Federal Register Vol. 80, No.210,

Federal Register Volume 80, Issue 210 (October 30, 2015)

Page Range66781-67259
FR Document

80_FR_210
Current View
Page and SubjectPDF
80 FR 67257 - Continuation of the National Emergency With Respect to SudanPDF
80 FR 66783 - Preparing for Implementation of the Joint Comprehensive Plan of Action of July 14, 2015 (JCPOA)PDF
80 FR 66781 - Delegation of Certain Functions and Authorities Under Section 213(b)(1) of the Iran Threat Reduction and Syria Human Rights Act of 2012PDF
80 FR 66938 - National Science Board; Sunshine Act Meetings; NoticePDF
80 FR 66937 - Sunshine Act Meetings; National Science BoardPDF
80 FR 66963 - Cost-of-Living Increase and Other Determinations for 2016PDF
80 FR 66938 - Sunshine Act Meeting NoticePDF
80 FR 66904 - Public Buildings Service; Information Collection; Application/Permit for Use of Space in Public Buildings and Grounds, GSA Form 3453PDF
80 FR 66851 - Preparer Tax Identification Number (PTIN) User Fee UpdatePDF
80 FR 66801 - Rimsulfuron; Pesticide TolerancesPDF
80 FR 66792 - Preparer Tax Identification Number (PTIN) User Fee UpdatePDF
80 FR 66795 - Metaflumizone; Pesticide TolerancePDF
80 FR 66880 - Sunshine Act MeetingsPDF
80 FR 66899 - Good Neighbor Environmental Board; Public Advisory Committee TeleconferencePDF
80 FR 66867 - Presidential Task Force on Combating Illegal Unreported and Unregulated (IUU) Fishing and Seafood Fraud Action PlanPDF
80 FR 66867 - Notice of Retraction of Publication of the Notice of Final Redetermination Pursuant to Court Remand, Wheatland Tube Co. v. United States, Court No. 12-00296PDF
80 FR 66915 - South Carolina; Amendment No. 8 to Notice of a Major Disaster DeclarationPDF
80 FR 66938 - Pacific Gas and Electric Company; Diablo Canyon Independent Spent Fuel Storage InstallationPDF
80 FR 66915 - Agency Information Collection Activities: Application for Identification CardPDF
80 FR 66916 - Changes in Flood Hazard DeterminationsPDF
80 FR 66887 - Inland Waterways Users Board Meeting NoticePDF
80 FR 66963 - Reporting and Recordkeeping Requirements Under OMB ReviewPDF
80 FR 66893 - Senior Executive Service Performance Review BoardPDF
80 FR 66961 - Data Collection Available for Public CommentsPDF
80 FR 66921 - Proposed Flood Hazard DeterminationsPDF
80 FR 66919 - Final Flood Hazard DeterminationsPDF
80 FR 66809 - Suspension of Community EligibilityPDF
80 FR 66912 - Performance Review Board MembersPDF
80 FR 66923 - Final Flood Hazard DeterminationsPDF
80 FR 66921 - Washington; Major Disaster and Related DeterminationsPDF
80 FR 66883 - Privacy Act of 1974; System of RecordsPDF
80 FR 66906 - Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Draft Guidance for Industry; AvailabilityPDF
80 FR 66912 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Impact of Ad Exposure Frequency on Perception and Mental Processing of Risks and Benefit Information in Direct-to-Consumer Prescription Drug AdsPDF
80 FR 66912 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patient PerceptionsPDF
80 FR 66910 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Controlled Correspondence Related to Generic Drug DevelopmentPDF
80 FR 66911 - Determination That TENSILON and TENSILON Preservative Free (Edrophonium Chloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or EffectivenessPDF
80 FR 66935 - Barium Chloride From China; DeterminationPDF
80 FR 66900 - Information Collection Being Submitted to the Office of Management and Budget for Emergency Review and ApprovalPDF
80 FR 66888 - Notice of Availability of the Draft Environmental Impact Statement for the Proposed Glades Reservoir Water Supply Project, Permit Application SAS-2007-00388 and the Announcement of a Public HearingPDF
80 FR 66853 - Genetic Information Nondiscrimination Act of 2008PDF
80 FR 66898 - Environmental Impact Statements; Notice of AvailabilityPDF
80 FR 66969 - SteelRiver Infrastructure Fund North America LP, SteelRiver Devco Holdings LLC and SR Transportation Holdings LLC-Control Exemption-Georgia Northeastern Railroad Company, Inc. and Blue Ridge Scenic Excursions, Inc.PDF
80 FR 66931 - Agency Information Collection Activities: Request for CommentsPDF
80 FR 66907 - Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards; Partial Stay and Republication of GuidancePDF
80 FR 66909 - Clinical Trials-Assessing Safety and Efficacy for Diverse Populations; Public Meeting; Request for CommentsPDF
80 FR 66893 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 2015-16 National Postsecondary Student Aid Study (NPSAS:16) Full Scale Student Data CollectionPDF
80 FR 66968 - Notice and Request for CommentsPDF
80 FR 66894 - Senior Executive Service Performance Review BoardPDF
80 FR 66968 - Intermodal RR Transfer, LLC-Lease and Operation Exemption-JACJON AssociatesPDF
80 FR 66894 - Agency Information Collection ExtensionPDF
80 FR 66891 - National Assessment Governing Board Quarterly Board MeetingPDF
80 FR 66867 - Privacy Act of 1974, Altered System of RecordsPDF
80 FR 66913 - Proposed Collection; 60-Day Comment Request; A Generic Clearance for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH)PDF
80 FR 66933 - Notice of Intent To Prepare an Environmental Impact Report/Environmental Impact Statement for the Sacramento Regional County Sanitation District South County Ag Water Recycling ProgramPDF
80 FR 66881 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
80 FR 66932 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; Programmatic Clearance for NPS-Sponsored Public SurveysPDF
80 FR 66889 - Privacy Act of 1974; System of RecordsPDF
80 FR 66885 - Proposed Collection; Comment RequestPDF
80 FR 66882 - TRICARE; Calendar Year 2016 TRICARE Young Adult Program Premium UpdatePDF
80 FR 66886 - Charter Amendment of Department of Defense Federal Advisory CommitteesPDF
80 FR 66881 - Privacy Act of 1974; System of RecordsPDF
80 FR 66883 - Submission for OMB Review; Comment RequestPDF
80 FR 66847 - Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Reopening of the Comment PeriodPDF
80 FR 66849 - Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Reopening of the Comment PeriodPDF
80 FR 66844 - Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment PeriodPDF
80 FR 66850 - Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
80 FR 66845 - Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for CommentsPDF
80 FR 66935 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Resource Justification ModelPDF
80 FR 66913 - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure CohortPDF
80 FR 66788 - Special Conditions: Honda Aircraft Company (Honda) Model HA-420, HondaJet; Cruise Speed Control SystemPDF
80 FR 66930 - Announcement of Meetings: North American Wetlands Conservation Council; Neotropical Migratory Bird Conservation Advisory GroupPDF
80 FR 66866 - Estimate of Peanuts and Peanut Products Available for DonationPDF
80 FR 66839 - Fisheries of the Exclusive Economic Zone Off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management AreaPDF
80 FR 66843 - Vocational Factors of Age, Education, and Work Experience in the Adult Disability Determination Process; Extending of the Comment PeriodPDF
80 FR 66898 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Diesel Emissions Reduction Act (DERA) Rebate Program (Renewal)PDF
80 FR 66880 - Procurement List AdditionsPDF
80 FR 66880 - Procurement List; Proposed Additions and DeletionPDF
80 FR 66978 - Notice of Availability of a Draft Environmental Impact Statement (EIS) for the Reconfiguration of VA Black Hills Health Care System (BHHCS)PDF
80 FR 66926 - Delta Research Station, Sacramento, CA; Draft Environmental Impact Report/Environmental Impact Statement, and Announcement of Public MeetingsPDF
80 FR 66903 - Notice of Termination, 10406, Community Capital Bank, Jonesboro, GeorgiaPDF
80 FR 66903 - Notice of Termination, 10089, Security Bank of North Fulton, Alpharetta, GeorgiaPDF
80 FR 66979 - National Research Advisory Council; Notice of MeetingPDF
80 FR 66967 - Agency Information Collection Activities: Proposed Request and Comment RequestPDF
80 FR 66914 - Proposed Collection; 60-Day Comment Request Consumer Health Information in Public Libraries User Needs Survey (NLM)PDF
80 FR 66970 - 60-Day Notice of Request for Renewal of a Previously Approved CollectionPDF
80 FR 66896 - Combined Notice of Filings #1PDF
80 FR 66897 - Notice of Commission Staff AttendancePDF
80 FR 66895 - Staff Notice of Alleged ViolationsPDF
80 FR 66896 - Eastern Shore Natural Gas Company; Notice of Request Under Blanket AuthorizationPDF
80 FR 66895 - Combined Notice of Filings #1PDF
80 FR 66897 - Combined Notice of Filings #2PDF
80 FR 66977 - Agency Information Collection (Supplement to VA Form 21P-4703) Activity Under OMB ReviewPDF
80 FR 66934 - Certain Radiotherapy Systems and Treatment Planning Software, and Components Thereof; Institution of InvestigationPDF
80 FR 66905 - Submission for OMB Review; Comment RequestPDF
80 FR 66941 - New Postal ProductPDF
80 FR 66977 - Submission for OMB Review; Comment RequestPDF
80 FR 66975 - Submission for OMB Review; Comment RequestPDF
80 FR 66976 - Submission for OMB Review; Comment RequestPDF
80 FR 66979 - Notice of Intent To Prepare an Environmental Impact Statement for a Replacement Robley Rex Veterans Affairs Medical Center, Louisville, KentuckyPDF
80 FR 66955 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Options Testing FacilityPDF
80 FR 66951 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving Proposed Rule Change, and Notice of Filing and Order Granting Accelerated Approval of Amendment Nos. 1 and 2 Thereto, Adopting New Equity Trading Rules Relating to Orders and Modifiers and the Retail Liquidity Program To Reflect the Implementation of Pillar, the Exchange's New Trading Technology PlatformPDF
80 FR 66944 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Establishing Procedures and Credits in Connection With the Re-Location of Equipment in the Exchange's Data CenterPDF
80 FR 66942 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Establishing Procedures and Credits in Connection With the Re-Location of Equipment in the Exchange's Data CenterPDF
80 FR 66958 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Establishing Procedures and Credits in Connection With the Re-location of Equipment in the Exchange's Data CenterPDF
80 FR 66787 - Practices and ProceduresPDF
80 FR 66972 - Submission for OMB Review; Comment RequestPDF
80 FR 66947 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Options Testing FacilityPDF
80 FR 66949 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Options Testing FacilityPDF
80 FR 66937 - Meeting of National Council on the HumanitiesPDF
80 FR 66936 - Federal Council on the Arts and the Humanities; Arts and Artifacts Indemnity Panel Advisory Committee MeetingPDF
80 FR 66866 - Tongass Advisory CommitteePDF
80 FR 66821 - Endangered and Threatened Wildlife and Plants; Establishment of a Nonessential Experimental Population of Black-footed Ferrets in WyomingPDF
80 FR 66963 - Military Reservist Economic Injury Disaster Loans; Interest Rate for First Quarter FY 2016PDF
80 FR 66962 - Washington Disaster #WA-00061PDF
80 FR 66960 - South Carolina Disaster Number SC-00032PDF
80 FR 66962 - South Carolina Disaster Number SC-00031PDF
80 FR 66900 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
80 FR 66811 - Assessment and Collection of Regulatory Fees for Fiscal Year 2014; Assessment and Collection of Regulatory Fees for Fiscal Year 2013; and Procedures for Assessment and Collection of Regulatory FeesPDF
80 FR 66902 - Information Collection Being Submitted for Review and Approval to the Office of Management and BudgetPDF
80 FR 66901 - Information Collection Being Submitted for Review and Approval to the Office of Management and BudgetPDF
80 FR 66960 - Texas Disaster #TX-00455PDF
80 FR 66962 - South Carolina Disaster Number SC-00032PDF
80 FR 66971 - Proposed Collection of Information: ACH Vendor/Miscellaneous Payment Enrollment FormPDF
80 FR 66817 - Hazardous Materials: Carriage of Battery-Powered Electronic Smoking Devices in Passenger BaggagePDF
80 FR 66904 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
80 FR 66866 - Submission for OMB Review; Comment RequestPDF
80 FR 66935 - Notice of Lodging of Proposed Consent Decree Under the Clean Air ActPDF
80 FR 66862 - Approval and Promulgation of Implementation Plans; Idaho: Interstate Transport of OzonePDF
80 FR 66805 - Teflubenzuron; Pesticide TolerancesPDF
80 FR 66980 - Commission on Care MeetingPDF
80 FR 67254 - Defense Federal Acquisition Regulation Supplement; Technical AmendmentsPDF
80 FR 67253 - Defense Federal Acquisition Regulation Supplement: New Designated Countries-Montenegro and New Zealand (DFARS Case 2015-D033)PDF
80 FR 67252 - Defense Federal Acquisition Regulation Supplement: Removal of Cuba From the List of State Sponsors of Terrorism (DFARS 2015-D032)PDF
80 FR 67243 - Defense Federal Acquisition Regulation Supplement: Requirements Relating to Supply Chain Risk (DFARS Case 2012-D050)PDF
80 FR 66841 - Airworthiness Directives; The Boeing Company AirplanesPDF
80 FR 66790 - Airworthiness Directives; Fiberglas-Technik Rudolf Lindner GmbH & Co. KG GlidersPDF
80 FR 66928 - Monomoy National Wildlife Refuge, Barnstable County, MA; Final Comprehensive Conservation Plan and Environmental Impact StatementPDF
80 FR 66785 - Federal Long Term Care Insurance Program Eligibility ChangesPDF
80 FR 67025 - Injurious Wildlife Species; Listing 10 Freshwater Fish and 1 CrayfishPDF
80 FR 66925 - Federal Property Suitable as Facilities To Assist the HomelessPDF
80 FR 66981 - Privacy Act of 1974, as Amended; System of RecordsPDF
80 FR 67125 - Program Integrity and ImprovementPDF
80 FR 67203 - Student Assistance General Provisions, Federal Family Education Loan Program, and William D. Ford Federal Direct Loan ProgramPDF
80 FR 67055 - Refinements to Policies and Procedures for Market-Based Rates for Wholesale Sales of Electric Energy, Capacity and Ancillary Services by Public UtilitiesPDF

Issue

80 210 Friday, October 30, 2015 Contents Agriculture Agriculture Department See

Commodity Credit Corporation

See

Forest Service

See

National Agricultural Statistics Service

Army Army Department NOTICES Privacy Act; Systems of Records, 66881-66882 2015-27709 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 66881 2015-27715 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 66904-66905 2015-27619 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 66905-66906 2015-27666 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

NOTICES Privacy Act; Systems of Records, 66867 2015-27719
Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 66880 2015-27685 2015-27686 Commodity Credit Commodity Credit Corporation NOTICES Estimate of Peanuts and Peanut Products Available for Donation, 66866 2015-27698 Commodity Futures Commodity Futures Trading Commission NOTICES Meetings; Sunshine Act, 66880-66881 2015-27787 Defense Acquisition Defense Acquisition Regulations System RULES Defense Federal Acquisition Regulation Supplement: New Designated Countries-Montenegro and New Zealand, 67253-67254 2015-27471 Removal of Cuba from the List of State Sponsors of Terrorism, 67252-67253 2015-27467 Requirements Relating to Supply Chain Risk, 67244-67252 2015-27463 Technical Amendments, 67254-67255 2015-27473 Defense Department Defense Department See

Army Department

See

Defense Acquisition Regulations System

See

Engineers Corps

See

Navy Department

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 66883, 66885-66886 2015-27708 2015-27712 Charter Amendments: Department of Defense Federal Advisory Committees, 66886-66887 2015-27710 Privacy Act; Systems of Records, 66883-66885 2015-27745 TRICARE: Young Adult Program Premium Update, 66882-66883 2015-27711
Education Department Education Department RULES Program Integrity and Improvement, 67126-67201 2015-27145 Student Assistance General Provisions, Federal Family Education Loan Program, and William D. Ford Federal Direct Loan Program, 67204-67242 2015-27143 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Postsecondary Student Aid Study 2015-16 Full Scale Student Data Collection, 66893 2015-27727 Meetings: National Assessment Governing Board, 66891-66893 2015-27720 Energy Department Energy Department See

Energy Information Administration

See

Federal Energy Regulatory Commission

NOTICES Designation of Performance Review Board Standing Register: Senior Executive Service Performance Review Board, 66893-66894 2015-27757 Senior Executive Service Performance Review Board, 66894 2015-27724
Energy Information Energy Information Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 66894-66895 2015-27721 Engineers Engineers Corps NOTICES Environmental Impact Statements; Availability, etc.: Proposed Glades Reservoir Water Supply Project, 66888-66889 2015-27736 Meetings: Inland Waterways Users Board, 66887-66888 2015-27759 Environmental Protection Environmental Protection Agency RULES Pesticide Tolerances: Metaflumizone, 66795-66801 2015-27788 Rimsulfuron, 66801-66805 2015-27790 Teflubenzuron, 66805-66809 2015-27593 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Idaho; Interstate Transport of Ozone, 66862-66865 2015-27594 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Diesel Emissions Reduction Act Rebate Program, 66898-66899 2015-27691 Environmental Impact Statements; Availability, etc., 66898 2015-27732 Meetings: Good Neighbor Environmental Board, Public Advisory Committee; Teleconference, 66899 2015-27786 Equal Equal Employment Opportunity Commission PROPOSED RULES Genetic Information Nondiscrimination Act of 2008, 66853-66862 2015-27734 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Fiberglas-Technik Rudolf Lindner GmbH & Co. KG Gliders, 66790-66792 2015-27440 Special Conditions: Honda Aircraft Company (Honda) Model HA-420, HondaJet; Cruise Speed Control System, 66788-66789 2015-27700 PROPOSED RULES Airworthiness Directives: The Boeing Company Airplanes, 66841-66843 2015-27447 Federal Communications Federal Communications Commission RULES Assessment and Collection of Regulatory Fees for Fiscal Years 2014 and 2013; Procedures for Assessment and Collection of Regulatory Fees, 66811-66817 2015-27630 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 66900-66903 2015-27628 2015-27629 2015-27631 2015-27737 Federal Deposit Federal Deposit Insurance Corporation NOTICES Privacy Act; Systems of Records, 66982-67024 2015-27288 Terminations of Receiverships: Community Capital Bank, Jonesboro, GA, 66903-66904 2015-27682 Security Bank of North Fulton, Alpharetta, GA, 66903 2015-27681 Federal Emergency Federal Emergency Management Agency RULES Suspension of Community Eligibility, 66809-66811 2015-27750 NOTICES Disaster Declarations: South Carolina; Amendment No. 8, 66915-66916 2015-27771 Flood Hazard Determinations, 66919-66924 2015-27748 2015-27752 2015-27755 Flood Hazard Determinations; Changes, 66916-66919 2015-27760 Major Disasters and Related Determinations: Washington, 66921 2015-27747 Federal Energy Federal Energy Regulatory Commission RULES Refinements to Policies and Procedures for Market-Based Rates for Wholesale Sales of Electric Energy, Capacity and Ancillary Services by Public Utilities, 67056-67123 2015-26908 NOTICES Alleged Violations, 66895-66896 2015-27674 Combined Filings, 66895-66898 2015-27671 2015-27672 2015-27676 Requests Under Blanket Authorization: Eastern Shore Natural Gas Co., 66896-66897 2015-27673 Staff Attendances, 66897 2015-27675 Fiscal Fiscal Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: ACH Vendor/Miscellaneous Payment Enrollment Form, 66971-66972 2015-27623 Fish Fish and Wildlife Service RULES Endangered and Threatened Wildlife and Plants: Black-Footed Ferrets in Wyoming; Establishment of a Nonessential Experimental Population, 66821-66838 2015-27639 PROPOSED RULES Injurious Wildlife Species: Listing 10 Freshwater Fish and 1 Crayfish, 67026-67054 2015-27366 NOTICES Environmental Impact Statements; Availability, etc.: Delta Research Station, Sacramento, CA, 66926-66927 2015-27683 Final Comprehensive Conservation Plan and Environmental Impact Statements: Monomoy National Wildlife Refuge, Barnstable County, MA, 66928-66929 2015-27439 Meetings: North American Wetlands Conservation Council; Neotropical Migratory Bird Conservation Advisory Group, 66930-66931 2015-27699 Food and Drug Food and Drug Administration PROPOSED RULES Guidance for Industry and Staff: Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products, 66850-66851 2015-27704 Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue—Regulatory Considerations; Reopening Comment Period, 66849-66850 2015-27706 Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Reopening Comment Period, 66844-66845 2015-27705 Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing, 66845-66847 2015-27703 Same Surgical Procedure Exception—Questions and Answers Regarding the Scope of the Exception; Reopening Comment Period, 66847-66848 2015-27707 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Controlled Correspondence Related to Generic Drug Development, 66910 2015-27741 Impact of Ad Exposure Frequency on Perception and Mental Processing of Risks and Benefit Information in Direct-to-Consumer Prescription Drug Ads, 66912 2015-27743 Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patient Perceptions, 66912 2015-27742 Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness: TENSILON and TENSILON Preservative Free (Edrophonium Chloride) Injectable, et al., 66911-66912 2015-27740 Guidance for Industry and Staff: Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application, 66907-66909 2015-27729 Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation, 66906-66907 2015-27744 Meetings: Clinical Trials—Assessing Safety and Efficacy for Diverse Populations, 66909-66910 2015-27728 Forest Forest Service NOTICES Meetings: Tongass Advisory Committee, 66866 2015-27640 General Services General Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application/Permit for Use of Space in Public Buildings and Grounds, 66904 2015-27807 Geological Geological Survey NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 66931-66932 2015-27730 Health and Human Health and Human Services Department See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

National Institutes of Health

NOTICES Designation of a Class of Employees for Addition to the Special Exposure Cohort, 66913 2015-27701 Performance Review Board Members, 66912-66913 2015-27749
Homeland Homeland Security Department See

Federal Emergency Management Agency

See

U.S. Customs and Border Protection

Housing Housing and Urban Development Department NOTICES Federal Property Suitable as Facilities to Assist the Homeless, 66925-66926 2015-27365 Interior Interior Department See

Fish and Wildlife Service

See

Geological Survey

See

National Park Service

See

Reclamation Bureau

Internal Revenue Internal Revenue Service RULES Preparer Tax Identification Number User Fee Update, 66792-66795 2015-27789 PROPOSED RULES Preparer Tax Identification Number User Fee Update, 66851-66853 2015-27791 International Trade Adm International Trade Administration NOTICES Retractions of Publications: Final Redetermination Pursuant to Court Remand, Wheatland Tube Co. v. United States, 66867 2015-27777 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Barium Chloride from China, 66935 2015-27739 Certain Radiotherapy Systems and Treatment Planning Software, and Components Thereof, 66934-66935 2015-27668 Justice Department Justice Department NOTICES Proposed Consent Decrees under the Clean Air Act, 66935 2015-27615 Labor Department Labor Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Resource Justification Model, 66935-66936 2015-27702 Merit Merit Systems Protection Board RULES Practices and Procedures, 66787-66788 2015-27652 National Agricultural National Agricultural Statistics Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 66866-66867 2015-27617 National Endowment for the Humanities National Endowment for the Humanities NOTICES Meetings: Federal Council on the Arts and the Humanities; Arts and Artifacts Indemnity Panel Advisory Committee, 66936-66937 2015-27642 National Council on the Humanities, 66937 2015-27643 National Foundation National Foundation on the Arts and the Humanities See

National Endowment for the Humanities

National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Consumer Health Information in Public Libraries User Needs Survey, 66914-66915 2015-27678 Generic Clearance for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Data and Specimen Hub, 66913-66914 2015-27717 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area, 66839-66840 2015-27694 NOTICES Presidential Task Force on Combating Illegal Unreported and Unregulated Fishing and Seafood Fraud Action Plan, 66867-66879 2015-27780 National Park National Park Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Programmatic Clearance for NPS-Sponsored Public Surveys, 66932-66933 2015-27714 National Science National Science Foundation NOTICES Meetings; Sunshine Act, 66937-66938 2015-27865 2015-27866 Navy Navy Department NOTICES Privacy Act; Systems of Records, 66889-66891 2015-27713 Nuclear Regulatory Nuclear Regulatory Commission NOTICES License Amendment Applications: Pacific Gas and Electric Company; Diablo Canyon Independent Spent Fuel Storage Installation, 66938-66941 2015-27770 Meetings; Sunshine Act, 66938 2015-27825 Personnel Personnel Management Office RULES Federal Long Term Care Insurance Program Eligibility Changes, 66785-66787 2015-27381 Pipeline Pipeline and Hazardous Materials Safety Administration RULES Hazardous Materials: Carriage of Battery-Powered Electronic Smoking Devices in Passenger Baggage, 66817-66821 2015-27622 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 66941-66942 2015-27664 2015-27665 Presidential Documents Presidential Documents ADMINISTRATIVE ORDERS Iran Threat Reduction and Syria Human Rights Act of 2012; Delegation of Functions and Authorities (Memorandum of October 18, 2015), 66781-66782 2015-27868 Iran; Joint Comprehensive Plan of Action Implementation (Memorandum of October 18, 2015), 66783-66784 2015-27869 Sudan; Continuation of National Emergency (Notice of October 28, 2015), 67257-67259 2015-27929 Reclamation Reclamation Bureau NOTICES Environmental Impact Statements; Availability, etc.: Sacramento Regional County Sanitation District South County Ag Water Recycling Program, 66933-66934 2015-27716 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: NASDAQ OMX BX, Inc., 66949-66951 2015-27649 NASDAQ OMX PHLX, LLC, 66955-66958 2015-27657 NASDAQ Stock Market, LLC, 66947-66949 2015-27650 New York Stock Exchange, LLC, 66942-66944 2015-27654 NYSE Arca, Inc., 66951-66955, 66958-66960 2015-27653 2015-27656 NYSE MKT, LLC, 66944-66947 2015-27655 Small Business Small Business Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 66961-66963 2015-27754 2015-27756 2015-27758 Disaster Declarations: South Carolina; Amendment 1, 66962-66963 2015-27624 South Carolina; Amendment 2, 66960-66961 2015-27634 South Carolina; Amendment 5, 66962 2015-27633 Texas, 66960 2015-27626 Washington, 66962 2015-27636 Military Reservist Economic Injury Disaster Loans: Interest Rate for First Quarter FY 2016, 66963 2015-27638 Social Social Security Administration PROPOSED RULES Vocational Factors of Age, Education, and Work Experience in the Adult Disability Determination Process; Comment Period Extention, 66843-66844 2015-27692 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 66967-66968 2015-27679 Cost-of-Living Increase and Other Determinations for 2016, 66963-66967 2015-27828 Surface Transportation Surface Transportation Board NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 66968-66969 2015-27726 Control Exemptions: SteelRiver Infrastructure Fund North America LP, et al.; Georgia Northeastern Railroad Co., Inc. and Blue Ridge Scenic Excursions, Inc., 66969-66970 2015-27731 Lease and Operation Exemptions: Intermodal RR Transfer, LLC; JACJON Associates, 66968 2015-27722 Transportation Department Transportation Department See

Federal Aviation Administration

See

Pipeline and Hazardous Materials Safety Administration

See

Surface Transportation Board

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 66970-66971 2015-27677
Treasury Treasury Department See

Fiscal Service

See

Internal Revenue Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 66972-66977 2015-27651 2015-27659 2015-27660 2015-27662 2015-27663
Customs U.S. Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Identification Card, 66915 2015-27767 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Supplement to VA Form, 66977-66978 2015-27670 Environmental Impact Statements; Availability, etc.: Reconfiguration of VA Black Hills Health Care System, 66978-66979 2015-27684 Replacement Robley Rex Veterans Affairs Medical Center, Louisville, KY, 66979-66980 2015-27658 Meetings: Commission on Care, 66980 2015-27589 National Research Advisory Council, 66979 2015-27680 Separate Parts In This Issue Part II Federal Deposit Insurance Corporation, 66982-67024 2015-27288 Part III Interior Department, Fish and Wildlife Service, 67026-67054 2015-27366 Part IV Energy Department, Federal Energy Regulatory Commission, 67056-67123 2015-26908 Part V Education Department, 67126-67201 2015-27145 Part VI Education Department, 67204-67242 2015-27143 Part VII Defense Department, Defense Acquisition Regulations System, 67244-67255 2015-27471 2015-27467 2015-27463 2015-27473 Part VIII Presidential Documents, 67257-67259 2015-27929 Reader Aids

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

To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.

80 210 Friday, October 30, 2015 Rules and Regulations OFFICE OF PERSONNEL MANAGEMENT 5 CFR Part 875 RIN 3206-AN05 Federal Long Term Care Insurance Program Eligibility Changes AGENCY:

U.S. Office of Personnel Management.

ACTION:

Final rule.

SUMMARY:

The United States Office of Personnel Management (OPM) is issuing a final rule to amend the Federal Long Term Care Insurance Program (FLTCIP) regulation to expand eligibility to apply for coverage under the Program. This rule expands the definition of “qualified relative” to include opposite-sex domestic partners of Federal and U.S. Postal Service employees, annuitants, members of the uniformed services, and retired members of the uniformed services. In addition, this rule provides that adult children of domestic partners will be considered one of the types of individuals comprising the statutory term “qualified relative” who may apply for FLTCIP coverage.

DATES:

Effective November 30, 2015.

FOR FURTHER INFORMATION CONTACT:

Ronald Brown, Policy Analyst, (202) 606-0004, or by email to [email protected].

SUPPLEMENTARY INFORMATION:

On November 13, 2014, OPM published proposed regulations in the Federal Register (79 FR 67377—67379) to (1) Expand the definition of “qualified relative” under 5 U.S.C. 9001(5)(D) to include both same-sex and opposite-sex domestic partners of Federal and U.S. Postal Service employees and annuitants and members and retired members of the uniformed services; (2) expand the definition of “qualified relative” to include adult children of domestic partners of Federal and U.S. Postal Service employees and annuitants, and members and retired members of the uniformed services; (3) allow the workforce member or his or her domestic partner to provide notice to the employing office if at any time between the time of application and the time coverage is scheduled to go into effect, any of the conditions for a domestic partnership are no longer met, in which case a domestic partnership is deemed terminated; (4) require domestic partners to provide documentation to establish that they meet the criteria for domestic partnership; (5) clarify that once coverage has begun, termination of a domestic partnership does not terminate a domestic partner's insurance coverage as long as the Carrier continues to receive the required premium when due; and (6) make other technical conforming amendments to the FLTCIP rules in connection with the extension of coverage to domestic partners and to adult children of domestic partners.

Comments were requested to be received on or before January 12, 2015. After reviewing the comments received OPM is issuing the final regulation as proposed.

Analysis of and Response to Public Comments

We received three comments on the proposed rule. All commenters expressed support for the proposed rule that extends important coverage to domestic partners and to children of domestic partners under the FLTCIP. One commenter approved the wording of the proposed rule with no suggested changes and this comment is not addressed. Below, please find our response to the remaining two comments we received.

Comment: The commenter had concerns as to the wording or the implications of this expansion primarily concerning states that do not recognize domestic partnerships, and requested to know how eligibility would be treated for qualified partners in states that do not recognize domestic partnerships. The commenter requested to know whether a couple that is considered, and could register as a domestic partnership in one state would be deemed ineligible in a state that does not recognize and does not register domestic partnerships or whether this would prohibit same-sex partnerships in states that prevent same-sex marriage. This commenter also noted that the FLTCIP regulation explains that one would not be deemed eligible if related in a way that would prohibit legal marriage in the U.S. jurisdiction in which the domestic partnership was formed and requested further clarification of how would this impact same-sex domestic partnerships in states that prevent same-sex marriage.

Response: The proposed and final regulations expand the definition of “qualified relative” to cover all individuals who are domestic partners (both same-sex and opposite-sex) of Federal and U.S. Postal Service employees, annuitants, members of the uniformed services, and retired members of the uniformed services no matter their state of residence. The regulation allows coverage for individuals who certify to their employing office that they meet the criteria in the regulatory definition of domestic partnership. The requirement in paragraph (v)(ii) of the definition of domestic partnership does not prevent those who reside in states that prohibit same-sex marriage to register as domestic partners. The requirement is meant to prevent those who are related by blood to certify to a domestic partnership as determined by their state of residence. This requirement already applies to same-sex domestic partners who can currently apply for coverage.

Comment: The commenter recommended that we amend the proposed rulemaking to ensure that all children of same-sex parents are eligible to access FLTCIP Benefits, regardless of their parents' ability to marry. The commenter stated that this can be achieved by redefining an eligible child to include the child of a person standing in loco parentis, where in loco parentis means those persons with day-to-day responsibilities to care for and financially support a child, and with whom a biological or legal relationship is not necessary.

Response: The proposed rule clarifies that OPM intends for children of domestic partners to be treated the same as currently eligible individuals. The eligibility of the stepchild does not depend upon the parent's ability to marry. The FLTCIP regulation provides that a “stepchild,” as defined in the proposed rule, may qualify for FLTCIP coverage as a qualified relative, if all eligibility requirements are met. The stepchild must be the child of the spouse or domestic partner of an employee, annuitant, member of the uniformed services, or retired member of the uniformed services. The stepchild(ren) may apply for coverage even if the employee does not apply, and his or her eligibility for FLTICP coverage is determined independent of the workforce member's ability to marry.

Regulatory Flexibility Act

I certify that this regulation will not have a significant economic impact on a substantial number of small entities because the regulation only adds additional groups to the list of groups eligible to apply for coverage under the FLTCIP. The FLTCIP is a voluntary, self-pay, benefits program with no Government contribution.

Executive Order 12866, Regulatory Review

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

Federalism

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

List of Subjects in 5 CFR Part 875

Administrative practice and procedure, Employee benefit plans, Government contracts, Government employees, health insurance, military personnel, organization and functions, Retirement.

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

Accordingly, OPM is amending 5 CFR part 875 as follows:

PART 875—FEDERAL LONG TERM CARE INSURANCE PROGRAM 1. The authority citation for 5 CFR part 875 continues to read as follows: Authority:

5 U.S.C. 9008.

Subpart A—Administration and General Provisions 2. Section 875.101 is amended by revising the definitions of “domestic partner” and “domestic partnership” and by adding in alphabetical order a definition of “stepchild(ren)” to read as follows:
§ 875.101 Definitions.

Domestic partner is defined as a person in a domestic partnership with an employee, annuitant, member of the uniformed services, or retired member of the uniformed services.

Domestic partnership means:

(1) A committed relationship between two adults, of the opposite sex or same sex, in which the partners—

(i) Are each other's sole domestic partner and intend to remain so indefinitely;

(ii) Maintain a common residence, and intend to continue to do so (or would maintain a common residence but for an assignment abroad or other employment-related, financial, or similar obstacle);

(iii) Are at least 18 years of age and mentally competent to consent to a contract;

(iv) Share responsibility for a significant measure of each other's financial obligations;

(v) Are not married or joined in a civil union to anyone else;

(vi) Are not a domestic partner of anyone else;

(vii) Are not related in a way that would prohibit legal marriage in the U.S. jurisdiction in which the domestic partnership was formed;

(viii) Provide documentation demonstrating fulfillment of the requirements of paragraphs (1)(i) through (vii) of this definition as prescribed by OPM; and

(ix) Certify that they understand that willful falsification of the documentation described in paragraph (1)(viii) of this definition may lead to disciplinary action and the recovery of the cost of benefits received related to such falsification and may constitute a criminal violation under 18 U.S.C. 1001.

(2) You or your domestic partner must notify the employing office if at any time between the time of application and the time coverage is scheduled to go into effect, any of the conditions listed in paragraphs (1)(i) through (vii) of this definition are no longer met, in which case a domestic partnership is deemed terminated. Such notification must be made as soon as possible, but in no event later than thirty calendar days after such conditions are no longer met.

Stepchild(ren), as set forth in section 9001 of title 5, United States Code, means the child(ren) of the spouse or domestic partner of an employee, annuitant, member of the uniformed services, or retired member of the uniformed services.

Subpart B—Eligibility 3. Section 875.208 is revised to read as follows:
§ 875.208 May I apply as a qualified relative if the person on whom I am basing my eligibility status has died?

You may not apply as a qualified relative if the workforce member on whom you are basing your qualified relative status died prior to the time you apply for coverage, unless you are receiving a survivor annuity as the spouse or an insurable interest annuity as the domestic partner of a deceased workforce member. In this case, your adult children and your current spouse or domestic partner are also considered to be qualified relatives.

4. In § 875.213, paragraph (a) is revised to read as follows:
§ 875.213 May I apply as a qualified relative if I am the domestic partner of a workforce member?

(a) You may apply for coverage as a qualified relative if you are a domestic partner, as described in § 875.101 of this chapter. As prescribed by OPM, you will be required to provide documentation to demonstrate that you meet these requirements, and you must submit to full underwriting requirements. However, as explained in § 875.210 of this chapter, if you lose your status as a domestic partner, and therefore a qualified relative, before your coverage goes into effect, you are no longer eligible for FLTCIP coverage.

Subpart D—Coverage 5. Section 875.405 is revised to read as follows:
§ 875.405 If I marry, may my new spouse apply for coverage; if I become a domestic partner, may my new domestic partner apply for coverage; and may other qualified relatives apply for coverage?

(a) Marriage. (1) If you are an active workforce member and you have married, your spouse is eligible to submit an application for coverage under this section within 60 days from the date of your marriage and will be subject to the underwriting requirements in force for the spouses of active workforce members during the most recent open season. You, however, are not eligible for abbreviated underwriting because of your marriage. You, your spouse, or both you and your spouse may apply for coverage during this 60-day period, but full underwriting will be required for you. After 60 days from the date of your marriage, you and/or your spouse may still apply for coverage but will be subject to full underwriting.

(2) If you are an active workforce member and you have entered into a domestic partnership, your domestic partner is eligible to submit an application for coverage under this section at any time from the commencing date of your domestic partnership and will be subject to full underwriting requirements. You are not eligible for abbreviated underwriting because of your domestic partnership. You, your domestic partner, or both you and your domestic partner may apply for coverage at any time, but full underwriting will be required for both of you.

(b) Domestic partnership. The new spouse or domestic partner of an annuitant or retired member of the uniformed services may apply for coverage with full underwriting at any time following the marriage or commencing date of the domestic partnership.

(c) Other qualified relatives. Other qualified relative(s) of a workforce member may apply for coverage with full underwriting at any time following the marriage or commencing date of the domestic partnership.

6. In § 875.412, the introductory text is revised and paragraph (e) is added to read as follows:
§ 875.412 When will my coverage terminate?

Except as provided in paragraph (e) of this section, your coverage will terminate on the earliest of the following dates:

(e) Termination of a domestic partnership does not terminate insurance coverage as long as the Carrier continues to receive the required premium when due.

[FR Doc. 2015-27381 Filed 10-29-15; 8:45 am] BILLING CODE 6325-63-P
MERIT SYSTEMS PROTECTION BOARD 5 CFR Part 1201 Practices and Procedures AGENCY:

Merit Systems Protection Board.

ACTION:

Interim final rule.

SUMMARY:

The Merit Systems Protection Board (MSPB or the Board) hereby amends its rules of practice and procedure to clarify that parties have a right to discovery under the MSPB's existing discovery procedures in compliance proceedings.

DATES:

This interim final rule is effective on October 30, 2015. Submit written comments concerning this interim final rule on or before December 29, 2015.

ADDRESSES:

Submit your comments concerning this interim final rule by one of the following methods and in accordance with the relevant instructions:

Email: [email protected] Comments submitted by email can be contained in the body of the email or as an attachment in any common electronic format, including word processing applications, HTML and PDF. If possible, commenters are asked to use a text format and not an image format for attachments. An email should contain a subject line indicating that the submission contains comments concerning the MSPB's interim final rule. The MSPB asks that commenters use email to submit comments if possible. Submission of comments by email will assist the MSPB to process comments and speed publication of a final rule.

Fax: (202) 653-7130. Comments submitted by fax should be addressed to William D. Spencer and contain a subject line indicating that the submission contains comments concerning the MSPB's interim final rule.

Mail or other commercial delivery: Comments submitted by mail should be addressed to William D. Spencer, Clerk of the Board, Merit Systems Protection Board, 1615 M Street NW., Washington, DC 20419.

Hand delivery or courier: Comments submitted by hand delivery or courier should be addressed to William D. Spencer, Clerk of the Board, Merit Systems Protection Board, 1615 M Street NW., Washington, DC 20419, and delivered to the 5th floor reception window at this street address. Such deliveries are only accepted Monday through Friday, 9 a.m. to 4:30 p.m., excluding Federal holidays.

Instructions: As noted above, the MSPB requests that commenters use email to submit comments, if possible. All comments received will be made available online at the Board's Web site, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information or other information whose disclosure is restricted by law. Those desiring to submit anonymous comments must submit comments in a manner that does not reveal the commenter's identity, include a statement that the comment is being submitted anonymously, and include no personally-identifiable information. The email address of a commenter who chooses to submit comments using email will not be disclosed unless it appears in comments attached to an email or in the body of a comment.

FOR FURTHER INFORMATION CONTACT:

William D. Spencer, Clerk of the Board, Merit Systems Protection Board, 1615 M Street NW., Washington, DC, 20419; phone: (202) 653-7200; fax: (202) 653-7130; or email: [email protected]

SUPPLEMENTARY INFORMATION:

This interim final rule is necessary because in Bernard v. Dep't of Agric., 788 F.3d 1365, 1367-70 (Fed. Cir. 2015), the United States Court of Appeals for the Federal Circuit held that the MSPB's regulations provide no clear guarantee that parties are authorized to undertake discovery in enforcement proceedings. This interim final rule amends the MSPB's regulations to address this holding and make clear that the parties have a right to discovery in such cases under the Board's existing discovery procedures.

Amendments Made by This Interim Final Rule

A new provision, section 1201.183(a)(9), is inserted to make clear that discovery may be undertaken in enforcement matters. This new provision makes clear that the Board's regular discovery procedures apply in enforcement matters and sets a deadline by which initial discovery requests must be filed. As in other Board cases, this deadline may be changed by the judge.

Justification for Use of Interim Final Rule

Ordinarily, the Administrative Procedure Act (APA) requires an agency to provide notice of proposed rulemaking and a period of public comment before the promulgation of a new regulation. 5 U.S.C. 553(b) and (c). However, section 553(b) of the APA specifically provides that the notice and comment requirements do not apply:

(A) To interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or

(B) when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest. The APA also requires the publication of any substantive rule at least thirty days before its effective date, 5 U.S.C. 553(d), except where the rule is interpretive, where the rule grants an exception or relieves a restriction, or “as otherwise provided by the agency for good cause found and published with the rule.” Id.

The Board finds that use of an immediately effective interim final rule instead of notice and comment rulemaking is appropriate here because the amendments contained herein merely reflect the decision of the Federal Circuit in Bernard and are necessary to avert any further confusion regarding the Board's practice and procedures governing the right to discovery in compliance cases. Under these circumstances, notice and comment rulemaking is unnecessary and not required by any public interest.

List of Subjects in 5 CFR Part 1201

Administrative practice and procedure.

Accordingly, for the reasons set forth in the preamble, the Board amends 5 CFR part 1201 as follows:

PART 1201—PRACTICES AND PROCEDURES 1. The authority citation for 5 CFR part 1201 continues to read as follows: Authority:

5 U.S.C. 1204, 1305, and 7701, and 38 U.S.C. 4331, unless otherwise noted.

2. Section 1201.183 is amended by adding paragraph (a)(9) to read as follows:
§ 1201.183 Procedures for processing petitions for enforcement.

(a) * * *

(9) Discovery may be undertaken in accordance with the Board's regular discovery procedures (§§ 1201.71 through 1201.75 of this part), except that unless otherwise directed by the judge, initial discovery requests must be served no later than 15 days after the alleged noncomplying party files a response to the petition for enforcement as required under paragraph (a)(1) of this section.

William D. Spencer, Clerk of the Board.
[FR Doc. 2015-27652 Filed 10-29-15; 8:45 am] BILLING CODE 7400-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 23 [Docket No. FAA-2015-3880; Special Conditions No. 23-271-SC] Special Conditions: Honda Aircraft Company (Honda) Model HA-420, HondaJet; Cruise Speed Control System AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final special conditions.

SUMMARY:

These special conditions are issued for the Honda Aircraft Company HA-420 airplane. This airplane will have a novel or unusual design feature(s) associated with the use of a cruise speed control system. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES:

These special conditions are effective October 30, 2015 and are applicable on October 26, 2015.

FOR FURTHER INFORMATION CONTACT:

Jeff Pretz, Federal Aviation Administration, Small Airplane Directorate, Aircraft Certification Service, 901 Locust, Room 301, Kansas City, MO 64106; telephone (816) 329-3239; facsimile (816) 329-4090.

SUPPLEMENTARY INFORMATION: Background

On October 11, 2006, Honda Aircraft Company applied for a type certificate for their new Model HA-420. On October 10, 2013, Honda Aircraft Company requested an extension with an effective application date of October 1, 2013. This extension changed the type certification basis to amendment 23-62.

The HA-420 is a four to five passenger (depending on configuration), two crew, lightweight business jet with a 43,000-foot service ceiling and a maximum takeoff weight of 9963 pounds. The airplane is powered by two GE-Honda Aero Engines (GHAE) HF-120 turbofan engines.

The HA-420 airplane will use a cruise speed control system (CSC), which is part of the automatic flight control system (AFCS), to reduce pilot workload during cruise flight only. The intended function is automatic airplane speed control during altitude hold AFCS mode by adjustment of the engine thrust within a narrow authority band utilizing the existing engine synchronization control. The CSC system does not back drive the throttles. The command authority is limited to values used for engine synchronization and can only be engaged when the throttle is positioned in a pre-determined range typically used for cruise power. This significantly reduces the CSC authority such that failure modes of the system should be minor. The proposed CSC system functions in a manner similar to an auto-throttle system, but has significantly less authority when compared to a traditional auto-throttle system.

Type Certification Basis

Under the provisions of 14 CFR 21.17, Honda Aircraft Company must show that the HA-420 meets the applicable provisions of part 23, as amended by amendments 23-1 through 23-62, thereto.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 23) do not contain adequate or appropriate safety standards for the HA-420 because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the HA-420 must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36. In addition, the FAA must issue a finding of regulatory adequacy pursuant to § 611 of Public Law 92-574, the “Noise Control Act of 1972.”

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.17(a)(2). Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

Novel or Unusual Design Features

The HA-420 will incorporate the following novel or unusual design features: Cruise Speed Control system

Discussion

As defined in the summary section, this airplane makes use of a CSC system, which is a novel design for this type of airplane. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. Mandating additional requirements, developed in part by adapting relevant portions of 14 CFR 25.1329, Automatic pilot systems, applicable to auto-throttle systems along with FAA experience with similar autothrust systems, mitigates the concerns associated with installation of the proposed CSC system.

Discussion of Comments

Notice of proposed special conditions No. 23-15-05-SC for the Honda Aircraft Company model HA-420 airplanes was published in the Federal Register on September 23, 2015 (80 FR 57312). No comments were received; therefore, the special conditions are adopted as proposed.

Applicability

As discussed above, these special conditions are applicable to the HA-420. Should Honda Aircraft Company apply at a later date for a change to the type certificate to include another model on the same type certificate incorporating the same novel or unusual design feature, the special conditions would apply to that model as well.

Under standard practice, the effective date of final special conditions would be 30 days after the date of publication in the Federal Register; however, as the certification date for the Honda Aircraft Company model HA-420 airplane is imminent, the FAA finds that good cause exists to make these special conditions effective upon issuance.

Conclusion

This action affects only certain novel or unusual design features on one model of HA-420 airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

List of Subjects in 14 CFR Part 23

Aircraft, Aviation safety, Signs and symbols.

The authority citation for these special conditions is as follows:

Authority:

49 U.S.C. 106(g), 40113, 44701, 14 CFR 21.16 and 21.17; and 14 CFR 11.38 and 11.19.

The Special Conditions

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Honda Aircraft Company HA-420 airplanes.

1. Cruise Speed Control.

In addition to the requirements of §§ 23.143, Controllability and Maneuverability—General; 23.1309, Equipment, systems, and installations; and 23.1329, Automatic pilot system; auto throttle systems of limited authority that do not back drive the throttles and for which all failure modes are shown to be no greater than minor, the following requirements apply:

(a) Quick disengagement controls for the autothrust functions must be provided for each pilot. Quick disengagement controls must be readily accessible to each pilot while operating the thrust control levers.

(b) The effects of a failure of the system to disengage the autothrust functions when manually commanded by the pilot must be assessed in accordance with the requirements of § 23.1309.

(c) Engagement or switching of the flight guidance system, a mode, or a sensor may not cause the autothrust system to effect a transient response that alters the airplane's flight path any greater than a minor transient, as defined in paragraph (l)(1) of this section.

(d) Under normal conditions, the disengagement of any automatic control function of a flight guidance system may not cause a transient response of the airplane's flight path any greater than a minor transient.

(e) Under rare normal and non-normal conditions, disengagement of any automatic control function of a flight guidance system may not result in a transient any greater than a significant transient, as defined in paragraph (l)(2) of this section.

(f) The function and direction of motion of each command reference control (such as CSC) must be plainly indicated on, or adjacent to, each control, if necessary to prevent inappropriate use or confusion.

(g) Under any condition of flight appropriate to its use, the flight guidance system may not produce hazardous loads on the airplane, nor create hazardous deviations in the flight path. This applies to both fault-free operation and in the event of a malfunction, and assumes that the pilot begins corrective action within a reasonable period of time.

(h) When the flight guidance system is in use, a means must be provided to avoid excursions beyond an acceptable margin from the speed range of the normal flight envelope. If the airplane experiences an excursion outside this range, a means must be provided to prevent the flight guidance system from providing guidance or control to an unsafe speed.

(i) The flight guidance system functions, controls, indications, and alerts must be designed to minimize flightcrew errors and confusion concerning the behavior and operation of the flight guidance system. Means must be provided to indicate the current mode of operation, including any armed modes, transitions, and reversions. Selector switch position is not an acceptable means of indication. The controls and indications must be grouped and presented in a logical and consistent manner. The indications must be visible to each pilot under all expected lighting conditions.

(j) Following disengagement of the autothrust function, a caution (visual and, unless there are no misleading or hazardous consequences associated with its absence, auditory) must be provided to each pilot.

(k) During autothrust operation, it must be possible for the flightcrew to move the thrust levers without requiring excessive force. The autothrust may not create a potential hazard when the flightcrew applies an override force to the thrust levers.

(l) For purposes of this section, a transient is a disturbance in the control or flight path of the airplane that is not consistent with response to flightcrew inputs or environmental conditions.

(1) A minor transient would not significantly reduce safety margins and would involve flightcrew actions that are well within their capabilities. A minor transient may involve a slight increase in flightcrew workload or some physical discomfort to passengers or cabin crew.

(2) A significant transient may lead to a significant reduction in safety margins, an increase in flightcrew workload, discomfort to the flightcrew, or physical distress to the passengers or cabin crew, possibly including non-fatal injuries. Significant transients do not require, in order to remain within or recover to the normal flight envelope, any of the following:

(i) Exceptional piloting skill, alertness, or strength.

(ii) Forces applied by the pilot which are greater than those specified in § 23.143(c).

(iii) Accelerations or attitudes in the airplane that might result in further hazard to secured or non-secured occupants.

Issued in Kansas City, Missouri, on October 26, 2015. Mel Johnson Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2015-27700 Filed 10-29-15; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-3300; Directorate Identifier 2015-CE-024-AD; Amendment 38-18309; AD 2015-22-04] RIN 2120-AA64 Airworthiness Directives; Fiberglas-Technik Rudolf Lindner GmbH & Co. KG Gliders AGENCY:

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

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for all Fiberglas-Technik Rudolf Lindner GmbH & Co. KG Models G103 TWIN ASTIR, G103 TWIN II, and G103A TWIN II ACRO gliders. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as a broken bell-crank installed in the air brake control system. We are issuing this AD to require actions to address the unsafe condition on these products.

DATES:

This AD is effective December 4, 2015.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in the AD as of December 4, 2015.

ADDRESSES:

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-3300; or in person at Document 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 service information identified in this AD, contact Fiberglas-Technik Rudolf Lindner GmbH & Co.KG, Steige 3, D-88487 Walpertshofen, Germany; phone: ++49 (0) 7353/22 43; fax: ++49 (0) 7353/30 96; email: [email protected]; Internet: www.ltb-lindner.com. You may view this referenced service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the Internet at http://www.regulations.gov by searching for Docket No. FAA-2015-3300.

FOR FURTHER INFORMATION CONTACT:

Jim Rutherford, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4165; fax: (816) 329-4090; email: [email protected].

SUPPLEMENTARY INFORMATION: Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to add an AD that would apply to all Fiberglas-Technik Rudolf Lindner GmbH & Co. KG Models G103 TWIN ASTIR, G103 TWIN II, and G103A TWIN II ACRO gliders. The NPRM was published in the Federal Register on August 10, 2015 (80 FR 47871). The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states:

A report was received concerning a broken bell-crank, installed in the air brake control circuit approximately 1.4 m outside the wing root rib of a GROB G 103 Twin II sailplane. Preliminary investigation results revealed additional cases of cracks on the same part, installed in the air brake control systems of the early Twin II type design.

The same bell-cranks are also installed at the same location in the control systems of other models belonging to the same type design (see list of affected models under Applicability).

This condition, if not detected and corrected, could lead to failure of the air brake system, possibly resulting in reduced control of the sailplane.

To address this potential unsafe condition, Fiberglas-Technik issued Technische Mitteilung (TM)/Service Bulletin (SB) TM-G08/SB-G08 (one document) and Anweisung (A)/Instructions (I) A/I-G08 (one document) to provide instructions for a check of the air brake locking forces, the inspection of the bell-crank and, if cracks are found, replacement of the bell-crank.

Additionally, TM-G07/SB-G07 (one document) and A/I-G07 (one document) provide instructions for the installation of inspection openings in the wing of GROB G 103 TWIN II and G 103 A TWIN II ACRO sailplanes to facilitate the inspection of the bell-crank. (For the TWIN ASTIR and TWIN ASTIR TRAINER sailplanes, such an opening is required by LBA AD 92-190/2 (GROB SB 315-45/2.) This installation is optional for sailplanes not exceeding the original intended life limit.

For the reason described above, this AD requires a check of the air brake locking forces, an inspection for cracks in the air brake control unit and, if cracks are found, replacement of the affected flight control system parts. This AD is a temporary measure and further AD action may follow.

The MCAI can be found in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-3300-0003.

Comments

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

Request Credit for Certain Inspections Done Before AD Was Issued

William Tisdale requested that the AD give credit for inspections that were done following Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G08), Edition April 24, 2015; and Fiberglas-Technik Rudolf Lindner Anweisung (English translation: Instructions), (A/I-G08), Ausgabe (English translation: Edition) April 24, 2015, within the year before the AD being issued as meeting the initial inspection requirement for both the tension and crack inspection.

We infer that the commenter made this request in order to prevent duplication of work already done.

We agree with the commenter. In paragraph (f) of this AD, the first sentence reads, “Unless already done, do the following actions:.” This sentence gives compliance credit to owners/operators of the affected gliders for actions required by this AD that have already been done before the effective date of this AD, if done following the service information required by this AD.

Because the requested change is already part of this AD, we have not changed the final rule AD action based on this comment.

Request to Use Lighted Borescope To Inspect the Bell-Crank

William Tisdale requested the use of a lighted borescope from either the wing rib root or access through the spoiler box push rod opening to inspect the bell-crank.

We infer that the commenter wants us to incorporate into the AD an allowance to use a lighted borescope to do the inspection of the bell-crank installed in the air brake control system.

We agree with the commenter about using a lighted borescope for the inspection from the wing rib root as it is already allowed in Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G08), Edition April 24, 2015; and Fiberglas-Technik Rudolf Lindner Anweisung (English translation: Instructions), (A/I-G08), Ausgabe (English translation: Edition) April 24, 2015. In the service information it states, “This inspection is done using an endoscope or small camera working through the wing root rib or using a mirror when working through an inspecting opening.” An endoscope consists of an optical system with a high intensity light source and is sometimes referred to as a borescope.

We disagree with the commenter with using a lighted borescope to do the inspection by accessing the area through the spoiler box push rod opening since this procedure is not specified in the required service information. The commenter may request an alternative method of compliance (AMOC) for this process. The request, including all substantiating data, may be submitted following 14 CFR 39.19 as specified in paragraph (g)(1) of this AD.

Conclusion

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the 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 (80 FR 47871, August 10, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 47871, August 10, 2015).

Related Service Information Under 1 CFR Part 51

We reviewed Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G08), Edition April 24, 2015; and Fiberglas-Technik Rudolf Lindner Anweisung/(English translation: Instructions), (A/I-G08), Ausgabe (English translation: Edition) April 24, 2015. The service information describes procedures for inspecting the air brake locking forces; inspecting the bell-crank; and, if cracks are found during the inspections, replacing the bell-crank. 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 of the AD.

Interim Action

We consider this AD interim action. The design approval holder is working toward a terminating action for the repetitive inspections. We may take further AD action in the future.

Costs of Compliance

We estimate that this AD will affect 106 products of U.S. registry. We also estimate that it will take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $18,020, or $170 per product.

In addition, we estimate that any necessary follow-on actions will be as follows:

• Replacement of bell-crank will take about 5 work-hours per product. Required parts will cost about $566 for a total of $991 per product.

• Installation of optional inspection openings will take about 15 work-hours per product. Required parts will cost about $1,004 for a total of $2,279 per product.

We have no way of determining the number of products that may need these actions.

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 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.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-3300; 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 the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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 AD: 2015-22-04 Fiberglas-Technik Rudolf Lindner GmbH & Co. KG: Amendment 38-18309; Docket No. FAA-2015-3300; Directorate Identifier 2015-CE-024-AD. (a) Effective Date

This airworthiness directive (AD) becomes effective December 4, 2015.

(b) Affected ADs

None.

(c) Applicability

This AD applies to Fiberglas-Technik Rudolf Lindner GmbH & Co. KG Models G103 TWIN ASTIR, G103 TWIN II, and G103A TWIN II ACRO gliders, all manufacturer serial numbers, certificated in any category.

(d) Subject

Air Transport Association of America (ATA) Code 27: Flight Controls.

(e) Reason

This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as a broken bell-crank installed in the air brake control system. We are issuing this AD to detect and correct a broken bell-crank which could lead to failure of the air brake system, possibly resulting in reduced control.

(f) Actions and Compliance

Unless already done, do the following actions:

(1) Within 30 days after December 4, 2015 (the effective date of this AD) and repetitively thereafter at intervals not to exceed 12 months, inspect the locking forces of the air brake control unit, and, if any discrepancy is found, before further flight, correct the locking forces. Do the inspection and correction of any discrepancy following the instructions of Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G08), Edition April 24, 2015; and Fiberglas-Technik Rudolf Lindner Anweisung (English translation: Instructions), (A/I-G08), Ausgabe (English translation: Edition) April 24, 2015.

Note 1 to paragraph (f)(1) of this AD:

This service information contains German to English translation. The European Aviation Safety Agency (EASA) used the English translation in referencing the document. For enforceability purposes, we will refer to the Fiberglas-Technik Rudolf Lindner service information as it appears on the document.

(2) Within 60 days after December 4, 2015 (the effective date of this AD), inspect the bell-crank installed in the air brake control system, and, if any cracks are found, before further flight, replace the bell-crank with a serviceable part. Do the inspection and replacement following the instructions of Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G08), Edition April 24, 2015; and Fiberglas-Technik Rudolf Lindner Anweisung (English translation: Instructions), (A/I-G08), Ausgabe (English translation: Edition) April 24, 2015.

Note 2 to paragraph (f)(2) of this AD:

In the lower wing surface inspection, openings near the bell-crank may be installed to simplify the inspection and make a possible replacement of the bell-crank possible. This optional installation is described in GROB Luft Und Raumfahrt Service Bulletin 315-45/2, dated December 21, 1995; and Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G07), Edition April 24, 2015.

(3) Within 30 days after replacing a bell-crank as required by paragraph (f)(2) of this AD or within the next 30 days after December 4, 2015 (the effective date of this AD), whichever occurs later, report the inspection results of the removed bell-crank to Fiberglas-Technik Rudolf Lindner GmbH & Co. KG. You may find contact information for Fiberglas-Technik Rudolf Lindner GmbH & Co. KG in paragraph (h) of this AD.

(g) Other FAA AD Provisions

The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Jim Rutherford, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4165; fax: (816) 329-4090; email: [email protected]. Before using any approved AMOC on any glider to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.

(2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.

(3) Reporting Requirements: For any reporting requirement in this AD, 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.

(h) Related Information

Refer to MCAI European Aviation Safety Agency (EASA) AD No.: 2015-0116, dated June 24, 2015; GROB Luft Und Raumfahrt Service Bulletin 315-45/2, dated December 21, 1995; and Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G07), Edition April 24, 2015, for related information. You may examine the MCAI on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-3300-0003.

(i) Material Incorporated by Reference

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

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

(i) Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G08), Edition April 24, 2015; and

(ii) Fiberglas-Technik Rudolf Lindner Anweisung (English translation: Instructions), (A/I-G08), Ausgabe (English translation: Edition) April 24, 2015.

(3) For Fiberglas-Technik Rudolf Lindner GmbH & Co. KG service information identified in this AD, contact Fiberglas-Technik Rudolf Lindner GmbH & Co. KG, Steige 3, D-88487 Walpertshofen, Germany; phone: ++49 (0) 7353/22 43; fax: ++49 (0) 7353/30 96; email: [email protected]; Internet: http://www.ltb-lindner.com.

(4) You may view this service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. In addition, you can access this service information on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-3300.

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

Issued in Kansas City, Missouri on October 22, 2015. Melvin Johnson, Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2015-27440 Filed 10-29-15; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 300 [T.D. 9742] RIN 1545-BN03 Preparer Tax Identification Number (PTIN) User Fee Update AGENCY:

Internal Revenue Service (IRS), Treasury.

ACTION:

Temporary regulations.

SUMMARY:

This document contains temporary regulations relating to the imposition of certain user fees on tax return preparers. The temporary regulations reduce the user fee to apply for or renew a preparer tax identification number (PTIN) and affect individuals who apply for or renew a PTIN. The Independent Offices Appropriations Act of 1952 authorizes the charging of user fees. The text of the temporary regulations also serves as the text of the proposed regulations (REG-121496-15) set forth in the notice of proposed rulemaking on this subject in the Proposed Rules section of this issue of the Federal Register.

DATES:

Effective Date: These regulations are effective on October 30, 2015.

Applicability Date: For date of applicability, see paragraph (d) of these temporary regulations.

FOR FURTHER INFORMATION CONTACT:

Concerning the temporary regulations, Hollie M. Marx at (202) 317-6844; concerning cost methodology, Eva J. Williams at (202) 803-9728.

SUPPLEMENTARY INFORMATION:

Background

The Independent Offices Appropriations Act of 1952 (IOAA), which is codified at 31 U.S.C. 9701, authorizes agencies to prescribe regulations that establish user fees for services provided by the agency. The charges must be fair and must be based on the costs to the government, the value of the service to the recipient, the public policy or interest served, and other relevant facts. The IOAA provides that regulations implementing user fees are subject to policies prescribed by the President; these policies are set forth in the Office of Management and Budget Circular A-25, 58 FR 38142 (July 15, 1993) (OMB Circular A-25).

Under OMB Circular A-25, federal agencies that provide services that confer benefits on identifiable recipients are to establish user fees that recover the full cost of providing the special benefit. An agency that seeks to impose a user fee for government-provided services must calculate the full cost of providing those services. In general, a user fee should be set at an amount that allows the agency to recover the direct and indirect costs of providing the service, unless the Office of Management and Budget grants an exception. OMB Circular A-25 provides that agencies are to review user fees biennially and update them as necessary.

PTIN Requirement

Section 6109(a)(4) of the Internal Revenue Code authorizes the Secretary to prescribe regulations for the inclusion of a tax return preparer's identifying number on a return, statement, or other document required to be filed with the IRS. On September 30, 2010, the Treasury Department and IRS published final regulations under section 6109 (REG-134235-08) in the Federal Register (TD 9501) (75 FR 60315) (PTIN regulations) to provide that, for returns or claims for refund filed after December 31, 2010, the identifying number of a tax return preparer is the individual's PTIN or such other number prescribed by the IRS in forms, instructions, or other appropriate guidance. The PTIN regulations require a tax return preparer who prepares or who assists in preparing all or substantially all of a tax return or claim for refund after December 31, 2010 to have a PTIN. The PTIN regulations also state that the IRS will set forth in forms, instructions or other appropriate guidance PTIN application and renewal procedures, including the payment of a user fee. The PTIN regulations further state that the IRS may conduct a Federal tax compliance check on an individual who applies for or renews a PTIN.

In accordance with section 1.6109-2(d) of the PTIN regulations, the IRS has set forth application and renewal procedures in Form W-12, IRS Paid Preparer Tax Identification Number (PTIN) Application and Renewal, and the Form W-12 Instructions. Individuals may also apply for or renew a PTIN and pay the user fee online at irs.gov/ptin. The annual PTIN application and renewal period generally begins in the fall (on October 15 in previous years) of the year preceding the filing season to which the PTIN relates. A third-party vendor processes applications to obtain or renew a PTIN and charges a reasonable fee that is separate from the user fee charged by the government.

Requiring the use of PTINs improves tax administration and tax compliance and benefits tax return preparers by allowing them to provide an identifying number on the return that is not an SSN. Requiring the use of PTINs enables the IRS to better collect and track data on tax return preparers, including the number of persons who prepare returns, the qualifications of those who prepare returns, and the number of returns each person prepares. PTIN use allows the IRS to more easily identify and communicate with tax return preparers who make errors on returns, which benefits tax return preparers by improving compliance and therefore reducing the number of client returns that are examined. The PTIN also enables the IRS to more easily locate and review returns prepared by a tax return preparer when instances of misconduct or potential misconduct are detected, which aids tax administration and compliance. These aids to tax administration and compliance in turn benefit taxpayers and tax return preparers by working to reduce preparer error and misconduct.

Section 1.6109-2(d) states that only individuals authorized to practice before the IRS under 31 U.S.C. 330 are eligible to obtain a PTIN. Under section 1.6109-2(h), the IRS may prescribe in forms, instructions, or other appropriate guidance exceptions to the requirements of the PTIN regulations, including the requirement that an individual must be authorized to practice before the IRS to be eligible to receive a PTIN. On December 30, 2010, the IRS released Notice 2011-6 (2011-3 IRB 315 (Jan. 17, 2011)), which stated that, until December 31, 2013, a provisional PTIN could be renewed upon proper application and payment of the applicable user fee, even if the individual holding the provisional PTIN was not authorized to practice before the IRS.

On June 3, 2011, the Treasury Department and the IRS published in the Federal Register (76 FR 32286) amendments to Treasury Department Circular No. 230 (31 CFR part 10), to regulate all tax return preparers under 31 U.S.C. 330. In Loving v. IRS, 917 F.Supp.2d 67 (D.D.C. 2013), the district court concluded that the IRS and Treasury Department lacked statutory authority to regulate tax return preparation as practice before the IRS under 31 U.S.C. 330 and enjoined the IRS and Treasury from enforcing the regulation of registered tax return preparers. The district court subsequently modified its order to clarify that the IRS's authority to require that tax return preparers obtain a PTIN is unaffected by the injunction. Loving v. IRS, 920 F.Supp.2d 108, 109 (D.D.C. 2013) (stating “Congress has specifically authorized the PTIN scheme by statute . . . [and that] scheme, therefore, does not fall within the scope of the injunction and may proceed as promulgated.”). The United States Court of Appeals for the District of Columbia Circuit affirmed the district court's decision and order for injunction. Loving v. IRS, 742 F.3d 1013 (D.C. Cir. 2014).

PTIN User Fee

Final regulations (REG-139343-08) published in the Federal Register (TD 9503) (75 FR 60316) (PTIN user fee regulations) on September 30, 2010, established a $50 user fee to apply for or renew a PTIN. The $50 user fee was based on an annual PTIN renewal period and an estimate that 1.2 million individuals would be applying for or renewing a PTIN each year.

The IRS and Treasury Department determined that a $50 user fee to apply for or renew a PTIN would recover the full direct and indirect costs that the government incurs to administer the PTIN application and renewal process. The initial determination of a $50 annual fee took into account certain costs that the IRS ascertained it would incur to provide the special benefit associated with the provision of PTINs. As explained in the PTIN user fee regulations, the initial projected costs included the development and maintenance of the IRS information technology system that would interface with a third-party vendor, the development and maintenance of internal applications that would have the capacity to process and administer the anticipated increase in PTIN applications, customer service support activities, which included Web site development and maintenance and call center staffing to respond to questions regarding PTIN usage and renewal. The $50 user fee was also determined to recover costs for personnel, administrative, and management support needed to evaluate and address tax compliance issues of individuals applying for and renewing a PTIN, to investigate and address conduct and suitability issues, and otherwise support and enforce the programs that required an individual to apply for and renew a PTIN.

The vendor's fee, currently set at $14.25 for new applications and $13 for renewal applications, is paid directly to the vendor and covers the costs incurred by the vendor to process applications and renewals. The agency user fee and the vendor fee pay for different aspects of the PTIN program, each of which is essential to the program.

Explanation of Provisions

Pursuant to the guidelines in OMB Circular A-25, the IRS has re-calculated its cost of providing services under the PTIN application and renewal process. The IRS has determined that the full cost of administering the PTIN program going forward has been reduced from $50 to $33 per application or renewal. Individuals who prepare or assist in preparing all or substantially all of a tax return or claim for refund for compensation are required to have a PTIN. The ability to prepare tax returns and claims for refund for compensation is a special benefit, for which the IRS may charge a user fee to recover the full costs of providing the special benefit.

The amount of the user fee is $33 for both initial PTIN applications and renewals because the activities the IRS is required to perform to issue a new PTIN or renew an existing PTIN are the same. Pursuant to the authority granted in section 6109(c), the IRS has determined that it requires certain information to assign (or, in the case of a renewal, re-assign) a PTIN to an individual. The required information is set forth in the Form W-12 and Form W-12 Instructions.

The PTIN user fee is based on direct costs of the PTIN program, which include staffing and contract-related costs for activities, processes, and procedures related to the electronic and paper registration and renewal submissions; tax compliance and background checks; professional designation checks; foreign preparer processing; compliance and IRS complaint activities; information technology and contract-related expenses; and communications. The PTIN user fee also takes into account various indirect program costs, including management and support costs.

The reduction in the fee amount is attributable to several factors, which include the reduced number of PTIN holders (approximately 700,000) from the number originally projected (1.2 million) in 2010, which reduced associated costs; the absorption of certain development costs in the early years of the program; and the fact that certain activities that would have been required to regulate registered tax return preparers will not be performed. In particular, the determination of the user fee no longer includes expenses for personnel who perform functions primarily related to continuing education and testing for registered tax return preparers. Additionally, expenses related to personnel who perform continuing education and testing for enrolled agents and enrolled retirement plan agents were also removed from the user fee.

Individuals who apply for or renew a PTIN will continue to pay a fee directly to a third-party vendor, which is separate from the user fee described in this Treasury decision. The vendor fee is increasing from $14.25 for original applications and $13 for renewal applications to $17 for original applications and $17 for renewal applications.

Special Analyses

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866, as supplemented by Executive Order 13563.

Historically, the annual PTIN application and renewal period has begun on October 15. For 2015, the date has been postponed to November 1. There is insufficient time before November 1 to provide an opportunity for notice and public comment and issue a final regulation prior to that date. To enable the reduced fee amount to be in effect for PTINs issued or renewed by tax return preparers preparing returns in 2016, the IRS and Treasury find that there is good cause to dispense with (1) notice and public comment pursuant to 5 U.S.C. 553(b) and (c) and (2) a delayed effective date pursuant to 5 U.S.C. 553(d). It would be impracticable, unnecessary, and contrary to the public interest to continue to charge the current fee when the IRS has determined pursuant to the biennial review conducted under OMB Circular A-25 that the fee should be reduced going forward. The IRS and Treasury Department will consider public comments submitted in response to the cross-referenced notice of proposed rulemaking published elsewhere in this issue of the Federal Register and will promulgate a final rule after considering those comments.

For applicability of the Regulatory Flexibility Act, please refer to the cross-referenced notice of proposed rulemaking published elsewhere in this issue of the Federal Register. Pursuant to section 7805(f), this Treasury decision has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

Drafting Information

The principal author of these regulations is Hollie M. Marx, Office of the Associate Chief Counsel (Procedure and Administration).

List of Subjects in 26 CFR Part 300

Reporting and recordkeeping requirements, User fees.

Adoption of Amendments to the Regulations

Accordingly, 26 CFR part 300 is amended as follows:

Paragraph 1. The authority citation for part 300 continues to read as follows: Authority:

31 U.S.C. 9701.

Par. 2. Section 300.13 is amended by removing and reserving paragraph (b) to read as follows:
§ 300.13 Fee for obtaining a preparer tax identification number.

(b) Fee. [Reserved]

Par. 3. Section 300.13T is added to read as follows:
§ 300.13T Fee for obtaining a preparer tax identification number.

(a) [Reserved]

(b) Fee. The fee to apply for or renew a preparer tax identification number is $33 per year, which is the cost to the government for processing the application for a preparer tax identification number and does not include any fees charged by the vendor.

(c) [Reserved]

(d) Effective/applicability date. This section will be applicable for all PTIN applications filed on or after November 1, 2015.

Karen M. Schiller, Acting Deputy Commissioner for Services and Enforcement. Approved: October 16, 2015. Mark J. Mazur, Assistant Secretary of the Treasury (Tax Policy).
[FR Doc. 2015-27789 Filed 10-29-15; 8:45 am] BILLING CODE 4830-01-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0607; FRL-9934-88] Metaflumizone; Pesticide Tolerance AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes a tolerance for the combined residues of the insecticide metaflumizone in or on the raw agricultural commodities citrus (crop group 10-10) at 0.04 parts per million (ppm); pome fruit (crop group 11-10) at 0.04 ppm; stone fruit (crop group 12-12) at 0.04 ppm; and tree nut (crop group 14-12) at 0.04 ppm. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective October 30, 2015. Objections and requests for hearings must be received on or before December 29, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0607, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR cite at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0607 in the subject line on the first page of your submission. All requests must be in writing, and must be received by the Hearing Clerk on or before December 29, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0607, by one of the following methods:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Background and Statutory Findings

In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP #4F8286) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.657 be amended by establishing a tolerance for the combined residues of the insecticide metaflumizone (2-[2-(4-cyanophenyl)-1-[3-(trifluoromethyl)phenyl]ethylidene]-N-[4-(trifluoromethoxy)phenyl] hydrazinecarboxamide; E and Z isomers) and its metabolite 4-{2-oxo-2-[3-(trifluoromethyl)phenyl]ethyl}-benzonitrile, in or on the raw agricultural commodities citrus (crop group 10-10) at 0.04 ppm; pome fruit (crop group 11-10) at 0.04 ppm; stone fruit (crop group 12-12) at 0.04 ppm; and tree nut (crop group 14-12) at 0.04 ppm. In addition, that petition requested removal of the existing tolerances for metaflumizone in or on fruit, citrus group 10 at 0.04 ppm and nut, tree, group 14 at 0.04 ppm upon establishment of the petitioned-for tolerances. That document included a summary of the petition prepared by BASF Corporation, the registrant. There were no substantive comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with FFDCA section 408(b)(2), for a tolerance for metaflumizone, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Hematotoxicity (toxicity of the blood) was the primary toxic effect of concern following subchronic or chronic oral exposures to metaflumizone. Splenic extramedullary hematopoiesis, increased hemosiderin, and anemia were the most common hematotoxic effects reported after repeated oral dosing with metaflumizone. Chronic oral (gavage) exposures to dogs resulted in slight decreases in mean corpuscular hemoglobin concentration and total hemoglobin, leading to increased plasma bilirubin, increased urinary urobilinogen, and increased hemosiderin in the liver. In a chronic toxicity/carcinogenicity study in mice, anemia was observed in the form of increased hemosiderin in the spleen, increased mean absolute reticulocyte count, decreased mean corpuscular volume, and mean corpuscular hemoglobin.

The postulated pesticidal mode of action of metaflumizone involves inhibition of sodium channels in target insect species; however, in mammals (rats), there were only clinical signs of neurotoxicity (i.e., piloerection and body temperature variations) with no neuropathology in the presence of systemic toxicity (e.g., recumbency and poor general state) following acute or repeated exposures. Similarly, several immune system organs seem to be affected following metaflumizone administration via the oral, dermal, and inhalation routes (e.g., the presence of macrophages in the thymus, lymphocyte necrosis in the mesenteric lymph nodes, and diffuse atrophy of the mandibular); however, there was no evidence of any functional deficits at the highest dose tested in a recently submitted and reviewed guideline immunotoxicity study. Therefore, the clinical neurotoxicity signs and the effects on the immune system organs following metaflumizone administration are likely to be secondary to the hematotoxic effects.

Metaflumizone induced an increased incidence of a missing subclavian artery at a relatively high dose that also caused severe maternal toxicity (e.g., late term abortions) in the developmental toxicity study in rabbits. There was no evidence (quantitative or qualitative) of increased susceptibility following in utero exposures to rats or rabbit and following pre- and post natal exposures. There was no evidence that metaflumizone is genotoxic and carcinogenicity studies with mice and rabbits were negative.

Specific information on the studies received and the nature of the adverse effects caused by metaflumizone as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document entitled, “Metaflumizone: Human Health Risk Assessment in Support of Section 3 Registrations for Application of Metaflumizone to Pome Fruit (crop group (CG) 11-10) and Stone Fruit (CG 12-12); Updating the CG Designation for Citrus to 10-10 and Tree Nuts to 14-12; and Permitting Aerial Application to Citrus Fruits, Grapes, Tree Nuts, and Nurseries Containing Field-/Container-Grown Nonbearing Stone and Pome Fruit Trees” in docket ID number EPA-HQ-OPP-2014-0607.

B. Toxicological Endpoints of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern (LOCs) to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for metaflumizone used for human risk assessment is provided below:

i. Acute Dietary Endpoint (General population including infants and children). An acute dietary endpoint was not established for this population group since an endpoint of concern (effect) attributable to a single dose was not identified in the database. Studies considered for this endpoint included the acute neurotoxicity study for which a LOAEL was not observed.

ii. Acute Dietary Endpoint (Females 13-49 years old). This endpoint was established based on a developmental effect observed in the rabbit developmental toxicity study that can be potentially due to a single dose of metaflumizone. This effect consisted of an increased incidence of an absent subclavian artery in the offspring at the LOAEL of 300 milligram/kilogram (mg/kg) body weight/day (bw/day) metaflumizone (NOAEL = 100 mg/kg bw/day). The rat developmental toxicity study was also considered for this endpoint; however, no developmental effects were observed in this study at the highest dose tested of 120 mg/kg bw/day metaflumizone. A combined uncertainty factor (UF) of 300 was applied to account for interspecies (10x) and intraspecies (10x) extrapolation. A Food Quality Protection Act (FQPA) safety factor (SF) of 3x was retained because the rabbit developmental toxicity study was performed via oral gavage dosing. In an absorption study submitted by the petitioner, dietary exposures (which are more relevant for human exposures) exhibited an approximately 2-fold greater absorption into the systemic circulation than oral gavage dosing and, thus, can potentially lead to toxicity at 2-fold lower levels of exposure. Thus, aPAD for females 13-49 years old is estimated to be 0.33 mg/kg bw/day.

iii. Chronic Dietary Endpoint. This endpoint was established based on results of a chronic toxicity study with dogs via capsule administration. The effects at the LOAEL of 30 mg/kg bw/day (NOAEL = 12 mg/kg bw/day), consisted of reduced general health condition, slight to severe ataxia, recumbency, and severe salivation, decreases in mean cell hemoglobin concentration (MCHC) and total hemoglobin (Hb) and increased bilirubin, increased urobilinogen, and increased hemosiderin in the liver. A combined UF of 300 was applied to account for interspecies (10x) and intraspecies (10x) extrapolation and an FQPA SF of 3x was retained for the higher absorption observed in dietary exposures to metaflumizone (see above). Thus, the chronic population adjusted dose (cPAD) is estimated to be 0.040 mg/kg bw/day.

iv. Incidental Oral (Short- and Intermediate-Term). This endpoint was selected on the basis of the maternal effects observed in the rat two-generation reproductive toxicity study at the LOAEL of 50 mg/kg bw/day metaflumizone (NOAEL = 20 mg/kg bw/day). Maternal toxicity consisted of poor general health and body weight deficits which were also associated with improper nursing behavior. Similar effects were also noted in a developmental neurotoxicity study (gavage, range finding) also considered for this endpoint. In this study, poor maternal health was also observed at the LOAEL of 120 mg/kg bw/day metaflumizone (NOAEL = 80 mg/kg bw/day). Both studies considered for this endpoint achieved a clear maternal NOAEL for the offspring effects, but the NOAEL of 20 mg/kg bw/day for the 2-generation reproductive toxicity study is considered more protective. A combined UF of 300 was applied to account for interspecies (10x) and intraspecies (10x) extrapolation, and an FQPA SF of 3x to account for the 2-fold greater absorption observed in dietary versus oral gavage exposures (see above). The LOC is 300.

v. Dermal (Short- and Intermediate-Term). This endpoint was based on a rat 90-day dermal toxicity study in which deficits in body weight, body-weight gain, and food consumption (in males and females); anogenital smearing; increased macrophages in the thymus; lymphocyte necrosis in the mesenteric lymph nodes; diffuse atrophy of the mandibular lymph node; and increased hemosiderin in the liver (females only) were observed at the LOAEL of 300 mg/kg bw/day (NOAEL = 100 mg/kg bw/day). The LOC, for both occupational and residential exposure is 100, based on a combined UF of 100 for interspecies (10x) and in intraspecies (10x) extrapolation. The FQPA SF is reduced to 1x for this exposure scenario because there is no residual uncertainty concerning potential effects on infants and children.

vi. Inhalation (Short- and Intermediate-Term). There is a 28-day inhalation study that is adequate for both exposure durations. There was no NOAEL identified for female rats. At the LOAEL of 0.10 milligrams per Liter (mg/L) metaflumizone (NOAEL = 0.03 mg/L), histopathology of the nasal tissues, lungs, thymus, prostate, and adrenal cortex was observed in males. The LOAEL of 0.03 mg/L identified in females resulted in lymphocyte necrosis in the mesenteric lymph node.

The methods and dosimetry equations described in EPA's reference concentration (RfC) guidance (1994) are suited for calculating human-equivalent concentrations (HECs) based on the inhalation toxicity point of departure (NOAEL, LOAEL, or Benchmark Dose Lower Confidence Limit (BMDL)) for use in MOE calculations. The regional-deposited-dose ratio (RDDR), which accounts for the particulate diameter (mass median aerodynamic diameter (MMAD) and geometric standard deviation (σg) of aerosols), can be used to estimate the different dose fractions deposited along the respiratory tract. The RDDR accounts for interspecies differences in ventilation and respiratory-tract surface areas. Thus, the RDDR can be used to adjust an observed inhalation particulate exposure of an animal to the predicted inhalation exposure for a human. For the subchronic inhalation toxicity study with metaflumizone, an RDDR was estimated at 2.81 based on systemic effects (lymphocyte necrosis in the mesenteric lymph node) in females at the LOAEL of 0.03 mg/L (no NOAEL established), and a MMAD of 1.7 micrometer (μm) and σg of 2.7.

For this action with metaflumizone, residential and occupational handler scenarios are being assessed. For residential handler scenarios, 2-hr/day inhalation exposures are assumed. Adjustment to shorter exposure scenarios relative to the animal toxicity study duration (e.g., 2 hr. residential exposures) should only be made if there is time-course information that would support a shorter time-frame. Since there is no such information available for metaflumizone, the unadjusted animal POD was used to assess the shorter duration residential handler exposures. Thus, the HEC equals the LOAEL from the study, and was calculated to be 0.084 mg/L. The FQPA SF of 10x is being retained for lack of a NOAEL for females in the study. The standard interspecies extrapolation UF can be reduced from 10x to 3x due to the HEC calculation accounting for pharmacokinetic (not pharmacodynamic) interspecies differences. The intraspecies UF remains at 10x. Therefore, the LOC for this scenario is 300, which includes the FQPA SF of 10x, interspecies (3x), and intraspecies (10x) extrapolation.

C. Exposure Assessment

1. Dietary Exposure from Food and Feed Uses. Tolerances have been established in (40 CFR 180.657) for the residues of metaflumizone, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from metaflumizone in food as follows:

i. Acute Exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for metaflumizone. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. As to residue levels in food, EPA assumed tolerance-level residues. It was further assumed that 100% of crops with the requested uses of metaflumizone were treated.

ii. Chronic Exposure. In conducting the chronic dietary exposure assessment, EPA used the food consumption data from the USDA NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance-level residues. It was further assumed that 100% of crops with the requested uses of metaflumizone were treated.

iii. Cancer. EPA has concluded that metaflumizone does not pose a cancer risk to humans; therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated Residue and Percent Crop Treated (PCT) Information. EPA did not use anticipated residue or PCT information in the dietary assessment for metaflumizone. Tolerance-level residues and 100 PCT were assumed for all food commodities.

2. Dietary Exposure from Drinking Water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for metaflumizone in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of metaflumizone. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of metaflumizone for acute exposures are estimated to be 1.03 parts per billion (ppb) for surface water and 1.09 x 10 12 ppb for ground water. The EDWCs of metaflumizone for chronic exposures for non-cancer chronic assessments are estimated to be 0.487 ppb for surface water and 1.09 x 10 12 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 1.03 ppb was used to assess the contribution of drinking water. For chronic dietary risk assessment, the water concentration value of 0.487 ppb was used to assess the contribution of drinking water.

3. From Non-Dietary Exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Metaflumizone is currently registered for the following uses that could result in residential exposures: As a fire ant bait for application to lawns, landscapes, golf courses, and other non-cropland area; and as a fly bait for use around industrial buildings, commercial facilities, agricultural structures/premises, and recreational facilities/areas.

EPA assessed residential exposure using the following assumptions: Fire ant bait applications to home lawns are expected to result in short-term, residential handler exposure to adults. Fire ant bait applications to lawns and golf-courses are expected to result in short-term, post-application dermal exposure to adults, children 11 to <16 years old, and children 1 to <2 years old, and incident oral exposure for children 1 to <2 years old. For the fly bait product, residential handler exposure is not expected, because the product is applied by commercial handlers. The fly bait product is expected to result in short-term, post-application dermal exposure to adults, children 11 to <16 years old, and children 1 to <2 years old, and incident oral exposure for children 1 to <2 years old.

For residential handlers, dermal and inhalation exposures are combined since the endpoints are similar for these routes. For children (1- to <2-year-olds), post-application hand-to-mouth and dermal exposures are combined. Since the LOCs for the dermal, inhalation and incidental oral routes are not the same (dermal LOC = 100, inhalation LOC = 300, and incidental oral LOC = 300), these routes were combined using the aggregate risk index approach. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

4. Cumulative Effects from Substances With a Common Mechanism of Toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to metaflumizone and any other substances and metaflumizone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action; therefore, EPA has not assumed that metaflumizone has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

1. In general. Section 408 of FFDCA provides that EPA shall apply an additional ten-fold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA SFs, as appropriate.

2. Prenatal and Postnatal Sensitivity. There is no evidence for increased qualitative or quantitative sensitivity/susceptibility resulting from pre- and/or postnatal exposures. In the rat prenatal development toxicity study, there was no offspring toxicity reported at any dose tested whereas in the rabbit study a maltransformation based on an absent subclavian artery was noted to occur only in the presence of severe maternal toxicity. Similarly, offspring mortality in the 2-generation reproductive toxicity occurred only in the presence of a poor maternal health state. Thus, there is no evidence for increased susceptibility.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced from 10x to 3x for all oral exposure scenarios; retained at 10x for inhalation exposure scenarios; and reduced to 1x for dermal exposures. That decision is based on the following findings:

i. The toxicological database for metaflumizone is adequate for risk assessment and FQPA SF evaluation. Several studies are available for evaluating the safety of metaflumizone, although differences in dose administration and a missing NOAEL warrant retention of various FQPA safety factors in this instance.

Dietary exposures exhibited an approximately 2-fold greater absorption into the systemic circulation as compared to oral gavage and, thus, can potentially lead to toxicity at 2-fold lower levels of exposure. Applying an FQPA SF of 3x for all oral exposure scenarios is adequate to protect against any greater toxicity that might occur in dietary exposures (absorption was noted to be 2-fold greater in dietary versus oral gavage studies).

The FQPA SF of 10x is being retained for inhalation exposure scenarios for the use of a LOAEL instead of a NOAEL (no NOAEL achieved) for histopathological lesions consisting of lymphocyte necrosis in the mesenteric lymph node. The FQPA SF of 10x is adequate because the effect (lymphocyte necrosis) is considered minimal to slight and does not exhibit a strong dose dependence.

The FQPA SF for dermal exposure scenarios is being reduced from 10x to 1x since there is a route-specific study with a clear NOAEL.

ii. There is no indication that metaflumizone directly affects the nervous system. Clinical signs indicative of neurotoxicity were observed in several studies; however, these signs were generally observed in the presence of poor animal health (e.g., reduced general health condition, loss of body weight, or death). In addition, no neuropathology was observed in any study with metaflumizone. There is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity.

iii. There are no residual concerns or uncertainties for increased sensitivity/susceptibility in developing animals resulting from pre- and/or postnatal exposure.

iv. There are no residual uncertainties identified in the exposure databases.

The dietary analyses assumed tolerance-level residues, 100 PCT, and modeled drinking water estimates. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to metaflumizone in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by metaflumizone. E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. Based on the proposed/registered uses and since inhalation, dermal, and incidental oral exposures can be combined, aggregate acute (dietary), short-term (dietary, incidental oral, and/or dermal), and chronic (dietary) assessments were conducted.

1. Acute Risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute aggregate exposure assessment consists of exposure from only food and water. The acute dietary exposure assessment for females 13-49 years old was 1.6% of the aPAD and therefore, does not exceed EPA's LOC.

2. Chronic Risk. Since there are no registered/proposed uses that result in chronic residential exposure, the chronic aggregate exposure assessment consists of exposure from only food and water. The chronic dietary exposure estimate was ≤7.2% the cPAD and therefore, does not exceed EPA's LOC.

3. Short-Term Risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Metaflumizone is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to metaflumizone. Since the LOC and toxicological points of departure for the short-term dermal and oral routes of exposure differ, the aggregate risk index method was used to determine aggregate risk (aggregate risk indices >1 are not a risk of concern).

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate risk indices of 42 for the general population, and 22 for children 1-2 years old. Because EPA's LOC for metaflumizone is an aggregate risk index less than 1, the aggregate risks are not of concern.

4. Intermediate-Term Risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Metaflumizone is not currently registered for uses that could result in intermediate-term residential exposure; however, since the PODs for the short- and intermediate-term durations are the same for metaflumizone, the short-term aggregate assessment is protective of intermediate-term exposures.

5. Aggregate Cancer Risk for U.S. Population. As discussed in Unit III.A., EPA does not expect metaflumizone to pose a cancer risk to humans.

6. Determination of Safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to metaflumizone residues.

IV. Other Considerations A. Analytical Enforcement Methodology

EPA previously reviewed method validation and independent laboratory validation (ILV) studies for the BASF high-performance liquid chromatography (HPLC)/mass spectrometry (MS)/MS analytical method 531/0 and forwarded the method to FDA for tolerance enforcement (46264221.der; D308394, T. Bloem, 30-Nov-2005; D328915, T. Bloem, 17-May-2006). It is noted that following method validation, BASF incorporated several minor modifications to method 531/0 with this revised method specified as 531/1 (method 531/1 is the current enforcement method). Based on the similarities of the proposed crops to that currently registered and since the grape, citrus, and tree nut residue samples were analyzed using a method very similar to the current enforcement method and since adequate validation data were submitted, EPA concludes that the current enforcement method is suitable for enforcement of the tolerances recommended herein. The limit of quantitation (LOQ) is 0.01 ppm for metaflumizone (E and Z isomers) and 0.018 ppm for M320I04 (expressed in parent equivalents).

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]

B. International Residue Limits

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

Codex MRLs are not established in/on the relevant crops for metaflumizone; therefore, harmonization is not an issue for this petition.

V. Conclusion

Therefore, the tolerance is established for the combined residues of the insecticide metaflumizone (2-[2-(4-cyanophenyl)-1-[3-(trifluoromethyl)phenyl]ethylidene]-N-[4-(trifluoromethoxy)phenyl] hydrazinecarboxamide; E and Z isomers), in or on the following raw agricultural commodities: Fruit, citrus, group 10-10 at 0.04 ppm; fruit, pome, group 11-10 at 0.04 ppm; fruit, stone, group 12-12 at 0.04 ppm; and nut, tree, group 14-12 at 0.04 ppm. The existing tolerances for fruit, citrus, group 10 at 0.04 ppm and for nut, tree, group 14 at 0.04 ppm are removed because they are superseded by the tolerances being established in this action.

VI. Statutory and Executive Order Reviews

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: October 21, 2015. G. Jeffrey Herndon, Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority:

21 U.S.C. 321(q), 346a and 371.

2. Section 180.657 is amended as follows: a. Remove the entries for “Fruit, citrus, group 10” and “Nut, tree, group 14” from the table in paragraph (a). b. Add alphabetically the following list of commodities to the table in paragraph (a).

The additions read as follows:

§  180.657 Metaflumizone; tolerances for residues.

(a) * * *

Commodity Parts per
  • million
  • *    *    *    *    * Fruit, citrus, group 10-10 0.04 Fruit, pome, group 11-10 0.04 Fruit, stone, group 12-12 0.04 *    *    *    *    * Nut, tree, group 14-12 0.04 *    *    *    *    *
    [FR Doc. 2015-27788 Filed 10-29-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2013-0035; FRL-9912-31] Rimsulfuron; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of rimsulfuron in or on sorghum, grain, forage; sorghum, grain, grain; and sorghum, grain, stover. E.I. du Pont de Nemours and Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective October 30, 2015. Objections and requests for hearings must be received on or before December 29, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2013-0035, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected].

    SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me?

    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

    B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the Office of Chemical Safety and Pollution Prevention (OCSPP) test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

    C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2013-0035 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 29, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2013-0035, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available athttp://www.epa.gov/dockets.

    II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 19, 2013 (78 FR 43115) (FRL-9392-9), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F8131) by E.I. du Pont de Nemours and Company, 1007 Market Street, Wilmington, DE 19898. The petition requested that 40 CFR 180.478 be amended by establishing tolerances for residues of the herbicide rimsulfuron, N-((4,6-dimethoxypyrimidin-2-yl)aminocarbonyl)-3-(ethylsulfonyl)-2-pyridinesulfonamide, in or on sorghum, forage; sorghum, grain; and sorghum, stover at 0.01 parts per million (ppm). That document referenced a summary of the petition prepared by E.I. du Pont de Nemours and Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

    Based upon review of the data supporting the petition, EPA has revised the proposed commodity definitions. EPA has also revised the chemical name nomenclature for rimsulfuron in the tolerance expression. The reasons for these changes are explained in Unit IV.C.

    III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

    Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for rimsulfuron including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with rimsulfuron follows.

    A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

    Rimsulfuron has low acute toxicity by oral, dermal, and inhalation routes of exposure. It is moderately irritating to the eye, non-irritating to the skin, and is not a skin sensitizer. In subchronic and chronic toxicity studies in rats, toxic effects included decreased body weight, decreased body weight gain, increased relative liver and absolute kidney weights, and diuresis. In the subchronic study in mice, increased red blood cell and hemoglobin, and decreased body weight gain and food efficiency were observed. In the chronic study in mice, decreased body weight, increased incidences of dilation and cysts in the glandular stomach, and degeneration of the testicular artery and tunica albuginea were observed. In the subchronic study in dogs, diuresis was indicated by urinary volume, platelet concentration, and kidney weights accompanied by decreased urinary osmolality. In the chronic study in dogs, increased absolute liver and kidney weights, increased seminiferous tubule degeneration, and increased number of spermatid giant cells present in epididymides in males were observed. In both sexes, decreases in mean body weights and body weight gain, and increases in serum cholesterol levels, alkaline phosphatase activity, absolute liver weight, relative liver, and relative kidney weights were observed.

    In the developmental toxicity study in rats, no toxicity was seen at the highest dose tested. In the developmental toxicity study in rabbits (in which both maternal and fetal death were observed), and in the 2-generation reproduction toxicity study in rats (in which decreases in body weight gain were observed in both parents and offspring), developmental and offspring effects were seen in the presence of maternal/systemic toxicity at the same dose levels.

    In the acute and subchronic neurotoxicity studies, no evidence of neurotoxicity was observed. In the immunotoxicity study, no evidence of immunosuppression was observed. In the mutagenicity studies, no evidence of clastogenicity or mutagenicity was observed. Rimsulfuron is classified as “Not Likely to be Carcinogenic to Humans” based on lack of evidence of carcinogenicity in rats and mice studies.

    Specific information on the studies received and the nature of the adverse effects caused by rimsulfuron as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Rimsulfuron. Human Health Risk Assessment for Proposed Section 3 Use on Acetolactase Synthase (ALS) Tolerant Grain Sorghum” at pp. 27-32 in docket ID number EPA-HQ-OPP-2013-0035.

    B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

    A summary of the toxicological endpoints for rimsulfuron used for human risk assessment is shown in Table 1 of this unit.

    Table 1—Summary of Toxicological Doses and Endpoints for Rimsulfuron for Use in Human Health Risk Assessment Exposure/scenario Point of departure
  • and uncertainty/
  • safety factors
  • RfD, PAD, LOC for
  • risk assessment
  • Study and toxicological effects
    Acute dietary (All populations) No endpoint attributable to a single dose identified. Chronic dietary (All populations) NOAEL = 11.8 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Chronic RfD = 0.118 mg/kg/day
  • cPAD = 0.118 mg/kg/day
  • Combined Chronic/Carcinogenicity—Rat.
  • LOAEL = 121 mg/kg/day in males; 568 mg/kg/day in females .
  • (NOAEL = 163 mg/kg/day in females), based on decreased body weight gains and liver effects.
  • FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. cPAD = chronic population adjusted dose. RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to rimsulfuron, EPA considered exposure under the petitioned-for tolerances as well as all existing rimsulfuron tolerances in 40 CFR 180.478. EPA assessed dietary exposures from rimsulfuron in food as follows:

    i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for rimsulfuron; therefore, a quantitative acute dietary exposure assessment is unnecessary.

    ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA's 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed that rimsulfuron residues were present at tolerance levels in all commodities for which tolerances have been established or proposed, and that 100% of those crops were treated with rimsulfuron.

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that rimsulfuron does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

    iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for rimsulfuron. Tolerance level residues and/or 100 PCT were assumed for all food commodities.

    2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for rimsulfuron in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of rimsulfuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM-GW), the estimated drinking water concentrations (EDWCs) of rimsulfuron for chronic exposures for non-cancer assessments are estimated to be 0.38 parts per billion (ppb) for surface water and 19.7 ppb for ground water.

    Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 19.7 ppb was used to assess the contribution to drinking water.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Rimsulfuron is not registered for any specific use patterns that would result in residential exposure.

    4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found rimsulfuron to share a common mechanism of toxicity with any other substances, and rimsulfuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that rimsulfuron does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

    D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Federal Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

    2. Prenatal and postnatal sensitivity. In the developmental toxicity study in rats, no developmental toxicity was seen at the highest dose tested. In the developmental toxicity study in rabbits and in the 2-generation reproductive study in rats, developmental and offspring toxicity were seen only in the presence of maternal/systemic toxicity. Consequently, there is no evidence of quantitative or qualitative increased susceptibility following pre- and/or postnatal exposures.

    3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x. That decision is based on the following findings:

    i. The toxicity database for rimsulfuron is complete.

    ii. There is no indication that rimsulfuron is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional Uncertainty Factor (UF) to account for neurotoxicity.

    iii. There is no evidence that rimsulfuron results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

    iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to rimsulfuron in drinking water. These assessments will not underestimate the exposure and risks posed by rimsulfuron.

    E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

    1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, rimsulfuron is not expected to pose an acute risk.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to rimsulfuron from food and water will utilize 1.4% of the cPAD for all infants less than 1-year old, the population group receiving the greatest exposure. There are no residential uses for rimsulfuron.

    3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

    Because there are no residential uses, no short- or intermediate-term aggregate risk assessments were conducted.

    4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, rimsulfuron is not expected to pose a cancer risk to humans.

    5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to rimsulfuron residues.

    IV. Other Considerations A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method DuPont-32277, a high performance liquid chromatography with tandem mass spectroscopy (HPLC/MS/MS)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

    B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established MRLs for rimsulfuron.

    C. Revisions to Petitioned-For Tolerances

    The Agency is revising the proposed commodity definitions of “sorghum, forage” to “sorghum, grain, forage”; “sorghum, grain” to “sorghum, grain, grain”; and “sorghum, stover” to “sorghum, grain, stover”. The tolerance expression is revised to reflect the preferred chemical name for rimsulfuron using CAS nomenclature.

    V. Conclusion

    Therefore, tolerances are established for residues of rimsulfuron, N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(ethylsulfonyl)-2-pyridinesulfonamide, in or on sorghum, grain, forage; sorghum, grain, grain; and sorghum, grain, stover at 0.01 ppm.

    VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

    This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).

    This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).

    VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: October 21, 2015. G. Jeffrey Herndon, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

    PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority:

    21 U.S.C. 321(q), 346a and 371.

    2. In § 180.478, revise paragraph (a) and add alphabetically the following commodities to the table in paragraph (a) to read as follows:
    § 180.478 Rimsulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the herbicide rimsulfuron, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only rimsulfuron, N-[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl]-3-(ethylsulfonyl)-2-pyridinesulfonamide.

    Commodity Parts per
  • million
  • *    *    *    *    * Sorghum, grain, forage 0.01 Sorghum, grain, grain 0.01 Sorghum, grain, stover 0.01 *    *    *    *    *
    [FR Doc. 2015-27790 Filed 10-29-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0600; FRL-9933-25] Teflubenzuron; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of teflubenzuron [N-[[(3,5-dichloro-2,4-difluorophenyl)amino]carbonyl]-2,6-difluorobenzamide] in or on multiple commodities which are identified and discussed later in this document. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective October 30, 2015. Objections and requests for hearings must be received on or before December 29, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0600, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

    Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]

    SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me?

    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

    B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

    C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0600 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 29, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0600, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

    Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    II. Summary of Petitioned-for Tolerance

    In the Federal Register of January 28, 2015 (80 FR 4525) (FRL-9921-55), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4E8230) by BASF Corporation, 26 Davis Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide teflubenzuron, in or on apple at 0.5 parts per million (ppm); apple, wet pomace at 0.8 ppm; broccoli at 0.2 ppm; cattle, meat byproducts at 0.01 ppm; cattle, muscle at 0.01 ppm; cauliflower at 0.01 ppm; citrus, oil at 90 ppm; coffee, bean, green at 0.6 ppm; corn, field, grain at 0.01 ppm; corn, field, refined oil at 0.02 ppm; egg at 0.01 ppm; goat, meat byproducts at 0.01 ppm; goat, muscle at 0.01 ppm; horse, meat byproducts at 0.01 ppm; horse, muscle at 0.01 ppm; lemon at 0.9 ppm; mango at 1.5 ppm; melon, at 0.3 ppm; milk at 0.01 ppm; orange at 0.6 ppm; papaya at 0.4 ppm; pineapple at 0.8 ppm; pork, muscle at 0.01 ppm; pork, meat byproducts at 0.01 ppm; poultry, meat byproducts at 0.01 ppm; poultry, muscle at 0.01 ppm; sheep, meat byproducts at 0.01 ppm; sheep, muscle at 0.01 ppm; soybean, hulls at 0.4 ppm; soybean, seed at 0.05 ppm; sugarcane, cane at 0.01 ppm; sunflower, seed at 0.3 ppm; tomato at 1.5 ppm; and tomato, paste at 5 ppm. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, http://www.regulations.gov. No tolerance-related comments were submitted. Based upon review of the data supporting the petition, EPA has edited tolerance levels for some food commodities, and declined to grant tolerances for others. The reasons for these changes are explained in Unit IV.C.

    III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

    Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for teflubenzuron including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with teflubenzuron follows.

    A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Exposure of animals to teflubenzuron has shown no evidence of neurotoxicity, immunotoxicity, or genotoxicity. It is categorized as having low acute lethality by oral, dermal and inhalation routes of exposure. It is not a dermal sensitizer or eye irritant. In all species tested, hepatotoxicity was indicated. The liver is the primary target organ for teflubenzuron. In the mouse, which is the most sensitive species compared to the rat and the dog, liver adenomas were observed following chronic exposure. Increased enzyme release and numerous microscopic indicators of liver injury (diffuse hypertrophy, disseminated single-cell necrosis, patchy glycogen storage, Kupffer cell proliferation, phagocytic foci, lipofuscin accumulation and centrilobular fatty change) were observed in all species exposed to teflubenzuron.

    The 2-generation reproductive study shows evidence of increased quantitative offspring susceptibility. There were no effects of teflubenzuron exposure on the parental generation, but effects on offspring consisted of decreased F2 litter weights and increased incidence of unilateral dilatation of the renal pelvis in F1 offspring. There is no evidence of increased fetal susceptibility in either the rat or rabbit developmental studies.

    Because rare liver tumors were observed only in male mice and there was no evidence of carcinogenicity from teflubenzuron in female mice or in male or female rats, the Agency is using a non-linear approach (i.e. reference dose (RfD)) to account for the observed carcinogenicity that could result from exposure to teflubenzuron. Moreover, there is no concern for mutagenicity.

    Specific information on the studies received and the nature of the adverse effects caused by teflubenzuron as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, “Teflubenzuron: Human Health Risk Assessment” at pp. 4, 13, 21, and 22 in docket ID number EPA-HQ-OPP-2014-0600.

    B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a RfD—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

    A summary of the toxicological endpoints for teflubenzuron used for human risk assessment is shown in Table 1 of this unit.

    Table 1—Summary of Toxicological Doses and Endpoints for Teflubenzuron for Use in Human Health Risk Assessment Exposure/scenario Point of departure
  • and uncertainty/
  • safety factors
  • RfD, PAD, LOC for
  • risk assessment
  • Study and toxicological effects
    Acute dietary (General population including infants and children) An endpoint of concern attributable to a single dose was not identified. An acute RfD was not established. Chronic dietary (All populations) NOAEL = 2.1 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Chronic RfD = 0.021 mg/kg/day
  • cPAD = 0.021 mg/kg/day
  • Carcinogenicity (mouse) LOAEL = 10.5 mg/kg/day based on increased microscopic lesions in the liver (diffuse hypertrophy, centrilobular single-cell necrosis, patchy glycogen storage, Kupffer cell proliferation, phagocytic foci, and centrilobular fatty change) associated with increased relative liver weight.
    Cancer (Oral, dermal, inhalation) The Agency is using a non-linear approach (i.e., RfD) that will adequately account for all chronic toxicity, including carcinogenicity that could result from exposure to teflubenzuron. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to teflubenzuron, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from teflubenzuron in food as follows:

    i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for teflubenzuron; therefore, a quantitative acute dietary exposure assessment is unnecessary.

    ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed teflubenzuron residues are present in all commodities at tolerance levels and that 100% of all crops are treated.

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a non-linear RfD approach is appropriate for assessing cancer risk to teflubenzuron. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii. chronic exposure.

    iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for teflubenzuron. Tolerance-level residues and/or 100 PCT were assumed for all food commodities.

    2. Dietary exposure from drinking water. Because there are no domestic agricultural or residential uses registered or proposed for teflubenzuron, there will be no exposure in drinking water; therefore, a drinking water assessment is not necessary.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

    Teflubenzuron is not registered for any specific use patterns that would result in residential exposure.

    4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

    EPA has not found teflubenzuron to share a common mechanism of toxicity with any other substances, and teflubenzuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that teflubenzuron does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site athttp://www.epa.gov/pesticides/cumulative.

    D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

    2. Prenatal and postnatal sensitivity. The rat 2-generation reproductive study showed evidence of increased quantitative offspring susceptibility to teflubenzuron. While there were no parental effects, adverse offspring effects were observed and consisted of decreased F2 litter weights and increased incidence of unilateral dilatation of the renal pelvis in F1 offspring. There were no effects of teflubenzuron in the developmental rat study up to the highest dose tested. In the developmental rabbit study, maternal effects were observed at the limit dose and were consistent with liver toxicity; no fetal effects were observed.

    3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

    i. The toxicity database for teflubenzuron is complete for assessing the safety of tolerances for which there is no associated U.S. pesticide registration.

    ii. There is no indication that teflubenzuron is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.

    iii. As discussed in Unit III.D.2., there is evidence of quantitative susceptibility in the rat in the 2-generation reproductive study. There is no residual concern or uncertainty regarding these effects as the study established a clear NOAEL and LOAEL. Moreover, the Agency is using a lower POD in its assessment, which will be protective of these effects.

    iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. There are no drinking water or residential exposures as there are no U.S. registrations of pesticides containing teflubenzuron. These assessments will not underestimate the exposure and risks posed by teflubenzuron.

    E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

    1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, teflubenzuron is not expected to pose an acute risk.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to teflubenzuron from food and water will utilize 50% of the cPAD for children 1-2 years old the population group receiving the greatest exposure. There are no residential uses for teflubenzuron.

    3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Teflubenzuron is for use on imported commodities only, no residential exposure or chronic exposure from water is expected. Because no short-term adverse effect was identified, teflubenzuron is not expected to pose a short-term risk.

    4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no intermediate-term adverse effect was identified, teflubenzuron is not expected to pose an intermediate-term risk.

    5. Aggregate cancer risk for U.S. population. Based on the results of the chronic assessment, EPA concludes that teflubenzuron will not pose a cancer risk for the U.S. population.

    6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to teflubenzuron residues.

    IV. Other Considerations A. Analytical Enforcement Methodology

    The petitioner submitted a high-performance liquid chromatography method with tandem mass-spectrometry detection (LC/MS/MS) analytical method, BASF Method L0160/01, for analysis of residues of teflubenzuronin/on dry and oily crop commodities. The method has been adequately validated by the petitioner as well as by an independent laboratory, and was also adequately radio validated using weathered samples obtained from metabolism studies. In addition, the Quechers multi residue method (MRM) is considered suitable for the analysis of teflubenzuron in fruits and vegetables.

    Adequate enforcement methodology (high-performance liquid chromatography with tandem mass spectrometry) is available to enforce the tolerance expression.

    B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

    The Codex has established a MRL for teflubenzuron in or on pome fruit at 1.0 ppm. The U.S. tolerance being established for residues of teflubenzuron on apples is harmonized with this value.

    C. Revisions to Petitioned-For Tolerances

    The petition requested tolerances for several livestock commodities (cattle, meat byproducts; cattle, muscle; egg; goat, meat byproducts; goat, muscle; horse, meat byproducts; horse, muscle; milk; pork, meat byproducts; pork, muscle; poultry, meat byproducts; poultry, muscle; sheep, meat byproducts; and sheep, muscle.) Based on the results of livestock feeding studies, EPA is not establishing tolerances for these commodities because there is no expectation of finite residues in livestock commodities. The tolerance proposal for apple, wet pomace is not being established because the commodity is not likely to be imported. The petitioned-for tolerance for tomato, paste is not being established because concentration of residues is not expected above the tolerance established for tomato (1.5 ppm); the tolerance for tomato will be adequate to cover any residues in tomato paste.

    In the case of apple, EPA is establishing a higher tolerance (from 0.5 ppm to 1.0 ppm) to harmonize with the established Codex MRL. Based on EPA's methods for calculating residue levels on processed commodities, EPA is establishing a higher tolerance for citrus, oil (90 ppm to 100 ppm) and a lower tolerance for soybean, hulls (0.4 ppm to 0.15 ppm) than what was requested. Using the Organization for Economic Cooperation and Development (OECD) calculation procedures, EPA is establishing a higher tolerance for papaya tolerance (0.4 ppm to 0.5 ppm) and a lower tolerance for the lemon (0.90 ppm to 0.80 ppm) than was requested.

    In addition, EPA is adding significant figures to tolerance levels in accordance with EPA policy for the following commodities: Broccoli; coffee, bean, green; melon, subgroup 9A; orange; pineapple; and sunflower, seed. EPA is also revising the commodity term “corn, field” to “corn, field, grain” to be consistent with the food and feed commodity vocabulary used for tolerances. Finally, EPA is establishing a tolerance for “melon, subgroup 9A” instead of “melon” as requested because the regulatory definition of “melon” includes all commodities listed under “melon, subgroup 9A.”

    V. Conclusion

    Therefore, tolerances are established for residues of teflubenzuron, in or on apple at 1.0 ppm; broccoli at 0.20 ppm; cauliflower at 0.01 ppm; citrus, oil at 100 ppm; coffee, bean, green at 0.60 ppm; corn, field, grain at 0.01 ppm; corn, field, refined oil at 0.02 ppm; lemon at 0.80 ppm; mango at 1.5 ppm; melon, subgroup 9A at 0.30 ppm; orange at 0.60 ppm; papaya at 0.50 ppm; pineapple at 0.80 ppm; soybean, seed at 0.05 ppm; soybean, hulls at 0.15 ppm; sugarcane, cane at 0.01 ppm; sunflower, seed at 0.30 ppm; and tomato at 1.5 ppm.

    VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

    This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

    This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

    VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: October 20, 2015. Jack E. Housenger, Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

    PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority:

    21 U.S.C. 321(q), 346a and 371.

    2. Add § 180.687 to subpart C to read as follows:
    § 180.687 Teflubenzuron; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the insecticide teflubenzuron, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only teflubenzuron (N-[[(3,5-dichloro-2,4-difluorophenyl)amino]carbonyl]-2,6-difluorobenzamide).

    Commodity Parts per
  • million
  • Apple 1 1.0 Broccoli 1 0.20 Cauliflower 1 0.01 Citrus, oil 1 100 Coffee, bean, green 1 0.60 Corn, field, grain 1 0.01 Corn, field, refined oil 1 0.02 Lemon 1 0.80 Mango 1 1.5 Melon, subgroup 9A 1 0.30 Orange 1 0.60 Papaya 1 0.50 Pineapple 1 0.80 Soybean, seed 1 0.05 Soybean, hulls 1 0.15 Sugarcane, cane 1 0.01 Sunflower, seed 1 0.30 Tomato 1 1.5 1 There are no U.S. registrations as of October 30, 2015.

    (b) Section 18 emergency exemptions. [Reserved]

    (c) Tolerances with regional registrations. [Reserved]

    (d) Indirect or inadvertent residues. [Reserved]

    [FR Doc. 2015-27593 Filed 10-29-15; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket ID FEMA-2015-0001; Internal Agency Docket No. FEMA-8407] Suspension of Community Eligibility AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Final rule.

    SUMMARY:

    This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at http://www.fema.gov/fema/csb.shtm.

    DATES:

    The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables.

    FOR FURTHER INFORMATION CONTACT:

    If you want to determine whether a particular community was suspended on the suspension date or for further information, contact Bret Gates, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-4133.

    SUPPLEMENTARY INFORMATION:

    The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register.

    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

    Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

    National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

    Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

    Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

    Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

    Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

    Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

    List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

    PART 64—[AMENDED] 1. The authority citation for part 64 continues to read as follows: Authority:

    42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp.; p. 376.

    § 64.6 [Amended]
    2. The tables published under the authority of § 64.6 are amended as follows: State and location Community No. Effective date authorization/cancellation of sale of flood insurance in community Current effective map date Date certain
  • Federal assistance no
  • longer available
  • in SFHAs
  • Region I Vermont: Arlington, Town of, Bennington County 500012 August 5, 1975, Emerg; July 17, 1986, Reg; December 2, 2015, Susp. Dec. 2, 2015 Dec. 2, 2015. Dorset, Town of, Bennington County 500014 July 29, 1975, Emerg; August 1, 1986, Reg; December 2, 2015, Susp. ......do   Do. Landgrove, Town of, Bennington County 500178 December 23, 1975, Emerg; September 18, 1985, Reg; December 2, 2015, Susp. ......do   Do. Manchester, Town of, Bennington County 500015 January 28, 1972, Emerg; April 3, 1978, Reg; December 2, 2015, Susp. ......do   Do. Manchester, Village of, Bennington County 500179 September 10, 1975, Emerg; August 19, 1986, Reg; December 2, 2015, Susp. ......do   Do. Peru, Town of, Bennington County 500181 August 12, 2013, Emerg; N/A, Reg; December 2, 2015, Susp. ......do   Do. Pownal, Town of, Bennington County 500016 July 9, 1975, Emerg; April 1, 1980, Reg; December 2, 2015, Susp. ......do   Do. Rupert, Town of, Bennington County 500018 May 27, 1975, Emerg; September 18, 1985, Reg; December 2, 2015, Susp. ......do   Do. Sandgate, Town of, Bennington County 500183 June 5, 2013, Emerg; N/A, Reg; December 2, 2015, Susp. ......do   Do. Shaftsbury, Town of, Bennington County 500019 July 2, 1975, Emerg; September 18, 1985, Reg; December 2, 2015, Susp. ......do   Do. Stamford, Town of, Bennington County 500020 June 10, 1975, Emerg; July 3, 1978, Reg; December 2, 2015, Susp. ......do   Do. Sunderland, Town of, Bennington County 500021 September 10, 1975, Emerg; November 1, 1985, Reg; December 2, 2015, Susp. ......do   Do. Winhall, Town of, Bennington County 500022 September 10, 1975, Emerg; June 19, 1989, Reg; December 2, 2015, Susp. ......do   Do. Woodford, Town of, Bennington County 500023 November 13, 1975, Emerg; September 18, 1985, Reg; December 2, 2015, Susp. ......do   Do. Region III Virginia: Isle of Wight County, Unincorporated Areas 510303 May 20, 1975, Emerg; August 19, 1991, Reg; December 2, 2015, Susp. ......do   Do. Smithfield, Town of, Isle of Wight County 510081 September 24, 1974, Emerg; December 5, 1990, Reg; December 2, 2015, Susp. ......do   Do. Windsor, Town of, Isle of Wight County 510295 August 11, 1988, Emerg; August 1, 1990, Reg; December 2, 2015, Susp. ......do   Do. Region V Illinois: Galena, City of, Jo Daviess County 175168 August 27, 1971, Emerg; July 20, 1973, Reg; December 2, 2015, Susp. ......do   Do. Jo Daviess County, Unincorporated Areas 170902 April 19, 1979, Emerg; January 18, 1984, Reg; December 2, 2015, Susp. ......do   Do. Region IX Arizona: Fort Mojave Indian Tribe, Mohave County 040133 January 31, 1992, Emerg; March 18, 1996, Reg; December 2, 2015, Susp. ......do   Do. *-do- =Ditto. Code for reading third column: Emerg.—Emergency; Reg.—Regular; Susp.—Suspension.
    Dated: October 20, 2015. Roy E. Wright, Deputy Associate Administrator, Federal Insurance and Mitigation Administration, Department of Homeland Security, Federal Emergency Management Agency.
    [FR Doc. 2015-27750 Filed 10-29-15; 8:45 am] BILLING CODE 9110-12-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 1 [MD Docket Nos. 12-201; 13-140; 14-92; FCC 14-88] Assessment and Collection of Regulatory Fees for Fiscal Year 2014; Assessment and Collection of Regulatory Fees for Fiscal Year 2013; and Procedures for Assessment and Collection of Regulatory Fees AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule.

    SUMMARY:

    In this document, the Commission amends language in its rules to reflect that regulatory fees must be paid electronically, and can no longer be paid by check or money order. Electronic payments are not only cost-effective, they are also efficient and can provide an electronic “paper trail”. As a result, in an effort to improve efficiency, the Commission discontinued the practice of paying regulatory fees with a check or money order.

    DATES:

    Effective November 30, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Roland Helvajian, Office of Managing Director at (202) 418-0444.

    SUPPLEMENTARY INFORMATION:

    These revisions to the Commission's rules were first published as a proposed rule along with the Commission's Assessment and Collection of Regulatory Fees for Fiscal Year 2014, Notice of Proposed Rulemaking, 79 FR 37982, July 3, 2014, but it is now being published as a final rule.

    I. Administrative Matters A. Final Regulatory Flexibility Analysis

    1. As required by the Regulatory Flexibility Act of 1980 (RFA),1 the Commission has prepared a Final Regulatory Flexibility Analysis (FRFA) relating to this Report and Order. The FRFA is contained towards the end of this document.

    1See 5 U.S.C. 603. The RFA, see 5 U.S.C. 601-612, has been amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), Public Law 104-121, Title II, 110 Stat. 847 (1996). The SBREFA was enacted as Title II of the Contract with America Advancement Act of 1996 (CWAAA).

    B. Final Paperwork Reduction Act of 1995 Analysis

    2. This document contains new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. The Commission submitted the PRA documents to the Office of Management and Budget (OMB) under section 3507(d) of the PRA, and obtained OMB approval on May 30, 2014. Consequently, the requirement to obtain OMB approval for new and modified information collection has been fulfilled. Finally, we note that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the Commission sought previous comment on how it might further reduce the information collection burden on small businesses with fewer than 25 employees.

    C. Congressional Review Act

    3. The Commission will send a copy of this Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act. 5 U.S.C. 801(a)(1)(A).

    II. Regulatory Flexibility Analysis

    4. As required by the Regulatory Flexibility Act of 1980, as amended (RFA),2 an Initial Regulatory Flexibility Analysis (IRFA) was included in the FY 2014 Notice of Proposed Rulemaking to which this Order was attached.3 The Commission sought written public comment on these proposals including comment on the IRFA. This Final Regulatory Flexibility Analysis (FRFA) conforms to the IRFA.4

    2 5 U.S.C. 603. The RFA, 5 U.S.C. 601-612 has been amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), Public Law 104-121, Title II, 110 Stat. 847 (1996).

    3Assessment and Collection of Regulatory Fees for Fiscal Year 2014, Assessment and Collection of Regulatory Fees for Fiscal Year 2013, and Procedures for Assessment and Collection of Regulatory Fees, Notice of Proposed Rulemaking, Second Further Notice of Proposed Rulemaking, and Order, MD Docket Nos. 14-92, 13-140, and 12-201, 29 FCC Rcd 6417 (2014) (FY 2014 NPRM).

    4 5 U.S.C. 604.

    A. Need for, and Objectives of, the Order

    5. In this Order, the Commission amends language to sections 1.1112, 1.1158, 1.1161, and 1.1164 of its rules to note that regulatory fee payments must be made electronically, and payments by check and/or money order will no longer be accepted.

    6. In various places within the Code of Federal Regulations (CFR), the Commission specifies the method of payment that can be made for various types of fees (e.g. regulatory fees, application fees, auction fees, etc.). The basic method of fee payment has historically been by check or money order, but in more recent times, electronic forms of payment (e.g. credit card, ACH Debit, and wire transfer) have dominated the payment process. Electronic payments are not only cost-effective, they are also efficient and can provide an electronic “paper trail”. As a result, in an effort to improve efficiency, the Commission discontinued the practice of paying regulatory fees with a check or money order. This Order amends the Commission's rules to state that payment of regulatory fees must be electronic and checks and/or money orders will no longer be accepted as a form of payment.

    B. Summary of the Significant Issues Raised by the Public Comments in Response to the IRFA

    7. None.

    C. Description and Estimate of the Number of Small Entities To Which the Rules Will Apply

    8. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the proposed rules and policies, if adopted.5 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” 6 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.7 A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.8 Nationwide, there are a total of approximately 27.9 million small businesses, according to the SBA.9

    5 5 U.S.C. 603(b)(3).

    6 5 U.S.C. 601(6).

    7 5 U.S.C. 601(3) (incorporating by reference the definition of “small-business concern” in the Small Business Act, 15 U.S.C. 632). Pursuant to 5 U.S.C. 601(3), the statutory definition of a small business applies “unless an agency, after consultation with the Office of Advocacy of the Small Business Administration and after opportunity for public comment, establishes one or more definitions of such term which are appropriate to the activities of the agency and publishes such definition(s) in the Federal Register.”

    8 15 U.S.C. 632.

    9See SBA, Office of Advocacy, “Frequently Asked Questions,” http://www.sba.gov/sites/default/files/FAQ_Sept_2012.pdf.

    9. Wired Telecommunications Carriers. The U.S. Census Bureau defines this industry as “establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired communications networks. Transmission facilities may be based on a single technology or a combination of technologies. Establishments in this industry use the wired telecommunications network facilities that they operate to provide a variety of services, such as wired telephony services, including VoIP services, wired (cable) audio and video programming distribution, and wired broadband internet services. By exception, establishments providing satellite television distribution services using facilities and infrastructure that they operate are included in this industry.” 10 The SBA has developed a small business size standard for Wired Telecommunications Carriers, which consists of all such companies having 1,500 or fewer employees.11 Census data for 2007 shows that there were 3,188 firms that operated that year. Of this total, 3,144 operated with less than 1,000 employees.12 Thus, under this size standard, the majority of firms in this industry can be considered small.

    10http://www.census.gov/cgi-bin/sssd/naics/naicsrch.

    11See 13 CFR 120.201, NAICS Code 517110.

    12http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ5&prodType=table.

    10. Local Exchange Carriers (LECs). Neither the Commission nor the SBA has developed a size standard for small businesses specifically applicable to local exchange services. The closest applicable NAICS Code category is Wired Telecommunications Carriers as defined in paragraph 6 of this FRFA. Under the applicable SBA size standard, such a business is small if it has 1,500 or fewer employees.13 According to Commission data, census data for 2007 shows that there were 3,188 firms that operated that year. Of this total, 3,144 operated with fewer than 1,000 employees.14 The Commission therefore estimates that most providers of local exchange carrier service are small entities that may be affected by the rules adopted.

    13 13 CFR 121.201, NAICS code 517110.

    14http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ5&prodType=table.

    11. Incumbent LECs. Neither the Commission nor the SBA has developed a small business size standard specifically for incumbent local exchange services. The closest applicable NAICS Code category is Wired Telecommunications Carriers as defined in paragraph 6 of this FRFA. Under that size standard, such a business is small if it has 1,500 or fewer employees.15 According to Commission data, 3,188 firms operated in that year. Of this total, 3,144 operated with fewer than 1,000 employees.16 Consequently, the Commission estimates that most providers of incumbent local exchange service are small businesses that may be affected by the rules and policies adopted. Three hundred and seven (307) Incumbent Local Exchange Carriers reported that they were incumbent local exchange service providers.17 Of this total, an estimated 1,006 have 1,500 or fewer employees.18

    15 13 CFR 121.201, NAICS code 517110.

    16http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ5&prodType=table.

    17See Trends in Telephone Service, Federal Communications Commission, Wireline Competition Bureau, Industry Analysis and Technology Division at Table 5.3 (Sept. 2010) (Trends in Telephone Service).

    18 Id.

    12. Competitive Local Exchange Carriers (Competitive LECs), Competitive Access Providers (CAPs), Shared-Tenant Service Providers, and Other Local Service Providers. Neither the Commission nor the SBA has developed a small business size standard specifically for these service providers. The appropriate NAICS Code category is Wired Telecommunications Carriers, as defined in paragraph 6 of this FRFA. Under that size standard, such a business is small if it has 1,500 or fewer employees.19 U.S. Census data for 2007 indicate that 3,188 firms operated during that year. Of that number, 3,144 operated with fewer than 1,000 employees.20 Based on this data, the Commission concludes that the majority of Competitive LECS, CAPs, Shared-Tenant Service Providers, and Other Local Service Providers, are small entities. According to Commission data, 1,442 carriers reported that they were engaged in the provision of either competitive local exchange services or competitive access provider services.21 Of these 1,442 carriers, an estimated 1,256 have 1,500 or fewer employees.22 In addition, 17 carriers have reported that they are Shared-Tenant Service Providers, and all 17 are estimated to have 1,500 or fewer employees.23 Also, 72 carriers have reported that they are Other Local Service Providers.24 Of this total, 70 have 1,500 or fewer employees.25 Consequently, based on internally researched FCC data, the Commission estimates that most providers of competitive local exchange service, competitive access providers, Shared-Tenant Service Providers, and Other Local Service Providers are small entities that may be affected by the rules adopted.

    19 13 CFR 121.201, NAICS code 517110.

    20http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ5&prodType=table.

    21See Trends in Telephone Service, at Table 5.3.

    22Id.

    23Id.

    24Id.

    25Id.

    13. Interexchange Carriers (IXCs). Neither the Commission nor the SBA has developed a definition for Interexchange Carriers. The closest NAICS Code category is Wired Telecommunications Carriers as defined in paragraph 6 of this FRFA. The applicable size standard under SBA rules is that such a business is small if it has 1,500 or fewer employees.26 U.S. Census data for 2007 indicates that 3,188 firms operated during that year. Of that number, 3,144 operated with fewer than 1,000 employees.27 According to internally developed Commission data, 359 companies reported that their primary telecommunications service activity was the provision of interexchange services.28 Of this total, an estimated 317 have 1,500 or fewer employees.29 Consequently, the Commission estimates that the majority of interexchange service providers are small entities that may be affected by the rules adopted.

    26 13 CFR 121.201, NAICS code 517110.

    27http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ5&prodType=table.

    28See Trends in Telephone Service, at Table 5.3.

    29Id.

    14. Prepaid Calling Card Providers. Neither the Commission nor the SBA has developed a small business size standard specifically for prepaid calling card providers. The appropriate NAICS Code category for prepaid calling card providers is Telecommunications Resellers. This industry comprises establishments engaged in purchasing access and network capacity from owners and operators of telecommunications networks and reselling wired and wireless telecommunications services (except satellite) to businesses and households. Mobile virtual networks operators (MVNOs) are included in this industry.30 Under the applicable SBA size standard, such a business is small if it has 1,500 or fewer employees.31 U.S. Census data for 2007 show that 1,523 firms provided resale services during that year. Of that number, 1,522 operated with fewer than 1,000 employees.32 Thus, under this category and the associated small business size standard, the majority of these prepaid calling card providers can be considered small entities. According to Commission data, 193 carriers have reported that they are engaged in the provision of prepaid calling cards.33 All 193 carriers have 1,500 or fewer employees.34 Consequently, the Commission estimates that the majority of prepaid calling card providers are small entities that may be affected by the rules adopted.

    30http://www.census.gov/cgi-bin/ssd/naics/naicsrch.

    31 13 CFR 121.201, NAICS code 517911.

    32http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ5&prodType=table.

    33See Trends in Telephone Service, at Table 5.3.

    34Id.

    15. Local Resellers. The SBA has developed a small business size standard for the category of Telecommunications Resellers. Under that size standard, such a business is small if it has 1,500 or fewer employees.35 Census data for 2007 show that 1,523 firms provided resale services during that year. Of that number, 1,522 operated with fewer than 1,000 employees.36 Under this category and the associated small business size standard, the majority of these local resellers can be considered small entities. According to Commission data, 213 carriers have reported that they are engaged in the provision of local resale services.37 Of this total, an estimated 211 have 1,500 or fewer employees.38 Consequently, the Commission estimates that the majority of local resellers are small entities that may be affected by the rules adopted.

    35 13 CFR 121.201, NAICS code 517911.

    36http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ5&prodType=table.

    37See Trends in Telephone Service, at Table 5.3.

    38Id.

    16. Toll Resellers. The Commission has not developed a definition for Toll Resellers. The closest NAICS Code Category is Telecommunications Resellers, and the SBA has developed a small business size standard for the category of Telecommunications Resellers. Under that size standard, such a business is small if it has 1,500 or fewer employees.39 Census data for 2007 show that 1,523 firms provided resale services during that year. Of that number, 1,522 operated with fewer than 1,000 employees.40 Thus, under this category and the associated small business size standard, the majority of these resellers can be considered small entities. According to Commission data, 881 carriers have reported that they are engaged in the provision of toll resale services.41 Of this total, an estimated 857 have 1,500 or fewer employees.42 Consequently, the Commission estimates that the majority of toll resellers are small entities that may be affected by the rules adopted.

    39http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ5&prodType=table.

    40Id.

    41Trends in Telephone Service, at Table 5.3.

    42Id.

    17. Other Toll Carriers. Neither the Commission nor the SBA has developed a definition for small businesses specifically applicable to Other Toll Carriers. This category includes toll carriers that do not fall within the categories of interexchange carriers, operator service providers, prepaid calling card providers, satellite service carriers, or toll resellers. The closest applicable NAICS Code category is for Wired Telecommunications Carriers as defined in paragraph 6 of this FRFA. Under the applicable SBA size standard, such a business is small if it has 1,500 or fewer employees.43 Census data for 2007 shows that there were 3,188 firms that operated that year. Of this total, 3,144 operated with fewer than 1,000 employees.44 Thus, under this category and the associated small business size standard, the majority of Other Toll Carriers can be considered small. According to internally developed Commission data, 284 companies reported that their primary telecommunications service activity was the provision of other toll carriage.45 Of these, an estimated 279 have 1,500 or fewer employees.46 Consequently, the Commission estimates that most Other Toll Carriers are small entities that may be affected by the rules and policies adopted.

    43 13 CFR 121.201, NAICS code 517110.

    44http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ5&prodType=table.

    45Trends in Telephone Service, at Table 5.3.

    46Id.

    18. Wireless Telecommunications Carriers (except Satellite). This industry comprises establishments engaged in operating and maintaining switching and transmission facilities to provide communications via the airwaves, such as cellular services, paging services, wireless internet access, and wireless video services.47 The appropriate size standard under SBA rules is that such a business is small if it has 1,500 or fewer employees. For this industry, Census data for 2007 show that there were 1,383 firms that operated for the entire year. Of this total, 1,368 firms had fewer than 1,000 employees. Thus under this category and the associated size standard, the Commission estimates that the majority of wireless telecommunications carriers (except satellite) are small entities. Similarly, according to internally developed Commission data, 413 carriers reported that they were engaged in the provision of wireless telephony, including cellular service, Personal Communications Service (PCS), and Specialized Mobile Radio (SMR) services.48 Of this total, an estimated 261 have 1,500 or fewer employees.49 Consequently, the Commission estimates that approximately half of these firms can be considered small. Thus, using available data, we estimate that the majority of wireless firms can be considered small.

    47 NAICS Code 517210. See http://www.census.gov/cgi-bin/ssd/naics/naiscsrch.

    48Trends in Telephone Service, at Table 5.3

    49Id.

    19. Cable Television and Other Subscription Programming. 50 Since 2007, these services have been defined within the broad economic census category of Wired Telecommunications Carriers. That category is defined as follows: “This industry comprises establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or a combination of technologies.” 51 The SBA has developed a small business size standard for this category, which is: All such firms having 1,500 or fewer employees.52 Census data for 2007 shows that there were 3,188 firms that operated that year. Of this total, 3,144 had fewer than 1,000 employees.53 Thus under this size standard, the majority of firms offering cable and other program distribution services can be considered small and may be affected by rules adopted.

    50 In 2014, “Cable and Other Subscription Programming,” NAICS Code 515210, replaced a prior category, now obsolete, which was called “Cable and Other Program Distribution.” Cable and Other Program Distribution, prior to 2014, was placed under NAICS Code 517110, Wired Telecommunications Carriers. Wired Telecommunications Carriers is still a current and valid NAICS Code Category. Because of the similarity between “Cable and Other Subscription Programming” and “Cable and other Program Distribution,” we will, in this proceeding, continue to use Wired Telecommunications Carrier data based on the U.S. Census. The alternative of using data gathered under Cable and Other Subscription Programming (NAICS Code 515210) is unavailable to us for two reasons. First, the size standard established by the SBA for Cable and Other Subscription Programming is annual receipts of $38.5 million or less. Thus to use the annual receipts size standard would require the Commission either to switch from existing employee based size standard of 1,500 employees or less for Wired Telecommunications Carriers, or else would require the use of two size standards. No official approval of either option has been granted by the Commission as of the time of the release of the FY 2015 NPRM. Second, the data available under the size standard of $38.5 million dollars or less is not applicable at this time, because the only currently available U.S. Census data for annual receipts of all businesses operating in the NAICS Code category of 515210 (Cable and other Subscription Programming) consists only of total receipts for all businesses operating in this category in 2007 and of total annual receipts for all businesses operating in this category in 2012. The data do not provide any basis for determining, for either year, how many businesses were small because they had annual receipts of $38.5 million or less. See http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2012_US_51I2&prodType=table.

    51 U.S. Census Bureau, 2007 NAICS Definitions, “517110 Wired Telecommunications Carriers” (partial definition), (Full definition stated in paragraph 6 of this IRFA) available at http://www.census.gov/cgi-bin/sssd/naics/naicsrch.

    52 13 CFR 121.201, NAICS code 517110.

    53http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US-51SSSZ5&prodType=Table.

    20. Cable Companies and Systems. The Commission has developed its own small business size standards for the purpose of cable rate regulation. Under the Commission's rules, a “small cable company” is one serving 400,000 or fewer subscribers nationwide.54 Industry data indicate that there are currently 4,600 active cable systems in the United States.55 Of this total, all but ten cable operators nationwide are small under the 400,000-subscriber size standard.56 In addition, under the Commission's rate regulation rules, a “small system” is a cable system serving 15,000 or fewer subscribers.57 Current Commission records show 4,600 cable systems nationwide.58 Of this total, 3,900 cable systems have less than 15,000 subscribers, and 700 systems have 15,000 or more subscribers, based on the same records.59 Thus, under this standard as well, we estimate that most cable systems are small entities.

    54 47 CFR 76.901(e).

    55 August 15, 2015 Report from the Media Bureau based on data contained in the Commission's Cable Operations And Licensing System (COALS). See www/fcc.gov/coals.

    56See SNL KAGAN at Https://snl.cominteractiveX top cable MSOs aspx?period2015Q1&sortcol=subscribersbasic&sortorder=desc.

    57 47 CFR 76.901(c).

    58See footnote 2, supra.

    59 August 5, 2015 report from the Media Bureau based on its research in COALS. See www.fcc.gov/coals.

    21. Cable System Operators (Telecom Act Standard). The Communications Act of 1934, as amended, also contains a size standard for small cable system operators, which is “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than 1 percent of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenues in the aggregate exceed $250,000,000.” 60 There are approximately 52,403,705 cable video subscribers in the United States today.61 Accordingly, an operator serving fewer than 524,037 subscribers shall be deemed a small operator if its annual revenues, when combined with the total annual revenues of all its affiliates, do not exceed $250 million in the aggregate.62 Based on available data, we find that all but nine incumbent cable operators are small entities under this size standard.63 We note that the Commission neither requests nor collects information on whether cable system operators are affiliated with entities whose gross annual revenues exceed $250 million.64 Although it seems certain that some of these cable system operators are affiliated with entities whose gross annual revenues exceed $250,000,000, we are unable at this time to estimate with greater precision the number of cable system operators that would qualify as small cable operators under the definition in the Communications Act.

    60 47 CFR 901 (f) and notes ff. 1, 2, and 3.

    61See SNL KAGAN at htpps://www.snl.com/interactivex/MultichannelIndustryBenchmarks.aspx.

    62 47.901(f) and notes ff. 1, 2, and 3.

    63See SNL KAGAN at www.snl.com/Interactivex/TopCable MSOs.aspx.

    64 The Commission does receive such information on a case-by-case basis if a cable operator appeals a local franchise authority's finding that the operator does not qualify as a small cable operator pursuant to 76.901(f) of the Commission's rules. See 47 CFR 76.901(f).

    22. All Other Telecommunications. “All Other Telecommunications” is defined as follows: This U.S. industry is comprised of establishments that are primarily engaged in providing specialized telecommunications services, such as satellite tracking, communications telemetry, and radar station operation. This industry also includes establishments primarily engaged in providing satellite terminal stations and associated facilities connected with one or more terrestrial systems and capable of transmitting telecommunications to, and receiving telecommunications from, satellite systems. Establishments providing Internet services or voice over Internet protocol (VoIP) services via client-supplied telecommunications connections are also included in this industry.65 The SBA has developed a small business size standard for “All Other Telecommunications,” which consists of all such firms with gross annual receipts of $32.5 million or less.66 For this category, census data for 2007 show that there were 2,383 firms that operated for the entire year. Of these firms, a total of 2,346 had gross annual receipts of less than $25 million.67 Thus, a majority of “All Other Telecommunications” firms potentially affected by the rules adopted can be considered small.

    65http://www.census.gov/cgi-bin/ssssd/naics/naicsrch.

    66 13 CFR 121.201; NAICS Code 517919.

    67http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ5&prodType=table.

    D. Description of Projected Reporting, Recordkeeping and Other Compliance Requirements

    23. This Report and Order does not adopt any new reporting, recordkeeping, or other compliance requirements.

    E. Steps Taken To Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered

    24. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its approach, which may include the following four alternatives, among others: (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.68

    68 5 U.S.C. 603(c)(1) through(c)(4).

    25. This Order does not adopt any new reporting requirements. Therefore no adverse economic impact on small entities will be sustained based on reporting requirements. There will be a regulatory fee instituted on DBS providers due to the adoption of a new fee category, but we anticipate that the two primary DBS companies required to pay these fees are not small entities. Similarly, a new regulatory fee for Responsible Organizations (Resp. Org) has also been instituted in FY 2015 for the toll free number fee category that was previously adopted—the fee rate adopted is 12 cents per year. This is not a new reporting requirement, and should not have any adverse economic impact on small Resp. Org. entities because they are able to recover these assessed fees from their customers.

    26. In keeping with the requirements of the Regulatory Flexibility Act, we have considered certain alternative means of mitigating the effects of fee increases to a particular industry segment. For example, beginning in FY 2015 the Commission has increased the de minimis threshold from under $10 to $500 (the total of all regulatory fees), which will impact many small entities that pay regulatory fees for ITSP, paging, cellular, cable, and Low Power Television/FM Translators. Historically, many of these small entities have been late in making their fee payments to the Commission by the due date. This increase in the de minimis threshold to $500 will relieve regulatees both financially and administratively. Finally, regulatees may also seek waivers or other relief on the basis of financial hardship. See 47 CFR 1.1166.

    F. Federal Rules That May Duplicate, Overlap, or Conflict

    27. None.

    III. Ordering Clauses

    28. Accordingly, IT IS ORDERED that, pursuant to sections 4(i) and (j), 9, and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 159, and 303(r), this Order IS HEREBY ADOPTED.

    29. IT IS FURTHER ORDERED that this Order SHALL BE EFFECTIVE November 30, 2015.

    30. IT IS FURTHER ORDERED that the Commission's Consumer & Governmental Affairs Bureau, Reference Information Center, SHALL SEND a copy of this Order, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the U.S. Small Business Administration.

    List of Subjects in 47 CFR Part 1

    Administrative practice and procedure.

    Federal Communications Commission. Marlene H. Dortch, Secretary. Rule Changes

    For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 1 as follows:

    PART 1—PRACTICE AND PROCEDURE 1. The authority citation for part 1 continues to read as follows: Authority:

    15 U.S.C. 79, et seq.; 47 U.S.C. 151, 154(i), 154(j), 155, 157, 160, 201, 225, 227, 303, 309, 332, 1403, 1404, 1451, 1452, and 1455.

    2. Section 1.1112 is amended by revising paragraphs (a) and (b), redesignating paragraphs (e) and (f) as paragraphs (f) and (g), and by adding new paragraph (e) to read as follows:
    § 1.1112 Form of payment.

    (a) Annual and multiple year regulatory fees must be paid electronically as described in paragraph (e) of this section. Fee payments, other than annual and multiple year regulatory fee payments, should be in the form of a check, cashier's check, or money order denominated in U.S. dollars and drawn on a United States financial institution and made payable to the Federal Communications Commission or by a Visa, MasterCard, American Express, or Discover credit card. No other credit card is acceptable. Fees for applications and other filings paid by credit card will not be accepted unless the credit card section of FCC Form 159 is completed in full. The Commission discourages applicants from submitting cash and will not be responsible for cash sent through the mail. Personal or corporate checks dated more than six months prior to their submission to the Commission's lockbox bank and postdated checks will not be accepted and will be returned as deficient. Third party checks (i.e., checks with a third party as maker or endorser) will not be accepted.

    (1) Although payments (other than annual and multiple year regulatory fee payments) may be submitted in the form of a check, cashier's check, or money order, payors of these fees are encouraged to submit these payments electronically under the procedures described in paragraph (e) of this section.

    (2) Specific procedures for electronic payments are announced in Bureau/Office fee filing guides.

    (3) It is the responsibility of the payer to insure that any electronic payment is made in the manner required by the Commission. Failure to comply with the Commission's procedures will result in the return of the application or other filing.

    (4) To insure proper credit, applicants making wire transfer payments must follow the instructions set out in the appropriate Bureau Office fee filing guide.

    (b) Applicants are required to submit one payment instrument (check, cashier's check, or money order) and FCC Form 159 with each application or filing; multiple payment instruments for a single application or filing are not permitted. A separate Fee Form (FCC Form 159) will not be required once the information requirements of that form (the Fee Code, fee amount, and total fee remitted) are incorporated into the underlying application form.

    (e) Annual and multiple year regulatory fee payments shall be submitted by online ACH payment, online Visa, MasterCard, American Express, or Discover credit card payment, or wire transfer payment denominated in U.S. dollars and drawn on a United States financial institution and made payable to the Federal Communications Commission. No other credit card is acceptable. Any other form of payment for regulatory fees (e.g., paper checks) will be rejected and sent back to the payor.

    3. Section 1.1158 is amended by revising the introductory text and paragraph (a) to read as follows:
    § 1.1158 Form of payment for regulatory fees.

    Any annual and multiple year regulatory fee payment must be submitted by online Automatic Clearing House (ACH) payment, online Visa, MasterCard, American Express, or Discover credit card payment, or wire transfer payment denominated in U.S. dollars and drawn on a United States financial institution and made payable to the Federal Communications Commission. No other credit card is acceptable. Any other form of payment for annual and multiple year regulatory fees (e.g., paper checks, cash) will be rejected and sent back to the payor. The Commission will not be responsible for cash, under any circumstances, sent through the mail.

    (a) Payors making wire transfer payments must submit an accompanying FCC Form 159-E via facsimile.

    4. Section 1.1161 is amended by revising paragraph (a) to read as follows:
    § 1.1161 Conditional license grants and delegated authorizations.

    (a) Grant of any application or an instrument of authorization or other filing for which an annual or multiple year regulatory fee is required to accompany the application or filing will be conditioned upon final payment of the current or delinquent regulatory fees. Current annual and multiple year regulatory fees must be paid electronically as described in § 1.1112(e). For all other fees, (e.g., application fees, delinquent regulatory fees) final payment shall mean receipt by the U.S. Treasury of funds cleared by the financial institution on which the check, cashier's check, or money order is drawn. Electronic payments are considered timely when a wire transfer was received by the Commission's bank no later than 6:00 p.m. on the due date; confirmation to pay.gov that a credit card payment was successful no later than 11:59 p.m. (EST) on the due date; or confirmation an ACH was credited no later than 11:59 p.m. (EST) on the due date.

    5. Section 1.1164 is amended by revising the introductory text to read as follows:
    § 1.1164 Penalties for late or insufficient regulatory fee payments.

    Electronic payments are considered timely when a wire transfer was received by the Commission's bank no later than 6:00 p.m. on the due date; confirmation to pay.gov that a credit card payment was successful no later than 11:59 p.m. (EST) on the due date; or confirmation an ACH was credited no later than 11:59 p.m. (EST) on the due date. In instances where a non-annual regulatory payment (i.e., delinquent payment) is made by check, cashier's check, or money order, a timely fee payment or installment payment is one received at the Commission's lockbox bank by the due date specified by the Commission or by the Managing Director. Where a non-annual regulatory fee payment is made by check, cashier's check, or money order, a timely fee payment or installment payment is one received at the Commission's lockbox bank by the due date specified by the Commission or the Managing Director. Any late payment or insufficient payment of a regulatory fee, not excused by bank error, shall subject the regulatee to a 25 percent penalty of the amount of the fee of installment payment which was not paid in a timely manner.

    [FR Doc. 2015-27630 Filed 10-29-15; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part 175 [Docket No. PHMSA-2015-0165] RIN 2137-AF12 Hazardous Materials: Carriage of Battery-Powered Electronic Smoking Devices in Passenger Baggage AGENCY:

    Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.

    ACTION:

    Interim final rule.

    SUMMARY:

    PHMSA is issuing an interim final rule to prohibit passengers and crewmembers from carrying battery-powered portable electronic smoking devices (e.g., e-cigarettes, e-cigs, e-cigars, e-pipes, e-hookahs, personal vaporizers, electronic nicotine delivery systems) in checked baggage and prohibit passengers and crewmembers from charging the devices and/or batteries on board the aircraft. These devices may continue to be carried in carry-on baggage. This action is consistent with a similar action taken by the International Civil Aviation Organization (ICAO) that incorporated this restriction into the 2015-2016 Edition of the ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air by way of an addendum and is necessary to address an immediate safety risk. This interim final rule does not impact the existing rules on the transport of lithium batteries or other portable electronic devices that are transported for personal use in a passenger's checked or carry-on baggage.

    Because the actions taken in this interim final rule address a public safety risk, PHMSA finds that good cause exists to amend the regulations without advance notice and opportunity for public comment. For the reasons described below, public notice is impracticable, unnecessary, and contrary to the public interest. PHMSA encourages persons to participate in this rulemaking by submitting comments containing relevant information, data, or views. We will consider all comments received on or before the closing date for comments. We will consider late filed comments to the extent practicable. This interim final rule may be amended based on comments received.

    DATES:

    Effective Date: The effective date of these amendments is November 6, 2015.

    Comments: Comments must be received by November 30, 2015.

    ADDRESSES:

    You may submit comments by any of the following methods:

    1. Federal Rulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

    2. Fax: 1-202-493-2251.

    3. Mail: Docket Management System; U.S. Department of Transportation, Dockets Operations, M-30, Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.

    4. Hand Delivery: To U.S. Department of Transportation, Dockets Operations, M-30, Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001 between 9 a.m. and 5 p.m. Monday through Friday, except Federal holidays.

    Instructions: Include the agency name and docket number PHMSA-2015-0165 or RIN 2137-AF12 for this rulemaking at the beginning of your comment. Note that all comments received will be posted without change to http://www.regulations.gov including any personal information provided. If sent by mail, comments must be submitted in duplicate. Persons wishing to receive confirmation of receipt of their comments must include a self-addressed stamped postcard.

    Privacy Act: Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the document (or signing the document, if submitted on behalf of an association, business, labor union, etc.), as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

    Docket: You may view the public docket through the Internet at http://www.regulations.gov or in person at the Docket Operations office at the above address (See ADDRESSES).

    FOR FURTHER INFORMATION CONTACT:

    Kevin A. Leary, Standards and Rulemaking Division, Pipeline and Hazardous Materials Safety Administration, telephone (202) 366-8553.

    SUPPLEMENTARY INFORMATION: I. Background

    A battery-powered portable electronic smoking device (e-cigarette), also called an e-cig, a personal vaporizer or electronic nicotine delivery system, is a battery-powered device that simulates tobacco smoking. E-cigarettes contain a liquid, an atomizer or heating element, and a battery. When an e-cigarette is operated by a user, the heating element vaporizes the liquid. Many e-cigarettes are designed to look like traditional cigarettes, but they are also made to look like cigars, pipes, and even everyday products such as pens. The use of e-cigarettes has been rising substantially and e-cigarettes have increasingly become a common item in passenger baggage. Airline passengers and crewmembers are currently permitted to carry these devices under the provisions for portable electronic devices contained in 49 CFR 175.10(a)(18). However, the provisions for portable electronic devices do not adequately address the safety risks posed by e-cigarettes, which include a heating element as a function of their design.

    Recent fire incidents involving e-cigarettes in checked baggage, along with actions taken by the Federal Aviation Administration (FAA) and ICAO, highlight the need for PHMSA to take prompt action to address this issue.

    On August 9, 2014, at Boston's Logan Airport, an e-cigarette contained in a passenger's checked bag in the cargo hold of a passenger aircraft caused a fire that forced an evacuation of the aircraft. An airline ramp agent noticed smoke coming from the bag. The bag was removed from the aircraft cargo compartment and investigators determined the source of the fire was an e-cigarette, which continued to burn after it was removed from the bag. Air carrier personnel extinguished the fire. Massport Fire responded and ensured the fire was no longer burning. The fire burned a hole approximately 4 inches in diameter in the outer pocket of the bag. Passengers were deplaned as a precaution.

    On January 4, 2015, at Los Angeles International Airport, a checked bag that arrived late and missed its connecting flight was found to be on fire in a baggage area. Emergency responders attributed the fire to an overheated e-cigarette inside the bag.

    These incidents have shown that e-cigarettes can overheat and cause fires when the heating element is accidentally activated or turned on. This danger may be exacerbated by the growing trend of users modifying and rebuilding their reusable e-cigarette devices and swapping components, which may include the use of batteries, heating elements, and electronic components not original to the manufactured e-cigarette.

    An October 2014 report from the U.S. Fire Administration 1 identified at least 25 incidents of explosion and fire involving e-cigarettes between 2009 and 2014. Many of these incidents occurred while the device was charging and resulted in the ignition of nearby combustible materials. This report highlights the risks associated with charging e-cigarettes.

    1 Electronic Cigarette Fires and Explosions, U.S. Fire Administration, October 2014 (See appendix 1 for a list of the incidents) https://www.usfa.fema.gov/downloads/pdf/publications/electronic_cigarettes.pdf.

    Following the fire at Logan Airport, on December 10, 2014, the ICAO issued an Electronic Bulletin (EB) titled, Dangerous Goods Carried by Passenger and Crew—Incidents Related to Electronic Cigarettes (EB 2014/074).2 The ICAO bulletin recommended that a passenger's e-cigarettes be carried in the cabin of the aircraft and not in checked baggage.

    2 Dangerous Goods Carried by Passenger and Crew—Incidents Related to Electronic Cigarettes, Electronic Bulletin (EB) 2104/074, International Civil Aviation Administration (ICAO), October 10, 2014, http://www.faa.gov/about/office_org/headquarters_offices/ash/ash_programs/hazmat/passenger_info/media/ICAO_ecigarettes_bulletin.pdf.

    On January 22, 2015, the FAA issued a Safety Alert for Operators (SAFO) 3 that highlighted current provisions of the hazardous materials regulations (HMR), which state, “transportation of battery-powered devices that are likely to create sparks or generate a dangerous evolution of heat is prohibited unless they are packaged in such a manner to preclude such an occurrence (see 49 CFR 173.21(c)).” The SAFO further recommended that air operators require their passengers to carry e-cigarettes only in the cabin of the aircraft.

    3 Fire Risk of Electronic Cigarettes (e-cigarettes) in Checked Baggage, Safety Alert for Operators—SAFO15003, Federal Aviation Administration (FAA), January 22, 2015, https://www.faa.gov/other_visit/aviation_industry/airline_operators/airline_safety/safo/all_safos/media/2015/SAFO15003.pdf.

    Effective June 9, 2015, the ICAO published an addendum to the 2015-2016 ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air to prohibit carriage of e-cigarettes in checked baggage and restrict the charging of these devices while on board the aircraft. This addendum constitutes an amendment to the 2015-2016 ICAO Technical Instructions, which took effect on January 1, 2015. On January 8, 2015, PHMSA published a rulemaking harmonizing the HMR with the 2015-2016 ICAO Technical Instructions. This issuance of this interim final rule is necessary to incorporate the June 9, 2015 amendment to the Technical Instructions to address the known safety risk.

    The partial restriction in this interim final rule applies only to battery-powered portable electronic smoking devices (e.g., e-cigarettes, e-cigs, e-cigars, e-pipes, e-hookahs, personal vaporizers, electronic nicotine delivery systems). Passengers and crewmembers can continue to carry battery-powered portable electronic smoking devices in carry-on baggage. This interim final rule does not prohibit a passenger from transporting other devices containing batteries for personal use (such as laptop computers, cell phones, cameras, etc.) in checked or carry-on baggage nor does it restrict a passenger from transporting batteries for personal use in carry-on baggage.

    II. Justification for Interim Final Rule

    PHMSA is issuing this interim final rule without providing an opportunity for prior public notice and comment as is normally required by the Administrative Procedure Act (APA). See 5 U.S.C. 553. The APA authorizes agencies to dispense with certain notice and comment procedures if the agency finds for good cause that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest. See 5 U.S.C. 553(b)(3)(B). “Good cause” exists in impracticable situations when notice unavoidably prevents the due and required execution of agency functions or when an agency finds that due and timely execution of its functions is impeded by the notice otherwise required by the APA. For example, an “impracticable” good cause situation might be where air safety rules should be amended without delay if the FAA determines that the safety of the traveling public is at stake. Public notice is unnecessary when the public does not need or benefit from the notice and comment, such as with a minor or technical amendment. “Public interest” supplements the other terms and requires that public rulemaking procedures must not prevent an agency from operating and that a lack of public concern warrants an agency dispensing with public procedure.

    In this case, the agency finds, for good cause, that notice and public comment is impracticable, unnecessary, and contrary to the public interest. The importance of the safety of the flying public provides good cause for this measure. Here, there is a credible indication of an emerging transportation safety risk from two recent incidents involving battery-powered portable electronic smoking devices in checked baggage and additional non-transportation incidents that occurred while these types of devices were being charged. In August 2014 at Boston's Logan Airport, an e-cigarette contained in a passenger's checked bag caught fire pre-flight and caused the evacuation of an airplane. Similarly, in January 2015 at Los Angeles International Airport, a bag containing an e-cigarette was found to be on fire in a baggage area. The bag in question had missed a flight connection, and should have been in the air at the time of the incident. Although neither airplane was in the air when the fires ignited, these incidents represent two near misses for the safety of aviation passengers. E-cigarettes in checked bags present a safety risk because the devices are capable of generating extreme heat and an incident can result in the ignition of nearby contents. Carriage of e-cigarettes in the passenger cabin addresses this safety risk by ensuring that if an incident does occur, it can be immediately identified and mitigated. PHMSA believes that a delay in implementing this measure could result in serious harm to the traveling public.

    Under these circumstances, notice is impracticable and contrary to the public interest. Because ICAO issued the addendum on a very short timeframe due to the gravity of the safety risk, the HMR are currently not harmonized with the ICAO Technical Instructions. Given the safety risks posed by e-cigarettes in checked baggage, PHMSA believes that public notice would frustrate the due and required execution of agency functions. Although some airlines have voluntarily complied with the SAFO recommendations, there is no domestic regulation to require continued compliance with the recently adopted ICAO amendment. Typically, PHMSA amends the HMR to conform to recent amendments to the ICAO Technical Instructions through periodic international harmonization rulemaking. If PHMSA utilized this process, this HMR amendment would become effective no earlier than January 1, 2017. The accelerated effective date of the addendum to the ICAO Technical Instructions ensures that passengers that travel on international airlines are subject to this provision before PHMSA would have time to issue a final rule through its regular harmonization rulemaking process. In light of the recent incidents and the serious harm that could result from the public safety risk of e-cigarettes in checked baggage, PHMSA believes that a delay caused by adhering to the APA notice-and-comment process to adopt conforming amendments is impracticable and contrary to the public interest.

    Further, PHMSA believes that APA notice and comment would be unnecessary because the public would not benefit from such notice. The scope of this regulatory change is very limited; PHMSA is including a new entry for e-cigarettes in 49 CFR 175.10 with carriage instructions. The change does not impact whether passengers may bring their e-cigarettes on an airplane. Instead, the new language affects how the e-cigarettes must be stowed. This rulemaking does not impact the ability to travel by air with these devices. FAA's January 2015 SAFO recommended that air carriers require their passengers to carry e-cigarettes and related devices exclusively in the cabin of the aircraft. In voluntary compliance with the SAFO, many airlines instruct passengers to carry their e-cigarettes in carry-on baggage only. Because a substantial degree of compliance with this safety provision already exists through voluntary airline actions, this amendment is limited in scope yet pivotal for the safety of the traveling public. Thus, in light of the recent safety incidents and limited scope of the June 9, 2015, ICAO amendment, PHMSA has determined that the notice and comment rulemaking process is unnecessary, impracticable, and contrary to the public interest in this instance.

    The DOT is taking immediate action to strengthen safeguards for the carriage of battery-powered portable electronic smoking devices in passenger checked baggage and prohibit passengers and crewmembers from charging the devices and/or batteries on board the aircraft. This interim final rule is effective seven days after publication in the Federal Register. The APA requires agencies to delay the effective date of regulations for 30 days after publication, unless the agency finds good cause to make the regulations effective sooner. See 5 U.S.C. 553(d). This interim final rule meets the good cause exception in this instance because of credible evidence from two separate incidents involving battery-powered portable electronic smoking devices in checked baggage and additional non-transportation incidents that occurred while the devices were being charged. The retroactive nature of the ICAO amendments makes a 30-day effective date impracticable and contrary to the public interest, because such a delay would further extend the time period in which the HMR does not harmonize with ICAO. Because several incidents have highlighted the safety risks of the charging and cargo carriage of these devices, the public interest is served by providing a seven-day effective date for this interim final rule.

    The Regulatory Policies and Procedures of DOT (44 FR 110034; February 26, 1979) provide that, to the maximum extent possible, DOT operating administrations should provide an opportunity for public comment on regulations issued without prior notice. Accordingly, PHMSA encourages persons to participate in this rulemaking by submitting comments containing relevant information, data, or views. We will consider all comments received on or before the closing date for comments. We will consider late filed comments to the extent practicable. This interim final rule may be amended based on comments received.

    III. Rulemaking Analysis and Notices A. Statutory/Legal Authority for This Rulemaking

    This interim final rule is published under authority of Federal hazardous materials transportation law (Federal hazmat law; 49 U.S.C. 5101 et seq.) and 49 U.S.C. 44701. Section 5103(b) of Federal hazmat law authorizes the Secretary of Transportation to prescribe regulations for the safe transportation, including security, of hazardous material in intrastate, interstate, and foreign commerce. 49 U.S.C. 44701 authorizes the Administrator of the Federal Aviation Administration to promote safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for practices, methods, and procedures the Administrator finds necessary for safety in air commerce and national security. 49 U.S.C. 5120(b) authorizes the Secretary of Transportation to ensure that, to the extent practicable, regulations governing the transportation of hazardous materials in commerce are consistent with standards adopted by international authorities. This final rule is amending the HMR to maintain alignment with the ICAO Technical Instructions.

    B. Executive Orders 13563 and 12866 and DOT Regulatory Policies and Procedures

    The Department has determined that the transportation of battery-powered portable electronic smoking devices in checked baggage is an immediate safety threat. Therefore, this rule is being issued to address an emergency situation within the meaning of Section 6(a)(3)(D) of Executive Order 12866. Under section 6(a)(3)(D), in emergency situations, an agency must notify OMB as soon as possible and, to the extent practicable, comply with subsections (a)(3)(B) and (C) of section 6 of EO 12866. The Department has notified and consulted with OMB on this interim final rule. We do not anticipate the actions in this interim final rule will impose a significant impact on airlines, airline passengers, crewmembers, or the Federal government. We expect airlines will incur minimal costs associated with updating notifications to airline passengers (e.g. Web sites, automated check-in facilities, signage and verbal notifications from the operator). Airlines already have mechanisms to notify airline passengers of hazardous materials restrictions and we expect that airlines would incorporate this additional provision into existing notifications. Airline passengers will still be permitted to carry their e-cigarettes in their carry-on baggage or on their person. Spare lithium batteries must be individually protected so as to prevent short circuits (by placement in original retail packaging or by otherwise insulating terminals, e.g., by taping over exposed terminals or placing each battery in a separate plastic bag or protective pouch). This is consistent with existing requirements for the carriage of spare lithium batteries for portable electronic devices. We do not anticipate this would result in any impact on passengers because these devices are a type of portable electronic device and spare lithium batteries for portable electronic devices are already required to be protected from short circuits and carried in carry-on baggage only. Some passengers may incur a non-quantifiable cost in the lost opportunity to charge their device while on board the aircraft. We expect that this will be a small number of passengers and that the per-passenger cost will also be small. The Transportation Security Administration may incur new costs associated with amending security procedures for checked baggage to inform security officers that these items should be treated as hazardous materials. PHMSA welcomes public comments on potential costs and benefits of this regulatory action.

    Under the Department of Transportation's Regulatory Policies and Procedures (44 FR 11034), this rule is considered to be an emergency regulation. The Department has determined that an immediate safety threat exists in the carriage of battery-powered portable electronic smoking devices in checked baggage and, therefore, this rule is considered to be an emergency regulation. Because of the need to move quickly to address this risk, it would be impractical, unnecessary, and contrary to the public interest to follow the usual procedures under the DOT order.

    C. Executive Order 13132

    This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”). This rule preempts State, local and Indian tribe requirements but does not impose any regulation that has substantial direct effects on the States, the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply.

    The Federal hazardous materials transportation law, 49 U.S.C. 5101-27, contains express preemption provisions (49 U.S.C. 5125) that preempt inconsistent State, local, and Indian tribe requirements, including requirements on the following subjects:

    (1) The designation, description, and classification of hazardous materials;

    (2) The packing, repacking, handling, labeling, marking, and placarding of hazardous materials;

    (3) The preparation, execution, and use of shipping documents related to hazardous materials and requirements related to the number, contents, and placement of those documents;

    (4) The written notification, recording, and reporting of the unintentional release in transportation of hazardous material; or

    (5) The design, manufacture, fabrication, marking, maintenance, recondition, repair, or testing of a packaging or container represented, marked, certified, or sold as qualified for use in transporting hazardous material.

    This rule addresses subject items (1) and (2) described above and, accordingly, State, local, and Indian tribe requirements on these subjects that do not meet the “substantively the same” standard will be preempted.

    Federal hazardous materials transportation law provides at § 5125(b)(2) that, if DOT issues a regulation concerning any of the covered subjects, DOT must determine and publish in the Federal Register the effective date of Federal preemption. The effective date may not be earlier than the 90th day following the date of issuance of a final rule and not later than two years after the date of issuance. The effective date of Federal preemption is 90 days from publication of this interim final rule in this matter in the Federal Register. This effective date for preemptive effect should not provide a conflict with the overall effective date for this interim final rule because the FAA Act, and various court decisions dealing with the regulation of air transport, generally preempts State and local requirements. Historically the States and localities are aware of this preemptive effect and do not regulate in conflict with Federal requirements in these situations.

    D. Executive Order 13175

    This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”). Because this interim final rule does not have tribal implications and does not impose direct compliance costs, the funding and consultation requirements of Executive Order 13175 do not apply.

    E. Regulatory Flexibility Act and Executive Order 13272

    Section 603 of the Regulatory Flexibility Act (RFA) requires an agency to prepare an initial regulatory flexibility analysis describing impacts on small entities whenever an agency is required by 5 U.S.C. 553 to publish a general notice of proposed rulemaking for any proposed rule. Similarly, section 604 of the RFA requires an agency to prepare a final regulatory flexibility analysis when an agency issues a final rule under 5 U.S.C. 553 after being required to publish a general notice of proposed rulemaking. Because of the need to move quickly to address the identified risk, prior notice and comment would be contrary to the public interest. As prior notice and comment under 5 U.S.C. 553 are not required to be provided in this situation, the analyses in 5 U.S.C.s 603 and 604 are not required.

    F. Unfunded Mandates Reform Act of 1995

    This rule does not impose unfunded mandates under the Unfunded Mandates Reform Act of 1995. It does not result in costs of $155,000,000 or more, adjusted for inflation, to either State, local or tribal governments, in the aggregate, or to the private sector in any one year, and is the least burdensome alternative that achieves the objective of the rule.

    G. Paperwork Reduction Act

    There are no new information collection requirements in this final rule.

    H. Regulation Identifier Number (RIN)

    A regulation identifier number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document may be used to cross-reference this action with the Unified Agenda.

    I. Environmental Assessment

    The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321-4347), requires Federal agencies to consider the consequences of major Federal actions and prepare a detailed statement on actions significantly affecting the quality of the human environment. This interim final rule prohibits the carriage of battery-powered portable electronic smoking devices in checked baggage and the charging of such devices on board a passenger-carrying aircraft. Airline passengers will still be permitted to carry their e-cigarettes in their carry-on baggage or on their person. In other words, the interim final rule only impacts how a passenger may carry battery-powered portable electronic smoking devices on aircraft, not whether a passenger can carry such devices. We find that there are no significant environmental impacts associated with this interim final rule.

    J. Privacy Act

    Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the document (or signing the document, 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) or you may visit http://www.regulations.gov/search/footer/privacyanduse.jsp

    List of Subjects in 49 CFR Part 175

    Air carriers, Hazardous materials transportation, Radioactive materials, Reporting and recordkeeping requirements.

    In consideration of the foregoing, we amend 49 CFR Chapter I as follows:

    PART 175—CARRIAGE BY AIRCRAFT 1. The authority citation for part 175 continues to read as follows: Authority:

    49 U.S.C. 5101-5128, 44701; 49 CFR 1.81 and 1.97.

    2. In § 175.10, redesignate paragraphs (a)(19) through (a)(24) as paragraphs (a)(20) through (a)(25) and add new paragraph (a)(19) to read as follows:
    § 175.10 Exceptions for passengers, crewmembers, and air operators.

    (a) * * *

    (19) Except as provided in § 173.21 of this subchapter, battery-powered portable electronic smoking devices (e.g., e-cigarettes, e-cigs, e-cigars, e-pipes, e-hookahs, personal vaporizers, electronic nicotine delivery systems) when carried by passengers or crewmembers for personal use must be carried on one's person or in carry-on baggage only. Spare lithium batteries must be individually protected so as to prevent short circuits (by placement in original retail packaging or by otherwise insulating terminals, e.g., by taping over exposed terminals or placing each battery in a separate plastic bag or protective pouch). Each lithium battery must be of a type which meets the requirements of each test in the UN Manual of Tests and Criteria, Part III, Sub-section 38.3. Recharging of the devices and/or the batteries on board the aircraft is not permitted. Each battery must not exceed the following:

    (i) For lithium metal batteries, a lithium content of 2 grams; or

    (ii) For lithium ion batteries, a Watt-hour rating of 100 Wh.

    Issued in Washington, DC, on October 23, 2015 under authority delegated in 49 CFR part 1.97 Marie Therese Dominguez, Administrator.
    [FR Doc. 2015-27622 Filed 10-29-15; 8:45 am] BILLING CODE 4910-60-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-R6-ES-2015-0013; FXES11130900000C6-145-FF09E42000] RIN 1018-BA42 Endangered and Threatened Wildlife and Plants; Establishment of a Nonessential Experimental Population of Black-footed Ferrets in Wyoming AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Final rule.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), in coordination with the State of Wyoming and other partners, will reestablish additional populations of the black-footed ferret (Mustela nigripes), a federally listed endangered mammal, into prairie dog (Cynomys spp.) occupied habitat in Wyoming and classify any reestablished population as a nonessential experimental population (NEP) under section 10(j) of the Endangered Species Act of 1973, as amended (Act). This final rule establishes the NEP area and provides for allowable legal incidental taking of the black-footed ferret within the defined NEP area. The best available data indicate the reintroduction of black-footed ferrets to Wyoming is biologically feasible and will promote conservation and recovery of the species. This NEP area and two previously designated NEPs in Wyoming collectively cover the entire State of Wyoming and provide consistent management flexibility Statewide. We are also amending the historical range column for the species within the List of Endangered and Threatened Wildlife (List) to include Mexico; the historical range information in the List is informational, not regulatory.

    DATES:

    This rule becomes effective November 30, 2015.

    ADDRESSES:

    This final rule, along with the public comments, environmental assessment (EA), and finding of no significant impact (FONSI), is available on the Internet at http://www.regulations.gov, Docket No. FWS-R6-ES-2015-0013. Comments and materials received, as well as supporting documentation used in the preparation of this rule, will also be available for public inspection, by appointment, during normal business hours at: U.S. Fish and Wildlife Service, Wyoming Ecological Services Field Office, 5353 Yellowstone Road, Suite 308A, Cheyenne, WY 82009; telephone 307-772-2374. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Services (FIRS) at 800-877-8339.

    FOR FURTHER INFORMATION CONTACT:

    Mark Sattelberg, Field Supervisor, Telephone: 307-772-2374. Direct all questions or requests for additional information to: BLACK-FOOTED FERRET QUESTIONS, U.S. Fish and Wildlife Service, Wyoming Ecological Services Field Office, 5353 Yellowstone Road, Suite 308A, Cheyenne, WY 82009. Individuals who are hearing-impaired or speech-impaired may call the Federal Relay Service at 1-800-877-8337 for TTY assistance.

    SUPPLEMENTARY INFORMATION:

    Executive Summary Purpose of the Regulatory Action

    This is a final rule to designate the black-footed ferret (Mustela nigripes) nonessential experimental population (NEP) area in the State of Wyoming in accordance with section 10(j) of the Endangered Species Act (Act). This designation increases the Service's flexibility and discretion in managing reintroduced endangered species and allows promulgation of regulations deemed appropriate for conservation of the reintroduced species. We have determined that the issuance of this rule will advance the recovery of the endangered black-footed ferret. Specifically, this rulemaking will facilitate the establishment of free-ranging populations of ferrets within the species' historical range in Wyoming, thereby contributing to the numerical and distributional population targets laid out in the recovery plan's delisting and downlisting (reclassifying from endangered to threatened) criteria (U.S. Fish and Wildlife Service 2013a, p. 6)

    Summary of the Major Provisions of the Regulatory Action In Question

    Under section 10(j) of the Act and our regulations at 50 CFR 17.81, the Service may establish an NEP, outside of the current range of the species, but within its historical range, for the purposes of reintroducing the species into formerly occupied habitat. Under this 10(j) rule, the Service is classifying any reestablished black-footed ferret population in the State of Wyoming as an NEP. The Service has determined that this NEP designation meets the requirements of the Act; the population is wholly geographically separate from other populations, and the experimental population is not essential to the continued existence of the black-footed ferret in the wild.

    This NEP designation will apply to all ferrets reintroduced to Wyoming, with the exception of animals found on lands managed by the National Park Service or U.S. Fish and Wildlife Service. Under a section 10(j) designation as an NEP, both the take prohibitions and consultation requirements of the Act are relaxed, easing regulatory burden associated with endangered species and facilitating acceptance by local landowners and managers.

    Once this rule takes effect, the Service, the Wyoming Game and Fish Department (WGFD), and other partners propose to reintroduce the black-footed ferret at one or more additional sites within the species' historical range in Wyoming. The WGFD will serve as the lead agency in the reintroduction and subsequent management of black-footed ferret in Wyoming; however, WGFD will continue to coordinate closely with the Service on these restoration efforts.

    Costs and Benefits

    Costs and benefits of a Statewide NEP designation in Wyoming will depend upon the number and type of reintroduction efforts initiated. The Black-footed Ferret Recovery Plan estimates that 35,000 acres (ac) (14,000 hectares (ha)) of purposefully managed prairie dog occupied habitat will be needed to meet Wyoming's portion of the rangewide habitat goal for downlisting, and 70,000 ac (28,000 ha) to meet their portion of the rangewide habitat goal for delisting (USFWS 2013a, Table 8). This equates to purposeful management of approximately 2 percent of prairie dog occupied habitat in Wyoming to meet their portion of the rangewide habitat goal for delisting. We completed an environmental assessment for this action, which analyzes potential impacts of reestablishing black-footed ferrets in Wyoming under section 10(j) of the Act. Participation in this recovery effort is entirely voluntary and would not occasion any substantive change in land use by participants; consequently, we anticipate that the benefits of reintroduction will off-set the costs incurred for any recovery partners who choose to participate.

    Background Statutory and Regulatory Framework

    The black-footed ferret was listed as endangered throughout its range on March 11, 1967 (32 FR 4001), and again on June 2, 1970 (35 FR 8491), under early endangered species legislation and was “grandfathered” under the Endangered Species Act of 1973, as amended (Act; 16 U.S.C. 1531 et seq.) without critical habitat. The Act provides that species listed as endangered are afforded protection primarily through the prohibitions of section 9 and the requirements of section 7. Section 9 of the Act, among other things, prohibits the take of endangered wildlife. “Take” is defined by the Act as harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to engage in any such conduct. Section 7 of the Act outlines the procedures for Federal interagency cooperation to conserve federally listed species and protect designated critical habitat. It mandates that all Federal agencies use their existing authorities to further the purposes of the Act by carrying out programs for the conservation of listed species. It also states that Federal agencies must, in consultation with the Service, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. Section 7 of the Act does not affect activities undertaken on private land unless they are authorized, funded, or carried out by a Federal agency.

    The 1982 amendments to the Act (16 U.S.C. 1531 et seq.) included the addition of section 10(j), which allows for the designation of reintroduced populations of listed species as “experimental populations.” Under section 10(j) of the Act and our regulations at 50 CFR 17.81, the Service may designate as an experimental population a population of endangered or threatened species that has been or will be released into suitable natural habitat outside the species' current natural range (but within its probable historical range, absent a finding by the Director of the Service in the extreme case that the primary habitat of the species has been unsuitable and irreversibly altered or destroyed). With the experimental population designation, the relevant population is treated as threatened for purposes of section 9 of the Act, regardless of the species' designation elsewhere in its range. Threatened designation allows us discretion in devising management programs and special regulations for such a population. Section 4(d) of the Act allows us to adopt whatever regulations are necessary and advisable to provide for the conservation of a threatened species. In these situations, the general regulations that extend most section 9 prohibitions to threatened species do not apply to that species, and the rule issued under section 10(j) of the Act (hereafter referred to as a 10(j) rule) contains the prohibitions and exemptions necessary and appropriate to conserve that species.

    Before authorizing the release as an experimental population of any population (including eggs, propagules, or individuals) of an endangered or threatened species, and before authorizing any necessary transportation to conduct the release, the Service must find, by regulation, that such release will further the conservation of the species. In making such a finding, the Service uses the best scientific and commercial data available to consider: (1) Any possible adverse effects on extant populations of a species as a result of removal of individuals, eggs, or propagules for introduction elsewhere; (2) the likelihood that any such experimental population will become established and survive in the foreseeable future; (3) the relative effects that establishment of an experimental population will have on the recovery of the species; and (4) the extent to which the introduced population may be affected by existing or anticipated Federal or State actions or private activities within or adjacent to the experimental population area.

    Furthermore, as set forth in 50 CFR 17.81(c), all regulations designating experimental populations under section 10(j) must provide: (1) Appropriate means to identify the experimental population, including, but not limited to, its actual or proposed location, actual or anticipated migration, number of specimens released or to be released, and other criteria appropriate to identify the experimental population(s); (2) a finding, based solely on the best scientific and commercial data available, and the supporting factual basis, on whether the experimental population is, or is not, essential to the continued existence of the species in the wild; (3) management restrictions, protective measures, or other special management concerns of that population, which may include but are not limited to, measures to isolate and/or contain the experimental population designated in the regulation from natural populations; and (4) a process for periodic review and evaluation of the success or failure of the release and the effect of the release on the conservation and recovery of the species.

    Under 50 CFR 17.81(d), the Service must consult with appropriate State fish and wildlife agencies, local governmental entities, affected Federal agencies, and affected private landowners in developing and implementing experimental population rules. To the maximum extent practicable, section 10(j) rules represent an agreement between the Service, the affected State and Federal agencies, and persons holding any interest in land which may be affected by the establishment of an experimental population.

    Based on the best scientific and commercial data available, we must determine whether the experimental population is essential or nonessential to the continued existence of the species. The regulations (50 CFR 17.80(b)) state that an experimental population is considered essential if its loss would be likely to appreciably reduce the likelihood of survival of that species in the wild. All other populations are considered nonessential. We have determined that any future experimental populations of black-footed ferrets in Wyoming would not be essential to the continued existence of the species in the wild. This determination has been made because loss of an experimental population in Wyoming will not affect the captive population or the 24 existing reintroduction sites in Arizona, Colorado, Kansas, Montana, New Mexico, South Dakota, Utah, and Wyoming; in Chihuahua, Mexico; and in Saskatchewan, Canada. Therefore, loss of an experimental population in Wyoming will not appreciably reduce the likelihood of future survival of the ferret rangewide.

    For the purposes of section 7 of the Act, we treat an NEP as a threatened species only when the NEP is located within a National Wildlife Refuge or unit of the National Park Service. In these areas, the Federal agency conservation requirements under section 7(a)(1) and the Federal agency consultation requirements of section 7(a)(2) of the Act apply. Section 7(a)(1) requires all Federal agencies to use their authorities to carry out programs for the conservation of listed species. Section 7(a)(2) requires that Federal agencies, in consultation with the Service, ensure that any action authorized, funded, or carried out is not likely to jeopardize the continued existence of a listed species or adversely modify its critical habitat.

    When NEPs are located outside a National Wildlife Refuge or National Park Service unit, then, for the purposes of section 7, we treat the population as proposed for listing and only section 7(a)(1) and section 7(a)(4) apply. In these instances, NEPs provide additional flexibility because Federal agencies are not required to consult with us under section 7(a)(2). Section 7(a)(4) requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a species proposed to be listed. The results of a conference are in the form of conservation recommendations that are optional as the agencies carry out, fund, or authorize activities. Because the NEP is, by definition, not essential to the continued existence of the species, the effects of proposed actions affecting the NEP will generally not rise to the level of jeopardizing the continued existence of the species. As a result, a formal conference will likely never be required for black-footed ferrets established within the NEP area. Nonetheless, some agencies voluntarily confer with the Service on actions that may affect a proposed species. Activities that are not carried out, funded, or authorized by Federal agencies are not subject to provisions or requirements in section 7.

    On April 10, 2015, the Service published a proposed rule in the Federal Register to establish a nonessential experimental population of black-footed ferrets in Wyoming, and announced the availability of a draft environmental assessment (EA) in accordance with the National Environmental Policy Act of 1969, as amended (NEPA) (80 FR 19263). This EA analyzed the potential environmental impacts associated with the proposed reintroduction of ferrets in Wyoming. We contacted interested parties including Federal and State agencies, local governments, scientific organizations, interest groups, and private landowners through a press release and related fact sheets, and emails. In addition, we notified the public and invited comments through news releases to local media outlets. The public comment period for the proposed rule and the draft EA closed on June 9, 2015. Prior to the April 10, 2015, publication of the proposed rule, we also held a series of informational public meetings across the State in concert with Wyoming Game and Fish Department.

    Section 10(j)(2)(C)(ii) of the Act states that critical habitat shall not be designated for any experimental population that is determined to be nonessential. Accordingly, we cannot designate critical habitat in areas where we establish an NEP.

    Biological Information

    The endangered black-footed ferret is the only ferret species native to the Americas (Anderson et al. 1986, p. 24). It is a medium-sized mustelid, typically weighing 1.4 to 2.5 pounds (645 to 1,125 grams) and measuring 19 to 24 inches (479 to 600 millimeters) in total length; upper body parts are yellowish buff, occasionally whitish, feet and tail tip are black, and a black “mask” occurs across the eyes (Hillman and Clark 1980, p. 30).

    The black-footed ferret depends almost exclusively on prairie dogs for food and on prairie dog burrows for shelter (Hillman 1968, p. 438; Biggins 2006, p. 3). Historical habitat of the ferret coincided with the ranges of the black-tailed prairie dog (Cynomys ludovicianus), white-tailed prairie dog (C. leucurus), and Gunnison's prairie dog (C. gunnisoni), which collectively occupied approximately 100 million ac (40 million ha) of intermountain and prairie grasslands extending from Canada to Mexico (Anderson et al. 1986, pp. 25-50; Biggins et al. 1997, p. 420). This amount of prairie dog habitat could have supported 500,000 to 1,000,000 ferrets (Anderson et al. 1986, p. 58). Since the late 1800s, ferret specimens have been collected from Arizona, Colorado, Kansas, Montana, Nebraska, New Mexico, North Dakota, Oklahoma, South Dakota, Texas, Utah, and Wyoming in the United States and Saskatchewan and Alberta in Canada (Anderson et al. 1986, pp. 25-50). In the 1990s, we concluded that the ferret's historical range also included Mexico, which is within the contiguous range of the black-tailed prairie dog as previously noted (Biggins et al. 1997, p. 420). This inclusion of Mexico in the ferret's historical range is described in more detail in the recovery plan and resulted in a ferret reintroduction initiated in 2001 (USFWS 2013a, pp. 16-17). This final rule also corrects the historical range of the species at 50 CFR 17.11(h); this action has no regulatory impact as this column is strictly informational.

    Black-footed ferrets historically occurred throughout most of Wyoming. Specifically, black-footed ferrets occurred within black-tailed prairie dog habitat in the eastern portion of the State and white-tailed prairie dog habitat in the west; black-footed ferrets did not occur in the extreme northwest corner of the State (Anderson et al. 1986, p. 48). The last wild population of ferrets (from which all surviving black-footed ferrets descend) was discovered near Meeteetse, Wyoming, in 1981, after the species was presumed extinct (Clark et al. 1986, p. 8; Lockhart et al. 2006, p. 8). Following disease outbreaks at Meeteetse, all surviving wild ferrets were removed from the wild between 1985 and 1987, to initiate a captive-breeding program (Lockhart et al. 2006, p. 8). No wild populations have been found since the capture of the last Meeteetse ferret despite extensive and intensive rangewide searches; it is unlikely that any undiscovered wild populations remain. Therefore, the Service considers the State of Wyoming unoccupied by wild ferrets, with the exception of reintroduced populations, which alleviates the requirement for project proponents to conduct presence/absence surveys for ferrets under section 7 of the Act prior to developing projects (USFWS 2013c).

    In 1991, a reintroduced population of ferrets was established in Shirley Basin, Wyoming as an NEP in accordance with section 10(j) of the Act. In 2001, the Wolf Creek, Colorado, reintroduction site was also established as an NEP under section 10(j), and includes a small portion of Sweetwater County, Wyoming, in the experimental population area. However, no evidence of ferrets from the Wolf Creek reintroduction effort has been found in Sweetwater County or elsewhere in Wyoming. The Shirley Basin NEP persists today. The map at the conclusion of this rule identifies the existing NEPs in Wyoming.

    Relationship of the Experimental Population to Recovery Efforts

    All known black-footed ferrets in the wild are the result of reintroduction efforts. There have been 24 ferret reintroduction projects, beginning in 1991, at Shirley Basin in the southeastern portion of Wyoming. Shirley Basin contains the only ferret population currently in Wyoming.

    The downlisting criteria for the black-footed ferret include establishing at least 1,500 free-ranging breeding adults in 10 or more populations, in at least 6 of 12 States within the historical range of the species, with no fewer than 30 breeding adult ferrets in any population; delisting criteria include establishing at least 3,000 free-ranging breeding adults in 30 or more populations, in at least 9 of 12 States within the historical range of the species, with no fewer than 30 breeding adults in any population (USFWS 2013a, pp. 61-62). In our recovery plan for the ferret, we suggest recovery guidelines for the States that are proportional to the amount of prairie dog habitat historically present. A proportional share for Wyoming would include approximately 171 free-ranging breeding adult ferrets to meet their portion of the rangewide numerical goal for downlisting and 341 breeding adults to meet their portion of the rangewide numerical goal for delisting (USFWS 2013a, Table 8).

    Approximately 100 breeding adult black-footed ferrets have been established at Shirley Basin, Wyoming (USFWS 2013a, Table 8). Shirley Basin is one of four currently successful ferret reintroduction sites—other successful sites include two in South Dakota and one in Arizona (USFWS 2013a, p. 73). We are confident that Wyoming can support additional successful reintroduction sites, based on the amount of available habitat (see the following section on Likelihood of Population Establishment and Survival) and a history of successful ferret management at Shirley Basin since 1991. Additional viable ferret populations within Wyoming will aid recovery of the species.

    Location of the Nonessential Experimental Population Area

    The NEP area for Wyoming is Statewide, with the exception of the two areas where a NEP designation for black-footed ferret already exists (see below). In combination, these three NEPs collectively cover the entire State of Wyoming. Suitable habitat for ferret reintroduction will likely be limited to Albany, Big Horn, Campbell, Carbon, Converse, Crook, Fremont, Goshen, Hot Springs, Johnson, Laramie, Lincoln, Natrona, Niobrara, Park, Platte, Sheridan, Sublette, Sweetwater, Uinta, Washakie, and Weston Counties because these counties have sufficient prairie dog habitat to support viable ferret populations. We are not aware of any prairie dog complexes suitable for ferret reintroduction on or adjacent to Tribal lands in Wyoming. The nearest potential reintroduction sites to Tribal lands are two white-tailed prairie dog complexes--Fifteen-mile Complex near Worland in Hot Springs County and Sweetwater Complex near Sweetwater Station in Fremont County (Luce 2008, pp. 29-30). Both sites are of intermediate potential for ferret reintroduction and are located approximately 19 miles (30 kilometers) from any reservation boundaries.

    Any ferrets found in Wyoming would be considered part of an NEP. There are many historical records of ferrets in Wyoming (Anderson et al. 1986, pp. 36-37). However, the species has been extirpated from the State since 1987, with the exception of a reintroduced ferret population in the Shirley Basin. As previously noted, a 10(j) designation already exists for the Shirley Basin ferret population in Albany County and portions of Carbon and Natrona Counties that are east of the North Platte River. A 10(j) designation also exists for the Wolf Creek, Colorado, ferret reintroduction site, which includes a small portion of Sweetwater County in Wyoming. Both of these reintroduction sites would remain outside the boundary of this newly designated NEP area and would continue to operate under their respective management plans. Any new reintroduction sites within this newly designated NEP area would require development of a new management plan approved by the Service.

    Several sites in Wyoming are suitable for reintroduction of black-footed ferrets in addition to the Shirley Basin site. The main requirements for ferret reintroduction are: (1) An area of occupied prairie dog habitat that is purposefully managed and of sufficient size to support a viable population of ferrets (a minimum of 1,500 ac (608 ha) of black-tailed prairie dog occupied habitat or 3,000 ac (1,215 ha) of white-tailed or Gunnison's prairie dog occupied habitat); (2) a willing landowner; and (3) a management plan that addresses sylvatic plague. Recent estimates of prairie dog occupied habitat in Wyoming include 2,893,487 ac (1,171,862 ha) in the white-tailed prairie dog range and 229,607 ac (92,991 ha) in the black-tailed prairie dog range (Van Pelt 2013, pp. 8, 14). Luce (2008, pp. 28-31) identified several sites in Wyoming with potential for ferret reintroduction including one site with potential for reintroduction within less than 3 years, 24 sites with potential for reintroduction within 3 to 10 years, and two sites with long-term potential for reintroduction.

    Likelihood of Population Establishment and Survival

    The Service and its partners have initiated 24 black-footed ferret reintroduction projects since 1991. These projects have experienced varying degrees of success. However, all reintroduction efforts have contributed to our understanding of the species' needs. Recovery of the species is a dynamic process that requires adaptive management.

    Some transfers of individual black-footed ferrets between populations will likely be necessary in perpetuity to maintain genetic diversity in the face of habitat fragmentation and as a management tool for sylvatic plague (until additional plague vaccines can be adapted for field use). Nevertheless, we believe that recovery can be achieved through a combination of expansion of ferret populations at existing reintroduction sites and reintroduction of ferrets at new sites, both of which are possible if conservation of prairie dog occupied habitat and disease management are aggressively pursued.

    Participation by all States within the historical range of the black-footed ferret is important to maximize resilience of ferret populations in the wild and to allow for an equitable distribution of the responsibility for achieving recovery goals. Federal, State, and local agencies in Wyoming have been active participants in ferret recovery since the last wild population was found at Meeteetse in 1981. We estimate 100 breeding adult ferrets are already established at Shirley Basin. The suggested numerical recovery guidelines for Wyoming are 171 breeding adults to support the State's share of the rangewide downlisting target and 341 breeding adults to support the State's share of the rangewide delisting target. Meeting their portion of the rangewide numerical goal for downlisting would require establishing one additional large reintroduction site similar to Shirley Basin or two to three smaller sites. Meeting their portion of the rangewide numerical goal for delisting would require establishing two large sites, six small sites, or a combination of large, medium, and small sites, in addition to the sites previously established for meeting their portion of the rangewide numerical goal for downlisting. The Recovery Plan estimates that 35,000 ac (14,000 ha) of purposefully managed prairie dog occupied habitat will be needed to meet Wyoming's portion of the rangewide habitat goal for downlisting and 70,000 ac (28,000 ha) to meet their portion of the rangewide habitat goal for delisting (USFWS 2013a, Table 8). This equates to purposeful management of approximately 2 percent of prairie dog occupied habitat in Wyoming to meet their portion of the rangewide habitat goal for delisting.

    Sustaining black-footed ferret numbers during periodic outbreaks of sylvatic plague will require ongoing management, potentially including dusting prairie dog burrows with flea control powder and vaccinating ferrets prior to release. Additionally, research is currently underway investigating the potential for supporting ferrets at reintroduction sites by providing a vaccine to wild prairie dogs via oral bait.

    Based upon the past history of successful management at Shirley Basin, Wyoming, and the substantial amount of prairie dog occupied habitat available for additional reintroduction of black-footed ferrets, we believe there is a high likelihood of population establishment and survival in Wyoming.

    Addressing Causes of Extirpation

    The black-footed ferret rangewide population declined for three principal reasons: (1) A major conversion of native rangeland to cropland, particularly in the eastern portion of the species' range, beginning in the late 1800s; (2) poisoning of prairie dogs to reduce competition with domestic livestock for forage, beginning in the early 1900s; and (3) the inadvertent introduction of sylvatic plague, which causes mortality to both ferrets and prairie dogs, beginning in the 1930s. The combined effects of these three factors resulted in a rangewide decrease in the amount of habitat occupied by prairie dogs from approximately 100 million ac (40.5 million ha) historically to 1.4 million ac (570,000 ha) in the 1960s (USFWS 2013a, pp. 23-24). This habitat loss and fragmentation resulted in a corresponding decrease in ferrets, which require relatively large areas of prairie dog occupied habitat to maintain viable populations. By the 1960s, only two remnant ferret populations remained—in Mellette County, South Dakota, and in Meeteetse, Wyoming (Lockhart et al. 2006, pp. 7-8).

    Wyoming has had less rangeland converted to cropland than most other States within the historical range of the black-footed ferret (U.S. Department of Agriculture 2005, Table 1). Consequently, prairie dog poisoning and sylvatic plague are likely the two primary reasons for extirpation of ferrets from the State. Extensive poisoning of prairie dogs had begun in Wyoming by 1916 (Clark 1973, p. 89), and plague was present in Wyoming by 1936 (Eskey and Haas 1940, p. 4). Occupied prairie dog habitat reached a low in Wyoming in the early 1960s when approximately 64,336 ac (26,056 ha) were reported (U.S. Bureau of Sport Fisheries and Wildlife 1961, Table 1). However, large-scale poisoning of prairie dogs no longer occurs, and the use of poisons is more closely regulated than it was historically. Improved plague management, including dusting prairie dog burrows with insecticide to control fleas (the primary vector for plague transmission), is also being used, and the development of vaccines that prevent plague in prairie dogs and black-footed ferrets is underway. The most recent surveys estimate 3,123,094 ac (1,264,853 ha) of occupied prairie dog habitat in Wyoming (Van Pelt 2013, pp. 8, 14). This considerable increase over the past 50 years indicates that there has been a reduction in threats and improved management of prairie dogs. This increases the likelihood of successful reintroduction of ferrets in Wyoming.

    Release Procedures

    The Service will cooperate with other Federal agencies, WGFD, Tribes, landowners, and other stakeholders to develop, implement, and maintain long-term site management before, during, and after releases. Partners will collect habitat data for site evaluation and documentation of baseline conditions and develop management plans for prairie dogs and plague prior to any release of black-footed ferrets. All applicable laws regulating the protection of ferrets will be followed (see section on Management Considerations and Protective Measures, below). Partners will develop annual site-specific reintroduction plans and submit them to the Service by mid-March as part of an annual ferret allocation process (which allocates available captive ferrets for release in specific numbers for specific sites). Reintroduction plans will include current estimates of prairie dog numbers and density, disease prevalence and management, and proposed reintroduction and monitoring methods. If the reintroduction plan covers years subsequent to the initial releases, it will also include a recent description of the status of ferrets on the site.

    All reintroduction efforts will follow techniques described in Roelle et al. (2006) as appropriate, which presents recommendations for managing captive populations, evaluating potential habitat, reestablishing populations, and managing disease. Captive-reared black-footed ferrets exposed to prairie dog burrows and natural prey in outdoor preconditioning pens prior to their release survive in the wild at significantly higher rates than cage-reared, non-preconditioned ferrets (Biggins et al. 1998, pp. 651-652; Vargas et al. 1998, p. 77). Therefore, all captive-reared ferrets released within the Wyoming NEP area will receive adequate preconditioning in outdoor pens at the National Black-footed Ferret Conservation Center or at another facility approved by the Service. We will vaccinate all ferrets for canine distemper and sylvatic plague, and mark them with passive integrated transponder tags prior to release. We will transport ferrets to the reintroduction site and release them directly from transport cages into prairie dog burrows. In conformance with standard ferret reintroduction protocol, no fewer than 20 captive-raised or wild-translocated ferrets will be released at any reintroduction site in Wyoming during the first year of the project. Twenty or more additional animals will be released annually for the next 2 to 4 years. Released ferrets will be excess to the needs of the captive-breeding program.

    Donor Stock Assessment and Effects on Captive or Wild-Born Donor Populations

    Eighteen black-footed ferrets were captured from the last wild population at Meeteetse, Wyoming in 1985-1987, and used to initiate a captive-breeding program (Lockhart et al. 2006, pp. 11-12). Of the 18 captured ferrets, 15 individuals, representing the genetic equivalent of 7 distinct founders, produced a captive population that is the foundation of present recovery efforts (Garelle et al. 2006, p. 4). Extant populations, both captive and reintroduced, descend from these “founder” animals. The purpose of the captive-breeding program is to provide animals for reintroduction to achieve recovery of the species, while maintaining maximum genetic diversity in the captive population (USFWS 2013a, p. 81).

    Black-footed ferrets used to establish any experimental population in the Wyoming NEP area will either be translocated wild-born kits from another self-sustaining reintroduced population (such as Shirley Basin) or come from one of six captive-breeding populations currently housed at the U.S. Fish and Wildlife Service National Black-footed Ferret Conservation Center near Wellington, Colorado; the Cheyenne Mountain Zoological Park, Colorado Springs, Colorado; the Louisville Zoological Garden, Louisville, Kentucky; the Smithsonian Biology Conservation Institute, Front Royal, Virginia; the Phoenix Zoo, Phoenix, Arizona; or the Toronto Zoo, Toronto, Ontario.

    The Service and its partners maintain a captive-breeding population of approximately 280 breeding adult black-footed ferrets in order to provide a sustainable source of ferrets for reintroduction. The captive-breeding facilities produce approximately 120 to 240 juvenile ferrets annually. Approximately 80 juveniles are retained annually at these facilities for future captive-breeding purposes. The remaining juveniles are allocated annually for reintroduction, or occasionally for research (USFWS 2013a, p. 81). Ferrets selected for reintroduction under this final rule will be genetically redundant to animals maintained for captive-breeding. Consequently, any loss of reintroduced ferrets will not impact the genetic diversity of the species. Only ferrets that are surplus to the needs of the captive-breeding program are used for reintroduction into the wild. Therefore, any loss of an experimental population in the wild will not threaten the survival of the species as a whole. Therefore, there will be no effects on donor populations beyond those which are intended and accounted for in the management of wild or captive populations.

    Status of Proposed Population

    The effects of using black-footed ferrets from any captive or wild-born donor populations for releases into the Wyoming NEP area will be examined through our section 10 permitting authority and section 7 consultation process to ensure that their use is not likely to jeopardize the continued existence of the species in the wild. We based this determination on the following: (1) As an NEP, black-footed ferrets utilized for reintroductions are not essential to the survival of the species; (2) The 10(j) rule is expected to result in the creation of additional reintroduction areas in Wyoming; (3) Measures to avoid and minimize the incidental take of black-footed ferrets will be implemented within reintroduced populations; (4) The 10(j) rule will likely constitute a beneficial effect for the black-tailed and white-tailed prairie dog, as it includes measures to reduce the incidence of sylvatic plague, the primary factor responsible for the decline of these two species. This will result in an increase in the reproduction, numbers and distribution of the black-footed ferret, and therefore not resulting in reducing appreciably the likelihood of survival and recovery.

    Additional successful reintroductions of ferrets are necessary for recovery of the species. Once this rule takes effect (see DATES, above), any releases of ferrets in Wyoming will be part of an NEP because of the need for increased management flexibility, which will encourage landowner participation and alleviate concerns regarding possible land use restrictions.

    This 10(j) rule is designed to broadly exempt from the section 9 take prohibitions any take of black-footed ferrets that is incidental to otherwise lawful activities. We provide this exemption because we believe that such incidental take of members of the NEP associated with otherwise lawful activities is necessary and advisable for the conservation of the species.

    This designation is justified because no adverse effects to extant wild or captive black-footed ferret populations will result from release of progeny from either a wild or captive donor population onto a new reintroduction site. We also expect that any reintroduction efforts in Wyoming will result in the successful establishment of a self-sustaining population, which will contribute to the recovery of the species.

    Management Considerations and Protective Measures

    We conclude that the effects of Federal, State, or private actions and activities will not pose a substantial threat to black-footed ferret establishment and persistence in Wyoming because most activities currently occurring in the NEP area are compatible with ferret recovery and there is no information to suggest that future activities would be incompatible with ferret recovery. We base this conclusion on experience at previous reintroduction sites, where incidental take associated with otherwise lawful activities such as ranching and energy development has been low. Poisoning of prairie dogs can occur in prairie dog habitat and could result in habitat loss or incidental take of ferrets. However, poisoning within a reintroduction site is very restricted, occurring only in specific instances where protection of residences, resources, or infrastructure on participating farm and ranch lands becomes necessary. These considerations are planned for in cooperation with participating landowners and stakeholders and documented in site-specific management plans that must be approved by the Service before ferrets are allocated to any reintroduction sites. Poisoning with the anticoagulant Rozol® at current and future reintroduction sites, however, is prohibited by Environmental Protection Agency label that governs use of Rozol (USFWS 2013a, p. 50). Prairie dog control programs may also be necessary at the boundary between ferret reintroduction sites and adjacent properties in order to maintain local support for the reintroduction. If boundary control is necessary because prairie dogs have encroached onto adjacent properties where prairie dogs are not wanted, it is carefully managed. Lethal control of prairie dogs should not be employed at a level that would reduce prairie dog occupied habitat to the extent that the viability of any potential ferret population is compromised—a minimum of 1,500 ac (608 ha) of black-tailed prairie dog occupied habitat or 3,000 ac (1,215 ha) of white-tailed or Gunnison's prairie dog occupied habitat is needed to sustain a viable ferret population.

    The Service will coordinate closely with WGFD and other partners in the management of any black-footed ferrets in Wyoming that are reintroduced under section 10(j) authorities. Management of ferret populations in the Wyoming NEP area will be guided by provisions in site-specific management plans developed by partners (WGFD) with input from any affected landowners and stakeholders such as U.S Animal and Plant Health Inspection Service, U.S. Bureau of Land Management (BLM), U.S. Forest Service (USFS), Natural Resources Conservation Service, Wyoming Department of Agriculture, or potentially affected Tribes. The responsibilities and commitments of the participating agencies will be documented in the management plan. As mentioned above, management plans must be approved by the Service before ferrets are allocated to any reintroduction sites.

    Management plans will be site-specific with management strategies based on site-specific characteristics (e.g., prairie dog distribution and expansion potential, sylvatic plague history, ferret movement barriers) and land use patterns (e.g., livestock grazing, recreational use, mineral development potential). Management plans are tailored to achieve conservation objectives using management strategies compatible with existing ranch, livestock, and mineral extraction operations so that neither lifestyles nor income potential are negatively affected. We expect that future management plans under this 10(j) rule will have many similarities to past plans for other reintroduction sites. Some examples of management strategies for Shirley Basin in Wyoming include: (1) Attempting to schedule ferret releases so overlap with hunting opening weekends does not occur; (2) allowing landowners and land managers the opportunity to cooperatively decide the number and distribution of prairie dogs (and correspondingly ferrets) that may occur on privately owned and leased lands; (3) annually obtaining landowner approval of human activity necessary for actions specified in this plan; (4) biannual review of the progress of ongoing activities by all concerned parties. Other management plans may contain provisions similar to these, although the specific content and details will vary by site.

    Most of the area containing suitable release sites with high potential for ferret establishment is managed by the BLM, the USFS, or private landowners, and is currently protected through the following mechanisms.

    (1) Federal Land Policy and Management Act of 1976 (43 U.S.C. 1701 et seq.)—The BLM's mission is set forth under the Federal Land Policy and Management Act, which mandates that BLM manage public land resources for a variety of uses, such as energy development, livestock grazing, recreation, and timber harvesting, while protecting the natural, cultural, and historical resources on those lands. The BLM manages listed and sensitive species under guidance provided in the BLM MS-6840 Manual—Special Status Species Management. The Manual directs BLM to proactively conserve species listed under the Act and the ecosystems upon which they depend, ensure that all actions authorized or carried out by BLM are in compliance with the Act, and cooperate with the planning and recovery of listed species. The BLM has experience in managing the black-footed ferret at four reintroduction sites in four States that occur at least in part on lands it manages, including Shirley Basin, Wyoming, and Wolf Creek, Colorado, which includes a small portion of Sweetwater County, Wyoming. Therefore, we anticipate appropriate management by BLM on any future ferret reintroduction sites that include BLM lands.

    (2) National Forest Management Act of 1976, as amended (16 U.S.C. 1600 et seq.)—The National Forest Management Act instructs the USFS to strive to provide for a diversity of plant and animal communities when managing national forest lands. The USFS identifies species listed as endangered or threatened under the Act, including the black-footed ferret, as Category 1 species at risk based on rangewide and national imperilment. The USFS has experience in managing the black-footed ferret at one reintroduction site in South Dakota that occurs at least in part on USFS lands. Therefore, we anticipate appropriate management by the USFS on any future ferret reintroduction sites that include USFS lands.

    (3) Wyoming State Law—The responsibilities of WGFD are defined in Wyoming Statute section 23-1-103, which instructs the WGFD to provide an adequate and flexible system for the control, management, protection, and regulation of all Wyoming wildlife. The Statute defines the black-footed ferret as a protected animal. The WGFD also defines the ferret as a “species of greatest conservation need” (Wyoming Game and Fish Department 2010, pp. IV-2-10-IV-2-13). This final rule has been developed in cooperation with the State to address any concerns and initiate additional ferret reintroductions in Wyoming. The WGFD has successfully managed the ferret at the Shirley Basin Reintroduction site since 1991. Therefore, we anticipate appropriate management by WGFD on any future ferret reintroduction sites in Wyoming.

    Management issues related to the black-footed ferret Wyoming NEP area that have been considered include:

    (a) Incidental Take: The regulations implementing the Act define “incidental take” as take that is incidental to, and not the purpose of, carrying out an otherwise lawful activity (50 CFR 17.3), such as agricultural activities and other rural development, and other activities that are in accordance with Federal, State, Tribal, and local laws and regulations. Experimental population rules contain specific prohibitions and exceptions regarding the taking of individual animals. Once this 10(j) rule becomes effective, incidental take of black-footed ferrets within the Wyoming NEP area will not be prohibited, provided that the take is unintentional and is in accordance with this 10(j) rule. However, if there is evidence of intentional take of this species within the NEP area that is not authorized by the 10(j) rule, we would refer the matter to the appropriate law enforcement entities for investigation.

    (b) Special handling: In accordance with 50 CFR 17.21(c)(3), any employee or agent of the Service or of a State wildlife agency may in the course of their official duties, handle black-footed ferrets to aid sick or injured ferrets, or to salvage dead ferrets. Employees or agents of other Federal, Tribal, or State agencies would need to acquire the necessary permits from the Service for these activities.

    (c) Coordination with landowners and land managers: This NEP designation under section 10(j) of the Act was discussed with potentially affected State and Federal agencies, Tribes, local governments, and other stakeholders within the expected reestablishment area. These agencies, landowners, and land managers have either indicated support for, or no opposition to, the establishment of future populations, provided an NEP is designated and a rule is promulgated to exempt incidental take from the section 9 take prohibitions. The Service and the WGFD will continue to coordinate to ensure local communities are fully engaged in any future black-footed ferret reintroduction efforts.

    (d) Public awareness and cooperation: We informed the general public of the importance of this reintroduction project for the overall recovery of the black-footed ferret through the proposed rule and associated public meetings. We notified a comprehensive list of stakeholders of the meetings including affected Federal and State agencies, Tribal entities, local governments, landowners, nonprofit organizations, and other interested parties. The comments we received are listed in the final EA, were included in the formulation of alternatives considered in the NEPA process, and are considered in this final rule designating an NEP area for reintroduced black-footed ferrets in Wyoming. Designation of the NEP area will increase reintroduction opportunities and provide greater flexibility in management of the reintroduced ferret. The NEP designation is necessary to secure needed cooperation of the State, landowners, and other interests in the affected area.

    (e) Potential impacts to other federally listed species: There are several federally listed, proposed (any species of fish, wildlife, or plant that is proposed in the Federal Register to be listed), and candidate (the Service has concluded that they should be proposed for listing) species in Wyoming. These species are identified in the following table.

    Table 1—Federally Listed, Proposed, and Candidate Species in Wyoming Species Current status in Wyoming under the act Black-footed ferret (Mustela nigripes) Shirley Basin NEP. Gray wolf (Canis lupus) NEP in Wyoming. Whooping crane (Grus americana) Endangered. Interior least tern (Sterna antillarum) Endangered. Piping plover (Charadrius melodus) Threatened. Wyoming toad (Bufo baxteri) Endangered. Bonytail (Gila elegans) Endangered. Colorado pikeminnow (Ptychocheilus lucius) Endangered. Humpback chub (Gila cypha) Endangered. Razorback sucker (Xyrauchen texamus) Endangered. Kendall Warm Springs dace (Rhinichthys osculus thermalis) Endangered. Pallid sturgeon (Scaphirhynchus albus) Endangered. Blowout penstemon (Penstemon haydenii) Endangered. Canada lynx (Lynx canadensis) Threatened, with critical habitat. Grizzly bear (Ursus arctos horribilis) Threatened. Preble's meadow jumping mouse (Zapus hudsonius preblei) Threatened. Yellow-billed cuckoo (Coccyzus americanus) Threatened, with critical habitat proposed. Colorado butterfly plant (Gaura neomexicana coloradensis) Threatened, with critical habitat. Desert yellowhead (Yermo xanthocephalus) Threatened, with critical habitat. Western prairie fringed orchid (Platanthera praeclara) Threatened. Ute ladies'-tresses (Spiranthes diluvialis) Threatened. Northern long-eared bat (Myotis septentrionalis) Threatened. Greater sage-grouse (Centrocercus urophasianus) Candidate at the time of the proposed 10(j) rule, recently found to be not warranted for listing. Fremont County rockcress (Boechera pusilla) Candidate. Whitebark pine (Pinus albicaulis) Candidate.

    Nearly all of the aforementioned species have habitat requirements such as forests, dunes, wetlands, or river systems that differ from the grassland prairie habitat requirements for the black-footed ferret. The only species that may be affected by reintroduction projects for the ferret in the Wyoming NEP area, other than the ferret, is the greater sage-grouse. At the time of the proposed 10(j) rule, the greater sage-grouse was a candidate species. Recently, the Service determined that the greater sage-grouse is no longer warranted for listing under the Act (80 FR 59858; October 2, 2015). The greater sage-grouse requires large, interconnected expanses of sagebrush (Connelly et al. 2004, p. 3-2; Stiver et al. 2006, p. I-2; Knick and Connelly 2011, p. 1). Habitat loss, degradation, and fragmentation are the primary stressors to the greater sage-grouse. A detailed description of the species' natural history, seasonal habitats, threats, and population trends can be found in the Service's recent 12-month not warranted finding (80 FR 59858; October 2, 2015). The ferret also requires large expanses of intact habitat, although it is dependent on prairie dogs, not sagebrush. However, some prairie dog habitat, particularly white-tailed prairie dog habitat, contains sagebrush.

    Direct adverse effects to greater sage-grouse can occur from the application of zinc phosphide-based pesticides to manage expanding prairie dog colonies at reintroduction sites. Because the application of zinc phosphide will occur in July through February, greater sage-grouse (males, hens, and broods) may ingest zinc phosphide and become sickened or die. We determined that the issuance of this Federal rule to designate the black-footed ferret as a nonessential experimental population in the State of Wyoming in accordance with section 10(j) of the Act is not likely to jeopardize the continued existence of the greater sage-grouse based on the following: (1) The use of zinc phosphide is anticipated to be relatively rare at reintroduction sites, which minimizes exposure risk; (2) zinc phosphide can only be applied by a certified pesticide applicator, which minimizes misapplication and exposure risk to non-targeted species; and (3) there are approximately 43,000,000 acres of estimated greater sage-grouse habitat in Wyoming. To meet delisting guidelines in the Black-footed Ferret Recovery Plan, there must be 70,000 acres of prairie dog habitat. Thus, most greater sage-grouse habitat in Wyoming would not be impacted by the proposed action.

    (f) Monitoring and Evaluation: Monitoring is a required element of all black-footed ferret reintroduction projects. The following types of monitoring will be conducted.

    Reintroduction Effectiveness Monitoring: Partners will monitor population demographics and potential sources of mortality, including plague, annually for 5 years following the last release using spotlight surveys, snow tracking, other visual survey techniques, and possibly radio-telemetry of some individuals. Thereafter, demographic and genetic surveys will be completed periodically to track population status. Surveys will incorporate methods to monitor breeding success and long-term survival rates. In general, the Service anticipates that monitoring will be conducted by the lead for each reintroduction site, which in Wyoming will be the WGFD and participating partners. The WGFD will present monitoring results in their annual reports.

    Donor Population Monitoring: Ferrets used for reintroduction will either be from the captive-breeding population or translocated from another viable reintroduction site. Ferrets in the captive-breeding population are managed and monitored in accordance with the Association of Zoos and Aquariums (AZA) Black-footed Ferret Species Survival Plan (SSP®). A breeding population of 280 animals will be maintained to provide a sustainable source of ferrets for reintroduction. The AZA SSP® Husbandry Manual provides up-to-date protocols for the care, propagation, preconditioning, and transportation of captive ferrets, and is used at all participating captive-breeding facilities. Ferrets may also be translocated from other reintroduction sites (which also originated from captive sources), provided their removal will not create adverse impacts upon the donor population and provided appropriate permits are issued in accordance with our regulations (50 CFR 17.22) prior to their removal. Population monitoring will be conducted at all donor sites.

    Monitoring Impacts to Other Listed Species: We do not expect impacts to other federally listed species (see discussion under (e), above). The greater sage-grouse is the only species with habitat that might overlap with the black-footed ferret. However, we do not expect ferret reintroduction efforts to adversely impact greater sage-grouse for the reasons previously discussed. The WGFD conducts annual monitoring of the greater sage-grouse statewide. Additional monitoring will occur on non-federal lands enrolled in the Wyoming Candidate Conservation Agreement with Assurances for the greater sage-grouse and on Federal lands enrolled in the Wyoming Candidate Conservation Agreement for the greater sage-grouse.

    Summary of Comments and Responses

    In the proposed rule published on April 10, 2015 (80 FR 19263), we requested that all interested parties submit written comments on the proposal by June 9, 2015. We also contacted appropriate federal and state agencies, Tribes, scientific experts and organizations, and other interested parties and invited them to comment on the proposal.

    During the public comment period on the proposed rule, we received a total of 29 comment letters addressing the proposed rule and several comments that were not relevant to the proposed rule. All substantive information provided during comment periods has either been incorporated directly into this final determination or addressed below.

    Peer Review

    In accordance with our peer review policy published on July 1, 1994 (59 FR 34270), we solicited expert opinion from three knowledgeable individuals with scientific expertise that included familiarity with the black-footed ferret and its habitat, biological needs, recovery efforts, and threats. We received responses from all three of the peer reviewers.

    We reviewed all comments we received from the peer reviewers for substantive issues and new information regarding the establishment of a nonessential experimental population designation for black-footed ferret in the State of Wyoming. In general, the peer reviewers stated that the proposed rule provided an accurate summation of the best available scientific information on the biology, current status, and recovery efforts for black-footed ferret, and that the proposed establishment of an NEP area in Wyoming to facilitate black-footed ferret reintroduction is well supported by the best available scientific information. The peer reviewers generally concurred with our methods and conclusions, and provided additional information, clarifications, and suggestions to improve the final rule. Peer reviewer comments are addressed in the following summary and incorporated into the final rule as appropriate.

    Peer Reviewer Comments

    (1) Comment: One reviewer and several commenters were concerned with the statement in the proposed rule that the WGFD would have primary management responsibilities for ferret reintroduction in Wyoming. The reviewer stated that “[t]urning primary authority for management of a federally endangered species over to a state, even under 10(j), would be unprecedented as far as I can determine”.

    Our Response: The Service will maintain authority for black-footed ferrets under the Act until the species is recovered and subsequently delisted. That said, as is true for nearly every endangered species recovery effort, recovery is a collaborative effort with success depending on the coordination and collaboration of a multitude of partners working towards a common goal. The WGFD is anticipated to play a lead role in recovery for the black-footed ferret in Wyoming under this 10(j) rule, likely conducting the actual on-the-ground ferret reintroduction and management work. This situation is in no way unprecedented, as on-the-ground reintroduction efforts under 10(j) are often managed by non-Service groups, including state agencies, non-governmental organizations, and Tribes. The Service considers participation by the WGFD invaluable to this recovery effort given their long history with black-footed ferret conservation and recovery, leadership in successful reintroductions in Shirley Basin (also under a 10(j) rule), intimate knowledge of local biological conditions, and familiarity with local landowners and other stakeholders.

    This cooperative approach is consistent with our 2013 Memorandum Of Uderstanding (MOU), which committed the Service, the State of Wyoming, and other Federal partners (“Parties”) to work collaboratively to develop and implement the NEP area designation (WGFD and USFWS 2013). This MOU includes the following guiding principles, among others: (1) The Parties agree that they will collaboratively identify, and prioritize, prospective ferret reintroduction sites in Wyoming outside of the current 10(j) areas (i.e., Shirley Basin and Wolf Creek); and (2) the Parties agree that future reintroductions of the ferret will be based on mutually affirmed prioritization of prospective reintroduction sites (WGFD and USFWS 2013, pp. 5-6).

    The Service will continue to play an active role in black-footed ferret recovery in Wyoming as outlined in the MOU and through the Service's oversight of the black-footed ferret allocation process. The Service determines, based on reintroduction proposals, which reintroduction sites receive captive born ferrets (i.e., kits) for release into the wild. Ferret allocation decisions made by the Service are based on the biological and scientific merit of the proposals, the suitability of proposed reintroduction sites, management capabilities of reintroduction programs, comprehensiveness of site work plans, the overall contribution to species recovery each project represents, and other considerations that may be unforeseen. Furthermore, the Service must be kept apprised of any post allocation changes in project design, direction, management, or field implementation of ferret reintroduction projects. No ferrets may be translocated, relocated, or removed from the wild (except for emergency health concerns) without prior Service notification and authorization.

    (2) Comment: One peer reviewer stated that our determination of “nonessential” is misleading and erroneous, as it is was based on the conclusion that a loss of the proposed NEP in Wyoming will not appreciably reduce the likelihood of future survival of the ferret rangewide (i.e., at the 23 reintroduction sites outside of Wyoming). This reviewer further stated that “it is not whether the loss of a future population in Wyoming will affect the survival of another population somewhere else, but whether that population is intended to contribute to the recovery of the species.” Another peer reviewer and several commenters also questioned how all populations in Wyoming could be designated as nonessential despite the anticipated future “essential” role of such populations for the recovery of the species. In other words, some collection of reintroduction sites will necessarily comprise an “essential” part of the future recovered population.

    Our Response: We agree with the contention that successfully reintroduced populations under this 10(j) rule will be a central part of black-footed ferret recovery. This is consistent with the Act's requirements for 10(j) experimental populations. Specifically, the Act requires that experimental populations further the conservation of the species. Conservation is defined by the Act as the use of all methods and procedures which are necessary to bring any endangered or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary (16 U.S.C. 1532(3)). In short, experimental populations must further the species' recovery.

    Under the revised Black-footed Ferret Recovery Plan, the species may be downlisted from endangered to threatened when at least 10 ferret populations, each with at least 30 breeding adults, are established. Thus, downlisting is based on biological parameters (e.g., number of breeding adults, number of successful sites). The recovery plan makes no distinction as to how these populations are designated once biological criteria are satisfied; each population will contribute toward recovery of the species whether it is designated as endangered, essential experimental, or nonessential experimental. The importance of future reintroduction sites to recovery, however, does not mean these populations are “essential” under section 10(j) of the Act. All reintroduction efforts are undertaken with the primary goal to move a species toward recovery. If importance to recovery was equated with essentiality, no reintroductions would qualify for nonessential status. This interpretation would conflict with Congress' expectation that “in most cases, experimental populations will not be essential” (H.R. Conference Report No. 835, supra at 34; USFWS 1984) and our 1984 implementing regulations, which indicated an essential population will be a special case and not the general rule (USFWS 1984).

    (3) Comment: Two reviewers and one commenter expressed concern over the reliance of the black-footed ferret recovery program on the captive population. Selection acts on captive populations, potentially resulting in animals adapted for survival in captivity and maladapted for life in the wild.

    Our Response: We agree that reliance on captive populations for species conservation is never ideal for numerous reasons, including those noted by the reviewers. Unfortunately, there are few alternatives for the black-footed ferret at this time. Thus, we recognize that it is vitally important for species persistence to expedite the establishment of reintroduction sites and wild populations whenever possible. For this reason, our recovery strategy emphasizes the rapid expansion of ferret recovery in the wild (USFWS 2013a, p. 68). Working in close coordination with the WGFD and other stakeholders, we fully expect establishment of additional wild populations in Wyoming under this 10(j) rule. An increase in successful reintroductions will result in a reduced reliance on the captive population in the future and allow for translocations of wild individuals to more fully support recovery efforts.

    (4) Comment: One reviewer stated that due to a potential for genetic adaptation to the captive environment, the assumption by the Service that replacing wild animals with captive animals is equivalent to maintaining wild populations is biologically and legally flawed. The reviewer further stated that this assertion should be clarified and/or deleted entirely.

    Our Response: Both in our proposal and this final rule, we state that animals lost during reintroduction efforts can be readily replaced through captive breeding, which produces juvenile ferrets in excess of the numbers needed to maintain the captive-breeding population. We do not make the assumption that replacement of wild animals with captive animals is equivalent to maintaining wild populations. It is always the Service's goal for reintroductions to be successful and contribute to recovery, which means the establishment of secure, self-sustaining populations in the wild. We recognize, however, that reintroductions are, by their nature, experiments whose outcome is uncertain. The point we are making with the above statement that “animals lost during reintroduction can be readily replaced through captive breeding” reflects the very real conservation status of the black-footed ferret; at this time, loss of the captive population could be catastrophic to the species, whereas the reverse is not true. The captive population of ferrets has been responsible for establishment of every wild ferret population in existence today, either wholly or primarily. Animals lost at reintroduction sites can be replaced by reintroduction of captive-bred individuals. We expect this trend will continue for the foreseeable future. Specifically, the captive population will remain important until establishment of the at least 30 wild populations needed for recovery is accomplished; both as a source of animals for reintroduction and as insurance against stochastic environmental events in wild populations (e.g., plague epizootics). Conversely, the populations in the Wyoming NEP can be established or re-established from the captive population. Thus, until the species is recovered, the Service considers the captive population to be far more important to the survival of the species in the wild than the planned Wyoming NEP. Whether the Wyoming NEP is essential to recovery of the species “in the wild” was discussed in more detail under Comment 2.

    (5) Comment: One reviewer suggested that instead of giving reasons why the NEP is not “essential” the Service should indicate its intentions for the experimental population as follows: “Once the ferret population reaches its delisting goal this 10(j) rule will be mooted, as the species will no longer require protection of the [Act]. The FWS will then enter into post-delisting monitoring and management agreements with Wyoming to ensure adequate persistence of and protection for reintroduced populations of ferrets to ensure that ferrets are no longer subject to relisting under the [Act].”

    Our Response: We are required under the Act to designate any experimental population as either “essential” or “nonessential.” Our nonessential determination is based on the best scientific and commercial data available and thus meets the requirements under the Act. This population satisfies all requirements for a 10(j) population and meets the standards for a nonessential population under this section of the Act. Although post-delisting management agreements are beyond the scope of this 10(j) rule, we do anticipate reintroductions authorized by this rule to advance the conservation of the species and that this progress may contribute to an eventual reclassification to threatened or full species recovery and delisting. Prior to delisting, it is likely we would pursue management agreements to provide us adequate confidence that recovery progress achieved will be maintained. This is consistent with the Black-footed Ferret Recovery Plan, which calls for the completion and implementation of a post-delisting monitoring and management plan, in cooperation with the states and Tribes, to ensure recovery goals are maintained (USFWS 2013a, p.6).

    (6) Comment: Two reviewers and several commenters were concerned about the potential use of anticoagulant poisons like Rozol® to control prairie, dogs due to the potential for secondary toxicities to predators like black-footed ferrets. While they recognized that details on anticoagulant poison use may be more appropriately addressed in site-specific plans, they thought a framework for how the Service intends to approach this issue needed to be set out in this rule.

    Our Response: Anticoagulant poisons can result in secondary impacts to any wildlife that consumes a poisoned prairie dog. In 2012, the Service completed formal consultation with the Environmental Protection Agency (EPA) to evaluate potential impacts to endangered and threatened species, including the black-footed ferret, from the use of the anticoagulant Rozol® to poison prairie dogs. Label restrictions resulting from this process prohibit application of Rozol® within current and future ferret recovery sites. It is a violation of Federal law to use a pesticide in a manner inconsistent with its labeling.

    The Service would have no additional section 7 consultation role regarding the use of Rozol® at reintroduction sites in Wyoming, except in National Parks and National Wildlife Refuges. However, through the allocation process of providing captive ferrets to reintroduction sites, we determine which sites will receive ferrets. We do not support the use of Rozol® or other anticoagulants for control of prairie dogs, particularly at black-footed ferret reintroduction sites. Boundary control of prairie dogs at reintroduction sites is sometimes necessary because prairie dogs have encroached onto adjacent properties where prairie dogs are not wanted. If boundary control becomes necessary to maintain relations with neighboring landowners, we support the use of zinc phosphide in these instances. In comparison with Rozol®, which has a high risk of secondary poisoning of wildlife, zinc phosphide-based pesticides pose fewer risks to non-target wildlife when properly applied by a certified pesticide applicator as required by label.

    (7) Comment: One reviewer expressed concern over WGFD management of future reintroductions, noting that WGFD has not consistently conducted annual monitoring for the Shirley Basin black-footed ferret population.

    Our Response: Long-term wildlife management and monitoring programs seldom are able to achieve 100 percent success when it comes to meeting monitoring goals. Potential impediments to meeting monitoring goals include such things as changing staff workloads and turnover, budget limitations, inclement weather, and equipment failures, among many others. Overall, we believe that during the last 20 years, WGFD has demonstrated a meaningful commitment to black-footed ferret conservation in Shirley Basin through data reporting, multiple scientific publications on the black-footed ferret, plague management, and the release of over 500 ferrets into the area. Therefore, we are confident in their ability to manage future reintroduction efforts in Wyoming.

    (8) Comment: One reviewer and several commenters requested we provide a specific timeline for completion of the identification and evaluation of reintroduction sites.

    Our Response: Stakeholders in Wyoming essentially viewed the implementation of a Statewide 10(j) rule as a prerequisite to participation in any ferret recovery actions in the State of Wyoming. Thus, implementation of this rule is only a first step in advancing black-footed ferret recovery in Wyoming. Under the 2013 MOU guiding principles, the WGFD and the Service will collaboratively identify and prioritize prospective reintroduction sites in the Wyoming NEP area. The steps that must be taken before a site can receive ferrets are substantial and calculated with the goal of selecting sites with the best potential of success. Steps include, but are not limited to: (1) Identification of interested and willing landowners; (2) biological evaluation of each site's potential to support at least 30 ferrets; and (3) creation of site-specific management plans (see Location of the Nonessential Experimental Population Area). At this time we do not have precise information on locations of all suitable habitat, nor have any prospective reintroduction sites been approved yet for allocation of captive-bred ferrets. Therefore, we believe reporting a specific timeline would be arbitrary and premature.

    Implementation of this Statewide 10(j) rule will significantly reduce the administrative burden that would have been associated with development of multiple site-specific rules. In this case, the WGFD is not precluded from coordinating simultaneously with multiple landowners and evaluating sites for potential reintroduction. We believe under this Statewide 10(j) rule, the process for black-footed ferret reintroductions in Wyoming will be effectively streamlined. Encouragingly, following publication of the proposed rule in the Federal Register, WGFD has reported that a number of landowners have approached them expressing interest in establishing a ferret population on their land following implementation of the 10(j) rule.

    (9) Comment: One reviewer and several commenters wanted greater detail on specific reintroduction and sylvatic plague management plans.

    Our Response: Many of the specific questions raised in the comments are answered under Release Procedures, above. Development of management plans for reintroductions and sylvatic plague are a cooperative effort between the Service, WGFD, other federal agencies, landowners, and affected stakeholders. Final plans must be approved by the Service as part of the ferret allocation process. Ferret allocation decisions are based on the considerations mentioned in our response to Comment 1. We expect that future site-specific management plans will have many similarities to past plans for other reintroduction sites.

    (10) Comment: One reviewer and several commenters wondered if the public would have an opportunity to comment on potential reintroduction sites in the future.

    Our Response: There is no formal public comment period for potential reintroduction sites or site-specific management plans, but there will be opportunities for public involvement. The Service and the WGFD recognize that local involvement is important to the success of recovery efforts and the long-term conservation of the black-footed ferret in Wyoming. Consequently, as required in the 2013 MOU, the Service and WGFD will coordinate to ensure local communities, including potentially affected landowners, stakeholder groups, local governments, and Tribes are fully engaged in any future black-footed ferret reintroduction efforts. Future management plans may contain provisions similar to the following, although the specific content and details will vary by reintroduction site. Public involvement may include but is not limited to the following: (1) Public meetings to outreach to all interested parties on determining potential reintroduction sites; (2) Coordination with all interested parties after a reintroduction site is determined; (3) Direct involvement of management plan development which could include state and federal agencies, County Commissioners, landowners, companies, academia, and other stakeholders, and tribes; (4) Allowing landowners and land managers the opportunity to cooperatively decide the number and distribution of prairie dogs (and correspondingly black-footed ferrets) that may occur on privately owned and leased lands; (5) Annually obtaining landowner approval of human activity necessary for actions specified in a plan; (6) Biannual review of the progress of ongoing activities by all concerned parties; (7) Direct involvement any interested parties in monitoring activities on reintroduction sites.

    (11) Comment: Two reviewers questioned whether the estimates for the number of black-footed ferrets currently in the wild were the most current estimates available.

    Our Response: As is true for many species, and particularly with one that is largely fossorial (i.e., lives mostly underground) and nocturnal like the black-footed ferret, determining precise population numbers is challenging. Black-footed ferret populations are difficult to count due to their remote locations, difficult accessibility, nocturnal habits, small population sizes, and logistical problems and costs associated with the requisite field work. More importantly, ferret populations can also fluctuate significantly from one year to the next depending on the presence or absence of plague and active plague management, or due to other environmental factors like drought. Accordingly, a tally of adult ferret numbers at any one point in time is likely a poor indicator of recovery progress. We view ferret population estimates at most sites as minimum numbers because of the aforementioned issues.

    We stated in the EA and proposed rule that there are approximately 418 breeding adult ferrets in the wild, including approximately 102 breeding adults in the reintroduced population at Shirley Basin, Wyoming, as was reported in the 2013 Black-footed Ferret Recovery Plan (USFWS 2013a, Table 2). The reviewers are correct that the value for Shirley Basin is an estimate derived from surveys conducted in 2010. A more recent report gives the same estimate of approximately 100 breeding adults in Shirley Basin based on the 2010 survey and approximately 295 breeding adults rangewide (Black-footed ferret Recovery and Implementation Team Conservation Subcommittee Report 2014, Table 1). The current Shirley Basin estimate is based on the best available science and is meant to provide the most accurate assessment of the magnitude of the population size rather than the precise number of individuals, which can fluctuate considerably for the reasons given above.

    (12) Comment: One reviewer questioned the meaning of the phrase “occupied prairie dog habitat,” noting that one could ask “occupied by what?”

    Our Response: When we use the phrase “occupied prairie dog habitat,” we mean areas that are occupied by prairie dogs. A review of the scientific literature on prairie dogs shows both “occupied prairie dog habitat” and “prairie dog occupied habitat” are commonly used terms to indicate habitat that is occupied by prairie dogs. While we agree with the comment in general as prairie dog colonies can and typically are “occupied” by a number of other species, in this case we believe, however, it is clear by the context that what is being referenced in this rule is occupancy by prairie dogs.

    (13) Comment: One reviewer questioned the criteria for evaluating potential reintroduction sites. The reviewer stated that occupancy of habitat by prairie dogs is a simplistic criterion considering prairie dog populations can fluctuate significantly over time, expanding and contracting for a number of reasons, including plague.

    Our Response: Determining occupancy by prairie dogs is simply a first step in determining the potential for reintroduction site. A large number of other factors are considered for determining the suitability of proposed reintroduction sites. Foremost in consideration for prioritizing black-footed ferret allocations (i.e., young ferrets available for release into the wild) is the size, density, health, and overall stability of potential ferret habitat. Additional non-biological requirements for ferret allocations include a willing landowner and a management plan that addresses sylvatic plague.

    (14) Comment: One reviewer agreed with our identification of plague as a major impediment to the recovery of black-footed ferret, but noted that the management of plague only “during periodic outbreaks of sylvatic plague” understates the problem. Recent research has shown that plague has serious negative effects on prairie dog populations not only during major “outbreaks” but also when present at lower levels.

    Our Response: Currently, management for sylvatic plague is carried out largely by dusting the impacted area with pesticides meant to kill the fleas that host the plague bacteria. This type of management can be effective. We agree, however, that this approach is not ideal, as it is typically only applied after plague has been detected, which is often too late, as mortality of ferrets and prairie dogs has already been significant. A new oral vaccine, currently being field tested, could provide a more effective, less expensive way to protect prairie dogs.

    The Service recognizes that understanding how to control or preferably eradicate sylvatic plague is critical to black-footed ferret conservation. The complex dynamics of sylvatic plague are not fully understood. As scientific knowledge of sylvatic plague advances, that information will be incorporated into management plans that address sylvatic plague. Although research projects are not required program elements for ferret allocations to reintroduction sites, the Service encourages, supports, and may give greater priority to projects that incorporate research elements addressing specific ferret recovery problems or questions.

    (15) Comment: One reviewer wanted to see affirmation that the Wind River Tribes concur with the application of 10(j) to tribal lands within the Wind River Indian Reservation. The reviewer stated that Tribes may have an interest in maintaining full protection for ferrets within their boundaries.

    Our Response: We contacted the Eastern Shoshone and Northern Arapaho Tribes of the Wind River Indian Reservation and invited them to comment on the proposal. We did not receive comments from either Tribe. It is unlikely that these two Tribes have adequate prairie dog occupied habitat that would be suitable for a future reintroduction of the black-footed ferret. This does not preclude coordination with the Tribes in the future if circumstances change.

    Comments From the State of Wyoming

    (16) Comment: The State of Wyoming and several commenters were concerned that the Service could change the NEP designation to experimental essential, endangered, or threatened in the future. The Service should clarify under what conditions a change in designation could occur.

    Our Response: We do not foresee the need to change the NEP designation for any reintroduced black-footed ferret population. One of the benefits of an NEP designation is that it provides flexibility in the regulatory requirements in the area where the reintroduction occurs. This regulatory relief is important because, prior to reintroduction, these sites had no regulation related to the subject species because the species was not present. Thus, State, tribal, and private landowners typically resist endangered species reintroductions that bring with them new Federal regulation. This resistance can be nearly insurmountable. Fewer black-footed ferret reintroductions would have been initiated during the past 20 years without the added flexibility of nonessential experimental designations. To date, 11 black-footed ferret reintroductions have occurred through use of section 10(j) designated NEP areas in the United States, including in the Shirley Basin in Wyoming (USFWS 2013a, pp. 38-39). We do not believe ferrets would likely exist today in Wyoming if not for their nonessential experimental designation in Shirley Basin and the resulting reduced regulatory burden.

    All determinations on essentiality are made prior to any reintroduction action being taken. It is instructive that Congress did not put requirements in section 10(j) to reevaluate the classification after a reintroduction has occurred. While our regulations require a “periodic review and evaluation of the success or failure of the release and the effect of the release on the conservation and recovery of the species” (50 CFR 17.81(c)(4)), this has not been interpreted as requiring reevaluation and reconsideration of sites' nonessential experimental status (USFWS 1991, 1994, and 1996). We believe Congressional intent was to ensure that our partners could rely upon the original rules promulgated for the reintroduction effort. We also contend that retracting the nonessential experimental designation following implementation of this 10(j) rule would be extremely detrimental to ferrets in Wyoming and the partnerships that sustain them. Furthermore, such an alteration of the regulatory framework post-reintroduction would undermine future reintroduction efforts.

    Typically, endangered species recovery efforts, including those for ferrets, depend on a myriad of partners working together to accomplish a common goal. In most cases, and particularly for ferrets, recovery would not be possible without substantial partner efforts. In looking back on ferret recovery over the last 25 years, we have gone from no ferret populations known in the wild to having 24 ferret reintroduction sites in the wild, with 17 of those sites continuing to have ferrets through 2015. Hundreds of partners have made this possible. We believe these are not trivial accomplishments. At nearly all the 24 ferret reintroduction sites, it is our partners who accomplish the actual on-the-ground ferret reintroduction and management work. The same will be true in this case, with WGFD taking the lead on implementation of reintroductions. Absent those partnerships, there would be far fewer reintroductions and likely no ferrets in Wyoming. Accordingly, the Service highly values those local partnerships that accomplish ferret recovery and is understandably cautious about undertaking actions that disrupt those partnerships.

    In 2009, the Service received a petition to reclassify three reintroduced black-footed ferret populations from nonessential experimental to endangered, including the Shirley Basin NEP in Wyoming. This petition was submitted pursuant to section 553 of the Administrative Procedure Act (5 U.S.C. 553) (WildEarth Guardians et al. 2009). The Service strongly believed and continues to believe that the ramifications of such an action would be detrimental to ferrets at these sites and the partnerships that sustain them. As we anticipated, the petition had immediate negative impacts to ferret recovery, prompting landowners to withdraw support for another planned reintroduction in Wyoming. The Service denied the petition in 2010 (USFWS 2010).

    As mentioned above, we do not foresee the need to change the NEP designation for any wild black-footed ferret population. The captive population is crucial to survival of the species in the wild at this time, and likely for the foreseeable future. However, a substantial loss of the captive population is highly improbable, as captive ferrets have been purposefully dispersed among six facilities, protecting the species from a single catastrophic event. In any circumstance, any change in the 10(j) listing would require a new proposed rule, a public comment period (including, if requested, public hearings), public meetings, NEPA compliance, and other documentation prior to publication of a final rule to change or abandon the NEP designation.

    (17) Comment: The State of Wyoming and several commenters requested that the Service provide assurance that if the 10(j) designation changed in any respect, the Service would remove the ferrets.

    Our Response: Under 50 CFR 17.84(g)(12), the following will apply to any reintroduced ferret populations under this 10(j) rule:

    “We will not include a reevaluation of the “nonessential experimental” designation for these populations during our review of the initial five year reintroduction program. We do not foresee any likely situation justifying alteration of the nonessential experimental status of these populations. Should any such alteration prove necessary and it results in a substantial modification to black-footed ferret management on non-Federal lands, any private landowner who consented to the introduction of black footed ferrets on their lands may rescind their consent, and at their request, we will relocate the ferrets pursuant to paragraph (g)(4)(iii) of this section.”

    (18) Comment: The State of Wyoming requested assurance from the Service that there will be thorough and appropriate consultation before any ferrets are brought into Wyoming under this rule.

    Our Response: We fully expect that all reintroductions efforts under this 10(j) rule will be conducted in close coordination with the WGFD, landowners, and affected stakeholders. This coordination will take place under previsions in the 2013 MOU and as part of the ferret allocation process.

    Public Comments

    (19) Comment: Two commenters stated that the Service's current prairie dog range estimate is not based on the best available science and information. Specifically the commenters point out that the Service claims there to be nearly 3.1 million acres of prairie dog occupied habitat in Wyoming, but previously (in USFWS 2009) has stated that the prairie dog occupies 2.4 million acres across its entire range.

    Our Response: It is important to clarify that the 2.4 million acres of occupied habitat estimated in USFWS 2009 is a rangewide estimate for black-tailed prairie dogs (one of four species of prairie dog) only. Our estimate in the proposed rule and above of the amount of prairie dog occupied habitat in Wyoming includes estimates for both species of prairie dog that occur in Wyoming. We cite recent estimates of prairie dog occupied habitat in Wyoming at 2,893,487 ac (1,171,862 ha) in the white-tailed prairie dog range and 229,607 ac (92,991 ha) in the black-tailed prairie dog range (Van Pelt 2013, pp. 8, 14). Black-tailed prairie dogs have a much smaller estimated range in the State of Wyoming while the estimated white-tailed prairie dog habitat in Wyoming is much larger. The combined estimate for both species of prairie dog in Wyoming is based on the best available scientific information.

    (20) Comment: Two commenters noted that aerial surveys overestimate occupied prairie dog habitat by as much as 94 percent (Sidle et al. 2012). One commenter stated that if the estimate of prairie dog habitat is inaccurate then the area to which black-footed ferrets may be introduced is exaggerated. The commenter also alleged that the Service has used inaccurate data to formulate population goals of both the black-footed ferret and black tailed prairie dogs.

    Our Response: We acknowledge that aerial surveys can overestimate the extent of active or occupied prairie dog habitat and that there is some degree of error attached to any such estimate. Overestimates of prairie dog colonies result because observers may have difficulty distinguishing active, occupied burrows from unoccupied burrows from the air. Researchers continue working to refine methods for accurately assessing active prairie dog populations from the air.

    It is important to note, however, that in the case of black-footed ferret reintroductions, aerial surveys are used only as a rough guide for identifying potential black-footed ferret habitat for reintroductions. Measurable fluctuations in prairie dog occupancy are a part of the natural dynamics of prairie dog populations, but fluctuations can be especially pronounced in areas experiencing plague or subjected to poisoning. The presence of unoccupied burrows conclusively indicates that prairie dogs occupied the area sometime in the recent past. Thus, while we may use aerial surveys as rough estimate of prairie dog habitat, we do not rely on aerial surveys to identify areas with the highest biological potential for black-footed ferret reintroductions. Reintroduction sites are chosen instead based on a number of other factors including the size, density, health, and overall stability of the prairie dog occupied habitat, information that is gathered from ground surveys and local knowledge of prairie dog colonies in a given area.

    States are encouraged to contribute to recovery goals in proportion to the amount of historical ferret habitat (i.e., prairie dog colonies) that once occurred on these lands. The Black-footed Ferret Recovery Plan estimates that 35,000 ac (14,000 ha) of purposefully managed prairie dog occupied habitat will be needed to meet Wyoming's portion of the rangewide habitat goal for downlisting and 70,000 ac (28,000 ha) to meet their portion of the rangewide habitat goal for delisting (USFWS 2013a, Table 8). For the State of Wyoming, this equates to purposeful management of approximately 2 percent of the estimated prairie dog habitat in Wyoming to meet their portion of the rangewide habitat goals for delisting. The best available science supports our estimates of occupied prairie dog habitat and potentially suitable habitat for black-footed ferret reintroductions.

    (21) Comment: Several commenters were concerned with potential impacts of black-footed ferret reintroductions on federal oil and gas lessees. They asserted that because federal oil and gas leases are interests in real property, the holder of a federal oil and gas lease is no different than a private surface owner.

    Our Response: We concluded in the proposed rule and the EA that the most prevalent land use activities, including energy development, currently occurring in the NEP area are compatible with ferret recovery and that there is no information to suggest that future activities would be incompatible with ferret recovery. Federal oil and gas leases will certainly be considered and lessees likely consulted during development of reintroduction proposals for the ferret allocation process. Current and future land management, principal land uses, and potential for change or land management conflicts are serious considerations for all potential reintroduction sites. Reintroduction allocation decisions are made based on a potential reintroduction site's probability for long-term success. We have little interest in allocating ferrets, an exceptionally limited resource, to areas where land management conflicts will be an obvious problem, either currently or in the future.

    (22) Comment: One commenter stated that black-footed ferrets are believed to be predators of sage-grouse nests and therefore will have negative impacts on sage-grouse.

    Our Response: Based on our extensive experience with both species in the wild and our review of the scientific literature, we are not aware of any evidence that black-footed ferrets are predators on sage-grouse at any life stage, including nests (eggs), adults, or chicks. Black-footed ferrets depend almost exclusively on prairie dogs for food.

    Summary of Changes From Proposed Rule

    In our proposed rule, the language under paragraph (g)(9)(viii) stated that “Any black-footed ferret found within the Wyoming Experimental Population Area will be considered part of the nonessential experimental population after the first breeding season following the first year of black-footed ferret release. A black-footed ferret occurring outside of the State of Wyoming would initially be considered as endangered, but may be captured for genetic testing.”

    As noted by one reviewer, this language was included in earlier 10(j) rules at a time when the discovery of other extant wild ferret populations was still considered plausible. There have been no verified reports of any extant black-footed ferret individuals or populations in any prairie dog complex since the discovery of the last known wild black-footed ferret population near Meeteetse, Wyoming, in 1981. Recently, the Service issued a `block clearance' letter for the ferret in the State of Wyoming (Service 2013c). Block clearance provides an acknowledgement that the likelihood of identifying ferrets in Wyoming, outside of those resulting from reintroductions, is distinctly minimal. Our revision of paragraph (g)(9)(viii) reflects this determination. Thus, once this 10(j) rule becomes effective, any black-footed ferret found within the Wyoming NEP Experimental Population Area will be considered part of the nonessential experimental population. A black-footed ferret that disperses beyond the boundaries of the nonessential experimental population takes on the status of that area (endangered, unless within another nonessential experimental population area).

    Finding

    We followed the procedures required by the Act, NEPA, and the Administrative Procedure Act during this Federal rulemaking process. We solicited public comment on the proposed NEP designation. We have considered all comments we received on the proposed rule and the draft EA before making this final determination. Based on the above information, and using the best scientific and commercial data available (in accordance with 50 CFR 17.81), we find that establishing this Wyoming NEP area will further conservation of the species, but that any future experimental populations of black-footed ferrets in Wyoming would not be essential to the continued existence of the species in the wild.

    Therefore, we are finalizing our proposal to designate most of Wyoming (the remainder of the State of Wyoming not covered under past NEPs) as an NEP area under section 10(j) of Act. The result of this designation and the two previous designations is that all black-footed ferrets found within the entire State of Wyoming are considered as an NEP. Black-footed ferrets will be managed under the associated NEP regulations, allowing greater management flexibility. We anticipate this will encourage partners to undertake new reintroductions, advancing the conservation and recovery of the species.

    Required Determinations Regulatory Planning and Review (Executive Orders 12866 and 13563)

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

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

    Regulatory Flexibility Act (5 U.S.C. 601 et seq.)

    Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 801 et seq.), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare, and make available for public comment, a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We certify that this rule will not have a significant economic effect on a substantial number of small entities. The following discussion explains our rationale.

    The area that will be affected by this rule includes release sites in Wyoming and adjacent areas in Wyoming into which black-footed ferrets may disperse. Because of the regulatory flexibility for Federal agency actions provided by the NEP designation and the exemption for incidental take in the 10(j) rule, we do not expect this rule to have significant effects on any activities within Federal, State, or private lands within the NEP. When NEPs are located outside a National Wildlife Refuge or National Park Service unit, then, for the purposes of section 7, we treat the population as proposed for listing and only section 7(a)(1) and section 7(a)(4) apply. In these instances, NEPs provide additional flexibility because Federal agencies are not required to consult with us under section 7(a)(2). Section 7(a)(4) requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a species proposed to be listed. However, because the NEP is, by definition, not essential to the survival of the species, conferring will likely never be required for the black-footed ferret populations within the NEP area. Furthermore, the results of a conference are advisory in nature and do not restrict agencies from carrying out, funding, or authorizing activities. In addition, section 7(a)(1) requires Federal agencies to use their authorities to carry out programs to further the conservation of listed species, which would apply on any lands within the NEP area. As a result, and in accordance with these regulations, some modifications to proposed Federal actions within the NEP area may occur to benefit the black-footed ferret, but we do not expect projects to be halted or substantially modified as a result of these regulations.

    This 10(j) rule will broadly authorize incidental take of the black-footed ferret within the NEP area. The regulations implementing the Act define “incidental take” as take that is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity such as, agricultural activities and other rural development, camping, hiking, hunting, vehicle use of roads and highways, and other activities in the NEP area that are in accordance with Federal, Tribal, State, and local laws and regulations. Intentional take for purposes other than authorized data collection or recovery purposes would not be permitted. Intentional take for research or recovery purposes would require a section 10(a)(1)(A) recovery permit under the Act.

    The principal activities on private property in the NEP area are livestock grazing and associated ranch management practices (e.g., fencing, weed treatments). We believe the presence of the black-footed ferret would not affect the use of lands for these purposes because there would be no new or additional economic or regulatory restrictions imposed upon states, non-federal entities, or members of the public due to the presence of the black-footed ferret, and federal agencies would only have to comply with sections 7(a)(1) and 7(a)(4) of the Act in these areas. Therefore, this rulemaking is not expected to have any significant adverse impacts to activities on private lands within the NEP area.

    Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.)

    In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.):

    (1) This rule will not “significantly or uniquely” affect small governments. We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq., that this rulemaking will not impose a cost of $100 million or more in any given year on local or state governments or private entities. A Small Government Agency Plan is not required. Small governments will not be affected because the NEP designation does not place additional requirements on any city, county, or other local municipalities.

    (2) This rule will not produce a Federal mandate of $100 million or greater in any year (i.e., it is not a “significant regulatory action” under the Unfunded Mandates Reform Act). This NEP designation for the black-footed ferret will not impose any additional management or protection requirements on the States or other entities.

    Takings (E.O. 12630)

    In accordance with Executive Order 12630, this final rule does not have significant takings implications. This rule allows for the take of reintroduced black-footed ferret when such take is incidental to an otherwise legal activity, such as recreation (e.g., hiking, hunting, fishing, bird watching), forestry, agriculture, and other activities that are in accordance with Federal, State, and local laws and regulations. Therefore, we do not believe that establishment of this NEP will conflict with existing or proposed human activities or hinder public use of ferret habitat in Wyoming.

    A takings implication assessment is not required because this rule: (1) Will not effectively compel a property owner to suffer a physical invasion of property, and (2) will not deny any economically beneficial or productive use of the land or aquatic resources. This rule will substantially advance a legitimate public interest (conservation and recovery of a listed species) and will not present a barrier to all reasonable and expected beneficial use of private property.

    Federalism (E.O. 13132)

    In accordance with Executive Order 13132 (70 FR 23775), we have considered whether this final rule has significant Federalism effects and have determined that a federalism summary impact statement is not required. This rule will not have substantial direct effects on the states, on the relationship between the Federal government and the states, or on the distribution of power and responsibilities among the various levels of government. In keeping with Department of the Interior policy, we requested information from and coordinated development of this final rule with the affected resource agencies in Wyoming. Achieving the recovery goals for this species will contribute to its eventual delisting and return to state management. No intrusion on state policy or administration is expected, roles or responsibilities of Federal or State governments will not change, and fiscal capacity will not be substantially directly affected. The final 10(j) rule operates to maintain the existing relationship between the State and the Federal governments and is being undertaken in coordination with the State of Wyoming. We have cooperated with WGFD in the preparation of this final rule. Therefore, this final rule does not have significant Federalism effects or implications to warrant the preparation of a federalism summary impact statement pursuant to the provisions of Executive Order 13132.

    Civil Justice Reform (E.O. 12988)

    In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and meets the requirements of sections (3)(a) and (3)(b)(2) of the Order.

    Paperwork Reduction Act

    Office of Management and Budget (OMB) regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), require that Federal agencies obtain OMB approval before collecting information from the public. This final rule does not include any new collections of information that require OMB approval under the Paperwork Reduction Act. OMB has approved our collection of information associated with reporting the taking of experimental populations (50 CFR 17.84) and assigned OMB Control Number 1018-0095, which expires on October 31, 2017. We 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.

    National Environmental Policy Act

    In compliance with all provisions of the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq.), we have analyzed the impact of this rule. Based on this analysis and information resulting from public comment on the proposed action, we determined that this action will not have significant impacts or effects. We have prepared a final EA and finding of no significant impact on this action, which are available for public inspection: (1) In person at the Wyoming Ecological Services Field Office (see ADDRESSES) and (2) online at http://www.regulations.gov. All appropriate NEPA documents were finalized before this rule was finalized.

    Government-to-Government Relationship With Tribes

    In accordance with the presidential memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 229511), Executive Order 13175 (65 FR 67249), and the Department of the Interior Manual Chapter 512 DM 2, we have considered possible effects on federally recognized Indian Tribes and have determined that Tribal lands overlap the Wyoming NEP in portions of Fremont and Hot Springs Counties. However, participation in black-footed ferret recovery is entirely voluntary. If suitable habitat for ferret recovery is available, non-Federal landowners, including Tribes, may choose to either not participate, or to participate through authorities under 10(j), 10(a)(1)(A), or the Safe Harbor Agreement (USFWS 2013b). If ferrets were reintroduced on non-tribal lands adjacent to Tribal lands and subsequently dispersed onto Tribal lands, the aforementioned authorities will provide a more relaxed regulatory situation under the Act through allowances for incidental take. However, as stated previously, we are not aware of any prairie dog complexes suitable for ferret reintroduction on or adjacent to Tribal lands. The nearest potential reintroduction sites are two white-tailed prairie dog complexes—Fifteen-mile Complex near Worland in Hot Springs County, and Sweetwater Complex near Sweetwater Station in Fremont County (Luce 2008, pp. 29-30). Both sites are of intermediate potential for ferret reintroduction and are located approximately 19 miles (30 kilometers) from reservation boundaries. We sent letters, describing our proposed action and requesting input, to the Northern Arapaho and Eastern Shoshone Tribes of the Wind River Reservation on September 4, 2014. We did not receive a response from either Tribe.

    Energy Supply, Distribution, or Use (E.O. 13211)

    Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This rule is not expected to significantly affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action, and no Statement of Energy Effects is required.

    References Cited

    A complete list of all references cited in this rule is available on the Internet at http://www.regulations.gov at Docket No. FWS-R6-ES-2015-0013, or upon request from the Wyoming Ecological Services Field Office (see ADDRESSES).

    Authors

    The authors of this final rule are staff members of the Wyoming Ecological Services Field Office (see ADDRESSES).

    List of Subjects in 50 CFR Part 17

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

    Regulation Promulgation

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

    PART 17—[AMENDED] 1. The authority citation for part 17 continues to read as follows: Authority:

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

    2. Amend § 17.11(h) by revising the entry for “Ferret, black-footed” under MAMMALS in the List of Endangered and Threatened Wildlife to read as follows:
    § 17.11 Endangered and threatened wildlife.

    (h) * * *

    Species Common name Scientific name Historic range Vertebrate population where endangered or threatened Status When listed Critical habitat Special rules Mammals *         *         *         *         *         *         * Ferret, black-footed Mustela nigripes Western U.S.A., Western Canada, Mexico Entire, except where listed as an experimental population E 1, 3, 433, 545, 546, 582, 646, 703, 737, 860 NA NA Ferret, black-footed Mustela nigripes Western U.S.A., Western Canada, Mexico U.S.A. (WY and specified portions of AZ, CO, MT, SD, and UT, see 17.84(g)(9)) XN 433, 545, 546, 582, 646, 703, 737, 860 NA 17.84(g) *         *         *         *         *         *         *
    3. Amend § 17.84 by: a. Revising paragraphs (g)(1) and (g)(6)(i); b. Adding paragraph (g)(9)(viii); and c. Adding a map entitled “Wyoming Nonessential Experiment Population (NEP) Area for the Black-footed Ferret” immediately following the map entitled “Rosebud Sioux Tribe ITOPA SAPA KIN (Black-footed Ferret) Experimental Population Area—South Dakota.”

    The revisions and additions read as follows:

    § 17.84 Special rules—vertebrates.

    (g) * * *

    (1) The black-footed ferret populations identified in paragraphs (g)(9)(i) through (viii) of this section are nonessential experimental populations. We will manage each of these populations, and each reintroduction site within the Wyoming Experimental Population Area, in accordance with their respective management plans.

    (6) * * *

    (i) Report such taking in Wyoming, including the Shirley Basin/Medicine Bow experimental population area, to the Field Supervisor, Ecological Services, Fish and Wildlife Service, Cheyenne, Wyoming (telephone: 307/772-2374).

    (9) * * *

    (viii) The Wyoming Experimental Population Area encompasses most of the State of Wyoming. The boundaries of the nonessential experimental population include all areas in the State of Wyoming outside of the Shirley Basin/Medicine Bow Management Area (see paragraph (g)(9)(i) of this section) and the small portion of Wyoming included as part of the Northwestern Colorado/Northeastern Utah Experimental Population Area (see paragraph (g)(9)(v) of this section). Collectively, however, these three 10(j) areas cover the entire State of Wyoming. Any black-footed ferret found within the Wyoming NEP Experimental Population Area will be considered part of a nonessential experimental population. A black-footed ferret that disperses beyond the boundaries of the nonessential experimental population area takes on the status of that area (endangered, unless within another nonessential experimental population area). Such animals may be captured for genetic testing and relocation. If necessary, disposition of the captured animal may occur in the following ways:

    (A) If an animal is genetically determined to have originated from the experimental population, we may return it to the reintroduction area or to a captive-breeding facility.

    (B) If an animal is determined to be genetically unrelated to the experimental population, we will place it in captivity under an existing contingency plan.

    ER30OC15.016
    Dated: October 21, 2015. Michael J. Bean, Principal Deputy Assistant Secretary for Fish and Wildlife and Parks.
    [FR Doc. 2015-27639 Filed 10-29-15; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 141021887-5172-02] RIN 0648-XE274 Fisheries of the Exclusive Economic Zone Off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area AGENCY:

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

    ACTION:

    Temporary rule; reallocation.

    SUMMARY:

    NMFS is exchanging unused Community Development Quota (CDQ) for CDQ acceptable biological catch (ABC) reserves. This action is necessary to allow the 2015 total allowable catch of rock sole and yellowfin sole in the Bering Sea and Aleutian Islands management area to be harvested.

    DATES:

    Effective October 30, 2015 through December 31, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Steve Whitney, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands management area (BSAI) according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

    The 2015 rock sole and yellowfin sole CDQ reserves specified in the BSAI are 6,875 metric tons (mt) and 17,321 mt as established by the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and following revisions (80 FR 65663, October 27, 2015). The 2015 rock sole, and yellowfin sole CDQ ABC reserves are 12,567 mt and 9,301 mt as established by the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and following revisions (80 FR 65663, October 27, 2015).

    The Bristol Bay Economic Development Corporation has requested that NMFS exchange 600 mt of rock sole CDQ reserves for 600 mt of yellowfin sole CDQ ABC reserves under § 679.31(d). Therefore, in accordance with § 679.31(d), NMFS exchanges 600 mt of rock sole CDQ reserves for 600 mt of yellowfin sole CDQ ABC reserves in the BSAI. This action also decreases and increases the TACs and CDQ ABC reserves by the corresponding amounts. Tables 11 and 13 of the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and following revisions (80 FR 65663, October 27, 2015) are further revised as follows:

    Table 11—Final 2015 Community Development Quota (CDQ) Reserves, Incidental Catch Amounts (ICAS), and Amendment 80 Allocations of the Aleutian Islands Pacific Ocean Perch, and BSAI Flathead Sole, Rock Sole, and Yellowfin Sole TACS [Amounts are in metric tons] Sector Pacific ocean perch Eastern
  • Aleutian
  • District
  • Central
  • Aleutian
  • District
  • Western
  • Aleutian
  • District
  • Flathead sole BSAI Rock sole BSAI Yellowfin sole BSAI
    TAC 8,000 7,000 9,000 17,187 65,315 159,998 CDQ 856 749 963 1,752 6,275 17,921 ICA 100 75 10 5,000 8,000 5,000 BSAI trawl limited access 704 618 161 0 0 16,165 Amendment 80 6,340 5,558 7,866 10,435 51,040 120,912 Alaska Groundfish Cooperative 3,362 2,947 4,171 1,708 13,318 44,455 Alaska Seafood Cooperative 2,978 2,611 3,695 8,727 37,722 76,457 Note: Sector apportionments may not total precisely due to rounding.
    Table 13—Final 2015 and 2016 ABC Surplus, Community Development Quota (CDQ) ABC Reserves, and Amendment 80 ABC Reserves in the BSAI for Flathead Sole, Rock Sole, and Yellowfin Sole [Amounts are in metric tons] Sector 2015 Flathead sole 2015 Rock sole 2015 Yellowfin sole 2016 Flathead sole 2016 Rock sole 2016 Yellowfin sole ABC 66,130 181,700 248,800 63,711 164,800 245,500 TAC 17,187 65,315 159,998 24,250 69,250 149,000 ABC surplus 48,943 116,385 88,802 39,461 95,550 96,500 ABC reserve 48,943 116,385 88,802 39,461 95,550 96,500 CDQ ABC reserve 5,324 13,167 8,701 4,222 10,224 10,326 Amendment 80 ABC reserve 43,619 103,218 80,101 35,239 85,326 86,175 Alaska Groundfish Cooperative for 2015 1 3,836 24,840 35,408 n/a n/a n/a Alaska Seafood Cooperative for 2015 1 39,783 78,378 44,693 n/a n/a n/a 1 The 2016 allocations for Amendment 80 species between Amendment 80 cooperatives and the Amendment 80 limited access sector will not be known until eligible participants apply for participation in the program by November 1, 2015. Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the flatfish exchange by the Bristol Bay Economic Development Corporation in the BSAI. Since these fisheries are currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 20, 2015.

    The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

    This action is required by § 679.20 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: October 27, 2015. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-27694 Filed 10-29-15; 8:45 am] BILLING CODE 3510-22-P
    80 210 Friday, October 30, 2015 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-4210; Directorate Identifier 2015-NM-067-AD] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model 767 airplanes. This proposed AD was prompted by a determination that certain splice plate locations of the aft pressure bulkhead web are hidden and cannot be inspected using existing manufacturer service information. This proposed AD would require repetitive open-hole high frequency eddy current (HFEC) inspections for cracking of the aft pressure bulkhead web. We are issuing this AD to detect and correct cracking in the aft pressure bulkhead web, which could result in rapid decompression and loss of structural integrity.

    DATES:

    We must receive comments on this proposed AD by December 14, 2015.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

    Hand Delivery: Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    For service information identified in this proposed AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-4210.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-4210; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Wayne Lockett, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6447; fax: 425-917-6590; email: [email protected]

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2015-4210; Directorate Identifier 2015-NM-067-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

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

    Discussion

    We have determined that certain splice plate locations of the aft pressure bulkhead web at station (STA) 1582 are hidden and cannot be inspected visually for cracking because they are hidden due to the installation of splice plates up to 5 inches in width. These locations cannot be inspected using existing manufacturer service information; therefore, fastener removal and repetitive open-hole HFEC inspections for cracking of the aft pressure bulkhead web at STA 1582 are needed. We are issuing this AD to detect and correct cracking in the aft pressure bulkhead web at STA 1582, which, if not found and repaired, could result in rapid decompression and loss of structural integrity.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 767-53A0266, dated April 20, 2015. The service information describes procedures for removing the aft row of fasteners from each of the splice plates and doing an open-hole HFEC inspection for cracking in the aft pressure bulkhead at STA 1582. 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 of this NPRM.

    FAA's Determination

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

    Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified in the service information identified previously, except as discussed under “Differences Between this Proposed AD and the Service Information.”

    For information on the procedures and compliance times, see this service information at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-4210.

    The phrase “corrective actions” is used in this proposed AD. “Corrective actions” are actions that correct or address any condition found. Corrective actions in an AD could include, for example, repairs.

    Explanation of “RC” Steps in Service Information

    The FAA worked in conjunction with industry, under the Airworthiness Directive Implementation Aviation Rulemaking Committee (ARC), to enhance the AD system. One enhancement was a new process for annotating which steps in the service information are required for compliance with an AD. Differentiating these steps from other tasks in the service information is expected to improve an owner's/operator's understanding of crucial AD requirements and help provide consistent judgment in AD compliance. The steps identified as required for compliance (RC) in any service information identified previously have a direct effect on detecting, preventing, resolving, or eliminating an identified unsafe condition.

    For service information that contains steps that are labeled as RC, the following provisions apply: (1) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD, and an alternative method of compliance (AMOC) is required for any deviations to RC steps, including substeps and identified figures; and (2) steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

    Differences Between This Proposed AD and the Service Information

    The service bulletin specifies to contact the manufacturer for instructions on how to repair certain conditions, but this proposed AD would require repairing those conditions in one of the following ways:

    • In accordance with a method that we approve; or

    • Using data that meet the certification basis of the airplane, and that have been approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) whom we have authorized to make those findings.

    Costs of Compliance

    We estimate that this proposed AD affects 430 airplanes of U.S. registry.

    We estimate the following costs to comply with this proposed AD:

    Estimated Costs Action Labor cost Parts cost Cost per product Cost on U.S. operators Repetitive inspections Up to 46 work-hours × $85 per hour = $3,910 per inspection cycle $0 Up to $3,910 per inspection cycle Up to $1,681,300 per inspection cycle.

    We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

    For the reasons discussed above, I certify this proposed regulation:

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): The Boeing Company: Docket No. FAA-2015-4210; Directorate Identifier 2015-NM-067-AD. (a) Comments Due Date

    We must receive comments by December 14, 2015.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all The Boeing Company Model 767-200, -300, -300F, and -400ER series airplanes, certificated in any category.

    (d) Subject

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

    (e) Unsafe Condition

    This AD was prompted by a determination that areas at certain splice plate locations of the aft pressure bulkhead web are hidden and cannot be inspected using existing manufacturer service information; therefore, an inspection for cracking of the aft pressure bulkhead web at station (STA) 1582 is needed. We are issuing this AD to detect and correct cracking in the aft pressure bulkhead web, which could result in rapid decompression and loss of structural integrity.

    (f) Compliance

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

    (g) Inspections of Station (STA) 1582 Aft Pressure Bulkhead Web Under the Pressure Slice Plates

    At the applicable times specified in Table 1 and Table 2 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 767-53A0266, dated April 20, 2015, except as required by paragraph (i) of this AD: Do an open-hole high frequency eddy current (HFEC) inspection for cracking in the aft pressure bulkhead web at STA 1582, and do all applicable corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 767-53A0266, dated April 20, 2015, except as required by paragraph (h) of this AD. Do all applicable corrective actions before further flight. Repeat the inspections thereafter at intervals not to exceed 12,000 flight cycles.

    (h) Repair

    If any crack is found during any inspection required by this AD, and Boeing Alert Service Bulletin 767-53A0266, dated April 20, 2015, specifies to contact Boeing for repair instructions: Before further flight, repair the crack in accordance with the procedures specified in paragraph (j) of this AD. Accomplishing a repair terminates the inspections required by paragraph (g) of this AD in the area under the repair only.

    (i) Exceptions to the Service Information

    Where Boeing Alert Service Bulletin 767-53A0266, dated April 20, 2015, specifies a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specified time after the effective date of this AD.

    (j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (k)(1) of this AD. Information may be emailed to: [email protected]

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

    (3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.

    (4) Except as required by paragraph (h) of this AD: For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (j)(4)(i) and (j)(4)(ii) apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

    (ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

    (k) Related Information

    (1) For more information about this AD, contact Wayne Lockett, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6447; fax: 425-917-6590; email: [email protected]

    (2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet https://www.myboeingfleet.com. 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.

    Issued in Renton, Washington, on October 19, 2015. Jeffrey E. Duven, Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2015-27447 Filed 10-29-15; 8:45 am] BILLING CODE 4910-13-P
    SOCIAL SECURITY ADMINISTRATION 20 CFR Parts 404 and 416 [Docket No. SSA-2014-0081] RIN 0960-AH74 Vocational Factors of Age, Education, and Work Experience in the Adult Disability Determination Process; Extending of the Comment Period AGENCY:

    Social Security Administration.

    ACTION:

    Advance notice of proposed rulemaking; extension of the comment period.

    SUMMARY:

    On September 14, 2015, we published in the Federal Register an advanced notice of proposed rulemaking (ANPRM) regarding Vocational Factors of Age, Education, and Work Experience in the Adult Disability Determination Process and solicited public comments. We provided a 60-day comment period ending on November 13, 2015. We are extending the comment period to December 14, 2015. Our extension of the comment date accommodates and facilitates public comments we expect in response to the National Disability Forum we are sponsoring on Friday, November 20, 2015. During the forum, we are hosting a moderator-led discussion entitled: The Realities of Work for Individuals with Disabilities: Impact of Age, Education, and Work Experience (for information on the forum see the SUPPLEMENTARY INFORMATION section).

    DATES:

    The comment period for the advanced notice of proposed rulemaking published on September 14, 2015 (80 FR 55050), is extended. To ensure that your written comments are considered, we must receive them on or before December 14, 2015.

    ADDRESSES:

    You may submit comments by any one of three methods—Internet, fax, or mail. Do not submit the same comments multiple times or by more than one method. Regardless of which method you choose, please state that your comments refer to Docket No. SSA-SSA-2014-0081 so that we may associate your comments with the correct regulation.

    Caution: You should be careful to include in your comments only information that you wish to make publicly available. We strongly urge you not to include in your comments any personal information, such as Social Security numbers or medical information.

    1. Internet: We strongly recommend that you submit your comments via the Internet. Please visit the Federal eRulemaking portal at http://www.regulations.gov. Use the Search function to find docket number SSA-2014-0081. The system will issue a tracking number to confirm your submission. You will not be able to view your comment immediately because we must post each comment manually. It may take up to a week for your comment to be viewable.

    2. Fax: Fax comments to (410) 966-2830.

    3. Mail: Address your comments to the Office of Regulations and Reports Clearance, Social Security Administration, 3100 West High Rise, 6401 Security Boulevard, Baltimore, Maryland 21235-6401.

    Comments are available for public viewing on the Federal eRulemaking portal at http://www.regulations.gov or in person, during regular business hours, by arranging with the contact person identified below.

    FOR FURTHER INFORMATION CONTACT:

    Mary Quatroche, Office of Disability Policy, Social Security Administration, 6401 Security Boulevard, Baltimore, MD 21235-6401, (410) 966-4794. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or visit our Internet site, Social Security Online, at http://www.socialsecurity.gov.

    SUPPLEMENTARY INFORMATION:

    This document extends the comment period to Monday, December 14, 2015, for the advanced notice of proposed rulemaking that we published on September 14, 2015. We are extending the comment period in light of the comments we anticipate receiving from our National Disability Forum occurring on November 20, 2015, which includes a panel discussion on the topic of our vocational factors. If you have already provided comments on the proposed rules, we will consider your comments and you do not need to resubmit them.

    Social Security Administration—National Disability Forum Friday, November 20, 2015, 1:00 p.m.-3:00 p.m., National Education Association, 1201 16th Street NW., Washington, DC 20036 Speakers • Paul Van de Water—Center on Budget and Policy Priorities—Moderator • Kate Lang—Justice in Aging • Rebecca Vallas—Center for American Progress • Mark Warshawsky—Mercatus Center at George Mason University • Ross Eisenbrey—Economic Policy Institute • Kim Hildred—Hildred Consulting, LLC Carolyn W. Colvin, Acting Commissioner of Social Security.
    [FR Doc. 2015-27692 Filed 10-29-15; 8:45 am] BILLING CODE 4191-02-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 [Docket No. FDA-2014-D-1696] Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification; reopening of the comment period.

    SUMMARY:

    The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff,” published in the Federal Register of December 23, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.

    DATES:

    Submit either electronic or written comments on the draft guidance by April 29, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2014-D-1696 for “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening the Comment Period.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential”. Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    FOR FURTHER INFORMATION CONTACT:

    Lori J. Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION: I. Background

    In the Federal Register of December 23, 2014 (79 FR 77012), FDA announced the availability of a draft document entitled “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff” dated December 2014. The draft guidance document provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, health care providers, and FDA staff with recommendations for meeting the 21 CFR 1271.10(a)(1) criterion of minimal manipulation. Interested persons were originally given until February 23, 2015, to comment on the draft guidance.

    Elsewhere in this issue of the Federal Register, FDA is announcing four other related documents. In a separate document, FDA is announcing a public hearing entitled “Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments” (part 15 hearing) to be held on April 13, 2016, to provide stakeholders with the opportunity to discuss FDA's policy on regulation of HCT/Ps related to the four draft guidances on the following topics: Homologous use, same surgical procedure exception, minimal manipulation, and adipose tissue.

    In a separate document, FDA is announcing the availability of a draft document entitled “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.”

    In separate documents, FDA is also reopening the comment periods to FDA's public dockets on the previously issued draft guidance documents on the following topics related to HCT/Ps: Adipose tissue (Docket No. FDA-2014-D-1856) and same surgical procedure exception (Docket No. FDA-2014-D-1584).

    II. Reopening of Comment Period

    Following publication of December 23, 2014, notice of availability, FDA received a request to allow interested persons additional time to comment. In conjunction with the part 15 hearing and announcement of availability of the homologous use draft guidance, FDA is reopening the comment period to allow potential respondents to thoroughly evaluate and address pertinent issues. The minimal manipulation draft guidance and other related guidances (homologous use, same surgical procedure exception, adipose tissue) all deal with the interpretation of the regulations under 21 CFR part 1271 that will be addressed as part of the part 15 hearing.

    Dated: October 27, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-27705 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 [Docket No. FDA-2015-D-3719] Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of public hearing; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing a 1-day public hearing to obtain input on four recently issued draft guidances relating to the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps). These draft guidances were issued by FDA in response to stakeholders' requests for guidance on FDA's current views about how manufacturers, establishments, and distributors of HCT/Ps and health care professionals can meet the criteria under the Agency's regulations that apply to HCT/Ps. FDA will consider information it obtains from the public hearing in the finalization of these guidances.

    DATES:

    The public hearing will be held on April 13, 2016, from 8 a.m. to 5 p.m. The meeting may be extended or end early depending on the level of public participation. Persons seeking to attend or to present at the public hearing must register by January 8, 2016. Section IV provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until April 29, 2016.

    ADDRESSES:

    The public hearing will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public hearing participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/aboutfda/workingatfda/buildingsandfacilities/whiteoakcampusinformation/ucm241740.htm.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2015-D-3719 for “Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    A link to the live Webcast of this public hearing will be available at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm on the day of the public hearing. A video record of the public hearing will be available at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm. A video record of the public hearing will be available at the same Web site address for 1 year.

    FOR FURTHER INFORMATION CONTACT:

    Lori Jo Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    HCT/Ps are defined in § 1271.3(d) (21 CFR 1271.3(d)) as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. FDA has implemented a risk-based approach to the regulation of HCT/Ps. Under the authority of section 361 of the Public Health Service (PHS) Act (42 U.S.C. 264), FDA established regulations for all HCT/Ps to prevent the introduction, transmission, and spread of communicable diseases. These regulations can be found in part 1271. An HCT/P is regulated solely under section 361 of the PHS Act and part 1271, if it meets all of the following criteria (§ 1271.10(a)):

    • The HCT/P is minimally manipulated;

    • The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;

    • The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage does not raise new clinical safety concerns with respect to the HCT/P; and

    • Either

    ○ The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function, or

    ○ The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and is for the following uses:

    Autologous,

    Allogeneic, in a first-degree or second-degree blood relative, or

    Reproductive.

    If an HCT/P does not meet all of the criteria set forth under § 1271.10(a), the HCT/P will be regulated as a drug, device, and/or biological product under the Federal Food, Drug, and Cosmetic Act, and/or section 351 of the PHS Act (42 U.S.C. 262).

    In certain circumstances as provided in § 1271.15, an establishment that manufactures HCT/Ps may be excepted from the requirements in part 1271. For example, an establishment is excepted from the requirements if it “removes HCT/Ps from an individual and implants such HCT/Ps into the same individual during the same surgical procedure” (§ 1271.15(b)).

    II. Draft Guidances

    As part of its commitment to public outreach and to explain the Agency's current thinking on the regulatory framework for HCT/Ps, FDA has issued the following four draft guidances:

    • Same Surgical Procedure Exception under § 1271.15(b): Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry (Same Surgical Procedure Exception Draft Guidance);

    • Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff (Minimal Manipulation Draft Guidance);

    • Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry (Adipose Tissue Draft Guidance); and

    • Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff (Homologous Use Draft Guidance).

    The Same Surgical Procedure Exception Draft Guidance was published in the Federal Register of October 23, 2014 (79 FR 63348), and provides answers to common questions regarding the scope of the exception.

    The Minimal Manipulation Draft Guidance was published in the 03'Federal Register of December 23, 2014 (79 FR 77012), and provides recommendations for meeting the § 1271.10(a)(1) criterion of minimal manipulation.

    The Adipose Tissue Draft Guidance was published in the Federal Register of December 24, 2014 (79 FR 77414), and provides those who manufacture and use adipose tissue with recommendations for complying with the regulatory framework for HCT/Ps.

    Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the Homologous Use Draft Guidance which provides recommendations for applying the § 1271.10(a)(2) homologous use criterion, and is also announcing the reopening of the comment periods on the Same Surgical Procedure Exception, Minimal Manipulation, and Adipose Tissue Draft Guidances.

    III. Purpose and Scope of the Public Hearing

    The purpose of this public hearing is to obtain comments on these four draft guidances. FDA is seeking feedback, both general and specific, from a broad group of stakeholders, including HCT/P manufacturers, tissue establishments, biological and device product manufacturers, health care professionals, clinicians, biomedical researchers, and the public. For example, FDA would like comments on the scope of each guidance, including the particular topics covered, the particular questions posed, whether there are additional issues for which they seek guidance, and whether FDA's recommendations for each topic are sufficiently clear and consistent within and across documents to provide meaningful guidance to stakeholders. In addition, FDA welcomes any comments that will enhance the usefulness and clarity of these documents.

    FDA recommends that comments exclude discussion of products which do not meet the definition of an HCT/P, such as platelet rich plasma. FDA also recommends that stakeholders coordinate comments when possible in order to allow for presentation of a wide range of perspectives within the allotted time of the meeting.

    IV. Attendance and Registration

    The FDA Conference Center at the White Oak location is a Federal facility with security procedures and limited seating. Attendance is free and will be on a first-come, first-served basis. Individuals who wish to present at the public hearing must register by sending an email to [email protected] on or before January 8, 2016, and provide complete contact information, including name, title, affiliation, address, email, and phone number. Those without email access may register by contacting Sherri Revell or Loni Warren Henderson at 240-402-7800. You should identify each guidance you wish to comment on in your presentation so that FDA can consider that information in organizing the presentations. Individuals and organizations with common interests should consolidate or coordinate their presentations and request time for a joint presentation. FDA will do its best to accommodate requests to speak and will determine the amount of time allotted for each oral presentation, and the approximate time that each oral presentation is scheduled to begin. FDA will notify registered presenters of their scheduled times, and make available an agenda at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm on or before February 5, 2016. Once FDA notifies registered presenters of their scheduled times, presenters should submit an electronic copy of their presentation to [email protected] by March 11, 2016.

    If you need special accommodations because of a disability, please contact Sherri Revell or Loni Warren Henderson at 240-402-7800 at least 7 days before the meeting.

    A link to the live Web cast of this public hearing will be available at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm on the day of the public hearing. A video record of the public hearing will be available at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm following the meeting. A video record of the public hearing will be available at the same Web site address for 1 year.

    V. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The hearing will be conducted by a presiding officer, accompanied by FDA senior management from the Office of the Commissioner and the Center for Biologics Evaluation and Research.

    Under § 15.30(f), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (21 CFR part 10, subpart C). Under 21 CFR 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b) (see section VI). To the extent that the conditions for the hearing, as described in this document, conflict with any provisions set out in part 15, this document acts as a waiver of those provisions as specified in § 15.30(h).

    VI. Transcripts

    Please be advised that as soon as a transcript is available, it will be accessible at www.regulations.gov and http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm. It may be viewed at the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov.

    Dated: October 27, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-27703 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 [Docket No. FDA-2014-D-1584] Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Reopening of the Comment Period AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification; reopening of the comment period.

    SUMMARY:

    The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled “Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry” announced in the Federal Register of October 23, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.

    DATES:

    Submit either electronic or written comments on the draft guidance by April 29, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions”.

    Instructions: All submissions received must include the Docket No. FDA-2014-D-1584 for “Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions”, publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential”. Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    FOR FURTHER INFORMATION CONTACT:

    Lori J. Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION: I. Background

    In the Federal Register of October 23, 2014 (79 FR 63348), FDA announced the availability of a draft document entitled “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry” dated October 2014. The draft guidance is intended for tissue establishments and health care professionals and discusses one of the exceptions for establishments from certain regulatory requirements. Interested persons were originally given until December 22, 2014, to comment on the draft guidance.

    Elsewhere in this issue of the Federal Register, FDA is announcing four other related documents. In a separate document, FDA is announcing a public hearing entitled “Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments” (part 15 hearing) to be held on April 13, 2016, to provide stakeholders with the opportunity to discuss FDA's policy on regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) related to the four draft guidances on the following topics: Homologous use, same surgical procedure exception, minimal manipulation, and adipose tissue.

    In a separate document, FDA is announcing the availability of a draft document entitled “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.”

    In separate documents, FDA is also reopening the comment periods to FDA's public dockets on the previously issued draft guidance documents on the following topics related to HCT/Ps: Minimal manipulation (Docket No. FDA-2014-D-1696) and adipose tissue (Docket No. FDA-2014-D-1856).

    II. Reopening of Comment Period

    Following publication of the October 23, 2014, notice of availability, FDA received a request to allow interested persons additional time to comment. In conjunction with the part 15 hearing and announcement of availability of the homologous use draft guidance, FDA is reopening the comment period to allow potential respondents to thoroughly evaluate and address pertinent issues. The same surgical procedure exception draft guidance and other related guidances (homologous use, minimal manipulation, adipose tissue) all deal with the interpretation of the regulations under 21 CFR part 1271 that will be addressed as part of the part 15 hearing.

    Dated: October 27, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-27707 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 [Docket No. FDA-2014-D-1856] Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Reopening of the Comment Period AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification; reopening of the comment period.

    SUMMARY:

    The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry” published in the Federal Register of December 24, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.

    DATES:

    Submit either electronic or written comments on the draft guidance by April 29, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2014-D-1856 for “Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential”. Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    FOR FURTHER INFORMATION CONTACT:

    Lori J. Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION: I. Background

    In the Federal Register of December 24, 2014 (79 FR 77414), FDA announced the availability of a draft document entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry” dated December 2014. The draft guidance document provides sponsors, clinicians, and other establishments that manufacture and use adipose tissue, with recommendations for complying with the regulatory framework for human cells, tissues, and cellular and tissue-based products (HCT/Ps). For purposes of applying the HCT/P regulatory framework, FDA considers connective tissue, including adipose tissue, to be a structural tissue. Interested persons were originally given until February 23, 2015, to comment on the draft guidance.

    Elsewhere in this issue of the Federal Register, FDA is announcing four other related documents. In a separate document, FDA is announcing a public hearing entitled “Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments” (part 15 hearing) to be held on April 13, 2016, to provide stakeholders with the opportunity to discuss FDA's policy on regulation of HCT/Ps related to the four draft guidances on the following topics: Homologous use, same surgical procedure exception, minimal manipulation, and adipose tissue.

    In a separate document, FDA is announcing the availability of a draft document entitled “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.”

    In separate documents, FDA is also reopening the comment periods to FDA's public dockets on the previously issued draft guidance documents on the following topics related to HCT/Ps: Minimal manipulation (Docket No. FDA-2014-D-1696) and same surgical procedure exception (Docket No. FDA-2014-D-1584).

    II. Reopening of Comment Period

    Following publication of December 24, 2014, notice of availability, FDA received several requests to allow interested persons additional time to comment. In conjunction with the part 15 hearing and announcement of availability of the homologous use draft guidance, FDA is reopening the comment period to allow potential respondents to thoroughly evaluate and address pertinent issues. The adipose tissue draft guidance and other related guidances (homologous use, minimal manipulation, same surgical procedure exception) all deal with the interpretation of the regulations under 21 CFR part 1271 that will be addressed as part of the part 15 hearing.

    Dated: October 27, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-27706 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 [Docket No. FDA-2015-D-3581] Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.” The draft guidance document provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, health care providers, and FDA staff, with recommendations for applying the criterion of “homologous use” as it applies to HCT/Ps. The interpretation and application of the homologous use criterion and related definitions have been of considerable interest to industry stakeholders since they were first proposed during the Agency's rulemaking on HCT/Ps.

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 29, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2015-D-3581 for “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff; Availability.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, or to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring MD 20993-0002, or you may send an email request to the Office of Combination Products at [email protected] If you are submitting a written request, send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Lori Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or Angela Krueger, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301-796-6380; or Leigh Hayes, Office of Combination Products, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5125, Silver Spring, MD 20993-0002, 301-796-8938.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft document entitled “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.” The draft guidance document provides HCT/P manufacturers, health care providers, and FDA staff, with recommendations for applying the § 1271.10(a)(2) (21 CFR 1271.10(a)(2)) criterion of homologous use. This guidance will improve stakeholders' understanding of the definition of homologous use in § 1271.3(c), and how to apply the regulatory criterion in § 1271.10(a)(2) to their HCT/P.

    HCT/Ps are defined in § 1271.3(d) as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. FDA has implemented a risk-based approach to the regulation of HCT/Ps. Under the authority of section 361 of the Public Health Service (PHS) Act (42 U.S.C. 264), FDA established regulations under part 1271 for all HCT/Ps to prevent the introduction, transmission, and spread of communicable diseases. HCT/Ps are regulated solely under section 361 of the PHS Act and 21 CFR part 1271, if they meet the criteria provided under § 1271.10(a).

    If an HCT/P does not meet all of the criteria set out under § 1271.10(a), and does not meet one of the exceptions in § 1271.15, the HCT/P will be regulated as a drug, device, and/or biological product under the Federal Food, Drug, and Cosmetic Act, and/or section 351 of the PHS Act (42 U.S.C. 262).

    The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA's current thinking on “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirement of the applicable statutes and regulations.

    In a separate document published elsewhere in this issue of the Federal Register, FDA is announcing a public hearing entitled “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products; Public Hearing; Request for Comments” to be held on April 13, 2016, to provide stakeholders with the opportunity to discuss FDA's policy on regulation of HCT/Ps related to the four draft guidances on the following topics: Homologous use, same surgical procedure exception, minimal manipulation, and adipose tissue.

    In separate documents published elsewhere in this issue of the Federal Register, FDA is also reopening the comment periods to FDA's public dockets on the previously issued draft guidance documents on the following topics related to HCT/Ps: Minimal manipulation (Docket No. FDA-2014-D-1696), adipose tissue (Docket No. FDA-2014-D-1856), and same surgical procedure exception (Docket No. FDA-2014-D-1584).

    II. Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 1271 have been approved under OMB control number 0910-0543.

    III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm or http://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/default.htm or http://www.regulations.gov. Persons unable to download an electronic copy of the draft guidance entitled “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff” may send an email request to [email protected] to receive an electronic copy of the document.

    Dated: October 27, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-27704 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 300 [REG-121496-15] RIN 1545-BN02 Preparer Tax Identification Number (PTIN) User Fee Update AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Notice of proposed rulemaking by cross-reference to temporary regulations.

    SUMMARY:

    In the Rules and Regulations section of this issue of the Federal Register, the IRS is issuing temporary regulations that will amend regulations (TD 9503) relating to the imposition of certain user fees on tax return preparers. The temporary regulations reduce the amount of the user fee to apply for or renew a preparer tax identification number (PTIN). The text of the temporary regulations also serves as the text of these proposed regulations.

    DATES:

    Written or electronic comments and requests for a public hearing must be received by January 28, 2016.

    ADDRESSES:

    Send submissions to: CC:PA:LPD:PR (REG-121496-15), Room 5203, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG-121496-15), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC 20224 or sent electronically via the Federal eRulemaking Portal at http://www.regulations.gov (IRS REG-121496-15). The public hearing will be held in the Auditorium of the Internal Revenue Building, 1111 Constitution Avenue NW., Washington, DC

    FOR FURTHER INFORMATION CONTACT:

    Concerning the proposed regulations, Hollie M. Marx at (202) 317-6844; concerning cost methodology, Eva J. Williams at (202) 803-9728; concerning submission of comments and/or requests for a public hearing, Oluwafunmilayo Taylor, (202) 317-6901 (not toll-free numbers).

    SUPPLEMENTARY INFORMATION:

    Background and Explanation of Provisions

    Temporary regulations in the Rules and Regulations section of this issue of the Federal Register amend regulations under 26 CFR part 300 setting a user fee for individuals who apply for or renew a PTIN. The text of the temporary regulations also serves as the text of these proposed regulations. The preamble to the temporary regulations explains the temporary regulations and these proposed regulations.

    Special Analyses

    It has been determined that this notice of proposed rulemaking is not a significant regulatory action as defined in Executive Order 12866, as supplemented by Executive Order 13563.

    It has been determined that an initial regulatory flexibility analysis is required for this notice of proposed rulemaking under 5 U.S.C. 603. This analysis is set forth under the heading “Initial Regulatory Flexibility Analysis.”

    Pursuant to section 7805(f), this notice of proposed rulemaking has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

    Initial Regulatory Flexibility Analysis

    When an agency issues a rulemaking proposal, the Regulatory Flexibility Act (5 U.S.C. chapter 6) (RFA) requires the agency “to prepare and make available for public comment an initial regulatory flexibility analysis” that will “describe the impact of the proposed rule on small entities.” See 5 U.S.C. 603(a). Section 605 of the RFA provides an exception to this requirement if the agency certifies that the proposed rulemaking will not have a significant economic impact on a substantial number of small entities. A small entity is defined as a small business, small nonprofit organization, or small governmental jurisdiction. See 5 U.S.C. 601(3) through (6). The IRS and the Treasury Department conclude that the proposed rule, if promulgated, may have a significant economic impact on a substantial number of small entities. As a result, an initial regulatory flexibility analysis is required.

    Description of the Reasons Why Action by the Agency Is Being Considered

    The IRS and the Treasury Department implemented regulatory changes in 2010 that required any individual who prepares or who assists in preparing all or substantially all of a tax return or claim for refund for compensation to obtain a PTIN. Pursuant to the PTIN regulations, only those individuals who apply for and maintain a current PTIN may prepare tax returns and claims for refund for compensation. Because the ability to prepare tax returns and claims for refund for compensation is limited to individuals who have a PTIN, the provision of a PTIN confers a special benefit. The IRS incurs costs associated with processing a PTIN application and providing the special benefit associated with the PTIN. The IRS and Treasury Department initially determined that the full cost of providing the special benefit conferred by a PTIN was $50 for each original application and each annual renewal. In accordance with OMB Circular A-25, the IRS and Treasury conducted a biennial review of the PTIN user fee amount in 2015 and determined that the full cost of providing the special benefit conferred by a PTIN had been reduced to $33 for each original application and each annual renewal.

    A Succinct Statement of the Objectives of, and Legal Basis for, the Proposed Rule

    The objective of the proposed regulations is to recover the costs to the government associated with providing the special benefit that an individual receives upon applying for or renewing a PTIN. These costs include activities, processes, and procedures related to the electronic and paper registration and renewal submissions; tax compliance and background checks; professional designation checks; foreign preparer processing; compliance and complaint activities; information technology and contract-related expenses; and communications. The PTIN user fee also takes into account various indirect program costs, including management and support costs. OMB Circular A-25 encourages user fees when special benefits are conferred on identifiable recipients. Individuals who obtain a PTIN receive the ability to prepare or assist in preparing all or substantially all of a tax return or claim for refund for compensation. The ability to prepare or assist in preparing all or substantially all of a tax return or claim for refund for compensation is a special benefit.

    The legal basis for the PTIN user fee is contained in section 9701 of title 31.

    A Description of and, Where Feasible, an Estimate of the Number of Small Entities to Which the Proposed Rule Will Apply

    The proposed regulations affect all individuals who prepare or assist in preparing all or substantially all of a tax return or claim for refund for compensation. Only individuals, not businesses, can apply for or renew a PTIN. Thus, the economic impact of these regulations on any small entity generally will be a result of an individual tax return preparer who is required to apply for or renew a PTIN owning a small business or a small business otherwise employing an individual tax return preparer who is required to apply for or renew a PTIN.

    The appropriate NAICS codes for PTINs are those that relate to tax preparation services (NAICS code 541213), offices of certified public accountants (NAICS code 541211), other accounting services (NAICS code 541219), and offices of lawyers (NAICS code 541110). Entities identified as tax preparation services, offices of certified public accountants, and other accounting services are considered small under the Small Business Administration size standards (13 CFR 121.201) if their annual revenue is less than $20.5 million. Entities identified as offices of lawyers are considered small under the Small Business Administration size standards if their annual revenue is less than $11 million. The IRS estimates that approximately 70 to 80 percent of the individuals subject to these proposed regulations are tax return preparers operating as or employed by small entities.

    A Description of the Projected Reporting, Recordkeeping and Other Compliance Requirements of the Proposed Rule, Including an Estimate of the Classes of Small Entities Which Will be Subject to the Requirement and the Type of Professional Skills Necessary for Preparation of the Report or Record

    No reporting or recordkeeping requirements are projected to be associated with this proposed regulation.

    An Identification, to the Extent Practicable, of all Relevant Federal Rules Which May Duplicate, Overlap, or Conflict With the Proposed Rule

    The IRS is not aware of any Federal rules that duplicate, overlap, or conflict with the proposed rule.

    A Description of Any Significant Alternatives to the Proposed Rule Which Accomplish the Stated Objectives of Applicable Statutes and Which Minimize Any Significant Economic Impact of the Proposed Rule on Small Entities

    The IOAA authorizes the charging of user fees for agency services, subject to policies designated by the President. OMB Circular A-25 implements presidential policies regarding user fees and encourages user fees when a government agency provides a special benefit to a member of the public. In the IOAA, Congress has stated a preference that special benefits be self-sustaining.

    A PTIN is required for an individual to prepare or assist in preparing all or substantially all of a tax return or claim for refund for compensation. PTINs are used by the IRS to collect and track data on tax return preparers. This data allows the IRS to track the number of persons who prepare or assist in preparing returns and claims for refund, the qualifications of those persons who prepare or assist in preparing returns and claims for refund, the number of returns each person prepares, and, when instances of misconduct or potential misconduct are detected, locate and review returns and claims for refund prepared by a specific tax return preparer. PTINs must be renewed annually to ensure that the identifying information associated with a PTIN is current.

    Due to the costs to the government to process the application for a PTIN, the requirement to include a PTIN on tax returns and claims for refund, and the expressed preference in the IOAA that special benefits be self-sustaining, there is no viable alternative to imposing a user fee.

    Comments and Public Hearing

    Before these proposed regulations are adopted as final regulations, consideration will be given to any written (a signed original and eight (8) copies) or electronic comments that are submitted timely to the IRS. The IRS and Treasury Department request comments on all aspects of these proposed regulations. All comments that are submitted by the public will be made available for public inspection and copying. A public hearing will be scheduled if requested in writing by any person who timely submits written comments. If a public hearing is scheduled, notice of the date, time, and place for the public hearing will be published in the Federal Register.

    Drafting Information

    The principal author of these regulations is Hollie M. Marx, Office of the Associate Chief Counsel (Procedure and Administration).

    List of Subjects in 26 CFR Part 300

    Reporting and recordkeeping requirements, User fees.

    Proposed Amendments to the Regulations

    Accordingly, 26 CFR part 300 is proposed to be amended as follows:

    Paragraph 1. The authority citation for part 300 continues to read as follows: Authority:

    31 U.S.C. 9701.

    Par. 2. Section 300.13 is amended by revising paragraphs (b) and (d) to read as follows:
    § 300.13 Fee for obtaining a preparer tax identification number.

    (b) [The text of proposed § 300.13(b) is the same as the text of § 300.13T(b) published elsewhere in this issue of the Federal Register ].

    (d) [The text of proposed § 300.13(d) is the same as the text of § 300.13T(d) published elsewhere in this issue of the Federal Register ].

    Karen M. Schiller, Acting Deputy Commissioner for Services and Enforcement.
    [FR Doc. 2015-27791 Filed 10-29-15; 8:45 am] BILLING CODE 4830-01-P
    EQUAL EMPLOYMENT OPPORTUNITY COMMISSION 29 CFR Part 1635 RIN 3046-AB02 Genetic Information Nondiscrimination Act of 2008 AGENCY:

    Equal Employment Opportunity Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Equal Employment Opportunity Commission (“EEOC” or “Commission”) is issuing a proposed rule that would amend the regulations implementing Title II of the Genetic Information Nondiscrimination Act of 2008 as they relate to employer wellness programs. The proposed regulations address the extent to which an employer may offer an employee inducements for the employee's spouse who is also a participant in the employer's health plan to provide information about the spouse's current or past health status as part of a health risk assessment administered in connection with the employer's offer of health services as part of an employer-sponsored wellness program. Several technical changes to the existing regulation are also proposed.

    DATES:

    Comments regarding this proposal must be received by the Commission on or before December 29, 2015. Please see the section below entitled ADDRESSES and SUPPLEMENTARY INFORMATION for additional information on submitting comments.

    ADDRESSES:

    You may submit comments, identified by RIN number 3046-AB02, by any of the following methods:

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

    FAX: (202) 663-4114. (There is no toll free FAX number). Only comments of six or fewer pages will be accepted via FAX transmittal, in order to assure access to the equipment. Receipt of FAX transmittals will not be acknowledged, except that the sender may request confirmation of receipt by calling the Executive Secretariat staff at (202) 663-4070 (voice) or (202) 663-4074 (TTY). (These are not toll free numbers).

    Mail: Bernadette Wilson, Acting Executive Officer, Executive Secretariat, Equal Employment Opportunity Commission, U.S. Equal Employment Opportunity Commission, 131 M Street NE., Washington, DC 20507.

    Hand Delivery/Courier: Bernadette Wilson, Acting Executive Officer, Executive Secretariat, Equal Employment Opportunity Commission, U.S. Equal Employment Opportunity Commission, 131 M Street NE., Washington, DC 20507.

    Instructions: The Commission invites comments from all interested parties. All comment submissions must include the agency name and docket number or the Regulatory Information Number (RIN) for this rulemaking. Comments need be submitted in only one of the above-listed formats. All comments received will be posted without change to http://www.regulations.gov, including any personal information you provide.

    Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov. Copies of the received comments also will be available for review at the Commission's library, 131 M Street NE., Suite 4NW08R, Washington, DC 20507, between the hours of 9:30 a.m. and 5:00 p.m., from December 29, 2015 until the Commission publishes the rule in final form.

    FOR FURTHER INFORMATION CONTACT:

    Christopher J. Kuczynski, Assistant Legal Counsel, at (202) 663-4665 (voice), or Kerry E. Leibig, Senior Attorney Advisor, at (202) 663-4516 (voice), or (202) 663-7026 (TTY). Requests for this notice in an alternative format should be made to the Office of Communications and Legislative Affairs at (202) 663-4191 (voice) or (202) 663-4494 (TTY).

    SUPPLEMENTARY INFORMATION:

    Introduction

    Congress enacted Title II of the Genetic Information Nondiscrimination Act of 2008 (“GINA”), codified at 42 U.S.C. 2000ff et seq., to protect job applicants, current and former employees, labor union members, and apprentices and trainees from employment discrimination based on their genetic information. In enacting GINA, Congress noted, “New knowledge about genetics may allow for the development of better therapies that are more effective against disease or have fewer side effects than current treatments. These advances give rise to the potential misuse of genetic information to discriminate in health insurance and employment.” See GINA Section 2(1), 42 U.S.C. 2000ff, note. Congress also expressed concerns about common misconceptions that an individual's genetic predisposition for a condition necessarily leads to the individuals developing the condition, explaining that

    [a]n employer might use information about an employee's genetic profile to deny employment to an individual who is healthy and able to perform the job. With these misconceptions so prevalent, employers may come to rely on genetic testing to “weed out” those employees who carry genes associated with diseases. Similarly, genetic traits may come to be used by health insurance companies to deny coverage to those who are seen as “bad genetic risks.” Enabling employers, health insurers and others to base decisions about individuals on the characteristics that are assumed to be their genetic destiny would be an undesirable outcome of our national investment in genetic research, and may significantly diminish the benefits that this research offers.1

    1 H. Rep. 110-28, Part 1, 28 (Mar. 5, 2007).

    Congress enacted GINA to address concerns prevalent at the time that individuals would not take advantage of the increasing number of genetic tests that could inform them as to whether they were at risk of developing specific diseases or disorders due to fear that genetic information would be used to deny health coverage or employment.2 Consequently, GINA restricts acquisition and disclosure of genetic information, and includes an absolute prohibition on the use of genetic information in making employment decisions.3 The EEOC issued implementing regulations on November 9, 2010, to provide all persons subject to Title II of GINA additional guidance with regard to the law's requirements. See 75 FR 68912 (Nov. 9, 2010).

    2See, e.g., S. Rep. No. 110-48, at 7 (2007) (noting that “a 2004 poll taken by the Genetics and Public Policy Center at Johns Hopkins University found that 92 percent of those surveyed felt that employers should not have access to genetic test results” and that “[f]ears about the possible misuse of genetic knowledge appear to influence the public's desire to protect the privacy of genetic information”); see also id. at 10 (“While people fear discriminatory action based on their genes, they also fear the unauthorized disclosure or collection of genetic information. The need to protect the privacy of genetic information is important. Knowledge that a person has a particular medical condition or genetic trait may be embarrassing or damaging to that individual, or his or her family members.”).

    3 S. Rep. No. 110-48, at 10 (2007); H.R. Rep. No. 110-28, pt. 3, at 29.

    Title II of GINA prohibits the use of genetic information in employment; restricts employers and other entities covered by GINA 4 from requesting, requiring, or purchasing genetic information, unless one or more of six narrow exceptions applies; and strictly limits the disclosure of genetic information by GINA covered entities. See 42 U.S.C. 2000ff et seq.; see also 29 CFR 1635.4-1635.9. The statute and the Title II final rule say that “genetic information” includes: Information about an individual's genetic tests; information about the genetic tests of a family member; information about the manifestation of a disease or disorder in family members of an individual (i.e., family medical history); 5 requests for and receipt of genetic services by an individual or a family member; and genetic information about a fetus carried by an individual or family member or of an embryo legally held by the individual or family member using assisted reproductive technology. See 42 U.S.C. 2000ff(4) and 2000ff-8(b); see also 29 CFR 1635.3. Family members of an individual include someone who is a dependent of an individual through marriage, birth, adoption, or placement for adoption and any other individual who is a first-, second-, third-, or fourth-degree relative of the individual. See 42 U.S.C. 2000ff(3)(A) (defining family member for purposes of GINA to include a dependent within the meaning of section 701(f)(2) of the Employee Retirement Income Security Act (ERISA)); see also 29 CFR 1635.3(a).6

    4 Unless otherwise noted, the term “GINA” refers to Title II of GINA.

    5 Congress recognized “that a family medical history could be used as a surrogate for genetic traits by a health plan or health insurance issuer. A consistent history of a heritable disease in a patient's family may be viewed to indicate that the patient himself or herself is at increased risk for that disease.” For that reason, Congress believed it was important to include family medical history in the definition of “genetic information.” S. Rep. No. 110-48, at 28 (2007).

    6 The Commission's definition of “dependent” is solely for purposes of interpreting Title II of GINA, and is not relevant to interpreting the term “dependent” under Title I of GINA or under section 701(f)(2) of ERISA and the parallel provisions of the Public Health Service Act (PHSA) and the Internal Revenue Code (Code). See the preamble to EEOC's regulations implementing Title II of GINA at 75 FR 68914, note 5 (November 9, 2010) and the preamble to the regulations implementing Title I of GINA at 74 FR 51664, 51666 (October 7, 2009) for additional information.

    Although similar to Title I of the Americans with Disabilities Act (ADA) in that both laws are concerned with limiting the use, acquisition, and disclosure of medical information in the employment setting, GINA, consistent with Congressional concern about the uniquely personal nature of genetic information, provides unique protections. Unlike the ADA, which allows employers to consider medical information in certain limited circumstances (such as using information from a post-offer medical examination to determine an applicant's current ability to perform a job), GINA prohibits employers from using genetic information in employment decisions in all circumstances, with no exceptions.7 GINA also is stricter in its limits of the acquisition of protected information than the ADA. For example, even though the ADA allows an employer to require a medical examination of all employees to whom it has offered a particular job, GINA limits the scope of medical examinations for employees who have been offered a particular job insofar as it prohibits inquiries about family medical history or other types of genetic information. GINA likewise prohibits employers from obtaining family medical history or any other type of genetic information through any medical examination required of employees for the purpose of determining continued fitness for duty.

    7 Sec. 202(a) of Title II of GINA limits employer use of genetic information. Employers cannot “fail or refuse to hire, or to discharge, any employee, or otherwise discriminate against any employee with respect to the compensation, terms, conditions, or privileges of employment” or otherwise “limit, segregate, or classify the employees” in any way that would tend to deprive the employee of employment opportunities based on genetic information. Section 202(a) provides no exceptions to prohibitions on employer use.

    There are only six very limited circumstances in which an employer 8 may request, require, or purchase genetic information about an applicant or employee. One of the six narrow exceptions to GINA's acquisition prohibition permits employers that offer health or genetic services, including such services offered as part of voluntary wellness programs,9 to request genetic information as part of these programs, as long as certain specific requirements are met.10 See 42 U.S.C. 2000ff-1(b)(2), 2000ff-2(b)(2), 2000ff-3(b)(2), 2000ff-4(b)(2); see also 29 CFR 1635.8(b)(2). The regulations implementing Title II currently make clear that one of the requirements is that the wellness program cannot condition inducements to employees on the provision of genetic information. This requirement is derived from Title I of GINA's explicit prohibition against adjusting premium or contribution amounts on the basis of genetic information.11

    8 GINA applies to individuals and covered entities in addition to employees and employers, including employment agencies, unions and their members, and joint-labor management training and apprenticeship programs. See 42 U.S.C. 2000ff-1, 2000ff-2, 2000ff-3 and 2000ff-4 (describing the prohibited practices of each of these entities); see also 29 CFR 1635.2(b) (definition of covered entity) and 29 CFR 1635.4 (description of prohibited practices). For the sake of readability, and recognizing that employers will be the covered entity most likely to offer wellness programs, the NPRM will refer to employers and employees throughout.

    9 A wellness program, defined as a “program offered by an employer that is designed to promote health or prevent disease,” is one type of health or genetic service that an employer might offer. Section 2705(j)(1)(A) of the PHSA, as amended by the Affordable Care Act. A wellness program that provides medical care (including genetic counseling) may constitute a group health plan required to comply with section 9802 of the Code, 26 U.S.C. 9802, section 702 of the ERISA, 29 U.S.C. 1182, or section 2705 of the PHSA (i.e., Title I of GINA). Regulations issued under these statutes address wellness programs that collect genetic information. Moreover, wellness programs that condition rewards on an individual satisfying a standard related to a health factor must meet additional requirements. See 26 CFR 54.9802-1(f), 29 CFR 2590.702(f), and 45 CFR 146.121(f). In addition, EEOC has issued proposed rules that would amend the regulations and interpretive guidance implementing Title I of the ADA as they relate to employer wellness programs. See 80 FR 21659 (April 20, 2015).

    10 Other health or genetic services include services such as an Employee Assistance Program or a health clinic that provides flu shots. Under GINA, employers may request genetic information as part of such health or genetic services, as long as the requirements of 29 CFR 1635.8(b)(2) are met.

    11 Title I of GINA applies to genetic information discrimination in health insurance and not employment. In the Commission's original GINA Title II regulation, the Commission, in consultation with the federal agencies responsible for enforcing Title I, determined that permitting employers to condition wellness program inducements on the provision of genetic information would undermine Title I's prohibition on adjusting premium or contribution amounts on the basis of genetic information. For more on the protections provided by Title I of GINA, see www.dol.gov/ebsa/faqs/faq-GINA.html. For a discussion of how Titles I and II of GINA allow employers and plans to use financial inducements to promote employee wellness and healthy lifestyles, see the preamble to the GINA Title II final rule at 75 FR 68923 (November 9, 2010).

    Although the EEOC received no comments prior to the publication of the Title II final rule in 2010 regarding how GINA's restriction on employers' acquiring genetic information interacts with the practice of offering employees inducements where a spouse participates in a wellness program, this question has arisen since publication of the final rule. The EEOC has received numerous inquiries about whether an employer will violate GINA and, in particular, 29 CFR 1635.8(b)(2), by offering an employee an inducement if the employee's spouse who is covered under the employer's group health plan 12 completes a health risk assessment (HRA)—including those involving a medical questionnaire, a medical examination (e.g., to detect high blood pressure or high cholesterol), or both—that seeks information about the spouse's current or past health status, in connection with the spouse's receipt of health or genetic services as part of an employer-sponsored wellness program. See, e.g., Letter from the ERISA Industry Committee to EEOC (February 17, 2012) available at http://www.eeoc.gov/eeoc/meetings/5-8-13/moore.cfm (attachment to written testimony). Online reports have raised the same concern. See, e.g., Tower Watson, Health Care Reform Bulletin (Oct. 2011) available at http://www.towerswatson.com/en/Insights/Newsletters/Americas/health-care-reform-bulletin/2011/Providing-Financial-Incentives-for-an-Employees-Spouse-to-Complete-a-Health-Risk-Assessment. Two panelists also raised this question during a May 2013 Commission meeting on Wellness Programs. See Written Testimony of Leslie Silverman available at http://www.eeoc.gov/eeoc/meetings/5-8-13/silverman.cfm and Written Testimony of Amy Moore available at http://www.eeoc.gov/eeoc/meetings/5-8-13/moore.cfm.

    12 The term “group health plan” includes both insured and self-insured group health plans and is used interchangeably with the terms “health plan” and “the plan” in this NPRM.

    Read in one way, conditioning all or part of an inducement on the provision of the spouse's current or past health information could be read to violate the 29 CFR 1635.8(b)(2)(ii) prohibition on providing financial inducements in return for an employee's protected genetic information. When an employer seeks information from a spouse (who is a “family member” under GINA as set forth at 29 CFR 1635.3(a)(1)) about his or her current or past health status, the employer is also treated under GINA as requesting genetic information about the employee. This is because GINA defines the term “genetic information” of an employee broadly to include information about a family member's (including a spouse's) current or past health status.13 However, the EEOC's regulations specifically permit employers to seek such information from a family member who is receiving health or genetic services from the employer, including such services offered as part of a voluntary wellness program, as long as each of the requirements of 29 CFR 1635.8(b)(2)(i) concerning health or genetic services provided on a voluntary basis are met. See 29 CFR 1635.8(c)(2).

    13 The term “genetic information” includes “the manifestation of a disease or disorder in family members of [an] individual.” 42 U.S.C. 2000ff(4)(a)(ii). An individual's family members include anyone who is “a dependent (as such term is used for purposes of section 1181(f)(2) of Title 29), which includes a spouse. 42 U.S.C. 2000ff(3)(a). See also 29 CFR 1635.3(a)(1) (defining “family member” to include “[a] person who is a dependent . . . as the result of marriage . . .”).

    The proposed regulations would clarify that GINA does not prohibit employers from offering limited inducements (whether in the form of rewards or penalties avoided 14 ) for the provision by spouses (covered by the employer's group health plan) of information about their current or past health status as part of a HRA, which may include a medical questionnaire, a medical examination (e.g., to detect high blood pressure or high cholesterol), or both, as long as the requirements of 29 CFR 1635.8(b)(2)(i) are satisfied. These requirements include that the provision of genetic information be voluntary and that the individual from whom the genetic information is being obtained provides prior, knowing, voluntary, and written authorization, which may include authorization in electronic format.15

    14 Under the PHSA, as amended by the Affordable Care Act, when a wellness program offers a reward, the term refers both to obtaining a reward (such as a discount or rebate of a premium or contribution, a waiver of all or part of a cost-sharing mechanism, an additional benefit, or any financial or other incentive) and avoiding a penalty (such as the absence of a premium surcharge or other financial or nonfinancial disincentive). See 26 CFR 54.9802-1(f)(1)(i), 29 CFR 2590.702(f)(1)(i), and 45 CFR 146.121(f)(1)(i). We have adopted this definition.

    15 The GINA notice and authorization requirement, which was included in the EEOC's regulations pursuant to a specific statutory requirement, see 42 U.S.C. 2000ff-(1)(b)(2)(B), is only met if the covered entity uses an authorization form that (1) is written so that the individual from whom the genetic information is being obtained is reasonably likely to understand it; (2) describes the type of genetic information that will be obtained and the general purpose for which it will be used; and (3) describes the restrictions on disclosure of genetic information. The GINA notice and authorization rule also requires that individually identifiable genetic information is provided only to the individual (or family member if the family member is receiving genetic services) and the licensed health care professionals or board certified genetic counselors involved in providing such services, and is not accessible to managers, supervisors, or others who make employment decisions, or to anyone else in the workplace; and, finally, that any individually identifiable genetic information provided under 29 CFR 1635.8(b)(2) is only available for purposes of such services and is not disclosed to the covered entity except in aggregate terms that do not disclose the identity of specific individuals. See 29 CFR 1635.8(b)(2)(i). When an employer requests only current or past health status information from the employee's spouse, authorization by the spouse for the acquisition of the information will suffice to meet GINA's requirement; the employee does not have to separately authorize acquisition of the spouse's current or past health status information. See 29 CFR 1635.8(b)(2)(i)(B).

    The ADA does not have the same statutory requirement for authorization as is in GINA. In light of this statutory difference, the NPRM on the ADA and wellness programs published by the Commission on April 20, 2015 would require a notice to employees in connection with such a HRA where a wellness program is part of a group health plan. The notice must clearly explain what medical information will be obtained, how it will be used, who will receive it, and the restrictions on disclosure. See 80 FR 21659 (April 20, 2015). The ADA proposed rule did not include an authorization requirement, although EEOC asked in the preamble whether one should be part of the final rule. The ADA proposed rule cannot alter the statutory authorization requirements under GINA.

    The Commission further proposes to add to the existing 1635.8(b)(2) requirements a requirement that any health or genetic services in connection with which an employer requests genetic information be reasonably designed to promote health or prevent disease. This addition will make the revised GINA regulations consistent with the proposed rule amending the ADA's regulations as they relate to wellness programs, which permits employers to collect medical information as part of a wellness program only if the program and the disability-related inquiries and medical examinations that are part of the program are reasonably designed to promote health or prevent disease.

    These regulations further propose that inducements in exchange for current or past health status information about an employee's children (biological and non-biological 16 ) are not permitted, although an employer may offer health or genetic services (including participation in a wellness program) to an employee's children on a voluntary basis and may ask questions about a child's current or past health status as part of providing such services. Although information about the manifestation of disease or disorder in spouses or children is genetic information protected by GINA, adopting a very narrow exception that permits inducements only for a spouse's current or past health status strikes the appropriate balance between GINA's goal of providing strong protections against employment discrimination based on the possibility that an employee may develop a disease or disorder in the future or may face discrimination because a family member is expected to become ill in the future, and the goal of the wellness program provisions of the Health Insurance Portability and Accountability Act (“HIPAA”), as amended by the Affordable Care Act, of promoting participation in employer-sponsored wellness programs. There is minimal, if any, chance of eliciting information about an employee's own genetic make-up or predisposition for disease from the information about current or past health status of the employee's spouse. By contrast, there is a significantly higher likelihood of eliciting information about an employee's own genetic make-up or predisposition for disease from information about the current or past health status of the employee's children, which is why the proposed revision does not permit inducements in exchange for such information. Further, the legislative history makes clear that Congress was particularly concerned about allowing employers access to information revealing the possible genetic conditions of employees' children.17

    16 GINA defines information about the manifestation of a disease or disorder in an employee's adopted child to be genetic information about the employee. See 29 CFR 1635.3(c)(1)(ii) (genetic information includes information about the “manifestation of disease or disorder in family members of the individual”) and 1635.3(a)(1) (a family member includes anyone who is a dependent “as the result of marriage, birth, adoption or placement for adoption). Family members also include first- through fourth-degree relatives of an individual or of the individual's dependents. 29 CFR 1635.3(a)(2). Thus, information about the manifested disease or disorder of a stepchild—the first-degree relative of an employee's spouse—is genetic information about the employee.

    17 GINA's legislative history recognized “that a family medical history could be used as a surrogate for [an employee's] genetic traits, [and that] a consistent history of a heritable disease in a patient's family may be viewed to indicate that the patient himself or herself is at increased risk for that disease.” S. Rep. No. 110-48, at 28 (2007). See, e.g., Statement of Sen. Edward M. Kennedy, GINA's principal sponsor in the Senate, 154 Cong. Rec. S3363, S337 (Apr. 28, 2008) (noting concerns of mother who paid out of pocket for anonymous genetic testing because she feared that the results would be used to discriminate against her daughters); Statement of Senator Christopher Dodd, 154 Cong. Rec. S3363, S3369-70 (Apr. 28, 2008) (“Many people are also afraid of affecting their children's ability to get jobs or obtain insurance. So without adequate protections against discrimination, people may forgo genetic testing, even in cases where the results have the potential to save their lives or the lives of their family.”); Statement of Sen. Brownback, id. (“Genetic discrimination against anyone is unacceptable, particularly those who are next generation, our children.”); Statement of Sen. Olympia Snowe (noting constituent's fears that having the BRAC test “would ruin her daughter's ability to obtain insurance in the future.”) id. at S3367.

    Furthermore, while the proposal allows inducements in return for a spouse's current and past health status, it does not allow inducements in return for the spouse providing his or her own genetic information, including the results of his or her genetic tests. Limiting inducements in this way not only promotes consistency with Title I of GINA, which prohibits inducements in return for the genetic information of a spouse who is a plan participant, but also ensures that the exception to the prohibition on inducements in return for genetic information is drawn narrowly.18 See 42 U.S.C. 300gg-4(b)(3)(A). Additionally, this approach has the advantage of reducing administrative burdens on employers by allowing them to use the same HRA—with questions about family medical history and other genetic information clearly identified and a statement that these questions need not be answered in order to receive an inducement—for employees and their spouses.

    18See John Hancock Mut. Life Ins. Co. v. Harris Trust & Sav. Bank, 510 U.S. 86, 97 (1993) (“[W]e [are] inclined, generally, to tight reading of exemptions from comprehensive [statutory] schemes.”) citing Commissioner v. Clark, 489 U.S. 726, 739-40 (1989) (when a general policy is qualified by an exception, the Court “usually read[s] the exception narrowly in order to the preserve the primary operation of the [policy]”), and A.H. Phillips, Inc. v. Walling, 324 U.S. 490, 493 (1945).

    This proposal would not alter the absolute prohibition against the use of genetic information in making employment decisions. Were an employer to use information about a spouse's current or past health status to make an employment decision about an employee, it would violate GINA's prohibition on using genetic information.19 Nor would the proposal permit inducements in return for genetic information of an employee in any circumstance other than where an employee's spouse who is enrolled in the employer's group health plan provides information about his or her current or past health as part of a HRA. Inducements in return for information about the current or past health of an employee's children, or in exchange for inquiries directed to an employee about the employee's family medical history or other genetic information, for example, are still prohibited.

    19 If the information about the spouse disclosed a disability, the employer would also violate the ADA's prohibition on discrimination based on association with someone with a disability. See 42 U.S.C. 12112(b)(4).

    The revisions also prohibit conditioning participation in a wellness program or any inducement on an individual, or an individual's spouse or family member, waiving GINA's confidentiality provisions.

    Summary of the Proposed Regulation Revisions to the Wellness Program Exception

    The EEOC proposes to make six substantive changes to its GINA regulations. First, we propose to add a new subsection to 29 CFR 1635.8(b)(2), to be numbered 1635.8(b)(2)(i)(A). It would explain that employers may request, require, or purchase genetic information as part of health or genetic services only when those services, including any acquisition of genetic information that is part of those services, are reasonably designed to promote health or prevent disease. In order to meet this standard, the program must have a reasonable chance of improving the health of, or preventing disease in, participating individuals, and must not be overly burdensome, a subterfuge for violating Title II of GINA or other laws prohibiting employment discrimination, or highly suspect in the method chosen to promote health or prevent disease. Collecting information on a health questionnaire without providing follow-up information or advice would not be reasonably designed to promote health or prevent disease. Additionally, a program is not reasonably designed to promote health or prevent disease if it imposes, as a condition of obtaining a reward, an overly burdensome amount of time for participation, requires unreasonably intrusive procedures, or places significant costs related to medical examinations on employees. A program is also not reasonably designed if it exists merely to shift costs from the covered entity to targeted employees based on their health.

    Second, we propose to add a subsection to 29 CFR 1635.8(b)(2), to be numbered 1635.8(b)(2)(iii). It would explain that, consistent with the requirements of paragraphs (b)(2)(i) and (b)(2)(ii), a covered entity may offer, as part of its health plan, an inducement to an employee whose spouse (1) is covered under the employee's health plan; (2) receives health or genetic services offered by the employer, including as part of a wellness program; and (3) provides information about his or her current or past health status as part of a HRA. No inducement may be offered, however, in return for the spouse providing his or her own genetic information, including results of his or her genetic tests.20

    20 29 CFR 1635.8(b)(2)(i)(B). Title I of GINA specifically prohibits a group health plan and a health insurance issuer in the group or individual market from collecting (including requesting, requiring or purchasing) genetic information prior to or in connection with enrollment in a group health plan or for underwriting purposes. See 26 CFR 54.9802-3T(b) and (d); 29 CFR 2590.702-1(b) and (d)); 45 CFR 146.122(b) and (d). “Underwriting purposes” includes rules for eligibility for benefits and the computation of premium or contribution amounts under the plan or coverage including any discounts, rebates, payments in kind, or other premium differential mechanisms in return for activities such as completing a HRA or participating in a wellness program. See 26 CFR 54.9802-3T(d)(1)(ii); 29 CFR 2590.702-1(d)(1)(ii); 45 CFR 146.122(d)(1)(ii). Consequently, wellness programs that provide rewards for completing HRAs that request a plan participant's genetic information, including family medical history, violate the prohibition against requesting genetic information for underwriting purposes, regardless of whether the plan participant provides authorization. Under Title I of GINA a group health plan and a health insurance issuer in the group or individual market may request genetic information through an HRA as long as the request is not in connection with enrollment and no rewards are provided.

    The HRA, which may include a medical questionnaire, a medical examination (e.g., to detect high blood pressure or high cholesterol), or both, must otherwise comply with paragraph (b)(2)(i) in the same manner as if completed by the employee, including the requirement that the spouse provide prior knowing, voluntary, and written authorization when the spouse is providing his or her own genetic information,21 and the requirement that the authorization form describe the confidentiality protections and restrictions on the disclosure of genetic information. The employer also must obtain authorization from the spouse when collecting information about the spouse's past or current health status, though a separate authorization for the acquisition of this information from the employee is not necessary.

    21 42 U.S.C. 2000ff-1(b)(2)(B) states that the “employee” must provide prior, knowing, voluntary, and written authorization. EEOC regulations implementing Title II of GINA, by contrast, use the broader term “individual” when describing the prior, knowing, voluntary and written authorization requirement. See 29 CFR 1635.8(b)(2)(i)(B). The Commission believes that “individual” best reflects the intent of Congress, especially when considering the provisions in 42 U.S.C. 2000ff-1(b), which prohibit employers from requesting, requiring, or purchasing genetic information about both employees and their family members with limited exceptions, and the general purpose of the statute.

    The total inducement to the employee and spouse may not exceed 30 percent of the total annual cost of coverage for the plan in which the employee and any dependents are enrolled. The 30 percent limit includes any inducement for a spouse's current or past health status information and any other inducements to the employee, as permitted under Title I of the ADA, for the employee's participation in a wellness program that asks disability-related questions or includes medical examinations. Thus, for example, if an employer offers health insurance coverage at a total cost (taking into account both employer and employee contributions towards the cost of coverage for the benefit package) of $14,000 to cover an employee and the employee's spouse and/or spouse and other dependents, and provides the option of participating in a wellness program to the employee and spouse covered by the plan, it may not offer a total inducement greater than 30 percent of $14,000, or $4,200.

    This type of inducement limit generally parallels the limitations set forth in section 1201 of the Affordable Care Act,22 which explains that when dependents of employees, such as spouses, are permitted to fully participate in a health-contingent wellness program, the reward offered must not exceed the applicable percentage of the total cost of the coverage in which an employee and dependents are enrolled. See 26 CFR 54.9802-1(f)(3)(ii) and (4)(ii); 29 CFR 2590.702(f)(3)(ii) and (4)(ii); 45 CFR 146.121(f)(3)(ii) and (f)(4)(ii). The limited exception that the Commission proposes to make under Title II of GINA thus allows a practice that is in line with Title I of GINA and the Affordable Care Act. See 26 CFR 54.9802-1(f)(3)(ii) and (4)(ii); 29 CFR 2590.702(f)(3)(ii) and (4)(ii); 45 CFR 146.121(f)(3)(ii) and (f)(4)(ii) for the references to the implementing Affordable Care Act regulations; see section 702(b)(3)(B) of ERISA (29 U.S.C. 1182(b)(3)(B)); section 2705(b)(3)(B) of the PHSA (42 U.S.C.300gg-4(b)(3)(B)); and section 9802(b)(3)(B) of the Code (26 U.S.C. 9802(b)(3)(B)) for references to Title I of GINA. The EEOC has determined that extending the 30 percent limit established by the Affordable Care Act for health-contingent wellness program inducements in return for information about the health status (but not the genetic information) of spouses promotes GINA's interest in limiting access to genetic information and ensuring that inducements are not so high as to be coercive, and thus prohibited. The EEOC consulted with the Departments of Health and Human Services, Labor, and the Treasury, which share interpretive jurisdiction over the wellness program provisions under HIPAA and the Affordable Care Act, and while the proposed revisions may differ in some respects from the wellness program standards set forth by the Affordable Care Act and its implementing regulations,23 the EEOC believes that employers will be able to comply with both the wellness requirements under the Affordable Care Act and these regulations.24

    22 Section 1201 of the Affordable Care Act added PHSA section 2705(j) and Section 1563 of the Affordable Care Act incorporated by reference such provision into section 715(a)(1) to the ERISA, and section 9815(a)(1) to the Code. See 29 U.S.C. 1182(j)(3)(A); 42 U.S.C. 300gg-4(j)(3)(A); 26 U.S.C. 9802(j)(3)(A).

    23 There are differences between the inducement limit provided in this proposal under GINA and the inducement limits under the wellness regulations implementing HIPAA, as amended by the Affordable Care Act, including that under those wellness regulations: (1) The inducement limit does not apply to “participatory wellness programs,” which include HRAs that all participants may answer, regardless of their health status (but only to “health-contingent wellness programs”); and (2) the inducement limit on health-contingent wellness programs does not contain specific rules apportioning the inducement between the spouse and the employee. See 26 CFR 54.9802-1(f); 29 CFR 2590.702(f); 45 CFR 146.121(f).

    24 Regulations implementing the wellness provisions in HIPAA, as amended by the Affordable Care Act, permit covered entities to offer financial incentives as high as 50 percent of the total cost of employee coverage for tobacco-related wellness programs, such as smoking cessation programs. See 26 CFR 54.9802-1(f)(5); 29 CFR 2590.702(f)(5); 45 CFR 146.121(f)(5). The inducement rules in 1635.8(b)(2) apply only to health and genetic services that request genetic information. A smoking cessation program that asks employees whether they use tobacco (or whether they ceased using tobacco upon completion of the program) or requires blood tests to determine nicotine levels is not a wellness program that requests genetic information and is therefore not covered by this proposed rule.

    Third, in addition to limiting the total inducement to 30 percent of the total cost of coverage for the plan in which the employee and any dependents are enrolled, the proposed rule, at new section 1635.8(b)(2)(iv), describes the manner in which inducements for employees and spouses are to be apportioned. The EEOC proposes that the maximum share of the inducement attributable to the employee's participation in an employer wellness program (or multiple employer wellness programs that request such information) be equal to 30 percent of the cost of self-only coverage, which is the maximum amount the Commission has proposed may be offered under the ADA for an employee to answer disability-related inquiries or take medical examinations in connection with a wellness program that is part of a group health plan. See 80 FR 21659, 21663 (April 20, 2015). The remainder of the inducement—equal to 30 percent of the total cost of coverage for the plan in which the employee and any dependents are enrolled minus 30 percent of the total cost of self-only coverage—may be provided in exchange for the spouse providing information to an employer wellness program (or multiple employer wellness programs that request such information) about his or her current or past health status. These limitations would be set forth at 29 CFR 1635.8(b)(2)(iv)(a) and (b).

    Thus, for example, if an employee is enrolled in a health plan that covers the employee and any class of dependents for which the total cost of coverage is $14,000, the maximum inducement the employer can offer for the employee and the employee's spouse to provide information about their current or past health status is 30 percent of $14,000, or $4,200. If the employer's self-only coverage costs $6,000, the maximum allowable incentive the employer may offer for the employee's participation is 30 percent of $6,000, or $1,800. The rest of the inducement, $4,200 minus $1,800, or $2,400, may be offered for the spouse to provide current or past health status information. However, an employer would be free to offer all or part of the $2,400 inducement in other ways as well, such as for the employee, the spouse, and/or another of the employee's dependents to undertake activities that would qualify as participatory or health-contingent programs but do not include requests for genetic information, disability-related inquiries, or medical examinations. Thus, in the example above, an employer could offer $1,800 for the employee to answer disability-related questions and/or to take medical examinations as part of a health risk assessment, could offer the same amount for the employee's spouse to answer the same questions and to take the same medical examinations, and could offer the remaining $600 for the employee, the spouse, or both to undertake an activity-based health-contingent program, such as a program that requires participants to walk a certain amount each week. Additionally, a wellness program may offer inducements in accordance with HIPAA and the Affordable Care Act without regard to the limits on apportionment set forth in this proposed rule if neither the employee nor the employee's spouse are required to provide current or past health status information, so long as the wellness program otherwise complies with the requirements of the ADA and GINA.

    Fourth, proposed section 1635.8(b)(2)(vi) would prohibit a covered entity from conditioning participation in a wellness program or an inducement on an employee, or the employee's spouse or other covered dependent, agreeing to the sale of genetic information or waiving protections provided under section 1635.9. Section 1635.9 prohibits the disclosure of genetic information, except in six narrowly defined circumstances.

    Fifth, we propose to add another example to 29 CFR 1635.8(c)(2) to make clear that an employer is permitted to seek information—through medical questionnaires, medical examinations (e.g., to detect high blood pressure or high cholesterol), or both—about the current or past health status of an employee's spouse who is covered by the employer's group health plan and is completing a HRA on a voluntary basis in compliance with 29 CFR 1635.8(b)(2). This provision of the regulations describes two circumstances under which the employer is permitted to request, require, or purchase genetic information or information about the past or current health status of an employee's family members who are receiving health or genetic services on a voluntary basis. The provision cross-references 29 CFR 1635.8(b)(2) to make clear that such acquisitions are only permitted if all of the requirements for seeking genetic information as part of a voluntary health or genetic service, including the rules on authorization and inducements, are met.

    Finally, the revisions would remove the term “financial” as a modifier of the type of inducements discussed in the regulation and make clear that the term “inducements” includes both financial and in-kind inducements, such as time-off awards, prizes, or other items of value, in the form of either rewards or penalties.25 Since promulgation of the original Title II regulations in 2010, the EEOC has become aware that inducements other than those that might be called purely financial are used with some frequency and intends that the regulations apply to all such inducements.

    25 Removal of the modifier “financial” is consistent with the HIPAA and the Affordable Care Act wellness program provisions, which generally define a permissible reward as “a discount or rebate of a premium or contribution, a waiver of all or part of a cost-sharing mechanism, an additional benefit, or any financial or other incentive.” See 26 CFR 54.9802-1(f)(1)(i); 29 CFR 2590.702(f)(1)(i); 45 CFR 146.121(f)(1)(i). See footnote 14 for additional discussion of the meaning of “inducement.”

    These revisions would require renumbering throughout 29 CFR 1635.8(b)(2), as well as the addition of a reference to the new subsections within 29 CFR 1635.8(b)(2)(ii).

    Technical Amendments

    The first sentence of 29 CFR 1635.8(b)(2)(iv) (which, in the proposed rule, will be renumbered as 29 CFR 1635.8(b)(2)(vii)) reads as follows: “Nothing in § 1635.8(b)(2)(iii) limits the rights or protections of an individual under the Americans with Disabilities Act (ADA), as amended, or under any other applicable civil rights law, or under the Health Insurance Portability and Accountability Act (HIPAA), as amended by GINA.” This subsection should have referred to subsection (b)(2)(ii) concerning inducements for completing HRAs, as well as subsection (b)(2)(iii) (which, in the proposed rule, will be renumbered as 29 CFR 1635.8(b)(2)(v)) concerning disease management or other programs that offer inducements for achieving certain health outcomes. We propose to revise the rule so that it references the appropriate subsections, including the newly proposed 29 CFR 1635.8(b)(2)(iii) and (iv) concerning inducements for spouses to complete HRAs. Finally, we propose to amend this and other subsections to include reference to HIPAA and the Affordable Care Act, where appropriate.

    Request for Comments

    The Commission invites written comments from members of the public on any issues related to this proposed rule about particular practices that might violate GINA. In addition, the Commission specifically requests comments on several issues:

    (1) Whether employers that offer inducements to encourage the spouses of employees to disclose information about current or past health must also offer similar inducements to persons who choose not to disclose such information, but who instead provide certification from a medical professional stating that the spouse is under the care of a physician and that any medical risks identified by that physician are under active treatment.

    (2) Should the proposed authorization requirement apply only to wellness programs that offer more than de minimis rewards or penalties to employees whose spouses provide information about current or past health status as part of a HRA? If so, how should the Commission define “de minimis”?

    (3) Which best practices or procedural safeguards ensure that employer-sponsored wellness programs are designed to promote health or prevent disease and do not operate to shift costs to employees with spouses who have health impairments or stigmatized conditions?

    (4) Given that, in contrast to the status quo when the ADA was enacted, most employers today store personnel information electronically, and in light of increasingly frequent breaches to electronically stored employment records, should the rule include more specific guidance to employers regarding how to implement the requirements of 29 CFR 1635.9(a) for electronically stored records? If so, what procedures are needed to achieve GINA's goal of ensuring the confidentiality of genetic information with respect to electronic records stored by employers?

    (5) In addition to any suggestions offered in response to the previous question, are there best practices or procedural safeguards to ensure that information about spouses' current health status is protected from disclosure?

    (6) Given concerns about privacy of genetic information, should the regulation restrict the collection of any genetic information by a workplace wellness program to only the minimum necessary to directly support the specific wellness activities, interventions, and advice provided through the program—namely information collected through the program's HRA and biometric screening? Should programs be prohibited from accessing genetic information from other sources, such as patient claims data and medical records data?

    (7) Whether employers offer (or are likely to offer in the future) wellness programs outside of a group health plan or group health insurance coverage that use inducements to encourage employees' spouses to provide information about current or past health status as part of a HRA, and the extent to which the GINA regulations should allow inducements provided as part of such programs.

    Regulatory Procedures Executive Order 12866

    Pursuant to Executive Order 12866, the EEOC has coordinated this proposed rule with the Office of Management and Budget. Under section 3(f)(1) of Executive Order 12866, the EEOC has determined that the proposed regulation will not have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities.

    Although a detailed cost-benefit assessment of the proposed regulation is not required, the Commission notes that the rule will aid compliance with Title II of GINA by employers. Currently, employers face uncertainty as to whether providing an employee with an inducement if his or her spouse provides information about the spouse's current or past health status on a HRA will subject them to liability under Title II of GINA. This rule will clarify that offering limited inducements in these circumstances is permitted by Title II of GINA if the requirements of section 202(b)(2)(A) of GINA otherwise have been met. We believe that a potential benefit of this rule is that it will provide employers that adopt wellness programs that include spousal inducements with clarity about their obligations under GINA.

    The Commission does not believe the costs to employers associated with the rule are significant. Under HIPAA, as amended by the Affordable Care Act, inducements of up to 30 percent of the total cost of coverage in which an employee is enrolled are permitted where the employee and the employee's dependents are given the opportunity to fully participate in the health-contingent wellness program. This proposed rule simply clarifies that a similar inducement is permissible under Title II of GINA where an employer offers inducements for an employee's spouse enrolled in the group health plan to provide current or past health status information.

    The Commission further believes that employers will face initial start-up costs to train human resources staff and others on the revised rule. The EEOC conducts extensive outreach and technical assistance programs, many of them at no cost to employers, to assist in the training of relevant personnel on EEO-related issues. For example, in FY 2013, the agency's outreach programs reached more than 280,000 persons through participation in more than 3,800 no-cost educational, training and outreach events. We expect to put information about the revisions to the GINA regulations in our outreach programs in general and to continue to offer GINA-specific outreach programs which will, of course, include information about the revisions once the proposed rule becomes final. We will also post technical assistance documents on our Web site explaining the revisions to the GINA regulations, as we do with all of our new regulations and policy documents.26

    26See, e.g., http://www.eeoc.gov/laws/types/genetic.cfm for documents explaining Title II of GINA.

    We estimate that there are approximately 782,000 employers with 15 or more employees subject to Title II of GINA 27 and, of that number, one half to two thirds (391,000 to 521,333) offer some type of wellness program.28 Assuming that nearly half of employer wellness programs are open for participation by the spouses or dependents of workers, and using the highest estimates, we assume that approximately 260,667 employers will be covered by this requirement.29 We further estimate that the typical human resources professional will need to dedicate, at most, 60 minutes to gain a satisfactory understanding of the revised regulations and that the median hourly pay rate of a human resources professional is approximately $49.41. See Bureau of Labor Statistics, Occupational Employment and Wages, May 2014 at http://www.bls.gov/oes/current/oes113121.htm. Assuming that an employer will train up to three human resources professionals/managers on the requirements of this rule, we estimate that initial training costs will be approximately 38,638,670.00.30

    27See Firm Size Data, at http://www.sba.gov/advocacy/849/12162.

    28See Rand Health, Workplace Wellness Programs Study Final Report (2013), sponsored by the U.S. Departments of Labor and Health and Human Services, available at http://www.rand.org/content/dam/rand/pubs/research_reports/RR200/RR254/RAND_RR254.pdf (hereinafter referred to as the RAND Final Study). See also The Kaiser Family Foundation and Health Research & Educational Trust 2014 Employer Health Benefits Survey, available at http://kff.org/health-costs/report/2014-employer-health-benefits-survey/ [hereinafter referred to as the Kaiser Survey]. According to the RAND Final Report, “approximately half of U.S. employers offer wellness promotion initiatives.” By contrast, the Kaiser Survey found that “[s]eventy-four percent of employers offering health benefits” offer at least one wellness program.

    29 Although the Kaiser Survey reports that 51 percent of large employers versus 32 percent of small employers ask employees to complete a HRA, we are not aware of any data indicating what percentage of those employers provide spouses with the opportunity to participate in the HRA. We therefore have substituted a more general statistic to allow an estimate of the number of employers who will be covered by the requirements of this proposed rule. See Kaiser Foundation, Workplace Wellness Programs Characteristics and Requirements (2015), available at http://kff.org/private-insurance/issue-brief/workplace-wellness-programs-characteristics-and-requirements/ (Noting that nearly half (48 percent) of employer wellness programs are open for participation by the spouses or dependents of workers, as well as workers).

    30 A study published in 2009 by the Society for Human Resource Management (SHRM) found that the median number of full-time equivalents for a HR department was three. See SHRM Human Capital Benchmarking Study, 2009 Executive Summary available at https://www.shrm.org/Research/SurveyFindings/Articles/Documents/09-0620_Human_Cap_Benchmark_FULL_FNL.pdf. Because we are not aware of any more specific data on the average number of human resources professionals per covered employer, we have based our estimates on this figure.

    Finally, GINA's plain language (at 42 U.S.C. 2000ff-(1)(b)(2)) and EEOC's regulations (at 29 CFR 1635.8(b)(2) and (c)(2)) make it clear that an employer must obtain authorization for the collection of genetic information as part of providing health or genetic services to employees and their family members on a voluntary basis. Consequently, this proposed rule imposes no new obligations with respect to authorization for the collection of genetic information. We welcome comments on this and all of our conclusions concerning the benefits and burdens of the revisions.

    Paperwork Reduction Act

    This proposal contains no new information collection requirements subject to review by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

    Regulatory Flexibility Act

    Title II of GINA applies to all employers with 15 or more employees, approximately 764,233 of which are small firms (entities with 15-500 employees) according to data provided by the Small Business Administration Office of Advocacy. See Firm Size Data, at http://www.sba.gov/advocacy/849/12162.

    The Commission certifies under 5 U.S.C. 605(b) that this proposed rule will not have a significant economic impact on a substantial number of small entities because it imposes no reporting burdens and only minimal costs on such firms. The proposed rule simply clarifies that employers that offer wellness programs are free to adopt a certain type of inducement without violating GINA. It also corrects an internal citation and provides citations to the Affordable Care Act. It does not require any action on the part of covered entities, except to the extent that those entities created documentation or forms which cite to GINA for the proposition that the entity is unable to offer inducements to employees in return for a spouse's completion of HRAs that request information about the spouse's current or past health. We do not have data on the number or size of businesses that may need to alter documents relating to their wellness programs. However, our experience with enforcing the ADA, which required all employers with 15 or more employees to remove medical inquiries from application forms, suggests that revising questionnaires to eliminate or alter an instruction would not impose significant costs.

    To the extent that employers will expend resources to train human resources staff and others on the revised rule, we reiterate that the EEOC conducts extensive outreach and technical assistance programs, many of them at no cost to employers, to assist in the training of relevant personnel on EEO-related issues. For example, in FY 2013, the agency's outreach programs reached more than 280,000 persons through participation in more than 3,800 no-cost educational, training and outreach events. We expect to put information about the revisions to the GINA regulations in our outreach programs in general and to continue to offer GINA-specific outreach programs which will, of course, include information about the revisions once the proposed rule becomes final. We will also post technical assistance documents on our Web site explaining the revisions to the GINA regulations, as we do with all of our new regulations and policy documents.

    We estimate that the typical human resources professional will need to dedicate, at most, 60 minutes to gain a satisfactory understanding of the revised regulations. We further estimate that the median hourly pay rate of a human resources professional is approximately $49.41. See Bureau of Labor Statistics, Occupational Employment and Wages, May 2014 at http://www.bls.gov/oes/current/oes113121.htm. Assuming that small entities have between one and five human resources professionals/managers, we estimate that the cost per entity of providing appropriate training will be between approximately $49.41 and $247.05. The EEOC does not believe that this cost will be significant for the impacted small entities. We urge small entities to submit comments concerning the EEOC's estimates of the number of small entities affected, as well as the cost to those entities.

    Unfunded Mandates Reform Act of 1995

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

    List of Subjects in 29 CFR Part 1635

    Administrative practice and procedure, Equal employment opportunity.

    Dated: October 27, 2015.

    For the Commission.

    Jenny R. Yang, Chair.

    For the reasons set forth in the preamble, the EEOC proposes to amend chapter XIV of title 29 of the Code of Federal Regulations as follows:

    PART 1635—[AMENDED] 1. The authority citation for 29 CFR part 1635 is revised to read as follows: Authority:

    29 U.S.C. 2000ff.

    2. In § 1635.8(b): a. Redesignate paragraphs (b)(2)(i)(A) through (D) as paragraphs (b)(2)(i)(B) through (E); b. Add new paragraph (b)(2)(i)(A); c. Revise paragraph (b)(2)(ii) introductory text; d. Redesignate paragraphs (b)(2)(iii) and (iv) as paragraphs (b)(2)(v) and (vii); e. Add new paragraphs (b)(2)(iii), (b)(2)(iv), and (b)(2)(vi); f. Revise newly redesignated paragraph (b)(2)(vii). g. Revise paragraph (c)(2).

    The revisions and additions read as follows:

    § 1635.8 Acquisition of genetic information.

    (b) * * *

    (2) * * *

    (i) * * *

    (A) The health or genetic services, including any acquisition of genetic information that is part of those services, are reasonably designed to promote health or prevent disease. A program satisfies this standard if it has a reasonable chance of improving the health of, or preventing disease in, participating individuals, and it is not overly burdensome, is not a subterfuge for violating Title II of GINA or other laws prohibiting employment discrimination, and is not highly suspect in the method chosen to promote health or prevent disease.

    (ii) Consistent with the requirements of paragraph (b)(2)(i) of this section, a covered entity may not offer an inducement (financial or in-kind), whether in the form of a reward or penalty, for individuals to provide genetic information, except as described in paragraphs (b)(2)(iii) and (iv) of this section, but may offer inducements for completion of health risk assessments that include questions about family medical history or other genetic information, provided the covered entity makes clear, in language reasonably likely to be understood by those completing the health risk assessment, that the inducement will be made available whether or not the participant answers questions regarding genetic information.

    (iii) Consistent with the requirements of paragraphs (b)(2)(i) and (ii) of this section, a covered entity may offer, as part of its health plan, an inducement to an employee whose spouse provides information about the spouse's own current or past health status as part of a health risk assessment when the employee has elected coverage for any class of dependents under the health plan, and the spouse is included in such coverage. No inducement may be offered, however, in return for the spouse's providing his or her own genetic information, including results of his or her genetic tests, for the current or past health status information of an employee's children, or for the genetic information of an employee's child. The health risk assessment, which may include a medical questionnaire, a medical examination (e.g., to detect high blood pressure or high cholesterol), or both, must otherwise comply with paragraph (b)(2)(i) of this section in the same manner as if completed by the employee, including the requirement that the spouse provide prior, knowing, voluntary, and written authorization, and the requirement that the authorization form describe the confidentiality protections and restrictions on the disclosure of genetic information. The health risk assessment must also be administered in connection with the spouse's receipt of health or genetic services offered by the employer, including such services offered as part of a wellness program. This inducement, when combined with any other inducement permitted under Title I of the Americans with Disabilities Act (ADA), for an employee's participation in a wellness program that asks disability-related questions or requires medical examinations, may not exceed 30 percent of the total cost of the coverage under the plan in which an employee and the spouse are enrolled. For example, if an employer offers health insurance coverage at a total cost of $14,000 for employees and their dependents (including spouses) and provides the option of participating in a wellness program to employees and spouses who are covered by the plan, the employer may not offer an inducement greater than 30 percent of $14,000, or $4,200.

    (iv) When an employer offers an inducement for an employee and the employee's spouse to participate in a wellness program that requests information about the spouse's current or past health status:

    (A) The maximum amount of the inducement for an employee's spouse to provide information about current or past health status may not exceed 30 percent of the total cost of coverage for the plan in which the employee is enrolled less 30 percent of the total cost of self-only coverage. For example, if an employer offers health insurance coverage at a total cost of $14,000 for employees and their dependents and $6,000 for self-only coverage, the maximum inducement the employer can offer for the employee and the employee's spouse to provide information about their current or past health status is 30 percent of $14,000, or $4,200. The maximum amount of the $4,200 inducement that could be offered for the employee's spouse to provide current or past health status information is $4,200 minus $1,800 (30 percent of the cost of self-only coverage), or $2,400

    (B) The maximum amount of the inducement the employer may offer to the employee for participation is 30 percent of the cost of self-only coverage. For example, if an employer offers health insurance coverage at a total cost of $14,000 for employees and their dependents and $6,000 for self-only coverage, the maximum inducement that may be offered for the employee to respond to disability-related inquiries or take medical examinations is $1,800.

    (vi) A covered entity may not, however, condition participation in a wellness program or provide any inducement to an employee, or the spouse or other covered dependent of the employee, in exchange for an agreement permitting the sale of genetic information, including information about the current health status of an employee's family member, or otherwise waiving the protections of § 1635.9.

    (vii) Nothing contained in paragraphs (b)(2)(ii) through (vi) of this section limits the rights or protections of an individual under the Americans with Disabilities Act (ADA), as amended, or other applicable civil rights laws, or under the Health Insurance Portability and Accountability Act (HIPAA), as amended by GINA. For example, if an employer offers an inducement for participation in disease management programs or other programs that promote healthy lifestyles and/or require individuals to meet particular health goals, the employer must make reasonable accommodations to the extent required by the ADA; that is, the employer must make “modifications or adjustments that enable a covered entity's employee with a disability to enjoy equal benefits and privileges of employment as are enjoyed by its other similarly situated employees without disabilities” unless “such covered entity can demonstrate that the accommodation would impose an undue hardship on the operation of its business.” 29 CFR 1630.2(o)(1)(iii); 29 CFR 1630.9(a). In addition, if the employer's wellness program provides (directly, through reimbursement, or otherwise) medical care (including genetic counseling), the program may constitute a group health plan and must comply with the special requirements for wellness programs that condition rewards on an individual satisfying a standard related to a health factor, including the requirement to provide an individual with a “reasonable alternative (or waiver of the otherwise applicable standard)” under HIPAA, when “it is unreasonably difficult due to a medical condition to satisfy” or “medically inadvisable to attempt to satisfy” the otherwise applicable standard. See section 9802 of the Internal Revenue Code (26 U.S.C. 9802, 26 CFR 54.9802-1 and 54.9802-3T), section 702 of the Employee Retirement Income Security Act of 1974 (ERISA) (29 U.S.C. 1182, 29 CFR 2590.702 and 2590.702-1), and section 2705 of the PHSA (45 CFR 146.121 and 146.122), as amended by section 1201 of the Affordable Care Act.

    (c) * * *

    (2) A covered entity does not violate this section when, consistent with paragraph (b)(2) of this section, it requests, requires, or purchases genetic information or information about the manifestation of a disease, disorder, or pathological condition of an individual's family member who is receiving health or genetic services on a voluntary basis. For example, an employer does not unlawfully acquire genetic information about an employee when it asks the employee's family member who is receiving health services from the employer if her diabetes is under control. Nor does an employer unlawfully acquire genetic information about an employee when it seeks information—through a medical questionnaire, a medical examination, or both—about the current or past health status of the employee's family member who is covered by the employer's group health plan and is completing a health risk assessment on a voluntary basis in connection with the family member's receipt of health or genetic services (including health or genetic services provided as part of a wellness program) offered by the employer in compliance with paragraph (b)(2) of this section.

    3. In § 1635.11, revise paragraphs (b)(1)(iii) and (iv) to read as follows:
    § 1635.11 Construction.

    (b) * * *

    (1) * * *

    (iii) Section 702(a)(1)(F) of ERISA (29 U.S.C. 1182(a)(1)(F)), section 2705(a)(6) of the Public Health Service Act (PHSA), as amended by section 1201 of the Affordable Care Act and section 9802(a)(1)(F) of the Internal Revenue Code (26 U.S.C. 9802(a)(1)(F)), which prohibit a group health plan or a health insurance issuer in the group or individual market from discriminating against individuals in eligibility and continued eligibility for benefits based on genetic information; or

    (iv) Section 702(b)(1) of ERISA (29 U.S.C. 1182(b)(1)), section 2705(b)(1) of the PHSA, as amended by section 1201 of the Affordable Care Act and section 9802(b)(1) of the Internal Revenue Code (26 U.S.C. 9802(b)(1)), as such sections apply with respect to genetic information as a health status-related factor, which prohibit a group health plan or a health insurance issuer in the group or individual market from discriminating against individuals in premium or contribution rates under the plan or coverage based on genetic information.

    [FR Doc. 2015-27734 Filed 10-29-15; 8:45 am] BILLING CODE P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R10-OAR-2015-0258; FRL-9936-31-Region 10] Approval and Promulgation of Implementation Plans; Idaho: Interstate Transport of Ozone AGENCY:

    Environmental Protection Agency.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Clean Air Act (CAA) requires each State Implementation Plan (SIP) to contain adequate provisions prohibiting emissions that will have certain adverse air quality effects in other states. On June 28, 2010, the State of Idaho made a submittal to the Environmental Protection Agency (EPA) to address these requirements. The EPA is proposing to approve the submittal as meeting the requirement that each SIP contain adequate provisions to prohibit emissions that will contribute significantly to nonattainment or interfere with maintenance of the 2008 ozone National Ambient Air Quality Standard (NAAQS) in any other state.

    DATES:

    Written comments must be received on or before November 30, 2015.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R10-OAR-2015-0258, by any of the following methods:

    http://www.regulations.gov: Follow the on-line instructions for submitting comments.

    Email: [email protected]

    Mail: Kristin Hall, EPA Region 10, Office of Air, Waste and Toxics (AWT-150), 1200 Sixth Avenue, Suite 900, Seattle, WA 98101

    Hand Delivery/Courier: EPA Region 10 9th Floor Mailroom, 1200 Sixth Avenue, Suite 900, Seattle, WA 98101. Attention: Kristin Hall, Office of Air, Waste and Toxics, AWT-150. Such deliveries are only accepted during normal hours of operation, and special arrangements should be made for deliveries of boxed information.

    Instructions: Direct your comments to Docket ID No. EPA-R10-OAR-2015-0258. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site is an “anonymous access” system, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through http://www.regulations.gov your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information the disclosure of which 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. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy during normal business hours at the Office of Air, Waste and Toxics, EPA Region 10, 1200 Sixth Avenue, Seattle, WA 98101.

    FOR FURTHER INFORMATION CONTACT:

    Kristin Hall at (206) 553-6357, [email protected], or the above EPA, Region 10 address.

    SUPPLEMENTARY INFORMATION:

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

    Table of Contents I. Background II. State Submittal III. EPA Evaluation IV. Proposed Action V. Statutory and Executive Order Reviews I. Background

    On March 12, 2008, the EPA revised the levels of the primary and secondary 8-hour ozone standards from 0.08 parts per million (ppm) to 0.075 ppm (73 FR 16436). The CAA requires states to submit, within three years after promulgation of a new or revised standard, SIPs meeting the applicable “infrastructure” elements of sections 110(a)(1) and (2). One of these applicable infrastructure elements, CAA section 110(a)(2)(D)(i), requires SIPs to contain “good neighbor” provisions to prohibit certain adverse air quality effects on neighboring states due to interstate transport of pollution. There are four sub-elements within CAA section 110(a)(2)(D)(i). This action addresses the first two sub-elements of the good neighbor provisions, at CAA section 110(a)(2)(D)(i)(I). These sub-elements require that each SIP for a new or revised standard contain adequate provisions to prohibit any source or other type of emissions activity within the state from emitting air pollutants that will “contribute significantly to nonattainment” or “interfere with maintenance” of the applicable air quality standard in any other state. We note that the EPA has addressed the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for the eastern portion of the United States in several past regulatory actions.1 We most recently promulgated the Cross-State Air Pollution Rule (CSAPR), which addressed CAA section 110(a)(2)(D)(i)(I) in the eastern portion of the United States.2 CSAPR addressed multiple national ambient air quality standards, but did not address the 2008 8-hour ozone standard.3

    1 NOX SIP Call, 63 FR 57371 (October 27, 1998); Clean Air Interstate Rule (CAIR), 70 FR 25172 (May 12, 2005); Cross-State Air Pollution Rule (CSAPR), 76 FR 48208 (August 8, 2011).

    2 76 FR 48208.

    3 CSAPR addressed the 1997 8-hour ozone, and the 1997 and 2006 fine particulate matter NAAQS.

    In CSAPR, the EPA used detailed air quality analyses to determine whether an eastern state's contribution to downwind air quality problems was at or above specific thresholds. If a state's contribution did not exceed the specified air quality screening threshold, the state was not considered “linked” to identified downwind nonattainment and maintenance receptors and was therefore not considered to significantly contribute to or interfere with maintenance of the standard in those downwind areas. If a state exceeded that threshold, the state's emissions were further evaluated, taking into account both air quality and cost considerations, to determine what, if any, emissions reductions might be necessary. For the reasons stated below, we believe it is appropriate to use the same approach we used in CSAPR to establish an air quality screening threshold for the evaluation of interstate transport requirements for the 2008 ozone standard.

    In CSAPR, the EPA proposed an air quality screening threshold of one percent of the applicable NAAQS and requested comment on whether one percent was appropriate.4 The EPA evaluated the comments received and ultimately determined that one percent was an appropriately low threshold because there were important, even if relatively small, contributions to identified nonattainment and maintenance receptors from multiple upwind states. In response to commenters who advocated a higher or lower threshold than one percent, the EPA compiled the contribution modeling results for CSAPR to analyze the impact of different possible thresholds for the eastern United States. The EPA's analysis showed that the one-percent threshold captures a high percentage of the total pollution transport affecting downwind states, while the use of higher thresholds would exclude increasingly larger percentages of total transport. For example, at a five percent threshold, the majority of interstate pollution transport affecting downwind receptors would be excluded.5 In addition, the EPA determined that it was important to use a relatively lower one-percent threshold because there are adverse health impacts associated with ambient ozone even at low levels.6 The EPA also determined that a lower threshold such as 0.5 percent would result in modest increases in the overall percentages of fine particulate matter and ozone pollution transport captured relative to the amounts captured at the one-percent level. The EPA determined that a “0.5 percent threshold could lead to emission reduction responsibilities in additional states that individually have a very small impact on those receptors—an indicator that emission controls in those states are likely to have a smaller air quality impact at the downwind receptor. We are not convinced that selecting a threshold below one percent is necessary or desirable.” 7

    4 CSAPR proposal, 75 FR 45210, 45237 (August 2, 2010).

    5See also Air Quality Modeling Final Rule Technical Support Document, Appendix F; Analysis of Contribution Thresholds.

    6 CSAPR, 76 FR 48208, 48236-37 (August 8, 2011).

    7 Id.

    In the final CSAPR, the EPA determined that one percent was a reasonable choice considering the combined downwind impact of multiple upwind states in the eastern United States, the health effects of low levels of fine particulate matter and ozone pollution, and the EPA's previous use of a one-percent threshold in CAIR. The EPA used a single “bright line” air quality threshold equal to one percent of the 1997 8-hour ozone standard, or 0.08 ppm.8 The projected contribution from each state was averaged over multiple days with projected high modeled ozone, and then compared to the one-percent threshold. We concluded that this approach for setting and applying the air quality threshold for ozone was appropriate because it provided a robust metric, was consistent with the approach for fine particulate matter used in CSAPR, and because it took into account, and would be applicable to, any future ozone standards below 0.08 ppm.9

    8 Id.

    9 Id.

    II. State Submittal

    CAA sections 110(a)(1) and (2) and section 110(l) require that revisions to a SIP be adopted by the State after reasonable notice and public hearing. The EPA has promulgated specific procedural requirements for SIP revisions in 40 CFR part 51, subpart F. These requirements include publication of notices by prominent advertisement in the relevant geographic area, a public comment period of at least 30 days, and an opportunity for a public hearing.

    On June 28, 2010, Idaho submitted a SIP to address the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for the ozone NAAQS. The Idaho submittal included documentation of a public comment period from May 11, 2010 through June 10, 2010, and opportunity for public hearing. We find that the process followed by Idaho in adopting the submittal complies with the procedural requirements for SIP revisions under CAA section 110 and the EPA's implementing regulations.

    With respect to the requirements in CAA section 110(a)(2)(D)(i)(I), the Idaho submittal referred to applicable rules in the Idaho SIP, meteorological and technical characteristics of areas with ozone nonattainment problems in surrounding states, data on nitrogen oxides (NOX) and volatile organic compound (VOC) emissions from Idaho sources, satellite monitoring data, and the impacts of terrain and prevailing wind direction on the potential for transport of ozone precursors. The Idaho submittal concluded that given the relatively low amount of NOX emitted by Idaho sources, the general lack of substantial concentrations of VOCs in areas surrounding Idaho, the impacts of significant terrain features on the movement of pollutants, and technical information on the two areas in states bordering Idaho that are having ozone attainment and maintenance problems (Upper Green River Basin, Wyoming and Clark County, Nevada), it is reasonable to conclude that emissions of ozone precursors from Idaho sources will not significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS in any other state.

    The Idaho submittal provided further information to support this conclusion by citing major source permitting regulations approved into the Idaho SIP that require new sources and modifications to protect the ambient air quality standards, including the 2008 ozone NAAQS. With respect to existing sources, the Idaho submittal stated that stationary source operating rules in the Idaho SIP require an owner or operator to demonstrate that the source does not cause or contribute to a violation of any ambient air quality standard.

    III. EPA Evaluation

    On August 4, 2015, the EPA issued a Notice of Data Availability (NODA) containing air quality modeling data that applies the CSAPR approach to contribution projections for the year 2017 for the 2008 8-hour ozone NAAQS.10 The moderate area attainment date for the 2008 ozone standard is July 11, 2018. In order to demonstrate attainment by this attainment deadline, states will use 2015 through 2017 ambient ozone data. Therefore, 2017 is an appropriate future year to model for the purpose of examining interstate transport for the 2008 ozone NAAQS. The EPA used photochemical air quality modeling to project ozone concentrations at air quality monitoring sites to 2017 and estimated state-by-state ozone contributions to those 2017 concentrations. This modeling used the Comprehensive Air Quality Model with Extensions (CAMx version 6.11) to model the 2011 base year, and the 2017 future base case emissions scenarios to identify projected nonattainment and maintenance sites with respect to the 2008 ozone NAAQS in 2017. The EPA used nationwide state-level ozone source apportionment modeling (CAMx Ozone Source Apportionment Technology/Anthropogenic Precursor Culpability Analysis technique) to quantify the contribution of 2017 base case NOX and volatile VOC emissions from all sources in each state to the 2017 projected receptors. The air quality model runs were performed for a modeling domain that covers the 48 contiguous United States and adjacent portions of Canada and Mexico. The NODA and the supporting technical documents have been included in the docket for this action.

    10See 80 FR 46271 (August 4, 2015) (Notice of Availability of the Environmental Protection Agency's Updated Ozone Transport Modeling Data for the 2008 Ozone National Ambient Air Quality Standard (NAAQS)).

    The modeling data released in the NODA on July 23, 2015, is the most up-to-date information the EPA has developed to inform our analysis of upwind state linkages to downwind air quality problems. For purposes of evaluating Idaho's interstate transport SIP submittal with respect to the 2008 8-hour ozone standard, the EPA is proposing that states whose contributions are less than one percent to downwind nonattainment and maintenance receptors are considered non-significant. The modeling indicates that Idaho's largest contribution to any projected downwind nonattainment site is 0.23 ppb and Idaho's largest contribution to any projected downwind maintenance-only site is 0.35 ppb.11 These values are below the one percent screening threshold of 0.75 ppb, and therefore there are no identified linkages between Idaho and 2017 downwind projected nonattainment and maintenance sites. Note that the EPA has not done an assessment to determine the applicability for the use of the one percent screening threshold for western states that contribute above the one percent threshold. There may be additional considerations that may impact regulatory decisions regarding “potential” linkages in the west identified by the modeling.

    11 80 FR 46271 at page 46276, Table 3.

    IV. Proposed Action

    As discussed in Section II, Idaho concluded based on its own technical analysis that emissions from the State do not significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone standard in any other state. The EPA's modeling, discussed in Section III, confirms this finding. Based on the modeling data and the information and analysis provided in Idaho's June 28, 2010 submittal, we are proposing to approve the submittal for purposes of meeting the CAA section 110(a)(2)(D)(i)(I) requirements for the 2008 ozone standard. The EPA's modeling confirms the results of the State's analysis: Idaho does not significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone standard in any other state.

    V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this 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 Order 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 it does not involve technical standards; and

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

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

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: October 15, 2015. Dennis J. McLerran, Regional Administrator, Region 10.
    [FR Doc. 2015-27594 Filed 10-29-15; 8:45 am] BILLING CODE 6560-50-P
    80 210 Friday, October 30, 2015 Notices DEPARTMENT OF AGRICULTURE Commodity Credit Corporation Estimate of Peanuts and Peanut Products Available for Donation AGENCY:

    Commodity Credit Corporation and Farm Service Agency, USDA.

    ACTION:

    Notice.

    SUMMARY:

    On behalf of the Commodity Credit Corporation (CCC), the Farm Service Agency estimates that during fiscal year 2016, peanuts and peanut products in CCC inventory may be made available for programming under section 416 of the Agricultural Act of 1949, as amended, in such quantities as may be determined appropriate for direct human feeding in a manner consistent with United States obligations under its international trade agreements.

    FOR FURTHER INFORMATION CONTACT:

    Tiffany Arthur; telephone (202) 720-4284. Persons with disabilities who require alternative means for communications should contact the USDA Target Center at (202) 720-2600 (voice).

    Authority:

    15 U.S.C. 714b and 7 U.S.C. 1431(b)(8)(B).

    Val Dolcini, Administrator, Farm Service Agency, and Executive Vice President, Commodity Credit Corporation.
    [FR Doc. 2015-27698 Filed 10-29-15; 8:45 am] BILLING CODE 3410-05-P
    DEPARTMENT OF AGRICULTURE Forest Service Tongass Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Tongass Advisory Committee (Committee) will meet in Ketchikan, Alaska. The Committee is established consistent with the Federal Advisory Committee Act of 1972 (FACA) (5 U.S.C. App. 2). Committee recommendations and advice may directly inform the development of a proposed action for modification of the 2008 Tongass Land Management Plan. Additional information concerning the Committee can be found by visiting the Committee's Web site at: http://www.fs.usda.gov/goto/R10/Tongass/TAC.

    DATES:

    The meetings will be held on:

    • Tuesday, December 1, 2015 from 8:30 a.m. to 5:00 p.m. (AKDT).

    • Wednesday, December 2, 2015 from 8:30 a.m. to 5:00 p.m. (AKDT).

    • Thursday, December 3, 2015 from 8:30 a.m. to 3:30 p.m. (AKDT).

    All meetings are subject to change and cancellation. For updated status of the meetings prior to attendance, please visit the Web site listed in the SUMMARY section, or contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meetings will be held at the Best Western Landing Hotel, Sunny Point Ball Room, 3434 Tongass Avenue, Ketchikan, Alaska 99901. Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and available for public inspection and copying. The public may inspect comments received at the Tongass National Forest Office. Please call ahead at 907-225-3101 to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Marina Whitacre, Committee Coordinator, by phone at 907-772-5934, or by email at [email protected] Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meetings is to:

    1. Review Draft Environmental Impact Statement for the Tongass National Forest Plan Amendment;

    2. Decide whether or not to amend the package of draft recommendations that was approved in May, 2015; and

    3. Finalize TAC input regarding the Implementation and Monitoring Council.

    The meetings are open to the public. For members of the public who are not able to attend the meeting in-person, but are interested in listening to the deliberations, a teleconference line will be available. Details regarding how to access the conference line will be posted at www.merid.org/tongassadvisorycommittee within 24 hours of the meeting start time.

    The agenda will include time for people to make oral statements of three minutes or less. Time is allotted for oral statements on Wednesday, December 2, 2015, between 8:30 a.m. and 9:30 a.m. Individuals wishing to make an oral statement should register at the meeting. Anyone who would like to bring related matters to the attention of the Committee may file written statements with the Committee's staff before or after the meeting. Written comments must be sent to Jason Anderson, Designated Federal Officer, Tongass National Forest, P.O. Box 309, Petersburg, Alaska 99833; by email at [email protected]; or via facsimile at 907-772-5895. Summary/minutes of the meeting will be posted on the Web site listed above within 45 days after the meeting.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case-by-case basis.

    Dated: October 20, 2015. Jason C. Anderson, Deputy Forest Supervisor, Tongass National Forest.
    [FR Doc. 2015-27640 Filed 10-29-15; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE National Agricultural Statistics Service Submission for OMB Review; Comment Request October 26, 2015.

    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 regarding (a) 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; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of 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 November 30, 2015 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 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. 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.

    National Agricultural Statistics Service

    Title: Bee and Honey Survey.

    OMB Control Number: 0535-0153.

    Summary of Collection: The National Agricultural Statistics Service (NASS) primary function is to prepare and issue State and national estimates of crop and livestock production. General authority for these data collection activities is granted under U.S. Code Title 7, Section 2204. Domestic honeybees are critical to the pollination of U.S. crops, especially fruits, some nuts, vegetables and some specialty crops. Africanized bees, colony collapse disorder, parasites, diseases, and pesticides threaten the survival of bees. Programs are provided by federal, State and local governments to assist in the survival of bees and to encourage beekeepers to maintain bee colonies.

    Need and Use of the Information: NASS will collect information on the number of colonies, honey production, stocks, and prices from beekeepers with five or more honey bee colonies and from a sampling of beekeepers that have less than five colonies. The survey will provide data needed by the Department and other government agencies to administer programs and to set trade quotas and tariffs. Without the information agricultural industry would not be aware of changes at the State and national level.

    Description of Respondents: Farms.

    Number of Respondents: 31,500.

    Frequency of Responses: Reporting: Annually.

    Total Burden Hours: 8,937.

    Charlene Parker, Departmental Information Collection Clearance Officer.
    [FR Doc. 2015-27617 Filed 10-29-15; 8:45 am] BILLING CODE 3410-20-P
    DEPARTMENT OF COMMERCE [Docket No. 150806684-5967-02] Privacy Act of 1974, Altered System of Records AGENCY:

    U.S. Census Bureau, U.S. Department of Commerce.

    ACTION:

    Notice of Proposed Amendment to Privacy Act System of Records: COMMERCE/CENSUS-9, Longitudinal Employer-Household Dynamics System.

    SUMMARY:

    The Department of Commerce publishes this notice to announce the effective date of a Privacy Act System of Records notice entitled Notice of Proposed Amendment to Privacy Act System of Records: COMMERCE/CENSUS-9, Longitudinal Employer-Household Dynamics System.

    DATES:

    The system of records becomes effective on October 30, 2015.

    ADDRESSES:

    For a copy of the system of records please mail requests to: Chief, Privacy Compliance Branch, Room—8H021, U.S. Census Bureau, Washington, DC 20233-3700.

    FOR FURTHER INFORMATION CONTACT:

    Chief, Privacy Compliance Branch, Room—8H021, U.S. Census Bureau, Washington, DC 20233-3700.

    SUPPLEMENTARY INFORMATION:

    On September 17, 2015 (80 FR 55831), the Department of Commerce published a notice in the Federal Register requesting comments on a proposed new Privacy Act System of Records notice entitled Notice of Proposed Amendment to Privacy Act System of Records: COMMERCE/CENSUS-9, Longitudinal Employer-Household Dynamics System. No comments were received in response to the request for comments. By this notice, the Department of Commerce is adopting the proposed new system as final without changes effective October 30, 2015.

    Dated: October 26, 2015. Michael J. Toland, Department of Commerce, Freedom of Information and Privacy Act Officer.
    [FR Doc. 2015-27719 Filed 10-29-15; 8:45 am] BILLING CODE 3510-07-P
    DEPARTMENT OF COMMERCE International Trade Administration Notice of Retraction of Publication of the Notice of Final Redetermination Pursuant to Court Remand, Wheatland Tube Co. v. United States, Court No. 12-00296 ACTION:

    Notice of retraction.

    SUMMARY:

    The International Trade Administration inadvertently published a notice of Final Redetermination Pursuant to Court Remand in Wheatland Tube Co. v. United States, in the Federal Register on Tuesday, October 20, 2015 (80 FR 63537) (“Notice”). The Notice is hereby retracted from the Federal Register, and as such, the Notice should be disregarded.

    FOR FURTHER INFORMATION CONTACT:

    Cara Lofaro, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5720.

    Dated: October 23, 2015. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2015-27777 Filed 10-29-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE285 Presidential Task Force on Combating Illegal Unreported and Unregulated (IUU) Fishing and Seafood Fraud Action Plan AGENCY:

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

    ACTION:

    Notice of Determination.

    SUMMARY:

    The National Ocean Council Committee on IUU Fishing and Seafood Fraud (NOC Committee) has finalized principles for determining seafood species at risk of IUU fishing and seafood fraud (at-risk species) and a list of at-risk species developed using the principles.

    DATES:

    List of principles and at-risk species is final upon October 30, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Danielle Rioux, Office of Sustainable Fisheries, National Marine Fisheries Service (phone 301-427-8516, or email [email protected]).

    SUPPLEMENTARY INFORMATION:

    According to NOAA statistics, in 2013, U.S. fishers landed 9.9 billion pounds of fish and shellfish worth $5.5 billion. Illegal, unreported, and unregulated (IUU) fishing and seafood fraud undermine the sustainability of U.S. and global seafood stocks and negatively impact general ecosystem health. At the same time, IUU fishing and fraudulent seafood products distort legal markets and unfairly compete with the products of law-abiding fishers and seafood industries globally. On March 15, 2015, the Presidential Task Force on Combating IUU Fishing and Seafood Fraud (Task Force), co-chaired by the Departments of Commerce and State, took an historic step to address these issues and published its Action Plan for Implementing Task Force Recommendations (Action Plan).

    The Action Plan

    (http://www.nmfs.noaa.gov/ia/iuu/noaa_taskforce_report_final.pdf) articulates the proactive steps that Federal agencies will take to implement the recommendations the Task Force made to the President in December 2014 on a comprehensive framework of integrated programs to combat IUU fishing and seafood fraud. The Action Plan identifies actions that will strengthen enforcement, create and expand partnerships with state and local governments, industry, and non-governmental organizations, and create a risk-based traceability program to track seafood from harvest to entry into U.S. commerce, including through the use of existing traceability mechanisms. The scope of action anticipated through the Action Plan approaches IUU and fraudulently-labeled seafood at the Flag State, Port State, and Market State levels. The work the Task Force began continues under the oversight of the NOC Committee, established in April 2015.

    This final notice is one of several steps in the plan to implement Task Force Recommendations 14 and 15, identifying “species of fish or seafood that are presently of particular concern because they are currently subject to significant seafood fraud or because they are at significant risk of being caught by IUU fishing.” To begin implementing these recommendations, the NOC Committee created a Working Group (Working Group), led by NOAA and composed of members from partner agencies: Department of State, Food and Drug Administration, Department of Homeland Security, Customs and Border Protection, and the Office of the U.S. Trade Representative.

    As the first step, the NOC Committee, through the Working Group, solicited public input through a Federal Register notice (80 FR 24246, April 30, 2015) on what principles should be used to determine the seafood species at risk of IUU fishing or seafood fraud. Public input was received both in writing and through webinars. Taking into consideration comments received, the Working Group developed draft principles and a draft list of at-risk species based on those principles. These principles and the draft list were then published in a Federal Register notice (80 FR 45955, August 3, 2015) to solicit additional public comment. This public comment period was extended through Federal Register notice (80 FR 50270, August 19, 2015) until September 11, 2015. The Working Group considered public input received during the public comment period and developed final principles to determine seafood species at risk of IUU fishing or seafood fraud and a final recommended list of at risk species.

    This publication is the NOC Committee's transmission of the list of species at risk of IUU fishing and seafood fraud to the agencies charged with implementing the Task Force recommendations for appropriate action, as requested in the Action Plan, as well as notification to the public. The list does not impose any legal requirements, but will inform the first phase of the risk-based seafood traceability program, as described in the Action Plan. The traceability program itself will be developed through notice-and-comment rulemaking, pursuant to the Magnuson-Stevens Fishery Conservation and Management Act, and that rulemaking will address data requirements, the design of the program, and the species to which the first phase of the program will be applied. Implementation and enforcement of the traceability program may require engagement of additional U.S. agencies.

    Principles for Determining Species at Risk of IUU Fishing and Seafood Fraud

    To develop principles, the Working Group considered public comments received through both public comment periods. The Working Group evaluated the strength and utility of various principles as indicators for potential risk of IUU fishing or seafood fraud as well as their measurability and the robustness of data available to assess them. The Working Group minimized overlap of principles to ensure that a species' alignment with several principles does not overstate associated risk, and also to distinguish between risk of IUU fishing and risk of seafood fraud. The Working Group then applied the principles to a base list of species to develop the list of species at risk of IUU fishing or seafood fraud.

    Based on the Working Group's evaluation and synthesis of comments received through both public comment periods, the final principles are listed below. Species and species groups were evaluated using these principles:

    Enforcement Capability: The existence and effectiveness of enforcement capability of the United States and other countries, which includes both the existing legal authority to enforce fisheries management laws and regulations and the capacity (e.g., resources, infrastructure, etc.) to enforce those laws and regulations throughout the geographic range of fishing activity for a species.

    Catch Documentation Scheme: The existence of a catch documentation scheme throughout the geographic range of fishing activity for a species, and the effectiveness of that scheme if it exists, including whether a lack of proper documentation leads to discrepancies between total allowable catch and trade volume of a species.

    Complexity of the Chain of Custody and Processing: Consideration of transparency of chain-of-custody for a species, such as the level of transshipment (in this context, the transfer of fish from one vessel to another, either at sea or in port) for a species, as well as the complexity of the supply chain and extent of processing (e.g., fish that goes across multiple country borders or fish that is commonly exported for processing or that is sold as fillet block vs. whole fish) as it pertains to comingling of species or catch.

    Species Misrepresentation: The history of known misrepresentation of a species related to substitution with another species, focused on mislabeling or other forms of misrepresentation of seafood products.

    Mislabeling or Other Misrepresentation: The history of known misrepresentation of information other than mislabeling related to species identification (e.g., customs misclassification or misrepresentation related to country of origin, whether product is wild vs. aquaculture, or product weight).

    History of Violations: The history of violations of fisheries laws and regulations in the United States and abroad for a species, particularly those related to IUU fishing.

    Human Health Risks: History of mislabeling, other forms of misrepresentation, or species substitution leading to human health concerns for consumers, including in particular, incidents when misrepresentation of product introduced human health concerns due to different production, harvest or handling standards, or when higher levels of harmful pathogens or other toxins were introduced directly from the substituted species.

    Application of Principles

    Given the large number of seafood species that are domestically landed or imported, the Working Group created a base list of species for evaluation using several factors: (1) The value of domestic landings and imports (all seafood species with an imported or domestically-landed value over $100 million USD in 2014 were included on the base list); (2) species identified by the Working Group due to a high cost of product per pound (which could increase the incentive for IUU fishing and fraud); and (3) species proposed based on the expertise of representatives from the Working Group agencies. In some cases, the Working Group combined related species together in its analysis (e.g., shrimp), because the supporting data utilized nomenclature which made further analytical breakouts unworkable. In other cases, the working group was able to target species within larger species groups (e.g. red snapper), based on commercial and marketplace significance.

    The Working Group determined that data from the past five years was the appropriate timeframe for decision-making because a longer timeframe might not reflect improvements that have been made in some fisheries over time and a shorter timeframe might not include sufficient data to identify risks to certain species.

    The resulting list of species and groups analyzed by applying the principles listed above is set forth below. Note that this list is not the list of at-risk species to which the first phase of the traceability program will be applied:

    Abalone; Billfish (Marlins, Spearfishes, and Sailfishes); Catfish (Ictaluridae); Cod, Atlantic; Cod, Pacific; Crab, Blue; Crab, Dungeness; Crab, King; Crab, Snow; Dolphinfish (Mahi Mahi); Oyster; Grouper; Haddock; Halibut, Atlantic; Halibut, Pacific; Lake or Yellow Perch; Lobster; Mackerel; Menhaden; Opah; Orange Roughy; Red Drum; Red Snapper; Sablefish; Salmon, Atlantic; Salmon, Chinook; Salmon, Chum; Salmon, Coho; Salmon, Pink; Salmon, Sockeye; Scallop; Sea bass; Sea cucumber; Shrimp; Sharks; Sole; Squid; Sturgeon caviar; Swordfish; Tilapia; Toothfish; Tunas (Albacore, Bigeye, Bluefin, Skipjack, Yellowfin); Wahoo; Walleye (Alaskan) Pollock; Pacific Whiting.

    Based on public comments received on the draft list of at-risk species, the following eight additional species/species groups were also analyzed according to the principles described above: Anchovies; Eels; Flounder (Southern and Summer); Octopus; Queen Conch; Weakfish; Skates and Rays.

    Both imported and domestically-landed species were evaluated using the same principles, data sources and methodology, as described below. Principles were not weighted and were evaluated evenly. Additionally, the Working Group considered the interaction of principles to be important. For example, the interaction between the enforcement capability, and history of violations was important when evaluating species. The presence or absence of one principle (e.g., catch documentation scheme) was not determinative in making the at-risk assessment.

    The following Federal agency offices contributed to the analysis of the list of species: the Office of Marine Conservation, Bureau of Oceans and International Environmental Affairs, Department of State; Office of the Under Secretary for Economic Growth, Energy, and Environment, Department of State; Office of International Affairs and Seafood Inspection, National Marine Fisheries Service, NOAA, Department of Commerce; Office of Sustainable Fisheries, National Marine Fisheries Service, NOAA, Department of Commerce; Office of Science and Technology, National Marine Fisheries Service, NOAA, Department of Commerce; Office of Law Enforcement, National Marine Fisheries Service, NOAA, Department of Commerce; Office of General Counsel, Enforcement Section, NOAA, Department of Commerce; and Office of General Counsel, Fisheries and Protected Resources Section, NOAA, Department of Commerce; U.S. Customs and Border Protection; U.S. Department of Homeland Security; Division of Seafood, Office of Food Safety, Food and Drug Administration; Office of Analytics and Outreach, Food and Drug Administration; Office of Compliance, Food and Drug Administration; Office of Environment and Natural Resources, U.S. Trade Representative; Office of General Counsel, U.S. Trade Representative. Resources from these offices, including data and expertise, drove the analysis and application of principles. Additional information used was from U.S. government-verifiable sources, such as data gathered by Regional Fisheries Management Organizations to which the United States is a member and whose scientific data is developed and reviewed with active U.S. government participation.

    Sub-working groups composed of subject matter experts from the agencies listed above were created to complete the analyses of each species under each individual principle. The Working Group then combined the analyses done by the sub-working groups to determine which species were most at risk of IUU fishing and seafood fraud. The Working Group noted that the suite of risks posed to species varied not only in terms of which risks affected which species, but also in terms of the scale of the risks. For example, a single documented case of species substitution for a species that is sold in high volumes was considered differently than one case for a species rarely found in U.S. markets.

    Additionally, as the Working Group discussed the suite of risks associated with the principles, a relationship became evident between the enforcement capability associated with a species and the history of violations. In many cases, a history of violations was indicative of a strong enforcement capability for a species. Conversely, for some species, a lack of violations history may have been due to an in-ability to detect or prosecute violations.

    After the second round of public comment, the Working Group reconvened to discuss the eight new species or species groups added to the analysis in response to public comments plus new, relevant, U.S. government-verifiable information from the past five years applicable to species already analyzed. Based upon these discussions, the list of species now deemed to be at risk of IUU fishing and seafood fraud has been modified from the draft list.

    Species at Risk of IUU Fishing and Seafood Fraud

    The Working Group recognizes that all species of fish can be susceptible to some risk of IUU fishing or seafood fraud due to the inherent complexities in the fishing industry and supply chain. However, the species list has been developed to identify species for which the current risks of IUU fishing or seafood fraud warrant prioritization for the first phase of the traceability program. Pursuant to the Action Plan, implementation of the first phase of the traceability program will be regularly evaluated, beginning with a report to be issued by December 2016, in order to determine “whether it is meeting the intended objectives and how it can be expanded to provide more information to prevent seafood fraud and combat IUU fishing.”

    Based on its evaluation, the Working Group identified the following list of species or species groups at risk of IUU fishing and seafood fraud, in alphabetical order. (Appendix A to this final notice lists the scientific names for these species and/or species groups.) Brief summaries of the Working Group findings are presented here. Detailed presentation of the data considered by the Working Group and its deliberations is protected from disclosure because of data confidentiality and enforcement implications.

    Abalone: Abalone is considered to be at-risk due to enforcement concerns. The fishery has a history of poaching, and there is a known black market for this expensive seafood. The fishery is primarily conducted by small vessels close to shore, and does not require specialized gear, which makes it difficult to detect illegal harvest, despite some enforcement capability. In addition to the IUU fishing risks for abalone, there is a history of species substitution where topshell is fraudulently marketed as abalone.

    Atlantic Cod: Atlantic cod has been the subject of species substitution with other white fish, and mislabeling due to over-glazing (ice coating), and short-weighting. Despite enforcement capability, Atlantic Cod have been targets of IUU fishing in parts of the geographic range of the species. Additional IUU fishing risk is tied to a lack of an effective catch documentation scheme throughout the geographic range of fishing activity, despite rigorous reporting requirements in some areas including the United States.

    Blue Crab: Atlantic Blue crab is sold in a number of different forms from live animals to significantly processed crab meat. In the crabmeat product form species identification is only possible through DNA testing. There is a strong history of both species substitution and mislabeling. Blue crab has been substituted or co-mingled with swimming crab, which is native to Southeast Asia. The mislabeling history is largely associated with misidentification of product origin, with crab from other locations sold as “Maryland crab,” although there have also been incidents of short-weighting in the sale of crab meat.

    Dolphinfish: Dolphinfish (also known as Mahi Mahi) is associated with a lack of enforcement capability and lacks a catch documentation scheme throughout the geographic range of fishing activity, which make it vulnerable to IUU fishing. Some dolphinfish is transshipped prior to entry into the United States, and there is concern over mislabeling associated with product origin. In addition, there is a history of species substitution, in which yellowtail flounder has been sold as dolphinfish.

    Grouper: Grouper refers to a group of species in the family Serranidae that are legally fished and sold under the names grouper and spotted grouper. Grouper, as a species group, has a history of fisheries violations, and lacks a catch documentation scheme throughout the geographic range of fishing activity for the species group. Additionally, this global species is transshipped, and processed both at the local level and at regionally-located or third-country processing plants. Grouper has a strong history of species substitution, including substitution using seafood that is of human health concern, such as escolar (which has a Gempylotoxin hazard).

    King Crab (red): King crab (red) has a significant history of fisheries violations, and insufficient enforcement capability in some parts of the world. Additional IUU fishing risk is tied to the lack of an effective catch documentation scheme throughout the geographic range of fishing activity, despite rigorous reporting requirements in some areas, including the United States. King crab is at risk of seafood fraud, mostly due to misrepresentation of product origin, as well as some species substitution. Further, King crab is often transshipped before entering the United States, which increases the IUU fishing and seafood fraud risks.

    Pacific cod: Pacific cod is a species at risk of IUU fishing despite significant enforcement capability associated with this fishery. Pacific cod is a target of global IUU fishing operators and has a clear history of fishing violations. It is also subject to highly globalized processing and transshipment. Additional IUU fishing risk is tied to a lack of an effective catch documentation scheme throughout the geographic range of fishing activity, despite rigorous reporting requirements in some areas including the United States. In addition, as with Atlantic cod, there is a history of species substitution using other white fish and concerns over mislabeling associated with over-glazing (ice coating) and short-weighting.

    Red Snapper: Red Snapper is at risk of IUU fishing, based upon the history of fisheries violations, as well as the lack of a catch documentation scheme throughout the geographic range of fishing activity, despite rigorous reporting requirements in some areas including the United States. There are also enforcement capability concerns for red snapper throughout the full geographic range of fishing activity for the species. Additionally, there is a strong history of species substitution with some of the substituted species (e.g., rockfish, porgy, other snappers) presenting a risk to human health due to parasites and natural toxins.

    Sea Cucumber: Sea cucumber is an IUU fishing concern, due to the lack of enforcement capability and known illegal harvesting and smuggling associated with this species. This species also lacks a catch documentation scheme throughout the geographic range of fishing activity and is subject to a significant amount of transshipment. Although sea cucumber is often sold live, it can also be processed into a dried product for preservation. There are mislabeling concerns for sea cucumber, often tied to falsification of shipping and export documentation to conceal illegally-harvested product.

    Sharks: “Sharks,” as included on the at-risk species list, refers to a group of species that are often sold as fins, with some species also sold as steaks or filets. Depending upon the product form, differentiating between species in this broad group is a challenge without identification guides or DNA testing. This led the Working Group to group all shark species together to assess risks. Sharks as a species group have a history of fishing violations because they are processed and transshipped, and there is a lack of enforcement capability throughout the geographic range of fishing activity. There is a global trade in shark fins that is a known enforcement concern. In addition to the IUU fishing risks associated with sharks, there are fraud concerns tied to the sale of imitation shark fin, which has been labeled as shark fin.

    Shrimp: Shrimp is produced through both aquaculture and wild harvest. The Working Group found that shrimp is at risk of IUU fishing activity due to the history of fishery violations. Shrimp is also often processed and co-mingled, which can make it vulnerable to seafood fraud. There is a significant amount of mislabeling and/or misrepresentation of shrimp, tied largely to misrepresentation of weight, including where product has been treated with Sodium Tripolyphosphate to increase water retention (the lack of labeling is fraudulent, not the use of Sodium Tripolyphosphate). Mislabeling is also a concern because aquacultured product is sometimes labeled as wild caught and product origin is sometimes falsified. Additionally, there is a history of substitution of one species of shrimp for another when imports cross the border into the United States.

    Swordfish: Swordfish are at risk of both IUU fishing and seafood fraud. Swordfish are a highly migratory species and their range crosses numerous jurisdictions, including the high seas. There is a history of fisheries violations in certain swordfish fisheries and regions, in addition to a lack of enforcement capability. The United States does, however, implement a statistical document program for swordfish pursuant to the International Commission for the Conservation of Atlantic Tunas (ICCAT) to help mitigate IUU fishing and seafood fraud risk. This document is required for all swordfish product entering the United States, regardless of the product form or ocean area where it was harvested, although it does not provide the full range of information that would likely be expected in a traceability program, particularly for fish harvested outside the Atlantic, which are not a part of the program. Swordfish is commonly transshipped and is also at risk of species substitution with mako shark.

    Tunas: Tunas are a high volume and high value species group that includes five main species: Albacore, bigeye, skipjack, yellowfin, and the bluefins. There is a history of fisheries violations in certain tuna fisheries and in certain regions. Further, harvesting, transshipment, and trade patterns for tunas can be complex, in particular for certain value-added products. While there are multilateral management and reporting measures in place for many stocks within the tuna species group, these management and reporting mechanisms vary in terms of information standards and requirements and some do not provide a complete catch documentation scheme. Tunas are also subject to complicated processing that includes comingling of species and transshipments. Further, there is a history of some species substitutions, with most instances involving substitution of one tuna species for another. Additionally, there have also been instances of escolar, which can contain a toxin, being substituted for albacore tuna.

    The Working Group sought public comment specifically on how to narrow the scope of tunas on the list of at-risk species. Public comment received highlighted that the risk levels vary greatly depending on species. The Working Group further discussed the variability of the risk levels for IUU fishing and seafood fraud on a species by species basis. The Working Group has determined that Bluefin tuna species are at a lower risk of IUU fishing and seafood fraud than other tuna species and has determined that it should not be included on the list of at-risk species. This decision reflects our conclusion that two of the principles analyzed demonstrate that there is a lower risk of IUU and seafood fraud as compared to other tunas. First, there are robust catch documentation scheme in place for Atlantic bluefin tuna and Southern bluefin tuna entering the U.S. market, which are implemented through Regional Fisheries Management Organizations. Bluefin tuna was historically a target of IUU fishing and thus had a catch documentation scheme implemented for two of the three species world-wide, which are the two species comprising the vast majority of Bluefin that enters U.S. Commerce. A catch documentation scheme is under development for Pacific Bluefin tuna. The existing catch documentation scheme for Bluefin tuna does not eliminate all risk of IUU fishing, but it mitigates the risk to a low level. Second, Bluefin tuna does not have the history of species substitution that other tunas have, in part because of its different color and texture compared to other tunas, as well as the sophistication of Bluefin buyers, in discerning Bluefin from other fish. Although the Working Group recognizes that there may be further variance in risk level among the three Bluefin species, we have chosen to remove all three stocks, so as not to create any incentive for new species substitution schemes among the three Bluefin species.

    Programs To Mitigate Risk

    Through the application of the principles for determining at-risk species, the Working Group identified two species—toothfish and catfish—that had a number of risk factors for IUU fishing or seafood fraud but, due to mechanisms to address those risks, are not being listed as at-risk species in this Notice.

    Toothfish has been known, historically, as a species with IUU fishing concerns, which led to the development, by the Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR), of a number of monitoring tools including a comprehensive catch documentation scheme. Without the existing level of reporting, documentation, and enforcement capability, including through measures adopted by CCAMLR, for this species, the Working Group would have found it to be at-risk.

    The Working Group found that while existing measures do not eliminate risk for toothfish, they mitigate the IUU fishing and seafood fraud risks to such a level that the Working Group is not listing toothfish as an at-risk species for the first phase of the traceability program.

    In the United States, seafood sold as catfish must be from the family Ictaluridae per section 403(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t)). There is a strong history of species substitution, in which non-Ictaluridae species are sold as catfish. Some of this species substitution has been tied to Siluriformes species, which could have a drug hazard associated with them, as well as other species that have been found contaminated with prohibited chemicals and pharmaceuticals. In addition to species substitution, there is a history of other mislabeling issues, including product origin and failure to accurately label product that has been treated with carbon monoxide.

    These risks were discussed and are fully recognized by the Working Group. However, there is a rulemaking on catfish inspection (http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201410&RIN=0583-AD36) under development, separate from the NOC Committee and Working Group actions. Once in effect, this pending rulemaking may mitigate risks identified by the Working Group. Taking into consideration the underlying principle of the Task Force to maximize the use of existing resources and expertise from across the federal government through increased federal agency collaboration, the Working Group did not include catfish on this initial list of at-risk species.

    Summary of Comments in Response to Draft Principles and Draft List of At-Risk Species (80 FR 45955, August 3, 2015)

    In response to the August 3, 2015, Federal Register notice (described above), and following outreach to foreign nations, the Working Group received 101 unique written comments from fishing industry groups both domestic and abroad, non-governmental organizations, foreign nations, and interested citizens. The comments covered a breadth of issues pertaining to seafood traceability. The Working Group considered all public comments, and has provided responses to all relevant issues raised by comments below. We have not responded to comments that were outside the scope of the public comment request and that may be more relevant to future steps in the process, e.g., the pending rulemaking on the design and implementation of the traceability system.

    1. Decision-making Transparency

    Comment: The Working Group received numerous public comments requesting additional information on what data was used in making the species risk determinations, as well as what experts were a part of the process.

    Response: This notice specifies all government offices that contributed data and expertise. The data came from across the U.S. Federal government and included government-verifiable data, such as that of certain Regional Fisheries Management Organizations. As noted earlier, details of the results have not been included because much of the data reviewed are sensitive and/or confidential, and could compromise the integrity of individual businesses, systems or enforcement capability if released.

    2. Approach for Analysis Should Be Quantitative

    Comment: We received comment that the application of principles should be quantitative, and use numbers and a systematic data driven approach.

    Response: The Working Group partially agrees. We used systems and expertise to apply the principles for determining seafood species at-risk of IUU fishing or seafood fraud evenly, and did not give any individual principle more weight than another. The application of these principles was not entirely quantitative, however, as some of the information we used was not quantitative. Incidents of illegal fishing and incidents of fraudulent activity vary in scope and scale from one to the next and the differences cannot be numerically calculated.

    3. Data Used Should Be From a Longer Time Period

    Comment: The Working Group received public comment that a longer time horizon would afford more data on violations and more ability to see trends over time.

    Response: The Working Group agrees that looking at a longer time horizon would produce more data from the databases utilized; however it would potentially decrease the accuracy of the determination regarding current risk. There have been efforts made in most fisheries to decrease the level of risk, and the Working Group does not think that data from further back than five years accurately depicts the current status of fisheries.

    4. Using Additional Authorities

    Comment: Comment was received regarding the legal authorities for the rulemaking and regulatory process that will implement a seafood traceability program for the species listed as at-risk.

    Response: This comment is outside the scope of this public comment request. The rulemaking process will provide an opportunity for public comment on the proposed seafood traceability program and this comment would be more appropriately directed toward that process.

    5. Country Specific Risk/Country of Origin Based

    Comment: The Working Group received numerous comments, including from many foreign nations that species risk should be tied to country of origin.

    Response: The Working Group acknowledges that the risk of IUU fishing will vary depending on the origin of catch and country of processing. However, the Working Group used enforcement capability and history of fisheries violations when determining the at-risk species to capture this element of the risk analysis because these more directly represent risk. These principles already take into account fisheries identified in NOAA's biennial report to Congress as implicated in IUU fishing (see 16 U.S.C. 1826h). In addition, the Working Group does not believe it is useful or appropriate to establish a principle based on country of origin.

    6. Vessel Specific

    Comment: The Working Group received a comment that the risk level and the application of the traceability program should be vessel specific, as that is the appropriate level at which to assess risk.

    Response: The Working Group used history of fisheries violations as a principle, which covers incidents from all vessels.

    7. Equality

    Comment: Numerous comments were received regarding equality. The majority of the comments received were tied to equality from one nation to another. These comments included requests that countries be treated equally in the analysis for identifying at-risk species, as well as comments outside of the scope of this comment request, pertaining to the equal and evenhanded implementation of the pending traceability program.

    Response: The Working Group applied each of the principles for determining risk level evenly and equally. The principles were applied equally to domestically-landed species and imported species.

    8. IUU Fishing Should Be Separate From Seafood Fraud

    Comment: The working group received a couple of comments that seafood fraud and IUU fishing are separate and should be analyzed as such.

    Response: The Working Group agrees and recognizes the difference between IUU fishing and seafood fraud. We recognize that, for example, they may occur at different points in the supply chain from harvest to entry into U.S. commerce; however the Working Group believes they are a part of the same system. The Working Group developed principles, informed by public comment, which are specific to the different components. For example, under the principles applied by the Working Group, the history of fishery violations is specific to the concept of IUU fishing, whereas species misrepresentation is specific to seafood fraud. When analyzing a species, the Working Group applied each principle individually and then analyzed the resulting findings across the supply chain for both IUU fishing and seafood fraud.

    9. Enforcement of Existing Laws

    Comment: Public comment encouraged the enforcement and application of existing laws before creating new laws.

    Response: This notice, which identifies at-risk species, does not, in and of itself, create any new legal requirements. Establishment of the seafood traceability program through a future rulemaking, as well as the resources devoted to implementation of current laws, are outside the scope of this comment request.

    10. Combatting IUU Fishing Requires Focus on Flag State, Port State, and Market State

    Comment: The Working Group received comment that proposing a list of at-risk species and the following implementation of a seafood traceability program focuses solely on the market drivers of IUU fishing and seafood fraud, and does not approach Flag State and Port State measures. The commenter stated that all three are critical components to combatting IUU fishing and seafood fraud, and that a narrow focus would limit effectiveness.

    Response: The Presidential Task Force on Combatting IUU Fishing and Seafood Fraud Action Plan contains 15 recommendations. This series of Federal Register notices pertained only to one component of recommendation 15, the identification of principles for determining at-risk species and the initial list of at-risk species. Other Task Force recommendations focus on Flag State and Port State measures, from actions on enforcement capacity building to working on obtaining entry into force of the Port State Measures Agreement.

    11. Biological Vulnerability/Overfished/Overfishing Should Be a Principle

    Comment: The Working Group received comments requesting that a principle for determining at-risk species be tied to the biological vulnerability and/or status of a species. Commenters note that as a species is overfished, the risk of IUU fishing can increase.

    Response: The Working Group acknowledges that the sustainability of fisheries resources is a priority for NOAA under the Magnuson-Stevens Fishery Conservation and Management Act (MSA), 16 U.S.C. 1801 et seq. Some vulnerable species identified in public comments such as sharks, sturgeon caviar, and abalone were added to the base list and analyzed by the Working Group. The Working Group agrees that as legal catch limits on a species are tightened, the incentive for IUU fishing often increases. However, the main focus of this process is to identify species at risk of IUU fishing or seafood fraud and enforcement capability and history of violations are better indicators of IUU fishing risk than species sustainability.

    12. Gear-Type

    Comment: The Working Group received a comment that the risk of IUU fishing is tied to gear type, and that gear type should be a principle for determining at-risk species.

    Response: The Working Group acknowledges that fishing gear used in IUU fishing can sometimes include illegal gear types that are indiscriminate and can have higher environmental impacts than legal gear types. However, the Working Group does not believe that gear type alone is a sufficiently strong determinant of IUU fishing or seafood fraud risk, and use of illegal gear types was covered through the information collected on enforcement capability and history of violations.

    13. Human Rights and/or Human Trafficking Concern

    Comment: Numerous comments were received recommending that a history of human rights violations or human trafficking concerns should be a principle used to identify species at risk of IUU fishing and seafood fraud.

    Response: Human rights and human trafficking are issues in the fishing industry that warrant consideration and action, but are not in and of themselves determinative of IUU fishing and seafood fraud. The Administration is addressing these issues in a variety of ways. On March 15, 2012, President Obama called on his cabinet to strengthen federal efforts to combat human trafficking and to expand partnerships with civil society and the private sector. The President's Interagency Task Force to Monitor and Combat Trafficking in Persons (PITF) and its operational arm, the Senior Policy Operating Group (SPOG), bring together federal departments and agencies to ensure a whole-of-government approach that addresses all aspects of human trafficking—enforcement of criminal and labor laws, development of victim identification and protection measures, support for innovations in data gathering and research, education and public awareness, enhanced partnerships and research opportunities, and strategically linked foreign assistance and diplomatic engagement. For more information on the Administration's effort to combat Trafficking of Persons, please visit http://www.state.gov/j/tip/response/usg/.

    14. Transparency of Vessel Ownership

    Comment: The Working Group received comment recommending that the transparency of vessel ownership be used as a principle for determining species at risk of IUU fishing and seafood fraud. The comment suggests that convoluted vessel ownership and flags of convenience are often tied to IUU fishing.

    Response: The Working Group agrees with the potential correlation between vessel ownership transparency and the potential for IUU fishing. This was addressed in the Working Group's discussions about enforcement capability; however there is not sufficient data available to analyze this as a principle for determining at-risk species.

    15. Complex Chain of Custody

    Comment: The Working Group received multiple comments on using the complexity of the chain of custody as a principle for determining IUU fishing risk. Many commenters agreed with the inclusion of this as a principle, while another group suggested there was no connection between IUU fishing and chain-of-custody complexity. The latter group requested more information on the relationship between the level of processing or chain-of-custody complexity and the risk of IUU fishing. We also received public comment stating that the two are not related, and thus this principle should not be used to determine at-risk species.

    Response: The Working Group does not believe that a complex chain of custody or high level of processing necessarily signifies fraudulent product or a connection to IUU fishing. In the more complex chains of custody, however, there are more opportunities for mixing illegally caught fish with legally caught fish, and for mislabeling, thereby increasing the risk of IUU fishing or seafood fraud. Transshipments make tracking the chain of custody harder and present opportunities to commingle legally and illegally caught fish. Seafood that undergoes a high amount of processing and enters U.S. Commerce through a long chain of custody may often be legal and not fraudulent, but that does not negate the increased risk. Therefore, the Working Group had retained complexity in the chain of custody as a principle for determining at-risk species.

    16. Harmful Antibiotics and Human Health Risk

    Comment: The Working Group received comment requesting that in the application of the human health risk principle, we extend our assessment of risk to harmful antibiotic use.

    Response: The application of the human health risk principle did include the use of harmful or unlawful antibiotic use. This principle does not, however, include the use of legal and non-harmful antibiotic use in aquaculture practice.

    17. Weighting of Principles

    Comment: The Working Group received public comment both requesting clarification on whether we weighted some principles more heavily than others, as well as comment requesting that we do so.

    Response: The Working Group considered all of the principles without giving weights to them. The discussion for each species evaluated covered all of the principles and the findings associated for each, and the Working Group reviewed the suite of risks as a whole picture, without any one principle having a designated higher level of importance.

    18. Number of Species

    Comment: The Working Group received comments requesting both that all species be part of the first phase of the pending traceability program as well as comments requesting that the list of at-risk species be limited to two to three species.

    Response: The Action Plan specifies that the Working Group is to prioritize species at risk of IUU fishing and seafood fraud in the first phase of a seafood traceability program that could eventually be expanded to cover all species. As directed by the Task Force, the Working Group completed a data driven analysis and listed species determined to be most at risk of IUU fishing or seafood fraud. This exercise was not predicated on creating a list with a certain number of species, rather the focus was on the most at-species, regardless of the numerical results.

    19. The Substitute Species Should Be Tracked (e.g., Blue Swimming Crab)

    Comment: Public comment received recommended that the traceability program track both the at-risk species and the species that are substitutes for those targets. For example, Atlantic Blue Crab is on the list of at-risk species, in part because Blue Swimmer Crab is known to be mislabeled and fraudulently marketed under the Atlantic Blue Crab name. The recommendation from public comment is that both are at-risk of seafood fraud and, therefore, both the target and the substitute should be tracked.

    Response: The Working Group believes that the species at risk of fraud is the one that other species are used to imitate and that, at this time, tracking of the target species is the most efficient approach.

    20. Aquaculture Species

    Comment: Commenters requested that aquaculture species be exempt from the pending traceability program, and removed from the list of at-risk species because aquacultured species are not subject to IUU fishing.

    Response: Both wild caught and aquacultured seafood can be at risk of seafood fraud (e.g., farmed shrimp mislabeled as wild-caught) and therefore both are included on the list of at-risk species.

    21. Consistency and Coordination With the Marine Mammal Rule

    Comment: Public comment was received regarding the relationship between this list of at-risk species, the pending seafood traceability program, and the proposed rulemaking promulgated under the Marine Mammal Protection Act (MMPA). The proposed MMPA rule aims to reduce marine mammal bycatch associated with commercial fishing operations. Under the proposed MMPA rule, nations wishing to export fish and fish products to the United States must demonstrate they have a regulatory program for reducing marine mammal incidental mortality and serious injury that is comparable in effectiveness to the U.S. program.

    Response: The MMPA proposed rulemaking is focused on reducing marine mammal bycatch, unlike this Federal Register Notice, which identifies species at risk of IUU fishing and seafood fraud. However, NOAA recognizes the importance of ensuring that its programs are consistent and coordinated.

    22. “High Volume,” “High Visibility”

    Comment: A commenter requested clarification regarding the meaning of the terms “high volume” and “high visibility” species when referring to tunas, in the Federal Register notice with the draft list of at-risk species.

    Response: In using those terms, the Working Group was trying to highlight that this is a popular group of species in the U.S. market. Tuna is a high volume import, and the text should have read that is it also a “high value” species.

    23. Use Scientific Names

    Comment: The Working Group received numerous comments requesting that scientific names be used to in the list of at-risk species, for greater clarity.

    Response: The Working Group agrees with this comment, and has included an appendix of the scientific names for the at-risk species.

    24. Government Resources

    Comment: Comments were received recommending that the U.S. government contribute adequate resources both domestically and in capacity building abroad to implement the pending traceability program effectively. A separate comment was also received stating that no additional government resources should be spent on implementing the pending program.

    Response: Implementation of the seafood traceability program is outside the scope of this Federal Register Notice, however, the Working Group notes that the Action Plan does not call for additional government resources for this effort.

    25. United Nations Food and Agricultural Organization (FAO) Catch Documentation Scheme

    Comment: The Working Group received comment that FAO has begun discussions about implementing a catch documentation scheme and that we should use their deliberations to inform our pending program.

    Response: The traceability program as outlined in the Action Plan is to be in at least two parts. The first phase applies to species most at risk of IUU fishing and seafood fraud and, by December 2016, an evaluation of the program will be conducted to inform a possible program expansion to all species. The FAO deliberations, if contemporary to the predetermined timeline for the U.S. program, could prove useful, as could additional work being contemplated by the FAO related specifically to traceability.

    26. Existing Efforts To Combat IUU Fishing and Seafood Fraud

    Comment: The public comment highlighted the importance of not duplicating efforts of existing programs and enforcement that target IUU fishing and seafood fraud.

    Response: The Working Group agrees, and the Presidential Task Force to Combat IUU Fishing and Seafood Fraud and the Action Plan both support the idea of coordination, not duplication.

    27. Third Party Certification

    Comment: The Working Group received public comment requesting clarification on whether third party certification (e.g., Marine Stewardship Council) would exempt product from the pending seafood traceability program. Comment was also received recommending that product should be exempt if it is certified by a third party.

    Response: Implementation of the traceability program, including any potential exemptions, is beyond the mandate of the Working Group and outside the scope of this Federal Register Notice. It will be addressed in the forthcoming rulemaking related to the traceability program.

    28. Fraud in the United States

    Comment: The Working Group received comments on the level of fraud that happens with seafood inside U.S. commerce, once seafood has entered into our markets. Comments requested information on how the pending traceability program will address the amount of fraud that happens once seafood is inside U.S. markets.

    Response: The scope of the traceability program is beyond the mandate of the Working Group and outside the scope of this Federal Register Notice. It will be addressed in the forthcoming rulemaking related to the traceability program.

    29. Chain of Custody Principle Discriminates Against Imports

    Comment: One commenter noted that using complex chain of custody as a principle will discriminate against imports.

    Response: The Working Group disagrees. The Working Group considered the frequency of transshipment, complexity of processing, and complexity of the supply chain (especially with respect to the potential for fish to be comingled) equally for domestically-harvested and imported fish.

    30. Carbon Monoxide

    Comment: One comment was received concerning the use of carbon monoxide to improve the color of fish to make it appear fresh. The commenter was concerned that this practice creates an unfair market for local seafood that is fresh and untreated with carbon monoxide. Another commenter was concerned about our inclusion of carbon monoxide as an example of fraud, as it is legal to use.

    Response: The Working Group recognizes the concerns raised by these comments. The use of carbon monoxide is legal; however, the product must be labeled appropriately. The mislabeling principle addressed the fraudulent practice of failing to properly label product that has been treated.

    31. Tripolyphosphate

    Comment: The Working Group received a comment that expressed concern about our inclusion of Tripolyphosphate as an example of fraud associated with shrimp, as it is legal to use.

    Response: The Working Group recognizes the concerns raised by these comments. The use of Tripolyphosphate is legal; however, the product must be labeled appropriately. The mislabeling principle addressed the fraudulent practice of failing to properly label product that has been treated.

    Canned Tuna

    Comment: Public comments noted that the majority of tuna in the United States is from canning companies that have industry-run traceability programs for contamination and human health reasons and thus have a lower level of IUU fishing and fraud risk.

    Response: The Working Group agrees that some canned tuna may have a lower level of IUU fishing and seafood fraud risk than other product forms. This is based both upon the existence and potential effectiveness of industry led traceability programs for canned tuna, and the fact that canned product that enters U.S. commerce as “dolphin safe,” is required to have a statement from the captain of the harvest vessel thus tying the product to the harvest vessel. The Working Group notes that the potentially lower level of risk for canned tuna products could be considered in the application of the data collections requirements of the forthcoming proposed traceability program or be addressed through the voluntary Trusted Trader Program to be developed by the Departments of Commerce and Homeland Security per Recommendations 14 and 15 of the Action Plan.

    32. Bioterrorism Act of 2002

    Comment: The Working Group received a comment requesting clarification on the relationship between the pending traceability program and this Bioterrorism Act of 2002.

    Response: The Bioterrorism Act of 2002 required FDA to establish requirements for the creation and maintenance of records needed to determine the immediate previous sources and the immediate subsequent recipients of food, (i.e., one up, one down). Such records are to allow FDA to address credible threats of serious adverse health consequences or death to humans or animals. Entities subject to these provisions are those that manufacture, process, pack, transport, distribute, receive, hold or import food. Farms and restaurants are exempt from these requirements.

    To carry out this provision in the Bioterrorism Act, the Food Safety Modernization Act (FSMA) was enacted and it included enhancing tracking and tracing of food and recordkeeping. Under FSMA, FDA, working with the U.S. Department of Agriculture (USDA) and State agencies, has established two product tracing pilot projects carried out by the Institute of Food Technologists (IFT). The projects will help determine which data are most needed to trace a product that is in the market back to a common source and, once the contaminated ingredient is identified, to trace the product forward to know where it has been distributed. IFT has recommended steps for traceability improvement, and the information is still under review and we cannot make any comparative analyses.

    33. Cooked Seafood

    Comment: The Working Group received comment requesting clarification as to whether the pending seafood traceability program would extend to cooked seafood, which is exempted from the Country of Origin Labeling (COOL) protocols.

    Response: The product types that will be a part of the program will be delineated in the traceability rule-making process and are beyond the scope of this Federal Register Notice.

    34. Base List of Species

    Comment: The Working Group received a public comment that the base list of species examined was skewed toward high value species, and the focus should be broadened to include mass-market fish.

    Response: Initially the Working Group looked at both high value and high volume fisheries, but many of the high volume fisheries were also high value fisheries. Generally the only high volume fisheries that did not meet the value threshold were from bait fish fisheries. Therefore, the Working Group concluded a separate look at high volume fisheries was not useful. There were a number of lower value, but higher volume (mass market), stocks analyzed using the standards noted as part of the base list. However, the level of risk associated with many of them did not warrant having them on a list of species at risk of IUU fishing and seafood fraud.

    35. European Union (EU) IUU Seafood Certification

    Comment: A number of comments included discussion of the EU approach to combatting IUU fishing, which is country-of-origin based, rather than species-based.

    Response: The Working Group is implementing the recommendations of the Presidential Task Force on Combatting IUU fishing and Seafood Fraud, which outlines a species specific approach as the basis for the first phase of the traceability scheme. As noted above, the Working Group does not believe it is appropriate to establish a principle based on country of origin. In addition, the U.S. government does not have active involvement with the EU country-based IUU fishing risk identification system. Therefore, the Working Group did not include a principle that would identify at-risk species based on whether they are associated with nations that have been issued a yellow or red card under the EU system. However, to the extent available, information generated or collected pursuant to the EU system that could be relevant to other principles used by the Working Group, such as enforcement capability and history of fisheries violations for specific species, was considered.

    36. Additional Species

    Comment: The Working Group received many comments requesting that additional species be added to the list of at-risk species. The additional species requested included: Anchovies, All Snappers, Eels, Flounder, Lobster, Mackerel, Pollock, Octopus, Salmon, Skates & Rays, Snow Crab, Squid, Totoaba, and Weakfish.

    Response: Lobster, Mackerel, Pollock, Salmon, Snow crab, and Squid were evaluated by the Working Group previously. The Working Group has confirmed that its earlier assessment of the species was accurate. Specific to the requests to have all snappers on the list, the Working Group determined that the species that is most at-risk for IUU fishing and seafood fraud is Red Snapper, and that the other snappers are generally used as a substitute for Red Snapper. Thus the Working Group did not expand the at-risk species to include all snappers. Totoaba, was requested for addition through public comment, but was not evaluated. Totoaba is listed as endangered under the Endangered Species Act (ESA), and is listed in Appendix 1 of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) as threatened with extinction. This listing eliminates legal trade and negates the need for including Totoaba on the list of at-risk species.

    The Working Group reviewed the following additional species, as suggested through public comments: Anchovies; Eels; Flounder (Southern and Summer); Octopus; Queen Conch; Weakfish; Skates and Rays. All of these species were evaluated using the same principles and methodology applied to the previously analyzed species. The Working Group did not find enough risk across the suite of principles to warrant adding any of the newly suggested species to the final list of at-risk species.

    37. Emphasis on Unregulated and Unreported Catch

    Comment: A comment was received suggesting the Working Group needed to increase attention on unregulated and unreported catch, while another comment suggested the Working Group needed to pay less attention to unregulated and unreported catch.

    Response: Illegal, unregulated and unreported catch all have negative impacts on the sustainability of fisheries and on legal fishing businesses across the world. In its analysis, the Working Group took into consideration unregulated and unreported catch concerns.

    Appendix 1 Common Scientific name
  • (to genus or to species)
  • Family Order
    abalone Haliotis spp Haliotidae GASTROPODA. albacore Thunnus alalunga Scombridae SCOMBROIDEI. Atlantic cod Gadus morhua Gadidae GADIFORMES. bigeye tuna Thunnus obesus Scombridae SCOMBROIDEI. blue crab Callinectes sapidus Portunidae BRACHYURA. dolphinfish Coryphaena hippurus Coryphaenidae PERCOIDEI. groupers Aethaloperca spp Serranidae PERCOIDEI. groupers Anyperodon spp Serranidae PERCOIDEI. groupers Caprodon spp Serranidae PERCOIDEI. groupers Cephalopholis spp Serranidae PERCOIDEI. groupers Cromileptes spp Serranidae PERCOIDEI. groupers Dermatolepis spp Serranidae PERCOIDEI. groupers Diplectrum spp Serranidae PERCOIDEI. groupers Epinephelus spp Serranidae PERCOIDEI. groupers Gracila spp Serranidae PERCOIDEI. groupers Hyporthodus spp Serranidae PERCOIDEI. groupers Mycteroperca spp Serranidae PERCOIDEI. groupers Plectropomus spp Serranidae PERCOIDEI. groupers Saloptia spp Serranidae PERCOIDEI. groupers Triso spp Serranidae PERCOIDEI. groupers Variola spp Serranidae PERCOIDEI. Pacific cod Gadus macrocephalus Gadidae GADIFORMES. red king crab Paralithodes camtschaticus Lithodidae ANOMURA. red snapper Lutjanus campechanus Lutjanidae PERCOIDEI. All Sea Cucumber Species, including the below list from the Food and Agricultural Organization sea cucumber Actinopyga spp Holothuriidae HOLOTHUROIDEA. sea cucumber Apostichopus spp Stichopodidae HOLOTHUROIDEA. sea cucumber Astichopus spp Stichopodidae HOLOTHUROIDEA. sea cucumber Athyonidium spp Cucumariidae HOLOTHUROIDEA. sea cucumber Australostichopus spp Stichopodidae HOLOTHUROIDEA. sea cucumber Bohadschia spp Holothuriidae HOLOTHUROIDEA. sea cucumber Cucumaria spp Cucumariidae HOLOTHUROIDEA. sea cucumber Heterocucumis spp Cucumariidae HOLOTHUROIDEA. sea cucumber Holothuria spp Holothuriidae HOLOTHUROIDEA. sea cucumber Isostichopus spp Stichopodidae HOLOTHUROIDEA. sea cucumber Molpadia spp Molpadiidae HOLOTHUROIDEA. sea cucumber Paradota spp Chiridotidae HOLOTHUROIDEA. sea cucumber Parastichopus spp Stichopodidae HOLOTHUROIDEA. sea cucumber Pearsonothuria spp Holothuriidae HOLOTHUROIDEA. sea cucumber Pseudocnus spp Cucumariidae HOLOTHUROIDEA. sea cucumber Pseudostichopus spp Synallactidae HOLOTHUROIDEA. sea cucumber Psolidium spp Psolidae HOLOTHUROIDEA. sea cucumber Psolus spp Psolidae HOLOTHUROIDEA. sea cucumber Staurocucumis spp Cucumariidae HOLOTHUROIDEA. sea cucumber Stichopus spp Stichopodidae HOLOTHUROIDEA. sea cucumber Thelenota spp Stichopodidae HOLOTHUROIDEA. sea cucumber Trachythyone spp Cucumariidae HOLOTHUROIDEA. All Shark Species (excluding skates and rays), including the below list from the Food and Agricultural Organization sharks Aculeola spp Squalidae SQUALIFORMES. sharks Alopias spp Alopiidae LAMNIFORMES. sharks Apristurus spp Scyliorhinidae CARCHARHINIFORMES. sharks Asymbolus spp Scyliorhinidae CARCHARHINIFORMES. sharks Atelomycterus spp Scyliorhinidae CARCHARHINIFORMES. sharks Aulohalaelurus spp Scyliorhinidae CARCHARHINIFORMES. sharks Brachaelurus spp Brachaeluridae ORECTOLOBIFORMES. sharks Carcharhinus spp Carcharhinidae CARCHARHINIFORMES. sharks Carcharias spp Odontaspididae LAMNIFORMES. sharks Carcharodon spp Lamnidae LAMNIFORMES. sharks Centrophorus spp Squalidae SQUALIFORMES. sharks Centroscyllium spp Squalidae SQUALIFORMES. sharks Centroscymnus spp Squalidae SQUALIFORMES. sharks Cephaloscyllium spp Scyliorhinidae CARCHARHINIFORMES. sharks Cephalurus spp Scyliorhinidae CARCHARHINIFORMES. sharks Cetorhinus spp Cetorhinidae LAMNIFORMES. sharks Chaenogaleus spp Hemigaleidae CARCHARHINIFORMES. sharks Chiloscyllium spp Hemiscylliidae ORECTOLOBIFORMES. sharks Chlamydoselachus spp Chlamydoselachidae HEXANCHIFORMES. sharks Cirrhigaleus spp Squalidae SQUALIFORMES. sharks Cirrhoscyllium spp Parascylliidae ORECTOLOBIFORMES. sharks Ctenacis spp Proscylliidae CARCHARHINIFORMES. sharks Dalatias spp Squalidae SQUALIFORMES. sharks Deania spp Squalidae SQUALIFORMES. sharks Echinorhinus spp Echinorhinidae SQUALIFORMES. sharks Eridacnis spp Proscylliidae CARCHARHINIFORMES. sharks Etmopterus spp Squalidae SQUALIFORMES. sharks Eucrossorhinus spp Orectolobidae ORECTOLOBIFORMES. sharks Euprotomicroides spp Squalidae SQUALIFORMES. sharks Euprotomicrus spp Squalidae SQUALIFORMES. sharks Eusphyra spp Sphyrnidae CARCHARHINIFORMES. sharks Furgaleus spp Triakidae CARCHARHINIFORMES. sharks Galeocerdo spp Carcharhinidae CARCHARHINIFORMES. sharks Galeorhinus spp Triakidae CARCHARHINIFORMES. sharks Galeus spp Scyliorhinidae CARCHARHINIFORMES. sharks Ginglymostoma spp Ginglymostomatidae ORECTOLOBIFORMES. sharks Glyphis spp Carcharhinidae CARCHARHINIFORMES. sharks Gogolia spp Triakidae CARCHARHINIFORMES. sharks Gollum spp Pseudotriakidae CARCHARHINIFORMES. sharks Halaelurus spp Scyliorhinidae CARCHARHINIFORMES. sharks Haploblepharus spp Scyliorhinidae CARCHARHINIFORMES. sharks Hemigaleus spp Hemigaleidae CARCHARHINIFORMES. sharks Hemipristis spp Hemigaleidae CARCHARHINIFORMES. sharks Hemiscyllium spp Hemiscylliidae ORECTOLOBIFORMES. sharks Hemitriakis spp Triakidae CARCHARHINIFORMES sharks Heptranchias spp Hexanchidae HEXANCHIFORMES. sharks Heterodontus spp Heterodontidae HETERODONTIFORMES. sharks Heteroscyllium spp Brachaeluridae ORECTOLOBIFORMES. sharks Heteroscymnoides spp Squalidae SQUALIFORMES. sharks Hexanchus spp Hexanchidae HEXANCHIFORMES. sharks Holohalaelurus spp Scyliorhinidae CARCHARHINIFORMES. sharks Hypogaleus spp Triakidae CARCHARHINIFORMES. sharks Iago spp Triakidae CARCHARHINIFORMES. sharks Isistius spp Squalidae SQUALIFORMES. sharks Isogomphodon spp Carcharhinidae CARCHARHINIFORMES. sharks Isurus spp Lamnidae LAMNIFORMES. sharks Lamiopsis spp Carcharhinidae CARCHARHINIFORMES. sharks Lamna spp Lamnidae LAMNIFORMES. sharks Leptocharias spp Leptochariidae CARCHARHINIFORMES. sharks Loxodon spp Carcharhinidae CARCHARHINIFORMES. sharks Megachasma spp Megachasmidae LAMNIFORMES. sharks Mitsukurina spp Mitsukurinidae LAMNIFORMES. sharks Mustelus spp Triakidae CARCHARHINIFORMES. sharks Nasolamia spp Carcharhinidae CARCHARHINIFORMES. sharks Nebrius spp Ginglymostomatidae ORECTOLOBIFORMES. sharks Negaprion spp Carcharhinidae CARCHARHINIFORMES. sharks Notorynchus spp Hexanchidae/Notorynchidae HEXANCHIFORMES. sharks Odontaspis spp Odontaspididae LAMNIFORMES. sharks Orectolobus spp Orectolobidae ORECTOLOBIFORMES. sharks Oxynotus spp Oxynotidae SQUALIFORMES. sharks Paragaleus spp Hemigaleidae CARCHARHINIFORMES. sharks Parascyllium spp Parascylliidae ORECTOLOBIFORMES. sharks Parmaturus spp Scyliorhinidae CARCHARHINIFORMES. sharks Pentanchus spp Scyliorhinidae CARCHARHINIFORMES. sharks Pliotrema spp Pristiophoridae PRISTIOPHORIFORMES. sharks Poroderma spp Scyliorhinidae CARCHARHINIFORMES. sharks Prionace spp Carcharhinidae CARCHARHINIFORMES. sharks Pristiophorus spp Pristiophoridae PRISTIOPHORIFORMES. sharks Proscyllium spp Proscylliidae CARCHARHINIFORMES. sharks Pseudocarcharias spp Pseudocarchariidae LAMNIFORMES. sharks Pseudotriakis spp Pseudotriakidae CARCHARHINIFORMES. sharks Rhincodon spp Rhincodontidae ORECTOLOBIFORMES. sharks Rhizoprionodon spp Carcharhinidae CARCHARHINIFORMES. sharks Schroederichthys spp Scyliorhinidae CARCHARHINIFORMES. sharks Scoliodon spp Carcharhinidae CARCHARHINIFORMES. sharks Scyliorhinus spp Scyliorhinidae CARCHARHINIFORMES. sharks Scylliogaleus spp Triakidae CARCHARHINIFORMES. sharks Scymnodalatias spp Squalidae SQUALIFORMES. sharks Scymnodon spp Squalidae SQUALIFORMES. sharks Somniosus spp Squalidae SQUALIFORMES. sharks Sphyrna spp Sphyrnidae CARCHARHINIFORMES. sharks Squaliolus spp Squalidae SQUALIFORMES. sharks Squalus spp Squalidae SQUALIFORMES. sharks Squatina spp Squatinidae SQUALIFORMES. sharks Stegostoma spp Stegostomatidae ORECTOLOBIFORMES. sharks Sutorectus spp Orectolobidae ORECTOLOBIFORMES. sharks Triaenodon spp Carcharhinidae CARCHARHINIFORMES. sharks Triakis spp Triakidae CARCHARHINIFORMES. All Shrimp Species in the Order Decapoda, including the below list from the Food and Agricultural Organization shrimps Acanthephyra spp Oplophoridae Decapoda (NATANTIA). shrimps Acetes spp Sergestidae Decapoda (NATANTIA). shrimps Alpheus spp Alpheidae Decapoda (NATANTIA). shrimps Argis spp Crangonidae Decapoda (NATANTIA). shrimps Aristaeomorpha spp Aristaeidae Decapoda (NATANTIA). shrimps Aristaeopsis spp Crangonidae Decapoda (NATANTIA). shrimps Aristeus spp Aristaeidae Decapoda (NATANTIA). shrimps Artemesia spp Penaeidae Decapoda (NATANTIA). shrimps Atya spp Atyidae Decapoda (NATANTIA). shrimps Atyopsis spp Atyidae Decapoda (NATANTIA). shrimps Atypopenaeus spp Penaeidae Decapoda (NATANTIA). shrimps Bentheogennema spp Benthesicymidae Decapoda (NATANTIA). shrimps Benthesicymus spp Benthesicymidae Decapoda (NATANTIA). shrimps Campylonotus spp Campylonotidae Decapoda (NATANTIA). shrimps Caridina spp Atyidae Decapoda (NATANTIA). shrimps Chlorotocus spp Pandalidae Decapoda (NATANTIA). shrimps Crangon spp Crangonidae Decapoda (NATANTIA). shrimps Cryphiops spp Palaemonidae Decapoda (NATANTIA). shrimps Cryptopenaeus spp Solenoceridae Decapoda (NATANTIA). shrimps Dichelopandalus spp Pandalidae Decapoda (NATANTIA). shrimps Eualus spp Hippolytidae Decapoda (NATANTIA). shrimps Exhippolysmata spp Hippolytidae Decapoda (NATANTIA). shrimps Exopalaemon spp Palaemonidae Decapoda (NATANTIA). shrimps Farfantepenaeus spp (now Penaeus) Penaeidae Decapoda (NATANTIA). shrimps Fenneropenaeus spp (now Penaeus) Penaeidae Decapoda (NATANTIA). shrimps Glyphocrangon spp Glyphocrangonidae Decapoda (NATANTIA). shrimps Glyphus spp Pasiphaeidae Decapoda (NATANTIA). shrimps Hadropenaeus spp Solenoceridae Decapoda (NATANTIA). shrimps Haliporoides spp Solenoceridae Decapoda (NATANTIA). shrimps Heptacarpus spp Hippolytidae Decapoda (NATANTIA). shrimps Heterocarpoides spp Pandalidae Decapoda (NATANTIA). shrimps Heterocarpus spp Pandalidae Decapoda (NATANTIA). shrimps Holthuispenaeopsis spp Penaeidae Decapoda (NATANTIA). shrimps Hymenocera spp Gnatophyllidae Decapoda (NATANTIA). shrimps Hymenodora spp Oplophoridae Decapoda (NATANTIA). shrimps Hymenopenaeus spp Solenoceridae Decapoda (NATANTIA). shrimps Latreutes spp Hippolytidae Decapoda (NATANTIA). shrimps Leandrites spp Palaemonidae Decapoda (NATANTIA). shrimps Leptocarpus spp Palaemonidae Decapoda (NATANTIA). shrimps Leptochela spp Pasiphaeidae Decapoda (NATANTIA). shrimps Lipkebe spp Palaemonidae Decapoda (NATANTIA). shrimps Lipkius spp Nematocarcinidae Decapoda (NATANTIA). shrimps Litopenaeus spp Penaeidae Decapoda (NATANTIA). shrimps Lysmata spp Hippolytidae Decapoda (NATANTIA). shrimps Macrobrachium spp Palaemonidae Decapoda (NATANTIA). shrimps Macropetasma spp Penaeidae Decapoda (NATANTIA). shrimps Marsupenaeus spp Penaeidae Decapoda (NATANTIA). shrimps Melicertus spp Penaeidae Decapoda (NATANTIA). shrimps Mesopaeneus spp Solenoceridae Decapoda (NATANTIA). shrimps Metacrangon spp Crangonidae Decapoda (NATANTIA). shrimps Metapenaeopsis spp Penaeidae Decapoda (NATANTIA). shrimps Metapenaeus spp Penaeidae Decapoda (NATANTIA). shrimps Microprosthema spp Stenopodidae Decapoda (NATANTIA). shrimps Nematocarcinus spp Nematocarcinidae Decapoda (NATANTIA). shrimps Nematopalaemon spp Palaemonidae Decapoda (NATANTIA). shrimps Notocrangon spp Crangonidae Decapoda (NATANTIA). shrimps Notostomus spp Oplophoridae Decapoda (NATANTIA). shrimps Ogyrides spp Ogyrididae Decapoda (NATANTIA). shrimps Oplophorus spp Oplophoridae Decapoda (NATANTIA). shrimps Palaemon spp Palaemonidae Decapoda (NATANTIA). shrimps Palaemonetes spp Palaemonidae Decapoda (NATANTIA). shrimps Pandalopsis spp Pandalidae Decapoda (NATANTIA). shrimps Pandalus spp Pandalidae Decapoda (NATANTIA). shrimps Pantomus spp Pandalidae Decapoda (NATANTIA). shrimps Paracrangon spp Crangonidae Decapoda (NATANTIA). shrimps Parapandalus spp Pandalidae Decapoda (NATANTIA). shrimps Parapenaeopsis spp Penaeidae Decapoda (NATANTIA). shrimps Parapenaeus spp Penaeidae Decapoda (NATANTIA). shrimps Paratya spp Atyidae Decapoda (NATANTIA). shrimps Pasiphaea spp Pasiphaeidae Decapoda (NATANTIA). shrimps Penaeopsis spp Penaeidae Decapoda (NATANTIA). shrimps Penaeus spp Penaeidae Decapoda (NATANTIA). shrimps Pleoticus spp Solenoceridae Decapoda (NATANTIA). shrimps Plesionika spp Pandalidae Decapoda (NATANTIA). shrimps Plesiopenaeus spp Aristaeidae Decapoda (NATANTIA). shrimps Pontocaris spp Crangonidae Decapoda (NATANTIA). shrimps Pontophilus spp Crangonidae Decapoda (NATANTIA). shrimps Processa spp Processidae Decapoda (NATANTIA). shrimps Protrachypene spp Penaeidae Decapoda (NATANTIA). shrimps Rhynchocinetes spp Rhynchocinetidae Decapoda (NATANTIA). shrimps Saron spp Hippolytidae Decapoda (NATANTIA). shrimps Sclerocrangon spp Crangonidae Decapoda (NATANTIA). shrimps Sergestes spp Sergestidae Decapoda (NATANTIA). shrimps Sicyonia spp Sicyoniidae Decapoda (NATANTIA). shrimps Solenocera spp Solenoceridae Decapoda (NATANTIA). shrimps Spirontocaris spp Hippolytidae Decapoda (NATANTIA). shrimps Stenopus spp Stenopodidae Decapoda (NATANTIA). shrimps Systellaspis spp Oplophoridae Decapoda (NATANTIA). shrimps Trachypenaeus spp Penaeidae Decapoda (NATANTIA). shrimps Trachysalambria spp Penaeidae Decapoda (NATANTIA). shrimps Xiphopenaeus spp Penaeidae Decapoda (NATANTIA). skipjack tuna Katsuwonus pelamis Scombridae SCOMBROIDEI. yellowfin tuna Thunnus albacares Scombridae SCOMBROIDEI. swordfish Xiphias gladiatus Xiphiidae SCOMBROIDEI.
    Dated: October 27, 2015. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.
    [FR Doc. 2015-27780 Filed 10-29-15; 8:45 am] BILLING CODE 3510-22-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List Additions AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Additions to the Procurement List.

    SUMMARY:

    This action adds a product and service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

    DATES:

    Effective Date: 11/29/2015.

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    Additions

    On 9/11/2015 (80 FR 54768) and 9/18/2015 (80 FR 56450), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed additions to the Procurement List.

    After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the product and service and impact of the additions on the current or most recent contractors, the Committee has determined that the product and service listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

    Regulatory Flexibility Act Certification

    I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

    1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the product and service to the Government.

    2. The action will result in authorizing small entities to furnish the product and service to the Government.

    3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product and service proposed for addition to the Procurement List.

    End of Certification

    Accordingly, the following product and service are added to the Procurement List:

    Product NSN(s)—Product Name(s): 1670-01-F05-1124—T-11R Parachute Insert, Army Mandatory Source(s) of Supply: Chautauqua County Chapter, NYSARC, Jamestown, NY Mandatory for: 100% of the requirement of the U.S. Army Contracting Activity: Dept of the Army, W6QK ACC-APG Natick, Natick, MA Distribution: C-List Service Service Type: Janitorial Service Service Mandatory for: U.S. Geological Survey, 4611 Research Park Circle, Suites D and E, Las Cruces, NM Mandatory Source(s) of Supply: Tresco, Inc., Las Cruces, NM Contracting Activity: Dept of the Interior, Geological Survey, Office of Acquisition and Grants—Denver, Denver, CO Barry S. Lineback, Director, Business Operations.
    [FR Doc. 2015-27686 Filed 10-29-15; 8:45 am] BILLING CODE 6353-01-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Proposed Additions and Deletion AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Proposed additions to and deletion from the Procurement List.

    SUMMARY:

    The Committee is proposing to add services to the Procurement List that will be provided by nonprofit agencies employing persons who are blind or have other severe disabilities and, deletes a product previously furnished by an agency.

    Comments Must be Received on or Before: 11/29/2015.

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

    Additions

    If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the services listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.

    The following services are proposed for addition to the Procurement List for production by the nonprofit agencies listed:

    Services Service Type: Furniture Design, Configuration and Installation Service Service Mandatory for: U.S. Department of the Interior, Stewart Lee Udall, Department of the Interior Building, 1849 C Street and South Interior Building, 1951 Constitution Avenue NW., Washington, DC Mandatory Source(s) of Supply: Industries for the Blind Inc., West Allis, WI Contracting Activity: U.S. Department of the Interior, Acquisition Services Directorate, Herndon, VA Service Type: Call Center Service Service Mandatory for: OPM, Retirement Service, Retirement Operations, 1137 Branchton Road, Boyers, PA Mandatory Source(s) of Supply: Orion Career Works, Auburn, WA; Beacon Group SW., Inc., Tucson, AZ Contracting Activity: Office of Personnel Management, Boyers Region (Non FISD), Boyers, PA Deletion

    The following product is proposed for deletion from the Procurement List:

    Product NSN(s)—Product Name(s): 7125-00-449-6862—Cabinet, Storage. Mandatory Source(s) of Supply: UNKNOWN Contracting Activity: Defense Logistics Agency Aviation, Richmond, VA Barry S. Lineback, Director, Business Operations.
    [FR Doc. 2015-27685 Filed 10-29-15; 8:45 am] BILLING CODE 6353-01-P
    COMMODITY FUTURES TRADING COMMISSION Sunshine Act Meetings Time and Date:

    10:00 a.m., Friday, November 6, 2015.

    Place:

    Three Lafayette Centre, 1155 21st Street NW., Washington, DC, 9th Floor Commission Conference Room.

    Status:

    Closed.

    Matters to be Considered:

    Surveillance, enforcement, and examinations matters. In the event that the time, date, or location of this meeting changes, an announcement of the change, along with the new time, date, and/or place of the meeting will be posted on the Commission's Web site at http://www.cftc.gov.

    Contact Person for More Information:

    Christopher Kirkpatrick, 202-418-5964.

    Natise Allen, Executive Assistant.
    [FR Doc. 2015-27787 Filed 10-28-15; 11:15 am] BILLING CODE 6351-01-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION [Docket No: CFPB-2015-0045] 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 Consumer Financial Protection Bureau (Bureau) is proposing a new information collection for Office of Management and Budget (OMB) approval titled, “Policy on No-Action Letters.”

    DATES:

    Written comments are encouraged and must be received on or before November 30, 2015 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 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: Policy on No-Action Letters.

    OMB Control Number: 3170-XXXX (will be assigned upon OMB approval).

    Type of Review: New Collection (Request for a new OMB control number).

    Affected Public: Private Sector.

    Estimated Number of Respondents: 3.

    Estimated Total Annual Burden Hours: 300.

    Abstract: The Policy provides a process for requesters to submit to Bureau staff a request that the staff issue a no-objection letter to proposed conduct, subject to specified conditions and limitations. Issuance of no-action letters, under the Policy, would be discretionary on the part of Bureau staff. The information will be collected from persons who request a no-action letter from Bureau staff. It will be used by Bureau staff to determine whether issuance of a no-action letter is warranted.

    Request for Comments: The Bureau issued a 60-day Federal Register notice on October 16, 2014, (79 FR 62118). 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: October 23, 2015. Linda F. Powell, Chief Data Officer, Bureau of Consumer Financial Protection.
    [FR Doc. 2015-27715 Filed 10-29-15; 8:45 am] BILLING CODE 4810-AM-P
    DEPARTMENT OF DEFENSE Department of the Army [Docket ID: USA-2015-HQ-0044] Privacy Act of 1974; System of Records AGENCY:

    Department of the Army, DoD.

    ACTION:

    Notice to reinstate a system of records.

    SUMMARY:

    The Department of the Army (DOA) proposes to reinstate a system of records, A0351 AMC, entitled “Student/Faculty Records: AMC Schools Systems” to its inventory of record systems to the Privacy Act of 1974, as amended. After publication of the deletion notice in the Federal Register (October 3, 2012, 77 FR 60412), the DOA discovered that the records had not yet been transferred to the National Personnel Records Center. Therefore, the DOA system of records notice should not have been deleted and is being reinstated in full below.

    DATES:

    Comments will be accepted on or before November 30, 2015. This proposed action will be effective on the date following the end of the comment period unless comments are received which result in a contrary determination.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

    * Federal Rulemaking Portal: http://www.regulations.gov.

    Follow the instructions for submitting comments.

    * Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.

    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:

    Ms. Tracy Rogers, Department of the Army, Privacy Office, U.S. Army Records Management and Declassification Agency, 7701 Telegraph Road, Casey Building, Suite 144, Alexandria, VA 22315-3860 or by phone at 703-428-7499.

    SUPPLEMENTARY INFORMATION:

    The Department of the Army systems of records notices subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT or at the Defense Privacy and Civil Liberties Office Web site at http://dpclo.defense.gov/.

    Dated: October 27, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. A0351 AMC System name:

    Student/Faculty Records: AMC Schools Systems (February 2, 1996, 61 FR 3916)

    System location:

    U.S. Army Management Engineering College, Rock Island, IL 61299-7040 and U.S. Army Defense Ammunition Center and School, Savanna, IL 61074-9639.

    Categories of individuals covered by the system:

    Students enrolled/attending schools identified above, faculty, instructors, and guest speakers.

    Categories of records in the system:

    Student academic records consisting of course completion and results, aptitudes and personal qualities, grades/ratings assigned; instructor/guest speaker qualifications and evaluations, including biographical data; class historical/academic achievements; and related information.

    Authority for maintenance of the system:

    5 U.S.C. 301 and E.O. 9397 (SSN).

    Purpose(s):

    To determine applicant eligibility, monitor individual's progress, maintain record of student/faculty achievements, and to provide bases for management assessment of curricula and faculty effectiveness and class standing.

    Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

    In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, these records or information contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

    The `Blanket Routine Uses' set forth at the beginning of the Army's compilation of systems of records notices also apply to this system.

    Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Storage:

    Paper records; cards; photographs; magnetic tapes/discs; and printouts.

    Retrievability:

    By name, Social Security Number, military service number.

    Safeguards:

    Records are maintained in locked cabinets within secured areas accessible only to authorized persons having an official need-to-know.

    Retention and disposal:

    Individual academic records are retained for 40 years, 3 of which are at the school which created them; they are subsequently transferred to the National Personnel Records Center, 9700 Page Boulevard, St. Louis, MO 63132-5200. Faculty/instructor qualifications records are retained until individual transfers from the facility, held for 5 years, and then destroyed. Other records are retained until no longer needed, at which time they are destroyed.

    System manager(s) and address:

    Commander, U.S. Army Materiel Command, 5001 Eisenhower Avenue, Alexandria, VA 22333-0001.

    Notification procedure:

    Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the Commandant/Director of the appropriate School/Agency.

    Individual should provide full name, rank/grade, Social Security Number, course title/class number, and date of attendance or, if a faculty member: Name, course(s) taught, and period in which instructed at named training facility.

    Record access procedures:

    Individuals seeking access to information about themselves contained in this system should address written inquiries to the Commandant/Director of the appropriate School/Agency.

    Individual should provide full name, rank/grade, Social Security Number, course title/class number, and date of attendance or, if a faculty member: Name, course(s) taught, and period in which instructed at named training facility.

    Contesting record procedures:

    The Army's rules for accessing records and for contesting contents and appealing initial agency determinations are contained in Army Regulation 340-21; 32 CFR part 505; or may be obtained from the system manager.

    Record source categories:

    From the individual student, faculty, instructor, guest speaker, and management analyses of class performance.

    Exemptions claimed for the system:

    None.

    [FR Doc. 2015-27709 Filed 10-29-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary TRICARE; Calendar Year 2016 TRICARE Young Adult Program Premium Update AGENCY:

    Office of the Secretary of Defense, Department of Defense.

    ACTION:

    Notice of updated TRICARE Young Adult premiums for calendar year 2016.

    SUMMARY:

    This notice provides the updated TRICARE Young Adult program premiums for Calendar Year (CY) 2016.

    DATES:

    The CY 2016 rates contained in this notice are effective for services on or after January 1, 2016.

    ADDRESSES:

    Defense Health Agency, TRICARE Health Plan, 7700 Arlington Boulevard, Suite 5101, Falls Church, Virginia 22042-5101.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Mark A. Ellis, (703) 681-0039.

    SUPPLEMENTARY INFORMATION:

    The final rule published in the Federal Register (FR) on May 29, 2013 (78 FR 32116-32121) sets forth rules to implement the TRICARE Young Adult (TYA) program as required by Title 10, United States Code, Section 1110b. Included in the final rule were provisions for updating the TYA premiums for each CY. By law, qualified young adult dependents are charged TYA premiums that represent the full government cost of providing such coverage.

    The Defense Health Agency has updated the monthly premiums for CY 2016 as shown below:

    Monthly TYA Premiums for CY 2016 Type of coverage Monthly rate TRICARE Standard Plans $228 TRICARE Prime Plans 306

    The above premiums are effective for services rendered on or after January 1, 2016.

    Dated: October 27, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-27711 Filed 10-29-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DoD-2015-HA-0036] Submission for OMB Review; Comment Request ACTION:

    Notice.

    SUMMARY:

    The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

    DATES:

    Consideration will be given to all comments received by November 30, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Fred Licari, 571-372-0493.

    SUPPLEMENTARY INFORMATION:

    Title, Associated Form and OMB Number: Statement of Personal Injury—Possible Third Party Liability, Defense Health Agency; DD Form 2527; OMB Control Number 0720-0003.

    Type of Request: Reinstatement, with change, of a previously approved collection for which approval has expired.

    Number of Respondents: 188,090.

    Responses per Respondent: 1.

    Annual Responses: 188,090.

    Average Burden per Response: 15 minutes.

    Annual Burden Hours: 47,023.

    Needs and Uses: This information collection is completed by TRICARE (formerly CHAMPUS) beneficiaries suffering from personal injuries and receiving medical care at Government expense. The information is necessary in the assertion of the Government's right to recovery under the Federal Medical Care Recovery Act. The data is used in the evaluation and processing of these claims.

    Affected Public: Individuals or households.

    Frequency: On occasion.

    Respondent's Obligation: Required to obtain or retain benefits.

    OMB Desk Officer: Mr. Joshua Brammer.

    Comments and recommendations on the proposed information collection should be emailed to Mr. Joshua Brammer, DoD Desk Officer, at [email protected] Please identify the proposed information collection by DoD Desk Officer and the Docket ID number and title of the information collection.

    You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

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

    Instructions: All submissions received must include the agency name, Docket ID 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.

    DOD Clearance Officer: Mr. Frederick Licari.

    Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.

    Dated: October 27, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-27708 Filed 10-29-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DoD-2015-OS-0115] Privacy Act of 1974; System of Records AGENCY:

    Office of the Secretary of Defense, DoD.

    ACTION:

    Notice to add a new system of records.

    SUMMARY:

    The Office of the Secretary of Defense proposes to add a new system of records, DMDC 20, entitled “Personnel Security Breach Notification and Mitigation Services Records”. The Department of Defense is providing notification and facilitating the provision of breach mitigation services to individuals affected by the breach of information in the Office of Personnel Management (OPM) background investigation databases the Department must establish this system in order to provide notification to and facilitate the provision of breach mitigation services. Due to the number and proportion of affected individuals belonging to the DoD, DoD entered into agreements with OPM to handle the breach notification and mitigation services. DoD will also use these records to respond to breach verification inquiries. Individuals may go to OPM's Web site and click on a link that will redirect them to a DoD Web site where they can enter their information to find out if they have been affected by this breach. These records may also be used for tracking, reporting, measuring, and improving The Department's effectiveness in implementing this data breach notification.

    DATES:

    Comments will be accepted on or before November 30, 2015. This proposed action will be effective the day following the end of the comment period unless comments are received which result in a contrary determination.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

    * Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.

    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:

    Ms. Cindy Allard, Chief, OSD/JS Privacy Office, Washington Headquarters Service, 1155 Defense Pentagon, Washington, DC 20301-1155, or by phone at (571) 372-0461.

    SUPPLEMENTARY INFORMATION:

    The Office of the Secretary of Defense notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT or at http://dpcld.defense.gov/.

    The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on October 27, 2015, to the House Committee on Oversight and Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

    Dated: October 27, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. DMDC 20 System name:

    Personnel Security Breach Notification and Mitigation Services Records.

    System location:

    Defense Manpower Data Center, DoD Center Monterey Bay, 400 Gigling Road, Seaside, CA 93955-6771.

    Categories of individuals covered by the system:

    Federal civilian and military personnel and applicants, and employees of government contractors, experts, instructors, and consultants to Federal programs who underwent a personnel background investigation after January 1, 1990. Other individuals whose Social Security Numbers (SSNs) were provided on an SF85, SF85-P and SF86 after January 1, 1990. Individuals who submit a breach verification inquiry. Minor children, who were minors as of July 1, 2015, of individuals described in this paragraph.

    Categories of records in the system:

    Last, first, and middle name; Social Security Number (SSN); date of birth, place of birth; citizenship status; country of citizenship; home and/or business addresses, phone numbers, and email addresses.

    Authority for maintenance of the system:

    The E-Government Act of 2002 (Pub. L. 107-347); the Federal Information Security Modernization Act of 2014 (Pub. L. 113-283) (44 U.S.C. 3551-3559); 10 U.S.C. 113, Secretary of Defense; 50 U.S.C. 3038, Responsibilities of Secretary of Defense Pertaining to National Intelligence Program; E.O. 12333, United States Intelligence Activities, as amended; E.O. 13402, Strengthening Federal Efforts to Protect Against Identity Theft, as amended; E.O. 13526, Classified National Security Information; White House Memorandum dated September 20, 2006, Subject: Recommendations for Identity Theft Related Data Breach Notification; and E.O. 9397 (SSN), as amended.

    Purpose(s):

    To provide breach notification and facilitate the provision of breach mitigation services to individuals affected by the breach of information in the Office of Personnel Management (OPM) background investigation databases. DoD will also use the data to respond to breach verification inquiries received from individuals using the link on OPM's Web site that redirects individuals to a DoD Web site where they can enter their information to find out if they have been affected by this breach. These records may also be used for tracking, reporting, measuring, and improving the Department's effectiveness in implementing this data breach notification.

    Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

    In addition to disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, these records may specifically be disclosed outside the DoD as follows:

    To commercial entities, under contract with DoD, for the sole purpose of verifying addresses of affected individuals in order to provide notification to such individuals.

    Law Enforcement Routine Use: If a system of records maintained by a DoD Component to carry out its functions indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and whether arising by general statute or by regulation, rule, or order issued pursuant thereto, the relevant records in the system of records may be referred, as a routine use, to the Federal agency concerned, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute, rule, regulation, or order issued pursuant thereto.

    Disclosure of Information to the National Archives and Records Administration Routine Use: A record from a system of records maintained by a DoD Component may be disclosed as a routine use to the National Archives and Records Administration for the purpose of records management inspections conducted under authority of 44 U.S.C. 2904 and 2906.

    Disclosure to the Office of Personnel Management Routine Use: A record from a system of records subject to the Privacy Act and maintained by a DoD Component may be disclosed to the OPM concerning information necessary for the OPM to carry out its legally authorized functions.

    Counterintelligence Purpose Routine Use: A record from a system of records maintained by a DoD Component may be disclosed as a routine use outside the DoD for the purpose of counterintelligence activities authorized by U.S. Law or Executive Order or for the purpose of enforcing laws which protect the national security of the United States.

    Data Breach Remediation Purposes Routine Use: A record from a system of records maintained by a Component may be disclosed to appropriate agencies, entities, and persons when (1) the Component suspects or has confirmed that the security or confidentiality of the information in the system of records has been compromised; (2) the Component has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Component or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Component's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.

    Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:

    Storage:

    Electronic storage media.

    Retrievability:

    Records may be retrieved by an individual's name, SSN, date and place of birth.

    Safeguards:

    Access to personally identifiable information is restricted to those who require access to the records in the performance of their official duties in connection with the breach notification process. Access to personally identifiable information is further restricted by the use of Personal Identity Verification (PIV) cards and PIN. Physical entry is restricted by the use of locks, key cards, security guards, and identification badges. All individuals granted access to this system of records will have completed annual Information Assurance and Privacy Act training and be appropriately vetted. Audit logs will be maintained to document access to data. All electronic records transfers into this system of records will be encrypted. Records will be maintained in a secure database with an intrusion detection system in a physically controlled area accessible only to authorized personnel.

    Retention and disposal:

    The National Archives and Records Administration has authorized the destruction of these records 3 (three) year(s) after credit monitoring and identity management services have concluded.

    System manager(s) and address:

    Deputy Director for Identity, Defense Manpower Data Center, 4800 Mark Center, Alexandria, VA 22350-4000.

    Deputy Director, Defense Manpower Data Center, DoD Center Monterey Bay, 400 Gigling Road, Seaside, CA 93955-6771.

    Notification procedure:

    Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the Defense Manpower Data Center (DMDC), DoD Center Monterey Bay, ATTN: Privacy Act Office, 400 Gigling Road, Seaside, CA 93955-6771.

    Signed, written requests must contain the full name (and any alias and/or alternate names used), SSN, and date and place of birth.

    Record access procedures:

    Individuals seeking information about themselves contained in this system should address written inquiries to the Office of the Secretary of Defense/Joint Staff Freedom of Information Act Requester Service Center, 1155 Defense Pentagon, Washington, DC 20301-1155.

    Individuals should provide their full name (and any alias and/or alternate names used), SSN, and date and place of birth.

    In addition, the requester must provide a notarized statement or an unsworn declaration made in accordance with 28 U.S.C. 1746, in the following format:

    If executed outside the United States: `I declare (or certify, verify, or state) under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed on (date). (Signature).'

    If executed within the United States, its territories, possessions, or commonwealths: `I declare (or certify, verify, or state) under penalty of perjury that the foregoing is true and correct. Executed on (date). (Signature).'

    Attorneys or other persons acting on behalf of an individual must provide written authorization from that individual for their representative to act on their behalf.

    Contesting record procedures:

    The OSD rules for accessing records and for contesting or appealing agency determinations are published in OSD Administrative Instruction 81, 32 CFR part 311; or may be obtained directly from the system manager.

    Record source categories:

    Individuals requesting verification via OPM's Web site who click on a link that will redirect them to a DoD Web site where they can enter their information to find out if they have been affected by this breach. The OPM (Personnel Investigations Records). Employees address records from Federal employers (e.g., OPM, Defense Finance and Accounting Service, Defense Manpower Data Center, Department of State, United States Postal Service, Library of Congress, the General Accountability Office, Death master files, the Executive Office of the President, Former Presidents Office, etc.) and address verification from cleared contractors and commercial vendors.

    Exemptions claimed for the system:

    Parts of this record system may be exempt under 5 U.S.C. 552a(k)(1), as applicable.

    An exemption rule for this record system has been promulgated according to the requirements of 5 U.S.C. 553(b)(1), (2), and (3), (c) and (e) and published in 32 CFR part 311. For additional information contact the system manager.

    [FR Doc. 2015-27745 Filed 10-29-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DoD-2015-OS-0114] Proposed Collection; Comment Request AGENCY:

    Defense Security Cooperation Agency, DoD.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the Defense Security Cooperation Agency announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have a practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) 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 December 29, 2015.

    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 of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.

    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 reviewing/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 Defense Security Cooperation Agency (DSCA) (ATTN: Paul Will), 220 12th Street South, Suite 312, Arlington, VA 22202-5408 or call (703) 601-3864.

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: The GlobalNET Collection; GlobalNET User Registration Form; OMB Control No. 0704-XXXX.

    Needs and Uses: The purpose of the GlobalNET system is to provide a collaborative social networking environment/capability where students, alumni, faculty, partners, and other community members and subject matter experts can find relevant and timely information about pertinent subject matter experts and conduct required training. GlobalNET also collects information on students in order to allow regional center personnel to manage students while enrolled at regional centers.

    Affected Public: Businesses or other for profit; Foreign Service Nationals; Guest Speakers and Lecturers involved in Security Cooperation Activities.

    Annual Burden Hours: 1,000 hours.

    Number of Respondents: 6,000.

    Responses per Respondent: 1.

    Average Burden per Response: 10 Minutes.

    Frequency: On occasion.

    Respondents are contractor personnel, Foreign Service nationals, guest speakers and lecturers involved in the Security Cooperation. If the information is not collected on the GlobalNET user request, IT personnel would not be able to validate the authenticity of user accounts, grant access critical training material required by participating partnering organization, enable Regional Center personnel to manage students while enrolled in training courses at regional centers, and ensure compliance with DepSecDef directive and federal law requiring the reporting of training of foreign nationals (ref. AECA).

    Dated: October 27, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-27712 Filed 10-29-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Charter Amendment of Department of Defense Federal Advisory Committees AGENCY:

    Department of Defense.

    ACTION:

    Amendment of Federal Advisory Committee.

    SUMMARY:

    The Department of Defense is publishing this notice to announce that it is amending the charter for the Threat Reduction Advisory Committee (“the Committee”).

    FOR FURTHER INFORMATION CONTACT:

    Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.

    SUPPLEMENTARY INFORMATION:

    This committee's charter is being amended in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(d).

    The Committee is a discretionary Federal advisory committee that provides the Secretary of Defense, through the Under Secretary of Defense for Acquisition, Technology, and Logistics (USD(AT&L)) and the Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs (ASD(NCB)), independent advice and recommendations on:

    a. Reducing the threat to the United States, its military forces, and its allies and partners posed by nuclear, biological, chemical, conventional, and special weapons;

    b. Combating WMD to include non-proliferation, counterproliferation, and consequence management;

    c. Nuclear deterrence transformation, nuclear material lockdown and accountability;

    d. Nuclear weapons effects;

    e. The nexus of counterproliferation and counter WMD terrorism; and

    f. Other AT&L, NCB, and Defense Threat Reduction Agency (DTRA) mission-related matters, as requested by the USD(AT&L).

    The Department of Defense (DoD), through the Office of the USD(AT&L), the Office of the ASD(NCB) Defense Programs, and DTRA, shall provide support, as deemed necessary, for the Committee's performance, and shall ensure compliance with the requirements of the FACA, the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended) (“the Sunshine Act”), governing Federal statutes and regulations, and established DoD policies and procedures.

    The Committee shall be composed of no more than 25 members who are eminent authorities in the fields of national defense, geopolitical and national security affairs, WMD, nuclear physics, chemistry, and biology.

    The Committee members are appointed by the Secretary of Defense or the Deputy Secretary of Defense and their appointments shall be renewed on an annual basis in accordance with DoD policies and procedures. Those members, who are not full-time or permanent part-time Federal officers or employees, shall be appointed as experts or consultants, pursuant to 5 U.S.C. 3109, to serve as special government employee (SGE) members. Committee members who are full-time or permanent part-time Federal employees shall be appointed, pursuant to 41 CFR 102-3.130(a), to serve as regular government employee (RGE) members.

    Committee members shall, with the exception of reimbursement for official Committee-related travel and per diem, serve without compensation, unless otherwise authorized by the Secretary of Defense.

    The Secretary of Defense, in consultation with USD(AT&L) and the ASD(NCB), shall select the Committee's Chair and Vice Chair from among the membership approved by the Secretary of Defense or the Deputy Secretary of Defense.

    The Secretary of Defense or the Deputy Secretary of Defense may approve the appointment of Committee members for one-to-four year terms of service; however, no member, unless authorized by the Secretary of Defense or the Deputy Secretary of Defense, may serve more than two consecutive terms of service, to include its subcommittees, or serve on more than two DoD Federal advisory committees at one time.

    Each Committee member is appointed to provide advice on the basis of his or her best judgment without representing any particular point of view and in a manner that is free from conflict of interest.

    The Department, when necessary and consistent with the Committee's mission and DoD policies and procedures, may establish subcommittees, task forces, or working groups to support the Committee. Establishment of subcommittees will be based upon written determination, to include terms of reference, by the Secretary of Defense, the Deputy Secretary of Defense, or the USD(AT&L), as the Committee's Sponsor.

    Such subcommittees shall not work independently of the chartered Committee, and shall report their findings and advice solely to the Committee for full deliberation and discussion. Subcommittees have no authority to make decisions and recommendations, verbally or in writing, on behalf of the chartered Committee. No subcommittee or any of its members can update or report directly to the DoD or to any Federal officers or employees.

    All subcommittee members shall be appointed in the same manner as the Committee members; that is, the Secretary of Defense or the Deputy Secretary of Defense shall appoint subcommittee members to a term of service of one-to-four years, with annual renewals, even if the member in question is already a Committee member. Subcommittee members shall not serve more than two consecutive terms of service, without approval by the Secretary of Defense or the Deputy Secretary of Defense. Subcommittee members are appointed to provide advice on the basis of their best judgment without representing a particular point of view and in a manner that is free from conflict of interest.

    Subcommittee members, if not full-time or part-time government employees, shall be appointed to serve as experts or consultants, pursuant to 5 U.S.C. 3109, to serve as SGE members. Those individuals who are full-time or permanent part-time Federal officers or employees shall be appointed, pursuant to 41 CFR 102-3.130(a), to serve as RGE members. With the exception of reimbursement for official Committee-related travel and per diem, subcommittee members shall serve without compensation.

    All subcommittees operate under the provisions of FACA, the Sunshine Act, governing Federal statutes and regulations, and established DoD policies and procedures.

    The Designated Federal Officer (DFO), pursuant to DoD policy, shall be a full-time or permanent part-time DoD employee, and shall be appointed in accordance with established DoD policies and procedures.

    In addition, the Committee's DFO is required to be in attendance at all committee and subcommittee meetings for the entire duration of each and every meeting. However, in the absence of the Committee's DFO, an Alternate DFO, duly appointed to the Committee, according to the DoD policies and procedures, shall attend the entire duration of the Committee or subcommittee meeting.

    The DFO, or the Alternate DFO, shall call all of the Committee's and subcommittee's meetings; prepare and approve all meeting agendas; and adjourn any meeting when the DFO, or the Alternate DFO, determines adjournment to be in the public interest or required by governing regulations or DoD policies and procedures.

    Pursuant to 41 CFR 102-3.105(j) and 102-3.140, the public or interested organizations may submit written statements to Committee membership about the Committee's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the Committee.

    All written statements shall be submitted to the DFO for the Committee, and this individual will ensure that the written statements are provided to the membership for their consideration. Contact information for the Committee's DFO can be obtained from the GSA's FACA Database—http://www.facadatabase.gov/.

    The DFO, pursuant to 41 CFR 102-3.150, will announce planned meetings of the Committee. The DFO, at that time, may provide additional guidance on the submission of written statements that are in response to the stated agenda for the planned meeting in question.

    Dated: October 27, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-27710 Filed 10-29-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Army, Corps of Engineers Inland Waterways Users Board Meeting Notice AGENCY:

    Department of the Army, U.S. Army Corps of Engineers, DoD.

    ACTION:

    Notice of open Federal advisory committee meeting.

    SUMMARY:

    The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the U.S. Army Corps of Engineers, Inland Waterways Users Board (Board). This meeting is open to the public. For additional information about the Board, please visit the committee's Web site at http://www.iwr.usace.army.mil/Missions/Navigation/InlandWaterwaysUsersBoard.aspx.

    DATES:

    The Army Corps of Engineers, Inland Waterways Users Board will meet from 9:00 a.m. to 1:00 p.m. on December 2, 2015. Public registration will begin at 8:15 a.m.

    ADDRESSES:

    The Board meeting will be conducted at the Embassy Suites by Hilton St. Louis—St. Charles Hotel, Two Convention Center Plaza, St. Charles, Missouri 63303 at 636-946-5544.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Mark R. Pointon, the Designated Federal Officer (DFO) for the committee, in writing at the Institute for Water Resources, U.S. Army Corps of Engineers, ATTN: CEIWR-GM, 7701 Telegraph Road, Casey Building, Alexandria, Virginia 22315-3868; by telephone at 703-428-6438; and by email at [email protected] Alternatively, contact Mr. Kenneth E. Lichtman, the Alternate Designated Federal Officer (ADFO), in writing at the Institute for Water Resources, U.S. Army Corps of Engineers, ATTN: CEIWR-GW, 7701 Telegraph Road, Casey Building, Alexandria, Virginia 22315-3868; by telephone at 703-428-8083; and by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    The committee 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.

    Purpose of the Meeting: The Board is chartered to provide independent advice and recommendations to the Secretary of the Army on construction and rehabilitation project investments on the commercial navigation features of the inland waterways system of the United States. At this meeting, the Board will receive briefings and presentations regarding the investments, projects and status of the inland waterways system of the United States and conduct discussions and deliberations on those matters. The Board is interested in written and verbal comments from the public relevant to these purposes.

    Proposed Agenda: At this meeting the agenda will include the status of funding for inland navigation projects and studies, the status of the Inland Waterways Trust Fund, the status of the Olmsted Locks and Dam Project, the Locks and Dams 2, 3, and 4 Monongahela River Project, efficient funding for Inland Waterways Trust Fund projects, status of the Inland Marine Transportation System (IMTS) Capital Investment Strategy (CIS), the Lock Performance Monitoring System (LPMS) Reporting modifications and reporting navigation notices to maritime interests, overview of the economic analysis and preparing traffic projections, and preliminary discussion of the Board's 2015 Annual Report.

    Availability of Materials for the Meeting. A copy of the agenda or any updates to the agenda for the December 2, 2015 meeting. The final version will be provided at the meeting. All materials will be posted to the Web site after the meeting.

    Public Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b, as amended, and 41 CFR 102-3.140 through 102-3.1 65, and subject to the availability of space, this meeting is open to the public. Registration of members of the public who wish to attend the meeting will begin at 8:15 a.m. on the day of the meeting. Seating is limited and is on a first-to-arrive basis. Attendees will be asked to provide their name, title, affiliation, and contact information to include email address and daytime telephone number at registration. Any interested person may attend the meeting, file written comments or statements with the committee, or make verbal comments from the floor during the public meeting, at the times, and in the manner, permitted by the committee, as set forth below.

    Special Accommodations: The meeting venue is fully handicap accessible, with wheelchair access. Individuals requiring special accommodations to access the public meeting or seeking additional information about public access procedures, should contact Mr. Pointon, the committee DFO, or Mr. Lichtman, the ADFO, at the email addresses or telephone numbers listed in the FOR FURTHER INFORMATION CONTACT section, at least five (5) business days prior to the meeting so that appropriate arrangements can be made.

    Written Comments or Statements: Pursuant to 41 CFR 102-3.105(j) and 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act, the public or interested organizations may submit written comments or statements to the Board about its mission and/or the topics to be addressed in this public meeting. Written comments or statements should be submitted to Mr. Pointon, the committee DFO, or Mr. Lichtman, the committee ADFO, via electronic mail, the preferred mode of submission, at the addresses listed in the FOR FURTHER INFORMATION CONTACT section in the following formats: Adobe Acrobat or Microsoft Word. The comment or statement must include the author's name, title, affiliation, address, and daytime telephone number. Written comments or statements being submitted in response to the agenda set forth in this notice must be received by the committee DFO or ADFO at least five (5) business days prior to the meeting so that they may be made available to the Board for its consideration prior to the meeting. Written comments or statements received after this date may not be provided to the Board until its next meeting. Please note that because the Board operates under the provisions of the Federal Advisory Committee Act, as amended, all written comments will be treated as public documents and will be made available for public inspection.

    Verbal Comments: Members of the public will be permitted to make verbal comments during the Board meeting only at the time and in the manner allowed herein. If a member of the public is interested in making a verbal comment at the open meeting, that individual must submit a request, with a brief statement of the subject matter to be addressed by the comment, at least three business (3) days in advance to the committee DFO or ADFO, via electronic mail, the preferred mode of submission, at the addresses listed in the FOR FURTHER INFORMATION CONTACT section. The committee DFO and ADFO will log each request to make a comment, in the order received, and determine whether the subject matter of each comment is relevant to the Board's mission and/or the topics to be addressed in this public meeting. A 15-minute period near the end of the meeting will be available for verbal public comments. Members of the public who have requested to make a verbal comment and whose comments have been deemed relevant under the process described above, will be allotted no more than three (3) minutes during this period, and will be invited to speak in the order in which their requests were received by the DFO and ADFO.

    Dated: October 27, 2015. David B. Olson, Federal Register Liaison Officer, U.S. Army Corps of Engineers.
    [FR Doc. 2015-27759 Filed 10-29-15; 8:45 am] BILLING CODE 3720-58-P
    DEPARTMENT OF DEFENSE Department of the Army, Corps of Engineers Notice of Availability of the Draft Environmental Impact Statement for the Proposed Glades Reservoir Water Supply Project, Permit Application SAS-2007-00388 and the Announcement of a Public Hearing AGENCY:

    Department of the Army, U.S. Army Corps of Engineers, DoD.

    ACTION:

    Notice of availability.

    SUMMARY:

    Notice is hereby given that the Corps has released a Draft Environmental Impact Statement (DEIS) for the proposed Glades Reservoir water supply project (Proposed Project), and will conduct a Public Hearing for this DEIS.

    DATES:

    Comments will be received until 5:00 p.m., December 29, 2015; or by letter postmarked no later than December 29, 2015. The public hearing will be held on December 8, 2015.

    ADDRESSES:

    Comments regarding the DEIS may be submitted to: U.S. Army Corps of Engineers, Savannah District, Regulatory Division, Attention: SAS-2007-00388, 100 West Oglethorpe Avenue, Savannah, Georgia 31401-3640

    FOR FURTHER INFORMATION CONTACT:

    Richard Morgan, Project Manager, at (912) 652-5139, or at [email protected]

    SUPPLEMENTARY INFORMATION:

    1. National Environmental Policy Act. The Corps prepared this DEIS to meet its National Environmental Policy Act (NEPA) (42 U.S.C. 4321 to 4370f) obligation in its evaluation of an application for a Department of the Army Permit pursuant to Section 404 of the Clean Water Act (CWA) (33 U.S.C. 1344) for the Proposed Project. This DEIS presents the direct, indirect, and cumulative impacts of the Proposed Project on the human and natural environment.

    2. Project Description. The Hall County Board of Commissioners submitted an application for a permit to construct an 850-acre pump-storage reservoir on Flat Creek, a tributary to the Chattahoochee River located approximately 35 miles northeast of Atlanta, near the upstream end of Lake Sidney Lanier, in Hall County, Georgia. The proposed dam would have a height of 140 feet, with a normal pool surface elevation of 1,180 feet above mean sea level. Dam and reservoir construction would result in the filling and inundation of 39.2 acres of wetland and 95,000 linear feet of stream. A 37 million gallon per day (mgd) intake and pump station would be constructed on the Chattahoochee River, and would transfer water from the river to the reservoir via a 48-inch diameter, 4-mile transmission pipeline. Water would be pumped from the Chattahoochee River to fill or refill the reservoir only when river flows are above the instream flow protection thresholds (IFPT), and only when the IFPT can be maintained in the river below the pump station. Water stored in the reservoir would be released into Flat Creek, flow downstream into Lake Lanier, and be withdrawn at an existing raw water intake operated by the City of Gainesville. The Proposed Project would provide a total storage volume of 11.7 billion gallons and an annual average water supply of 50 mgd, to meet Hall County's projected water demand through the year 2060.

    2. Alternatives. This DEIS evaluated 13 alternatives for the Proposed Project based on a range of Lake Lanier allocations, reservoir sites, reservoir yield, and transmission and treatment strategies. A wide range of water supply sources such as water conservation, additional Lake Lanier water supply allocation, purchase from adjacent counties, and additional groundwater develop.m.ent were identified prior to evaluating the need for any built alternatives. A range of potential Lake Lanier water supply allocations for Gainesville/Hall County were considered in the Alternatives Analysis, resulting in a range of reservoir safe yields for meeting the projected 2060 water supply needs.

    3. Issues. There are several potential environmental and public interest issues that were addressed in this DEIS. Public interest issues include but are not limited to potential effects to downstream flows of the Chattahoochee River; Lake Lanier water level and water supply capacity; potential aquatic resources impacts to streams, wetlands and aquatic organisms; and potential effects to cultural resources, aesthetics, recreation, infrastructure, navigation, transportation, and threatened and endangered species.

    4. Scoping. A Notice of Intent (NOI) to prepare an EIS was published in the Federal Register on February 17, 2012. The Corps held a total of three public scoping meetings in March 2012, in Alabama, Florida and Georgia, which are located in the Apalachicola-Chattahoochee-Flint (ACF) River Basin.

    5. Cooperating Agencies. The U.S. Environmental Protection Agency and the Georgia Environmental Protection Division have been participating in the NEPA process as cooperating agencies (40 CFR 1501.6, 1508.5). Formal cooperating agency agreements were executed between the Corps and these two agencies.

    6. Availability of the DEIS. The DEIS and appendices are available to the public for review in the following formats:

    a. In the Federal Register dated October 30, 2015.

    b. Online as PDF documents at http://www.gladesreservoir.com/.

    c. As a CD upon written request to the Corps address listed above.

    7. Public Review and Comment. The public comment period will commence with the publication of this notice and will end 60 days after its publication, on December 29, 2015. All persons and organizations that have an interest in the proposed action, including minority, low-income, disadvantaged, and Native American groups, are urged to participate in this NEPA environmental analysis process by reviewing the DEIS and submitting comments for consideration. Further information regarding the DEIS, including all available documents, background and historical information, and updates is available online at http://www.gladesreservoir.com/.

    8. Comments may be submitted via the following methods:

    a. At the public hearing through comment forms.

    b. Verbally through the court reporter at public hearing.

    c. By emailing [email protected].

    d. By letter addressed to the Corps address listed above.

    e. Online at http://www.gladesreservoir.com/.

    9. Open House and Public Hearing. The Corps will hold an open house and public hearing to allow for public presentation of comments. The open house and public hearing will be held on Tuesday, December 8, 2015 from 5:00-9:00 p.m., at the Hall County Board of Commissioners' Auditorium, located at 2875 Browns Bridge Road, Gainesville, Georgia 30504. The open house will be from 5:00 p.m. to 6:00 p.m., with public hearing to begin at 6:00 p.m. and end at 9:00 p.m.

    David M. Lekson, Chief, Regulatory Division.
    [FR Doc. 2015-27736 Filed 10-29-15; 8:45 am] BILLING CODE 3720-58-P
    DEPARTMENT OF DEFENSE Department of the Navy [Docket ID: USN-2015-HQ-0014] Privacy Act of 1974; System of Records AGENCY:

    Department of the Navy, DoD.

    ACTION:

    Notice to add a new system of records.

    SUMMARY:

    The Department of the Navy proposes to add a new system of records, N01000-6, entitled “Strategic Programs (SP) 205 Training Records” to provide support and track the training progress of naval personnel (commissioned officers and enlisted) who manage, operate, and maintain Strategic Weapons System (SWS) and Attack Weapon System (AWS). To document and track the completion of and/or validate the training courses. To provide the status of the training to the commands, DoD training managers, and to the Navy personnel.

    DATES:

    Comments will be accepted on or before November 30, 2015. This proposed action will be effective the day following the end of the comment period unless comments are received which result in a contrary determination.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

    * Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.

    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:

    Ms. Robin Patterson, Head, PA/FOIA Office (DNS-36), Department of the Navy, 2000 Navy Pentagon, Washington, DC 20350-2000, or by phone at (202) 685-6545.

    SUPPLEMENTARY INFORMATION:

    The Department of the Navy notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT or from the Defense Privacy and Civil Liberties Division Web site at http://dpcld.defense.gov/.

    The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on May 20, 2015, to the House Committee on Oversight and Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

    Dated: October 27, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. N01000-6 System name:

    Strategic Programs (SP) 205 Training Records.

    System location:

    Training records are located at multiple locations:

    Chenega Logistics, 6506 Loisdale Road, Suite 200, Springfield, VA 22150-1815.

    Trident Training Facility, 2000 Thresher Avenue, Silverdale, WA 9838-2004.

    Trident Training Facility, 1040 Georgia Avenue, Kings Bay, GA 31547-2150.

    Each of the following Naval Commands will also retain the Training Records:

    USS Ohio SSGN 726

    USS Michigan SSGN 727

    USS Florida SSGN 728

    USS Georgia SSGN 729

    USS Henry M. Jackson SSBN 730

    USS Alabama SSBN 731

    USS Alaska SSBN 732

    USS Nevada SSBN 733

    USS Tennessee SSBN 734

    USS Pennsylvania SSBN 735

    USS West Virginia SSBN 736

    USS Kentucky SSBN 737

    USS Maryland SSBN 738

    USS Nebraska SSBN 739

    USS Rhode Island SSBN 740

    USS Maine SSBN 741

    USS Wyoming SSBN 742

    USS Louisiana SSBN 743

    Categories of individuals covered by the system:

    All active duty naval personnel who are responsible for managing, operating, or maintaining the Strategic Weapon System (SWS) and Attack Weapon System (AWS).

    Categories of records in the system:

    Records include name, Social Security Number (SSN), DoD ID Number, date of birth, place of birth, rate/rank, military status, mailing/home address, role (e.g. student, afloat administrator, and Manager afloat) Unique Identification Code (UIC), command name or command group, Corporate Enterprise Training Activity Resource System Identification (CeTARS ID), student course assignment, and transcript.

    Authority for maintenance of the system:

    5 U.S.C. 301, Departmental Regulations; 10 U.S.C. 5013, Secretary of the Navy; OPNAVINST 1510.10C, Corporate Enterprise Training Activity Resource System; DoDI 1322.26, Development, Management and Delivery of Distributed Learning; and E.O. 9397 (SSN), as amended.

    Purpose(s):

    The Strategic Programs (SP) 205 Training Records system is designed to provide support and track the training progress of naval personnel (commissioned officers and enlisted) who manage, operate, and maintain Strategic Weapons System (SWS) and Attack Weapon System (AWS). To document and track the completion of and/or validate the training courses. To provide the status of the training to the commands, DoD training managers, and to the Navy personnel.

    Routine uses of records maintained in the system, including categories of users and the purpose of such uses:

    In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, these records contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

    The DoD Blanket Routine Uses set forth at the beginning of the Department of Navy's compilation of system of records notices may apply to this system. The complete list of DoD Blanket Routine Uses can be found online at: http://dpcld.defense.gov/Privacy/SORNsIndex/BlanketRoutineUses.aspx.

    Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Storage:

    Electronic storage media.

    Retrievability:

    Name, SSN, DoD ID Number, command name or command group, UIC, and/or CeTARS ID.

    Safeguards:

    Physical access to the system is provided on a need-to-know and to Common Access Card (CAC) authorized and authenticated personnel. CAC authorization, assignment and monitoring are the responsibility of the functional training managers.

    Retention and disposal:

    SP-205 Training Records are permanent. Cutoff at end of calendar year and transferred to the Washington National Records Center when 4 years old, and then transferred to the National Archives when 30 years old.

    All third-party requests for disclosure of data from the SP-205 Training Records will be retained on board and destroyed when 2 years old. Deletion of individual records will be accomplished by erasing.

    System manager(s) and address:

    Director, Strategic Systems Programs HQ, 1250 10th Street, Washington Navy Yard, DC 20347-5127.

    Notification procedure:

    Individuals seeking to determine whether this system of records contain information about themselves should address written inquiries to the Director, Strategic Systems Programs HQ, 1250 10th Street, Washington Navy Yard, DC 20347-5127.

    The request should contain full name, date of birth, place of birth, SSN, DoD ID Number, mailing/home address and signature of the requester.

    In addition, the requestor must provide a notarized statement or an unsworn declaration made in accordance with 28 U.S.C. 1746, in the following format:

    If executed outside the United States: “I declare [or certify, verify, or state] under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed on [date]. [Signature]”

    If executed within the United States, its territories, possessions, or commonwealths: “I declare [or certify, verify, or state] under penalty of perjury that the foregoing is true and correct. Executed on [date]. [Signature]”

    Record access procedures:

    Individuals seeking access to records about themselves contained in this system of records should address written inquiries to the Director, Strategic Systems Programs HQ, 1250 10th Street, Washington Navy Yard, DC 20347-5127.

    The request should contain full name, date of birth, place of birth, SSN, DoD ID Number, mailing/home address and signature of the requester.

    In addition, the requestor must provide a notarized statement or an unsworn declaration made in accordance with 28 U.S.C. 1746, in the following format:

    If executed outside the United States: “I declare [or certify, verify, or state] under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed on [date]. [Signature]”

    If executed within the United States, its territories, possessions, or commonwealths: “I declare [or certify, verify, or state] under penalty of perjury that the foregoing is true and correct. Executed on [date]. [Signature]”

    Contesting record procedures:

    The Navy's rule for accessing records and for contesting contents and appealing initial agency determination are published in Secretary in the Navy Instruction 5211.5; 32 CFR part 701; or may be obtained from the system manager.

    Record source categories:

    Individual, score reports, and Corporate Enterprise Training Activity Resource System Identification (CeTARS).

    Exemptions claimed for the system:

    None.

    [FR Doc. 2015-27713 Filed 10-29-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION National Assessment Governing Board Quarterly Board Meeting AGENCY:

    National Assessment Governing Board, U.S. Department of Education.

    ACTION:

    Announcement of open and closed meetings.

    SUMMARY:

    This notice sets forth the agenda for the November 19-21, 2015 Quarterly Meeting of the National Assessment Governing Board (hereafter referred to as Governing Board). This notice provides information to members of the public who may be interested in attending the meeting or providing written comments on the meeting. The notice of this meeting is required under section 10(a)(2) of the Federal Advisory Committee Act (FACA).

    DATES:

    The Quarterly Board meeting will be held on the following dates:

    • November 19, 2015 from 3:00 p.m. to 6:00 p.m.

    • November 20, 2015 from 8:30 a.m. to 5:00 p.m.

    • November 21, 2015 from 7:30 a.m. to 12:00 p.m.

    ADDRESSES:

    Westin Crystal City, 1800 Jefferson Davis Highway, Arlington, VA 22202.

    FOR FURTHER INFORMATION CONTACT:

    Munira Mwalimu, Executive Officer, 800 North Capitol Street NW., Suite 825, Washington, DC 20002, telephone: (202) 357-6938, fax: (202) 357-6945.

    SUPPLEMENTARY INFORMATION:

    Statutory Authority and Function: The National Assessment Governing Board is established under Title III—National Assessment of Educational Progress Authorization Act, Public Law 107-279. Information on the Board and its work can be found at www.nagb.gov.

    The Board is established to formulate policy for the National Assessment of Educational Progress (NAEP). The Board's responsibilities include the following: Selecting subject areas to be assessed, developing assessment frameworks and specifications, developing appropriate student achievement levels for each grade and subject tested, developing standards and procedures for interstate and national comparisons, improving the form and use of NAEP, developing guidelines for reporting and disseminating results, and releasing initial NAEP results to the public.

    November 19-21, 2015 Committee Meetings

    The Board's standing committees will meet to conduct regularly scheduled work, based on agenda items planned for this quarterly Board meeting, and follow-up items as reported in the Board's committee meeting minutes available at http://nagb.gov/what-we-do/board-committee-reports-and-agendas.html.

    Detailed Meeting Agenda: November 19-21, 2015 November 19: Informational Briefing and Executive Committee Meeting

    What Gallup is Learning about Education: Open Session: 3:00 p.m.-4:00 p.m.

    Executive Committee: Open Session: 4:30 p.m.-5:15 p.m.; Closed Session: 5:15 p.m.-6:00 p.m.

    November 20: Full Board Meeting

    Full Board: Open Session: 8:30 a.m.-9:45 a.m.; Closed Session: 12:50 p.m.-2:20 p.m.; Open Session: 2:20 p.m.-5:00 p.m.

    November 20: Committee Meetings Reporting and Dissemination Committee (R&D) and Assessment

    Development Committee (ADC): Joint Closed Session: 10:00 a.m.-11:00 a.m.

    ADC: Open Session: 11:00 a.m.-11:30 a.m.; Closed Session: 11:30 a.m.-12:30 p.m.

    R&D: Open Session: 11:00 a.m.-12:30 p.m.

    Committee on Standards, Design and Methodology (COSDAM): Open Session: 10:00 a.m.-10:05 a.m.; Closed Session: 10:05 a.m.-12:10 p.m.; Open Session: 12:10 a.m.-12:30 p.m.

    November 21: Full Board and Committee Meetings

    Nominations Committee: Closed Session: 7:30 a.m.-8:15 a.m.

    Full Board: Closed Session: 8:30 a.m.-9:35 a.m.; Open Session: 10:00 a.m.-12:00 p.m.

    On November 19, 2015, from 3:00 p.m. to 4:00 p.m., the Board will receive a briefing in open session on What Gallup is Learning About Education. Thereafter, the Executive Committee will convene in open session from 4:30 p.m. to 5:15 p.m., and in closed session from 5:15 p.m. to 6:00 p.m.

    During the closed session, the Executive Committee will receive and discuss cost estimates and implications for implementing NAEP's Assessment Schedule for 2014-2024. This meeting must be conducted in closed session because public disclosure of this information would likely have an adverse financial effect on the NAEP program by providing confidential cost details and proprietary contract costs of current contractors to the public. Discussion of this information would be likely to significantly impede implementation of a proposed agency action if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of Title 5 U.S.C.

    On November 20, 2015, the Full Board will meet in open session from 8:30 a.m. to 9:45 a.m. The Board will review and approve the November 19-21, 2015 Board meeting agenda and meeting minutes from the August 2015 Quarterly Board meeting. This session will be followed by the Chairman's introduction of new Board members and remarks from new members. Thereafter, the Executive Director of the Governing Board, Bill Bushaw, will provide his report, followed by an update on the work of IES provided by Ruth Neild, Deputy Director for Policy and Research, IES. The NCES update will be provided by the Acting Commissioner of the NCES, Peggy Carr. The Board will recess for Committee meetings at 9:45 a.m. scheduled from 10:00 a.m. to 12:30 p.m.

    The Assessment Development Committee (ADC) and the Reporting and Dissemination (R&D) Committee will meet in a joint closed session from 10:00 a.m. to 11:00 a.m. Thereafter R&D Committee will meet in open session from 11:00 a.m. to 12:30 p.m. The ADC will meet in open session from 11:00 a.m. to 11:30 a.m. and in closed session from 11:30 a.m. to 12:30 p.m. The purpose of the joint closed session is to review the embargoed reporting Web site content for the 2014 grade 8 Technology and Engineering Literacy (TEL) Report Card. This meeting is being conducted in closed session because the TEL results are embargoed and have not been released to the public. Public disclosure of the secure data would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of Title 5 U.S.C.

    The ADC will meet in open session from 11:00 a.m. to 11:30 a.m. to receive a briefing on NAEP digital-based assessments. From 11:30 a.m. to 12:30 p.m. the ADC will meet in closed session to receive a briefing on in-depth analyses of the 2015 Reading and Mathematics results at grades 4 and 8. This meeting must be closed because the briefing will include secure NAEP items from reading and math test results at grades 4 and 8. Public disclosure of the secure data would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of Title 5 U.S.C.

    R&D will meet in open session from 11:00 a.m. to 12:30 p.m. to discuss NAEP Report Card releases and the Governing Board's ongoing work on reporting and dissemination.

    The Committee on Standards, Design and Methodology (COSDAM) will meet in open session from 10:00 a.m. to 10:05 a.m. to introduce new Committee members and review the Committee meeting agenda. The Committee will meet in closed session from 10:05 a.m. to 12:10 p.m. and thereafter in open session from 12:10 p.m. to 12:30 p.m.

    During the first part of the closed session COSDAM will discuss information regarding analyses of the 2015 bridge studies for paper-and-pencil and digital-based assessments, and discuss secure NAEP Reading and Mathematics data. This part of the meeting must be conducted in closed session because the analysis involves the use of secure data for the NAEP Reading and Mathematics assessments on digital-based platforms. Public disclosure of secure data would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of Title 5 U.S.C.

    During the second part of the closed session, COSDAM will discuss the proposed 2014 NAEP Technology and Engineering Literacy (TEL) achievement levels for grade 8, which includes secure NAEP TEL data. This part of the meeting must be conducted in closed session because the analysis involves the use of secure data for the NAEP TEL assessment. Public disclosure of secure data would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of Title 5 U.S.C. COSDAM will meet in open session from 12:10 p.m. to 12:30 p.m. to take Committee action on achievement levels and discuss ongoing Committee work.

    Following the Committee meetings, the Board will convene in closed session on November 20, 2015 from 12:50 p.m. to 2:20 p.m. to discuss the proposed 2014 NAEP Technology and Engineering Literacy (TEL) achievement levels for grade 8, which includes secure NAEP TEL data. This part of the meeting must be conducted in closed session because the analysis involves the use of secure data for the NAEP TEL assessment. Public disclosure of secure data would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of Title 5 U.S.C.

    Thereafter, the Board will meet in open session from 2:45 p.m. to 5:00 p.m. From 2:45 p.m. to 3:30 p.m., the Board will meet in open session to receive a briefing on the 2015 Trial Urban District Assessment (TUDA) Report Card in English and Mathematics. From 3:30 p.m. to 4:15 p.m., the Board will receive the annual briefing from the Council of Chief State School Officers and Governing Board Policy Task Force Vice Chair and Assistant Superintendent form the Virginia Department of Education, Shelly Loving-Ryder. From 4:15 p.m. to 4:30 p.m. the Governing Board members will be provided with the annual ethics briefing from Office of General Counsel staff.

    The November 20, 2015 session of the Board meeting will adjourn at 5:00 p.m.

    On November 21, 2015, the Nominations Committee will meet in closed session from 7:30 a.m. to 8:15 a.m. to discuss the final slate of candidates for seven Board vacancies for terms beginning on October 1, 2016. The Committee's discussions pertain solely to internal personnel rules and practices of an agency and information of a personal nature where disclosure would constitute an 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. Following the closed session, the Committee will meet in open session from 8:15 a.m. to 8:20 a.m. to discuss and take action on the slate of finalists in the Chief State School Officer category for 2015. The final slate of candidates for this open position will be brought before the Board for discussion and action on November 21, 2015.

    The full Board will convene in closed session on Saturday, November 21, 2015 from 8:30 a.m. to 8:35 a.m. The purpose of the closed session is to receive and discuss the slate of finalists being recommended for action by the Nominations Committee for the Chief State School Officer position, to be appointed by the Secretary of Education in 2016. At 8:35 a.m., the Board will take action in open session on the slate of Chief State School Officer finalists for the vacancy.

    The Board will meet in closed session from 8:45 a.m. to 9:35 a.m. to receive an update on the NAEP budget and planned changes to the NAEP Assessment Schedule. During the closed session, the Board will receive and discuss cost estimates and implications for implementing NAEP's Assessment Schedule for 2014-2024. This meeting must be conducted in closed session because public disclosure of this information would likely have an adverse financial effect on the NAEP program by providing confidential cost details and proprietary contract costs of current contractors to the public. Discussion of this information would be likely to significantly impede implementation of a proposed agency action if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of Title 5 U.S.C.

    The Board will take action on the NAEP Assessment Schedule from 9:35 a.m. to 9:45 a.m. in open session. Thereafter, from 10:00 a.m. to 11:00 a.m. the Board will receive updates on NCES' Future of NAEP Activities and the Governing Board's Strategic Planning Initiative.

    From 11:30 a.m. to 12:00 p.m. the Board will receive reports from the standing committees and take action proposed by the Committee on Standards, Design and Methodology on the TEL Achievement Levels at Grade 8. The November 21, 2015 meeting is scheduled to adjourn at 12:00 p.m.

    Access to Records of the Meeting: Pursuant to FACA requirements, the public may also inspect the meeting materials at www.nagb.gov on Thursday, November 19, 2015 by 7:00 a.m. ET. The official verbatim transcripts of the public meeting sessions will be available for public inspection no later than 30 calendar days following the meeting.

    Reasonable Accommodations: The meeting site is accessible to individuals with disabilities. If you will need an auxiliary aid or service to participate in the meeting (e.g., interpreting service, assistive listening device, or materials in an alternate format), notify the contact person listed in this notice at least two weeks before the scheduled meeting date. Although we will attempt to meet a request received after that date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.

    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.

    Authority:

    Pub. L. 107-279, Title III—National Assessment of Educational Progress section 301.

    Dated: October 27, 2015. William J. Bushaw, Executive Director, National Assessment Governing Board (NAGB), U.S. Department of Education.
    [FR Doc. 2015-27720 Filed 10-29-15; 8:45 am] BILLING CODE P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2015-ICCD-0126] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 2015-16 National Postsecondary Student Aid Study (NPSAS:16) Full Scale Student Data Collection AGENCY:

    National Center for Education Statistics (NCES), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before November 30, 2015.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2015-ICCD-0126. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 2E105, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Kashka Kubzdela at (202) 502-7411 or by email [email protected].

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: 2015-16 National Postsecondary Student Aid Study (NPSAS:16) Full Scale Student Data Collection

    OMB Control Number: 1850-0666.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: Individuals.

    Total Estimated Number of Annual Responses: 86,000.

    Total Estimated Number of Annual Burden Hours: 75,811.

    Abstract: The National Postsecondary Student Aid Study (NPSAS), a nationally representative study of how students and their families finance postsecondary education, was first implemented by the National Center for Education Statistics (NCES) in 1987 and has been fielded every 3 to 4 years since. The next major data collection will occur in 2016 following a field test collection in 2015. This submission is for the ninth cycle in the series, NPSAS:16, which will also serve as the base year study for the 2016 Baccalaureate and Beyond Longitudinal Study (B&B) which provides data on the various paths of recent college graduates into employment and additional education. The NPSAS:16 sample will include about 2,000 institutions and about 128,000 students. Institution contacting began in October 2015 and student data collection will be conducted from January through September 2016. The NPSAS:16 full scale institution contacting and enrollment list collection was approved in July 2015 (OMB# 1850-0666 v.15-16). This submission covers NPSAS:16 full scale materials and procedures required for student record abstractions, student surveying, and matching data to administrative files. Because the institution contacting and enrollment list collection will still be ongoing at the time this request is approved, the burden and materials from the NPSAS:16 Full Scale Institution Contacting And Enrollment List Collection request (OMB# 1850-0666 v.15-16) are being carried over in this submission.

    Dated: October 27, 2015. Stephanie Valentine, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2015-27727 Filed 10-29-15; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Senior Executive Service Performance Review Board AGENCY:

    Department of Energy.

    ACTION:

    Designation of Performance Review Board Standing Register.

    SUMMARY:

    This notice provides the Performance Review Board Standing Register for the Department of Energy. This listing supersedes all previously published lists of PRB members.

    DATES:

    This appointment is effective as of September 30, 2015.

    Bremer, John Brown, Fred Cooper, Suzanne Dickinson, Mark Erhart, Steven Gilbertson, Mark Grose, Amy Lee, Terri Lenhard, Joseph Livengood, Joanna Mays, Cyndi McMillian, Jimmy Mefford, Penny Mollot, Darren Moore, Johnny O'Konski, Peter Pearson, Gina Issued in Washington, DC, October 23, 2015. Erin S. Moore, Acting Director, Office of Corporate Executive Management, Office of the Chief Human Capital Officer.
    [FR Doc. 2015-27757 Filed 10-29-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Senior Executive Service Performance Review Board AGENCY:

    Department of Energy.

    ACTION:

    Designation of Performance Review Board Chair.

    SUMMARY:

    This notice provides the Performance Review Board Chair designee for the Department of Energy. This listing supersedes all previously published lists of Performance Review Board Chair.

    DATES:

    This appointment is effective as of September 30, 2015: Dennis M. Miotla.

    Issued in Washington, DC: October 23, 2015. Erin S. Moore, Acting Director, Office of Corporate Executive Management, Office of the Chief Human Capital Officer.
    [FR Doc. 2015-27724 Filed 10-29-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Energy Information Administration Agency Information Collection Extension AGENCY:

    U.S. Energy Information Administration (EIA), Department of Energy.

    ACTION:

    Agency Information Collection Activities: Information Collection Extension with Changes; Notice and Request for Comments.

    SUMMARY:

    The EIA invites public comment on the proposed collection of information, EIA-882T, “Generic Clearance for Questionnaire Testing, Evaluation, and Research” that EIA is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995. 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 collection of information, including the validity of the methodology and assumptions used; ways to enhance the quality, utility, and clarity of the information to be collected; and 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.

    DATES:

    Comments regarding this proposed information collection must be received on or before December 29, 2015. If you anticipate difficulty in submitting comments within that period, contact the person listed in ADDRESSES as soon as possible.

    ADDRESSES:

    Written comments may be sent to Jacob Bournazian, Energy Information Administration, 1000 Independence Avenue SW., Washington DC 20585 or by fax at 202-586-0552 or by email at [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Jacob Bournazian, Energy Information Administration, 1000 Independence Avenue SW., Washington, DC 20585, phone: 202-586-5562, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    This information collection request contains:

    (1) OMB No.: 1905-0186;

    (2) Information Collection Request Title: Generic Clearance for Questionnaire Testing, Evaluation, and Research;

    (3) Type of Request: Revision;

    (4) Purpose: The U.S. Energy Information Administration (EIA) is planning to request a three-year approval from the Office of Management and Budget (OMB) to utilize qualitative and quantitative methodologies to pretest questionnaires and validate the quality of the data collected on EIA forms. This authority would allow EIA to conduct pretest surveys, pilot surveys, respondent debriefings, cognitive interviews, usability interviews, and focus groups. Through the use of these methodologies, EIA will improve the quality of data being collected for measuring market activity and assessing supply conditions in energy markets, reduce or minimize respondent burden, increase agency efficiency, and improve responsiveness to the public. This authority also improves EIA's ability to collect relevant and timely information that meets the data needs of EIA's customers.

    The specific methods proposed for the coverage by this clearance are described below. Also outlined is the legal authority for these voluntary information gathering activities.

    The following methods are proposed:

    Field Testing. Field testing surveys conducted under this clearance will generally be methodological studies. The field testing samples drawn may not be representative of the survey respondent universe because they will be designed to clarify particular issues. Collection may be on the basis of fuel market coverage related to the issues that are the subject to the research, market size of the respondent, position of the respondent in the upstream and/or downstream market for a particular fuel group, and convenience, e.g., limited to specific geographic locations. The sample sizes and designs will be determined at the time of development and will vary based on the content of the information collection or survey being tested.

    Pilot Surveys. Pilot surveys conducted under this clearance will generally be methodological studies, but will always employ statistically representative samples. The pilot surveys will replicate all components of the methodological design, sampling procedures (where possible) and questionnaires of the full scale survey. Pilots will normally be utilized when EIA undertakes a complete redesign of a particular data collection methodology or when EIA undertakes data collection in new areas, such as greenhouse gases or alternative fueled motor vehicle transportation system studies.

    Respondent Debriefings. Respondent debriefings conducted under this clearance will generally be methodological or cognitive research studies. The debriefing form is administered after a respondent completes a questionnaire either in paper format, electronically, or through in-person interviews. The debriefings contain probing questions to determine how respondents interpret the survey questions, how much time and effort was spent completing the questionnaire, and whether they have problems in completing the survey/questionnaire. Respondent debriefings also are useful in determining potential issues with data quality and in estimating respondent burden.

    Cognitive Interviews. Cognitive interviews are typically one-on-one interviews in which the respondent is usually asked to “think aloud” or is asked “retrospective questions” as he or she answers survey questions, reads survey materials, or completes other activities as part of a survey process. A number of different techniques may be involved, including asking respondents what specific words or phrases mean, and asking respondents probing questions to determine how they estimate or calculate specific data elements on a survey form. The objective of these interviews is to identify problems of ambiguity or misunderstanding, to identify other difficulties respondents have answering questions, reduce measurement error in a survey, and assess the burden for reporting energy information.

    Usability Interviews. Usability interviews are similar to cognitive interviews in which a respondent is typically asked to “think aloud” or asked “retrospective questions” as he or she reviews an electronic questionnaire, Web site and/or associated materials, or hard copy form. The objective of a usability interview is to make sure that respondents can easily and intuitively navigate electronic questionnaires, Web sites and other associated materials, or other survey instruments.

    Focus Groups. Focus groups involve group sessions guided by a moderator who follows a topic guide containing questions or topics focused on a particular issue rather than adhering to a standardized questionnaire. Focus groups are useful for surfacing and exploring issues with populations of interest, e.g., a specific group of stakeholders.

    (5) Annual Estimated Number of Respondents: 2,000;

    (6) Annual Estimated Number of Total Responses: 2,000;

    (7) Annual Estimated Number of Burden Hours: 2,000;

    (8) Annual Estimated Reporting and Recordkeeping Cost Burden: There are no additional costs associated with these survey methods other than the burden hours. The information is maintained in the normal course of business. The cost of burden hours to the respondents is estimated to be $143,940 (2,000 burden hours times $71.97 per hour), which represents a reduction of 1,006 burden hours from the prior renewal of this collection. Therefore, other than the cost of burden hours, EIA estimates that there are no additional costs for generating, maintaining and providing the information.

    Statutory Authority:

    Section 13(b) of the Federal Energy Administration Act of 1974, Public Law 93-275, codified at 15 U.S.C. 772(b).

    Issued in Washington, DC, on October 26, 2015. Nanda Srinivasan, Director, Office of Survey Development and Statistical Integration, U.S. Energy Information Administration.
    [FR Doc. 2015-27721 Filed 10-29-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC16-18-000.

    Applicants: Cedar Bluff Wind, LLC, Golden Hills Wind, LLC, Golden Hills Interconnection, LLC.

    Description: Application for Approval under Section 203 of the Federal Power Act and Request for Expedited Action of Cedar Bluff Wind, LLC, et al.

    Filed Date: 10/23/15.

    Accession Number: 20151023-5400.

    Comments Due: 5 p.m. ET 11/13/15.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER15-2647-000.

    Applicants: Tres Amigas, LLC.

    Description: Supplement to September 11, 2015 Tres Amigas, LLC submits tariff filing.

    Filed Date: 10/23/15.

    Accession Number: 20151023-5396.

    Comments Due: 5 p.m. ET 10/30/15

    Docket Numbers: ER15-2676-000.

    Applicants: Cedar Bluff Wind, LLC.

    Description: Revision to September 18, 2015 Cedar Bluff Wind, LLC tariff filing.

    Filed Date: 10/20/15.

    Accession Number: 20151020-5264.

    Comments Due: 5 p.m. ET 11/10/15.

    Take notice that the Commission received the following qualifying facility filings:

    Docket Numbers: QF16-132-000.

    Applicants: Hollingsworth & Vose Company.

    Description: Form 556 of Hollingsworth & Vose Company.

    Filed Date: 10/23/15.

    Accession Number: 20151023-5135.

    Comments Due: None Applicable.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 26, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-27672 Filed 10-29-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Staff Notice of Alleged Violations

    Take notice 1 that in a nonpublic investigation pursuant to 18 CFR part 1b (2015), the staff of the Office of Enforcement of the Federal Energy Regulatory Commission has preliminarily determined that Berkshire Power Company LLC (Berkshire) and Powerplant Management Services LLC violated the Commission's Anti-Manipulation Rule, 18 CFR 1c.2 (2015) by engaging in a manipulative scheme to conceal maintenance work and associated outages beginning at least as early as January 2008 and continuing through March 2011.

    1Enforcement of Statutes, Regulations, and Orders, 129 FERC ¶ 61,247 (2009), order on reh'g, 134 FERC ¶ 61,054 (2011).

    Staff also has preliminarily determined that Berkshire violated Commission-approved reliability standards by failing to provide outage information to its Transmission Operator and failing to inform its Transmission Operator and Host Balancing Authority of all generation resources available for use.

    Finally, Staff also has preliminarily determined that Berkshire violated Commission regulations 35.41(a) by failing to comply with various provisions of the ISO-New England (ISO-NE) Tariff and § 35.41(b) by making false and misleading statements to ISO-NE regarding its maintenance work and associated outages.

    This notice does not confer a right on third parties to intervene in the investigation or any other right with respect to the investigation.

    Dated: October 23, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-27674 Filed 10-29-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC16-16-000.

    Applicants: Entergy Rhode Island State Energy, L.P.

    Description: Application of Entergy Rhode Island State Energy, L.P. for Section 203 approval and request for shortened notice period and expedited treatment.

    Filed Date: 10/22/15.

    Accession Number: 20151022-5294.

    Comments Due: 5 p.m. ET 11/12/15.

    Take notice that the Commission received the following exempt wholesale generator filings:

    Docket Numbers: EG16-13-000.

    Applicants: Marshall Wind Energy LLC.

    Description: Self-Certification as an Exempt Wholesale Generator of Marshall Wind Energy LLC.

    Filed Date: 10/23/15.

    Accession Number: 20151023-5157.

    Comments Due: 5 p.m. ET 11/13/15.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER16-137-000.

    Applicants: Enserco Energy LLC.

    Description: Tariff Cancellation: Cancellation to be effective 12/23/2015.

    Filed Date: 10/23/15.

    Accession Number: 20151023-5102.

    Comments Due: 5 p.m. ET 11/13/15.

    Docket Numbers: ER16-138-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) Rate Filing: Letter Agreement Addressing RAS Affecting Silver State Solar Power South LGIA to be effective 10/24/2015.

    Filed Date: 10/23/15.

    Accession Number: 20151023-5145.

    Comments Due: 5 p.m. ET 11/13/15.

    Docket Numbers: ER16-139-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: Revisions to Attachment W to Update Index of Grandfathered Agreements to be effective 1/1/2016.

    Filed Date: 10/23/15.

    Accession Number: 20151023-5165.

    Comments Due: 5 p.m. ET 11/13/15.

    Take notice that the Commission received the following electric securities filings:

    Docket Numbers: ES15-71-000.

    Applicants: PPL Electric Utilities Corporation.

    Description: Amendment to September 18, 2015 Application under Section 204 of the Federal Power Act of PPL Electric Utilities Corporation.

    Filed Date: 10/22/15.

    Accession Number: 20151022-5288.

    Comments Due: 5 p.m. ET 11/2/15.

    Docket Numbers: ES15-72-000.

    Applicants: Interstate Power and Light Company.

    Description: Amendment to September 18, 2015 Application under Section 204 of the Federal Power Act of Interstate Power and Light Company.

    Filed Date: 10/22/15.

    Accession Number: 20151022-5286.

    Comments Due: 5 p.m. ET 11/12/15.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 23, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-27676 Filed 10-29-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP16-5-000] Eastern Shore Natural Gas Company; Notice of Request Under Blanket Authorization

    Take notice that on October 13, 2015 Eastern Shore Natural Gas Company (Eastern Shore), 1110 Forrest Avenue, Dover, Delaware, 19904, filed in the above referenced docket a prior notice application pursuant to sections 157.205, 157.208, and 157.210 of the Federal Energy Regulatory Commission's (Commission) regulations under the Natural Gas Act (NGA), and Eastern Shore's blanket certificate issued in Docket No. CP96-128-000. Eastern Shore seeks authorization to increase the certificated capacity of its Receipt Zone 1 facilities by 53,000 dekatherms per day, all as more fully set forth in the application, which is open to the public for inspection.

    The filing may also be viewed on the Web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or TTY, contact (202) 502-8659.

    Any questions concerning this application may be directed to William Rice, King & Spalding LLP, 1700 Pennsylvania Avenue NW., Suite 200, Washington, DC 20006, by phone 202-626-9602, by fax 202-626-3737, or by email [email protected]

    Specifically, Eastern Shore's Receipt Zone 1 consists of eight-mile long sixteen-inch diameter pipeline and interconnect with Texas Eastern Transmission, LP (Texas Eastern) in Chester County, PA. Eastern Shore proposes to increase meter capacity and upgrade pressure and flow control equipment at the interconnect with Texas Eastern to accommodate additional capacity. Eastern Shore states that proposed project has been designed based on the customer requests received during an open season that Eastern Shore conducted in the month of June, 2015. Eastern Shore further states that the total estimated cost of the project is $1,375,038 and will be covered by the customer commitments.

    Any person or the Commission's staff may, within 60 days after issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and pursuant to section 157.205 of the regulations under the NGA (18 CFR 157.205), a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for filing a protest. If a protest is filed and not withdrawn within 30 days after the allowed time for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding, or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    Dated: October 23, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-27673 Filed 10-29-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meeting related to the transmission planning activities of the New York Independent System Operator, Inc.

    The New York Independent System Operator, Inc. Electric System Planning Working Group Meeting October 29, 2015, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via Web conference and teleconference.

    The above-referenced meeting is open to stakeholders.

    Further information may be found at: http://www.nyiso.com/public/markets_operations/services/planning/index.jsp.

    The New York Independent System Operator, Inc. Electric System Planning Working Group Meeting November 10, 2015, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via Web conference and teleconference.

    The above-referenced meeting is open to stakeholders.

    Further information may be found at: http://www.nyiso.com/public/markets_operations/services/planning/index.jsp.

    The discussions at the meeting described above may address matters at issue in the following proceedings:

    New York Independent System Operator, Inc., Docket No. ER13-102. ISO New England Inc., et al., Docket Nos. ER13-1957, et al. ISO New England Inc., Docket Nos. ER13-193 and ER13-196. New York Independent System Operator, Inc., Docket No. ER15-2059. New York Power Authority, Docket No. ER15-2102. New York Transco, LLC, Docket No. ER15-572.

    For more information, contact James Eason, Office of Energy Market Regulation, Federal Energy Regulatory Commission at (202) 502-8622 or [email protected]

    Dated: October 23, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-27675 Filed 10-29-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #2

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-2137-014; ER14-2798-006; ER14-2799-006; ER12-161-013; ER12-164-013; ER15-1873-003; ER12-645-015; ER10-2130-014; ER10-2131-014; ER10-2138-014; ER10-2139-014; ER10-2140-014; ER10-2141-014; ER14-2187-008; ER11-4044-015; ER11-4046-014; ER10-2127-013; ER10-2125-014; ER14-25-010; ER15-1041-003; ER15-2205-002; ER10-2133-014; ER10-2124-013; ER11-3872-015; ER10-2764-013; ER10-2132-013; ER10-2128-013.

    Applicants: Beech Ridge Energy LLC, Beech Ridge Energy II LLC, Beech Ridge Energy Storage LLC, Bishop Hill Energy LLC, Bishop Hill Energy III LLC, Buckeye Wind Energy LLC, California Ridge Wind Energy LLC, Forward Energy LLC, Grand Ridge Energy LLC, Grand Ridge Energy II LLC, Grand Ridge Energy III LLC, Grand Ridge Energy IV LLC, Grand Ridge Energy V LLC, Grand Ridge Energy Storage LLC, Gratiot County Wind LLC, Gratiot County Wind II LLC, Invenergy TN LLC, Judith Gap Energy LLC, Prairie Breeze Wind Energy LLC, Prairie Breeze Wind Energy II LLC, Prairie Breeze Wind Energy III LLC, Sheldon Energy LLC, Spring Canyon Energy LLC, Stony Creek Energy LLC, Vantage Wind Energy LLC, Willow Creek Energy LLC, Wolverine Creek Energy LLC.

    Description: Notification of Change in Facts of Beech Ridge Energy LLC, et al.

    Filed Date: 10/23/15.

    Accession Number: 20151023-5271.

    Comments Due: 5 p.m. ET 11/13/15.

    Docket Numbers: ER15-13-003.

    Applicants: Transource Wisconsin, LLC.

    Description: Compliance filing: Transource Wisconsin Deficiency Compliance Filing to be effective12/1/2014.

    Filed Date: 10/23/15.

    Accession Number: 20151023-5220.

    Comments Due: 5 p.m. ET 11/13/15.

    Docket Numbers: ER15-958-003.

    Applicants: Transource Kansas, LLC.

    Description: Compliance filing: Transource Kansas Deficiency Filing to be effective 4/3/2015.

    Filed Date: 10/23/15.

    Accession Number: 20151023-5320.

    Comments Due: 5 p.m. ET 11/13/15.

    Docket Numbers: ER16-140-000.

    Applicants: PJM Interconnection, L.L.C., Pennsylvania Electric Company, Jersey Central Power & Light, Metropolitan Edison Company.

    Description: § 205(d) Rate Filing: Penelec, et al. submit SA Nos. 4221, 4222, 4223 with Reverse Power Flow Agreement to be effective 12/22/2015.

    Filed Date: 10/23/15.

    Accession Number: 20151023-5176.

    Comments Due: 5 p.m. ET 11/13/15.

    Docket Numbers: ER16-141-000.

    Applicants: Conetoe II Solar, LLC.

    Description: Baseline eTariff Filing: MBR Tariff and Application to be effective 10/26/2015.

    Filed Date: 10/23/15.

    Accession Number: 20151023-5326.

    Comments Due: 5 p.m. ET 11/13/15.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 23, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-27671 Filed 10-29-15; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-9023-7] Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General Information (202) 564-7146 or http://www2.epa.gov/nepa.

    Weekly receipt of Environmental Impact Statements Filed 10/19/2015 Through 10/23/2015 Pursuant to 40 CFR 1506.9. Notice

    Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at: http://cdxnodengn.epa.gov/cdx-nepa-public/action/eis/search.

    EIS No. 20150295, Draft, NPS, REG, Revision of 9B Regulations Governing Non-Federal Oil and Gas Activities, Comment Period Ends: 12/28/2015, Contact: Michael B. Edwards 303-969-2694. EIS No. 20150296, Final, FEMA, OR, Southern Flow Corridor Project, Review Period Ends: 11/30/2015, Contact: Mark Eberlein 425-487-4735. EIS No. 20150297, Final, USA, HI, Schofield Generating Station Project U.S. Army Garrison-Hawaii, Review Period Ends: 11/30/2015, Contact: Lisa Graham 808-656-3075. EIS No. 20150298, Draft, USACE, MS, Proposed Port of Gulfport Expansion Project, Comment Period Ends: 12/14/2015, Contact: Philip Hegji 251-690-3222. EIS No. 20150299, Final, NRC, WI, Construction Permit for the SHINE Medical Radioisotope Production Facility, Final Report, NUREG-2183, Review Period Ends: 11/30/2015, Contact: Michelle Moser 301-415-6509. EIS No. 20150300, Draft, USACE, GA, Glades Reservoir Water Supply Project, Comment Period Ends: 12/29/2015, Contact: Richard W. Morgan 912-652-5139. EIS No. 20150301, Draft, USFWS, CA, Delta Research Station Project: Estuarine Research Station and Fish Technology Center, Comment Period Ends: 12/14/2015, Contact: Barbara Beggs 916-930-5637. EIS No. 20150302, Draft, NPS, WY, Moose-Wilson Corridor Draft Comprehensive Management Plan, Comment Period Ends: 12/29/2015, Contact: Chris Church 303-969-2276. EIS No. 20150303, Final, AFS, BLM, NV, Greater Sage Grouse Bi-State Distinct Population Segment Forest Plan Amendment, Review Period Ends: 11/30/2015, Contact: James Winfrey 775-355-5308. Dated: October 27, 2015. Karin Leff, Acting Director, NEPA Compliance Division, Office of Federal Activities.
    [FR Doc. 2015-27732 Filed 10-29-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2012-0103; FRL-9936-39-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Diesel Emissions Reduction Act (DERA) Rebate Program (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency has submitted an information collection request (ICR), “Diesel Emissions Reduction Act (DERA) Rebate Program” (EPA ICR No. 2461.02, OMB Control No. 2060-0686) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through October 31, 2015. Public comments were previously requested via the Federal Register on August 25, 2015 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 November 30, 2015.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2012-0103, 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:

    Tyler Cooley, Office of Transportation and Air Quality, (Mail Code: 6406A), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 415-972-3937; fax number: 202-343-2803; 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, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Abstract: The Diesel Emissions Reduction Act program (DERA) is authorized by Title VII, Subtitle G (Sections 791 to 797) of the Energy Policy Act of 2005 (Pub. L. 109-58), as amended by the Diesel Emissions Reduction Act of 2010 (Pub. L. 111-364), codified at 42 U.S.C. 16131 et seq. DERA provides the Environmental Protection Agency (EPA) with the authority to award grants, rebates or low-cost revolving loans on a competitive basis to eligible entities to fund the costs of projects that significantly reduce diesel emissions from mobile sources through implementation of a certified engine configuration, verified technology, or emerging technology. Eligible mobile sources include buses (including school buses), medium heavy-duty or heavy heavy-duty diesel trucks, marine engines, locomotives, or nonroad engines or diesel vehicles or equipment used in construction, handling of cargo (including at ports or airports), agriculture, mining, or energy production. In addition, eligible entities may also use funds awarded for programs or projects to reduce long-duration idling using verified technology involving a vehicle or equipment described above. The objective of the assistance under this program is to achieve significant reductions in diesel emissions in terms of tons of pollution produced and reductions in diesel emissions exposure, particularly from fleets operating in areas designated by the Administrator as poor air quality areas.

    EPA uses approved procedures and forms to collect necessary information to operate its grant and rebate programs as authorized by Congress under the DERA program. EPA collects information from applicants to the DERA rebate program. Information collected is used to ensure eligibility of applicants and engines to receive funds under DERA, and to calculate estimated and actual emissions benefits that result from activities funded with rebates as required in DERA's authorizing legislation.

    Form Numbers: 2060-0686.

    Respondents/affected entities: Entities interested in applying for a rebate under EPA's Diesel Emission Reduction Act (DERA) Rebate Program and include but are not limited to the following NAICS (North American Industry Classification System) codes: 23 Construction; 482 Rail Transportation; 483 Water Transportation; 484 Truck Transportation; 485 Transit and Ground Passenger Transportation; 48831 Port and Harbor Operations; 61111 Elementary and Secondary Schools; 61131 Colleges, Universities, and Professional Schools; 9211 Executive, Legislative, and Other Government Support; and 9221 Justice, Public Order, and Safety Activities.

    Respondent's obligation to respond: Voluntary.

    Estimated number of respondents: 500-1,000 (total).

    Frequency of response: Voluntary as needed.

    Total estimated burden: 2,827 hours (per year). Burden is defined at 5 CFR 1320.03(b).

    Total estimated cost: $100,592.58 (per year), includes $0 annualized capital or operation & maintenance costs.

    Changes in the Estimates: There is an increase of 1,933 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase is due to a higher level of interest in the rebate program than originally anticipated. The revised burden of 2,827 hours reflects an updated estimate of 771 applicants (respondents) and is based on the number of applications submitted under previous rebate funding opportunities. In the ICR currently approved by OMB, EPA estimated an annual burden of 894 hours for 120 applicants. EPA received over 1,000 applications for the 2012 pilot program and over 500 applications for the 2014 funding opportunity.

    Courtney Kerwin, Acting Director, Collection Strategies Division.
    [FR Doc. 2015-27691 Filed 10-29-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL 9936-34-OARM] Good Neighbor Environmental Board; Public Advisory Committee Teleconference AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of public advisory committee teleconference.

    SUMMARY:

    Pursuant to the Federal Advisory Committee Act, Public Law 92-463, notice is hereby given that the Good Neighbor Environmental Board (Board) will hold a public teleconference on November 30, 2015. For further information regarding the teleconference and background materials, please contact Ann-Marie Gantner at the number and email provided below.

    DATES:

    The Board will hold a public teleconference on November 30, 2015 from 11 a.m. to 3 p.m. Eastern Standard Time.

    SUPPLEMENTARY INFORMATION:

    Background: The Good Neighbor Environmental Board is a federal advisory committee chartered under the Federal Advisory Committee Act, Public Law 92-463. By statute, the Board is required to submit an annual report to the President on environmental and infrastructure issues along the U.S. border with Mexico.

    Purpose of Meeting: The purpose of this teleconference is to discuss and approve the Board's advice letter to the President, which focuses on climate change resilience in the U.S.-Mexico border region.

    General Information: The agenda and teleconference materials, as well as general information about the Board, can be found at http://www2.epa.gov/faca/gneb. If you wish to make oral comments or submit written comments to the Board, please contact Ann-Marie Gantner at least five days prior to the teleconference.

    Meeting Access: For information on access or services for individuals with disabilities, please contact Ann-Marie Gantner at (202) 564-4330 or email at [email protected] To request accommodation of a disability, please contact Ann-Marie Gantner at least 10 days prior to the meeting to give EPA as much time as possible to process your request.

    Dated: October 20, 2015. Ann-Marie Gantner, Acting Designated Federal Officer.
    [FR Doc. 2015-27786 Filed 10-29-15; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0609] 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 December 29, 2015. 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 Cathy Williams, FCC, via email to [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: 3060-0609.

    Title: Section 76.934(e), Petitions for Extension of Time.

    Form Number: Not applicable.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities; and State, local, or tribal governments.

    Number of Respondents and Responses: 20 respondents; 10 responses.

    Frequency of Response: On occasion reporting requirement; Third party disclosure requirement.

    Estimated Time per Response: 4 hours.

    Total Annual Burden: 80 hours.

    Total Annual Costs: None.

    Privacy Impact Assessment: No impact(s).

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority is contained in Sections 4(i) and 623 of the Communications Act of 1934, as amended.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Needs and Uses: 47 CFR 76.934(e) states that small cable systems may obtain an extension of time to establish compliance with rate regulations provided that they can demonstrate that timely compliance would result in severe economic hardship. Requests for the extension of time should be addressed to the local franchising authorities (“LFAs”) concerning rates for basic service tiers.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2015-27631 Filed 10-29-15; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-XXXX] Information Collection Being Submitted to the Office of Management and Budget for Emergency Review and Approval 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 (Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the 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 Commission may not conduct or sponsor a collection of information unless it displays a currently valid 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 Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before November 13, 2015.

    ADDRESSES:

    Direct all PRA comments to Nicholas A. Fraser, OMB, via email [email protected]; and to Cathy Williams, FCC, via email [email protected] and to [email protected]. Include in the comments the Title as shown in the “Supplementary Information” section below.

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    The Commission is requesting emergency OMB processing of the information collection requirement(s) contained in this notice and has requested OMB approval no later than 19 days after the collection is received at OMB. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page http://www.reginfo.gov/public/do/PRAMain, (2) look for the section of the Web page called “Currently Under Review,” (3) click on the downward-pointing arrow in the “Select Agency” box below the “Currently Under Review” heading, (4) select “Federal Communications Commission” from the list of agencies presented in the “Select Agency” box, (5) click the “Submit” button to the right of the “Select Agency” box, (6) when the list of Commission ICRs currently under review appears, look for the Title of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed.

    OMB Control Number: 3060-XXXX.

    Title: Application to Participate in a Reverse Incentive Auction, FCC Form 177.

    Form Number: FCC Form 177.

    Type of Review: New information collection.

    Respondents: Business or other for-profit entities, not-for-profit institutions, and state, local or tribal governments.

    Estimated Number of Respondents and Responses: 600 respondents and 600 responses.

    Estimated Time per Response: 90 minutes.

    Frequency of Response: One-time reporting requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for the currently approved information collection is contained in sections 154(i) and 309(j)(5) of the Communications Act, as amended, 47 U.S.C.s 4(i), 309(j)(5), and sections 1.2204 and 73.3700(h)(4)(i), (h)(4)(ii), and (h)(6) of the Commission's rules, 47 CFRs 1.2204, 73.3700(h)(4)(i), (h)(4)(ii), and (h)(6).

    Estimated Total Annual Burden: 900 hours.

    Total Annual Costs: None.

    Nature and Extent of Confidentiality: Certain information collected on FCC Form 177 will be treated as confidential for various periods of time during the course of the broadcast incentive auction (BIA) pursuant to 47 U.S.C. 1452(a)(3) and section 1.2206(b) of the Commission's rules, 47 CFR 1.2206(b). To the extent necessary, respondents may request confidential treatment of information collected on FCC Form 177 that is not already being treated as confidential pursuant to section 0.459 of the Commission's rules. See 47 CFR 0.459.

    Privacy Act Impact Assessment: No impact(s).

    Needs and Uses: On February 22, 2012, the President signed the Spectrum Act, which, among other things, authorized the Commission to conduct incentive auctions, and directed that the Commission use this innovative tool for an incentive auction of broadcast television spectrum to help meet the Nation's growing spectrum needs. See Middle Class Tax Relief and Job Creation Act of 2012, Pub. L. 112-96, sections 6402, 6403, 125 Stat. 156 (2012) (Spectrum Act). The Commission's broadcast incentive auction (BIA) will have three main components: (1) A reverse auction in which broadcast television licensees will submit bids to voluntarily relinquish their spectrum usage rights in exchange for defined shares of proceeds from the forward auction; (2) a repacking of the broadcast television bands; and (3) a forward auction of initial licenses for flexible use of the newly available spectrum. The information collection requirements reported under this new collection are the result of various Commission actions in which the Commission adopted general rules to govern the auction—including various application disclosures and certifications that must be made by broadcast television licensees to establish their eligibility to participate in the reverse auction—in order to implement the new and novel incentive auction approach for use in the BIA.

    Under this information collection, the Commission will collect information that will be used to determine whether an applicant is legally qualified to participate in a reverse incentive auction. To aid in collecting this information, the Commission has created FCC Form 177, which the public will use to participate in reverse incentive auctions, including the Commission's upcoming broadcast incentive reverse auction. The Commission's auction rules and related requirements are designed to ensure that the competitive bidding process is limited to serious qualified applicants, deter possible abuse of the bidding and licensing process, and enhance the use of competitive bidding to assign Commission licenses and permits in furtherance of the public interest. The information collected on FCC Form 177 will be used by the Commission to determine if an applicant is legally qualified to participate in the reverse auction. Commission staff will review the information collected on FCC Form 177 as part of the pre-auction process, prior to the start of the reverse auction. Staff will determine whether each applicant satisfies the Commission's requirements to participate in the reverse auction. Without the information collected on FCC Form 177, the Commission will not be able to determine if an applicant is legally qualified to participate in the reverse auction and has complied with the various applicable regulatory and statutory auction requirements for such participation.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2015-27737 Filed 10-29-15; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [3060-0065] Information Collection Being Submitted for Review and Approval to the Office of Management and Budget 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 comments should be submitted on or before November 30, 2015. 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 contacts below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicholas A. Fraser, OMB, via email [email protected]; and to Nicole Ongele, FCC, via email [email protected] and to [email protected]. Include in the comments the OMB control number as shown in the Supplementary Information section below.

    FOR FURTHER INFORMATION CONTACT:

    For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991.

    To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page http://www.reginfo.gov/public/do/PRAMain, (2) look for the section of the Web page called “Currently Under Review,” (3) click on the downward-pointing arrow in the “Select Agency” box below the “Currently Under Review” heading, (4) select “Federal Communications Commission” from the list of agencies presented in the “Select Agency” box, (5) click the “Submit” button to the right of the “Select Agency” box, (6) when the list of FCC ICRs currently under review appears, look for the OMB control number of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0065.

    Title: Applications for New Authorization or Modification of Existing Authorization Under Part 5 of the FCC Rules—Experimental Radio Service.

    Form Number: FCC Form 442.

    Type of Review: Revision of a currently approved collection.

    Respondents: Business or other for-profit entities; Not-for-profit institutions, and Individuals or household.

    Number of Respondents: 495 respondents; 560 responses.

    Estimated Time per Response: 4 hours.

    Frequency of Response: On occasion reporting requirements; Recordkeeping requirements; and third party disclosure.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. Sections 4, 302, 303, 307 and 306 of the Communications Act of 1934, as amended.

    Total Annual Burden: 3,049 hours.

    Total Annual Cost: $41,600.

    Nature and Extent of Confidentiality: There is no need for confidentiality, except for personally identifiable information individuals may submit, which is covered by a system of records, FCC/OET-1, “Experimental Radio Station License Files,” 71 FR 17234, April 6, 2006.

    Privacy Act Impact Assessment: No impact(s).

    Needs and Uses: The Commission will submit this revised information collection to the Office of Management and Budget (OMB), in order to obtain the full three year clearance from them. The Commission is requesting a revision (there has been a program change in the reporting, recordkeeping requirements and/or third party disclosure requirements, the number of respondents increased from 400 to 495, therefore, the annual burden hours increased from 2,240 to 3,049 and the cost has also increased from $32,400.00 to $41,600).

    On January 31, 2013, the Commission adopted a Report and Order, in ET Docket No. 10-236 and 06-155; FCC 13-15, which updates Part 5 of the CFR—“Experimental Radio Service” (ERS). The Commission's recent Report and Order revises and streamlines rules under for the Experimental Radio Service (ERS).1 These rule changes update procedures used to obtain and use an experimental license.

    1See In the Matter of Promoting Expanded Opportunities for Radio Experimentation and Market Trials Under Part 5 of the Commission's Rules and Streamlining Other Related Rules, ET Docket No. 10-236; 2006 Biennial Review of Telecommunications Regulations—Part 2, Administered by the Office of Engineering and Technology (OET), ET Docket No. 06-155; 28 FCC Rcd 758 (2013), FCC 13-15.

    The new rules provide additional license categories to potential licensees. The new license categories are:

    • Program Experimental Radio License—This type of license is issued to qualified institutions to conduct an ongoing program of research and experimentation under a single experimental authorization. Program experimental radio licenses are available to colleges, universities, research laboratories, manufacturers of radio frequency equipment, manufacturers that integrate radio frequency equipment into their end products, and medical research institutions.

    • Medical Program Experimental Radio License—This type of license is issued to hospitals and health care institutions that demonstrate expertise in testing and operation of experimental medical devices that use wireless telecommunications technology or communications functions in clinical trials for diagnosis, treatment, or patient monitoring.

    • Compliance testing experimental radio license—This type of license will be issued to laboratories recognized by the FCC to perform:

    (i) Product testing of radio frequency equipment, and

    (ii) Testing of radio frequency equipment in an Open Area Test Site.

    To accomplish this transition, the Commission will updates the current “Experimental Licensing Radio” electronic filing system. The existing ELS Form 442 interface will require modification; and the ELS database will require modification to facilitate inter-operability with the new ELS notification Web site. There will are new screen shots for the Web site/licensees. Office of Engineering and Technology Web site http://www.fcc.gov/els.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2015-27628 Filed 10-29-15; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [3060-0806] Information Collection Being Submitted for Review and Approval to the Office of Management and Budget 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 comments should be submitted on or before November 30, 2015. 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 contacts below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicholas A. Fraser, OMB, via email [email protected]; and to Nicole Ongele, FCC, via email [email protected] and to [email protected]. Include in the comments the OMB control number as shown in the SUPPLEMENTARY INFORMATION section below.

    FOR FURTHER INFORMATION CONTACT:

    For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991.

    To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page <http://www.reginfo.gov/public/do/PRAMain>, (2) look for the section of the Web page called “Currently Under Review,” (3) click on the downward-pointing arrow in the “Select Agency” box below the “Currently Under Review” heading, (4) select “Federal Communications Commission” from the list of agencies presented in the “Select Agency” box, (5) click the “Submit” button to the right of the “Select Agency” box, (6) when the list of FCC ICRs currently under review appears, look for the OMB control number of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0806.

    Title: Universal Service—Schools and Libraries Universal Service Program, FCC Forms 470 and 471.

    Form Numbers: FCC Forms 470 and 471.

    Type of Review: Revision of a currently approved collection.

    Respondents: State, local or tribal government public institutions, and other not-for-profit institutions.

    Number of Respondents and Responses: 52,700 respondents, 82,090 responses.

    Estimated Time per Response: 3.5 hours for FCC Form 470 (3 hours for response; 0.5 hours for recordkeeping); 4.5 hours for FCC Form 471 (4 hours for response; 0.5 hours for recordkeeping).

    Frequency of Response: On occasion, annual reporting, and recordkeeping requirements.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. sections 151-154, 201-205, 218-220, 254, 303(r), 403, and 405.

    Total Annual Burden: 334,405 hours.

    Total Annual Cost: No cost.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no assurance of confidentiality provided to respondents concerning this information collection. However, respondents may request materials or information submitted to the Commission or to the Administrator be withheld from public inspection under 47 CFR 0.459 of the FCC's rules.

    Needs and Uses: The Commission seeks to revise OMB 3060-0806 to conform this information collection to the program changes set forth in the Second Report and Order and Order on Reconsideration (Second E-Rate Modernization Order) (WC Docket No. 13-184, WC Docket No. 10-90, FCC 14-189; 80 FR 5961, February 4, 2015).

    Collection of the information on FCC Forms 470 and 471 is necessary so that the Commission and the Universal Service Administrative Company (USAC) have sufficient information to determine if entities are eligible for funding pursuant to the schools and libraries support mechanism (the E-rate program), to determine if entities are complying with the Commission's rules, and to prevent waste, fraud, and abuse. In addition, the information is necessary for the Commission to evaluate the extent to which the E-rate program is meeting the statutory objectives specified in section 254(h) of the 1996 Act, and the Commission's own performance goals established in the Report and Order and Further Notice of Proposed Rulemaking (E-rate Modernization Order) (WC Docket No. 13-184, FCC 14-99; 79 FR 49160, August 19, 2014) and Second E-rate Modernization Order. This information collection is being revised to modify FCC Form 471 pursuant to program and rule changes in the Second E-rate Modernization Order and to accommodate USAC's new online portal as well as the requirement that all FCC Forms 471 be electronically filed. On June 22, 2015, OMB approved an emergency request to revise OMB 3060-0806 which included revisions to the FCC Form 470 only. This revision does not propose changes to the FCC Form 470 but does seek to extend the six-month emergency extension to the full three years.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2015-27629 Filed 10-29-15; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination, 10089, Security Bank of North Fulton, Alpharetta, Georgia

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10089, Security Bank of North Fulton, Alpharetta, Georgia (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Security Bank of North Fulton (Receivership Estate); The Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective November 1, 2015 the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: October 27, 2015. Federal Deposit Insurance Corporation Robert E. Feldman, Executive Secretary.
    [FR Doc. 2015-27681 Filed 10-29-15; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination, 10406, Community Capital Bank, Jonesboro, Georgia

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10406, Community Capital Bank, Jonesboro, Georgia (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Community Capital Bank (Receivership Estate); The Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective October 1, 2015 the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: October 27, 2015. Federal Deposit Insurance Corporation Robert E. Feldman, Executive Secretary.
    [FR Doc. 2015-27682 Filed 10-29-15; 8:45 am] BILLING CODE 6714-01-P
    GENERAL SERVICES ADMINISTRATION [OMB Control No. 3090-0044; Docket 2015-0001; Sequence 11] Public Buildings Service; Information Collection; Application/Permit for Use of Space in Public Buildings and Grounds, GSA Form 3453 AGENCY:

    Public Buildings Service, General Services Administration (GSA).

    ACTION:

    Notice of request for comments regarding an extension to an existing OMB clearance.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding the Application/Permit for Use of Space in Public Buildings and Grounds, GSA Form 3453. A notice was published in the Federal Register at 80 FR 27308 on May 13, 2015. No comments were received.

    DATES:

    Submit comments on or before: November 30, 2015.

    ADDRESSES:

    Submit comments identified by Information Collection 3090-0044, Application/Permit for Use of Space in Public Buildings and Grounds, GSA Form 3453, by any of the following methods:

    Regulations.gov: http://www.regulations.gov.

    Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Submit a Comment” that corresponds with “Information Collection 3090-0044, Application/Permit for Use of Space in Public Buildings and Grounds, GSA Form 3453.” Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 3090-0044, Application/Permit for Use of Space in Public Buildings and Grounds, GSA Form 3453,” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 3090-0044, Application/Permit for Use of Space in Public Buildings and Grounds, GSA Form 3453.

    Instructions: Please submit comments only and cite Information Collection 3090-0044, Application/Permit for Use of Space in Public Buildings and Grounds, GSA Form 3453, in all correspondence related to this collection. All comments received will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Karen Handsfield, Public Buildings Service, at telephone 202-208-2444, or via email to [email protected].

    SUPPLEMENTARY INFORMATION: A. Purpose

    The general public uses Application/Permit for Use of Space in Public Buildings and Grounds, GSA Form 3453, to request the use of public space in Federal buildings and on Federal grounds for cultural, educational, or recreational activities. A copy, sample, or description of any material or item proposed for distribution or display must also accompany this request.

    B. Annual Reporting Burden

    Respondents: 8,000.

    Responses per Respondent: 1.

    Hours per Response: 0.05.

    Total Burden Hours: 400.

    C. Public Comments

    Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 3090-0044, Application/Permit for Use of Space in Public Buildings and Grounds, GSA Form 3453, in all correspondence.

    Dated: October 27, 2015. David A. Shive, Acting Chief Information Officer.
    [FR Doc. 2015-27807 Filed 10-29-15; 8:45 am] BILLING CODE 6820-34-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS-10415] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments must be received by December 29, 2015.

    ADDRESSES:

    When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

    1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

    2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number ___,— Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected].

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    Reports Clearance Office at (410) 786-1326.

    SUPPLEMENTARY INFORMATION: Contents

    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

    CMS-10415 Generic Clearance for the Collection Customer Satisfaction Surveys

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

    Information Collection

    1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Generic Clearance for the Collection Customer Satisfaction Surveys; Use: This collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.

    Collecting voluntary customer feedback is the least burdensome, most effective way for the Agency to determine whether or not its public Web sites are useful to and used by its customers. Generic clearance is needed to ensure that the Agency can continuously improve its Web sites though regular surveys developed from these pre-defined questions. Surveying the Agency Web sites on a regular, ongoing basis will help ensure that users have an effective, efficient, and satisfying experience on any of the Web sites, maximizing the impact of the information and resulting in optimum benefit for the public. The surveys will ensure that this communication channel meets customer and partner priorities, builds the Agency's brands, and contributes to the Agency's health and human services impact goals. Form Number: CMS-10415 (OMB control number: 0938-1185); Frequency: Occasionally; Affected Public: Individuals and Households, Business or other for-profits and Not-for-profit institutions, State, Local or Tribal Governments; Number of Respondents: 1,000,000; Total Annual Responses: 1,000,000; Total Annual Hours: 35,000. (For policy questions regarding this collection contact John Booth at 410-786-6577.

    Dated: October 26, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2015-27619 Filed 10-29-15; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request

    Title: Administration for Native Americans Annual Data Collection (Annual Data Report).

    OMB No.: New collection.

    Description: Content and formatting changes are being made to the Objective Progress Report (OPR). Content changes are being made to the OPR, now known as the Annual Data Report (ADR) previously approved under information collection OMB No. 0980-0204. ANA has determined that the requirement for ANA grantees to submit information about the project activities on quarterly basis creates undue burden for Grantees. Therefore, ANA has reformatted the OPR to require Grantees submit an annual report instead of quarterly report when reporting on partnerships, youth and elder engagement, impact indicators, community involvement etc. This will reduce the administrative burden on Grantees, especially the smaller organizations. The majority of content being requested from the grantees essentially remain same except for the frequency of reporting. The other sections of the document with reference to “quarterly” information will be changed to reflect the shift from four-times a year reporting requirement to once per year and once at the end of the project period.

    Respondents: Tribal Government, Native non-profit organizations, Tribal Colleges & Universities receiving ANA funding.

    Annual Burden Estimates

    The following is the hour of burden estimate for this information collection:

    Instrument Number of
  • respondents
  • Number of
  • responses per respondent
  • Average
  • burden hours per response
  • Total burden hours
    ADR 275 2 2 275

    Estimated Total Annual Burden Hours: 275.

    Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]

    OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected], Attn: Desk Officer for the Administration for Children and Families.

    Robert Sargis, Reports Clearance Officer.
    [FR Doc. 2015-27666 Filed 10-29-15; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0093 (Formerly Docket ID 2002D-0337)] Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled “Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.” This revised draft guidance document replaces the draft of the same name that published on August 21, 2002. This revised draft guidance provides recommendations to applicants on the chemistry, manufacturing, and controls (CMC); pharmacokinetics and bioavailability; and labeling documentation for liposome drug products submitted in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) reviewed by the Center for Drug Evaluation and Research (CDER).

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 29, 2015.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2002-D-0093 (formerly docket ID 2002D-0337) for “Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Richard T. Lostritto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4148, Silver Spring, MD 20993-0002, 301-796-1697.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The FDA is announcing the availability of a revised draft guidance for industry entitled “Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.” This revised draft guidance provides recommendations to applicants on the CMC, human pharmacokinetics and bioavailability, and labeling documentation for liposome drug products submitted in NDAs, ANDAs, and BLAs reviewed by CDER. This revision adds BLAs and ANDAs. It also updates the discussions on liposome technology.

    In the Federal Register of August 21, 2002 (67 FR 54220), FDA announced the availability of a draft version of this guidance. FDA received comments in response to the draft guidance, and this revised guidance reflects FDA's careful consideration of these comments. Most of the changes to the revised draft guidance were made to clarify statements in the 2002 draft guidance. In addition, FDA decided to publish a revised draft guidance because of changes in technology since the draft was first published in 2002, the addition of BLAs reviewed by CDER as a result of a CDER and Center for Biologics Evaluation and Research reorganization in 2003, and the addition of ANDAs.

    The revised draft guidance does not provide recommendations on clinical efficacy and safety studies, nonclinical pharmacology and/or toxicology studies, liposome formulations of vaccine adjuvants or biologics, or drug-lipid complexes.

    This revised draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This revised draft guidance, when finalized, will represent the Agency's current thinking on liposome drug products. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. The Paperwork Reduction Act of 1995

    This revised draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001.

    III. Electronic Access

    Persons with access to the Internet may obtain the revised draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-27744 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0503] Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards; Partial Stay and Republication of Guidance AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of administrative stay of action.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is announcing a stay of portions of the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled “Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an IND.” We are republishing the guidance with the portions that are being stayed clearly identified so readers can distinguish parts of the guidance that remain in effect from parts that are subject to this stay.

    DATES:

    This stay is effective October 30, 2015 Submit either electronic or written comments on FDA guidances at any time.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2010-D-0503 for “Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards; Partial Stay and Republication of Guidance.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    FOR FURTHER INFORMATION CONTACT:

    Philip L. Chao, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2112, email: [email protected]; or Ebla Ali-Ibrahim, Center for Drug Evaluation and Research (HFD-160), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3691; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.

    SUPPLEMENTARY INFORMATION: I. Background

    In the Federal Register of October 14, 2010 (75 FR 63189), we announced the availability of a draft guidance entitled “Guidance for Industry: Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies can be Conducted without an IND” (“the draft guidance”). In the Federal Register of September 10, 2013 (78 FR 55262), we published a document announcing the availability of the final version of the guidance, now entitled “Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards (IRBs) on Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an IND” (“the final guidance”). We received multiple comments asking for a further opportunity to comment on subsections VI.C and VI.D of the final guidance, which discuss when an IND is needed for studies involving products marketed as cosmetics or foods, respectively. Accordingly, on February 6, 2014, we issued a document reopening the comment period on only those subsections of the final guidance that address the applicability of the IND regulations to clinical research studies involving products marketed as cosmetics or foods (including dietary supplements) (79 FR 7204) (“notice to reopen”). The comment period closed on April 7, 2014. We received comments from trade organizations, individual companies, scientific associations, public interest organizations, and individuals in response to our notice to reopen. These comments raised questions about application of the IND requirement to certain clinical studies of conventional foods, dietary supplements, and cosmetics being investigated for uses covered by the drug definition in section 201(g)(1)(B) or (C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(g)(1)(B) or (C)).

    II. The Stay

    FDA is staying part of the final guidance to allow for further consideration of issues raised by the comments submitted in response to the notice to reopen. Specifically, we are staying portions of subsection VI.D.2, “Conventional Food,” and all of subsection VI.D.3, “Studies Intended to Support a Health Claim,” except as to studies intended to evaluate whether a food substance reduces the risk of a disease in individuals less than 12 months old, those with altered immune systems, and those with serious or life-threatening medical conditions. Subsections VI.D.2 and VI.D.3 discuss, respectively, conventional food studies generally and studies intended to support a health claim for a conventional food or dietary supplement. The portions of subsection VI.D.2 that are being stayed are the third paragraph (which pertains to clinical studies intended to evaluate a food's effect on the structure or function of the body) and a sentence in the fourth paragraph concerning clinical studies intended to evaluate a non-nutritional effect on the structure or function of the body. In subsection VI.D.3, a text box inserted below the subsection heading explains that clinical investigations intended to evaluate whether a food substance may reduce the risk of a disease in three categories of medically vulnerable subjects (individuals less than 12 months old, those with altered immune systems, and those with serious or life-threatening medical conditions) are excluded from the stay, and that subsection VI.D.3 is in effect for such investigations.

    The stay of portions of subsection VI.D.2 and all of subsection VI.D.3 (subject to the exclusion for studies in the medically vulnerable populations described in this document) of the final guidance is effective immediately. All other parts of the final guidance remain in effect. We are republishing the guidance with the stayed material clearly identified so readers can distinguish parts of the guidance that remain in effect from parts that are subject to the stay.

    FDA generally does not intend to seek INDs for studies in the stayed categories while the stay is in effect. This stay does not, however, preclude enforcement of any provision of the FD&C Act or other relevant Federal statutes or regulations other than IND requirements (e.g., human subject protection laws and regulations). This stay does not affect investigations of conventional foods or dietary supplements studied for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Products intended for such uses meet the definition of a “drug” at section 201(g)(1)(B) of the FD&C Act; such investigations will continue to be subject to IND requirements. For example, dietary supplements containing bacteria have been given to infants born prematurely for prevention of necrotizing enterocolitis. The investigation of such use, and similar uses of conventional foods or dietary supplements to diagnose, cure, mitigate, treat, or prevent a disease, continues to require an IND.

    In summary, while the partial stay of the final guidance is in effect, FDA does not consider clinical investigators or study sponsors to be under any obligation to obtain an IND for the following types of studies evaluating the effects of a product marketed as a conventional food or dietary supplement:

    For conventional foods:

    • Clinical studies designed to evaluate whether a conventional food may reduce the risk of a disease, intended to support a new or expanded health claim, and conducted in a population that does not include individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions;

    • Clinical studies designed to evaluate a non-nutritional effect of a conventional food on the structure or function of the body.

    For dietary supplements:

    • Clinical studies designed to evaluate whether a dietary supplement may reduce the risk of a disease, intended to support a new or expanded health claim, and conducted in a population that does not include individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions.

    Further, as noted in the final guidance itself, no IND is required for clinical studies designed to evaluate the nutritional effects of a conventional food, clinical studies designed to evaluate a dietary supplement's effects on the structure or function of the body, or clinical studies designed to evaluate the relationship between a conventional food or dietary supplement and reduced risk of a disease, if there is already an authorized health claim for the substance-disease relationship.

    The following types of studies do continue to require an IND for the reasons explained in the final guidance:

    For conventional foods:

    • Clinical studies designed to evaluate a conventional food's ability to diagnose, cure, mitigate, treat, or prevent a disease, except for studies designed to evaluate whether a conventional food reduces the risk of a disease, intended to support a health claim, and conducted in a population that does not include individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions;

    • Clinical studies designed to evaluate whether a food substance reduces the risk of a disease, intended to support a new or expanded health claim, and conducted in a population that includes individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions.

    For dietary supplements:

    • Clinical studies designed to evaluate a dietary supplement's ability to diagnose, cure, mitigate, treat, or prevent a disease, except for studies designed to evaluate whether a dietary supplement reduces the risk of a disease, intended to support a health claim, and conducted in a population that does not include individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions;

    • Clinical studies designed to evaluate whether a dietary supplement reduces the risk of a disease, intended to support a new or expanded health claim, and conducted in a population that includes individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions.

    For cosmetics:

    • Clinical studies designed to evaluate a cosmetic's effect on the structure or function of the body or its ability to diagnose, cure, mitigate, treat, or prevent a disease.

    Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-27729 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3805] Clinical Trials—Assessing Safety and Efficacy for Diverse Populations; Public Meeting; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of meeting; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA), in collaboration with the Johns Hopkins Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop entitled “Clinical Trials—Assessing Safety and Efficacy in Diverse Populations.” The purpose of the meeting is to discuss approaches in clinical trial design and subgroup analyses for therapeutic product development and life-cycle management.

    DATES:

    The meeting will be held on December 2, 2015, from 9 a.m. to 5 p.m.

    ADDRESSES:

    The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2015-N-3805 for Clinical Trials—Assessing Safety and Efficacy for Diverse Populations; Public Meeting; Request for Comments. Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted onhttp://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    FOR FURTHER INFORMATION CONTACT:

    Martin Mendoza, Office of Minority Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2306, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    The purpose of this public workshop is to facilitate a unique opportunity for relevant stakeholders, including industry, academia, patients, and FDA, to discuss the importance of diversity in medical research and the incorporation of participant diversity in the design, analysis, and regulation of medical interventions. Medical interventions may have different benefits and harms for subgroups within a population. If clinical trials do not include an adequate number of participants who are representative of people likely to use an approved intervention, then the average results of clinical trials might not be replicated in practice. Even if clinical trials include representative participants, important subgroup differences might not be detectable if their representation is not adequate. For these reasons, regulators might use a combination of information from clinical trials and other data sources to address questions about heterogeneity across large and diverse populations. The use of data from patients in their usual care setting (“real-world” data) may be particularly valuable for understanding this heterogeneity.

    Agenda: The agenda is located at: http://www.jhsph.edu/research/centers-and-institutes/center-of-excellence-in-regulatory-science-and-innovation/news-and-events/clinical-trials-assessing-safety-and-efficacy-for-diverse-population.html. (FDA has verified the Web site addresses throughout this notice, but FDA is not responsible for subsequent changes to the Web sites after this document publishes in the Federal Register).

    Registration: There is no registration fee to attend this meeting. Seats are limited, and registration will be on a first-come, first-served basis. To register, please complete registration online at http://www.surveymonkey.com/r/ClinicalTrialsWorkshop120215. (FDA has verified the Web address, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.)

    Accommodations: Attendees are responsible for their own hotel accommodations. If you need special accommodations due to a disability, please contact Jill Zung at [email protected] at least 7 days in advance.

    Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-27728 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1167] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Controlled Correspondence Related to Generic Drug Development AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Guidance for Industry on Controlled Correspondence Related to Generic Drug Development” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected].

    SUPPLEMENTARY INFORMATION:

    On July 9, 2015, the Agency submitted a proposed collection of information entitled “Guidance for Industry on Controlled Correspondence Related to Generic Drug Development” to OMB for review and clearance under 44 U.S.C. 3507. 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. OMB has now approved the information collection and has assigned OMB control number 0910-0797. The approval expires on September 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-27741 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3894] Determination That TENSILON and TENSILON Preservative Free (Edrophonium Chloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

    FOR FURTHER INFORMATION CONTACT:

    Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363, [email protected]

    SUPPLEMENTARY INFORMATION:

    In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

    The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book”. Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

    Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.

    FDA has become aware that the drug products listed in the table in this document are no longer being marketed.

    Application No. Drug Applicant NDA 007959 TENSILON and TENSILON Preservative Free (edrophonium chloride) Injectable; Intravenous, 10 milligrams/milliliter (mg/mL) IGI Laboratories, Inc., 105 Lincoln Ave., Buena, NJ 08310. NDA 013416 NORGESIC and NORGESIC FORTE (aspirin, caffeine, orphenadrine citrate) Tablet; Oral,385 mg/30 mg/25 mg; 770 mg/60 mg/50 mg Medicis Pharmaceuticals, Division of Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. NDA 018225 BUMEX (bumetanide) Tablet; Oral, 0.5 mg; 1 mg; 2 mg Validus Pharmaceuticals, LLC, 119 Cherry Hill Rd., Suite 310, Parsippany, NJ 07054. NDA 018343 CAPOTEN (captopril) Tablet; Oral, 12.5 mg; 25 mg; 50 mg; 100 mg Par Pharmaceutical Inc., 1 Ram Ridge Rd., Chestnut Ridge, NY 10977. NDA 019322 TEMOVATE (clobetasol propionate) Cream; Topical, 0.05% Fougera Pharmaceuticals Inc., 60 Baylis Rd., P.O. Box 2006, Melville, NY 11747. NDA 020337 TEMOVATE (clobetasol propionate) Gel; Topical, 0.05% Do. NDA 020340 TEMOVATE E (clobetasol propionate) Cream; Topical, 0.05% Do. NDA 020638 VISTIDE (cidofovir) Injectable; Intravenous, 75 mg base/mL Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404. NDA 021700 AVANDARYL (glimepiride, rosiglitazone maleate) Tablet; Oral, 1 mg/4 mg; 2 mg/4 mg; 4 mg/4 mg; 2 mg/8 mg; 4 mg/8 mg SmithKline Beecham (Cork) Ltd., Ireland, 2301 Renaissance Blvd., Mail Code RN 0420, King of Prussia, PA 19406. NDA 022411 OLEPTRO (trazodone HCl); Extended-Release Tablet; Oral, 150 mg; 300 mg Angelini Pharma Inc., 8322 Helgerman Ct., Gaithersburg, MD 20877. NDA 050461 ANCEF (cefazolin sodium) Injectable; Intravenous, 1 gram (g)/vial; 10 g/vial GlaxoSmithKline, 1 Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101. NDA 050495 AMIKIN (amikacin sulfate) Injectable; Intravenous, EQ 50 mg base/mL; 250 mg base/mL Apothecon, Inc., P.O. Box 4500, Princeton, NJ 08543. ANDA 064169 Cefazolin Sodium Injectable; Intravenous, 500 mg base/vial; 1 g base/vial Fresenius Kabi USA, LLC, 3 Corporate Dr., Lake Zurich, IL 60047.

    FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.

    Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

    Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-27740 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1794] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Impact of Ad Exposure Frequency on Perception and Mental Processing of Risks and Benefit Information in Direct-to-Consumer Prescription Drug Ads AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Impact of Ad Exposure Frequency on Perception and Mental Processing of Risks and Benefit Information in Direct-to-Consumer Prescription Drug Ads” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected].

    SUPPLEMENTARY INFORMATION:

    On June 29, 2015, the Agency submitted a proposed collection of information entitled “Impact of Ad Exposure Frequency on Perception and Mental Processing of Risks and Benefit Information in Direct-to-Consumer Prescription Drug Ads” to OMB for review and clearance under 44 U.S.C. 3507. 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. OMB has now approved the information collection and has assigned OMB control number 0910-0803. The approval expires on September 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-27743 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1491] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patient Perceptions AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patient Perceptions” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected].

    SUPPLEMENTARY INFORMATION:

    On May 28, 2015, the Agency submitted a proposed collection of information entitled “Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patient Perceptions” to OMB for review and clearance under 44 U.S.C. 3507. 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. OMB has now approved the information collection and has assigned OMB control number 0910-0801. The approval expires on September 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-27742 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Performance Review Board Members

    Title 5, U.S.C. Section 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95-454, requires that the appointment of Performance Review Board Members be published in the Federal Register.

    The following persons may be named to serve on the Performance Review Boards or Panels, which oversee the evaluation of performance appraisals of Senior Executive Service members of the Department of Health and Human Services.

    Employee last name Employee first name Agrawal Shantanu Atkinson Leslie Boulanger Jennifer Bowers Tonya Burton Adriane Cannistra Jennifer Cantwell Kathleen Carter