyl fentanyl was recorded in December 2015 in Oregon. From December 2015 through September 2016, a total of 494 submissions to state and local forensic laboratories identifying furanyl fentanyl were reported in NFLIS as a result of law enforcement encounters in California, Connecticut, Florida, Iowa, Kentucky, Massachusetts, Minnesota, Missouri, New Jersey, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Virginia, and Wisconsin (query date: November 2, 2016). The DEA is not aware of any laboratory identifications of furanyl fentanyl prior to 2015.

    Evidence suggests that the pattern of abuse of fentanyl analogues, including furanyl fentanyl, parallels that of heroin and prescription opioid analgesics. Seizures of furanyl fentanyl have been encountered in powder form. Furanyl fentanyl has also been encountered in drug paraphernalia commonly associated with heroin or other opioid abuse including glassine bags, and as a residue on spoons and bottle caps. Furanyl fentanyl has been encountered as a single substance as well as in combination with other substances of abuse, including heroin, fentanyl, butyryl fentanyl, and U-47700. Furanyl fentanyl has been connected to fatal overdoses, in which intravenous routes of administration are documented.

    Factor 5. Scope, Duration and Significance of Abuse

    The scientific literature and reports collected by the DEA demonstrate furanyl fentanyl is being abused for its opioid properties. This abuse of furanyl fentanyl has resulted in morbidity and mortality (see updated DEA 3-Factor Analysis for full discussion). The DEA has received reports for at least 128 confirmed fatalities associated with furanyl fentanyl. The information on these deaths occurring in 2015 and 2016 was collected from email communications or toxicology and medical examiner reports received by the DEA. These deaths were reported from five states—Illinois (36), Maryland (41), New Jersey (1), North Carolina (49), and Ohio (1). The scientific literature notes additional fatal overdoses connected to furanyl fentanyl. STARLiMS and NFLIS have a total of 607 drug reports in which furanyl fentanyl was identified in drug exhibits submitted to forensic laboratories from December 2015 through September 2016 from law enforcement encounters. It is likely that the prevalence of furanyl fentanyl in opioid analgesic-related emergency room admissions and deaths is underreported as standard immunoassays may not differentiate this substance from fentanyl.

    The population likely to abuse furanyl fentanyl overlaps with the population abusing prescription opioid analgesics and heroin. This is evidenced by the routes of drug administration and drug use history documented in furanyl fentanyl fatal overdose cases. Because abusers of furanyl fentanyl are likely to obtain this substance through unregulated sources (i.e. on-line purchases or drug dealers), the identity, purity, and quantity are uncertain and inconsistent, thus posing significant adverse health risks to the end user. Individuals who initiate (i.e. use a drug for the first time) furanyl fentanyl abuse are likely to be at risk of developing substance use disorder, overdose, and death similar to that of other opioid analgesics (e.g., fentanyl, morphine, etc.).

    Factor 6. What, if Any, Risk There Is to the Public Health

    Furanyl fentanyl exhibits pharmacological profiles similar to that of fentanyl and other µ-opioid receptor agonists. The toxic effects of furanyl fentanyl in humans are demonstrated by overdose fatalities involving this substance. Abusers of furanyl fentanyl may not know the origin, identity, or purity of this substance, thus posing significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone.

    Based on reports in the scientific literature and information received by the DEA, the abuse of furanyl fentanyl leads to the same qualitative public health risks as heroin, fentanyl and other opioid analgesic substances. As with any non-medically approved opioid, the health and safety risks for users are great. The public health risks attendant to the abuse of heroin and opioid analgesics are well established and have resulted in large numbers of drug treatment admissions, emergency department visits, and fatal overdoses.

    Furanyl fentanyl has been associated with a number of fatalities and non-fatal overdoses as detailed in the scientific literature. The DEA has received information connecting furanyl fentanyl to at least 128 confirmed overdose deaths occurring in 2015 and 2016 in Illinois (36), Maryland (41), New Jersey (1), North Carolina (49), and Ohio (1).

    Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard to Public Safety

    In accordance with 21 U.S.C. 811(h)(3), based on the data and information summarized above, the continued uncontrolled manufacture, distribution, importation, exportation, and abuse of furanyl fentanyl pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for this substance in treatment in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed into schedule I. Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for furanyl fentanyl indicate that this substance has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a letter dated June 22, 2016, notified the Assistant Secretary of the DEA's intention to temporarily place this substance into schedule I.

    Conclusion

    In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, herein sets forth the grounds for his determination that it is necessary to temporarily schedule furanyl fentanyl into schedule I of the CSA, and finds that placement of this synthetic opioid into schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. Because the Administrator hereby finds it necessary to temporarily place this synthetic opioid into schedule I to avoid an imminent hazard to the public safety, this final order temporarily scheduling furanyl fentanyl will be effective on the date of publication in the Federal Register, and will be in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h) (1) and (2).

    The CSA sets forth specific criteria for scheduling a drug or other substance. Permanent scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures done “on the record after opportunity for a hearing” conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The permanent scheduling process of formal rulemaking affords interested parties with appropriate process and the government with any additional relevant information needed to make a determination. Final decisions that conclude the permanent scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6).

    Requirements for Handling

    Upon the effective date of this final order, furanyl fentanyl will become subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, engagement in research, and conduct of instructional activities or chemical analysis with, and possession of schedule I controlled substances including the following:

    1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, furanyl fentanyl must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312, as of November 29, 2016. Any person who currently handles furanyl fentanyl, and is not registered with the DEA, must submit an application for registration and may not continue to handle furanyl fentanyl as of November 29, 2016, unless the DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312. Retail sales of schedule I controlled substances to the general public are not allowed under the CSA. Possession of any quantity of this substance in a manner not authorized by the CSA on or after November 29, 2016 is unlawful and those in possession of any quantity of this substance may be subject to prosecution pursuant to the CSA.

    2. Disposal of stocks. Any person who does not desire or is not able to obtain a schedule I registration to handle furanyl fentanyl, must surrender all quantities of currently held furanyl fentanyl.

    3. Security. Furanyl fentanyl is subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of November 29, 2016.

    4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of furanyl fentanyl must be in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302. Current DEA registrants shall have 30 calendar days from November 29, 2016, to comply with all labeling and packaging requirements.

    5. Inventory. Every DEA registrant who possesses any quantity of furanyl fentanyl on the effective date of this order must take an inventory of all stocks of this substance on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all inventory requirements. After the initial inventory, every DEA registrant must take an inventory of all controlled substances (including furanyl fentanyl) on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

    6. Records. All DEA registrants must maintain records with respect to furanyl fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304, and 1312, 1317 and § 1307.11. Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all recordkeeping requirements.

    7. Reports. All DEA registrants who manufacture or distribute furanyl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304, and 1312 as of November 29, 2016.

    8. Order Forms. All DEA registrants who distribute furanyl fentanyl must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of November 29, 2016.

    9. Importation and Exportation. All importation and exportation of furanyl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of November 29, 2016.

    10. Quota. Only DEA registered manufacturers may manufacture furanyl fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of November 29, 2016.

    11. Liability. Any activity involving furanyl fentanyl not authorized by, or in violation of the CSA, occurring as of November 29, 2016, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

    Regulatory Matters

    Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. As provided in this subsection, the Attorney General may, by order, schedule a substance in schedule I on a temporary basis. Such an order may not be issued before the expiration of 30 days from (1) the publication of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and (2) the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary. 21 U.S.C. 811(h)(1).

    Inasmuch as section 201(h) of the CSA directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, the DEA believes that the notice and comment requirements of the Administrative Procedure Act (APA) at 5 U.S.C. 553, do not apply to this temporary scheduling action. In the alternative, even assuming that this action might be subject to 5 U.S.C. 553, the Administrator finds that there is good cause to forgo the notice and comment requirements of 5 U.S.C. 553, as any further delays in the process for issuance of temporary scheduling orders would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety.

    Further, the DEA believes that this temporary scheduling action is not a “rule” as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act. The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by the APA or any other law to publish a general notice of proposed rulemaking.

    Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget (OMB).

    This action will 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. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

    As noted above, this action is an order, not a rule. Accordingly, the Congressional Review Act (CRA) is inapplicable, as it applies only to rules. However, if this were a rule, pursuant to the Congressional Review Act, “any rule for which an agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the federal agency promulgating the rule determines.” 5 U.S.C. 808(2). It is in the public interest to schedule this substance immediately to avoid an imminent hazard to the public safety. This temporary scheduling action is taken pursuant to 21 U.S.C. 811(h), which is specifically designed to enable the DEA to act in an expeditious manner to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h) exempts the temporary scheduling order from standard notice and comment rulemaking procedures to ensure that the process moves swiftly. For the same reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to move quickly to place this substance into schedule I because it poses an imminent hazard to the public safety, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, this order shall take effect immediately upon its publication. The DEA has submitted a copy of this final order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808 because, as noted above, this action is an order, not a rule.

    List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.

    For the reasons set out above, the DEA amends 21 CFR Part 1308 as follows: PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES 1. The authority citation for part 1308 continues to read as follows: Authority:

    21 U.S.C. 811, 812, 871(b), unless otherwise noted.

    2. Amend § 1308.11 by adding paragraph (h)(19) to read as follows:
    § 1308.11 Schedule I.

    (h) * * *

    (19) N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: Furanyl fentanyl) (9834).

    Dated: November 22, 2016 Chuck Rosenberg, Acting Administrator.
    [FR Doc. 2016-28693 Filed 11-28-16; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE 28 CFR Part 90 [OVW Docket No. 120] RIN 1105-AB46 Conforming STOP Violence Against Women Formula Grant Program Regulations to Statutory Change; Definitions and Confidentiality Requirements Applicable to All OVW Grant Programs AGENCY:

    Office on Violence Against Women, Justice.

    ACTION:

    Final rule.

    SUMMARY:

    This rule amends the regulations for the STOP (Services•Training•Officers•Prosecutors) Violence Against Women Formula Grant Program (STOP Program) and the general provisions governing Office on Violence Against Women (OVW) programs to comply with statutory changes and reduce repetition of statutory language. Also, this rule implements statutory requirements for nondisclosure of confidential or private information relating to all OVW grant programs.

    DATES:

    This rule is effective December 29, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Marnie Shiels, Office on Violence Against Women, 145 N Street NE., Suite 10W.100, Washington, DC 20530, by telephone (202) 307-6026 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Executive Summary

    The Violence Against Women Act (VAWA) was enacted on September 13, 1994, by title IV of the Violent Crime Control and Law Enforcement Act of 1994, Public Law 103-322, 108 Stat. 1796. The STOP Program is codified at 42 U.S.C. 3796gg through 3796gg-5 and 3796gg-8. The final rule for this program, found at 28 CFR part 90, subpart B, was promulgated on April 18, 1995. General provisions affecting all OVW grant programs are found at 28 CFR part 90, subpart A.

    This rule amends the general provisions applicable to all OVW grant programs and the regulations governing the STOP Program to comply with the amendments to these programs enacted by the Violence Against Women Act of 2000 (VAWA 2000), Division B of the Victims of Trafficking and Violence Protection Act of 2000, Public Law 106-386, 114 Stat. 1464 (Oct. 28, 2000), the Violence Against Women and Department of Justice Reauthorization Act of 2005 (VAWA 2005), Public Law 109-162, 119 Stat. 2960 (Jan. 5, 2006), and the Violence Against Women Reauthorization Act of 2013 (VAWA 2013), Public Law 113-4, 127 Stat. 54 (Mar. 7, 2013). These changes to the regulations incorporate the statutory changes, make minor technical corrections, implement enhanced administrative and planning practices for formula grantees, and streamline existing regulations to reduce repetition of statutory language.

    In addition, this rule amends an existing regulatory provision, § 90.2, that sets forth certain definitions that apply to all OVW grant programs. Furthermore, the rule adds a new regulatory provision, § 90.4, that is applicable to all OVW grant programs to implement statutory amendments requiring nondisclosure of confidential or private information pertaining to victims of domestic violence, dating violence, sexual assault and stalking.

    II. Background A. Overview of the Violence Against Women Act and Subsequent Reauthorizations

    In 1994, Congress passed the Violence Against Women Act (VAWA), a comprehensive legislative package aimed at ending violence against women. VAWA was enacted on September 13, 1994, as title IV of the Violent Crime Control and Law Enforcement Act of 1994, Public Law 103-322, 108 Stat. 1796. VAWA was designed to improve criminal justice system responses to domestic violence, sexual assault, and stalking, and to increase the availability of services for victims of these crimes. VAWA was reauthorized and amended in 2000, 2005, and 2013, with each new reauthorization making improvements to the law and adding new programs and provisions.

    VAWA recognized the need for specialized responses to violence against women given the unique barriers that impede victims from accessing assistance from the justice system. To help communities develop these specialized responses, VAWA authorized the STOP Program, among others. See 42 U.S.C. 3796gg through 3796gg-5 and 3796gg-8; 28 CFR part 90, subpart B.

    VAWA requires a coordinated community response to domestic violence, dating violence, sexual assault and stalking crimes and encourages jurisdictions to bring together stakeholders from multiple disciplines to share information and to improve community responses. These often include victim advocates, police officers, prosecutors, judges, probation and corrections officials, health care professionals, and survivors. In some communities, these multidisciplinary teams also include teachers, leaders within faith communities, public officials, civil legal attorneys, health care providers, advocates from population-specific community-based organizations representing underserved populations, and others.

    VAWA's legislative history indicates that Congress passed VAWA to improve justice system responses to violence against women. For example, Congress wanted to encourage jurisdictions to treat domestic violence as a serious crime, by instituting comprehensive reforms in their arrest, prosecution, and judicial policies. Congress was further interested in giving law enforcement and prosecutors the tools to pursue domestic violence and sexual assault cases without blaming victims for behavior that is irrelevant in determining whether a crime occurred, while discouraging judges from issuing lower sentences for sexual assault crimes than for other violent crimes. VAWA was intended to bring an end to archaic prejudices throughout the justice system, provide support for victims and assurance that their attackers will be prosecuted, and focus criminal proceedings on the conduct of attackers rather than the conduct of victims.1

    1See S. Rep. No. 103-138, at 37-48 (Sept. 10, 1993).

    VAWA added a part T to the Omnibus Crime Control and Safe Streets Act of 1968, Public Law 90-351, codified at 42 U.S.C. 3711 et seq., titled Grants to Combat Violent Crimes Against Women, which authorizes four OVW-administered grant programs, including the STOP Program. STOP Program grants are awarded by population-based formula to states to develop and strengthen the justice system's response to violence against women and to support and enhance services for victims.

    On October 28, 2000, Congress enacted the Violence Against Women Act of 2000 (VAWA 2000), Division B of the Victims of Trafficking and Violence Protection Act of 2000, Public Law 106-386, 114 Stat. 1464. VAWA 2000 continued and strengthened the federal government's commitment to helping communities change the way they respond to violence against women. VAWA 2000 reauthorized critical grant programs, established new programs, and strengthened federal law. It had an emphasis on increasing responses to victims of dating violence and expanding options and services for immigrant and other vulnerable victims.

    VAWA 2000 made several changes relevant to the STOP Program. First, it amended the statutory purposes for which grant funds may be used. Second, it clarified the eligibility of courts as subgrantees. Third, it modified the requirement under the STOP Program that, to be eligible for funding, states must certify that victims not bear the costs for certain filing fees related to domestic violence cases. Finally, it added a new provision applicable to all OVW grant programs requiring grantees to report on the effectiveness of activities carried out with program funds.

    On January 5, 2006, Congress enacted the Violence Against Women and Department of Justice Reauthorization Act (VAWA 2005), Public Law 109-162, 119 Stat. 2960. VAWA 2005 strengthened provisions of the previous Acts, including revising the STOP Program, and created a number of new grant programs. It also created a set of universal definitions and grant conditions, including a confidentiality provision, that apply to all programs authorized by VAWA and subsequent legislation. VAWA 2005 had an emphasis on enhancing responses to sexual assault, youth victims, and victims in Indian country. Its provisions included new sexual-assault-focused programs, the addition of sexual assault to a number of OVW grant programs, new youth-focused programs, and the creation of a comprehensive violence against women program for tribal governments.

    The revisions to the STOP Program made by VAWA 2005 included adding new purpose areas to the program and modifying the requirements for the development of state implementation plans, the allocation of funds to subgrantees, and documentation of consultation with victim service programs. VAWA 2005 also required that the regulations governing the program ensure that states would recognize and meaningfully respond to the needs of underserved populations and distribute funds intended for culturally specific services—for which the Act created a new set-aside—equitably among culturally specific populations. It further amended the certification requirement under the program related to payment for forensic medical exams for victims of sexual assault and added new certifications related to prohibiting the use of polygraph examinations in sexual assault cases and to judicial notification to domestic violence offenders of laws prohibiting their possession of a firearm.

    On March 7, 2013, Congress enacted the Violence Against Women Reauthorization Act of 2013 (VAWA 2013), Public Law 113-4, 127 Stat. 54. VAWA 2013 made further improvements to the OVW grant programs, including several new requirements for the STOP Program. It also included two new historic provisions, one extending civil rights protections based on gender identity and sexual orientation and another recognizing the inherent jurisdiction of Indian tribes to prosecute non-Indians who commit certain domestic violence offenses in Indian country.2

    2 These two provisions are not addressed in this rule but were addressed in a set of frequently asked questions on the new civil rights provision and in two Federal Register notices related to the implementation of the new provision on tribal jurisdiction. See U.S. Department of Justice, Office of Justice Programs, Office for Civil Rights, “Frequently Asked Questions: Nondiscrimination Grant Condition in the Violence Against Women Reauthorization Act of 2013” (April 9, 2014), available at: http://www.justice.gov/sites/default/files/ovw/legacy/2014/06/20/faqs-ngc-vawa.pdf; Pilot Project for Tribal Jurisdiction Over Crimes of Domestic Violence, 78 FR 35961 (June 14, 2013); Pilot Project for Tribal Jurisdiction Over Crimes of Domestic Violence, 78 FR 71645 (Nov. 29, 2013).

    VAWA 2013 amended the universal definitions and grant conditions established by VAWA 2005 for all OVW grant programs and amended and added to the STOP Program purpose areas. It also amended the requirements under the STOP Program that states develop and submit with their applications and implementation plan—including documentation of planning committee members' participation in the development of the plan—and consult and coordinate with a variety of entities and stakeholders. VAWA 2013 modified the allocation requirements governing STOP subgrants, creating a set-aside for projects addressing sexual assault, and made changes to the statute's requirement that states provide matching funds for their grant awards. It also made several changes to provisions governing payment for forensic medical exams for sexual assault victims and certain filing costs related to cases of domestic violence, dating violence, sexual assault, and stalking.

    B. History Regarding the STOP Program and General Provisions Applicable to OVW Grant Programs

    The STOP Program regulations and general provisions were originally promulgated in April, 1995. On December 30, 2003, OVW published a proposed rule to clarify the match requirement for the STOP Program, which was never finalized and subsequently was superseded by changes to the statute made by VAWA 2005. On January 21, 2004, section 90.3, regarding participation by faith based organizations was added to the general provisions. OVW published the Notice of Proposed Rulemaking for the current update on May 11, 2016 at 81 Federal Register 29215. In developing the proposed rule, OVW held a series of listening sessions with relevant constituencies to solicit input on updating the STOP Program regulations and general provisions. The specific sessions were focused on state STOP Program administrators, state coalitions, culturally specific and underserved populations, tribes and tribal coalitions, nonprofit organizations, and the justice system. Comments on the proposed rule were due by July 11, 2016.

    C. Costs and Benefits

    As discussed in more detail under Executive Orders 12866 and 13563 (in the Regulatory Review discussion below), the rule clarifies the statutory requirements, but does not alter the existing program structure. Updating the existing regulations to clearly and accurately reflect the statutory parameters will facilitate state compliance with VAWA, and thus avoid potentially costly non-compliance findings.

    III. Discussion of Comments and Changes Made by This Rule

    As discussed above, this rule updates the regulations for the STOP Program and the general provisions governing OVW grant programs, including definitions and requirements for nondisclosure of confidential victim information, to comply with statutory changes and reduce repetition of statutory language. The structure and section numbering of the proposed rule has not been changed in the final rule, but some of the specific provisions have, as described below.

    A. Summary of Comments and Changes from the Proposed Rule

    OVW received 12 comments from state STOP grant administrators, national organizations focusing on violence against women, one state domestic violence coalition, individuals, and one creator of a cloud-based database for domestic violence and sexual assault service providers. Comments generally fell into six categories: (1) Reducing administrative burdens on state administering agencies, (2) encouraging victim-centered best practices, (3) clarifying requirements about the states' STOP implementation planning processes, (4) clarifying other STOP Program requirements, particularly those related to underserved and culturally specific populations, (5) clarifying the statutory confidentiality provision that restricts the release of victim identifying information, and (6) enhancing language access. The most significant changes in response to the comments are as follows:

    1. Changed the definition of “prevention” to clarify the difference between primary and secondary prevention (90.2(d)).

    2. Provided additional detail and clarification regarding the confidentiality provision (90.4(b)).

    3. Provided additional guidance to states on assessing qualifications of applicants for the culturally specific set aside of funds and clarified that they are encouraged to exceed the minimum statutory set aside of three percent (90.11(c)(3)).

    4. Increased the time period covered by state implementation plans from three years to four (90.12(a)).

    5. Clarified the requirement to consult with various entities in the process of developing and updating implementation plans and the documentation required regarding such consultation (90.12(b) and (c)).

    6. Clarified that, if the Prison Rape Elimination Act (PREA) requirements no longer apply to the STOP Program, then states will not need to address PREA compliance in their implementation plans and that only states that submitted assurances under PREA need to submit information on how they will spend the funds toward coming into compliance with PREA (90.12(g)(7)).

    7. Clarified when states may reallocate returned STOP funds and funds from allocations for which the state did not receive sufficient applications (90.25).

    B. Overarching Comments

    OVW received one comment expressing overall support for the proposed rule. OVW also received an overarching comment stating that the commenter would like to see more flexibility in categories within the STOP Program to better meet victim needs, such as more flexibility in emergency victim assistance. As long as a particular cost is related to victim safety and allowable under the cost principles in 2 CFR part 200, states have flexibility regarding how to use victim service funds. For example, states may use STOP funds to support emergency transportation, medical expenses, and other necessities where needed for victim safety. Because states already have considerable discretion to direct funding to emergency victim assistance, no change was made in the final rule. The other comments all pertained to specific sections of the proposed rule.

    C. Definitions and Confidentiality Requirements Applicable to All OVW Grant Programs

    VAWA 2005 established universal definitions and grant conditions for OVW grant programs, and VAWA 2013 amended these provisions. One of these grant conditions protects the confidentiality and privacy of persons receiving victim services for the purpose of ensuring victim safety. This section discusses the comments received on Subpart A, the definitions and grant conditions sections of the proposed rule, including provisions dealing with confidentiality, and any changes made to this subpart in the final rule.

    § 90.1. General

    Section 90.1 provides general information, including specification of which statutes are implemented by the rule and an explanation of the different subparts of the rule. In the final rule OVW also has added language to clarify to which grants and subgrants this updated rule will apply. Specifically, it will take effect with grants issued by OVW after the effective date of the rule (30 days from publication in the Federal Register). For subgrants, it will take effect with subgrants issued by states under the STOP and Sexual Assault Services Formula Grant Programs after that date, even if such subgrants are made with grant funds awarded by OVW prior to that date.

    § 90.2. Definitions

    The universal definitions added by VAWA 2005, codified at 42 U.S.C. 13925(a), superseded previous program-specific definitions originally enacted in 1994. The rule revises the definitions section of part 90, 28 CFR 90.2, by removing definitions from the existing regulations that are codified in statute, adding definitions for terms that are used in statute but not defined, and clarifying statutory definitions that, based on OVW's experience managing its grant programs, require further explanation.

    Section 90.2 currently contains definitions for the following terms: Domestic violence, forensic medical examination, Indian tribe, law enforcement, prosecution, sexual assault, state, unit of local government, and victim services. This rule removes the definitions for domestic violence, Indian tribe, law enforcement, sexual assault, state, and victim services, as they all appear in the statute and do not need further clarification.

    The rule revises the definition of “forensic medical examination,” a term that is used but not defined in a statutory provision directing that states, Indian tribal governments, and units of local government may not receive STOP Program funds unless they incur the full out-of-pocket cost of forensic medical exams for victims of sexual assault. See 42 U.S.C. 3796gg-4(a)(1). The rule changes the list of minimum elements that the exam should include to bring the definition in line with best practices for these exams as they have developed since part 90 was implemented in 1995, and, in particular, with the Department of Justice's national protocol for sexual assault medical forensic examinations (SAFE Protocol), which was updated in April 2013.3 OVW received several comments on this definition. Three commenters recommended adding “obtaining informed consent” to the definition and two of them also suggested adding an assessment of the patient's state of mind. Although these are best practices as discussed in the SAFE Protocol, they are not appropriate for inclusion here, because this definition applies to the specific context of meeting the certification requirement for the STOP Program that states must ensure victims do not incur “out of pocket” costs for forensic medical examinations. The definition is not intended to be a comprehensive description of best practices for conducting the examination but rather a list of elements for which victims should not incur “out of pocket” costs.

    3 U.S. Department of Justice, Office on Violence Against Women, “A National Protocol for Sexual Assault Medical Forensic Examinations: Adults/Adolescents” (2d ed. 2013), available at https://www.ncjrs.gov/pdffiles1/ovw/241903.pdf.

    One commenter also suggested adding “medical care and treatment” to the definition of “forensic medical examination.” Again, although this does represent best practice as exemplified in the SAFE Protocol, it is not appropriate for inclusion in this context because it would impose an increased cost to states not mandated by the STOP Program statute. The current rule allows states flexibility in determining whether to cover medical costs that are not within the definition of forensic medical examination, such as testing and treatment for sexually transmitted diseases. Many states do cover such expenses, but not all do. Payment for such expenses is often available through programs funded through the Victims of Crime Act (VOCA). OVW also notes that the definition does include “head-to-toe examination of the patient,” which is for both medical and forensic purposes. This examination is used to identify injuries for treatment purposes and provide documentation that could potentially be used by the criminal justice system. This commenter also suggested changing “sexual assault victim” to “victim of sexual assault” to clarify that the provision also applies to domestic violence survivors who are sexually assaulted. OVW agrees and has made this change to paragraph 90.2(c).

    The rule's definition of “prosecution” contains minor technical changes from the definition in the existing regulation. These changes implement the VAWA 2005 provision making the definitions applicable to all OVW grant programs and conform the definition to the statute. The definition retains the existing regulation's clarification of the statutory definition, which explains that prosecution support services fall within the meaning of the term for funding purposes. This clarification continues to be important because allocating prosecution grant funds to activities such as training and community coordination helps to achieve the statutory goal of improving prosecution response to domestic violence, dating violence, sexual assault, and stalking. OVW received one comment on this definition, noting that it included participation in domestic violence task forces and enforcing domestic violence restraining orders, but did not include task forces and restraining orders focused on sexual assault, dating violence, or stalking. OVW has added dating violence, sexual assault, and stalking to paragraph 90.2(e) to correct this oversight.

    In addition, the statutory definition for “prosecution” uses, but does not define, the term “public agency,” which the rule defines using the definition for this term in the Omnibus Crime Control and Safe Streets Act. See 42 U.S.C. 3791.

    The rule revises the definition of “unit of local government,” which did not have a statutory definition specific to all OVW grant programs until the enactment of VAWA 2013, to make it consistent with the statutory language. In addition, it includes in the definition a list of entities and organizations that do not qualify as units of local government for funding purposes and would need a unit of local government to apply on their behalf for those programs where “unit of local government” is an eligible entity but other types of public or private entities are not eligible. The list reflects OVW's long-standing interpretation of the term “unit of local government” and is consistent with OVW's practice of excluding these entities and organizations from eligibility to apply for OVW funding as units of local government. The one comment on this definition was a recommendation for OVW to consult with tribes on the impact of the change. OVW declines to take this suggestion for two reasons. First, the change eliminating tribes from the definition of “unit of local government” is dictated by the definition in VAWA 2013 and cannot be changed by regulation. By excluding tribes from the definition of “unit of local government,” VAWA 2013 excluded tribes from a provision in the authorizing statute for the Grants to Encourage Arrest Policies and Enforcement of Protection Orders Program that reduces the award amount to states and units of local government by five percent if the jurisdiction does not have certain laws, regulations, or policies regarding HIV testing of sex offenders. Second, even if the regulation could alter the statutory definition, OVW notes that this statutory change has no impact on tribal eligibility for OVW grants. “Tribal government” is an eligible entity for every OVW grant program that includes “unit of local government” as an eligible entity.

    The rule also adds definitions to the regulation for terms that are used in OVW grant program statutes but are undefined and that OVW believes would be helpful to applicants and grantees. The term “community-based organization” is defined in 42 U.S.C. 13925(a), but the term “community-based program,” which also appears in OVW grant program statutes, is not. To preserve consistency across OVW programs and minimize confusion, OVW is proposing to use the statutory definition for both terms.

    The rule provides a definition of “prevention” that distinguishes the term from “outreach” both because OVW has observed that some grant applicants propose outreach activities to implement prevention programming under OVW programs and because funding for “prevention” is more limited than funding for “outreach.” The proposed rule defined “prevention program” as “a program that has a goal of stopping domestic violence, dating violence, sexual assault, or stalking from happening in the first place. Prevention is distinguished from `outreach,' which has the goal of informing victims and potential victims about available services.” OVW received three different comments on this definition. The first recommends that the definition describe the distinction between “primary” and “secondary” prevention so that programs that interrupt and prevent future domestic violence, dating violence, sexual assault, and stalking after it has taken place can be distinguished from programs that focus on these crimes in a context where they have not yet taken place. This commenter specifically recommended using language from the Family Violence Prevention and Services Office within the Department of Health and Human Services. The second commenter recommended changing “programs” in the definition to “activities and strategies.” The third commenter recommended deleting “in the first place” from the definition. OVW agrees with all the comments and the definition in paragraph 90.2(d) has been revised to make clear that ”prevention” includes both primary and secondary prevention efforts and to define the terms primary and secondary prevention. The final sentence from the proposed rule, which distinguishes “prevention” from “outreach” is retained in the final rule.

    Finally, the rule adds a definition for “victim services division or component of an organization, agency, or government” because the rule uses this term in implementing the confidentiality provision enacted by VAWA 2005 and amended by VAWA 2013, which is discussed in more detail in the next section.

    § 90.4. Grant Conditions

    VAWA 2005 added grant conditions for all OVW grant programs, including a provision on confidentiality and privacy of victim information and these provisions were amended by VAWA 2013. See 42 U.S.C. 13925(b). Section 90.4(a) provides that the grant conditions in 42 U.S.C. 13925(b) apply to all grants awarded by OVW and all subgrants under such awards. One commenter requested that OVW also specify that grantees and subgrantees are required to comply with Title VI of the Civil Rights Act of 1964 and section 504 of the Rehabilitation Act. The commenter correctly notes that all grantees and subgrantees must comply with these laws. The grantmaking process, however, already requires grantees and subgrantees to comply with these and other civil rights statutes through standard assurances that the grantee signs. These are available on the OVW Web site at www.usdoj.gov/OVW. Because compliance with all applicable civil rights laws is already addressed through these assurances, it is not necessary to include compliance with two of these laws in this regulation.

    The statutory confidentiality provision recognizes the critical importance to victim safety of protecting victims' personally identifying information. It generally requires grantees and subgrantees to protect victim confidentiality and privacy to ensure the safety of victims and their families and prohibits the disclosure of victims' information without their informed, written, and reasonably time-limited consent. These requirements, implemented in section 90.4(b), apply to all OVW grant programs, not just STOP grants. In administering this confidentiality provision, OVW has received numerous inquiries regarding what kinds of disclosures require written consent, and OVW is attempting to answer these questions in this rule.

    In the Notice of Proposed Rulemaking, OVW requested comments about the propriety of placing victim information on third-party (or “cloud”) servers. Seven commenters responded to this request. Commenters were generally concerned about the privacy of information on such third-party servers, but also noted the need for flexibility in access to client information as service provision models expand from just office-based services. Commenters raised specific questions related to the use of third-party servers, such as who owns the data, who has access to the data, what security measures are in place to prevent unauthorized release of information, and what happens if the provider receives a subpoena for release of client information. Some commenters recommended specifying the answers to the above questions in the agreement between the victim service provider and the cloud storage provider. Some commenters also recommended the use of encryption to protect the client information. Two commenters specifically recommended the use of “zero knowledge” encryption, where the encryption key is stored on the victim service provider's server so the storage provider only has access to encrypted (and therefore unreadable) information. Two commenters recommended the use of background checks of the employees of the storage providers. One commenter noted that, while they felt that cloud storage should be acceptable, it should not include sharing of client information in regional or statewide databases such as Homeless Management Information Systems. Based on these comments, OVW added a new paragraph (b)(5) to § 90.4: “Inadvertent release. Grantees and subgrantees are responsible for taking reasonable efforts to prevent inadvertent releases of personally identifying information or individual information that is collected as described in paragraph (b)(2).” The reasonable efforts mentioned here apply not just to third-party electronic storage, but also protections for paper copies of information or information stored on internet-connected computers at the victim service provider. As suggested by one commenter, the use of third-party storage is not, by itself, a release, but can lead to release without sufficient precautions. “Reasonable efforts” in the case of third-party storage include, but are not limited to, ensuring that the contract with the storage provider specifies that the service provider owns the information and ensuring that there are sufficient security protocols to protect the information.

    Section 90.4(b)(2)(iii) provides that the confidentiality provision applies to disclosures from victim service divisions or components of an organization, agency, or government to other non-victim services divisions or components and to the leadership of such organization, agency, or government. It also provides that the leadership shall have access without releases only in “extraordinary and rare” circumstances. OVW requested comments on this provision and received three comments. Two commenters were concerned that the phrase “extraordinary and rare circumstances” is too vague and asked OVW to provide additional guidance. In response, OVW has added a statement clarifying that “Such [extraordinary and rare] circumstances do not include routine monitoring and supervision[]” to the end of paragraph (b)(2)(iii). OVW decided against including a list of circumstances that justify disclosure because such determinations will be fact-based. OVW notes, however, that one example of such an extraordinary and rare circumstance justifying release to an organization's leadership would be where there are allegations of fraud against the victim service division or one of its staff members. One commenter was concerned that this provision could be read to include victim-witness programs at prosecution or law enforcement offices. By statute (42 U.S.C. 13925(b)(2)(D)(i)(III)), the confidentiality provision does not apply to “law enforcement-generated and prosecution-generated information necessary for law enforcement and prosecution purposes.” In addition, § 90.2(h) of this rule defines “victim services division or component of an organization, agency, or government” as a “division within a larger organization, agency, or government, where the agency has as its primary purpose to assist or advocate for victims of domestic violence, dating violence, sexual assault, or stalking and has a documented history of work concerning such victims.” Victim-witness programs in prosecution or law enforcement offices would generally be for law enforcement or prosecution purposes, even if they are also assisting victims.

    Section 90.4(b)(3) governs releases of personally identifying information or individual information collected in connection with services. One commenter requested that OVW add language providing that releases must be accessible to all victims, including those with limited literacy and/or English language proficiency. OVW declines to make this change because it is not necessary. Both the statute and the regulation require informed releases; if the victim does not understand the release, it cannot be truly “informed.” Section 90.4(b)(3)(ii), as revised, requires that the grantee or subgrantee engage in a conversation with the victim regarding the purpose for and limits on the release, and the grantee or subgrantee should record the agreement as to the scope of the release. This conversation should ensure that the victim understands the release. In addition, with regard to language access, there are already civil rights laws and regulations requiring that grantees and subgrantees take reasonable steps to provide meaningful access to their programs and activities for persons with limited English proficiency. Grantees and subgrantees explicitly agree to comply with these laws by signing relevant assurances and certifications when applying for OVW grants and upon the receipt of OVW financial assistance. For more information on language access requirements, the Office of Justice Programs, Office for Civil Rights (OCR) has information on its Web page at http://ojp.gov/about/ocr/lep.htm.

    Section 90.4(b)(3)(i) addresses the circumstances under which identifying information about victims served by OVW grantees and subgrantees may be released, one of which is when the release is compelled by a court mandate (§ 90.4(b)(3)(i)(C)). One commenter requested that OVW clarify that “court mandates” include case law mandates, such as those imposing a “duty to warn” when there is a specified threat of harm. OVW accepts this comment. It is consistent with guidance that OVW has provided to grantees. Section 90.4(b)(3)(i)(C) has been revised to read “release is compelled by court mandate, which includes a legal mandate created by case law, such as a common-law duty to warn.”

    Section 90.4(b)(3)(ii) addresses criteria for victim releases. One commenter recommended that, within the context of signing a release of information, grantees and subgrantees must reach agreement with the victim about what information the victim wants shared and record that agreement as part of the release. Another commenter recommended that the victim specify to whom and what specific information is to be shared. OVW agrees and has rewritten the third sentence of this paragraph to specify that grantees and subgrantees must discuss with the victim why the information might be shared, who would have access to the information, and what information could be shared under the release. They must also reach agreement with the victim about what information would be shared and with whom and record the agreement about the scope of the release.

    Section 90.4(b)(3)(ii)(C) and (D) address releases for minors and legally incapacitated persons with court-appointed guardians. With regard to minor children, the rule provides that both the minor and the parent or guardian sign the release. One commenter noted that the rule should account for situations where the child is too young to sign the release. OVW agrees and has added language to clarify that, if a minor is incapable of knowingly consenting, the parent or guardian of that minor may provide consent. The rule also provides that, if a parent or guardian consents for a minor, the service provider should attempt to notify the minor as appropriate. Another commenter requested that OVW include language that consent for release may not be given by the abuser of the minor or the abuser of the other parent of the minor. Such language already was included in section 90.4(b)(3)(ii)(C) of the proposed rule.

    Section 90.4(b)(4) addresses release of information about deceased victims for fatality reviews. OVW solicited comments on this provision and received four responses. The proposed rule provided that the prohibition on sharing information did not apply to information about deceased victims being sought for fatality reviews if the review met certain criteria. All commenters were concerned about the impact on victims if, prior to their deaths, they were aware of the possibility of release and recommended not allowing release without consent. Four commenters noted that such consent could be provided by a personal representative of the victim, if available. OVW is seeking to balance these concerns with the important work that is done by fatality reviews. In a fatality review, community responders examine homicides and suicides resulting from domestic violence to identify gaps in services, responses, and prevention efforts. These reviews can lead to systemic improvements that can prevent future deaths. The final rule requires grantees to make a reasonable effort to gain consent from a personal representative, but, if they are not able to do so after such efforts, it does not preclude their full participation in the fatality review. Also, the final rule permits sharing identifying victim information only when the fatality review has an underlying objective to prevent future deaths, enhance victim safety, and increase offender accountability, and includes both policies and protocols to protect against the release of information outside the fatality review team and limits release to information that is necessary for the purposes of the fatality review. OVW notes that many states or tribes have specific confidentiality and privilege laws that apply to victim service providers and other OVW grantees and subgrantees. This provision would allow release for VAWA purposes but would not override state or tribal laws that do not allow for release. Some laws, however, specifically authorize victim service providers to release information for fatality reviews. The language of the final rule is an attempt to ensure that the VAWA confidentiality provision is implemented in a manner that is compatible with such state or tribal laws, including both where those laws are more protective of victim confidentiality and where they authorize release.

    Section 90.4(b)(6) (renumbered from (5) in the proposed rule) requires grantees and subgrantees to document their compliance with the confidentiality requirement by submitting an acknowledgement form indicating that they have notice of the requirement and that they will create and maintain documentation of compliance. OVW received one comment on this provision. The commenter recommended that OVW also require grantees and subgrantees to document their compliance with Title VI of the Civil Rights Act of 1964 and section 504 of the Rehabilitation Act. The standard assurances (available at https://www.justice.gov/ovw/how-apply) contain a provision that requires STOP Program grantees and subgrantees to comply with applicable civil rights laws, including the Civil Rights Act, the Rehabilitation Act, and VAWA. Title VI requires grantees and subgrantees to provide appropriate language-access services to limited English proficient (LEP) beneficiaries. See 28 CFR 42.405(d). The U.S. Department of Justice has issued guidance for recipients on their responsibility under Title VI to provide language-access services. See Department of Justice, Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons, 67 FR 41,455 (June 18, 2002). OVW, through the Office of Justice Programs, Office on Civil Rights (OCR), conducts compliance reviews to ensure that recipients are serving LEP beneficiaries and LEP service populations. State administering agencies that subgrant STOP Program funds to other organizations must have “Methods of Administration” (28 CFR 42.105(d)(2)) that monitor whether their subrecipients have a language assistance plan. OCR provides technical assistance to recipients about their obligation to provide language-access services through an online training program (http://ojp.gov/about/ocr/ocr-training-videos/video-ocr-training.htm (last visited July 21, 2016)), in-person presentations, and telephone consultations. In addition, aggrieved parties (and third parties) may file an administrative complaint with the OCR alleging a recipient's failure to provide appropriate language-access services in violation of Title VI (28 CFR. 42.107(b)) and VAWA (28 CFR 42.205). OCR will investigate the complaint, and, if the complaint has merit, OCR will seek appropriate remedies. The enforcement scheme that is already in place holds recipients accountable for providing appropriate language-access services to LEP beneficiaries in accordance with Title VI and VAWA. Therefore there is no need for additional documentation under this rule.

    An additional comment on this paragraph recommended the language, which was already included in the proposed rule, that requires grantees and subgrantees to document compliance with the confidentiality requirement.

    OVW also has added a new section 90.4(c) to specify that victim eligibility for direct services is not dependent on the victim's immigration status, for consistency with the Office for Victims of Crime Victims of Crime Act (VOCA) Assistance Program Final Rule, which was issued after the OVW proposed rule. This is also consistent with the Attorney General Order on Specification of Community Programs Necessary for Protection of Life or Safety under Welfare Reform Legislation (Attorney General Order No. 2353-2001, 66 F. R. 3616 (Jan. 16, 2001)). In addition, on August 5, 2016, Attorney General Loretta E. Lynch, Secretary Sylvia Mathews Burwell of the U.S. Department of Health and Human Services (HHS) and Secretary Julián Castro of the U.S. Department of Housing and Urban Development (HUD) released a letter 4 to recipients of federal funding to provide more information on access to services for immigrant victims. The letter explains that immigrants cannot be denied access to certain services necessary to protect life or safety on the basis of their immigration status.

    4https://www.justice.gov/ovw/file/883641/download.

    D. STOP Formula Grant Program 1. Organization

    OVW proposed significant changes in the proposed rule to the organization of Subpart B, the STOP Program regulations, and is retaining these changes, without further alteration, in the final rule. The following chart shows the changes from the current rule to both the proposed and final rules.

    Section No. Current rule Disposition of current section Proposed rule/final rule 90.10 Description of STOP (Services-Training-Officers—Prosecutors) Violence Against Women Formula Grant Program Same STOP (Services-Training-Officers—Prosecutors) Violence Against Women Formula Grant Program—General. 90.11 Program Criteria Merged with 90.10 and 90.12 State office. 90.12 Eligible Purposes Merged with 90.10 Implementation plans. 90.13 Eligibility Now in 90.10 Forensic medical examination payment requirement. 90.14 Forensic Medical Examination Payment Requirement Now 90.13 Judicial notification requirement. 90.15 Filing Costs for Criminal Charges Same Costs for criminal charges and protection orders. 90.16 Availability and Allocation of Funds (a) Is now in 90.17, (b) and (c) are merged with 90.12 Polygraph testing prohibition. 90.17 Matching Requirements Now 90.18 Subgranting of funds. 90.18 Non-supplantation Removed Matching funds. 90.19 State Office Now 90.11 Application content. 90.20 Application Content Now 90.19 90.21 Evaluation Same Evaluation. 90.22 Review of State Applications Same Review of State applications. 90.23 State Implementation Plan Now 90.12 Annual grantee and subgrantee reporting. 90.24 Grantee Reporting Now 90.23 Activities that may compromise victim safety and recovery. 90.25 Reallocation of funds. 2. Removing Duplicative Regulatory Language

    OVW is removing much of the existing regulation to avoid duplication with the statute. Specifically, OVW is removing the following sections and paragraphs of the current regulation for this reason: §§ 90.10; 90.11(a); 90.12; 90.16(a); and 90.18. Other sections have been streamlined by referencing the statutory provision rather than repeating the statutory language.

    3. Statutory Changes

    As discussed above, VAWA of 2000, VAWA 2005, and VAWA 2013 have amended and enhanced the STOP Program. Specific changes are as follows:

    • Expanded purpose areas (incorporated by reference in § 90.10) • Changes in allocations: (1) The victim services allocation increased from 25 percent to 30 percent; (2) a set aside was added of ten percent of the victim services funds (or three percent of the total award) for culturally specific community-based organizations; (3) a set aside was added of five percent to courts; and (4) a 20-percent set aside was added for programs that meaningfully address sexual assault in two or more of the specified allocations (§ 90.11(c)) • Changes in the implementation planning process, including an expanded list of entities with which the state is required to consult and additional information that needs to be included in a state's implementation plan (§ 90.12) • Changes to the existing certification requirements and additions of new certification requirements (§ 90.13, forensic medical examination payment; § 90.14, judicial notification; § 90.15, costs for criminal charges and protection orders; and § 90.16, polygraph testing prohibition) The rule also removes references to the Assistant Attorney General for the Office of Justice Programs to reflect statutory changes made by the Violence Against Women Office Act, Title IV of the 21st Century Department of Justice Appropriations Authorization Act, Public Law 107-273 (Nov. 2, 2002). 4. Section-by-Section Summary of the Regulatory Text

    This section describes each provision of the regulatory text, any comments received, and any changes made to the final rule.

    § 90.10 STOP (Services-Training-Officers-Prosecutors) Violence Against Women Formula Grant Program—General

    Section 90.10 lists the eligible applicants for the program and specifies that the purposes, criteria, and requirements for the program are established by 42 U.S.C. 3796gg et seq. The only comments on this section expressed support.

    § 90.11 State Office

    Section 90.11 describes the role of the state office, which is to be designated by the chief executive of the state. As detailed in § 90.11(a) and (b), the state office is responsible for submitting the application, including certifications, developing the implementation plan, and administering the funds. Three commenters felt that paragraph (b) was too burdensome in that it required the state administering agencies for various programs to coordinate on disbursement of funds (rather than implementation planning). The requirement to coordinate on disbursement is in the current rule, but, since the issuance of that rule, VAWA 2013 added the requirement to coordinate on implementation planning. OVW agrees that the existing requirement to coordinate with other state administering agencies on disbursement of funds is no longer necessary in light of the VAWA 2013 amendment and is removing it from the final rule. The requirement to coordinate on implementation planning is at § 90.12(b)(6).

    Section 90.11(c) is intended to ensure that statutorily allocated funds are meaningfully targeted to the appropriate entities and activities. Paragraph (c)(3) discusses the allocation for culturally specific services. One commenter recommended changing the second sentence to clarify that recipients should have expertise specifically on services to address the demonstrated needs of the targeted racial and ethnic minority group. OVW agrees and has changed the second sentence accordingly. This commenter also requested that the rule make clear that the set aside of ten percent (out of the thirty percent for victim services) is a minimum and not a cap. OVW agrees and has added language to § 90.11(c)(3) to encourage states to provide funding above the three percent minimum to address the needs of racial and ethnic minority groups.

    Another commenter expressed support for the paragraph's language clarifying eligibility for the culturally specific set aside and recommended that OVW go further in delineating an assessment approach for subgrant applications under this category. OVW accepts this recommendation and is adding a new sentence to paragraph (c)(3) that provides that states should tailor their subgrant application process to meaningfully assess the qualifications of applicants for the culturally specific set aside.

    One additional commenter noted that the definition of “culturally specific” is not the same as the definition of “underserved” and that therefore some populations of victims (such as Deaf and lesbian, gay, bisexual, and transgender (LGBT)) are excluded. OVW cannot alter the definition to include additional underserved populations because of a statutory change in VAWA 2013. Prior to VAWA 2013, states could use the culturally specific set aside to provide culturally specific services to any underserved population. VAWA 2013 changed the definition of culturally specific so that it now means “primarily directed toward racial and ethnic minority groups.” 42 U.S.C. 13925(b)(6). As a result, the STOP Program's set aside for culturally specific community-based organizations may only fund subgrantees that target racial and ethnic minority groups. 42 U.S.C. 3796gg-1(c)(4)(C). States are still required to consider the full range of underserved populations in the state and ensure that funds are equitably distributed toward the needs of such populations, 42 U.S.C. 3796gg-1(e)(2)(D).

    Section 90.11(c)(4) provides guidance with regard to the twenty-percent sexual assault set aside. One commenter supported language directing how states evaluate whether projects qualify for the sexual assault set aside generally, but objected to allowing states to assess the percentage of a project that addresses sexual assault and count that percentage toward the set aside. The commenter noted that projects that primarily address other crimes should not count toward the sexual assault set aside. OVW agrees that only projects that truly address sexual assault should be counted and has removed the sentence that would permit states to aggregate percentages from projects that do not primarily address sexual assault. Projects that qualify for the set aside may include, but are not limited to, sexual assault victim advocacy services, sexual assault forensic examiner programs, Sexual Assault Response Teams, law enforcement or prosecution training on or specialized units for sexual assault, projects addressing rape kit backlogs, and projects that involve implementation of the Prison Rape Elimination Act of 2012 (PREA) standards in working with incarcerated victims.

    OVW also has added a new paragraph (d) on pass-through administration, based on the Office for Victims of Crime's VOCA Victim Assistance Program Final Rule, which was issued after the OVW proposed rule. Under both the STOP and Victim Assistance Programs, some states administer the program by awarding the funds to an organization such as a state domestic violence or sexual assault coalition and permitting that organization to identify and monitor subgrantees. OVW wishes to be consistent with OVC's regulations regarding this practice.

    § 90.12 Implementation Plans

    Section 90.12 implements new requirements for the state planning process added by VAWA 2013. One commenter had an overarching recommendation that this section refer to the statute without any additional detail. The commenter opined that such detail is more appropriate for guidance and “frequently asked questions” issued by OVW, rather than regulations. Finally, the commenter maintained that the requirements spelled out in this section are too burdensome for states and not consistent with existing state processes. OVW disagrees. The procedures in this rule are consistent with guidance that OVW previously provided to states and therefore state processes should already align with the rule's requirements. Although the rule does require certain documentation, OVW has determined that this documentation is necessary for OVW to ensure compliance with the detailed statutory requirements that Congress put in place in VAWA 2013. The provisions of this section balance the needs of the state with the complexity of the statute. As discussed below, however, state plans will be due on a four-year cycle instead of a three-year one.

    The proposed rule included language in section 90.12(a) incorporating a long-standing OVW practice of allowing states to submit a full implementation plan every three years and then submit updates to the plan in the other two years. Several commenters requested that the plan extend for five years, to cover the period between VAWA reauthorizations, rather than three, to reduce the burden on states. OVW is partially accepting this recommendation by making the plan due every four years, starting with the FY 2017 application. Accordingly, the plan submitted in FY 2017 must cover the years 2017-2020. This will give the states more time to develop their plans each cycle and reduce the burden on states, while ensuring that the plans are updated with reasonable frequency. OVW declines to align the plan cycle with VAWA reauthorizations because OVW cannot know if or when Congress will reauthorize VAWA. Depending on the changes made to the STOP Program statute in a reauthorization, however, a new state plan may not be required due to a reauthorization. For example, if purpose areas are added or changed, the state could develop an update noting whether or not it plans to use the new purpose areas. Because of the longer plan period, the final rule provides in paragraph (b) that consultation is required for updating a plan as well as for developing the full plan. If there are no updates, or only minor changes, then the consultation may be brief.

    Paragraphs (b) and (c) of section 90.12 are new to the regulation, but incorporate provisions from 42 U.S.C. 3796gg-1(c)(2) and (i) regarding consultation and coordination. The statute, as amended by VAWA 2013, provides a list of entities that states must consult with during the implementation planning process and requires documentation from members of the planning committee as to their participation in the planning process. OVW must ensure that states consult with all the required entities and fully document such consultation. The final rule strikes a balance between requiring sufficient documentation within the implementation plan and minimizing the burdens on state administrators inherent in providing such documentation.

    Section 90.12(b) addresses consultation and coordination with the entities specified in 42 U.S.C. 3796gg-1(c)(2). Paragraph (b)(2) addresses population-specific organizations, representatives from underserved populations, and culturally specific organizations. Two commenters noted that the proposed rule required the inclusion of “significant underserved or culturally specific populations in the state” but did not define “significant.” OVW declines to define “significant” because what significant means will be different for every state. Instead, OVW has inserted language in paragraph (c) that requires states to explain in their implementation plans how they determined which underserved and culturally specific populations to include. OVW also has amended paragraph (b)(2) to provide that states consider, in addition to demographics, barriers to service, including historical lack of access to services, for each population. These commenters noted a similar concern with paragraph (b)(7), which is addressed in the final rule through these change to paragraphs (b)(2) and (c).

    Two commenters requested that OVW add language to paragraph (b)(2) with specific recommendations on how states should engage in meaningful outreach, such as having a mailing list with organizations in specific areas, including nonprofit and faith-based organizations, and conducting information sessions beyond regular business hours and in local communities. Although OVW agrees in principle with these suggestions, OVW believes they are too detailed and specific for inclusion in the regulations and more appropriate for technical assistance.

    Section 90.12(b)(3) requires consultation with all state and federally recognized tribes in the planning process. One commenter agreed but also noted that there is a need for states to have mechanisms for tribes to participate meaningfully and recommended that OVW require states to document their attempts to reduce barriers to participation by tribes. OVW agrees and has added this to paragraph (c)(2)(iii). Examples of ways that states have successfully reached tribes include tours of the reservations in the state and regional meetings with tribal leaders.

    Section 90.12(b)(4) provides that, if possible, states should include survivors of domestic violence, dating violence, sexual assault, and stalking in the planning process. One commenter noted the value and importance of including survivors in the planning process. Another recommended changing the provision to reflect that states are “encouraged” to include survivors, but also noted concerns that states could recruit and solicit input from survivors in ways that violate survivor confidentiality and autonomy. As a result, OVW has changed the provision to remind states that include survivors in their consultation process that they should address safety and confidentiality concerns. OVW recommends that state STOP administrators work with organizations within their states, such as state coalitions, victim service providers, and culturally and population specific organizations, that may have survivor advisory panels or may be able to assist with recruiting survivors who are interested in providing input regarding the state plan. Survivors do not need to participate in person and their input may be obtained through means such as online or paper surveys, conference calls, or web meetings.

    Section 90.12(b)(6) implements the statutory requirement at 42 U.S.C. 3796gg-1(c)(3) that the state coordinate the plan with the plans for the Family Violence Prevention and Services Act (42 U.S.C. 10407), the State Victim Assistance Formula Grants under the Victims of Crime Act (42 U.S.C. 10603), and the Rape Prevention and Education Program (42 U.S.C. 280b-1b). Two commenters noted that this coordination can be difficult if the STOP Program administrator does not control the other funding streams. They also noted that the VOCA Assistance state administrator may be better positioned to lead this coordination, as that program disburses substantially more funding. Because each state is structured differently, OVW will give states discretion how to handle this statutory requirement. Some examples include a single meeting with the various state administrators to discuss plan priorities, having a shared planning process, having the different administrators serve on the STOP planning committee, and sharing a draft plan with the other administrators for feedback. If a state chooses to have another administrator, such as the VOCA administrator, lead the processes, it may do that at its discretion.

    Section 90.12(c) provides information on how states must document their consultation with the various required entities. The rule requires states to submit to OVW documentation of the extent of each partner's participation, a summary of any significant concerns that were raised during the planning process, and a description of how those concerns were resolved. Paragraph (c) is intended to ensure meaningful collaboration with partners, while minimizing the administrative burden on states. One commenter noted that the term “checklist” can be confusing because OVW also uses a checklist of the required plan elements. The commenter recommended changing “checklist” to “documentation of collaboration.” OVW agrees and has made this change.

    OVW received several comments on this section, both expressing support and expressing concerns about the burden on STOP administrators. Some commenters recommended using a certification of compliance with collaboration instead of requiring the documentation. One commenter recommended removing some of the specific details regarding what to retain and instead provide a general requirement for states to document and keep on file a description of the planning process. One commenter noted that the requirement to provide a summary of major concerns is duplicative. However, another commenter specifically supported the level of documentation and the focus on documenting major issues and how they are resolved. After consideration of these diverging views, OVW has determined that the level of documentation required by the rule is necessary for management of the program and is consistent with current practices and OVW guidance. OVW, however, has rewritten this section to clarify what documentation must be retained and what must be submitted as part of the implementation plan. OVW may review the retained documentation as part of monitoring, such as a site visit or where there is a suspicion of noncompliance with the collaboration requirements. Furthermore, by amending section 90.12(a) to require a new plan every four years instead of every three years, OVW has reduced the burden of retaining or submitting this documentation. Also, one commenter noted that requiring participants to fax or email proof of their attendance on calls and webinars is not necessary. OVW agrees and has modified that paragraph accordingly.

    Section 90.12(d) implements 42 U.S.C. 3796gg-1(e)(2), which requires states to describe in the implementation plan how they will provide for equitable distribution of funds with certain considerations, such as geographic diversity and meeting the needs of underserved populations. One commenter noted that states must ensure that eligible underserved and culturally specific entities are aware of the funding opportunity. OVW agrees but recognizes that this kind of outreach is needed not just for underserved populations, but for other categories in this paragraph such as different types of geographic areas. Therefore, OVW has added a new paragraph (d)(5) to require that states take steps to ensure that eligible applicants are aware of the STOP Program funding opportunity, including applicants serving different geographic areas and culturally specific and other underserved populations. Another commenter expressed a concern with paragraph (d)(4), which specifies that states must recognize and meaningfully respond to the needs of underserved populations and ensure that monies set aside to fund linguistically and culturally specific services and activities for underserved populations are distributed equitably among “those populations.” This commenter was concerned that the term “those populations” will be seen as limiting the equitable distribution to culturally specific populations under the ten-percent set aside. OVW agrees and has amended paragraph (d)(4) to clarify that it applies to both culturally specific populations and the broader range of underserved populations.

    Section 90.12(e) implements 42 U.S.C. 3796gg-1(i)(2)(E). The paragraph allows states the flexibility to identify underserved populations, while requiring a description of why the specific populations were selected. One commenter noted in response to both this paragraph and paragraph (d) that the states must address statewide needs and that the ten-percent set aside is a minimum and not a cap. As discussed above, OVW has made changes to section 90.12(c)(3) that address these concerns. This commenter also requested that OVW include a reminder that states must develop language access plans to ensure that, in distribution of funding, they provide “meaningful access” for persons with limited English proficiency. This specific reminder is not needed because it is already required and addressed through other mechanisms, as discussed above in response to a similar comment regarding § 90.4(b)(6). OVW does include language in all its solicitations about language access and use of funds for this purpose. OVW encourages states to use the same or similar language in their solicitations. The 2016 STOP Program solicitation includes the following:

    Accommodations and Language Access

    Recipients of OVW funds must comply with applicable federal civil rights laws, which, among other things, prohibit discrimination on the basis of disability and national origin. This includes taking reasonable steps to ensure that persons with limited English proficiency (LEP) have meaningful access to recipients' programs or activities. More information on these obligations is available in the OVW FY 2014 Solicitation Companion Guide and at www.lep.gov. Applicants are encouraged to allocate grant funds to support activities that help to ensure individuals with disabilities, Deaf individuals, and persons with limited English proficiency have meaningful and full access to their programs. For example, grant funds can be used to support American Sign Language (ASL) interpreter services, language interpretation and translation services, or the purchase of adaptive equipment.

    Applicants proposing to use grant funds to create Web sites, videos, and other materials must ensure that the materials are accessible to persons with disabilities. Grant funds may be allocated for these purposes.

    Section 90.12(f) implements 42 U.S.C. 3796gg-1(i)(2)(G), which requires state implementation plans to include goals and objectives for reducing domestic violence-related homicide. This paragraph requires states to include statistics on domestic violence homicide within the state, consult with relevant entities such as law enforcement and victim service providers, and establish specific goals and objectives to reduce homicide, including addressing challenges specific to the state and how the plan can overcome them.

    Section 90.12(g) outlines additional content that implementation plans must include. These required elements are designed to help OVW ensure that states meet statutory requirements for the program and to provide a better understanding of how the state plans to allocate its STOP Program funds. One commenter requested that OVW remind states to provide outreach to targeted community groups, which should be translated or interpreted to other languages and broadcast in ethnic media. The need for outreach has been addressed in paragraph (d)(5) as discussed above. Also, as discussed above, the specific reminder about interpretation is unnecessary because it is covered by other laws, regulations, guidance, and resources for grantees.

    Paragraph (g)(7), regarding the Prison Rape Elimination Act (PREA), is designed to ensure that states that submit assurances under PREA that they will spend five percent of “covered funds” towards compliance with PREA are including such funds in their planning. One commenter noted that there is pending legislation that could separate PREA from STOP. To address this possibility, OVW has added the phrase, “if applicable” to paragraph (g)(7). If the legislation passes, it will no longer be applicable, and states will not need to address it. Another commenter opined that, because the decision whether to submit a certification, assurance, or neither under PREA is the responsibility of the governor, it should only be included in the implementation plan if the grantee is using PREA set-aside funds for victim services and has control through direct contracting. OVW agrees in part and disagrees in part. Although it is true that the state STOP administrator does not have control over PREA certification and assurance decisions, the administrator should be aware of the governor's decisions and should be able to report on the use of STOP funds if the state submitted an assurance that it would use five percent of covered funds under STOP towards coming into compliance with PREA. Therefore, OVW has changed the paragraph to note that the state needs to specify whether it submitted a certification, assurance, or neither under PREA, and, if an assurance, how it plans to spend the STOP funds set aside for PREA compliance.

    Section 90.12(h) implements a change in VAWA 2013 that makes the implementation plans due at the time of application rather than 180 days after award. One commenter complained that this does not give states enough time to complete the plan and requested 90 days after the award to complete the plan. OVW disagrees because states do not need to wait for the solicitation to write the plan. Since the previous plan was due in 2014, OVW has been encouraging states to work on their 2017 plans. States may use the 2014 solicitation, guidance on the OVW Web page, and this rule to help develop their plans. In addition, if a state is not able to complete their plan by the application deadline, they may submit information on what is needed to complete the plan. If they have not completed the plan by the time the award is issued, the state will still receive the award, but with a condition withholding all the funds until the plan is submitted and approved.

    § 90.13 Forensic Medical Examination Payment Requirement

    Section 3796gg-4 of Title 42 requires states to ensure that the state or another governmental entity bears the “full out-of-pocket” costs of sexual assault medical forensic examinations. Section 90.13(b) provides a definition of “full out-of-pocket costs.” Paragraph (d) clarifies that, if states use victims' personal health insurance to pay for the exams, they must ensure that any expenses not covered by insurance are not billed to the victims, as these would constitute “out-of-pocket” costs. Paragraph (e) implements a new provision from VAWA 2013, 42 U.S.C. 3796gg-4(a)(1)(B), which requires states to coordinate with health care providers in the region to notify victims of the availability of forensic examinations.

    Two commenters expressed that the victim's insurance should never be billed. In some cases, insurance billing can present a hardship for victims. For example, a victim of spousal rape may not want her husband to find out that she sought a forensic exam. If the victim is forced to submit the claim to her insurance company and she is covered by her husband's insurance, he may receive a statement from the insurance indicating that she received the exam. OVW agrees and strongly discourages the practice of billing a victim's insurance. The statute, however, clearly permits it. See 42 U.S.C. 3796gg-4(c) (specifying that states may only use grant funds to pay for forensic examinations if the examinations are performed by a trained examiner and victims are not required to seek reimbursement from their insurance). OVW, however, has added language to section 90.13(d) to discourage the practice. Another commenter wrote in response to this section as well as sections 90.15 (the provision prohibiting polygraph testing) and 90.16 (regarding fees and costs for criminal charges and protection orders) to request that states be required to provide notice to victims of their rights in relevant languages. Section 90.13(e) (implementing 42 U.S.C. 3796gg-4(1)(B)) already contains a notice requirement regarding rape examination payment. Additional reminders with regard to language access are not needed in this rule because it is covered by the relevant federal civil rights laws and regulations. Finally, although OVW encourages states to inform victims about the prohibition on polygraph testing and the provisions relating to costs for criminal charges and protection orders, OVW declines to impose a notice requirement, because Congress included it in the rape examination payment certification but did not in the certifications regarding polygraph testing and costs for criminal charges and protection orders.

    § 90.14 Judicial Notification Requirement

    Section 90.14 implements the requirements of 42 U.S.C. 3796gg-4(e), which provides that states and units of local government are not entitled to funds unless they certify that their judicial administrative policies and practices include notification to domestic violence offenders of relevant federal, state, and local firearms prohibitions that might affect them. This requirement was added by VAWA 2005. One commenter stated that the judicial notice should be in the language of the offender and that funding should be reduced if it is not. OVW declines to make this change because, as discussed above, language access is addressed by existing civil rights laws and regulations.

    § 90.15 Costs for Criminal Charges and Protection Orders

    Section 90.15 implements the requirements of 42 U.S.C. 3796gg-5, which provides that states, tribes, and units of local government are not entitled to funds unless they certify that victims of domestic violence, dating violence, sexual assault, or stalking are not charged certain costs associated with criminal prosecution or protection orders. These requirements were amended by VAWA 2000 and VAWA 2013. No comments were received on this section other than the comment regarding notice discussed above under § 90.13.

    § 90.16 Polygraph Testing Prohibition

    Section 90.16 implements 42 U.S.C. 3796gg-8, which provides that, to be eligible for STOP Program funding, states, tribes, and units of local government must certify that their laws, policies, and practices ensure that law enforcement officers, prosecutors, and other government officials do not ask or require sexual assault victims to submit to a polygraph examination or other truth telling device as a condition for investigating the offense. These requirements were added by VAWA 2005. OVW received two comments on this section, in addition to the comment regarding notice discussed above under § 90.13. The first recommended language to clarify that state-level police and prosecutors must comply with this requirement. OVW has not accepted this suggestion, because although it is correct that the state must comply, OVW believes the language of the proposed rule is clear. The second commenter recommended that polygraphing be prohibited outright. OVW lacks the authority to do this because the statute (and therefore the regulation) only prohibits polygraphing as a condition of proceeding with the investigation of the offense. OVW, however, has changed “restricting” in paragraph (a) to “prohibiting” to track the language of the statute. OVW also agrees that polygraphing of victims should not be done as a routine matter. The Attorney General Guidelines for Victim and Witness Assistance (2011 Edition, https://www.justice.gov/sites/default/files/olp/docs/ag_guidelines2012.pdf) provides that investigating agents may request victims to take a polygraph only in extraordinary circumstances and only with the concurrence of the Special Agent in Charge or the Supervisory Assistant United States Attorney. The guidelines further provide that all reasonable alternative investigatory methods should be exhausted before requesting or administering a sexual assault victim polygraph examination. OVW recommends that states and local jurisdictions adopt similar guidelines to limit the improper use of polygraph tests on sexual assault victims.

    § 90.17 Subgranting of Funds

    Section 90.17(a) describes the type of entities that may receive subgrants from the state (state agencies and offices, courts, local governments, public agencies, tribal governments, victim service providers, community-based organizations, and legal services programs).

    Section 90.17(b) allows states to use up to ten percent of each allocation category (law enforcement, prosecution, victim services, courts, and discretionary) to support the state's administrative costs. Examples of such costs include the salary and benefits of staff who administer the program and costs of conducting peer review. This paragraph codifies a long-standing OVW policy regarding state administrative costs. OVW added language from the OVC VOCA Assistance Program Rule regarding the use of funds for administrative costs. The programs often have the same administrators, so it is important that the regulations governing the two programs are consistent.

    § 90.18 Matching Funds

    Section 90.18 implements the match provisions of 42 U.S.C. 3796gg-1(f) and 13925(b)(1). VAWA 2005 provided that match could not be required for subgrants to tribes, territories, or victim service providers. It also authorized a waiver of match for states that have “adequately demonstrated [their] financial need.” 42 U.S.C. 13925(b)(1). VAWA 2013 further specified that the costs of subgrants for victim services or tribes would not count toward the total amount of the STOP award in calculating match. 42 U.S.C. 3796gg-1(f).

    Section 90.18(a) states the match requirement in general and reflects that the match requirement does not apply to territories.

    Section 90.18(b) allows for in-kind match, consistent with 2 CFR 200.306, and provides information on calculating the value of in-kind match.

    Section 90.18(c) provides that states may not require match for subgrants for Indian tribes or victim service providers. This is consistent with 42 U.S.C. 13925(b)(1), as added by VAWA 2005.

    Section 90.18(d) implements the waiver provisions of 42 U.S.C. 13925(b)(1), as added by VAWA 2005. In developing the criteria for waiver, OVW balanced the importance of state and local support for the efforts funded under the STOP Program with the need for waiver where there is demonstrated financial need. The paragraph ensures that the financial need identified by the state is specifically tied to funding for violence against women programs. For example, if a state has had across-the-board budget cuts, it would need to show how those cuts have impacted state funding for violence against women programs (and hence, its ability to provide matching funds). In most cases, a state would receive a partial waiver based on the specific impact of the cuts. For example, if the state had a 20 percent reduction in violence against women funding, then it would receive a 20 percent waiver. The 20 percent cut should leave the state with 80 percent of funds that could still be used toward match. In most cases, the states pass the match on to subgrantees, except for Indian tribes and victim service providers. In cases of awards to Indian tribes or awards to victim service providers for victim services purposes, as opposed to another purpose, such as law enforcement training, the state is exempted from the match requirement.

    Section 90.18(e) provides that matching funds must be used for the same purposes as the federal funds and must be tracked for accountability purposes.

    OVW received one comment on section 90.18. The commenter was seeking clarification that subgrants to victim service providers that are either awarded from the discretionary allocation or from funds that were returned from subgrantees under other allocations are exempt from match. OVW agrees and has amended paragraph (a) in the final rule to clarify that funds awarded under these two scenarios are excluded from the total award amount for purposes of calculating match.

    § 90.19 Application Content

    Section 90.19 provides that states must apply for STOP Program funding using an annual solicitation issued by OVW. VAWA 2013 streamlined the application process by including most information and documentation in the implementation plan, but also requiring the plan to be submitted at the time of application. No comments were received on this section.

    § 90.21 Evaluation

    Section 90.21 encourages states to have plans for evaluating the impact and effectiveness of their projects and requires them to cooperate with federally-sponsored evaluations of their projects. No comments were received on this section.

    § 90.22 Review of State Applications

    Section 90.22 provides the statutory basis for review of state applications and implements the Single Point of Contact requirement of Executive Order 12372 (Intergovernmental Review of Federal Programs). No comments were received on this section.

    § 90.23 Annual Grantee and Subgrantee Reporting

    Section 90.23 describes the annual reporting requirement for the program. Subgrantees submit annual progress reports to the state, which then forwards them to OVW, or as otherwise directed by OVW. States also must submit an annual progress report. Information on progress reports, along with the forms and instructions, are available at http://muskie.usm.maine.edu/vawamei/stopformulamain.htm. OVW received one comment on this section. The commenter was concerned that the current annual reports are time consuming, expensive, and intrusive to survivors and recommended that OVW consider whether the reporting process can be simplified. OVW is considering ways to improve the progress reporting process. Under the current process, it is expected that grantees and subgrantees will determine in some cases that, under the circumstances, it is not appropriate to ask a victim for certain information. The grantee or subgrantee only needs to report demographic information to the extent that it can be obtained in the course of providing victim-centered services, and there is generally an “unknown” category they can use, if needed. The information generated from the progress reports is used for a report to Congress, which highlights the accomplishments of the program, and also has other valuable uses. For example, progress reports are used by both OVW and states for monitoring purposes, and data from the progress reports may be used at the state and national level for identifying trends, promising practices, and areas of need.

    § 90.24 Activities That May Compromise Victim Safety and Recovery

    Section 90.24 provides that grant funds may not be used to support activities that compromise victim safety and recovery. This section is based on the overall purpose of VAWA to enhance victim safety. Specific examples of such activities are included in the STOP Program solicitation each year and in special conditions attached to each OVW grant award. For example, past solicitations explained that such unsafe activities include procedures or policies that exclude victims from receiving safe shelter, advocacy services, counseling, and other assistance based on their actual or perceived age, immigration status, race, religion, sexual orientation, gender identity, mental health condition, physical health condition, criminal record, work in the sex industry, or the age and/or gender of their children. No comments were received on this section.

    § 90.25 Reallocation of Funds

    Section 90.25 implements a new provision from VAWA 2013, 42 U.S.C. 3796gg-1(j), which allows states to reallocate funds in the law enforcement, prosecution, courts, and victim services (including culturally specific services) allocation categories if they did not receive “sufficient eligible applications.” The section defines an “eligible” application and provides the information that states must maintain on file to document a lack of sufficient eligible applications. The section ensures that states conduct sufficient outreach to the eligible category of subgrantees before reallocating the funds. One commenter noted that, while they generally agree with the provision, they request more detail on what is needed for a state to be allowed to reallocate funds to another category. Another commenter specifically stated that, if there have been insufficient applications in the culturally specific category, the state should also provide documentation as to whether there were applicants that applied but failed to qualify and if the state reached out to any applicants that failed to apply. OVW agrees with these suggestions but has concluded that they apply not just to the culturally specific category, but to all of the categories. OVW has added a requirement regarding additional documentation on applications that were unfunded for all of the categories (i.e., law enforcement, courts, victim services, prosecution, and culturally-specific) and reorganized the section for better clarity.

    IV. Regulatory Certifications Executive Orders 12866 and 13563—Regulatory Review

    This regulation has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review,” section 1(b), Principles of Regulation, and in accordance with Executive Order 13563, “Improving Regulation and Regulatory Review,” section 1(b). General Principles of Regulation.

    The Department of Justice has determined that this rule is not a “significant regulatory action” under Executive Order 12866, section 3(f) because it is not likely to: (1) Have an annual effect on the economy of $100 million or more; (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.

    (1) The rule's impact is limited to OVW grant funds. It does not change the economic impact of the grant funds and will impose very few economic costs as discussed below.

    (2) The Department of Health and Human Services (HHS) has a similar program under the Family Violence Prevention and Services Act (FVPSA), which uses some of the same definitions and a similar confidentiality provision. OVW and the HHS FVPSA office coordinate to ensure consistency in implementation of programs.

    (3) The requirements in the rule are statutory and apply only to OVW grantees. In some cases, OVW has added some additional specificity to clarify the statutory requirements. The rule provides details on what information the states must provide as “documentation,” but does not impose new requirements.

    (4) This rule does not raise any novel legal or policy issues.

    Further, both Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and to select regulatory approaches that maximize net benefits. The Department has assessed the costs and benefits of this regulation and believes that the regulatory approach selected maximizes net benefits. In most cases, the rule simply clarifies the statutory requirements, such as providing definitions, which would not have any cost or might reduce costs by providing administrators with clear guidance.

    OVW provides the following analysis of the most noteworthy costs, benefits, and alternative choices.

    Subpart A. In general, most of this subpart comes from the statute. OVW developed all of these provisions to answer questions received regularly from grantees and provide greater clarity for grantees and save them the time and effort of analyzing the requirements and seeking further guidance from OVW staff. Under this final rule, a victim service component of a larger organization, agency, or government will need a victim release to share identifying victim information with other divisions or leadership of the organization, agency or government. The use of the release will increase the degree of control that the victim has over his/her information, which is widely considered a best practice in the violence against women field. The cost of the rule is the time and administrative burden in executing and tracking the release. This cost cannot be quantified, however, because the discussion of release with the victim would take place in the context of a larger conversation between the victim and the service provider about options for the victim and next steps. OVW considered whether to prevent the release of information about deceased victims in the context of fatality reviews, out of consideration for surviving family members. OVW found a balance that allows for release but also requires the fatality review to attempt to get permission from an authorized representative and surviving minor children (and/or guardians of such) and limits the release to information necessary for the fatality review.

    Subpart B. In general, changes to subpart B reflect a balance between the burden on the state administrators and the need to ensure compliance with the statute. The relevant statute requires state implementation plans that must identify how the state will use STOP funds and meet certain statutory requirements. OVW opted to require full plans only every four years to reduce the burden on states in developing these plans. In the other years, states only submit updates to their plans.

    Executive Order 13132—Federalism

    This regulation will not have substantial direct effects on the states, on the relationship between the national government and the states, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

    Regulatory Flexibility Act

    The OVW, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and, by approving it, certifies that this regulation will not have a significant economic impact upon a substantial number of small entities for the following reason: Except for the match provisions in § 90.18, the direct economic impact is limited to the OVW's appropriated funds. For more information on economic impact, please see above.

    Executive Order 12988—Civil Justice Reform

    This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

    Executive Order 13175—Consultation and Coordination With Indian Tribal Governments

    This rule will not result in substantial direct increased costs to Indian tribal governments. The definitions and confidentiality provisions of the rule will impact grantees that are tribes. OVW currently has 351 active awards to 226 tribes and tribal organizations, for a total of over $182 million. As discussed above, any financial costs imposed by the rule are minimal.

    In addition, although a small number of tribes are subgrantees of the STOP Program, discussed in subpart B, the requirements of the rule are imposed on grantees, not subgrantees. The one provision in subpart B that will have a direct effect on tribes is § 90.12(b)(3), which implements the statutory requirement that states consult with “tribal governments in those States with State or federally recognized Indian tribes.” 42 U.S.C. 3796gg-1(c)(2)(F). The rule requires states to invite all state or federally recognized tribes in the state to participate in the planning process. This approach was recommended by tribal participants in the tribal listening session and at OVW's annual government-to-government tribal consultations in 2013 and 2014.

    As discussed above, OVW included regulatory implementation of statutory changes to the STOP Program as a topic at its annual tribal consultations in 2013 and 2014. At the 2013 consultation, tribal leaders were asked for testimony on terms that should be defined in the regulations, additional entities that states should consult with in developing their implementation plans, how states should document the participation of planning committee members, and how states should consult with tribes, among other specific questions. The questions presented at the 2014 consultation included how states might better consult with tribes during STOP implementation planning, and how states should include tribes in the equitable distribution of funds for underserved populations and culturally specific services. At both consultations, tribal leaders emphasized the importance of states engaging in meaningful consultation with all tribes in their state. Tribal leaders noted that such consultation should involve a cooperative decision-making process designed to reach consensus before a decision is made or action is taken, and that effective consultation leads to an implementation plan that takes into account the needs of tribes. Tribal leaders also pointed out that a state's failure to consult with tribes can prevent tribes from accessing STOP funds or even being aware that they are available. Finally, testimony at the tribal consultations raised concerns about states asking tribal shelters to volunteer to provide matching funds in order to receive STOP subgrant funding.

    Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

    Small Business Regulatory Enforcement Fairness Act of 1996

    This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This 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 in domestic and export markets.

    List of Subjects in 28 CFR Part 90

    Grant programs; Judicial administration.

    For the reasons set forth in the preamble, the Office on Violence Against Women amends 28 CFR part 90 as follows:

    PART 90—VIOLENCE AGAINST WOMEN 1. The authority for part 90 is revised to read as follows: Authority:

    42 U.S.C. 3796gg et seq.; 42 U.S.C. 3796hh et seq., 42 U.S.C. 13925

    Subpart A—General Provisions 2. Section 90.1 is revised to read as follows:
    § 90.1 General

    (a) This part implements certain provisions of the Violence Against Women Act (VAWA), and subsequent legislation as follows:

    (1) The Violence Against Women Act (VAWA), Title IV of the Violent Crime Control and Law Enforcement Act of 1994, Public Law 103-322 (Sept. 13, 1994);

    (2) The Violence Against Women Act of 2000 (VAWA 2000), Division B of the Victims of Trafficking and Violence Protection Act of 2000, Public Law 106-386 (Oct. 28, 2000);

    (3) The Violence Against Women Office Act, Title IV of the 21st Century Department of Justice Appropriations Authorization Act, Public Law 107-273 (Nov. 2, 2002);

    (4) The Violence Against Women and Department of Justice Reauthorization Act of 2005 (VAWA 2005), Public Law 109-162 (January 5, 2006); and,

    (5) The Violence Against Women Reauthorization Act of 2013 (VAWA 2013), Public Law 113-4 (Mar. 7, 2013).

    (b) Subpart B of this part defines program eligibility criteria and sets forth requirements for application for and administration of formula grants to States to combat violent crimes against women. This program is codified at 42 U.S.C. 3796gg through 3796gg-5 and 3796gg-8.

    (c) Subpart C of this part was removed on September 9, 2013.

    (d) Subpart D of this part defines program eligibility criteria and sets forth requirements for the discretionary Grants to Encourage Arrest Policies and Enforcement of Protection Orders Program.

    (e) Subpart A of this part applies to all grants made by OVW and subgrants made under the STOP Violence Against Women Formula Program (STOP Program) and the Sexual Assault Services Formula Grant Program after the effective date of this rule. Subpart B of this part applies to all STOP Program grants issued by OVW after the effective date of the rule and to all subgrants issued by states under the STOP Program after the effective date of the rule, even if the underlying grant was issued by OVW prior to the effective date of the rule.

    3. Section 90.2 is revised to read as follows:
    § 90.2 Definitions

    (a) In addition to the definitions in this section, the definitions in 42 U.S.C. 13925(a) apply to all grants awarded by the Office on Violence Against Women and all subgrants made under such awards.

    (b) The term “community-based program” has the meaning given the term “community-based organization” in 42 U.S.C. 13925(a).

    (c) The term “forensic medical examination” means an examination provided to a victim of sexual assault by medical personnel to gather evidence of a sexual assault in a manner suitable for use in a court of law.

    (1) The examination should include at a minimum:

    (i) Gathering information from the patient for the forensic medical history;

    (ii) Head-to-toe examination of the patient;

    (iii) Documentation of biological and physical findings; and

    (iv) Collection of evidence from the patient.

    (2) Any costs associated with the items listed in paragraph (c)(1) of this section, such as equipment or supplies, are considered part of the “forensic medical examination.”

    (3) The inclusion of additional procedures (e.g., testing for sexually transmitted diseases) may be determined by the State, Indian tribal government, or unit of local government in accordance with its current laws, policies, and practices.

    (d) The term “prevention” includes both primary and secondary prevention efforts. “Primary prevention” means strategies, programming, and activities to stop both first-time perpetration and first-time victimization. Primary prevention is stopping domestic violence, dating violence, sexual assault, and stalking before they occur. “Secondary prevention” is identifying risk factors or problems that may lead to future domestic violence, dating violence, sexual assault, or stalking and taking the necessary actions to eliminate the risk factors and the potential problem. “Prevention” is distinguished from “outreach,” which has the goal of informing victims and potential victims about available services.

    (e) The term “prosecution” means any public agency charged with direct responsibility for prosecuting criminal offenders, including such agency's component bureaus (such as governmental victim services programs). Public agencies that provide prosecution support services, such as overseeing or participating in Statewide or multi-jurisdictional domestic violence, dating violence, sexual assault, or stalking task forces, conducting training for State, tribal, or local prosecutors or enforcing victim compensation and domestic violence, dating violence, sexual assault, or stalking-related restraining orders also fall within the meaning of “prosecution” for purposes of this definition.

    (f) The term “public agency” has the meaning provided in 42 U.S.C. 3791.

    (g) For the purpose of this part, a “unit of local government” is any city, county, township, town, borough, parish, village, or other general purpose political subdivision of a State. The following are not considered units of local government for purposes of this part:

    (1) Police departments;

    (2) Pre-trial service agencies;

    (3) District or city attorneys' offices;

    (4) Sheriffs' departments;

    (5) Probation and parole departments;

    (6) Shelters;

    (7) Nonprofit, nongovernmental victim service agencies including faith-based or community-based organizations; and

    (8) Universities.

    (h) The term “victim services division or component of an organization, agency, or government” refers to a division within a larger organization, agency, or government, where the division has as its primary purpose to assist or advocate for domestic violence, dating violence, sexual assault, or stalking victims and has a documented history of work concerning such victims.

    4. Section 90.4 is added to subpart A to read as follows:
    § 90.4 Grant conditions.

    (a) Applicability. In addition to the grant conditions in paragraphs (b) and (c) of this section, the grant conditions in 42 U.S.C. 13925(b) apply to all grants awarded by the Office on Violence Against Women and all subgrants made under such awards.

    (b) Nondisclosure of confidential or private information—(1) In general. In order to ensure the safety of adult, youth, and child victims of domestic violence, dating violence, sexual assault, or stalking and their families, grantees and subgrantees under this part shall protect the confidentiality and privacy of persons receiving services.

    (2) Nondisclosure. (i) Subject to paragraph (b)(3) of this section, grantees and subgrantees shall not disclose any personally identifying information or individual information collected in connection with services requested, utilized, or denied through grantees' and subgrantees' programs, regardless of whether the information has been encoded, encrypted, hashed, or otherwise protected.

    (ii) This paragraph applies whether the information is being requested for a Department of Justice grant program or another Federal agency, State, tribal, or territorial grant program. This paragraph also limits disclosures by subgrantees to grantees, including disclosures to Statewide or regional databases.

    (iii) This paragraph also applies to disclosures from the victim services divisions or components of an organization, agency, or government to other non-victim service divisions within an organization, agency, or government. It also applies to disclosures from victim services divisions or components of an organization, agency, or government to the leadership of the organization, agency, or government (e.g., executive director or chief executive). Such executives shall have access without releases only in extraordinary and rare circumstances. Such circumstances do not include routine monitoring and supervision.

    (3) Release. (i) Personally identifying information or individual information that is collected as described in paragraph (b)(2) of this section may not be released except under the following circumstances:

    (A) The victim signs a release as provided in paragraph (b)(3)(ii) of this section;

    (B) Release is compelled by statutory mandate, which includes mandatory child abuse reporting laws; or

    (C) Release is compelled by court mandate, which includes a legal mandate created by case law, such as a common-law duty to warn.

    (ii) Victim releases must meet the following criteria—

    (A) Releases must be written, informed, and reasonably time-limited. Grantees and subgrantees may not use a blanket release and must specify the scope and limited circumstances of any disclosure. At a minimum, grantees and subgrantees must: Discuss with the victim why the information might be shared, who would have access to the information, and what information could be shared under the release; reach agreement with the victim about what information would be shared and with whom; and record the agreement about the scope of the release. A release must specify the duration for which information may be shared. The reasonableness of this time period will depend on the specific situation.

    (B) Grantees and subgrantees may not require consent to release of information as a condition of service.

    (C) Releases must be signed by the victim unless the victim is a minor who lacks the capacity to consent to release or is a legally incapacitated person and has a court-appointed guardian. Except as provided in paragraph (b)(3)(ii)(D) of this section, in the case of an unemancipated minor, the release must be signed by the minor and a parent or guardian; in the case of a legally incapacitated person, it must be signed by a legally-appointed guardian. Consent may not be given by the abuser of the minor or incapacitated person or the abuser of the other parent of the minor. If a minor is incapable of knowingly consenting, the parent or guardian may provide consent. If a parent or guardian consents for a minor, the grantee or subgrantee should attempt to notify the minor as appropriate.

    (D) If the minor or person with a legally appointed guardian is permitted by law to receive services without the parent's or guardian's consent, the minor or person with a guardian may consent to release information without additional consent.

    (iii) If the release is compelled by statutory or court mandate, grantees and subgrantees must make reasonable efforts to notify victims affected by the disclosure and take steps necessary to protect the privacy and safety of the affected persons.

    (4) Fatality reviews. Grantees and subgrantees may share personally identifying information or individual information that is collected as described in paragraph (b)(2) of this section about deceased victims being sought for a fatality review to the extent permitted by their jurisdiction's law and only if the following conditions are met:

    (i) The underlying objectives of the fatality review are to prevent future deaths, enhance victim safety, and increase offender accountability;

    (ii) The fatality review includes policies and protocols to protect identifying information, including identifying information about the victim's children, from further release outside the fatality review team;

    (iii) The grantee or subgrantee makes a reasonable effort to get a release from the victim's personal representative (if one has been appointed) and from any surviving minor children or the guardian of such children (but not if the guardian is the abuser of the deceased parent), if the children are not capable of knowingly consenting; and

    (iv) The information released is limited to that which is necessary for the purposes of the fatality review.

    (5) Inadvertent release. Grantees and subgrantees are responsible for taking reasonable efforts to prevent inadvertent releases of personally identifying information or individual information that is collected as described in paragraph (b)(2) of this section.

    (6) Confidentiality assessment and assurances. Grantees and subgrantees are required to document their compliance with the requirements of this paragraph. All applicants for Office on Violence Against Women funding are required to submit a signed acknowledgement form, indicating that they have notice that, if awarded funds, they will be required to comply with the provisions of this paragraph, will mandate that subgrantees, if any, comply with this provision, and will create and maintain documentation of compliance, such as policies and procedures for release of victim information, and will mandate that subgrantees, if any, will do so as well.

    (c) Victim eligibility for services. Victim eligibility for direct services is not dependent on the victim's immigration status.

    (d) Reports. An entity receiving a grant under this part shall submit to the Office on Violence Against Women reports detailing the activities undertaken with the grant funds. These reports must comply with the requirements set forth in 2 CFR 200.328 and provide any additional information that the Office on Violence Against Women requires.

    5. Subpart B is revised to read as follows: Subpart B—The STOP (Services * Training * Officers * Prosecutors) Violence Against Women Formula Grant Program Sec. 90.10 STOP (Services * Training * Officers * Prosecutors) Violence Against Women Formula Grant Program—general. 90.11 State office. 90.12 Implementation plans. 90.13 Forensic medical examination payment requirement. 90.14 Judicial notification requirement. 90.15 Costs for criminal charges and protection orders. 90.16 Polygraph testing prohibition. 90.17 Subgranting of funds. 90.18 Matching funds. 90.19 Application content. 90.21 Evaluation. 90.22 Review of State applications. 90.23 Annual grantee and subgrantee reporting. 90.24 Activities that may compromise victim safety and recovery. 90.25 Reallocation of funds.
    § 90.10 STOP (Services * Training * Officers * Prosecutors) Violence Against Women Formula Grant Program—general.

    The purposes, criteria, and requirements for the STOP Violence Against Women Formula Grant Program are established by 42 U.S.C. 3796gg et seq. Eligible applicants for the program are the 50 States, American Samoa, Guam, Puerto Rico, Northern Mariana Islands, U.S. Virgin Islands, and the District of Columbia, hereinafter referred to as “States.”

    § 90.11 State office.

    (a) Statewide plan and application. The chief executive of each participating State shall designate a State office for the purposes of:

    (1) Certifying qualifications for funding under this program;

    (2) Developing a Statewide plan for implementation of the STOP Violence Against Women Formula Grants as described in § 90.12; and

    (3) Preparing an application to receive funds under this program.

    (b) Administration and fund disbursement. In addition to the duties specified by paragraph (a) of this section, the State office shall administer funds received under this program, including receipt, review, processing, monitoring, progress and financial report review, technical assistance, grant adjustments, accounting, auditing, and fund disbursements.

    (c) Allocation requirement. (1) The State office shall allocate funds as provided in 42 U.S.C. 3796gg-1(c)(4) to courts and for law enforcement, prosecution, and victim services (including funds that must be awarded to culturally specific community-based organizations).

    (2) The State office shall ensure that the allocated funds benefit law enforcement, prosecution and victim services and are awarded to courts and culturally specific community-based organizations. In ensuring that funds benefit the appropriate entities, if funds are not subgranted directly to law enforcement, prosecution, and victim services, the State must require demonstration from the entity to be benefitted in the form of a memorandum of understanding signed by the chief executives of both the entity and the subgrant recipient, stating that the entity supports the proposed project and agrees that it is to the entity's benefit.

    (3) Culturally specific allocation: 42 U.S.C. 13925 defines “culturally specific” as primarily directed toward racial and ethnic minority groups (as defined in 42 U.S.C. 300u-6(g)). An organization will qualify for funding for the culturally specific allocation if its primary mission is to address the needs of racial and ethnic minority groups or if it has developed a special expertise regarding services to address the demonstrated needs of a particular racial and ethnic minority group. The organization must do more than merely provide services to the targeted group; rather, the organization must provide culturally competent services designed to meet the specific needs of the target population. This allocation requires States to set aside a minimum of ten percent (within the thirty-percent allocation for victim services) of STOP Program funds for culturally specific services, but States are encouraged to provide higher levels of funding to address the needs of racial and ethnic minority groups. States should tailor their subgrant application process to assess the qualifications of applicants for the culturally specific set aside, such as reviewing the mission statement of the applicant, the make-up of the board of directors or steering committee of the applicant (with regard to knowledge and experience with relevant cultural populations and language skills), and the history of the organization.

    (4) Sexual assault set aside: As provided in 42 U.S.C. 3796gg-1(c)(5), the State must also award at least 20 percent of the total State award to projects in two or more allocations in 42 U.S.C. 3796gg-1(c)(4) that meaningfully address sexual assault. States should evaluate whether the interventions are tailored to meet the specific needs of sexual assault victims including ensuring that projects funded under the set aside have a legitimate focus on sexual assault and that personnel funded under such projects have sufficient expertise and experience on sexual assault.

    (d) Pass-through administration. The State office has broad latitude in structuring its administration of the STOP Violence Against Women Formula Grant Program. STOP Program funding may be administered by the State office itself or by other means, including the use of pass-through entities (such as State domestic violence or sexual assault coalitions) to make determinations regarding award distribution and to administer funding. States that opt to use a pass-through entity shall ensure that the total sum of STOP Program funding for administrative and training costs for the State and pass-through entity is within the limit established by § 90.17(b), the reporting of activities at the subgrantee level is equivalent to what would be provided if the State were directly overseeing sub-awards, and an effective system of monitoring sub-awards is used. States shall report on the work of the pass-through entity in such form and manner as OVW may specify from time to time.

    § 90.12 Implementation plans.

    (a) In general. Each State must submit a plan describing its identified goals under this program and how the funds will be used to accomplish those goals. The plan must include all of the elements specified in 42 U.S.C. 3796gg-1(i). The plan will cover a four-year period. In years two through four of the plan, each State must submit information on any updates or changes to the plan, as well as updated demographic information.

    (b) Consultation and coordination. In developing and updating this plan, a State must consult and coordinate with the entities specified in 42 U.S.C. 3796gg-1(c)(2).

    (1) This consultation process must include at least one sexual assault victim service provider and one domestic violence victim service provider and may include other victim service providers.

    (2) In determining what population specific organizations, representatives from underserved populations, and culturally specific organizations to include in the consultation process, States should consider the demographics of their State as well as barriers to service, including historical lack of access to services, for each population. The consultation process should involve any significant underserved and culturally specific populations in the State, including organizations working with lesbian, gay, bisexual, and transgender (LGBT) people and organizations that focus on people with limited English proficiency. If the State does not have any culturally specific or population specific organizations at the State or local level, the State may use national organizations to collaborate on the plan.

    (3) States must invite all State or federally recognized tribes to participate in the planning process. Tribal coalitions and State or regional tribal consortia may help the State reach out to the tribes but cannot be used as a substitute for consultation with all tribes.

    (4) States are encouraged to include survivors of domestic violence, dating violence, sexual assault, and stalking in the planning process. States that include survivors should address safety and confidentiality considerations in recruiting and consulting with such survivors.

    (5) States should include probation and parole entities in the planning process.

    (6) As provided in 42 U.S.C. 3796gg-1(c)(3), States must coordinate the plan with the State plan for the Family Violence Prevention and Services Act (42 U.S.C. 10407), the State Victim Assistance Formula Grants under the Victims of Crime Act (42 U.S.C. 10603), and the Rape Prevention and Education Program (42 U.S.C. 280b-1b). The purposes of this coordination process are to provide greater diversity of projects funded and leverage efforts across the various funding streams.

    (7) Although all of the entities specified in 42 U.S.C. 3796gg-1(c)(2) must be consulted, they do not all need to be on the “planning committee.” The planning committee must include the following, at a minimum:

    (i) The State domestic violence and sexual assault coalitions as defined by 42 U.S.C. 13925(a)(32) and (33) (or dual coalition)

    (ii) A law enforcement entity or State law enforcement organization

    (iii) A prosecution entity or State prosecution organization

    (iv) A court or the State Administrative Office of the Courts

    (v) Representatives from tribes, tribal organizations, or tribal coalitions

    (vi) Population specific organizations representing the most significant underserved populations and culturally specific populations in the State other than tribes, which are addressed separately.

    (8) The full consultation should include more robust representation than the planning committee from each of the required groups as well as all State and Federally recognized tribes.

    (c) Documentation of consultation. As part of the implementation plan, the State must either submit or retain documentation of collaboration with all the entities specified in paragraph (b) of this section and in 42 U.S.C. 3796gg-1(c)(2), as provided in this paragraph.

    (1) States must retain all of the following documentation but are not required to submit it to OVW as part of the implementation plan:

    (i) For in-person meetings, a sign-in sheet with name, title, organization, which of the required entity types (e.g., tribal government, population specific organization, prosecution, court, state coalition) the person is representing, phone number, email address, and signature;

    (ii) For online meetings, the web reports or other documentation of who participated in the meeting;

    (iii) For phone meetings, documentation of who was on the call, such as a roll call or minutes; and

    (iv) For any method of document review that occurred outside the context of a meeting, information such as to whom the draft implementation plan was sent, how it was sent (for example, email versus mail), and who responded.

    (2) States must submit all of the following documentation to OVW as part of the implementation plan:

    (i) A summary of major concerns that were raised during the planning process and how they were addressed or why they were not addressed, which should be sent to the planning committee along with any draft implementation plan and the final plan;

    (ii) Documentation of collaboration for each planning committee member that documents, at a minimum:

    (A) Which category the participant represents of the entities listed in 42 U.S.C. 3796gg-1(c)(2), such as law enforcement, state coalition, or population specific organization;

    (B) Whether they were informed about meetings;

    (C) Whether they attended meetings;

    (D) Whether they were given drafts of the implementation plan to review;

    (E) Whether they submitted comments on the draft;

    (F) Whether they received a copy of the final plan and the summary of major concerns; and

    (G) Any significant concerns with the final plan;

    (iii) A description of efforts to reach tribes, if applicable;

    (iv) An explanation of how the State determined which underserved and culturally specific populations to include.

    (d) Equitable distribution. The implementation plan must describe, on an annual or four-year basis, how the State, in disbursing monies, will:

    (1) Give priority to areas of varying geographic size with the greatest showing of need based on the range and availability of existing domestic violence and sexual assault programs in the population and geographic area to be served in relation to the availability of such programs in other such populations and geographic areas, including Indian reservations;

    (2) Determine the amount of subgrants based on the population and geographic area to be served;

    (3) Equitably distribute monies on a geographic basis including nonurban and rural areas of various geographic sizes;

    (4) Recognize and meaningfully respond to the needs of underserved populations and ensure that monies set aside to fund linguistically and culturally specific services and funds for underserved populations are distributed equitably among culturally specific and other underserved populations; and

    (5) Take steps to ensure that eligible applicants are aware of the STOP Program funding opportunity, including applicants serving different geographic areas and culturally specific and other underserved populations.

    (e) Underserved populations. Each State may determine the methods it uses for identifying underserved populations within the State, which may include public hearings, needs assessments, task forces, and United States Census Bureau data. The implementation plan must include details regarding the methods used and the results of those methods. It must also include information on how the State plans to meet the needs of identified underserved populations, including, but not limited to, culturally specific populations, victims who are underserved because of sexual orientation or gender identity, and victims with limited English proficiency.

    (f) Goals and objectives for reducing domestic violence homicide. As required by 42 U.S.C. 3796gg-1(i)(2)(G), State plans must include goals and objectives for reducing domestic violence homicide.

    (1) The plan must include available statistics on the rates of domestic violence homicide within the State.

    (2) As part of the State's consultation with law enforcement, prosecution, and victim service providers, the State and these entities should discuss and document the perceived accuracy of these statistics and the best ways to address domestic violence homicide.

    (3) The plan must identify specific goals and objectives for reducing domestic violence homicide, based on these discussions, which include challenges specific to the State and how the plan can overcome them.

    (g) Additional contents. State plans must also include the following:

    (1) Demographic information regarding the population of the State derived from the most recent available United States Census Bureau data including population data on race, ethnicity, age, disability, and limited English proficiency.

    (2) A description of how the State will reach out to community-based organizations that provide linguistically and culturally specific services.

    (3) A description of how the State will address the needs of sexual assault victims, domestic violence victims, dating violence victims, and stalking victims, as well as how the State will hold offenders who commit each of these crimes accountable.

    (4) A description of how the State will ensure that eligible entities are aware of funding opportunities, including projects serving underserved populations as defined by 42 U.S.C. 13925(a).

    (5) Information on specific projects the State plans to fund.

    (6) An explanation of how the State coordinated the plan as described in paragraph (b)(6) and the impact of that coordination on the contents of the plan.

    (7) If applicable, information about whether the State has submitted an assurance, a certification, or neither under the Prison Rape Elimination Act (PREA) standards (28 CFR part 115) and, if an assurance, how the State plans to spend STOP funds set aside for PREA compliance.

    (8) A description of how the State will identify and select applicants for subgrant funding, including whether a competitive process will be used.

    (h) Deadline. State plans will be due at application. If the Office on Violence Against Women determines the submitted plan is incomplete, the State will receive the award, but will not be able to access funding until the plan is completed and approved. The State will have 60 days from the award date to complete the plan. If the State does not complete it in that time, then the funds may be deobligated and the award closed.

    § 90.13 Forensic medical examination payment requirement.

    (a) To be eligible for funding under this program, a State must meet the requirements at 42 U.S.C. 3796gg-4(a)(1) with regard to incurring the full out-of-pocket costs of forensic medical examinations for victims of sexual assault.

    (b) “Full out-of-pocket costs” means any expense that may be charged to a victim in connection with a forensic medical examination for the purpose of gathering evidence of a sexual assault (e.g., the full cost of the examination, an insurance deductible, or a fee established by the facility conducting the examination). For individuals covered by insurance, full out-of-pocket costs means any costs that the insurer does not pay.

    (c) Coverage of the cost of additional procedures (e.g., testing for sexually transmitted diseases) may be determined by the State or governmental entity responsible for paying the costs.

    (d) States are strongly discouraged from billing a victim's private insurance and may only do so as a source of payment for the exams if they are not using STOP Program funds to pay for the cost of the exams. In addition, any expenses not covered by the insurer must be covered by the State or other governmental entity and cannot be billed to the victim. This includes any deductibles or denial of claims by the insurer.

    (e) The State or other governmental entity responsible for paying the costs of forensic medical exams must coordinate with health care providers in the region to notify victims of sexual assault of the availability of rape exams at no cost to the victims. States can meet this obligation by partnering with associations that are likely to have the broadest reach to the relevant health care providers, such as forensic nursing or hospital associations. States with significant tribal populations should also consider reaching out to local Indian Health Service facilities.

    § 90.14 Judicial notification requirement.

    (a) To be eligible for funding under this program, a State must meet the requirements of 42 U.S.C. 3796gg-4(e) with regard to judicial notification to domestic violence offenders of Federal prohibitions on their possession of a firearm or ammunition in 18 U.S.C. 922(g)(8) and (9) and any applicable related Federal, State, or local laws..

    (b) A unit of local government shall not be eligible for subgrants from the State unless it complies with the requirements of 42 U.S.C. 3796gg-4(e) with respect to its judicial administrative policies and practices.

    § 90.15 Costs for criminal charges and protection orders.

    (a) To be eligible for funding under this program, a State must meet the requirements of 42 U.S.C. 3796gg-5 with regard to not requiring victims to bear the costs for criminal charges and protection orders in cases of domestic violence, dating violence, sexual assault, or stalking.

    (b) An Indian tribal government, unit of local government, or court shall not be eligible for subgrants from the State unless it complies with the requirements of 42 U.S.C. 3796gg-5 with respect to its laws, policies, and practices not requiring victims to bear the costs for criminal charges and protection orders in cases of domestic violence, dating violence, sexual assault, or stalking.

    § 90.16 Polygraph testing prohibition.

    (a) For a State to be eligible for funding under this program, the State must meet the requirements of 42 U.S.C. 3796gg-8 with regard to prohibiting polygraph testing of sexual assault victims.

    (b) An Indian tribal government or unit of local government shall not be eligible for subgrants from the State unless it complies with the requirements of 42 U.S.C. 3796gg-8 with respect to its laws, policies, or practices prohibiting polygraph testing of sexual assault victims.

    § 90.17 Subgranting of funds.

    (a) In general. Funds granted to qualified States are to be further subgranted by the State to agencies, offices, and programs including, but not limited to, State agencies and offices; State and local courts; units of local government; public agencies; Indian tribal governments; victim service providers; community-based organizations; and legal services programs to carry out programs and projects to develop and strengthen effective law enforcement and prosecution strategies to combat violent crimes against women, and to develop and strengthen victim services in cases involving violent crimes against women, and specifically for the purposes listed in 42 U.S.C. 3796gg(b) and according to the allocations specified in 42 U.S.C. 3796gg-1(c)(4) for law enforcement, prosecution, victim services, and courts.

    (b) Administrative costs. States are allowed to use up to ten percent of the award amount for each allocation category under 42 U.S.C. 3796gg-1(c)(4) (law enforcement, prosecution, courts, victim services, and discretionary) to support the State's administrative costs. Amounts not used for administrative costs should be used to support subgrants.

    (1) Funds for administration may be used only for costs directly associated with administering the STOP Program. Where allowable administrative costs are allocable to both the STOP Program and another State program, the STOP Program grant may be charged no more than its proportionate share of such costs.

    (2) Costs directly associated with administering the STOP Program generally include the following:

    (i) Salaries and benefits of State office staff and consultants to administer and manage the program;

    (ii) Training of State office staff, including, but not limited to, travel, registration fees, and other expenses associated with State office staff attendance at technical assistance meetings and conferences relevant to the program;

    (iii) Monitoring compliance of STOP Program subgrantees with Federal and State requirements, provision of technical assistance, and evaluation and assessment of program activities, including, but not limited to, travel, mileage, and other associated expenses;

    (iv) Reporting and related activities necessary to meet Federal and State requirements;

    (v) Program evaluation, including, but not limited to, surveys or studies that measure the effect or outcome of victim services;

    (vi) Program audit costs and related activities necessary to meet Federal audit requirements for the STOP Program grant;

    (vii) Technology-related costs, generally including for grant management systems, electronic communications systems and platforms (e.g., Web pages and social media), geographic information systems, related equipment (e.g., computers, software, facsimile and copying machines, and TTY/TDDs) and related technology support services necessary for administration of the program;

    (viii) Memberships in organizations that support the management and administration of violence against women programs, except if such organizations engage in lobbying, and publications and materials such as curricula, literature, and protocols relevant to the management and administration of the program;

    (ix) Strategic planning, including, but not limited to, the development of strategic plans, both service and financial, including conducting surveys and needs assessments;

    (x) Coordination and collaboration efforts among relevant Federal, State, and local agencies and organizations to improve victim services;

    (xi) Publications, including, but not limited to, developing, purchasing, printing, distributing training materials, victim services directories, brochures, and other relevant publications; and

    (xii) General program improvements—enhancing overall State office operations relating to the program and improving the delivery and quality of STOP Program funded services throughout the State.

    § 90.18 Matching funds.

    (a) In general. Subject to certain exclusions, States are required to provide a 25-percent non-Federal match. This does not apply to territories. This 25-percent match may be cash or in-kind services. States are expected to submit written documentation that identifies the source of the match. Funds awarded to victim service providers for victim services or to tribes are excluded from the total award amount for purposes of calculating match. This includes funds that are awarded under the “discretionary” allocation for victim services purposes and funds that are reallocated from other categories to victim services.

    (b) In-kind match. In-kind match may include donations of expendable equipment; office supplies; workshop or education and training materials; work space; or the monetary value of time contributed by professional and technical personnel and other skilled and unskilled labor, if the services provided are an integral and necessary part of a funded project. Value for in-kind match is guided by 2 CFR 200.306. The value placed on loaned equipment may not exceed its fair rental value. The value placed on donated services must be consistent with the rate of compensation paid for similar work in the organization or the labor market. Fringe benefits may be included in the valuation. Volunteer services must be documented and, to the extent feasible, supported by the same valuation methods used by the recipient organization for its own employees. The value of donated space may not exceed the fair rental value of comparable space, as established by an independent appraisal of comparable space and facilities in a privately owned building in the same locality. The value for donated supplies shall be reasonable and not exceed the fair market value at the time of the donation. The basis for determining the value of personal services, materials, equipment, and space must be documented.

    (c) Tribes and victim services providers. States may not require match to be provided in subgrants for Indian tribes or victim services providers.

    (d) Waiver. States may petition the Office on Violence Against Women for a waiver of match if they are able to adequately demonstrate financial need.

    (1) State match waiver. States may apply for full or partial waivers of match by submitting specific documentation of financial need. Documentation must include the following:

    (i) The sources of non-Federal funds available to the State for match and the amount available from each source, including in-kind match and match provided by subgrantees or other entities;

    (ii) Efforts made by the State to obtain the matching funds, including, if applicable, letters from other State agencies stating that the funds available from such agencies may not be used for match;

    (iii) The specific dollar amount or percentage waiver that is requested;

    (iv) Cause and extent of the constraints on projected ability to raise violence against women program matching funds and changed circumstances that make past sources of match unavailable; and

    (v) If applicable, specific evidence of economic distress, such as documentation of double-digit unemployment rates or designation as a Federal Emergency Management Agency-designated disaster area.

    (vi) In a request for a partial waiver of match for a particular allocation, the State could provide letters from the entities under that allocation attesting to their financial hardship.

    (2) Demonstration of ability to provide violence against women matching funds. The State must demonstrate how the submitted documentation affects the State's ability to provide violence against women matching funds. For example, if a State shows that across the board budget cuts have directly reduced violence against women funding by 20 percent, that State would be considered for a 20 percent waiver, not a full waiver. Reductions in Federal funds are not relevant to State match unless the State can show that the reduced Federal funding directly reduced available State violence against women funds.

    (e) Accountability. All funds designated as match are restricted to the same uses as the program funds as set forth in 42 U.S.C. 3796gg(b) and must be expended within the grant period. The State must ensure that match is identified in a manner that guarantees its accountability during an audit.

    § 90.19 Application content.

    (a) Format. Applications from the States for the STOP Program must be submitted as described in the annual solicitation. The Office on Violence Against Women will notify each State office as designated pursuant to § 90.11 when the annual solicitation is available. The solicitation will include guidance on how to prepare and submit an application for grants under this subpart.

    (b) Requirements. The application shall include all information required under 42 U.S.C. 3796gg-1(d).

    § 90.21 Evaluation.

    (a) Recipients of funds under this subpart must agree to cooperate with Federally-sponsored evaluations of their projects.

    (b) Recipients of STOP Program funds are strongly encouraged to develop a local evaluation strategy to assess the impact and effectiveness of the program funded under the STOP Program. Funds may not be used for conducting research or evaluations. Applicants should consider entering into partnerships with research organizations that are submitting simultaneous grant applications to the National Institute of Justice for this purpose.

    § 90.22 Review of State applications.

    (a) General. The provisions of Part T of the Omnibus Crime Control and Safe Streets Act of 1968, 42 U.S.C. 3796gg et seq., and of this subpart provide the basis for review and approval or disapproval of State applications and amendments.

    (b) Intergovernmental review. This program is covered by Executive Order 12372 (Intergovernmental Review of Federal Programs) and implementing regulations at 28 CFR part 30. A copy of the application submitted to the Office on Violence Against Women should also be submitted at the same time to the State's Single Point of Contact, if there is a Single Point of Contact.

    § 90.23 Annual grantee and subgrantee reporting.

    Subgrantees shall complete annual progress reports and submit them to the State, which shall review them and submit them to OVW or as otherwise directed. In addition, the State shall complete an annual progress report, including an assessment of whether or not annual goals and objectives were achieved.

    § 90.24 Activities that may compromise victim safety and recovery.

    Because of the overall purpose of the STOP Program to enhance victim safety and offender accountability, grant funds may not be used to support activities that compromise victim safety and recovery. The grant program solicitation each year will provide examples of such activities.

    § 90.25 Reallocation of funds.

    This section implements 42 U.S.C. 3796gg-1(j), regarding reallocation of funds.

    (a) Returned funds. A State may reallocate funds returned to the State, within a reasonable amount of time before the award end date.

    (b) Insufficient eligible applications. A State may also reallocate funds if the State does not receive sufficient eligible applications to award the full funding under the allocations in 42 U.S.C. 3796gg-1(c)(4). An “eligible” application is one that is from an eligible entity that has the capacity to perform the proposed services, proposes activities within the scope of the program, and does not propose significant activities that compromise victim safety. States should have the following information on file to document the lack of sufficient eligible applications:

    (1) A copy of their solicitation;

    (2) Documentation on how the solicitation was distributed, including all outreach efforts to entities from the allocation in question, which entities the State reached out to that did not apply, and, if known, why those entities did not apply;

    (3) An explanation of their selection process;

    (4) A list of who participated in the selection process (name, title, and employer);

    (5) Number of applications that were received for the specific allocation category;

    (6) Information about the applications received, such as what agency or organization they were from, how much money they were requesting, and any reasons the applications were not funded;

    (7) If applicable, letters from any relevant State-wide body explaining the lack of applications, such as from the State Court Administrator if the State is seeking to reallocate money from courts; and

    (8) For the culturally specific allocation, in addition to the items in paragraphs (b)(1) through (7) of this section, demographic statistics of the relevant racial and ethnic minority groups within the State and documentation that the State has reached out to relevant organizations within the State or national organizations.

    Dated: November 17, 2016. Bea Hanson, Principal Deputy Director.
    [FR Doc. 2016-28437 Filed 11-28-16; 8:45 am] BILLING CODE 4410-FX-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R01-OAR-2015-0351; A-1-FRL-9950-92-Region 1] Air Plan Approval; MA; Decommissioning of Stage II Vapor Recovery Systems AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the Massachusetts Department of Environmental Protection (MassDEP). This revision includes regulatory amendments that allow gasoline dispensing facilities (GDFs) to decommission their Stage II vapor recovery systems as of January 2, 2015, and a demonstration that such removal is consistent with the Clean Air Act and EPA guidance. This revision also includes regulatory amendments that strengthen Massachusetts' requirements for Stage I vapor recovery systems at GDFs. The intended effect of this action is to approve Massachusetts' revised vapor recovery regulations. This action is being taken in accordance with the Clean Air Act.

    DATES:

    This rule is effective on December 29, 2016.

    ADDRESSES:

    EPA has established a docket for this action under Docket Identification No. EPA-R01-OAR-2015-0351. All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available at http://www.regulations.gov or at the U.S. Environmental Protection Agency, EPA New England Regional Office, Office of Ecosystem Protection, Air Quality Planning Unit, 5 Post Office Square, Suite 100, Boston, MA. EPA requests that if at all possible, you contact the contact listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Ariel Garcia, Air Quality Planning Unit, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square, Suite 100 (mail code: OEP05-2), Boston, MA 02109-3912, telephone number (617) 918-1660, fax number (617) 918-0660, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

    Organization of this document. The following outline is provided to aid in locating information in this preamble.

    I. Background and Purpose II. Response to Comments III. Final Action IV. Incorporation by Reference V. Statutory and Executive Order Reviews I. Background and Purpose

    On March 9, 2016 (81 FR 12440), EPA published a Notice of Proposed Rulemaking (NPR) for the Commonwealth of Massachusetts. The NPR proposed approval of Massachusetts' revised regulations 310 Code of Massachusetts Regulations (CMR) 7.00, Air Pollution Control: Definitions, 310 CMR 7.24(3), Distribution of Motor Vehicle Fuel, 310 CMR 7.24(4), Motor Vehicle Fuel Tank Trucks, and 310 CMR 7.24(6), Dispensing of Motor Vehicle Fuel. These regulations had been amended to allow the decommissioning of Stage II vapor recovery systems and to strengthen Stage I vapor recovery requirements. The SIP revision was submitted by the MassDEP on May 5, 2015 and also included a demonstration that the decommissioning of Stage II vapor recovery systems at gasoline dispensing facilities is consistent with the Clean Air Act and EPA guidance.

    A detailed discussion of Massachusetts' May 5, 2015 SIP revision and EPA's rationale for proposing approval of the SIP revision were provided in the NPR and will not be restated in this notice, except to the extent relevant to our responses to public comments we received on our proposal.

    II. Response to Comments

    EPA received one comment on the NPR from the Vapor Recovery Association. That comment is summarized below with EPA's response.

    Comment: The commenter opposes EPA's proposed approval of Massachusetts' revised Stage II vapor recovery regulation. The commenter believes that eliminating Stage II vapor recovery systems at GDFs and relying solely on Onboard Refueling Vapor Recovery (ORVR) systems located within the vehicles to mitigate refueling emissions will have a negative impact on air quality; cause adverse health impacts to motorists, GDF employees, and members of the community; and result in a severe negative burden in Environmental Justice (EJ) areas in Massachusetts.

    Furthermore, the commenter asserts that MassDEP's rationale for decommissioning Stage II vapor recovery systems is not based in science and that it can be mathematically shown that emissions will be increased rather than decreased as a result of the elimination of the Stage II vapor recovery program. However, the commenter did not submit any calculations in support of its claims of the increased emissions, health impacts, and the impacts on EJ areas that the commenter alleges would result from decommissioning Stage II vapor recovery systems at GDFs in Massachusetts. Nor did the commenter specify what specific aspects of the technical analyses conducted by the MassDEP in support of its SIP revision were scientifically unsupportable.

    Finally, the commenter believes that in terminating the Massachusetts Stage II vapor recovery program, the MassDEP is not adhering to its mission statement. The commenter also believes that the technical details of fuel storage tank evaporative losses and the alleged significant increase in refueling emissions impacts caused by Massachusetts' removal of Stage II vapor recovery, should have received more thought, analysis and quantification. Again, however, the commenter did not provide specific criticism of the analyses conducted by MassDEP, did not identify any specific aspects of those analyses that the commenter believes are incorrect, and did not assert any alternative specific results or conclusions that the commenter believes would result if the issues were evaluated according to the commenter's unspecified preferred alternative methodology.

    Response: EPA disagrees with the Vapor Recovery Association's assertion that there will be significant increased emissions from this action. Massachusetts' May 5, 2015 SIP revision contains a Clean Air Act (CAA) section 110(l) demonstration which was performed in accordance with EPA's final rule determining that ORVR is now in widespread use in the national motor vehicle fleet (77 FR 28770, May 16, 2012) and with EPA's “Guidance on Removing Stage II Gasoline Vapor Control Programs from State Implementation Plans and Assessing Comparable Measures” (EPA-457/B-12-001, August 7, 2012), hereafter, EPA's August 7, 2012 Guidance (a copy of this guidance has been placed in the public docket for this action).

    The Massachusetts rule allows GDFs to decommission Stage II systems as of January 2, 2015, and requires all GDFs equipped with Stage II vapor recovery systems to decommission their Stage II systems by January 2, 2017 (by the end of 2016). As discussed in the NPR, Appendix Table A-1 of EPA's August 7, 2012 Guidance illustrates that by the end of 2016, approximately 85% of the vehicles in the national motor vehicle fleet will be equipped with ORVR. The number of ORVR-equipped vehicles in Massachusetts will likely be even higher due to Massachusetts having a more accelerated motor vehicle fleet turnover when compared to the national motor vehicle fleet.1 Appendix Table A-1 also illustrates that by the end of 2016, about 89% of the gasoline dispensed nationally will be to ORVR-equipped vehicles, which is also likely to be higher in Massachusetts due to a newer motor vehicle fleet. At that point in time, since a vast majority of Massachusetts vehicles being refueled at gasoline dispensing facilities will be equipped with ORVR systems, the ORVR systems will be controlling the volatile organic compound (VOC) emissions, making Stage II vapor recovery systems a redundant, and potentially incompatible, emissions control technology in Massachusetts. Therefore, removing the Stage II systems is not expected to result in a significant emissions increase, and is actually expected to avoid emissions increases resulting from the incompatibility of some Stage II systems with ORVR controls.

    1Air Program Support for Stage I and Stage II Programs in Massachusetts Final Report, Eastern Research Group, Inc. and de la Torre-Klausmeier Consulting, December 12, 2012, includes an analysis of vehicle registration data, from the Massachusetts motor vehicle inspection and maintenance program database, illustrating that 76% of motor vehicles inspected in 2011 throughout Massachusetts had ORVR controls. This is much more accelerated than EPA's end of 2011 calendar year national estimate that 67.1% of vehicles in the national motor vehicle fleet were equipped with ORVR.

    EPA also disagrees with the commenter's assertion that the alleged increase in emissions resulting from the removal of Stage II controls will result in a large increase in adverse health impacts to motorists, GDF employees, and members of the community. EPA's August 7, 2012 Guidance states that “EPA believes it is reasonable to conclude that the incremental emissions control that Stage II achieves beyond ORVR is de minimis if it is less than 10 percent of the area-wide emissions inventory associated with refueling highway motor vehicles.” As noted in the NPR, Massachusetts appropriately calculated the increase in refueling-associated emissions from the decommissioning of Stage II systems in 2013 as 5.2 percent of that inventory, thus meeting this de minimis threshold. As also noted in the NPR, the increase in emissions from Stage II system decommissioning calculated by Massachusetts for 2013 (463 tons of VOC) is only about 0.3 percent of the total anthropogenic VOC emissions in Massachusetts (see EPA's 2011 National Emissions Inventory database Version 2 at www.epa.gov/ttn/chief/net/2011inventory.html). Also, as explained in EPA's ORVR rulemaking and in EPA's August 7, 2012 Guidance, these foregone emissions reductions in the near term continue to diminish rapidly over time as ORVR phase-in continues. Therefore, since the de minimis criteria discussed in EPA's August 7, 2012 Guidance have been met, EPA is approving Massachusetts' SIP revision.

    Furthermore, we note that Massachusetts' revised 310 CMR 7.24(3) regulation also includes new Stage I vapor recovery requirements that will lead to additional emission reductions. Specifically, the regulation requires GDFs to upgrade their Stage I vapor recovery systems to Stage I Enhanced Vapor Recovery (EVR) systems certified by the California Air Resources Board (CARB) or a Stage I vapor recovery system composed of EVR system components (Stage I EVR component systems). The upgrade to Stage I EVR systems or Stage I EVR component systems is required upon facility start-up for facilities beginning operation or installing a fuel storage tank as of January 2, 2015. In addition, as of January 2, 2015, any component of a pre-existing Stage I vapor recovery system that is replaced is required to be replaced with a CARB-certified Stage I EVR component. The Massachusetts regulation further requires that all Stage I systems be CARB-certified Stage I EVR systems or Stage I EVR component systems by January 2, 2022. CARB-certified Stage I EVR systems have been certified to achieve a 98 percent reduction in VOC emissions, as compared to 95 percent for pre-EVR Stage I systems. Thus, when pre-EVR Stage I systems in Massachusetts are replaced with CARB-certified Stage I EVR systems, a greater emission reduction will be achieved. Also, when a component of a pre-EVR Stage I system is replaced with a CARB-certified Stage I EVR component, a somewhat greater reduction is expected to be achieved. These additional reductions will further mitigate any temporary declining emissions increases, which are already de minimis, resulting from the removal of Stage II equipment.

    Although the commenter generally asserted that MassDEP's analyses and demonstrations were not scientifically supported and that emissions increases could be mathematically shown to result from the removal of Stage II equipment, the commenter provided no information, data, or analytical critiques to support these allegations. The commenter has therefore not raised with reasonable specificity any objections to the underlying analyses and demonstrations supporting EPA's proposed approval of Massachusetts' SIP revision. Consequently, it is not possible for EPA to respond to any specific criticisms that the commenter may have had of the MassDEP's analyses, other than to reiterate that EPA concludes that Massachusetts has conducted its demonstration consistently with EPA's applicable regulations and guidance under the Clean Air Act, as described and evaluated in detail in the NPR. See, 81 FR at 12442-43.

    Finally, EPA disagrees with the comment that MassDEP is not adhering to its mission statement and that an insufficient amount of thought, analysis, and quantification was provided by MassDEP regarding the impacts of decommissioning Stage II vapor recovery systems in Massachusetts. MassDEP's analysis was conducted in accordance with EPA's ORVR rulemaking and EPA's August 7, 2012 Guidance. In fact, prior to the issuance of EPA's August 7, 2012 Guidance, MassDEP hired independent consultants to conduct an analysis on the emissions impacts of the proposed changes to the Massachusetts Stage I and Stage II vapor recovery programs.2 One of the noteworthy results presented in the consultant's report was the analysis of whether removal of Stage II controls would result in disproportionate air quality impacts in EJ communities. The consultant's analysis determined that, previous to the April 2012 point at which EPA determined ORVR to have become in widespread use, EJ communities had a slightly lower proportion of ORVR-equipped vehicles (73% of the motor vehicle fleet) than non-EJ communities (77% of the motor vehicle fleet), based on 2011 data in Massachusetts. Although this shows that continuing to operate Stage II systems in Massachusetts EJ communities would not as quickly become redundant and potentially incompatible with ORVR controls as in non-EJ Massachusetts communities, Appendix Table A-1 of EPA's August 7, 2012 Guidance illustrates that only about 67% of the national motor vehicle fleet consisted of ORVR-equipped vehicles in 2011, which is still less than the 73% rate for EJ communities in Massachusetts. The commenter has provided no information indicating that the rate of fleet turnover and the rate at which gasoline is dispensed to ORVR equipped vehicles in Massachusetts EJ communities has subsequently fallen behind the corresponding national rates they were exceeding in 2011. Therefore, in response to the comment, EPA has no reason to believe that the emissions impact of decommissioning Stage II vapor recovery systems in EJ communities in Massachusetts is more significant than that discussed in EPA guidance as an acceptable national average impact.

    2Air Program Support for Stage I and Stage II Programs in Massachusetts Final Report, Eastern Research Group, Inc. and de la Torre-Klausmeier Consulting, December 12, 2012.

    III. Final Action

    EPA is approving Massachusetts' May 5, 2015 SIP revision. Specifically, EPA is approving, and incorporating into the Massachusetts SIP, the following amended Massachusetts regulations: 310 CMR 7.00, “Air Pollution Control: Definitions;” 310 CMR 7.24(3), “Distribution of Motor Vehicle Fuel;” 310 CMR 7.24(4), “Motor Vehicle Fuel Tank Trucks;” and 310 CMR 7.24(6), “Dispensing of Motor Vehicle Fuel.” EPA is approving this SIP revision because it meets all applicable requirements of the Clean Air Act and EPA guidance, and it will not interfere with any applicable requirement concerning National Ambient Air Quality Standards attainment and reasonable further progress or with any other applicable requirement of the Clean Air Act.

    Massachusetts' May 5, 2015 SIP revision satisfies the “comparable measures” requirement of CAA section 184(b)(2), because as stated in EPA's August 7, 2012 Guidance, “the comparable measures requirement is satisfied if phasing out a Stage II control program in a particular area is estimated to have no, or a de minimis, incremental loss of area-wide emissions control.” As noted in the NPR, Massachusetts' SIP revision meets the de minimis criteria outlined in EPA's August 7, 2012 Guidance. In addition, since emissions are de minimis, the anti-back sliding requirements of CAA section 110(l) have also been satisfied.

    IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Massachusetts regulations described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available through http://www.regulations.gov.

    V. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

    In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

    Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 30, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: August 1, 2016. H. Curtis Spalding, Regional Administrator, EPA New England.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:

    PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority:

    42 U.S.C. 7401 et seq.

    Subpart W—Massachusetts 2. Section 52.1120 is amended by adding paragraph (c)(144) to read as follows:
    § 52.1120 Identification of plan.

    (c) * * *

    (144) Revisions to the State Implementation Plan submitted by the Massachusetts Department of Environmental Protection on May 5, 2015.

    (i) Incorporation by reference.

    (A) Regulation 310 CMR 7.00 entitled “Air Pollution Control: Definitions,” the definitions listed below, effective January 2, 2015, as published in the Massachusetts Register, Issue S1277, January 2, 2015:

    (1) Aboveground Storage Tank or AST;

    (2) Business Day;

    (3) California Air Resources Board (or California ARB or CARB);

    (4) Commence Operations;

    (5) Emergency Motor Vehicle;

    (6) Emergency Situation;

    (7) Executive Order;

    (8) Minor Modification;

    (9) Monthly Throughput;

    (10) Motor Vehicle;

    (11) Motor Vehicle Fuel;

    (12) Motor Vehicle Fuel Dispensing Facility;

    (13) Responsible Official;

    (14) Routine Maintenance;

    (15) Stage I CARB Enhanced Vapor Recovery (EVR) Component or EVR;

    (16) Stage I CARB Enhanced Vapor Recovery (EVR) System;

    (17) Stage I Component Enhanced Vapor Recovery (EVR) System;

    (18) Stage I Minor Modification;

    (19) Stage I Non-Enhanced Vapor Recovery System;

    (20) Stage I Routine Maintenance;

    (21) Stage I Substantial Modification;

    (22) Stage I System;

    (23) Stage II Minor Modification;

    (24) Stage II Routine Maintenance;

    (25) Stage II Substantial Modification;

    (26) Stage II System;

    (27) Submerged Filling;

    (28) Tank Truck;

    (29) Vacuum Assist System;

    (30) Vapor;

    (31) Vapor Balance System;

    (32) Vapor-Mounted Seal; and

    (33) Vapor-Tight.

    (B) Regulation 310 CMR 7.24, “Organic Material Storage and Distribution,” the sections listed below, effective January 2, 2015, as published in the Massachusetts Register, Issue S1277, January 2, 2015:

    (1) 7.24(3) “Distribution of Motor Vehicle Fuel”;

    (2) 7.24(4) “Motor Vehicle Fuel Tank Trucks”; and

    (3) 7.24(6) “Dispensing of Motor Vehicle Fuel”.

    (ii) Additional materials.

    (A) Letter from the Massachusetts Department of Environmental Protection, dated May 5, 2015, submitting a revision to the Massachusetts State Implementation Plan.

    3. In § 52.1167, Table 52.1167 is amended by adding new entries for the existing state citations for 310 CMR 7.00, 310 CMR 7.24(3), 310 CMR 7.24(4), and 310 CMR 7.24(6) to read as follows:
    § 52.1167 EPA-approved Massachusetts State regulations. Table 52.1167—EPA-Approved Rules and Regulations [See Notes at end of table] State
  • citation
  • Title/subject Date
  • submitted
  • by State
  • Date
  • approved
  • by EPA
  • Federal Register
  • citation
  • 52.1120(c) Comments/unapproved sections
    *         *         *         *         *         *         * 310 CMR 7.00 Air Pollution Control: Definitions 5/5/15 11/29/16 [Insert Federal Register citation] 144 Revises definitions that relate to Stage I and Stage II vapor recovery systems. *         *         *         *         *         *         * 310 CMR 7.24(3) Distribution of Motor Vehicle Fuel 5/5/15 11/29/16 [Insert Federal Register citation] 144 Revised to require Stage I Enhanced Vapor Recovery systems certified by the California Air Resources Board. 310 CMR 7.24(4) Motor Vehicle Fuel Tank Trucks 5/5/15 11/29/16 [Insert Federal Register citation] 144 Revised to make minor clarifying amendments. *         *         *         *         *         *         * 310 CMR 7.24(6) Dispensing of Motor Vehicle Fuel 5/5/15 11/29/16 [Insert Federal Register citation] 144 Revised to require the decommissioning of Stage II vapor recovery systems. *         *         *         *         *         *         * Notes: 1. This table lists regulations adopted as of 1972. It does not depict regulatory requirements which may have been part of the Federal SIP before this date. 2. The regulations are effective statewide unless otherwise stated in comments or title section.
    [FR Doc. 2016-28587 Filed 11-28-16; 8:45 am] BILLING CODE 6560-50-P
    SURFACE TRANSPORTATION BOARD 49 CFR Part 1109 [Docket No. EP 734] Dispute Resolution Procedures Under the Fixing America's Surface Transportation Act of 2015 AGENCY:

    Surface Transportation Board.

    ACTION:

    Final rules.

    SUMMARY:

    The Surface Transportation Board (Board) adopts final rules to implement passenger rail-related dispute resolution provisions under the Fixing America's Surface Transportation Act of 2015 (FAST Act).

    DATES:

    These rules are effective on December 29, 2016.

    ADDRESSES:

    Information or questions regarding these final rules should reference Docket No. EP 734 and be in writing addressed to: Chief, Section of Administration, Office of Proceedings, Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001.

    FOR FURTHER INFORMATION CONTACT:

    Scott M. Zimmerman, (202) 245-0386. Assistance for the hearing impaired is available through Federal Information Relay Service (FIRS) at (800) 877-8339.

    SUPPLEMENTARY INFORMATION:

    Title XI of the FAST Act,1 entitled “Passenger Rail Reform and Investment Act of 2015,” adds to the Board's existing passenger rail adjudicatory responsibilities related to the National Railroad Passenger Corporation (Amtrak). Among other things, Title XI includes new provisions involving cost recovery by Amtrak for Amtrak's operation of “state-supported routes” and for the costs allocated to states (including state entities) using the Northeast Corridor rail facilities for their commuter rail operations. As relevant here, Title XI gives the Board jurisdiction to resolve cost allocation and access disputes between Amtrak, the states, and potential non-Amtrak operators of intercity passenger rail service.2 The FAST Act directs the Board to establish procedures for the resolution of certain of these disputes, “which may include the provision of professional mediation services.” 49 U.S.C. 24712(c)(2) and 24905(c)(4).

    1 Fixing America's Surface Transportation Act of 2015, Public Law 114-94 (signed Dec. 4, 2015).

    2 Currently, Amtrak is the only operator of regularly scheduled, common carrier intercity passenger rail service in the United States. Certain statutory provisions contemplate the possibility, in the future, of other such intercity passenger rail operators. See, e.g., 49 U.S.C. 24711 and 49 U.S.C. 24308(f).

    On July 28, 2016, the Board issued a notice of proposed rulemaking (NPR) (81 FR 51147), seeking comment on proposed rules pursuant to the FAST Act. In the NPR, the Board noted that because it does not have in place a general set of procedural rules to govern the presentation and conduct of proceedings involving passenger rail matters under 49 U.S.C. 24101-24910,3 which would include contested matters arising under Title XI of the FAST Act, parties seeking to bring contested matters before the Board should be guided by the Board's existing Rules of Practice (49 CFR parts 1100-1129), as applicable. However, the potential to offer “professional mediation services” is unique to the authority granted under the FAST Act, and the Board's existing Rules of Practice contain no applicable provisions. Therefore, the Board proposed new regulations to address requests from one or more parties for informal assistance in securing outside professional mediation services pursuant to the FAST Act.

    3See 49 CFR 1100.1 (limiting the scope of the Rules of Practice to matters under title 49, subtitle IV of the United States Code, 49 U.S.C. 10101 et seq.).

    Specifically, the NPR provided that, under a new 49 CFR 1109.5, parties to a dispute involving the State-Sponsored Route Committee or the Northeast Corridor Commission would be permitted to request the Board's assistance in securing outside professional mediation services by submitting a letter to the Board's Office of Public Assistance, Governmental Affairs, and Compliance (OPAGAC). OPAGAC would then contact the requesting party or parties in response to such requests within 14 days of receipt of the request to assist in arranging for professional mediation services.

    After careful consideration of the comments received, the Board is promulgating a set of procedural rules that adopt and clarify the provisions of the NPR regarding professional mediation services with respect to certain passenger rail matters under Title XI of the FAST Act.

    FAST Act Provisions

    The State-Supported Route Committee. Section 11204 of the FAST Act adds a new section to the United States Code: 49 U.S.C. 24712, “State supported routes operated by Amtrak.” State-supported routes are intercity rail passenger routes for which operating and capital costs are established and allocated among the states and Amtrak under section 209 of the Passenger Rail Investment and Improvement Act of 2008 (PRIIA).4 Under these agreements, Amtrak currently receives funding from states and state-related entities to operate routes under 750 miles in length. New section 24712 establishes a State-Supported Route Committee comprised of Amtrak, the U.S. Department of Transportation/Federal Railroad Administration, and states that subsidize state-supported routes, to implement the cost-allocation methodology previously developed under section 209 of PRIIA through negotiation between Amtrak and the affected states and approved by the Board. See Amtrak's Pet. for Determination of PRIIA Sec. 209 Cost Methodology, FD 35571 (STB served Mar. 15, 2012). The Committee may also amend that cost-allocation methodology. Section 24712(c)(1) gives the Board jurisdiction to “conduct dispute resolution” pertaining to (1) the Committee's rules and procedures, (2) the invoices to be produced by Amtrak or reports to be produced by Amtrak or the states as described in section 24712(b), and (3) the implementation of or compliance with the cost allocation methodology. Section 24712(c)(2) requires the Board to establish procedures for resolving such disputes, which procedures “may include provision of professional mediation services.”

    4 Public Law 110-432, Section 209; 49 U.S.C. 24101 note.

    The Northeast Corridor Commission. Section 11305 of the FAST Act, which amends 49 U.S.C. 24905, involves the powers and obligations of the Northeast Corridor Commission (NEC Commission), created by Congress in 2008 as part of PRIIA.5 The NEC Commission is responsible for developing and implementing a standardized policy for determining and allocating costs, revenues, and compensation between Amtrak and the providers of commuter rail passenger transportation on the Northeast Corridor. The FAST Act amends 49 U.S.C. 24905 with respect to the Board's role in resolving disputes between Amtrak and the states in determining compensation for use of the Northeast Corridor in light of the policy approved by the NEC Commission. Under the new subsection, 49 U.S.C. 24905(c)(4), the FAST Act permits the NEC Commission, Amtrak, or public authorities providing commuter rail passenger transportation on the Northeast Corridor to request that the Board conduct dispute resolution if a dispute arises over implementation of, or compliance with, the NEC Commission's cost allocation policy. The new subsection requires the Board to establish procedures for resolving such disputes and provides that those procedures “may include the provision of professional mediation services.”

    5 The NEC Commission was originally established as the Northeast Corridor Infrastructure and Operations Advisory Commission. See 49 U.S.C. 24905. It is composed of voting representatives from Amtrak, the U.S. Department of Transportation, and the states comprising the Northeast Corridor (including the District of Columbia).

    Comments

    The Board sought comments on the proposed regulations by August 31, 2016, and replies by September 30, 2016. The Board received comments from six parties: California Department of Transportation (Caltrans), Los Angeles-San Diego-San Luis Obispo Rail Corridor Agency (LOSSAN Agency), Amtrak, U.S. Department of Transportation (DOT), San Joaquin Joint Powers Authority (SJJPA), and Capitol Corridor Joint Powers Authority (CCJPA). Amtrak filed a reply.

    Caltrans, LOSSAN Agency, SJJPA, and CCJPA (California Entities) all assert that the NPR did not meet the intent and requirement of the FAST Act. They state that the proposed mediation regulation is non-binding and that in order to efficiently resolve disputes, parties should have recourse to a binding mechanism for resolving such disputes. The California Entities suggest that the Board adopt binding arbitration, either before the Board or a third-party arbitrator, as the dispute resolution procedures required under section 24712. They further propose that arbitration be mandatory and that the Board compel arbitration upon request from a State or Amtrak. Lastly, the California Entities suggest that the Board clarify the proposed mediation regulation to address whether the Board will: (1) Maintain a list of mediators; (2) intervene if parties cannot agree to a mediator; (3) establish terms for payment of mediation services; and (4) require parties to participate in mediation.

    In its initial comments, Amtrak supports the proposed rule and suggest two clarifications. First, Amtrak asserts that the proposed 49 CFR 1109.5 is ambiguous as to whether the Board's existing mediation rules apply to formally contested matters involving the State-Supported Route Committee (section 209 of PRIIA) or the Northeast Corridor Commission (section 212 of PRIIA). Amtrak suggests adding language which explicitly states, “mediation procedures under [49 CFR] 1109.1, 1109.2, and 1109.3 are applicable” to disputes arising under sections 209 or 212 of PRIIA. Second, Amtrak proposes that the Board clarify and expand the procedures following the filing of a request with OPAGAC for securing professional mediation assistance.

    In its reply comments, Amtrak responded to the California Entities' requests for the Board to adopt binding arbitration. Amtrak states that arbitration is a voluntary alternate dispute mechanism and that nothing in the FAST Act suggests that the Board should impose arbitration on unwilling parties. Amtrak also argues that the FAST Act does not authorize the Board to delegate its decision-making power to a third-party arbitrator. Lastly, Amtrak argues that binding arbitration is not the best tool for resolving recurring issues in which uniformity among multiple parties is needed.

    The Final Rules

    After considering the comments received, the Board is adopting final rules, as set forth in the Appendix, for the mediation of passenger rail disputes involving the State-Sponsored Route Committee or the Northeast Corridor Commission. Formal disputes under 49 U.S.C. 24712 and 24905 would be conducted using the Board's existing Rules of Practice as a guide. Parties interested in professional mediation services could seek the Board's informal assistance in securing such services by submitting a letter to OPAGAC. Such informal assistance may be sought even if no party has filed a formal complaint with the Board.

    The Board does not agree with the California Entities that section 11204 of the FAST Act authorizes or requires the Board to resolve PRIIA section 209 disputes through binding arbitration. (Neither does any such authorization or requirement appear in FAST Act section 11305, with regard to PRIIA section 212.) While the FAST Act specifically mentions professional mediation services, it does not state or otherwise suggest the use of arbitration as a potential dispute resolution procedure. Further, as Amtrak points out, parties have to agree on arbitration as the method to resolve their disputes. Therefore, provisions for binding arbitration will not be included as part of the regulations adopted here.

    CCJPA argues that the plain language of the FAST Act contemplates a more significant role for the Board than providing informal assistance in securing outside professional mediation services—specifically, that the statute contemplates “dispute resolution” by the Board itself. (CCJPA Comments 2.) To the extent that CCJPA is arguing that the Board should be involved in “dispute resolution” by issuing decisions on disputes arising under the FAST Act, as noted above, parties may bring contested matters under section 11204 or section 11305 of the FAST Act before the Board, guided by the Board's existing Rules of Practice. See, e.g., Pet. of the Nat'l R.R. Passenger Corp. for Relief Pursuant to 49 U.S.C. 24905, FD 36048 (STB served Oct. 3, 2016). Alternatively, if CCJPA believes that the Board should engage in dispute resolution by conducting mediation itself and not simply relying on outside professional mediators, as discussed further below, the new rules provide that in cases where a formal complaint is brought under sections 209 or 212 of PRIIA, the Board's existing rules under part 1109 for mediation in Board proceedings would apply.

    The California Entities have asked that the Board clarify the proposed rule to address questions about choosing professional mediators, payment of mediation services, and whether participation in mediation would be mandatory. (Caltrans Comments 1; CCJPA Comments 3; SJJPA Comments 2; LOSSAN Agency Comments 2.) Similarly, Amtrak proposes expanding 49 CFR 1109.5 to include specifics such as timing and means of service of the requesting letter on all affected parties, whether parties must consent, the purpose for which OPAGAC will contact the requesting party, and whether and how OPAGAC will contact other affected parties. However, as these rules are intended to provide guidance for informal requests, in which parties and OPAGAC retain maximal flexibility in arranging for professional mediation, the Board believes that these issues should not be codified in regulations but left in the first instance to discussions between OPAGAC and the requesting party or parties, following receipt of a request. Accordingly, the Board will not adopt commenters' suggestions to address such specifics.

    Amtrak also asks that the rules clarify whether the Board's existing mediation rules apply to contested matters under section 209 or 212 of PRIIA. The Board's proposed rule contemplated that the existing, applicable mediation procedures under 49 CFR part 1109 6 would be available in formal complaint cases brought under sections 209 or 212 of PRIIA. See § 1109.5(a) and (b) (noting that requests for assistance in securing professional mediation services are “[i]n addition to the mediation procedures under this Part 1109 that are available following the filing of a complaint . . .”) (emphasis added). We reiterate here that, in cases where a formal complaint is brought under sections 209 or 212 of PRIIA, the preexisting mediation rules under part 1109 shall apply.

    6 Rather than identifying each individual subsection, this language encompasses the existing procedures available to parties after the filing of a complaint in §§ 1109.1, 1109.2, and 1109.3. The mediation rules for rate cases under the stand-alone cost methodology (49 CFR 1109.4) are inapplicable here.

    In asking for this last clarification, Amtrak states that there may be ambiguity with respect to whether the current provisions of part 1109 apply in a contested matter under PRIIA because part 1109 deals with mediation after the filing of a complaint. It is the Board's intention that an informal request for assistance in securing professional mediation services be available not only in instances where there has not been a formal complaint filed, but also during the pendency of a formal complaint case—as long as a motion is filed in that formal proceeding requesting that it be held in abeyance in light of the request for informal assistance. Thus, we have modified the rules proposed in the NPR to include this clarification. See § 1109.5(a) and (b).

    Paperwork Reduction Act

    In the NPR, the Board sought comments under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501-3549, and Office of Management and Budget (OMB) regulations at 5 CFR 1320.8(d)(3). No comments addressing PRA issues were received. Due to a technical omission in the NPR under the PRA, the Board will continue to seek OMB approval for this collection in a separate notice. Any comments received by the Board from that notice will be forwarded to OMB for its review and will be posted under this docket.

    Regulatory Flexibility Act Certification

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, generally requires a description and analysis of new rules that would have a significant economic impact on a substantial number of small entities. In drafting a rule, an agency is required to: (1) Assess the effect that its regulation will have on small entities; (2) analyze effective alternatives that may minimize a regulation's impact; and (3) make the analysis available for public comment. 5 U.S.C. 601-604. In its notice of proposed rulemaking, the agency must either include an initial regulatory flexibility analysis, section 603(a), or certify that the proposed rule would not have a “significant impact on a substantial number of small entities.” section 605(b). The impact must be a direct impact on small entities “whose conduct is circumscribed or mandated” by the proposed rule. White Eagle Coop. v. Conner, 553 F.3d 467, 480 (7th Cir. 2009).

    In the NPR, the Board certified under 5 U.S.C. 605(b) that the proposed rules would not have a significant economic impact on a substantial number of small entities within the meaning of the RFA.7 The Board explained that the proposed regulations would specify procedures related to dispute resolution of certain passenger rail transportation matters by the Board and do not mandate or circumscribe the conduct of small entities. The Board further noted that if a party wishing to utilize the proposed procedures files a complaint, petition, application, or request for dispute resolution, that entity will not encounter any additional burden and that, rather, the procedures are being updated and clarified by the regulations. The NPR was served upon the Chief Counsel for Advocacy, Office of Advocacy, U.S. Small Business Administration.

    7 Effective June 30, 2016, for the purpose of RFA analysis for rail carriers subject to our jurisdiction, the Board defines a “small business” as a rail carrier classified as a Class III rail carrier under 49 CFR 1201.1-1. See Small Entity Size Standards Under the Regulatory Flexibility Act, EP 719 (STB served June 30, 2016) (with Commissioner Begeman dissenting). Class III carriers have annual operating revenues of $20 million or less in 1991 dollars, or $36,633,119 or less when adjusted for inflation using 2015 data. Class II rail carriers have annual operating revenues of up to $250 million in 1991 dollars or up to $457,913,997 when adjusted for inflation using 2015 data. The Board calculates the revenue deflator factor annually and publishes the railroad revenue thresholds on its Web site. 49 CFR 1201.1-1.

    The final rules adopted here make slight modifications to the proposed rule, but the same basis for the Board's certification of the proposed rule applies to the final rules adopted here. The modification adopted in the final rule refines the proposed rule by clarifying the circumstances under which the informal process for seeking Board assistance in pursuing professional mediation services will be available. Therefore, the Board 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 as defined by the RFA. A copy of this decision will be served upon the Chief Counsel for Advocacy, Office of Advocacy, U.S. Small Business Administration, Washington, DC 20416.

    List of Subjects in 49 CFR Part 1109

    Administrative practice and procedure, Maritime carriers, Motor carriers, Railroads.

    It is ordered:

    1. The Board adopts the final rules as set forth in this decision. Notice of the adopted rules will be published in the Federal Register.

    2. A copy of this decision will be served upon the Chief Counsel for Advocacy, Office of Advocacy, U.S. Small Business Administration, Washington, DC 20416.

    3. This decision is effective December 29, 2016.

    Decided: November 22, 2016.

    By the Board, Chairman Elliott, Vice Chairman Miller, and Commissioner Begeman.

    Kenyatta Clay, Clearance Clerk.

    For the reasons set forth in the preamble, the Surface Transportation Board amends part 1109 of title 49, chapter X, of the Code of Federal Regulations as follows:

    PART 1109—USE OF MEDIATION IN BOARD PROCEEDINGS 1. Revise the authority citation for part 1109 to read as follows: Authority:

    5 U.S.C. 571 et seq. and 49 U.S.C. 1321(a), 24712(c), and 24905(c).

    2. Add § 1109.5 to read as follows:
    § 1109.5 Resolution of certain disputes involving the State Sponsored Route Committee and the Northeast Corridor Commission.

    (a) In addition to the mediation procedures under this part that are available following the filing of a complaint in a proceeding before the Board, Amtrak or a State member of the State Supported Route Committee established under 49 U.S.C. 24712 may request that the Board informally assist in securing outside professional mediation services in order to resolve disputes arising from: Implementation of, or compliance with, the cost allocation methodology for State-Supported Routes developed under section 209 of the Passenger Rail Investment and Improvement Act of 2008 or amended under 49 U.S.C. 24712(a)(6); invoices or reports provided under 49 U.S.C. 24712(b); or rules and procedures implemented by the State Supported Route Committee under 49 U.S.C. 24712(a)(4). With respect to a particular dispute, such a request for informal assistance in securing outside professional mediation services may be submitted to the Board:

    (1) In the absence of a complaint proceeding before the Board; or

    (2) If, while a formal complaint is pending before the Board, a motion is filed in that formal proceeding requesting that it be held in abeyance in light of the request for informal assistance.

    (b) In addition to the mediation procedures under this part that are available following the filing of a complaint in a proceeding before the Board, the Northeast Corridor Commission established under 49 U.S.C. 24905, Amtrak, or public authorities providing commuter rail passenger transportation on the Northeast Corridor may request that the Board informally assist in securing outside professional mediation services in order to resolve disputes involving implementation of, or compliance with, the policy developed under 49 U.S.C. 24905(c)(1). With respect to a particular dispute, such a request for informal assistance in securing outside professional mediation services may be submitted to the Board:

    (1) In the absence of a complaint proceeding before the Board; or

    (2) If, while a formal complaint is pending before the Board, a motion is filed in that formal proceeding requesting that it be held in abeyance in light of the request for informal assistance.

    (c) A request for informal Board assistance in securing outside professional mediation services under paragraph (a) or (b) of this section shall be submitted by letter duly authorized to be submitted to the Board by the requesting party. The request letter shall be addressed to the Director of the Board's Office of Public Assistance, Governmental Affairs, and Compliance, and shall include a concise description of the issues for which outside professional mediation services are sought. The Office of Public Assistance, Governmental Affairs, and Compliance shall contact the requesting party in response to such request within 14 days of receipt of the request.

    [FR Doc. 2016-28610 Filed 11-28-16; 8:45 am] BILLING CODE 4915-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 151130999-6225-01] RIN 0648-XF049 Fisheries of the Northeastern United States; Atlantic Bluefish Fishery; Quota Transfers AGENCY:

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

    ACTION:

    Temporary rule; approval of quota transfers.

    SUMMARY:

    NMFS announces its approval of two transfers of 2016 commercial bluefish quota from the Commonwealth of Virginia to the State of New York. The approval of these transfers complies with the Atlantic Bluefish Fishery Management Plan quota transfer provision. This announcement also informs the public of the revised commercial quotas for Virginia and New York.

    DATES:

    Effective November 28, 2016, through December 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Reid Lichwell, Fishery Management Specialist, (978) 281-9112.

    SUPPLEMENTARY INFORMATION:

    Regulations governing the Atlantic bluefish fishery are found in 50 CFR 648.160 through 648.167. The regulations require annual specification of a commercial quota that is apportioned among the coastal states from Maine through Florida. The process to set the annual commercial quota and the percent allocated to each state are described in § 648.162.

    The final rule implementing Amendment 1 to the Bluefish Fishery Management Plan published in the Federal Register on July 26, 2000 (65 FR 45844), and provided a mechanism for transferring bluefish quota from one state to another. Two or more states, under mutual agreement and with the concurrence of the Administrator, Greater Atlantic Region, NMFS (Regional Administrator), can request approval of a transfer of bluefish commercial quota under § 648.162(e)(1)(i) through (iii). The Regional Administrator must first approve any such transfer based on the criteria in § 648.162(e).

    Virginia and New York have requested two transfers totaling 80,000 lb (36,287 kg) of bluefish commercial quota from Virginia to New York. Both states have certified that the transfers meet all pertinent state requirements. These quota transfers were requested by New York to ensure that its 2016 quota would not be exceeded. The Regional Administrator has approved these quota transfers based on his determination that the criteria set forth in § 648.162(e)(1)(i) through (iii) have been met. The revised bluefish quotas for calendar year 2016 are: Virginia, 370,287 lb (167,959 kg); and New York, 877,289 lb (397,932 kg). These quota adjustments revise the quotas specified in the final rule implementing the 2016-2018 Atlantic Bluefish Specifications published on August 4, 2016 (81 FR 51370), and reflect all subsequent commercial bluefish quota transfers completed to date. For information of previous transfers for fishing year 2016 visit: http://go.usa.gov/xZT8H.

    Classification

    This action is taken under 50 CFR part 648 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: November 22, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-28658 Filed 11-28-16; 8:45 am] BILLING CODE 3510-22-P
    81 229 Tuesday, November 29, 2016 Proposed Rules DEPARTMENT OF TRANSPORTATION Office of the Secretary 14 CFR Part 259 [Docket No. DOT-OST-2016-0208] RIN 2105-AE53 Refunding Baggage Fees for Delayed Checked Bags AGENCY:

    Office of the Secretary (OST), Department of Transportation (DOT).

    ACTION:

    Extension of comment period on advance notice of proposed rulemaking.

    SUMMARY:

    This action extends the comment period for an Advance Notice of Proposed Rulemaking on refunding baggage fees for delayed checked bags that was published in the Federal Register on October 31, 2016. The Department of Transportation is extending the period for persons to submit comments on this rulemaking from November 30, 2016, to January 17, 2017. This extension is in response to a petition by Airlines for America.

    DATES:

    Comments should be filed by January 17, 2017. Late-filed comments will be considered to the extent practicable.

    ADDRESSES:

    You may file comments identified by the docket number DOT-OST-2016-0208 by any of the following methods:

    Federal eRulemaking Portal: go to http://www.regulations.gov and follow the online instructions for submitting comments.

    Mail: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Ave. SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001.

    Hand Delivery or Courier: West Building Ground Floor, Room W12-140, 1200 New Jersey Ave. SE., between 9:00 a.m. and 5:00 p.m. ET, Monday through Friday, except Federal holidays.

    Fax: (202) 493-2251.

    Instructions: You must include the agency name and docket number DOT-OST-2016-0208 or the Regulatory Identification Number (RIN) for the rulemaking at the beginning of your comment. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided.

    Privacy Act: Anyone is able to search the electronic form of all comments received in any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act statement in the Federal Register published on April 11, 2000 (65 FR 19477-78), or you may visit http://DocketsInfo.dot.gov.

    Docket: For access to the docket to read background documents and comments received, go to http://www.regulations.gov or to the street address listed above. Follow the online instructions for accessing the docket.

    FOR FURTHER INFORMATION CONTACT:

    Clereece Kroha, Senior Trial Attorney, Office of Aviation Enforcement and Proceedings, U.S. Department of Transportation, 1200 New Jersey Ave. SE., Washington, DC 20590, 202-366-9342, 202-366-7152 (fax), [email protected] (email).

    SUPPLEMENTARY INFORMATION:

    On October 31, 2016, the Department of Transportation published an Advance Notice of Proposed Rulemaking (ANPRM) to solicit public comment on how to appropriately implement a statutory requirement in recent legislation for airlines to refund checked baggage fees when they fail to deliver the bags in a timely manner. Specifically, the Department seeks comment on how to define a baggage delay, and the appropriate method for providing the refund for delayed baggage. See 81 FR 75347 (October 31, 2016). Comments on the matters discussed in the ANPRM were to be received 30 days after publication or by November 30, 2016.

    On November 15, 2016, we received a petition from Airlines for America (A4A) for a 48-day extension of the comment period for this rulemaking. According to the petition, the extension is appropriate because the ANPRM concerns a requirement that implicates several operational and financial disciplines within the airlines, which will require the assessment of how internal information systems should be re-worked. A4A also indicates that additional time is needed in order to coordinate comments from different member carriers. Further, A4A points out that the current comment period is effectively diminished by the Thanksgiving holiday and an extension into December would be similarly diminished by the Christmas holiday season because many personnel would take extended vacations during these time periods. We received no comments on A4A's petition for extension.

    After carefully considering A4A's petition, we have decided to grant the extension of 48 days (January 17, 2017), for the public to comment on the ANPRM.

    Issued this 18th day of November, 2016, in Washington, DC. Judith S. Kaleta, Deputy General Counsel.
    [FR Doc. 2016-28681 Filed 11-28-16; 8:45 am] BILLING CODE 4910-9X-P
    POSTAL REGULATORY COMMISSION 39 CFR Part 3015 [Docket No. RM2017-1; Order No. 3624] Competitive Postal Products AGENCY:

    Postal Regulatory Commission.

    ACTION:

    Advance notice of proposed rulemaking.

    SUMMARY:

    The Commission is initiating a review to determine whether competitive products provide the appropriate minimum contribution to the Postal Service's institutional costs. This advance notice informs the public of the docket's initiation, invites public comment, and takes other administrative steps.

    DATES:

    Comments are due: January 23, 2017. Reply Comments are due: March 9, 2017.

    ADDRESSES:

    Submit comments electronically via the Commission's Filing Online system at http://www.prc.gov. Those who cannot submit comments electronically should contact the person identified in the FOR FURTHER INFORMATION CONTACT section by telephone for advice on filing alternatives.

    FOR FURTHER INFORMATION CONTACT:

    David A. Trissell, General Counsel, at 202-789-6820.

    SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. Background III. Invitation to Comment IV. Ordering Paragraphs I. Introduction

    The Commission initiates this rulemaking to seek comments and facilitate the Commission's examination of the appropriate minimum contribution to the Postal Service's institutional costs that competitive products must provide, pursuant to 39 U.S.C. 3633(b).

    II. Background

    The Postal Accountability and Enhancement Act (PAEA) directed the Commission to promulgate regulations to ensure that competitive products, collectively, cover an appropriate share of the Postal Service's institutional costs.1 In the initial rulemaking setting the appropriate share, the Commission gave considerable weight to the historical contribution made by items categorized as competitive products by the PAEA and set the minimum contribution level for competitive products at 5.5 percent of total institutional costs.2 The 5.5 percent minimum contribution level was set in line with the competitive products' estimated contribution to institutional costs of 5.4 percent in Fiscal Year (FY) 2005 and 5.7 percent in FY 2006.3

    1 Postal Accountability and Enhancement Act (PAEA), Public Law 109-435, 120 Stat. 3198 (2006); See 39 U.S.C. 3633(a)(3). See also 39 CFR 3015.7(c).

    2 Docket No. RM2007-1, Order No. 43, Order Establishing Ratemaking Regulations for Market Dominant and Competitive Products, October 29, 2007, ¶¶ 3040-47.

    3See Docket No. RM2007-1, Order No. 26, Order Proposing Regulations to Establish a System of Ratemaking, August 15, 2007, at ¶ 3059.

    The PAEA further directs the Commission to revisit competitive products' minimum contribution level every 5 years and determine whether the institutional cost contribution requirement of 39 U.S.C. 3633(a)(3) should be retained in its current form, modified, or eliminated. See 39 U.S.C. 3633(b).

    The Commission's first 5-year review occurred in Docket No. RM2012-3.4 In that docket, the Commission found the minimum contribution level of 5.5 percent for competitive products should be retained.5

    4 Docket No. RM2012-3, Order Reviewing Competitive Products' Appropriate Share Contributions to Institutional Costs, August 23, 2012 (Order No. 1449).

    5 Order No. 1449 at 24-26. The Commission considered circumstances such as a lack of evidence of a Postal Service competitive advantage; the market share analysis; changes to the market and competitors; historical competitive contribution levels; changes to competitive product offers and the mail mix; and uncertainties raised in the proceeding. Id. at 24.

    Five years have passed since the Commission's previous review. As such, the Commission initiates Docket No. RM2017-1 to conduct its second review of the competitive products' appropriate share contribution requirement. The Commission will decide whether 39 CFR 3015.7(c) should be retained in its current form, modified, or eliminated. See 39 CFR 3015.7(c).

    III. Invitation To Comment

    Interested persons are invited to provide written comments to facilitate the Commission in its examination of the appropriateness of the current contribution level for competitive products. Only comments filed in the instant docket will be considered as part of the Commission's review. Comments related to the Commission's 5-year review and competitive products' appropriate share of institutional costs filed in other dockets will not be considered.6

    6 In Docket No. RM2016-2, as part of Proposal Three, UPS petitioned for a review of competitive products' share of institutional costs. Docket No RM2016-2, Petition of United Parcel Service, Inc. for the Initiation of Proceedings to Make Changes to Postal Service Costing Methodologies, October 8, 2015, at Proposal Three. In its final order in that docket, the Commission declined to consider Proposal Three but stated it will conduct its review as required by section 3633(b). Docket No. RM2016-2, Order No. 3506, Order Concerning United Parcel Service, Inc.'s Proposed Changes to Postal Service Costing Methodologies (UPS Proposals One, Two, and Three), September 9, 2016.

    Comments are due no later than January 23, 2017. Reply comments are due no later than March 9, 2017. All comments and suggestions received will be available for review on the Commission's Web site, http://www.prc.gov.

    Pursuant to 39 U.S.C. 505, Kenneth R. Moeller is appointed to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in the above-captioned docket.

    IV. Ordering Paragraphs

    It is ordered:

    1. The Commission establishes Docket No. RM2017-1, in compliance with 39 U.S.C. 3633(b).

    2. Comments are due no later than January 23, 2017. Reply comments are due no later than March 9, 2017.

    3. Pursuant to 39 U.S.C. 505, the Commission appoints Kenneth R. Moeller to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this docket.

    4. The Secretary shall arrange for publication of this Notice in the Federal Register.

    By the Commission.

    Stacy L. Ruble, Secretary.
    [FR Doc. 2016-28603 Filed 11-28-16; 8:45 am] BILLING CODE 7710-FW-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2007-0989; FRL-9955-03-Region 6] Approval and Promulgation of Implementation Plans; Oklahoma; Revisions to Minor New Source Review Permitting Program AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve severable portions of revisions to the Oklahoma New Source Review (NSR) State Implementation Plan (SIP) submitted by the State of Oklahoma on February 14, 2002 (the February 14, 2002, SIP submittal). This action addresses revisions to the Oklahoma Administrative Code (OAC), Title 252, Chapters 4 and 100, concerning the State's Minor New Source Review air permitting program. Many revisions are administrative in nature and modify redundant or incorrect text within the SIP. The revisions also include renumbered or codified portions of the SIP and new sections that incorporate Federal rules. This rulemaking is being taken in accordance with section 110 of the Clean Air Act (CAA).

    DATES:

    Written comments must be received on or before December 29, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket No. EPA-R06-OAR-2007-0989, at http://www.regulations.gov or via email to [email protected] Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the Web, cloud, or other file sharing system). For additional submission methods, please contact Rick Barrett, 214-665-7227, [email protected] For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    Docket: The index to the docket for this action is available electronically at www.regulations.gov and in hard copy at the EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available at either location (e.g., CBI).

    FOR FURTHER INFORMATION CONTACT:

    Mr. Rick Barrett, 214-665-7227, [email protected] To inspect the hard copy materials, please schedule an appointment with Rick Barrett or Mr. Bill Deese at 214-665-7253.

    SUPPLEMENTARY INFORMATION:

    Throughout this document, “we,” “us,” or “our” means the EPA.

    I. Background II. Oklahoma's Program for Minor New Source Review III. EPA's Evaluation of Proposed SIP Revisions IV. Proposed Action V. Incorporation by Reference VI. Statutory and Executive Order Reviews I. Background

    The SIP is a set of air pollution regulations, control strategies and technical analyses developed by the state, to ensure that the state meets the National Ambient Air Quality Standards (NAAQS). These ambient standards are established under section 109 of the Act and they currently address six criteria pollutants: Carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide. The SIP is required by section 110 of the Act and can be extensive, containing state regulations or other enforceable documents and supporting information such as emission inventories, monitoring networks, and modeling demonstrations. EPA has promulgated implementing regulations for the preparation, adoption, and submittal of SIPs. 40 CFR part 51.

    The Clean Air Act at section 110(a)(2)(C) requires states to develop and implement permitting programs (called new source review or NSR) for attainment and nonattainment areas; these NSR programs cover both construction and modification of stationary sources.1 Each SIP must include legally enforceable procedures that enable the state to determine whether the construction or modification of a stationary source will result in a violation of applicable portions of a control strategy or the interference with the attainment or maintenance of a NAAQS. 40 CFR 51.160. EPA rules set forth detailed requirements for the development of approvable SIP provisions related to the construction of new major stationary sources and major modifications to existing major stationary sources (Major NSR) located in both attainment and nonattainment areas. See, e.g., 40 CFR 51.165-166; however, the requirements for the development of approvable SIP provisions related to the construction and modification of minor sources and minor modifications to existing major stationary sources (Minor NSR) are governed by the more general provisions of 40 CFR 51.160-51.164. EPA has previously approved rules submitted by Oklahoma to implement the Major NSR permitting program, including revisions to rules that are also the subject of this rulemaking, but only as those rules relate to the Major NSR program. See, e.g., 75 FR 72695, November 26, 2010. The next section provides a description of Oklahoma's Minor NSR program and the portions of the February 14, 2002 SIP submittal related to Oklahoma's Minor NSR program that are being acted upon in this proposed rulemaking.

    1 The definition of “stationary source” or “source” used herein is equivalent to ODEQ's definition of “facility,” as defined at OAC 252:100-1-3.

    Some severable provisions submitted by the State of Oklahoma on February 14, 2002, are not addressed in today's action. For these provisions, the EPA has severed the submitted provisions from today's proposed rulemaking and will address them at a later date. The table below and the TSD accompanying our rulemaking identifies the submitted provisions that we are proposing to approve and those provisions we are neither evaluating nor acting upon in this proposed rulemaking.

    II. Oklahoma's Program for Minor New Source Review

    A. Overview—The EPA-approved Oklahoma SIP rules comprising Oklahoma's Minor New Source Review (NSR) program may be found in Regulation 1.4, Air Resources Management Permits Required. A revision to Regulation 1.4 was approved by EPA on November 8, 1999 (64 FR 60683) as part of the Oklahoma visibility SIP. The EPA's November 26, 2010 rulemaking mentioned above also revised Regulation 1.4 of the Oklahoma SIP, but only as it applied to Oklahoma's Major NSR program. See 75 FR 72695 and OAC 252:100-8. Oklahoma's Minor NSR program has been significantly modified and expanded. Elements of Oklahoma's Minor NSR program may now be found in OAC 252:4-1 (General Provisions), OAC 252:4-7 (Environmental Permit Process), Appendix C (Permitting Process Summary), OAC 252:100-5 (Registration, Emission Inventory and Annual Operating Fees), OAC 252:100-7 (Permits for Minor Facilities), Appendix H (De Minimis Facilities) and OAC 252:100-8 (Permits for Part 70 Sources). Those rules before us for action are limited to Minor NSR, and the effect of our rulemaking action, if finalized, will be the removal of Regulation 1.4 from the Oklahoma SIP (except as it applies to Minor NSR permitting under OAC 252:100-8) and the incorporation of specific provisions in the other regulations referenced above into the Oklahoma SIP.

    B. Types of Minor NSR Permitting Actions—Oklahoma divides its permitting program between “Permits for Minor Facilities” found in OAC 252:100-7, and “Permits for Part 70 Sources” which includes Major New Source Review (NSR) Sources, found in OAC 252:100-8. Oklahoma's February 14, 2002 SIP submittal includes OAC 252:100-7 which establishes three types of construction and operating permits for minor facilities: A permit by rule (PBR), a general permit, and an individual permit. The PBR program applies to facilities emitting less than 40 tons per year (TPY) of any regulated pollutant, in an industry group for which a rule has been promulgated. The general permitting program generally applies to facilities emitting between 40 TPY and 100 TPY, in an industry group for which a general permit has been issued. Minor facilities which do not qualify for either of these shall obtain an individual permit. De minimis facilities are those facilities which emit less than 5 TPY and are not required to obtain a permit. As discussed later, Oklahoma's Minor NSR Program also applies to minor modifications of existing major stationary sources, covered by OAC 252:100-8, although we are not proposing action on the Minor NSR-related rules in OAC 252:100-8 at this time. We also note that OAC:252 100-7 and OAC:252:100-8 have requirements for both construction and operating permits; however, only the construction permitting requirements are required under the CAA and 40 CFR part 51, subpart I.

    OAC 252:100-7 also deletes the lower limit of 5 TPY for PBR facilities. This allows facilities subject to New Source Performance Standards (NSPS) with emissions less than 5 TPY to apply for a PBR instead of obtaining an individual permit.

    A PBR or general permit may be issued if there are a sufficient number of facilities that have similar operations, emissions, and activities that are subject to the same standards, limitations, and operating and monitoring requirements. OAC 252:100-7 Part 9 and OAC 252:100-7 Part 3 outline the criteria required to qualify for these permits: (1) A facility may apply for a PBR if the facility's actual emissions are less than 40 TPY, except hazardous air pollutants (HAPs); the facility does not emit or have the potential to emit 10 TPY or more of any single hazardous air pollutant (HAP) or 25 TPY or more of any combination of HAPs; the ODEQ must have established a permit by rule for the industry; the facility certifies that it will comply with the applicable PBR; and the facility is not operated in conjunction with another facility or source that is subject to air quality permitting; and (2) A minor facility may apply for a general permit if its actual emissions are less than 100 TPY of each regulated air pollutant, except for HAPs; the facility does not emit or have the potential to emit 10 TPY or more of any single HAP or 25 TPY or more of any combination of HAPs; and ODEQ has issued a general permit for the industry.

    In general, a facility may apply for an individual permit if the facility's actual emissions are less than 100 TPY; the facility does not emit or have the potential to emit 10 TPY or more of any single hazardous air pollutant (HAP) or 25 TPY or more of any combination of HAPs; the facility submits an application form from the ODEQ that provides all data and information required by OAC 252:100-7, such as site information, process description, emission data; and the facility provides information necessary for any required BACT 2 determination, modeling and sampling point data. Individual permits may be applied for even if the facility qualifies for a PBR or a general permit.

    2See definition of “Best Available Control Technology” or “BACT” at OAC 252:100-7.1.1 as it applies to Oklahoma's Minor NSR program, as compared to the BACT requirements for Oklahoma's Major NSR program at OAC 252:100-8-34, as previously approved by EPA into the Oklahoma SIP (75 FR 72695, November 26, 2010).

    C. Permitting Practice and Procedures for Minor Facilities and Minor Revisions—OAC 252:4 (Rules of Practice and Procedure) provides administrative procedures for permit issuance, public notice, and administrative proceedings. OAC 252:4 was adopted to meet the requirements of the Oklahoma Administrative Procedures Act, which requires each State agency to adopt rules describing its organization, method of operation and methods by which the public may obtain or provide information to the agency. These rules also specify the requirements of all formal and informal procedures available, including a description of forms and instructions.

    OAC 252:4-1 (General Provisions) includes the practices and procedures of the Environmental Quality Board, Advisory Councils, and the Department of Environmental Quality; the availability of records; and fees for copying, faxing, records search and mail services.

    OAC 252:4-7 (Environmental Permit Process) includes Part 1 (The Process) and Part 3 (Air Quality Division Tiers and Time Lines). Representative sections of Part 1 include OAC 252:4-7-2 (Preamble), OAC 252:4-7-13 (Notices) and OAC 252:4-7-15 (Permit issuance or denial). Representative sections of Part 3 include OAC 252:4-7-31 (Air quality time lines) and OAC 252:4-7-33 (Air quality applications—Tier II). OAC 252:4-7 is briefly discussed in more detail below.

    The Preamble of OAC 252:4-7 is the introductory section, referencing the Uniform Environmental Permitting Act (UEPA), which requires that DEQ fit licenses, permits, certificates, approvals and registrations into a category, or Tier, established under the uniform environmental permitting rules. The UEPA was created to streamline the permitting process and is located in Oklahoma Statute Title 27A Environment and Natural Resources, Chapter 2: Oklahoma Environmental Quality Code, Sections 1 through 12. Tier I are administrative decisions made by a technical supervisor without public participation, aside from the landowner. Tier II are administrative decisions made by the Division Director with some public participation, including notice to the public, and the opportunity for a public meeting and public comment. Tier III are administrative decisions made by the Executive Director with extensive public participation, e.g., an administrative evidentiary hearing.

    The UEPA requires an applicant to give notice. Notice requirements include providing notice to the landowner if the applicant does not own the property, providing a draft notice for approval to DEQ prior to publication, and proof of publication; these are in addition to the notice requirements for permits under the UEPA.

    OAC 252:4, Appendix C (Permitting Process Summary) lists the permit processing steps required under each of the three Tiers. As explained below, Tier I covers permitting for minor facilities and minor revisions to facilities.

    D. Oklahoma's Permitting Regulations and Revisions Submitted in the February 14, 2002 SIP Submittal—OAC 252:100 (Air Pollution Control) provides, in part, details regarding permitting fees, permitting for minor facilities, permitting for Part 70 Sources, and Prevention of Significant Deterioration (PSD) requirements for major stationary sources.

    Oklahoma's February 14, 2002 SIP submittal includes three separate revisions to OAC 252:100-5 (Registration, Emission Inventory and Annual Operating Fees). The first revision to OAC 252:100-5 was adopted by Oklahoma in 1998 and includes requirements to file an emission inventory, formerly located in OAC 252:100-7; requirements to pay annual operating fees, formerly located in OAC 252:100-7 and OAC 252:100-8; and increases to the annual operating fees for minor facilities and non-Part 70 sources. The second revision to OAC 252:100-5 was adopted by Oklahoma in 1999, to modify the base annual operating fee for minor facilities and the annual operating fee for Part 70 sources. The third revision to OAC 252:100-5 was adopted by Oklahoma in 2000, allowing the agency to bill annual operating fees on a flexible schedule and providing edits that define billing dates and identifying how errors will be handled. The changes allow fees to be based on the most recent emissions data and require inventories to be submitted prior to March 1. Miscellaneous edits delete redundant text and clarify text; the revisions are not substantive.

    Oklahoma's February 14, 2002 SIP submittal also included several revisions to OAC 252:100-7 (Permits for Minor Facilities). As stated in Part I above, the EPA took no action on OAC 252:100-7 in Oklahoma's 1994 SIP submittal, so Regulation 1.4 remained in the SIP. Today's rulemaking proposes to approve revisions to eliminate Regulation 1.4 from the Oklahoma SIP, with the exception of its applicability to Minor NSR permitting under OAC 252:100-8, while also taking action on identified revisions to OAC 252:100-7 that have been adopted by the State since the EPA's November 8, 1999 rulemaking.

    A brief discussion of each of the revisions related to what is now OAC 252:100-7 (hereinafter “Subchapter 7”), as submitted by Oklahoma on February 14, 2002, for EPA review and approval into the Oklahoma SIP, is presented below. Please note that rules adopted by Oklahoma in the first five revisions listed below are superseded by the last three revisions listed, and they are provided for background information purposes.

    The first set of revisions was adopted by Oklahoma effective May 6, 1988, and affect the permitting regulations for new and existing sources of air pollution by increasing construction and operating permit fees for new sources and requiring all permits to be renewable on an annual basis. Renewal fees are assessed annually on all regulated sources.

    In 1990, the State Legislature passed the Oklahoma Administrative Procedures Act which mandated a common format for Oklahoma's rules and regulations. The Oklahoma State Department of Health was assigned to Title 310 in the OAC, the Air Pollution Control Rules were assigned to Chapter 200, and each regulation was assigned to a Subchapter. Regulation 1.4 became OAC Title 310, Chapter 200, Subchapter 7 or OAC 310:200-7, and was renamed “Permits.” This recodification of Regulation 1.4 to OAC 310:200-7 and change in fee provisions were the second revisions to Subchapter 7, adopted by Oklahoma and effective June 1, 1993.

    In 1993, the Oklahoma Air Quality Service became the Air Quality Division (AQD) of the newly created ODEQ. As a result, the Air Pollution Control Rules were recodified to OAC 252:100, adopted by Oklahoma effective May 26, 1994, and submitted by the Governor of Oklahoma to the EPA as a revision to the Oklahoma SIP on May 16, 1994.

    The fourth set of revisions to Subchapter 7 was adopted by Oklahoma, effective July 1, 1996, and affects operating time limits for permitted and unpermitted minor sources.

    The fifth set of revisions to Subchapter 7 was adopted by Oklahoma, effective June 2, 1997, and excludes total suspended particulates (TSP) from being considered as regulated air pollutants for purposes of fee calculation only.

    The sixth set of revisions to Subchapter 7 was adopted by Oklahoma, effective June 25, 1998. These revisions incorporate a new permit classification system that includes environmental impact, emission levels, and source changes in Oklahoma. Other changes remove requirements for Part 70 and major sources (which are relocated to Subchapter 8); define and exempt “de minimis” facilities (less than 5 tons); revise minor permit application fees; and introduce the PBR, general and individual permits.

    The seventh set of revisions to Subchapter 7 was adopted by Oklahoma, effective June 11, 1999, and includes modifications to language applicable to de minimis facilities, PBR, and general permits. Additional changes increase various application fees for minor facilities.

    The eighth set of revisions to Subchapter 7 was adopted by Oklahoma, effective June 1, 2001. Provisions of Regulation 1.4 were moved into OAC 252:100-7-2, requiring applications be signed by the applicant; the signature constitutes an implied agreement that the applicant shall be responsible for assuring construction or operation, as applicable, in accordance with the application and OAC 252:100; and the applicant's duty to correct any errors or omissions on the application.

    In addition to the revisions to OAC 252:100-7 discussed above, Oklahoma's February 14, 2002 SIP submittal includes revisions to OAC 252:100, Subchapter 8 (Permits for Part 70 Sources). The State reasons that it would be difficult to separate the Subchapter 8 rules that are based solely on Title V program requirements from those Subchapter 8 rules that are based upon SIP requirements, without omitting essential requirements. As such, Oklahoma submitted all of the Subchapter 8 rule revisions noted herein for approval into the Oklahoma SIP.

    Oklahoma's February 14, 2002 SIP submittal revises OAC 252:100-8, Part 1 (General Provisions), OAC 252:100-8, Part 5 (Permits for Part 70 Sources), OAC 252:100-8, Part 7 (Prevention of Significant Deterioration (PSD) Requirements for Attainment Areas), and OAC 252:100-8, Part 9 (Major Sources Affecting Nonattainment Areas). These sections include general information, including eligibility criteria for general and individual permits; sources subject to the permit requirements and permit contents; administrative requirements, including format, transmission of information, review and petitions; applicability of new sources to NSR requirements; demonstration of best available control technology and evaluation of air quality impact. As stated in Section I discussion above, the EPA's November 26, 2010 rulemaking (75 FR 72695) approved OAC 252:100-8, Parts 7 and 9 as well as OAC 252:100-8, Parts 1 and Part 5 (as they apply to sources subject to the Major NSR program requirements) into the Oklahoma SIP. EPA considers the Minor NSR provisions in Subchapter 8 for Part 70 sources severable from the Subchapter 7 Minor NSR requirements for minor facilities. We also note that additional SIP submittals with Subchapter 8 revisions are currently before the EPA for action. In today's proposal, the EPA is not proposing approval of those portions of OAC 252:100-8, Parts 1 and 5 as they apply to Oklahoma's Minor NSR permitting program; the EPA will address the Minor NSR program aspects of OAC 252: 100-8 in a separate action.

    Finally, OAC 252:100, Appendix H (De Minimis Facilities) is referenced in Section 252:100-7-1.1. Appendix H lists the facilities that qualify as De Minimis, such as agricultural (lawn care), woodworking (portable wood chipping operations), office/janitorial, and cleaning/surface preparation (cold degreasing operations).

    Additional discussion of the above SIP revisions is located below and also in the Technical Support Document (TSD) which is in the docket for this proposed rule.

    III. EPA Evaluation of Proposed SIP Revisions

    A. EPA Evaluation of Requirements for Minor NSR—As stated above, the EPA regulations governing the criteria that states must satisfy for EPA SIP approval of regulations specific to Minor NSR programs are contained in 40 CFR Sections 51.160-51.164. More specifically, the provisions of a Minor NSR program must include legally enforceable procedures that enable the permitting authority to determine whether the construction or modification of a source will result in a violation of applicable portions of the control strategy or interfere with attainment or maintenance of a NAAQS. 40 CFR 51.160(a). To accomplish this goal, the state's Minor NSR program must include the means by which the permitting authority will prevent such construction or modification if it would result in a violation of applicable portions of a control strategy or interfere with the attainment or maintenance of a NAAQS. 40 CFR 51.160(b). Other requirements for an approvable Minor NSR program are contained in 40 CFR 51.160(c)-(f) as well as in 40 CFR 51.161-51.164. As discussed in Section II above, elements of Oklahoma's Minor NSR program may be found in both OAC 252:100-7 (Permits for Minor Facilities) as well as in OAC 252:100-8 (Permits for Part 70 Sources); however, the EPA will not be taking action on the Minor NSR program elements located in OAC 252:100-8 at this time. Regulation 1.4 of the currently approved SIP will continue to apply to the minor NSR program as it applies to sources subject to Part 70 (See OAC 252:100-8).The TSD which accompanies this proposed rulemaking contains a detailed review of Oklahoma's February 14, 2002 SIP submittal and how the submitted regulations being acted upon in this proposed rulemaking meet the requirements for an approvable Minor NSR program. A summary of our evaluation is provided below.

    Under the permitting requirements for minor facilities in OAC 252:100-7 Permits for Minor Facilities, no person may commence construction or modification of any minor facility, may operate any new minor facility, or may relocate any minor portable source without obtaining a permit from ODEQ, except for de minimis facilities.

    The provisions in OAC 252:100-7 Permits for Minor Facilities establish both an initial construction permit and a subsequent operating permit. Under OAC 252:100-7-15(b) three types of construction permits are available: A permit by rule (PBR), a general permit, and an individual permit. These provisions allow ODEQ to develop and issue PBR, general, and individual minor source permits. Minor NSR sources may seek authorization under the PBR or general permit, in lieu of an individual permit, if they meet the requirements of the PBR provisions or general permitting program and the specific requirements of each PBR or general permit. Regardless of the type of permit applied for, the applicant must provide specific information which is evaluated by the ODEQ both in the application process and on an ongoing basis. For example, OAC 252:100-7-15(d) requires that all three types of minor construction permits contain provisions that: (1) Require the permittee to comply with all applicable air pollution rules, (2) prohibit the exceedance of ambient air quality standards, and (3) may establish permit conditions and limitations as necessary to assure compliance with all rules. The specific PBR or general permit rule and application form requires that data and information be provided which includes, but is not limited to, process description, emission data, any required BACT 3 determination, modeling and sampling point data. Under OAC 252:100-7-18(d)(1), Operating permit conditions, the emission limitations established and made a part of the construction permit are incorporated into and become enforceable limitations of the subsequently issued operating permit. Under OAC 252:100-5-2.1 Emission Inventory, any facility that is a source of air emissions shall submit a complete emission inventory annually, except every 5 years for a PBR with emissions less than 5 tons per year. Therefore, as required by the provisions of Chapter 4 and Chapter 100, the PBR, general and individual permits must contain terms and conditions that assure sources authorized via the construction permit and subsequent operating permit will meet all applicable requirements under the Act (e.g., NSR, NSPS, NESHAP) and will not cause or contribute to an exceedance of the NAAQS. Also, see OAC 252:4-7-32 and OAC 252:100-7-15(d)(2).

    3Id.

    As discussed above, the EPA believes that provisions of OAC 252:100-7 satisfy the requirements of 40 CFR 51.160(a) and enable the permitting authority to determine whether the construction or modification will result in a violation of applicable portions of the control strategy or interfere with attainment or maintenance of a national ambient air quality standard. Further, these provisions satisfy the requirements of 40 CFR 51.160(d) which require that approval of any construction or modification must not affect the responsibility of the owner or operator to comply with applicable portions of the control strategy.

    Based on our evaluation, we propose to find that the severable portions of the Minor NSR program requirements in OAC 252:4-1 (General Provisions), OAC 252:4-7 (Environmental Permit Process), Appendix C (Permitting Process Summary), OAC 252:100-5 (Registration, Emission Inventory and Annual Operating Fees), OAC 252:100-7 (Permits for Minor Facilities) and Appendix H are approvable as meeting CAA requirements for a Minor NSR program. These severable Minor NSR permit provisions provide for the necessary procedures and applicable requirements for approvable Minor NSR programs. Additional details regarding our evaluation are found in the TSD accompanying this proposed rulemaking. The TSD is available in the docket and from the EPA Region 6 office.

    B. CAA 110(l) Analysis—Each revision to an implementation plan submitted by a state under the Clean Air Act shall be adopted by such state after reasonable notice and public hearing. ODEQ adopted the proposed revisions after reasonable notice and public hearing. CAA section 110(l) also states that the Administrator shall not approve a revision of a plan if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in CAA section 171), or any other applicable requirement of the Act. For purposes of the analysis under CAA section 110(l), we have taken into account the overall effect of the revisions included in this action. Given that these revisions primarily concern recodified portions of the Oklahoma SIP, new sections that incorporate Federal and state rules, deletions of duplicative and outdated rules, and edits that simplify text and correct errors, we propose to find that the overall effect of the revisions would improve the Oklahoma SIP, and our approval would not interfere with any CAA requirement.

    EPA's review of the proposed revisions and appendix, in accordance with section 110 of the CAA, forms the basis for demonstrating noninterference with applicable CAA requirements for attainment, including violation of any NAAQS or contribution to a PSD increment exceedance. The TSD contained in the docket for this action contains our review of the individual sections for each regulation associated with this proposed SIP revision rulemaking. Our review demonstrates that the changes made to the Oklahoma rules being acted upon in today's proposed rulemaking reflect either the same regulatory language or are consistent with the requirements found in the federal rules related to Minor NSR SIP programs. The TSD also contains references to supporting technical documentation in the docket regarding specific aspects of the proposed revisions, including Appendix H. De Minimis Facilities.

    In its review of the proposed revisions and appendix identified above, the EPA also took into consideration the following factors. There is no currently designated nonattainment area for any air pollutant in the State of Oklahoma. The entire State is currently in attainment for all criteria pollutants, and has been since the original promulgation and subsequent revisions of the NAAQS and PSD increments. Also, air quality has generally remained at the same level or has steadily improved both statewide and in the largest metropolitan statistical areas of Oklahoma City and Tulsa, as shown in the EPA's “Air Quality System” repository, and the EPA's “Air Quality Trends by City” monitoring data averages from 1990 through 2015. Furthermore, since the list of exempted source categories (Appendix H) included in the proposed revisions have historically operated without coverage by an air permit and there are no anticipated increases in emissions or in the number of these types of sources resulting from the approval of the de minimis exemption list into the Oklahoma SIP, the EPA finds there is a low possibility of adverse impacts on ambient air quality from the emission sources and activities included in Appendix H. Our conclusion is supported by ambient air monitoring trends in Oklahoma, as more specifically discussed in the TSD associated with this proposed rulemaking. Our noninterference determination and proposed approval of OAC 252:100, Appendix H is consistent with our assessment of the environmental significance associated with emissions covered by this Appendix. The ODEQ has been implementing the Minor NSR air permitting program based on the codification of their permitting policy without any indication that the de minimis facilities listed in Appendix H have interfered with attainment or any other applicable requirement of the CAA. Therefore, the EPA proposes to approve Appendix H into the Oklahoma SIP since it meets CAA requirements for Minor NSR and the requirements of CAA section 110.

    Based on historical trends and supporting air quality monitoring data documenting air quality improvements throughout the State, we believe the proposed Minor NSR SIP revision meets the requirements of CAA section 110(l) and is consistent with the provisions of 40 CFR 51.160(e) which provide state agencies the latitude to define the types and sizes of facilities, buildings, structures, or installations subject to review. We believe the implementation of these rules will not interfere with any applicable requirement concerning attainment, reasonable further progress, maintaining PSD increment, or any other applicable requirement of the CAA.

    Accordingly, the EPA is proposing approval of these revisions under section 110 of the Act. Further discussion of CAA section 110(l) is contained in the TSD for this proposed rule. The TSD is available in the docket and from the EPA Region 6 office.

    IV. Proposed Action

    We are proposing to approve severable portions of revisions relating to the Minor NSR program of the Oklahoma SIP, as submitted to the EPA on February 14, 2002. The revisions include portions of OAC 252:4, Rules of Practice and Procedure, and OAC 252:100, Air Pollution Control. These revisions replace the corresponding regulations in the Oklahoma SIP found in Regulation 1.4, Air Resources Management Permits Required, with the exception of the continued applicability of Regulation 1.4 to Minor NSR permitting under OAC 252:100-8. EPA has made its determination in accordance with the CAA and the EPA regulations at 40 CFR 51.160—51.164. Therefore, under section 110 of the Act, and for the reasons presented above and in our accompanying TSD, the EPA proposes approval of severable portions of revisions to the Oklahoma Minor NSR SIP identified in Table 1 below.

    Table 1—Revisions to the Oklahoma SIP Proposed for Approval Section Title Effective date Submittal date Chapter 4 (OAC 252:4). Rules of Practice and Procedure Subchapter 1. General Provisions OAC 252:4-1-1 Purpose and Authority June 11, 2001 February 14, 2002. OAC 252:4-1-2 Definitions June 11, 2001 February 14, 2002. OAC 252:4-1-3 Organization June 11, 2001 February 14, 2002. OAC 252:4-1-4 Office hours and locations; communications June 11, 2001 February 14, 2002. OAC 252:4-1-5, except (a) 2nd sentence, which EPA will address in a separate action General Provisions, Availability of a record June 11, 2001 February 14, 2002. OAC 252:4-1-6 Administrative fees June 11, 2001 February 14, 2002. OAC 252:4-1-7 Fee credits for regulatory fees June 11, 2001 February 14, 2002. OAC 252:4-1-8 Board and Councils June 11, 2001 February 14, 2002. OAC 252:4-1-9 Severability June 11, 2001 February 14, 2002. Subchapter 7. Environmental Permit Process OAC 252:4-7-1 Authority June 11, 2001 February 14, 2002. OAC 252: 4-7-2, except 2nd sentence, which EPA will address in a separate action Preamble June 11, 2001 February 14, 2002. OAC 252: 4-7-3 Compliance June 11, 2001 February 14, 2002. OAC 252:4-7-4, except (a) 1st sentence, which EPA will address in a separate action. Filing an application June 11, 2001 February 14, 2002. OAC 252:4-7-5 Fees June 11, 2001 February 14, 2002. OAC 252: 4-7-6 Receipt of Applications June 11, 2001 February 14, 2002. OAC 252:4-7-7 Administrative completeness review June 11, 2001 February 14, 2002. OAC 252:4-7-8 Technical review June 11, 2001 February 14, 2002. OAC 252:4-7-9 When review times stops June 11, 2001 February 14, 2002. OAC 252:4-7-10 Supplemental time June 11, 2001 February 14, 2002. OAC 252:4-7-11 Extensions June 11, 2001 February 14, 2002. OAC 252:4-7-12 Failure to meet deadline June 11, 2001 February 14, 2002. OAC 252:4-7-13, except (a), which EPA will address in a separate action Notices June 11, 2001 February 14, 2002. OAC 252:4-7-14 Withdrawing applications June 11, 2001 February 14, 2002. OAC 252:4-7-15 Permit issuance or denial June 11, 2001 February 14, 2002. OAC 252:4-7-17 Permit decision-making authority June 11, 2001 February 14, 2002. OAC 252:4-7-18 Pre-issuance permit review and correction June 11, 2001 February 14, 2002 OAC 252:4-7-19 Consolidation of permitting process June 11, 2001 February 14, 2002. Part 3. Air Quality Division Tiers and Timelines OAC 252:4-7-31 Air quality time lines June 11, 2001 February 14, 2002. OAC 252: 4-7-32, except (a) and (c)(1), which EPA will address in a separate action Air quality applications—Tier I June 11, 2001 February 14, 2002. Appendices for OAC 252: Chapter 4 OAC 252: 4. Appendix C, except the Tier I column, which EPA will address in a separate action Permitting process summary June 11, 2001 February 14, 2002. Chapter 100 (OAC 252:100) Air Pollution Control Subchapter 5. Registration, Emission Inventory and Annual Operating Fees OAC 252: 100-5-1 Purpose June 12, 2000 February 14, 2002. OAC 252: 100-5-1.1 Definitions June 12, 2000 February 14, 2002. OAC 252: 100-5-2 Registration of potential sources of air contaminants June 12, 2000 February 14, 2002. OAC 252: 100-5-2.1 Emission inventory June 12, 2000 February 14, 2002. OAC 252: 100-5-2.2 Annual operating fees June 12, 2000 February 14, 2002. OAC 252: 100-5-3 Confidentiality of proprietary information June 12, 2000 February 14, 2002. Subchapter 7. Permits for Minor Facilities Part 1. General Provisions OAC 252: 100-7-1 Purpose June 25, 1998 February 14, 2002. OAC 252: 100-7-1.1 Definitions June 11, 1999 February 14, 2002. OAC 252: 100-7-2, except (a) 2nd sentence, which EPA will address in a separate action Requirement for permits for minor facilities June 1, 2001 February 14, 2002. Part 3. Construction Permits OAC 252: 100-7-15 Construction permit June 11, 1999 February 14, 2002. Part 4. Operating Permits OAC 252: 100-7-17 Relocation permits for portable sources June 25, 1998 February 14, 2002. OAC 252: 100-7-18 Operating permit June 11, 1999 February 14, 2002. Part 9. Permits by Rule OAC 252: 100-7-60 Permit by rule June 11, 1999 February 14, 2002. OAC 252: 100-7-60.1 Cotton gins June 11, 1999 February 14, 2002. OAC 252: 100-7-60.2 Grain elevators June 11, 1999 February 14, 2002. Subchapter 8. Permits for Part 70 Sources EPA will address applicability to Minor NSR permitting under OAC 252:100-8 in a separate action OAC 252: 100. Appendix H DE MINIMIS FACILITIES June 25, 1998 February 14, 2002. V. Incorporation by Reference

    In this action, we are proposing to include in a final rule regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, we are proposing to incorporate by reference revisions to the Oklahoma regulations as described in the Proposed Action section above. We have made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the EPA Region 6 office.

    VI. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

    In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide, Volatile organic compounds.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: November 16, 2016. Ron Curry, Regional Administrator, Region 6.
    [FR Doc. 2016-28673 Filed 11-28-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION 48 CFR Part 1 [FAR Case 2016-005; Docket No. 2016-0005, Sequence No.1] RIN 9000-AN29 Federal Acquisition Regulation: Effective Communication between Government and Industry AGENCY:

    Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).

    ACTION:

    Proposed rule.

    SUMMARY:

    DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement a section of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2016. This rule clarifies that agency acquisition personnel are permitted and encouraged to engage in responsible and constructive exchanges with industry, so long as those exchanges are consistent with existing law and regulation and do not promote an unfair competitive advantage to particular firms.

    DATES:

    Interested parties should submit comments to the Regulatory Secretariat Division at one of the addresses shown below on or before January 30, 2017 to be considered in the formulation of a final rule.

    ADDRESSES:

    Submit comments in response to FAR case 2016-005 by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by entering “FAR Case 2016-005” under the heading “Enter Keyword or ID” and selecting “Search.” Select the link “Comment Now” that corresponds with “FAR Case 2016-005.” Follow the instructions provided on the screen. Please include your name, company name (if any), and “FAR Case 2016-005” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division, ATTN: Ms. Flowers, 1800 F Street NW., 2nd Floor, Washington, DC 20405.

    Instructions: Please submit comments only and cite “FAR Case 2016-005: Effective Communication between Government and Industry” in all correspondence related to this case. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    For clarification of content, contact Mr. Michael O. Jackson, Procurement Analyst, at 202-208-4949. For information pertaining to status or publication schedules, contact the Regulatory Secretariat Division at 202-501-4755. Please cite “FAR Case 2016-005.”

    SUPPLEMENTARY INFORMATION: I. Background

    DoD, GSA, and NASA (the “Councils”) are proposing to amend the FAR to implement section 887 of NDAA for FY 2016. The rule clarifies that agency acquisition personnel are permitted and encouraged to engage in responsible and constructive exchanges with industry, in a manner that is consistent with existing law and regulation, and does not promote an unfair competitive advantage.

    FAR 1.102 establishes the guiding principles within the FAR to—

    (1) Satisfy the customer in terms of cost, quality, and timeliness of the delivered product or service;

    (2) Minimize administrative operating costs;

    (3) Conduct business with integrity, fairness, and openness; and

    (4) Fulfill public policy objectives.

    FAR 1.102-2 provides the requirements or “performance standards” for transforming these principles into positive, results-oriented acquisition strategies. A communication policy that takes into account a range of approaches for effectively describing the Government's requirements to private industry is an essential component of the Federal acquisition process. This concept is in keeping with the direction expressed by Congress in section 887 of the NDAA for FY 2016.

    II. Discussion and Analysis

    The proposed rule will amend FAR 1.102-2(a)(4) to specifically state that Government acquisition personnel are permitted and encouraged to engage in responsible and constructive exchanges with industry, so long as those exchanges are consistent with existing laws and regulations, and promote a fair competitive environment. This revision, coupled with the existing guidance in the FAR subpart 1.1 and the market research strategies set forth in FAR part 10, will better equip Federal acquisition officials with the information needed to issue high-quality solicitations.

    III. Public Feedback

    In the winter of 2011, the Office of Federal Procurement Policy (OFPP) launched a campaign to address misconceptions commonly held by industry and Government regarding the role of communication during the acquisition process in order to encourage early, frequent, and constructive engagement with industry to achieve better acquisition outcomes. The first of two “myth-busting” memoranda, issued in February 2011, focused on misconceptions on the part of Federal agencies and a second memorandum, issued in May 2012, addressed misconceptions that may be held by some in the vendor community. Both memoranda described best practices for effective communication that have been put into use by the acquisition community, with good results. Copies of these memoranda, “Myth-Busting: Addressing Misconceptions to Improve Communication with Industry during the Acquisition Process” and “Myth-Busting 2: Addressing Misconceptions and Further Improving Communication During the Acquisition Process,” are available at https://www.whitehouse.gov/omb/procurement_index_memo. The Councils seek to continue the conversation initiated by these memoranda and welcome any suggestions from the public to further enhance open communication between industry and the Federal acquisition community. The Councils specifically request information regarding the following:

    • Which phase(s) of the Federal acquisition process—i.e., acquisition planning/market research; solicitation/award; post award—would benefit from more exchanges with industry and what specific policies or procedures would enhance communication during these phases?

    • Is there a current FAR policy that may inhibit communication? If so, what is the policy, and how could this policy be revised to remove barriers to effective communication?

    • Might it be beneficial to encourage, or require, contracting officers to conduct discussions with offerors after establishing the competitive range for contracts of a high dollar threshold? If so, what would be the appropriate dollar threshold?

    IV. Executive Order 12866 and 13563

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

    V. Regulatory Flexibility Act

    DoD, GSA, and NASA do not expect the proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act 5 U.S.C. 601, et seq., because the proposed changes relate to internal Government business practices. However, an Initial Regulatory Flexibility Analysis (IRFA) has been prepared and is summarized as follows:

    DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement section 887 of the National Defense Authorization Act (NDAA) for FY 2016, which provides that agency acquisition personnel are permitted and encouraged to engage in responsible and constructive exchanges with industry. Any effect to small businesses should be positive in that industry, including small business, will benefit from better communication with the Government. Based on data obtained from the Federal Procurement Data System—Next Generation (FPDS-NG) on June 21, 2016, approximately 112,150 businesses received Federal contracts during fiscal year 2015, and of these, approximately 75,000 or 67 percent were small businesses.

    This rule does not impose any new reporting, recordkeeping or other compliance requirements. The rule does not duplicate, overlap, or conflict with any other Federal rules.

    The Regulatory Secretariat Division has submitted a copy of the IRFA to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the IRFA may be obtained from the Regulatory Secretariat Division. DoD, GSA and NASA invite comments from small business concerns and other interested parties on the expected impact of this proposed rule on small entities.

    DoD, GSA, and NASA will also consider comments from small entities concerning the existing regulations in subparts affected by this proposed rule consistent with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (FAR Case 2016-005) in correspondence.

    VI. Paperwork Reduction Act

    The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

    List of Subjects in 48 CFR Part 1

    Government procurement.

    Dated: November 21, 2016. William F. Clark, Director, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy.

    Therefore, DoD, GSA, and NASA are proposing to amend 48 CFR part 1 as set forth below:

    PART 1—FEDERAL ACQUISITION REGULATIONS SYSTEM 1. The authority citation for 48 CFR part 1 continues to read as follows: Authority:

    40 U.S.C. 121(c); 10 U.S.C. chapter 137; and 51 U.S.C. 20113.

    2. Amend section 1.102-2 by— a. Revising paragraph (a)(4); b. Redesignating paragraphs (a)(5) through (7) as paragraphs (a)(6) through (8), respectively; and c. Adding a new paragraph (a)(5).

    The revision and addition read as follows:

    1.102-2 Performance standards.

    (a) * * *

    (4) The Government must not hesitate to communicate with the commercial sector as early as possible in the acquisition cycle to help the Government determine the capabilities available in the commercial marketplace. Government acquisition personnel are permitted and encouraged to engage in responsible and constructive exchanges with industry as part of market research (see 10.002), so long as those exchanges are consistent with existing laws, regulations, and promote a fair competitive environment.

    (5) The Government will maximize its use of commercial products and services in meeting Government requirements.

    [FR Doc. 2016-28450 Filed 11-28-16; 8:45 am] BILLING CODE 6820-EP-P
    AGENCY FOR INTERNATIONAL DEVELOPMENT 48 CFR Part 752 RIN 0412-AA85 Government Property—USAID Reporting Requirements AGENCY:

    U.S. Agency for International Development.

    ACTION:

    Proposed rule.

    SUMMARY:

    The U.S. Agency for International Development (USAID) seeks public comment on a proposed rule that would amend the USAID Acquisition Regulation (AIDAR) clarifying accountability for all mobile Information Technology equipment provided as government-furnished property by Government officials.

    DATES:

    Comments must be received no later than January 30, 2017.

    ADDRESSES:

    Address all comments concerning this proposed rule to Carol Ketrick, Bureau for Management, Office of Acquisition and Assistance, Policy Division (M/OAA/P), Room 867F, SA-44, Washington, DC 20523-2052. Submit comments, identified by title of the action and Regulatory Information Number (RIN) by any of the following methods:

    1. Through the Federal eRulemaking Portal at http://www.regulations.gov by following the instructions for submitting comments.

    2. By Email: Submit electronic comments to [email protected] See SUPPLEMENTARY INFORMATION for file formats and other information about electronic filing.

    3. By Mail addressed to: USAID, Bureau for Management, Office of Acquisition & Assistance, Policy Division, Room 867-F, SA-44, Washington, DC 20523-2052.

    FOR FURTHER INFORMATION CONTACT:

    Carol Ketrick, Telephone: 202-567-4676 or Email: [email protected].

    SUPPLEMENTARY INFORMATION:

    A. Instructions

    All comments must be in writing and submitted through one of the methods specified in the ADDRESSES section above. All submissions must include the title of the action and RIN for this rulemaking. Please include your name, title, organization, postal address, telephone number, and email address in the text of the message.

    Comments submitted by email must be included in the text of the email or attached as a PDF file. Please avoid using special characters and any form of encryption. Please note that USAID recommends sending all comments to the Federal eRulemaking Portal because security screening precautions have slowed the delivery and dependability of surface mail to USAID/Washington.

    Three days after receipt of a comment and until finalization of the action, all comments will be made available at http://www.regulations.gov for public review without change, including any personal information provided. We recommend you do not submit information that you consider Confidential Business Information (CBI) or any information that is otherwise protected from disclosure by statute.

    USAID will only address comments that explain why the rule would be inappropriate, ineffective, or unacceptable without a change. Comments that are insubstantial or outside the scope of the rule may not be considered.

    B. Background

    The Federal Government has been taking proactive steps to improve management and oversight of IT equipment especially in light of recent federal cybersecurity incidents. As part of a larger Agency effort to strengthen and clarify existing policy and procedures for accountability of all USAID Information Technology (IT) equipment and access to agency facilities and information systems, USAID is clarifying the requirements in the clause in the AIDAR at § 752.245-70, Government Property—USAID reporting requirements. While the clarifications are minor in nature, the entire clause at § 752.245-70 is being replaced at this time to correct formatting.

    As stated in the clause at § 752.245-70, government-furnished property includes personal property furnished either prior to or during the performance of the contract by any U.S. Government accountable officer to the contractor for use in connection with performance of this contract and identified by such officer as accountable. Instead of requiring designation of mobile IT as accountable on a case-by-case basis, the clause is being amended to clarify that all mobile Information Technology (IT) equipment is identified as accountable. This includes both mobile IT equipment that is USAID-owned and furnished to the contractor, as well as contractor acquired mobile IT equipment, title to which vests in the U.S. Government. Mobile IT equipment includes, but is not limited to, mobile phones (e.g. smartphones), laptops, tablets, and encrypted devices. The format of the required Annual Report of Government Property in Contractor's Custody is corrected to read that all accountable government-furnished property must be reported.

    C. Regulatory Planning and Review

    This rule has been determined to be “nonsignificant” under Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993 and, therefore, is not subject to review.

    This rule is not a major rule under 5 U.S.C. 804.

    D. Regulatory Flexibility Act

    The proposed rule does not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. Therefore, an Initial Regulatory Flexibility Analysis has not been performed.

    E. The proposed rule clarifies but does not establish a new collection of information that requires the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

    List of Subjects in 48 CFR Part 752

    Government procurement.

    For the reasons discussed in the preamble, USAID proposes to amend 48 CFR Chapter 7 as set forth below:

    PART 752—SOLICITATION PROVISIONS AND CONTRACT CLAUSES 1. The authority citation for 48 CFR part 752 continues to read as follows: Authority:

    Sec. 621, Pub. L. 87-195, 75 Stat. 445, (22 U.S.C. 2381) as amended; E.O. 12163, Sept. 29, 1979, 44 FR 56673; and 3 CFR 1979 Comp., p. 435.

    2. Revise 752.245-70 to read as follows:
    752.245-70 Government property—USAID reporting requirements.

    USAID contracts, except those for commercial items, must contain the following preface and reporting requirement as additions to the appropriate Government Property clause prescribed by (48 CFR) FAR 45.107, per a GAO audit recommendation.

    Preface: to be inserted preceding the text of the FAR clause.

    Government Property—USAID Reporting Requirements (XXX 2016)

    (a)(1) The term Government-furnished property, wherever it appears in the following clause, shall mean (1) non-expendable personal property owned by or leased to the U.S. Government and furnished to the contractor, and (2) personal property furnished either prior to or during the performance of this contract by any U.S. Government accountable officer to the contractor for use in connection with performance of this contract and identified by such officer as accountable. All mobile Information Technology (IT) equipment, including but not limited to, mobile phones (e.g. smartphones), laptops, tablets, and encrypted devices, either provided as government furnished property, or acquired by the contractor, title to which vests in the U.S. Government, are considered accountable.

    (2) The term Government property, wherever it appears in the following clause, shall mean Government-furnished property and non-expendable personal property title to which vests in the U.S. Government under this contract, including “Contractor-acquired Property” title to which vests with the U.S. Government. Non-expendable personal property, for purposes of this contract, is defined as personal property that is complete in itself, does not lose its identity or become a component part of another article when put into use; is durable, with an expected service life of two years or more; and that has a unit cost of more than $500.

    (b) Reporting Requirement: To be inserted following the text of the (48 CFR) FAR clause.

    Reporting Requirements: The Contractor will submit an annual report on all Government property in a form and manner acceptable to USAID substantially as follows:

    Annual Report of Government Property in Contractor's Custody [Name of contractor as of (end of contract year), 20XX] Motor vehicles Furniture and furnishings— Office Living quarters Other
  • government
  • property
  • A. Value of property as of last report B. Transactions during this reporting period 1. Acquisitions (add): a. Contract acquired property 1 b. Transferred from USAID 2 c. Transferred from others, without reimbursement 3 2. Disposals (deduct): a. Returned to USAID b. Transferred to USAID—Contractor purchased c. Transferred to other Government agencies 3 d. Other disposals 3 C. Value of property as of reporting date D. Estimated average age of contractor held property Years Years Years Years 1 Personal property that is complete in itself, does not lose its identity or become a component part of another article when put into use; is durable, with an expected service life of two years or more; and that has a unit cost of more than $500. 2 Government-furnished property listed in this contract as nonexpendable or accountable. 3 Explain if transactions were not processed through or otherwise authorized by USAID.
    Property Inventory Verification

    I attest that (1) physical inventories of Government property are taken not less frequently than annually; (2) the accountability records maintained for Government property in our possession are in agreement with such inventories; and (3) the total of the detailed accountability records maintained agrees with the property value shown opposite line C above, and the estimated average age of each category of property is as cited opposite line D above.

    Authorized Signature Name Title Date
    Dated: October 20, 2016. Roy Plucknett, Chief Acquisition Officer.
    [FR Doc. 2016-28338 Filed 11-28-16; 8:45 am] BILLING CODE 6116-01-P
    DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Chapter V [Docket No. NHTSA-2016-0090], Notice 3 Federal Automated Vehicles Policy AGENCY:

    National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).

    ACTION:

    Notice of public meeting.

    SUMMARY:

    NHTSA is announcing a public meeting to seek input specifically on the Model State Policy and Modern Regulatory Tools sections of the recently released Federal Automated Vehicles Policy (the Policy). The Policy is guidance that seeks to speed the delivery of an initial regulatory framework for highly automated vehicles (HAVs) as well as encourage conformance with best practices to guide manufacturers and other entities in the safe design, development, testing, and deployment of HAVs.

    The Model State Policy builds on collective knowledge gathered from safety stakeholders, and is intended to help avoid a patchwork of inconsistent laws and regulations. It outlines States' roles in regulating HAVs and lays out model procedures and requirements for use by States that wish to enact laws governing HAVs.

    The Modern Regulatory Tools section includes potential new tools and authorities that could help NHTSA overcome the challenges and take advantage of the opportunities involved in the safe and expeditious development of HAVs.

    Held in two distinct parts, the public meeting in the morning session will be an open listening session for the Model State Policy. In the afternoon session, there will be moderated panel discussions on the Modern Regulatory Tools. All comments during the public meeting will be oral.

    DATES:

    NHTSA will hold the public meeting on December 12, 2016, in Arlington, VA. The meeting will start at 8:30 a.m. and continue until 5 p.m. local time. Check-in will begin at 8 a.m. Attendees should arrive early enough to be seated by 8:30 a.m.

    ADDRESSES:

    The meeting will be held at the United States Army Conference and Event Center (CEC), located at 2425 Wilson Boulevard, Arlington, VA 22201 (Courthouse Metro Station). This facility is accessible to individuals with disabilities. The meeting will also be webcast live, and a link to the webcast will be available through http://www.nhtsa.gov/nhtsa/av/index.html.

    Docket: A docket (NHTSA-2016-0090) was created as an option for members of the public to submit written comments on the Policy. The formal docket comment period closed on November 22, 2016. Additional comments may still be submitted. Comments not received in time to be considered in the next iteration of the document will be considered in a future iteration of it. For access to the docket, go to http://www.regulations.gov at any time or to 1200 New Jersey Avenue SE., West Building, Ground Floor, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. Telephone: 202-366-9826.

    Privacy Act: Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78), you may visit http://www.dot.gov/privacy.html.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about the public meeting, please contact Ms. Yvonne Clarke, Program Assistant, Office of Vehicle Safety Research at (202) 366-1845 or by email at [email protected]

    SUPPLEMENTARY INFORMATION: Background

    On September 20, 2016, DOT released the Federal Automated Vehicles Policy (the Policy). The Policy is intended to ensure automated vehicle technologies are safely introduced and achieve their full safety potential by removing possible roadblocks to the integration of innovative automotive technology. The full Policy can be found at www.nhtsa.gov/AV.

    Following publication of the Policy and during the open comment period of the Policy, NHTSA held the first in a series of public meetings on November 10, 2016. The morning session of the meeting focused on all four sections of the Policy: Section I: Vehicle Performance Guidance for Automated Vehicles, Section II: Model State Policy, Section III: NHTSA's Current Regulatory Tools, and Section IV: Modern Regulatory Tools. Comments were presented in an open listening session forum. The afternoon session focused specifically on the Safety Assessment, included under Section I: Vehicle Performance Guidance for Automated Vehicles. NHTSA extended invitations to specific organizations and individuals to ensure a broad perspective regarding submission of a Safety Assessment Letter. The session closed with opening the floor for further comments as desired.

    Meeting

    NHTSA is seeking input through this series of public meetings to further refine the Policy. The public meeting on December 12, 2016, the second in the series, is being held to provide individuals an opportunity to offer oral feedback regarding the following sections of the Policy: Section II: Model State Policy and Section IV: Modern Regulatory Tools.

    During the morning session, the agency will seek input specifically on Section II: Model State Policy. This session will focus on gathering feedback regarding how the States, manufacturers, and other entities have understood and interpreted the Model State Policy. States have already begun passing laws and developing regulations surrounding HAVs. A national dialogue is necessary to gather additional information on any potential challenges foreseen, suggestions for clarification, and recommended improvements to assist in avoiding a patchwork of inconsistent laws and regulations. The session will be an open listening session in which individuals or organizations can register to speak or, if time permits, provide oral comments at the conclusion of the morning session.

    During the afternoon session of the meeting, the Agency will seek specific input on Section IV: Modern Regulatory Tools. This section identifies potential new regulatory tools and statutory authorities that may aid the safe and efficient deployment of new lifesaving technologies. This session will focus on gathering feedback on the new tools and authorities discussed in this section, as well as other ideas and suggestions to assist in the safe development, testing, and deployment of HAVs. This session will consist of six moderated panels. Each panel will run approximately 35 minutes and be guided by questions appropriate for the topic at hand. Panels will focus on the following subject areas:

    Panel I: Safety Assurance: Tools to demonstrate that entities design, manufacturing, and testing processes apply the NHTSA performance guidance, industry best practices, and other performance criteria and standards to assure the safe operation of motor vehicles, before those vehicles are deployed on public roads.

    Panel II: Pre-Market Approval Authority: Pre-market approval is a substantially different regulatory approach than the current self-certification used by NHTSA. The discussion provided in the Policy is a preliminary exploration of issues and not intended as an endorsement.

    Panel III: Imminent Hazard Authority: This authority would enable NHTSA to require manufacturers to take immediate action to mitigate safety risks deemed imminent hazards.

    Panel IV: Expanded Exemption Authority for HAVs: Expanded exemption authority could change the volume and or time limit of the existing exemption authority to allow for greater flexibility and increase opportunities for data collection, analysis, and planning.

    Panel V: Post-Sale Tools To Regulate Software Changes: Post-Sale updates in software could substantially change the functionality and operation that HAVs had when they were certified at the time of their manufacture. Additional tools may be useful in monitoring and regulating such updates.

    Panel VI: Tools: The Policy highlights multiple tools that could potentially be used in safe deployment if given authority or clarification: Variable test procedures to ensure behavioral competence and avoid gaming of tests, functional and system safety, regular reviews for making agency testing protocols iterative and forward-looking, additional record keeping/reporting, and enhanced data collection tools.

    Registration is necessary for all attendees. Attendees, including those who do not plan to make any oral remarks at the meeting, should register at: https://docs.google.com/forms/d/152ETANkzDa62u2_b5AkuC1Qj00xDMKP292AYZk03R78/edit by December 9, 2016. Please provide your name, email address, and affiliation, indicate if you wish to offer oral technical remarks, and please indicate whether you require accommodations such as a sign language interpreter. Space is limited, so advanced and early registration is highly encouraged.

    Although attendees will be given the opportunity to offer technical remarks, there will not be time for attendees to make audio-visual presentations during the meeting. Additionally, NHTSA may not be able to accommodate all attendees who wish to make oral remarks. NHTSA will conduct the public meeting informally, and technical rules of evidence will not apply. We will arrange for a written transcript of the meeting. You may make arrangements for copies of the transcripts directly with the court reporter. The transcript will also be posted in the docket when it becomes available.

    Should it be necessary to cancel the meeting due to inclement weather or other emergency, NHTSA will take all available measures to notify registered participants.

    Draft Meeting Agenda 8:00-8:30 a.m.—Arrival/Check-In 8:30-8:45 a.m.—Welcome/Important Notices/Format 8:45-9:00 a.m.—NHTSA Leadership Address 9:00-12:00 p.m.—Open Listening Session on Section II: Model State Policy 12:00-1:00 p.m.—Lunch (on your own)/Arrival/Check-In 1:00-1:35 p.m.—Modern Regulatory Tools—Panel I: Safety Assurance 1:35-2:10 p.m.—Modern Regulatory Tools—Panel II: Pre-Market Approval 2:10-2:45 p.m.—Modern Regulatory Tools—Panel III: Imminent Hazard Authority 2:45-3:00 p.m.—Break 3:00-3:35 p.m.—Modern Regulatory Tools—Panel IV: Expanded Exemption Authority 3:35-4:10 p.m.—Modern Regulatory Tools—Panel V: Post Sale Tools to Regulate Software Changes 4:10-4:45 p.m.—Modern Regulatory Tools—Panel VI: Tools 4:45-5:00 p.m.—Closing Remarks/Adjourn Morning Session Meeting Topic

    The morning session of the meeting will be an open listening session and an opportunity for individuals to offer oral remarks on Section II: Model State Policy of the Federal Automated Vehicles Policy (the Policy). This section describes the responsibilities of both the Federal and State governments in regards to the regulation of HAVs and recommends policy areas for States to consider for the validation, testing, and deployment of highly automated vehicles with the goal of generating a consistent national framework.

    Specifically, commenters are asked to discuss the following topics at the meeting:

    • Content

    The agency seeks comment on the content included within the Model State Policy:

    Are there any areas within the Model State Policy that need additional clarification?

    Are there any gaps that you have identified in the Model State Policy?

    What barriers or challenges do you foresee that might hinder the ability for implementation of the guidance?

    • The Federal and State Roles

    The agency seeks comment on the Federal and State Roles portion of the Model State Policy. Does the Policy clearly identify the appropriate roles and division of regulatory responsibilities for motor vehicle operations between Federal and State authorities?

    • Application for Manufacturers or Other Entities To Test HAVs on Public Roadways

    The agency seeks comment on the amount and type of information that a jurisdiction would deem appropriate to receive from NHTSA that would identify that each vehicle used for testing by manufacturers or other entities follows the Performance Guidance set forth by NHTSA and meets all applicable Federal Motor Vehicle Safety Standards?

    • Liability and Insurance

    States are responsible for determining liability rules for HAVs. For example, if a HAV is determined to be at fault in a crash then who should be held liable? For Insurance, States need to determine who (owner, operator, passenger, manufacturer, etc.) must carry motor vehicle insurance. What additional insurance and liability issues have States identified? Would it be desirable for NHTSA to create a commission to study such and make recommendations to the States?

    Afternoon Session Meeting Topic

    The afternoon session of the meeting provides an opportunity for invited individuals to comment on Section IV: Modern Regulatory Tools. This session will consist of six moderated panels. The panels will run approximately 35 minutes and be guided by questions appropriate for the topics at hand: Panel I: Safety Assurance, Panel II: Pre-Market Approval Authority, Panel III: Imminent Hazard Authority, Panel IV: Expanded Exemption Authority for HAVs, Panel V: Post-Sale Tools To Regulate Software Changes, and Panel VI: Tools. This section identifies potential new regulatory tools and statutory authorities that may aid the safe and efficient deployment of new lifesaving technologies.

    Nathaniel Beuse, Associate Administrator for Vehicle Safety Research.
    [FR Doc. 2016-28628 Filed 11-28-16; 8:45 am] BILLING CODE 4910-59-P
    81 229 Tuesday, November 29, 2016 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request November 23, 2016.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by December 29, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Rural Business Cooperative Service

    Title: Rural Cooperative Development Grants—7 CFR 4284-F.

    OMB Control Number: 0570-0006.

    Summary of Collection: Section 310B of the Consolidated Farm and Rural Development Act (as amended) (Pub. L. 107-171) authorizes the Rural Cooperative Development Grants (RCDG) program. The program is administered through State Rural Development Offices on behalf of the Rural Business Cooperative Service (RBS). The primary objective of the program is to improve the economic condition of rural areas through cooperative development. Grant funds are awarded on a competitive basis using a scoring system that gives preference to applications that demonstrate a proven track record. The applicants, who are non-profit corporations or institutions of higher education, will provide information using various forms and supporting documentation.

    Need and Use of the Information: Information is collected by RBS and Rural Development State and Area office staff, as delegated, from applicants and grantees. RBS will use the information collected to evaluate the applicant's ability to carry out the purposes of the program. Grantees are required to submit financial status and performance reports to confirm funds are being expended as approved and requests for advance or reimbursement to request payment. If this information were not collected, RBS would have no basis on which to evaluate the relative merit of each application.

    Description of Respondents: Not for profit institutions.

    Number of Respondents: 55.

    Frequency of Responses: Recordkeeping; Reporting: On occasion.

    Total Burden Hours: 6,342.

    Charlene Parker, Departmental Information Collection Clearance Officer.
    [FR Doc. 2016-28677 Filed 11-28-16; 8:45 am] BILLING CODE 3410-XY-P
    DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request November 23, 2016.

    The Department of Agriculture has submitted the following information collection requirement(s) to Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by December 29, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725-17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Rural Utility Service

    Title: Rural Energy Savings Program.

    OMB Control Number: 0572-0151.

    Summary of Collection: Passage of section 6407 of the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171; 116 Stat. 424 as amended) created the Rural Energy Savings Program (RESP) and the Consolidated Appropriations Act, 2016 (Pub. L. 114-113), provided authorization and funding to provide zero-percent loans to Rural Utilities Service borrowers or other eligible entities to relend to consumers for cost-effective energy efficiency measures. On June 21, 2016, the agency announced the RESP through a Notice of Funding Availability opening the program to applications so as to comply with the legislative mandate. The program is carried out through the Rural Utilities Service (RUS).

    Need and Use of the Information: The application process consists of two steps. Step 1: An applicant seeking financing must submit a Letter of Intent to apply in an electronic Portable Document Format (pdf). The Letter of Intent contains the tax identification number, legal name and organization status; verification of rural status (counties to be served and populations); financial status; point of contact; description of program; implementation plan; and a list of eligible energy efficiency measures to be implemented. Step 2: RESP application—after review of the letter of intent, RUS notifies the eligible entity if it is invited to submit the loan application. Required application information is used to determine a borrower's ability to meet financial obligations, includes analyses and document review of the applicant's historical, current, and projected costs, revenues, cash flows, assets, and other factors that may be relevant on a case by case basis. The collection of information is essential to the mission of the agency and the RESP, and is necessary so that RUS can establish applicant and project eligibility.

    Description of Respondents: Businesses or other for-profit; Not-for-profit institutions.

    Number of Respondents: 33.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 1,422.

    Charlene Parker, Departmental Information Collection Clearance Officer.
    [FR Doc. 2016-28661 Filed 11-28-16; 8:45 am] BILLING CODE 3410-15-P
    DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request November 23, 2016.

    The Department of Agriculture will submit the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13 on or after the date of publication of this notice. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, Washington, DC; New Executive Office Building, 725 17th Street NW., Washington, DC 20503. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602.

    Comments regarding these information collections are best assured of having their full effect if received by December 29, 2016. Copies of the submission(s) may be obtained by calling (202) 720-8681.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Agricultural Marketing Service

    Title: Tart Cherries Grown in the states of MI, NY, PA. OR, UT, WA, and WI.

    OMB Control Number: 0581-0177.

    Summary of Collection: Marketing Order No. 930 (7 CFR part 930) regulates the handling of tart cherries grown in Michigan, New York, Pennsylvania, Oregon, Utah, Washington and Wisconsin. The Agricultural Marketing Agreement Act of 1937 was designed to permit regulation of certain agricultural commodities for the purpose of providing orderly marketing conditions in inter and intrastate commerce and improving returns to growers. The primary objective of the Order is to stabilize the supply of tart cherries. Only tart cherries that will be canned or frozen will be regulated. The Order is administered by an 18 member Board comprised of producers, handlers and one public member, plus alternates for each. The members will serve for a three-year term of office.

    Need and Use of the Information: Various forms were developed by the Board for persons to file required information relating to tart cherry inventories, shipments, diversions and other needed information to effectively carry out the requirements of the Order. The information collected is used to ensure compliance, verify eligibility, and vote on amendments, monitor and record grower's information. Authorized Board employees and the industry are the primary users of the information. If information were not collected, it would eliminate needed data to keep the industry and the Secretary abreast of changes at the State and local level.

    Description of Respondents: Business or other for profit; Not-for-profit institutions.

    Number of Respondents: 640.

    Frequency of Responses: Reporting: Annually; Quarterly; On occasion.

    Total Burden Hours: 741.

    Charlene Parker, Departmental Information Collection Clearance Officer.
    [FR Doc. 2016-28666 Filed 11-28-16; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2016-0040] Notice of Request To Renew an Approved Information Collection (Specified Risk Materials) AGENCY:

    Food Safety and Inspection Service, USDA.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, the Food Safety and Inspection Service (FSIS) is announcing its intention to renew the approved information collection regarding specified risk materials in cattle. The approval for this information collection will expire April 30, 2017.

    DATES:

    Submit comments on or before January 30, 2017.

    ADDRESSES:

    FSIS invites interested persons to submit comments on this information collection. Comments may be submitted by one of the following methods:

    Federal eRulemaking Portal: This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for submitting comments.

    Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, Docket Clerk, Patriots Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163A, Washington, DC 20250-3700.

    Hand- or courier-delivered submittals: Deliver to Patriots Plaza 3, 355 E Street SW., Room 8-163A, Washington, DC 20250-3700.

    Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2016-0028. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to http://www.regulations.gov.

    Docket: For access to background documents or comments received, go to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW., Room 8-164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday through Friday.

    FOR FURTHER INFORMATION CONTACT:

    Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW., Room 6065, South Building, Washington, DC 20250; (202)720-5627.

    SUPPLEMENTARY INFORMATION:

    Title: Specified Risk Materials.

    OMB Number: 0583-0129.

    Expiration Date of Approval: 4/30/2017.

    Type of Request: Renewal of a currently approved information collection.

    Abstract: FSIS has been delegated the authority to exercise the functions of the Secretary as specified in the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq.). This statute provides that FSIS is to protect the public by verifying that meat products are safe, wholesome, not adulterated, and properly labeled and packaged.

    FSIS requires official establishments that slaughter cattle or process carcasses or parts of cattle to develop written procedures for the removal, segregation, and disposition of SRMs. The Agency requires that these establishments maintain daily records to document the implementation and monitoring of their procedures for the removal, segregation, and disposition of SRMs and any corrective actions that they take to ensure that the procedures are effective (9 CFR 310.22).

    FSIS also requires official slaughter establishments that transport carcasses or parts of cattle containing vertebral columns from cattle 30 months of age and older to another federally inspected establishment for further processing to maintain records verifying that the official establishment that received the carcasses or parts, removed and properly disposed of the portions of the vertebral column designated as SRMs (9 CFR 310.22(g)).

    This monitoring and recordkeeping is necessary for establishments to further ensure—and for FSIS to verify—that meat and meat products distributed in commerce for use as human food do not contain SRMs.

    The approval for this information collection will expire on April 30, 2017. There are no changes to the existing information collection. FSIS has made the following estimates for the renewal information collection:

    Estimate of Burden: FSIS estimates that it will take respondents an average of approximately .12 hours per response.

    Respondents: Official establishments that slaughter cattle or process parts of cattle.

    Estimated No. of Respondents: 3,512.

    Estimated No. of Annual Responses per Respondent: 303.

    Estimated Total Annual Burden on Respondents: 123,916 hours.

    Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence SW., 6065, South Building, Washington, DC 20250; (202)720-5627.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of FSIS's functions, including whether the information will have practical utility; (b) the accuracy of FSIS's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both FSIS, at the addresses provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20253.

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

    Additional Public Notification

    Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS Web page located at: http://www.fsis.usda.gov/federal-register.

    FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Update is available on the FSIS Web page. Through the Web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

    USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.

    How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized representative.

    Send your completed complaint form or letter to USDA by mail, fax, or email: Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410, Fax: (202) 690-7442, Email: [email protected]

    Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

    Done at Washington, DC, on: November 22, 2016. Alfred V. Almanza, Acting Administrator.
    [FR Doc. 2016-28611 Filed 11-28-16; 8:45 am] BILLING CODE 3410-DM-P
    DEPARTMENT OF AGRICULTURE Forest Service Coconino and Tonto National Forests; Arizona; Fossil Creek Wild and Scenic River Comprehensive River Management Plan and Environmental Impact Statement AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of intent to prepare an environmental impact statement.

    SUMMARY:

    The Coconino and Tonto national forests are preparing a Comprehensive River Management Plan (CRMP) for the Fossil Creek Wild and Scenic River, designated by Congress in 2009. Fossil Creek is located within the administrative boundaries of the Coconino and Tonto National Forests. Fossil Creek is the only intact perennial system with continuous flow without any water diversions in Arizona and is the only uninterrupted river system between the Verde River and the Mogollon Rim, spanning and connecting a number of biotic communities from upper Sonoran desert scrub through ponderosa pine forests. In response to the approximately 17-mile river Wild and Scenic River corridor designation, the Forest Service must establish a CRMP, in accordance with the Wild and Scenic Rivers Act (WSRA), to provide detailed direction, implementation actions, and monitoring to protect or enhance outstandingly remarkable values (ORVs) of the Wild and Scenic River. Since full flows returned to Fossil Creek with the decommissioning of a historic hydropower dam in 2005, public use has dramatically increased. Impacts from recreational use have threatened the river's water quality, free-flowing condition and its ORVs, potentially compromising their benefit and enjoyment by present and future generations. Planning for Fossil Creek has been ongoing for several years, and the environmental analysis for the Fossil Creek CRMP is being elevated from an environmental assessment (EA) to a more detailed environmental impact statement (EIS) in order to more fully analyze potential effects. The Forest Service has developed a proposed action and alternatives for future management of Fossil Creek through the CRMP.

    DATES:

    Comments concerning the scope of the analysis must be received by January 13, 2017. The draft environmental impact statement is expected in summer 2017, and the final environmental impact statement is expected in spring 2018.

    ADDRESSES:

    Send written comments via email to [email protected] (include “Fossil Creek CRMP” in the subject line); via mail to Coconino National Forest, Attention: Fossil Creek CRMP, P.O. Box 20429, Sedona, AZ 86341; via facsimile to (928) 203-7539; or in person at the Red Rock Ranger District Office, 8375 State Route 179, Sedona, AZ 86351.

    FOR FURTHER INFORMATION CONTACT:

    Contact Marcos Roybal, Fossil Creek Project Coordinator, by email at [email protected] or by phone at (928) 203-2915. For information about the project, including proposed alternatives and other project documents, visit http://tinyurl.com/FossilCreekCRMP. Hard copy documents may be requested from the phone number above.

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1 (800) 877-8339 between 8 a.m. and 8 p.m., Eastern Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION: Purpose and Need for Action

    The purpose of the project is to prepare a CRMP for the Fossil Creek Wild and Scenic River to meet the requirements of Section 3(d)(1) of the WSRA. The CRMP is needed to provide for the protection or enhancement of Fossil Creek's water quality, free-flowing condition, and its ORVs, and to fulfill WSRA Section 3(b) requirements to establish river corridor boundaries and recreation and wild segment classifications.

    Since the decommissioning of a historic hydropower dam in 2005, public use dramatically increased as visitors sought to explore the heavily publicized Arizona landscape. Recreational use during the high-use season (June-September), for example, increased from an estimated 20,000 visitors in 2006 to approximately 80,000 visitors by 2013, with thousands turned away daily at the entrance barricades due to overcrowding. River values that need protection from impacts of recreational use include water quality, recreation, geology, Western Apache traditional and contemporary cultural values, and biological values (especially the high diversity of fish and wildlife species). Impacts have resulted from uncontrolled dispersed camping, creation of unapproved camp sites, creation of unplanned trail systems, excessive littering, and human waste near the creek. Monitoring since 2011 indicates there are increasing impacts to upland vegetation that is habitat for wildlife species; damage to heritage sites; and unsafe conditions for visitors, Forest Service personnel and emergency responders. In April 2016, an interim management reservation system was successfully implemented to reduce the daily capacity of visitors during the high-use season; this interim management reservation system will remain in place until the CRMP's completion.

    Proposed Action

    The Coconino and Tonto National Forests propose to establish a CRMP to guide management of the designated 17-mile Fossil Creek Wild and Scenic River corridor and to protect or enhance the area's outstandingly remarkable values. Within a range of alternatives, the proposed action is designated to include the most flexibility to increase capacity and recreation infrastructure—maximizing recreation opportunities in the future—while providing protection for sensitive river and tribal values at the same time through both a management plan and site-specific actions. Project actions would address recreation capacity, corridor access, recreation facilities, services, and public health and safety.

    During all or part of the year, a reservation system would manage visitor use by limiting the number of people at one time (PAOT) in the river corridor. The initial PAOT in the river corridor would be set at the current 2016 reservation management level—approximately 154 vehicles and 780 PAOT, including administrative use. Over time, if appropriate, adaptive management would increase capacity to a permitted maximum of approximately 338 vehicles and 1,705 PAOT if infrastructure is built, management capacity allows, and visitor behavior promotes sustainable river value protection. The proposed action also includes the following potential elements:

    • Existing recreation sites would be expanded, particularly at the Irving site.

    • Additional trails would be developed to link recreation sites and provide a greater variety of opportunities for a different hiking levels.

    • A portion of Forest Road 708 would become a motorized trail.

    • A limited amount of camping would be allowed at designated sites.

    • Opportunities for outfitters/guides and concessionaries would be provided.

    • Limited or no waterplay would exist at some creek locations due to cultural or natural resource issues.

    • Some system routes would be closed or decommissioned, and other restoration actions would occur.

    The existing Coconino and Tonto Forest Plans would be programmatically amended under the 2012 Planning Rule to incorporate management direction for the Fossil Creek WSR corridor. The proposed amendments would add, replace, delete or revise (as needed) direction for the management of the Wild and Scenic River corridor.

    Possible Alternatives

    A range of alternatives to the proposed action, including a no action alternative and three additional action alternatives, are being considered. The no action alternative (Alternative A) represents no change (a CRMP would not be established) and serves as the baseline for comparison of the effects of the action alternatives. The four action alternatives, which are based on extensive public engagement that has occurred since 2010, include: Alternative B (Enhanced Protections), Alternative C (Non-motorized Experience), Alternative D (Motorized Use and Refugia), and Alternative E (Long-term Adaptive Management—Proposed Action). More detailed descriptions of the proposed action and alternatives can be found online at http://tinyurl.com/FossilCreekCRMP or be requested through the contact information provided above.

    Lead and Cooperating Agencies

    Arizona Game and Fish Department has cooperating agency status in order to assist the Coconino and the Tonto National Forests in the preparation of the Fossil Creek Wild and Scenic River CRMP and EIS.

    Responsible Official

    Laura Jo West, the Forest Supervisor on the Coconino National Forest, is the responsible official.

    Nature of Decision To Be Made

    Given the purpose and need of the project, the Coconino Forest Supervisor will review the proposed action, other alternatives, and the effects analysis in the EIS in order to determine: (1) Which alternative, or combination of alternatives, should be implemented; (2) what actions will be taken to protect and enhance the river's water quality, free-flowing condition and its ORVs, as required by WSRA; (3) the location and extent of infrastructure development, restoration activities, and changes in permitted visitor capacity; (4) the design features, mitigation measures and monitoring requirements; and, (5) consistency with the forest plans in place at the time of the decision and the need for amendments.

    Preliminary Issues

    Since 2010, public involvement regarding management of the Fossil Creek Wild and Scenic River has informed key issues and the alternatives that have been developed. Three key issues have arisen: (1) Recreation opportunities and recreational impacts on natural and cultural resources; (2) the level of recreation development; and (3) public health and safety. These issues form the basis for the alternatives presented in this Notice.

    Scoping Process

    This Notice of Intent initiates the scoping process, which guides the development of the environmental impact statement. Several scoping meetings will be held, and interested parties should check the Fossil Creek CRMP Web page at http://tinyurl.com/FossilCreekCRMP for dates and locations.

    This project is subject to the objection process pursuant to 36 CFR 218 and is not being authorized under the Healthy Forest Restoration Act (HFRA). As such, those who provide specific written comments during designated comment periods in accordance with 36 CFR 218.5 will be eligible to participate in the objection process. Issues raised in objections must be based on previously submitted timely, specific written comments regarding the proposed project unless new information arises after designated opportunities (36 CFR 218.7). Several previous scoping periods have occurred since 2010, and provide standing to object under 36 CFR 218 to those who commented during designated comment periods.

    It is important that reviewers provide their comments at such times and in such manner that they are useful to the agency's preparation of the environmental impact statement. Therefore, comments should be provided prior to the close of the comment period and should clearly articulate the reviewer's concerns and contentions.

    Comments received in response to this solicitation, including names and addresses of those who comment, will be part of the public record for this proposed action. Comments submitted anonymously will be accepted and considered, but will not be eligible for objection per 36 CFR 218.5.

    Dated: November 22, 2016. Laura Jo West, Coconino National Forest Supervisor.
    [FR Doc. 2016-28683 Filed 11-28-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Rural Business-Cooperative Service Notice of Solicitation of Applications for the Rural Energy for America Program for Federal Fiscal Year 2017; Correction AGENCY:

    Rural Business-Cooperative Service, USDA.

    ACTION:

    Notice; correction.

    SUMMARY:

    The Rural Business-Cooperative Service (the Agency) published a notice in the Federal Register of October 18, 2016, announcing the acceptance of applications for funds available under the Rural Energy for America Program (REAP) for Fiscal Year (FY) 2017. The 2014 Farm Bill provides funding for the program for FY 2017. This notice provides corrections to: Section III. Eligibility Information, subsection D. Cost Sharing or Matching, paragraph (2) to indicate that applicants that have been previously been awarded energy audit or renewable energy development assistance grants and have not expended 50 percent of those funds are considered a “risk” pursuant to 2 CFR 200.205; Section V. Application Review Information, subsection (B) Review and Selection Process, paragraphs (1)(a) through (d), and paragraph (3) application window closing dates of May 1, 2017 are being modified to March 31, 2017; Section V. Application Review Information, subsection C. State Director and Administrator Points, paragraph (1)(b)is replacing “will” with “may” to indicate that the awarding of State Director and Administrator points is at the discretion of the State Director or Administrator and to remove the last sentence of subparagraph (b) because the Agency will use information provided in the application verses a certification; and Section VIII. Other Information, subsection B. Nondiscrimination Statement is being updated.

    FOR FURTHER INFORMATION CONTACT:

    For information about this Notice, please contact Maureen Hessel, Business Loan and Grant Analyst, USDA Rural Development, Energy Division, 1400 Independence Avenue SW., Stop 3225, Room 6870, Washington, DC 20250. Telephone: (202) 401-0142. Email: [email protected].

    SUPPLEMENTARY INFORMATION:

    This Notice makes certain corrections to the original Notice published on October 18, 2016 at 81 Federal Register 71689. Unfortunately, the October 18, 2016 Notice did not reflect all of the changes made in clearance. This Notice captures the omitted changes. In FR Doc. 2016-25163 of October 18, 2016 (81 FR 71689), make the following corrections:

    Summary of Changes

    1. In the first column on page 71691, Section III. Eligibility Information, Subsection D. Cost Sharing or Matching, paragraph (2), the last sentence which continues into the second column is replaced with the following text:

    An applicant who has received one or more grants under this program must have a satisfactory history of performance which, as it relates to the expenditure of grant funds, the Agency interprets as the expenditure of 50 percent or more of the previously awarded grants by January 31, 2017. Those who cannot meet this requirement will be determined to be a “risk” pursuant to 2 CFR 200.205 and may be denied a subsequent grant or have special conditions imposed.

    2. In the first column on page 71694, under Section V. Application Review Information, subsection B. Review and Selection Process, subparagraph (1)(a) is being revised to read as follows:

    (a) Funds for renewable energy system and energy efficiency improvements grants of $20,000 or less will be allocated to the States. Eligible applications must be submitted by October 31, 2016, or March 31, 2017, in order to be considered for these set-aside funds. Approximately 50 percent of these funds will be made available for those complete applications the Agency receives by October 31, 2016, and approximately 50 percent of the funds for those complete applications the Agency receives by March 31, 2017. All unused State allocated funds for grants of $20,000 or less will be pooled to the National Office.

    3. In the first column on page 71694, under Section V. Application Review Information, subsection B. Review and Selection Process, subparagraph (1)(b) the first sentence is being revised to read as follows:

    Eligible applications received by March 31, 2017, for renewable energy system and energy efficiency improvements grants of $20,000 or less, that are not funded by State allocations can be submitted to the National Office to compete against grant applications of $20,000 or less from other States at a national competition.

    4. In the first column on page 71694, under Section V. Application Review Information, subsection B. Review and Selection Process, subparagraph (1)(c) the first sentence is revised to read as follows:

    Eligible applications for renewable energy system and energy efficiency improvements, regardless of the amount of the funding request, received by March 31, 2017, can compete for unrestricted grant funds.

    5. In the first column on page 71694, under Section V. Application Review Information, subsection B. Review and Selection Process, subparagraph (1)(d) is being revised to read as follows:

    (d) National unrestricted grant funds for all eligible renewable energy system and energy efficiency improvements grant applications received by March 31, 2017, which include grants of $20,000 or less, that are not funded by State allocations can be submitted to the National Office to compete against grant applications from other States at a final national competition.

    6. In the second column on page 71694, under Section V. Application Review Information, subsection B. Review and Selection Process, paragraph (3), the last sentence is revised to read as follows:

    All unfunded eligible applications for combined grant and guaranteed loan applications that are received by March 31, 2017, and that are not funded by State allocations can be submitted to the National Office to compete against other grant and combined grant and guaranteed loan applications from other States at a final national competition.

    7. In the third column on page 71694, under Section V. Application Review Information, subsection C. State Director and Administrator Points, is revised to read as follows:

    The State Director and the Administrator may take into consideration paragraphs V.C.(1) and (2) below in the awarding of points for eligible renewable energy systems and energy efficiency improvement grant applications submitted in Federal FY 2017:

    8. In the third column on page 71694, under Section V. Application Review Information, subsection C. State Director and Administrator Points, subparagraph (1)(b) is revised to read as follows:

    Owned by a member of a socially-disadvantaged group, which are groups whose members have been subjected to racial, ethnic, or gender prejudice because of their identity as members of a group without regard to their individual qualities.

    9. In the first column on page 71696, under Section VIII. Other Information, subsection B. Nondiscrimination Statement is revised to read as follows:

    In accordance with Federal civil rights law and USDA civil rights regulations and policies, USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

    Persons with disabilities who require alternative means of communication for program information (e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

    To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at http://www.ascr.usda.gov/complaint_filing_cust.html and at any USDA office, or write a letter addressed to USDA providing all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by:

    (1) Mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW., Washington, DC 20250-9410;

    (2) Fax: (202) 690-7442; or

    (3) Email: [email protected].

    USDA is an equal opportunity provider, employer, and lender.

    Dated: November 18, 2016. Samuel H. Rikkers, Administrator, Rural Business-Cooperative Service.
    [FR Doc. 2016-28737 Filed 11-28-16; 8:45 am] BILLING CODE 3410-XY-P
    ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD [Docket No. ATBCB-2016-0001] RIN 3014-0012 Proposed Renewal of Information Collection; OMB Control Number 3014-0012, Online Architectural Barriers Act (ABA) Complaint Form AGENCY:

    Architectural and Transportation Barriers Compliance Board.

    ACTION:

    30-Day Notice and request for comments.

    SUMMARY:

    We, the Architectural and Transportation Barriers Compliance Board (Access Board), plan to seek renewed approval from the Office of Management and Budget (OMB) for the information collection described below, namely our Online Architectural Barriers Act (ABA) Complaint Form (OMB Control Number 3014-0012), in accordance with the Paperwork Reduction Act of 1995. We have been using this complaint form since 2013 and propose to continue using it for an additional three years. By notice published on July 26, 2016, we solicited public comment on the proposed collection of information for a period of 60 days. See 81 FR 48739 (July 26, 2016). One comment was received, but it was not relevant to the information collection, and no revisions were made to the proposed Online ABA Complaint Form. The purpose of this notice is to allow an additional 30 days for public comment.

    DATES:

    Submit comments by December 29, 2016.

    ADDRESSES:

    Written comments should be identified as “Paperwork Reduction Act Comments, U.S. Access Board: ABA Complaint Form” and directed to OMB, Office of Information and Regulatory Affairs, Attention: Joe Nye, U.S. Access Board Desk Officer, by email at [email protected] or by mail to Room 10235, 725 17th Street NW., Washington, DC 20503. Please also send a copy to Mario Damiani, Office of the General Counsel, U.S. Access Board, 1331 F Street NW., Suite 1000, Washington, DC 20004-1111 or to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For further information regarding this proposed information request, contact Mario Damiani, Office of the General Counsel, U.S. Access Board, 1331 F Street NW., Suite 1000, Washington, DC 20004-1111. Telephone number: 202-272-0050 (voice); 202-272-0064 (TTY). Email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Title of Collection: Online Architectural Barriers Act (ABA) Complaint Form.

    OMB Control Number: 3014-0012.

    Type of Request: Renewal of information collection.

    Abstract

    The Architectural and Transportation Barriers Compliance Board (Access Board) is seeking to renew its information collection for its Online Architectural Barriers Act (ABA) Complaint Form. The instrument allows complainants to submit a complaint online using a standardized Web-based complaint form posted on the agency's Web site, which prompts users to provide allegations and other pertinent data necessary for the Access Board to investigate their ABA complaint. The online form is user-friendly and accessible, and allows for greater efficiency, clarity, and timeliness in the complaint filing process. To view the Online ABA Complaint Form, please visit: http://cts.access-board.gov/formsiq/form.do?formset_id=2&ds=fdd&reload=true#.

    Use of the Information

    The Access Board enforces the ABA by investigating complaints submitted by members of the public concerning buildings or facilities designed, altered, or built by or on behalf of the federal government, leased by the federal government, or financed with federal funds. The Access Board uses the information provided by complainants concerning the building or facility and alleged accessibility barriers, along with any photographs or other supporting documentation which may be provided, to conduct its investigation. If complainants choose to provide personal contact information, which is optional, that information is not disclosed outside the agency without the written permission of the complainant.

    Detailed Description of the Instrument

    As noted above, the Online ABA Complaint Form is a standardized, web-based form available on the Access Board's Web site, and it can be filed 24 hours per day, seven days per week. Over 90 percent of complaints the Access Board receives each year are submitted using the Online ABA Complaint Form; the remainder are submitted in writing (without use of a form) by email, mail, or fax.

    The Online ABA Complaint Form first prompts complainants to complete the form fields for the name and address of the building or facility. Second, complainants must select a barrier category from a drop-down menu (e.g., doors, accessible routes, parking, etc.) for each barrier they allege to exist, then describe each barrier. Third, complainants are prompted to provide personal information, including their name, address, telephone number(s), and email address; again, this information is entirely optional, as complaints can be submitted anonymously. Complainants also have the option to attach electronic files containing pictures, drawings, or other relevant documents to the online complaint form when it is filed. Once any additional information is attached and the complaint is submitted, the system provides complainants confirmation that their complaint has been submitted successfully, together with an automatically generated complaint number for them to use when making inquiries about the status of their complaint.

    We note that use of the Online ABA Complaint Form has greatly improved the completeness of the information included in complaints that are submitted for investigation, and that this in turn has expedited the processing of complaints.

    Estimate of Burden

    Public reporting burden for this collection of information is estimated to average less than 30 minutes to complete the Online ABA Complaint Form, depending on the number of alleged barriers the complainant identifies.

    There is no financial burden on the complainant. Use of the online form relieves much of the burden that the prior practice of using a paper complaint form put on complainants by making it clear which information is required and which is optional, and by essentially walking complainants through the process, step-by-step. As noted above, over 90 percent of all ABA complaints are submitted using the online form, though the Access Board continues to accept written complaints (without the use of any form) submitted by email, mail, or fax for complainants who prefer or need to use these filing methods.

    Respondents: Individuals.

    Estimated Number of Responses: 200 responses annually.

    Frequency of Responses: Nearly all complainants only ever file one ABA complaint. Approximately 200 individuals file ABA complaints with the Access Board each year.

    Estimated Total Annual Burden on Respondents: Each Online ABA Complaint Form takes approximately 30 minutes to complete, for a total of 100 hours annually (200 complaints × .5 hours). There is no financial burden on complainants.

    Comments Requested

    Comments are invited on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the estimated burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information from respondents; and (d) ways to minimize the burden of the collection of information on those who are to respond.

    David M. Capozzi, Executive Director.
    [FR Doc. 2016-28743 Filed 11-28-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE International Trade Administration [A-469-814 and A-570-898] Chlorinated Isocyanurates From Spain and the People's Republic of China: Continuation of the Antidumping Duty Orders AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) and the International Trade Commission (the ITC) have determined that revocation of the antidumping duty (AD) orders on chlorinated isocyanurates (chlorinated isos) from Spain and the People's Republic of China (PRC) would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States. Therefore, the Department is publishing a notice of continuation for these AD orders.

    DATES:

    Effective November 29, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Chien-Min Yang or Jacqueline Arrowsmith, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5484 or (202) 482-5255, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    The Department published the antidumping duty orders on chlorinated isos from Spain and the PRC on June 24, 2005.1 On September 1, 2015, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act), the Department initiated sunset reviews of the antidumping duty orders on chlorinated isos from Spain and the PRC.2 On September 11, 2015, the Department received a notice of intent to participate from Clearon Corporation (Clearon), Occidental Chemical Corporation (OxyChem), and Bio-Lab, Inc. (Bio-Lab), (collectively, the petitioners), within the deadline specified in 19 CFR 351.218(d)(1)(i). Petitioners are manufacturers of a domestic like product in the United States and, accordingly, are domestic interested parties pursuant to section 771(9)(C) of the Act.

    1See Chlorinated Isocyanurates from Spain: Notice of Antidumping Duty Order, 70 FR 36562 (June 24, 2005). (“Spain Order”); see also Notice of Antidumping Duty Order: Chlorinated Isocyanurates from the People's Republic of China, 70 FR 36561 (June 24, 2005) (“PRC Order”).

    2See Initiation of Five-Year (“Sunset”) Review, 78 FR 60253 (October 1, 2013).

    On October 1, 2015, the Department received an adequate substantive response to the notice of initiation from the domestic interested parties within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i). The Department did not receive any responses from the respondent interested parties, i.e., chlorinated isos producers and exporters from Spain or the PRC. On the basis of the notice of intent to participate and adequate substantive response filed by the petitioners and the inadequate response from any respondent interested party, the Department conducted expedited sunset reviews of these orders pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C).

    As a result of its reviews, the Department determined that revocation of the AD orders from Spain and the PRC would likely lead to continuation or recurrence of the dumping. Therefore, the Department notified the ITC of the magnitude of the margins likely to prevail should the orders be revoked, pursuant to sections 751(c)(1) and 752(b) and (c) of the Act.3

    3See Chlorinated Isocyanurates From Spain and the People's Republic of China: Final Results of the Expedited Sunset Reviews of the Antidumping Duty Orders, 81 FR 461, (January 6, 2016).

    On November 22, 2016, the ITC published its determination that revocation of the AD orders on chlorinated isos from Spain and the PRC would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time, pursuant to section 751(c) of the Act.4

    4See Chlorinated Isocynurates from China and Spain; Determinations, 81 FR 83871 (November 22, 2016).

    Scope of the Orders

    The products covered by the orders are chlorinated isos, which are derivatives of cyanuric acid, described as chlorinated s-triazine triones. There are three primary chemical compositions of chlorinated isos: (1) Trichloroisocyanuric acid (Cl3(NCO)3), (2) sodium dichloroisocyanurate (dehydrate) (NaCl2 (NCO)3(2H2O), and (3) sodium dichloroisocyanurate (anhydrous) (Nacl2(NCO)3). The orders cover all chlorinated isos. Chlorinated isos are currently classifiable under subheadings 2933.69.6015, 2933.69.021, 2933.69.6050, 3808.40.5000, 3808.50.4000 and 3808.94.5000 of the Harmonized Tariff Schedule of the United States (“HTSUS”). The tariff classification 2933.69.6015 covers sodium cichloroisocyanurates (anhydrous and dehydrate forms) and trichloroisocyanuric acid. The tariff classifications 2933.69.6021 and 2933.69.6050 represent basket categories that include chlorinated isos and other compounds including an unfused triazine ring. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this order is dispositive.

    Continuation of the Orders

    As a result of the determinations by the Department and the ITC that revocation of the AD orders would likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 75l(d)(2) of the Act and 19 CFR 351.218(a), the Department hereby orders the continuation of the AD orders on chlorinated isocyanurates from Spain and the PRC. U.S. Customs and Border Protection will continue to collect AD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise.

    The effective date of the continuation of the AD orders will be the date of publication in the Federal Register of this notice of continuation. Pursuant to section 751(c)(2) of the Act and 19 CFR 351.218(c)(2), the Department intends to initiate the next five-year review of these orders not later than 30 days prior to the fifth anniversary of the effective date of this continuation notice.

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

    Administrative Protective Order

    This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return/destruction or conversion to judicial protective order of proprietary information disclosed under APO in accordance with 19 CFR351.305(a)(3). Failure to comply is a violation of the APO which may be subject to sanctions.

    This five-year (sunset) review and notice are in accordance with section 751(c) and published pursuant to 777(i) of the Act, and 19 CFR 351.218(f)(4).

    Dated: November 23, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-28702 Filed 11-28-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-533-872] Finished Carbon Steel Flanges From India: Preliminary Affirmative Countervailing Duty Determination AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that countervailable subsidies are being provided to producers and exporters of finished carbon steel flanges (steel flanges) from India. The period of investigation (POI) is April 1, 2015, through March 31, 2016. Interested parties are invited to comment on this preliminary determination.

    DATES:

    Effective November 29, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Emily Maloof or Davina Friedmann, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5649 or (202) 482-0698, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On July 28, 2016, the Department published the notice of initiation of this investigation.1 For a complete description of the events that followed the initiation of this investigation, see the memorandum that is dated concurrently with this determination and hereby adopted by this notice.2 A list of topics included in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov, and to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be found at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content.

    1See Finished Carbon Steel Flanges From India: Initiation of Countervailing Duty Investigation, 81 FR 49625 (July 28, 2016) (Initiation Notice).

    2See Memorandum to Paul Piquado, “Decision Memorandum for the Preliminary Affirmative Determination: Countervailing Duty Investigation of Finished Carbon Steel Flanges from India,” dated November 21, 2016 (Preliminary Decision Memorandum).

    Scope of the Investigation

    The product covered by this investigation is steel flanges from India. For a complete description of the scope of the investigation, see Appendix I.

    Scope Comments

    We received no comments from interested parties regarding the scope of the investigation as it appeared in the Initiation Notice.

    Methodology

    The Department is conducting this countervailing duty (CVD investigation in accordance with section 701 of the Tariff Act of 1930 (the Act). For each of the subsidy programs found countervailable, we preliminarily determine that there is a subsidy (i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient) and that the subsidy is specific.3 For a full description of the methodology underlying our preliminary conclusions, see the Preliminary Decision Memorandum.

    3See sections 771(5)(B) and (D) of the Act regarding financial contribution; section 771(5)(E) of the Act regarding benefit; and section 771(5A) of the Act regarding specificity.

    Preliminary Determination and Suspension of Liquidation

    In accordance with section 703(d)(1)(A)(i) of the Act, we calculated a CVD rate for each individually-investigated producer/exporter of the subject merchandise. We preliminarily determine that countervailable subsidies are being provided with respect to the manufacture, production, or exportation of the subject merchandise. For a full description of the programs which have preliminarily determined to be countervailable, as well as those not used during the POI, see the Preliminary Decision Memorandum. In accordance with sections 703(d) and 705(c)(5)(A) of the Act, for companies not individually examined, we apply an “all-others” rate, which is normally calculated by weight-averaging the individual company subsidy rates of each of the companies investigated.

    Under section 705(c)(5)(A)(i) of the Act, the all-others rate should exclude zero and de minimis rates or any rates based entirely on facts otherwise available pursuant to section 776 of the Act. Neither of the mandatory respondents' rates in this preliminary determination were zero or de minimis or based entirely on facts otherwise available. Notwithstanding the language of section 705(c)(5)(A)(i) of the Act, we have not calculated the “all-others” rate by weight-averaging the rates of the two individually investigated respondents, because doing so risks disclosure of proprietary information. Instead, we have calculated the all-others rate using a simple average of the final rates for the two mandatory company respondents.4

    4See Preliminary Decision Memorandum at “CALCULATION OF THE ALL-OTHERS RATE” (for further explanation of the business propretiary information concerns); see also Memorandum to the File, “Countervailing Duty Investigation of Finished Carbon Steel Flanges: Preliminary Determination Margin Calculation for All-Others,” dated concurrently with this memorandum.

    We preliminarily determine the countervailable subsidy rates to be:

    Company Subsidy rate
  • (percent)
  • Norma (India) Limited, USK Exports Private Limited, UMA Shanker Khandelwal & Co., and Bansidhar Chiranjilal 2.76 R.N. Gupta & Company Limited 3.66 All-Others 3.21

    In accordance with sections 703(d)(1)(B) and (2) of the Act, we are directing U.S. Customs and Border Protection (CBP) to suspend liquidation of all entries of steel flanges from India that are entered, or withdrawn from warehouse, for consumption on or after the date of the publication of this notice in the Federal Register, and to require a cash deposit for such entries of merchandise in the amounts indicated above.

    Verification

    As provided in section 782(i)(1) of the Act, we intend to verify the information submitted by the respondents prior to making our final determination.

    U.S. International Trade Commission

    In accordance with section 703(f) of the Act, we will notify the U.S. International Trade Commission (ITC) of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information relating to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order, without the written consent of the Assistant Secretary for Enforcement and Compliance.

    In accordance with section 705(b)(2) of the Act, if our final determination is affirmative, the ITC will make its final determination within 45 days after the Department makes its final determination.

    Disclosure and Public Comment

    The Department intends to disclose calculations performed for this preliminary determination to the parties within five days of the date of public announcement of this determination in accordance with 19 CFR 351.224(b). Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the final verification report is issued in this proceeding, and rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.5 A table of contents, list of authorities used, and an executive summary of issues should accompany any briefs submitted to the Department, pursuant to 19 CFR 351.309(c)(2) and (d)(2). This summary should be limited to five pages total, including footnotes.

    5See 19 CFR 351.309; see also 19 CFR 351.303 (for general filing requirements).

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, filed electronically using ACCESS. An electronically-filed request must be received successfully, and in its entirety, by ACCESS by 5:00 p.m. Eastern Time, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number; the number of participants; and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, at a date, time, and specific location to be determined. Parties will be notified of the date, time, and location of any hearing. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).

    Dated: November 23, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I Scope of the Investigation

    The scope of this investigation covers finished carbon steel flanges. Finished carbon steel flanges differ from unfinished carbon steel flanges (also known as carbon steel flange forgings) in that they have undergone further processing after forging, including, but not limited to, beveling, bore threading, center or step boring, face machining, taper boring, machining ends or surfaces, drilling bolt holes, and/or deburring or shot blasting. Any one of these post-forging processes suffices to render the forging into a finished carbon steel flange for purposes of this investigation. However, mere heat treatment of a carbon steel flange forging (without any other further processing after forging) does not render the forging into a finished carbon steel flange for purposes of this investigation. While these finished carbon steel flanges are generally manufactured to specification ASME 816.5 or ASME 816.47 series A or series 8, the scope is not limited to flanges produced under those specifications. All types of finished carbon steel flanges are included in the scope regardless of pipe size (which may or may not be expressed in inches of nominal pipe size), pressure class (usually, but not necessarily, expressed in pounds of pressure, e.g., 150, 300, 400, 600, 900, 1500, 2500, etc.), type of face (e.g., flat face, full face, raised face, etc.), configuration (e.g., weld neck, slip on, socket weld, lap joint, threaded, etc.), wall thickness (usually, but not necessarily, expressed in inches), normalization, or whether or not heat treated. These carbon steel flanges either meet or exceed the requirements of the ASTM A105, ASTM A694, ASTM A181, ASTM A350 and ASTM A707 standards (or comparable foreign specifications). The scope includes any flanges produced to the above-referenced ASTM standards as currently stated or as may be amended. The term “carbon steel” under this scope is steel in which: (a) Iron predominates, by weight, over each of the other contained elements: (b) The carbon content is 2 percent or less, by weight; and (c) none of the elements listed below exceeds the quantity, by weight, as indicated:

    (i) 0.87 percent of aluminum;

    (ii) 0.0105 percent of boron;

    (iii) 10.10 percent of chromium;

    (iv) 1.55 percent of columbium;

    (v) 3.10 percent of copper;

    (vi) 0.38 percent of lead;

    (vii) 3.04 percent of manganese;

    (viii) 2.05 percent of molybdenum;

    (ix) 20.15 percent of nickel;

    (x) 1.55 percent of niobium;

    (xi) 0.20 percent of nitrogen;

    (xii) 0.21 percent of phosphorus;

    (xiii) 3.10 percent of silicon;

    (xiv) 0.21 percent of sulfur;

    (xv) 1.05 percent of titanium;

    (xvi) 4.06 percent of tungsten;

    (xvii) 0.53 percent of vanadium; or

    (xviii) 0.015 percent of zirconium.

    Finished carbon steel flanges are currently classified under subheadings 7307.91.5010 and 7307.91.5050 of the Harmonized Tariff Schedule of the United States (HTSUS). They may also be entered under HTSUS subheadings 7307.91.5030 and 7307.91.5070. The HTSUS subheadings are provided for convenience and customs purposes; the written description of the scope is dispositive.

    Appendix II List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope Comments IV. Scope of the Investigation V. Alignment VI. Injury Test VII. Subsidies Valuation VIII. Loan Benchmark and Interest Rates IX. Use of Facts Otherwise Available X. Analysis of Programs XI. Calculation of All-Others Rate XII. International Trade Commission XIII. Disclosure and Public Comment XIV. Conclusion
    [FR Doc. 2016-28704 Filed 11-28-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-428-844] Certain Carbon and Alloy Steel Cut-To-Length Plate From the Federal Republic of Germany: Amended Preliminary Determination of Sales at Less Than Fair Value AGENCY:

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

    SUMMARY:

    On November 14, 2016, the Department of Commerce (the Department) published in the Federal Register the Preliminary Determination of the antidumping duty investigation of certain carbon and alloy steel cut-to-length plate (CTL plate) from the Federal Republic of Germany (Germany). The Department is amending the Preliminary Determination of the investigation to correct three ministerial errors.

    DATES:

    Effective November 29, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Ross Belliveau or David J. Goldberger, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4952 or (202) 482-4136, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On November 14, 2016, the Department published in the Federal Register the Preliminary Determination of CTL plate from Germany.1 On November 14, 2016, Nucor Corporation (Nucor), a petitioner in this investigation, alleged that the Department made significant ministerial errors in the Preliminary Determination. 2

    1See Certain Carbon and Alloy Steel Cut-to-Length Plate from the Federal Republic of Germany: Preliminary Determination of Sales at Less Than Fair Value and Postponement of Final Determination, 81 FR 79446 (November 14, 2016) (Preliminary Determination).

    2See letter from Nucor entitled, “Nucor's Ministerial Error Comments Regarding Salzgitter,” dated November 14, 2016 (Nucor Letter).

    Scope of the Investigation

    The product covered by this investigation is CTL plate from Germany. For a full description of the scope of this investigation, see the “Scope of the Investigation,” in Appendix I of this notice.

    Significant Ministerial Error

    A ministerial error is defined in 19 CFR 351.224(f) as “an error in addition, subtraction, or other arithmetic function, clerical error resulting from inaccurate copying, duplication, or the like, and any other similar type of unintentional error which the Secretary considers ministerial.” Further, 19 CFR 351.224(e) provides that the Department “will analyze any comments received and, if appropriate, correct any significant ministerial error by amending the preliminary determination.” A significant ministerial error is defined as a ministerial error, the correction of which, singly or in combination with other errors, would result in: (1) A change of at least five absolute percentage points in, but not less than 25 percent of, the weighted-average dumping margin calculated in the original (erroneous) preliminary determination; or (2) a difference between a weighted-average dumping margin of zero or de minimis and a weighted-average dumping margin of greater than de minimis or vice versa.3

    3See 19 CFR 351.224(g)(1) and (2).

    Ministerial Error Allegations

    Nucor alleges that the Department made three ministerial errors in its calculation of the preliminary determination margin for Ilsenburger Grobblech GmbH, Salzgitter Mannesmann Grobblech GmbH, Salzgitter Flachstahl GmbH, and Salzgitter Mannesmann International GmbH (collectively, Salzgitter):

    • In making the adjustment to U.S. price for reported freight revenue and capping that adjustment by the reported freight expense, the Department did not include freight revenue reported as a billing adjustment in the freight revenue cap.

    • The Department recalculated U.S. credit expenses incorrectly by deducting freight revenue from the U.S. price used in the calculation. However, the reported U.S. price did not include freight revenue.

    • The Department made an adjustment to U.S. price for inventory carrying expenses without converting the reported amount from euros to U.S. dollars.

    We agree that the alleged errors were made. Moreover, pursuant to 19 CFR 351.224(g)(2), these ministerial errors are significant because the correction of these errors results in a change from a weighted-average dumping margin of zero or de minimis to a weighted-average dumping margin of greater than de minimis. Therefore, we are correcting the ministerial errors alleged by Nucor and we are amending our preliminary determination accordingly.4

    4See Memorandum to the File entitled “Amended Preliminary Determination Margin Calculation for Salzgitter” (Amended Preliminary Determination Memorandum) for further discussion of our calculations for this amended preliminary determination.

    Amended Preliminary Determination

    We are amending the preliminary determination of sales at less-than-fair-value for CTL plate from Germany to reflect the correction of ministerial errors made in the margin calculation of that determination for Salzgitter. In addition, because we calculated a de minimis weighted-average dumping margin for Salzgitter in the Preliminary Determination, the preliminary “All-Others” Rate was based on the estimated weighted-average dumping margin calculated for Dillinger, the other mandatory respondent in this investigation. Thus, we are also amending the “All-Others” rate to account for the change in the Salzgitter margin. Accordingly, we are amending the calculation of the all-others rate to base it on the weighted-average of the margins calculated for Dillinger and Salzgitter using publicly-ranged data. Because we cannot apply our normal methodology of calculating a weighted-average margin due to requests to protect business-proprietary information, we find this rate to be the best proxy of the actual weighted-average margin determined for these respondents.5 As a result of the correction of the ministerial error, the revised weighted-average dumping margins are as follows:

    5See, e.g., Welded Line Pipe from the Republic of Turkey: Final Determination of Sales at Less Than Fair Value, 80 FR 61362, 61363 (October 13, 2015). For further discussion of the amended calculation of the all-others rate, see Amended Preliminary Determination Memorandum.

    Exporter/manufacturer Weighted-average dumping margin
  • (percent)
  • AG der Dillinger Hüttenwerke 6.56 Ilsenburger Grobblech GmbH, Salzgitter Mannesmann Grobblech GmbH, Salzgitter Flachstahl GmbH, and Salzgitter Mannesmann International GmbH 5.00 All-Others 5.17
    Amended Cash Deposits and Suspension of Liquidation

    The collection of cash deposits and suspension of liquidation will be revised according to the rates established in this amended preliminary determination, in accordance with section 733(d) and (f) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.224. Because the rates are increasing from the Preliminary Determination, the amended cash deposit rates will be effective on the date of publication of this notice in the Federal Register.

    International Trade Commission Notification

    In accordance with section 733(f) of the Act, we notified the International Trade Commission of our amended preliminary determination.

    Disclosure

    We intend to disclose the calculations performed to parties in this proceeding within five days after public announcement of the amended preliminary determination, in accordance with 19 CFR 351.224.

    This amended preliminary determination is issued and published in accordance with sections 733(f) and 777(i) of the Act and 19 CFR 351.224(e).

    Dated: November 21, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I Scope of the Investigation

    The products covered by this investigation are certain carbon and alloy steel hot-rolled or forged flat plate products not in coils, whether or not painted, varnished, or coated with plastics or other non-metallic substances (cut-to-length plate). Subject merchandise includes plate that is produced by being cut-to-length from coils or from other discrete length plate and plate that is rolled or forged into a discrete length. The products covered include (1) Universal mill plates (i.e., flat-rolled products rolled on four faces or in a closed box pass, of a width exceeding 150 mm but not exceeding 1250 mm, and of a thickness of not less than 4 mm, which are not in coils and without patterns in relief), and (2) hot-rolled or forged flat steel products of a thickness of 4.75 mm or more and of a width which exceeds 150 mm and measures at least twice the thickness, and which are not in coils, whether or not with patterns in relief. The covered products described above may be rectangular, square, circular or other shapes and include products of either rectangular or non-rectangular cross-section where such non-rectangular cross-section is achieved subsequent to the rolling process, i.e., products which have been “worked after rolling” (e.g., products which have been beveled or rounded at the edges).

    For purposes of the width and thickness requirements referenced above, the following rules apply:

    (1) Except where otherwise stated where the nominal and actual thickness or width measurements vary, a product from a given subject country is within the scope if application of either the nominal or actual measurement would place it within the scope based on the definitions set forth above; and

    (2) where the width and thickness vary for a specific product (e.g., the thickness of certain products with non-rectangular cross-section, the width of certain products with non-rectangular shape, etc.), the measurement at its greatest width or thickness applies.

    Steel products included in the scope of this investigation are products in which: (1) Iron predominates, by weight, over each of the other contained elements; and (2) the carbon content is 2 percent or less by weight.

    Subject merchandise includes cut-to-length plate that has been further processed in the subject country or a third country, including but not limited to pickling, oiling, levelling, annealing, tempering, temper rolling, skin passing, painting, varnishing, trimming, cutting, punching, beveling, and/or slitting, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the cut-to-length plate.

    All products that meet the written physical description are within the scope of this investigation unless specifically excluded or covered by the scope of an existing order. The following products are outside of, and/or specifically excluded from, the scope of this investigation:

    (1) Products clad, plated, or coated with metal, whether or not painted, varnished or coated with plastic or other non-metallic substances;

    (2) military grade armor plate certified to one of the following specifications or to a specification that references and incorporates one of the following specifications:

    • MIL-A-12560,

    • MIL-DTL-12560H,

    • MIL-DTL-12560J,

    • MIL-DTL-12560K,

    • MIL-DTL-32332,

    • MIL-A-46100D,

    • MIL-DTL-46100-E,

    • MIL-46177C,

    • MIL-S-16216K Grade HY80,

    • MIL-S-16216K Grade HY100,

    • MIL-S-24645A HSLA-80;

    • MIL-S-24645A HSLA-100,

    • T9074-BD-GIB-010/0300 Grade HY80,

    • T9074-BD-GIB-010/0300 Grade HY100,

    • T9074-BD-GIB-010/0300 Grade HSLA80,

    • T9074-BD-GIB-010/0300 Grade HSLA100, and

    • T9074-BD-GIB-010/0300 Mod. Grade HSLA115,

    except that any cut-to-length plate certified to one of the above specifications, or to a military grade armor specification that references and incorporates one of the above specifications, will not be excluded from the scope if it is also dual- or multiple-certified to any other non-armor specification that otherwise would fall within the scope of this order;

    (3) stainless steel plate, containing 10.5 percent or more of chromium by weight and not more than 1.2 percent of carbon by weight;

    (4) CTL plate meeting the requirements of ASTM A-829, Grade E 4340 that are over 305 mm in actual thickness;

    (5) Alloy forged and rolled CTL plate greater than or equal to 152.4 mm in actual thickness meeting each of the following requirements:

    (a) Electric furnace melted, ladle refined & vacuum degassed and having a chemical composition (expressed in weight percentages):

    • Carbon 0.23-0.28,

    • Silicon 0.05-0.20,

    • Manganese 1.20-1.60,

    • Nickel not greater than 1.0,

    • Sulfur not greater than 0.007,

    • Phosphorus not greater than 0.020,

    • Chromium 1.0-2.5,

    • Molybdenum 0.35-0.80,

    • Boron 0.002-0.004,

    • Oxygen not greater than 20 ppm,

    • Hydrogen not greater than 2 ppm, and

    • Nitrogen not greater than 60 ppm;

    (b) With a Brinell hardness measured in all parts of the product including mid thickness falling within one of the following ranges:

    (i) 270-300 HBW,

    (ii) 290-320 HBW, or

    (iii) 320-350 HBW;

    (c) Having cleanliness in accordance with ASTM E45 method A (Thin and Heavy): A not exceeding 1.5, B not exceeding 1.0, C not exceeding 0.5, D not exceeding 1.5; and

    (d) Conforming to ASTM A578-S9 ultrasonic testing requirements with acceptance criteria 2 mm flat bottom hole;

    (6) Alloy forged and rolled steel CTL plate over 407 mm in actual thickness and meeting the following requirements:

    (a) Made from Electric Arc Furnace melted, Ladle refined & vacuum degassed, alloy steel with the following chemical composition (expressed in weight percentages):

    • Carbon 0.23-0.28,

    • Silicon 0.05-0.15,

    • Manganese 1.20-1.50,

    • Nickel not greater than 0.4,

    • Sulfur not greater than 0.010,

    • Phosphorus not greater than 0.020,

    • Chromium 1.20-1.50,

    • Molybdenum 0.35-0.55,

    • Boron 0.002-0.004,

    • Oxygen not greater than 20 ppm,

    • Hydrogen not greater than 2 ppm, and

    • Nitrogen not greater than 60 ppm;

    (b) Having cleanliness in accordance with ASTM E45 method A (Thin and Heavy): A not exceeding 1.5, B not exceeding 1.5, C not exceeding 1.0, D not exceeding 1.5;

    (c) Having the following mechanical properties:

    (i) With a Brinell hardness not more than 237 HBW measured in all parts of the product including mid thickness; and having a Yield Strength of 75 ksi min and UTS 95 ksi or more, Elongation of 18% or more and Reduction of area 35% or more; having charpy V at −75 degrees F in the longitudinal direction equal or greater than 15 ft. lbs (single value) and equal or greater than 20 ft. lbs (average of 3 specimens) and conforming to the requirements of NACE MR01-75; or

    (ii) With a Brinell hardness not less than 240 HBW measured in all parts of the product including mid thickness; and having a Yield Strength of 90 ksi min and UTS 110 ksi or more, Elongation of 15% or more and Reduction of area 30% or more; having charpy V at −40 degrees F in the longitudinal direction equal or greater than 21 ft. lbs (single value) and equal or greater than 31 ft. lbs (average of 3 specimens);

    (d) Conforming to ASTM A578-S9 ultrasonic testing requirements with acceptance criteria 3.2 mm flat bottom hole; and

    (e) Conforming to magnetic particle inspection in accordance with AMS 2301;

    (7) Alloy forged and rolled steel CTL plate over 407 mm in actual thickness and meeting the following requirements:

    (a) Made from Electric Arc Furnace melted, ladle refined & vacuum degassed, alloy steel with the following chemical composition (expressed in weight percentages):

    • Carbon 0.25-0.30,

    • Silicon not greater than 0.25,

    • Manganese not greater than 0.50,

    • Nickel 3.0-3.5,

    • Sulfur not greater than 0.010,

    • Phosphorus not greater than 0.020,

    • Chromium 1.0-1.5,

    • Molybdenum 0.6-0.9,

    • Vanadium 0.08 to 0.12

    • Boron 0.002-0.004,

    • Oxygen not greater than 20 ppm,

    • Hydrogen not greater than 2 ppm, and

    • Nitrogen not greater than 60 ppm.

    (b) Having cleanliness in accordance with ASTM E45 method A (Thin and Heavy): A not exceeding 1.0(t) and 0.5(h), B not exceeding 1.5(t) and 1.0(h), C not exceeding 1.0(t) and 0.5(h), and D not exceeding 1.5(t) and 1.0(h);

    (c) Having the following mechanical properties: A Brinell hardness not less than 350 HBW measured in all parts of the product including mid thickness; and having a Yield Strength of 145 ksi or more and UTS 160 ksi or more, Elongation of 15% or more and Reduction of area 35% or more; having charpy V at −40 degrees F in the transverse direction equal or greater than 20 ft. lbs (single value) and equal or greater than 25 ft. lbs (average of 3 specimens);

    (d) Conforming to ASTM A578-S9 ultrasonic testing requirements with acceptance criteria 3.2 mm flat bottom hole; and

    (e) Conforming to magnetic particle inspection in accordance with AMS 2301.

    The products subject to the investigation are currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under item numbers: 7208.40.3030, 7208.40.3060, 7208.51.0030, 7208.51.0045, 7208.51.0060, 7208.52.0000, 7211.13.0000, 7211.14.0030, 7211.14.0045, 7225.40.1110, 7225.40.1180, 7225.40.3005, 7225.40.3050, 7226.20.0000, and 7226.91.5000.

    The products subject to the investigation may also enter under the following HTSUS item numbers: 7208.40.6060, 7208.53.0000, 7208.90.0000, 7210.70.3000, 7210.90.9000, 7211.19.1500, 7211.19.2000, 7211.19.4500, 7211.19.6000, 7211.19.7590, 7211.90.0000, 7212.40.1000, 7212.40.5000, 7212.50.0000, 7214.10.0000, 7214.30.0010, 7214.30.0080, 7214.91.0015, 7214.91.0060, 7214.91.0090, 7225.11.0000, 7225.19.0000, 7225.40.5110, 7225.40.5130, 7225.40.5160, 7225.40.7000, 7225.99.0010, 7225.99.0090, 7226.11.1000, 7226.11.9060, 7226.19.1000, 7226.19.9000, 7226.91.0500, 7226.91.1530, 7226.91.1560, 7226.91.2530, 7226.91.2560, 7226.91.7000, 7226.91.8000, and 7226.99.0180.

    The HTSUS subheadings above are provided for convenience and customs purposes only. The written description of the scope of the investigation is dispositive.

    [FR Doc. 2016-28703 Filed 11-28-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Institute of Standards and Technology [Docket No.: 160830797-6797-01] National Cybersecurity Center of Excellence (NCCoE) Mobile Application Single Sign On (SSO) for the Public Safety & First Responder Sector AGENCY:

    National Institute of Standards and Technology, Department of Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The National Institute of Standards and Technology (NIST) invites organizations to provide products and technical expertise to support and demonstrate security platforms for Mobile Application Single Sign On (SSO) for the Public Safety & First Responder sector. This notice is the initial step for the National Cybersecurity Center of Excellence (NCCoE) in collaborating with technology companies to address cybersecurity challenges identified under the Public Safety & First Responder sector program. Participation in the use case is open to all interested organizations.

    DATES:

    Interested parties must contact NIST to request a letter of interest template to be completed and submitted to NIST. Letters of interest will be accepted on a first come, first served basis. Collaborative activities will commence as soon as enough completed and signed letters of interest have been returned to address all the necessary components and capabilities, but no earlier than December 29, 2016. When the use case has been completed, NIST will post a notice on the NCCoE Public Safety & First Responder sector program Web site at https://nccoe.nist.gov/projects/building_blocks/mobile-sso announcing the completion of the use case and informing the public that it will no longer accept letters of interest for this use case.

    ADDRESSES:

    The NCCoE is located at 9700 Great Seneca Highway, Rockville, MD 20850. Letters of interest must be submitted to [email protected] or via hardcopy to National Institute of Standards and Technology, 100 Bureau Drive Mail Stop 2002, Gaithersburg, MD 20899. Organizations whose letters of interest are accepted in accordance with the process set forth in the SUPPLEMENTARY INFORMATION section of this notice will be asked to sign a Cooperative Research and Development Agreement (CRADA) with NIST. A CRADA template can be found at: http://nccoe.nist.gov/node/138.

    FOR FURTHER INFORMATION CONTACT:

    Paul Grassi or William Fisher via email to [email protected]; by telephone 301-975-0200; or by mail to National Institute of Standards and Technology, NCCoE; 100 Bureau Drive Mail Stop 2002, Gaithersburg, MD 20899. Additional details about the Public Safety & First Responder sector program are available at https://nccoe.nist.gov/projects/building_blocks/mobile-sso.

    SUPPLEMENTARY INFORMATION:

    Background: The NCCoE, part of NIST, is a public-private collaboration for accelerating the widespread adoption of integrated cybersecurity tools and technologies. The NCCoE brings together experts from industry, government, and academia under one roof to develop practical, interoperable cybersecurity approaches that address the real-world needs of complex Information Technology (IT) systems. By accelerating dissemination and use of these integrated tools and technologies for protecting IT assets, the NCCoE will enhance trust in U.S. IT communications, data, and storage systems; reduce risk for companies and individuals using IT systems; and encourage development of innovative, job-creating cybersecurity products and services.

    Process: NIST is soliciting responses from all sources of relevant security capabilities (see below) to enter into a Cooperative Research and Development Agreement (CRADA) to provide products and technical expertise to support and demonstrate security platforms for the Mobile Application Single Sign On (SSO) for the Public Safety & First Responder Sector. The full use case can be viewed at: https://nccoe.nist.gov/projects/building_blocks/mobile-sso.

    Interested parties should contact NIST using the information provided in the FOR FURTHER INFORMATION CONTACT section of this notice. NIST will then provide each interested party with a letter of interest template, which the party must complete, certify that it is accurate, and submit to NIST. NIST will contact interested parties if there are questions regarding the responsiveness of the letters of interest to the use case objective or requirements identified below. NIST will select participants who have submitted complete letters of interest on a first come, first served basis within each category of product components or capabilities listed below up to the number of participants in each category necessary to carry out this use case. However, there may be continuing opportunity to participate even after initial activity commences. Selected participants will be required to enter into a consortium CRADA with NIST (for reference, see ADDRESSES section above). NIST published a notice in the Federal Register on October 19, 2012 (77 FR 64314) inviting U.S. companies to enter into National Cybersecurity Excellence Partnerships (NCEPs) in furtherance of the NCCoE. For this demonstration project, NCEP partners will not be given priority for participation.

    Use Case Objective

    When responding to an emergency, public safety personnel require on-demand access to data. The ability to quickly and securely authenticate in order to access public safety data is critical to ensuring that first responders can deliver the proper care and support during an emergency. In order to adequately meet the need of diverse public safety personnel, missions, and operational environments, authentication mechanisms need to support deployments where devices may be shared amongst personnel and authentication factors have usability constraints.

    The challenge that first responders face in authenticating quickly and securely to public safety systems is compounded when a first responder is forced to authenticate individually to multiple mobile applications. In addition, when authorizing application access to shared resources, first responders may be subjected to an additional authentication step at the resource provider. To address the challenge identified by the public safety community, the National Cybersecurity Center of Excellence (NCCoE) plans to develop a Mobile Application Single Sign On (SSO) reference design and implementation that meets these unique authentication requirements and allows first responders to take advantage of the latest mobile authentication technology and best practices.

    A detailed description of the Mobile Application Single Sign On (SSO) is available at: https://nccoe.nist.gov/projects/building_blocks/mobile-sso.

    Requirements: Each responding organization's letter of interest should identify which security platform component(s) or capability(ies) it is offering. Letters of interest should not include company proprietary information, and all components and capabilities must be commercially available. Components are listed in section 3 of the Mobile Application Single Sign On (SSO) for the Public Safety & First Responder use case (for reference, please see the link in the PROCESS section above) and include, but are not limited to:

    • Mobile devices

    • Mobile platforms for biometric authentication

    • Hardware based authenticators that interoperate with mobile platforms • Software Development Kit (SDK) or platform that enables mobile single sign on capabilities

    Each responding organization's letter of interest should identify how their products address one or more of the following desired solution characteristics in section 3 of the Mobile Application Single Sign On (SSO) for the Public Safety & First Responder use case (for reference, please see the link in the PROCESS section above):

    1. A standards-based approach and a solution architecture that selects the most effective and secure approach to implement mobile SSO leveraging native capabilities of the mobile OS.

    2. Support mobile SSO both for authentication and delegated authorization (as in OAuth Client Applications).

    3. Ensure that mobile applications do not have access to user credentials.

    4. Support multiple authenticators taking into account unique environmental constraints faced by first responders in emergency medical services, law enforcement, and the fire service such as:

    a. Gloved, one-handed, or hands-free operation b. Use of smoke hoods, fire hoods or gas masks that may prevent facial or iris recognition c. Proximity based authenticators (new yubikeys) d. Biometric based continuous authentication mechanisms that meet the requirements of draft NIST Special Publication 800-63B

    5. Allow multi-user operation of shared mobile devices.

    6. Support for multiple authentication protocols. If appropriate, public sector agencies must be able to leverage multifactor authentication. This may be accomplished by adopting Fast IDentity Online (FIDO 2.0) Universal Authentication Framework (UAF), Universal 2nd Factor (U2F), PKI, or some other means.

    7. Support a spectrum of BYOD (Bring Your Own Device) and COPE (Corporate Owned, Personally Enabled) scenarios.

    Responding organizations need to understand and, in their letters of interest, commit to provide:

    1. Access for all participants' project teams to component interfaces and the organization's experts necessary to make functional connections among security platform components 2. Support for development and demonstration of the Mobile Application Single Sign On (SSO) for the Public Safety & First Responder use case in NCCoE facilities which will be conducted in a manner consistent with Federal requirements (e.g., FIPS 200, FIPS 201, SP 800-53, and SP 800-63)

    Additional details about the Mobile Application Single Sign On (SSO) for the Public Safety & First Responder sector use case are available at: https://nccoe.nist.gov/projects/building_blocks/mobile-sso.

    NIST cannot guarantee that all of the products proposed by respondents will be used in the demonstration. Each prospective participant will be expected to work collaboratively with NIST staff and other project participants under the terms of the consortium CRADA in the development of the Mobile Application Single Sign On (SSO) for the Public Safety & First Responder sector capability. Prospective participants' contribution to the collaborative effort will include assistance in establishing the necessary interface functionality, connection and set-up capabilities and procedures, demonstration harnesses, environmental and safety conditions for use, integrated platform user instructions, and demonstration plans and scripts necessary to demonstrate the desired capabilities. Each participant will train NIST personnel, as necessary, to operate its product in capability demonstrations to the Public Safety & First Responder community. Following successful demonstrations, NIST will publish a description of the security platform and its performance characteristics sufficient to permit other organizations to develop and deploy security platforms that meet the security objectives of the Mobile Application Single Sign On (SSO) for the Public Safety & First Responder sector use case. These descriptions will be public information.

    Under the terms of the consortium CRADA, NIST will support development of interfaces among participants' products by providing IT infrastructure, laboratory facilities, office facilities, collaboration facilities, and staff support to component composition, security platform documentation, and demonstration activities.

    The dates of the demonstration of the Mobile Application Single Sign On (SSO) for the Public Safety & First Responder sector capability will be announced on the NCCoE Web site at least two weeks in advance at http://nccoe.nist.gov/. The expected outcome of the demonstration is to improve mobile application single sign-on across an entire Public Safety & First Responder sector enterprise. Participating organizations will gain from the knowledge that their products are interoperable with other participants' offerings.

    For additional information on the NCCoE governance, business processes, and NCCoE operational structure, visit the NCCoE Web site http://nccoe.nist.gov/.

    Kent Rochford, Associate Director for Laboratory Programs.
    [FR Doc. 2016-28627 Filed 11-28-16; 8:45 am] BILLING CODE 3510-13-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Ocean Exploration Advisory Board (OEAB) AGENCY:

    Office of Oceanic and Atmospheric Research (OER) National Oceanic and Atmospheric Administration (NOAA) Department of Commerce (DOC).

    ACTION:

    Notice of Membership Solicitation for the OEAB.

    SUMMARY:

    OAR publishes this notice to solicit applications to fill a single membership vacancy on the Ocean Exploration Advisory Board (OEAB) with an individual demonstrating expertise in data science and management and one other area of expertise relevant to ocean exploration, such as seafloor mapping. The new OEAB member will serve an initial three-year term, renewable once.

    The purpose of the OEAB is to advise the Under Secretary of Commerce for Oceans and Atmosphere on matters pertaining to ocean exploration including: The identification of priority areas that warrant exploration; the development and enhancement of technologies for exploring the oceans; managing the data and information; and disseminating the results. The OEAB also provides advice on the relevance of the program with regard to the NOAA Strategic Plan, the National Ocean Policy Implementation Plan, and other appropriate guidance documents.

    APPLICATIONS:

    An application is required to be considered for OEAB membership. To apply, please submit (1) full name, title, institutional affiliation, and contact information (mailing address, email, telephones, fax); (2) a short description of his/her qualifications relative to data science and management, and at least one other area of expertise related to ocean exploration; (3) a resume or curriculum vitae (maximum length 4 pages); and (4) A cover letter stating their interest in serving on the OEAB and highlighting specific areas of expertise relevant to the purpose of the OEAB.

    DATES:

    Application materials should be sent to the mailing or email address specified below and must be received no later than 15 days after publication of this Federal Register Notice.

    ADDRESSES:

    Submit resume and application materials to Yvette Jefferson via mail or email. Mail: NOAA, 1315 East West Highway, SSMC3 Rm 10315, Silver Spring, MD 20910; Email: [email protected].

    FOR FURTHER INFORMATION CONTACT:

    David McKinnie, OEAB Designated Federal Officer, NOAA/OER, 7600 Sand Point Way NE., Seattle, WA 98115; 206-526-6950; [email protected].

    SUPPLEMENTARY INFORMATION:

    The OEAB functions as an advisory body in accordance with the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. App., with the exception of section 14. It reports to the Under Secretary, as directed by 33 U.S.C. 3405.

    The OEAB consists of approximately ten members including a Chair and Co-chair(s), designated by the Under Secretary in accordance with FACA requirements and the terms of the approved OEAB Charter.

    The OEAB:

    a. advises the Under Secretary on all aspects of ocean exploration including areas, features, and phenomena that warrant exploration; and other areas of program operation, including development and enhancement of technologies for exploring the ocean, managing ocean exploration data and information, and disseminating the results to the public, scientists, and educators;

    b. assists the program in the development of a 5-year strategic plan for the fields of ocean, marine, and Great Lakes science, exploration, and discovery, as well as makes recommendations to NOAA on the evolution of the plan based on results and achievements;

    c. annually reviews the quality and effectiveness of the proposal review process established under [correct]; and

    d. provides other assistance and advice as requested by the Under Secretary.

    OEAB members are appointed as special government employees (SGEs) and will be subject to the ethical standards applicable to SGEs. Members are reimbursed for actual and reasonable expenses incurred in performing such duties but will not be reimbursed for their time. All OEAB members serve at the discretion of the Under Secretary.

    The OEAB meets three to four times each year, exclusive of subcommittee, task force, and working group meetings.

    As a Federal Advisory Committee, the OEAB's membership is required to be balanced in terms of viewpoints represented and the functions to be performed as well as including the interests of geographic regions of the country and the diverse sectors of our society.

    For more information about the OEAB, please visit oeab.noaa.gov.

    OER BACKGROUND:

    NOAA's Office of Ocean Exploration and Research is part of the NOAA Office of Ocean Exploration and Research. OER's mission is to explore the ocean for national benefit.

    OER:

    e. Explores the ocean to make discoveries of scientific, economic, and cultural value, with priority given to the U.S. Exclusive Economic Zone and Extended Continental Shelf;

    f. Promotes technological innovation to advance ocean exploration;

    g. Provides public access to data and information;

    h. Encourages the next generation of ocean explorers, scientists, and engineers; and,

    i. Expands the national ocean exploration program through partnerships.

    For more information about the Office of Ocean Exploration and Research please visit oceanexplorer.noaa.gov.

    Dated: November 21, 2016. Jason Donaldson, Chief Financial Officer and Chief Administrative Officer, Office of Oceanic and Atmospheric Research, National Oceanic and Atmospheric Administration.
    [FR Doc. 2016-28594 Filed 11-28-16; 8:45 am] BILLING CODE 3510-KA-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF052 Western Pacific Fishery Management Council; Public Meeting; Correction AGENCY:

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

    ACTION:

    Notice of a change to a public meeting notice.

    SUMMARY:

    The Western Pacific Fishery Management Council (Council) announces a change in location for its Hilo, HI public meetings and scoping sessions to discuss fishery management regulations for the Monument Expanded Area in the Northwestern Hawaiian Islands.

    DATES:

    The Council will hold meetings in Hilo, HI on Tuesday, December 6, 2016, between 6 p.m. and 9 p.m. All times listed are local island times. For specific times and agendas, see SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    The Hilo meeting will be held at the University of Hawaii at Hilo, Edith Kanakaole Hall Room 126, 200 W Kawili St, Hilo, HI 96720.

    FOR FURTHER INFORMATION CONTACT:

    Kitty M. Simonds, Executive Director, Western Pacific Fishery Management Council; telephone: (808) 522-8220.

    SUPPLEMENTARY INFORMATION:

    The original notice published in the Federal Register on November 21, 2016 (81 FR 83204). The location of the meeting was changed from the previous notice. The agenda has not changed and public scoping and comment periods will be provided in the agenda. The order in which agenda items are addressed may change. The meetings will run as late as necessary to complete scheduled business.

    Schedule and Agenda for All Meetings 1. Visit Informational Booths 2. Informational Briefing on Presidential Proclamation, Council Role in Rule-making Process, Data Discovery 3. Public Comment/Scoping Session 4. Adjourn Special Accommodations

    These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: November 22, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-28614 Filed 11-28-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF029 Taking and Importing of Marine Mammals AGENCY:

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

    ACTION:

    Notice; affirmative finding annual renewals for Ecuador, El Salvador, Guatemala, Mexico, and Spain.

    SUMMARY:

    The NMFS Assistant Administrator (Assistant Administrator) has issued affirmative finding annual renewals for the Governments of Ecuador, El Salvador, Guatemala, Mexico, and Spain (Hereafter known as “The Nations”) under the Marine Mammal Protection Act (MMPA). These affirmative finding annual renewals will allow yellowfin tuna and yellowfin tuna products harvested in the eastern tropical Pacific Ocean (ETP) in compliance with the Agreement on the International Dolphin Conservation Program (AIDCP) by The Nations' flagged purse seine vessels or purse seine vessels operating under The Nations' jurisdiction to be imported into the United States. The affirmative finding annual renewals were based on reviews of documentary evidence submitted by the Governments of The Nations and by information obtained from the Inter-American Tropical Tuna Commission (IATTC).

    DATES:

    These affirmative finding annual renewals are effective for the one-year period of April 1, 2016, through March 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Justin Greenman, West Coast Region, National Marine Fisheries Service, 501 W. Ocean Blvd., Long Beach, CA 90802. Phone: 562-980-3264. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The MMPA, 16 U.S.C. 1361 et seq., allows for importation into the United States of yellowfin tuna harvested by purse seine vessels in the ETP under certain conditions. If requested by the harvesting nation, the Assistant Administrator will determine whether to make an affirmative finding based upon documentary evidence provided by the government of the harvesting nation, the IATTC, or the Department of State.

    The affirmative finding process requires that the harvesting nation is meeting its obligations under the AIDCP and obligations of membership in the IATTC. Every five years, the government of the harvesting nation must request a new affirmative finding and submit the required documentary evidence directly to the Assistant Administrator. On an annual basis, NMFS reviews the affirmative finding and determines whether the harvesting nation continues to meet the requirements. A nation may provide information related to compliance with AIDCP and IATTC measures directly to NMFS on an annual basis or may authorize the IATTC to release the information to NMFS to annually renew an affirmative finding determination without an application from the harvesting nation.

    An affirmative finding will be terminated, in consultation with the Secretary of State, if the Assistant Administrator determines that the requirements of 50 CFR 216.24(f) are no longer being met or that a nation is consistently failing to take enforcement actions on violations, thereby diminishing the effectiveness of the AIDCP.

    As a part of the affirmative finding process set forth in 50 CFR 216.24(f)(8), the Assistant Administrator considered documentary evidence submitted by the governments of The Nations and obtained from the IATTC, and has determined that The Nations have met the MMPA's requirements to receive affirmative finding annual renewals.

    After consultation with the Department of State, the Assistant Administrator issued affirmative finding annual renewals to The Nations, allowing the continued importation into the United States of yellowfin tuna and products derived from yellowfin tuna harvested in the ETP by The Nations' flagged purse seine vessels or purse seine vessels operating under The Nations' jurisdiction for the one-year period of April 1, 2016, through March 31, 2017.

    El Salvador's five-year affirmative finding will remain valid through March 31, 2018 and Ecuador, Guatemala, Mexico, and Spain's five-year affirmative findings will remain valid through March 31, 2020, subject to subsequent annual reviews by NMFS.

    Dated: November 23, 2016. Eileen Sobeck, Assistant Administrator for Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-28731 Filed 11-28-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF025 Notice of Availability of a Draft Environmental Assessment for the Bluefield Holdings, Inc. Site 2 Shoreline Restoration Project Credit Purchase AGENCY:

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

    ACTION:

    Notice of availability of a Draft Environmental Assessment; request for comments.

    SUMMARY:

    Notice is hereby given that a document entitled, “Draft Environmental Assessment for the Bluefield Holdings, Inc. Site 2 Shoreline Restoration Project Credits Purchase” (Draft EA) is available for public review and comment. This document has been prepared by the state, tribal, and Federal natural resource trustee agencies (the “Trustees”)—NOAA, United States Fish & Wildlife Service (USFWS) acting on behalf of the U.S. Department of the Interior (DOI), Washington Department of Ecology (as lead State trustee), Washington Department of Fish and Wildlife, Muckleshoot Indian Tribe, and the Suquamish Tribe—to evaluate potential impacts to the environment from purchasing 30 credits in the Bluefield Holdings, Inc. Site 2 Shoreline Restoration Project (Site 2). The proposed credits purchase in the Site 2 project is a component of the overall effort to restore natural resources and resource services that have been injured and lost resulting from releases of hazardous substances into the Lower Duwamish River (LDR). This draft EA is tiered from the June 2013 Final LDR NRDA Restoration Plan and Programmatic Environmental Impact Statement (RP/EIS). The EA describes the Trustees' proposed plan to purchase 30 credits in the Site 2 project. The purchase would utilize a portion of the funds provided to the Trustees from the Pacific Sound Resources settlement (United States et al. v. Pacific Sound Resources et al., Civ. No. C94-687 (W.D. Wash. Aug. 29, 1994)). The Trustees may only use these funds for restoration purposes. The Trustees will consider comments received during the public comment period before finalizing this EA.

    DATES:

    Comments on the Draft EA must be submitted in writing on or before December 27, 2016.

    ADDRESSES:

    Requests for copies of the Draft EA should be sent to Rebecca Hoff of NOAA at 7600 Sand Point Way NE., DARC Building 1, Seattle, WA 98115 or by email: [email protected]. The Draft EA is also available for downloading at http://bit.ly/2fJlE8G. Comments on this plan are to be sent in writing to Rebecca Hoff of NOAA. These written comments may be submitted either by mail at the address provided above; by fax to 206-526-6665, or by email to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Rebecca Hoff, at 206-526-6276, or email: [email protected].

    SUPPLEMENTARY INFORMATION:

    The LDR is the estuarine portion of the Duwamish River, and starts from the mouth at the East and West Waterways on both sides of Harbor Island at Seattle's Elliott Bay and ends at the natural rock formation commonly known as North Winds Weir (approximately 7 miles), in central Puget Sound. Historic operations of various entities resulted in releases of hazardous substances, such as polynuclear aromatic hydrocarbons (PAHs), polychlorinated biphenyls (PCBs), heavy metals, and other hazardous compounds, into the LDR.

    The RP/PEIS describes the type of restoration that the Trustees believe would be most effective in addressing the injuries in the LDR resulting from releases of hazardous substances—Integrated Habitat Restoration. The Site 2 project will create the full suite of habitats identified in the Integrated Habitat Restoration approach, and is consistent with the description of projects and project impacts discussed in the RP/PEIS. The Draft EA released today identifies the Trustees' proposed use of some of the settlement funds to purchase restoration credits sufficient to allow Bluefield Holdings to begin implementing the Site 2 project. The Site 2 project will create and/or rehabilitate shallow subtidal habitat, intertidal mudflat habitat, marsh habitat, and riparian habitat.

    In undertaking this NRDA restoration effort and in releasing this Draft EA, the Trustees are acting in accordance with their designation and authorities under section 107(f) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), 42 U.S.C. 9607(f) of the Federal Water Pollution and Control Act (FWPCA), 33 U.S.C. 1321, Subpart G of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), 40 CFR 300.600 through 300.615, and regulations at 43 CFR part 11, which are applicable to natural resource damage assessments under CERCLA. The Trustees act on behalf of the public under these authorities to protect and restore natural resources injured or lost resulting from discharges or releases of hazardous substances.

    Dated: November 22, 2016. Patricia A. Montanio, Director, Office of Habitat Conservation, National Marine Fisheries Service.
    [FR Doc. 2016-28617 Filed 11-28-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Digital Economy Board of Advisors Meeting AGENCY:

    National Telecommunications and Information Administration, U.S. Department of Commerce.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces an open meeting of the Digital Economy Board of Advisors. The Board advises and provides recommendations to the Secretary of Commerce, through the Assistant Secretary of Commerce for Communications and Information and the National Telecommunications and Information Administration (NTIA), on a broad range of issues concerning the digital economy and Internet policy.

    DATES:

    The meeting will be held on December 15, 2016, from 8:30 a.m. to 12:00 p.m., Eastern Standard Time (EST).

    ADDRESSES:

    The meeting will be held at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230. Public comments may be mailed to: Digital Economy Board of Advisors, National Telecommunications and Information Administration, 1401 Constitution Avenue NW., Room 4725, Washington, DC 20230; or emailed to: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Evelyn Remaley, Designated Federal Officer (DFO), at (202) 482-3821 or [email protected]; and/or visit NTIA's Web site at https://www.ntia.doc.gov/category/digital-economy-board-advisors.

    SUPPLEMENTARY INFORMATION:

    Background: Economic prosperity is increasingly tied to the digital economy, which is a key driver of competitiveness, business expansion, and innovation. Indeed, virtually every modern company relies on the Internet to grow and thrive. As a result, the Department of Commerce (Department) has made technology and Internet policy a top priority, investing resources to address challenges and opportunities businesses face in a global economy.

    Last year, the Secretary of Commerce unveiled the Department's Digital Economy Agenda, which will help businesses and consumers realize the potential of the digital economy to advance growth and opportunity. The Agenda focuses on four key objectives: Promoting a free and open Internet worldwide; promoting trust online; ensuring access for workers, families, and companies; and promoting innovation. To support the Agenda, the Secretary directed NTIA to create the Digital Economy Board of Advisors as a mechanism for receiving regular advice from leaders in industry, academia, and civil society. See Committee Charter at https://www.ntia.doc.gov/files/ntia/publications/deba_charter_12222015.pdf.

    The Digital Economy Board of Advisors convened its first meeting on May 16, 2016, to determine preliminary priorities and work streams. The Board convened its second meeting on September 30, 2016, and reviewed progress made on each of the work streams identified during the first open meeting.

    This Board is subject to the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2, and is consistent with the National Telecommunications and Information Administration Act, 47 U.S.C. 904(b). The Board functions solely as an advisory body in compliance with the FACA. For more information about the Board, visit https://www.ntia.doc.gov/category/digital-economy-board-advisors.

    Matters to be Considered: The Board provides independent advice and recommendations to the Secretary, through the Assistant Secretary, on a broad range of policy issues impacting the digital economy. The Board's mission is to provide advice to the Department on increasing domestic prosperity, improving education, and facilitating participation in political and cultural life through the application and expansion of digital technologies. The Board's advice focuses on ensuring the Internet continues to thrive as an engine of growth, innovation, and free expression. The Department will use the advice provided by the Board to inform its decision-making processes and to advance Administration goals.

    NTIA will post a detailed agenda on its Web site, https://www.ntia.doc.gov/category/digital-economy-board-advisors, prior to the meeting. To the extent that the meeting time and agenda permit, any member of the public may speak to or otherwise address the Board regarding the agenda items during the meeting.

    Time and Date: The meeting will be held on December 15, 2016, from 8:30 a.m. to 12:00 p.m., Eastern Standard Time (EST). The meeting will be available via two-way audio link and may be webcast. Please refer to NTIA's Web site, https://www.ntia.doc.gov/category/digital-economy-board-advisors, for the most up-to-date meeting agenda and access information for the meeting.

    Place: The meeting will be held at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230. Public comments may be mailed to: Digital Economy Board of Advisors, National Telecommunications and Information Administration, 1401 Constitution Avenue NW., Room 4725, Washington, DC 20230. The meeting will be open to the public and press on a first-come, first-served basis. Space is limited. The meeting is physically accessible to people with disabilities. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, are asked to notify Ms. Remaley at (202) 482-3821 or [email protected] at least five (5) business days before the meeting.

    Status: Interested parties are invited to attend and to submit written comments to the Board at any time before or after the meeting. Parties wishing to submit written comments for consideration by the Board in advance of the meeting must send them to NTIA at the above-listed address. Comments must be received five (5) business days before the scheduled meeting date to provide sufficient time for review. Comments received after this date will be distributed to the Board, but may not be reviewed prior to the meeting. We also request that comments be submitted electronically to [email protected] with the subject: “DEBA Third Meeting Comment.” Comments provided via email also may be submitted in writing.

    Records: NTIA maintains records of all Board proceedings. Board records are available for public inspection at NTIA's Washington, DC office at the address above. Documents, including the Board's charter, member list, agendas, minutes, and any reports are available on NTIA's Web site at https://www.ntia.doc.gov/category/digital-economy-board-advisors.

    Dated: November 23, 2016. Milton Brown, Deputy Chief Counsel, National Telecommunications and Information Administration.
    [FR Doc. 2016-28708 Filed 11-28-16; 8:45 am] BILLING CODE 3510-60-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION [Docket No. CFPB-2016-0049] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice and request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Consumer Financial Protection (Bureau or CFPB) is proposing a new information collection titled, “Consumer Response Customer Response Survey.”

    DATES:

    Written comments are encouraged and must be received on or before December 29, 2016 to be assured of consideration.

    ADDRESSES:

    You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:

    Electronic: http://www.regulations.gov. Follow the instructions for submitting comments.

    OMB: Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503 or fax to (202) 395-5806. Mailed or faxed comments to OMB should be to the attention of the OMB Desk Officer for the Bureau of Consumer Financial Protection.

    Please note that comments submitted after the comment period will not be accepted. In general, all comments received will become public records, including any personal information provided. Sensitive personal information, such as account numbers or Social Security numbers, should not be included.

    FOR FURTHER INFORMATION CONTACT:

    Documentation prepared in support of this information collection request is available at www.reginfo.gov (this link becomes active on the day following publication of this notice). Select “Information Collection Review,” under “Currently under review, use the dropdown menu “Select Agency” and select “Consumer Financial Protection Bureau” (recent submissions to OMB will be at the top of the list). The same documentation is also available at http://www.regulations.gov. Requests for additional information should be directed to the Consumer Financial Protection Bureau, (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552, (202) 435-9575, or email: [email protected] Please do not submit comments to this email box.

    SUPPLEMENTARY INFORMATION:

    Title of Collection: Consumer Response Customer Response Survey.

    OMB Control Number: 3170-XXXX.

    Type of Review: New collection (Request for a new OMB control number).

    Affected Public: Individuals or Households.

    Estimated Number of Respondents: 93,700.

    Estimated Total Annual Burden Hours: 4,685.

    Abstract: The purpose of this information collection is to incorporate a short survey into the complaint closing process. Consumers will have the option to provide feedback on the company's response to and handling of their complaint via all channels including online, phone, fax, and mail. The results of this feedback will be shared with the company that responded to the complaint to inform its complaint handling. The feedback will also be used to inform the Bureau's work to supervise companies, enforce federal consumer financial laws, write better rules and regulations, and monitor the market for consumer financial products and services. Consistent with the Bureau's policy statement on Disclosure of Consumer Complaint Data, the Bureau will evaluate the data collected from consumer feedback before publication on the Consumer Complaint Database. The Bureau anticipates publication of consumer feedback to highlight positive company behavior, provide the public with timely and understandable information about consumer financial products and services, and improve the functioning, transparency, and efficiency of markets for such products and services. Only those feedback narratives for which opt-in consumer consent is obtained, and to which robust personal information scrubbing standard and methodology is applied, will be eligible for publication.

    This information collection reflects comments received in response to the March 24, 2015 (80 FR 15583) Notice and Request for Information (RFI), seeking input from the public on the potential collection and sharing of information about consumers' positive interactions with financial service providers including providing more information about a company's complaint handling such as highlighting the quality of responses to consumers by replacing the consumer “dispute” function with a two-part consumer feedback process as well as comments received during the 60-day comment period and user testing conducting concurrent with the 60-day comment period. The consumer will have the ability to answer three questions about the company's response to and handling of his or her complaint, to rate the company's overall response using one-to-five stars and provide a narrative description in support of the rating. Positive feedback about the company's handling of the consumer's complaint would be reflected by both high satisfaction scores and by the narrative in support of the score. Negative feedback about the company's handling of the consumer's complaint would be better supported and more useful to companies than the current “dispute” function. The Consumer Complaint Company Response Survey will replace the “dispute” option and allow consumers to offer both positive and negative feedback on their complaint experience.

    Request for Comments: The Bureau issued a 60-day Federal Register notice on August 1, 2016, 81 FR 50484, Docket Number: CFPB-2016-0041. Comments were solicited and continue to be invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record.

    Dated: November 22, 2016. Darrin A. King, Paperwork Reduction Act Officer, Bureau of Consumer Financial Protection.
    [FR Doc. 2016-28651 Filed 11-28-16; 8:45 am] BILLING CODE 4810-AM-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2013-OS-0179] Proposed Collection; Comment Request AGENCY:

    Office of the Under Secretary of Defense (Personnel and Readiness), DoD.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense (Personnel and Readiness) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

    DATES:

    Consideration will be given to all comments received by January 30, 2017.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information. Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at http://www.regulations.gov for submitting comments. Please submit comments on any given form identified by docket number, form number, and title.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Office of the Under Secretary of Defense (Personnel and Readiness) (Defense Human Resource Activity), ATTN: Robert Eves, 4800 Mark Center Drive, Alexandria, VA 22350-4000, or submit an email to [email protected]

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Application for Identification Card/DEERS Enrollment; DD Form 1172-2; OMB Control Number 0704-0415.

    Needs and Uses: This information collected is used to determine an individual's eligibility for benefits and privileges, to provide a proper identification card reflecting those benefits and privileges, and to maintain a centralized database of the eligible population.

    Affected Public: Individuals or Households.

    Annual Burden Hours: 135,000.

    Number of Respondents: 2,700,000.

    Responses per Respondent: 1.

    Annual Responses: 2,700,000.

    Average Burden per Response: 3 minutes.

    Frequency: On Occasion.

    Dated: November 23, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-28688 Filed 11-28-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID DOD-2016-OS-0113] Manual for Courts-Martial; Proposed Amendments AGENCY:

    Joint Service Committee on Military Justice (JSC), Department of Defense.

    ACTION:

    Notice of proposed amendments to the Manual for Courts-Martial, United States (2012 ed.) and notice of public meeting.

    SUMMARY:

    The Department of Defense requests comments on proposed changes to the Manual for Courts-Martial, United States (2012 ed.) (MCM). The proposed changes concern the rules of procedure and evidence applicable in trials by courts-martial. The approval authority for these changes is the President. These proposed changes have not been coordinated within the Department of Defense under DoD Directive 5500.01, “Preparing, Processing and Coordinating Legislation, Executive Orders, Proclamations, Views Letters, and Testimony,” June 15, 2007, and do not constitute the official position of the Department of Defense, the Military Departments, or any other Government agency.

    The proposed changes also concern supplementary materials that accompany the rules of procedure and evidence and punitive articles. The Department of Defense, in conjunction with the Department of Homeland Security, publishes these supplementary materials to accompany the Manual for Courts-Martial. Supplementary materials consist of Discussions (accompanying the Preamble, the Rules for Courts-Martial, the Military Rules of Evidence, and the Punitive Articles), Analyses, and various appendices. The approval authority for changes to the supplementary materials is the General Counsel, Department of Defense; changes to these items do not require Presidential approval.

    DATES:

    Comments on the proposed changes must be received no later than January 30, 2017. A public meeting for comments will be held on December 15, 2016, at 10 a.m. in the United States Court of Appeals for the Armed Forces building, 450 E Street NW., Washington, DC 20442-0001.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name and docket number for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    Major Harlye S.M. Carlton, USMC, Executive Secretary, JSC, (703) 693-9299, ha[email protected] The JSC website is located at http://jsc.defense.gov.

    SUPPLEMENTARY INFORMATION:

    This notice is provided in accordance with DoD Directive 5500.17, “Role and Responsibilities of the Joint Service Committee (JSC) on Military Justice,” May 3, 2003.

    The JSC invites members of the public to comment on the proposed changes; such comments should address specific recommended changes and provide supporting rationale.

    This notice also sets forth the date, time, and location for a public meeting of the JSC to discuss the proposed changes.

    This notice is intended only to improve the internal management of the Federal Government. It is not intended to create any right or benefit, substantive or procedural, enforceable at law by any party against the United States, its agencies, its officers, or any person.

    The proposed amendments to the MCM are as follows:

    Section 1. Part II of the Manual for Courts-Martial, United States, is amended as follows: (a) R.C.M. 104(b)(1)(B) is amended to read as follows:

    “(B) Give a less favorable rating or evaluation of any defense counsel or special victims' counsel because of the zeal with which such counsel represented any client. As used in this rule, “special victims' counsel” are judge advocates, and civilian counsel, who, in accordance with 10 U.S.C. 1044e, are designated as Special Victims' Counsel.”

    (b) R.C.M. 601(d)(2)(B) is amended to read as follows:

    “The convening authority has received the advice of the staff judge advocate required under Article 34.”

    (c) R.C.M. 701(g)(2) is amended to read as follows:

    “(2) Protective and modifying orders. Upon a sufficient showing the military judge may at any time order that the discovery or inspection be denied, restricted, or deferred, or make such other order as is appropriate. If any rule requires, or upon motion by a party, the military judge may review any materials in camera, and permit the party to make such showing, in whole or in part, in writing to be inspected only by the military judge in camera. If the military judge reviews any materials in camera, the entirety of any materials not ordered disclosed by the military judge shall be sealed and attached to the record of trial as an appellate exhibit. Such material may only be examined by reviewing or appellate authorities in accordance with R.C.M. 1103A.”

    (d) R.C.M. 704(c) is amended to read as follows:

    “(c) Authority to grant immunity. A general court-martial convening authority, or designee, may grant immunity, and may do so only in accordance with this rule.”

    (e) R.C.M. 704(c)(1) is amended to read as follows:

    “(1) Persons subject to the code. A general court-martial convening authority, or designee, may grant immunity to a person subject to the code. However, a general court-martial convening authority, or designee, may grant immunity to a person subject to the code extending to a prosecution in a United States District Court only when specifically authorized to do so by the Attorney General of the United States or other authority designated under chapter 601 of title 18 of the U.S. Code.”

    (f) R.C.M. 704(c)(2) is amended to read as follows:

    “(2) Persons not subject to the code. A general court-martial convening authority, or designee, may grant immunity to persons not subject to the code only when specifically authorized to do so by the Attorney General of the United States or other authority designated under chapter 601 of title 18 of the U.S. Code.”

    (g) R.C.M. 704(c)(3) is amended to read as follows:

    “(3) Other limitations. Subject to Service regulations, the authority to grant immunity under this rule may be delegated in writing at the discretion of the general court-martial convening authority to a subordinate special court-martial convening authority. Further delegation is not permitted. The authority to grant or delegate immunity may be limited by superior authority.”

    (h) The first sentence of R.C.M. 704(e) is amended to read as follows:

    “(e) Decision to grant immunity. Unless limited by superior competent authority, the decision to grant immunity is a matter within the sole discretion of the general court-martial convening authority, or designee.”

    (i) The header for R.C.M. 1103(b) is amended to read as follows:

    “(b) General and special courts-martial.

    (j) R.C.M. 1103(b)(2)(A) is amended to read as follows:

    “(A) In general. The record of trial in each general and special court-martial shall be separate, complete, and independent of any other document.”

    (k) R.C.M. 1103(b)(3)(G) is amended to read as follows:

    “(G) Any post-trial recommendation of the staff judge advocate or legal officer and proof of service on defense counsel in accordance with R.C.M. 1106(f)(1);”

    (l) R.C.M. 1103(b)(3)(H) is amended to read as follows:

    “(H) Any response by defense counsel to any post-trial review;”

    (m) R.C.M. 1103(b)(3)(J) is amended to read as follows:

    “(J) Any statement as to why it is impracticable for the convening authority to act;”

    (n) R.C.M. 1103(c) is amended to read as follows:

    “(c) [DELETED]”

    (o) R.C.M. 1103A is amended to read as follows:

    “(a) In general. If the report of preliminary hearing or record of trial contains exhibits, proceedings, or other materials ordered sealed by the preliminary hearing officer or military judge, counsel for the government or trial counsel shall cause such materials to be sealed so as to prevent unauthorized examination or disclosure. Counsel for the government or trial counsel shall ensure that such materials are properly marked, including an annotation that the material was sealed by order of the preliminary hearing officer or military judge, and inserted at the appropriate place in the original record of trial. Copies of the report of preliminary hearing or record of trial shall contain appropriate annotations that materials were sealed by order of the preliminary hearing officer or military judge and have been inserted in the report of preliminary hearing or original record of trial. This Rule shall be implemented in a manner consistent with Executive Order 13526, concerning classified national security information.

    (b) Examination and disclosure of sealed materials. Except as provided in the following subsections to this rule, sealed materials may not be examined or disclosed.

    (1) Prior to referral. Prior to referral of charges, the following individuals may examine and disclose sealed materials only if necessary for proper fulfillment of their responsibilities under the Code, this Manual, governing directives, instructions, regulations, applicable rules for practice and procedure, or rules of professional responsibility: The judge advocate advising the convening authority who directed the Article 32 preliminary hearing; the convening authority who directed the Article 32 preliminary hearing; the staff judge advocate to the general court-martial convening authority; and the general court-martial convening authority.

    (2) Referral through authentication. Prior to authentication of the record by the military judge, sealed materials may not be examined or disclosed in the absence of an order from the military judge based upon good cause.

    (3) Authentication through action. After authentication and prior to disposition of the record of trial pursuant to R.C.M. 1111, sealed materials may not be examined or disclosed in the absence of an order from the military judge upon a showing of good cause at a post-trial Article 39(a) session directed by the convening authority.

    (4) After action.

    (A) Examination by reviewing and appellate authorities. Reviewing and appellate authorities may examine sealed materials when those authorities determine that examination is reasonably necessary to a proper fulfillment of their responsibilities under the Code, this Manual, governing directives, instructions, regulations, applicable rules for practice and procedure, or rules of professional responsibility.

    (B) Examination by appellate counsel. Appellate counsel may examine sealed materials subject to the following procedures:

    (i) Sealed materials released to trial government or defense counsel. Materials presented or reviewed at trial and subsequently sealed, as well as materials reviewed in camera, released to trial government or defense counsel, and subsequently sealed, may be examined by appellate counsel upon a colorable showing to the reviewing or appellate authority that examination is reasonably necessary to a proper fulfillment of their responsibilities under the Code, this Manual, governing directives, instructions, regulations, applicable rules for practice and procedure, or rules of professional responsibility.

    (ii) Sealed materials reviewed in camera but not released to trial government or defense counsel. Materials reviewed in camera by a military judge, not released to trial government or defense counsel, and subsequently sealed may be examined by reviewing or appellate authorities. After examination of said materials, the reviewing or appellate authority may permit examination by appellate counsel for good cause.

    (C) Disclosure. Appellate counsel shall not disclose sealed material in the absence of:

    (i) Prior authorization of the Judge Advocate General in the case of review under R.C.M. 1201(b) or 1112; or

    (ii) Prior authorization of the appellate court before which a case is pending review under R.C.M. 1203 and 1204.

    (D) For purposes of this rule, reviewing and appellate authorities are limited to:

    (i) Judge advocates reviewing records pursuant to R.C.M. 1112;

    (ii) Officers and attorneys in the office of the Judge Advocate General reviewing records pursuant to R.C.M. 1201(b);

    (iii) Appellate judges of the Courts of Criminal Appeals and their professional staffs;

    (iv) The judges of the United States Court of Appeals for the Armed Forces and their professional staffs;

    (v) The Justices of the United States Supreme Court and their professional staffs; and

    (vi) Any other court of competent jurisdiction.

    (5) Examination of sealed materials. For purposes of this rule, “examination” includes reading, inspecting, and viewing.

    (6) Disclosure of sealed materials. For purposes of this rule, “disclosure” includes photocopying, photographing, disseminating, releasing, manipulating, or communicating the contents of sealed materials in any way.”

    Section 2. Part III of the Manual for Courts-Martial, United States, is amended as follows: (a) Mil. R. Evid. 311(c)(4) is amended to read as follows:

    “(4) Reliance on Statute or Binding Precedent. Evidence that was obtained as a result of an unlawful search or seizure may be used when the official seeking the evidence acted in objectively reasonable reliance on a statute or on binding precedent later held violative of the Fourth Amendment.”

    (b) Mil. R. Evid. 311(d)(5)(A) is amended to read as follows:

    “(A) In general. When the defense makes an appropriate motion or objection under subdivision (d), the prosecution has the burden of proving by a preponderance of the evidence that the evidence was not obtained as a result of an unlawful search or seizure, that the evidence would have been obtained even if the unlawful search or seizure had not been made, that the evidence was obtained by officials who reasonably and with good faith relied on the issuance of an authorization to search, seize, or apprehend or a search warrant or an arrest warrant; that the evidence was obtained by officials in objectively reasonable reliance on a statute or on binding precedent later held violative of the Fourth Amendment; or that the deterrence of future unlawful searches or seizures is not appreciable or such deterrence does not outweigh the costs to the justice system of excluding the evidence.”

    (c) Mil. R. Evid. 505(l) is amended to read as follows:

    “(l) Record of Trial. If under this rule any information is reviewed in camera by the military judge and withheld from the accused, the accused objects to such withholding, and the trial continues to an adjudication of guilt of the accused, the entire unaltered text of the relevant documents as well as any motions and any materials submitted in support thereof must be sealed in accordance with R.C.M. 701(g)(2) and 1103A and attached to the record of trial as an appellate exhibit. Such material will be made available to reviewing and appellate authorities in accordance with R.C.M. 1103A. The record of trial with respect to any classified matter will be prepared under R.C.M. 1103(h) and 1104(b)(1)(D).”

    (d) Mil. R. Evid. 506(m) is amended to read as follows:

    “(m) Record of Trial. If under this rule any information is reviewed in camera by the military judge and withheld from the accused, the accused objects to such withholding, and the trial continues to an adjudication of guilt of the accused, the entire unaltered text of the relevant documents as well as any motions and any materials submitted in support thereof must be sealed in accordance with R.C.M. 701(g)(2) and 1103A and attached to the record of trial as an appellate exhibit. Such material will be made available to reviewing and appellate authorities in accordance with R.C.M. 1103A.”

    (e) Mil. R. Evid. 513(e)(6) is amended to read as follows:

    “(6) The motion, related papers, and the record of the hearing must be sealed in accordance with R.C.M. 701(g)(2) or 1103A.”

    (f) Mil. R. Evid. 514(e)(6) is amended to read as follows:

    “(6) The motion, related papers, and the record of the hearing must be sealed in accordance with R.C.M. 701(g)(2) or 1103A.”

    Section 3. Appendix 21, Analysis of Rules for Courts-Martial is amended as follows: (a) R.C.M. 704(c) is amended by inserting the following at the end:

    2017 Amendment: A new second paragraph was added to the Discussion after R.C.M. 704(c). The Response Systems to Adult Sexual Assault Crimes Panel's (RSP) June 2014 report recommended a study into grants of immunity for victim collateral misconduct in sexual assault cases. This new paragraph encourages convening authorities to respond to requests for immunity as soon as practicable if an expedited response is requested by the victim of an alleged offense. The RSP was a congressionally mandated panel tasked to conduct an independent review and assessment of the systems used to investigate, prosecute, and adjudicate crimes involving adult sexual assault and related offenses.”

    (b) R.C.M. 704 is amended by inserting the following at the end:

    2017 Amendment: Modifications were made throughout R.C.M. 704. The Response Systems to Adult Sexual Assault Crimes Panel's (RSP) June 2014 report recommended a study into grants of immunity for victim collateral misconduct in sexual assault cases. Subject to Service regulations, these modifications permit general court-martial convening authorities to delegate the authority to grant immunity to subordinate special court-martial convening authorities and no further. The RSP was a congressionally mandated panel tasked to conduct an independent review and assessment of the systems used to investigate, prosecute, and adjudicate crimes involving adult sexual assault and related offenses.”

    (c) R.C.M. 1103A is amended by inserting the following at the end:

    2017 Amendment: The Rule was reorganized and revised. It better addresses the two types of sealed materials commonly found in records of trial: Those materials that had been disclosed to trial government and defense counsel prior to sealing and those materials that were not disclosed to trial government or defense counsel prior to sealing. The changes also maintain consistency with R.C.M. 701(g)(2), United States v. Romano, 46 M.J. 269 (C.A.A.F. 1997), and United States v. Rivers, 49 M.J. 434 (C.A.A.F. 1998), by requiring the appellate court or reviewing authority to conduct a review of sealed materials on appeal which had been reviewed in camera, not disclosed to trial government or defense counsel, and subsequently sealed prior to permitting appellate counsel the opportunity to examine such sealed matters. Finally, the rule better defines the difference between “examination” and “disclosure” of sealed materials and the additional authorization needed prior to disclosure by appellate counsel.”

    Section 4. Appendix 22, Analysis of the Military Rules of Evidence is amended as follows: (a) Mil. R. Evid. 311 is amended by inserting the following at the end:

    2017 Amendment: The change to (c)(4) and(d)(5)(A) incorporates the Supreme Court's holding in Davis v. United States, 564 U.S. 229 (2011). In Davis, the Supreme Court found that the exclusionary rule did not apply because the police officer acted in objectively reasonable reliance on precedent that was binding on the officer at the time of the search. Id.

    Section 5. The Discussion to Part II of the Manual for Courts-Martial, United States, is amended as follows: (a) A new Discussion is inserted immediately after R.C.M. 104(b)(1)(B) and before R.C.M. 104(b)(2) and reads as follows:

    “This rule applies when the counsel in question has been detailed, assigned, or authorized to represent the client as a defense or special victims' counsel. Nothing in this rule prohibits supervisors from taking appropriate action for violations of ethical, procedural, or other rules, or for conduct outside the scope of representation.

    “Special Victims' Counsel,” as used in this rule, includes Victims' Legal Counsel within the Navy and Marine Corps.”

    (b) The Discussion immediately following R.C.M. 308(a) and before R.C.M. 308(b) is amended to read as follows:

    “When notice is given, a certificate to that effect on the Charge Sheet should be completed. See Appendix 4. However, in cases where charges are immediately referred after preferral, service of referred charges under R.C.M. 602 fulfills the notice requirement of this rule. In those cases, the notice certificate on the Charge Sheet need not be completed and should be lined out.”

    (c) A new paragraph is added at the end of the Discussion immediately following R.C.M. 601(d)(2)(B) and before R.C.M. 601(e) and reads as follows:

    “A specification under a charge may not be referred to a general court-martial unless the advice of the staff judge advocate concludes the specification alleges an offense under the Code, is warranted by the evidence, and a court-martial would have jurisdiction over the accused and the offense. See Article 34 and R.C.M. 406.”

    (d) The first sentence of the Discussion immediately following R.C.M. 704(c) is amended to read as follows:

    “Only general court-martial convening authorities or their designees are authorized to grant immunity.”

    (e) The Discussion immediately following R.C.M. 704(c) is amended by inserting a new paragraph in between the first and second paragraphs, which reads as follows:

    “When the victim of an alleged offense requests an expedited response to a request for immunity for misconduct that is collateral to the underlying offense, the convening authority should respond to the request as soon as practicable.”

    (f) A new Discussion paragraph is inserted immediately prior to the existing paragraph following R.C.M. 704(c)(3) and reads as follows:

    “A general court-martial convening authority has wide latitude under this section to exercise his or her discretion in delegating immunity authority. For example, a general court-martial convening authority may decide to delegate only the authority for a designee to grant immunity for certain offenses, such as a list of specific offenses or any offense not warranting a punitive discharge, while withholding authority to grant immunity for all others. A general court-martial convening authority may also delegate only authority for certain categories of grantees, such as victims of alleged sex-related offenses.”

    (g) A new Discussion is inserted immediately following R.C.M. 1103A(a) and prior to R.C.M. 1103A(b) and reads as follows:

    “Upon request or otherwise for good cause, a military judge may seal matters at his or her discretion.

    The terms “examination” and “disclosure” are defined in (b)(5) and (6) of this rule.”

    (h) A Discussion is re-inserted immediately following R.C.M. 1103A(b)(3) and prior to R.C.M. 1103A(b)(4) and reads as follows:

    “A convening authority who has granted clemency based upon review of sealed materials in the record of trial is not permitted to disclose the contents of the sealed materials when providing a written explanation of the reason for such action, as directed under R.C.M. 1107.”

    (i) A new Discussion is inserted immediately following R.C.M. 1103A(b)(4)(B)(ii) and prior to R.C.M. 1103A(b)(4)(C) and reads as follows:

    “For disclosure procedures, see (b)(4)(C) of this rule.”

    (j) A new Discussion is inserted immediately following R.C.M. 1103A(b)(4)(C)(ii) and prior to R.C.M. 1103A(b)(4)(D) and reads as follows:

    “In general, the Judge Advocate General or an appellate court should authorize disclosure of sealed material when such disclosure is necessary for review. Authorizations may place conditions on disclosure.”

    Section 6. The Discussion to Part III of the Manual for Courts-Martial, United States, is amended as follows: (a) A new Discussion is inserted immediately after Mil. R. Evid. 506(b) and before Mil. R. Evid. 506(c) and reads as follows:

    “For additional procedures concerning information contained in safety investigations, consult Service regulations and DoD Instruction 6055.07, “Mishap Notification, Investigation, Reporting, and Record Keeping.” ”

    Dated: November 22, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-28630 Filed 11-28-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Defense Health Board; Notice of Federal Advisory Committee Meeting AGENCY:

    Department of Defense (DoD).

    ACTION:

    Notice of Federal Advisory Committee meeting.

    SUMMARY:

    The Department of Defense is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Health Board (DHB) Health Care Delivery Subcommittee will take place.

    DATES:

    Wednesday, December 14, 2016 8:00 a.m.-12:00 p.m. (Preparatory Session) 12:00 p.m.-2:00 p.m. (Open Session) 2:00 p.m.-3:00 p.m. (Preparatory Session) ADDRESSES:

    Defense Health Headquarters (DHHQ), Pavilion Salon A, 7700 Arlington Blvd., Falls Church, Virginia 22042 (escort required; see guidance in SUPPLEMENTARY INFORMATION, “Public's Accessibility to the Meeting”).

    FOR FURTHER INFORMATION CONTACT:

    The Executive Director (Acting) of the Defense Health Board is CAPT Juliann Althoff, 7700 Arlington Boulevard, Suite 5101, Falls Church, Virginia 22042, (703) 681-6653, Fax: (703) 681-9539, [email protected]. For meeting information, please contact Ms. Kendal Brown, 7700 Arlington Boulevard, Suite 5101, Falls Church, Virginia 22042, [email protected], (703) 681-6670, Fax: (703) 681-9539.

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.

    Electronic registration is available at the following link: http://www.surveygizmo.com/s3/3191755/December-14-Meeting-Registration.

    Purpose of the Meeting

    The purpose of the meeting is for the Health Care Delivery Subcommittee members to receive public comments concerning pediatric health care services during an open forum. The Subcommittee is examining opportunities to improve the overall provision of health care and related services for children of members of the Armed Forces to better promote the health of this beneficiary population and potentially realize cost savings for the Military Health System. The focus of this meeting will be on the primary and specialty care aspects of the tasking (excluding behavioral/mental health care) to the Subcommittee as outlined below:

    • Identify the extent to which children receive developmentally appropriate and age appropriate health care services, including clinical preventive services, in both the direct care and purchased care components.

    • Evaluate whether children have ready access to primary and specialty pediatric care.

    • Address any issues associated with the TRICARE definition of “medical necessity” as it might specifically pertain to children and determine if the requirement for TRICARE to comply with Medicare standards disadvantages children from receiving needed health care.

    Comments from the public can range from insight on pediatric-related health issues to personal accounts and objective input.

    Agenda

    Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165 and subject to availability of space, the DHB Health Care Delivery Subcommittee meeting is open to the public from 12:00 p.m. to 2:00 p.m. on December 14, 2016. The DHB Health Care Delivery Subcommittee anticipates receiving public comments on pediatric-related health services issues. The DFO, in conjunction with the Subcommittee Chair, may restrict speaking time per person to an estimated 3-5 minutes. Additional comments, however, may be submitted in writing (see guidance in this SUPPLEMENTARY INFORMATION, “Written Statements” section). Any changes to the agenda can be found at the link provided in this SUPPLEMENTARY INFORMATION section.

    Availability of Materials for the Meeting

    A copy of the agenda or any updates to the agenda for the December 14, 2016 meeting, as well as any other materials presented in the meeting, may be obtained at the meeting.

    Public's Accessibility to the Meeting

    Pursuant to 5 U.S.C. 552b, and 41 CFR 102-3.140 through 102-3.165 and subject to availability of space, this meeting is open to the public. Seating is limited and is on a first-come basis. All members of the public who wish to attend the public meeting must contact Ms. Kendal Brown at the number listed in the section FOR FURTHER INFORMATION CONTACT no later than 12:00 p.m. on Thursday, December 8, 2016 to register and make arrangements for a DHHQ escort, if necessary. Public attendees requiring escort should arrive at the DHHQ Visitor's Entrance with sufficient time to complete security screening no later than 11:30 a.m. on December 14. To complete security screening, please come prepared to present two forms of identification, one of which must be a picture identification card.

    Special Accommodations

    Individuals requiring special accommodations to access the public meeting should contact Ms. Kendal Brown at least five (5) business days prior to the meeting so that appropriate arrangements can be made.

    Written Statements

    Any member of the public wishing to provide comments to the DHB Health Care Delivery Subcommittee may do so in accordance with section 10(a)(3) of the Federal Advisory Committee Act, 41 CFR 102-3.105(j) and 102-3.140, and the procedures described in this notice.

    Individuals desiring to provide comments to the DHB Health Care Delivery Subcommittee may do so by submitting a written statement to the DHB Designated Federal Officer (DFO) (see FOR FURTHER INFORMATION CONTACT). Written statements should not be longer than two type-written pages and address the following details: The issue, discussion, and a recommended course of action. Supporting documentation may also be included, as needed, to establish the appropriate historical context and to provide any necessary background information.

    If the written statement is not received at least five (5) business days prior to the meeting, the DFO may choose to postpone consideration of the statement until the next open meeting.

    The DFO will review all timely submissions with the Subcommittee Chair and ensure they are provided to members of the Health Care Delivery Subcommittee before the meeting that is subject to this notice. After reviewing the written comments, the Subcommittee Chair and the DFO may choose to invite the submitter to orally present their issue during an open portion of this meeting or at a future meeting. The DFO, in consultation with the Subcommittee Chair, may allot time for members of the public to present their issues for review and discussion by the Health Care Delivery Subcommittee.

    Dated: November 23, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-28674 Filed 11-28-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Army, U.S. Army Corps of Engineers Withdrawal of Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Lower Passaic River Ecosystem Restoration Project, Essex, Hudson, Passaic, and Bergen Counties, NJ: Feasibility Phase AGENCY:

    Department of the Army, U.S. Army Corps of Engineers, DoD.

    ACTION:

    Notice of Intent; Withdrawal.

    SUMMARY:

    The U.S. Army Corps of Engineers, New York District (NY District), is withdrawing its intent to prepare a Draft Environmental Impact Statement (EIS) for the Study. The Notice of Intent to prepare the Draft EIS was published in the Tuesday, December 28, 2004 issue of the Federal Register (69 FR 77744).

    ADDRESSES:

    U.S. Army Corps of Engineers, New York District, Planning Division, Environmental Analysis Branch, 26 Federal Plaza, Room 2151, New York, NY 10278-0090.

    FOR FURTHER INFORMATION CONTACT:

    Diana Kohtio, Project Biologist, at [email protected] or 917.790.8619.

    SUPPLEMENTARY INFORMATION:

    The U.S. Army Corps of Engineers, NY District published a notice of intent to prepare a Draft Environmental Impact Statement in the December 28, 2004 issue of the Federal Register (FR Doc. 2004-28332). In an effort to streamline work in early 2015, the U.S. Army Corps of Engineers, New York District, consolidated multiple parallel USACE ecosystem restoration feasibility studies into the Hudson Raritan Estuary Ecosystem Restoration Feasibility Study (HRE) Study.

    This streamlining is consistent with the Civil Works Transformation Initiative and Specific, Measurable, Attainable, Risk Informed, Timely (SMART) Planning principles, and maximizes efficiencies, resources and benefits. The other feasibility studies include:

    • HRE—Lower Passaic River Ecosystem Restoration Feasibility Study;

    • HRE—Hackensack Meadowlands Ecosystem Restoration Feasibility Study;

    • Flushing Creek and Bay Ecosystem Restoration Feasibility Study;

    • Bronx River Basin Ecosystem Restoration Feasibility Study;

    • Jamaica Bay, Marine Park, Plumb Beach Ecosystem Restoration Feasibility Study.

    As such, a Draft EIS is no longer necessary. Each Feasibility Study was at a different stage prior to the decision to consolidate into the HRE Feasibility Report/Environmental Assessment (FR/EA). The planning was conducted independently with their non-federal sponsor and resulted in the selection of specific recommendations within each watershed. These combined efforts resulted in the recommendations included in the broader HRE FR/EA. The HRE FR/EA will be prepared and circulated for review by agencies and the public. The New York District invites participation and consultation of agencies and individuals that have special expertise, legal jurisdiction, or interest in the preparation of the draft environmental assessment. Comments received, including the names and addresses of those who comment, will be considered part of the public record for this proposal. As a result of the process, if it is determined that the project may have significant impacts, the EIS process will be reinitiated and a NOI published.

    Peter Weppler, Chief, Environmental Analysis Branch.
    [FR Doc. 2016-28730 Filed 11-28-16; 8:45 am] BILLING CODE 3720-58-P
    DEPARTMENT OF DEFENSE Department of the Army, U.S. Army Corps of Engineers Withdrawal of Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Hackensack Meadowlands Ecosystem Restoration Project, Hackensack Meadowlands District, Bergen and Hudson Counties, NJ: Feasibility Phase AGENCY:

    U.S. Army Corps of Engineers, Department of the Army, DoD.

    ACTION:

    Notice of intent; withdrawal.

    SUMMARY:

    The U.S. Army Corps of Engineers, New York District (NY District), is withdrawing its intent to prepare a Draft Environmental Impact Statement (EIS) for the Study. The Notice of Intent to prepare the Draft EIS was published in the Tuesday, December 28, 2004 issue of the Federal Register (69 FR 77744).

    ADDRESSES:

    U.S. Army Corps of Engineers, New York District, Planning Division, Environmental Analysis Branch, 26 Federal Plaza, Room 2151, New York, NY 10278-0090.

    FOR FURTHER INFORMATION CONTACT:

    Diana Kohtio, Project Biologist, at [email protected] or 917.790.8619.

    SUPPLEMENTARY INFORMATION:

    The U.S. Army Corps of Engineers, NY District published a notice of intent to prepare a Draft Environmental Impact Statement in the December 28, 2004 issue of the Federal Register (FR Doc. 2004-28331). In an effort to streamline work in early 2015, the U.S. Army Corps of Engineers, New York District, consolidated multiple parallel USACE ecosystem restoration feasibility studies into the Hudson Raritan Estuary Ecosystem Restoration Feasibility Study (HRE) Study.

    This streamlining is consistent with the Civil Works Transformation Initiative and Specific, Measurable, Attainable, Risk Informed, Timely (SMART) Planning principles, and maximizes efficiencies, resources and benefits. The other feasibility studies include:

    • HRE—Lower Passaic River Ecosystem Restoration Feasibility Study;

    • HRE—Hackensack Meadowlands Ecosystem Restoration Feasibility Study;

    • Flushing Creek and Bay Ecosystem Restoration Feasibility Study;

    • Bronx River Basin Ecosystem Restoration Feasibility Study;

    • Jamaica Bay, Marine Park, Plumb Beach Ecosystem Restoration Feasibility Study.

    As such, a Draft EIS is no longer necessary. Each Feasibility Study was at a different stage prior to the decision to consolidate into the HRE Feasibility Report/Environmental Assessment (FR/EA). The planning was conducted independently with their non-federal sponsor and resulted in the selection of specific recommendations within each watershed. These combined efforts resulted in the recommendations included in the broader HRE FR/EA. The HRE FR/EA will be prepared and circulated for review by agencies and the public. The New York District invites participation and consultation of agencies and individuals that have special expertise, legal jurisdiction, or interest in the preparation of the draft environmental assessment. Comments received, including the names and addresses of those who comment, will be considered part of the public record for this proposal. As a result of the process, if it is determined that the project may have significant impacts, the EIS process will be reinitiated and a NOI published.

    Peter Weppler, Chief, Environmental Analysis Branch.
    [FR Doc. 2016-28729 Filed 11-28-16; 8:45 am] BILLING CODE 3720-58-P
    DEPARTMENT OF DEFENSE Department of the Navy Notice of Intent To Grant Exclusive Patent License; Anasys Instruments AGENCY:

    Department of the Navy, DoD.

    ACTION:

    Notice.

    SUMMARY:

    The Department of the Navy hereby gives notice of its intent to grant to Anasys Instruments, a revocable, nonassignable, exclusive license to practice in the field of use of photo-thermal infrared spectroscopy and microscopy of solids, liquids, and gases in the United States, the Government-owned inventions described in U.S. Patent No. 9,091,594: Chemical Mapping Using Thermal Microscopy at the Micro and Nano Scales, Navy Case No. 101,493 and U.S. Patent Application No. 14/748,430: Chemical Mapping Using Thermal Microscopy at the Micro and Nano Scales, Navy Case No. 101,493 and any continuations, divisionals or re-issues thereof.

    DATES:

    Anyone wishing to object to the grant of this license must file written objections along with supporting evidence, if any, not later than December 14, 2016.

    ADDRESSES:

    Written objections are to be filed with the Naval Research Laboratory, Code 1004, 4555 Overlook Avenue SW., Washington, DC 20375-5320.

    FOR FURTHER INFORMATION CONTACT:

    Charles Steenbuck, Acting Head, Technology Transfer Office, NRL Code 1004, 4555 Overlook Avenue SW., Washington, DC 20375-5320, telephone 202-767-3083. Due to U.S. Postal delays, please fax 202-404-7920, email: [email protected] or use courier delivery to expedite response.

    Authority:

    35 U.S.C. 207, 37 CFR part 404.

    Dated: November 22, 2016. C.D. Mora, Commander, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer.
    [FR Doc. 2016-28676 Filed 11-28-16; 8:45 am] BILLING CODE 3810-FF-P
    DEPARTMENT OF EDUCATION National Advisory Council on Indian Education Meeting Notice AGENCY:

    National Advisory Council on Indian Education (NACIE), U.S. Department of Education.

    ACTION:

    Announcement of closed video/teleconference meetings.

    SUMMARY:

    This notice sets forth the schedule of an upcoming closed meeting of NACIE. Notice of the meeting is required by Section 10(a)(2) of the Federal Advisory Committee Act. In order to ensure there are sufficient members in attendance to meet the quorum requirement, this notice is being published in less than 15 calendar days prior to the scheduled meeting dates.

    DATES:

    The NACIE video/teleconference meetings will be held on November 29, 2016 and November 30, 2016, from 1:00 p.m.-4:00 p.m. Eastern Daylight Saving Time.

    FOR FURTHER INFORMATION CONTACT:

    Tina Hunter, Designated Federal Official, Office of Elementary and Secondary Education, U.S. Department of Education, 400 Maryland Avenue SW., Washington, DC 20202. Telephone: 202-205-8527. Fax: 202-205-0310.

    SUPPLEMENTARY INFORMATION:

    NACIE's Statutory Authority and Function: NACIE is authorized by Section 6141 of the Elementary and Secondary Education Act of 1965 (ESEA), as amended by the Every Student Succeeds Act (ESSA), 20 U.S.C. 7471. NACIE is governed by the provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2, which sets forth requirements for the formation and use of advisory committees. NACIE is established within the Department of Education (Department) to advise the Secretary of Education (Secretary) on the funding and administration (including the development of regulations, and administrative policies and practices) of any program over which the Secretary has jurisdiction and that includes Indian children or adults as participants or that may benefit Indian children or adults, including any program established under Title VI, Part A of the ESEA. NACIE also makes recommendations to the Secretary for filling the position of Director of Indian Education whenever a vacancy occurs. Finally, NACIE submits to the Congress, not later than June 30 of each year, a report on the activities of NACIE, including recommendations that NACIE considers appropriate for the improvement of Federal education programs that include Indian children or adults as participants, or that may benefit Indian children or adults, and recommendations concerning the funding of any such program.

    Meeting Agenda: The purpose of the meetings is to discuss recommendations for the Secretary for filling the recently vacated position of Director of Indian Education. NACIE's discussions during the closed meetings will pertain solely to internal personnel rules and practices of an agency and information of a personal nature where disclosure would constitute a clearly unwarranted invasion of personal privacy. As such, the discussions are protected by exemptions 2 and 6 of Section 552b(c) of Title 5 of the United States Code.

    Access to Records of the Meeting: The Department will post a closed meeting report on NACIE's Web site.

    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 Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site. You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Ary Amerikaner, Deputy Assistant Secretary, Delegated the Duties of Assistant Secretary for Elementary and Secondary Education.
    [FR Doc. 2016-28713 Filed 11-28-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Western Area Power Administration Final 2025 Salt Lake City Area Integrated Projects Power Marketing Plan AGENCY:

    Western Area Power Administration, Department of Energy (DOE).

    ACTION:

    Notice of the Final 2025 Power Marketing Plan for the Salt Lake City Area Integrated Projects.

    SUMMARY:

    Western Area Power Administration (WAPA), Colorado River Storage Project Management Center (CRSP MC), a Federal power marketing agency of the Department of Energy, announces the Final 2025 Power Marketing Plan (2025 Marketing Plan) for the Salt Lake City Area Integrated Projects (SLCA/IP). The Post-1989 General Power Marketing and Allocation Criteria (Post-1989 Plan), February 7, 1986, as extended June 25, 1999, will expire on September 30, 2024. After consideration of the public comments received, WAPA has decided to implement the Proposed 2025 Marketing Plan with the exception that WAPA will not create a new, 2-percent resource pool for potential new customers. This Federal Register notice is published to announce WAPA's decision for the Final 2025 Marketing Plan, respond to the comments received on the Proposed 2025 Marketing Plan, and specify the terms and conditions under which WAPA will market SLCA/IP firm hydroelectric resources beginning October 1, 2024.

    DATES:

    The 2025 Marketing Plan will become effective December 29, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Parker Wicks, Public Utilities Specialist, or Mr. Steve Mullen, Public Utilities Specialist, Western Area Power Administration, CRSP Management Center, 150 East Social Hall Avenue, Suite 300, Salt Lake City, UT 84111-1580, telephone (801) 524-5493, or email to [email protected]. Information can also be found at https://www.wapa.gov/regions/CRSP/PowerMarketing/Pages/power-marketing.aspx.

    SUPPLEMENTARY INFORMATION:

    Brief descriptions of the projects included in the SLCA/IP are provided below:

    Colorado River Storage Project (CRSP)

    Authorized by Congress in 1956, the CRSP and participating projects initiated the comprehensive development and use of water resources of the Upper Colorado River. The CRSP is comprised of the Glen Canyon, Flaming Gorge, Blue Mesa, Crystal, and Morrow Point dams and powerplants. CRSP storage units stabilize the erratic flows of the Colorado River and its tributaries so annual water delivery commitments to the Lower Colorado River Basin, as well as to farmers, municipalities, and industries in the Upper Basin, can be met. Delivery of this water to consumers is accomplished, in part, through the participating projects discussed below, and additional project development may occur in future years. Initial hydroelectric generation began at the CRSP facilities in 1963. The maximum operating capacity of the five original CRSP powerplants is currently approximately 1,760 MW. The average annual generation from 1994 through 2014 was approximately 5,208,238 MWh.

    Participating Projects

    Seedskadee Project (Fontenelle Powerplant): The Seedskadee Project is in the Upper Green River Basin in southwestern Wyoming. The Fontenelle Dam, powerplant, and reservoir are the principal features of the Seedskadee Project. The powerplant commenced operation in May 1968. The maximum operating capacity of Fontenelle Powerplant is 10 MW. The average annual generation from 1994-2014 was 53,477 MWh.

    Dolores Project (McPhee Dam and Towaoc Canal Powerplants): The Dolores Project was authorized by the Colorado River Basin Act of September 30, 1968, as a participating project under the CRSP Act. The maximum operating capacity of the two powerplants is 12.8 MW, and the combined average annual output of McPhee Dam and Towaoc Canal powerplants from 1994-2014 was 18,161 MWh.

    Integrated Projects

    WAPA consolidated and operationally integrated the Collbran and Rio Grande projects with CRSP beginning on October 1, 1987. These integrated projects have retained their separate financial obligations for repayment; however, the SLCA/IP rate is set to recover revenues to meet the repayment requirements of all projects. The maximum operating capacity of the eleven SLCA/IP powerplants is 1,818.6 MW, and the average annual generation from 1994-2014 was about 5,635,057 MWh. The SLCA/IP resources are currently marketed to approximately 135 long-term customers, and many more electric service providers benefit from this power indirectly through parent organizations that are direct customers of the SLCA/IP. Existing SLCA/IP contracts will terminate at the end of the September 2024 billing period.

    Collbran Project (Upper Molina and Lower Molina Powerplants): The Colbran Project was authorized in 1952 and has been in service since 1962. The maximum operating capacity of the two powerplants is presently 13.5 MW. The average annual generation from 1994-2014 was 41,915 MWh.

    Rio Grande Project (Elephant Butte Powerplant): The Rio Grande Project was authorized in 1905, and the powerplant went into service in 1940. The maximum operating capacity of the Elephant Butte Powerplant is 27.0 MW. The average annual generation was 66,743 MWh from 1994-2014.

    Background Information

    The Post-1989 Plan provided the power marketing principles used to market what is now referred to as the SLCA/IP firm hydropower resources. The Firm Electric Service (FES) contracts associated with the Post-1989 Plan were initially set to expire October 1, 2004, and were extended to September 30, 2024.

    WAPA published its Proposed 2025 Marketing Plan, 80 FR 78222 (December 16, 2015), and held a Public Information Forum on January 14, 2016, in Salt Lake City, Utah, and a Public Comment Forum on February 17, 2016, in Salt Lake City, Utah, to provide the public an opportunity to submit comments. During these meetings, the CRSP MC announced it would complete and post a preliminary determination of the 2025 SLCA/IP Marketable Resource, which would help determine if WAPA would offer a 2-percent New Customer Power Pool, as proposed. WAPA extended the comment period, 81 FR 17163 (March 28, 2016), to May 31, 2016, to allow customers the opportunity to comment on the analysis and to make additional comments about the Proposed 2025 Marketing Plan. On May 10, 2016, the CRSP MC posted notice on its Web site that, based on its Analysis of Potential Marketable Resource, insufficient sustainable hydro power (SHP) energy existed to offer a New Customer Power Pool.

    WAPA received oral comments at the public comment forum as well as 18 written comment letters during the comment period. WAPA's responses to the comments received are included in this notice.

    Response to Comments Received on the Proposed 2025 Marketing Plan Right to Re-Evaluate Allocations and Contract Term

    Comment: Commenters supported a 40-year contract term for FES contracts. Several commenters did not support the concept of a reopener, or re-evaluation, at a 20-year interval during the contract period. Several commenters supported a 20-year contract term with an automatic right of renewal for an additional 20 years, without resource reduction considerations, if favorable hydrology exists.

    Response: In 2017, WAPA will begin the process of offering new FES contracts with a 40-year length of contract. However, depending on when contracts are actually negotiated and offered for signature, the period of performance may be less than 40 years. For example, a new contract executed in January 2017 would be let for 40 years and terminate in January 2057, while the period of performance and delivery of firm electric service would be approximately 33 years—as the existing contract remains in effect until September 30, 2024. This is due entirely to the 40-year limit to both length of contract and period of performance established by the Reclamation Project Act of 1939. Moreover, WAPA agrees with commenters and will not offer allocations for the first 20 years and then require a re-evaluation of the allocations later. WAPA will work with its customers to ensure that the FES contracts provide sufficient flexibility to address issues of changing hydrology or resource availability.

    New Resource Pool

    Comment: Several commenters opposed the creation of a 2-percent resource pool for new customers. Several commenters supported the creation of a new resource pool only if power is available without reduction to existing Post-1989 Plan customers and only for the benefit of tribal customers not already receiving SLCA/IP power.

    Response: Modeling of SLCA/IP resources by the CRSP MC indicates there is no additional marketable capacity and energy available. WAPA will not offer a new customer resource pool under the 2025 Marketing Plan.

    Hydropower Allocation to Tribe Served by SLCA/IP Customer

    Comment: A Native American tribe stated that it did not receive an allocation during WAPA's prior remarketing, but instead receives the benefits of the hydropower allocation through its local electric cooperative. The tribe stated that Indian self-determination must be furthered and WAPA should recognize that the benefits of receiving Federal preference power may potentially be greater for smaller tribes. The tribe requested WAPA consider allocating directly to the tribe.

    Response: WAPA does not have additional marketable capacity and energy to create an allocation for new customers. However, WAPA will work directly with the tribe to ensure Indian self-determination is furthered at all levels through whatever means WAPA has available—such as discussing arrangements made with the tribe's servicing utility.

    Request for Additional Resources

    Comment: A commenter requested an increase in the amount of energy it receives to meet its growing loads and also stated that additional energy should be provided to correct for load factor issues.

    Response: WAPA is unable to provide additional energy because modeling of SLCA/IP resources indicate there is no additional marketable capacity and energy available. WAPA will extend the seasonal firm capacity allocations, referenced in the FES contracts as the Contract Rate of Delivery (CROD), along with the associated seasonal energy allocations, to the existing SLCA/IP firm power customers.

    Priority of Preference in Proposed 2025 Marketing Plan

    Comment: Request for clarification on priority consideration for entities satisfying the marketing criteria.

    Response: WAPA will not offer a new customer resource pool under the 2025 Marketing Plan; but to reiterate the clarification given during the comment period, priority consideration for the 2-percent resource pool for potential new customers under the Proposed Marketing Plan would have been provided in the following order: (A) Federally recognized Native American tribes; (B) Municipal corporations and political subdivisions, including irrigation or other districts, municipalities, and other governmental organizations, electric cooperatives and public utilities, other than electric utilities, that are recognized as utilities by their applicable legal authorities, are nonprofit in nature, have electrical facilities, and are independently governed and financed; (C) Other eligible applicants.

    Distribution of Additional Resources

    Comment: Should an increase in SLCA/IP resources ever occur, several commenters supported a pro-rata distribution of any additional resources to existing customers while several other commenters supported prioritizing new tribal customers over new non-tribal customers.

    Response: If additional marketable resources become available, WAPA will determine, through appropriate procedures and in consultation with its customers, how to allocate those additional resources. Moreover, WAPA will work with its customers to ensure that the FES contracts provide sufficient flexibility to address issues with changing hydrology or resource availability.

    Marketing Area

    Comment: Several commenters supported the Post-1989 Plan marketing area and requested WAPA make no changes to the Northern and Southern Division areas.

    Response: WAPA concurs and will preserve the Post-1989 Plan marketing area. No changes will be made to the Northern and Southern Division areas in the 2025 Marketing Plan.

    Adjustment of Contract Rate of Delivery

    Comment: Several commenters do not support an overall reduction in the contracted customer shares, at any time. Several commenters support WAPA having the right to adjust the CROD and associated energy on 5 years written notice, provided WAPA collaborates and meets with Preference Customers prior to giving any such notice.

    Response: WAPA will reserve the right to adjust, through appropriate procedures and in consultation with its customers, the CROD on 5 years advance written notice in response to changes in hydrology and river operations.

    Service Seasons

    Comment: Several commenters support using the SLCA/IP definition currently implemented for the Winter Season (October-March) and Summer Season (April-September). One commenter supports the flexibility to determine monthly energy patterns within its seasonal allocation.

    Response: WAPA will continue the use of existing summer and winter seasons and work with its customers to determine if monthly energy allocation patterns could be adjusted within a season to better match customer needs and hydropower availability.

    Replacement Power

    Comment: Several commenters indicated support for the capacity replacements programs currently in place through Customer Displacement Power (CDP) and Western Replacement Power (WRP) programs.

    Response: WAPA appreciates the commenters' support for the CDP and WRP programs. The 2025 Marketing Plan FES contracts will continue to include CDP and WRP programs.

    Transmission Availability for Replacement Power

    Comment: Several commenters support the sale of unused firm transmission on a non-firm basis when that capacity is not used to deliver customer allocations or customer CDP/WRP so long as any revenue generated from such sales is applied in order to reduce the rate for CRSP customers.

    Response: WAPA will continue to include all projected revenues during the rate calculation process. Unused transmission will be made available per the Open Access Transmission Tariff (OATT) when that capacity is not needed for delivery of WRP, CDP, or the customers' allocations.

    Use of Renewables

    Comment: Has WAPA considered the use of renewable energy to make up for the loss of hydropower to Post-2025 customers?

    Response: WAPA has considered the use of renewable energy as firming resources in the past and will in the future. If WAPA experiences a projected decrease in marketable hydropower resources, it will consider firming purchases from available resources, including renewables, in accordance with its power marketing authority. However, no such decrease is currently projected. WAPA has a long-term purchase power policy, as set forth in 10 CFR part 905—subpart E, whereby WAPA will develop criteria to consider long-term power purchases, which can include renewable resources, to meet long-term resource needs. Any long-term resource acquisition would be made in close consultation with the customers.

    Renewable Energy Credits

    Comment: CRSP customers should receive Renewable Energy Credits (REC) in manner consistent with the Loveland Area Projects (LAP) REC program.

    Response: Consistent with WAPA's REC policy, the SLCA/IP generating units are registered with Western Renewable Energy Generation Information System (WREGIS), and the CRSP MC uploads monthly generation data. The monthly generation loaded into the WREGIS system creates one REC for every megawatthour of energy produced. Based on the amount generated from SLCA/IP hydropower facilities during the preceding calendar year, REC are dispersed annually to each customer proportionally based on its SLCA/IP allocation. Unlike the LAP, there is no special consideration for the smaller hydro facilities versus the large facilities. However, future changes to the REC distribution policy can be discussed with the customers for possible implementation.

    Extension of Existing Contracts

    Comment: Several commenters support the extension of the customers' existing CROD allocations for the contract term. Several commenters suggested customers should be offered amended and restated contracts, developed with appropriate diligence and expedience, to extend the existing contracts at the existing CROD and associated energy commitments.

    Response: WAPA will offer new contracts that maintain the CROD allocations, with associated energy, to the existing SLCA/IP FES customers. WAPA will not offer amended and restated contracts, but will work with existing FES customers to develop a new contract.

    Contract Development and Implementation

    Comment: Draft contracts should be developed with appropriate diligence and expedience and with minimal changes from the existing contract terms and conditions. Customer meetings to discuss the draft contracts should be limited and follow a formal process that includes notice and comment periods of reasonable duration and additional agency/customer/applicant dialogue on an individualized basis unless such topics advance to affect broader customer interests.

    Response: WAPA will collaborate with the FES customers on contract development while not impacting timely contract implementation. WAPA will provide timely notice and allow for reasonable periods of informal review and comments in order to facilitate customer participation.

    General Power Contract Provisions

    Comment: Several commenters support the continued use of the current General Power Contract Provisions (GPCP), dated September 1, 2007, for the proposed contract.

    Response: While specific contract provisions are outside of the 2025 Marketing Plan, WAPA intends to use the GPCP dated September 1, 2007.

    Creditworthiness Procedures

    Comment: The inclusion of “creditworthiness” provisions in new FES contracts was not supported by commenters since the existing customers have a demonstrated history of paying WAPA timely, and no basis exists for WAPA to justify insertion of this type of provision.

    Response: Specific contractual provisions such as creditworthiness provisions are beyond the scope of the 2025 Marketing Plan. However, existing WAPA policy requires creditworthiness provisions in FES contracts and it is the intent of CRSP to include them in its FES contracts.

    Customer Profile Data

    Comment: Only new customers should submit customer profile data; existing customers should not be required to submit customer profile data or applications for power.

    Response: WAPA concurs and no customer load profile data or applications will be required from existing customers. Furthermore, there will be no new customers because modeling of SLCA/IP resources indicate there is no additional marketable capacity and energy available.

    Methods Report

    Comment: Commenters questioned some of the methodologies and assumptions WAPA made in determining the availability of future hydropower generation, as explained in the Methodology for SLCA/IP Resource Analysis for Consideration in the Development of the 2025 Marketing Plan (Methods Report). These commenters questioned the use of certain hydrologic traces, particular assumptions about weekend versus weekday load patterns, and requested that only the current operating criteria be used for modeling purposes.

    Response: WAPA appreciates the interest and review of its Methods Report. After reviewing the comments, WAPA does not believe the items questioned would affect its decision to use the existing power and energy commitments in the 2025 Marketing Plan because these would result in only minimal changes to the modeling results.

    Hydropower Production Scenarios

    Comment: Several commenters support WAPA proposing a variety of Marketing Plan approaches that address differing hydroelectric power production scenarios. Several commenters noted WAPA's reliance on a specific Department of the Interior (DOI) proposed Environmental Impact Statement (EIS) methodology in WAPA's resource analysis and urged WAPA to avoid reliance on any specific environmental-mitigation proposal in advance of any final DOI decision on that matter.

    Response: There are various impacts to hydropower availability such as drought, maintenance issues, transmission availability, and water delivery requirements in addition to operational changes made to mitigate potential environmental impacts. WAPA will continue to work with its customers to ensure that the FES contracts provide sufficient flexibility to address issues with changing hydrology and resource availability. For the Long-term Experimental and Management Plan (LTEMP) EIS, DOI has identified a preferred alternative, and WAPA is using this alternative for planning purposes only. If DOI implements a Glen Canyon Dam operation that significantly differs from the preferred alternative, WAPA will consider a change to its 2025 Marketing Plan.

    Modeling of Marketable Resources

    Comment: Several commenters requested information describing the fundamental differences among GTMax, GTMax Lite, and GTMax Superlite v1 software platforms WAPA used to model hydropower.

    Response: The GTMax model uses an older platform and architecture, which can only model 1 year at a time—under a single hydrological condition. GTMax Lite performs the same functions as GTMax but only simulates hydropower operations at Glen Canyon Dam rather than all of the CRSP facilities. This allows for various operational scenarios at Glen Canyon Dam to be modeled quickly. The GTMax Superlite model used by WAPA to model hydropower availability has all of the features and capabilities of the full GTMax model. The advantage of using GTMax Superlite for the 2025 Marketing Plan study is that it allows simulation and optimization of decades of operations, under numerous hydrological conditions, in a relatively short amount of time.

    Final 2025 Power Marketing Plan and Marketing Criteria

    WAPA's 2025 Marketing Plan will provide the existing CROD commitments with associated energy to current SLCA/IP FES customers as set forth in the existing FES contracts, which implemented the Post-1989 General Power Marketing Criteria and Post-2004 PMI. The 2025 Marketing Plan principles are as follows:

    Final 2025 Marketing Plan Principles

    1. Contract Term: The maximum 40-year contract term, as provided for in the Reclamation Project Act of 1939, will be used for FES contracts.

    2. Existing Marketable Resource: WAPA will extend the CROD commitments with associated energy to the existing SLCA/IP FES customers as set forth in the existing FES contracts, which implemented the Post-1989 General Power Marketing Criteria and Post-2004 PMI.

    3. New Resource Pool: Modeling of SLCA/IP resources by WAPA indicates there is no additional marketable capacity and energy available. WAPA will not establish a new customer resource pool under the 2025 Marketing Plan.

    4. Firm Electric Service Contract Provisions: Existing SLCA/IP FES contracts will serve as the basis for new FES contracts. CDP and WRP contract provisions will be included in the new FES contracts.

    5. Benefit Crediting Contracts: For those Native American tribes that do not operate their own electric utilities, Benefit Crediting Contracts will be available to deliver the benefit of the Federal hydropower allocation to those tribes.

    6. Marketing Area: The SLCA/IP marketing area remains unchanged, which is divided into Northern and Southern Divisions.

    A. The Northern Division consists of the states of Colorado, New Mexico, Utah, and Wyoming; the City of Page, Arizona; a portion of the area in Arizona which lies in the drainage area of the Upper Colorado River Basin to be served by the Navajo Tribal Utility Authority; and White Pine County and portions of Elko and Eureka counties in Nevada.

    B. The Southern Division consists of the remaining portion of the state of Arizona and that part of the state of Nevada in Clark, Lincoln, and Nye counties that comprise the southern portion of the state.

    7. Hydrology and River Operations Withdrawal Provision: WAPA will continue to reserve the right to adjust, at its discretion and sole determination, the CROD on 5 years advance written notice in response to changes in hydrology and river operations. Any such adjustments would occur after an appropriate public process.

    8. Service Seasons: Summer and winter seasons remain unchanged.

    A. Summer Season: The 6-month period from the first day of the April billing period through the last day of the September billing period in any calendar year.

    B. Winter Season: The 6-month period from the first day of the October billing period of any calendar year through the last day of the March billing period of the next succeeding calendar year.

    Availability of Information

    Documents developed or retained by WAPA during this public process will be available by appointment for inspection and copying at the CRSP MC, located at 150 East Social Hall Avenue, Suite 300, Salt Lake City, Utah. WAPA will post information concerning the Final 2025 Marketing Plan on its Web site at: https://www.wapa.gov/regions/CRSP/PowerMarketing/Pages/power-marketing.aspx.

    Procedural Requirements Environmental Compliance

    In compliance with the National Environmental Policy Act (NEPA) of 1969, 42 U.S.C. 4321, et seq., the Council on Environmental Quality Regulations for implementing NEPA, 40 CFR parts 1500 through 1508, and the Integrated DOE NEPA Implementing Procedures, 10 CFR part 1021, WAPA has determined this action is categorically excluded from the preparation of an environmental assessment or an EIS.

    Determination Under Executive Order 12866

    WAPA has an exemption from centralized regulatory review under Executive Order 12866; accordingly, no clearance of this notice by the Office of Management and Budget is required.

    Regulatory Flexibility Analysis

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601, et seq., requires a Federal agency to perform a regulatory flexibility analysis whenever the agency is required by law to publish a general notice of proposed rulemaking for any proposed rule, unless the agency can certify that the rule will not have a significant economic impact on a substantial number of small entities. In defining the term “rule,” the RFA specifies that a “rule” does not include “a rule of particular applicability relating to rates [and] services . . . or to valuations, costs or accounting, or practices relating to such rates [and] services . . . .” 5 U.S.C. 601. WAPA has determined that this action relates to rates or services offered by WAPA and, therefore, is not a rule within the purview of the RFA.

    Dated: November 18, 2016. Mark A. Gabriel, Administrator.
    [FR Doc. 2016-28690 Filed 11-28-16; 8:45 am] BILLING CODE 6450-01-P
    ENVIRONMENTAL PROTECTION AGENCY [Petition IV-2015-3; FRL-9955-79-Region 4] Clean Air Act Operating Permit Program; Petition for Objection to State Operating Permit for Tennessee Valley Authority—Bull Run (Anderson County, Tennessee) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of final order on petition to object to state operating permit.

    SUMMARY:

    The EPA Administrator signed an Order, dated November 10, 2016, granting petition to object to Clean Air Act (CAA) title V operating permit issued by the Tennessee Department of Environment and Conservation (TDEC) to the Tennessee Valley Authority (TVA) Bull Run facility located in Clinton, Anderson County, Tennessee. This Order constitutes a final action on the petition submitted by Sierra Club and Environmental Integrity Project (Petitioners) and received by EPA on September 29, 2015.

    ADDRESSES:

    Copies of the Order, the petition, and all pertinent information relating thereto are on file at the following location: EPA Region 4; Air, Pesticides and Toxics Management Division; 61 Forsyth Street SW.; Atlanta, Georgia 30303-8960. The Order is also available electronically at the following address: https://www.epa.gov/sites/production/files/2016-11/documents/tva_bull_run_order_granting_petition_to_object_to_permit_.pdf.

    FOR FURTHER INFORMATION CONTACT:

    Art Hofmeister, Air Permits Section, EPA Region 4, at (404) 562-9115 or [email protected]

    SUPPLEMENTARY INFORMATION:

    The CAA affords EPA a 45-day period to review and, as appropriate, the authority to object to operating permits proposed by state permitting authorities under title V of the CAA, 42 U.S.C. 7661-7661f. Section 505(b)(2) of the CAA and 40 CFR 70.8(d) authorize any person to petition the EPA Administrator to object to a title V operating permit within 60 days after the expiration of EPA's 45-day review period if EPA has not objected on its own initiative. Petitions must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the state, unless the petitioner demonstrates that it was impracticable to raise these issues during the comment period or the grounds for the issues arose after this period.

    Petitioners submitted a petition regarding the aforementioned TVA Bull Run facility, requesting that EPA object to the CAA title V operating permit (#01-0009/567519). Petitioners alleged that the permit was not consistent with the CAA because it lacks sufficient monitoring to assure compliance with the opacity limit established pursuant to Tennessee Comprehensive Rules & Regulations 1200-03-05-.01.

    On November 10, 2016, the Administrator issued an Order granting the petition. The Order explains EPA's rationale for granting the petition.

    Dated: November 18, 2016. Heather McTeer Toney, Regional Administrator, Region 4.
    [FR Doc. 2016-28742 Filed 11-28-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2013-0246; FRL—9955-81-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Information Requirements for New Marine Compression Ignition Engines at or Above 30 Liters per Cylinder (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency has submitted an information collection request (ICR), “Information Requirements for New Marine Compression Ignition Engines at or Above 30 Liters per Cylinder (Revision),” EPA ICR Number 2345.04, OMB Number 2060-00641, to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through November 30, 2016. Public comments were previously requested via the Federal Register (81 FR 65634) on September 23, 2016 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before December 29, 2016.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number Docket ID No. EPA-HQ-OAR-2013-0246, to (1) EPA online using www.regulations.gov (our preferred method), by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to [email protected] Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Nydia Yanira Reyes-Morales, Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Mail Code 6403J, Washington, DC 20460; telephone number: 202-343-9264; fax number: 202-343-2804; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information, visit http://www.epa.gov/dockets.

    Abstract: For this ICR, EPA is seeking a revision to an existing package with a three year extension. Title II of the Clean Air Act, (42 U.S.C. 7521 et seq.; CAA), charges the Environmental Protection Agency (EPA) with issuing certificates of conformity for those engines that comply with applicable emission standards. Such a certificate must be issued before engines may be legally introduced into commerce. Under this ICR, EPA collects information necessary to (1) issue certificates of compliance with emission statements, and (2) verify compliance with various programs and regulatory provisions pertaining to marine compression-ignition engines with a specific engine displacement at or above 30 liters per cylinder, also referred to as Category 3 engines. To apply for a certificate of conformity, manufacturers are required to submit descriptions of their planned production engines, including detailed descriptions of emission control systems and test data. This information is organized by “engine family” groups expected to have similar emission characteristics. There are recordkeeping requirements of up to eight years. The Act also mandates EPA to verify that manufacturers have successfully translated their certified prototypes into mass produced engines, and that these engines comply with emission standards throughout their useful lives.

    Under the Production Line Testing Program (“PLT Program”), manufacturers of Category 3 engines are required to test each engine at the sea trial of the vessel in which the engine is installed or within the first 300 hours of operation, whichever comes first. This self-audit program allows manufacturers to monitor compliance and minimize the cost of correcting errors through early detection. In addition, owners and operators of marine vessels with Category 3 engines must record certain information and send minimal annual notifications to EPA to show that engine maintenance and adjustments have not caused engines to be noncompliant. From time to time, EPA may test in-use engines to verify compliance with emission standards throughout the marine engine's useful life and may ask for information about the engine family to be tested.

    Proprietary information is kept confidential in accordance with the Freedom of Information Act (FOIA), EPA regulations at 40 CFR parts 2 and 1042.915, and class determinations issued by EPA's Office of General Counsel. Non-confidential business information may be disclosed as requested under FOIA. That information may be used by trade associations, environmental groups, and the public. Most of the information is collected in electronic format and stored in CD's databases.

    Form Numbers: 5900-90 (Annual Production Report); 5900-297 (PLT CumSum Report); 5900-298 (PLT Non-CumSum Report); 5900-124 (Application for Certification).

    Respondents/affected entities: Manufacturers, owners or operators of marine compression-ignition engines above 30 liters per cylinder and the vessels in which those engines are installed, within the following North American Industry Classification System (NAICS) codes: 333618 (Other Engine Equipment Manufacturing), 336611 (Manufacturers of Marine Vessels); 811310 (Engine Repair and Maintenance); 483 (Water transportation, freight and passenger).

    Respondent's obligation to respond: Required to obtain or retain a benefit. Manufacturers must respond to this collection if they wish to sell and/or operate their Category 3 engines in the US, as prescribed by Section 206(a) of the CAA (42 U.S.C. 7521) and 40 CFR part 1042. Certification reporting is mandatory (Section 206(a) of CAA (42 U.S.C. 7521) and 40 CFR part 1042, subpart C). PLT reporting is mandatory (Section 206(b)(1) of CAA and 40 CFR part 1042, subpart D).

    Estimated number of respondents: 201 (total).

    Frequency of response: Quarterly, Annually, On Occasion, depending on the type of response.

    Total estimated burden: 24,813 hours per year. Burden is defined at 5 CFR 1320.03(b).

    Total estimated cost: $2,012,094 (per year), includes an estimated $760,734 annualized capital or maintenance and operational costs.

    Changes in the Estimates: There is no change in the total estimated burden from the burden currently identified in the OMB Inventory of Approved ICR Burdens.

    Courtney Kerwin, Director, Regulatory Supprt Division.
    [FR Doc. 2016-28672 Filed 11-28-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2016-0630; FRL-9955-01] Agency Information Collection Activities; Proposed Renewal of EPA ICR No. 0616.12; Comment Request AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act (PRA), this document announces that EPA is planning to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). The ICR, entitled: “Compliance Requirement for Child-Resistant Packaging” and identified by EPA ICR No. 0616.12 and OMB Control No. 2070-0052, represents the renewal of an existing ICR that is scheduled to expire on July 31, 2017. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection that is summarized in this document. The ICR and accompanying material are available in the docket for public review and comment.

    DATES:

    Comments must be received on or before January 30, 2017.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2016-0630, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    Joe Hogue, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-9072; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), EPA specifically solicits comments and information to enable it to:

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

    2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

    3. Enhance the quality, utility, and clarity of the information to be collected.

    4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

    II. What information collection activity or ICR does this action apply to?

    Title: Compliance Requirement for Child-Resistant Packaging.

    ICR number: EPA ICR No. 0616.12.

    OMB control number: OMB Control No. 2070-0052.

    ICR status: This ICR is currently scheduled to expire on July 31, 2017. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the Code of Federal Regulations (CFR), after appearing in the Federal Register when approved, are listed in 40 CFR part 9, are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.

    Abstract: This information collection program is designed to provide the EPA with assurances that the packaging of pesticide products sold and distributed to the general public in the United States meets standards set forth by the Agency pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Registrants must certify to the Agency that the packaging or device meets these standards. Responses to the collection of information are mandatory. Section 25(c)(3) of FIFRA authorizes EPA to establish standards for packaging of pesticide products and pesticidal devices to protect children and adults from serious illness or injury resulting from accidental ingestion or contact. Unless a pesticide product qualifies for an exemption, if the product meets certain criteria regarding toxicity and use, it must be sold and distributed in child-resistant packaging. Compliance regulations are contained in 40 CFR part 157.

    Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 114 hours per response. Burden is defined in 5 CFR 1320.3(b).

    The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized here:

    Respondents/Affected Entities: Entities potentially affected by this ICR are entities involved in manufacturing of pesticide chemicals, wholesale merchandising of pesticide products, or pest management activities. The North American Industrial Classification System (NAICS) codes for respondents under this ICR include 325320 (Pesticide and other Agricultural Chemical Manufacturing), 424690 (Other Chemical and Allied Products Merchant Wholesalers), and 561710 (Exterminating and Pest Control Services).

    Estimated total number of potential respondents: 31.

    Frequency of response: On occasion.

    Estimated total average number of responses for each respondent: 1.

    Estimated total annual burden hours: 3,535 hours.

    Estimated total annual costs: $249,292. This includes an estimated burden cost of $249,292 and an estimated cost of $0 for capital investment or maintenance and operational costs.

    III. Are there changes in the estimates from the last approval?

    There is a decrease of 1,972 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This decrease reflects EPA's updating of burden estimates for this collection, including an increase in the estimated burden per response, and a decrease in the number of responses per year. This change is an adjustment.

    IV. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Authority:

    44 U.S.C. 3501 et seq.

    Dated: November 15, 2016. James Jones, Assistant Administrator, Office of Chemical Safety and Pollution Prevention.
    [FR Doc. 2016-28739 Filed 11-28-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2015-0393; FRL-9953-53] Registration Review; Draft Human Health and/or Ecological Risk Assessments; Notice of Availability AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the availability of EPA's draft human health and ecological risk assessments for the registration review of aliphatic esters, cyclanilide, cymoxanil, and certain other pesticides and opens a public comment period on these documents. This notice also announces both the opening of the registration review docket and the availability of the registration review draft human health and ecological risk assessments for aliphatic esters and momfluorothrin. EPA Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. As part of the registration review process, the Agency has completed comprehensive draft human health and/or ecological risk assessments for all uses of the pesticides herein. After reviewing comments received during the public comment period, EPA will issue a revised risk assessment, explain any changes to the draft risk assessment, and respond to comments and may request public input on risk mitigation before completing a proposed registration review decision for the pesticides herein. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.

    DATES:

    Comments must be received on or before January 30, 2017.

    ADDRESSES:

    Submit your comments, docket identification (ID) number EPA-HQ-OPP-2015-0393 by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    For pesticide specific information contact: The Chemical Review Manager for the pesticide of interest identified in Table 1 of Unit III.

    For general questions on the registration review program, contact: Richard Dumas, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8015; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this action apply to me?

    This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the Chemical Review Manager identified in Table 1 of Unit III.

    B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

    3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticide(s) discussed in this document, compared to the general population.

    II. Authority

    EPA is conducting its registration review of the chemicals listed in Table 1 of Unit III pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other things, that the registrations of pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with widespread and commonly recognized practice, the pesticide product must perform its intended function without unreasonable adverse effects on the environment; that is, without any unreasonable risk to man or the environment, or a human dietary risk from residues that result from the use of a pesticide in or on food.

    III. Registration Reviews

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide registration for the pesticides listed in Table 1 to ensure that it continues to satisfy the FIFRA standard for registration—that is, that these chemicals can still be used without unreasonable adverse effects on human health or the environment.

    Table 1-Draft Risk Assessments Being Made Available for Public Comment Registration review case name and No. Docket ID No. Contact and contact
  • information
  • Aliphatic Esters, 4005 EPA-HQ-OPP-2015-0084 Brian Kettl, [email protected], (703) 347-0535. Bifenthrin, 7402 EPA-HQ-OPP-2010-0384 Marquea King, [email protected], (703) 305-7432. Cyclanilide, 7018 EPA-HQ-OPP-2011-0153 Katherine St. Clair, stclair.kather[email protected], (703) 347-8778. Cyfluthrins (& beta), 7405 EPA-HQ-OPP-2010-0684 Garland Waleko, [email protected], (703) 308-8049. Cymoxanil, 7023 EPA-HQ-OPP-2012-0148 Moana Appleyard, [email protected], (703) 308-8175. Cypermethrin (alpha & zeta), 7218/2130 EPA-HQ-OPP-2012-0167 Susan Bartow, [email protected], (703) 603-0065. Cyphenothrin, 7412 EPA-HQ-OPP-2009-0842 Margaret Hathaway, [email protected], (703) 305-5076. D-phenothrin, 0426 EPA-HQ-OPP-2011-0539 James Parker, [email protected], (703) 306-0469.
  • Rachel Ricciardi, [email protected], (703) 347-0465.
  • Deltamethrin, 7414 EPA-HQ-OPP-2009-0637 Bilin Basu, [email protected], (703) 347-0455. Dimethomorph, 7021 EPA-HQ-OPP-2013-0045 Nathan Sell, [email protected], (703) 347-8020. Esfenvalerate, 7406 EPA-HQ-OPP-2009-0301 Marianne Mannix, [email protected], (703) 347-0275. Etofenprox, 7407 EPA-HQ-OPP-2007-0804 Wilhelmena Livingston, [email protected], (703) 308-8025. Fenpropathrin, 7601 EPA-HQ-OPP-2010-0422 Garland Waleko, [email protected], (703) 308-8049. Flumethrin, 7456 EPA-HQ-OPP-2016-0031 Maria Piansay, [email protected], (703) 308-8063. Gamma-cyhalothrin, 7437 EPA-HQ-OPP-2010-0479 Wilhelmena Livingston, [email protected], (703) 308-8025. Imiprothrin, 7426 EPA-HQ-OPP-2011-0692 Margaret Hathaway, [email protected], (703) 305-5076. Kresoxim-Methyl, 7026 EPA-HQ-OPP-2012-0861 Bonnie Alder, [email protected], (703) 308-8523. Lambda-cyhalothrin, 7408 EPA-HQ-OPP-2010-0480 Wilhelmena Livingston, [email protected], (703) 308-8025. Linuron, 0047 EPA-HQ-OPP-2010-0228 Katherine St. Clair, [email protected], (703) 347-8778. Metalaxyl and Mefenoxam, 0081 EPA-HQ-OPP-2009-0863 Leigh Rimmer, [email protected], (703) 347-0553. MGK-264, 2430 EPA-HQ-OPP-2012-0415 Bilin Basu, [email protected], (703) 347-0455. Momfluorothrin, 7457 EPA-HQ-OPP-2015-0752 Bilin Basu, [email protected], (703) 347-0455. Permethrin, 2510 EPA-HQ-OPP-2011-0039 Brittany Pruitt, [email protected], (703) 347-0289. Phosmet, 0242 EPA-HQ-OPP-2009-0316 Maria Piansay, [email protected], (703) 308-8063. Prallethrin, 7418 EPA-HQ-OPP-2011-1009 Wilhelmena Livingston, [email protected], (703) 308-8025. Pyrethrins, 2580 EPA-HQ-OPP-2011-0885 Brian Kettl, [email protected], (703) 347-0535. Tau-fluvalinate, 2295 EPA-HQ-OPP-2010-0915 Miguel Zavala, [email protected], (703) 347-0504. Tefluthrin, 7409 EPA-HQ-OPP-2012-0501 Marianne Mannix, [email protected], (703) 347-0275. Tetramethrin, 2660 EPA-HQ-OPP-2011-0907 Nathan Sell, [email protected], (703) 347-8020.

    Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity, through this notice of availability, for interested parties to provide comments and input concerning the Agency's draft human health and ecological risk assessment for aliphatic esters, cyclanilide, cymoxanil, d-phenothrin, dimethomorph, fenpropathrin, imiprothrin, kresoxim-methyl, linuron, metalaxyl and mefenoxam, MGK-264, momfluorothrin, phosmet, prallethrin, tau-fluvalinate, tefluthrin, tetramethrin and opens a public comment period on these documents. In addition, this notice announces the availability of EPA's draft ecological risk assessments for the registration review of bifenthrin, cyfluthrins (& beta), cypermethrin (alpha & zeta), cyphenothrin, deltamethrin, esfenvalerate, etofenprox, flumethrin, gamma-cyhalothrin, lambda-cyhalothrin, permethrin, pyrethrins and opens a public comment period on these documents. Such comments and input could address, among other things, the Agency's risk assessment methodologies and assumptions, as applied to a draft risk assessment. The Agency will consider all comments received during the public comment period and make changes, as appropriate, to a draft human health and/or ecological risk assessment. EPA will then issue a revised risk assessment, explain any changes to the draft risk assessment, and respond to comments. In the Federal Register notice announcing the availability of the revised risk assessment, if the revised risk assessment indicates risks of concern, the Agency may provide a comment period for the public to submit suggestions for mitigating the risk identified in the revised risk assessment before developing a proposed registration review decision on the pesticides herein.

    1. Other related information. Additional information on the registration review status of the chemicals listed in Table 1 of Unit III, as well as information on the Agency's registration review program and on its implementing regulation is available at http://www.epa.gov/pesticide-reevaluation.

    2. Information submission requirements. Anyone may submit data or information in response to this document. To be considered during a pesticide's registration review, the submitted data or information must meet the following requirements:

    • To ensure that EPA will consider data or information submitted, interested persons must submit the data or information during the comment period. The Agency may, at its discretion, consider data or information submitted at a later date.

    • The data or information submitted must be presented in a legible and useable form. For example, an English translation must accompany any material that is not in English and a written transcript must accompany any information submitted as an audiographic or videographic record. Written material may be submitted in paper or electronic form.

    • Submitters must clearly identify the source of any submitted data or information.

    • Submitters may request the Agency to reconsider data or information that the Agency rejected in a previous review. However, submitters must explain why they believe the Agency should reconsider the data or information in the pesticide's registration review.

    As provided in 40 CFR 155.58, the registration review docket for each pesticide case will remain publicly accessible through the duration of the registration review process; that is, until all actions required in the final decision on the registration review case have been completed.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: October 19, 2016. Charles Smith, Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs.
    [FR Doc. 2016-28740 Filed 11-28-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL ACCOUNTING STANDARDS ADVISORY BOARD Notice of Issuance of Annual Report for Fiscal Year 2016 and Three-Year Plan AGENCY:

    Federal Accounting Standards Advisory Board

    ACTION:

    Notice.

    Board Action: Pursuant to 31 U.S.C. 3511(d, the Federal Advisory Committee Act (Pub. L. 92-463), as amended, and the FASAB Rules Of Procedure, as amended in October 2010, notice is hereby given that the Federal Accounting Standards Advisory Board (FASAB) has issued its Annual Report for Fiscal Year 2016 and Three-Year Plan. The Board also plans to conduct online surveys to help in assessing the most important priorities for the future and the next steps in its reporting model and performance reporting projects. The annual planning survey is available at https://tell.gao.gov/fasabplanning. The financial and performance reporting survey is available at https://tell.gao.gov/fasabreporting/. The surveys will open on November 30, 2016, and close on January 30, 2017.

    The Annual Report for Fiscal Year 2016 and Three-Year Plan is available on the FASAB Web site at http://www.fasab.gov/our-annual-reports/. Copies can be obtained by contacting FASAB at (202) 512-7350.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Wendy M. Payne, Executive Director, 441 G Street NW., Mailstop 6H19, Washington, DC 20548, or call (202) 512-7350.

    Authority:

    Federal Advisory Committee Act, Pub. L. 92-463.

    Dated: November 22, 2016. Wendy M. Payne, Executive Director.
    [FR Doc. 2016-28615 Filed 11-28-16; 8:45 am] BILLING CODE 1610-02-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0713] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written PRA comments should be submitted on or before January 30, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email to [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0713.

    Title: Alternative Broadcast Inspection Program (ABIP) Compliance Notification.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Businesses or other for-profit, Not-for-profit institutions.

    Number of Respondents and Responses: 53 respondents; 2,650 responses.

    Estimated Time per Response: 5 minutes (0.084 hours).

    Frequency of Response: On occasion reporting requirement and third party disclosure requirement.

    Obligation to Respond: Voluntary. Statutory authority for this collection of information is contained in 47 U.S.C. 303(n) and 47 CFR Section 73.1225.

    Total Annual Burden: 223 hours.

    Total Annual Cost: No cost.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: The Commission is not requesting that respondents submit confidential information to the Commission. If the Commission requests that respondents submit information which respondents believe is confidential, respondents may request confidential treatment of such information pursuant to section 0.459 of the Commission's rules, 47 CFR Section 0.459.

    Needs and Uses: The Alternative Broadcast Inspection Program (ABIP) is a series of agreements between the Federal Communications Commission's (FCC) Enforcement Bureau and a private entity, usually a state broadcast association, whereby the private entity agrees to facilitate inspections (and re-inspections, where appropriate) of participating broadcast stations to determine station compliance with FCC regulations. Broadcast stations participate in ABIP on a voluntary basis. The private entities notify their local FCC District Office or Resident Agent Office in writing of those stations that pass the ABIP inspection and have been issued a Certificate of Compliance by the ABIP inspector. The FCC uses this information to determine which broadcast stations have been certified in compliance with FCC Rules and will not be subject to certain random FCC inspections.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2016-28649 Filed 11-28-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0289] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written PRA comments should be submitted on or before January 30, 2017. If you anticipate that you will submit comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email P[email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0289.

    Title: Section 76.76.601, Performance Tests; Section 76.1704, Proof of Performance Test Data; Section 76.1705, Performance Tests (Channels Delivered); 76.1717, Compliance with Technical Standards.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities; State, local or Tribal Government.

    Number of Respondents and Responses: 4,450 respondents; 5,955 responses.

    Estimated Time per Response: 0.5-70 hours.

    Frequency of Response: Recordkeeping requirement, Semi-annual and Triennial reporting requirements; Third party disclosure requirement.

    Total Annual Burden: 104,125 hours.

    Total Annual Costs: None.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in Sections 4(i) and 624(e) of the Communications Act of 1934, as amended.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Privacy Impact Assessment: No impact(s).

    Needs and Uses: 47 CFR 76.601(b) requires the operator of each cable television system shall conduct complete performance tests of that system at least twice each calendar year (at intervals not to exceed seven months), unless otherwise noted below. The performance tests shall be directed at determining the extent to which the system complies with all the technical standards set forth in § 76.605(a) and shall be as follows:

    (1) For cable television systems with 1,000 or more subscribers but with 12,500 or fewer subscribers, proof-of-performance tests conducted pursuant to this section shall include measurements taken at six (6) widely separated points. However, within each cable system, one additional test point shall be added for every additional 12,500 subscribers or fraction thereof (e.g., 7 test points if 12,501 to 25,000 subscribers; 8 test points if 25,001 to 37,500 subscribers, etc.). In addition, for technically integrated portions of cable systems that are not mechanically continuous (i.e., employing microwave connections), at least one test point will be required for each portion of the cable system served by a technically integrated microwave hub. The proof-of-performance test points chosen shall be balanced to represent all geographic areas served by the cable system. At least one-third of the test points shall be representative of subscriber terminals most distant from the system input and from each microwave receiver (if microwave transmissions are employed), in terms of cable length. The measurements may be taken at convenient monitoring points in the cable network: Provided, that data shall be included to relate the measured performance of the system as would be viewed from a nearby subscriber terminal. An identification of the instruments, including the makes, model numbers, and the most recent date of calibration, a description of the procedures utilized, and a statement of the qualifications of the person performing the tests shall also be included.

    (2) Proof-of-performance tests to determine the extent to which a cable television system complies with the standards set forth in § 76.605(a)(3), (4), and (5) shall be made on each of the NTSC or similar video channels of that system. Unless otherwise as noted, proof-of-performance tests for all other standards in § 76.605(a) shall be made on a minimum of four (4) channels plus one additional channel for every 100 MHz, or fraction thereof, of cable distribution system upper frequency limit (e.g., 5 channels for cable television systems with a cable distribution system upper frequency limit of 101 to 216 MHz; 6 channels for cable television systems with a cable distribution system upper frequency limit of 217-300 MHz; 7 channels for cable television systems with a cable distribution upper frequency limit to 300 to 400 MHz, etc.). The channels selected for testing must be representative of all the channels within the cable television system.

    (3) The operator of each cable television system shall conduct semi-annual proof-of-performance tests of that system, to determine the extent to which the system complies with the technical standards set forth in § 76.605(a)(4) as follows. The visual signal level on each channel shall be measured and recorded, along with the date and time of the measurement, once every six hours (at intervals of not less than five hours or no more than seven hours after the previous measurement), to include the warmest and the coldest times, during a 24-hour period in January or February and in July or August.

    (4) The operator of each cable television system shall conduct triennial proof-of-performance tests of its system to determine the extent to which the system complies with the technical standards set forth in § 76.605(a)(11).

    Note 1 to 47 CFR 76.601 states prior to additional testing pursuant to Section 76.601(c), the local franchising authority shall notify the cable operator, who will then be allowed thirty days to come into compliance with any perceived signal quality problems which need to be corrected.

    47 CFR 76.1704 requires that proof of performance test required by 47 CFR 76.601 shall be maintained on file at the operator's local business office for at least five years. The test data shall be made available for inspection by the Commission or the local franchiser, upon request. If a signal leakage log is being used to meet proof of performance test recordkeeping requirement in accordance with Section 76.601, such a log must be retained for the period specified in 47 CFR 76.601(d).

    47 CFR 76.1705 requires that the operator of each cable television system shall maintain at its local office a current listing of the cable television channels which that system delivers to its subscribers.

    47 CFR 76.1717 states that an operator shall be prepared to show, on request by an authorized representative of the Commission or the local franchising authority, that the system does, in fact, comply with the technical standards rules in part 76, subpart K.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2016-28650 Filed 11-28-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Agency Information Collection Activities: Submission for OMB Review; Comment Request (3064-0025, -0057, 0140 & -0176) AGENCY:

    Federal Deposit Insurance Corporation (FDIC).

    ACTION:

    Notice and request for comment.

    SUMMARY:

    The FDIC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on the renewal of existing information collections, as required by the Paperwork Reduction Act of 1995. On September 22, 2016, (81 FR 65643), the FDIC requested comment for 60 days on a proposal to renew the information collections described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of these collections, and again invites comment on this renewal.

    DATES:

    Comments must be submitted on or before December 29, 2016.

    ADDRESSES:

    Interested parties are invited to submit written comments to the FDIC by any of the following methods:

    http://www.FDIC.gov/regulations/laws/federal/notices.html.

    Email: [email protected] Include the name and number of the collection in the subject line of the message.

    Mail: Manny Cabeza (202-898-3767), Counsel, MB-3007, Federal Deposit Insurance Corporation, 550 17th Street NW., Washington, DC 20429.

    Hand Delivery: Comments may be hand-delivered to the guard station at the rear of the 17th Street Building (located on F Street), on business days between 7:00 a.m. and 5:00 p.m.

    All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
    FOR FURTHER INFORMATION CONTACT:

    Manny Cabeza, at the FDIC address above.

    SUPPLEMENTARY INFORMATION:

    Proposal to renew the following currently approved collections of information:

    1. Title: Application for Consent to Exercise Trust Powers.

    OMB Number: 3064-0025.

    Form Number: FDIC 6200/09.

    Affected Public: Insured state nonmember banks wishing to exercise trust powers.

    Burden Estimate Type of
  • burden
  • Estimated
  • number of
  • respondents
  • Estimated
  • hours per
  • response
  • Frequency
  • of response
  • Total
  • annual
  • estimated
  • burden
  • (hours)
  • Eligible depository institutions Reporting 8 8 On Occasion 64 Not-eligible depository institutions Reporting 4 24 On Occasion 96 Totals 12 160

    General Description of Collection: FDIC regulations (12 CFR 333.2) prohibit any insured State nonmember bank from changing the general character of its business without the prior written consent of the FDIC. The exercise of trust powers by a bank is usually considered a change in the general character of a bank's business if the bank did not exercise those powers previously. Therefore, unless a bank is currently exercising trust powers, it must file a formal application to obtain the FDIC's written consent to exercise trust powers. State banking authorities, not the FDIC, grant trust powers to their banks. The FDIC merely consents to the exercise of such powers. Applicants use form FDIC 6200/09 to obtain FDIC's consent.

    2. Title: Certified Statement for Quarterly Deposit Insurance Assessment.

    OMB Number: 3064-0057.

    Form Number: 6420/07.

    Affected Public: FDIC-insured depository institutions.

    Estimated Number of Respondents: 6,081.

    Frequency of Response: Quarterly.

    Estimated Time Burden per Response: 20 minutes.

    Total Estimated Annual Burden: 8,108 hours.

    General Description of Collection: The FDIC collects deposit insurance assessments on a quarterly basis. Each assessment is based on the institution's quarterly report of condition for the prior calendar quarter. The FDIC collects the quarterly payments by means of direct debits through the Automated Clearing House network. The collection dates for the first period of any given year (January through June) are June 30 and September 30 of the current year. The collection dates for the second period (July through December) are December 30 of the current year and March 30 of the following year. The information collection consists of recordkeeping associated with reviews by officials of the insured institutions to confirm that the assessment data are accurate and, in cases of inaccuracy, submission of corrected data.

    3. Title: Insurance Products Consumer Protections.

    OMB Number: 3064-0140.

    Form Number: None.

    Affected Public: Insured State nonmember banks and savings associations that sell insurance products; persons who sell insurance products in or on behalf of insured State nonmember banks and savings associations.

    Burden Estimate Type of burden Estimated
  • number of
  • respondents
  • Estimated
  • hours per
  • response
  • Frequency of
  • response
  • Total annual
  • estimated
  • burden
  • (hours)
  • Review disclosure materials Recordkeeping 2,020 1 On Occasion 2,020 Make disclosures to consumers Disclosure 2,020 4 On Occasion 8,080 Totals 10,100

    General Description of Collection: Respondents must prepare and provide certain disclosures to consumers (e.g., that insurance products and annuities are not FDIC-insured) and obtain consumer acknowledgments, at two different times: (1) Before the completion of the initial sale of an insurance product or annuity to a consumer; and (2) at the time of application for the extension of credit (if insurance products or annuities are sold, solicited, advertised, or offered in connection with an extension of credit).

    4. Title: Reverse Mortgage Products.

    OMB Number: 3064-0176.

    Form Number: None.

    Affected Public: Insured State nonmember banks and savings associations.

    Burden Estimate Type of burden Estimated
  • number of
  • respondents
  • Estimated
  • hours per
  • response
  • Frequency of
  • response
  • Total annual
  • estimated
  • burden
  • (hours)
  • Implementation Reporting 1 40 Annually 40 Ongoing Reporting 26 8 Annually 200 Totals 240

    General Description of Collection: In August, 2010, the OCC, FDIC, FRB and NCUA issued guidance focusing on the need to provide adequate information to consumers about reverse mortgage products; to provide qualified independent counseling to consumers considering these products; and to avoid potential conflicts of interest. The guidance also addressed related policies, procedures, internal controls, and third party risk management. Prior to the effective date of the final guidance, the Agencies obtained PRA approval from OMB for the information collection requirements contained therein. These information collection requirements included implementation of policies and procedures, training, and program maintenance. The requirements are outlined below:

    • Institutions offering reverse mortgages should have written policies and procedures that prohibit the practice of directing a consumer to a particular counseling agency or contacting a counselor on the consumer's behalf.

    • Policies should be clear so that originators do not have an inappropriate incentive to sell other products that appear linked to the granting of a mortgage.

    • Legal and compliance reviews should include oversight of compensation programs so that lending personnel are not improperly encouraged to direct consumers to particular products.

    • Training should be designed so that relevant lending personnel are able to convey information to consumers about product terms and risks in a timely, accurate, and balanced manner.

    Request for Comment

    Comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collections, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

    Dated at Washington, DC, this 23rd day of November 2016. Federal Deposit Insurance Corporation Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-28679 Filed 11-28-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL HOUSING FINANCE AGENCY [No. 2016-N-12] Proposed Collection; Comment Request AGENCY:

    Federal Housing Finance Agency.

    ACTION:

    30-Day Notice of submission of information collection for approval from Office of Management and Budget.

    SUMMARY:

    In accordance with the requirements of the Paperwork Reduction Act of 1995, the Federal Housing Finance Agency (FHFA or the Agency) is seeking public comments concerning the information collection known as the “Affordable Housing Program,” which has been assigned control number 2590-0007 by the Office of Management and Budget (OMB). FHFA intends to submit the information collection to OMB for review and approval of a three-year extension of the control number, which is due to expire on November 30, 2016.

    DATES:

    Interested persons may submit comments on or before December 29, 2016.

    ADDRESSES:

    Submit comments to the Office of Information and Regulatory Affairs of the Office of Management and Budget, Attention: Desk Officer for the Federal Housing Finance Agency, Washington, DC 20503, Fax: (202) 395-3047, Email: [email protected]. Please also submit comments to FHFA, identified by “Proposed Collection; Comment Request: `Affordable Housing Program, (No. 2016-N-12)' ” by any of the following methods:

    Agency Web site: www.fhfa.gov/open-for-comment-or-input.

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. If you submit your comment to the Federal eRulemaking Portal, please also send it by email to FHFA at [email protected] to ensure timely receipt by the agency.

    Mail/Hand Delivery: Federal Housing Finance Agency, Eighth Floor, 400 Seventh Street SW., Washington, DC 20219, ATTENTION: Proposed Collection; Comment Request: “Affordable Housing Program, (No. 2016-N-12)”.

    U.S. Mail, United Parcel Service, Federal Express, or Other Mail Service: The mailing address for comments is: Alfred M. Pollard, General Counsel, Attention: Comments/2016-N-12, Federal Housing Finance Agency, 400 Seventh Street SW., Eighth Floor, Washington, DC 20219.

    We will post all public comments we receive without change, including any personal information you provide, such as your name and address, email address, and telephone number, on the FHFA Web site at http://www.fhfa.gov. In addition, copies of all comments received will be available for examination by the public on business days between the hours of 10 a.m. and 3 p.m., at the Federal Housing Finance Agency, Eighth Floor, 400 Seventh Street SW., Washington, DC 20219. To make an appointment to inspect comments, please call the Office of General Counsel at (202) 649-3804.

    FOR FURTHER INFORMATION CONTACT:

    Deattra D. Perkins, Senior Policy Analyst, Division of Housing Mission & Goals, [email protected], (202) 649-3133; or Sylvia C. Martinez, Manager, Federal Home Loan Bank Housing and Community Investment Programs, Division of Housing Mission & Goals, [email protected], (202) 649-3301 (these are not toll-free numbers); Federal Housing Finance Agency, 400 Seventh Street SW., Washington, DC 20219. The Telecommunications Device for the Hearing Impaired is (800) 877-8339.

    SUPPLEMENTARY INFORMATION: A. Background

    The Federal Home Loan Bank System consists of eleven regional Federal Home Loan Banks (Banks) and the Office of Finance (a joint office of the Banks that issues and services their debt securities). The Banks are wholesale financial institutions, organized under authority of the Federal Home Loan Bank Act (Bank Act) to serve the public interest by enhancing the availability of residential housing finance and community lending credit through their member institutions and, to a limited extent, through eligible non-member “housing associates.” 1 Each Bank is structured as a regional cooperative that is owned and controlled by member financial institutions located within its district, which are also its primary customers.

    1 Certain non-member entities are permitted by statute to engage in limited business activities with a Bank. See 12 U.S.C. 1430b. FHFA's regulations refer to these entities as “housing associates.” See 12 CFR part 1264.

    Section 10(j) of the Bank Act requires FHFA to promulgate regulations under which each of the eleven Banks must establish an Affordable Housing Program (AHP) to provide subsidy to the Bank's member institutions to: (1) Finance homeownership by households with incomes at or below 80 percent of the area median income (low- or moderate-income households); and (2) to finance the purchase, construction, or rehabilitation of rental housing in which at least 20 percent of the units will be occupied by and affordable for households earning 50 percent or less of the area median income (very low-income households).2 Section 10(j) also establishes standards and requirements for providing such subsidized funding to Bank members and requires each Bank to contribute 10 percent of its previous year's net earnings to its AHP annually, subject to a minimum annual combined contribution by the eleven Banks of $100 million.3

    2See 12 U.S.C. 1430(j)(1) and (2).

    3See 12 U.S.C. 1430(j)(5)(C).

    FHFA's AHP regulation, which implements the statutory AHP requirements, is located at 12 CFR part 1291. The regulation requires that each Bank establish and fund an AHP and sets forth the parameters within which the Banks' programs must operate. The regulation permits the Banks a degree of discretion in determining how their individual programs are to be implemented and requires that each Bank adopt an AHP Implementation Plan setting forth the specific requirements for that Bank's program.4

    4See 12 CFR 1291.3.

    Competitive Application Programs

    The AHP regulation requires each Bank to establish a competitive application program under which the Bank accepts applications for AHP subsidized advances or direct subsidies (grants) submitted by its members on behalf of non-member entities having a significant connection to the projects for which subsidy is being sought (project sponsors).5 Each Bank accepts applications for AHP subsidy under its competitive application program during a specified number of funding periods each year, as determined by the Bank.6 A Bank must determine for each application it receives whether the proposed project meets the AHP regulatory eligibility requirements.7 The Bank must score each application according to AHP regulatory and Bank-specific scoring guidelines, and approve the highest scoring projects within that funding period for AHP subsidy.8

    5See 12 CFR 1291.5. Under the regulation, an AHP project sponsor may be an entity that either: (1) Has an ownership interest in a rental project; (2) is integrally involved in an owner-occupied project, such as by exercising control over the planning, development, or management of the project, or by qualifying borrowers and providing or arranging financing for the owners of the units; (3) operates a loan pool; or (4) is a revolving loan fund. 12 CFR 1291.1 (definition of “sponsor”).

    6See 12 CFR 1291.5(b)(1).

    7See 12 CFR 1291.5(c).

    8See 12 CFR 1291.5(d).

    The regulation provides that, prior to each disbursement of AHP subsidy for a project approved under a Bank's competitive application program, the Bank must confirm that the project continues to meet the AHP regulatory eligibility requirements, as well as all commitments made in the approved AHP application.9 As part of this process, Banks typically require that the member and project sponsor provide documentation demonstrating continuing compliance.

    9See 12 CFR 1291.5(g)(3).

    The regulation permits a Bank to approve a modification to the terms of an approved application that would change the score that the application received in the funding period in which it was originally scored and approved, had the changed facts been operative at that time. To approve a modification: (i) The project, incorporating the changes, must continue to meet the regulatory eligibility requirements; (ii) the application, as reflective of the changes, must continue to score high enough to have been approved in the funding period in which it was originally scored and approved; and (iii) there must be good cause for the modification, and the analysis and justification for the modification must be documented by the Bank in writing.10 Banks typically require the member and project sponsor requesting a modification to provide a written analysis and justification as part of their modification request.

    10See 12 CFR 1291.5(f).

    The regulation requires generally that a Bank monitor each owner-occupied and rental project receiving AHP subsidy under its competitive application program prior to and after project completion. For initial monitoring, a Bank must determine whether the project is making satisfactory progress towards completion, in compliance with the commitments made in the approved application, Bank policies, and the AHP regulatory requirements. Following project completion, the Bank must determine whether satisfactory progress is being made towards occupancy of the project by eligible households, and whether the project meets the regulatory requirements and the commitments made in the approved application.11 For long-term monitoring of rental projects, subject to certain exceptions in the AHP regulation, the Bank must determine whether, during the 15-year retention period, the household incomes and rents comply with the income targeting and rent commitments made in the approved application.12 For both the initial and long-term monitoring, a Bank must review appropriate documentation maintained by the project sponsor.

    11See 12 CFR 1291.7(a)(1).

    12See 12 CFR 1291.7(a)(4).

    Homeownership Set-Aside Programs

    The AHP regulation also authorizes each Bank, in its discretion, to allocate up to the greater of $4.5 million or 35 percent of its annual required AHP contribution to establish homeownership set-aside programs for the purpose of promoting homeownership for low- or moderate-income households.13 Under these homeownership set-aside programs, a Bank may provide to its members AHP direct subsidies, which are to be provided by the members to eligible households as a grant to pay for down payment, closing cost, counseling cost or rehabilitation assistance in connection with the household's purchase of a primary residence or rehabilitation of an owner-occupied residence.14 Prior to the Bank's disbursement of a direct subsidy under its homeownership set-aside program, the member must provide a certification that the subsidy will be provided in compliance with all applicable regulatory eligibility requirements.15

    13See 12 CFR 1291.2(b)(2); 1291.6.

    14See 12 CFR 1291.6(c)(4).

    15See 12 CFR 1291.7(b)(2).

    AHP Information Submitted by Banks to FHFA

    FHFA's Data Reporting Manual (DRM) requires each Bank to submit to FHFA aggregate AHP information.16 The DRM requires each Bank to submit to FHFA project-level information regarding its competitive application program and household-level information regarding its homeownership set-aside program semi-annually. The information the Banks are required to submit to FHFA under the DRM is derived from the documentation submitted by Bank members and project sponsors that is described above.

    16 The AHP reporting requirements are located in chapter 5 of the DRM, which is available electronically on FHFA's public Web site at http://www.fhfa.gov/SupervisionRegulation/FederalHomeLoanBanks/Documents/FHFB-Resolutions/2006/2006-13-Attachment.pdf.

    B. Need for and Use of the Information Collection

    The Banks use the information collected under part 1291 to determine whether: (1) Projects for which Bank members and project sponsors are seeking subsidies under the Banks' competitive application programs satisfy the applicable statutory and regulatory requirements and score highly enough in comparison with other applications submitted during the same funding period to be approved for AHP subsidies; (2) projects approved under the Banks' competitive application programs continue to meet the applicable requirements and to comply with the commitments made in the approved applications each time subsidy is disbursed; (3) requests for modifications of projects approved under the Banks' competitive application programs meet the regulatory requirements for approval; (4) projects approved under the Banks' competitive application programs are making satisfactory progress towards completion, and following project completion, are making satisfactory progress towards occupancy of the project by eligible households, in compliance with the commitments made in the approved applications, Bank policies, and the regulatory requirements (initial monitoring); (5) during the 15-year retention period, completed rental projects continue to comply with the household income targeting and rent commitments made in the approved applications (long-term monitoring); and (6) applications for direct subsidy under Banks' homeownership set-aside programs were approved, and the direct subsidies disbursed, in accordance with the regulatory requirements.

    FHFA uses the information required to be submitted by the Banks under the DRM to verify that the Banks' funding decisions, and the use of the funds awarded, were consistent with statutory and regulatory requirements.

    The OMB control number for the information collection is 2590-0007. The current clearance expires on November 30, 2016. The likely respondents are institutions that are Bank members and non-member entities that sponsor an AHP project.

    C. Burden Estimate

    FHFA has analyzed each of the six facets of this information collection in order to estimate the hour burdens that the collection will impose upon Bank members and AHP project sponsors annually over the next three years. Based on that analysis, FHFA estimates that the total annual hour burden will be 115,750. The method FHFA used to determine the annual hour burden for each facet of the information collection is explained in detail below.

    I. AHP Competitive Applications

    FHFA estimates that Bank members, on behalf of project sponsors, will submit to the Banks an annual average of 1,350 applications for AHP subsidies under the Banks' competitive application programs and that the average preparation time for each application will be 24 hours. The estimate for the total annual hour burden on members and project sponsors in connection with the preparation and submission of AHP competitive applications is 32,400 hours (1,350 applications × 24 hours).

    II. Compliance Submissions for Approved Competitive Application Projects at AHP Subsidy Disbursement

    FHFA estimates that Bank members, on behalf of project sponsors, will make an annual average of 700 submissions to the Banks documenting that projects approved under the Banks' competitive application programs continue to comply with the regulatory eligibility requirements and all commitments made in the approved applications at the time each AHP subsidy is disbursed, and that the average preparation time for each submission will be 1 hour. The estimate for the total annual hour burden on members and project sponsors in connection with the preparation and submission of these compliance submissions is 700 hours (700 submissions × 1 hour).

    III. Modification Requests for Approved Competitive Application Projects

    FHFA estimates that Bank members, on behalf of project sponsors, will submit to the Banks an annual average of 300 requests for modifications to projects that have been approved under the Banks' competitive application programs, and that the average preparation time for each request will be 2.5 hours. The estimate for the total annual hour burden on members and project sponsors in connection with the preparation and submission of these modification requests is 750 hours (300 requests × 2.5 hours).

    IV. Initial Monitoring Submissions for Approved Competitive Application Projects

    FHFA estimates that project sponsors will make an annual average of 500 submissions of documentation to the Banks for purposes of the Banks' initial monitoring of in-progress and recently completed projects approved under their competitive application programs, and that the average preparation time for each submission will be 5 hours. The estimate for the total annual hour burden on project sponsors in connection with the preparation and submission of documentation required for initial monitoring of competitive application projects is 2,500 hours (500 submissions × 5 hours).

    V. Long-Term Monitoring Submissions for Approved Competitive Application Program Projects

    FHFA estimates that project sponsors will make an annual average of 4,800 submissions of documentation to the Banks for purposes of the Banks' long-term monitoring of completed projects approved under their competitive application programs, and that the average preparation time for each submission will be 3 hours. The estimate for the total annual hour burden on project sponsors in connection with the preparation and submission of documentation required for long-term monitoring of competitive application projects is 14,400 hours (4,800 submissions × 3 hours).

    VI. Homeownership Set-Aside Program Applications and Certifications

    FHFA estimates that Bank members will submit to the Banks an annual average of 13,000 applications and required certifications for AHP direct subsidies under the Banks' homeownership set-aside programs, and that the average preparation time for those submissions together will be 5 hours. The estimate for the total annual hour burden on members in connection with the preparation and submission of homeownership set-aside program applications and certifications is 65,000 hours (13,000 applications/certifications × 5 hours).

    D. Comment Request

    In accordance with the requirements of 5 CFR 1320.8(d), FHFA published an initial notice requesting comments regarding this information collection in the Federal Register on September 23, 2016.17 The 60-day comment period closed on September 22, 2016. No comments were received.

    17See 81 FR 65648 (Sept. 23, 2016).

    In accordance with the requirements of 5 CFR 1320.10(a), FHFA is publishing this second notice to request comments regarding the following: (1) Whether the collection of information is necessary for the proper performance of FHFA functions, including whether the information has practical utility; (2) the accuracy of FHFA's estimates of the burdens of the collection of information; (3) ways to enhance the quality, utility and clarity of the information collected; and (4) ways to minimize the burden of the collection of information on members and project sponsors, including through the use of automated collection techniques or other forms of information technology. Comments should be submitted in writing to both OMB and FHFA as instructed above in the COMMENTS section.

    Dated: November 23, 2016. Kevin Winkler, Chief Information Officer, Federal Housing Finance Agency.
    [FR Doc. 2016-28707 Filed 11-28-16; 8:45 am] BILLING CODE 8070-01-P
    FEDERAL MARITIME COMMISSION Notice of Agreement Filed

    The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the Federal Register. A copy of the agreement is available through the Commission's Web site (www.fmc.gov) or by contacting the Office of Agreements at (202)-523-5793 or [email protected].

    Agreement No.: 012443.

    Title: Hyundai Glovis/Sallaum Cooperative Working Agreement.

    Parties: Hyundai Glovis Co. Ltd. and Sallaum Lines DMCC.

    Filing Party: Wayne R. Rohde, Esq.; Cozen O'Conner; 1200 Nineteenth Street NW; Washington, DC 20036.

    Synopsis: The Agreement authorizes the parties to charter space to/from one another and coordinate the sailings of their ro-ro vessels in the trade from the Atlantic and Gulf Coasts of the United States to ports in West and South Africa. The Parties request expedited review.

    By Order of the Federal Maritime Commission.

    Dated: November 22, 2016. Rachel E. Dickon, Assistant Secretary.
    [FR Doc. 2016-28629 Filed 11-28-16; 8:45 am] BILLING CODE 6731-AA-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than December 23, 2016.

    A. Federal Reserve Bank of San Francisco (Gerald C. Tsai, Director, Applications and Enforcement) 101 Market Street, San Francisco, California 94105-1579:

    1. BayCom Corp, Walnut Creek, California; to become a bank holding company by acquiring 100 percent of Bay Commercial Bank, also of Walnut Creek, California.

    Board of Governors of the Federal Reserve System, November 23, 2016. Michele Taylor Fennell, Assistant Secretary of the Board.
    [FR Doc. 2016-28694 Filed 11-28-16; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-17-16ET] Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected]. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

    Proposed Project

    Comprehensive HIV Prevention and Care for Men Who Have Sex with Men of Color (THRIVE)—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Approximately 40,000 people in the United States are newly infected with HIV each year. Gay, bisexual, and other men who have sex with men (MSM) remain the population most affected by HIV infection in the United States. Among MSM, those who are black and Hispanic comprise 64% of all new infections. Goals of the National HIV Prevention Strategy include increasing the number of MSM of color living with HIV infection who achieve HIV viral suppression with antiretroviral treatment, and decreasing the number of new HIV infections among MSM of color at risk of acquiring an HIV infection. Achieving these outcomes requires that men utilize a broad variety of HIV prevention and care services.

    In 2015, CDC developed a cooperative agreement program to promote use and adoption of Targeted Highly-Effective Interventions to Reverse the HIV Epidemic (THRIVE). Awardees are seven state and local health departments that are developing and implementing demonstration projects to provide comprehensive HIV prevention and care services for MSM of color. Each THRIVE awardee is creating a collaborative with community-based organizations, health care, behavioral health, and social services providers in its jurisdiction to strengthen referrals and coordination of HIV testing, prevention, and treatment services. Overall, approximately 80 partner organizations are participating in THRIVE collaboratives.

    Each THRIVE collaborative is required to address a total of 24 HIV prevention and care services, including 13 HIV prevention services for MSM of color at substantial risk for HIV infection and 11 HIV care services for MSM of color living with HIV infection. HIV prevention services include: 1. HIV testing that uses lab-based 4th generation HIV tests; 2. Assessment of indications for pre-exposure prophylaxis (PrEP) and non-occupational post-exposure prophylaxis (nPEP); 3. Provision of PrEP and nPEP; 4. Adherence interventions for PrEP and nPEP; 5. Immediate linkage to care, antiretoriviral treatment, and partner services for those diagnosed with acute HIV infection; 6. Expedient linkage to care, antiretoriviral treatment, and partner services for those diagnosed with established HIV infection; 7. STD screening and treatment; 8. Partner services for patients with STDs; 9. Behavioral risk-reduction interventions; 10. Screening for behavioral health and social services needs; 11. Linkage to behavioral health and social services; 12. Navigators to assist utilizing HIV prevention and behavioral health and social services; 13. Navigators to assist enrollment in a health plan.

    HIV care services include: 1. HIV primary care, including antiretroviral treatment; 2. Retention interventions; 3. Re-engagement interventions; 4. Adherence interventions; 5. STD screening and treatment; 6. Partner services; 7. Behavioral risk reduction interventions; 8. Screening patients for behavioral health and social services needs; 9. Linkage to behavioral health and social services; 10. Navigators to assist linking to care and accessing behavioral health and social services; 11. Navigators to assist enrollment in a health plan.

    CDC requests OMB approval to collect the information needed to monitor and assess the demonstration projects. In general, information collection will be conducted in 2 steps: THRIVE collaborative partners will report information to their respective health department (THRIVE awardee), and THRIVE awardees will provide reports to CDC. The monitoring and evaluation plan is based on semi-annual reports of Monitoring and Evaluation (M&E) Variables, comprised primarily of de-identified or coded client-level data on demographics and services received. The M&E files will be transmitted electronically. Recognizing that THRIVE awardees and partners vary in terms of existing infrastructure, CDC has established guidelines and specifications for M&E content, but is permitting a flexible approach to electronic reporting. A similar approach will be applied to electronic transmission of the annual Funding Allocation Report (FAR). The FAR is only required for THRIVE awardees.

    Information collection also includes an Annual Collaborative Process and Outcome Evaluation based on semi-structured interviews and completion of a questionnaire called the Annual Collaborative Assessment Tool. These information collections will allow CDC to assess how successful THRIVE awardees have been in creating, engaging, and sustaining collaborative partnerships and to understand how these partnerships contributed to achieving the goals of the project. Both tools will be submitted to CDC electronically on an annual basis.

    CDC will use findings to provide technical assistance to THRIVE awardees and to develop recommendations for the coordination of comprehensive HIV testing, prevention, and treatment services for MSM of color.

    OMB approval is requested for three years. Participation is required as a condition of THRIVE funding and there are no costs to respondents other than their time. The total estimated annualized burden hours are 1,543.

    Estimated Annualized Burden Hours Type of
  • respondent
  • Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • THRIVE Partners Monitoring and Evaluation Data Elements on HIV Prevention and Care Services 80 2 9 Qualitative Interview: Collaborative Process Evaluation 80 1 40/60 Collaborative Assessment Tool 80 1 20/60 THRIVE Awardees Monitoring and Evaluation Data Elements on HIV Prevention and Care Services 7 2 1 Qualitative Interview: Collaborative Process Evaluation 7 1 40/60 Collaborative Assessment Tool 7 1 20/60 Funding Allocation Report 7 1 20/60
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-28588 Filed 11-28-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-17-0214] Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

    Proposed Project

    National Health Interview Survey (NHIS) (OMB No. 0920-0214, expires 01/31/2019)—Revision—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Section 306 of the Public Health Service (PHS) Act (42 U.S.C. 242k), as amended, authorizes that the Secretary of Health and Human Services (DHHS), acting through NCHS, shall collect data on the extent and nature of illness and disability of the population of the United States.

    The annual National Health Interview Survey is a major source of general statistics on the health of the U.S. population and has been in the field continuously since 1957. Clearance is sought for three years, to collect data from 2017 to 2019.

    This voluntary and confidential household-based survey collects demographic and health-related information from a nationally representative sample of noninstitutionalized, civilian persons and households throughout the country. Personal identification information is requested from survey respondents to facilitate linkage of survey data with health-related administrative and other records. In 2017 the NHIS will collect information from approximately 45,000 households, which contain about 100,000 individuals. Information is collected using computer assisted personal interviews (CAPI).

    A core set of data is collected each year that remains largely unchanged, whereas sponsored supplements vary from year to year. The core set includes socio-demographic characteristics, health status, health care services, and health behaviors. For 2017, supplemental questions will be cycled in pertaining to alternative and integrative medicine, cognitive disability, receipt of culturally and linguistically appropriate health care services, epilepsy, and heart disease and stroke. Supplemental topics that continue or are enhanced from 2016 pertain to the Affordable Care Act, chronic pain, diabetes, disability and functioning, family food security, ABCS of heart disease and stroke prevention, hepatitis B/C screening, immunizations, smokeless tobacco and e-cigarettes, vision, and children's mental health. Questions from 2016 on balance, Crohn's disease and colitis, and blood donation have been removed. In addition to these core and supplemental modules, a subsample of NHIS respondents and/or members of commercial survey panels may be identified to participate in short, Web-based methodological and cognitive testing activities that will inform the upcoming 2018 NHIS questionnaire redesign. The aims of these standalone assessments include pilot testing new and/or updated questionnaire items, evaluating the impact of different categorical response option formats on answer choices, and measuring respondent comprehension of health care-related terms and concepts.

    In accordance with the 1995 initiative to increase the integration of surveys within the DHHS, respondents to the NHIS serve as the sampling frame for the Medical Expenditure Panel Survey conducted by the Agency for Healthcare Research and Quality. The NHIS has long been used by government, academic, and private researchers to evaluate both general health and specific issues, such as smoking, diabetes, health care coverage, and access to health care. It is a leading source of data for the Congressionally-mandated “Health US” and related publications, as well as the single most important source of statistics to track progress toward the National Health Promotion and Disease Prevention Objectives, “Healthy People 2020.”

    There is no cost to the respondents other than their time. The total estimated annualized burden hours are 49,000.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Adult Family Member Family Core 45,000 1 23/60 Sample Adult Adult Core 36,000 1 15/60 Adult Family Member Child Core 14,000 1 10/60 Adult Family Member Supplements 45,000 1 20/60 Adult Family Member Methodological Projects 15,000 1 20/60 Adult Family Member Reinterview Survey 5,000 1 5/60
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-28641 Filed 11-28-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request

    Title: Center for States Evaluation Ancillary Data Collection.

    OMB No.: New Collection.

    Description: The Evaluation of the Child Welfare Capacity Building Collaborative, Center for States is sponsored by the Children's Bureau, Administration for Children and Families of the U.S. Department of Health and Human Services. The purpose of this evaluation is to respond to a set of cross-cutting evaluation questions posed by the Children's Bureau. This new information collection is an ancillary part of a larger data collection effort being conducted for the evaluation of the Child Welfare Capacity Building Collaborative. Two groups of instruments for the larger evaluation have already been submitted, and requests for clearance have been submitted to the Office of Management and Budget (see Federal Register Volume 80, No. 211, November 2, 2015; Federal Register Volume 81, No. 41, March 2, 2016; Federal Register Volume 81, No. 111, June 9, 2016; Federal Register Volume 81, No. 186, September 26, 2016), with the first group of instruments approved on August 31, 2016. This notice details a group of instruments that are specific only to the Center for States. The instruments focus on (1) evaluating an innovative approach to engaging professionals in networking and professional development through virtual conferences, (2) understanding fidelity to and effectiveness of the Center for States' Capacity Building Model, and (3) capturing consistent information during the updated annual assessment process focused on related contextual issues impacting potential service delivery such as implementation of new legislation.

    Respondents: Respondents of these data collection instruments will include child welfare agency staff and stakeholders who directly receive services.

    Annual Burden Estimates Instrument Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • Total annual burden hours
    Virtual Conference (VC) Session Surveys 450 6 .08 216 VC Focus Group Guide 30 1 1 30 VC Interview Guide 20 1 .5 10 VC Registration Data 1000 1 .03 30 Tailored Services Practice Model Survey 130 1 .25 32.5 Assessment Observation—group debrief 50 1 .25 12.5 Service Delivery and Tracking and Adjustment Observation—group debrief 45 1 .25 11.3 Assessment and Service Delivery and Tracking and Adjustment State Lead Interviews 20 1 .5 10 Annual Assessment Update (8 systematic questions) 54 1 .08 4.3

    Estimated Total Annual Burden Hours: 356.6.

    In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for C