Federal Register Vol. 80, No.245,

Federal Register Volume 80, Issue 245 (December 22, 2015)

Page Range79459-79653
FR Document

80_FR_245
Current View
Page and SubjectPDF
80 FR 79615 - Sunshine Act Meeting; National Science BoardPDF
80 FR 79476 - Allocation of Assets in Single-Employer Plans; Interest Assumptions for Valuing BenefitsPDF
80 FR 79564 - Countervailing Duty Investigation of Certain Cold-Rolled Steel Flat Products From the Russian Federation: Preliminary Affirmative Countervailing Duty Determination, Preliminary Negative Critical Circumstances Determination, and Alignment of Final Determination With Final Antidumping Duty DeterminationPDF
80 FR 79567 - Countervailing Duty Investigation of Certain Cold-Rolled Steel Flat Products From the Republic of Korea: Preliminary Negative Determination and Alignment of Final Determination With Final Antidumping Duty DeterminationPDF
80 FR 79569 - Countervailing Duty Investigation of Certain Cold-Rolled Steel Flat Products From Brazil: Preliminary Affirmative Determination and Alignment of Final Determination With Final Antidumping Duty DeterminationPDF
80 FR 79562 - Countervailing Duty Investigation of Certain Cold-Rolled Steel Flat Products From India: Preliminary Affirmative Determination and Alignment of Final Determination With Final Antidumping Duty DeterminationPDF
80 FR 79558 - Countervailing Duty Investigation of Certain Cold-Rolled Steel Flat Products From the People's Republic of China: Preliminary Affirmative Determination, Preliminary Partial Affirmative Critical Circumstances Determination, and Alignment of Final Determination With Final Antidumping Duty DeterminationPDF
80 FR 79490 - United States Standards for Rough Rice, Brown Rice for Processing, and Milled RicePDF
80 FR 79528 - Implementing Programs under Title I of the Elementary and Secondary Education ActPDF
80 FR 79557 - Submission for OMB Review; Comment RequestPDF
80 FR 79650 - Union Pacific Railroad Company-Temporary Trackage Rights Exemption-BNSF Railway CompanyPDF
80 FR 79558 - Approval of Subzone Status Haier America Trading, LLC Olive Branch, MississippiPDF
80 FR 79561 - Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Preliminary Rescission of Antidumping Duty New Shipper Review; 2014-2015PDF
80 FR 79581 - Orders Granting Authority To Import and Export Natural Gas, To Import and Export Liquefied Natural Gas, To Export Compressed Natural Gas, and To Vacate Authority During October 2015PDF
80 FR 79472 - Amendment of Restricted Areas R-2932, R-2933, R-2934 and R-2935; Cape Canaveral, FLPDF
80 FR 79649 - Office of Commercial Space Transportation; Notice of Availability of the Finding of No Significant Impact (FONSI) for Issuing or Modifying Launch Licenses for Space Exploration Technologies Corp. (SpaceX) Falcon Launch Vehicle Landings at Landing Complex-1 at Cape Canaveral Air Force Station (CCAFS), FloridaPDF
80 FR 79649 - Air Traffic Procedures Advisory CommitteePDF
80 FR 79651 - Proposed Collection; Comment Request for Form 6252PDF
80 FR 79652 - Proposed Collection; Comment Request for Form 990-WPDF
80 FR 79651 - Proposed Collection; Comment Request for Form 1099-KPDF
80 FR 79605 - Privacy Act of 1974; Computer Matching ProgramPDF
80 FR 79594 - Prospective Grant of an Exclusive Start-Up Option License: Potent and Selective Analogues of Monamine Transporters; Methods of Making; and Uses ThereofPDF
80 FR 79459 - Donation of Foods for Use in the United States, Its Territories and Possessions and Areas Under Its JurisdictionPDF
80 FR 79591 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
80 FR 79459 - Law Enforcement AuthoritiesPDF
80 FR 79459 - Determining Eligibility for Free and Reduced Price Meals and Free Milk in SchoolsPDF
80 FR 79477 - Regulated Navigation Area; Reporting Requirements for Barges Loaded With Certain Dangerous Cargoes, Inland Rivers, Eighth Coast Guard District; Expiration of Stay (Suspension) and Administrative ChangesPDF
80 FR 79459 - Child and Adult Care Food ProgramPDF
80 FR 79480 - Safety Zone; Pleasure Beach Bridge, Bridgeport, CT.PDF
80 FR 79586 - Alliance Pipeline, L.P.; Notice of Informal Settlement ConferencePDF
80 FR 79588 - Energy Resources USA Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing ApplicationsPDF
80 FR 79584 - Commission Information Collection Activities (FERC-725K); Comment RequestPDF
80 FR 79586 - National Fuel Gas Supply Corporation; Notice of ApplicationPDF
80 FR 79586 - UGI Sunbury, LLC; Revised Notice of Schedule for Environmental Review of the Sunbury Pipeline ProjectPDF
80 FR 79588 - Florida Gas Transmission Company, LLC; Notice of Revised Schedule for Environmental Review of the Jacksonville Expansion ProjectPDF
80 FR 79584 - Combined Notice of FilingsPDF
80 FR 79586 - Combined Notice of Filings #2PDF
80 FR 79587 - Combined Notice of Filings #1PDF
80 FR 79459 - Inspection of Eggs (Egg Products Inspection Act)PDF
80 FR 79460 - Labeling, Marking Devices, and ContainersPDF
80 FR 79460 - Regulations Under the Packers and Stockyards ActPDF
80 FR 79460 - Adjustment of Status to That of Person Admitted for Permanent ResidencePDF
80 FR 79459 - Change of Nonimmigrant ClassificationPDF
80 FR 79572 - Digital Economy Board of Advisors, Extension of Nomination DeadlinePDF
80 FR 79614 - Labor Certification Process for the Temporary Employment of Aliens in Agriculture in the United States: 2016 Adverse Effect Wage RatesPDF
80 FR 79460 - Savings Associations-OperationsPDF
80 FR 79461 - AdvancesPDF
80 FR 79609 - Filing of Plats of Survey, Wyoming and NebraskaPDF
80 FR 79614 - Notice of Lodging Proposed Consent DecreePDF
80 FR 79485 - Fisheries of the Northeastern United States; Summer Flounder Fishery; Quota TransferPDF
80 FR 79606 - Endangered and Threatened Wildlife and Plants; Revised Draft Recovery Plan for the Giant Garter SnakePDF
80 FR 79522 - National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for Streets and Highways; Request for CommentPDF
80 FR 79473 - Crowdfunding; CorrectionPDF
80 FR 79610 - Notice of Proposed Information Collection; Request for Comments for 1029-0080PDF
80 FR 79611 - Notice of Proposed Information Collection; Request for Comments for 1029-0057PDF
80 FR 79609 - Receipt of an Incidental Take Permit Application for Participation in the Oil and Gas Industry Conservation Plan for the American Burying Beetle in OklahomaPDF
80 FR 79613 - Notice of Lodging of Proposed Modification To Consent Decree Under the Clean Water ActPDF
80 FR 79460 - Reserve Requirements of Depository InstitutionsPDF
80 FR 79483 - Payment of Emergency Medication by VAPDF
80 FR 79594 - Government-Owned Inventions; Availability for LicensingPDF
80 FR 79596 - Submission for OMB review; 30-Day Comment Request; Collection of Customer Service, Demographic, and Smoking/Tobacco Use Information From the National Cancer Institute's Cancer Information Service (CIS) Clients (NCI)PDF
80 FR 79583 - Environmental Management Site-Specific Advisory Board, Northern New MexicoPDF
80 FR 79581 - Environmental Management Site-Specific Advisory Board, Oak Ridge ReservationPDF
80 FR 79580 - Application to Export Electric Energy; Ontario Power Generation, Inc.PDF
80 FR 79650 - National Freight Advisory Committee: Notice of Public MeetingPDF
80 FR 79574 - Applications for New Awards; Talent Search ProgramPDF
80 FR 79612 - Certain Arrowheads With Deploying Blades and Components Thereof and Packaging Therefor; Institution of InvestigationPDF
80 FR 79611 - Large Residential Washers From China; Institution of an Antidumping Duty investigation and Scheduling of a Preliminary Phase InvestigationPDF
80 FR 79638 - Third Avenue Trust and Third Avenue Management LLC; Notice of Application and Temporary OrderPDF
80 FR 79572 - 36(b)(1) Arms Sales NotificationPDF
80 FR 79627 - Product Change-Priority Mail Negotiated Service AgreementPDF
80 FR 79628 - Product Change-Priority Mail Negotiated Service AgreementPDF
80 FR 79628 - Product Change-Parcel Select Negotiated Service AgreementPDF
80 FR 79628 - Product Change-First-Class Package Service Negotiated Service AgreementPDF
80 FR 79648 - Data Collection Available for Public CommentsPDF
80 FR 79647 - Data Collection Available for Public CommentsPDF
80 FR 79555 - Notice of Intent To Seek OMB Approval To Collect Information: Forms Pertaining to the Peer Preview of ARS Research ProjectsPDF
80 FR 79557 - Notice of Intent To Grant Exclusive LicensePDF
80 FR 79597 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
80 FR 79599 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
80 FR 79600 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
80 FR 79615 - Request for Comments on Category Management Policy 16-1: Improving the Acquisition and Management of Common Information Technology: Software LicensingPDF
80 FR 79571 - Visiting Committee on Advanced TechnologyPDF
80 FR 79530 - Petitions for Reconsideration of Public Notice Regarding Application Procedures for Broadcast Incentive AuctionPDF
80 FR 79589 - Information Collections Being Submitted for Review and Approval to the Office of Management and BudgetPDF
80 FR 79644 - Proposed Collection; Comment RequestPDF
80 FR 79642 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Extend the Cabinet Trading Pilot ProgramPDF
80 FR 79632 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule Change To Merge FINRA Dispute Resolution, Inc. Into and With FINRA Regulation, Inc.PDF
80 FR 79640 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Deleting Rule 410B-Equities Governing Reporting Requirements for Off-Exchange TransactionsPDF
80 FR 79645 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Extending Its Program That Allows Transactions To Take Place at a Price That Is Below $1 Per Option Contract Until January 5, 2017PDF
80 FR 79630 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Extending Its Program That Allows Transactions to Take Place at a Price That Is Below $1 Per Option Contract Until January 5, 2017PDF
80 FR 79644 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Deleting Rule 410B Governing Reporting Requirements for Off-Exchange TransactionsPDF
80 FR 79629 - Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to Rule 13.3, Forwarding of Proxy and Other Issuer Materials; Proxy VotingPDF
80 FR 79636 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to Rule 13.3, Forwarding of Proxy and Other Issuer Materials; Proxy VotingPDF
80 FR 79640 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Order ExposurePDF
80 FR 79597 - Center for Scientific Review; Notice of Closed MeetingPDF
80 FR 79595 - National Institute on Aging; Notice of Closed MeetingsPDF
80 FR 79595 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of MeetingPDF
80 FR 79484 - Review of the Emergency Alert SystemPDF
80 FR 79647 - Reporting and Recordkeeping Requirements Under OMB ReviewPDF
80 FR 79653 - Pricing for the 2016 Mark Twain Commemorative Coin ProgramPDF
80 FR 79652 - Pricing for the 2016 100th Anniversary of the National Park Service Commemorative Coin ProgramPDF
80 FR 79493 - General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp ProductsPDF
80 FR 79505 - Sunlamp Products; Proposed Amendment to Performance StandardPDF
80 FR 79591 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial ReviewPDF
80 FR 79592 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial ReviewPDF
80 FR 79593 - Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC)PDF
80 FR 79592 - Advisory Committee on Breast Cancer in Young Women (ACBCYW)PDF
80 FR 79590 - Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)PDF
80 FR 79607 - Endangered Species; Wild Bird Conservation; Receipt of Applications for PermitPDF
80 FR 79626 - New Postal ProductPDF
80 FR 79625 - New Postal ProductPDF
80 FR 79627 - New Postal ProductPDF
80 FR 79653 - Allowance for Private Purchase of an Outer Burial Receptacle (or Grave Liner) in Lieu of a Government-Furnished Grave Liner for Use in a VA National CemeteryPDF
80 FR 79531 - Federal Motor Vehicle Safety Standards; Small Business Impacts of Motor Vehicle SafetyPDF
80 FR 79593 - Agency Information Collection Activities: Proposed Collection: Public Comment RequestPDF
80 FR 79616 - Southern California Edison Company; San Onofre Nuclear Generating Station, Units 2 and 3PDF
80 FR 79474 - New Animal Drugs for Use in Animal Feeds; Bacitracin MethylenedisalicylatePDF
80 FR 79533 - Endangered and Threatened Wildlife and Plants; 90-Day and 12-Month Findings on a Petition To List the Miami Tiger Beetle as an Endangered or Threatened Species; Proposed Endangered Species Status for the Miami Tiger BeetlePDF
80 FR 79491 - Proposed Revisions to the FDIC's Rules and Regulations Requiring the Registration of Securities Transfer AgentsPDF
80 FR 79526 - Prohibition of the Sale or Rental of Sexually Explicit Material on DoD PropertyPDF
80 FR 79601 - Assistance to Firefighters Grant ProgramPDF
80 FR 79487 - Privacy Act of 1974; Implementation of Exemptions; Department of Homeland Security, U.S. Customs and Border Protection-DHS/CBP-007 Border Crossing Information, System of RecordsPDF
80 FR 79648 - Decision To Maintain Presidential Permit for the Vantage Pipeline Border Facilities in Divide County, North Dakota Following Change in OwnershipPDF
80 FR 79466 - Airworthiness Directives; Airbus HelicoptersPDF
80 FR 79617 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards ConsiderationsPDF
80 FR 79469 - Airworthiness Directives; Airbus AirplanesPDF
80 FR 79461 - Airworthiness Directives; The Boeing Company AirplanesPDF

Issue

80 245 Tuesday, December 22, 2015 Contents Agricultural Research Agricultural Research Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Forms Pertaining to the Peer Preview of ARS Research Projects, 79555-79557 2015-32065 Exclusive Licenses, 79557 2015-32064 Agriculture Agriculture Department See

Agricultural Research Service

See

Food and Nutrition Service

See

Food Safety and Inspection Service

See

Grain Inspection, Packers and Stockyards Administration

See

Rural Utilities Service

RULES Inspection of Eggs (Egg Products Inspection Act); CFR Correction, 79459 2015-32121 Law Enforcement Authorities, 79459 2015-32137
Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 79591-79592 2015-32139 Meetings: Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health, 79590-79591 2015-32014 Advisory Committee on Breast Cancer in Young Women, 79592-79593 2015-32015 Board of Scientific Counselors, National Center for Injury Prevention and Control, 79593 2015-32016 Disease, Disability, and Injury Prevention and Control Special Emphasis Panel, 79591 2015-32018 Coast Guard Coast Guard RULES Regulated Navigation Areas: Reporting Requirements for Barges Loaded with Certain Dangerous Cargoes, Inland Rivers, Eighth Coast Guard District; Expiration of Stay (Suspension) and Administrative Changes, 79477-79480 2015-32135 Safety Zones: Pleasure Beach Bridge, Bridgeport, CT, 79480-79483 2015-32133 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Institute of Standards and Technology

See

National Oceanic and Atmospheric Administration

See

National Telecommunications and Information Administration

Comptroller Comptroller of the Currency RULES Savings Associations--Operations; CFR Correction, 79460 2015-32113 Defense Department Defense Department PROPOSED RULES Prohibition of the Sale or Rental of Sexually Explicit Material on DoD Property, 79526-79528 2015-31918 NOTICES Arms Sales, 79572-79574 2015-32077 Education Department Education Department PROPOSED RULES Implementing Programs under the Elementary and Secondary Education Act, 79528-79530 2015-32178 NOTICES Applications for New Awards: Talent Search Program, 79574-79580 2015-32089 Employment and Training Employment and Training Administration NOTICES Labor Certification Process for the Temporary Employment of Aliens in Agriculture in the U.S.; 2016 Adverse Effect Wage Rates, 79614-79615 2015-32114 Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Applications to Export Electric Energy: Ontario Power Generation, Inc., 79580-79581 2015-32091 Authority to Import and Export Natural Gas, etc.: Portland General Electric Co., et al., 79581-79583 2015-32160 Meetings: Environmental Management Site-Specific Advisory Board, Northern New Mexico, 79583-79584 2015-32092 2015-32094 Environmental Management Site-Specific Advisory Board, Oak Ridge Reservation, 79581 2015-32093
Executive Office Executive Office for Immigration Review RULES Adjustment of Status to That of Person Admitted for Permanent Residence; CFR Correction, 79460 2015-32118 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Airbus Airplanes, 79469-79472 2015-30820 Airbus Helicopters, 79466-79469 2015-31849 The Boeing Company Airplanes, 79461-79466 2015-30818 Restricted Areas: R-2932, R-2933, R-2934 and R-2935; Cape Canaveral, FL, 79472-79473 2015-32159 NOTICES Environmental Assessments; Availability, etc.: Issuing or Modifying Launch Licenses for Space Exploration Technologies Corp. Falcon Launch Vehicle Landings at Landing Complex-1 at Cape Canaveral Air Force Station, FL, 79649 2015-32158 Meetings: Air Traffic Procedures Advisory Committee, 79649-79650 2015-32156 Federal Communications Federal Communications Commission RULES Review of the Emergency Alert System, 79484-79485 2015-32034 PROPOSED RULES Petitions for Reconsideration: Application Procedures for Broadcast Incentive Auction, 79530 2015-32057 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 79589-79590 2015-32056 Federal Deposit Federal Deposit Insurance Corporation PROPOSED RULES Regulations Requiring the Registration of Securities Transfer Agents; Revisions, 79491-79493 2015-31941 Federal Emergency Federal Emergency Management Agency NOTICES Assistance to Firefighters Grant Program, 79601-79605 2015-31905 Federal Energy Federal Energy Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 79584-79586 2015-32128 Applications: National Fuel Gas Supply Corp., 79586-79587 2015-32127 Combined Filings, 79584, 79586-79588 2015-32122 2015-32123 2015-32124 Environmental Assessments; Availability, etc.: Florida Gas Transmission Co., LLC; Jacksonville Expansion Project, 79588 2015-32125 UGI Sunbury LLC; Sunbury Pipeline Project, 79586 2015-32126 Meetings: Alliance Pipeline, LP; Informal Settlement Conference, 79586 2015-32132 Preliminary Permit Applications: Energy Resources USA, Inc., 79588-79589 2015-32130 Federal Highway Federal Highway Administration PROPOSED RULES National Standards for Traffic Control Devices: Manual on Uniform Traffic Control Devices for Streets and Highways, 79522-79526 2015-32107 Federal Housing Finance Agency Federal Housing Finance Agency RULES Advances; CFR Correction, 79461 2015-32112 Federal Reserve Federal Reserve System RULES Reserve Requirements of Depository Institutions, 79460-79461 2015-32099 Fish Fish and Wildlife Service PROPOSED RULES Endangered and Threatened Wildlife and Plants: 90-day and 12-month Findings on a Petition to List the Miami Tiger Beetle as an Endangered or Threatened Species, 79533-79554 2015-31982 NOTICES Endangered and Threatened Wildlife and Plants: Giant Garter Snake; Revised Draft Recovery Plan, 79606-79607 2015-32108 Endangered Species Permit Applications: Wild Bird Conservation, 79607-79608 2015-32013 Incidental Take Permit Applications: American Burying Beetle in Oklahoma; Oil and Gas Industry Conservation Plan, 79609 2015-32103 Food and Drug Food and Drug Administration RULES New Animal Drugs for Use in Animal Feeds: Bacitracin Methylenedisalicylate, 79474-79476 2015-32000 PROPOSED RULES General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products, 79493-79505 2015-32024 Sunlamp Products; Proposed Amendment to Performance Standard, 79505-79522 2015-32023 Food and Nutrition Food and Nutrition Service RULES Child and Adult Care Food Program; CFR Correction, 79459 2015-32134 Determining Eligibility for Free and Reduced Price Meals and Free Milk in Schools; CFR Correction, 79459 2015-32136 Donation of Foods for Use in the United States, its Territories and Possessions and Areas under its Jurisdiction; CFR Correction, 79459 2015-32140 Food Safety Food Safety and Inspection Service RULES Labeling, Marking Devices, and Containers; CFR Correction, 79460 2015-32120 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 79557 2015-32174 Foreign Trade Foreign-Trade Zones Board NOTICES Approvals of Subzone Status: Haier America Trading, LLC, Olive Branch, MS, 79558 2015-32163 Grain Inspection Grain Inspection, Packers and Stockyards Administration RULES Regulations under the Packers and Stockyards Act; CFR Correction, 79460 2015-32119 PROPOSED RULES United States Standards for Rough Rice, Brown Rice for Processing, and Milled Rice, 79490-79491 2015-32181 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 79593-79594 2015-32004 Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

RULES Change of Nonimmigrant Classification; CFR Correctioin, 79459 2015-32116 PROPOSED RULES Privacy Act; Systems of Records, 79487-79490 2015-31898 NOTICES Privacy Act; Computer Matching Program, 79605-79606 2015-32149
Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

See

Surface Mining Reclamation and Enforcement Office

Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 79651-79652 2015-32150 2015-32151 2015-32152 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Cold-Rolled Steel Flat Products from Brazil, 79569-79571 2015-32221 Cold-Rolled Steel Flat Products from India, 79562-79564 2015-32218 Cold-Rolled Steel Flat Products from the People's Republic of China, 79558-79561 2015-32215 Cold-Rolled Steel Flat Products from the Republic of Korea, 79567-79569 2015-32222 Cold-Rolled Steel Flat Products from the Russian Federation, 79564-79567 2015-32223 Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, from the People's Republic of China, 79561-79562 2015-32161 International Trade Com International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Large Residential Washers from China, 79611-79612 2015-32083 Investigations; Determinations, Modifications, and Rulings, etc.: Arrowheads with Deploying Blades and Components Thereof and Packaging Therefor, 79612-79613 2015-32087 Justice Department Justice Department See

Executive Office for Immigration Review

NOTICES Consent Decrees under the Clean Water Act; Proposed Modifications, 79613-79614 2015-32102 Proposed Consent Decrees, 79614 2015-32110
Labor Department Labor Department See

Employment and Training Administration

Land Land Management Bureau NOTICES Plats of Survey: Wyoming and Nebraska, 79609-79610 2015-32111 Management Management and Budget Office NOTICES Category Management Policy 16-1: Improving the Acquisition and Management of Common Information Technology: Software Licensing, 79615 2015-32059 National Highway National Highway Traffic Safety Administration PROPOSED RULES Federal Motor Vehicle Safety Standards: Small Business Impacts of Motor Vehicle Safety, 79531-79533 2015-32005 National Institute National Institute of Standards and Technology NOTICES Meetings: Visiting Committee on Advanced Technology, 79571-79572 2015-32058 National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Collection of Customer Service, Demographic, and Smoking/Tobacco Use Information from the National Cancer Institute's Cancer Information Service Clients, 79596-79597 2015-32095 Government-Owned Inventions; Availability for Licensing, 79594 2015-32096 Meetings: Center for Scientific Review, 79597 2015-32037 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 79595-79596 2015-32035 National Institute on Aging, 79595 2015-32036 Prospective Grants of Exclusive Start-Up Option Licenses: Potent and Selective Analogues of Monamine Transporters; Methods of Making; and Uses Thereof, 79594-79595 2015-32141 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Northeastern United States: Summer Flounder Fishery; Quota Transfer, 79485-79486 2015-32109 National Science National Science Foundation NOTICES Meetings; Sunshine Act, 79615 2015-32287 National Telecommunications National Telecommunications and Information Administration NOTICES Requests for Nominations: Digital Economy Board of Advisors; Extension, 79572 2015-32115 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Environmental Assessments; Availability, etc.: Southern California Edison Co., San Onofre Generating Station, Units 2 and 3, 79616-79617 2015-32003 Facility Operating and Combined Licenses: Applications and Amendments Involving Proposed No Significant Hazards Considerations, 79617-79625 2015-31754 Pension Benefit Pension Benefit Guaranty Corporation RULES Allocation of Assets in Single-Employer Plans: Interest Assumptions for Valuing Benefits, 79476-79477 2015-32225 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 79625-79627 2015-32008 2015-32009 2015-32010 Postal Service Postal Service NOTICES Product Changes: First-Class Package Service Negotiated Service Agreement, 79628 2015-32068 Parcel Select Negotiated Service Agreement, 79628 2015-32069 Priority Mail Negotiated Service Agreement, 79627-79628 2015-32070 2015-32071 2015-32072 2015-32073 2015-32074 Rural Utilities Rural Utilities Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 79557-79558 2015-32169 Securities Securities and Exchange Commission RULES Crowdfunding; Correction, 79473 2015-32106 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 79644-79645 2015-32053 Applications: Third Avenue Trust and Third Avenue Management, LLC, 79638-79640 2015-32079 Self-Regulatory Organizations; Proposed Rule Changes: BATS Exchange, Inc., 79636-79638 2015-32045 BATS Y-Exchange, Inc., 79629-79630 2015-32046 Financial Industry Regulatory Authority, Inc., 79632-79636 2015-32051 NASDAQ OMX BX, Inc., 79640-79642 2015-32044 NASDAQ OMX PHLX, LLC, 79642-79644 2015-32052 New York Stock Exchange, LLC, 79644 2015-32047 NYSE Arca, Inc., 79630-79632 2015-32048 NYSE MKT, LLC, 79640, 79645-79647 2015-32049 2015-32050 Small Business Small Business Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 79647-79648 2015-32032 2015-32033 2015-32066 2015-32067 State Department State Department NOTICES Decision to Maintain Presidential Permit for the Vantage Pipeline Border Facilities in Divide County, ND, Following Change in Ownership, 79648-79649 2015-31873 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 79597-79601 2015-32061 2015-32062 2015-32063 Surface Mining Surface Mining Reclamation and Enforcement Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 79610-79611 2015-32104 2015-32105 Surface Transportation Surface Transportation Board NOTICES Temporary Trackage Rights Exemptions: Union Pacific Railroad Co. from BNSF Railway Co., 79650 2015-32166 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

National Highway Traffic Safety Administration

See

Surface Transportation Board

NOTICES Meetings: National Freight Advisory Committee; Webinars, 79650-79651 2015-32090
Treasury Treasury Department See

Comptroller of the Currency

See

Internal Revenue Service

See

United States Mint

U.S. Mint United States Mint NOTICES Pricing for the 2016 100th Anniversary of the National Park Service Commemorative Coin Program, 79652-79653 2015-32030 Pricing for the 2016 Mark Twain Commemorative Coin Program, 79653 2015-32031 Veteran Affairs Veterans Affairs Department RULES Payment of Emergency Medication by VA, 79483-79484 2015-32098 NOTICES Allowance for Private Purchase of an Outer Burial Receptacle or Grave Liner in Lieu of a Government-Furnished Grave Liner for Use in a VA National Cemetery, 79653 2015-32006 Reader Aids

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

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80 245 Tuesday, December 22, 2015 Rules and Regulations DEPARTMENT OF AGRICULTURE Office of the Secretary 7 CFR Part 1a Law Enforcement Authorities CFR Correction In Title 7 of the Code of Federal Regulations, Parts 1 to 26, revised as of January 1, 2015, on page 119, in § 1a.3, remove the phrase “subject to 1a. and” and add in its place “subject to 1a.5 and”. [FR Doc. 2015-32137 Filed 12-21-15; 8:45 am] BILLING CODE 1505-01-D DEPARTMENT OF AGRICULTURE Office of the Secretary 7 CFR Part 57 Inspection of Eggs (Egg Products Inspection Act) CFR Correction

In Title 7 of the Code of Federal Regulations, Parts 53 to 209, revised as of January 1, 2015, make the following corrections:

1. On page 74, in § 57.720, in paragraph (a)(4), remove the phrase “Products Products” and add the term “Products Processing” in its place, and 2. On page 75, in § 57.900, in paragraph (a), reinstate the last sentence to read “The importation of any egg in violation of the regulations of this part is prohibited.”
[FR Doc. 2015-32121 Filed 12-21-15; 8:45 am] BILLING CODE 1505-01-D
DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Part 226 Child and Adult Care Food Program CFR Correction In Title 7 of the Code of Federal Regulations, Parts 210 to 299, revised as of January 1, 2015, on page 212, in § 226.6, remove the term “renewing” and add the term “participating” in its place, in paragraphs (c)(3)(iii)(B)(1)(ii) and (c)(3)(iii)(B)(2)(iii). [FR Doc. 2015-32134 Filed 12-21-15; 8:45 am] BILLING CODE 1505-01-D DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Part 245 Determining Eligibility for Free and Reduced Price Meals and Free Milk in Schools CFR Correction In Title 7 of the Code of Federal Regulations, Parts 210 to 299, revised as of January 1, 2015, on page 339, in § 245.6a, in paragraph (h), after the first sentence, reinstate the following sentences:
§ 245.6a Verification requirements.

(h) * * * These required data elements will be specified by FNS. Contingent upon new funding to support this purpose, FNS will also require each local educational agency to collect and report the number of students who were terminated as a result of verification but who were reinstated as of February 15th. The first report containing this data element would be required in the school year beginning July 1, 2005 and each school year thereafter. State agencies may develop paper or electronic reporting forms to collect this data from local educational agencies, as long as all required data elements are collected from each local educational agency. Local educational agencies shall retain copies of the information reported under this section and all supporting documents for a minimum of 3 years. All verified applications must be readily retrievable on an individual school basis and include all documents submitted by the household for the purpose of confirming eligibility, reproductions of those documents, or annotations made by the determining official which indicate which documents were submitted by the household and the date of submission. All relevant correspondence between the households selected for verification and the school or local educational agency must be retained. Local educational agencies are encouraged to collect and report any or all verification data elements before the required dates.

[FR Doc. 2015-32136 Filed 12-21-15; 8:45 am] BILLING CODE 1505-310-D
DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Part 250 Donation of Foods for Use in the United States, Its Territories and Possessions and Areas Under Its Jurisdiction CFR Correction In Title 7 of the Code of Federal Regulations, Parts 210 to 299, revised as of January 1, 2015, on page 566, in § 250.30, in paragraph (f)(2), in the second sentence, add the word “food” after “donated” and before the comma. [FR Doc. 2015-32140 Filed 12-21-15; 8:45 am] BILLING CODE 1505-01-D DEPARTMENT OF HOMELAND SECURITY 8 CFR Part 248 Change of Nonimmigrant Classification CFR Correction In Title 8 of the Code of Federal Regulations, revised as of January 1, 2015, on page 655, in § 248.1, in paragraph (c)(1), add the phrase “USCIS will” at the beginning of the second sentence. [FR Doc. 2015-32116 Filed 12-21-15; 8:45 am] BILLING CODE 1505-01-D DEPARTMENT OF JUSTICE Executive Office for Immigration Review 8 CFR Part 1245 Adjustment of Status to That of Person Admitted for Permanent Residence CFR Correction In Title 8 of the Code of Federal Regulations, revised as of January 1, 2015, on page 1052, in § 1245.10, in paragraph (a)(2)(i), remove “8 CFR chapter” and add “8 CFR chapter I” in its place. [FR Doc. 2015-32118 Filed 12-21-15; 8:45 am] BILLING CODE 1505-01-D DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration 9 CFR Part 201 Regulations Under the Packers and Stockyards Act CFR Correction In Title 9 of the Code of Federal Regulations, Part 200 to End, revised as of January 1, 2015, on page 27, in § 201.100, in paragraph (c)(2)(v), add “and” at the end of the paragraph, after the semicolon. [FR Doc. 2015-32119 Filed 12-21-15; 8:45 am] BILLING CODE 1505-01-D DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Part 317 Labeling, Marking Devices, and Containers CFR Correction

In Title 9 of the Code of Federal Regulations, Part 200 to End, revised as of January 1, 2015, on page 218, make the following changes:

1. In § 317.344, remove the term “ground pork”. 2. In § 317.345, in paragraph (d), remove the word “should” and add in its place “for products covered in paragraphs (a)(1) and (a)(2) must”.
[FR Doc. 2015-32120 Filed 12-21-15; 8:45 am] BILLING CODE 1505-01-D
DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency 12 CFR Part 163 Savings Associations—Operations CFR Correction In Title 12 of the Code of Federal Regulations, Parts 1 to 199, revised as of January 1, 2015, on page 920, in § 163.76, at the end of paragraph (c), reinstate a signature line and date line, and reinstate paragraph (d) to read as follows:
§ 163.76 Offers and sales of securities at an office of a Federal savings association.

(c) * * *

Signature: Date:

(d) For purposes of this section, an “office” of an association means any premises used by the association that are identified to the public through advertising or signage using the association's name, trade name, or logo.

[FR Doc. 2015-32113 Filed 12-21-15; 8:45 am] BILLING CODE 1505-01-D
FEDERAL RESERVE SYSTEM 12 CFR Part 204 [Regulation D; Docket No. R-1527] RIN 7100 AE-41 Reserve Requirements of Depository Institutions AGENCY:

Board of Governors of the Federal Reserve System.

ACTION:

Final rule.

SUMMARY:

The Board of Governors of the Federal Reserve System (“Board”) is amending Regulation D (Reserve Requirements of Depository Institutions) to revise the rate of interest paid on balances maintained to satisfy reserve balance requirements (“IORR”) and the rate of interest paid on excess balances (“IOER”) maintained at Federal Reserve Banks by or on behalf of eligible institutions. The final amendments specify that IORR is 0.50 percent and IOER is 0.50 percent, a 0.25 percentage point increase from their prior levels. The amendments are intended to enhance the role of such rates of interest in moving the Federal funds rate into the target range established by the Federal Open Market Committee (“FOMC” or “Committee”).

DATES:

The amendments to part 204 (Regulation D) are effective December 22, 2015. The IORR and IOER rate changes were applicable on December 17, 2015, as specified in 12 CFR 204.10(b)(5), as amended.

FOR FURTHER INFORMATION CONTACT:

Clinton N. Chen, Attorney (202-452-3952), or Stephanie Martin, Associate General Counsel (202-452-3198), Legal Division, or Thomas R. Keating, Financial Analyst (202-973-7401), or Laura Lipscomb, Section Chief (202-973-7964), Division of Monetary Affairs; for users of Telecommunications Device for the Deaf (TDD) only, contact (202-263-4869); Board of Governors of the Federal Reserve System, 20th and C Streets NW., Washington, DC 20551.

SUPPLEMENTARY INFORMATION: I. Statutory and Regulatory Background

For monetary policy purposes, section 19 of the Federal Reserve Act (“the Act”) imposes reserve requirements on certain types of deposits and other liabilities of depository institutions. Regulation D, which implements section 19 of the Act, requires that a depository institution meet reserve requirements by holding cash in its vault, or if vault cash is insufficient, by maintaining a balance in an account at a Federal Reserve Bank (“Reserve Bank”).1 Section 19 also provides that balances maintained by or on behalf of certain institutions in an account at a Reserve Bank may receive earnings to be paid by the Reserve Bank at least once each quarter, at a rate or rates not to exceed the general level of short-term interest rates. Institutions that are eligible to receive earnings on their balances held at Reserve Banks (“eligible institutions”) include depository institutions and certain other institutions.2 Section 19 also provides that the Board may prescribe regulations concerning the payment of earnings on balances at a Reserve Bank.3 Prior to these amendments, Regulation D specified a rate of 1/4 percent for both IORR and IOER.4

1 12 CFR 204.5(a)(1).

2 Section 19(b)(1)(A) defines “depository institution” as any insured bank as defined in section 3 of the Federal Deposit Insurance Act or any bank which is eligible to make application to become an insured bank under section 5 of such Act; any mutual savings bank as defined in section 3 of the Federal Deposit Insurance Act or any bank which is eligible to make application to become an insured bank under section 5 of such Act; any savings bank as defined in section 3 of the Federal Deposit Insurance Act or any bank which is eligible to make application to become an insured bank under section 5 of such Act; any insured credit union as defined in section 101 of the Federal Credit Union Act or any credit union which is eligible to make application to become an insured credit union pursuant to section 201 of such Act; any member as defined in section 2 of the Federal Home Loan Bank Act; [and] any savings association (as defined in section 3 of the Federal Deposit Insurance Act) which is an insured depository institution (as defined in such Act) or is eligible to apply to become an insured depository institution under the Federal Deposit Insurance Act. See 12 U.S.C. 461(b)(1)(A). Eligible institution also includes any trust company, corporation organized under section 25A or having an agreement with the Board under section 25, or any branch or agency of a foreign bank (as defined in section 1(b) of the International Banking Act of 1978). Federal Reserve Act section 19(b)(12)(C), 12 U.S.C. 461(b)(12)(C), see 12 CFR 204.2(y) (definition of “eligible institution”).

3 See Federal Reserve Act section 19(b)(12), 12 U.S.C. 461(b)(12).

4 See § 204.10(b)(5) of Regulation D, 12 CFR 204.10(b)(5).

II. Amendments to IORR and IOER

The Board is amending § 204.10(b)(5) of Regulation D to specify that IORR is 0.50 percent and IOER is 0.50 percent. This 0.25 percentage point increase in the IORR and IOER was associated with an increase in the target range for the federal funds rate, from a target range of 0 to 1/4 percent to a target range of 1/4 to 1/2 percent, announced by the FOMC on December 16, 2015 with an effective date of December 17, 2015. A press release on the same day as the announcement noted that:

The Committee judges that there has been considerable improvement in labor market conditions this year, and it is reasonably confident that inflation will rise, over the medium term, to its 2 percent objective. Given the economic outlook, and recognizing the time it takes for policy actions to affect future economic outcomes, the Committee decided to raise the target range for the federal funds rate to 1/4 to 1/2 percent. The stance of monetary policy remains accommodative after this increase, thereby supporting further improvement in labor market conditions and a return to 2 percent inflation.

A Federal Reserve Implementation note released simultaneously with the announcement indicated that:

The Board of Governors of the Federal Reserve System voted unanimously to raise the interest rate paid on required and excess reserve balances to 0.50 percent, effective December 17, 2015.

As a result, section 204.10(b)(5) of Regulation D has been amended to change IORR to 0.50 percent and IOER to 0.50 percent.

III. Administrative Procedure Act

The Board has determined that delaying implementation of the changes in the rates of interest to be paid in order to allow notice and public comment would be unnecessary and contrary to the public interest. Therefore, the Board has found good cause to not follow the provisions of 5 U.S.C. 553(b) relating to notice and public participation. The Board's revisions to these rates were taken with a view to accommodating commerce and business and with regard to their bearing upon the general credit situation of the country. Notice and public participation would prevent the Board's action from being effective as promptly as necessary in the public interest. A delay would permit speculators or others to reap unfair profits and could provoke other consequences contrary to the public interest. Seeking notice and comment on the rate changes would not aid the persons affected and would otherwise serve no useful purpose. For these same reasons, the Board also has found good cause not to provide 30 days prior notice of the effective date of the rule under 5 U.S.C. 553(d).

IV. Regulatory Flexibility Analysis

The Regulatory Flexibility Act (“RFA”) does not apply to a rulemaking where a general notice of proposed rulemaking is not required.5 As noted previously, the Board has determined that it is unnecessary and contrary to the public interest to publish a general notice of proposed rulemaking for this final rule. Accordingly, the RFA's requirements relating to an initial and final regulatory flexibility analysis do not apply.

5 5 U.S.C. 603 and 604.

V. Paperwork Reduction Act

In accordance with the Paperwork Reduction Act (“PRA”) of 1995 (44 U.S.C. 3506; 5 CFR part 1320 Appendix A.1), the Board reviewed the final rule under the authority delegated to the Board by the Office of Management and Budget. The final rule contains no requirements subject to the PRA.

List of Subjects in 12 CFR Part 204

Banks, Banking, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, the Board amends 12 CFR part 204 as follows:

PART 204—RESERVE REQUIREMENTS OF DEPOSITORY INSTITUTIONS (REGULATION D) 1. The authority citation for part 204 continues to read as follows: Authority:

12 U.S.C. 248(a), 248(c), 371a, 461, 601, 611, and 3105.

2. Section 204.10 is amended by revising paragraph (b)(5) to read as follows:
§ 204.10 Payment of interest on balances.

(b) * * *

(5) The rates for IORR and IOER are:

Rate
  • (percent)
  • Effective
    IORR 0.50 12/17/2015 IOER 0.50 12/17/2015
    By order of the Board of Governors of the Federal Reserve System, December 17, 2015. Robert deV. Frierson, Secretary of the Board.
    [FR Doc. 2015-32099 Filed 12-21-15; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL HOUSING FINANCE AGENCY 12 CFR Part 1266 Advances CFR Correction In Title 12 of the Code of Federal Regulations, Parts 1200 to 1599, revised as of January 1, 2015, on page 308, in § 1266.4, in paragraph (g)(2)(ii), remove the term “§ 950.2(a)” and add the term “§ 1266.2(a)” in its place. [FR Doc. 2015-32112 Filed 12-21-15; 8:45 am] BILLING CODE 1505-01-D DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2013-0300; Directorate Identifier 2011-NM-163-AD; Amendment 39-18339; AD 2015-25-01] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 757-200, 757-200CB, and 757-200PF airplanes. This AD was prompted by a report that a forward-most cam latch of the forward center cam latch pair on a main cargo door (MCD) broke during flight. This AD requires doing a general visual inspection for broken or missing cam latches, latch pins, and latch pin cross bolts; torqueing the cross bolts in the latch pins; measuring the extension of the latch pins; replacing all alloy steel cross bolts through the latch pins with corrosion resistant steel (CRES) cross bolts; doing a general visual inspection of all cam latches for lip deformation; doing an inspection of cam latch 1 and cam latch 2 for cracks and replacing all cracked or broken parts; checking the rig of the MCD and re-rigging as applicable; and doing related investigative and corrective actions, if necessary. This AD also requires doing certain repetitive inspections until MCD rigging is done. This AD also requires repetitive MCD post-rigging inspections and corrective actions if necessary. We are issuing this AD to detect and correct discrepancies of the cam latches, latch pins, and latch pin cross bolts, which could reduce the structural integrity of the MCD, and result in potential loss of the cargo door and rapid decompression of the airplane.

    DATES:

    This AD is effective January 26, 2016.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of January 26, 2016.

    ADDRESSES:

    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, Washington. 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-2013-0300.

    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-2013-0300; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Kimberly DeVoe, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6495; fax: 425-917-6590; email: [email protected].

    SUPPLEMENTARY INFORMATION: Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 757-200, 757-200CB, and 757-200PF airplanes. The NPRM published in the Federal Register on April 11, 2013 (78 FR 21576). The NPRM was prompted by a report that a forward-most cam latch of the forward center cam latch pair on a MCD broke during flight. The NPRM proposed to require performing repetitive inspections of the MCD cam latches; replacing cam latches, certain bolts, and door hinge fittings; performing related investigative and corrective actions, if necessary; and MCD rigging. We are issuing this AD to detect and correct discrepancies of the cam latches, latch pins, and latch pin cross bolts, which could reduce the structural integrity of the MCD, and result in potential loss of the cargo door and rapid decompression of the airplane.

    Actions Since the NPRM (78 FR 21576, April 11, 2013) Was Issued

    Since we issued the NPRM (78 FR 21576, April 11, 2013), we have reviewed Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014. We referred to Boeing Alert Service Bulletin 757-52A0091, dated March 9, 2010, as the appropriate source of service information for accomplishing the actions specified in the NPRM. Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014, clarifies the inspection conditions and the on-condition actions for certain conditions. Certain inspections of the cam latches and latch pins were changed from detailed inspections to general visual inspections. Also, a detailed inspection of mating parts and immediately adjacent cam latches and latch pins for any cracks, or any gouges in critical areas was added to certain on-condition actions specified in the service information.

    Also, the on-condition action for latch pin extensions that are between 0.84 and 0.89 inch or between 0.91 and 0.94 inch was changed. For those latch pins, Boeing Alert Service Bulletin 757-52A0091, dated March 9, 2010, specifies repetitive detailed inspections and certain other specified actions. However, for those latch pins, Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014, specifies replacement of the discrepant latch pin, a detailed inspection, and certain other specified actions (which are the same on-condition actions specified in Boeing Alert Service Bulletin 757-52A0091, dated March 9, 2010, for latch pin extensions that are less than 0.84 inch or greater than 0.94 inch).

    Explanation of Certain Changes to NPRM (78 FR 21576, April 11, 2013)

    We have revised paragraphs (c), (g), (h), (j)(1), and (j)(2) of this AD to refer to Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014. We have also added new paragraph (k) of this AD to give credit for doing actions before the effective date of this AD in accordance with Boeing Alert Service Bulletin 757-52A0091, dated March 9, 2010. We have redesignated subsequent paragraphs accordingly.

    In addition, since certain inspections and conditions were revised in Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014, we have revised the description of the actions in this AD to correspond with the terminology in Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014. As a result, certain paragraphs in the proposed AD (78 FR 21576, April 11, 2013) have been rearranged and the corresponding paragraph identifiers have been redesignated in this AD, as listed in the following table:

    Revised Paragraph Identifiers Action in the NPRM (78 FR 21576,
  • April 11, 2013)
  • Corresponding
  • requirement in
  • this AD
  • paragraph (g) paragraph (g) paragraph (h) paragraph (g) paragraph (i) paragraph (h) paragraph (j) paragraph (h) paragraph (k) paragraph (i) paragraph (l) paragraph (j)

    We have also revised the Costs of Compliance paragraph in this final rule to reflect the work-hours in Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014.

    Comments

    We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (78 FR 21576, April 11, 2013) and the FAA's response to each comment.

    Clarification of Applicability

    FedEx stated that it would withhold its comments because the FedEx Express Model 757 fleet was converted to freighters under ST Aerospace Mobile Engineering Inc. Supplemental Type Certificate (STC) ST03562AT (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/C21335554C0E37C4862574B20065BA46?OpenDocument&Highlight=st03562at), which was not mentioned in the applicability of the NPRM (78 FR 21576, April 11, 2013). Fedex stated it would withhold its comments unless and until an NPRM is issued for STC ST03562AT.

    We acknowledge FedEx's comment. As specified in paragraph (c) of this AD, this AD applies to Model 757-200, 757-200CB, and 757-200PF airplanes as identified in Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014. The effectivity of Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014, identifies the affected airplanes by variable number.

    Request To Emphasize Inspection Conditions/Findings of the NPRM (78 FR 21576, April 11, 2013)

    Boeing requested that paragraph (h) of the proposed AD (78 FR 21576, April 11, 2013) be rewritten to clarify the relative severity of the inspection conditions and the appropriate actions needed. Boeing stated that the actions in paragraph (h) of the proposed AD should progress from the most serious condition findings to the least serious findings while providing logical evaluation paths for the conditions.

    We agree that the progression of the inspection conditions and their appropriate related investigative and corrective actions should correspond with what is described in the referenced service information. As stated previously, we have revised the terminology in this final rule to match the actions (e.g., inspections and related investigative and corrective actions) specified in Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014, which addresses the commenter's concerns.

    Request To Delay AD Issuance Pending Revised Service Information

    European Air Transport Leipzig GmbH/DHL Air Ltd. (EATL/DHL) requested that we delay issuing the AD until applicable service information is revised. EATL/DHL stated that despite accomplishing the re-rigging using the current service information, it continues to find wear on the cam latches during post-rigging inspections, and has had to replace a total of 69 cam latches and 17 latch pins in one year. As a result, EATL/DHL stated that the financial impact is higher than the inspection costs only.

    EATL/DHL stated that a rigging check of the cam hook mechanism must be included in Boeing Alert Service Bulletin 757-52A0091 to address the identified unsafe condition. EATL/DHL stated that unintended wear of the cam latches can be avoided only by first re-rigging the cam hook mechanism to either side of the door to ensure that the cam latches and latch pins are involved only in the door-locking process and not in the door-closing process. EATL/DHL stated that it has been adjusting the cam hook mechanism using the cam hook adjustment procedure in the applicable airplane maintenance manual (AMM), but that it is difficult to attain the tolerances stated in that AMM procedure. EATL/DHL concluded that the AMM procedure must be clarified and simplified.

    We disagree with delaying this AD until revised service information that includes a new AMM procedure is available. We understand that there could be additional root causes and procedures that need to be clarified if operators, experienced with accomplishing the current procedures, determine that there are more effective means of accomplishing the repairs. However, we disagree with delaying issuance of this final rule until service information containing revised re-rigging procedures becomes available. We have determined that the actions specified in this AD using Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014, are an effective means of accomplishing the repairs. Accomplishing the actions required by this AD adequately addresses the identified unsafe condition. We have determined that to delay this final rule would be inappropriate, because inspections and repairs to the MCD cam latches are needed to reduce the risk of the identified unsafe condition. Operators should continue to communicate any findings resulting from failures, as well as deficiencies in maintenance documentation, to Boeing so that inspection and repair procedures can be reviewed and revised as necessary. Operators can always request approval of an AMOC under the provisions of paragraph (l) of this AD if alternative re-rigging procedures are available and address the identified unsafe condition. We have not changed this final rule in this regard.

    Request To Revise Compliance Time

    UPS requested that we revise paragraphs (g), (h), and (i) of the proposed AD (78 FR 21576, April 11, 2013) to remove all references to service information containing compliance times stated in calendar days. UPS stated that crack initiation and subsequent propagation is dependent on flight cycles due to pressurization and/or flight loads, and not to MCDs sitting idle, so the use of calendar days is irrelevant. UPS stated that removing calendar days should have no negative effect on safety, and that a calendar-based compliance schedule merely imposes economic, maintenance, and scheduling burdens. UPS also questioned the need for repetitive inspections of the MCD cam latches, and stated that it does not concur with the finding that improper door rigging is the root cause of failure. UPS stated that the only identified direct cause of cam latch failure is a sheared cross bolt that migrated into the cam envelope, and that initial inspections would identify cases of sheared cross bolts, migrated pins, corrosion, lip deformation, etc. UPS asked what changes occur to the system that warrant reinspection if the latch system far exceeds 10 9 reliability, after the root cause of the failed latch is resolved.

    We disagree with the request to remove all compliance times stated in calendar days from this final rule or to remove the repetitive inspections because the damage was determined to have been brought on by a poorly rigged MCD and the torque impact from the cam latch rotation during latching and unlatching operations. Therefore, it is possible for the MCD system to be changed after a failed latch has been repaired.

    For this reason, a calendar-based inspection interval has been calculated along with the flight cycle interval, as specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014. Paragraph (g) of this AD requires compliance within the times specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014.

    However, paragraph (h) of this AD requires compliance within the times specified in table 2 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014, which specifies repetitive intervals in flight cycles only.

    Specific changes in compliance time or inspection intervals may be requested by submitting a request for approval of an AMOC according to the procedures specified in paragraph (l) of this AD. We have not changed this final rule in this regard.

    Request To Extend Compliance Time

    UPS requested that if calendar-based compliance times are retained, for airplanes that had successfully passed the initial detailed inspections of the cam latches and latch pins, torqued the cross bolts, and measured the latch pin extension, the next inspection be extended by 3,000 flight cycles or 24 months.

    We disagree with extending the compliance times of this AD. However, we note that certain inspections required by this AD are at the intervals specified by the commenter. In developing an appropriate compliance time for these actions, we considered the urgency associated with the subject unsafe condition, the practical aspect of accomplishing the required modification and the normal scheduled maintenance times for most affected operators. In consideration of these items, we have determined that the repetitive intervals specified in tables 1 and 2 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014, will ensure an acceptable level of safety. No change has been made to this AD in this regard.

    Request To Allow Ferry Flight

    UPS requested that we revise the proposed AD (78 FR 21576, April 11, 2013) to allow an airplane having a discrepant cam/pin to be ferried to a location where the airplane can be modified. UPS stated that, since significant loads are the result of the pressurization and/or flight loads, and not the result of whether the door is closed, an airplane with findings needs to be ferried to a maintenance facility for repair, especially in view of the given proposed time frames for the inspection.

    We agree that special flight permits should be allowed because the inspection intervals do not necessarily correspond to scheduled maintenance intervals, and allowance should be made for operators to ferry an airplane to a location where repairs can be made without the need to request a special flight permit. Unpressurized flight does not subject the airplane to possible rapid decompression of the airplane should the damaged cam latch, latch pin, or latch pin cross bolt fail, resulting in loss of the MCD during flight.

    However, it is not necessary to revise this final rule because special flight permits are already allowed. Unless otherwise specified in the AD, special flight permits are currently allowed as described in section 21.197 and section 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the airplane to a location where the airplane can be modified (if the operator elects to do so), provided no passengers are onboard. We do not find it necessary to change the final rule in this regard.

    Conclusion

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

    • Αre consistent with the intent that was proposed in the NPRM (78 FR 21576, April 11, 2013) for correcting the unsafe condition; and

    • Do not add any additional burden upon the public than was already proposed in the NPRM (78 FR 21576, April 11, 2013).

    We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014. The service information describes procedures for doing a general visual inspection for broken or missing cam latches, latch pins, and latch pin cross bolts; torqueing the cross bolts in the latch pins; measuring the extension of the latch pins; replacing all alloy steel cross bolts through the latch pins with CRES cross bolts; doing a general visual inspection of all cam latches for lip deformation; doing a high frequency eddy current (HFEC) or magnetic particle inspection of cam latch 1 and cam latch 2 for cracks and replacing all cracked or broken parts; checking the rig of the MCD and re-rigging as applicable; and doing related investigative and corrective actions. The service information also describes doing repetitive inspections for certain conditions specified in the service information, which end after the MCD rigging is done as specified in the service information. The service information also describes procedures for doing MCD post-rigging inspections and corrective actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    Costs of Compliance

    We estimate that this AD affects 9 airplanes of U.S. registry.

    We estimate the following costs to comply with this AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S. operators
    Inspections, torque, and measurement 4 work-hours × $85 per hour = $340 None $340 $3,060 Rigging MCD and replacing bolts 49 work-hours × $85 per hour = $4,165 0 [1] 4,165 37,485 [1] We have received no definitive data that would enable us to provide parts cost for the bolt replacement specified in this AD.

    We estimate the following costs to do any necessary related investigative actions and certain replacements that would be required based on the results of the inspections. We have no way of determining the number of aircraft that might need these actions:

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Related investigative actions 2 work-hours × $85 per hour = $170 $0 $170 Replacements of broken/missing parts 2 work-hours × $85 per hour = $170 [2] 0 170 [2] We have received no definitive data that would enable us to provide parts cost for the part replacements specified in this AD.

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

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2015-25-01 The Boeing Company: Amendment 39-18339; Docket No. FAA-2013-0300; Directorate Identifier 2011-NM-163-AD. (a) Effective Date

    This AD is effective January 26, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to The Boeing Company Model 757-200, 757-200CB, and 757-200PF airplanes; certificated in any category; as identified in Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014.

    (d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

    (e) Unsafe Condition

    This AD was prompted by a report that a forward-most cam latch on the forward center cam latch pair on a main cargo door (MCD) broke during flight. We are issuing to detect and correct cracked or damaged cam latches, latch pins, and latch pin cross bolts, which could reduce the structural integrity of the MCD, and result in potential loss of the cargo door and rapid decompression of the airplane.

    (f) Compliance

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

    (g) Repetitive MCD Inspections, Other Specified Actions, Related Investigative Actions, and Corrective Actions (Including Bolt Replacement and MCD Rigging)

    At the applicable times specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014, except as provided by paragraph (j)(1) of this AD: Do a general visual inspection for broken or missing cam latches, latch pins, and latch pin cross bolts; torque the cross bolts in the latch pins; measure the extension of the latch pins; replace all alloy steel cross bolts through the latch pins with corrosion resistant steel (CRES) cross bolts; do a general visual inspection of all cam latches for lip deformation; do a high frequency eddy current (HFEC) or magnetic particle inspection of cam latch 1 and cam latch 2 for cracks and replace all cracked or broken parts; check the rig of the MCD and re-rig as applicable; and do all applicable related investigative and corrective actions; and thereafter do all applicable repetitive inspections specified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014, except as required by paragraph (j)(2) of this AD. Do all applicable related investigative and corrective actions at the applicable time specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014. Do all applicable repetitive inspections at the applicable time and intervals specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014, until the rig of the MCD has been checked in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014.

    (1) For Condition 2 as defined in Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014: Do repetitive general visual inspections for broken or missing cam latches, latch pins, and latch pin cross bolts.

    (2) For Condition 3 as defined in Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014: Repetitive general visual inspections for broken or missing cam latches, latch pins, and latch pin cross bolts and repetitive detailed inspections of the discrepant cam latch and mating latch pin for any cracks, or gouges in critical areas.

    (3) For Condition 4 as defined in Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014: Repetitive general visual inspections for broken or missing cam latches, latch pins, and latch pin cross bolts; repetitive detailed inspections of the cam latches and latch pins for any cracks, or any gouges in critical areas; and, unless replaced with new or reworked parts, repetitive HFEC or magnetic particle inspections of cam latch 1 and cam latch 2 for any cracks.

    (h) Repetitive MCD Post-Rigging Inspections and Corrective Actions

    At the applicable times specified in table 2 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014: Do general visual inspections for any broken or missing cam latches, latch pins, and latch pin cross bolts; a detailed inspection of the cam latches and latch pins for any cracks, or any gouges in critical areas; and an HFEC or magnetic particle inspection of cam latch 1 and cam latch 2 for cracks; and do all applicable corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014; except as required by paragraph (j)(2) of this AD. Do all applicable corrective actions before further flight. Repeat the inspections thereafter at the applicable times specified in table 2 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014.

    (i) Parts Installation Prohibition

    As of the effective date of this AD, no person may install an alloy steel bolt as a cross bolt through any latch pin fitting assembly in the lower sill of the MCD on any airplane.

    (j) Exceptions to Service Bulletin Specifications

    The following exceptions apply in this AD.

    (1) Where Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014, specifies a compliance time after the original issue date of that service bulletin, this AD requires compliance within the specified compliance time after the effective date of this AD.

    (2) Where Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014, specifies to contact Boeing for appropriate action: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (l) of this AD.

    (k) Credit for Previous Actions

    This paragraph provides credit for the corresponding actions required by paragraphs (g) and (h) of this AD, if those actions were done before the effective date of this AD, using Boeing Alert Service Bulletin 757-52A0091, dated March 9, 2010, which is not incorporated by reference in this AD.

    (l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (m)(1) of this AD. Information may be emailed to: [email protected]

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

    (3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane and the approval must specifically refer to this AD.

    (m) Related Information

    (1) For more information about this AD, contact Kimberly DeVoe, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6495; fax: 425-917-6590; email: [email protected]

    (2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (n)(3) and (n)(4) of this AD.

    (n) Material Incorporated by Reference

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

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

    (i) Boeing Alert Service Bulletin 757-52A0091, Revision 1, dated December 19, 2014.

    (ii) Reserved.

    (3) 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.

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

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

    Issued in Renton, Washington, on November 25, 2015. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2015-30818 Filed 12-21-15; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-2714; Directorate Identifier 2014-SW-052-AD; Amendment 39-18349; AD 2015-26-01] RIN 2120-AA64 Airworthiness Directives; Airbus Helicopters AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for Airbus Helicopters Model AS332C1, AS332L1, AS332L2, EC225LP, AS-365N2, AS 365 N3, EC 155B, and EC155B1 helicopters with an energy absorbing seat (seat). This AD requires inspecting for the presence of labels that prohibit stowing anything under the seat. If a label is missing or not clearly visible to each occupant, we require installing a label. This AD was prompted by the discovery that required labels had not been systematically installed. The actions of this AD are intended to prevent objects from being stowed under the seat as these objects could reduce the energy-absorbing function of the seat, resulting in injury to the seat occupants during an accident.

    DATES:

    This AD is effective January 26, 2016.

    The Director of the Federal Register approved the incorporation by reference of certain documents listed in this AD as of January 26, 2016.

    ADDRESSES:

    For service information identified in this final rule, contact Airbus Helicopters, Inc., 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at http://www.airbushelicopters.com/techpub. You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-2714; or in person at the Docket Operations Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the European Aviation Safety Agency (EASA) AD, any incorporated-by-reference service information, the economic evaluation, any comments received, and other information. The street address for the Docket Operations Office (phone: 800-647-5527) is U.S. Department of Transportation, Docket Operations Office, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Robert Grant, Aviation Safety Engineer, Safety Management Group, FAA, 2601 Meacham Blvd., Fort Worth, Texas 76137; telephone (817) 222-5110; email [email protected]

    SUPPLEMENTARY INFORMATION: Discussion

    On July 14, 2015, at 80 FR 40947, the Federal Register published our notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR part 39 by adding an AD that would apply to Airbus Helicopters Model AS332C1, AS332L1, AS332L2, EC225LP, AS-365N2, AS 365 N3, EC 155B, and EC155B1 helicopters with certain energy absorbing seats. The NPRM proposed to require inspecting for the presence of labels that would prohibit stowing anything under the seat. If a label is missing or not clearly visible to each occupant, the NPRM proposed to require installing a label. The proposed requirements were intended to prevent objects from being stowed under the seat as these objects could reduce the energy-absorbing function of the seat, resulting in injury to the seat occupants during an accident.

    The NPRM was prompted by AD No. 2014-0204, dated September 11, 2014, and corrected September 12, 2014, by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for Airbus Helicopters Model AS332C1, AS332L1, AS332L2, EC225LP, AS-365N2, AS 365 N3, EC 155B, and EC155B1 helicopters. EASA advises that during certification of an energy absorbing seat with a new part number, the labels that require keeping the space under the seat free of any object were not systematically installed. EASA states that this condition, if not corrected, could prompt occupants to stow objects under an energy absorbing seat, which would reduce the effectiveness of the seat and the occupants' chance of surviving an accident. The EASA AD consequently requires a one-time inspection for the presence of labels and, if they are missing or unreadable, making and installing labels prohibiting the placing of an object under an energy absorbing seat.

    Since the NPRM was issued, the FAA Southwest Regional Office has relocated and a group email address has been established for requesting an FAA Alternative Methods of Compliance (AMOC) for a helicopter of foreign design. Therefore, we have revised the physical address throughout the AD and the email address for requesting an AMOC.

    Comments

    We gave the public the opportunity to participate in developing this AD, but we received no comments on the NPRM (80 FR 40947, July 14, 2015).

    FAA's Determination

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

    Related Service Information Under 1 CFR Part 51

    Airbus Helicopters issued Alert Service Bulletin (ASB) No. AS332-01.00.85 for Model AS332C1, AS332L1, and AS332L2 helicopters; ASB No. AS365-01.00.66 for Model AS-365N2 and AS 365 N3 helicopters; ASB No. EC155-04A013 for EC 155B and EC155B1 helicopters; and ASB No. EC225-04A012 for Model EC225LP helicopters. All ASBs are Revision 0 and dated August 26, 2014. The ASBs state that during certification of an energy absorbing seat with a new part number, it was observed that the label, which indicates that the space under the seats must remain free of objects, was not systematically installed. Objects stowed under these seats reduce the energy absorbing function and thus jeopardize the occupant's survival in the event of a crash, the ASBs state. Pending a definitive solution, Airbus Helicopters calls for affixing a label that states that nothing can be stored under the seats.

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

    Costs of Compliance

    We estimate that this AD affects 52 helicopters of U.S. Registry and that labor costs average $85 a work-hour. Based on these estimates, we expect that the inspection for the presence of a label takes a quarter work-hour for a labor cost of about $21. The cost of parts and time for installing a label are minimal, for a total cost of $21 per helicopter and $1,092 for the U.S. fleet.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    (3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

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

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2015-26-01 Airbus Helicopters: Amendment 39-18349; Docket No. FAA-2015-2714; Directorate Identifier 2014-SW-052-AD. (a) Applicability

    This AD applies to Airbus Helicopters Model AS332C1, AS332L1, AS332L2, EC225LP, AS-365N2, AS 365 N3, EC 155B, and EC155B1 helicopters with an energy absorbing seat (seat) listed in Figure 1 to paragraph (a) of this AD, certificated in any category.

    Figure 1 to Paragraph (a) Seat manufacturer Seat type Generic part No. Fischer + Entwicklungen H110 9606-()-()-() H140 0520-()-()-() H160 0718-()-()-()-() 185/410 9507-()-()-() 236/406 9608-()-()-() SICMA Aero Seat or Zodiac Seats France Sicma 192 192xx-xx-xx Sicma 159 1591718-xx 159110 Socea Sogerma ST102 2510102-xx-xx ST107 2010107-xx-xx ST120 2520120-xx Note 1 to Figure 1 to paragraph (a) of this AD:

    “xx” can be any two alphanumeric characters and “()” can be any number of alphanumeric characters.

    (b) Unsafe Condition

    This AD defines the unsafe condition as an object stowed under an energy absorbing seat. This condition could reduce the efficiency of the energy-absorbing function of the seat, resulting in injury to the seat occupants during an accident.

    (c) Effective Date

    This AD becomes effective January 26, 2016.

    (d) Compliance

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

    (e) Required Actions

    Within 110 hours time in service:

    (1) For Model AS332C1, AS332L1, AS332L2, and EC225LP helicopters:

    (i) Inspect the cabin and cockpit for labels, placards, or markings that prohibit stowing anything under the seats in the locations shown in the figure in the Appendix of Airbus Helicopters Alert Service Bulletin No. AS332-01.00.85 (ASB AS332-01.00.85) or No. EC225-04A012 (ASB EC225-04A012), both Revision 0 and dated August 26, 2014, as applicable for your model helicopter.

    (ii) If a label, placard, or marking is not located in every location depicted in the figure in the Appendix or is not visible and legible to every occupant, before further flight, install a placard in accordance with the Accomplishment Instructions, paragraph 3.B., of ASB AS332-01.00.85 or ASB EC225-04A012, as applicable for your model helicopter.

    (2) For Model AS-365N2, AS 365 N3, EC 155B, and EC155B1 helicopters:

    (i) Inspect each seat leg in the cabin and cockpit for labels, placards, or markings that prohibit stowing anything under the seats.

    (ii) If a label, placard, or marking does not exist on one leg of each seat or is not visible and legible, before further flight, install a placard in accordance with the Accomplishment Instructions, paragraph 3.B., and the Appendix of Airbus Helicopters Alert Service Bulletin No. AS365-01.00.66 or No. EC155-04A013, both Revision 0 and dated August 26, 2014, as applicable for your model helicopter.

    (f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs for this AD. Send your proposal to: Robert Grant, Aviation Safety Engineer, Safety Management Group, FAA, 2601 Meacham Blvd., Fort Worth, Texas 76137; telephone (817) 222-5110; email email [email protected]

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

    (g) Additional Information

    The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2014-0204, dated September 11, 2014, and corrected September 12, 2014. You may view the EASA AD on the Internet at http://www.regulations.gov in Docket No. FAA-2015-2714.

    (h) Subject

    Joint Aircraft Service Component (JASC) Code: 1100, Placards and Markings.

    (i) Material Incorporated by Reference

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

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

    (i) Airbus Helicopters Alert Service Bulletin No. AS332-01.00.85, Revision 0, dated August 26, 2014.

    (ii) Airbus Helicopters Alert Service Bulletin No. EC225-04A012, Revision 0, dated August 26, 2014.

    (iii) Airbus Helicopters Alert Service Bulletin No. AS365-01.00.66, Revision 0, dated August 26, 2014.

    (iv) Airbus Helicopters Alert Service Bulletin No. EC155-04A013, Revision 0, dated August 26, 2014.

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

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

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

    Issued in Fort Worth, Texas, on December 11, 2015. Lance T. Gant, Manager, Rotorcraft Directorate, Aircraft Certification Service.
    [FR Doc. 2015-31849 Filed 12-21-15; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-0675; Directorate Identifier 2014-NM-213-AD; Amendment 39-18340; AD 2015-25-02] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for certain Airbus Model A330-200, -200 Freighter, and -300 series airplanes; and all Airbus Model A340-200, -300, -500, and -600 series airplanes. This AD was prompted by reports of cracks at certain frames of the forward cargo door. This AD requires a detailed inspection for cracking of certain forward cargo doors, and repair if necessary. We are issuing this AD to detect and correct cracking at certain frames, which could result in the loss of structural integrity of the forward cargo door.

    DATES:

    This AD becomes effective January 26, 2016.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of January 26, 2016.

    ADDRESSES:

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-0675; or in person at the Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

    For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email [email protected]; Internet http://www.airbus.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-0675.

    FOR FURTHER INFORMATION CONTACT:

    Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149.

    SUPPLEMENTARY INFORMATION: Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Model A330-200, -200 Freighter, and -300 series airplanes; and all Airbus Model A340-200, -300, -500, and -600 series airplanes. The NPRM published in the Federal Register on March 31, 2015 (80 FR 17000). We are issuing this AD to detect and correct cracking at certain frames, which could result in the loss of structural integrity of the forward cargo door.

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0228, dated October 20, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-200, -200 Freighter, and -300 series airplanes; and all Airbus Model A340-200, -300, -500, and -600 series airplanes. The MCAI states:

    An A330 aeroplane operator reported recently cases of crack findings on two different aeroplanes, at frame 20A and at frame 20B close to beam 3 of the forward cargo door. The first finding was detected during scheduled maintenance, while the second one was found during an inspection prompted by the first finding. Subsequent analyses of these cracks identified that the first crack initiated at frame 20B, which is the first primary load path, leading to excessive loads at frame 20A and consequent cracking. Nevertheless, on the other aeroplane, a crack was detected on frame 20A only. Rupture of both frames 20A and 20B could lead to frame 21 failure after a limited number of flight cycles (FC).

    This condition, if not detected and corrected, may potentially result in the loss of structural integrity of the forward cargo door, which could ultimately jeopardise the aeroplane's safe flight.

    Prompted by these findings, Airbus issued Alert Operators Transmission (AOT) A52L010-14 to provide instructions for a one-time inspection of frames 20A, 20B and 21 in the area of beam 3, until the half pitch between beam 2 and beam 3.

    For the reasons described above, this [EASA] AD requires identification of the Part Number (P/N) of the affected forward cargo doors, a one-time detailed inspection (DET) of each affected door and, depending on findings, accomplishment of applicable corrective action(s) [contacting Airbus].

    This [EASA] AD is considered to be an interim action and further AD action may follow.

    Required actions also include sending inspection results to Airbus. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-0675-0002.

    Correction for Service Information Typo

    On page 1 of Airbus AOT A52L010-14, dated September 30, 2014, at section “2. Referenced Documentation,” “Ref. 5” specifies page block “PB.801,” which is incorrect. This page block should be “PB.401” instead. We have added new paragraph (k) to this AD to account for this correction, and have redesignated subsequent paragraphs.

    Comments

    We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 17000, March 31, 2015) and the FAA's response to each comment.

    Request To Revise Part Number List Sequencing

    American Airlines (AA) requested that we revise the proposed AD (80 FR 17000, March 31, 2015) by swapping the part numbers listed in paragraphs (g)(1)(ii) and (g)(1)(x) of the proposed AD to maintain alphanumeric order. American Airlines reasoned that the flow of the list is confusing.

    We agree to revise paragraphs (g)(1)(ii) and (g)(1)(x) of this AD for the reasons requested by American Airlines.

    Request for Justification

    AA asked whether a root cause has been determined that justifies the proposed inspection threshold. AA noted that paragraph (g)(1) of the proposed AD (80 FR 17000, March 31, 2015) proposed that inspections on all affected doors be completed within 200 flight cycles from the effective date of the AD. AA further noted from Airbus AOT A52L010-14, dated September 30, 2014, that the service events that led to the issuance of this inspection occurred on airplanes with 16,170 and 16,556 total accumulated flight cycles. Following release of Airbus AOT A52L010-14, dated September 30, 2014, AA reported that it completed four inspections in accordance with Airbus AOT A52L010-14, dated September 30, 2014, with no findings, and those inspected airplanes had accumulated 8,849 to 9,093 total flight cycles.

    We infer that AA considers the proposed compliance times to be unjustifiably short. We disagree to revise the compliance times in this AD. At the time of issuance of EASA AD 2014-0228, dated October 20, 2014, it had been determined that fatigue calculations were showing low life factors at frame C20B. After a failure of frame C20B, the edge member C20A would be overloaded and could potentially fail within 800 flight cycles, according to damage tolerance calculations. The failure of the tow frame would be catastrophic. Therefore the decision was made to mandate a one-time inspection with a compliance time of within 200 flight cycles after the effective date of this AD, which corresponds to the compliance time specified in EASA AD 2014-0228, dated October 20, 2014. We have made no changes to this AD in this regard.

    Request for Credit for Reporting

    AA requested that we revise paragraph (i)(2) of the proposed AD (80 FR 17000, March 31, 2015) to allow credit for reporting that has already been accomplished before the effective date of this AD. AA explained that the proposed AD would require operators to submit a report within 30 days after the AD effective date if the inspection was done before the effective date of the AD. AA reasoned that this does not allow for credit to be taken for reports that were submitted in accordance with Airbus AOT A52L010-14, dated September 30, 2014, prior to the AD effective date. AA requested that paragraph (i)(2) of the proposed AD state, “[i]f the inspection was done before the effective date of this AD: Submit the report within 30 days after the effective date of this AD, unless the inspection report was previously submitted.”

    We agree to allow credit for reporting that has already been accomplished before the effective date of this AD. The compliance time in paragraph (i)(2) of this AD is within 30 days after the effective date of this AD. Reports submitted before that compliance time, including those submitted before the effective date of this AD (as specified in paragraph (f) of this AD), are acceptable for compliance with paragraph (i)(2) of this AD. We have made no changes to this AD in this regard.

    Request To Revise Applicability

    Delta requested that we limit the applicability of the proposed AD to airplanes equipped with any of the forward cargo doors with the manufacturer part numbers (MPNs) listed in paragraphs (g)(1)(i) through (g)(1)(xii) of the proposed AD. Delta noted that paragraphs (c)(1) and (c)(2) of the proposed AD would apply to the identified airplane models, unless Modification 202702 had been embodied in production on certain airplanes.

    Delta stated it had requested clarification from Airbus about the relationship between the MPNs identified in paragraphs (g)(1)(i) through (g)(1)(xii) of the proposed AD and airplanes in the pre-Mod 50528 configuration, as specified in Airbus AOT A52L010-14, dated September 30, 2014. According to Delta, Airbus confirmed via Airbus Message 80036162, dated April 1, 2015, that because cargo doors are components and can be swapped during in-service life, Airbus had intentionally extended the affected airplanes for the required inspections to include pre-Mod 202702 airplanes that may have affected doors. Delta then reasoned that since operators can track the modification status only by the individual airplane, the applicability should be written to include the MPNs to ensure that operators understand which airplanes are affected by the AD.

    We disagree with the request to limit the applicability of this AD (paragraph (c) of this AD) to airplanes having the MPNs identified in paragraphs (g)(1)(i) through (g)(1)(xii) of this AD. The “Parts Installation Prohibition” specified in paragraph (j) of this AD applies to all airplanes identified in the paragraph (c) of this AD to ensure the affected MPNs are not installed on those airplanes. However, the inspection required by paragraph (g) of this AD is limited to airplanes having the affected MPNs. We have therefore made no changes to this AD in this regard.

    Request To Revise Cost

    Delta requested that we revise the “Costs of Compliance” paragraph in the NPRM (80 FR 17000, March 31, 2015) to state, “However, Airbus has confirmed that out of qty (260) affected MPN Fwd cargo doors inspected, all were reported with NIL [no findings] findings.” Delta agreed that there is no way of determining the number of aircraft that might need the corrective actions for inspection findings, but added that the compliance window of 200 flight cycles for the inspection is a fairly short compliance window and may likely need to be accomplished in a line environment. Delta expressed that it may be prudent to communicate to operators that out of a quantity of 260 forward cargo doors already inspected, there have been NIL findings (as noted in Airbus Message 80036162, dated April 1, 2015).

    We agree with Delta's request and have revised the “Costs of Compliance” paragraph accordingly in this final rule.

    Request for Records Review

    Delta requested that we revise paragraph (g)(1) of the proposed AD (80 FR 17000, March 31, 2015) to allow for a records review if the part number can be conclusively determined from that review. Delta reasoned that without this provision, the operators may consider a physical review of each forward cargo door to be required.

    For the reason stated by Delta, we agree to allow for a review of airplane maintenance records to verify whether cargo doors with part numbers listed in paragraphs (g)(1)(i) through (g)(1)(xii) of this AD are installed on the airplane. We have revised paragraph (g)(1) of this AD accordingly.

    Conclusion

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

    • Are consistent with the intent that was proposed in the NPRM (80 FR 17000, March 31, 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 17000, March 31, 2015).

    We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

    Related Service Information Under 1 CFR Part 51 C

    Airbus has issued AOT A52L010-14, dated September 30, 2014. The service information describes procedures for an inspection for and repair of cracking of certain forward cargo doors. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    Costs of Compliance

    We estimate that this AD affects 89 airplanes of U.S. registry.

    We also estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost $0 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $7,565, or $85 per product.

    In addition, we estimate that any necessary follow-on actions will take about 32 work-hours and require parts costing $654,850, for a cost of $657,570 per product. We have no way of determining the number of airplanes that might need these actions. However, Airbus has confirmed that out of 260 affected MPN forward cargo doors already inspected, all were reported with NIL findings; therefore, we anticipate that few, if any, airplanes will require these follow-on 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 that this AD:

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-0675; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2015-25-02 Airbus: Amendment 39-18340. Docket No. FAA-2015-0675; Directorate Identifier 2014-NM-213-AD. (a) Effective Date

    This AD becomes effective January 26, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to the airplanes identified in paragraphs (c)(1) and (c)(2) of this AD, certificated in any category.

    (1) Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes, all manufacturer serial numbers, except those on which Airbus Modification 202702 has been embodied in production.

    (2) Airbus Model A340-211, -212, -213, -311, -312, -313, -541, and -642 airplanes, all manufacturer serial numbers.

    (d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

    (e) Reason

    This AD was prompted by reports of cracks at certain frames of the forward cargo door. We are issuing this AD to detect and correct cracking at certain frames, which could result in the loss of structural integrity of the forward cargo door.

    (f) Compliance

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

    (g) Inspection and Repair

    (1) Within 200 flight cycles after the effective date of this AD, do a detailed inspection for cracking of an affected forward cargo door, having a part number identified in paragraphs (g)(1)(i) through (g)(1)(xii) of this AD, at frames 20A, 20B, and 21 areas located above beam 3, from outside and inside, in accordance with Airbus Alert Operators Transmission (AOT) A52L010-14, dated September 30, 2014, except as required by paragraph (k) of this AD. A review of airplane maintenance records is acceptable to determine if an affected forward cargo door is installed provided that the part number of the forward cargo door can be conclusively determined from that review.

    (i) F523-70500-000.

    (ii) F523-70500-004.

    (iii) F523-70500-006.

    (iv) F523-70500-008.

    (v) F523-70500-010.

    (vi) F523-70500-012.

    (vii) F523-70500-014.

    (viii) F523-70550-000.

    (ix) F523-70550-002.

    (x) F523-70550-004.

    (xi) F523-70550-008.

    (xii) F523-70550-050.

    (2) If any crack is found during the inspection required by paragraph (g)(1) of this AD, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).

    (h) Definition of Detailed Inspection

    For the purposes of this AD, a detailed inspection is an intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at an intensity deemed appropriate. Inspection aids such as a mirror, magnifying lenses, etc., may be necessary. Surface cleaning and elaborate procedures may be required.

    (i) Reporting Requirement

    Submit a report of the findings (both positive and negative) of the inspection required by paragraph (g)(1) of this AD to Serge KIYMAZ, Structure Engineer, Structure Engineering—SEES1 CUSTOMER SERVICES, Phone: +33(0)5 82 05 10 33, Fax: +33(0)5 61 93 36 14, email: [email protected], at the applicable time specified in paragraph (i)(1) or (i)(2) of this AD. The report must include the information identified in Airbus AOT A52L010-14, dated September 30, 2014.

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

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

    (j) Parts Installation Limitation

    As of the effective date of this AD, installation of a forward cargo door having any part number specified in paragraphs (g)(1)(i) through (g)(1)(xii) of this AD is permitted on any airplane, provided that prior to installation, the door is inspected and, depending on the findings, corrected, in accordance with Airbus AOT A52L010-14, dated September 30, 2014, except as required by paragraph (k) of this AD.

    (k) Exception to the Service Information

    On page 1 of Airbus AOT A52L010-14, dated September 30, 2014, at section “2. Referenced Documentation,” “Ref. 5” specifies page block “PB.801,” which is incorrect. This page block should be “PB.401” instead.

    (l) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM 116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

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

    (3) Reporting Requirements: A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately 5 minutes per response, including the time for reviewing instructions, completing and reviewing the collection of information. All responses to this collection of information are mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn: Information Collection Clearance Officer, AES 200.

    (m) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0228, dated October 20, 2014, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-0675-0002.

    (n) Material Incorporated by Reference

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

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

    (i) Airbus Alert Operators Transmission A52L010-14, dated September 30, 2014.

    (ii) Reserved.

    (3) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email [email protected]; Internet http://www.airbus.com.

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

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

    Issued in Renton, Washington, on November 25, 2015. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2015-30820 Filed 12-21-15; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 73 [Docket No. FAA-2015-7213; Airspace Docket No. 15-ASO-12] RIN 2120-AA66 Amendment of Restricted Areas R-2932, R-2933, R-2934 and R-2935; Cape Canaveral, FL AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This action updates the using agency information for restricted areas R-2932, R-2933, R-2934 and R-2935; Cape Canaveral, FL. This is an administrative change to reflect the current organization tasked with using agency responsibilities for the restricted areas. It does not affect the boundaries, designated altitudes, time of designation or activities conducted within the restricted areas.

    DATES:

    Effective date: 0901 UTC, March 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.

    This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it updates the using agency for restricted areas R-2932, R-2933, R-2934 and R-2935; Cape Canaveral, FL to reflect the current organization responsible for the restricted areas.

    The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR) part 73 by updating the using agency name for restricted areas R-2932, R-2933, R-2934 and R-2935; Cape Canaveral, FL, to Commander, 45th Space Wing, Patrick AFB, FL. The name change reflects the current organization assigned using agency responsibilities for the restricted areas. This is an administrative change that does not affect the boundaries, designated altitudes, or activities conducted within the restricted areas; therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.

    Regulatory Notices and Analyses

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

    Environmental Review

    The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5.d. This airspace action is an administrative change to the description of restricted areas R-2932, R-2933, R-2934 and R-2935; Cape Canaveral, FL, to update the using agency name. It does not alter the dimensions, altitudes, time of designation, or use of the airspace; therefore, it is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exists that warrant preparation of an environmental assessment.

    List of Subjects in 14 CFR Part 73

    Airspace, Prohibited areas, Restricted areas.

    Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 73, as follows:

    PART 73—SPECIAL USE AIRSPACE 1. The authority citation for part 73 continues to read as follows: Authority:

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

    § 73.29 [Amended]
    2. § 73.29 is amended as follows: R-2932 Cape Canaveral, FL [Amended]

    By removing the words “Using agency. Commander, 1st Range Operations Squadron, Cape Canaveral AFS, FL” and inserting in their place “Using agency. Commander, 45th Space Wing, Patrick AFB, FL.”

    R-2933 Cape Canaveral, FL [Amended]

    By removing the words “Using agency. Commander, 1st Range Operations Squadron, Cape Canaveral AFS, FL” and inserting in their place “Using agency. Commander, 45th Space Wing, Patrick AFB, FL.”

    R-2934 Cape Canaveral, FL [Amended]

    By removing the words “Using agency. Commander, 1st Range Operations Squadron, Cape Canaveral AFS, FL” and inserting in their place “Using agency. Commander, 45th Space Wing, Patrick AFB, FL.”

    R-2935 Cape Canaveral, FL [Amended]

    By removing the words “Using agency. Commander, 1st Range Operations Squadron, Cape Canaveral AFS, FL” and inserting in their place “Using agency. Commander, 45th Space Wing, Patrick AFB, FL.”

    Issued in Washington, DC, on December 14, 2015. Leslie M. Swann, Acting Manager, Airspace Policy Group.
    [FR Doc. 2015-32159 Filed 12-21-15; 8:45 am] BILLING CODE 4910-13-P
    SECURITIES AND EXCHANGE COMMISSION 17 CFR Parts 200, 227, 232, 239, 240, 249, 269, and 274 [Release Nos. 33-9974A; 34-76324A; File No. S7-09-13] RIN 3235-AL37 Crowdfunding; Correction AGENCY:

    Securities and Exchange Commission.

    ACTION:

    Final rule; correction.

    SUMMARY:

    The Securities and Exchange Commission published in the Federal Register of November 16, 2015, the final rule, Regulation Crowdfunding, under the Securities Act of 1933 and the Securities Exchange Act of 1934 to implement the requirements of Title III of the Jumpstart Our Business Startups Act of 2012. The effective date for subpart U, which adds Form Funding Portal, was inadvertently omitted in the DATES section of the Federal Register. This correction adds the effective date for subpart U, Form Funding Portal.

    DATES:

    Effective December 22, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Timothy White or Erin Galipeau, Division of Trading and Markets, at (202) 551-5550, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549.

    SUPPLEMENTARY INFORMATION: Correction

    In rule FR Doc. 2015-28220 published on November 16, 2015, (80 FR 71388) make the following correction:

    On page 71388, in the first column, the DATES section is revised to read as follows:

    DATES: The final rules and forms are effective May 16, 2016, except for instruction 3 adding part 227, instruction 12 adding subpart U to part 249, and instruction 15 amending Form ID, which are effective January 29, 2016.”

    Dated: December 17, 2015. Brent J. Fields, Secretary.
    [FR Doc. 2015-32106 Filed 12-21-15; 8:45 am] BILLING CODE 8011-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2015-N-0002] New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot cattle. This supplemental approval reflects FDA's effectiveness conclusions that relied on the National Academy of Sciences/National Research Council Drug Efficacy Study Group's evaluation of the effectiveness of this drug as well indications for use not subject to this review.

    DATES:

    This rule is effective December 22, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Matthew Lucia, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0589, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of August 8, 2003 (68 FR 47332), as corrected October 7, 2003 (68 FR 57911), as part of the Drug Efficacy Study Implementation (DESI) program, the Center for Veterinary Medicine (CVM) announced the effective conditions of use for several drug products and use combinations that were listed in 21 CFR 558.15. CVM proposed to withdraw the NADAs for those products or use combinations lacking substantial evidence of effectiveness following a 90-day opportunity to supplement the NADAs with labeling conforming to the relevant findings of effectiveness.

    In response to that notice of opportunity for a hearing (NOOH), Pennfield Oil Co. (Pennfield), 14040 Industrial Rd., Omaha, NE 68144, filed a hearing request for its approved, non-DESI finalized NADA 141-137 for a bacitracin methylenedisalicylate Type A medicated article.

    In March 2015, Pennfield transferred sponsorship of NADA 141-137 to Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 28405 (Pharmgate) (80 FR 13226, March 13, 2015). Subsequently, Pharmgate filed a supplement to NADA 141-137 for PENNITRACIN MD 50G (bacitracin Type A medicated article) with labeling conforming to the findings of effectiveness in the 2003 NOOH. In addition, the submitted labeling included indications for use approved by FDA that were not subject to DESI findings of effectiveness (34 FR 7906, May 20, 1969).

    The supplemental NADA provides for use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for several production and therapeutic indications in broiler and replacement chickens, growing turkeys, growing pheasants, growing quail, and beef steers and heifers fed in confinement for slaughter. The supplemental NADA is approved as of October 6, 2015, and the regulations are amended in 21 CFR 558.76 to reflect the approval. Pharmgate, as successor to Pennfield, has since withdrawn the hearing request for NADA 141-137.

    Approval of this supplemental NADA did not require review of any new safety or effectiveness data. Therefore, a freedom of information summary was not prepared.

    The DESI evaluation was concerned only with the effectiveness of the drug products and use combinations. Nothing in this document constitutes a bar to further proceedings with respect to questions of safety of the subject drugs in treated animals or of the drugs or their metabolites in food products derived from treated animals.

    Products that comply with FDA's findings of effectiveness are eligible for copying, as described in the “Generic Animal Drug and Patent Term Restoration Act; Eighth Policy Letter,” August 21, 1991 (56 FR 41561). Accordingly, sponsors may now obtain approval of abbreviated NADAs for this Type A medicated article.

    The Agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

    List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows:

    PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: Authority:

    21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

    2. Amend § 558.76 as follows: a. Revise the section heading and paragraph (a); b. Redesignate paragraphs (b), (c), and (d) as paragraphs (c), (d), and (e); c. Add new paragraph (b); and d. Revise newly redesignated paragraph (e)(1).

    The revisions and addition read as follows:

    § 558.76 Bacitracin methylenedisalicylate.

    (a) Specifications. (1) Type A medicated articles containing 10, 25, 30, 40, 50, 60, or 75 grams bacitracin methylenedisalicylate per pound.

    (2) Type A medicated article containing 50 grams bacitracin methylenedisalicylate per pound.

    (b) Sponsors. See sponsors in § 510.600(c) of this chapter:

    (1) No. 054771 for use of products in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(iii), (e)(1)(v) through (xiii), and (e)(1)(xv) of this section.

    (2) No. 069254 for use of products in paragraph (a)(2) of this section as in paragraphs (e)(1)(ii), (e)(1)(iv), (e)(1)(xiv), and (e)(1)(xvi) of this section.

    (e) * * *

    (1) It is used as follows:

    Bacitracin methylenedisalicylate amount Combination in grams per ton
  • (g/ton)
  • Indications for use Limitations Sponsor
    (i) 4 to 50 g/ton Chickens, turkeys, and pheasants: For increased rate of weight gain and improved feed efficiency 054771 (ii) 4 to 50 g/ton Broiler and replacement chickens, growing turkeys, and growing pheasants: For increased rate of weight gain and improved feed efficiency 069254 (iii) 5 to 20 g/ton Quail not over 5 weeks of age: For increased rate of weight gain and improved feed efficiency 054771 (iv) 5 to 20 g/ton Growing quail: For increased rate of weight gain and improved feed efficiency For use in quail not over 5 weeks of age 069254 (v) 10 to 25 g/ton Chickens: For increased egg production and improved feed efficiency for egg production For first 7 months of production 054771 (vi) 10 to 30 g/ton Swine: For increased rate of weight gain and improved feed efficiency For growing and finishing swine 054771 (vii) 10 to 30 g/ton Chlortetracycline approximately 400, varying with body weight and food consumption to provide 10 milligrams (mg) per pound of body weight per day Swine: For increased rate of weight gain and improved feed efficiency; for treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline Feed for not more than 14 days; bacitracin methylenedisalicylate provided by No. 054771; chlortetracycline provided by Nos. 054771 and 069254 in § 510.600(c) of this chapter 054771
  • 069254
  • (viii) 10 to 30 g/ton Swine: For control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline Feed for not more than 14 days; chlortetracycline and bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (ix) 50 g/ton Broiler chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens: As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin Feed continuously as sole ration 054771 (x) 100 to 200 g/ton Broiler chickens: As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Replacement chickens: As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin Feed continuously as sole ration. Start at first clinical signs of disease, vary dosage based on severity of infection, administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce medication to prevention level (50 g/ton) 054771 (xi) 200 g/ton Turkeys: As an aid in the control of transmissible enteritis in growing turkeys complicated by organisms susceptible to bacitracin methylenedisalicylate. Quail: For the prevention of ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylenedisalicylate Feed continuously as the sole ration 054771 (xii) 250 g/ton 1. Growing/finishing swine: For control of swine dysentery Treponema hyodysenteriae on premises with history of swine dysentery but where signs of the disease have not yet occurred; or following an approved treatment of the disease condition As the sole ration. Not for use in swine weighing more than 250 pounds. Diagnosis should be confirmed by a veterinarian a when results are not satisfactory 054771 2. Pregnant sows: For control of clostridial enteritis caused by C. perfringens in suckling piglets As the sole ration. Feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. Diagnosis should be confirmed by veterinarian when results are not satisfactory (xiii) To provide 70 mg per head per day Feedlot beef cattle: For reduction in the number of liver condemnations due to abscesses Administer continuously throughout the feeding period 054771 (xiv) To provide 70 mg per head per day Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses Administer continuously throughout the feeding period 069254 (xv) To provide 250 mg per head per day Feedlot beef cattle: For reduction in the number of liver condemnations due to abscesses Administer continuously for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period 054771 (xvi) To provide 250 mg per head per day Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses Administer continuously for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period 069254
    Dated: December 16, 2015. Bernadette Dunham, Director, Center for Veterinary Medicine.
    [FR Doc. 2015-32000 Filed 12-21-15; 8:45 am] BILLING CODE 4164-01-P
    PENSION BENEFIT GUARANTY CORPORATION 29 CFR Part 4044 Allocation of Assets in Single-Employer Plans; Interest Assumptions for Valuing Benefits AGENCY:

    Pension Benefit Guaranty Corporation.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule amends the Pension Benefit Guaranty Corporation's regulation on Allocation of Assets in Single-Employer Plans to prescribe interest assumptions under the asset allocation regulation for valuation dates in the first quarter of 2016. The interest assumptions are used for valuing benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC. As discussed below, PBGC has published a separate final rule document dealing with interest assumptions under its regulation on Benefits Payable in Terminated Single-Employer Plans for January 2016.

    DATES:

    Effective January 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Catherine B. Klion ([email protected]), Assistant General Counsel for Regulatory Affairs, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street NW., Washington, DC 20005, 202-326-4024. (TTY/TDD users may call the Federal relay service toll free at 1-800-877-8339 and ask to be connected to 202-326-4024.)

    SUPPLEMENTARY INFORMATION:

    PBGC's regulation on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) prescribes actuarial assumptions—including interest assumptions—for valuing plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulation are also published on PBGC's Web site (http://www.pbgc.gov).

    The interest assumptions in Appendix B to Part 4044 are used to value benefits for allocation purposes under ERISA section 4044. Assumptions under the asset allocation regulation are updated quarterly and are intended to reflect current conditions in the financial and annuity markets. This final rule updates the asset allocation interest assumptions for the first quarter (January through March) of 2016.

    The first quarter 2016 interest assumptions under the allocation regulation will be 2.82 percent for the first 20 years following the valuation date and 2.95 percent thereafter. In comparison with the interest assumptions in effect for the fourth quarter of 2015, these interest assumptions represent no change in the select period (the period during which the select rate (the initial rate) applies), an increase of 0.36 percent in the select rate, and a decrease of 0.03 percent in the ultimate rate (the final rate).

    PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

    Because of the need to provide immediate guidance for the valuation of benefits under plans with valuation dates during the first quarter of 2016, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

    PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

    Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

    List of Subjects in 29 CFR Part 4044

    Employee benefit plans, Pension insurance, Pensions.

    In consideration of the foregoing, 29 CFR part 4044 is amended as follows:

    PART 4044—ALLOCATION OF ASSETS IN SINGLE-EMPLOYER PLANS 1. The authority citation for part 4044 continues to read as follows: Authority:

    29 U.S.C. 1301(a), 1302(b)(3), 1341, 1344, 1362.

    2. In appendix B to part 4044, a new entry for January-March 2016, as set forth below, is added to the table. Appendix B to Part 4044—Interest Rates Used to Value Benefits For valuation dates occurring in the month— The values of i t are: i t for t = i t for t = i t for t = *         *         *         *         *         *         * January-March 2016 0.0282 1-20 0.0295 >20 N/A N/A Issued in Washington, DC, on this 17th day of December, 2015. Judith Starr, General Counsel, Pension Benefit Guaranty Corporation.
    [FR Doc. 2015-32225 Filed 12-21-15; 8:45 am] BILLING CODE 7709-02-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2013-0760] RIN 1625-AA11 Regulated Navigation Area; Reporting Requirements for Barges Loaded With Certain Dangerous Cargoes, Inland Rivers, Eighth Coast Guard District; Expiration of Stay (Suspension) and Administrative Changes AGENCY:

    Coast Guard, DHS.

    ACTION:

    Interim rule; request for comments.

    SUMMARY:

    Through this interim rule, the Coast Guard is providing administrative changes to the existing reporting requirements under the Regulated Navigation Area (RNA) applicable to barges loaded with certain dangerous cargoes on the inland rivers in the Eighth District area of responsibility. The current stay of reporting requirements under the RNA is scheduled to expire on December 31, 2015. This interim rule limits the reporting requirements in that rule for an interim period while also requesting comments before proposing or finalizing any long term or permanent revisions to the existing reporting requirements.

    DATES:

    This interim rule is effective beginning January 1, 2016. Comments and related material must be received by the Coast Guard on or before June 20, 2016. See SUPPLEMENTARY INFORMATION for details on enforcement and compliance.

    ADDRESSES:

    The docket for this interim rule and request for comments, [USCG-2013-0760] is available at http://www.regulations.gov. You may submit comments identified by docket number USCG-2013-0760 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    For information about this document email the Coast Guard via Shelley R. Miller at [email protected] or Captain Paul E. Dittman at [email protected] or call the Coast Guard at 504-671-2330.

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CDC Certain Dangerous Cargo CFR Code of Federal Regulations DHS Department of Homeland Security E.O. Executive order FR Federal Register IRVMC Inland River Vessel Movement Center NOI Notice of intent NPRM Notice of proposed rulemaking Pub. L. Public Law RNA Regulated navigation area U.S.C. United States Code II. Background Information and Regulatory History

    The reporting requirements under 33 CFR 165.830, “Regulated Navigation Area; Reporting Requirements for Barges Loaded with Certain Dangerous Cargoes, Inland Rivers, Eighth Coast Guard District,” were initially suspended (“stayed”) in January 2011 due to the expiration of the contract for the Inland River Vessel Movement Center (IRVMC). The IRVMC was the Coast Guard office responsible for collecting the information required by the regulated navigation area (RNA) at § 165.830. Upon expiration of the contract for the IRVMC, the Coast Guard was not able to receive and process reports. Therefore, the suspension of reporting requirements was published in the Federal Register on January 10, 2011 and was due to expire on January 15, 2013 (76 FR 1360). On January 2, 2013 the Coast Guard extended the suspension through September 30, 2013 (78 FR 25) and on October 1, 2013 the Coast Guard extended the suspension once again through December 31, 2015 (78 FR 60216).

    In January 2015 the Coast Guard published a final rule, titled Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System (80 FR 5282). This rule implemented new and updated Notices of Arrival (NOA) reporting requirements under 33 CFR 160 Subpart C, providing an exemption, at 33 CFR 160.204(a)(3), for any vessel required to report movements, its cargo, or the cargo in barges it is towing under 33 CFR 165.830 after December 31, 2015. This rule, which was initially proposed in 2008 before the RNA reporting requirements were suspended, relied on the existing reporting requirements at 33 CFR 165.830 to support the exemption. Starting on January 1, 2016, a vessel would only be eligible for the exemption if it is required to report its movements or cargo as specified in § 160.204(a)(3).

    On November 24, 2015, the Coast Guard published a notice of intent (NOI) informing the public that the stay would expire on December 31, 2015, and that reporting would resume in a limited form (80 FR 73156). This rule makes changes to limit the suspended reporting requirements, which would otherwise come into effect in full on January 1, 2016.

    Also relevant to this interim rule and request for comments is the portion of the January 2015 rule requiring that all vessels engaged in the movement of Certain Dangerous Cargos (CDC) have Class A Automatic Information System (AIS) beginning in March 2016, pending Office of Management and Budget (OMB) approval of a collection of information associated with that regulatory requirement. These AIS requirements provided under 33 CFR 164.46, if enforced, may provide an alternative method of reporting that could potentially satisfy the requirements under 33 CFR 165.830 and qualify these vessels for the 33 CFR 160.204(a)(3) exemption. As indicated in the Federal Register publications establishing and extending the RNA suspension, during the suspension periods, the Coast Guard assessed potentially modifying the reporting required under the RNA and potential suitable alternative Coast Guard offices and programs to receive and disseminate the reported information. The new AIS requirement, once in full effect, will still be assessed as a potential alternative reporting method. At this time, the Coast Guard has determined that using already-established Coast Guard offices and units centralized at the Eighth District level to receive required reports is the appropriate interim solution to resume the reporting requirements necessary for both maritime domain awareness and to satisfy the exemption in 33 CFR 160.204(a)(3). This interim rule provides the necessary administrative changes to the existing reporting requirements, requiring reporting in a limited form while also requesting comments to better assess a potential permanent reporting system.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this interim rule to limit the RNA reporting requirements that will come into effect after December 31 when the stay of § 165.830 expires. This rule is necessary to stay compliance with certain provisions of the existing rule, and to make administrative changes replacing the references to IRVMC, which is no longer operational. The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231, the same authority providing for the initial establishment of the RNA.

    The Coast Guard is issuing this interim rule without prior opportunity to comment, pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule for several reasons. It is unnecessary to publish an NPRM because this interim rule makes only administrative changes to the existing RNA regulation under 33 CFR 165.830, and does not propose or establish new restrictions or requirements. This interim rule merely stays compliance with portions of an existing requirement, allowing select existing provisions to resume upon expiration of a stay in effect through December 31, 2015 and makes the administrative changes necessary to redirect reporting from the IRVMC to the District. Additionally, publishing an NPRM was impracticable because of the relatively short time between the publication of the NOA final rule and the expiration of the stay, as well as the uncertain enforcement date of certain provisions of the AIS portion of that rule. These circumstances did not allow adequate time to develop an NPRM, solicit and consider public comment, and develop and publish a final rule before the expiration of the stay. Instead, the Coast Guard is soliciting public comment with this interim rule while it is in effect and while the AIS requirement will be in effect, if that information collection is approved by OMB, so that the public's experience with this interim rule and the AIS requirement can be reflected in public comments.

    This interim rule is effective January 1, 2016. We forgo the 30-day delay in effective date, under the authority of 5 U.S.C. 553(d)(1) to the extent it relieves the reporting obligations that would otherwise come into effect upon the December 31, 2015 expiration of the stay, and under 5 U.S.C. 553(d)(3) because the Coast Guard finds that the imminent expiration of the stay constitutes good cause for forgoing the 30-day delay of effective date. The Coast Guard published a NOI on November 24, 2015 informing the public that it intended to allow the stay suspending reporting requirements under this RNA to expire on December 31, 2015 as published, and that reporting would resume in a limited form upon such expiration. Delaying the effective date of this interim rule to provide a 30 day notice—in addition to the notice provided by the NOI—would be impracticable and contrary to public interest because a January 1, 2016, effective date is necessary to avoid submission of reports to the IRVMC which is no longer in operation.

    IV. Discussion of the Interim Rule

    The Coast Guard's suspension of reporting requirements under 33 CFR 165.830 will expire as scheduled, in part, on December 31, 2015. On January 1, 2016, reporting requirements under 33 CFR 165.830 will become effective in a limited form. The Coast Guard is not reinstating reporting, 24 hours per day, 365 days per year, at 90-plus reporting points under the existing RNA currently published in the CFR. Under revisions made by this interim rule, reporting requirements will be enforced only when directed by the District Commander or a designated representative. This rule does not change the type of information to be reported.

    This interim rule makes administrative changes that remove or revise references to the IRVMC, as it is no longer operational, and replace them with the new Coast Guard office, the Eighth District CDC Reporting Unit (D8 CDCRU), which when activated will be responsible for collecting reported information. The entities required to report, and the information required, remain the same. However, reporting is required only as directed by the District Commander or a designated representative, based on assessment of prevailing safety and security conditions to ensure and enhance maritime domain awareness. In effect, the Coast Guard is allowing existing paragraphs (d)(1)(ix), (d)(2)(iv), (f)(9), and (g)(4) to come into effect, with administrative changes to accommodate the closure of IRVMC. We will continue to use the reporting points listed in paragraph (e) to describe where reporting is required. This rule “stays” (suspends) compliance with the other existing reporting requirements.

    The District Commander or designated representative will inform vessel operators and fleeting facilities when and where reporting is required, by using established coordination and communication mechanisms already in place and which are used to alert these same vessel operators and fleeting facilities of an increase in Maritime Security level. These notice mechanisms include, but are not limited to, coordination with industry trade organizations, Notices of Enforcement, Marine Safety Information Bulletins, and email notifications.

    Reports required under this RNA may be provided via email at [email protected]mil. Alternative reporting contact methods, including telephone and fax numbers, will be provided in the notification from the District Commander or designated representative. Additionally, paragraph (h) allows for alternative methods to be submitted for approval by the District Commander. These are the same type of reporting methods listed in the current RNA at 33 CFR 165.830(d)(4), however there will not be a dedicated web link. The information required to be reported, is not changed by this interim rule.

    The Coast Guard chose to suspend, rather than remove, several paragraphs of the existing rule in order to evaluate their necessity and to retain the ability to reinstate them (using appropriate administrative processes) if necessary. All public comments are welcome, but we specifically solicit comment on the following: The appropriate type and frequency of reporting related to CDC barges in D8; the potential to use AIS to satisfy reporting goals; and the extent to which complying with the AIS rule would render this rule unnecessary.

    V. Regulatory Analyses

    We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.

    A. Regulatory Planning and Review

    E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

    No new requirements are established or imposed by this rule. This interim rule suspends compliance with certain provisions of an existing regulation that will come into effect when the current stay expires on December 31, 2015 thereby continuing to relieve a reporting obligation while the Coast Guard solicits public comment regarding appropriate reporting. As a result, the currently-stayed requirement will resume only in a limited form. The rule also makes administrative changes affecting which Coast Guard entity directs and receives reporting. None of these changes will have a significant impact on regulated entities.

    B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels intending to transit the RNA may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

    Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

    C. Collection of Information

    This rule does not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The existing collection is approved by the Office of Management and Budget under OMB control number 1625-0105.

    D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.

    Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

    E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

    F. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves administrative changes to resuming reporting requirements in a limited form under an established RNA. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. This interim rule limits the existing, suspended, 24 hours a day, 7 days a week, 365 days a year reporting requirement throughout the entire RNA to require reporting only when and where directed by the District Commander, reducing the time frame and area that the reporting requirements are enforced. An environmental analysis checklist and categorical exclusion determination are not required. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

    G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

    VI. Public Participation and Request for Comments

    We view public participation as essential, and will consider all comments and material received during the comment period. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

    We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

    We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

    Documents mentioned in this interim rule as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or additional publications or supplemental information is provided.

    List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, and Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

    PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

    2. In § 165.830: a. Revise paragraph (b); b. In paragraph (c), remove the words “Inland River Vessel Movement Center or (IRVMC)” and add in their place the words “Eighth District CDC Reporting Unit or (D8 CDCRU)”; c. In paragraph (d) introductory text, remove the words “Inland River Vessel Movement Center (IRVMC)” and add in their place the words “Eighth District CDC Reporting Unit Eighth District (D8 CDCRU)”; d. In paragraphs (d)(1) introductory text and (d)(1)(ii), remove the text “IRVMC” and add, in its place, the text “D8 CDCRU”; e. In paragraph (d)(1)(ix), remove the text “IRVMC” and add in its place the text “District Commander or designated representative”; f. In paragraph (d)(2) introductory text, remove the text “IRVMC” and add in its place the text “D8 CDCRU”; g. In paragraph (d)(2)(iv), remove the text “IRVMC” and add in its place the text “District Commander or designated representative”; h. Revise paragraph (d)(4). i. In paragraphs (e), (f) introductory text, and (g) introductory text and the headings to tables 165.830(f) and 165.830(g), remove the text “IRVMC” and add in its place the text “D8 CDCRU”; j. In paragraphs (f)(9) and (g)(4), remove the text “IRVMC” and add in its place the text “District Commander or designated representative”; k. In paragraph (i), remove the text “the IRVMC” and add in its place the text “designated representative”; and l. Amend § 165.830 by removing all other occurrences of the text “IRVMC” and adding, in its place, the text “D8 CDCRU”.

    The revisions read as follows:

    § 165.830 Regulated Navigation Area; Reporting Requirements for Barges Loaded with Certain Dangerous Cargoes, Inland Rivers, Eight Coast Guard District.

    (b) Enforcement and applicability. (1) Beginning January 1, 2016, reporting requirements under this RNA will be enforced only when directed by the District Commander or designated representative under paragraphs (d)(1)(ix), (d)(2)(iv), (f)(9), and (g)(4) of this section. Reporting points as listed in paragraph (e) of this section may be used to determine and inform where reporting is required. Compliance under other parts of this section is stayed until a future date published in the Federal Register, if determined necessary.

    (2) This section applies to towing vessel operators and fleeting area managers responsible for CDC barges in the RNA. This section does not apply to:

    (i) Towing vessel operators responsible for barges not carrying CDCs barges, or

    (ii) Fleet tow boats moving one or more CDC barges within a fleeting area.

    (d) * * *

    (4) When required, reports under this section must be made either by email at [email protected] or via phone or fax as provided in the notification as directed by the District Commander or designated representative through the D8 CDCRU. Notification of when and where reporting is required may be made through Marine Safety Information Bulletins, Notices of Enforcement, email and/or through industry outreach. At all other times, reporting under this section is not required and communications should be directed to the Captain of the Port.

    Dated: December 8, 2015. D.R. Callahan, Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
    [FR Doc. 2015-32135 Filed 12-21-15; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2015-1088] RIN 1625-AA00 Safety Zone; Pleasure Beach Bridge, Bridgeport, CT. AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone within the Coast Guard Sector Long Island Sound (LIS) Captain of the Port (COTP) Zone. This temporary final rule is necessary to provide for the safety of life on navigable waters. Entry into, transit through, mooring or anchoring within the safety zone is prohibited unless authorized by COTP Sector LIS.

    DATES:

    This rule is effective without actual notice from 12:01 a.m. on December 22, 2015 until 12 a.m. on January 01, 2016. For the purposes of enforcement, actual notice will be used from the date the rule was signed, December 10, 2015, until December 22, 2015.

    ADDRESSES:

    Documents mentioned in this preamble are part of docket [USCG-2015-1088]. To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rulemaking. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, contact Lieutenant Junior Grade Martin Betts, Prevention Department, Coast Guard Sector Long Island Sound, telephone (203) 468-4432, email [email protected] If you have questions on viewing or submitting material to the docket, call Cheryl Collins, Program Manager, Docket Operations, telephone (202) 366-9826.

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations COTP Captain of the Port DHS Department of Homeland Security E.O. Executive order FR Federal Register NPRM Notice of Proposed Rulemaking NAD 83 North American Datum 1983 II. Background Information and Regulatory History

    This rulemaking establishes a safety zone for the waters around Pleasure Beach Bridge, Bridgeport, CT. Corresponding regulatory history is discussed below.

    The Coast Guard was made aware of damage sustained to Pleasure Beach Bridge, the result of which created a hazard to navigation.

    The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM with respect to this rule because doing so would be impracticable and contrary to the public interest. There is insufficient time to publish an NPRM and solicit comments from the public before establishing a safety zone to address an existing hazard to navigation. The nature of the navigational hazard requires the immediate establishment of a safety zone. Publishing an NPRM and delaying the effective date of this rule to await public comment inhibits the Coast Guard's ability to fulfill its statutory mission to protect ports, waterways and the maritime public.

    Under 5 U.S.C. 553(d)(3), and for the same reasons stated in the preceding paragraph, the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register.

    III. Legal Authority and Need for Rule

    The legal basis for this temporary rule is 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5 and Department of Homeland Security Delegation No. 0170.1 which collectively authorize the Coast Guard to define regulatory safety zones.

    On December 09, 2015, the Coast Guard was made aware of damage sustained to Pleasure Beach Bridge, Bridgeport, CT that has created a hazard to navigation. The COTP Sector LIS has determined that the safety zone established by this temporary final rule is necessary to provide for the safety of life on navigable waterways.

    IV. Discussion of the Rule

    The safety zone established by this rule will cover all navigable waters of the entrance channel to Johnsons Creek in the vicinity of Pleasure Beach Bridge, Bridgeport, CT. This safety zone will be bound inside an area that starts at a point on land at position 41-10.2N, 073-10.7W and then east along the shoreline to a point on land at position 41-9.57N, 073-9.54W and then south across the channel to a point on land at position 41-9.52N, 073-9.58W and then west along the shoreline to a point on land at position 41-9.52N, 073-10.5W and then north across the channel back to the point of origin.

    This rule prevents vessels from entering, transiting, mooring, or anchoring within the area specifically designated as a safety zone during the period of enforcement unless authorized by the COTP or designated representative.

    The Coast Guard will notify the public and local mariners of this safety zone through appropriate means, which may include, but are not limited to, publication in the Federal Register, the Local Notice to Mariners, and Broadcast Notice to Mariners.

    V. Regulatory Analyses

    We developed this rule after considering numerous statutes and E.O.s related to rulemaking. Below we summarize our analyses based on these statutes and E.O.s and we discuss First Amendment rights of protestors.

    A. Regulatory Planning and Review

    E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget. The Coast Guard determined that this rulemaking is not a significant regulatory action for the following reasons: (1) The enforcement of this safety zone will be relatively short in duration; (2) persons or vessels desiring to enter the safety zone may do so with permission from the COTP Sector LIS or a designated representative; (3) this safety zone is designed in a way to limit impacts on vessel traffic, permitting vessels to navigate in other portions of the waterway not designated as a safety zone; and (4) the Coast Guard will notify the public of the enforcement of this rule via appropriate means, such as via Local Notice to Mariners and Broadcast Notice to Mariners to increase public awareness of this safety zone.

    B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

    This temporary final rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit, anchor, or moor within a safety zone during the period of enforcement, from December 10, 2015 to January 1, 2016. However, this temporary final rule will not have a significant economic impact on a substantial number of small entities for the same reasons discussed in the Regulatory Planning and Review section.

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above.

    Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

    C. Collection of Information

    This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

    D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132. Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

    E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

    F. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This temporary rule involves the establishment of a safety zone. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination, and EA Checklist, WILL BE in the docket for review. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

    G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

    List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record keeping requirements, Security Measures, and Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

    PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for Part 165 continues to read as follows: Authority:

    33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5 and Department of Homeland Security Delegation No. 0170.1

    2. Add § 165.T01-1088 to read as follows:
    § 165.T01-1088 Safety Zone; Pleasure Beach Bridge, Bridgeport, CT.

    (a) Location. The following area is a safety zone: All navigable waters of the entrance channel to Johnsons Creek in the vicinity of Pleasure Beach Bridge, Bridgeport, CT bound inside an area that starts at a point on land at position 41-10.2N, 073-10.7W and then east along the shoreline to a point on land at position 41-9.57N, 073-9.54W and then south across the channel to a point on land at position 41-9.52N, 073-9.58W and then west along the shoreline to a point on land at position 41-9.52N, 073-10.5W and then north across the channel back to the point of origin.

    (b) Enforcement period. This rule will be enforced from 12 p.m. on December 10, 2015, to 12 a.m. on January 1, 2016.

    (c) Definitions. The following definitions apply to this section: A “designated representative” is any Coast Guard commissioned, warrant or petty officer of the U.S. Coast Guard who has been designated by the COTP, Sector Long Island Sound, to act on his or her behalf. The designated representative may be on an official patrol vessel or may be on shore and will communicate with vessels via VHF-FM radio or loudhailer. “Official patrol vessels” may consist of any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement vessels assigned or approved by the COTP Sector Long Island Sound. In addition, members of the Coast Guard Auxiliary may be present to inform vessel operators of this regulation.

    (a) Regulations. (1) The general regulations contained in 33 CFR 165.23 apply.

    (2) In accordance with the general regulations in 33 CFR 165.23, entry into or movement within this zone is prohibited unless authorized by the Captain of the Port, Long Island Sound.

    (3) Operators of vessels desiring to enter or operate within the safety zone should contact the COTP Sector Long Island Sound at 203-468-4401 (Sector LIS command center) or the designated representative via VHF channel 16 to obtain permission to do so.

    (4) Any vessel given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP Sector Long Island Sound, or the designated on-scene representative.

    (5) Upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light or other means, the operator of the vessel shall proceed as directed.

    Dated: December 10, 2015. E.J. Cubanski, III, Captain, U.S. Coast Guard, Captain of the Port Sector Long Island Sound.
    [FR Doc. 2015-32133 Filed 12-21-15; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 17 RIN 2900-AP34 Payment of Emergency Medication by VA AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Final rule.

    SUMMARY:

    The Department of Veterans Affairs (VA) is amending its medical regulations that govern reimbursement of emergency treatment provided by non-VA medical care providers. VA is clarifying its regulations insofar as it involves the reimbursement of medications prescribed or provided to the veteran during the episode of non-VA emergency treatment.

    DATES:

    This regulation is effective January 21, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Kristin J. Cunningham, Director, Business Policy, Chief Business Office (10NB6), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Ave. NW., Washington, DC 20420; (202) 382-2508. (This is not a toll-free number.)

    SUPPLEMENTARY INFORMATION:

    VA is authorized under 38 U.S.C. 1725 to reimburse an eligible veteran (or the provider of the emergency treatment or another person or entity who paid such expenses on the veteran's behalf) for the reasonable value of emergency treatment furnished to the Veteran at a non-VA medical facility. Under 38 U.S.C. 1728, VA is authorized to reimburse eligible veterans (or the provider of the emergency treatment or another person or entity who paid such expenses on the veteran's behalf) for the customary and usual charges of non-VA emergency treatment furnished to the veteran.

    Current VA regulations implementing 38 U.S.C. 1725 and 1728 each state that covered emergency treatment includes “medication, including a short course of medication related to and necessary for the treatment of the emergency condition that is provided directly to the patient for use after the emergency condition is stabilized and the patient is discharged.” See 38 CFR 17.120(b) and 17.1002. It is undisputed that medications directly provided to the veteran or administered to the veteran as part of the emergency treatment are covered. VA has determined that the language “provided directly to the patient” is vague inasmuch as it does not clearly indicate that it also extends to a short course of necessary medication provided to the veteran by way of a prescription that is written or called in to an outpatient or commercial pharmacy by the emergency non-VA provider with instructions to the veteran-patient to obtain and use the medication post-discharge, as directed.

    On July 27, 2015, we proposed to amend §§ 17.120(b) and 17.1002 to address this issue. See 80 FR 44318. We proposed amending § 17.120(b) to clarify that VA reimburses the cost of a short course of medication prescribed for the veteran at the time that the veteran was receiving emergency treatment, by stating that emergency treatment includes “a short course of medication related to and necessary for the treatment of the emergency condition that is provided directly to or prescribed for the patient for use after the emergency condition is stabilized and the patient is discharged.” We proposed making a similar amendment to the introductory paragraph of § 17.1002. The proposed amendments in this rulemaking are consistent with current VA policy and help ensure our regulations are not interpreted more narrowly than VA intends.

    We provided a 60-day comment period, which ended on September 25, 2015. We received 1 comment in support of the proposed rule. Based on the rationale set forth in the Supplementary Information to the proposed rule and in this final rule, VA is adopting the proposed rule as a final rule with no changes.

    Effect of Rulemaking

    Title 38 of the Code of Federal Regulations, as revised by this final rulemaking, represents VA's implementation of its legal authority on this subject. Other than future amendments to this regulation or governing statutes, no contrary guidance or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible or, if not possible, such guidance is superseded by this rulemaking.

    Paperwork Reduction Act

    This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

    Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule directly affects only individuals and will not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604.

    Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” which requires review by the Office of Management and Budget (OMB) unless OMB waives such review, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

    The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's Web site at http://www.va.gov/orpm/, by following the link for VA Regulations Published From FY 2004 Through Fiscal Year to Date.

    Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.

    Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans Dental Care; 64.012, Veterans Prescription Service; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 64.022, Veterans Home Based Primary Care; and 64.024, VA Homeless Providers Grant and Per Diem Program.

    Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Nabors II, Chief of Staff, Department of Veterans Affairs, approved this document on December 16, 2015, for publication.

    List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Foreign relations, Government contracts, Grant programs—health, Grant programs—veterans, Health care, Health facilities, Health professions, Health records, Homeless, Incorporation by reference, Medical and dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Philippines, Reporting and recordkeeping requirements, Scholarships and fellowships, Travel and transportation expenses, Veterans.

    Dated: December 17, 2015. William F. Russo Director, Office of Regulation Policy & Management, Office of the General Counsel, Department of Veterans Affairs.

    For the reasons set forth in the preamble, VA amends 38 CFR part 17 as follows:

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

    38 U.S.C. 501, and as noted in specific sections.

    § 17.120 [Amended]
    2. Amend the first sentence of § 17.120(b) by adding “or prescribed for” immediately after “provided directly to”.
    § 17.1002 [Amended]
    3. Amend the introductory text of § 17.1002 by adding “or prescribed for” immediately after “provided directly to”.
    [FR Doc. 2015-32098 Filed 12-21-15; 8:45 am] BILLING CODE 8320-01-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 11 [EB Docket No. 04-296; FCC 15-60] Review of the Emergency Alert System AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule; announcement of effective date.

    SUMMARY:

    In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection associated with the Commission's EAS Test Reporting System (ETRS). This notice is consistent with the Emergency Alert System (EAS) Sixth Report and Order, FCC 15-60, which stated that the Commission would publish a document in the Federal Register announcing the effective date of those rules.

    DATES:

    The amendments to 47 CFR 11.21(a) and 11.61(a)(3)(iv) published at 80 FR 37167, June 30, 2015, are effective on December 31, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Lisa Fowlkes, Deputy Bureau Chief, Public Safety and Homeland Security Bureau, at (202) 418-7452, or by email at [email protected].

    SUPPLEMENTARY INFORMATION:

    This document announces that, on December 4, 2015, OMB approved, for a period of three years, the information collection requirements relating to the access stimulation rules contained in the Commission's EAS Sixth Report and Order, FCC 15-60, published at 80 FR 37167, June 30, 2015.

    The OMB Control Number is 3060-0207. The Commission publishes this notice as an announcement of the effective date of the rules. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Nicole Ongele, Federal Communications Commission, Room A-C620, 445 12th Street SW., Washington, DC 20554. Please include the OMB Control Number, 3060-0207, in your correspondence. The Commission will also accept your comments via email at [email protected].

    To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

    Synopsis

    As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on December 4, 2015, for the information collection requirements contained in the modifications to the Commission's rules in 47 CFR part 11. Under 5 CFR 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

    No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-0207.

    The foregoing notice is required by the Paperwork Reduction Act of 1995, Pub. L. 104-13, October 1, 1995, and 44 U.S.C. 3507.

    The total annual reporting burdens and costs for the respondents are as follows:

    OMB Control Number: 3060-0207.

    OMB Approval Date: December 4, 2015.

    OMB Expiration Date: December 31, 2018.

    Title: Part 11, Emergency Alert System (EAS), Sixth Report and Order.

    Form Number: N/A.

    Respondents: Business or other for-profit entities, not-for-profit institutions, and state, local or tribal government.

    Number of Respondents and Responses: 63,080 respondents; 3,569,028 responses.

    Estimated Time per Response: 43 hours.

    Frequency of Response: On occasion reporting requirement and recordkeeping requirement.

    Obligation to Respond: Obligatory for all entities required to participate in EAS.

    Total Annual Burden: 82,008 hours.

    Total Annual Cost: No cost.

    Nature and Extent of Confidentiality: Filings will be given the presumption of confidentiality. The Commission will allow test data and reports containing individual test data to be shared on a confidential basis with other Federal agencies and state governmental emergency management agencies that have confidentiality protection at least equal to that provided by the Freedom of Information Act (FOIA). See 5 U.S.C. 552 (2006), amended by OPEN Government Act of 2007, Pub. L. 110-175, 121 Stat. 2524 (stating the FOIA confidentiality standard, along with relevant exemptions).

    Privacy Act: No impact.

    Needs and Uses: Part 11 contains rules and regulations addressing the nation's Emergency Alert System (EAS). The EAS provides the President with the capability to provide immediate communications and information to the general public at the national, state and local area level during periods of national emergency. The EAS also provides state and local governments and the National Weather Service with the capability to provide immediate communications and information to the general public concerning emergency situations posing a threat to life and property.

    EAS Participants must utilize the ETRS to file identifying and test result data as part of their participation in the second nationwide EAS test. Although the ETRS adopted in this Sixth Report and Order in EB Docket No. 04-296, FCC 15-60, largely resembles the version used during the first nationwide EAS test, it also contains certain improvements, such as support for pre-population of form data, and integration of form data into an EAS “Mapbook.” ETRS will continue to collect such identifying information as station call letters, license identification number, geographic coordinates, EAS designation, EAS monitoring assignment, and emergency contact information. EAS Participants will submit this identifying data prior to the test date. On the day of the test, EAS Participants will input test results into ETRS (e.g., whether the test message was received and processed successfully). They will input the remaining data called for by our reporting rules (e.g., more detailed test results) within 45 day of the test. The Commission believes that structuring ETRS in this fashion will allow EAS Participants to timely provide the Commission with test data in a minimally burdensome fashion.

    Our analysis indicates that this revised collection will cause no change in the burden estimates or reporting and recordkeeping requirements that the Commission submitted (and which OMB subsequently approved) for the 2011 system. The revised information collection requirements contained in this collection are as follows: Section 11.21(a) requires EAS Participants to provide the identifying information required by the ETRS no later than sixty days after the publication in the Federal Register of a notice announcing the approval by the Office of Management and Budget of the modified information collection requirements under the Paperwork Reduction Act of 1995 and an effective date of the rule amendment, or within sixty days of the launch of the ETRS, whichever is later, and shall renew this identifying information on a yearly basis or as required by any revision of the EAS Participant's State EAS Plan filed pursuant to section 11.21 of this part, and consistent with the requirements of paragraph 11.61(a)(3)(iv) of this part. Section 11.61(a)(3)(iv) requires test results to be logged by all EAS Participants into the ETRS as determined by the Commission's Public Safety and Homeland Security Bureau, subject to the following requirements. EAS Participants shall provide the identifying information required by the ETRS initially no later than sixty days after the publication in the Federal Register of a notice announcing the approval by the Office of Management and Budget of the modified information collection requirements under the Paperwork Reduction Act of 1995 and an effective date of the rule amendment, or within sixty days of the launch of the ETRS, whichever is later, and shall renew this identifying information on a yearly basis or as required by any revision of the EAS Participant's State EAS Plan filed pursuant to section 11.21 of this part. EAS Participants must also file “day of test” data in the ETRS within 24 hours of any nationwide test or as otherwise required by the Public Safety and Homeland Security Bureau.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2015-32034 Filed 12-21-15; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 140117052-4402-02] RIN 0648-XE347 Fisheries of the Northeastern United States; Summer Flounder Fishery; Quota Transfer AGENCY:

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

    ACTION:

    Temporary rule; quota transfer.

    SUMMARY:

    NMFS announces that the States of North Carolina and Maine and the Commonwealth of Virginia are transferring portions of their 2015 commercial summer flounder quotas to the State of Connecticut. These quota adjustments are necessary to comply with the Summer Flounder, Scup and Black Sea Bass Fishery Management Plan quota transfer provision. This announcement informs the public of the revised commercial quota for each state involved.

    DATES:

    Effective December 21, 2015, through December 31, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth Scheimer, Fishery Management Specialist, (978)-281-9236.

    SUPPLEMENTARY INFORMATION:

    Regulations governing the summer flounder fishery are in 50 CFR 648.100 through 50 CFR 648.110. The regulations require annual specification of a commercial quota that is apportioned among the coastal states from Maine through North Carolina. The process to set the annual commercial quota and the percent allocated to each state are described in § 648.102.

    The final rule implementing Amendment 5 to the Summer Flounder Fishery Management Plan, as published in the Federal Register on December 17, 1993 (58 FR 65936), provided a mechanism for transferring summer flounder commercial quota from one state to another. Two or more states, under mutual agreement and with the concurrence of the NMFS Greater Atlantic Regional Administrator, can transfer or combine summer flounder commercial quota under § 648.102(c)(2). The Regional Administrator is required to consider the criteria in § 648.102(c)(2)(i) in the evaluation of requests for quota transfers or combinations.

    Connecticut is receiving the following 2015 summer flounder commercial quota transfers: 10,000 lb (4,534 kg) from North Carolina, 10,000 lb (4,534 kg) from Virginia, and 5,200 lb (2,359 kg) from Maine. These transfers were prompted by state officials in Connecticut to ensure their commercial summer flounder quota is not exceeded. The Regional Administrator has determined that the criteria set forth in § 648.102(c)(2)(i) are met. The revised summer flounder quotas for calendar year 2015 are: North Carolina, 2,966,243 lb (1,345,465 kg); Maine, 65 lb (29 kg); Virginia, 2,391,568 lb (1,084,796 kg); and Connecticut, 275,045 lb (124,758 kg), based on the final 2015 Summer Flounder, Scup and Black Sea Bass Specifications and Commercial Summer Flounder Quota Adjustments, as published in the Federal Register on December 30, 2014 (79 FR 78311).

    Classification

    This action is taken under 50 CFR part 648 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: December 17, 2015. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-32109 Filed 12-21-15; 8:45 am] BILLING CODE 3510-22-P
    80 245 Tuesday, December 22, 2015 Proposed Rules DEPARTMENT OF HOMELAND SECURITY Office of the Secretary 6 CFR Part 5 [Docket No. DHS-2015-0075] Privacy Act of 1974; Implementation of Exemptions; Department of Homeland Security, U.S. Customs and Border Protection—DHS/CBP-007 Border Crossing Information, System of Records AGENCY:

    Department of Homeland Security, Privacy Office.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Department of Homeland Security is giving notice of proposed rulemaking pursuant to the Privacy Act of 1974 in connection with a current system of records titled “Department of Homeland Security/U.S. Customs and Border Protection-007 Border Crossing Information (BCI) System of Records.” The exemptions for the system of records notice published May 28, 2013, continue to apply for the updated system of records for those categories of records listed in the previous System of Records Notice. This document proposes to exempt portions of certain new categories of records ingested from the Advance Passenger Information System (APIS) claimed for those records in that system pursuant to the United States Code.

    DATES:

    Comments must be received on or before January 21, 2016.

    ADDRESSES:

    You may submit comments, identified by docket number DHS-2015-0075 by one of the following methods:

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

    Fax: 202-343-4010.

    Mail: Karen L. Neuman, Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528.

    Instructions: All submissions received must include the agency name and docket number for this rulemaking. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided.

    Docket: For access to the docket to read background documents or comments received, please visit http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    For general questions, please contact: John Connors, (202) 344-1610, Privacy Officer, U.S. Customs and Border Protection, Privacy and Diversity Office, 1300 Pennsylvania Avenue NW., Washington, DC 20229. For privacy questions, please contact: Karen L. Neuman, (202) 343-1717, Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528.

    SUPPLEMENTARY INFORMATION: I. Background

    In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the Department of Homeland Security (DHS), U.S. Customs and Border Protection (CBP) is giving notice of a proposed rulemaking that DHS/CBP intends to update its regulations to exempt portions of a system of records from certain provisions of the Privacy Act. Specifically, the Department proposes to exempt portions of the “DHS/CBP-007 Border Crossing Information System of Records” from one of more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements. DHS reissued the current DHS/CBP-007 Border Crossing Information (BCI) System of Records in the Federal Register on May 11, 2015 (80 FR 26937), to provide notice to the public that DHS/CBP is updating the categories of records to include the capture of certain biometric information and Advance Passenger Information System (APIS) records at the border.

    CBP's priority mission is to prevent terrorists and terrorist weapons from entering the country while facilitating legitimate travel and trade. To accomplish this mission, CBP maintains border crossing information about all individuals who enter, are admitted or paroled into, and (when available), exit from the United States regardless of method or conveyance. Border crossing information includes certain biographic and biometric information; photographs; certain mandatory or voluntary itinerary information provided by air, sea, bus, and rail carriers or any other forms of passenger transportation; and the time and location of the border crossing. Border crossing information resides on the TECS (not an acronym) information technology platform. DHS/CBP provided notice to the public about the update and expansion of the categories of records as part of DHS's ongoing effort to better reflect the categories of records in its collection of information. DHS/CBP published this updated system of records notice in the Federal Register on May 11, 2015 (80 FR 26937).

    CBP is responsible for collecting and reviewing border crossing information from travelers entering and departing the United States as part of DHS/CBP's overall border security and enforcement missions. All individuals crossing the border are subject to CBP processing upon arrival in the United States. Each traveler entering the United States is required to establish his or her identity, nationality, and admissibility to the satisfaction of a CBP officer during the clearance process. To manage this process, CBP creates a record of an individual's admission or parole into the United States at a particular time and port of entry. CBP also collects information about U.S. citizens and certain aliens (in-scope travelers pursuant to 8 CFR 215.8, “requirements for biometric identifiers from aliens on departure from the United States”) upon departure from the United States for law enforcement purposes and to document their border crossing.

    DHS is statutorily mandated to create and integrate an automated entry and exit system that records the arrival and departure of aliens, verifies alien identities, and authenticates alien travel documents through the comparison of biometric identifiers (8 U.S.C. 1365(b)). Certain aliens may be required to provide biometrics (including digital fingerprint scans, palm prints, photographs, facial and iris images, or other biometric identifiers) upon arrival in or departure from the United States. The biometric data is stored on the Automated Biometric Identification System (IDENT) information technology platform. IDENT stores and processes biometric data (e.g., digital fingerprints, palm prints, photographs, and iris scans) and links biometrics with biographic information to establish and verify identities. The IDENT information technology platform serves as the biometric repository for the Department, and also stores related biographic information.

    Previously DHS established the United States Visitor and Immigrant Status Indicator Technology (US-VISIT) Program to manage an automated entry and exit system. On March 16, 2013, US-VISIT's entry and exit operations (including deployment of a biometric exit system) were transferred to CBP through the Consolidated and Further Continuing Appropriations Act of 2013 (Pub. L. 113-6, H.R. 933). The Act also transferred US-VISIT's overstay analysis function to U.S. Immigration and Customs Enforcement (ICE) and US-VISIT's biometric identity management services to the Office of Biometric Identity Management (OBIM), within the DHS National Protection and Programs Directorate (NPPD). CBP assumed biometric entry and exit operations on April 1, 2013.

    CBP has continued to develop mechanisms to collect biometric information from departing aliens since assuming responsibility for US-VISIT's entry and exit operations. During these operations, CBP officers may employ technology (e.g., wireless handheld devices or standalone kiosk) to collect biographic and biometric information from certain aliens determined to be in-scope pursuant to 8 CFR 215.8 “Requirements for biometric identifiers from aliens on departure from the United States” prior to exiting the United States. Biometrics are checked against the IDENT system's watchlist of known or suspected terrorists (KST), criminals, and immigration violators to help determine if a person is using an alias or attempting to use fraudulent identification. Biographic and biometric data is encrypted when it is collected and the data is transmitted in an encrypted format to the IDENT system. The data is automatically deleted from the mobile device after the transmission is complete. The handheld mobile devices incorporate strict physical and procedural controls, such as Federal Information Processing Standard (FIPS)-compliant data encryption; residual information removal; and required authorization for users to sign-in using approved user account names and passwords.

    Collection of additional biometric information from individuals crossing the border (such as information regarding scars, marks, tattoos, and palm prints) aids biometric sharing between the Department of Justice (DOJ) Integrated Automated Fingerprint Identification System (IAFIS)/Next Generation Identification (NGI) and the IDENT system. The end result is enhanced access to (and in some cases acquisition of) IAFIS/NGI information by the IDENT system and its users. DHS, DOJ/FBI, and the Department of State (DOS)/Bureau of Consular Services entered into a Memorandum of Understanding (MOU) for Improved Information Sharing Services in 2008. The MOUs established the framework for sharing information in accordance with an agreed-upon technical solution for expanded IDENT/IAFIS/NGI interoperability, which provides access to additional data for a greater number of authorized users.

    CBP collects border crossing information stored in this system of records through a number of sources, for example: (1) Travel documents (e.g., a foreign passport) presented by an individual at a CBP port of entry when he or she provided no advance notice of the border crossing to CBP; (2) carriers that submit information in advance of travel through APIS; (3) information stored in the Global Enrollment System (GES) (see DHS/CBP-002 Global Enrollment System (GES) SORN, 78 FR 3441, (January 16, 2013)) as part of a trusted or registered traveler program; (4) non-federal governmental authorities that issued valid travel documents approved by the Secretary of DHS (e.g., an Enhanced Driver's License (EDL)); (5) another federal agency that issued a valid travel document (e.g., data from a DOS visa, passport including passport card, or Border Crossing Card); or (6) the Canada Border Services Agency (CBSA) pursuant to the Beyond the Border Entry/Exit Program. When a traveler enters, is admitted to, paroled into, or departs from the United States, his or her biographical information, photograph (when available), and crossing details (time and location) is maintained in accordance with the DHS/CBP-007 Border Crossing Information SORN.

    DHS/CBP updated the categories of records to provide notice that CBP is collecting biometrics such as digital fingerprints, photographs, and iris scans from certain non-U.S. citizens at the time of the border crossing or in support of their use of Global Entry or another trusted traveler program. In addition, CBP updated the categories of records in the SORN to provide notice that CBP plans to collect information regarding scars, marks, tattoos, and palm prints from individuals at the border to aid biometric interoperability between the IAFIS/NGI and the IDENT system. Finally, CBP updated the categories of records associated with APIS transmissions to better reflect the information collected and maintained in the DHS/CBP-007 BCI SORN.

    Consistent with DHS's information sharing mission, information stored in the DHS/CBP-007 BCI SORN may be shared with other DHS components that have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions.

    The exemptions for the system of records notice published May 28, 2013 (78 FR 31958) continue to apply for the updated system of records for those categories of records listed in the previous System of Records Notice. However, this document proposes to exempt portions of certain new categories of records ingested from APIS (see DHS/CBP-005 APIS SORN, 80 FR 13407 (March 13, 2015) claimed for those records in that system pursuant to 5 U.S.C. 552a(j)(2) and 5 U.S.C. 552a(k)(2). Furthermore, to the extent certain categories of records are ingested from other systems, the exemptions applicable to the source systems will remain in effect.

    DHS is issuing this Notice of Proposed Rulemaking to exempt portions of DHS/CBP-007 Border Crossing Information System of Records from certain provisions of the Privacy Act.

    II. Privacy Act

    The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which the Federal Government collects, maintains, uses, and disseminates individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals when systems of records maintain information on U.S. citizens, lawful permanent residents, and visitors.

    The Privacy Act allows government agencies to exempt certain records from the access and amendment provisions. If an agency claims an exemption, however, it must issue a Notice of Proposed Rulemaking to make clear to the public the reasons why a particular exemption is claimed.

    DHS is claiming exemptions from certain requirements of the Privacy Act for portions of DHS/CBP-007 Border Crossing Information System of Records. Specifically, certain records ingested from the DHS/CBP-005 Advance Passenger Information System (APIS) SORN into the DHS/CBP-007 Border Crossing Information System of Records will continue to be covered by the exemptions claimed for those records in that system pursuant to 5 U.S.C. 552a(j)(2) and 5 U.S.C. 552a(k)(2). Information in DHS/CBP-007 Border Crossing Information System of Records relates to official DHS national security and law enforcement activities. These exemptions are needed to protect information relating to DHS law enforcement investigations from disclosure to subjects of investigations and others who could interfere with investigatory and law enforcement activities. Specifically, the exemptions are required to preclude subjects of these activities from frustrating the investigative process; to avoid disclosure of investigative techniques; protect the identities and physical safety of confidential informants and of law enforcement personnel; ensure DHS's and other federal agencies' ability to obtain information from third parties and other sources; protect the privacy of third parties; and safeguard sensitive information. Disclosure of information to the subject of the inquiry could also permit the subject to avoid detection or apprehension.

    In appropriate circumstances, when compliance would not appear to interfere with or adversely affect the law enforcement purposes of this system and the overall law enforcement process, the applicable exemptions may be waived on a case by case basis.

    DHS will not assert any exemption with respect to information maintained in the system that is collected from a person at the time of crossing and submitted by that person's air, sea, bus, or rail carriers, if that person, or his or her agent, seeks access or amendment of such information. The DHS/CBP-007 Border Crossing Information System of Records Notice was published in the Federal Register on May 11, 2015.

    List of Subjects in 6 CFR Part 5

    Freedom of Information, Privacy.

    For the reasons stated in the preamble, DHS proposes to amend chapter I of title 6, Code of Federal Regulations, as follows:

    PART 5—DISCLOSURE OF RECORDS AND INFORMATION 1. The authority citation for part 5 continues to read as follows: Authority:

    Pub. L. 107-296, 116 Stat. 2135; (6 U.S.C. 101 et seq.); 5 U.S.C. 301. Subpart A also issued under 5 U.S.C. 552. Subpart B also issued under 5 U.S.C. 552a.

    2. In appendix C to part 5, revise paragraph 46 to read as follows: Appendix C to Part 5—DHS Systems of Records Exempt From the Privacy Act

    46. The DHS/CBP-007 Border Crossing Information System of Records consists of electronic and paper records and will be used by DHS and its components. The DHS/CBP-007 Border Crossing Information System of Records is a repository of information held by DHS in connection with its several and varied missions and functions, including, but not limited to the enforcement of civil and criminal laws; investigations, inquiries, and proceedings there under; law enforcement, border security and intelligence activities. The DHS/CBP-007 Border Crossing Information System of Records contains information that is collected by, on behalf of, in support of, or in cooperation with DHS and its components and may contain personally identifiable information collected by other federal, state, local, tribal, foreign, or international government agencies. At the time of border crossing and during the process of determining admissibility, CBP collects two types of data for which it claims different exemptions.

    (a) CBP will not assert any exemption to limit an individual from accessing or amending his or her record with respect to information maintained in the system that is collected from a person at the time of crossing and submitted by that person's air, sea, bus, or rail carriers.

    The Privacy Act requires DHS to maintain an accounting of the disclosures made pursuant to all routine uses. Pursuant to 5 U.S.C. 552a(j)(2), CBP will not disclose the fact that a law enforcement or intelligence agency has sought particular records because it may affect ongoing law enforcement activities. The Secretary of Homeland Security has exempted this system from sections (c)(3), (e)(8), and (g) of the Privacy Act of 1974, as amended, as is necessary and appropriate to protect this information. Further, DHS will claim exemption from section (c)(3) of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(k)(2) as is necessary and appropriate to protect this information. Exemptions from these particular subsections are justified, on a case-by-case basis to be determined at the time a request is made, for the following reasons:

    (i) From subsection (c)(3) (Accounting for Disclosures) because release of the accounting of disclosures could alert the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of that investigation and reveal investigative interest on the part of DHS as well as the recipient agency. Disclosure of the accounting would therefore present a serious impediment to law enforcement efforts and/or efforts to preserve national security. Disclosure of the accounting would also permit the individual who is the subject of a record to impede the investigation, to tamper with witnesses or evidence, and to avoid detection or apprehension, which would undermine the entire investigative process.

    (ii) From subsection (e)(8) (Notice on Individuals) because compliance would interfere with DHS's ability to obtain, serve, and issue subpoenas, warrants, and other law enforcement mechanisms that may be filed under seal and could result in disclosure of investigative techniques, procedures, and evidence.

    (iii) From subsection (g) (Civil Remedies) to the extent that the system is exempt from other specific subsections of the Privacy Act.

    (b) Additionally, this system contains records or information recompiled from or created from information contained in other systems of records that are exempt from certain provisions of the Privacy Act. For these records or information only, the Secretary of Homeland Security, pursuant to 5 U.S.C. 552a(j)(2), has exempted this system from the following provisions of the Privacy Act: 5 U.S.C. 552a(c)(3), (c)(4); (d)(1)-(4); (e)(1), (e)(2), (e)(3), (e)(4)(G), (e)(4)(H), (e)(4)(I), (e)(5) and (e)(8); (f); and (g). Additionally, the Secretary of Homeland Security, pursuant to 5 U.S.C. 552a(k)(2), has exempted this system from the following provisions of the Privacy Act, 5 U.S.C. 552a(c)(3); (d)(1)-(4); (e)(1), (e)(4)(G), (e)(4)(H), (e)(4)(I); and (f). Exemptions from these particular subsections are justified, on a case-by-case basis to be determined at the time a request is made, for the following reasons:

    (i) From subsection (c)(3) and (c)(4) (Accounting for Disclosures) because release of the accounting of disclosures could alert the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of that investigation and reveal investigative interest on the part of DHS as well as the recipient agency. Disclosure of the accounting would therefore present a serious impediment to law enforcement efforts and/or efforts to preserve national security. Disclosure of the accounting would also permit the individual who is the subject of a record to impede the investigation, to tamper with witnesses or evidence, and to avoid detection or apprehension, which would undermine the entire investigative process.

    (ii) From subsection (d) (Access to Records) because access to the records contained in this system of records could inform the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of that investigation and reveal investigative interest on the part of DHS or another agency. Access to the records could permit the individual who is the subject of a record to impede the investigation, and to avoid detection or apprehension. Amendment of the records could interfere with ongoing investigations and law enforcement activities and would impose an unreasonable administrative burden by requiring investigations to be continually reinvestigated. In addition, permitting access and amendment to such information could disclose security-sensitive information that could be detrimental to homeland security.

    (iii) From subsection (e)(1) (Relevancy and Necessity of Information) because in the course of investigations into potential violations of federal law, the accuracy of information obtained or introduced occasionally may be unclear, or the information may not be strictly relevant or necessary to a specific investigation. In the interests of effective law enforcement, it is appropriate to retain all information that may aid in establishing patterns of unlawful activity.

    (iv) From subsection (e)(2) (Collection of Information from Individuals) because requiring that information be collected from the subject of an investigation would alert the subject to the nature or existence of the investigation, thereby interfering with that investigation and related law enforcement activities.

    (v) From subsection (e)(3) (Notice to Subjects) because providing such detailed information could impede law enforcement by compromising the existence of a confidential investigation or reveal the identity of witnesses or confidential informants.

    (vi) From subsections (e)(4)(G), (e)(4)(H), and (e)(4)(I) (Agency Requirements) and (f) (Agency Rules), because portions of this system are exempt from the individual access provisions of subsection (d) for the reasons noted above, and therefore DHS is not required to establish requirements, rules, or procedures with respect to such access. Providing notice to individuals with respect to existence of records pertaining to them in the system of records or otherwise setting up procedures pursuant to which individuals may access and view records pertaining to themselves in the system would undermine investigative efforts and reveal the identities of witnesses, potential witnesses, and confidential informants.

    (vii) From subsection (e)(5) (Collection of Information) because with the collection of information for law enforcement purposes, it is impossible to determine in advance what information is accurate, relevant, timely, and complete. Compliance with subsection (e)(5) would preclude DHS agents from using their investigative training and exercise of good judgment to both conduct and report on investigations.

    (viii) From subsection (e)(8) (Notice on Individuals) because compliance would interfere with DHS's ability to obtain, serve, and issue subpoenas, warrants, and other law enforcement mechanisms that may be filed under seal and could result in disclosure of investigative techniques, procedures, and evidence.

    (ix) From subsection (g) (Civil Remedies) to the extent that the system is exempt from other specific subsections of the Privacy Act.

    Dated: December 10, 2015. Karen L. Neuman, Chief Privacy Officer, Department of Homeland Security.
    [FR Doc. 2015-31898 Filed 12-21-15; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration 7 CFR Part 868 United States Standards for Rough Rice, Brown Rice for Processing, and Milled Rice AGENCY:

    Grain Inspection, Packers and Stockyards Administration, USDA.

    ACTION:

    Request for information.

    SUMMARY:

    The United States Department of Agriculture's (USDA) Grain Inspection, Packers, and Stockyards Administration (GIPSA) is seeking comment from the public regarding the United States (U.S.) Standards for Rough Rice, Brown Rice for Processing, and Milled Rice under the Agriculture Marketing Act of 1946 (AMA). To ensure that standards and official grading practices remain relevant, GIPSA invites interested parties to comment on whether the current rice standards and grading practices need to be changed.

    DATES:

    We will consider comments we receive by March 21, 2016.

    ADDRESSES:

    You may submit written or electronic comments on this proposed rule to:

    Mail: Irene Omade, GIPSA, USDA, STOP 3642, 1400 Independence Avenue SW., Room 2530-B, Washington, DC 20250-3604.

    Fax: (202) 690-2173

    Internet: Go to http://www.regulations.gov and follow the on-line instructions for submitting comments.

    All comments will become a matter of public record and should be identified as “U.S. Standards for Rough Rice, Brown Rice for Processing, and Milled Rice request for information comments,” making reference to the date and page number of this issue of the Federal Register. All comments received become the property of the Federal government, are a part of the public record, and will generally be posted to www.regulations.gov without change. If you send an email comment directly to GIPSA without going through www.regulations.gov, or you submit a comment to GIPSA via fax, the originating email address or telephone number will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. Also, all personal identifying information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information.

    Electronic submissions should avoid the use of special characters, avoid any form of encryption, and be free of any defects or viruses, since these may prevent GIPSA from being able to read and understand, and thus consider your comment.

    GIPSA will post a transcript or report summarizing each substantive oral comment that we receive. This would include comments made at any public meetings hosted by GIPSA during the comment period, unless GIPSA publically announces otherwise.

    All comments will also be available for public inspection at the above address during regular business hours (7 CFR 1.27(b)). Please call the GIPSA Management and Budget Services support staff (202) 720-8479 for an appointment to view the comments.

    FOR FURTHER INFORMATION CONTACT:

    Beverly A. Whalen at GIPSA, USDA, 10383 N. Ambassador Drive, Kansas City, MO, 64153; Telephone: (816) 659-8410; Fax Number: (816) 872-1258; email: [email protected].

    SUPPLEMENTARY INFORMATION:

    Under the authority of the AMA (7 U.S.C. 1621-1627), as amended, GIPSA establishes and maintains a variety of quality and grade standards for agricultural commodities that serve as a fundamental starting point to define commodity quality in the domestic and global marketplace. Standards developed by GIPSA under the AMA include rice, whole dry peas, split peas, feed peas, lentils, and beans. The AMA standards are voluntary and widely used in private contracts, government procurement, marketing communication, and, for some commodities, consumer information. The U. S. Standards for Rough Rice, Brown Rice for Processing, and Milled Rice standards were last revised in 2002 and appear in the AMA regulations at 7 CFR 868.202 through 868.316. The standards facilitate the marketing of rice in foreign and domestic trade, and provide a uniform measure of quality by providing a common language to describe commodity attributes for U.S. producers, exporters and their customers. Official procedures for inspections are provided in GIPSA's Rice Inspection Handbook for determining the various grading factors.

    GIPSA inspects shipments of rice in accordance with AMA standards to establish the grade of the rice and issues inspection certificates for each shipment. GIPSA-issued certificates describing the quality and condition of graded rice are accepted as prima facie evidence in all Federal courts. U. S. rice standards and the affiliated grading and testing services offered by GIPSA verify that a seller's rice meets specified requirements, and ensure that customers receive the quality of rice they purchased. In addition to Federal usage, the rice standards are applied by one State and one private cooperator.

    In order for U. S. standards and grading procedures for Rough Rice, Brown Rice for Processing, and Milled Rice to remain relevant, GIPSA is issuing this request for information to invite interested parties to submit comments, ideas, and suggestions on all aspects of the U. S. Standards for Rice and inspection procedures.

    Authority:

    7 U.S.C. 1621-1627

    Larry Mitchell, Administrator, Grain Inspection, Packers and Stockyards Administration.
    [FR Doc. 2015-32181 Filed 12-21-15; 8:45 am] BILLING CODE 3410-KD-P
    FEDERAL DEPOSIT INSURANCE CORPORATION 12 CFR Part 341 RIN 3064-AE41 Proposed Revisions to the FDIC's Rules and Regulations Requiring the Registration of Securities Transfer Agents AGENCY:

    Federal Deposit Insurance Corporation (FDIC).

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The FDIC is proposing to amend its regulations requiring insured State nonmember banks, or subsidiaries of such banks, that act as transfer agents for qualifying securities under section 12 of the Securities Exchange Act of 1934 ('34 Act) to register with the FDIC. First, the proposed amendments would require insured State savings associations and subsidiaries of such State savings associations that act as transfer agents for qualifying securities to register with the FDIC, similar to the registration requirements applicable to insured State nonmember banks and subsidiaries of such banks. Second, the proposed amendments would revise the definition of qualifying securities to reflect statutory changes to the '34 Act made by the Jumpstart Our Business Startups Act (JOBS Act). The proposed amendments are consistent with the FDIC's continuing review of its regulations under the Economic Growth and Regulatory Paperwork Reduction Act of 1996.

    DATES:

    Comments must be received by February 22, 2016.

    ADDRESSES:

    You may submit comments, identified by RIN 3064-AE41, by any of the following methods:

    Agency Web site: http://www.fdic.gov/regulations/laws/federal/. Follow instructions for submitting comments on the Agency Web site.

    Email: [email protected]. Include the RIN 3064-AE41 on the subject line of the message.

    Mail: Robert E. Feldman, Executive Secretary, Attention: Comments, Federal Deposit Insurance Corporation, 550 17th Street NW., Washington, DC 20429.

    Hand Delivery: Comments may be hand-delivered to the guard station at the rear of the 550 17th Street Building (located on F Street) on business days between 7:00 a.m. and 5:00 p.m.

    Public Inspection: All comments received must include the agency name and RIN for this rulemaking. All comments received will be posted without change to http://www.fdic.gov/regulations/laws/federal/, including any personal information provided. Paper copies of public comments may be ordered from the FDIC Public Information Center, 3501 North Fairfax Drive, Room E-1002, Arlington, VA 22226 by telephone at 1 (877) 275-3342 or 1 (703) 562-2200.

    FOR FURTHER INFORMATION CONTACT:

    Judy Gross, Senior Policy Analyst, (202) 898-7074, [email protected]; or Rachel Ackmann, Counsel, (202) 898-6858, [email protected].

    SUPPLEMENTARY INFORMATION: I. Background

    The '34 Act provides that an entity must register as a transfer agent if it functions as a transfer agent with respect to any security registered under section 12 of the '34 Act (Section 12) or if it would be required to be registered except for the exemption from registration provided by Section 12(g)(2)(B) or Section 12(g)(2)(G).1 A transfer agent registers by filing an application for registration with the appropriate regulatory agency.2 Prior to the enactment of the Dodd-Frank Wall Street Reform and Consumer Protection Act 3 (Dodd-Frank Act), the FDIC was the appropriate regulatory agency only for a state-chartered (State) insured bank that is not a member of the Federal Reserve System and a subsidiary of any such bank, and the Office of Thrift Supervision (OTS) was the appropriate regulatory agency for a State or federal savings association.4

    1 15 U.S.C. 78q-1(c)(1).

    2 15 U.S.C. 78q-1(c)(2).

    3 Public Law 111-203 (2010).

    4 15 U.S.C. 78c. Additionally, the FDIC has authority to make such rules and regulations as may be necessary to implement the provisions in the '34 Act related to the registration of transfer agents of any institution for which it is the appropriate regulatory agency. 15 U.S.C. 78w(a).

    In 2010, the Dodd-Frank Act provided for a substantial reorganization of the regulation of State and Federal savings associations and their holding companies. On July 21, 2011, (the “transfer date” established by section 311 of the Dodd-Frank Act), the powers, duties, and functions formerly assigned to, or performed by, the OTS were transferred to (i) the FDIC, as to State savings associations; (ii) the Office of the Comptroller of the Currency (OCC), as to Federal savings associations; and (iii) the Board of Governors of the Federal Reserve System, as to savings and loan holding companies. The Dodd-Frank Act also amended the '34 Act to define the FDIC as the appropriate regulatory agency for insured State savings associations, and subsidiaries thereof, along with insured State nonmember banks, and subsidiaries thereof.5

    5 Public Law 111-203, Section 376(a) (2010).

    In 2012, the JOBS Act increased the thresholds at which securities must be registered under Section 12(g)(1) with the Securities and Exchange Commission (SEC).6 As amended by the JOBS Act, Section 12(g)(1) generally requires securities' issuers to register their securities when the issuer has total assets exceeding $10,000,000 and a class of equity security (other than an exempted security) held of record by either— (i) 2,000 persons or (ii) 500 persons who are not accredited investors (as such term is defined by the SEC).7

    6 Public Law 112-106 (2012).

    7 15 U.S.C. 78l(g)(1)(A).

    The JOBS Act also amended Section 12(g)(1) to provide that in the case of an issuer that is a bank or a bank holding company, the issuer's securities must be registered when the issuer has total assets exceeding $10,000,000 and a class of equity security (other than an exempted security) held of record by 2,000 or more persons.8

    8 15 U.S.C. 78l(g)(1)(B).

    Part 341 of the FDIC's regulations (part 341) implements Section 12 of the '34 Act by requiring State nonmember banks and subsidiaries thereof that are transfer agents of qualifying securities to register with the FDIC.9 (Part 341 does not currently include requirements for State savings associations or their subsidiaries.) Part 341 defines “qualifying securities” as securities registered on a national securities exchange; or securities issued by a company or bank with 500 or more shareholders and $1 million or more in total assets, except for securities exempted from registration with the SEC by Section 12(g)(2) (C, D, E, F and H).10 The second prong of the definition of qualifying securities, regarding securities issued by a company or bank with 500 or more shareholders and $1 million or more in total assets, is derived from the statutory requirements in Section 12(g)(1) for registering securities with the SEC.11 As a result of the amendments to the '34 Act made by the Dodd-Frank Act and the JOBS Act, the current exclusion of State savings associations and subsidiaries thereof and the regulatory definition of qualifying securities currently found in part 341 is inconsistent with the statutory threshold for registration requirements now provided in Section 12(g)(1).

    9 12 CFR part 341.

    10 12 CFR 341.2.

    11 15 U.S.C. 78l.

    The OTS did not issue a rule regarding the registration of securities transfer agents. Instead, the OTS issued a memorandum to covered financial institutions informing such institutions that because of statutory changes in the Financial Services Regulatory Relief Act of 2006,12 savings and loan associations, their subsidiaries, and savings and loan holding companies should register as transfer agents with the OTS rather than the SEC.13 Therefore, this proposed rule would not rescind any regulation issued by the OTS that was transferred to the FDIC following the transfer date.

    12 Public Law 109-301 (2006).

    13 OTS CEO Memorandum Number 258 (July 27, 2007), available at http://www.occ.gov/static/news-issuances/ots/ceo-memos/ots-ceo-memo-258.pdf.

    II. Description of the Proposed Rule a. Section 341.1 Scope

    The proposed rule is part of the FDIC's continuing efforts to enact rule changes required by the Dodd-Frank Act and more recent statutory changes, such as the JOBS Act, and would make it clear that part 341 would apply to insured State nonmember banks, insured State savings associations, and the subsidiaries of such institutions. Expanding the scope of part 341 to include State savings associations is consistent with provisions of the Dodd-Frank Act and serves to increase regulatory consistency for all FDIC-supervised institutions. To that end, the proposed rule would define the term “covered institution” to include an insured State nonmember bank, an insured State savings association, and the subsidiaries of such institutions.

    b. Section 341.2 Definitions

    The proposed rule would reconcile the regulatory definition of qualifying securities with the statutory amendments to the '34 Act required by the JOBS Act. The proposed rule would define qualifying securities as (1) securities registered on a national securities exchange pursuant to Section 12(b) (15 U.S.C. 78l(b)) or (2) securities required to be registered under Section 12(g)(1) (15 U.S.C. 78l(g)(1)), except for securities exempted from registration with the SEC by Section 12(g)(2) (C, D, E, F, and H). As such, securities exempted from registration with the SEC by sections 12(g)(2)(B) and (G) of the '34 Act would be included in the definition of qualifying securities. (Section 12(g)(2)(B) of the '34 Act includes securities issued by an investment company registered pursuant to section 8 of the Investment Company Act of 1940 (15 U.S.C. 80a-8), and Section 12(g)(2)(G) refers to securities of certain insurance companies.) Therefore, the proposed definition of qualifying securities would include: (a) Securities registered on a national securities exchange; (b) securities issued by (1) a company with total assets in excess of $10 million and a class of equity securities (other than exempted securities) held of record by either: (i) 2,000 persons, or (ii) 500 persons who are not accredited investors or (2) a bank with total assets exceeding $10 million and a class of equity securities (other than exempted securities) held of record by 2,000 or more persons; (c) securities issued by investment companies registered pursuant to section 15 U.S.C. 80a-8; and (d) securities issued by insurance companies exempt from registration under Section 12(g)(2)(G).

    The proposed definition of “qualifying securities” would cite to Section 12(g)(1) instead of reciting specific quantitative standards to ensure that the FDIC's regulations remain consistent with any future statutory changes to Section 12(g)(1) .

    c. Section 341.7 Delegations of Authority

    The proposed rule would remove the delegations of authorities related to the registration of securities transfer agents from the rule. In the past, the FDIC has taken steps to remove delegations of authority from its regulations in order to provide the agency greater flexibility in the decision-making process.14 The proposed removal of the delegations of authority from the regulation would not change the existing delegation; it would simply move the delegation from the FDIC's regulations. Interested parties may access the FDIC's current delegations of authority on the agency's Web site, at www.fdic.gov.

    14 67 FR 79246 (Dec. 27, 2002).

    d. Technical Corrections

    The proposed rule would also make certain technical corrections to part 341, such as revising outdated citations and updating the name of the FDIC division granted delegated authority to act on disclosure matters.

    III. Request for Comment

    The FDIC invites comment on all aspects of the proposed rule. Specifically, should the rule include the definition of “qualifying securities” instead of referring to the exemptions in the `34 Act?

    IV. Regulatory Analyses A. Paperwork Reduction Act

    In accordance with the requirements of the Paperwork Reduction Act of 1995 (PRA), the agencies may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.15 The FDIC has reviewed the proposed rule and determined that it would not introduce any new collection of information pursuant to the PRA.

    15 44 U.S.C. 3501-3521. The current OMB Control Numbers for state nonmember banks filing the transfer agent registration and amendment form is OMB Control No: 3064-0026. The current OMB Control Numbers for state savings associations filing the transfer agent registration and amendment form is OMB Control No: 3064-0027.

    B. Regulatory Flexibility Act Analysis

    The Regulatory Flexibility Act, 5 U.S.C. 601 et seq. (RFA), requires an agency, in connection with a proposed rule, to prepare an Initial Regulatory Flexibility Analysis describing the impact of the proposed rule on small entities (defined by the Small Business Administration for purposes of the RFA to include banking entities with total assets of $550 million or less) or to certify that the proposed rule would not have a significant economic impact on a substantial number of small entities. For the reasons provided below, the FDIC certifies that the proposed rule would not have a significant economic impact on a substantial number of small entities. Accordingly, an initial regulatory flexibility analysis is not required.

    The proposed rule would not affect a substantial number of small entities.16 Currently only 17 entities are registered with the FDIC as registered transfer agents. Additionally, the FDIC has not received any new registrations for several years. In fact, over the last 10 years, 18 entities have deregistered as transfer agents (the most recent deregistration was in 2014). Furthermore, if any currently registered transfer agent does not meet the threshold requirements, it could deregister if the proposed rule were adopted as a final rule. Therefore, the proposed rule would likely reduce burden on small entities by increasing the number of entities that could deregister with the FDIC. As such, the proposed rule would not have a significant economic impact on a substantial number of small entities.

    16 In 2010, the OTS estimated that 5 savings associations would be required to register as transfer agents. 75 FR 22184 (2010).

    C. Plain Language

    Section 722 of the Gramm-Leach-Bliley Act requires the FDIC to use plain language in all proposed and final rules published after January 1, 2000. The FDIC invites comment on how to make this proposed rule easier to understand. For example:

    • Has the FDIC organized the material to suit your needs? If not, how could the FDIC present the rule more clearly?

    • Are the requirements in the rule clearly stated? If not, how could the rule be more clearly stated?

    • Do the regulations contain technical language or jargon that is not clear? If so, which language requires clarification?

    • Would a different format (grouping and order of sections, use of headings, paragraphing) make the regulation easier to understand? If so, what changes would achieve that?

    • Is this section format adequate? If not, which of the sections should be changed and how?

    • What other changes can the FDIC incorporate to make the regulation easier to understand?

    List of Subjects in 12 CFR Part 341

    Banks, banking, Reporting and recordkeeping requirements, Savings associations, Securities.

    Federal Deposit Insurance Corporation 12 CFR Chapter III Authority and Issuance

    For the reasons stated in the preamble, the Federal Deposit Insurance Corporation proposes to amend part 341 of chapter III of title 12, Code of Federal Regulations as follows:

    PART 341—Registration of Securities Transfer Agents 1. The authority citation for part 341 continues to read as follows: Authority:

    Secs. 2, 3, 17, 17A and 23(a), Securities Exchange Act of 1934, as amended (15 U.S.C. 78b, 78c, 78q, 78q-1 and 78w(a)).

    2. Revise § 341.1 to read as follows:
    § 341.1 Scope.

    This part is issued by the Federal Deposit Insurance Corporation (the FDIC) under sections 2, 3(a)(34)(B), 17, 17A and 23(a) of the Securities Exchange Act of 1934 (the Act), as amended (15 U.S.C. 78b, 78c(a)(34)(B), 78q, 78q-1 and 78w(a)) and applies to all insured State nonmember banks, insured State savings associations, or subsidiaries of such institutions, that act as transfer agents for securities registered under section 12 of the Act (15 U.S.C. 78l), or for securities exempt from registration under subsections (g)(2)(B) or (g)(2)(G) of section 12 (15 U.S.C. 781(g)(2)(B) and (G)) (securities of investment companies, including mutual funds, and certain insurance companies). Such securities are qualifying securities for purposes of this part.

    3. Amend § 341.2 by revising paragraphs (h) and (i) to read as follows:
    § 341.2 Definitions.

    (h) The term covered institution means an insured State nonmember bank, an insured State savings association, and any subsidiary of such institutions.

    (i) The term qualifying securities means:

    (1) Securities registered on a national securities exchange (15 U.S.C. 78l(b)); or

    (2) Securities required to be registered under section 12(g)(1) of the Act (15 U.S.C. 78l(g)(1)), except for securities exempted from registration with the SEC by section 12(g)(2) (C, D, E, F, and H) of the Act.

    4. Amend § 341.3 by revising paragraph (a) and the last sentence in paragraph (c) to read as follows:
    § 341.3 Registration as securities transfer agent.

    (a) Requirement for registration. Any covered institution that performs any of the functions of a transfer agent as described in § 341.2(a) with respect to qualifying securities shall register with the FDIC in the manner indicated in this section.

    (c) * * * Form TA-1 may be completed electronically and is available from the FDIC at www.fdic.gov or the Federal Financial Institutions Examination Council at www.ffiec.gov, or upon request, from the Director, Division of Risk Management Supervision (RMS), FDIC, Washington, DC 20429.

    5. Amend § 341.5 by revising the last sentence in paragraph (b) to read as follows:
    § 341.5 Withdrawal from registration.

    (b) * * * A Request for Deregistration form is available electronically from www.fdic.gov or by request from the Director, Division of Risk Management Supervision (RMS), FDIC, Washington, DC 20429.

    § 341.7 [Removed]
    6. Remove § 341.7.

    By order of the Board of Directors.

    Dated at Washington, DC, this 15th day of December, 2015. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2015-31941 Filed 12-21-15; 8:45 am] BILLING CODE 6714-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2015-N-1765] RIN 0910-AH14 General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is proposing to establish device restrictions for sunlamp products, which would restrict their use to individuals age 18 and older, require prospective users to sign a risk acknowledgement certification before use, and require the provision of user manuals.

    DATES:

    Submit either electronic or written comments on the proposed rule by March 21, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 22, 2016. See Section VIII for the proposed effective date of a final rule based on this proposed rule.

    ADDRESSES:

    FDA is explicitly seeking comment on the risks to health that should be included in the risk acknowledgement certification. 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-1765 for “General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products.” 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 comments on information collection issues to the Office of Management and Budget in the following ways:

    • Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to [email protected] All comments should be identified with the title “Restricted Sale, Distribution, and Use of Sunlamp Products.”

    FOR FURTHER INFORMATION CONTACT:

    Neil R.P. Ogden, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1438, Silver Spring, MD 20993-0002, 301-796-6397.

    SUPPLEMENTARY INFORMATION: I. Background and Legal Authority

    Sunlamp products are both “devices” under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(h)), and “electronic products” under section 531(2) of the FD&C Act (21 U.S.C. 360hh(2)). They are designed to incorporate one or more ultraviolet (UV) lamps intended for irradiation of any part of the living human body, by UV radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning (see §§ 878.4635(a) and 1040.20(b)(9) (21 CFR 878.4635(a) and 1040.20(b)(9))). Sunlamp products include tanning beds and tanning booths. Sunlamp products, as defined in proposed § 878.4635, do not include—and this proposed rulemaking does not address—ultraviolet lamps for dermatological disorders regulated under 21 CFR 878.4630.1

    1 UV emitting lamps that are medical devices and have different intended uses than devices classified under 21 CFR 878.4635 (intended to tan skin) would not fall under that regulation. Manufacturers of such devices would have to obtain approval, clearance or authorization to market their device under the premarket approval, 510(k) or de novo pathway. The use of such devices in a pediatric population is beyond the scope of this document.

    The FD&C Act establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) defines three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

    FDA regulates electronic products under chapter 5, subchapter C, of the FD&C Act (21 U.S.C. 360hh et seq.). Under these provisions, FDA administers an electronic product radiation control program to protect the public health and safety. This authority provides for developing, amending, and administering radiation safety performance standards for electronic products, including sunlamp products.

    FDA is undertaking three initiatives to address the risks associated with sunlamp products. First, in a final reclassification order that issued June 2, 2014 (79 FR 31205 at 31213), FDA reclassified sunlamp products and UV lamps intended for use in sunlamp products from class I to class II, and established special controls and premarket notification (510(k)) requirements under the medical device authorities of the FD&C Act. The special controls include performance testing and labeling requirements, including a warning that sunlamp products are not to be used on persons under the age of 18 years.

    Second, and simultaneously with this proposed rule, FDA is proposing amendments to the sunlamp products and UV lamps performance standard at § 1040.20, which includes technical and labeling requirements issued under the radiological health provisions of the FD&C Act. As explained elsewhere in this issue of the Federal Register, FDA is taking this action to reflect current scientific knowledge related to sunlamp product use, harmonize it more closely with International Electrotechnical Commission (IEC) International Standard 60335-2-27, Ed. 5.0: 2009-12, and strengthen the warning statement required by § 1040.20(d)(1)(i) in accordance with the results of the study FDA conducted under section 230 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85).

    Finally, in this action, FDA is proposing device restrictions under section 520(e) of the FD&C Act (21 U.S.C. 360j(e)), which authorizes FDA to issue regulations imposing restrictions on the sale, distribution, or use of a device, if, because of its potentiality for harmful effects or the collateral measures necessary to its use, FDA determines that absent such restrictions, there cannot be a reasonable assurance of its safety and effectiveness. The proposed device restrictions would require that:

    1. Tanning facility operators permit use of sunlamp products only if the prospective user is age 18 or older;

    2. Tanning facility operators, upon request by the user or prospective user, provide a copy of the sunlamp product user manual or name and address of the manufacture or distributor from whom a user manual may be obtained;

    3. 510(k) holders assure that a user manual accompanies each sunlamp product and, upon request, provide a copy of the user manual to any tanning facility operator, user or prospective user; and

    4. Tanning facility operators obtain each prospective user's signature on a risk acknowledgement certification.

    These device restrictions would primarily apply to tanning facility operators, and to a lesser extent, device manufacturers and distributors. FDA considers a tanning facility operator to be any person offering for sale the use of sunlamp products. FDA would not consider people who use their own tanning beds (home users) to be tanning facility operators.

    Certain provisions of the FD&C Act relate specifically to FDA's authority over restricted devices. For example, sections 502(q) and (r) of the FD&C Act (21 U.S.C. 352(q) and (r)) provide that a restricted device distributed or offered for sale in any state shall be deemed to be misbranded if its advertising is false or misleading or fails to include certain information regarding the device, or it is sold, distributed, or used in violation of regulations prescribed under section 520(e), and section 704(a) of the FD&C Act (21 U.S.C. 374(a)) authorizes FDA to inspect certain records relating to restricted devices.

    If this proposed rule becomes final, it may be enforced by means of seizure of the sunlamp product, under section 304 of the FD&C Act (21 U.S.C. 334); a suit for injunction, under section 302 of the FD&C Act (21 U.S.C. 332); imposition of civil money penalties, under section 303 of the FD&C Act (21 U.S.C. 333); or criminal prosecution, under section 303 of the FD&C Act. FDA expects to cooperate with counterpart agencies at the state level in enforcing the proposed requirements, if they become final. Consumer complaints to FDA and State Agencies would be important in identifying entities that violate the conditions for sale or use of these devices.

    II. Risks Posed by the Device

    The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (2010 Advisory Panel) met on March 25, 2010, to review and discuss recent information regarding the risks to the general public from exposure to sunlamp products, and identified the following risks to health for sunlamp products.2 These risks are well documented and discussed in published literature.

    2 See http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm205684.htm.

    A. Increased Skin Cancer Risk From Cumulative, Repeated UV Radiation Exposure

    UV radiation exposure can lead to permanent damage to DNA in the skin, which has been shown to lead to an increased risk of skin cancer (Refs. 1-3). Skin cancers that have been associated with cumulative repeated UV radiation exposure include melanoma and non-melanoma skin cancers (NMSC) such as basal cell carcinoma and squamous cell carcinoma (Ref. 4). One study suggests that doses of UV-A radiation emitted by high power sunlamp products may be up to 10 to 15 times higher than that of the midday sun, resulting in an intense amount of exposure that does not exist in nature (Ref. 5). Users with a personal history of melanoma have an increased risk of skin cancer, as do users with familial melanoma—having one first-degree relative with melanoma doubles one's risk of developing melanoma (Refs. 6, 7). There is also evidence suggesting that individuals who begin indoor tanning at ages younger than 18 years are particularly vulnerable to the carcinogenic impact of indoor tanning (see section III.A for further discussion).

    B. Ocular Injury

    UV and visible radiation from sunlamp products can be harmful to the eyes if proper protective eyewear is not worn. The UV radiation from sunlamp products can cause keratitis and corneal burns, which can be painful and affect vision (Ref. 8). The intense visible light from some sunlamp products can damage the retina and permanently affect vision (Ref. 8). Artificial UV radiation has also been linked to ocular melanoma, which can cause vision loss and often spreads to other parts of the body (Ref. 9).

    C. Discomfort, Pain, and Tenderness on the Skin Resulting From Burns to the Skin Due to Acute Overexposure to UV Radiation

    A recent study showed that, despite protective properties touted by commercial tanning facilities such as claims that indoor tanning limits exposure time and intensity, 66 percent of female college-age users reported skin erythema (or redness due to sunburn) from indoor tanning, and these users reported one episode of sunburn out of every five tanning sessions (Ref. 10). Those findings are in line with a previous report that found that 58 percent of sunlamp product users ages 11 years to 18 years had experienced sunburns from exposure to sunlamp products (Ref. 11).

    In certain individuals who are photosensitive, skin exposure to UV radiation may induce unexpected reactions such as rash, severe burns, and hypersensitivity (Ref. 12). Various drugs may cause a photosensitivity reaction in the skin. Some drugs may cause a phototoxic reaction when they absorb UV-A radiation and cause cellular damage. These drugs include anti-infective drugs such as tetracyclines and fluoroquinolones, cardiovascular drugs like hydrochlorothiazide and amiodarone, psychiatric drugs such as phenothiazines, and retinoids such as isotretinoin (Ref. 13). Some dietary supplements may also cause photosensitivity (Ref. 13).

    Sunlamp products, like most light sources, generate heat that can cause thermal skin burns, similar to any hot surface. Individuals with open wounds or lesions are particularly susceptible to burns from UV radiation because these individuals lack the protective epidermal layer of the skin that provides the body's greatest protection from UV irradiation (Ref. 14).

    D. Skin Damage

    Cumulative, repeated exposure to UV radiation emitted by sunlamp products may lead to accelerated aging of skin due in part to DNA and skin cell damage (Ref. 15). UV irradiation inhibits the production of collagen precursor molecules such as type I and type III procollagen (Ref. 16). UV irradiation stimulates skin metalloproteinases, which break down skin proteins that then lead to photoaging (Ref. 17). On a cellular level, UV radiation has been known to cause DNA damage (Ref. 1).

    III. Proposed Device Restrictions

    FDA is proposing the following restrictions which, because of the potential for harmful effects from the device, are necessary for a reasonable assurance of safety and effectiveness of sunlamp products:

    A. Use Would Be Restricted to Individuals Age 18 and Older

    Although the risks associated with sunlamp products are applicable to all persons, FDA is proposing to restrict the use of this device to persons age 18 and older because children and adolescents who are exposed to UV radiation may be at higher risk of developing certain types of skin cancer than persons who begin exposure later in life as adults (Ref. 18). In the final reclassification order for this device, FDA established special controls labeling regarding minors' use of sunlamp products and UV lamps intended for use in sunlamp products (see § 878.4635(b)(6)). Based on the increased risk of developing skin cancer and minors' difficulty in appreciating the risks posed by the devices (see Refs. 19 to 24), FDA has determined that use of sunlamp products by minors is not appropriate and is therefore establishing a proposed restriction in this rulemaking action to complement the special controls labeling.

    Published medical evidence demonstrates that there is a direct correlation between sunlamp product use among youths and their developing melanoma skin cancer, as well as other skin cancers (Refs. 25, 26). Melanoma is a leading cause of cancer death in women ages 15 years to 29 years and there is some evidence that suggests use of sunlamp products is an underlying cause (Refs. 27, 28).

    There is increasing epidemiological evidence that shows that tanning at ages younger than 18 years increases the risk of developing melanoma (Refs. 25, 29 to 32). Melanoma (of the types of skin cancer, this is the more concerning type due to greater potential for fatality) is currently the second leading type of cancer in persons age 20 years to 39 years, and many experts believe that at least one cause for this is the increasing use of sunlamp products (Refs. 30, 33). A 2009 International Agency for Research in Cancer (IARC) report linked UV exposure (including from indoor tanning devices) by individuals under age 35 to higher rates of melanoma as compared to a similar cohort of individuals who had not used sunlamp products, and recommended that minors not use sunlamp products. Similarly, a meta-analysis by Gallagher et al. that evaluated metrics of sunlamp product exposure, including in young adults, indicated a significantly increased risk of cutaneous melanoma subsequent to sunlamp product exposure (Ref. 34). In particular, the analysis showed a positive association between first exposure as a young adult and subsequent melanoma. Further, a case control study in Connecticut found a relative risk of 1.4 for melanoma diagnosis when individuals are exposed to sunlamp products before the age of 25 (Ref. 35).

    In addition, there is increasing epidemiological evidence that shows that tanning at ages younger than 18 years increases the risk of developing NMSC. For example, recent studies found a significantly higher risk for basal cell carcinoma for individuals who used sunlamp products during high school and college as compared to those who used sunlamp products between the ages of 25 and 35 (Refs. 36, 37).

    Individuals under 18 who are exposed to UV radiation are at an increased risk of developing skin cancer because (1) there is evidence suggesting that they are particularly vulnerable to the damaging effects of UV radiation and (2) the cumulative effects of exposure have been linked to higher incidence of skin cancer. First, evidence suggests that minors exposed to UV radiation are particularly vulnerable to developing skin cancer (Ref. 38). In particular, migration studies compare people who moved from less UV-intense environments to more UV-intense environments at a young age, for example, children who moved from the United Kingdom to Australia. A number of biological factors, such as skin development and formation of nevi at a young age, are identified as potentially causing the increase in the risk of developing melanoma from exposure to UV radiation, like that from sunlamps (Refs. 18, 39). Second, as with other radiation exposure, increased cumulative lifetime UV exposure results in increased skin cancer risk (Ref. 40).

    The age restriction also is necessary because individuals under 18 often fail to appropriately evaluate the significant health risks associated with indoor tanning. For example, a study has shown that college age students often use sunlamp products despite awareness of the long-term risks (Refs. 41 to 43). Rather, persons under age 18 years appear to be discounting whatever risk information they are receiving or may have difficulty incorporating the information into their decisionmaking. For example, a recent study links indoor tanning by high school students to other risk-taking behaviors, including binge-drinking, unhealthy weight control, sexual intercourse, and illegal drug or steroid use (Ref. 20). This linkage suggests that, like other risk-taking behaviors, adolescents use sunlamp products for self-esteem or sensation seeking reasons, irrespective of known health risks (Ref. 20). Similarly, another recent study showed that psychosocial and demographic characteristics strongly correlated with adolescent indoor tanning (Ref. 22). By restricting sunlamp product use to individuals 18 and older, we would be protecting a subpopulation that generally tends to discount risk information and favor risk taking.

    Based on the scientific evidence available at the time, some members of the 2010 Advisory Panel recommended an age restriction to preclude use by persons under 18 years of age to reduce the unintended health effects of these devices (Ref. 44). The scientific literature published since that meeting, as described in this document, offers further support for an age restriction (Refs. 20, 22, 41).

    Various professional organizations also support an age restriction on sunlamp product use. The World Health Organization (WHO) has classified UV radiation from sunlamp products as a class I carcinogen based on the 2009 IARC report that linked sunlamp product use by individuals under age 35 to higher rates of melanoma and strongly urged consideration of restricting minors from using sunlamp products (Ref. 45). Accordingly, the WHO recommends that persons under age 18 not use sunlamp products (Ref. 46).

    The American Academy of Dermatology (AAD) recognizes WHO's declaration that sunlamp products are cancer-causing agents and are in the same risk category as tobacco, and supports the position that minors should not use sunlamp products (Ref. 47). In 2011, the American Academy of Pediatrics published a policy statement similar to that of the AAD calling for a restriction on sunlamp product use by minors (Refs. 48, 49).

    Experts in pediatrics, public health, and dermatology also support a legislative age restriction on sunlamp product use. For example, recent studies cited other peer reviewed articles to examine the effects of legislation on indoor tanning use (Refs. 22, 50, 51). They concluded that an age restriction or ban would be far more effective at reducing youth indoor tanning than other potential actions such as parental consent (Refs. 22, 50, 51).

    This scientific evidence also has led many State and foreign governments to institute age restrictions in the last few years on the use of sunlamp products by minors (Ref. 50). To date, more than 40 states have age restrictions on sunlamp product use (Ref. 52). These restrictions have age limits ranging from ages 14 to 18. At least 11 countries have restricted the use of sunlamp products to adults age 18 and older, including Great Britain and France (Refs. 52 to 54).

    Restricting use of these devices to individuals 18 and over should reduce future morbidity and mortality from melanoma and other skin cancers and would help to protect the public health, according to both expert advisory opinion and findings from current scientific, medical, and public health policy literature (Ref. 54). In the journal Health Policy in 2009, Hirst et al. estimated that preventing minors from indoor tanning has the potential to reduce the incidence of skin cancers and related medical costs (Ref. 54).

    This restriction is particularly important because, as previously discussed, it has been shown that increased knowledge of the risks of UV exposure among adolescents and young adults does not appreciably alter their tanning behavior and attitudes (Refs. 19, 41, 42, 55). The use of sunlamp products has been suggested to have both a psychological reinforcing effect in minors due to feedback from others on minors' cosmetic appearance or self-perceptions that leads to continued or increased use, in addition to the physical reinforcing effect that has been linked to high rates of use (Refs. 19, 56).

    This age restriction is also important because parental awareness of the risks, educational campaigns, and parental consent to the risks, on their own, have been shown to be insufficient in reducing indoor tanning in young age groups (Refs. 21, 22, 41).

    The risks associated with use of sunlamp products by individuals under 18 are particularly concerning given the widespread use of these devices among high school students. The Centers for Disease Control and Prevention has documented high rates of use in U.S. high school students from its 2011 Behavioral Risk Survey: 13 percent of all high school students report indoor tanning, and 29 percent of white female high school students report usage in the last year (Ref. 53). There are a number of collaborative studies that have demonstrated that young women, in particular, use sunlamp products at increasingly high rates (Refs. 22 to 24, 57). For example, one study found that indoor tanning usage (defined as tanning during the previous 12 months) progressively increased in adolescents (age 14-17) from 5.5 percent at age 14 to 16.5 percent at age 17, which suggests that adolescents use indoor tanning more often as they get older (Ref. 22). Another study analyzed the results of a survey of over 10,000 U.S. individuals age 12 years to 18 years and found nearly 10 percent of respondents used a sunlamp product during the previous year and rates increased to 35 percent for females by age 17, highlighting that teenage girls are more likely than their male counterparts to use indoor tanning facilities (Ref. 24).

    FDA seeks comments on its proposal to restrict use of these devices to individuals 18 years of age and over as well as data and information in support of any comments. In addition, although FDA has strong reservations about a parent-consent process in this setting, we recognize parents' decision-making role. We welcome comment on parental consent and its potential scope, including comments on experiences in jurisdictions that have a parental consent provision for use of sunlamp products.

    B. Sunlamp Product User Manuals Would Have To Be Provided to Users, Prospective Users, and Tanning Facility Operators Upon Request

    User manuals provide valuable information to operators and users. Sunlamp product user manuals can include vital information such as instructions for use, exposure schedules, maintenance guidance, and device warnings. In order to help ensure the dissemination of this important information to sunlamp product users, FDA is proposing that tanning facility operators be required to provide a copy of the user manual or the name and address of the manufacturer or distributor that can provide a copy of the user manual to any user or prospective user that requests one. Similarly, FDA is also proposing that 510(k) holders be required to provide user manuals to any tanning facility operator, user, or prospective user that requests one. The electronic product performance standard currently requires manufacturers to provide manuals to purchasers and, upon request, to others for the life of the sunlamp product (see § 1040.20(e)). FDA believes that access to the information contained in the user manual would help prospective users make informed decisions when considering whether to use the device and would also inform tanning facility operators and users on how to use the device properly.

    C. Prospective Users Would Have To Sign a Risk Acknowledgement Certification Before Sunlamp Product Use

    FDA is proposing that tanning facility operators would have to provide, and sunlamp product prospective users 18 and older would have to sign, the certification set forth in proposed § 878.4635(c)(4) prior to use of any sunlamp product, unless the prospective user has previously signed the risk acknowledgement certification within the preceding 6 months. The certification provides warnings regarding sunlamp products as well as information regarding the proper use of the devices. By making this information available to users in a direct and accessible manner, the certification would better enable consumers to make informed decisions about their use of sunlamp products. Moreover, and as discussed more fully in this section III.C, the information could counteract any false or misleading information that sunlamp product users may have received regarding the risks of indoor tanning.

    Compliance with this proposed requirement would not be unduly burdensome for tanning facilities. The certification has already been drafted by FDA and, as discussed in the economic analysis in Docket FDA-2015-N-1765 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 58), tanning facility operators would need only a brief amount of time to explain to the user the purpose of the certification and to process or file the signed certification. Reading and signing the certification would not be overly burdensome for prospective users—the user would need only a brief amount of time to read and sign the form, if they choose to proceed (Ref. 58).

    FDA proposes that the text of the risk acknowledgement certification would have to be at least 10-point font and that the tanning facility operator would have to provide a copy of the signed acknowledgement certification to the prospective user and retain a copy of the signed acknowledgement certification for 1 year or until the prospective user signs a new risk acknowledgement certification, whichever is sooner. The statements in the certification are intended to inform prospective users of the risks they may be exposing themselves to by using the device and the inherent risks posed by UV radiation, as well as provide information regarding the proper use of the device.

    When developing the certification, FDA aimed to inform readers of the most serious risks in a clear and succinct manner in order to promote rapid comprehension and not take more time than necessary for the key information to be conveyed and understood. Readability analysis, human participants' usability testing, and human factors/risk communication analysis were conducted on the certification to ensure the certification achieved its intended goals clearly and succinctly (Refs. 58 and 59). After obtaining feedback from the testing, the certification was revised consistent with recommendations made in the testing and is presented in this proposed rule with its refined content and format. FDA welcomes comment on the proposed certification form.

    Unlike a label that must be affixed to a device (see § 878.4635(b)(6)(i)(A)), a risk acknowledgement certification can include more comprehensive warnings to ensure that users are aware of the risks associated with the use of the devices (Refs. 50 and 59). FDA expects that users will consider the risks carefully when signing the certification. If users were provided the certification but not required to sign it, they would be less likely to read the risk information in the certification, and they may even opt not to read the certification, mistakenly thinking that it was promotional material provided by the tanning facility.

    Members of the 2010 Advisory Panel recommended that sunlamp product users be required to read and sign an acknowledgement of risks related to sunlamp products before using the device. Since this meeting, FDA has become aware of additional information regarding the use of sunlamp products that further supports the need for risk acknowledgement certifications.

    There are reports in the literature that document tanning facility operators failing to inform patrons of certain risks, causing various groups to call for “informed consent” or better informing users at indoor tanning facilities (Ref. 60).

    In keeping with the literature, on February 1, 2012, staff of the U.S. House of Representatives Committee on Energy and Commerce released a report summarizing their findings regarding false and misleading information provided to patrons of indoor tanning salons, especially teenage women. They found, for example, that 90 percent of operators responded that indoor tanning presented no risks (Ref. 61). When pressed about skin cancer specifically, more than half of the operators claimed indoor tanning would not increase the risk (Ref. 61). Some operators who did inform their patrons of skin cancer risks nevertheless mischaracterized the magnitude and the vulnerable subpopulations (Ref. 60). Other operators provided misleading benefit information, including claims that indoor tanning would protect patrons from cancer or beneficially create vitamin D (Ref. 61).

    These reported practices support the need for risk acknowledgement certifications, which could counteract any false or misleading information communicated to prospective users. This risk acknowledgment will provide prospective users with accurate information about the risks and proper use of the devices so that they can make informed decisions about their use of these devices.

    IV. Environmental Impact

    The Agency has determined that under 21 CFR 25.34(f) this proposed action will not result in increases in the existing levels of use or changes in the intended uses of the product or its substitutes. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    V. Analysis of Economic Impacts

    FDA has examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). OMB has determined that this proposed rule is a significant regulatory action as defined by Executive Order 12866.

    The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. We believe this proposed rule would result in a significant impact on a substantial number of small entities, but the impacts are uncertain.

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount.

    The proposed rule would restrict the use of sunlamp products to individuals aged 18 years and over and require all prospective users to read and sign a risk acknowledgement certification before use (unless the prospective user has previously signed the form within the preceding 6 months). The social benefits from this proposed rule stem from a potential reduction in the incidence of skin cancer. The social costs of the proposed rule are associated with the value of time spent by users and tanning facility operators on the risk acknowledgement certifications and verifying proof of age, as well as other compliance costs. As discussed more fully in the complete assessment, analyzing the impact of the proposed rule is difficult because of the uncertainty of how users would be affected by reading and signing the risk acknowledgment certification and how nonuse when under 18 years of age would affect later adult use. Because of this uncertainty, we use a 1 to 10 percent range in the response rate to the risk information and age restriction, assuming that the age restriction reduces future tanning. Under these scenarios, assuming a discount rate of 7 percent the annualized cost over 10 years would range from $104 million to $114 million; annualized benefits would range from $70 to $115 million. With a 3 percent discount rate the annualized cost over 10 years would range from $122 million to $144 million; annualized benefits would range from $151 to $248 million.

    In addition to the social costs, the proposed rule would likely generate distribution effects from the reduced demand for tanning services. The annualized reduction in indoor tanning revenues would range from about $500 million to $820 million at a 7 percent discount rate over 10 years and from about $500 million to $825 million at a 3 percent discount rate.

    Table 1—Summary of the Impact of the Proposed Rule [$ millions] 7% Discount rate, 5%
  • impact
  • 7% Discount rate, 1%
  • impact
  • 7% Discount rate, 10%
  • impact
  • 3% Discount rate, 5%
  • impact
  • 3% Discount rate, 1%
  • impact
  • 3% Discount rate, 10%
  • impact
  • Present Value over 10 Years Benefits 632.9 491.7 806.8 1,657.3 1,284.4 2,115.7 Costs 763.4 732.2 801.7 1,126.4 1,043.3 1,228.6 Net Benefits −130.5 −240.5 5.1 530.9 241.1 887.1 Lost Revenue 4,532.9 3,527.2 5,770.4 5222.4 4287.4 7040.7 Annualized Value over 10 Years Benefits 90.1 70.0 114.9 194.3 150.6 248.0 Costs 107.2 104.2 114.1 132.1 122.3 144.0 Net Benefits −18.6 −34.2 0.7 62.2 28.3 104.0 Revenue Loss 645.4 502.2 821.6 647.4 502.6 825.4 Note: The impacts are tied to the acknowledgement certification and changing habits, which we interpret as the effect of age restrictions in disrupting the development of a habit for indoor tanning.

    Tanning salons and most of the other establishments who offer commercial tanning services are classified as Other Personal Care Services under the North American Industry Classification System (NAICS 812199). We do not have information on the size distribution of this industry but most, if not all, entities are small businesses. There are 18,000 to 19,000 indoor tanning salons and 15,000 to 20,000 other facilities that offer indoor tanning services. The proposed rule would have a significant impact on a substantial number of small entities chiefly due to the loss of revenue.

    The full assessment of the economic analysis is available in Docket FDA-2015-N-1765 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 62). Table 2 summarizes the analysis.

    Table 2—Summary of Benefits, Costs and Distributional Effects of the Proposed Rule Category Primary
  • estimate
  • Low estimate High estimate Units Year dollars Discount rate
  • (%)
  • Period
  • covered
  • (years)
  • Notes
    Benefits: Annualized Monetized $millions/year $90.10 $70.00 $114.90 2014 7 10 194.30 150.60 248.00 2014 3 10 Annualized Quantified 2014 7 10 2014 3 10 Qualitative Costs: Annualized 107.20 104.20 114.10 2014 7 10 Monetized $millions/year 132.10 122.30 144.00 2014 3 10 Annualized 2014 7 10 Quantified 2014 3 10 Qualitative Transfers: Federal Annualized 2014 7 20 Monetized $millions/year 2014 3 20 From: To: Other Annualized 645.4 502.2 821.6 2014 7 10 Monetized $millions/year 647.4 502.6 825.4 2014 3 10 From: Industry To: Consumer Effects This will have a significant impact on a substantial number of small entities.
    VI. Federalism

    FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain State requirements “different from or in addition to” certain Federal requirements applicable to devices (21 U.S.C. 360k; See Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)). This proposed rule creates a requirement under 21 U.S.C. 360k.

    At the time of publication of this proposed rule, most States and some localities have acted to impose some form or restriction on tanning for minors.3 Section 521(b) of the FD&C Act (21 U.S.C. 360k(b)) provides that the Commissioner of Food and Drugs may, upon application of a State or local government, exempt a requirement from preemption, if the State or local requirement for the device is more stringent than the requirement under the FD&C Act, or if the requirement is necessitated by compelling local conditions and compliance with it would not cause the device to be in violation of a requirement under the FD&C Act. Following this process, and if this rule becomes final, a State or local government may request an exemption from preemption for those State or local requirements pertaining to sunlamp products that are preempted by the Agency's final rule. FDA's rules that detail the content of such requests and the process for considering them are contained within 21 CFR part 808.

    3 National Conference of State Legislators, Indoor Tanning Restrictions for Minors—A State-by-State Comparison, http://www.ncsl.org/research/health/indoor-tanning-restrictions.aspx (last updated July 1, 2015).

    VII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown in this section VII with an estimate of the annual recordkeeping. Included in the estimate is the time for maintaining documentation and disclosing materials.

    FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Title: Restricted sale, distribution, and use of sunlamp products.

    Description: FDA is requesting OMB approval of the requirements set forth in this proposed rule, which would: (1) Restrict the use of sunlamp products to individuals age 18 years and over (§ 878.4635(c)(1)); (2) require that tanning facility operators provide a user manual to users and prospective users that request one, or the name and address of the manufacturer or distributor from who a user manual may be obtained (21 CFR 878.4635(c)(2)); (3) require that sunlamp product 510(k) holders accompany each product with a user manual and provide a user manual to users and tanning facility operators that request one (§ 878.4635(c)(3)); and (4) require all prospective users to read and sign a risk acknowledgement certification before use (unless the prospective user has previously signed the certification within the preceding 6 months) (§ 878.4635(c)(4)).

    Description of Respondents: The requirements apply to manufacturers and distributors of sunlamp products, sunlamp product users and prospective users, as well as tanning facility operators.

    Burden: FDA estimates the burden of this collection of information to be as follows:

    Table 3—Estimated Annual Recordkeeping Burden 1 Activity/21 CFR section Number of recordkeepers Number of records per
  • recordkeeper
  • Total annual records Average
  • burden per
  • recordkeeping
  • Total hours
    Facility maintains signed certification (878.4635(c)(4)(iii)) 36,000 594 21,384,000 0.004 (0.25 minutes, i.e., 15 seconds) 85,536 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 4—Estimated Annual Third-Party Disclosure Burden 1 Activity/21 CFR section Number of
  • respondents
  • Number of
  • disclosures
  • per
  • respondent
  • Total annual disclosures Average
  • burden per
  • disclosure
  • Total hours Total capital costs
    One-Time Burden Facility explains certification on user's first visit 36,000 297 10,692,000 0.008 (30 seconds) 85,536 $2,000,000 Manufacturer/Distributor provides user manual with device; provides copy of manual upon request (878.4635(c)(3)) 20 1 20 15 300 27,800 Total one-time burden 85,836 2,027,800 Annual Burden Facility provides user manual upon request (878.4635(c)(2)) 36,000 297 10,692,000 0.004 (0.25 minutes, i.e., 15 seconds) 42,768 1 There are no operating and maintenance costs associated with this collection of information.

    The economic analysis for this rulemaking provides a range of 33,000 to 39,000 for the number of tanning facilities (18,000 to 19,000 indoor tanning salons and 15,000 to 20,000 other facilities that offer indoor tanning services). In the PRA analysis we use the mean, 36,000 facilities, for the estimated number of facility-respondents. The economic analysis also provides a range for the number of sunlamp product users (after accounting for the impact of the age restriction and the communication of the risk information) of 10.2 to 11.2 million. We used the mean, 10.7 million, to calculate the average number of users per facility (10.7 million users divided by 36,000 facilities equals an average of 297 users per facility).

    Proposed § 878.4635(c)(2) of the proposed rule would require, upon request by a user, tanning facility operators to supply a copy of the user manual for their sunlamp products; or the tanning facility could supply the name and address where the user could request a copy of the manual. We believe the incremental compliance costs to tanning facilities would be negligible because facilities receive the user manual with the equipment and likely already use the information to train their employees. Requests from users would not be frequent and the tanning facility need only supply the name and address, which could be an email address, of the 510(k) holder. We expect it will take approximately 15 seconds for the facility to provide the address.

    Proposed § 878.4635(c)(3) of the proposed rule would require the 510(k) holders of sunlamp products to, upon request, supply tanning facility operators, users, and potential users copies of their user manuals. The 510(k) holders would have to develop standard operating procedures (SOPs) for responding to requests. In our experience, it would take a company about 5 hours of management time to develop the SOPs and set up a system for response. We believe most of the approximately 20 510(k) holders would satisfy this proposed requirement by making the manuals available on the Internet so recurring costs to satisfy requests for the user manual should be negligible. Many companies already make user manuals available online but for those who do not, it may take up to 10 hours of a computer programmer's time to modify the company's Web site and to upload the manuals for both current and past models that could still be in use. About 20 firms manufacture and distribute sunlamp products that could be affected by these proposed requirements. Because we do not know how many of them have user manuals online and all would have to modify their Web pages so product users could find the manuals, we are assuming all firms will incur one-time costs of 5 hours for SOPs and 10 hours to modify their Web pages. We include an estimate of $27,800 for one-time capital costs to account for the wage rate for a manager and computer programmer.

    Proposed § 878.4365(c)(4)(iii) would require tanning facilities to maintain signed risk acknowledgement certifications for at least 1 year or until the user signs a new risk acknowledgement certification, whichever is earlier. The 10.7 million users divided among the 36,000 tanning facilities yields an average of 297 users per facility and since users must sign the certification twice per year, this is 594 certifications to be maintained by each tanning facility per year. Multiplying the 594 certifications by the 36,000 facilities yields 21,384,000 total certifications to be filed per year. FDA expects that filing the certification, either paper or electronic, will take the facility 15 seconds or 0.004 hours and this multiplied by the 21,384,000 total certifications yields a burden estimate of 85,536 hours for this recordkeeping requirement. As mentioned previously, the number of facilities and users is an average based on the range of facilities and users stated in the economic analysis of this rulemaking. Therefore, the resulting hour burden is consistent with, but not identical to, the hours stated in the economic analysis.

    We also assume that the first time a user visits a tanning facility after the date the proposed requirements become effective, a tanning facility operator would take an extra 30 seconds to explain to the prospective user the purpose of the certification and the facility's policy regarding its implementation. We have therefore included a one-time burden estimate for facilities to explain the certification to users. As mentioned previously, the numbers of facilities and users are averages based on the ranges of facilities and users stated in the economic analysis of this rulemaking. Therefore, the resulting hour-burden is consistent with, but not identical to, the hours stated in the economic analysis. We estimate the one-time cost burden will be $2 million, the mean of the range ($1.9 to 2.1 million) stated in the economic analysis.

    In addition, FDA concludes that the user's proof of age in § 878.4635(c)(1) and the risk acknowledgement certification in § 878.4635(c)(4) do not constitute information but are rather “Affidavits, oaths, affirmations, certifications, receipts, changes of address, consents, or acknowledgments . . .” (5 CFR 1320.3(h)(1)).

    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this proposed rule to OMB for review. To ensure that comments on information collection are received, OMB recommends that written comments be faxed or emailed (see ADDRESSES). These requirements will not be effective until FDA obtains OMB approval. FDA will publish a notice concerning OMB approval of these requirements in the Federal Register.

    VIII. Proposed Effective Date

    FDA proposes that any final rule based on this proposal become effective 90 days after its date of publication in the Federal Register.

    IX. References

    The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and online at http://www.regulations.gov (FDA has verified all the Web site addresses in this reference section, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)

    1. Cadet, J., E. Sage, and T. Douki, “Ultraviolet Radiation-Mediated Damage to Cellular DNA.” Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis, 571(1-2):3-17, 2005. 2. Wolff, K. ,L.A. Goldsmith, S.I. Katz, et al., Fitzpatrick's Dermatology in General Medicine, 7th ed., p. 999, 2006. 3. Lazovich, D., R.I. Vogel, M. Berwick, et al., “Indoor Tanning and Risk of Melanoma: A Case-Control Study in a Highly Exposed Population.” Cancer Epidemiology, Biomarkers & Prevention, 19(6):1557-1568, 2010. 4. Wolff, K., L.A. Goldsmith, S.I. Katz, et al., Fitzpatrick's Dermatology in General Medicine, 7th ed., p. 814, 2006. 5. Gerber, B., P. Mathys, M. Moser, et al., “Ultraviolet Emission Spectra of Sunbeds.” Photochemistry and Photobiology, 76:664-668, 2002. 6. Salama, A.K., N. deRosa, R.P. Scheri, et al. “Hazard-Rate Analysis and Patterns of Recurrence in Early Stage Melanoma: Moving Towards a Rationally Designed Surveillance Strategy.” PLoS One, 8(3):e57665, 2013. 7. Niendorf, K.B. and H. Tsao, “Cutaneous Melanoma: Family Screening and Genetic Testing.” Dermatologic Therapy, 19:1, 2006. 8. Walters, B.L. and T.M. Kelley, “Commercial Tanning Facilities: A New Source of Eye Injury.” The American Journal of Emergency Medicine, 5(5):386-389, 1987. 9. Vajdic, C.M., A. Kricker, M. Giblin, et al., “Artificial Ultraviolet Radiation and Ocular Melanoma in Australia.” International Journal of Cancer, 112(5):896-900, 2004. 10. Stapleton, J.L., J. Hillhouse, R. Turrisi, et al., “Erythema and Ultraviolet Indoor Tanning: Findings From a Diary Study.” Translational Behavioral Medicine, 3(10):10-16, 2013. 11. Cokkinides, V., M. Weinstock, D. Lazovich, et al., “Indoor Tanning Use Among Adolescents in the U.S., 1998-2004.” Cancer, 115:190-198, 2009. 12. Wolff, K. L.A. Goldsmith, S.I. Katz, et al., Fitzpatrick's Dermatology in General Medicine, 7th ed., p. 828, 2006. 13. Shields, KM, “Drug-Induced Photosensitivity.” Pharmacist's Letter 20:200509, May 2004. 14. Wolff, K. L.A. Goldsmith, S.I. Katz, et al., Fitzpatrick's Dermatology in General Medicine, 7th ed., p. 57, 2006. 15. Wolff, K. L.A. Goldsmith, S.I. Katz, et al., Fitzpatrick's Dermatology in General Medicine, 7th ed., p. 815, 2006. 16. Fisher, G.J., S. Kang, J. Varani, et al., “Mechanisms of Photoaging and Chronological Skin Aging.” Archives of Dermatology, 138(11):1462-1470, 2002. 17. Quan, T., Z. Qin, W. Xia, et al., “Matrix-Degrading Metalloproteinases in Photoaging.” Journal of Investigative Dermatology Symposium Proceedings, 14(1);20-24, 2009. 18. Autier, P. and P. Boyle, “Artificial Ultraviolet Sources and Skin Cancers: Rationale for Restricting Access to Sunbed Use Before 18 years of Age.” Nature Clinical Practice. Oncology, 5(4):178-179, 2008. 19. Boldeman, C., B. Jansson, B. Nilsson, et al., “Sunbed Use in Swedish Urban Adolescents Related to Behavioral Characteristics.” Preventive Medicine, 26:114-119, 1997. 20. Guy, G.P., Z. Berkowitz, E. Tai, et al., “Indoor Tanning Among High School Students in the United States, 2009 and 2011.” Journal of the American Medical Association Dermatology, 150(5):501-511, 2014. 21. Demko, C.A., E.A. Borawski, S.M. Debanne, et al., “Use of Indoor Tanning Facilities by White Adolescents in the United States.” Archives of Pediatrics & Adolescent Medicine, 157(9):854-860, 2003. 22. Mayer, J.A., S.I. Woodruff, D.J. Slymen, et al., “Adolescents' Use of Indoor Tanning: A Large-Scale Evaluation of Psychosocial, Environmental, and Policy-Level Correlates.” American Journal of Public Health, 101(5):930-938, 2011. 23. Paul, C.L., A. Girgis, F. Tzelepis, et al., “Solaria Use by Minors in Australia: Is There a Cause for Concern?” Australian and New Zealand Journal of Public Health, 28:90, 2004. 24. Geller, A.C., G. Colditz, S. Oliveria, et al., “Use of Sunscreen, Sunburning Rates, and Tanning Bed Use Among More Than 10,000 U.S. Children and Adolescents.” Pediatrics, 109(6):1009-1014, June 2002. 25. Cust, A.E., B.K. Armstrong, C. Goumas, et al., “Sunbed Use During Adolescence and Early Adulthood Is Associated With Increased Risk of Early-Onset Melanoma.” International Journal of Cancer, 128:2425-2435, 2011. 26. Balk, S.J., D.E. Fisher, and A.C. Geller, “Teens and Indoor Tanning: A Cancer Prevention Opportunity for Pediatricians.” Pediatrics, 131:772-785, 2013. 27. Diffey, B., “Sunbeds, Beauty and Melanoma.” British Journal of Dermatology, 157(2): 215-216, 2007. 28. Herzog, C., A.S. Pappo, M.L. Bondy, et al., “Malignant Melanoma.” In: A. Bleyer, M. O'Leary and L.A.G. Ries (Eds.), Cancer Epidemiology in Older Adolescents and Young Adults 15 to 29 Years of Age (National Cancer Institute, NIH Pub. No. 06-5767, chapt. 5, pp. 53-63) 2007. Bethesda, MD: U.S. Department of Health and Human Services. 29. Reed, K.B., J.D. Brewer, C.M. Lohse, et al., “Increasing Incidence of Melanoma Among Young Adults: An Epidemiological Study in Olmsted County, Minnesota.” Mayo Clinic Proceedings, 87(4):328-334, 2012. 30. Boniol, M., P. Autier, P. Boyle, et al., “Cutaneous Melanoma Attributable to Sunbed Use: Systematic Review and Meta-Analysis.” BMJ, 345:e4757, 2012. 31. Colantonio, S., M.B. Bracken, and J. Beecker, “The Association of Indoor Tanning and Melanoma in Adults: Systematic Review and Meta-Analysis.” Journal of the American Academy of Dermatology, 70(5):847-857, 2014. 32. Wehner, M.R., M.L. Shive, M.M. Chren, et al., “Indoor Tanning and Non-Melanoma Skin Cancer: Systematic Review and Meta-Analysis.” BMJ, 345:e5909, 2012. 33. Bleyer, R.B., “Cancer in Young Adults 20 to 39 Years of Age: Overview.” Seminars in Oncology, 36(3):194-206, 2009. 34. Gallagher, R.P., J.J. Spinelli, and T.K. Lee, “Tanning Beds, Sunlamps, and Risk of Cutaneous Malignant Melanoma.” Cancer Epidemiology, Biomarkers & Prevention, 14(3):562-566, 2005. 35. Chen, Y.T., R. Dubrow, T. Zheng, et al., “Sunlamp Use and the Risk of Cutaneous Malignant Melanoma: A Population-Based Case-Control Study in Connecticut, USA.” International Journal of Epidemiology, 27:758-765, 1998. 36. Zhang, M., A.A. Qureshi, A.C. Geller, et al., “Use of Tanning Beds and Incidence of Skin Cancer.” Journal of Clinical Oncology, 30(14):1588-1593, 2012. 37. Karagas, M.R., M.S. Zens, Z. Li, et al., “Early-Onset Basal Cell Carcinoma and Indoor Tanning: A Population-Based Study.” Pediatrics, 134:e4-e12, 2014. 38. Whiteman, D.C., C.A. Whiteman, and A.C. Green, “Childhood Sun Exposure as a Risk Factor for Melanoma: A Systematic Review of Epidemiological Studies.” Cancer Causes and Control, 12:69-82, 2001. 39. Gandini, S., F. Sera, M.S. Cattaruzza, et al., “Meta-Analysis of Risk Factors for Cutaneous Melanoma: I. Common and Atypical Naevi.” European Journal of Cancer, 41:28-44, 2005. 40. Chang, Y.M., J.H. Barret, D.T. Bishop, et al., “Sun Exposure and Melanoma Risk at Different Latitudes: A Pooled Analysis of 5,700 Cases and 7,216 Controls.” International Journal of Epidemiology, 38:814-830, 2009. 41. Knight, J.M., A.N. Kirincich, E.R. Farmer, et al., “Awareness of the Risks of Tanning Lamps Does Not Influence Behavior Among College Students,” Archives of Dermatology, 138:1311-1315, 2002. 42. Poorsatter, S.P. and R.L. Hornung, “UV Light Abuse and High-Risk Tanning Behavior Among Undergraduate College Students.” Journal of the American Academy of Dermatology, 56:375-379, 2007. 43. Jerkegren, E., L. Sandrieser, Y. Brandberg, et al., “Sun-Related Behaviour and Melanoma Awareness Among Swedish University Students.” European Journal of Cancer Prevention, 8:27-34, 1999. 44. FDA, 2010 Meeting materials, including presentations, a meeting transcript, and meeting summary. Available at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm205684.htm. 45. IARC Working Group on Artificial Ultraviolet Light (UV) and Skin Cancer: “The Association of Use of Sunbeds With Cutaneous Malignant Melanoma and Other Skin Cancers: A Systematic Review.” International Journal of Cancer, 120:1116-1122, 2009. 46. WHO, “The World Health Organization Recommends That No Person Under 18 Should Use a Sunbed.” Available at: http://www.who.int/mediacentre/news/notes/2005/np07/en/. 47. AAD, “Dangers of Indoor Tanning.” Available at: https://www.aad.org/media-resources/stats-and-facts/prevention-and-care/dangers-of-indoor-tanning. 48. Skin Cancer Foundation, “American Academy of Pediatrics Calls for Ban on Youth Tanning.” Available at: http://www.skincancer.org/news/tanning/american-academy-of-pediatrics-calls-for-ban-on-youth-tanning. 49. American Academy of Pediatrics, “Policy Statement—Ultraviolet Radiation: A Hazard to Children and Adolescents.” Pediatrics, 127(3):588-597, 2011. Available at: http://pediatrics.aappublications.org/content/early/2011/02/28/peds.2010-3501.full.pdf+html. 50. Pawlak, M.T., M. Bui, M. Amir, et al., “Legislation Restricting Access to Indoor Tanning Throughout the World.” Archives of Dermatology, 148:1006-1012, 2012. 51. Guy, G.P., Z. Berkowitz, S.E. Jones, et al., “State Indoor Tanning Laws and Adolescent Indoor Tanning.” American Journal of Public Health, 104(4):e69-e74, 2014. 52. National Conference of State Legislatures, “Indoor Tanning Restrictions for Minors—A State-by-State Comparison.” Washington, DC and Denver, CO: National Conference of State Legislatures. Available at: http://www.ncsl.org/issues-research/health/indoor-tanning-restrictions-for-minors.aspx. 53. Centers for Disease Control and Prevention (CDC), “Skin Cancer: Indoor Tanning.” Available at: http://www.cdc.gov/cancer/skin/basic_info/indoor_tanning.htm. 54. Hirst, N., L. Gordon, P. Gies, et al., “Estimation of Avoidable Skin Cancers and Cost-Savings to Government Associated With Regulation of the Solarium Industry in Australia.” Health Policy, 89(3):303-311, 2009. 55. Beasley, M.T. and B.S. Kittel, “Factors That Influence Health Risk Behaviors Among Tanning Salon Patrons.” Evaluation & the Health Professions, 20(4):371-388, 1997. 56. Feldman, S.R., A. Liguori, M. Kucenic, et al., “Ultraviolet Exposure Is a Reinforcing Stimulus in Frequent Indoor Tanners.” Journal of the American Academy of Dermatology, 51(1):45-51, July 2004. 57. Schneider, S. and H. Krämer, “Who Uses Sunbeds? A Systematic Literature Review of Risk Groups in Developed Countries.” Journal of the European Academy of Dermatology and Venereology, 24:639-648, 2010. 58. http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. 59. Huntley-Fenner Advisors, “HFA Review of Risks of Indoor UV Tanning Devices Form,” submitted to FDA, August 9, 2013. 60. Heilig, L.F., R. D'Ambrosia, A.L. Drake, et al., “A Case for Informed Consent? Indoor UV Tanning Facility Operator's Provision of Health Risks Information (United States).” Cancer Causes and Control, 16(5):557-560, 2005. 61. http://democrats.energycommerce.house.gov/sites/default/files/documents/False-Health-Info-by-Indoor-Tanning-Industry-2012-2-1.pdf. List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 878 be amended as follows:

    PART 878—GENERAL AND PLASTIC SURGERY DEVICES 1. The authority citation for part 878 continues to read as follows: Authority:

    21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

    2. Section 878.4635 is amended as follows: a. Redesignate paragraph (c) as paragraph (d); b. Add new paragraph (c); c. Revise the heading of newly designated paragraph (d).

    The revisions and additions read as follows:

    § 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.

    (c) Restrictions on sale, distribution, and use of sunlamp products. (1) A tanning facility operator must not permit the use of a sunlamp product unless the prospective user is at least 18 years of age and has signed the risk acknowledgement certification described in paragraph (c)(4) of this section.

    (2) A tanning facility operator must, upon request by a sunlamp product user or prospective user, with respect to any sunlamp product that the operator operates, provide a copy of the sunlamp product user manual or the name and address of the manufacturer or distributor from whom a user manual may be obtained.

    (3) In addition to assuring that a user manual accompanies each sunlamp product, a 510(k) holder must provide, upon request, a copy of the sunlamp product user manual to any tanning facility operator, sunlamp product user, or prospective user with respect to any sunlamp product it manufactures/manufactured or distributes/distributed.

    (4) Risk acknowledgement certification. (i) The tanning facility operator must not permit the use of a sunlamp product unless it obtains each prospective user's signature on a risk acknowledgement certification that contains the following statement prior to use of the sunlamp product, unless the prospective user has previously signed the risk acknowledgement certification within the preceding 6 months:

    BILLING CODE 4164-01-P EP22DE15.004

    (ii) The text of the risk acknowledgement certification shall be at least 10-point font.

    (iii) The tanning facility operator shall provide a copy of the signed acknowledgement certification to the prospective user and the tanning facility shall retain a copy of the signed risk acknowledgement certification for 1 year or until the prospective user signs a new risk acknowledgement certification, whichever is earlier.

    (d) Electronic product performance standard. * * *

    Dated: December 16, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-32024 Filed 12-18-15; 8:45 am] BILLING CODE 4164-01-C
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1002 and 1040 [Docket No. FDA-1998-N-0880 (Formerly 1998N-1170)] RIN 0910-AG30 Sunlamp Products; Proposed Amendment to Performance Standard AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is proposing to amend the performance standard for sunlamp products and ultraviolet (UV) lamps intended for use in these products. This standard was last amended in 1985. The current amendments seek to improve consumer safety by requiring more effective communication regarding the risks posed by these products. They also would reduce risks to consumers by updating technical requirements to reflect current science, and by adopting and incorporating by reference certain elements from the International Electrotechnical Commission (IEC) International Standard 60335-2-27, Ed. 5.0: 2009-12.

    DATES:

    Submit either electronic or written comments on the proposed rule by March 21, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by January 21, 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-1998-N-0880 for “Sunlamp Products; Proposed Amendment to Performance Standard.” 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 comments on information collection issues to the Office of Management and Budget (OMB) in the following ways:

    • Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to [email protected] All comments should be identified with the title, “Sunlamp Products; Proposed Amendment to Performance Standard.”

    FOR FURTHER INFORMATION CONTACT:

    Sharon Miller, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4234, Silver Spring, MD 20993-0002, 301-796-2471.

    SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Regulatory Action

    The Safe Medical Devices Act of 1990 (Pub. L. 101-629), enacted on November 28, 1990, transferred the provisions of the Radiation Control for Health and Safety Act of 1968 (Pub. L. 90-602) from Title III of the Public Health Service Act to Chapter V, subchapter C of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360hh et seq.). Under these provisions, FDA administers an electronic product radiation control program to protect the public health and safety. This authority provides for developing, amending, and administering radiation safety performance standards for electronic products, including sunlamp products.

    A sunlamp product is a device that emits UV radiation to induce tanning. The device incorporates one or more UV lamps as a radiation source. Examples of sunlamp products are tanning beds, which are used while lying down, and tanning booths, which are used while standing. UV radiation-emitting products not used for tanning would not be affected by this proposed rule. Devices emitting UV radiation to treat dermatological disorders are regulated separately and are not part of this proposed rule. As electronic products, sunlamp products are subject to the regulations for electronic product radiation control, including parts 1000 to 1010 (21 CFR parts 1000 through 1010) and § 1040.20 (21 CFR 1040.20).

    Sunlamp products emit UV radiation to induce tanning. The adverse effects of UV radiation are well known. UV radiation can cause acute injuries such as sunburns and eye irritations (e.g., photokeratitis). Long-term UV exposure has been associated with skin cancer (including squamous cell carcinoma, basal cell carcinoma, and melanoma), skin aging, and cataracts. Epidemiological studies of the effects of UV radiation on incidence of cancer and other health problems are complicated by latency between exposure and disease, difficulty controlling for environmental exposure to UV radiation, and other factors. Nevertheless, a recent meta-analysis found an increase in the risk of melanoma for each additional session of sunlamp product use per year (Ref. 1).

    FDA is concerned about the safety risks from UV radiation. Therefore, FDA is updating our requirements for sunlamp products which allow for indoor exposure to UV radiation. There have been many changes in our understanding of how UV radiation interacts with human skin since FDA published the document entitled “Sunlamp Products; Performance Standard” in the Federal Register of September 6, 1985 (50 FR 36548). There have also been many changes in the indoor tanning industry which affect the type of equipment on the market and the measurement techniques used by manufacturers. FDA is updating requirements for sunlamp products to bring our regulations up to date with current science. FDA also wants to improve consumers' understanding of the risks related to UV radiation exposure.

    Summary of the Major Provisions of the Regulatory Action in Question

    The objective of this proposed rule is to align the performance standards for sunlamp products with current scientific knowledge and our understanding of how these products are used. This proposed rule seeks to facilitate compliance, improve awareness among operators and consumers about risks of use, and ultimately improve public health.

    FDA proposes to incorporate certain elements of the International Electrotechnical Commission (IEC) International Standard 60335-2-27, Ed. 5.0: 2009-12, “Household and Similar Electrical Appliances—Safety—Part 2-27: Particular Requirements for Appliances for Skin Exposure to Ultraviolet and Infrared Radiation,” by reference. Harmonizing the FDA standard with the current IEC standard would bring it up to date with current science and better protect consumers from the risks posed by these devices. Harmonization would have benefits for sunlamp product manufacturers as well. Currently, many firms producing sunlamp products for sale within the United States and abroad have to follow both IEC and FDA standards. Aligning these standards would mean that such firms would need to comply with a single set of rules instead of two different ones, at least for the particular clauses which are being adopted and incorporated by reference.

    FDA proposes to amend the requirements of part 1002 as specified in table 1 to require that manufacturers of UV lamps intended to be used in sunlamp products are subject to the same record and reporting requirements as manufacturers of sunlamp products. FDA wants to ensure that all test data necessary to ensure compliance with § 1040.20 are collected and maintained. Currently, manufacturers of UV lamps are required to submit only product reports. Under proposed § 1002.1, manufacturers of UV lamps would also be required to submit supplemental reports and annual reports and to maintain test records and distribution records. Moreover, proposed § 1002.1 would also require that manufacturers of protective eyewear maintain test records demonstrating that the eyewear complies with applicable UV and visible transmittance requirements as well as distribution records. In addition, proposed § 1002.1 would also require that manufacturers of protective eyewear submit annual reports, supplemental reports, and product reports to FDA.

    Proposed § 1040.20(c)(1) would set an absolute limit for UVC radiation. An absolute limit on UVC (200-290 nanometer (nm)) irradiance would provide greater assurance of user safety because a ratio permits higher doses of UVC (as long as they correspond to higher doses in the 260 to 320 nm range). UVC, which is not present in sunlight that reaches the Earth's surface, is potentially harmful to users while less effective for tanning than UVA or UVB. FDA has chosen not to adopt the limit for UVC radiation in Ed. 5.0 of IEC 60335-2-27 because this limit is 10 times lower than the limit in Ed. 4.2 and FDA believes that it would be difficult for some manufacturers to measure irradiance at this level.

    Proposed § 1040.20(c)(2)(ii) would limit the maximum timer interval to one that would result in a biologically effective (also referred to as erythemal-effective) dose that would not exceed 500 joules/meter2 (J/m2) which is approximately equivalent to the 624 J/m2 value (weighted with the CIE LYTLE action spectrum) that was specified in the 1986 FDA Policy Letter on Maximum Timer Interval and Exposure Schedule. FDA has determined that a dose of 500 J/m2 (weighted with the CIE erythemal action spectrum) provides a biologically equivalent dose that is more closely matched to the current 624 J/m2 value than does the IEC dose limit of 600 J/m2.

    Proposed § 1040.20(c)(3) would add a requirement that the control enabling manual termination of radiation emission (sometimes referred to as the “panic button” or “emergency stop”) be easily accessible and readily identifiable to the user. This would ensure that users could easily turn the sunlamp product off for any reason.

    Proposed § 1040.20(c)(4)(ii) would expand application of the performance requirements to all protective eyewear intended to be used with sunlamp products, whether sold together with a sunlamp product or sold separately. UV wavelengths can cause serious eye damage, and exposure to the shorter wavelength region of the UV spectrum is especially dangerous. The spectral transmittance requirements for protective eyewear are necessary to protect users of sunlamp products from these risks, which directly result from the UV radiation emitted by the sunlamp product.

    Proposed § 1040.20(d)(1)(i) would modify the warning statement required to appear on the label of all sunlamp products. FDA believes that the current warning statement is too long, not user-friendly, and that its content and format could be improved to more effectively communicate the risks of indoor tanning to users. Based on its analysis of the consumer testing, FDA concluded that the current warning statement could be made more effective by changing its required language, formatting, and location. FDA believes that the proposed warning statement would most effectively convey the risks of indoor tanning to users.

    The proposed rule would also improve user safety by adopting the IEC's “equivalency code” system for ensuring compatibility between sunlamp products (e.g., tanning beds and booths) and the UV lamps that are used in them. Proposed § 1040.20(d)(1)(vi) would require the label of all sunlamp products to indicate the equivalency code range of the UV lamp to be used in the sunlamp product. Proposed § 1040.20(d)(2)(ii) would require the label of each UV lamp to indicate its UV lamp equivalency code. FDA believes the adoption of the IEC's absolute rating system for replacement UV lamps would eliminate confusion regarding proper lamp replacement, facilitate the enforcement of lamp compatibility requirements, and improve the safety of sunlamp products.

    Proposed § 1040.20(d)(3) would retain the requirement of the current FDA standard that the required label information must be legible and readily accessible to view by a sunlamp product user immediately prior to use. Proposed § 1040.20(d)(3)(i) would incorporate specifications into the rule regarding the location, spacing, and font of the required warning statement. FDA believes that these label specifications would ensure that users see the required warning prior to use, and would result in a more comprehensive and effective standard.

    Proposed § 1040.20(e)(3) would add a requirement for the provision of the required warning statement in all catalogs, specification sheets, and descriptive brochures intended for consumers in which sunlamp products are offered for sale, and on all consumer-directed Web pages on which sunlamp products are offered for sale. This requirement would ensure that consumers are fully informed of the risks presented by sunlamp products at the time they consider purchasing it.

    Proposed § 1040.20(g) is also modeled after the proposed FDA Performance Standard for Laser Products (78 FR 37723, June 24, 2013). FDA believes the addition of these requirements, which have been used successfully over the past two decades for laser products, would improve safety by ensuring that modifications that affect performance would be held to the same standards as original manufacturing.

    Costs and Benefits

    Estimated one-time costs are $20,917 to $113,240 and annual costs are $4,686 to $7,230. The present discounted costs are $57,181 to $151,390 at 7 percent and $61,498 to $165,883 at 3 percent. Annualized at 7 percent over 10 years, total costs are $8,141 to $21,498. At 3 percent, annualized total costs are $7,867 to $19,447.

    The primary benefit of the proposed rule would be from reduced injuries, including sunburn, photokeratitis, skin cancer, cataracts and ocular melanoma, and from reduced exposure to UV radiation. We are unable to quantify the benefits, but where possible, demonstrate that they satisfy breakeven tests using very conservative assumptions. The benefits of this proposed rule would justify the costs.

    Table of Contents I. Background II. Contents of the Proposed Regulation A. Overview B. Changes to § 1002.1 C. Changes to § 1040.20 III. Legal Authority IV. Proposed Effective Date V. Environmental Impact VI. Analysis of Impacts VII. Federalism VIII. Paperwork Reduction Act of 1995 A. Reporting Burden B. Recordkeeping Burden C. Third Party Disclosure Burden IX. Incorporation by Reference X. Comments XI. References I. Background

    The Safe Medical Devices Act of 1990 (Pub. L. 101-629), enacted on November 28, 1990, transferred the provisions of the Radiation Control for Health and Safety Act of 1968 (Pub. L. 90-602) from Title III of the Public Health Service Act to Chapter V, subchapter C of the FD&C Act (21 U.S.C. 360hh et seq.). Under these provisions, FDA administers an electronic product radiation control program to protect the public health and safety. This authority provides for developing, amending, and administering radiation safety performance standards for electronic products, including sunlamp products.

    Until recently, sunlamp products intended for tanning were class I medical devices and exempt from premarket notification requirements, subject to the limitation in 21 CFR 878.9 (see 53 FR 23856, June 24, 1988; 59 FR 63005, December 7, 1994). On March 25, 2010, FDA held a meeting of the General and Plastic Surgery Devices Panel of the FDA/Center for Devices and Radiological Health (CDRH) Medical Devices Advisory committee to seek input on whether the classification or regulatory controls needed to be changed. For a summary of this meeting, see http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/UCM206522.pdf. On June 2, 2014, based on the panel's recommendations, among other things, FDA reclassified UV lamps intended to tan the skin from class I and exempt from premarket notification to class II and subject to premarket notification, and renamed them sunlamp products and UV lamps intended for use in sunlamp products (see 21 CFR 878.4635; 79 FR 31205, June 2, 2014).

    As electronic products, sunlamp products are subject to the regulations for electronic product radiation control, including parts 1000 through 1010 and § 1040.20. The sunlamp products performance standard in § 1040.20 was originally published in the Federal Register on November 9, 1979 (44 FR 65352). In the Federal Register of September 6, 1985 (50 FR 36548), FDA amended § 1040.20 and made it applicable to all sunlamp products manufactured on or after September 8, 1986.

    FDA also issued several policy letters pertaining to specific aspects of its regulation of sunlamp products. On June 25, 1985, FDA issued a policy letter entitled “Policy on Warning Label Required on Sunlamp Products” (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095333.pdf) (Ref. 2). This document pertained to the location, spacing, and legibility of the required warning label. On August 21, 1986, FDA issued a policy letter entitled “Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products” (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095333.pdf) (Ref. 3). This document explained the criteria FDA uses to evaluate the adequacy of the exposure schedule and the recommended maximum exposure time for sunlamp products. On September 2, 1986, FDA issued another policy letter entitled “Policy on Lamp Compatibility,” (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095325.pdf) (Ref. 4). This document listed the criteria FDA uses to evaluate appropriate replacement lamps for sunlamp products.

    Before prescribing any electronic product performance standards, FDA is required to consult a statutory advisory committee, the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). See section 534(f)(1)(A) of the FD&C Act (21 U.S.C. 360kk(f)(1)(A)). At the September 23 and 24, 1998, meeting of TEPRSSC, FDA presented general concepts for amendments to the performance standard for sunlamp products, which are embodied in this proposed rule. The committee recommended that FDA pursue development of the amendments.

    On February 9, 1999, CDRH published an Advance Notice of Proposed Rulemaking (ANPRM) (Docket No. 98N-1170), 64 FR 6288 (February 9, 1999), for the following reasons:

    1. FDA was concerned that inadequate attention was being given to recommended exposure schedules, which are designed to minimize consumer risk.

    2. FDA was concerned that the warnings for sunlamp products were not reaching many users of sunlamp products prior to their purchase and use, and that purchasers may not be aware of the risks associated with UV exposure from sunlamp products.

    3. Sunlamp products technology has changed since the FDA Performance Standard was amended in 1985. These changes can affect both the intensity and spectral characteristics of the UV emission from sunlamps.

    4. Because there is no uniform grading/rating system, choosing a replacement lamp can be confusing for sunlamp product owners and tanning facilities. It also makes the job of tanning facility inspectors more difficult because they cannot easily verify whether the correct lamps are installed in the sunlamp products. The use of incorrect replacement lamps can lead to sunburns.

    The specific amendments under consideration were as follows:

    1. Harmonizing the sunlamp product performance standard with IEC Standard 60335-2-27;

    2. Revising and updating the August 21, 1986, guidance entitled “Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products,” and incorporating the updated guidance into the sunlamp product performance standard;

    3. Adding a provision clarifying that “manufacturing” under the FD&C Act includes a modification of a sunlamp product that affects any aspect of its performance or intended function for which § 1040.20 has an applicable requirement;

    4. Updating the warning statement required by § 1040.20(d)(1)(i) to simplify the wording and to highlight the risk of developing skin cancers;

    5. Requiring reproduction of the text of the warning statement specified in § 1040.20(d)(1)(i) in catalogs, specification sheets, and brochures; and

    6. Developing a biological efficacy rating scale for UV lamps intended for use in sunlamp products to simplify appropriate lamp replacement.

    In response to this ANPRM, FDA received 26 comments from State and local radiation control agencies, manufacturers, the American Academy of Dermatology, the Skin Cancer Foundation, an industry educational association, a tanning facility owner, and a trade organization. FDA considered these comments in developing this proposal.

    FDA presented recommendations for amendments to the sunlamp performance standard to TEPRSSC on June 21, 2000. FDA explained to TEPRSSC that it was prepared to move forward with some of the amendments at that time, but did not have sufficient scientific data to move forward with the lamp classification or the exposure schedule amendment. TEPRSSC advised FDA to develop scientifically-based exposure schedule guidelines before incorporating these requirements into the Performance Standard itself. FDA scientists obtained special funding from FDA's Office of Women's Health to conduct this research. Upon completion, FDA presented guidelines for exposure schedules to the IEC TC (Technical Committee) 61, MT (Maintenance Team) 16 that is responsible for developing standards for these products. The IEC accepted these guidelines and incorporated them into IEC 60335-2-27 standard (Ed. 5.0), which published on December 14, 2009.

    In February 2002, FDA held a 2-day meeting with the indoor tanning industry and representatives from the U.S. Army Environmental Hygiene Agency, Health Canada, the Swedish Radiation Protection Institute, and the North Carolina Department of Radiation Protection. The purpose of this meeting was to solicit input from the affected parties on the lamp equivalence issue and other possible amendments to the FDA Performance Standard for Sunlamp Products, which we considered in the development of this proposed rule.

    The IEC TC 61, MT 16 committee met in October 2002, and decided to work with IEC SC (subcommittee) 34A to develop practical standardized test methods and a classification scheme for low-pressure, fluorescent tanning lamps to facilitate replacement of these lamps when they wear out. IEC SC 34A has responsibility for the IEC 61228 standard entitled “Fluorescent Ultraviolet Lamps Used for Tanning—Measurement and Specification Method” (Ref. 5). At their meeting in 2003, IEC TC 61, MT 16 and IEC SC 34A reached a consensus position on lamp testing and classification. This position has now been incorporated into the IEC 60335-2-27, Ed. 5.0 standard (Ref. 6) and the IEC 61228, Ed. 2.0 standard (Ref. 5).

    In October 2003, FDA presented six amendments to TEPRSSC and all were approved with modifications to two of the proposals. These six amendments, along with others, are being presented in this proposed rule and are outlined in section II.

    In addition, FDA has informed radiological health representatives from the states of our intentions to amend the Sunlamp Products Performance Standard through semi-annual meetings with the state Conference of Radiation Control Program Directors. See Web site at http://www.crcpd.org/.

    FDA is concerned about the safety risks from UV radiation. Therefore, FDA is updating our requirements for sunlamp products—which allow for indoor exposure to UV radiation.

    FDA is undertaking three initiatives to address the risks associated with sunlamp products. First, in a final reclassification order that issued June 2, 2014 (79 FR 31205 at 31213), FDA reclassified sunlamp products and UV lamps intended for use in sunlamp products from class I to class II, and established special controls and premarket notification (510(k)) requirements under the medical device authorities of the FD&C Act. The special controls include performance testing and labeling requirements, including a warning that sunlamp products are not to be used on persons under the age of 18 years.

    Second, and simultaneously with this proposed rule, FDA is proposing device restrictions under section 520(e) of the FD&C Act (21 U.S.C. 360j(e)), which authorizes FDA to issue regulations imposing restrictions on the sale, distribution or use of a device, if, because of its potentiality for harmful effects or the collateral measures necessary to its use, FDA determines that absent such restrictions, there cannot be a reasonable assurance of its safety and effectiveness. As explained elsewhere in this issue of the Federal Register, the proposed device restrictions would require that:

    1. Tanning facility operators permit use of sunlamp products only if the prospective user is age 18 or older;

    2. Tanning facility operators, upon request by the user or prospective user, provide a copy of the sunlamp product user manual or name and address of the manufacturer or distributor from who a user manual may be obtained;

    3. 510(k) holders assure that a user manual accompanies each sunlamp product and, upon request, provide a copy of the user manual to any tanning facility operator, user or prospective user; and

    4. Tanning facility operators obtain each prospective user's signature on a risk acknowledgement certification before use that states that they have been informed of the risks to health that may result from use of these devices.

    These device restrictions would primarily apply to tanning facility operators, and to a lesser extent, device manufacturers and distributors. FDA would not consider people who use their own tanning beds (home users) to be tanning facility operators.

    Finally, in this action, FDA is proposing amendments to the sunlamp products and UV lamps performance standard at § 1040.20 (21 CFR 1040.20) (last updated in 1985), which includes technical and labeling requirements issued under the radiological health provisions of the FD&C Act. FDA is taking this action to reflect current scientific knowledge related to sunlamp product use, harmonize it more closely with IEC International Standard 60335-2-27, Ed. 5.0: 2009-12, and strengthen the warning statement required by § 1040.20(d)(1)(i) in accordance with the results of the study FDA conducted under section 230 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85).

    II. Contents of the Proposed Regulation A. Overview

    This preamble will focus on the proposed changes to § 1002.1 and § 1040.20, which include:

    • Requiring that UV lamp manufacturers follow the same reporting requirements as sunlamp product manufacturers,

    • Requiring that protective eyewear manufacturers maintain distribution records and test records relating to the UV and visible transmittance of the eyewear as well as requiring the submission of annual reports, supplemental reports, and product reports to FDA,

    • Changing the content, format, and location of the required warning statement to make it more effective at communicating the risks of indoor tanning to consumers,

    • Replacing the current limit on the ratio of UVC to UVB irradiance with an absolute limit on UVC irradiance,

    • Limiting the maximum timer interval to one that would not exceed a maximum dose of 500 J/m2, weighted with the CIE Reference Action Spectrum for Erythema (1999),

    • Adopting the IEC “equivalency code” system for labeling and measuring the strength of replacement lamps to prevent original lamps being replaced with more powerful lamps, which can lead to sunburn,

    • Changing the current subjective requirement regarding the visible transmittance of protective eyewear to an objective, quantitative requirement, adopted from the IEC standard,

    • Adding a cap on the amount of visible transmittance allowed through the protective eyewear, to protect the users' retina from intense visible light,

    • Updating the guidelines for the required manufacturer-recommended exposure schedule, by requiring conformity to the IEC standard, which is based on current science,

    • Requiring that a reproduction of the warning label be provided in all catalogs, specification sheets, brochures, and consumer-directed Web pages on which sunlamp products are offered for sale, and

    • Requiring that persons involved in significant modification of sunlamp products re-certify the product just as the manufacturer of a new product would. This requirement currently exists in the FDA Laser Standard (21 CFR 1040.10(i)).

    B. Changes to § 1002.1

    FDA proposes to amend the requirements of part 1002 as specified in table 1 to require that manufacturers of UV lamps intended to be used in sunlamp products are subject to the same record and reporting requirements as manufacturers of sunlamp products. When table 1 was first codified, it was common for the manufacturers of UV lamps to be the same entity that manufactured the sunlamp product. Today, the market has changed and there are some manufacturers that manufacture only UV lamps. FDA wants to ensure that all test data necessary to ensure compliance with § 1040.20 are collected and maintained. Currently, manufacturers of UV lamps are required to submit only product reports. Under proposed § 1002.1, manufacturers of UV lamps would also be required to submit supplemental reports and annual reports and to maintain test records and distribution records. In addition, manufacturers of protective eyewear would also need to maintain distribution records as well as test records demonstrating that the eyewear complies with applicable UV and visible transmittance requirements. Proposed § 1002.1 would also require that manufacturers of protective eyewear submit annual reports, supplemental reports, and product reports to FDA.

    C. Changes to § 1040.20 1. Incorporation by Reference

    FDA proposes to incorporate certain elements of the IEC International Standard 60335-2-27, Ed. 5.0: 2009-12 entitled “Household and Similar Electrical Appliances—Safety—Part 2-27: Particular Requirements for Appliances for Skin Exposure to Ultraviolet and Infrared Radiation,” by reference (Ref. 6). See proposed § 1040.20(a)(2). A similar approach has been used successfully with the FDA standard for laser products, § 1040.10, see FDA Guidance, “Laser Products—Conformance With IEC 60825-1 and IEC 60601-2-22” (Ref. 7), and FDA has proposed to incorporate by reference several provisions of IEC 60825-1, Ed. 2, into the laser products performance standard (78 FR 37723). Harmonizing the FDA standard with the current IEC standard would bring it up to date with current science and better protect consumers from the risks posed by these devices. FDA has representation on the IEC committee and has had significant influence on changes made to the IEC standard over the past decade. Working with this committee, which includes representatives from industry, government, and the medical community, has provided FDA with useful expertise and perspectives to which it may not otherwise have access.

    Harmonization would have benefits for sunlamp product manufacturers as well. Currently, many firms producing sunlamp products for sale within the United States and abroad have to follow both IEC and FDA standards. Aligning these standards would mean that such firms would need to comply with a single set of rules instead of two different ones, at least for the particular clauses which are being adopted and incorporated by reference.

    2. Definitions

    “Protective goggles” would be added to the definition of “protective eyewear” in proposed § 1040.20(b) since this is the synonymous term used in the IEC standard.

    The definition of “sunlamp product” would be amended to make clear that tanning beds and tanning booths are included within this term.

    We propose adding a definition for “tanning course.” This term is used in Annex DD of IEC 60335-2-27, Ed. 5.0, to aid the manufacturer in the development of its exposure schedule. In the context of exposure schedules, “tanning course” means the period of time over which a tan is developed, starting with the first short exposure and building up to longer exposures over time, usually requiring a period of 3 to 4 weeks. In an effort to ensure that a useful recommendation is provided to the user about maximum annual exposure, this concept is utilized in the exposure schedule requirements at proposed § 1040.20(d)(1)(iv) and the example exposure schedule provided therein. FDA is uncertain how users might best keep track of their exposure over many weeks and months, and is particularly interested in comments on the best approach for informing users about limiting their annual exposure.

    3. Performance Requirements

    Proposed § 1040.20(c)(1) would set the irradiance limit for UVC radiation (200-290 nm) at 0.03 Watts/meter2 (W/m2) at the shortest recommended exposure distance from the sunlamp product. This limit is the same as the one in the previous version of IEC 60335-2-27 (Ed. 4.2: 2007-04). This requirement would replace the current limit on the ratio of irradiance in the 200 to 260 nm wavelength range to the irradiance in the 260 to 320 nm wavelength range (see § 1040.20(c)(1)). One of the comments received in response to the 1999 ANPRM recommended that the current ratio limit in § 1040.20(c)(1) be dropped since it is no longer necessary, considering current low-pressure lamp technology, and because a limit on the UVC/UVB ratio provides less safety than an absolute limit on the UVC emissions from a sunlamp product. FDA agrees with this comment. An absolute limit on UVC (200-290 nm) irradiance would provide greater assurance of user safety because a ratio permits higher doses of UVC (as long as they correspond to higher doses in the 260 to 320 nm range). UVC, which is not present in sunlight that reaches the Earth's surface, is potentially harmful to users while less effective for tanning than UVA or UVB. FDA has chosen not to adopt the limit for UVC radiation in Ed. 5.0 of IEC 60335-2-27 because this limit is 10 times lower than the limit in Ed. 4.2 and FDA believes that it would be difficult for some manufacturers to measure irradiance at this level. FDA is particularly interested in comments on this proposal.

    FDA proposes to change § 1040.20(c)(2) by adding a dose-based limit similar to the one in FDA's 1986 FDA Policy Letter on Maximum Timer Interval and Exposure Schedule (Ref. 3) to the maximum timer interval requirement in paragraph (c)(2)(ii). FDA also proposes to remove paragraph (v) from § 1040.20(c)(2).

    Proposed § 1040.20(c)(2)(ii) would incorporate by reference the action spectrum used in figure 103 of IEC 60335-2-27, Ed. 5.0 for calculating the effective dose that defines the maximum timer interval. This method uses the internationally-accepted CIE Reference Action Spectrum for Erythema (Ref. 8) instead of the CIE LYTLE action spectrum that was defined in the 1986 FDA Policy Letter on Maximum Timer Interval and Exposure Schedule (Ref. 3). Since 1986, the CIE Action Spectrum for Erythema has been verified and accepted by research laboratories across the globe. As a result, it is used worldwide in the calculation of the UV Index.

    The 1986 FDA Policy Letter on Maximum Timer Interval and Exposure Schedule also recommends the use of the Parrish 1982 melanogenesis action spectrum, in addition to the CIE LYTLE erythema action spectrum, as a secondary means of calculating the maximum timer interval. As it has been found that the two action spectra are highly correlated, this calculation does not provide independent characterization data and the requirement is redundant. Therefore, proposed § 1040.20(c)(2)(ii) would not require a second calculation of the maximum timer interval.

    Proposed § 1040.20(c)(2)(ii) would limit the maximum timer interval to one that would result in a biologically-effective (also referred to as erythemal-effective) dose that would not exceed 500 J/m2, which is approximately equivalent to the 624 J/m2 value (weighted with the CIE LYTLE action spectrum) that was specified in the 1986 FDA Policy Letter on Maximum Timer Interval and Exposure Schedule (Ref. 3). Although the FDA would like to harmonize its standard as much as possible with the IEC standard, consumer safety is our main concern. Based on spectral irradiance data submitted to the Agency and on data presented at the 2004 Commission Internationale de l'Eclairage (CIE) Symposium on “Light and Health: Non-visual effects” (Ref. 10), FDA has determined that a dose of 500 J/m2 (weighted with the CIE erythemal action spectrum) provides a biologically-equivalent dose that is more closely matched to the current 624 J/m2 value than does the IEC dose limit of 600 J/m2. FDA invites comment on this proposal.

    Proposed § 1040.20(c)(3) would add a requirement that the control enabling manual termination of radiation emission (sometimes referred to as the “panic button” or “emergency stop”) be easily accessible and readily identifiable to the user. This would ensure that users can easily turn the sunlamp product off for any reason.

    Proposed § 1040.20(c)(4)(ii) would expand application of the performance requirements to all protective eyewear intended to be used with sunlamp products, whether sold together with a sunlamp product or sold separately. As we have previously explained, UV wavelengths can cause serious eye damage, and exposure to the shorter wavelength region of the UV spectrum is especially dangerous. (See 42 FR 65189 at 65191, December 30, 1977.) Short-term risks include photokeratitis, which is very painful and causes temporary loss of vision, and there is also a risk of retinal damage from short-term or long-term exposure, which could cause blind spots to form in the retina. Repeated, long-term UV exposure increases the risk of cataracts, and there is evidence of an association between UV exposure and ocular melanoma (Ref. 11).

    The spectral transmittance requirements for protective eyewear are necessary to protect users of sunlamp products from these risks, which directly result from the UV radiation emitted by the sunlamp product. Users of sunlamp products, especially those who tan in tanning facilities, often use protective eyewear manufactured by an entity other than the manufacturer of the sunlamp product. Use of sunlamp products with eyewear that does not meet these requirements would increase the risk posed by the radiation emitted by the sunlamp product and undermine the protection provided by the performance standard. Therefore it is necessary to apply the standard to all protective eyewear intended to be used with sunlamp products.

    The proposal would also modify the protective eyewear transmittance requirements of § 1040.20(c)(4)(ii) to better ensure user safety and achieve harmony with the IEC standard. (See clause 32.102 of IEC 60335-2-27, Ed. 5.0.) The requirements for spectral transmittance in the UV range of 200-400 nm would remain the same as in the current FDA standard. The proposed rule would adopt the limit of 5 percent on the visible transmittance in the range of 400-550 nm from clause 32.102 of the IEC standard. This requirement would provide additional safety to protect the retina from intense visible light. Currently, there is no such requirement included in the FDA standard. The proposed rule would abandon the current requirement that spectral transmittance shall be sufficient over the wavelength range greater than 400 nm to provide visibility to the user, and instead adopt the lower limit of 1 percent on luminous transmission from clause 32.102 of the IEC standard. Replacing the subjective standard with an objective one would make compliance easier to verify and improve uniformity and consistency.

    4. Label Requirements

    Proposed § 1040.20(d)(1)(i) would modify the warning statement required to appear on the label of all sunlamp products. FDA believes that the current warning statement is too long, not user-friendly, and that its content and format could be improved to more effectively communicate the risks of indoor tanning to users. As discussed in section I, FDA has been considering updating the required warning since 1999. In 2007, Congress required FDA to conduct consumer focus group testing to evaluate the adequacy of sunlamp product warning labels in conveying certain risk information to consumers, including the risk of skin cancer. (See section 230 of the Food and Drug Administration Amendments Act of 2007, Pub. L. 110-85.) Based on its analysis of the consumer testing, FDA concluded that the current warning statement could be made more effective by changing its required language, formatting, and location. See the FDA Report to Congress entitled “Labeling Information on the Relationship Between the Use of Indoor Tanning Devices and Development of Skin Cancer or Other Skin Damage” (Ref. 12).

    FDA would like to harmonize its standard as much as possible with the IEC 60335-2-27 Ed. 5.0 standard. However, based on the results of the focus group testing, we believe it is appropriate for some differences to remain between the FDA warning statement and the IEC warning statement, especially since the IEC warning statement provides only the general substance to be conveyed (since it is intended for use in multiple languages) and does not provide formatting specifications. FDA believes that the proposed warning statement would most effectively convey the risks of indoor tanning to users. Specifically, the label of each sunlamp product would have to contain a warning statement with the following language and format:

    “DANGER—Ultraviolet Radiation (UV)

    UV can cause:

    • Skin Cancer • Skin Burns • Premature Skin Aging such as wrinkles and age spots • Eye Damage (both short- and long-term)

    Wear FDA-compliant protective eyewear to prevent eye damage, such as burns or cataracts.

    Follow the recommended exposure schedule to avoid severe skin burns.

    Talk to your doctor or pharmacist before tanning if you use medicines and/or cosmetics. Some of these products can make you more sensitive to skin and eye damage from UV.”

    Currently, § 1040.20(d)(1)(iv) requires sunlamp product labels to include a recommended exposure schedule containing certain information. FDA proposes to add a requirement that the exposure schedule be developed in accordance with the specific parameters in IEC 60335-2-27, Ed. 5.0, Annex DD, which would be incorporated by reference. The proposed rule provides an example of a recommended exposure schedule that would meet the guidelines/parameters in IEC 60335-2-27, Ed. 5.0, Annex DD. See proposed § 1040.20(d)(1)(iv). These parameters are different from those provided in the 1986 FDA Policy Letter on Maximum Timer Interval and Exposure Schedule (Ref. 3), and are based on current science, including recent human research conducted at FDA. This requirement is aimed at reducing the cumulative UV dose to sunlamp product users and attaining closer harmonization of FDA and the IEC standard.

    Proposed § 1040.20(d)(1)(iv) would also require a warning to appear either directly above or below the exposure schedule stating “Skin Type I individuals (always burns, never tans) should never use sunlamp products.” This warning is based on years of published research showing that Skin Type I individuals sunburn easily and cannot tan and are therefore at the greatest risk for skin cancer. By “Skin Type” we are referring to the historical Fitzpatrick skin typing system (Ref. 13) developed in 1975 by dermatologist Thomas Fitzpatrick to predict skin reactivity in phototherapy. Under this categorization scheme, Skin Type I is the fairest and most sensitive while Skin Type VI is the darkest and least sensitive to UV radiation. The Skin Types that are most likely to tan through the use of sunlamp products are Skin Types II through IV. It has been shown (Ref. 14) that Skin Types III and IV can attain a tan with UV doses that are similar to what is needed for Skin Type II. Thus, the same dose can be used to develop and maintain a tan for all three Skin Types. This was confirmed in clinical studies performed at FDA (Ref. 15). This is a change from the approach of the 1986 Policy Letter, which called for exposure schedules to be differentiated by Skin Type.

    The proposed rule would also improve user safety by adopting the IEC's “equivalency code” system for ensuring compatibility between sunlamp products (e.g., tanning beds and booths) and the UV lamps (sometimes referred to as light bulbs) that are used in them. Proposed § 1040.20(d)(1)(vi) would require the label of all sunlamp products to indicate the equivalency code range of the UV lamp to be used in the sunlamp product. The equivalency code range would have to be determined in accordance with clause 22.111 and Annex CC of IEC 60335-2-27, Ed. 5.0, which would be incorporated by reference. Proposed § 1040.20(d)(2)(ii) would require the label of each UV lamp to indicate its UV lamp equivalency code, as defined in Annex CC of IEC 60335-2-27, Ed. 5.0. In determining the “UV code” component of the UV lamp equivalency code, output would have to be measured in accordance with IEC 61228, Ed. 2.0, “Fluorescent Ultraviolet Lamps used for Tanning—Measurement and Specification Method,” (Ref. 5) which would be incorporated by reference.

    FDA believes the adoption of the IEC's absolute rating system for replacement lamps would eliminate confusion regarding proper lamp replacement, facilitate the enforcement of lamp compatibility requirements, and improve the safety of sunlamp products. Currently, FDA relies on a relative system in which the lamp manufacturer has to provide to FDA and to users a list of lamps with which the manufacturer's lamp is compatible. (See §§ 1002.10 and 1040.20(e)(2)(iii).) As new lamp manufacturers and new lamp models enter the marketplace, while other manufacturers abandon old models of lamps or leave the marketplace, it is increasingly cumbersome to keep track of which lamps are compatible with the lamps originally provided with the sunlamp product. This can cause confusion for tanning facility owners, FDA, and State or local inspectors. When incorrect lamps are used as replacements, the erythema-effective intensity may be greater, resulting in burns. Therefore, FDA has decided that an absolute rating system is needed, which would require that a code be printed on the lamp to indicate its erythema-effective output, and a code range be printed on the sunlamp product, to indicate which lamps to use with it. Another advantage of adopting the provisions in both of these IEC standards is that they provide detailed measurement specifications, which would ensure consistency among manufacturers.

    Proposed § 1040.20(d)(3) would retain the requirement of the current FDA standard that the required label information must be legible and readily accessible to view by a sunlamp product user immediately prior to use. FDA provided details regarding compliance with this requirement in its June 25, 1985, policy letter entitled “Policy on Warning Label Required on Sunlamp Products” (Ref. 2). Proposed § 1040.20(d)(3)(i) would incorporate similar specifications into the rule regarding the location, spacing, and font of the required warning statement. The proposal specifies that the warning statement would have to be readily accessible to view whether the tanning bed canopy or tanning booth door is open or closed when the user approaches, which may necessitate that it appear in more than one location on the sunlamp product. FDA believes that these label specifications would ensure that users see the required warning prior to use, and would result in a more comprehensive and effective standard.

    Proposed § 1040.20(d)(3)(ii) specifies that required UV lamp information would have to appear on the packaging of the lamp in addition to being permanently affixed or inscribed on the lamp itself. This would ensure that anyone replacing a UV lamp would be aware of the lamp equivalency code and required warnings before and after purchase.

    We propose revising § 1040.20(d)(3)(iv) to achieve consistency with the requirement in the device labeling regulations at 21 CFR 801.15(c)(1) that all words, statements, and other information required by or under authority of the FD&C Act to appear on the label or labeling of a device must appear in the English language (or a foreign language for articles distributed solely in Puerto Rico or in a Territory where the predominant language is not English). Since the labeling of UV lamps must comply with the labeling requirements of part 801 and § 1040.20, we propose to remove the language in § 1040.20(d)(3)(iv) that permits the manufacturer to express the manufacturer's name and month and year of manufacture as code or symbols. FDA is not aware of any request to use symbols or codes for this purpose in the past.

    5. User Information

    The proposal would remove § 1040.20(e)(1)(iv) since the recommended exposure schedule no longer needs to be differentiated by skin type and would be required to be prominently displayed at the beginning of the users' instructions under proposed § 1040.20(e)(1)(i).

    Proposed § 1040.20(e)(1)(v) would add a requirement for the provision of instructions and warnings regarding assembly, operation, and maintenance, which is modeled on the proposed FDA Performance Standard for Laser Products (78 FR 37723). This would better protect individuals who assemble, test, and maintain sunlamp products.

    Proposed § 1040.20(e)(3) would add a requirement for the provision of the required warning statement in all catalogs, specification sheets, and descriptive brochures intended for consumers in which sunlamp products are offered for sale, and on all consumer-directed Web pages on which sunlamp products are offered for sale. This requirement would ensure that consumers are fully informed of the risks presented by sunlamp products at the time they consider purchasing it.

    6. Test for Determination of Compliance

    Proposed § 1040.20(f) would add a requirement that the performance requirements for the measuring instrument in clause 32.101 of IEC 60335-2-27 Ed. 5.0 would apply.

    7. Modification of Certified Sunlamp Products

    Proposed § 1040.20(g) is also modeled after the proposed FDA Performance Standard for Laser Products (78 FR 37723). FDA believes the addition of these requirements, which have been used successfully over the past 2 decades for laser products, would improve safety by ensuring that modifications that affect performance would be held to the same standards as original manufacturing.

    III. Legal Authority

    Section 532 of the FD&C Act (21 U.S.C. 360ii) authorizes FDA to establish and administer an electronic product radiation control program to protect the public health and safety. Section 534 of the FD&C Act gives FDA authority to issue regulations establishing performance standards for electronic products to control their emission of radiation. These standards may include requirements for product testing and radiation measurement, the attachment of warning signs and labels, and the provision of instructions for product installation, operation, and use. Section 1003(b)(2)(E) of the FD&C Act (21 U.S.C. 393(b)(2)(E)) requires FDA to ensure that public health and safety are protected from electronic product radiation. In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) authorizes the Agency to issue regulations for the efficient enforcement of the FD&C Act.

    Section 230 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) directed FDA to determine whether changes to the warning statement would more effectively communicate the risks of indoor tanning, such as skin cancer, and to submit a report that includes an explanation of the measures being implemented to significantly reduce the risks associated with indoor tanning devices. As explained in section II, based on consumer testing, FDA determined that the proposed warning statement would better communicate the risks of indoor tanning to consumers, and is proposing these amendments to the sunlamp products performance standard to significantly reduce the risks associated with these products.

    IV. Proposed Effective Date

    FDA proposes that any final rule issued based on this proposal become effective 1 year after the date of publication of the final rule in the Federal Register.

    V. Environmental Impact, No Significant Impact

    The Agency has determined under 21 CFR 25.34(c) that this proposed action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environment impact statement is required.

    VI. Economic Analysis of Impacts

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

    The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. We do not believe this proposed rule would result in a significant impact on a substantial number of small entities, but the impacts are uncertain so we are explicitly seeking comment on the impacts.

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount.

    The proposed rule would affect several aspects of the performance standards to reduce risks associated with use. The costs are summarized in table 1. Estimated one-time costs are $20,917 to $113,240 and annual costs are $4,686 to $7,230. The present discounted costs are $57,181 to $151,390 at 7 percent and $61,498 to $165,883 at 3 percent. Annualized at 7 percent over 10 years, total costs are $8,141 to $21,498. At 3 percent, annualized total costs are $7,867 to $19,447.

    The primary benefit of the proposed rule would be from reduced injuries, including sunburn, photokeratitis, skin cancer, cataracts and ocular melanoma and from reduced exposure to UV radiation. We are unable to quantify the benefits, but demonstrate that they satisfy breakeven tests using very conservative assumptions. The benefits of this proposed rule would justify the costs.

    Table 1—Present Discounted Costs of the Proposed Rule Year Low cost scenario High cost scenario Discounted @7 percent $57,181 $151,390 Discounted @3 percent 61,498 165,883 10-Year Annualized @7 percent 8,141 21,498 10-Year Annualized @3 percent 7,867 19,447

    The full assessment of the economic analysis is available in Docket FDA-1998-N-0880 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 16).

    VII. Federalism

    FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive Order requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision at section 542 of the FD&C Act (21 U.S.C. 360ss) that preempts the States from establishing, or continuing in effect, any standard with respect to an electronic product which is applicable to the same aspect of product performance as a Federal standard prescribed under section 534 of the FD&C Act and which is not identical to the Federal standard. If this proposed rule is made final, the final rule would prescribe a Federal standard under section 534 of the FD&C Act. However, section 542 of the FD&C Act does not “prevent the Federal Government or the government of any State or political subdivision thereof from establishing a requirement with respect to emission of radiation from electronic products procured for its own use if such requirement imposes a more restrictive standard than that required to comply with the otherwise applicable Federal standard.” (Section 542 of the FD&C Act.)

    VIII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A description of these provisions is given in the paragraphs that follow with an estimate of the annual reporting, recordkeeping, and third-party disclosure burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

    FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Title: Sunlamp Products; Proposed Amendment to § 1002.1 (Record and Reporting Requirements) and § 1040.20 (Performance Standard).

    Description: The Safe Medical Devices Act of 1990 (Pub. L. 101-629) transferred the provisions of the Radiation Control for Health and Safety Act of 1968 (Pub. L. 90-602) from Title III of the Public Health Service Act (42 U.S.C. 201 et seq.) to Chapter V, subchapter C of the FD&C Act (21 U.S.C. 301 et seq.). Under the FD&C Act, FDA administers an electronic product radiation control program to protect the public health and safety. FDA also develops and administers radiation safety performance standards for electronic products, including sunlamp products.

    Current § 1002.1 requires that sunlamp product manufacturers submit product reports, supplemental reports, and annual reports and requires that test records and distribution records are maintained, used for summary data submitted in the annual report, and made available upon request. In addition, current § 1002.1 requires UV lamp manufacturers to submit product reports. Proposed § 1002.1 would require that manufacturers of UV lamps also submit supplemental reports and annual reports and maintain test records and distribution records.

    Proposed § 1002.1 would also require that manufacturers of protective eyewear maintain test records and distribution records as well as submit annual reports, supplemental reports, and product reports. The eyewear must meet certain transmittance limits in the UV and visible wavelength range. Both manufacturers of sunlamp products that include eyewear with their products and manufacturers of protective eyewear that is sold separately would be responsible for maintaining records of the results yielded by the testing and reporting these results to FDA. (See § 1002.1.) There are no operating and maintenance costs associated with testing the eyewear because this requirement reflects current market practices.

    Proposed § 1040.20(d)(2)(ii) would require that the UV lamp labeling include a replacement lamp code instead of a list of compatible replacement lamps. Although the single UV lamp manufacturer in the United States is already required to conduct spectral irradiance testing of lamps in order to demonstrate compatibility with other model lamps (whether made by that company or other manufacturers), proposed § 1040.20(d)(2)(ii) would require testing in accordance with test methods as specified in IEC 61228, Ed. 2.0, “Fluorescent Ultraviolet Lamps Used for Tanning—Measurement and Specification Method.” The spectral irradiance data obtained is used to calculate the UV code that would be required to be printed on the lamp by proposed § 1040.20(d)(2)(ii). Manufacturers would be responsible for maintaining and reporting records of the results yielded by the testing as well as imprinting the lamp with the replacement lamp code.

    Proposed § 1040.20(d)(2)(iii) would require that each UV lamp have a label containing the model identification of the lamp, if applicable. Manufacturers would be responsible for printing the model number on the lamp itself.

    Proposed § 1040.20(d)(3)(iii) would permit the manufacturer of the sunlamp product or UV lamp to submit a request to the Director, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health for an approval of alternate labeling if the size, configuration, design, or function of the sunlamp product or UV lamp would preclude compliance with the requirements for any required label or would render the required wording of such label inappropriate or ineffective. In these circumstances, manufacturers would be responsible for reporting the request to FDA. The operating and maintenance costs associated with this provision are based on correspondence costs (postage) for non-email communications.

    Proposed § 1040.20(d)(3)(iv) would permit manufacturers of UV lamps to permanently affix or inscribe the tags or labels required by §§ 1010.2(b) and 1010.3(a) on the lamp packaging associated with the UV lamps, rather than the UV lamps themselves. The third party disclosure burden of this provision would be the time it takes to inscribe the label or tag on the UV lamp packaging.

    Proposed § 1040.20(e)(1)(v) would require instructions for sunlamp “assembly, operation, and maintenance,” and would include a schedule of maintenance. This information would also protect those maintaining and assembling sunlamp products from inadvertent exposure to UV radiation by providing adequate instructions to avoid UV exposure during assembly or maintenance. We presume that the maintenance schedules would be developed from known information about how to properly maintain these devices. The third party disclosure burden of this provision would be the time spent bringing this known information into a user-friendly format and disclosing it to users. We also assume that this information would be identical for all units of a given model of sunlamp products.

    Proposed § 1040.20(g) would require that those who change the function or performance characteristics of a sunlamp are manufacturers and would need to recertify and re-identify the device. This requirement applies only if the modification affects any aspect of the product's performance or intended function(s) for which § 1040.20 has an applicable requirement. We believe some sunlamp owners (e.g., tanning facility owners) view such modifications as a less expensive alternative to purchasing a new sunlamp product. We believe some owners, otherwise inclined to alter their sunlamp's performance characteristics, would be deterred from doing so by our proposal because recertification would cost a tanning facility owner more than $30,000 in operating and maintenance costs since tanning facility owners do not typically have the equipment necessary to recertify sunlamp products. However, if a tanning facility owner chooses to recertify the sunlamp product, documentation must be submitted to FDA.

    Description of Respondents: Respondents for these information collections are manufacturers of sunlamp products and UV lamps intended for use in sunlamp products, and manufacturers of protective eyewear that is intended to be used with sunlamp products.

    FDA estimates the burden of this collection of information as follows:

    Table 2—Estimated Annual Reporting Burden 21 CFR section Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • Total hours Capital and
  • operating and
  • maintenance costs
  • 1002.1(b)—Lamp only 1 9 9 2 18 1002.1(b)—Protective eyewear 5 4 20 0.5 10 1040.20(d)(2)(ii) 1 1 1 1 1 1040.20(d)(3)(iii) 1 1 1 .17 .17 (10 minutes) 1040.20(g) 1 1 1 8 8 $43,000 Total 37 $43,000
    Table 3—Estimated Annual Recordkeeping Burden 21 CFR section Number of
  • recordkeepers
  • Number of
  • records per
  • recordkeeper
  • Total annual
  • records
  • Average
  • burden per
  • recordkeeping
  • Total hours Capital and
  • operating and
  • maintenance costs
  • 1002.1(b)—Lamp only 1 2 2 2.5 5 1002.1(b)—Protective eyewear 5 3 15 7 105 1040.20(d)(2)(ii) 1 75 75 0.8 60 $30,000 Total 170 $30,000
    Table 4—Estimated Annual Third Party Disclosure Burden 1 21 CFR section Number of
  • respondents
  • Number of
  • disclosures per
  • respondent
  • Total annual
  • disclosures
  • Average
  • burden per
  • disclosure
  • Total hours
    1040.20(d)(1)(vi) 5 5,200 26,000 .0034 88 1040.20(d)(2)(ii) 1 286,000 286,000 .0017 486 1040.20(d)(2)(iii) 1 286,000 286,000 .0017 486 1040.20(d)(3)(ii) 1 286,000 286,000 .0017 486 1040.20(d)(3)(iv) 1 23,833 23,833 .0017 41 1040.20(e)(1)(v) 5 10 50 12 600 Total 2,187 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    A. Reporting Burden

    For § 1002.1(b)—Lamp only, we estimate the single U.S.-based manufacturer of UV lamps would need to submit 2 new types of reports (supplemental reports and an annual report) for the 75 models. Based on previous submissions, we estimate that nine supplemental reports would be submitted per year. Annual reports are submitted once per year. We estimate that it takes approximately 2 hours to complete each report for a total of 18 burden hours.

    For § 1002.1(b)—Protective eyewear, we estimate that the five respondents would need to report the information annually and that each of the manufacturers produces two models of protective eyewear. Manufacturers are not required to produce two types of eyewear; however, FDA estimates that each of the five respondents produces two types of eyewear that could be made available with sunlamp products. Manufacturers would fill out and submit the annual, supplemental, and product reports demonstrating conformance to the performance standard, and this process is estimated to take 30 minutes per report for a total of 10 hours.

    For § 1040.20(d)(2)(ii), we estimate that the single U.S.-based manufacturer of UV lamps would test 75 UV lamps and that the time needed to incorporate the data into the product report is 1 hour.

    For § 1040.20(d)(3)(iii), we estimate that one sunlamp product and UV lamp manufacturer would submit a request for alternate labeling approval to FDA. This task is expected to be performed by clerical staff that prepare the request and submit it to FDA. This process is expected to take 10 minutes (.17 hours) to type the request and email it. The request is expected to be submitted electronically and does not involve any operating and maintenance cost.

    For § 1040.20(g), we estimate that, at most, one respondent per year would decide to re-certify a sunlamp product with the Agency, instead of the less expensive alternative of purchasing a new sunlamp product. The $43,000 capital costs for recertifying the sunlamp product includes the required instrumentation and calibration light sources such as a double-grating spectroradiometer with integrating sphere and software. We estimate the time needed to make the necessary spectral measurements and compile them into a report that would be sent to FDA to take 8 hours.

    B. Recordkeeping Burden

    For § 1002.1(b)—Lamp only, we estimate the single U.S.-based manufacturer of UV lamps would need to maintain 2 types of records (test records and distribution records) for each of the 75 models and that it takes approximately 2 minutes per model per record for a total of 300 minutes, or 5 burden hours.

    For § 1002.1(b)—Protective eyewear, we estimate that there are five U.S. manufacturers of protective eyewear that would be affected by this amendment. However, this number is uncertain and we welcome comment on this issue. We estimate that each of the manufacturers produces 2 models of protective eyewear and the manufacturer would sample approximately 10 units per model. The time required to perform the necessary testing, including time to verify the instrument, set up the test and prepare and file a report takes approximately 7 hours per model. Protective eyewear manufacturers would also be required to maintain distribution records for their products. We estimate that 7 hours per year would be necessary for the manufacturer to log and file the distribution data. We estimate a total of 105 hours for each manufacturer to maintain the single distribution record for both models of protective eyewear as well as perform the testing for the individual test records that are to be maintained for each model of protective eyewear.

    For § 1040.20(d)(2)(ii), we expect that the single U.S.-based lamp manufacturer does not use IEC UV codes and would have to test and label its models under the proposed rule. The manufacturer has an estimated 30 to 120 models and we chose the mean number of models (75) for our calculations. The mean cost of testing each model is $350 and the cost for an ink stamp is $50 per model, yielding an approximate $30,000 in operating and maintenance cost for § 1040.20(d)(2)(ii). Manufacturers are already performing similar spectral irradiance testing to determine lamp compatibility. We estimate that it would take 0.8 hours per model to modify the test setup to measure spectral irradiance in order to determine the UV code as well as file the results, for a total of 60 hours. We estimate that the single U.S.-based lamp manufacturer is already maintaining records of these tests, so there should be no additional cost associated with proposed § 1002.1 that requires lamp manufacturers now also to maintain test records, although FDA is seeking comment on this understanding.

    C. Third Party Disclosure Burden

    For § 1040.20(d)(1)(vi), we estimate that the five respondents would need to list the code range that can be used in each of the 5,200 sunlamp products produced annually. We estimate 2 minutes to print and affix this label on each the 26,000 sunlamp products, for a total of 88 hours.

    For § 1040.20(d)(2)(ii), the single U.S.-based lamp manufacturer would need to inscribe the UV lamp equivalency code onto each lamp. We estimate it would take 1 minute to ink stamp 10 lamps with the new UV lamp equivalency code. The operating and maintenance costs for this information collection are subsumed in the recordkeeping burden estimate for § 1040.20(d)(2)(ii). The lamp manufacturer produces 286,000 new lamps per year so this process is expected to take approximately 28,600 minutes per year, or about 486 hours.

    For § 1040.20(d)(2)(iii), the single U.S.-based lamp manufacturer would need to inscribe the model identification onto each lamp. We estimate it would take 1 minute to ink stamp ten lamps with the model identifier. The operating and maintenance costs for this information collection are subsumed in the recordkeeping burden estimate for § 1040.20(d)(2)(ii). The lamp manufacturer produces 286,000 new lamps per year so this process is expected to take approximately 28,600 minutes per year, or about 486 hours.

    For § 1040.20(d)(3)(iv), we estimate that the single U.S.-based lamp manufacturer would permanently affix or inscribe the tags or labels required by §§ 1010.2(b) and 1010.3(a) on the packaging of all the UV lamps rather than the lamps themselves. Since lamps are typically packaged and sold in cases of 12, this yields 23,833 packages that must bear the third party disclosure required by § 1040.20(d)(3)(iv). We estimate it would take 1 minute to ink stamp 10 lamp packages with the tags or labels required by §§ 1010.2(b) and 1010.3(a) for a total of 41 hours.

    For § 1040.20(d)(3)(ii), the single U.S.-based lamp manufacturer would need to inscribe or affix the UV lamp equivalency code on the packaging of each lamp. We estimate it would take 1 minute to ink stamp 10 lamp packages with the new UV lamp equivalency code. The lamp manufacturer produces 286,000 new lamps per year so this process is expected to take 28,600 minutes per year, or about 486 hours.

    For § 1040.20(e)(1)(v), we estimate the 5 respondents would need to go through this reporting exercise once for each of their 10 models of sunlamp products. We estimate that 10 hours of a technician's time would be required to collect all the necessary information regarding maintenance and assembly and 2 hours of a manager's time to review this information once it is re-formatted into the user instructions. Thus, we estimate a total of 12 hours per model of sunlamp product would be required for a total of 600 hours. This would be a one-time cost.

    This proposed rule also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA. The collections of information found in proposed § 1040.20(d)(1)(ii); (d)(1)(iii); (d)(1)(iv), 1st sentence; (d)(1)(v); (e)(1)(i) to (e)(1)(iv); (e)(2)(i), and (e)(2)(ii) have been approved under OMB control number 0910-0025 (expires January 1, 2017); the collections of information found in § 1040.20(d)(3)(v) have been approved under OMB control number 0910-0485 (expires February 28, 2015).

    In addition, FDA concludes that proposed § 1040.20(d)(1)(i); (d)(1)(iv), 2nd and 3rd sentences; (d)(2)(i); (d)(2)(iv); (d)(3)(i); and (e)(3) do not constitute “collection[s] of information” under the PRA. Rather, the labeling statements are “public disclosure[s] of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public.” (5 CFR 1320.3(c)(2).)

    To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB (see ADDRESSES). All comments should be identified with the title “Sunlamp Products; Proposed Amendment to § 1002.1 (Record and Reporting Requirements) and § 1040.20 (Performance Standard).”

    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this proposed rule to OMB for review. These requirements will not be effective until FDA obtains OMB approval. FDA will publish a notice concerning OMB approval of these requirements in the Federal Register.

    IX. Incorporation by Reference

    FDA is proposing to incorporate by reference certain portions of the IEC International Standards 60335-2-27, Ed. 5.0: 2009-12 entitled “Household and Similar Electrical Appliances—Safety—Part 2-27: Particular Requirements for Appliances for Skin Exposure to Ultraviolet and Infrared Radiation”; and 61228, Ed. 2.0, “Fluorescent Ultraviolet Lamps Used for Tanning—Measurement and Specification Method.” You may purchase a copy of these materials from the International Electrotechnical Commission (EC Central Office), 3 rue de Varembe, CH-1211 Geneva 20, Switzerland, call +41 22-919-02-11, https://webstore.iec.ch/. FDA is also proposing to incorporate by reference the American National Standard C81.10-1976, entitled “Specifications for Electric Lamp Bases and Holders—Screw-Shell Types.” You may purchase a copy of the material from the American National Standards Institute, 1889 L St. NW., 11th Floor, Washington, DC 20036, call 202-293-8020, www.ansi.org.

    The IEC 60335 standard describes technical specifications that address the safety of electrical appliances that incorporate emitters for exposing the skin to UV and infrared radiation, including those found in tanning salons or other facilities. The IEC 61228 standard describes the method to measure, evaluate, and specify the characteristics of fluorescent UV lamps that are used in appliances for tanning purposes. The ANSI standard describes technical specifications that will help ensure only appropriate bulbs can be fitted to the appliance.

    X. Comments

    Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). FDA is explicitly seeking comment on how the proposed requirements would impact small entities.

    Comments on the following two proposals listed are of special interest to FDA:

    1. The Use of the Limit on UVC Irradiance of 0.03 W/cm2 in IEC 60335-2-27, Ed. 4.2: 2007-4 Instead of the Limit of 0.003 W/cm2 in IEC 60335-2-27, Ed. 5.0: 2009-12.

    2. The Use of a Limit of 500 J/m2 on the Maximum Dose Used to Calculate the Maximum Timer Limit, Instead of the 600 J/m2 Limit in IEC 60335-2-27, Ed. 5.0: 2009-12.

    XI. References

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

    1. Boniol, M., P. Autier, P. Boyle, and S. Gandini, “Cutaneous Melanoma Attributable to Sunbed Use: Systematic Review and Meta-analysis,” British Medical Journal, 345:e8503, December 2012. 2. FDA, Policy on Warning Label Required on Sunlamp Products, Department of Health and Human Services, Center for Devices and Radiological Health, Rockville, MD, June 25, 1985, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095333.pdf. 3. FDA, Policy on Maximum Timer Intervals and Exposure Schedule for Sunlamps, Department of Health and Human Services, Center for Devices and Radiological Health, Rockville, MD, August 21, 1986, http://www.fda.gov/downloads/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/UCM192707.pdf. 4. FDA, Policy on Lamp Compatibility, Department of Health and Human Services, Center for Devices and Radiological Health, Rockville, MD, September 2, 1986, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095325.pdf. 5. IEC 61228, Ed. 2.0, “Fluorescent Ultraviolet Lamps Used for Tanning—Measurement and Specification Method,” IEC, Geneva, Switzerland. 6. IEC 60335-2-27, Ed. 5.0, “Household and Similar Electrical Appliances—Safety—Part 2-27: Particular Requirements for Appliances for Skin Exposure to Ultraviolet and Infrared Radiation,” IEC, Geneva, Switzerland, 2009. 7. FDA Guidance for Industry and FDA Staff, “Laser Products—Conformance With IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50),” June 24, 2007, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094366.pdf. 8. CIE S 007/E-1998/ISO 17166: 1999(E) Erythemal Reference Action Spectrum and Standard Erythema Dose, CIE Vienna, Austria. 9. “Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph,” FDA, Department of Health and Human Services, 64 FR 27666, May 21, 1999. 10. Dowdy, J.C. and R.M. Sayre, “Comparison of IEC and U.S. FDA Sunlamp Standards: Critical Discrepancies in Exposure Timers and Annual Exposure Limits,” Proceedings of the CIE Symposium 2004 on Light and Health: Non-Visual Effects, Vienna, Austria, pp. 183-188. 11. Vajdic, C.M., A. Kricker, M. Giblin, et al, “Sun Exposure Predicts Risk of Ocular Melanoma in Australia,” International Journal of Cancer, 101(2): 175-182, September 2002. 12. FDA, “Report to Congress: Labeling Information on the Relationship Between the Use of Indoor Tanning Devices and Development of Skin Cancer or Other Skin Damage,” submitted December 2008, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109288.htm. 13. Fitzpatrick, T.B., “The Validity and Practicality of Sun-Reactive Skin Type I Through VI,” Archives of Dermatology, 124: 869-871, 1988. 14. Pathak, M.A. and D.L. Fanselow, “Photobiology of Melanin Pigmentation: Dose/Response of Skin to Sunlight and its Contents,” Journal of the American Academy of Dermatology, 9: 724-733, 1983. 15. Miller, S.A., S.G. Coelho, S.W. Miller, et al., “Evidence for a New Paradigm for UV Exposure: A Universal Schedule That is Skin Phototype-Independent,” Photoderm Photoimm Photomed, 28: 187-195, 2012. 16. http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. List of Subjects 21 CFR Part 1002

    Electronic products, Radiation protection, Reporting and recordkeeping requirements.

    21 CFR Part 1040

    Electronic products, Incorporation by reference, Labeling, Lasers, Medical devices, Radiation protection, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR parts 1002 and 1040 be amended as follows:

    PART 1002—RECORDS AND REPORTS 1. The authority citation for part 1002 is revised to read as follows: Authority:

    21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 374, 393.

    2. Section 1002.1 is amended by revising Table 1 to read as follows:
    § 1002.1 Applicability. Table 1—Record and Reporting Requirements by Product Manufacturer Products Product
  • reports
  • § 1002.10
  • Supplemental
  • reports
  • § 1002.11
  • Abbreviated
  • reports
  • § 1002.12
  • Annual
  • reports
  • § 1002.13
  • Test records
  • § 1002.30(a) 1
  • Distribution
  • records
  • § 1002.30(b) 2
  • Dealer and
  • distributor
  • Distribution
  • records
  • §§ 1002.40
  • and 1002.41
  • DIAGNOSTIC X-RAY 3 (§§ 1020.30, 1020.31, 1020.32, and 1020.33): Computed tomography X X X X X X X-ray system 4 X X X X X X Tube housing assembly X X X X X X-ray control X X X X X X X-ray high voltage generator X X X X X X X-ray table or cradle X X X X X-ray film changer X X X Vertical cassette holders mounted in a fixed location and cassette holders with front panels X X X X Beam-limiting devices X X X X X X Spot-film devices and image intensifiers manufactured after April 26, 1977 X X X X X X Cephalometric devices manufactured after February 25, 1978 X X X Image receptor support devices for mammographic X-ray systems manufactured after September 5, 1978 X X X X CABINET X RAY (§ 1020.40): Baggage inspection X X X X X X Other X X X X X PRODUCTS INTENDED TO PRODUCE PARTICULATE RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC OR CABINET DIAGNOSTIC X-RAY: Medical X X X X Analytical X X X X Industrial X X X X TELEVISION PRODUCTS (§ 1020.10): <25 kilovolt (kV) and <0.1 milliroentgen per hour (mR/hr IRLC 5 6 X X 6 ≥25kV and <0.1mR/hr IRLC 5 X X X ≥0.1mR/hr IRLC 5 X X X X X MICROWAVE/RF: MW ovens (§ 1030.10) X X X X X MW diathermy X MW heating, drying, security systems X RF sealers, electromagnetic induction and heating equipment, dielectric heaters (2-500 megahertz) X OPTICAL: Phototherapy products X X Laser products (§§ 1040.10 and 1040.11) Class I lasers and products containing such lasers 7 X X X Class I laser products containing class IIa, II, IIIa, lasers 7 X X X X Class IIa, II, IIIa lasers and products other than class I products containing such lasers 7 X X X X X X Class IIIb and IV lasers and products containing such lasers 7 X X X X X X Sunlamp products (§ 1040.20) Lamps only X X X X X Sunlamp products X X X X X X Protective eyewear X X X X X Mercury vapor lamps (§ 1040.30) T lamps X X X R lamps X ACOUSTIC: Ultrasonic therapy (§ 1050.10) X X X X X X Diagnostic ultrasound X Medical ultrasound other than therapy or diagnostic X X Nonmedical ultrasound X 1 However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained. 2 The requirement includes §§ 1002.31 and 1002.42, if applicable. 3 Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see § 1020.30(d)(1) through (d)(3). 4 Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in § 1020.30(c). 5 Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (§ 1020.10(c)(3)(iii)). 6 Annual report is for production status information only. 7 Determination of the applicable reporting category for a laser product hall be based on the worst-case hazard present within the laser product.
    PART 1040—PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS 1. The authority citation for 21 CFR part 1040 is revised to read as follows: Authority:

    21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371, 381, 393.

    2. Section 1040.20 is revised to read as follows:
    § 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.

    (a) Applicability. The provisions of this section, as amended, are applicable as specified to all sunlamp products and ultraviolet lamps intended for use in sunlamp products not later than [A DATE WILL BE ADDED 1 YEAR AFTER DATE OF PUBLICATION OF A FUTURE FINAL RULE IN THE Federal Register].

    (b) Definitions. As used in this section, the following definitions apply:

    Exposure position means any position, distance, orientation, or location relative to the radiating surfaces of the sunlamp product at which the user is intended to be exposed to ultraviolet radiation from the sunlamp product, as recommended by the manufacturer.

    Irradiance means the radiant power incident on a surface at a specified location and orientation relative to the radiating surface divided by the area of the surface, as the area becomes vanishingly small, expressed in units of watts per square centimeter (W/cm2).

    Maximum exposure time (Te) means the greatest continuous exposure time interval recommended by the manufacturer of the sunlamp product.

    Maximum timer interval means the greatest time interval setting on the timer of a sunlamp product.

    Protective eyewear or protective goggles means any device designed to be worn by users of a sunlamp product to reduce exposure of the eyes to radiation emitted by the product.

    Spectral irradiance (E λ ) means the irradiance resulting from radiation within a wavelength range divided by the wavelength range as the range becomes vanishingly small, expressed in units of watts per square centimeter per nanometer (W/(cm2/nm)).

    Spectral transmittance (T λ ) means the spectral irradiance transmitted through protective eyewear divided by the spectral irradiance incident on the protective eyewear.

    Sunlamp product means any device designed to incorporate one or more ultraviolet lamps intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. This definition includes tanning beds and tanning booths.

    Tanning course means a consecutive series of tanning exposures until a tan is developed, usually spanning a period of 3 to 4 weeks.

    Timer means any device incorporated into a sunlamp product that terminates radiation emission after a preset time interval.

    Ultraviolet lamp means any lamp that produces ultraviolet radiation in the wavelength interval of 200 to 400 nanometers in air and that is intended for use in any sunlamp product.

    (c) Performance requirements—(1) UVC (200-290 nm) irradiance. The total irradiance emitted by a sunlamp product in the wavelength range between 200 and 290 nm (UVC) shall not exceed 0.03 W/m2. UVC irradiance shall be measured at the shortest exposure distance recommended by the manufacturer, as required to be provided on the label of the sunlamp product by paragraph (d)(1)(ii) of this section. UVC irradiance shall be calculated using the following formula:

    EP22DE15.001 Where: E is the total irradiance over the wavelength range of interest Eλ is the spectral irradiance in W/(m2-nm) Δλ is the wavelength interval (nm). The wavelength interval shall be 1 nm or less.

    (2) Timer system. (i) Each sunlamp product shall incorporate a timer system with multiple timer settings adequate for the recommended exposure time intervals for different exposure positions and expected results of the products as specified in the label information required by paragraph (e) of this section.

    (ii) The maximum timer interval may not exceed the manufacturer's recommended maximum exposure time (Te) that is indicated on the label, as required by paragraph (d)(1)(iv) of this section. In addition, the maximum timer interval shall not result in a biologically-effective dose that exceeds 500 J/m2, weighted with the erythema action spectrum provided in figure 103 of IEC 60335-2-27, Ed. 5.0, which is incorporated by reference. The manufacturer's recommended maximum exposure time (Te) shall be determined using the following formula:

    EP22DE15.002 Where: Sλ is the erythema action spectrum in figure 103 of IEC 60335-2-27, Ed. 5.0 Eλ is the spectral irradiance in W/(m2-nm) Δλ is the wavelength interval (nm). The wavelength interval shall be 1 nm or less.

    (iii) No timer interval may have an error greater than 10 percent of the maximum timer interval of the sunlamp product.

    (iv) The timer may not automatically reset and cause radiation emission to resume for a period greater than the unused portion of the timer cycle, when emission from the sunlamp product has been prematurely terminated.

    (3) Control for termination of radiation emission. Each sunlamp product shall incorporate a control on the product to enable the person being exposed to manually terminate radiation emission from the product at any time without disconnecting the electrical plug or removing the ultraviolet lamp. This control shall be easily accessible to the user and be readily identified by touch and sight.

    (4) Protective eyewear. (i) Each sunlamp product shall be accompanied by the number of sets of protective eyewear that is equal to the maximum number of persons that the instructions provided under paragraph (e)(1)(ii) of this section recommend to be exposed simultaneously to radiation from such product.

    (ii) The spectral transmittance to the eye of all protective eyewear intended to be used with the sunlamp product shall not exceed a value of 0.001 over the wavelength range of greater than 200 nm through 320 nm, shall not exceed a value of 0.01 over the wavelength range of greater than 320 nm through 400 nm, and shall not exceed a value of 0.05 over the wavelength range of greater than 400 nm through 550 nm. In order to ensure adequate visibility through the protective eyewear, the luminous transmittance shall not be less than 1.0 percent. Spectral transmittance and luminous transmittance must be measured in accordance with clause 32.102 of IEC 60335-2-27, Ed. 5.0, which is incorporated by reference.

    (5) Compatibility of lamps. An ultraviolet lamp shall not be capable of insertion and operation in either the “single-contact medium screw” or the “double-contact medium screw” lampholders described in C81.10-1976, which is incorporated by reference.

    (d) Label requirements. In addition to the labeling requirements in part 801 of this chapter and the certification and identification requirements of §§ 1010.2 and 1010.3 of this chapter, each sunlamp product and ultraviolet lamp is subject to the labeling requirements prescribed in this paragraph and paragraph (e) of this section.

    (1) Labels for sunlamp products. Each sunlamp product shall have labels which contain:

    (i) A warning statement with the following language and format:

    EP22DE15.003

    (ii) Exposure position(s) that may be expressed either in terms of a distance specified both in meters and in feet (or in inches) or through the use of markings or other means to indicate clearly the recommended exposure position.

    (iii) Directions for achieving the recommended exposure position(s) and a warning that the use of other positions may result in overexposure.

    (iv) The manufacturer's recommended exposure schedule, including maximum exposure times per session, and overall maximum exposure time, in minutes, and spacing of sequential exposures. This schedule, with the following exceptions, must be developed in accordance with Annex DD of IEC 60335-2-27, Ed. 5.0, which is incorporated by reference.:

    (A) The maximum single dose (which corresponds to the maximum timer interval at 1040.20(c)(2)(ii)) is 500 J/m2 (not 600 J/m2 as stated in Annex DD).

    (B) Information regarding the maximum number of exposures per year must be based on a maximum yearly dose of 15 kJ/m2, weighted according to the erythema action spectrum shown in figure 103 of IEC 60335-2-27, Ed. 5.0.

    (C) The exposure schedule must also include the following warning: “Skin Type I individuals (always burns, never tans) should never use sunlamp products.” The exposure schedule must also include the statement: “Maximum sessions per week = 2.”

    (D) Example schedule. For a sunlamp product whose maximum exposure time (Te) = 20 minutes, the following table provides an example of what the exposure schedule might look like where a single tanning course covers a 4-week period:

    Manufacturer-Recommended Exposure Schedule Maximum exposure time must not exceed 20 minutes Session # 1 2 3 4 5 6 7 8 Minutes (maximum) per session 4 6 8 10 13 16 20 20 Minimum time between exposures = 48 hours Maximum sessions per week = 2 Maximum tanning courses per year = 6 Skin Type I individuals (always burns, never tans) should never use sunlamp products

    (v) A statement indicating the time it may take before the expected results appear.

    (vi) The designation of the ultraviolet lamp equivalency code range to be used in the sunlamp product as defined in Clause 22.111 and Annex CC of IEC 60335-2-27, Ed. 5.0, which is incorporated by reference.

    (2) Labels for ultraviolet lamps. Each ultraviolet lamp shall have a label which contains:

    (i) The warning: “Sunlamp—DANGER—Ultraviolet radiation. Follow instructions.”

    (ii) The UV lamp equivalency code as defined in Annex CC of IEC 60335-2-27, Ed. 5.0, which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (i) of this section. In determining the “UV code” component of the UV lamp equivalency code, output must be measured in accordance with IEC 61228, Ed. 2.0 (iii) The model identification, if applicable.

    (iv) The words “Use ONLY in fixture equipped with a timer.”

    (3) Label specifications. (i) The labels prescribed in paragraph (d)(1) of this section for sunlamp products shall be permanently affixed or inscribed on the product when fully assembled for use so as to be legible and readily accessible to view by the person who will be exposed immediately before the use of the product. The labels shall be of sufficient durability to remain legible throughout the expected lifetime of the product. To be legible and readily accessible to view, the sunlamp product warning statement required by paragraph (d)(1)(i) of this section shall comply with the following:

    (A) It shall appear on a prominent part or panel displayed under normal conditions of use so that it is readily accessible to view whether the tanning bed canopy (or tanning booth door) is open or closed when the person who will be exposed approaches the equipment;

    (B) It shall be physically separate and visually distinct from the other required label information;

    (C) It shall meet the following font size and font color requirements: The lettering in the word “DANGER” shall be at least 10 millimeters (height), at least double the height of the other words in the warning statement, in all capital letters, and in red or another font color that is legible and distinct from the other words in the warning statement. The lettering in the other words in the warning statement shall be at least 5 millimeters (height) and in lower case or title case.

    (ii) The information prescribed in paragraph (d)(2) of this section for ultraviolet lamps shall be permanently affixed or inscribed on the lamp itself so as to be legible and readily accessible to view, as well as on the packaging of the lamp.

    (iii) If the size, configuration, design, or function of the sunlamp product or ultraviolet lamp would preclude compliance with the requirements for any required label or would render the required wording of such label inappropriate or ineffective, the Director, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, on the Director's own initiative or upon written application by the manufacturer, may approve alternate means of providing such information or alternate wording for such label, as appropriate.

    (iv) In lieu of permanently affixing or inscribing tags or labels on the ultraviolet lamp as required by §§ 1010.2(b) and 1010.3(a) of this chapter, the manufacturer of the ultraviolet lamp may permanently affix or inscribe such required tags or labels on the lamp packaging uniquely associated with the lamp, if the name of the manufacturer and month and year of manufacture are permanently affixed or inscribed on the exterior surface of the ultraviolet lamp so as to be legible and readily accessible to view.

    (v) A label may contain statements or illustrations in addition to those required by this paragraph if the additional statements are not false or misleading in any particular, e.g., if they do not diminish the impact of the required statements, and are not prohibited by this chapter.

    (e) Informational requirements—User information. Each manufacturer of a sunlamp product or ultraviolet lamp shall provide or cause to be provided to purchasers and, upon request, to others at a cost not to exceed the cost of publication and distribution, adequate instructions for use to minimize the potential for injury to the user, including the following information:

    (1) Sunlamp Products. The users' instructions for a sunlamp product shall contain:

    (i) A reproduction of all the label information required by paragraph (d)(1) of this section prominently displayed at the beginning of the instructions.

    (ii) A statement of the maximum number of people who may be exposed to the sunlamp product at the same time and a warning that only that number of protective eyewear has been provided.

    (iii) Instructions for the proper operation of the sunlamp product including the function, use, and setting of the timer and other controls, and the use of protective eyewear.

    (iv) Instructions for obtaining repairs and recommended replacement components and accessories which are compatible with the sunlamp product, including compatible protective eyewear, ultraviolet lamps, timers, reflectors, and filters, which will, when installed and used as instructed, result in continued compliance with the standard.

    (v) Manufacturers of sunlamp products shall provide as an integral part of any user instruction or operation manual that is regularly supplied with the product, or, if not so supplied, shall cause to be provided with each sunlamp product: Adequate instructions for assembly, operation, and maintenance, including clear warnings concerning precautions to avoid possible exposure to ultraviolet radiation during assembly, testing, and maintenance, and a schedule of maintenance necessary to keep the sunlamp product in compliance with this section.

    (2) Ultraviolet lamps. The users' instructions for an ultraviolet lamp not accompanying a sunlamp product shall contain:

    (i) A reproduction of the label information required in paragraph (d)(2) of this section, prominently displayed at the beginning of the instructions.

    (ii) A warning that the instructions accompanying the sunlamp product must always be followed to avoid or to minimize potential injury.

    (3) Promotional materials. Manufacturers of sunlamp products shall provide or cause to be provided in all catalogs, specification sheets, and descriptive brochures intended for consumers in which sunlamp products are offered for sale, and on all consumer-directed Web pages on which sunlamp products are offered for sale, a legible reproduction (color optional) of the warning statement required by paragraph (d)(1)(i) of this section.

    (f) Test for determination of compliance. Tests on which certification under § 1010.2 of this chapter is based shall account for all errors and statistical uncertainties in the process and, wherever applicable, for changes in radiation emission or degradation in radiation safety with age of the sunlamp product. Measurements for certification purposes shall be made under those operational conditions, lamp voltage, current, and position as recommended by the manufacturer. For these measurements, the measuring instrument shall be positioned at the recommended exposure position and so oriented as to result in the maximum detection of the radiation by the instrument. The performance requirements for the measuring instrument specified in IEC 60335-2-27, Ed. 5.0 Clause 32.101, which is incorporated by reference, shall apply.

    (g) Modification of certified sunlamp products. The modification of a sunlamp product, previously certified under § 1010.2 of this chapter, constitutes manufacturing under the Federal Food, Drug, and Cosmetic Act if the modification affects any aspect of the product's performance or intended function(s) for which this section has an applicable requirement. The person who performs such modification shall recertify and re-identify the sunlamp product in accordance with the provisions of §§ 1010.2 and 1010.3 of this chapter.

    (h) Medical device classification regulation. Sunlamp products and ultraviolet lamps intended for use in sunlamp products are subject to special controls and restrictions on sale, distribution, and use as set forth in § 878.4635 of this chapter.

    (i) Incorporation by reference. The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at the Food and Drug Administration, Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available from the following sources. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    (1) American National Standards Institute (ANSI), 1889 L St. NW., 11th Floor, Washington, DC 20036, [email protected], www.ansi.org, 202-293-8020.

    (i) ANSI C81.10-1976, “Specifications for Electric Lamp Bases and Holders—Screw-Shell Types,” dated September 1976.

    (ii) [Reserved]

    (2) International Electrotechnical Commission (IEC), EC Central Office, 3 rue de Varembe, CH-1211 Geneva 20, Switzerland, www.iec.ch, call 41-22-919-02-11.

    (i) IEC 60335-2-27, Ed. 5.0: 2009-12, “Household and Similar Electrical Appliances—Safety—Part 2-27: Particular Requirements for Appliances for Skin Exposure to Ultraviolet and Infrared Radiation,” dated December 2009.

    (ii) IEC 61228, Ed. 2.0, “Fluorescent Ultraviolet Lamps Used for Tanning—Measurement and Specification Method,” dated January 2008.

    Dated: December 16, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-32023 Filed 12-18-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF TRANSPORTATION Federal Highway Administration 23 CFR Part 655 [FHWA Docket No. FHWA-2015-0028] National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for Streets and Highways; Request for Comment AGENCY:

    Federal Highway Administration (FHWA), Department of Transportation (DOT).

    ACTION:

    Request for Comments (RFC).

    SUMMARY:

    The Manual on Uniform Traffic Control Devices for Streets and Highways (MUTCD) is incorporated in our regulations, approved by FHWA, and recognized as the national standard for traffic control devices used on all streets, highways, bikeways, and private roads open to public travel. This document asks for responses to a series of questions regarding the future direction of the MUTCD. Specific topic areas include target audience/intended user, content and organization, process for introducing new traffic control devices, and frequency of MUTCD editions.

    DATES:

    Comments must be received on or before February 18, 2016.

    ADDRESSES:

    Mail or hand deliver comments to the U.S. Department of Transportation, Dockets Management Facility, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, or fax comments to (202) 493-2251. Alternatively, comments may be submitted to the Federal eRulemaking portal at http://www.regulations.gov. All comments must include the docket number that appears in the heading of this document. All comments received will be available for examination and copying at the above address from 9 a.m. to 5 p.m., e.t., Monday through Friday, except Federal holidays. Those desiring notification of receipt of comments must include a self-addressed, stamped postcard or you may print the acknowledgment page that appears after submitting comments electronically. Anyone is able to search the electronic form of all comments in any one of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, or labor union). Anyone may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70, Pages 19477-78).

    FOR FURTHER INFORMATION CONTACT:

    For questions about the program discussed herein, contact Mr. Kevin Sylvester, MUTCD Team Leader, FHWA Office of Transportation Operations, (202) 366-2161, or via email at [email protected] For legal questions, please contact Mr. William Winne, Office of the Chief Counsel, (202) 366-1397, or via email at [email protected] Office hours are from 8:00 a.m. to 4:30 p.m., e.t., Monday through Friday, except Federal holidays.

    SUPPLEMENTARY INFORMATION: Electronic Access and Filing

    You may submit or retrieve comments online through the Federal eRulemaking portal at: http://www.regulations.gov. The Web site is available 24 hours each day, 365 days each year. Please follow the instructions. Electronic submission and retrieval help and guidelines are available under the help section of the Web site. An electronic copy of this document may also be downloaded from the Office of the Federal Register's home page at: http://www.archives.gov and the Government Printing Office's Web page at: http://www.access.thefederalregister.org/nara. Anyone is able to search the electronic form of all comments in any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, or labor union). 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://DocketsInfo.dot.gov.

    Purpose of This Notification

    The FHWA is interested in planning for future editions of the MUTCD 1 that will reflect the growing number and application of traffic control devices, changes in technology not only for traffic control devices, but for viewing content in the MUTCD, and developing a structure for the MUTCD that is efficient and easy to use. The FHWA initiated the public comment process by publishing an RFC at 78 FR 2347 (Docket ID: FHWA-2012-0118) on January 11, 2013, that included two options for restructuring the MUTCD and several questions regarding content and public use of the MUTCD. The FHWA's response to the comments, issued June 17, 2013 at 78 FR 36132 (Docket ID: FHWA-2012-0118-0187), indicated that over one half of the commenters recommended postponing any action to restructure the manual pending results from the ongoing National Cooperative Highway Research Program (NCHRP) strategic planning effort.2 That effort is now complete.

    1 The 2009 edition of the MUTCD can be accessed at the following Internet Web site: http://mutcd.fhwa.dot.gov/.

    2 NCHRP 20-07/Task 323, Developing a Long-Range Strategic Plan for the MUTCD, can be accessed at the following Internet Web site: http://apps.trb.org/cmsfeed/TRBNetProjectDisplay.asp?ProjectID=3203.

    The purpose of this notice is to solicit comments from users of the MUTCD about the direction of future editions of the MUTCD. This notice includes a set of specific questions for which FHWA requests comments. Comments and input may be offered on any part of this notification.

    Background

    The MUTCD is incorporated by reference within Federal regulations at 23 CFR part 655, approved by FHWA, and recognized as the national standard for traffic control devices used on all public roads. The MUTCD was incorporated by reference into the Code of Federal Regulations beginning with the publication of the 1971 edition. There have been 10 editions of the MUTCD, beginning with the first edition in 1935. The current MUTCD is the 2009 Edition, incorporating Revisions 1 and 2, dated May 2012 and is available to the public at http://mutcd.fhwa.dot.gov/kno_2009r1r2.htm.

    Over the last several years, the transportation community has expressed concern over several issues related to the MUTCD: (1) Size, (2) complexity in finding information, (3) amount/type of information in the MUTCD, and (4) timeframe required for new traffic control devices or applications to be incorporated. To begin to address these issues, FHWA published an RFC at 78 FR 2347 (Docket ID: FHWA-2012-0118) on January 11, 2013, requesting comment on a potential restructuring of the MUTCD into two documents: The MUTCD and an Applications Supplement (herein referred to as “Restructuring RFC”). The FHWA's response to the comments, issued June 17, 2013, at 78 FR 36132 (Docket ID: FHWA-2012-0118-0187), indicated that given the lack of support from the MUTCD user community, FHWA would not proceed with restructuring the MUTCD into two documents. As discussed in the response to comments, more than 90 percent of the docket letters were either against splitting the MUTCD into two separate documents (approximately 56 percent of responses), or recommended postponing any action to split the manual pending results from the ongoing NCHRP strategic planning effort (approximately 34 percent of responses), which was expected to be available in January 2014. The strategic planning effort was to address many issues that would impact future MUTCD content and structure, including consideration of an MUTCD that would consist of more than one volume. In addition to requesting that FHWA wait for the results of the NCHRP strategic planning effort, many State and local agencies, associations, and consultants suggested that if a decision were to be made to restructure the MUTCD in any significant way, it would be critical for FHWA to partner with stakeholders to develop content for a restructured MUTCD.

    The NCHRP task to which the commenters were referring, NCHRP 20-07/Task 323, is now complete. The objective of the task was to develop a long-range Vision and Strategic Plan for the MUTCD. The plan was delivered to the American Association of State Highway and Transportation Officials' Highway Subcommittee on Traffic Engineering, which approved it by ballot, and then to the National Committee on Uniform Traffic Control Devices (NCUTCD) where that organization adopted the plan (herein referred to as the Vision and Strategic Plan) at its January 2014 meeting.3 The Vision and Strategic Plan contains a discussion of opinions, challenges, needs and questions followed by a presentation of a vision for the MUTCD of the mid-2030s. To achieve that vision, the document includes a strategic plan for transitioning from the current edition to future editions through a series of incremental changes. With the NCHRP effort now complete, and in response to comments from the Restructuring RFC, FHWA believes it is now appropriate for a wider audience of MUTCD users to provide comments to FHWA on the direction of future editions of the MUTCD. It is important to note that FHWA is not seeking comments on the Vision and Strategic Plan document itself. Nor is FHWA seeking comment on any specific proposals for change.

    3 The NCUTCD's January 9, 2014, 20-Year Vision and Strategic Plan for the Manual on Uniform Traffic Control Devices can be viewed at the following Internet Web site: http://www.ncutcd.org/doc/MUTCD-20%20Year%20Vision%20NCUTCD%20Appvd%201-9-14%20FINAL.pdf.

    Concurrent with this effort, FHWA is preparing a Notice of Proposed Amendments (NPA) for the next edition of the MUTCD. The publication date of the NPA is not yet known. Depending on the nature and extent of comments submitted for this RFC, FHWA may incorporate some of the suggestions in the next edition of the MUTCD. More importantly, FHWA is looking to begin planning for MUTCD editions further into the future with the comments submitted for this RFC.

    As discussed above, the public may submit comments online through the Federal eRulemaking portal at: http://www.regulations.gov. In an effort to streamline the process for organizing and reviewing docket comments, the public is invited to submit comments in a spreadsheet that has been specifically developed for this notice. The spreadsheet is available for review and download on http://www.regulations.gov under the docket number listed in the heading of this document. Commenters who wish to use the spreadsheet for their comments are encouraged to download and fill in the spreadsheet, then upload the completed file as indicated in comment instructions. Alternatively, commenters may submit their comments in the comment box and/or via uploading a different file.

    Topic Area 1: Target Audience/Intended User

    Over the years, the MUTCD has expanded in size, due in part to the belief that the MUTCD needs to contain information that is appropriate for all its users. The size and complexity of the MUTCD have significantly increased primarily because of an expansion of the number of devices included in the MUTCD and the desire to provide more specifics in conveying the intent of the language in order to avoid uncertainty. The first edition of the MUTCD, published in 1935, had 166 pages, whereas the current MUTCD contains 820 pages of technical provisions. As discussed in the Restructuring RFC in 2012, FHWA is interested in examining ways to simplify and streamline the MUTCD in a manner that is most user-friendly, while maintaining the appropriate amount of information.

    The MUTCD is used by a wide audience, from State, local, and consulting traffic engineers, to traffic control device technicians, and to some extent, the public. The Vision and Strategic Plan suggests that the size and the complexity of the MUTCD may be reduced by targeting the MUTCD to a more specific audience or organizing it to provide information for different types of users. While FHWA understands that the MUTCD has gained a wide audience, writing or organizing the MUTCD accordingly may be cumbersome and may not have the intended result of simplifying the MUTCD. The MUTCD is currently designed as an engineering reference manual.

    Topic Area 1 Questions

    1A. Should MUTCD content continue to be written with a traffic engineer as the intended audience?

    Topic Area 2: Simplifying and Reorganizing the MUTCD

    As indicated above, FHWA previously issued the Restructuring RFC to identify potential options for simplifying the MUTCD. Comments were not in favor of splitting the MUTCD into two separate documents and many suggested waiting on the results of the Vision and Strategic Plan before determining whether or not the MUTCD should be restructured in a significant way.

    In addition to simplifying, FHWA is exploring several of the reorganizing suggestions received from the Restructuring RFC. The current structure of the MUTCD is based on the type of device and the specialized application of devices. The 2009 edition includes Parts 1 through 4 for types of devices and Parts 5 through 9 for specialized applications of devices. This has been the basic structure of the MUTCD since its inception. In the 2000 edition, FHWA added the current headings of content (Standard, Guidance, Option, and Support paragraphs). The headings provide a clear level of mandate associated with specific content. However, this division by level of mandate can create challenges in providing text that reads well and flows together.

    In order to provide greater flexibility in the MUTCD, the Vision and Strategic Plan recommends an additional level of mandate that would include two versions of Standard statements rather than one. Both types would be requirements, but one level would relate to uniformity while the other would relate to consistency. The uniformity Standard would require the same action in every case and would not allow for deviation based on site conditions. The consistency Standard would require the same action in every case unless a deviation was warranted to accommodate local conditions. The meanings of Guidance (recommended) and Option (permissible) provisions would remain unchanged. The FHWA believes that this concept is not viable for several reasons. First, it would tend to make the MUTCD more complex rather than less complex. Second, because both conditions would be requirements, it is not likely that any legal distinction could be made between the two. The provisions of the current MUTCD do not preclude the application of engineering considerations.

    Coordination within the MUTCD regarding the use of related devices at a single location is often limited. An MUTCD user that is trying to make decisions regarding aspects of traffic control devices used at a specific location might need to reference several different portions of the MUTCD to determine the optimal combination of devices and device features. For example, to review all provisions related to crosswalks, a reader could potentially need to consider Parts 2, 3, 4, 6, 7, 8, and 9, depending on the extent to which the design involves the basic devices of signs, markings, and signals; and specialized applications such as temporary traffic control, school zones, rail grade crossings, and shared-use paths. Cross referencing within the MUTCD is usually provided as appropriate to direct users to related provisions in other Sections or Parts of the MUTCD.

    The tendency for future editions of the MUTCD is likely to expand the amount of content, potentially exacerbating the difficulty in using and finding information in the MUTCD. The FHWA is seeking comment to assess options for structuring the MUTCD to make it easier to use. The following are potential options for simplifying and reorganizing the MUTCD:

    a. Maintain the current structure and format of the MUTCD.

    b. Reorganize the MUTCD content. Potential reorganization structures include:

    i. Traffic control devices by application. Parts 2, 3, and 4 in the current MUTCD would be combined to address applications such as urban intersections, rural highways, and collector streets. These applications would address the use of signs, markings, and signals within that context. Parts 5-9 of the current MUTCD currently use this approach. Such a structure would provide most of the content needed for a given application in a consolidated location within the MUTCD.

    ii. By level of mandate (e.g., Standard and Guidance). Separating Standard, Guidance, Option, and Support provisions within each section may help MUTCD users find information more easily. For example, more experienced MUTCD users may only need to review specific requirements and would want to review only the Standard and Guidance provisions.

    iii. By MUTCD user (e.g., field personnel and engineers). Field personnel typically focus on the field location, installation, and inspection of traffic control devices. Engineers and technicians typically focus on the overall design, operations, and context of a traffic control device in relation to the transportation facilities and other traffic control devices. Consolidating provisions related to user types may simplify the MUTCD for those individuals.

    c. Relocate some of the content from the MUTCD into a companion document that has a similar structure as the MUTCD. The companion document would not contain requirements and could be revised without the rulemaking process. This restructuring would take place in a future edition, not the next edition.

    i. The restructured MUTCD could include traffic control device standards that do not change such as the meaning, appearance, and other key standards.

    ii. The companion document could include traffic control device guidelines that relate to selection, location, operation, and maintenance of devices. The companion document would need to be developed through a consensus-building process that involves appropriate stakeholders with expertise in the use of traffic control devices. The companion document could be revised more frequently than the MUTCD, because it would not be subject to rulemaking.

    Topic Area 2 Questions

    2A. In future editions, should FHWA strive to reduce the amount of explanatory language included in the MUTCD?

    2B. If so, what types of explanatory language should be removed from the MUTCD?

    2C. If explanatory/supplementary information is removed, should it be retained in a separate document?

    2D. What organizational structure should be considered for future MUTCDs? Potential alternatives include:

    a. Current structure.

    b. Application information (e.g., urban intersections, rural highways, and collector streets).

    c. By type of information (design and applications, installation, maintenance).

    d. Other.

    2E. If a different format is not appropriate, what potential alternatives/tools would help users more easily find information?

    2F. As we move toward more electronic use of the MUTCD through computers, tablets, and handheld devices, what additional electronic formats or tools would be useful?

    Topic Area 3: MUTCD Edition Frequency

    There have been 10 editions of the MUTCD (1935, 1942, 1948, 1961, 1971, 1978, 1988, 2000, 2003, and 2009). Timing of revisions of individual editions has varied, with most editions having a limited number of revisions between editions.

    Changes to the MUTCD are made through the rulemaking process because the manual is regulatory in nature. Major changes to the MUTCD are incorporated and added through the publication of new editions of the manual. Occasionally, there is a need to initiate special rulemakings between editions of the MUTCD to incorporate important content without waiting for the next edition of the MUTCD. These are called “Revisions” and are incorporated into the official MUTCD on FHWA's MUTCD Web site. In between editions or revisions of the MUTCD, new traffic control devices or applications can be approved for use through the official experimentation and interim approval processes, as described in Section 1A.10 of the MUTCD.4 Information regarding these experimentations and interim approvals is also posted on FHWA's MUTCD Web site.

    4 Section 1A.10 of the MUTCD can be viewed at the following Internet Web link: http://mutcd.fhwa.dot.gov/pdfs/2009r1r2/mutcd2009r1part1.pdf.

    Developing technical content for inclusion in the MUTCD is a deliberative process. Material associated with new traffic control devices is based on laboratory and/or in-service research evaluations that consider the human factors and performance aspects of the device, which can take several years. The results are then used to develop technical provisions related to that device that can then be considered for a rulemaking activity to amend the MUTCD. The rulemaking process involves publishing a proposed revision for public comment, analyzing the public comments submitted to the docket, and then publishing a final rule that addresses the public comments. For a new edition of the MUTCD, this process typically takes approximately 2 years from the publication of the proposed rulemaking document to the final rule. After the final rule, States have up to 2 years to adopt the new MUTCD or their State equivalent. Given this timeline, it would be impractical to publish new editions of the MUTCD with significant new content at intervals less frequent than 6 years. The next edition of the MUTCD is currently targeted for publication in late 2018, representing 9 years between new editions.5

    5 Revisions 1 and 2 to the 2009 MUTCD were published in May 2012.

    Currently, 18 States adopt the national MUTCD as their standard, without any supplement. Ten States develop their own MUTCD based on the national MUTCD. Twenty-two States and the District of Columbia and Puerto Rico develop supplements to the national MUTCD.

    Developing supplements to the national MUTCD and developing State-specific MUTCDs is likely to be costly to the States and introduces a potential for conflicts with the national MUTCD. State agency resources are already provided to review and comment on national MUTCD rulemaking and many State agencies support their staff member participation in the NCUTCD meetings and activities. As a result, FHWA would like to better understand why States develop their own MUTCDs or supplements. The FHWA believes that a better understanding of why States develop their own MUTCDs could better inform the development of future editions of the national MUTCD. It should be noted that FHWA is not discouraging States from developing their own MUTCDs or supplements.

    The FHWA is interested in comments related to the timing of new editions of the MUTCD and intermediate revisions of the MUTCD between editions, as well as the information about the development of State MUTCDs and supplements.

    3A. If the minimum practical interval between editions is 6 to 8 years, should FHWA promulgate rulemakings to issue one or more revisions that are focused on individual traffic control devices between new editions of the MUTCD?

    3B. What about the national MUTCD or State law makes it necessary for some States to develop their own MUTCDs or supplements?

    3C. Is there anything in the national MUTCD that could be changed to reduce the burden for States to review, revise, prepare, and adopt their own State MUTCD or supplement?

    Authority:

    23 U.S.C. 101(a), 104, 109(d), 114(a), 217, 315, and 402(a); 23 CFR 1.32; and, 49 CFR 1.85.

    Issued on: December 10, 2015. Gregory G. Nadeau, Administrator, Federal Highway Administration.
    [FR Doc. 2015-32107 Filed 12-21-15; 8:45 am] BILLING CODE 4910-22-P
    DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 235 [Docket ID: DOD-2013-OS-0220] RIN 0790-AJ15 Prohibition of the Sale or Rental of Sexually Explicit Material on DoD Property AGENCY:

    Under Secretary of Defense for Personnel and Readiness, DoD.

    ACTION:

    Proposed rule.

    SUMMARY:

    This rulemaking codifies in the Code of Federal Regulations the policy for restrictions on the sale or rental of sexually explicit materials on property under the jurisdiction of the DoD, or by Service members or DoD civilian employees acting in their official capacities based on 10 U.S.C. 2495b. It also establishes the Resale Activities Review Board (referred to in this rule as the “Board”).

    DATES:

    Comments must be received by February 22, 2016.

    ADDRESSES:

    You may submit comments, identified by docket number and/or RIN 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 or Regulatory Information Number (RIN) 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:

    Ryan Atkins, 703-588-0619.

    SUPPLEMENTARY INFORMATION:

    Revisions to the rulemaking will be reported in future status updates as part of DoD's retrospective plan under Executive Order 13563 completed in August 2011. DoD's full plan can be accessed at: http://www.regulations.gov/#!docketDetail;D=DOD-2011-OS-0036.

    Executive Summary

    10 U.S.C. 2495b prohibits the sale or rental of sexually explicit material on property under DoD jurisdiction. The section also requires DoD to establish the Resale Activities Review Board (the Board) to review material offered for sale or rental on property under DoD jurisdiction and to make recommendations to the Secretary of Defense, in accordance with section 2495b. Any material that is determined to be sexually explicit, as defined by section 2495b, is not offered and if materials are already on store shelves, they are removed.

    This proposed rule will cost the DoD approximately $5,500 annually for the life of the rule to manage the Board. It is anticipated that the costs will recur for the life of the proposed rule varying for inflation. 10 U.S.C. 2495b authorizes Board members travel expenses while away from their homes or regular places of business in the performance of services for the Board. DoD implemented section 2495b by issuing DoD Instruction (DoDI) 4105.70, “Prohibition of the Sale or Rental of Sexually Explicit Material on DoD Property” (the Instruction). This instruction is available on the Internet from the DoD Issuances Web site at http://www.dtic.mil/whs/directives. The Instruction established DoD policy that prohibits the sale or rental of sexually explicit material on property under DoD jurisdiction, and no Service member or DoD civilian employee, acting in his or her official capacity, will provide for sale, remuneration, or rental any sexually explicit material to another person. This proposed rule facilitates DoD's compliance with the requirements of 10 U.S.C. 2495b and fulfills the requisite public notification of the DoD process to implement this statutory requirement.

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

    Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This proposed rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, this proposed rule has been reviewed by the Office of Management and Budget.

    Sec. 202, Public Law 104-4, “Unfunded Mandates Reform Act”

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4) requires agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2014, that threshold is approximately $141 million. This proposed rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.

    Public Law 96-354, “Regulatory Flexibility Act” (5 U.S.C. 601)

    The Department of Defense certifies that this proposed rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

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

    It has been certified that 32 CFR part 235 does not impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995.

    Executive Order 13132, “Federalism”

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

    List of Subjects in 32 CFR Part 235

    Business and industry, Concessions, Government contracts, Military personnel.

    Accordingly 32 CFR part 235 is proposed to be revised to read as follows:

    PART 235—PROHIBITION OF THE SALE OR RENTAL OF SEXUALLY EXPLICIT MATERIAL ON DOD PROPERTY Sec. 235.1 Purpose. 235.2 Applicability. 235.3 Definitions. 235.4 Policy. 235.5 Responsibilities. 235.6 Resale Activities Review Board. Authority:

    10 U.S.C. 2495b.

    § 235.1 Purpose.

    (a) Pursuant to 10 U.S.C. 2495b and consistent with DoD Instruction 1330.09 “Armed Services Exchange Policy,” (available at http://www.dtic.mil/whs/directives/corres/pdf/133009p.pdf), this part establishes policy and assigns responsibilities concerning the prohibition on the sale or rental of sexually explicit materials:

    (1) On property under the jurisdiction of the DoD; and

    (2) By Service members or DoD civilian employees acting in their official capacities.

    (b) Establishes the Resale Activities Review Board (the Board) pursuant to 10 U.S.C. 2495b and consistent with DoD Instruction 5105.18, “DoD Intergovernmental and Intragovernmental Committee Management Program” (available at http://www.dtic.mil/whs/directives/corres/pdf/510518p.pdf).

    § 235.2 Applicability.

    This part applies to the Office of the Secretary of Defense, the Military Departments, the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities, and all other organizational entities within the DoD (referred to collectively in this part as the “DoD Components”).

    § 235.3 Definitions.

    Unless otherwise noted, these terms and their definitions are for the purpose of this part.

    Dominant theme. A theme of any material that is superior in power, influence, and importance to all other themes in the material combined.

    Lascivious. Lewd and intended or designed to elicit a sexual response.

    Material. An audio recording, a film or video recording, or a periodical with visual depictions, produced in any medium.

    Property under the jurisdiction of the DoD. Includes commissaries, all facilities operated by the Army and Air Force Exchange Service, the Navy Exchange Service Command, the Navy Resale and Services Support Office, and the Marine Corps Exchange; and ship stores.

    Sexually explicit material. Material, the dominant theme of which is the depiction or description of nudity, including sexual or excretory activities or organs, in a lascivious way.

    § 235.4 Policy.

    It is DoD policy that:

    (a) No sexually explicit material will be offered for sale or rental on property under DoD jurisdiction.

    (b) No Service member or DoD civilian employee, acting in an official capacity, may offer for sale, remuneration, or rental sexually explicit material to another person.

    § 235.5 Responsibilities.

    (a) The Assistant Secretary of Defense for Manpower and Reserve Affairs (ASD(M&RA)), under the authority, direction, and control of the Under Secretary of Defense for Personnel and Readiness (USD(P&R)), and in accordance with DoD Directive 5124.02, “Under Secretary of Defense for Personnel and Readiness (USD(P&R))” (available at http://www.dtic.mil/whs/directives/corres/pdf/512402p.pdf) and DoD Directive 5124.09, “Assistant Secretary of Defense for Readiness and Force Management (ASD(R&FM))” (available at http://www.dtic.mil/whs/directives/corres/pdf/512409p.pdf), will:

    (1) Monitor and ensure compliance with this part.

    (2) Establish the nine-member Board.

    (3) Appoint six Board members and three alternates in accordance with 10 U.S.C. 2495b and paragraph (a) of § 235.6.

    (4) Designate one Board member to be the Chair.

    (5) Monitor the activities of the Board and ensure that the Board discharges its responsibilities as described in § 235.6.

    (6) Review the Board's recommendations and make the final determination whether material is sexually explicit, as defined by 10 U.S.C. 2495b.

    (b) Under the authority, direction, and control of the ASD(M&RA), the Deputy Assistant Secretary of Defense for Military Community and Family Policy (DASD(MC&FP)) will:

    (1) Administer the Board and provide military resale policy guidance.

    (2) Publicize the Board's recommendations through the Office of the USD(P&R) public Web site.

    (c) The General Counsel of the Department of Defense will provide legal advice to the Board.

    (d) The Secretaries of the Military Departments will:

    (1) Ensure that their respective Department's resale activities comply with this part.

    (2) Each appoint one member to the Board, in accordance with 10 U.S.C. 2495b.

    (3) Provide nominees to the ASD(M&RA) concerning the six Board members and three alternates appointed by the ASD(M&RA) in accordance with paragraph (a) of § 235.6.

    (4) Promptly notify the DASD(MC&FP) of a current or projected vacancy on the Board.

    (e) The Chief of the National Guard Bureau recommends to the ASD(M&RA) a senior noncommissioned officer for appointment to the Board who will represent the Senior Enlisted Advisor of the National Guard Bureau.

    § 235.6 Resale Activities Review Board.

    (a) Composition. The Board will have nine members and three alternates, including at least one member appointed by the ASD(M&RA) with experience managing or advocating for military family programs and who is also an eligible patron of the Defense commissary system and the Defense exchange system.

    (1) Board members and alternates will be representatives of the following:

    (i) The Senior Enlisted Advisors of the Army, the Navy, the Air Force, Marine Corps, and the National Guard Bureau;

    (ii) The Surgeons General of the Army, the Navy, and the Air Force;

    (iii) The military community and family programs of the Army, Navy, Air Force, and Marine Corps.

    (2) Board members will be senior full-time or permanent part-time DoD civilian employees or active duty Service members not currently assigned to or employed by the Army and Air Force Exchange Service, the Navy Exchange Service Command, or the Marine Corps Exchange Service.

    (3) The ASD(M&RA) will appoint one member to be Chair for a 2-year term; the Chair will rotate among the Military Departments.

    (4) A vacancy on the Board will be filled in the same manner as the original appointment.

    (b) Authorities. (1) The Board has the authority and responsibility to review material offered or to be offered for sale or rental on property under DoD jurisdiction and to recommend to the ASD(M&RA) whether any such material is sexually explicit as defined in 10 U.S.C. 2495b.

    (2) If the ASD(M&RA) determines that any material offered for sale or rental on property under DoD jurisdiction is sexually explicit, such material must be withdrawn from all retail outlets where it is sold or rented and returned to distributors or suppliers. Any material that is determined to be sexually explicit will not be offered for sale or rental on property under DoD jurisdiction unless the Board reconsiders the material under paragraph (c)(4) of this section, and the ASD(M&RA) decides that the material is not sexually explicit.

    (c) Procedures. (1) The Board will convene at least once a year, and additionally as necessary, to review and make recommendations to the ASD(M&RA) concerning whether any material offered or to be offered for sale or rental on property under DoD jurisdiction is sexually explicit as defined in 10 U.S.C. 2495b. The Board will, to the extent practicable, maintain and update relevant information about Board recommendations.

    (2) At the conclusion of the Board's review and the ASD(M&RA) determination, the ASD(M&RA) will issue guidance to the Military Departments for exchange service headquarters, purchasing agents, and managers of retail outlets about the purchase, withdrawal, and return of sexually explicit material. The ASD(M&RA) may also provide guidance to the Military Departments for exchange service headquarters, purchasing agents, and managers of retail outlets about material that he or she has determined is not sexually explicit. Purchasing agents and managers of retail outlets will continue to follow their usual purchasing and stocking practices unless instructed otherwise by the ASD(M&RA).

    (3) Any purchasing agent or manager of a retail outlet must request in writing a review from the Board and ASD(M&RA) determination about questionable material either before purchase or as soon as possible if:

    (i) He or she has reason to believe that material offered or to be offered for sale or rental on property under DoD jurisdiction may be sexually explicit as defined in 10 U.S.C. 2495b.

    (ii) Such material is not addressed by the ASD(M&RA)'s guidance issued in paragraph (c)(2) of this section.

    (4) Material determined to be sexually explicit by the ASD(M&RA) may be submitted to the Board for reconsideration every 5 years. If substantive changes in the publication standards occur earlier, the purchasing agent or manager of a retail outlet under DoD jurisdiction may request a review.

    (5) The Board will establish procedures for the exchange services to provide material for the Board to review.

    Dated: December 15, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-31918 Filed 12-21-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION 34 CFR Chapter II [Docket ID ED-2015-OESE-0130] Implementing Programs under Title I of the Elementary and Secondary Education Act AGENCY:

    Department of Education (Department).

    ACTION:

    Request for information and notice of meetings.

    SUMMARY:

    The Secretary of Education (Secretary) is soliciting advice and recommendations from interested parties prior to publishing proposed regulations to implement programs under title I of the Elementary and Secondary Education Act of 1965, as amended (title I). Programs under title I are designed to help disadvantaged children meet high academic standards. The Secretary invites advice and recommendations concerning topics for which regulations may be helpful to assist States, school districts, and schools to implement the new law. In addition, we will convene two regional meetings at which interested parties may provide additional advice and recommendations.

    DATES:

    We must receive your written comments on or before January 21, 2016. The dates, times, and locations of the regional meetings are listed under the SUPPLEMENTARY INFORMATION section of this document.

    ADDRESSES:

    Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments by fax or email. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.

    Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on using Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket is available on the site under the “Help” tab.

    Postal Mail, Commercial Delivery, or Hand Delivery: If you mail or deliver your comments in response to this request, address them to Deborah Spitz, U.S. Department of Education, 400 Maryland Avenue SW., Room 3E306, Washington, DC 20202.

    Privacy Note: The Department's policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available.

    FOR FURTHER INFORMATION CONTACT:

    Deborah Spitz, U.S. Department of Education, 400 Maryland Avenue SW., Room 3E306, Washington, DC 20202. Telephone: (202) 260-3793 or by email: [email protected].

    If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION:

    Background: On December 10, 2015, the President signed into law the “Every Student Succeeds Act” (ESSA), amending the Elementary and Secondary Education Act of 1965 (ESEA). The ESSA reauthorizes the ESEA and advances the ESEA's legacy of equity and opportunity by, among other things, requiring States to hold all students to high academic standards that prepare them for success in college and careers. The ESSA also requires that, if students fall behind in meeting these standards, States and local educational agencies (LEAs) implement evidence-based interventions to help them and their schools improve, with a particular focus on the lowest-performing schools, high schools with low graduation rates, and schools in which subgroups of students are underperforming.

    The programs included in title I are designed to help disadvantaged children meet high academic standards. These programs include: Improving Basic Programs Operated by State and Local Educational Agencies (part A); State Assessment Grants (part B); Education of Migratory Children (part C); Prevention and Intervention Programs for Children and Youth who are Neglected, Delinquent, or At-Risk (part D); and Flexibility for Equitable Per-Pupil Funding (part E).

    The ESSA maintained a number of requirements for, and made a number of significant changes to, the title I programs, including the following:

    • Maintaining the requirement for statewide assessments in at least reading/language arts and mathematics in each of grades 3-8 and once in high school; and in science in each of three grade spans (3-5, 6-9, and 10-12), while adding flexibility related to locally selected high school assessments and innovative assessment systems.

    • Eliminating the requirement to calculate adequate yearly progress (AYP) and replacing it with a requirement for each State educational agency to develop an accountability system that—

    • Includes State-designed, long-term goals and measurements of interim progress for all students and separately for each subgroup of students, on academic achievement and graduation rate, that expect greater progress from groups that are further behind;

    • Annually measures, for all students and separately for each subgroup of students, the following indicators: Academic achievement (which, for high schools, may include a measure of student growth, at the State's discretion); for elementary and middle schools, a measure of student growth, if determined appropriate by the State, or another valid and reliable statewide academic indicator; for high schools, the four-year adjusted cohort graduation rate and, at the State's discretion, the extended-year adjusted cohort graduation rate; progress in achieving English language proficiency for English learners; and at least one valid, reliable, comparable, statewide indicator of school quality or student success; and

    • Establishes a system of meaningfully differentiating all public schools on an annual basis that is based on all indicators in the State's accountability system and that, with respect to achievement, growth or the other academic indicator for elementary and middle schools, graduation rate, and progress in achieving English language proficiency, affords: Substantial weight to each such indicator; and, in the aggregate, much greater weight than is afforded to the indicator or indicators of school quality or student success.

    • Eliminating the requirement to identify schools for improvement, corrective action, or restructuring based on missing AYP over a number of years and instead requiring—

    • Identification of, and comprehensive, evidence-based intervention in, the lowest-performing five percent of title I schools, all public high schools with a graduation rate below 67 percent, and public schools in which one or more subgroups of students are performing at a level similar to the performance of the lowest-performing five percent of title I schools and have not improved after receiving targeted interventions for a State-determined number of years; and

    • Identification of, and targeted, evidence-based intervention and support in, schools in which any subgroup of students consistently underperforms.

    • Maintaining and updating the requirement that State title I plans describe how low-income and minority children enrolled in title I schools are not served at disproportionate rates by ineffective (this term was “unqualified” in the prior version of the ESEA), out-of-field, or inexperienced teachers.

    • Expanding the list of elements that must be included in State and district report cards (e.g., adding a requirement to report per-pupil expenditures of Federal, State, and local funds).

    • Maintaining the requirement that title I, part A funds be used to supplement, and not supplant, non-Federal funds, but revising the manner in which an LEA must demonstrate compliance with this requirement by requiring an LEA to demonstrate that the methodology it uses to allocate State and local funds to each title I school ensures that the school receives all the State and local funds it would receive in the absence of participation in title I.

    This list is not exhaustive. Interested parties should review the statute (available at: https://www.thefederalregister.org/fdsys/pkg/BILLS-114s1177enr/pdf/BILLS-114s1177enr.pdf) for complete information on the amendments made to the ESEA by the ESSA. Please also note that this list is not intended to restrict the topics or issues that commenters may address when providing advice and recommendations in response to this document.

    Advice and Recommendations

    The Secretary invites advice and recommendations from interested parties involved with the implementation and operation of programs under title I concerning topics for which regulations or nonregulatory guidance may be necessary or helpful as States and LEAs transition from NCLB and implement the ESSA. The Secretary specifically invites advice and recommendations from State and local education administrators, parents, teachers and teacher organizations, principals, other school leaders (including charter school leaders), paraprofessionals, members of local boards of education, civil rights and other organizations representing the interests of students (including historically underserved students), representatives of the business community, and other organizations involved with the implementation and operation of title I programs.

    Under the ESSA, prior to issuing proposed rules under title I on standards, assessments under section 1111(b)(2), and the requirement under section 1118 that funds be used to supplement, and not supplant, State and local funds, the Department must establish a negotiated rulemaking process.

    Negotiated rulemaking can improve the substance of regulations; increase understanding of, and support for, those regulations; encourage affected parties to communicate with each other and share information, knowledge, expertise, and analysis; and discourage expensive and time-consuming litigation concerning the regulations.

    The Secretary is considering conducting negotiated rulemaking on academic assessments and the requirement that funds under title I, part A be used to supplement, and not supplant, State and local funds. The Secretary specifically invites comments on these issues.

    If the Secretary determines to proceed with negotiated rulemaking, the Secretary will select individuals to participate in this process from among the individuals or groups providing advice and recommendations on title I regulatory issues. The Secretary will publish a separate document in the Federal Register announcing our intent to establish a negotiated rulemaking committee, soliciting nominations of potential negotiators, and providing details about the negotiated rulemaking process.

    In addition to inviting specific comments on the issues on which the Secretary is considering conducting negotiated rulemaking, the Secretary invites comments on other regulatory issues concerning provisions under title I, including suggestions that regulations are not needed to resolve a particular issue.

    The Secretary requests that each commenter identify his or her interest in education or organizational affiliation, if applicable (e.g., a representative of an association, agency, or school; an individual teacher, student, or parent). The Secretary urges each commenter to be specific regarding his or her recommendations.

    During and after the comment period, you may inspect all public comments in response to this document by accessing Regulations.gov. You may also inspect the comments in person at U.S. Department of Education, 400 Maryland Avenue SW., Room 3E306, Washington, DC, between 8:30 a.m. and 4:00 p.m., Washington, DC time, Monday through Friday of each week except Federal holidays. Please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Regional Meetings: In addition to the invitation to provide written comments in response to this document, the Secretary is offering an opportunity at two regional meetings for the public to provide advice and recommendations concerning issues for which regulations may be helpful to clarify statutory ambiguities or to provide appropriate flexibility.

    The regional meetings will be held, from 9:00 a.m. to 5:00 p.m., local time, on the following dates at the following locations:

    1. January 11, 2016, at the U.S. Department of Education, 400 Maryland Avenue SW., Barnard Auditorium, Washington, DC.

    2. January 19, 2016, at the University of California, Los Angeles (UCLA), Carnesale Commons, 251 Charles E. Young Drive West, Palisades Room, Los Angeles, CA.

    Individuals who would like to present comments at the regional meetings must register by sending an email to [email protected] no later than 5:00 p.m. local time on January 5, 2016, for the Washington, DC meeting, and no later than 5:00 p.m. local time on January 12, 2016, for the Los Angeles meeting. The email should include the name of the presenter along with the name of the organization the presenter represents (if any), as well as the regional meeting at which the individual would like to speak. Note that it is likely that each participant will be limited to five minutes.

    The Department will notify registrants whether they have been selected to present comments at a regional meeting. An individual may make only one presentation at the regional meetings. If we receive more registrations than we are able to accommodate, the Department reserves the right to reject the registration of an entity or individual that is affiliated with an entity or individual that is already scheduled to present comments, and to select among registrants to ensure that a broad range of entities and individuals is allowed to present.

    We will accept walk-in registrations on the day of the meeting for any remaining time slots on a first-come, first-served basis, beginning at 8:30 a.m.

    The regional meetings are open to the public. Registration is not required to observe the regional meetings. However, due to capacity limitations, space may be limited. Admission to observe the meetings will be provided on a first-come, first-served basis. Space for speakers will be reserved. The regional meeting in Washington, DC will be streamed live at: http://edstream.ed.gov/webcast/Play/7592f68fb7404eedb2b89ea72032188c1d.

    If you need a sign language interpreter or any other accommodation for the regional meeting, please notify the program contact person listed under FOR FURTHER INFORMATION CONTACT at least seven days prior to the meeting you plan to attend, and indicate in your request which meeting you plan to attend.

    The Department will post transcriptions of the hearings on the Department's Web site. The Department will be livestreaming the meeting in Washington, DC, but will not be filming the meeting in Los Angeles. As these are both public meetings, speakers should be aware that they may be filmed or recorded by members of the public.

    Speakers, including any prospective presenter whose request to speak is rejected due to time limitations or other considerations, may also submit written comments at the regional meetings. In addition, the Department will accept written comments through January 21, 2016. See the ADDRESSES sections of this document for more information on how to submit comments.

    Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or 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.

    Dated: December 16, 2015. Arne Duncan, Secretary of Education.
    [FR Doc. 2015-32178 Filed 12-18-15; 8:45 am] BILLING CODE 4000-01-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 1, 20, 27, and 73 [AU Docket No. 14-252, GN Docket No. 12-268, WT Docket No. 12-269; Report No. 3036] Petitions for Reconsideration of Public Notice Regarding Application Procedures for Broadcast Incentive Auction AGENCY:

    Federal Communications Commission.

    ACTION:

    Petitions for reconsideration; correction.

    SUMMARY:

    On December 10, 2015, the Federal Communications Commission (FCC) published a summary of a Public Notice, 80 FR 76649, announcing that oppositions to Petitions for Reconsideration must be filed by December 28, 2015, and replies to an opposition must be filed by December 21, 2015. This document corrects the due date for replies to an opposition.

    FOR FURTHER INFORMATION CONTACT:

    Mark Montano, Wireless Telecommunications Bureau, (202) 418-0691, email: [email protected]

    Correction

    In the Federal Register of December 10, 2015, in FR Doc. 2015-31256, on page 76649, in the first column, correct the DATES caption to read:

    DATES:

    Oppositions to Petitions for Reconsideration must be filed on or before December 28, 2015. Replies to an opposition must be filed on or before January 7, 2016.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2015-32057 Filed 12-21-15; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 571 [Docket No. NHTSA-2015-0100] Federal Motor Vehicle Safety Standards; Small Business Impacts of Motor Vehicle Safety AGENCY:

    National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).

    ACTION:

    Notice of regulatory review; Request for comments.

    SUMMARY:

    NHTSA seeks comments on the economic impact of its regulations on small entities. As required by Section 610 of the Regulatory Flexibility Act, we are attempting to identify rules that may have a significant economic impact on a substantial number of small entities. We also request comments on ways to make these regulations easier to read and understand. The focus of this notice is rules that specifically relate to passenger cars, multipurpose passenger vehicles, trucks, buses, trailers, motorcycles, and motor vehicle equipment.

    DATES:

    You should submit comments early enough to ensure that Docket Management receives them not later than February 22, 2016.

    ADDRESSES:

    You may submit comments [identified by Docket Number NHTSA-2015-0100] by any of the following methods:

    Internet: To submit comments electronically, go to the U.S. Government regulations Web site at http://www.regulations.gov. Follow the online instructions for submitting comments.

    Mail: Send comments to Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590.

    Hand Delivery: If you plan to submit written comments by hand or courier, please do so at 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC between 9 a.m. and 5 p.m. Eastern Time, Monday through Friday, except federal holidays.

    Fax: Written comments may be faxed to 202-493-2251.

    • You may call Docket Management at 1-800-647-5527.

    Instructions: For detailed instructions on submitting comments and additional information see the COMMENTS heading of the SUPPLEMENTARY INFORMATION section of this document. Note that all comments received will be posted without change to http://www.regulations.gov, including any personal information provided. Please see the Privacy Act heading in the SUPPLEMENTARY INFORMATION.

    FOR FURTHER INFORMATION CONTACT:

    Juanita Kavalauskas, Office of Regulatory Analysis and Evaluation, National Center for Statistics and Analysis, National Highway Traffic Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590 (telephone 202-366-2584, fax 202-366-3189).

    SUPPLEMENTARY INFORMATION: I. Section 610 of the Regulatory Flexibility Act A. Background and Purpose

    Section 610 of the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), requires agencies to conduct periodic reviews of final rules that have a significant economic impact on a substantial number of small business entities. The purpose of the reviews is to determine whether such rules should be continued without change, or should be amended or rescinded, consistent with the objectives of applicable statutes, to minimize any significant economic impact of the rules on a substantial number of such small entities.

    B. Review Schedule

    On November 24, 2008, NHTSA published in the Federal Register (73 FR 71401) a 10-year review plan for its existing regulations. The National Highway Traffic Safety Administration (NHTSA, “we”) has divided its rules into 10 groups by subject area. Each group will be reviewed once every 10 years, undergoing a two-stage process—an Analysis Year and a Review Year. For purposes of these reviews, a year will coincide with the fall-to-fall publication schedule of the Semiannual Regulatory Agenda, see http://www.regulations.gov. Year 1 (2008) begins in the fall of 2008 and ends in the fall of 2009; Year 2 (2009) begins in the fall of 2009 and ends in the fall of 2010; and so on.

    During the Analysis Year, we will request public comment on and analyze each of the rules in a given year's group to determine whether any rule has a significant impact on a substantial number of small entities and, thus, requires review in accordance with section 610 of the Regulatory Flexibility Act. In each fall's Regulatory Agenda, we will publish the results of the analyses we completed during the previous year. For rules that have subparts, or other discrete sections of rules that do have a significant impact on a substantial number of small entities, we will announce that we will be conducting a formal section 610 review during the following 12 months.

    The section 610 review will determine whether a specific rule should be revised or revoked to lessen its impact on small entities. We will consider: (1) The continued need for the rule; (2) the nature of complaints or comments received from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other federal rules or with state or local government rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. At the end of the Review Year, we will publish the results of our review. The following table shows the 10-year analysis and review schedule:

    National Highway Traffic Safety Administration Section 610 Reviews Year Regulations to be reviewed Analysis year Review year 1 49 CFR 571.223 through 571.500, and parts 575 and 579 2008 2009 2 23 CFR parts 1200 and 1300 2009 2010 3 49 CFR parts 501 through 526 and 571.213 2010 2011 4 49 CFR 571.131, 571.217, 571.220, 571.221, and 571.222 2011 2012 5 49 CFR 571.101 through 571.110, and 571.135, 571.138 and 571.139 2012 2013 6 49 CFR parts 529 through 578, except parts 571 and 575 2013 2014 7 49 CFR 571.111 through 571.129 and parts 580 through 588 2014 2015 8 49 CFR 571.201 through 571.212 2015 2016 9 49 CFR 571.214 through 571.219, except 571.217 2016 2017 10 49 CFR parts 591 through 595 and new parts and subparts 2017 2018 C. Regulations Under Analysis

    During Year 8, we will continue to conduct a preliminary assessment of the following sections of 49 CFR 571.201 through 571.212:

    Section Title 571.201 Occupant Protection in Interior Impact. 571.202 Head Restraints; Applicable at the Manufacturers Option Until September 1, 2009. 571.202a Head Restraints; Mandatory Applicability Begins on September 1, 2009. 571.203 Impact Protection for the Driver From the Steering Control System. 571.204 Steering Control Rearward Displacement. 571.205 Glazing Materials. 571.205(a) Glazing Equipment Manufactured Before September 1, 2006 and Glazing Materials Used in Vehicles Manufactured Before November 1, 2006. 571.206 Door Locks and Door Retention Components. 571.207 Seating Systems. 571.208 Occupant Crash Protection. 571.209 Seat Belt Assemblies. 571.210 Seat Belt Assembly Anchorages. 571.211 [Reserved]. 571.212 Windshield Mounting.

    We are seeking comments on whether any requirements in 49 CFR 571.201 through 571.212 have a significant economic impact on a substantial number of small entities. “Small entities” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations under 50,000. Business entities are generally defined as small businesses by Standard Industrial Classification (SIC) code, for the purposes of receiving Small Business Administration (SBA) assistance. Size standards established by SBA in 13 CFR 121.201 are expressed either in number of employees or annual receipts in millions of dollars, unless otherwise specified. The number of employees or annual receipts indicates the maximum allowed for a concern and its affiliates to be considered small. If your business or organization is a small entity and if any of the requirements in 49 CFR 571.201 through 571.212 have a significant economic impact on your business or organization, please submit a comment to explain how and to what degree these rules affect you, the extent of the economic impact on your business or organization, and why you believe the economic impact is significant.

    If the agency determines that there is a significant economic impact on a substantial number of small entities, it will ask for comment in a subsequent notice during the Review Year on how these impacts could be reduced without reducing safety.

    II. Plain Language A. Background and Purpose

    Executive Order 12866 and the Presidential memorandum of June 1, 1998 entitled “Plain Language in Government Writing” require each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:

    • Have we organized the material to suit the public's needs?

    • Are the requirements in the rule clearly stated?

    • Does the rule contain technical language or jargon that is not clear?

    • Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?

    • Would more (but shorter) sections be better?

    • Could we improve clarity by adding tables, lists, or diagrams?

    • What else could we do to make the rule easier to understand?

    If you have any responses to these questions, please include them in your comments on this document.

    B. Review Schedule

    In conjunction with our section 610 reviews, we will be performing plain language reviews over a ten-year period on a schedule consistent with the section 610 review schedule. We will review 49 CFR 571.201 through 571.212 determine if these regulations can be reorganized and/or rewritten to make them easier to read, understand, and use. We encourage interested persons to submit draft regulatory language that clearly and simply communicates regulatory requirements, and other recommendations, such as for putting information in tables that may make the regulations easier to use.

    Comments How do I prepare and submit comments?

    Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the docket number of this document in your comments.

    Your comments must not be more than 15 pages long. (49 CFR 553.21.) We established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments.

    Please submit one copy of your comments, including the attachments, to Docket Management at the address given above under ADDRESSES.

    Please note that pursuant to the Data Quality Act, in order for substantive data to be relied upon and used by the agency, it must meet the information quality standards set forth in the OMB and DOT Data Quality Act guidelines. Accordingly, we encourage you to consult the guidelines in preparing your comments. OMB's guidelines may be accessed at http://www.whitehouse.gov/omb/fedreg_reproducible. DOT's guidelines may be accessed at http://dmses.dot.gov/submit/DataQualityGuidelines.pdf.

    Privacy Act: Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78) or you may visit http://www.regulations.gov.

    How can I be sure that my comments were received?

    If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.

    How do I submit confidential business information?

    If you wish to submit any information under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, NHTSA, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590. In addition, you should submit a copy, from which you have deleted the claimed confidential business information, to Docket Management at the address given above under ADDRESSES. When you send a comment containing information claimed to be confidential business information, you should include a cover letter setting forth the information specified in our confidential business information regulation. (49 CFR part 512.)

    Will the agency consider late comments?

    We will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under DATES. To the extent possible, we will also consider comments that Docket Management receives after that date.

    How can I read the comments submitted by other people?

    You may read the comments received by Docket Management at the address given above under ADDRESSES. The hours of the Docket are indicated above in the same location.

    You may also see the comments on the Internet. To read the comments on the Internet, take the following steps:

    (1) Go to the Federal Docket Management System (FDMS) at http://www.regulations.gov.

    (2) FDMS provides two basic methods of searching to retrieve dockets and docket materials that are available in the system: (a) “Quick Search” to search using a full-text search engine, or (b) “Advanced Search,” which displays various indexed fields such as the docket name, docket identification number, phase of the action, initiating office, date of issuance, document title, document identification number, type of document, Federal Register reference, CFR citation, etc. Each data field in the advanced search may be searched independently or in combination with other fields, as desired. Each search yields a simultaneous display of all available information found in FDMS that is relevant to the requested subject or topic.

    (3) You may download the comments. However, since the comments are imaged documents, instead of word processing documents, the “pdf” versions of the documents are word searchable.

    Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically check the Docket for new material.

    Authority:

    49 U.S.C. 30111, 30168; delegation of authority at 49 CFR 1.95 and 501.8.

    Terry Shelton, Associate Administrator for the National Center for Statistics and Analysis.
    [FR Doc. 2015-32005 Filed 12-21-15; 8:45 am] BILLING CODE 4910-59-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-R4-ES-2015-0164; 4500030113] RIN 1018-BA16 Endangered and Threatened Wildlife and Plants; 90-Day and 12-Month Findings on a Petition To List the Miami Tiger Beetle as an Endangered or Threatened Species; Proposed Endangered Species Status for the Miami Tiger Beetle AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Proposed rule; notice of 90-day and 12-month findings.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), propose to list the Miami tiger beetle (Cicindelidia floridana) as an endangered species throughout its range under the Endangered Species Act of 1973, as amended (Act). If we finalize this rule as proposed, it would extend the Act's protections to this species.

    This document also serves as the 90-day and 12-month findings on a petition to list the species as an endangered or threatened species.

    DATES:

    Written Comments: We will accept comments received or postmarked on or before February 22, 2016. Comments submitted electronically using the Federal eRulemaking Portal (see ADDRESSES, below) must be received by 11:59 p.m. Eastern Time on the closing date. We have scheduled a public hearing for January 13, 2016 (see Public Hearing, below).

    ADDRESSES:

    You may submit comments by one of the following methods:

    (1) Electronically: Go to the Federal eRulemaking Portal: http://www.regulations.gov. In the Search box, enter FWS-R4-ES-2015-0164, which is the docket number for this rulemaking. Then, in the Search panel on the left side of the screen, under the Document Type heading, click on the Proposed Rules link to locate this document. You may submit a comment by clicking on “Comment Now!”

    (2) By hard copy: Submit by U.S. mail or hand-delivery to: Public Comments Processing, Attn: FWS-R4-ES-2015-0164, U.S. Fish and Wildlife Service, MS: BPHC, 5275 Leesburg Pike, Falls Church, VA 22041-3803.

    We request that you send comments only by the methods described above. We will post all comments on http://www.regulations.gov. This generally means that we will post any personal information you provide us (see Public Comments, below, for more information).

    (3) Public Hearing: Comments received at the public hearing held on January 13, 2016 at Miami Dade College—Kendall Campus, Building 6000, 11011 SW. 104th Street, Miami, Florida 33176-3396 from 6:00 p.m. to 9:00 p.m.

    FOR FURTHER INFORMATION CONTACT:

    Roxanna Hinzman, Field Supervisor, U.S. Fish and Wildlife Service, South Florida Ecological Services Office, 1339 20th Street, Vero Beach, FL 32960; by telephone 772-562-3909; or by facsimile 772-562-4288. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800-877-8339.

    SUPPLEMENTARY INFORMATION:

    Executive Summary

    Why we need to publish a rule. Under the Act, if we determine that a species is an endangered or threatened species throughout all or a significant portion of its range, we must publish a proposed rule to list the species in the Federal Register and make a determination on our proposal within 1 year. Listing a species as an endangered or threatened species can only be completed by issuing a rule.

    This rule proposes the listing of the Miami tiger beetle (Cicindelidia floridana) as an endangered species. This rule assesses all available information regarding the status of and threats to the Miami tiger beetle.

    The basis for our action. Under the Act, we may determine that a species is an endangered or threatened species based on any of five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. We have determined that the threats to the Miami tiger beetle consist of habitat loss, degradation, fragmentation, and proposed future development of habitat (Factor A); collection, trade, and sale (Factor B); inadequate protection from existing regulatory mechanisms (Factor D); and a small isolated population with a restricted geographical range, limited genetic exchange, and restricted dispersal potential that is subject to demographic and environmental stochasticity, including climate change and sea level rise (Factor E).

    We will seek peer review. We will invite independent specialists (peer reviewers) to comment on our listing proposal to ensure that it is based on scientifically sound data, assumptions, and analyses.

    Information Requested Public Comments

    We intend that any final action resulting from this proposed rule will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments or information from other concerned governmental agencies, Native American tribes, the scientific community, industry, or any other interested parties concerning this proposed rule. We particularly seek comments concerning:

    (1) The Miami tiger beetle's biology, range, population trends, and habitat, including:

    (a) Biological or ecological requirements of the species, including habitat requirements for feeding, breeding, and sheltering;

    (b) Taxonomy, including genetic information;

    (c) Historical and current range, including distribution patterns and dispersal distances;

    (d) Historical and current range or distribution, including the locations of any additional occurrences of the beetle, population levels, current and projected population trends, and viability;

    (e) Past and ongoing conservation measures for the species, its habitat, or both;

    (f) Survey methods appropriate to detect trends in tiger beetle population distribution and abundance; and

    (g) The use of previously undocumented or altered habitat types (e.g., use of road edges and fire breaks), especially in areas that may not be burned regularly.

    (2) Factors that may affect the continued existence of the species, which may include habitat modification or destruction, overutilization (e.g., collection, sale, or trade), disease, predation, the inadequacy of existing regulatory mechanisms, or other natural or manmade factors.

    (3) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to the species and existing regulations that may be addressing those threats.

    (4) Current or planned activities in the areas occupied by the species and possible impacts of these activities on the species.

    (5) Overutilization for commercial, recreational, scientific, or educational purposes, including information regarding over-collection at permitted sites, evidence of collection or collection rates in general, and recreational or commercial trade and sale.

    (6) The following specific information on:

    (a) The amount and distribution of habitat for the Miami tiger beetle;

    (b) Any occupied or unoccupied areas that are essential for the conservation of the species and why;

    (c) Special management considerations or protections that may be needed for the essential features in potential critical habitat areas, including managing for the potential effects of climate change.

    Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.

    Because we will consider comments and all other information we receive during the public comment period, our final determination may differ from this proposal.

    Please note that submissions merely stating support for or opposition to the action under consideration without providing supporting information, although noted, will not be considered in making a determination, as section 4(b)(1)(A) of the Act (16 U.S.C. 1531 et seq.) directs that determinations as to whether any species is an endangered or threatened species must be made “solely on the basis of the best scientific and commercial data available.”

    You may submit your comments and materials concerning this proposed rule by one of the methods listed in the ADDRESSES section. We request that you send comments only by the methods described in the ADDRESSES section.

    If you submit information via http://www.regulations.gov, your entire submission—including any personal identifying information—will be posted on the Web site. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on http://www.regulations.gov.

    Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on http://www.regulations.gov, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, South Florida Ecological Services Office (see FOR FURTHER INFORMATION CONTACT).

    Public Hearing

    Section 4(b)(5) of the Act provides for one or more public hearings on this proposal, if requested. A public hearing will be held on January 13, 2016 from 6:00 p.m. to 9:00 p.m. at Miami Dade College—Kendall Campus, Building 6000, 11011 SW 104th Street, Miami, Florida 33176-3396.

    Peer Review

    In accordance with our joint policy with the National Marine Fisheries Service on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), we are seeking expert opinions of appropriate and independent specialists regarding this proposed rule. The purpose of peer review is to ensure that our proposed listing actions are based on scientifically sound data, assumptions, and analyses. The peer reviewers have expertise in insect biology, habitat, physical or biological factors, and so forth, which will inform our determination. We invite comment from these peer reviewers during this public comment period.

    Previous Federal Actions

    In 2013, we began assessing the status and threats to the Miami tiger beetle and considering the need to add the beetle to the List of Endangered and Threatened Wildlife. On December 11, 2014, we received a petition from the Center for Biological Diversity (CBD), the Miami Blue Chapter of the North American Butterfly Association, South Florida Wildlands Association, Tropical Audubon Society, Sandy Koi, Al Sunshine, and Chris Wirth requesting that the Miami tiger beetle be emergency listed as endangered, and that critical habitat be designated under the Act (CBD et. al. 2014, entire). The petition clearly identified itself as such and included the requisite identification information for the petitioner, as required by title 50 of the Code of Federal Regulations (CFR) at section 424.14(a) (50 CFR 424.14(a)). In a February 13, 2015, letter to the petitioners, we acknowledged receipt of the petition and stated that although we determined that emergency listing was not warranted, we would review the petitioned request for listing. The Service's review concluded that listing was warranted, and that we should proceed in an expeditious manner with the proposed listing of the species under the Act. Therefore, this document also constitutes, in addition to the proposed listing, both our 90-day and 12-month findings on the petition to list the Miami tiger beetle.

    Background Species Description

    The Miami tiger beetle is an elongate beetle with an oval shape and bulging eyes, and is one of the smallest (6.5-9.0 millimeters (mm) (0.26-0.35 inches (in))) tiger beetles in the United States (Knisley 2015a, p. 3; 2015b, p. 3). The underside of the abdomen is orange to orange-brown in color like many other Cicindelidia species (Pearson 1988, p. 134; Knisley 2015a, p. 3; Knisley 2015b, p. 3). The Miami tiger beetle is uniquely identified by the shiny dark green dorsal surface, sometimes with a bronze cast and, without close examination in the field, may appear black; the pair of green hardened forewings covering the abdomen (elytra) have reduced white markings (maculations) consisting only of a small patch at the posterior tip of each elytron (Brzoska et al. 2011, pp. 2-6).

    As is typical of other tiger beetles, adult Miami tiger beetles are active diurnal predators that use their keen vision to detect movement of small arthropods and run quickly to capture prey with their well-developed jaws (mandibles). Observations by various entomologists indicate small arthropods, especially ants, are the most common prey for tiger beetles. Choate (1996, p. 2) indicated ants were the most common prey of tiger beetles in Florida. Willis (1967, pp. 196-197) lists over 30 kinds of insects from many families as prey for tiger beetles, and scavenging is also common in some species (Knisley and Schultz 1997, pp. 39, 103).

    Tiger beetle larvae have an elongate, white, grub-like body and a dark or metallic head with large mandibles. Larvae are sedentary sit-and-wait predators occurring in permanent burrows flush with the ground surface (Essig 1926, p. 372; Essig 1942, p. 532; Pearson 1988, pp. 131-132). When feeding, larvae position themselves at the burrow mouth and quickly strike at and seize small arthropods that pass within a few centimeters (cm) of the burrow mouth (Essig 1942, pp. 531-532; Pearson 1988, p. 132). An enlarged dorsal portion of the fifth abdominal segment, with two pairs of hooks, anchors the larvae into its permanent burrow while the upper portion of the body extends to capture prey (Pearson 1988, p. 127; Choate 1996, p. 2). Larvae prey on small arthropods, similar to adults.

    Taxonomy

    The Miami tiger beetle (Cicindelidia floridana Cartwright) is a described species in the Subfamily Cicindelinae of the Family Carabidae (ground beetles). Previously, tiger beetles were considered a separate family, but are now classified as a subfamily of the family Carabidae on the basis of recent genetic studies and other characters (Bousquet 2012, p. 30). The Miami tiger beetle is in the C. abdominalis group that also includes the eastern pinebarrens tiger beetle (C. abdominalis), scrub tiger beetle (C. scabrosa), and Highlands tiger beetle (C. highlandensis). New treatments of tiger beetles (Bousquet 2012, p. 30; Pearson et al. 2015, p. 138) have also elevated most of the previous subgenera of tiger beetles to genera, resulting in a change of the genus of the tiger beetles in the C. abdominalis group from Cicindela to Cicindelidia. These genera were originally proposed by Rivalier (1954, entire) and are widely used by European scientists (Wiesner 1992, entire), but are considered subgenera by many American scientists. The return to Rivalier's system has also been supported by a new study using genetic evidence (Duran and Gwiazdowski, in preparation).

    The four species in the Cicindelidia abdominalis group all share a small body size (7-11 mm (0.28-0.43 in) long) and orange underside, and they occur in inland sandy habitats. The four beetles maintain separate ranges along the U.S. east coast and exhibit a significant gradient in range size: The eastern pinebarrens tiger beetle occurs from New York south along the coastal plain to north Florida; the scrub tiger beetle is present throughout much of peninsular Florida, south to Ft. Lauderdale; the Highlands tiger beetle is restricted to the Lake Wales Ridge of Highlands and Polk Counties, Florida; and the Miami tiger beetle is found only in Miami-Dade County, Florida.

    The Miami tiger beetle was first documented from collections made in 1934, by Frank Young (see Distribution, below). There were no observations after this initial collection, and the species was thought to be extinct until it was rediscovered in 2007, at the Zoo Miami Pine Rockland Preserve in Miami-Dade County. The rediscovery of a Miami tiger beetle population provided additional specimens to the 1934 collection and prompted a full study of its taxonomic status, which elevated it to a full species, Cicindelidia floridana (Brzoska et al. 2011, entire).

    The Miami tiger beetle is distinguished from the three other species of the abdominalis group based on: (1) Morphology (color, maculation (spots or markings), and elytral (modified front wing) microsculpture); (2) distribution; (3) habitat requirements; and (4) seasonality (Brzoska et al. 2011, entire; Bousquet 2012, p. 313; Pearson et al. 2015, p. 138). This array of distinctive characters is comparable to the characters used to separate the other three species of the C. abdominalis group.

    Although color is often variable and problematic as a sole diagnostic trait in tiger beetles, it is useful when combined with other factors (Brzoska et al. 2011, p. 4). In comparison with the closely related scrub tiger beetle, the Miami tiger beetle has a green or bronze-green elytra, rarely with a post median marginal spot, and without evidence of a middle band, while the scrub tiger beetle has a black elytra, with a post median marginal spot, usually with a vestige of a middle band (Brzoska et al. 2011, p. 6) (see Brzoska et al. 2011 for detailed description, including key). There are also noticeable differences in the width of the apical lunule (crescent shape), with the Miami tiger beetle's being thin and the scrub tiger beetle's medium to thick.

    In addition, the Miami tiger beetle has a narrower, restricted range where its distribution does not overlap with the other three species in the C. abdominalis group (i.e., the Miami tiger beetle has only been documented in Miami-Dade County). The Miami tiger beetle also occupies a unique habitat type (i.e., pine rockland versus scrub or open sand and barren habitat).

    Lastly, the Miami tiger beetle has a broader period of adult activity than the “late spring to mid-summer” cycle that is observed in the scrub tiger beetle (Brzoska et al. 2011, p. 6) (see also Distribution, Habitat, and Biology sections, below). Adult Miami tiger beetles have been observed from early May through mid-October; this is an unusually long flight period that suggests either continual emergence or two emergence periods (Brzoska et al. 2011, p. 6). In summary, the Miami tiger beetle is recognized as a distinct full species, based upon its differences in morphology, distribution, habitat, and seasonality (Brzoska et al. 2011, entire; Bousquet 2012, p. 313; Pearson et al. 2015, p. 138).

    Genetic analyses for the Miami tiger beetle to date are limited to one nonpeer-reviewed study, and available techniques (e.g., genomics, which can better study the process of speciation) are evolving. A limited genetic study using mitochondrial DNA (mtDNA) suggested that the eastern pinebarrens tiger beetle, Highlands tiger beetle, scrub tiger beetle, and Miami tiger beetle are closely related and recently evolved (Knisley 2011a, p. 14). As with other similar Cicindela groups, these three sister species were not clearly separable by mtDNA analysis alone (Knisley 2011a, p. 14). The power of DNA sequencing for species resolution is limited when species pairs have very recent origins, because in such cases new sister species will share alleles for some time after the initial split due to persistence of ancestral polymorphisms, incomplete lineage sorting, or ongoing gene flow (Sites and Marshall 2004, pp. 216-221; McDonough et al. 2008, pp. 1312-1313; Bartlett et al. 2013, pp. 874-875). Changing sea levels and coincidental changes in the size of the land mass of peninsular Florida during the Pleistocene Era (2.6 million years ago to 10,000 years ago) is thought to be the key factor in the very recent evolutionary divergence and speciation of the three Florida species from C. abdominalis (Knisley 2015a, p. 5; Knisley 2015b, p. 4). Despite the apparent lack of genetic distinctiveness from the one non peer-reviewed, limited genetic study, tiger beetle experts and peer-reviewed scientific literature agree that based on the morphological uniqueness, geographic separation, habitat specialization, and extended flight season, the Miami tiger beetle warrants species designation (Brzoska et al. 2011, entire; Bousquet 2012, p. 313; Pearson et al. 2015, p. 138).

    The most current peer-reviewed scientific information confirms that Cicindelidia floridana is a full species, and this taxonomic change is used by the scientific community (Brzoska et al. 2011, entire; Bousquet 2012, p. 313; Pearson et al. 2015, p. 138; Integrated Taxonomic Information System (ITIS), 2015, p. 1). One source researched for the Miami tiger beetle's taxonomic designation is the ITIS, which was created by a White House Subcommittee on Biodiversity and Ecosystem Dynamics to provide scientifically credible taxonomic information and standardized nomenclature on species. The ITIS is partnered with Federal agencies, including the Service, and is used by agencies as a source for validated taxonomic information. The ITIS recognizes the Miami tiger beetle as a valid species (ITIS, 2015, p. 1). Both the ITIS (2015, p. 1) and Bousquet (2012, p. 313) continue to use the former genus, Cicindela (see discussion above). The Florida Natural Areas Inventory (FNAI) (2015, p. 16) and NatureServe (2015, p. 1) also accept the Miami tiger beetle's taxonomic status as a species and use the new generic designation, Cicindelidia. In summary, although there is some debate about the appropriate generic designation (Cicindelidia versus Cicindela) based upon the best available scientific information, the Miami tiger beetle is a valid species.

    Distribution Historical Range

    The historical range of the Miami tiger beetle is not completely known, and available information is limited based on the single historical observation prior to the species' rediscovery in 2007. It was initially documented from collections made in 1934, by Frank Young within a very restricted range in the northern end of the Miami Rock Ridge, in a region known as the Northern Biscayne Pinelands. The Northern Biscayne Pinelands, which extend from the city of North Miami south to approximately SW 216th Street, are characterized by extensive sandy pockets of quartz sand, a feature that is necessary for the Miami tiger beetle (see Habitat section, below) (Service 1999, p. 3-162). The type locality (the place where the specimen was found) was likely pine rockland habitat, though the species is now extirpated from the area (Knisley and Hill 1991, pp. 7, 13; Brzoska et al. 2011, p. 2; Knisley 2015a, p. 7). The exact location of the type locality in North Miami was determined by Rob Huber, a tiger beetle researcher who contacted Frank Young in 1972. Young recalled collecting the type specimens while searching for land snails at the northeast corner of Miami Avenue and Gratigny Road (119th Street), North Miami. Huber checked that location the same year and found that a school had been built there. A more thorough search for sandy soil habitats throughout that area found no potential habitat (Knisley and Hill 1991, pp. 7, 11-12). Although the contact with Young did not provide habitat information for the type locality, a 1943 map of habitats in the Miami area showed pine rockland with sandy soils reaching their northern limit in the area of the type locality (Knisley 2015a, p. 27), and Young's paper on land snails made reference to pine rockland habitat (Young 1951, p. 6). Recent maps, however, show that the pine rockland habitat has been mostly developed from this area, and remaining pine rockland habitat is mostly restricted to Miami-Dade County owned sites in south Miami (Knisley 2015a, p. 7). In summary, it is likely that the Miami tiger beetle historically occurred throughout pine rockland habitat on the Miami Rock Ridge.

    Current Range

    The Miami tiger beetle was thought to be extinct until 2007, when a population was discovered at the Richmond Heights area of south Miami, Florida, known as the Richmond Pine Rocklands (Brzoska et al. 2011, p. 2; Knisley 2011a, p. 26). The Richmond Pine Rocklands is a mixture of publically and privately owned lands that retain the largest area of contiguous pine rockland habitat within the urbanized areas of Miami-Dade County and outside of the boundaries of Everglades National Park (ENP). Surveys and observations conducted at Long Pine Key in ENP have found no Miami tiger beetles, and habitat conditions are considered unsuitable for the species (Knisley 2015a, p. 42; J. Sadle, 2015, pers. comm.). At this time, known extant occurrences are found on four contiguous sites of pine rockland habitat in the Richmond Pine Rocklands: (1) Zoo Miami Pine Rockland Preserve (Zoo Miami) (293 hectares (ha); 723 acres (ac)), (2) Larry and Penny Thompson Park (121 ha; 300 ac), (3) U.S. Coast Guard property (USCG) (96 ha; 237 ac), and (4) University of Miami's Center for Southeastern Tropical Advanced Remote Sensing property (CSTARS) (31 ha; 76 ac). Most recently (September 2015), Miami tiger beetles were found outside of and within approximately 5.0 km (3.1 mi) of the four Richmond Pine Rockland parcels listed above. Based on historical records, current occurrences, and habitat needs of the species (see Habitat section, below), the current range of the species is considered to be any pine rockland habitat (natural or disturbed) within the Miami Rock Ridge (Knisley 2015a, p. 7; CBD et al. 2014, pp. 13-16, 31-32).

    The Miami tiger beetle is extremely rare and only known to occur in two separate locations within pine rockland habitat in Miami-Dade County. The Richmond population occurs on four contiguous parcels within the Richmond Pine Rocklands: Zoo Miami, Larry and Penny Thompson Park, CSTARS, and USCG. The second location, which was recently identified, is within approximately 5.0 km (3.1 mi) of the Richmond population and separated by urban development (D. Cook, 2015, pers. comm.).

    Miami tiger beetles within the four contiguous occupied parcels in the Richmond population are within close proximity to each other. There are apparent connecting patches of habitat and few or no barriers (contiguous and border each other on at least one side) between parcels. Given the contiguous habitat with few barriers to dispersal, frequent adult movement among individuals is likely, and the occupied Richmond parcels probably represent a single population (Knisley 2015a, p. 10). Information regarding Miami tiger beetles at the new location is very limited, but beetles here are within approximately 5.0 km (3.1 mi) of the Richmond population and separated by ample urban development, which likely represents a significant barrier to dispersal, and the Miami tiger beetles at the new location are currently considered a second population.

    The Richmond population occurs within an approximate 2 square kilometer (km2) (494 ac) block, but currently much of the habitat is overgrown with vegetation, leaving few remaining open patches for the beetle. Survey data documented a decline in the number of open habitat patches, and Knisley (2015a, pp. 9-10) estimated that less than 10 percent of the mostly pine rockland habitat within this area supports the species in its current condition.

    Habitat

    Based on surveys to date, the Miami tiger beetle is found exclusively on the Miami Rock Ridge within the urbanized areas of Miami-Dade County and outside the boundaries of ENP (Knisley 2015a, pp. 6-7). This area extends from the ENP boundary, near the Park entrance road, northeast approximately 72 km (45 miles (mi)) to its end near North Miami. The pine rocklands are a unique ecosystem found on limestone substrates in three areas in Florida: The Miami Rock Ridge, the Florida Keys, and the Big Cypress Swamp. The pine rocklands differ to some degree between and within these three areas with regard to substrate (e.g., amount of exposed limestone, type of soil), elevation, hydrology, and species composition (both plant and animal).

    Pine rockland occurs on relatively flat terrain, approximately 2.0-7.0 m (6.5-23.0 ft) above sea level with an average elevation of approximately 3.0 m (9.8 ft) (Service 1999, p. 3-167; FNAI 2010, p. 62). On the Miami Rock Ridge, oolitic limestone is at or very near the surface, and solution holes occasionally form where the surface limestone is dissolved by organic acids. There is typically very little soil development, consisting primarily of accumulations of low-nutrient sand, marl, clayey loam, and organic debris found in solution holes, depressions, and crevices on the limestone surface (FNAI 2010, p. 62). However, sandy pockets can be found at the northern end of the Miami Rock Ridge, beginning from approximately the city of North Miami Beach and extending south to approximately to SW 216 Street (Service 1999, p. 3-162). These microhabitat parameters (e.g., bare patches of sandy soil) are absent or limited throughout most of the extant pine rockland habitat (URS et al. 2007, p. 5).

    Pine rockland has an open canopy of South Florida slash pine, generally with multiple age classes. The diverse, open shrub and subcanopy layer is composed of more than 100 species of palms and hardwoods (FNAI 2010, p. 1), most derived from the tropical flora of the West Indies (FNAI 2010, p. 1). These vegetative layers and habitat conditions (e.g., canopy height, percent cover, density) change depending upon fire frequency, fire intensity, and other factors. Plant composition includes species such as Serenoa repens (saw palmetto), Sabal palmetto (cabbage palm), Coccothrinax argentata (silver palm), Thrinax morrisii (brittle thatch palm), Morella cerifera. (wax myrtle), Myrsine floridana (myrsine), Metopium toxiferum (poisonwood), Byrsonima lucida (locustberry), Dodonaea viscosa (varnishleaf), Tetrazygia bicolor (tetrazygia), Guettarda scabra (rough velvetseed), Ardisia escallonioides (marlberry), Mosiera longipes (mangrove berry), Sideroxylon salicifolium (willow bustic), and Rhus copallinum (winged sumac). Short-statured shrubs include Quercus pumila (running oak), Randia aculeata (white indigoberry), Crossopetalum ilicifolium (Christmas berry), Morinda royoc (redgal), and Chiococca alba (snowberry).

    Grasses, forbs, and ferns make up a diverse herbaceous layer ranging from mostly continuous in areas with more soil development and little exposed rock to sparse where more extensive outcroppings of rock occur. Typical herbaceous species include Andropogon spp., S. rhizomatum, and S. sanguineum (bluestems), Aristida purpurascens (arrowleaf threeawn), Sorghastrum secundum (lopsided indiangrass), Muhlenbergia capillaris (hairawn muhly), Rhynchospora floridensis (Florida white-top sedge), Tragia saxicola (pineland noseburn), Echites umbellatus (devil's potato), Croton linearis (pineland croton), several species of Chamaesyce spp. (sandmats), Chamaecrista fasciculata (partridge pea), Zamia pumila (coontie), Anemia adiantifolia (maidenhair pineland fern), Pteris bahamensis (Bahama brake), and Pteridium var. caudatum (lacy bracken) (FNAI 2010, p. 1).

    Pine rockland habitat is maintained by regular fire, and is susceptible to other natural disturbances such as hurricanes, frost events, and sea-level rise (SLR) (Ross et al. 1994, p. 144). Fires historically burned on an interval of approximately every 3 to 7 years (FNAI 2010, p. 3), and were typically started by lightning strikes during the frequent summer thunderstorms (FNAI 2010, p. 3).

    Presently, prescribed fire must be periodically introduced into pine rocklands to sustain community structure, prevent invasion by woody species, maintain high herbaceous diversity (Loope and Dunevitz 1981, pp. 5-6; FNAI 2010, p. 3), and prevent succession to rockland hammock. The amount of woody understory growth is directly related to the length of time since the last fire (FNAI 2010, p. 3). Herbaceous diversity declines with time since the last fire. The ecotone between pine rockland and rockland hammock is abrupt when regular fire is present in the system. However, when fire is removed, the ecotone becomes more gradual and subtle as hammock hardwoods encroach into the pineland (FNAI 2010, p. 3).

    The lifecycle of the Miami tiger beetle occurs entirely within the pine rocklands. Adult Miami tiger beetles require patches of open sandy areas within the pine rocklands for behavioral thermoregulation (avoiding or seeking sources of heat to regulate body temperature) so that they can successfully capture small arthropod prey (Knisley 2015a, p. 8). They are visual hunters that use keen eyesight to locate and rapid movement to capture small arthropods. Females oviposit (lay eggs) in these same bare patches (Knisley 2015a, p. 8). The larvae, which are sit-and-wait predators, can capture prey and complete development in sandy areas, without interference from encroaching vegetation (Knisley 2015a, p. 8). At most of the remaining pine rockland sites on the Miami Rock Ridge, bare patches of sandy soil are absent or limited (URS et al. 2007, p. 5) (see “Microhabitat,” below).

    Microhabitat

    Microhabitat conditions are not completely understood, due in part to few known occurrences and limited surveys at some parcels. At the Zoo Miami parcel, which was most thoroughly surveyed, adults and larvae were restricted to a small number of scattered patches of bare ground. The patches were small, typically 2 to 6 square meters (m2) (22 to 65 square feet (ft2)) in size and ovoid to linear in shape with encroaching and overhanging vegetation around the edges and with 15-30 percent ground cover of leaf, grass, and plant litter (Knisley 2015a, p. 8). Patches smaller than 2 to 6 m2 (22-65 ft2) typically had no adults (Knisley 2015a, p. 8). Some of the more linear patches were apparent current or past trails or paths, possibly maintained by animal activity. Soil in these open patches where adults and larvae were found was classified as sandy to loamy sand with primarily very fine (0.130 mm (0.005 in)) to medium grain (0.50 mm (0.02 in)), white to gray colored sand with less than 5 percent organic matter (Knisley 2011a, p. 32). Soil depth was 15.24 cm or more (6.00 in), and moist below the surface (Knisley 2015a, p. 8). This microhabitat is different from that used by either the Highlands or scrub tiger beetles, which in Florida are typically found in much larger, naturally open patches among the vegetation (usually greater than 25 m2 (269 ft2)) or along open paths, roads, and scrub edges (Knisley 2015a, p. 8). The sand for these other species is also white “sugar” sand, which is very deep, drier, and with less organic matter mixed in (Knisley 2015a, pp. 8-9).

    Biology

    In tiger beetles, the adult female determines the habitat and microhabitat of the larva by the selection of an oviposition (egg-laying) site (Knisley and Schultz 1997, p. 28). Generally, the same microhabitats are occupied by both larvae and adults. Females will often touch the soil with the antennae, bite it, and even dig trial holes, possibly to determine suitable soil characteristics (Willis 1967, p. 194) before placing a single egg into a shallow oviposition burrow (1 to 2 cm (0.39 to 0.79 in)) dug into the soil with the ovipositor. The egg hatches, apparently after sufficient soil wetting, and the first instar larvae digs a burrow at the site of oviposition. Development in tiger beetles includes three larval instars followed by a pupal and adult stage. In most species of tiger beetles, development requires 2 years, but can range from 1 to 4 or more years depending on climate and food availability. The life cycle of most tiger beetles in the United States follows either a summer or spring-fall adult activity pattern (Knisley and Schultz 1997, pp. 19-21). These life cycles patterns all indicate the length of the adult flight season is typically 2 to 3 months, but the life span of individual adults is likely to be less.

    Based on available information, the Miami tiger beetle appears to have only limited dispersal abilities. Among tiger beetles there is a general trend of decreasing flight distance with decreasing body size (Knisley and Hill 1996, p. 13). The Miami tiger beetle is one of the smallest tiger beetles (less than half an inch in length); it is likely to be a weak flier based on its size and the limited flight distance of the closely related Highlands tiger beetle (usually flying only 5-10 m (16.4-32.8 ft)) (Knisley and Hill 2013, p. 39). Additionally, tiger beetle species in woodland, scrub, or dune habitats seem to disperse less than water edge species, and this could further explain the apparent limited dispersal of the species (Knisley and Hill 1996, p. 13). Evidence for longer distance dispersal has been reported for some tiger beetle species, but these are generally larger, coastal species that occupy more widespread habitats and use frequent winds or coastal storms to aid in dispersal. For example, a dispersal distance of 160 km (99 mi) was reported for the s-banded tiger beetle (Cicindelidia trifasciata), a coastal mud flat species, that was found in light traps on offshore oil platforms in the Gulf of Mexico (Graves 1981, pp. 45-47). Similarly, extensive mark and recapture studies of the northeastern beach tiger beetle (Cicindela dorsalis), a water edge species approximately twice the size of the Miami tiger beetle, found that the majority of marked adults moved 2 km (1.2 mi) or less, but a few individuals moved over 15-30 km (9-19 mi), some of which required crossing open water (Service 1993, pp. 15-17). Dispersal by storms is unknown to occur in the Miami tiger beetle, and is unlikely to be a successful dispersal strategy as the species is only known to occur in a narrowly distributed habitat type (i.e., remaining pine rocklands) that is interspersed among unsuitable habitat and mixed land uses within a restricted geographical range.

    As a group, tiger beetles occupy ephemeral habitats where local extinction from habitat loss or degradation is common, so dispersal to establish new populations in distant habitat patches is a likely survival strategy for most species (Knisley 2015b, p. 10). Limited dispersal capabilities and other constraints (e.g., few populations, limited numbers, and barriers created by intervening unsuitable habitat), however, can disrupt otherwise normal metapopulation dynamics and contribute to imperilment.

    Results of monthly surveys at the Zoo Miami parcel in 2009, and additional late summer and fall surveys through 2014, indicated the adult flight period for the Miami tiger beetle ranges from May 15 through October 17 (Knisley 2015a, p. 5). No adults were found during an April 18 survey, meaning emergence had not yet occurred (Knisley 2015a, p. 6). In 2009, only two adults were found on September 2, either because conditions were not ideal (although they seemed to be suitable) or activity may have ended earlier in the year. In 2014, some adults were active on September 10 and 30, but not on October 14. This 5-month long adult flight period is unusual in tiger beetles and is much longer than the seasonality of the other three species in the C. abdominalis group with ranges in Florida (Knisley 2015a, p. 6).

    There is no clear explanation for the long adult flight period of the Miami tiger beetle, but it is possible that there are two cohorts of Miami tiger beetle adults emerging during this period (Knisley 2015a, p. 6). Adults emerging in May and June would mate, oviposit, and produce larvae that could develop and emerge as a second cohort of adults in late July and August as the earlier cohort of adults were dying off. Larvae from these later active adults would develop through fall and winter, emerging as adults the following May. The rapid completion of development within 2 months would not be unusual given the small size of this species and the continually warm temperatures in south Florida (Knisley 2015a, p. 6). Rate of development is likely increased during the summer rainy season when prey is more abundant (Knisley 2015a, p. 6).

    Population Estimates and Status

    The visual index count is the standard survey method that has been used to determine presence and abundance of the Miami tiger beetle. Using this method, surveyors either walk slowly or stand still in appropriate open habitats, while taking a count of any beetle observations. Although the index count has been the most commonly used method to estimate the population size of adult tiger beetles, various studies have demonstrated it significantly underestimates actual numbers present. As noted earlier, several studies comparing various methods for estimating adult tiger beetle abundance have found numbers present at a site are typically 2 to 3 times higher than that produced by the index count (Knisley and Schultz 1997, p. 15; Knisley 2009, entire; Knisley and Hill 2013, pp. 27, 29; S. Spomer, 2014, pers. comm.). Numbers are underestimated because tiger beetles are elusive, and some may fly off before being detected while others may be obscured by vegetation in some parts of the survey area. Even in defined linear habitats like narrow shorelines where there is no vegetation and high visibility, index counts produce estimates that are 2 to 3 times lower than the numbers present (Knisley and Schultz 1997, p. 152).

    Information on the Richmond population size is limited because survey data are inconsistent, and some sites are difficult to access due to permitting, security, and liability concerns. Of the occupied sites, the most thoroughly surveyed site for adult and larval Miami tiger beetles is the Zoo Miami parcel (over 30 survey dates from 2008 to 2014) (Knisley 2015a, p. 10). Adult beetle surveys at the CSTARS and USCG parcels have been infrequent, and access was not permitted in 2012 through early summer of 2014. In October 2014, access to both the CSTARS and USCG parcels was permitted, and no beetles were observed during October 2014 surveys. As noted earlier, Miami tiger beetles were recently found at Larry and Penny Thompson Park (D. Cook, 2015, pers. comm.); however, thorough surveys at this location have not been conducted. For details on index counts and larval survey results from the three surveyed parcels (Zoo Miami, USCG, and CSTARS), see Table 2 in Supporting Documents on http://www.regulations.gov.

    Raw index counts found adults in four areas (Zoo A, Zoo B, Zoo C, and Zoo D) of the Zoo Miami parcel. Two of these patches (Zoo C and Zoo D) had fewer than 10 adults during several surveys at each. Zoo A, the more northern site where adults were first discovered, had peak counts of 17 and 22 adults in 2008 and 2009, but declined to 0 and 2 adults in six surveys from 2011 to 2014, despite thorough searches on several dates throughout the peak of the adult flight season (Knisley 2015, pp. 9-10). Zoo B, located south of Zoo A, had peak counts of 17 and 20 adults from 2008 to 2009, 36 to 42 adults from 2011 to 2012, and 13 and 18 adults in 2014 (Knisley 2015a, pp. 9-10). These surveys at Zoo A and Zoo B also recorded the number of suitable habitat patches (occupied and unoccupied). Surveys between 2008 and 2014 documented a decline in both occupied and unoccupied open habitat patches. Knisley (2015, pp. 9-10) documented a decrease at Zoo A from 7 occupied of 23 patches in 2008, to 1 occupied of 13 patches in 2014. At Zoo B, there was a decrease from 19 occupied of 26 patches in 2008, to 7 occupied of 13 patches in 2014 (Knisley 2015, pp. 9-10). Knisley (2015a, p. 10) suggested this decline in occupied and unoccupied patches is likely the result of the vegetation that he observed encroaching into the open areas that are required by the beetle.

    At the CSTARS site, the only survey during peak season was on August 20, 2010, when much of the potential habitat was checked. This survey produced a raw count of 38 adults in 11 scattered habitat patches, with 1 to 9 adults per patch, mostly in the western portion of the site (Knisley 2015a, p. 10). Three surveys at the USCG included only a portion of the potential habitat and produced raw adult counts of two, four, and two adults in three separate patches from 2009, 2010, and 2011, respectively (Knisley 2015a, p. 10). Additional surveys of the CSTARS and the USCG parcels on October 14 to 15, 2014, surveyed areas where adults were found in previous surveys and some new areas; however, no adults were observed. The most likely reasons for the absence of adults were because counts even during the peak of the flight season were low (thus detection would be lower off-peak), and mid-October is recognized as the end of the flight season (Knisley 2014a, p. 2). As was noted for the Zoo Miami sites, habitat patches at the CSTARS and USCG parcels that previously supported adults seemed smaller due to increased vegetation growth, and consequently these patches appeared less suitable for the beetle than in the earlier surveys (Knisley 2015a, p. 10).

    Surveys of adult numbers over the years, especially the frequent surveys in 2009, did not indicate a bimodal adult activity pattern (Knisley 2015a, p. 10). Knisley (2015a, p. 10) suggests that actual numbers of adult Miami tiger beetles could be 2 to 3 times higher than indicated by the raw index counts. Several studies comparing methods for estimating population size of several tiger beetle species, including the Highlands tiger beetle, found total numbers present were usually more than two times that indicated by the index counts (Knisley and Hill 2013, pp. 27-28). The underestimates from raw index counts are likely to be comparable or greater for the Miami tiger beetle, because of its small size and occurrence in small open patches where individuals can be obscured by vegetation around the edges, making detection especially difficult (Knisley 2015a, p. 10).

    Surveys for larvae at the Zoo Miami parcel (Zoos A and B) were conducted in several years during January when lower temperatures would result in a higher level of larval activity and open burrows (Knisley and Hill 2013, p. 38) (see Table 2 in Supporting Documents on http://www.regulations.gov). The January 2010 survey produced a count of 63 larval burrows, including 5 first instars, 36 second instars, and 22 third instars (Knisley 2013, p. 4). All burrows were in the same bare sandy patches where adults were found. In March 2010, a followup survey indicated most second instar larvae had progressed to the third instar (Knisley 2015a, p. 11). Additional surveys to determine larval distribution and relative abundance during January or February in subsequent years detected fewer larvae in section Zoo B: 5 larvae in 2011, 3 larvae in 2012, 3 and 5 larvae in 2013, 3 larvae in 2014, and 15 larvae in 2015 (Knisley 2013, pp. 4-5; Knisley 2015c, p. 1). The reason for this decline in larval numbers (i.e., from 63 in 2010, to 15 or fewer in each survey year from 2011 to 2015) is unknown. Possible explanations are that fewer larvae were present because of reduced recruitment by adults from 2010 to 2014, increased difficulty in detecting larval burrows that were present due to vegetation growth and leaf litter, environmental factors (e.g., temperature, precipitation, predators), or a combination of these factors (Knisley 2015a, pp. 10-11). Larvae, like adults, also require open patches free from vegetation encroachment to complete their development. The January 2015 survey observed vegetation encroachment, as indicated by several of the numbered tags marking larval burrows in open patches in 2010 covered by plant growth and leaf litter (Knisley 2015c, p. 1). No larvae were observed in the January 2015 survey of Zoo A (Knisley 2015c, p. 1). Knisley (2015d, p. 3) reported that the area had been recently burned (mid-November) and low vegetation was absent, resulting in mostly bare ground with extensive pine needle coverage.

    Surveys for the beetle's presence outside of its currently known occupied range found no Miami tiger beetles at a total of 42 sites (17 pine rockland sites and 25 scrub sites) throughout Miami-Dade, Broward, Palm Beach, and Martin Counties (Knisley 2015a, pp. 9, 41-45). The absence of the Miami tiger beetle from sites north of Miami-Dade was probably because it never ranged beyond pine rockland habitat of Miami-Dade County and into scrub habitats to the north (Knisley 2015a, p. 9). Sites without the Miami tiger beetle in Miami-Dade County mostly had vegetation that was too dense and were lacking the open patches of sandy soil that are needed by adults for oviposition and larval habitat (Knisley 2015a, pp. 9, 41-45).

    The Miami tiger beetle is considered as one of two tiger beetles in the United States most in danger of extinction (Knisley et al. 2014, p. 93). The viability of the remaining population is unknown, as no population viability analysis is available (B. Knisley, 2015d, pers. comm.). The Florida Fish and Wildlife Conservation Commission (FWC) (2012, p. 89) regarded it as a species of greatest conservation need. The Miami tiger beetle is currently ranked S1 and G1 by the FNAI (2015, p. 16), meaning it is critically imperiled globally because of extreme rarity (5 or fewer occurrences, or fewer than 1,000 individuals) or because of extreme vulnerability to extinction due to some natural or manmade factor.

    In summary, the overall population size of the Miami tiger beetle is exceptionally small and viability is uncertain. Based upon the index count data to date, it appears that the two populations exist in extremely low numbers (Knisley 2015a, pp. 2, 10-11, 24).

    Summary of Factors Affecting the Species

    Section 4 of the Act (16 U.S.C. 1533), and its implementing regulations at 50 CFR part 424, set forth the procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. Under section 4(a)(1) of the Act, we may list a species based on any of the following five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; and (E) other natural or manmade factors affecting its continued existence. Listing actions may be warranted based on any of the above threat factors, singly or in combination. Each of these factors is discussed below.

    Factor A. The Present or Threatened Destruction, Modification, or Curtailment of Its Habitat or Range

    The Miami tiger beetle is threatened by habitat loss and modification caused by changes in land use and inadequate land management, including the lack of prescribed burns and vegetation (native and nonnative) encroachment (discussed separately below). Habitat loss and modification are expected to continue and increase, affecting any populations on private lands as well as those on protected lands that depend on management actions (i.e., prescribed fire) where these actions could be precluded by surrounding development.

    Habitat Loss

    The Miami tiger beetle has experienced substantial destruction, modification, and curtailment of its habitat and range (Brzoska et al. 2011, pp. 5-6; Knisley 2013, pp. 7-8; Knisley 2015a, p. 11). The pine rockland community of south Florida, on which the beetle depends, is critically imperiled globally (FNAI 2013, p. 3). Destruction of the pinelands for economic development has reduced this habitat by 90 percent on mainland south Florida (O'Brien 1998, p. 208). Outside of ENP, only about 1 percent of the Miami Rock Ridge pinelands have escaped clearing, and much of what is left is in small remnant blocks isolated from other natural areas (Herndon 1998, p. 1).

    The two known populations of the Miami tiger beetle occur within the Richmond Pine Rocklands, on parcels of publicly or privately owned lands that are partially developed, yet retain some undeveloped pine rockland habitat. In the 1940s, the Naval Air Station Richmond was built largely on what is currently the Zoo Miami parcel. Much of the currently occupied Miami tiger beetle habitat on the Zoo Miami parcel was scraped for the creation of runways and blimp hangars (Wirth 2015, entire). The fact that this formerly scraped pine rockland area now provides suitable habitat for the Miami tiger beetle demonstrates the restoration potential of disturbed pine rockland habitat (Possley 2015, entire; Wirth 2015, entire).

    Any current known or unknown, extant Miami tiger beetle populations or potentially suitable habitat that may occur on private lands or non-conservation public lands, such as elsewhere within the Richmond Pine Rocklands or surrounding pine rocklands, are vulnerable to habitat loss. Miami-Dade County leads the State in gross urban density at 15.45 people per acre (Zwick and Carr 2006, pp. 1, 13), and development and human population growth are expected to continue in the future. By 2025, Miami-Dade County is predicted to exceed a population size of over 3 million people (Zwick and Carr 2006, p. 20). This predicted economic and population growth will further increase demands for land, water, and other resources, which will undoubtedly impact the survival and recovery of the Miami tiger beetle.

    Remaining habitat is at risk of additional losses and degradation. Of high and specific concern are proposed development projects within the Richmond Pine Rocklands (CBD et al. 2014, pp. 19-24). In 2013, plans for potential development on portions of the Zoo Miami and USCG parcels were announced in local newspapers (Munzenrieder 2013, entire) and subsequently advertised through other mechanisms (https://www.miamidade.gov/dpmww/SolicitationDetails.aspx?Id=Invitation%20To%20Negotiate%20(ITN) [accessed April 24, 2014]). The proposed development is to include the following: Theme park rides; a seasonally opened water park; a 400-room hotel with a Sony Music Theatre performance venue; a 30,000-ft2 (2,787-m2) retail and restaurant village; an entertainment center with movie theaters and bowling; an outdoor area for sports; a landscaped pedestrian and bike path; parking; and a 2.4-km (1.5-mi) transportation link that unifies the project's parts (Dinkova 2014a, p.1). The proposed development will require at least a portion of the USCG parcel, which would occur through purchase or a land swap (Dinkova 2014b, p. 1).

    The Service notified Miami-Dade County in a December 2, 2014, letter about proposed development concerns with potential impacts to listed, candidate, and imperiled species, including the Miami tiger beetle. Plans for the proposed development on the Zoo Miami and USCG parcels have yet to be finalized, so potential impacts to the Miami tiger beetle and its habitat cannot be fully assessed. However, based upon available information provided to date, it appears that the proposed development will impact suitable or potentially suitable beetle habitat.

    In July 2014, the Service became aware of another proposed development project on privately owned lands within the Richmond Pine Rocklands. In a July 15, 2014, letter to the proposed developer, the Service named the Miami tiger beetle (along with other federally listed and proposed species and habitats) as occurring within the project footprint, and expressed concern over indirect impacts (e.g., the ability to conduct prescribed fire within the Richmond Pine Rocklands). Based upon applicant plans received in May 2015, the proposed project will contain a variety of commercial, residential, and other development within approximately 138 ac (56 ha) (Ram 2015, p. 4). It is unknown if the Miami tiger beetle occurs on the proposed development site, as only one limited survey has been conducted on a small portion (approximately 1.7 ha (4.3 ac)) of the proposed development area and more surveys are needed. Based upon available information, it appears that the proposed developments will likely impact suitable or potentially suitable beetle habitat, because roughly 33 acres of the proposed development are planned for intact and degraded pine rocklands (Ram 2015, p. 91). The Service has met with the developers to learn more about their plans and address listed, candidate, and imperiled species issues; negotiations are continuing, and a draft habitat conservation plan has been developed (Ram 2015, entire).

    Given the species' highly restricted range and uncertain viability, any additional losses are significant. Additional development might further limit the ability to conduct prescribed burns or other beneficial management activities that are necessary to maintain the open areas within pine rockland habitat that are required by the beetle. The pattern of public and private ownership presents an urban wildland interface, which is a known constraint for implementing prescribed fire in similar pine rockland habitats (i.e., at National Key Deer Refuge and in southern Miami-Dade County) (Snyder et al. 2005, p. 2; Service 2009, p. 50; 79 FR 47180, August 12, 2014; 79 FR 52567, September 4, 2014). The Florida Department of Forestry has limited staff in Miami-Dade County, and they have been reluctant to set fires for liability reasons (URS 2007, p. 39) (see “Land Management,” below).

    In summary, given the Miami tiger beetle's highly restricted range and uncertain viability, any additional losses of habitat within its current range present substantial threats to its survival and recovery.

    Land Management

    The threat of habitat destruction or modification is further exacerbated by a lack of adequate fire management (Brzoska et al. 2011, pp. 5-6; Knisley 2013, pp. 7-8; Knisley 2015a, p. 2). Historically, lightning-induced fires were a vital component in maintaining native vegetation within the pine rockland ecosystem, as well as for opening patches in the vegetation required by the beetles (Loope and Dunevitz 1981, p. 5; Slocum et al. 2003, p. 93; Snyder et al. 2005, p. 1; Knisley 2011a, pp. 31-32). Open patches in the landscape, which allow for ample sunlight for thermoregulation, are necessary for Miami tiger beetles to perform their normal activities, such as foraging, mating, and oviposition (Knisley 2011a, p. 32). Larvae also require these open patches to complete their development free from vegetation encroachment. Without fire, successional change from tropical pineland to hardwood hammock is rapid, and displacement of native plants by invasive, nonnative plants often occurs, resulting in vegetation overgrowth and litter accumulation in the open, bare, sandy patches that are necessary for the Miami tiger beetle. In the absence of fire, pine rockland will succeed to tropical hardwood hammock in 20 to 30 years, as thick duff layer accumulates and eventually results in the appearance of humic soils rather than mineral soils (Alexander 1967, p. 863; Wade et al. 1980, p. 92; Loope and Dunevitz 1981, p. 6; Snyder et al. 1990, p. 260).

    Miami-Dade County has implemented various conservation measures, such as burning in a mosaic pattern and on a small scale, during prescribed burns, to help conserve the Miami tiger beetles and other imperiled species and their habitats (J. Maguire, 2010, pers. comm.). Miami-Dade County Parks and Recreation staff has burned several of its conservation lands on fire return intervals of approximately 3 to 7 years. However, implementation of the county's prescribed fire program has been hampered by a shortage of resources, logistical difficulties, smoke management, and public concern related to burning next to residential areas (Snyder et al. 2005, p. 2; FNAI 2010, p. 5). Many homes and other developments have been built in a mosaic of pine rockland, so the use of prescribed fire in many places has become complicated because of potential danger to structures and smoke generated from the burns. The risk of liability and limited staff in Miami-Dade County have hindered prescribed fire efforts (URS 2007, p. 39). Nonprofit organizations, such as the Institute for Regional Conservation, have faced similar challenges in conducting prescribed burns, due to difficulties with permitting and obtaining the necessary permissions, as well as hazard insurance limitations (Bradley and Gann 2008, p. 17; G. Gann, 2013, pers. comm.). Few private landowners have the means or desire to implement prescribed fire on their property, and doing so in a fragmented urban environment is logistically difficult and costly (Bradley and Gann 2008, p. 3). Lack of management has resulted in rapid habitat decline on most of the small pine rockland fragments, with the disappearance of federally listed and candidate species where they once occurred (Bradley and Gann 2008, p. 3).

    Despite efforts to use prescribed fire as a management tool in pine rockland habitat, sites with the Miami tiger beetle are not burned as frequently as needed to maintain suitable beetle habitat. Most of the occupied beetle habitat at Miami-Dade County's Zoo Miami parcel was last burned in January and October of 2007; by 2010, there was noticeable vegetation encroachment into suitable habitat patches (Knisley 2011a, p. 36). The northern portion (Zoo A) of the Zoo Miami site was burned in November 2014 (Knisley 2015c, p. 3). Several occupied locations at the CSTARS parcel were burned in 2010, but four other locations at CSTARS were last burned in 2004 and 2006 (Knisley 2011a, p. 36). No recent burns are believed to have occurred at the USCG parcel (Knisley 2011a, p. 36). The decline in adult numbers at the two primary Zoo Miami patches (A and B) in 2014 surveys, and the few larvae found there in recent years, may be a result of the observed loss of bare open patches (Knisley 2015a, p. 12; Knisley 2015c, pp. 1-3). Surveys of the CSTARS and USCG parcels in 2014 found similar loss of open patches from encroaching vegetation (Knisley 2015a, p. 13).

    Alternatives to prescribed fire, such as mechanical removal of woody vegetation are not as ecologically effective as fire. Mechanical treatments do not replicate fire's ability to recycle nutrients to the soil, a process that is critical to many pine rockland species (URS 2007, p. 39). To prevent organic soils from developing, uprooted woody debris requires removal, which adds to the required labor. The use of mechanical equipment can also damage soils and inadvertently include the removal or trampling of other non-target species or critical habitat (URS 2007, p. 39).

    Nonnative plants have significantly affected pine rocklands (Bradley and Gann 1999, pp. 15, 72; Bradley and Gann 2005, page numbers not applicable; Bradley and van der Heiden 2013, pp. 12-16). As a result of human activities, at least 277 taxa of nonnative plants have invaded pine rocklands throughout south Florida (Service 1999, p. 3-175). Neyraudia neyraudiana (Burma reed) and Schinus terebinthifolius (Brazilian pepper), which have the ability to rapidly invade open areas, threaten the habitat needs of the Miami tiger beetle (Bradley and Gann 1999, pp. 13, 72). S. terebinthifolius, a nonnative tree, is the most widespread and one of the most invasive species. It forms dense thickets of tangled, woody stems that completely shade out and displace native vegetation (Loflin 1991, p. 19; Langeland and Craddock Burks 1998, p. 54). Acacia auriculiformis (earleaf acacia), Melinis repens (natal grass), Lantana camara (shrub verbena), and Albizia lebbeck (tongue tree) are some of the other nonnative species in pine rocklands. More species of nonnative plants could become problems in the future, such as Lygodium microphyllum (Old World climbing fern), which is a serious threat throughout south Florida.

    Nonnative, invasive plants compete with native plants for space, light, water, and nutrients, and make habitat conditions unsuitable for the Miami tiger beetle, which responds positively to open conditions. Invasive nonnatives also affect the characteristics of a fire when it does occur. Historically, pine rocklands had an open, low understory where natural fires remained patchy with low temperature intensity. Dense infestations of Neyraudia neyraudiana and Schinus terebinthifolius cause higher fire temperatures and longer burning periods. With the presence of invasive, nonnative species, it is uncertain how fire, even under a managed situation, will affect habitat conditions or Miami tiger beetles.

    Management of nonnative, invasive plants in pine rocklands in Miami-Dade County is further complicated because the vast majority of pine rocklands are small, fragmented areas bordered by urban development. Fragmentation results in an increased proportion of “edge” habitat, which in turn has a variety of effects, including changes in microclimate and community structure at various distances from the edge (Margules and Pressey 2000, p. 248); altered spatial distribution of fire (greater fire frequency in areas nearer the edge) (Cochrane 2001, pp. 1518-1519); and increased pressure from nonnative, invasive plants and animals that may out-compete or disturb native plant populations. Additionally, areas near managed pine rockland that contains nonnative species can act as a seed source of nonnatives, allowing them to continue to invade the surrounding pine rockland (Bradley and Gann 1999, p. 13).

    Conservation Efforts To Reduce the Present or Threatened Destruction, Modification, or Curtailment of Habitat or Range

    In 2005, the Service funded the Institute for Regional Conservation (IRC) to facilitate restoration and management of privately owned pine rockland habitats in Miami-Dade County. This initiative included prescribed burns, nonnative plant control, light debris removal, hardwood management, reintroduction of pines where needed, and development of management plans. The Pine Rockland Initiative includes 10-year cooperative agreements between participating landowners and the Service/IRC to ensure restored areas will be managed appropriately during that time. Although most of these objectives regarding nonnative plant control, creation of fire breaks, removal of excessive fuel loads, and management plans have been achieved, IRC has not been able to conduct the desired prescribed burns, due to logistical difficulties as discussed above (see “Land Management”). IRC has recently resolved some of the challenges regarding contractor availability for prescribed burns and the Service has extended IRC's funding period through August 2016. Results from anticipated fire management restoration activities will be available in the fall of 2016.

    Fairchild Tropical Botanic Garden (FTBG), with the support of various Federal, State, local, and nonprofit organizations, has established the “Connect to Protect Network.” The objective of this program is to encourage widespread participation of citizens to create corridors of healthy pine rocklands by planting stepping stone gardens and rights-of-way with native pine rockland species, and restoring isolated pine rockland fragments. Although these projects may serve as valuable components toward the conservation of pine rockland species and habitat, they are dependent on continual funding, as well as participation from private landowners, both of which may vary through time.

    Summary of Factor A

    We have identified a number of threats to the habitat of the Miami tiger beetle, which have occurred in the past, are impacting the species now, and will continue to impact the species in the future. Habitat loss, fragmentation, and degradation, and associated pressures from increased human population, are major threats; these threats are expected to continue, placing the species at greater risk. The species' occurrence on pine rocklands that are partially protected from development (see “Local” under Factor D, below) tempers some impacts, yet the threat of further loss and fragmentation of habitat remains. Various conservation programs are in place, and while these help to reduce some threats of habitat loss and modification, these programs are limited in nature. In general, available resources and land management activities (e.g., prescribed fire and invasive plant control) on public and private lands are inadequate to prevent modification and degradation of the species' habitat. Therefore, based on our analysis of the best available information, the present and future loss and modification of the species' habitat are major threats to the Miami tiger beetle throughout its range.

    Factor B. Overutilization for Commercial, Recreational, Scientific, or Educational Purposes Collection

    Rare beetles, butterflies, and moths are highly prized by collectors. Tiger beetles are the subject of more intense collecting and study than any other single beetle group (Pearson 1988, pp. 123-124; Knisley and Hill 1992a, p. 9; Choate 1996, p. 1; Knisley et al. 2014, p. 94). Interest in the genus Cicindela (and Cicindelidia) is reflected in a journal entitled “Cicindela,” which has been published quarterly since 1969 and is exclusively devoted to the genus. Tiger beetle collecting and the sale and trade of specimens have increased in popularity in recent years (Knisley et al. 2014, p. 138). Among the professional researchers and many amateurs that collect tiger beetles are individuals that take only small numbers; however, there are also avid collectors who take as many specimens as possible, often for sale or trade. At present, it is estimated that nationally 50 to 100 individuals collect tiger beetles, and approximately 50 individuals are avid collectors (Knisley 2015b, p. 14). Knowledge of and communication with many of these collectors suggest sale and trading of specimens has become much more common in recent years. The increased interest in collecting, along with photographing specimens, seems to have been stimulated in part due to the publication of the tiger beetle field guide (Pearson et al. 2006, entire). Collectors are especially interested in the less common forms, and may have little regard for their conservation (Knisley 2015b, p. 14). There is ample evidence of collectors impacting imperiled and endangered butterflies (Gochfeld and Burger 1997, pp. 208- 209) and even contributing to extirpations (Duffey 1968, p. 94). For example, the federally endangered Mitchell's satyr (Neonympha mitchellii mitchellii) is believed to have been extirpated from New Jersey due to overcollecting (57 FR 21567, May 20, 1992; Gochfeld and Burger 1997, p. 209).

    Collection is serious threat to the Miami tiger beetle due to extreme rarity (a factor that increases demand by collectors) and vulnerability (i.e., uncertain status and viability with just two known populations and few individuals). Collection is especially problematic if adults are taken prior to oviposition or from small, isolated, or poor-quality sites. Because no large, high-quality sites are currently known, any collection can have serious ramifications on the survival of the remaining population(s).

    The recent description of the species did not disclose the exact locations of occurrence, due to concerns with collection (Brzoska et al. 2011, p. 5); however, it is now believed that occurrences at Zoo Miami, USCG, and CSTARS in the Richmond population are fairly well known, especially in the tiger beetle collecting community (B. Knisley, 2014b, pers. comm.). We have no specific information on the collection pressure for the Miami tiger beetle, but it is expected to be high based upon what has transpired in comparable situations with other federally listed and imperiled tiger beetles and butterflies both nationwide and in Florida. For example, the federally endangered Ohlone tiger beetle (Cicindela ohlone) was collected from its type locality in California after its description in the scientific literature (66 FR 50340, October 3, 2001) (Knisley 2015a, p. 14). Similarly, overcollection of the Highlands tiger beetle may have contributed to the extirpation of that species from its type locality in Florida (Knisley and Hill 1992a, p. 9). An estimated 500 to 1,000 adult Highlands tiger beetles had been collected at this site during a several year period after its initial discovery (Knisley and Hill 1992a, p. 10).

    Markets currently exist for tiger beetles. Specimens of two Florida tiger beetles, the Highlands tiger beetle, a federal candidate species, and the scrub tiger beetle are regularly offered for sale or trade through online insect dealers (The Bugmaniac 2015 and eBay 2015). Considering the recent rediscovery of the Miami tiger beetle and concerns regarding its continued existence, the desirability of this species to private collectors is expected to increase, which may lead to similar markets and increased demand.

    Another reason it is not possible to assess actual impacts from collection is that known occurrences of the Miami tiger beetle are not regularly monitored. Two known occurrences on the USCG and CSTARS parcels are gated and accessible only by permit, so collection from these sites is unlikely unless authorized by the property owners. However, other occupied and potential habitats at neighboring and surrounding areas are much more accessible. Risk of collection is concerning at any location and is more likely at less secure sites. Collection potential at Zoo Miami and other accessible sites is high, in part because it is not entirely gated and only periodically patrolled (B. Knisley, 2014b, pers. comm.). Most of the remaining pine rockland habitat outside of ENP in Miami Dade County is owned by the County or in private ownership and not regularly monitored or patrolled.

    We consider collection to be a significant threat to the Miami tiger beetle in light of the few known remaining populations, low abundance, and highly restricted range. Even limited collection from the remaining populations could have deleterious effects on reproductive and genetic viability of the species and could contribute to its extinction. Removal of adults early in the flight season or prior to oviposition can be particularly damaging, as it further reduces potential for successful reproduction. A population may be reduced to below sustainable numbers (Allee effect) by removal of females, reducing the probability that new occurrences will be founded. Small and isolated occurrences in poor habitat may be at greatest risk (see Factor E discussion, below) as these might not be able to withstand additional losses. Collectors may be unable to recognize when they are depleting occurrences below the thresholds of survival or recovery (Collins and Morris 1985, pp. 162-165).

    With regard to scientific research, we do not believe that general techniques used to date have had negative impacts on the species or its habitat. Visual index surveys and netting for identification purposes have been performed during scientific research and conservation efforts with the potential to disturb or injure individuals or damage habitat. Limited collection as part of laboratory rearing studies or taxonomic verification has occurred at some sites, with work authorized by permits. Based on the extreme rarity of the species, various collecting techniques (e.g., pitfall traps, Malaise traps, light traps) for other more general insect research projects should be considered a potential threat.

    Summary of Factor B

    Collection interest in tiger beetles, especially rare species, is high, and markets currently exist. While it is not possible to quantify the impacts of collection on the Miami tiger beetle, collection of the Highlands tiger beetle has been documented in large numbers, and collection is currently occurring. The risk of collection of the Miami tiger beetle from both occupied and other potential habitat is high, as some sites are generally accessible and not monitored or patrolled. Due to the few remaining populations, low abundance, and restricted range, we have determined that collection is a significant threat to the species and could potentially occur at any time. Even limited collection from the remaining populations could have negative effects on reproductive and genetic viability of the species and could contribute to its extinction.

    Factor C. Disease or Predation

    There is no evidence of disease or pathogens affecting the Miami tiger beetle, although this threat has not been investigated. Parasites and predators, however, have been found to have significant impacts on adult and larval tiger beetles. In general, parasites are considered to have greater effects on tiger beetles than predators (Nagano 1982, p. 34; Pearson 1988, pp. 136-138). While parasites and predators play important roles in the natural dynamics of tiger beetle populations, the current small size of the Miami tiger beetle populations may render the species more vulnerable to parasitism and predation than historically, when the species was more widely distributed and therefore more resilient.

    Known predators of adult tiger beetles include birds, lizards, spiders, and especially robber flies (family Asilidae) (Pearson et al. 2006, p. 183). Researchers and collectors have often observed robber flies in the field capturing tiger beetles out of the air. Pearson (1985, pp. 68-69; 1988, p. 134) found tiger beetles with orange abdomens (warning coloration) were preyed upon less frequently than similar-sized tiger beetles without the orange abdomens. His field trials also determined that size alone provided some protection from robber flies, which are usually only successful in killing prey that is smaller than they are. This was the case with the hairy-necked tiger beetle (Cicindela hirticollis) being attacked at a significantly higher rate than the larger northeastern beach tiger beetle in Maryland (Knisley and Hill 2010, pp. 54-55). On the basis of these field studies, it was estimated that robber flies may cause over 50 percent mortality to the hairy-necked tiger beetle and 6 percent to the northeastern beach tiger beetle population throughout the flight season (Knisley and Hill 2010, pp. 54-55). The small body size of the Miami tiger beetle, even with its orange abdomen, suggests it would be susceptible to robber fly attack. No robber flies have been observed during the limited field studies on the Miami tiger beetle; however, they are a common predator of the closely related Highlands tiger beetle (Knisley and Hill 2013, p. 40). In 24 hours of field study, Knisley and Hill (2013, p. 40) observed 22 attacks by robber flies on Highlands tiger beetles, 5 of which resulted in the robber fly killing and consuming the adult beetles.

    Most predators of adult tiger beetles are opportunistic, feeding on a variety of available prey, and therefore probably have only a limited impact on tiger beetle populations. However, predators, and especially parasites, of larvae are more common and some attack only tiger beetles. Ants are regarded as important predators on tiger beetles, and although not well studied, they have been reported having significant impact on first instar larvae of some Arizona tiger beetles (Cicindela spp.) (Knisley and Juliano 1988, p. 1990). A study with the Highlands tiger beetle found ants accounted for 11 to 17 percent of larval mortality at several sites, primarily involving first instars (Knisley and Hill 2013, p. 37). During surveys for the Miami tiger beetle, various species of ants were commonly seen co-occurring in the sandy patches with adults and larvae, but their impact, if any, is unknown at this time.

    Available literature indicates that the most important tiger beetle natural enemies are tiphiid wasps and bombyliid flies, which parasitize larvae (Knisley and Schultz 1997, pp. 53-57). The wasps enter the larvae burrows, and paralyze and lay an egg on the larvae. The resulting parasite larva consumes the host tiger beetle larva. Bombyliid flies (genus Anthrax) drop eggs into larval burrows with the resulting fly larvae consuming the tiger beetle larva. These parasitoids accounted for 20 to 80 percent mortality in larvae of several northeastern tiger beetles (Pearson and Vogler 2001, p. 172). Parasitism from bombyliid flies accounted for 13 to 25 percent mortality to larvae of the Highlands tiger beetle at several sites (Knisley and Hill 2013, p. 37). Generally, these rates of parasitism are similar to those reported for other species of tiger beetles (Bram and Knisley 1982, p. 99; Palmer 1982, p. 64; Knisley 1987, p. 1198). No tiphiid wasps or bombyliid flies were observed during field studies with the Miami tiger beetle (Knisley 2015a, p. 15); however, tiphiid wasps are small, secretive, and evidence of their attacks is difficult to find (Knisley 2015b, p. 16).

    Summary of Factor C

    Potential impacts from predators or parasites to the Miami tiger beetle are unknown. Given the small size of the Miami tiger beetle's two populations, the species is likely vulnerable to predation and parasitism.

    Factor D. The Inadequacy of Existing Regulatory Mechanisms

    Section 4(b)(1)(A) of the Act requires the Service to take into account “those efforts, if any, being made by any State or foreign nation, or any political subdivision of a State or foreign nation, to protect such species. . . .” In relation to Factor D, we interpret this language to require the Service to consider relevant Federal, State, and Tribal laws, plans, regulations, and other such mechanisms that may minimize any of the threats we describe in threat analyses under the other four factors, or otherwise enhance conservation of the species. We give strongest weight to statutes and their implementing regulations and to management direction that stems from those laws and regulations. An example would be State governmental actions enforced under a State statute or constitution, or Federal action under statute.

    Federal

    The Miami tiger beetle currently has no Federal protective status and has limited regulatory protection in its known occupied and suitable habitat. The species is not known to occur on National Wildlife Refuge or National Park land. The Miami tiger beetle is known to occur on USCG lands within the Richmond Pinelands Complex, and there are limited protection for the species on this property; any USCG actions or decisions that may have an effect on the environment would require consideration and review under the National Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq.). No Federal permit or other authorization is currently needed for potential impacts to known occurrences on county-owned and private land. The Miami tiger beetle could be afforded limited protections from sections 7 and 10 of the Act based on its co-occurrence with listed species or their critical habitat, if applicable, within the Richmond Pine Rocklands, including species such as the Bartram's scrub-hairstreak butterfly (Strymon acis bartrami), Florida leafwing butterfly (Anaea troglodyta floridalis), Florida bonneted bat (Eumops floridanus), Florida brickell-bush (Brickellia mosieri), Carter's small-flowered flax (Linum carteri var. carteri), deltoid spurge (Chamaesyce deltoidea ssp. deltoidea), and tiny polygala (Polygala smallii). However, effect determinations and minimization and avoidance criteria for any of these listed species are unlikely to be fully protective to the Miami tiger beetle considering its extreme rarity. The listed species have broader distributions that allow for more flexibility with appropriate conservation measures. In contrast, with only two known populations and few remaining adults, the Miami tiger beetle has a much lower threat tolerance. Although the beetle is not currently federally protected, the Service has met with Miami-Dade County, the USCG, the University of Miami, and potential developers to express our concern regarding listed, proposed, candidate, and imperiled species in the Richmond Pine Rocklands, including the Miami tiger beetle. We have recommended that management and habitat conservation plans include and fully consider this species and its habitat.

    State

    The Miami tiger beetle is not currently listed as endangered or threatened by the State of Florida, so there are no existing regulations designated to protect it. The Miami tiger beetle is recognized as a species of greatest conservation need by the FWC (FWC 2012, p. 89). Species of greatest conservation need designation is part of the State's strategy to recognize and seek funding opportunities for research and conservation of these species, particularly through the State Wildlife Grants program. The list is extensive and, to date, we are unaware of any dedicated funding from this program for the beetle. The Miami tiger beetle is not known to occur on lands owned by the State of Florida; however, not all State-owned pine rockland parcels have been adequately surveyed. It is possible that some State-owned parcels do provide potentially suitable habitat, and support occurrences of, the Miami tiger beetle.

    Local

    In 1984, section 24-49 of the Code of Miami-Dade County established regulation of County-designated Natural Forested Communities (NFCs), which include both pine rocklands and tropical hardwood hammocks. These regulations were placed on specific properties throughout the county by an act of the Board of County Commissioners in an effort to protect environmentally sensitive forest lands. The Miami-Dade County Department of Regulatory and Economic Resources (RER) has regulatory authority over NFCs, and is charged with enforcing regulations that provide partial protection on the Miami Rock Ridge. Miami-Dade Code typically allows up to 20 percent of a pine rockland designated as NFC to be developed, and requires that the remaining 80 percent be placed under a perpetual covenant. In certain circumstances, where the landowner can demonstrate that limiting development to 20 percent does not allow for “reasonable use” of the property, additional development may be approved. NFC landowners are also required to obtain an NFC permit for any work within the boundaries of the NFC on their property. The NFC program is responsible for ensuring that NFC permits are issued in accordance with the limitations and requirements of the code and that appropriate NFC preserves are established and maintained in conjunction with the issuance of an NFC permit. The NFC program currently regulates approximately 600 pine rockland or pine rockland/hammock properties, comprising approximately 1,200 ha (3,000 ac) of habitat (J. Joyner, 2013, pers. comm.). When RER discovers unpermitted activities, it takes appropriate enforcement action, and seeks restoration when possible. Because these regulations allows for development of pine rockland habitat, and because unpermitted development and destruction of pine rockland continues to occur, the regulations are not fully effective at protecting against loss of Miami tiger beetles or their potential habitat.

    Under Miami-Dade County ordinance (section 26-1), a permit is required to conduct scientific research (rule 9) on county environmental lands. In addition, rule 8 of this ordinance provides for the preservation of habitat within County parks or areas operated by the Parks and Recreation Department. The scientific research permitting effectively allows the County to monitor and manage the level of scientific research and collection of the Miami tiger beetle, and the preservation of pine rockland habitat benefits the beetle.

    Fee Title Properties: In 1990, Miami-Dade County voters approved a 2-year property tax to fund the acquisition, protection, and maintenance of environmentally endangered lands (EEL). The EEL Program identifies and secures these lands for preservation. Under this program to date, Miami-Dade County has acquired a total of approximately 255 ha (630 ac) of pine rocklands. In addition, approximately 445 ha (1,100 ac) of pine rocklands are owned by the Miami-Dade County Parks and Recreation Department and managed by the EEL Program, including some of the largest remaining areas of pine rockland habitat on the Miami Rock Ridge outside of ENP (e.g., Larry and Penny Thompson Park, Zoo Miami pinelands, and Navy Wells Pineland Preserve).

    Summary of Factor D

    There are some regulatory mechanisms currently in place to protect the Miami tiger beetle and its habitat on non-Federal lands. However, there are no Federal regulatory protections for the Miami tiger beetle, other than the limited protections afforded for listed species and critical habitat that co-occur with the Miami tiger beetle. While local regulations provide some protection, they are generally not fully effective (e.g., NFC regulations allow development of 20 percent or more of pine rockland habitat) or implemented sufficiently (e.g., unpermitted clearing of pine rockland habitat) to alleviate threats to the Miami tiger beetle and its habitat. The degradation of habitat for the Miami tiger beetle is ongoing despite existing regulatory mechanisms. Based on our analysis of the best available information, we find that existing regulatory measures, due to a variety of constraints, are inadequate to fully address threats to the species throughout its range.

    Factor E. Other Natural or Manmade Factors Affecting Its Continued Existence Few, Small, Isolated Populations

    The Miami tiger beetle is vulnerable to extinction due to its severely reduced range, the fact that only two small populations remain, and the species' relative isolation.

    Demographic stochasticity refers to random variability in survival or reproduction among individuals within a population (Shaffer 1981, p. 131). Demographic stochasticity can have a significant impact on population viability for populations that are small, have low fecundity, and are short-lived. In small populations, reduced reproduction or die-offs of a certain age-class will have a significant effect on the whole population. Although of only minor consequence to large populations, this randomly occurring variation in individuals becomes an important issue for small populations.

    Environmental stochasticity is the variation in birth and death rates from one season to the next in response to weather, disease, competition, predation, or other factors external to the population (Shaffer 1981, p. 131). For example, drought or predation, in combination with a low population year, could result in extirpation. The origin of the environmental stochastic event can be natural or human-caused.

    In general, tiger beetles that have been regularly monitored consistently exhibit extreme fluctuations in population size, often apparently due to climatic or other habitat factors that affect recruitment, population growth, and other population parameters. In 20 or more years of monitoring, most populations of the northeastern beach and puritan tiger beetles (Cicindela puritan) have exhibited 2 to 5 or more fold differences in abundance (Knisley 2012, entire). Annual population estimates of the Coral Pink Sand Dunes tiger beetle (Cicindela albissima) (have ranged from fewer than 600 to nearly 3,000 adults over a 22-year period (Gowan and Knisley 2014, p. 124). The Miami tiger beetle has not been monitored as extensively as these species, but in areas where Miami tiger beetles were repeatedly surveyed, researchers found fluctuations that were several fold in numbers (Knisley 2015a, p. 24). While these fluctuations appear to be the norm for populations of tiger beetles (and most insects), the causes and effects are not well known. Among the suggested causes of these population trends are annual rainfall patterns for the Coral Pink Sand Dunes tiger beetle (Knisley and Hill 2001, p. 391; Gowan and Knisley 2014, p. 119), and shoreline erosion from storms for the northeastern beach and puritan tiger beetles (Knisley 2011b, p. 54). As a result of these fluctuations, many tiger beetle populations will experience episodic low numbers (bottlenecks) or even local extinction from genetic decline, the Allee effect, or other factors. Given that the Miami tiger beetle is only known from two remaining populations with few adult individuals, any significant decrease in the population size could easily result in extinction of the species.

    Dispersal and movement of the Miami tiger beetle is unknown, but is considered to be very limited. A limited mark-recapture study with the closely related Highlands tiger beetle found that adult beetles moved no more than 150 m (490 ft), usually flying only 5-10 m (16-33 ft) at a time (Knisley and Hill 2013). Generally, tiger beetles are known to easily move around, so exchange of individuals among separated sites will commonly occur if there are habitat connections or if the sites are within dispersal range—which is not the case with the population structure of the Miami tiger beetle. Species in woodland, scrub, or dune habitats also seem to disperse less than water-edge species (Knisley and Hill 1996, p. 13). Among tiger beetles, there is a general trend of decreasing flight distance with decreasing body size (Knisley and Hill 1996, p. 13). The Miami tiger beetle has a small body size. Given these factors, dispersal may be limited for the Miami tiger beetle.

    Small, isolated population size was listed as one of several of the threats in the petition received to list the Miami tiger beetle (CBD et. al. 2014, pp. 17, 30). The effects of low population size on population viability are not known for tiger beetles, but population viability analyses for the northeastern beach, puritan, and Coral Pink Sand Dunes tiger beetles determined that stochasticity, specifically the fluctuations in population size, was the main factor accounting for the high risk of extinction (Gowan and Knisley 2001, entire; 2005, p. 13; Knisley and Gowan 2009, pp. 13-23). The long-term monitoring of northeastern beach and puritan tiger beetles found that, despite the fluctuations, some small populations with fewer than 50 to 100 adults experienced several fold declines, but persisted (Knisley 2015b, p. 20). Several Highlands tiger beetle sites with fewer than 20 to 50 adults were lost over the past 15-20 years, while several others have persisted during that period (Knisley 2015b, p. 20). Losses may have been due to habitat disturbance or low population size effects. Knisley predicts that the Highlands tiger beetle populations (extinct and extant) are isolated from each other with little chance for dispersal between populations and immigration rescues (B. Knisley, 2015d, pers. comm.). With only two known populations of the Miami tiger beetle, separated by substantial urban development, the potential for immigration rescue is low.

    Pesticides

    Pesticides used in and around pine rockland habitat are a potential threat to the Miami tiger beetle through direct exposure to adults and larvae, secondary exposure from insect prey, overall reduction in availability of adult and larval prey, or any combination of these factors. The use of pesticides for agriculture and mosquito control presents potential risks to nontarget insects, especially imperiled insects (EPA 2002, p. 32; 2006a, p. 58; 2006b, p. 44). The negative effect of insecticides on several tiger beetle species was suggested by Nagano (1980, p. 34) and Stamatov (1972, p. 78), although impacts from pesticides do not appear to be well studied in tiger beetles.

    Efforts to control mosquitoes and other insect pests in Florida have increased as human activity and population size have increased. To control mosquito populations, organophosphate (naled) and pyrethroid (permethrin) adulticides are applied by mosquito control districts throughout south Florida, including Miami-Dade County. These compounds have been characterized as being highly toxic to nontarget insects by the U.S. Environmental Protection Agency (2002, p. 32; 2006a, p. 58; 2006b, p. 44). The use of such pesticides (applied using both aerial and ground-based methods) for mosquito control presents a potential risk to the Miami tiger beetle.

    In order for mosquito control pesticides to be effective, they must make direct contact with mosquitoes. For this to happen, pesticides are applied using methods to promote drift through the air, so as to increase the potential for contact with their intended target organism. Truck-based permethrin application methods are expected to produce a swath of suspended pesticides approximately 91 m (300 ft) wide (Prentiss 2007, p. 4). The extent of pesticide drift from this swath is dependent on several factors, including wind speed, wind direction, and vegetation density. Hennessey and Habeck (1989, pp. 1-22; 1991, pp. 1-68) and Hennessey et al. (1992, pp. 715-721) illustrated the presence of mosquito spray residues long after application in habitat of the federally endangered Schaus swallowtail butterfly (Papilio aristodemus ponceanus), as well as the Florida leafwing butterfly (Anaea troglodyta floridalis), Bartram's scrub-hairstreak butterfly, and other imperiled species. Residues of aerially applied naled were found 6 hours after application in a pineland area that was 750 m (2,460 ft) from the target area; residues of fenthion (an adulticide previously used in the Florida Keys) applied via truck were found up to 50 m (160 ft) downwind in a hammock area 15 minutes after application in adjacent target areas (Hennessey et al. 1992, pp. 715-721).

    More recently, Pierce (2009, pp. 1-17) monitored naled and permethrin deposition following mosquito control application. Permethrin, applied by truck, was found to drift considerable distances from target areas, with residues that persisted for weeks. Permethrin was detected at concentrations lethal to three butterfly species at a distance of approximately 227 m (745 ft) away from targeted truck routes. Naled, applied by plane, was also found to drift into nontarget areas, but was much less persistent, exhibiting a half-life (time for half of the naled applied to chemically break down) of approximately 6 hours. To expand this work, Pierce (2011, pp. 6-11) conducted an additional deposition study in 2010, focusing on permethrin drift from truck spraying, and again documented low but measurable amounts of permethrin in nontarget areas. In 2009, Bargar (2012, p. 3) conducted two field trials that detected significant naled residues at locations within nontarget areas up to 366 m (1,200 ft) from the edge of zones targeted for aerial applications. After this discovery, the Florida Keys Mosquito Control District recalibrated the on-board model (Wingman, which provides flight guidance and flow rates). Naled deposition was reduced in some of the nontarget zones following recalibration (Bargar 2012, p. 3).

    In addition to mosquito control chemicals entering nontarget areas, the toxic effects of such chemicals to nontarget organisms have also been documented. Lethal effects on nontarget moths and butterflies have been attributed to fenthion and naled in both south Florida and the Florida Keys (Emmel 1991, pp. 12-13; Eliazar and Emmel 1991, pp. 18-19; Eliazar 1992, pp. 29-30). Zhong et al. (2010, pp. 1961-1972) investigated the impact of single aerial applications of naled on the endangered Miami blue butterfly (Cyclargus thomasi bethunebakeri) larvae in the field. Survival of butterfly larvae in the target zone was 73.9 percent, which was significantly lower than in both the drift zone (90.6 percent) and the reference (control) zone (100 percent), indicating that direct exposure to naled poses significant risk to Miami blue butterfly larvae. Fifty percent of the samples in the drift zone also exhibited detectable concentrations, once again exhibiting the potential for mosquito control chemicals to drift into nontarget areas. Bargar (2012, p. 4) observed cholinesterase activity depression, to a level shown to cause mortality in the laboratory, in great southern white (Ascia monuste) and Gulf fritillary butterflies (Agraulis vanillae) exposed to naled in both target and nontarget zones.

    Based on these studies, it can be concluded that mosquito control activities that involve the use of both aerial and ground-based spraying methods have the potential to deliver pesticides in quantities sufficient to cause adverse effects to nontarget species in both target and nontarget areas. Pesticide drift at a level of concern to nontarget invertebrates (butterflies) has been measured up to approximately 227 m (745 ft) from truck routes (Pierce 2011, pp. 3-5, 7; Rand and Hoang 2010, pp. 14, 23) and 400 m (1,312 ft) from aerial spray zones (Bargar 2012, p. 3). It should be noted that many of the studies referenced above dealt with single application scenarios and examined effects on only one or two butterfly life stages. Under a realistic scenario, the potential exists for exposure to all life stages to occur over multiple applications in a season. In the case of a persistent compound like permethrin, whose residues remain on vegetation for weeks, the potential exists for nontarget species to be exposed to multiple pesticides within a season (e.g., permethrin on vegetation coupled with aerial exposure to naled).

    Prior to 2015, aerial applications of mosquito control pesticides occurred on a limited basis (approximately two to four aerial applications per year since 2010) within some of Miami-Dade County's pine rockland areas. The Miami tiger beetle is not known to occupy any of these aerial spray zone sites, but any unknown occupied sites could have been exposed, either directly or through drift. The Richmond Pine Rocklands region is not directly treated either aerially or by truck (C. Vasquez, 2013, pers. comm.), so any potential pesticide exposure in this area would be through drift from spray zones adjacent to the Richmond area. Pesticide drift from aerial spray zones to the two known populations of Miami tiger beetles is unlikely, based on the considerable distance from spray zone boundaries to known occurrences of the beetle (estimated minimum distances range from 2.0-3.0 km (1.2-1.9 mi) from the Richmond population and 434 m (0.3 mi) for the second population). In the past, truck-based applications occurred within 227 m (745 ft) of known occupied Miami tiger beetle habitat, a distance under which pesticide drift at a concentration of concern for nontarget invertebrates had been measured (Pierce 2011, pp. 3-5, 7; Rand and Hoang 2010, pp. 14, 23). For the 2015 mosquito season (May through October), Miami-Dade Mosquito Control coordinated with the Service to institute 250-m truck-based and 400-m aerial spray buffers around critical habitat for the Bartram's scrub-hairstreak butterfly, with the exclusion of pine rocklands in the Navy Wells area, which is not known to be occupied by the Miami tiger beetle. These newly implemented buffers will also reduce exposure to any other imperiled species occurring on pine rockland habitat within Bartram's scrub-hairstreak butterfly critical habitat, such as the Miami tiger beetle. Assuming that the Miami tiger beetle is no more sensitive to pesticide exposure than the tested butterfly species, these spray buffers should avoid adverse impacts to the Miami tiger beetle population.

    Based on Miami-Dade Mosquito Control's implementation of spray buffers, mosquito control pesticides are not considered a major threat for the Miami tiger beetle at this time. If these buffers were to change or Miami tiger beetles were found to occur on habitat that is not protected by Bartram's scrub-hairstreak butterfly critical habitat, then the threat of pesticide exposure would have to be reevaluated.

    Human Disturbance

    Human disturbance, depending upon type and frequency, may or may not be a threat to tiger beetles or their habitats. Knisley (2011b, entire) reviewed both the negative and positive effects of human disturbances on tiger beetles. Vehicles, bicycles, and human foot traffic have been implicated in the decline and extirpation of tiger beetle populations, especially for species in more open habitats like beaches and sand dunes. The northeastern beach tiger beetle was extirpated throughout the northeast coincidental with the development of recreational use from pedestrian foot traffic and vehicles (Knisley et al. 1987, p. 301). Habroscelimorpha dorsalis media (southeastern beach tiger beetle) was extirpated from a large section of Assateague Island National Seashore, Maryland, after the initiation of off- highway vehicle (OHV) use (Knisley and Hill, 1992b, p. 134). Direct mortality and indirect effects on habitat from OHVs have been found to threaten the survival of Coral Pink Sand Dunes tiger beetle (Gowan and Knisley 2014, pp. 127-128). However, there are other documented cases of the beneficial effects of these types of disturbances, by creating open areas of habitat for tiger beetles, particularly at sites where vegetation growth has eliminated these open habitat patches (Knisley 2011, pp. 44-45). The Ohlone tiger beetle has been eliminated from nearly all natural grassland areas in Santa Cruz, California, except where pedestrian foot traffic, mountain bike use, or cattle grazing has created or maintained trails and open patches of habitat (Knisley and Arnold 2013, p. 578). Similarly, over 20 species of tiger beetles, including Cicindela decemnotata (Badlands tiger beetle) at Dugway Proving Ground in Utah, are almost exclusively restricted to roads, trails, and similar areas kept open by vehicle use or similar human disturbances (Knisley 2011b, pp. 44-45).

    Vehicle activity on seldom-used roads may have some negative effect on the Miami tiger beetle (i.e., lethal impacts to adults or larvae or impacts to the habitat), but limited field observations to date indicate that effects are minimal (Knisley 2015a, p. 16). Observations in 2014 at Zoo Miami found a few adults along a little-used road and the main gravel road adjacent to interior patches where adults were more common (Knisley 2015, p. 16). These adults may have dispersed from their primary interior habitat, possibly due to vegetation encroachment (Knisley 2015a, p. 16). Several of the adults at both CSTARS and the USCG parcels were also found along dirt roads that were not heavily used and apparently provided suitable habitat.

    The parcels that comprise the two known populations of the Miami tiger beetle are not open to the public for recreational use, so human disturbance is unlikely. For any unknown occurrences of the species, human disturbance from recreational use is a possibility, as some of the remaining pine rockland sites in Miami-Dade County are open to the public for recreational use. Miami-Dade County leads the State in gross urban density at 15.45 people per acre (Zwick and Carr 2006, pp. 1, 13), and development and human population growth are expected to continue in the future. By 2025, Miami-Dade County is predicted to exceed a population size of over 3 million people (Zwick and Carr 2006, p. 20). With the expected future increase in human population and development, there will likely be an increase in the use of recreational areas, including sites with potentially suitable habitat and unknown occurrences of Miami tiger beetles. Projected future increases in recreational use, may increase levels of human disturbance and negatively impact any unknown occurrences of the Miami tiger beetle and their habitat.

    In summary, vehicular activity and recreational use within the known population of the Miami tiger beetle presents minimal impacts to the species. However, future negative impacts to unknown beetle occurrences on lands open to the public are possible and are expected to increase with the projected future population growth.

    Climate Change and Sea Level Rise

    Climatic changes, including sea level rise (SLR), are major threats to Florida, and could impact the Miami tiger beetle and the few remaining parcels of pine rockland habitat left in Miami-Dade County. Our analyses include consideration of ongoing and projected changes in climate. The terms “climate” and “climate change” are defined by the Intergovernmental Panel on Climate Change (IPCC). “Climate” refers to the mean and variability of different types of weather conditions over time, with 30 years being a typical period for such measurements, although shorter or longer periods also may be used (IPCC 2007a, p. 78). The term “climate change” thus refers to a change in the mean or variability of one or more measures of climate (e.g., temperature or precipitation) that persists for an extended period, typically decades or longer, whether the change is due to natural variability, human activity, or both (IPCC 2007a, p. 78).

    Scientific measurements spanning several decades demonstrate that changes in climate are occurring, and that the rate of change has been faster since the 1950s. Based on extensive analyses of global average surface air temperature, the most widely used measure of change, the IPCC concluded that warming of the global climate system over the past several decades is “unequivocal” (IPCC 2007a, p. 2). In other words, the IPCC concluded that there is no question that the world's climate system is warming. Examples of other changes include substantial increases in precipitation in some regions of the world and decreases in other regions (for these and additional examples, see IPCC 2007a, p. 30; Solomon et al. 2007, pp. 35-54, 82-85). Various environmental changes (e.g., shifts in the ranges of plant and animal species, increasing ground instability in permafrost regions, conditions more favorable to the spread of invasive species and of some diseases, changes in amount and timing of water availability) are occurring in association with changes in climate (see IPCC 2007a, pp. 2-4, 30-33; Global Climate Change Impacts in the United States 2009, pp. 27, 79-88).

    Results of scientific analyses presented by the IPCC show that most of the observed increase in global average temperature since the mid-20th century cannot be explained by natural variability in climate, and is “very likely” (defined by the IPCC as 90 percent or higher probability) due to the observed increase in greenhouse gas (GHG) concentrations in the atmosphere as a result of human activities, particularly carbon dioxide emissions from fossil fuel use (IPCC 2007a, pp. 5-6 and figures SPM.3 and SPM.4; Solomon et al. 2007, pp. 21-35). Further confirmation of the role of GHGs comes from analyses by Huber and Knutti (2011, p. 4), who concluded it is extremely likely that approximately 75 percent of global warming since 1950 has been caused by human activities.

    Scientists use a variety of climate models, which include consideration of natural processes and variability, as well as various scenarios of potential levels and timing of GHG emissions, to evaluate the causes of changes already observed and to project future changes in temperature and other climate conditions (e.g., Meehl et al. 2007, entire; Ganguly et al. 2009, pp. 11555, 15558; Prinn et al. 2011, pp. 527, 529). All combinations of models and emissions scenarios yield very similar projections of average global warming until about 2030. Although projections of the magnitude and rate of warming differ after about 2030, the overall trajectory of all the projections is one of increased global warming through the end of this century, even for projections based on scenarios that assume that GHG emissions will stabilize or decline. Thus, there is strong scientific support for projections that warming will continue through the 21st century, and that the magnitude and rate of change will be influenced substantially by the extent of GHG emissions (IPCC 2007a, pp. 44-45; Meehl et al. 2007, pp. 760-764; Ganguly et al. 2009, pp. 15555-15558; Prinn et al. 2011, pp. 527, 529).

    In addition to basing their projections on scientific analyses, the IPCC reports projections using a framework for treatment of uncertainties (e.g., they define “very likely” to mean greater than 90 percent probability, and “likely” to mean greater than 66 percent probability; see Solomon et al. 2007, pp. 22-23). Some of the IPCC's key projections of global climate and its related effects include: (1) It is virtually certain there will be warmer and more frequent hot days and nights over most of the earth's land areas; (2) it is very likely there will be increased frequency of warm spells and heat waves over most land areas; (3) it is very likely that the frequency of heavy precipitation events, or the proportion of total rainfall from heavy falls, will increase over most areas; and (4) it is likely the area affected by droughts will increase, that intense tropical cyclone activity will increase, and that there will be increased incidence of extreme high sea level (IPCC 2007b, p. 8, table SPM.2). More recently, the IPCC published additional information that provides further insight into observed changes since 1950, as well as projections of extreme climate events at global and broad regional scales for the middle and end of this century (IPCC 2011, entire).

    Various changes in climate may have direct or indirect effects on species. These may be positive, neutral, or negative, and they may change over time, depending on the species and other relevant considerations, such as interactions of climate with other variables such as habitat fragmentation (for examples, see Franco et al. 2006; IPCC 2007a, pp. 8-14, 18-19; Forister et al. 2010; Galbraith et al. 2010; Chen et al. 2011). In addition to considering individual species, scientists are evaluating possible climate change-related impacts to, and responses of, ecological systems, habitat conditions, and groups of species; these studies include acknowledgement of uncertainty (e.g., Deutsch et al. 2008; Berg et al. 2009; Euskirchen et al. 2009; McKechnie and Wolf 2009; Sinervo et al. 2010; Beaumont et al. 2011; McKelvey et al. 2011; Rogers and Schindler 2011).

    Many analyses involve elements that are common to climate change vulnerability assessments. In relation to climate change, vulnerability refers to the degree to which a species (or system) is susceptible to, and unable to cope with, adverse effects of climate change, including climate variability and extremes. Vulnerability is a function of the type, magnitude, and rate of climate change and variation to which a species is exposed, its sensitivity, and its adaptive capacity (IPCC 2007a, p. 89; see also Glick et al. 2011, pp. 19-22). There is no single method for conducting such analyses that applies to all situations (Glick et al. 2011, p. 3). We use our expert judgment and appropriate analytical approaches to weigh relevant information, including uncertainty, in our consideration of various aspects of climate change.

    As is the case with all stressors that we assess, even if we conclude that a species is currently affected or is likely to be affected in a negative way by one or more climate-related impacts, it does not necessarily follow that the species meets the definition of an “endangered species” or a “threatened species” under the Act. If a species is listed as endangered or threatened, knowledge regarding its vulnerability to, and known or anticipated impacts from, climate-associated changes in environmental conditions can be used to help devise appropriate strategies for its recovery.

    Global climate projections are informative, and, in some cases, the only or the best scientific information available for us to use. However, projected changes in climate and related impacts can vary substantially across and within different regions of the world (e.g., IPCC 2007a, pp. 8-12). Therefore, we use “downscaled” projections when they are available and have been developed through appropriate scientific procedures, because such projections provide higher resolution information that is more relevant to spatial scales used for analyses of a given species (see Glick et al. 2011, pp. 58-61, for a discussion of downscaling). For our analysis for the Miami tiger beetle, downscaled projections are available.

    According to the Florida Climate Center, Florida is by far the most vulnerable State in the United States to hurricanes and tropical storms (http://climatecenter.fsu.edu/topics/tropical-weather). Based on data gathered from 1856 to 2008, Klotzbach and Gray (2009, p. 28) calculated the climatological probabilities for each State being impacted by a hurricane or major hurricane in all years over the 152-year timespan. Of the coastal States analyzed, Florida had the highest climatological probabilities, with a 51 percent probability of a hurricane (Category 1 or 2) and a 21 percent probability of a major hurricane (Category 3 or higher). From 1856 to 2008, Florida actually experienced more major hurricanes than predicted; out of the 109 hurricanes, 36 were major hurricanes. The most recent hurricane to have major impacts to Miami-Dade County was Hurricane Andrew in 1992. While the species persisted after this hurricane, impacts to the population size and distribution from the storm are unknown, because no surveys were conducted until its rediscovery in 2007. Given the few, isolated populations of the Miami tiger beetle within a location prone to storm influences (located approximately 8 km (5 mi) from the coast), the species is at substantial risk from stochastic environmental events such as hurricanes, storm surges, and other extreme weather that can affect recruitment, population growth, and other population parameters.

    Other processes to be affected by climate change, related to environmental stochasticity, include temperatures, rainfall (amount, seasonal timing, and distribution), and storms (frequency and intensity). Temperatures are projected to rise from 2-5 degrees Celsius (°C) (3.6-9 degrees Fahrenheit (°F)) for North America by the end of this century (IPCC 2007a, pp. 7-9, 13). Based upon predictive modeling, Atlantic hurricane and tropical storm frequencies are expected to decrease (Knutson et al. 2008, pp. 1-21). By 2100, there should be a 10-30 percent decrease in hurricane frequency. Hurricane frequency is expected to drop, due to more wind shear impeding initial hurricane development. However, hurricane winds are expected to increase by 5-10 percent. This is due to more hurricane energy available for intense hurricanes. These stronger winds will result in damage to the pine rockland vegetation and an increased storm surge (discussed below). In addition to climate change, weather variables are extremely influenced by other natural cycles, such as El Niño Southern Oscillation, with a frequency of every 4-7 years; solar cycle (every 11 years); and the Atlantic Multi-decadal Oscillation. All of these cycles influence changes in Floridian weather. The exact magnitude, direction, and distribution of all of these changes at the regional level are difficult to project.

    The long-term record at Key West shows that sea level rose on average 0.229 cm (0.090 in) annually between 1913 and 2013 (National Oceanographic and Atmospheric Administration (NOAA) 2013, p. 1). This equates to approximately 22.9 cm (9.02 in) over the last 100 years. IPCC (2008, p. 28) emphasized it is very likely that the average rate of SLR during the 21st century will exceed the historical rate. The IPCC Special Report on Emission Scenarios (2000, entire) presented a range of scenarios based on the computed amount of change in the climate system due to various potential amounts of anthropogenic greenhouse gases and aerosols in 2100. Each scenario describes a future world with varying levels of atmospheric pollution, leading to corresponding levels of global warming and corresponding levels of SLR. The IPCC Synthesis Report (2007a, entire) provided an integrated view of climate change and presented updated projections of future climate change and related impacts under different scenarios.

    Subsequent to the 2007 IPCC Report, the scientific community has continued to model SLR. Recent peer-reviewed publications indicate a movement toward increased acceleration of SLR. Observed SLR rates are already trending along the higher end of the 2007 IPCC estimates, and it is now widely held that SLR will exceed the levels projected by the IPCC (Rahmstorf et al. 2012, p. 1; Grinsted et al. 2010, p. 470). Taken together, these studies support the use of higher end estimates now prevalent in the scientific literature. Recent studies have estimated global mean SLR of 1.0-2.0 m (3.3-6.6 ft) by 2100 as follows: 0.75-1.90 m (2.5-6.2 ft; Vermeer and Rahmstorf 2009, p. 21530), 0.8-2.0 m (2.6-6.6 ft; Pfeffer et al. 2008, p. 1342), 0.9-1.3 m (3.0-4.3 ft; Grinsted et al. 2010, pp. 469-470), 0.6-1.6 m (2.0-5.2 ft; Jevrejeva et al. 2010, p. 4), and 0.5-1.40 m (1.6-4.6 ft; National Research Council 2012, p. 2).

    All of the scenarios, from small climate change shifts to major changes, indicate negative effects on pine rockland habitat throughout Miami-Dade County. Prior to inundation, pine rocklands are likely to undergo habitat transitions related to climate change, including changes to hydrology and increasing vulnerability to storm surge. Hydrology has a strong influence on plant distribution in these and other coastal areas (IPCC 2008, p. 57). Such communities typically grade from salt to brackish to freshwater species. From the 1930s to 1950s, increased salinity of coastal waters contributed to the decline of cabbage palm forests in southwest Florida (Williams et al. 1999, pp. 2056-2059), expansion of mangroves into adjacent marshes in the Everglades (Ross et al. 2000, pp. 101, 111), and loss of pine rockland in the Keys (Ross et al. 1994, pp. 144, 151-155). In one Florida Keys pine rockland with an average elevation of 0.89 m (2.9 ft), Ross et al. (1994, pp. 149-152) observed an approximately 65 percent reduction in an area occupied by South Florida slash pine over a 70-year period, with pine mortality and subsequent increased proportions of halophytic (salt-loving) plants occurring earlier at the lower elevations. During this same time span, local sea level had risen by 15.0 cm (6.0 in), and Ross et al. (1994, p. 152) found evidence of groundwater and soil water salinization. Extrapolating this situation to pine rocklands on the mainland is not straightforward, but suggests that similar changes to species composition could arise if current projections of SLR occur and freshwater inputs are not sufficient to prevent salinization. Furthermore, Ross et al. (2009, pp. 471-478) suggested that interactions between SLR and pulse disturbances (e.g., storm surges) can cause vegetation to change sooner than projected based on sea level alone. Effects from vegetation shifts in the pine rockland habitat on the Miami tiger beetle are unknown, but because the beetle occurs in a narrow range and microhabitat parameters are still being studied, vegetation shifts could cause habitat changes or disturbance that would have a negative impact on beetle recruitment and survival. Alexander (1953, pp. 133-138) attributed the demise of pinelands on northern Key Largo to salinization of the groundwater in response to SLR. Patterns of human development will also likely be significant factors influencing whether natural communities can move and persist (IPCC 2008, p. 57; USCCSP 2008, pp. 7-6).

    The Science and Technology Committee of the Miami-Dade County Climate Change Task Force (Wanless et al. 2008, p. 1) recognized that significant SLR is a very real threat to the near future for Miami-Dade County. In a January 2008 statement, the committee warned that sea level is expected to rise at least 0.9-1.5 m (3-5 ft) within this century (Wanless et al. 2008, p. 3). With a 0.9-1.2 m (3-4 ft) rise in sea level (above baseline) in Miami-Dade County: “Spring high tides would be at about 6 to 7 ft; freshwater resources would be gone; the Everglades would be inundated on the west side of Miami-Dade County; the barrier islands would be largely inundated; storm surges would be devastating; landfill sites would be exposed to erosion contaminating marine and coastal environments. Freshwater and coastal mangrove wetlands will not keep up with or offset SLR of 2 ft per century or greater. With a 5-ft rise (spring tides at nearly +8 ft), Miami-Dade County will be extremely diminished” (Wanless et al. 2008, pp. 3-4).

    Drier conditions and increased variability in precipitation associated with climate change are expected to hamper successful regeneration of forests and cause shifts in vegetation types through time (Wear and Greis 2012, p. 39). Although it has not been well studied, existing pine rocklands have probably been affected by reductions in the mean water table. Climate changes are also forecasted to extend fire seasons and the frequency of large fire events throughout the Coastal Plain (Wear and Greis 2012, p. 43). While restoring fire to pine rocklands is essential to the long-term viability of the Miami tiger beetle (see Factor A discussion, above), increases in the scale, frequency, or severity of wildfires could have negative effects on the species (e.g., if wildfire occurs over the entire area occupied by the two known populations during the adult flight season when adults are present).

    To accommodate the large uncertainty in SLR projections, researchers must estimate effects from a range of scenarios. Various model scenarios developed at Massachusetts Institute of Technology (MIT) and GeoAdaptive Inc. have projected possible trajectories of future transformation of the south Florida landscape by 2060, based upon four main drivers: climate change, shifts in planning approaches and regulations, human population change, and variations in financial resources for conservation (Vargas-Moreno and Flaxman 2010, pp. 1-6). The scenarios do not account for temperature, precipitation, or species habitat shifts due to climate change, and no storm surge effects are considered. The current MIT scenarios range from an increase of 0.09-1.00 m (0.3-3.3 ft) by 2060.

    Based on the most recent estimates of SLR and the data available to us at this time, we evaluated potential effects of SLR using the current “high” range MIT scenario, as well as comparing elevations of remaining pine rockland fragments and extant occurrences of the Miami tiger beetle. The “high” range (or “worst case”) MIT scenario assumes high SLR (1.0 m (3.3 ft) by 2060), low financial resources, a `business as usual' approach to planning, and a doubling of human population. Based on this scenario, pine rocklands along the coast in central Miami-Dade County would become inundated. The “new” sea level (1.0 m (3.3 ft) higher) would come up to the edge of pine rockland fragments at the southern end of Miami-Dade County, translating to partial inundation or, at a minimum, vegetation shifts for these pine rocklands. While sea level under this scenario would not overtake other pine rocklands in urban Miami-Dade County, including the known locations for the Miami tiger beetle, changes in the salinity of the water table and soils would surely cause vegetation shifts that may negatively impact the viability of the beetle. In addition, many existing pine rockland fragments are projected to be developed for housing as the human population grows and adjusts to changing sea levels under this “high” range (or “worst case”) MIT scenario. Actual impacts may be greater or less than anticipated based upon high variability of factors involved (e.g., SLR, human population growth) and assumptions made in the model.

    When simply looking at current elevations of pine rockland fragments and occurrences of the Miami tiger beetle, it appears that an SLR of 1 m (3.3 ft) will inundate the coastal and southern pine rocklands and cause vegetation shifts largely as described above. SLR of 2 m (6.6 ft) appears to inundate much larger portions of urban Miami-Dade County. The western part of urban Miami-Dade County would also be inundated (barring creation of sea walls or other barriers), creating a virtual island of the Miami Rock Ridge. After a 2-m rise in sea level, approximately 75 percent of the remaining pine rockland would still be above sea level but an unknown percentage of these fragments would be negatively impacted by salinization of the water table and soils, which would be exacerbated due to isolation from mainland fresh water flows. Above 2 m (6.6 ft) of SLR, very little pine rockland would remain, with the vast majority either being inundated or experiencing vegetation shifts.

    The climate of southern Florida is driven by a combination of local, regional, and global events, regimes, and oscillations. There are three main “seasons”: (1) The wet season, which is hot, rainy, and humid from June through October; (2) the official hurricane season that extends 1 month beyond the wet season (June 1 through November 30), with peak season being August and September; and (3) the dry season, which is drier and cooler, from November through May. In the dry season, periodic surges of cool and dry continental air masses influence the weather with short-duration rain events followed by long periods of dry weather.

    Climate change may lead to increased frequency and duration of severe storms (Golladay et al. 2004, p. 504; McLaughlin et al. 2002, p. 6074; Cook et al. 2004, p. 1015). Hurricanes and tropical storms can modify habitat (e.g., through storm surge) and have the potential to destroy the only known population of the Miami tiger beetle and its suitable habitat. With most of the historical habitat having been destroyed or modified, the two known remaining populations of the beetle are at high risk of extirpation due to stochastic events.

    Alternative Future Landscape Models and Coastal Squeeze

    The Miami tiger beetle is anticipated to face major risks from coastal squeeze, which occurs when habitat is pressed between rising sea levels and coastal development that prevents landward movement (Scavia et al. 2002, entire; FitzGerald et al. 2008, entire; Defeo et al. 2009, p. 8; LeDee et al. 2010, entire; Menon et al. 2010, entire; Noss 2011, entire). Habitats in coastal areas (i.e., Charlotte, Lee, Collier, Monroe, Miami-Dade Counties) are likely the most vulnerable. Although it is difficult to quantify impacts due to the uncertainties involved, coastal squeeze will likely result in losses in habitat for the beetles as people and development are displaced further inland.

    Summary of Factor E

    Based on our analysis of the best available information, we have identified a wide array of natural and manmade factors affecting the continued existence of the Miami tiger beetle. The beetle is immediately vulnerable to extinction, due to the effects of few remaining small populations, restricted range, and isolation. Aspects of the Miami tiger beetle's natural history (e.g., limited dispersal) and environmental stochasticity (including hurricanes and storm surge) may also contribute to imperilment. Other natural (e.g., changes to habitat, invasive and exotic vegetation) and anthropogenic (e.g., habitat alteration, impacts from humans) factors are also identifiable threats. Climate change, sea-level rise, and coastal squeeze are major concerns. Collectively, these threats have occurred in the past, are impacting the species now, and will continue to impact the species in the future.

    Cumulative Effects From Factors A Through E

    The limited distribution, small population size, few populations, and relative isolation of the Miami tiger beetle makes it extremely susceptible to further habitat loss, modification, degradation, and other anthropogenic threats. The Miami tiger beetle's viability at present is uncertain, and its continued persistence is in danger, unless protective actions are taken. Mechanisms causing the decline of this beetle, as discussed above, range from local (e.g., lack of adequate fire management, vegetation encroachment), to regional (e.g., development, fragmentation, nonnative species), to global influences (e.g., climate change, SLR). The synergistic effects of threats (such as hurricane effects on a species with a limited distribution consisting of just two known populations) make it difficult to predict population viability now and in the future. While these stressors may act in isolation, it is more probable that many stressors are acting simultaneously (or in combination) on the Miami tiger beetle.

    Determination

    We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to the Miami tiger beetle. Habitat loss, degradation, and fragmentation have destroyed an estimated 98 percent of the historical pine rockland habitat in Miami-Dade County, with only two known populations remaining. The threat of habitat loss is continuing from development, inadequate habitat management resulting in vegetation encroachment, and environmental effects resulting from climatic change (see discussions under Factors A and E). Due to the restricted range, small population size, few populations, and relative isolation (see Factor E), collection is a significant threat to the species and could potentially occur at any time (see discussions under Factor B). Additionally, the species is currently threatened by a wide array of natural and manmade factors (see Factor E). Existing regulatory mechanisms do not provide adequate protection for the species (see Factor D). As a result, impacts from increasing threats, singly or in combination, are likely to result in the extinction of the species because the magnitude of threats is high.

    The Act defines an endangered species as any species that is “in danger of extinction throughout all or a significant portion of its range” and a threatened species as any species “that is likely to become endangered throughout all or a significant portion of its range within the foreseeable future.” We find that the Miami tiger beetle is presently in danger of extinction throughout its entire range based on the severity and immediacy of threats currently affecting the species. The overall range has been significantly impacted because of significant habitat loss, degradation, and fragmentation of pine rockland habitat. Newly proposed development is currently threating the only known population of this species. The fragmented nature of Miami-Dade County's remaining pine rockland habitat and the influx of development around them may preclude the ability to conduct prescribed burns or other beneficial management actions that are needed to prevent vegetation encroachment. The remaining two known, small populations of the Miami tiger beetle appears to occupy relatively small habitat patches, which make the population vulnerable to local extinction from normal fluctuations in population size, genetic problems from small population size, or environmental catastrophes. Limited dispersal abilities in combination with limited habitat may result in local extirpations.

    Therefore, on the basis of the best available scientific and commercial information, we propose to list the Miami tiger beetle as an endangered species in accordance with sections 3(6) and 4(a)(1) of the Act. We find that a threatened species status is not appropriate for the Miami tiger beetle because of significant habitat loss (i.e., 98 percent of pine rockland habitat in Miami-Dade County) and degradation; the fact that only two known small populations of the species remain; and the imminent threat of large development projects in the Richmond pine rocklands.

    Under the Act and our implementing regulations, a species may warrant listing if it is endangered or threatened throughout all or a significant portion of its range. The threats to the survival of the species occur throughout the species' range and are not restricted to any particular significant portion of that range. Accordingly, our assessment and proposed determination apply to the species throughout its entire range.

    Available Conservation Measures

    Conservation measures provided to species listed as endangered or threatened under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness, and conservation by Federal, State, Tribal, and local agencies; private organizations; and individuals. The Act encourages cooperation with the States and other countries and calls for recovery actions to be carried out for listed species. The protection required by Federal agencies and the prohibitions against certain activities are discussed, in part, below.

    The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Subsection 4(f) of the Act calls for the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The recovery planning process involves the identification of actions that are necessary to halt or reverse the species' decline by addressing the threats to its survival and recovery. The goal of this process is to restore listed species to a point where they are secure, self-sustaining, and functioning components of their ecosystems.

    Recovery planning includes the development of a recovery outline shortly after a species is listed and preparation of a draft and final recovery plan. The recovery outline guides the immediate implementation of urgent recovery actions and describes the process to be used to develop a recovery plan. Revisions of the plan may be done to address continuing or new threats to the species, as new substantive information becomes available. The recovery plan also identifies recovery criteria for review of when a species may be ready for downlisting or delisting, and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Recovery teams (composed of species experts, Federal and State agencies, nongovernmental organizations, and stakeholders) are often established to develop recovery plans. When completed, the recovery outline, draft recovery plan, and the final recovery plan will be available on our Web site (http://www.fws.gov/endangered), or from the South Florida Ecological Services Office (see FOR FURTHER INFORMATION CONTACT).

    Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, States, Tribes, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration (e.g., restoration of native vegetation), research, captive propagation and reintroduction, and outreach and education. The recovery of many listed species cannot be accomplished solely on Federal lands because their range may occur primarily or solely on non-Federal lands. To achieve recovery of this species requires cooperative conservation efforts on private, State, and Tribal lands. If the Miami tiger beetle is listed, funding for recovery actions will be available from a variety of sources, including Federal budgets, State programs, and cost share grants for non-Federal landowners, the academic community, and nongovernmental organizations. In addition, pursuant to section 6 of the Act, the State of Florida would be eligible for Federal funds to implement management actions that promote the protection or recovery of the Miami tiger beetle. Information on our grant programs that are available to aid species recovery can be found at: http://www.fws.gov/grants.

    Although the Miami tiger beetle is only proposed for listing under the Act at this time, please let us know if you are interested in participating in recovery efforts for this species. Additionally, we invite you to submit any new information on this species whenever it becomes available and any information you may have for recovery planning purposes (see FOR FURTHER INFORMATION CONTACT).

    Section 7(a) of the Act requires Federal agencies to evaluate their actions with respect to any species that is proposed or listed as an endangered or threatened species and with respect to its critical habitat, if any is designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any action that is likely to jeopardize the continued existence of a species proposed for listing or result in destruction or adverse modification of proposed critical habitat. If a species is listed subsequently, section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of the species or destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into consultation with the Service.

    Federal agency actions within the species' habitat that may require conference or consultation or both, as described in the preceding paragraph, include management and any other landscape-altering activities on Federal lands administered by the U.S. Coast Guard, U.S. Army Corps of Engineers, and other Federal agencies; issuance of section 404 Clean Water Act (33 U.S.C. 1251 et seq.) permits by the U.S. Army Corps of Engineers; and construction and maintenance of roads or highways by the Federal Highway Administration.

    The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to all endangered and threatened wildlife. The prohibitions of section 9(a)(2) of the Act, codified at 50 CFR 17.21 for endangered wildlife, in part, make it illegal for any person subject to the jurisdiction of the United States to take (includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these), import, export, ship in interstate commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any listed species. Under the Lacey Act (18 U.S.C. 42-43; 16 U.S.C. 3371-3378), it is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. Certain exceptions apply to agents of the Service and State conservation agencies. 50 CFR 17.31 generally applies the prohibitions for endangered wildlife to threatened wildlife, unless a rule issued under section 4(d) of the Act is adopted by the Service.

    We may issue permits to carry out otherwise prohibited activities involving endangered and threatened wildlife species under certain circumstances. Regulations governing permits are codified at 50 CFR 17.22 for endangered species, and at 17.32 for threatened species. With regard to endangered wildlife, a permit must be issued for the following purposes: For scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities. There are also certain statutory exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.

    Activities Under Section 9

    It is our policy, as published in the Federal Register on July 1, 1994 (59 FR 34272), to identify, to the maximum extent practicable at the time a species is listed, those activities that would or would not constitute a violation of section 9 of the Act. The intent of this policy is to increase public awareness of the effect of a proposed listing on proposed and ongoing activities within the range of species proposed for listing. Based on the best available information, the following activities involving the Miami tiger beetle (including all of its metamorphic life stages) may potentially result in a violation of section 9 of the Act; this list is not comprehensive:

    (1) Unauthorized possession, collecting, trapping, capturing, killing, harassing, sale, delivery, or movement, including interstate and foreign commerce, or harming or attempting any of these actions, at any life stage without a permit (research activities where Miami tiger beetles are surveyed, captured (netted), or collected will require a permit under section 10(a)(1)(A) of the Act).

    (2) Incidental take without a permit pursuant to section 10(a)(1)(B) of the Act.

    (3) Sale or purchase of specimens, except for properly documented antique specimens of this taxon at least 100 years old, as defined by section 10(h)(1) of the Act.

    (4) Unauthorized use of pesticides/herbicides that results in take.

    (5) Release of biological control agents that attack any life stage.

    (6) Discharge or dumping of toxic chemicals, silts, or other pollutants into, or other alteration of the quality of, habitat supporting the Miami tiger beetles that result in take.

    (7) Unauthorized activities (e.g., plowing; mowing; burning; herbicide or pesticide application; land leveling/clearing; grading; disking; soil compaction; soil removal; dredging; excavation; deposition of dredged or fill material; erosion and deposition of sediment/soil; grazing or trampling by livestock; minerals extraction or processing; residential, commercial, or industrial developments; utilities development; road construction; or water development and impoundment) that take eggs, larvae, or adult Miami tiger beetles or that modify Miami tiger beetle habitat in such a way that take Miami tiger beetles by adversely affecting their essential behavioral patterns, including breeding, foraging, sheltering, or other life functions. Otherwise lawful activities that incidentally take Miami tiger beetles, but have no Federal nexus, will require a permit under section 10(a)(1)(B) of the Act.

    Questions regarding whether specific activities would constitute a violation of section 9 of the Act should be directed to the South Florida Ecological Services Office (see FOR FURTHER INFORMATION CONTACT).

    Critical Habitat

    Section 3(5)(A) of the Act defines critical habitat as “(i) the specific areas within the geographical area occupied by the species, at the time it is listed . . . on which are found those physical or biological features (I) Essential to the conservation of the species and (II) which may require special management considerations or protection; and (ii) specific areas outside the geographical area occupied by the species at the time it is listed . . . upon a determination by the Secretary that such areas are essential for the conservation of the species.” Section 3(3) of the Act (16 U.S.C. 1532(3)) defines the terms “conserve,” “conserving,” and “conservation” to mean “to use and the use of all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to this Act are no longer necessary.”

    Section 4(a)(3) of the Act, as amended, and implementing regulations (50 CFR 424.12), require that, to the maximum extent prudent and determinable, the Secretary shall designate critical habitat at the time the species is determined to be an endangered or threatened species. Our regulations (50 CFR 424.12(a)(1)) state that the designation of critical habitat is not prudent when one or both of the following situations exist:

    (1) The species is threatened by taking or other human activity, and identification of critical habitat can be expected to increase the degree of threat to the species, or

    (2) Such designation of critical habitat would not be beneficial to the species.

    There is currently an imminent threat of take attributed to collection or vandalism described under Factor B, above, for the species. However, it is believed that the majority of occurrences of Miami tiger beetles are well known. Although the location of the new population is less well known, awareness of this population is increasing in the natural resource community. We believe that the benefits of designating critical habitat will outweigh the risks associated with increased collection from mapping and identifying critical habitat.

    Therefore, in the absence of finding that the designation of critical habitat would increase threats to a species, if there are any benefits to a critical habitat designation, a finding that designation is prudent is warranted. Here, the potential benefits of designation include: (1) Triggering consultation under section 7 of the Act, in new areas for actions in which there may be a Federal nexus where it would not otherwise occur because, for example, it is unoccupied; (2) focusing conservation activities on the most essential features and areas; (3) providing educational benefits to State or county governments or private entities; and (4) preventing people from causing inadvertent harm to these species.

    Because we have determined that the designation of critical habitat will not likely increase the degree of threat to the species and may provide some measure of benefit, we determine that designation of critical habitat may be prudent for the Miami tiger beetle.

    Our regulations (50 CFR 424.12(a)(2)) further state that critical habitat is not determinable when one or both of the following situations exists: (1) Information sufficient to perform required analysis of the impacts of the designation is lacking; or (2) the biological needs of the species are not sufficiently well known to permit identification of an area as critical habitat. On the basis of a review of available information, we find that critical habitat for the Miami tiger beetle is not determinable because the specific information sufficient to perform the required analysis of the impacts of the designation is currently lacking. Specifically, we are still in the process of obtaining all the information needed to properly evaluate the economic impacts of designation.

    Required Determinations Clarity of the Rule

    We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

    (1) Be logically organized;

    (2) Use the active voice to address readers directly;

    (3) Use clear language rather than jargon;

    (4) Be divided into short sections and sentences; and

    (5) Use lists and tables wherever possible.

    If you feel that we have not met these requirements, send us comments by one of the methods listed in the ADDRESSES section. To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

    National Environmental Policy Act (42 U.S.C. 4321 et seq.)

    We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act, need not be prepared in connection with listing a species as an endangered or threatened species under the Endangered Species Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

    References Cited

    A complete list of references cited in this rulemaking is available on the Internet at http://www.regulations.gov and upon request from the South Florida Ecological Services Office (see FOR FURTHER INFORMATION CONTACT).

    Authors

    The primary authors of this proposed rule are the staff members of the South Florida Ecological Services Office.

    List of Subjects in 50 CFR Part 17

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

    Proposed Regulation Promulgation

    Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the CFR, as set forth below:

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

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

    2. Amend § 17.11(h) by adding an entry for “Beetle, Miami tiger” to the List of Endangered and Threatened Wildlife in alphabetical order under INSECTS 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
    *         *         *         *         *         *         * Insects *         *         *         *         *         *         * Beetle, Miami tiger Cicindelidia floridana U.S.A. (FL) NA E NA NA *         *         *         *         *         *         *
    Dated: December 10, 2015. Stephen Guertin, Acting Director, U.S. Fish and Wildlife Service.
    [FR Doc. 2015-31982 Filed 12-21-15; 8:45 am] BILLING CODE 4333-15-P
    80 245 Tuesday, December 22, 2015 Notices DEPARTMENT OF AGRICULTURE Agricultural Research Service Notice of Intent To Seek OMB Approval To Collect Information: Forms Pertaining to the Peer Preview of ARS Research Projects AGENCY:

    Agricultural Research Service (ARS), USDA.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act of 1995 and OMB implementing regulations. The Department is soliciting public comments on the subject proposal.

    DATES:

    Written comments on this notice must be received by February 22, 2016.

    ADDRESSES:

    Address all comments concerning this notice to: Michael S. Strauss, Peer Review Program Coordinator, Office of Scientific Quality Review (OSQR); Agricultural Research Agency, USDA; 5601 Sunnyside Avenue, Beltsville, Maryland 20705; Phone: 301-504-3283; Fax: 301-504-1251.

    FOR FURTHER INFORMATION CONTACT:

    Michael S. Strauss, 301-504-3283.

    SUPPLEMENTARY INFORMATION:

    The OSQR will seek approval from OMB to update six existing forms and one new form that will allow the ARS to efficiently manage data associated with the peer review of agricultural research. All forms are transferred and received in an electronic storage format that does not include online access.

    Abstract: The OSQR was established in September of 1999 as a result of the Agricultural Research, Extension, and Education Reform Act 1998 (“The Act”) (Pub. L. 105-185). The Act included mandates to perform scientific peer reviews of all research activities conducted by the USDA. The Office manages the ARS peer review system by centrally planning peer panel reviews for ARS research projects on a 5-year cycle.

    Each set of reviews is assigned a chairperson to govern the review process. Peer reviewers are, with few exceptions, non-ARS scientists. Peer review panels are convened to provide in-depth discussion and review of the research project plans. Each panel reviewer receives information on between 1 and 5 ARS research projects.

    On average, 165 research projects are reviewed annually by an estimated 200 reviewers; whereby approximately 155 are reviewed by panel and approximately 15 are reviewed through an ad hoc (written review) process. The organization and management of this peer review system, particularly panel reviews, is highly dependent on the use of forms.

    The OSQR will seek OMB approval of the following forms:

    1. Confidentiality Agreement Form—USDA uses this form to document that a selected reviewer is responsible for keeping confidential any information learned during the subject peer review process. The Confidentiality Agreement is signed prior to the reviewer's involvement in the peer review process. This form requires an original signature. Electronically transmitted scans of signed forms are also accepted.

    2. Panelist Information Form—USDA uses this form to gather up-to-date background information about the reviewer as well as information relevant to the paying of an honorarium and for travel, where appropriate. Reviewers often include sensitive information on this form and, thus it is not retained or recorded in electronic form by the OSQR.

    3. Peer Review of an ARS Research Project Form (Peer Review Form)—USDA uses this form to guide the reviewer's in-depth written comments on the subject project. The form contains the reviewing criteria and space for the reviewer's narrative comments and evaluation.

    3. Reviewer Comment Form (New). This form is supplied to members of a panel not receiving the above Peer Review Form to provide a vehicle whereby they may record comments or recommendations for any plan before their panel but for which they do not have in-depth review responsibility.

    4. Ad Hoc Review Form. USDA uses this in select cases (for Ad Hoc Reviewers who are not members of a review panel), a check-off listing of action classes at the end of the form allows them to provide an overall rating of the plan.

    5. Recommendations for ARS Research Project Form—(Recommendations Form)—USDA uses this form to guide the panel's evaluation and critique of the review process. The form contains the recommendations of the panel for the subject research project.

    6. Panel Expense Report Form (Expense Report)—USDA uses this form to document a panel reviewer's expense incurred traveling to and attending a peer review meeting. The Expense Report includes lodging, meals, and transportation expenses. When completed, the form contains sensitive information, but is used only in the rare circumstance that a panel meeting requires travel of the participants.

    7. Panel Invoice Form (Honorarium Form)—USDA uses this form to document the transfer of an honorarium to a peer reviewer. Reviewers receive honoraria as compensation for serving as peer review panelists. This form requires an original signature. It is used only in special circumstances where reviewers cannot accept a direct bank transfer of the honorarium. In such cases this is used in lieu of the SF-1034 to provide OSQR a written record of the honorarium payment.

    (1) USDA's collection of information on the Confidentiality Agreement Form is needed to document that a selected reviewer is responsible for keeping confidential any information learned during the subject peer review process. The Confidentiality Agreement would be signed prior to the reviewer's involvement in the peer review process.

    (2) USDA's collection of information on the Panelist Information Form is needed to gather up-to-date background information about the reviewer. It contains sensitive information.

    (3) USDA's collection of information on the Peer Review Form and Reviewer Comment Form is needed to guide the reviewer's comments on the subject project. Both contain review guidance and space to insert comments.

    (4) USDA's collection of information on the Ad Hoc Review Form is needed to guide reviewer comments of those not participating in a chaired panel and affords a place to select an overall Action Class rating for the plan.

    (5) USDA's collection of information on the Recommendations Form is needed to guide the panel's critique of the review process. It contains the recommendations of the panel for the subject research project.

    (6) USDA's collection of information on the Expense Report Form is needed to document a panel reviewer's expenses incurred by attending a peer review meeting. The Expense Report includes lodging, meals, and transportation expenses. It includes sensitive information.

    (7) USDA's collection of information on the Honorarium Form is needed to document the transfer of an honorarium to the peer reviewer in those rare cases where an SF-1034 is not completed. The honorarium is given to reviewers as appreciation for their time spent on the panel review process.

    Estimate of Burden: The burden associated with this approval process is the minimum required to achieve program objectives. The information collection frequency is the minimum consistent with program objectives. The following estimates of time required to complete the forms are based on OSQR's experience in working with reviewers and accepting their input into our procedures.

    1. Confidentiality Agreement Form: This form takes up to10 minutes to complete. It only requires a signature and date, but the reviewer must read and consider the terms of the agreement.

    2. Panelist Information Form: This form takes about 30 minutes to complete. It resembles a typical request for personal information; many reviewers provide the same data as grant reviewers in other peer review programs.

    3. Peer Review of an ARS Research Project Form (Peer Review Form). This form may take 4-7 hours to complete. Because this is a review, the page length varies. Reviewers are free to write as much as they wish, but to complete the form they must thoroughly read and evaluate a research project plan that may exceed 60-70 pages in length.

    4. Reviewer Comment Form (New). This form takes 1 hours to complete. It typically contains a general assessment of the plan with only brief comments and is usually one page or less when completed.

    5. Recommendations for ARS Research Project Form (Recommendations Form).

    This form takes 1-2 hours to complete. Because this is a review, the page length significantly varies. For most plans it is completed by the OSQR from the Peer Review Forms and Reviewer Comment Forms and reviewed and revised by reviewers as part of their panel discussions. For the rare occasion where a panel meets in-person, the form is prepared by the designated primary reviewer for that plan who combines comments from all reviewers as found on the Peer Review Form and Reviewer Comment Form, and further analyses derived from the panel's discussions.

    5. Panel Expense Report Form (Expense Report): This form takes 30 minutes to complete.

    6. Panel Invoice Form (Honorarium Form): This form takes 3 minutes to complete. This form has the reviewer's personal information pre-filled and the reviewer only verifies its accuracy and signs.

    Respondents and Estimated Number of Respondents: Scientific experts, currently working in the same discipline as the research projects under review, are selected to review research projects. These experts are notable peers within and external to the ARS. Annually, about 165 peer reviewers complete these forms. As most plans are discussed using an online/telephone conference utility travel is not generally required and, thus, most reviewers do not complete Expense Report and Invoice Forms.

    Frequency of Response: Form Number of
  • respondents
  • Annual frequency
    Confidentiality Agreement 165 1 per respondent (Total of 165). Peer Review Forms (Required for all reviewers and they have 2 review assignments on average.) 155 2 per panel respondent (Total of 310.). Reviewer Comment Form (Optional where reviewer does not have primary or secondary review assignment for a plan) 155 On average, 2 per panel respondent (Total of 310). Expense Report (Only for those reviewers traveling to the review) 10 1 per respondent (Total of 10). Honorarium Form (Only for those reviewers paid by check) 10 1 per respondent (Total of 10). Panelist Information Forms 165 1 per respondent for each form (Total of 165). Recommendations Form (For use only for panels not meeting online.) 10 2 per respondent (Total of 20).
    Estimated Total Annual Burden on Respondents Form
  • (time required to complete)
  • Number
  • completed
  • annually
  • Total burden
  • (hr.)
  • Confidentiality Agreement (10 min.) 165 28 Panelist Information Forms (30 min.) 155 78 Peer Review Forms (~6 hrs) 155 930 Recommendations Form (2 hr) 10 20 Reviewer Comment Form (New) (1 hr) 310 310 Honorarium Form (3 min.) 10 .5 Expense Report (30 min.) 10 5

    Authority: The Paperwork Reduction Act of 1995, 44 U.S.C. chap.35.

    Comments: The Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection is necessary for the proper performance of ARS functions, including whether the information will have practical utility; (2) Evaluate the accuracy of the estimated burden from proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. All responses to this notice will be summarized and included in the request for OMB approval.

    All comments will become a matter of public record.

    Dated: December 9, 2015. Simon Y. Liu, Associate Administrator, ARS.
    [FR Doc. 2015-32065 Filed 12-21-15; 8:45 am] BILLING CODE 3410-03-P
    DEPARTMENT OF AGRICULTURE Agricultural Research Service Notice of Intent To Grant Exclusive License AGENCY:

    Agricultural Research Service, USDA.

    ACTION:

    Notice of intent.

    SUMMARY:

    Notice is hereby given that the U.S. Department of Agriculture, Agricultural Research Service, intends to grant to Oregon State University of Corvallis, Oregon, an exclusive license to the variety of blackberry described in U.S. Plant Patent Application Serial No. 14/756,637, “Blackberry Plant Named `Columbia Giant',” filed on September 28, 2015.

    DATES:

    Comments must be received on or before January 21, 2016.

    ADDRESSES:

    Send comments to: USDA, ARS, Office of Technology Transfer, 5601 Sunnyside Avenue, Rm. 4-1174, Beltsville, Maryland 20705-5131.

    FOR FURTHER INFORMATION CONTACT:

    Mojdeh Bahar of the Office of Technology Transfer at the Beltsville address given above; telephone: 301-504-5989.

    SUPPLEMENTARY INFORMATION:

    The Federal Government's patent rights in this plant variety are assigned to the United States of America, as represented by the Secretary of Agriculture. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published Notice, the Agricultural Research Service receives written evidence and argument which establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

    Mojdeh Bahar, Assistant Administrator.
    [FR Doc. 2015-32064 Filed 12-21-15; 8:45 am] BILLING CODE 3410-03-P
    DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service Submission for OMB Review; Comment Request December 16, 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 should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Food Safety and Inspection Service

    Title: Laboratories.

    OMB Control Number: 0583-0158.

    Summary of Collection: The Food Safety and Inspection Service (FSIS) has been delegated the authority to exercise the functions of the Secretary as provided in the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451, et seq.), and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031). These statues mandate that FSIS protect the public by verifying that meat and poultry products are safe, wholesome, unadulterated, and properly labeled and packaged.

    Need and Use of the Information: FSIS will use two forms to collect information for two distinct laboratory programs. FSIS will use the PEPRL-F-0008-04 form as a self assessment audit checklist to collect information related to the quality assurance/quality control procedures in place at in-plant and private laboratories participating n the Pasteurized Egg Product Recognized Laboratory program. FSIS uses the data collected in the desk audit of existing labs or in the appraisal of a new applicant. Any non-federal laboratory that is applying for the FSIS Accredited Laboratory program will need to complete an Application for FSIS Accredited Laboratory Program 10,110-2 form. FSIS will use the information collected by the form to help access the laboratory applying for admission to the FSIS Accredited Laboratory program.

    Description of Respondents: Business or other for-profit.

    Number of Respondents: 14.

    Frequency of Responses: Reporting: Annually.

    Total Burden Hours: 13.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2015-32174 Filed 12-21-15; 8:45 am] BILLING CODE 3410-DM-P
    DEPARTMENT OF AGRICULTURE Rural Utility Service Submission for OMB Review; Comment Request December 16, 2015.

    The Department of Agriculture has submitted the following information collection requirement(s) to Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments 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 should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, 725—17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. 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.

    Rural Utilities Service

    Title: Request for Approval to Sell Capital Assets.

    OMB Control Number: 0572-0020.

    Summary of Collection: The Rural Utilities Service (RUS) is a credit agency of the U.S. Department of Agriculture (USDA). It makes mortgage loans and loan guarantees to finance electric, telecommunications, and water and waste facilities in rural areas. In addition to providing loans and loan guarantees, one of RUS' main objectives is to safeguard loan security until the loan is repaid. Accordingly, RUS manages loan programs in accordance with the Rural Electrification Act of 1936, 7 U.S.C. 901 et.seq., as amended, (RE ACT) and as prescribed by Office of Management and Budget (OMB) Circular A-129, Policies for Federal Credit Programs and Non-Tax Receivables, which states that agencies must, based on a review of a loan application, determine that an applicant complies with statutory, regulatory, and administrative eligibility requirements for loan assistance.

    Need and Use of the Information: RUS borrower will use form 369, Request for Approval to Sell Capital Assets, to seek agency permission to sell some of its assets. The form is used to collect detailed information regarding the proposed sale of a portion of the borrowers systems. RUS will collect information to determine whether or not the agency should approve a sale and also to keep track of what property exists to secure the loan. If the information in Form 369 is not collected when capital assets are sold, the capital assets securing the Government's loans could be liquidated and the Government's security either eliminated entirely or diluted to an undesirable level.

    Description of Respondents: Not-for-profit institutions; Business or other for-profit.

    Number of Respondents: 5.

    Frequency of Responses: Recordkeeping; Reporting: On occasion.

    Total Burden Hours: 15.

    Charlene Parker, Departmental Information Collection Clearance Officer.
    [FR Doc. 2015-32169 Filed 12-21-15; 8:45 am] BILLING CODE 3410-15-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-113-2015] Approval of Subzone Status Haier America Trading, LLC Olive Branch, Mississippi

    On July 29, 2015, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Northern Mississippi FTZ, Inc., grantee of FTZ 262, requesting subzone status subject to the existing activation limit of FTZ 262, on behalf of Haier America Trading, LLC, in Olive Branch, Mississippi.

    The application was processed in accordance with the FTZ Act and Regulations, including notice in the Federal Register inviting public comment (80 FR 45943, August 3, 2015). The FTZ staff examiner reviewed the application and determined that it meets the criteria for approval.

    Pursuant to the authority delegated to the FTZ Board's Executive Secretary (15 CFR Sec. 400.36(f)), the application to establish Subzone 262B is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, and further subject to FTZ 262's 680-acre activation limit.

    Dated: December 16, 2015. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2015-32163 Filed 12-21-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-570-030] Countervailing Duty Investigation of Certain Cold-Rolled Steel Flat Products From the People's Republic of China: Preliminary Affirmative Determination, Preliminary Partial Affirmative Critical Circumstances Determination, and Alignment of Final Determination With Final Antidumping Duty Determination AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that countervailable subsidies are being provided to producers/exporters of certain cold-rolled steel flat products (cold-rolled steel) from the People's Republic of China (the PRC). The period of investigation is January 1, 2014, through December 31, 2014. We invite interested parties to comment on this preliminary determination.

    DATES:

    Effective Date: December 22, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Yasmin Bordas or John Corrigan, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-3813 or (202) 482-7438, respectively.

    SUPPLEMENTARY INFORMATION: Scope of the Investigation

    The products covered by this investigation are cold-rolled steel flat products from the PRC. For a complete description of the scope of this investigation, see Appendix II.

    Methodology

    The Department is conducting this countervailing duty (CVD) investigation in accordance with section 701 of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, we preliminarily determine that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific.1 For a full description of the methodology underlying our preliminary conclusions, see the Preliminary Decision Memorandum.2 A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix I to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    1See sections 771(5)(B) and (D) of the Act regarding financial contribution; section 771(5)(E) of the Act regarding benefit; and section 771(5A) of the Act regarding specificity.

    2See Memorandum from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance, “Decision Memorandum for the Preliminary Affirmative Determination in the Countervailing Duty Investigation of Certain Cold-Rolled Steel Flat Products from the People's Republic of China,” dated concurrently with this notice (Preliminary Decision Memorandum).

    The Department notes that, in making this preliminary determination, we relied, in part, on facts available and, because respondents did not act to the best of their ability to respond to the Department's requests for information, we drew an adverse inference where appropriate in selecting from among the facts otherwise available with respect to those respondents.3 For further information, see “Use of Facts Otherwise Available and Adverse Inferences” in the accompanying Preliminary Decision Memorandum.

    3See sections 776(a) and (b) of the Act.

    Alignment

    As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), we are aligning the final CVD determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of cold-rolled steel from the PRC based on a request made by Petitioners.4 Consequently, the final CVD determination will be issued on the same date as the final AD determination, which is currently scheduled to be issued no later than May 8, 2016,5 unless postponed.

    4 AK Steel Corporation, ArcelorMittal USA EEC, Nucor Corporation, Steel Dynamics, Inc., and the United States Steel Corporation (collectively, Petitioners); see also Letter from Petitioners dated, December 14, 2015.

    5 We note that the current deadline for the final AD determination is May 8, 2016, which is a Saturday. Pursuant to Department practice, the signature date will be the next business day, which is Monday, May 9, 2016. See Notice of Clarification: Application of “Next Business Day” Rule for Administrative Determination Deadlines Pursuant to the Tariff Act of 1930, As Amended, 70 FR 24533 (May 10, 2005).

    Preliminary Affirmative Determination of Critical Circumstances

    On October 30, 2015, Petitioners filed a timely critical circumstances allegation, pursuant to section 703(e)(1) of the Act and 19 CFR 351.206(c)(1), alleging that critical circumstances exist with respect to imports of certain cold-rolled steel flat products from the PRC.6 We preliminarily determine, on the basis of adverse facts available, that critical circumstances exist for Angang Group Hong Kong Co., Ltd. (Angang Hong Kong), Benxi Iron and Steel (Group) Special Steel Co., Ltd. (Benxi Iron and Steel), and Qian'an Golden Point Trading Co., Ltd. (Qian'an Golden Point). We reached a negative preliminary critical circumstances determination for all other producers/exporters of cold-rolled steel from the PRC because we do not find massive imports pursuant to 19 CFR 351.206(h)-(i). A discussion of our determination can be found in the Preliminary Decision Memorandum at the section, “Preliminary Determination of Critical Circumstances.”

    6See Letter from Petitioners dated October 30, 2015.

    Preliminary Determination and Suspension of Liquidation

    In accordance with sections 776(a)(1), 776(a)(2), and 776(b) of the Act, we applied facts otherwise available with an adverse inference, to assign countervailable subsidy rates for non-cooperative mandatory respondents Angang Hong Kong, Benxi Iron and Steel, and non-cooperative exporter Qian'an Golden Point. With respect to the all-others rate, section 705(c)(5)(A)(ii) of the Act provides that if the countervailable subsidy rates established for all exporters and producers individually investigated are determined entirely in accordance with section 776 of the Act, the Department may use any reasonable method to establish an all-others rate for exporters and producers not individually investigated. In this case, the rates assigned to Angang Hong Kong, Benxi Iron and Steel, and Qian'an Golden Point are based entirely on facts otherwise available, with an adverse inference, under section 776 of the Act. There is no other information on the record with which to determine an all-others rate. As a result, in accordance with section 705(c)(5)(A)(ii) of the Act, we have established the all-others rate by applying the countervailable subsidy rates for mandatory respondents Angang Hong Kong and Benxi Iron and Steel, which are the same as the rate applied to non-selected exporter Qian'an Golden Point. The preliminary estimated countervailable subsidy rates are summarized in the table below.

    Company Subsidy
  • rate
  • Angang Group Hong Kong Co., Ltd 227.29 Benxi Iron and Steel (Group) Special Steel Co., Ltd. 227.29 Qian'an Golden Point Trading Co., Ltd 227.29 All-Others 227.29

    In accordance with sections 703(d)(1)(B) and (d)(2) of the Act, we are directing U.S. Customs and Border Protection (CBP) to suspend liquidation of all entries of cold-rolled steel from the PRC, as described in the “Scope of the Investigation,” that are entered, or withdrawn from warehouse, for consumption on or after the date of the publication of this notice in the Federal Register, and to require a cash deposit for such entries of merchandise in the amounts indicated above. Moreover, because we preliminarily find that critical circumstances exist for Angang Hong Kong, Benxi Iron and Steel, and Qian'an Golden Point, in accordance with section 703(e)(2)(A) of the Act, we are directing CBP to apply the suspension of liquidation to any unliquidated entries entered, or withdrawn from warehouse for consumption by these companies, on or after the date which is 90 days prior to the date of publication of this notice in the Federal Register.

    International Trade Commission Notification

    In accordance with section 703(f) of the Act, we will notify the International Trade Commission (ITC) of our preliminary determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information relating to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order, without the written consent of the Assistant Secretary for Enforcement and Compliance.

    In accordance with section 705(b)(2) of the Act, if our final determination is affirmative, the ITC will make its final determination within 45 days after the Department makes its final determination.

    Public Comment

    For a schedule of the deadlines for filing case briefs, rebuttal briefs, and hearing requests, see the Preliminary Decision Memorandum.

    This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).

    Dated: December 15, 2015. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope Comments IV. Scope of the Investigation V. Injury Test VI. Application of the CVD Law to Imports From the PRC VII. Alignment VIII. Use of Facts Otherwise Available and Adverse Inferences IX. Calculation of the All-Others Rate X. Preliminary Determination of Critical Circumstances XI. ITC Notification XII. Public Comment XIII. Conclusion Appendix II Scope of the Investigation

    The products covered by this investigation are certain cold-rolled (cold-reduced), flat-rolled steel products, whether or not annealed, painted, varnished, or coated with plastics or other non-metallic substances. The products covered do not include those that are clad, plated, or coated with metal. The products covered include coils that have a width or other lateral measurement (“width”) of 12.7 mm or greater, regardless of form of coil (e.g., in successively superimposed layers, spirally oscillating, etc.). The products covered also include products not in coils (e.g., in straight lengths) of a thickness less than 4.75 mm and a width that is 12.7 mm or greater and that measures at least 10 times the thickness. The products covered also include products not in coils (e.g., in straight lengths) of a thickness of 4.75 mm or more and a width exceeding 150 mm and measuring at least twice the thickness. The products described above may be rectangular, square, circular, or other shape and include products of either rectangular or non-rectangular cross-section where such cross-section is achieved subsequent to the rolling process, i.e., products which have been “worked after rolling” (e.g., products which have been beveled or rounded at the edges). For purposes of the width and thickness requirements referenced above:

    (1) Where the nominal and actual measurements vary, a product is within the scope if application of either the nominal or actual measurement would place it within the scope based on the definitions set forth above, and

    (2) Where the width and thickness vary for a specific product (e.g., the thickness of certain products with non-rectangular cross-section, the width of certain products with non-rectangular shape, etc.), the measurement at its greatest width or thickness applies.

    Steel products included in the scope of this investigation are products in which: (1) Iron predominates, by weight, over each of the other contained elements; (2) the carbon content is 2 percent or less, by weight; and (3) none of the elements listed below exceeds the quantity, by weight, respectively indicated:

    • 2.50 percent of manganese, or • 3.30 percent of silicon, or • 1.50 percent of copper, or • 1.50 percent of aluminum, or • 1.25 percent of chromium, or • 0.30 percent of cobalt, or • 0.40 percent of lead, or • 2.00 percent of nickel, or • 0.30 percent of tungsten (also called wolfram), or • 0.80 percent of molybdenum, or • 0.10 percent of niobium (also called columbium), or • 0.30 percent of vanadium, or • 0.30 percent of zirconium

    Unless specifically excluded, products are included in this scope regardless of levels of boron and titanium.

    For example, specifically included in this scope are vacuum degassed, fully stabilized (commonly referred to as interstitial-free (IF)) steels, high strength low alloy (HSLA) steels, motor lamination steels, Advanced High Strength Steels (AHSS), and Ultra High Strength Steels (UHSS). IF steels are recognized as low carbon steels with micro-alloying levels of elements such as titanium and/or niobium added to stabilize carbon and nitrogen elements. HSLA steels are recognized as steels with micro-alloying levels of elements such as chromium, copper, niobium, titanium, vanadium, and molybdenum. Motor lamination steels contain micro-alloying levels of elements such as silicon and aluminum. AHSS and UHSS are considered high tensile strength and high elongation steels, although AHSS and UHSS are covered whether or not they are high tensile strength or high elongation steels.

    Subject merchandise includes cold-rolled steel that has been further processed in a third country, including but not limited to annealing, tempering, painting, varnishing, trimming, cutting, punching, and/or slitting, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the cold-rolled steel.

    All products that meet the written physical description, and in which the chemistry quantities do not exceed any one of the noted element levels listed above, are within the scope of this investigation unless specifically excluded. The following products are outside of and/or specifically excluded from the scope of this investigation:

    • Ball bearing steels; 7

    7 Ball bearing steels are defined as steels which contain, in addition to iron, each of the following elements by weight in the amount specified: (i) not less than 0.95 nor more than 1.13 percent of carbon; (ii) not less than 0.22 nor more than 0.48 percent of manganese; (iii) none, or not more than 0.03 percent of sulfur; (iv) none, or not more than 0.03 percent of phosphorus; (v) not less than 0.18 nor more than 0.37 percent of silicon; (vi) not less than 1.25 nor more than 1.65 percent of chromium; (vii) none, or not more than 0.28 percent of nickel; (viii) none, or not more than 0.38 percent of copper; and (ix) none, or not more than 0.09 percent of molybdenum.

    • Tool steels; 8

    8 Tool steels are defined as steels which contain the following combinations of elements in the quantity by weight respectively indicated: (i) more than 1.2 percent carbon and more than 10.5 percent chromium; or (ii) not less than 0.3 percent carbon and 1.25 percent or more but less than 10.5 percent chromium; or (iii) not less than 0.85 percent carbon and 1 percent to 1.8 percent, inclusive, manganese; or (iv) 0.9 percent to 1.2 percent, inclusive, chromium and 0.9 percent to 1.4 percent, inclusive, molybdenum; or (v) not less than 0.5 percent carbon and not less than 3.5 percent molybdenum; or (vi) not less than 0.5 percent carbon and not less than 5.5 percent tungsten.

    • Silico-manganese steel; 9

    9 Silico-manganese steel is defined as steels containing by weight: (i) not more than 0.7 percent of carbon; (ii) 0.5 percent or more but not more than 1.9 percent of manganese, and (iii) 0.6 percent or more but not more than 2.3 percent of silicon.

    • Grain-oriented electrical steels (GOES) as defined in the final determination of the U.S. Department of Commerce in Grain-Oriented Electrical Steel From Germany, Japan, and Poland. 10

    10Grain-Oriented Electrical Steel From Germany, Japan, and Poland: Final Determinations of Sales at Less Than Fair Value and Certain Final Affirmative Determination of Critical Circumstances, 79 FR 42,501, 42,503 (Dep't of Commerce, July 22, 2014). This determination defines grain-oriented electrical steel as “a flat-rolled alloy steel product containing by weight at least 0.6 percent but not more than 6 percent of silicon, not more than 0.08 percent of carbon, not more than 1.0 percent of aluminum, and no other element in an amount that would give the steel the characteristics of another alloy steel, in coils or in straight lengths.”

    • Non-Oriented Electrical Steels (NOES), as defined in the antidumping orders issued by the U.S. Department of Commerce in Non-Oriented Electrical Steel From the People's Republic of China, Germany, Japan, the Republic of Korea, Sweden, and Taiwan. 11

    11Non-Oriented Electrical Steel From the People's Republic of China, Germany, Japan, the Republic of Korea, Sweden, and Taiwan: Antidumping Duty Orders, 79 FR 71,741, 71,741-42 (Dep't of Commerce, Dec. 3, 2014). The orders define NOES as “cold-rolled, flat-rolled, alloy steel products, whether or not in coils, regardless of width, having an actual thickness of 0.20 mm or more, in which the core loss is substantially equal in any direction of magnetization in the plane of the material. The term `substantially equal' means that the cross grain direction of core loss is no more than 1.5 times the straight grain direction (i.e., the rolling direction) of core loss. NOES has a magnetic permeability that does not exceed 1.65 Tesla when tested at a field of 800 A/m (equivalent to 10 Oersteds) along (i.e., parallel to) the rolling direction of the sheet (i.e., B800 value). NOES contains by weight more than 1.00 percent of silicon but less than 3.5 percent of silicon, not more than 0.08 percent of carbon, and not more than 1.5 percent of aluminum. NOES has a surface oxide coating, to which an insulation coating may be applied.”

    The products subject to these investigations are currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under item numbers: 7209.15.0000, 7209.16.0030, 7209.16.0060, 7209.16.0070, 7209.16.0091, 7209.17.0030, 7209.17.0060, 7209.17.0070, 7209.17.0091, 7209.18.1530, 7209.18.1560, 7209.18.2510, 7209.18.2520, 7209.18.2580, 7209.18.6020, 7209.18.6090, 7209.25.0000, 7209.26.0000, 7209.27.0000, 7209.28.0000, 7209.90.0000, 7210.70.3000, 7211.23.1500, 7211.23.2000, 7211.23.3000, 7211.23.4500, 7211.23.6030, 7211.23.6060, 7211.23.6075, 7211.23.6085, 7211.29.2030, 7211.29.2090, 7211.29.4500, 7211.29.6030, 7211.29.6080, 7211.90.0000, 7212.40.1000, 7212.40.5000, 7225.50.6000, 7225.50.8015, 7225.50.8085, 7225.99.0090, 7226.92.5000, 7226.92.7050, and 7226.92.8050. The products subject to the investigations may also enter under the following HTSUS numbers: 7210.90.9000, 7212.50.0000, 7215.10.0010, 7215.10.0080, 7215.50.0016, 7215.50.0018, 7215.50.0020, 7215.50.0061, 7215.50.0063, 7215.50.0065, 7215.50.0090, 7215.90.5000, 7217.10.1000, 7217.10.2000, 7217.10.3000, 7217.10.7000, 7217.90.1000, 7217.90.5030, 7217.90.5060, 7217.90.5090, 7225.19.0000, 7226.19.1000, 7226.19.9000, 7226.99.0180, 7228.50.5015, 7228.50.5040, 7228.50.5070, 7228.60.8000,and 7229.90.1000.

    The HTSUS subheadings above are provided for convenience and customs purposes only. The written description of the scope of the investigation is dispositive.

    [FR Doc. 2015-32215 Filed 12-21-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-601] Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Preliminary Rescission of Antidumping Duty New Shipper Review; 2014-2015 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    DATES:

    Effective date: December 22, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth Eastwood, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3874.

    SUPPLEMENTARY INFORMATION: Background

    On June 23, 2015, we received a timely request from Zhejiang Changxing CTL Auto Parts Manufacturing Co., Ltd., (Changxing) that the Department conduct a new shipper review of the antidumping duty (AD) order on tapered roller bearings and parts thereof, finished and unfinished (TRBs) from the People's Republic of China (PRC).1 On August 3, 2015, the Department of Commerce (the Department) found that the request for review with respect to Changxing met all of the statutory and regulatory requirements for initiating an AD new shipper review.2

    1See Changxing's letter to the Department entitled, “Tapered Roller Bearings from the People's Republic of China—Request for New Shipper Review,” dated June 23, 2015.

    2See Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Initiation of Antidumping Duty New Shipper Reviews, 80 FR 45944 (August 3, 2015).

    On September 21, 2015, we requested additional information from Changxing regarding entries to the United States that may have occurred prior to the period of review (POR) and relevant documentation for those entries.3 However, Changxing did not respond to the Department's request. On October 16, 2015, Changxing withdrew its request for a new shipper review.4

    3See Memorandum to The File entitled, “Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: New Shipper Review of Zhejiang Changxing CTL Auto Parts Manufacturing Co., Ltd.—Telephone Conversation with Representative,” dated September 21, 2015.

    4See Letter from Changxing Re: “Tapered Roller Bearings from the People's Republic of China: Withdrawal of Request for New Shipper Review,” dated October 16, 2015.

    Scope of the Order

    Imports covered by the order are shipments of tapered roller bearings and parts thereof, finished and unfinished, from the PRC; flange, take up cartridge, and hanger units incorporating tapered roller bearings; and tapered roller housings (except pillow blocks) incorporating tapered rollers, with or without spindles, whether or not for automotive use. These products are currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) item numbers 8482.20.00, 8482.91.00.50, 8482.99.15, 8482.99.45, 8483.20.40, 8483.20.80, 8483.30.80, 8483.90.20, 8483.90.30, 8483.90.80, 8708.70.6060, 8708.99.2300, 8708.99.4850, 8708.99.6890, 8708.99.8115, and 8708.99.8180. Although the HTSUS item numbers are provided for convenience and customs purposes, the written description of the scope of the order is dispositive.

    Application of Adverse Facts Available and Preliminary Rescission of Review

    Pursuant to 19 CFR 351.214(f)(1), the Department may rescind a new shipper review if the party that requested the review withdraws the request within 60 days of the date of publication of notice of initiation of the requested review. In this case, as noted above, Changxing submitted its withdrawal request on October 16, 2015, which is after the 60-day withdrawal deadline. Therefore, because the withdrawal request was untimely, we are not rescinding this review on this basis.

    Nonetheless, information on the record indicates that Changxing may have had entries of subject merchandise prior to its declared entry in this new shipper review. Changxing failed to respond to the Department's September 21, 2015, request for additional information regarding these entries, and indeed affirmatively withdrew from this proceeding. Because we find that Changxing has withheld information requested of it within the meaning of section 776(a)(2)(A) of the Tariff Act of 1930, as amended (the Act), we are making a determination on the basis of the facts otherwise available. In selecting from among the facts available, we find that an adverse inference pursuant to section 776(b) of the Act is appropriate due to Changxing's failure to act to the best of its ability in responding to the Department's request. As adverse facts available, we determine that Changxing had additional entries of subject merchandise that were not reported to the Department at the time of Changxing's request for a new shipper review.

    Based on the foregoing, we preliminarily find that Changxing does not meet the minimum requirements for a new shipper review under 19 CFR 351.214(b)(2)(iv)(C) in that Changxing's request did not contain documentation establishing the date of its first sale to an unaffiliated customer in the United States. Because we find that Changxing's request for a new shipper review did not satisfy the regulatory requirements for initiation of a new shipper review, we are preliminarily rescinding the new shipper review of the AD order on TRBs from the PRC with respect to Changxing.

    Public Comment

    Interested parties are invited to comment on this preliminary rescission and submit written arguments or case briefs within 30 days after the publication of this notice in the Federal Register, unless otherwise notified by the Department.5 Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.6 Parties who submit case or rebuttal briefs are requested to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.7 Case and rebuttal briefs should be filed using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS), which is available to registered users at http://access.trade.gov, and in the Central Records Unit, Room B0824 of the main Department of Commerce building.8

    5See 19 CFR 351.309(c)(1)(ii).

    6See 19 CFR 351.309(d).

    7See 19 CFR 351.309(c)(2) and (d)(2).

    8See 19 CFR 351.303.

    Any interested party may request a hearing within 30 days after the day of publication of this notice.9 Hearing requests should contain the following information: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed.10 Issues raised in the hearing will be limited to those raised in case briefs. If a request for a hearing is made, parties will be notified of the date and time for the hearing to be held at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW, Washington, DC 20230.11

    9See 19 CFR 351.310(c).

    10See 19 CFR 351.310(c).

    11See 19 CFR 351.310(d).

    We intend to issue the final results of this new shipper review, including the results of our analysis of issues raised in any case briefs, within 90 days after the date on which this preliminary rescission is issued, unless the deadline for our final results is extended.12

    12See section 751(a)(2)(B)(iv) of the Act; and 19 CFR 351.214(i).

    Assessment Rates

    As the Department intends to rescind this new shipper review, we are not making a determination as to whether Changxing qualifies for a separate rate. Therefore, if the Department proceeds to a final rescission, Changxing will remain part of the PRC entity and, accordingly, its entries covered by this new shipper review will be assessed at the PRC-wide rate.

    Cash Deposit Requirements

    Effective upon publication of the final rescission of the new shipper review of Changxing, the Department will instruct U.S. Customs and Border Protection to discontinue the option of posting a bond or security in lieu of a cash deposit for entries of subject merchandise from Changxing.13 Because we did not calculate a dumping margin for Changxing or grant Changxing a separate rate in this new shipper review, we preliminarily find that Changxing continues to be part of the PRC-wide entity. The cash deposit rate for the PRC-wide entity is 92.84 percent. These cash deposit requirements shall remain in effect until further notice.

    13See section 751(a)(2)(B)(iii) of the Act; 19 CFR 351.214(e).

    Notification to Importers

    This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    This new shipper review and notice are in accordance with sections 751(a)(2)(B) and 777(i) of the Act and 19 CFR 351.214(f)(3).

    Dated: December 15, 2015. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2015-32161 Filed 12-21-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-533-866] Countervailing Duty Investigation of Certain Cold-Rolled Steel Flat Products From India: Preliminary Affirmative Determination and Alignment of Final Determination With Final Antidumping Duty Determination AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that countervailable subsidies are being provided to producers/exporters of certain cold-rolled steel flat products (cold-rolled steel) from India. The period of investigation is January 1, 2014, through December 31, 2014. We invite interested parties to comment on this preliminary determination.

    DATES:

    Effective Date: December 22, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Erin Kearney or Trisha Tran, 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) 482-0167 and (202) 482-4852, respectively.

    SUPPLEMENTARY INFORMATION: Scope of the Investigation

    The products covered by this investigation are cold-rolled steel flat products from India. For a complete description of the scope of this investigation, see Appendix II.

    Methodology

    The Department is conducting this countervailing duty (CVD) investigation in accordance with section 701 of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, we preliminarily determine that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific.1 For a full description of the methodology underlying our preliminary conclusions, see the Preliminary Decision Memorandum.2 A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix I to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov and it is available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    1See sections 771(5)(B) and (D) of the Act regarding financial contribution; section 771(5)(E) of the Act regarding benefit; and section 771(5A) of the Act regarding specificity.

    2See Memorandum from Christian Marsh, Deputy Assistance Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance, “Decision Memorandum for the Preliminary Results of the Countervailing Duty Investigation of Certain Cold-Rolled Steel Flat Products from India,” dated concurrently with this notice (“Preliminary Decision Memorandum”).

    Alignment

    As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), we are aligning the final CVD determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of cold-rolled steel from India based on a request made by Petitioners.3 Consequently, the final CVD determination will be issued on the same date as the final AD determination, which is currently scheduled to be issued no later than May 8, 2016,4 unless postponed.

    3 AK Steel Corporation, ArcelorMittal USA LLC, Nucor Corporation, Steel Dynamics Inc., and the United States Steel Corporation (collectively, Petitioners).

    4 The current deadline for the final AD determination, May 8, 2016, is a Sunday. Pursuant to Department practice, the signature date will be the next business day, which is Monday, May 9, 2016. See Notice of Clarification: Application of “Next Business Day” Rule for Administrative Determination Deadlines Pursuant to the Tariff Act of 1930, As Amended, 70 FR 24533 (May 10, 2005).

    Preliminary Determination and Suspension of Liquidation

    In accordance with section 703(d)(1)(A)(i) of the Act, we calculated a CVD rate for each individually investigated producer/exporter of the subject merchandise. We preliminarily determine that countervailable subsides are being provided with respect to the manufacture, production, or exportation of the subject merchandise. We preliminarily determine the countervailable subsidy rates to be:

    Company Subsidy rate
  • (percent)
  • JSW Steel Limited and JSW Steel Coated Products Limited 4.45 All Others 4.45

    In accordance with sections 703(d)(1)(B) and (d)(2) of the Act, we are directing U.S. Customs and Border Protection to suspend liquidation of all entries of cold-rolled steel from India that are entered, or withdrawn from warehouse, for consumption on or after the date of the publication of this notice in the Federal Register, and to require a cash deposit for such entries of merchandise in the amounts indicated above.

    In accordance with sections 703(d) and 705(c)(5)(A) of the Act, for companies not investigated, we apply an “all-others” rate, which is normally calculated by weighting the subsidy rates of the individual companies selected as respondents by those companies' exports of the subject merchandise to the United States. Under section 705(c)(5)(A)(i) of the Act, the all-others rate should exclude zero and de minimis rates calculated for the exporters and producers individually investigated. Because we individually investigated only one producer/exporter, we have applied the rate calculated for that producer/exporter as the “all-others” rate.

    Verification

    As provided in section 782(i)(1) of the Act, we intend to verify the information submitted by the respondent prior to making our final determination.

    International Trade Commission Notification

    In accordance with section 703(f) of the Act, we will notify the International Trade Commission (ITC) of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information relating to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order, without the written consent of the Assistant Secretary for Enforcement and Compliance.

    In accordance with section 705(b)(2) of the Act, if our final determination is affirmative, the ITC will make its final determination within 45 days after the Department makes its final determination.

    Disclosure and Public Comment

    The Department intends to disclose to interested parties the calculations performed in connection with this preliminary determination within five days of its public announcement.5 Interested parties may submit case briefs and rebuttal briefs, as well as request a hearing.6 For a schedule of the deadlines for filing case briefs, rebuttal briefs, and hearing requests, see the Preliminary Decision Memorandum.

    5See 19 CFR 351.224(b).

    6See 19 CFR 351.309(c)-(d), 19 CFR 351.310(c).

    This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).

    Dated: December 15, 2015. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope Comments IV. Scope of the Investigation V. Alignment VI. Injury Test VII. Subsidies Valuation VIII. Analysis of Programs IX. Calculation of the All-Others Rate X. ITC Notification XI. Disclosure and Public Comment XII. Verification XIII. Conclusion Appendix II Scope of the Investigation

    The products covered by this investigation are certain cold-rolled (cold-reduced), flat-rolled steel products, whether or not annealed, painted, varnished, or coated with plastics or other non-metallic substances. The products covered do not include those that are clad, plated, or coated with metal. The products covered include coils that have a width or other lateral measurement (“width”) of 12.7 mm or greater, regardless of form of coil (e.g., in successively superimposed layers, spirally oscillating, etc.). The products covered also include products not in coils (e.g., in straight lengths) of a thickness less than 4.75 mm and a width that is 12.7 mm or greater and that measures at least 10 times the thickness. The products covered also include products not in coils (e.g., in straight lengths) of a thickness of 4.75 mm or more and a width exceeding 150 mm and measuring at least twice the thickness. The products described above may be rectangular, square, circular, or other shape and include products of either rectangular or non-rectangular cross-section where such cross-section is achieved subsequent to the rolling process, i.e., products which have been “worked after rolling” (e.g., products which have been beveled or rounded at the edges). For purposes of the width and thickness requirements referenced above:

    (1) Where the nominal and actual measurements vary, a product is within the scope if application of either the nominal or actual measurement would place it within the scope based on the definitions set forth above, and

    (2) where the width and thickness vary for a specific product (e.g., the thickness of certain products with non-rectangular cross-section, the width of certain products with non-rectangular shape, etc.), the measurement at its greatest width or thickness applies.

    Steel products included in the scope of this investigation are products in which: (1) Iron predominates, by weight, over each of the other contained elements; (2) the carbon content is 2 percent or less, by weight; and (3) none of the elements listed below exceeds the quantity, by weight, respectively indicated:

    • 2.50 percent of manganese, or • 3.30 percent of silicon, or • 1.50 percent of copper, or • 1.50 percent of aluminum, or • 1.25 percent of chromium, or • 0.30 percent of cobalt, or • 0.40 percent of lead, or • 2.00 percent of nickel, or • 0.30 percent of tungsten (also called wolfram), or • 0.80 percent of molybdenum, or • 0.10 percent of niobium (also called columbium), or • 0.30 percent of vanadium, or • 0.30 percent of zirconium

    Unless specifically excluded, products are included in this scope regardless of levels of boron and titanium.

    For example, specifically included in this scope are vacuum degassed, fully stabilized (commonly referred to as interstitial-free (IF)) steels, high strength low alloy (HSLA) steels, motor lamination steels, Advanced High Strength Steels (AHSS), and Ultra High Strength Steels (UHSS). IF steels are recognized as low carbon steels with micro-alloying levels of elements such as titanium and/or niobium added to stabilize carbon and nitrogen elements. HSLA steels are recognized as steels with micro-alloying levels of elements such as chromium, copper, niobium, titanium, vanadium, and molybdenum. Motor lamination steels contain micro-alloying levels of elements such as silicon and aluminum. AHSS and UHSS are considered high tensile strength and high elongation steels, although AHSS and UHSS are covered whether or not they are high tensile strength or high elongation steels.

    Subject merchandise includes cold-rolled steel that has been further processed in a third country, including but not limited to annealing, tempering, painting, varnishing, trimming, cutting, punching, and/or slitting, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the cold-rolled steel.

    All products that meet the written physical description, and in which the chemistry quantities do not exceed any one of the noted element levels listed above, are within the scope of this investigation unless specifically excluded. The following products are outside of and/or specifically excluded from the scope of this investigation:

    • Ball bearing steels; 1

    1 Ball bearing steels are defined as steels which contain, in addition to iron, each of the following elements by weight in the amount specified: (i) Not less than 0.95 nor more than 1.13 percent of carbon; (ii) not less than 0.22 nor more than 0.48 percent of manganese; (iii) none, or not more than 0.03 percent of sulfur; (iv) none, or not more than 0.03 percent of phosphorus; (v) not less than 0.18 nor more than 0.37 percent of silicon; (vi) not less than 1.25 nor more than 1.65 percent of chromium; (vii) none, or not more than 0.28 percent of nickel; (viii) none, or not more than 0.38 percent of copper; and (ix) none, or not more than 0.09 percent of molybdenum.

    • Tool steels; 2

    2 Tool steels are defined as steels which contain the following combinations of elements in the quantity by weight respectively indicated: (i) More than 1.2 percent carbon and more than 10.5 percent chromium; or (ii) not less than 0.3 percent carbon and 1.25 percent or more but less than 10.5 percent chromium; or (iii) not less than 0.85 percent carbon and 1 percent to 1.8 percent, inclusive, manganese; or (iv) 0.9 percent to 1.2 percent, inclusive, chromium and 0.9 percent to 1.4 percent, inclusive, molybdenum; or (v) not less than 0.5 percent carbon and not less than 3.5 percent molybdenum; or (vi) not less than 0.5 percent carbon and not less than 5.5 percent tungsten.

    • Silico-manganese steel; 3

    3 Silico-manganese steel is defined as steels containing by weight: (i) Not more than 0.7 percent of carbon; (ii) 0.5 percent or more but not more than 1.9 percent of manganese, and (iii) 0.6 percent or more but not more than 2.3 percent of silicon.

    • Grain-oriented electrical steels (GOES) as defined in the final determination of the U.S. Department of Commerce in Grain-Oriented Electrical Steel From Germany, Japan, and Poland. 4

    4Grain-Oriented Electrical Steel From Germany, Japan, and Poland: Final Determinations of Sales at Less Than Fair Value and Certain Final Affirmative Determination of Critical Circumstances, 79 FR 42,501, 42,503 (Dep't of Commerce, July 22, 2014). This determination defines grain-oriented electrical steel as “a flat-rolled alloy steel product containing by weight at least 0.6 percent but not more than 6 percent of silicon, not more than 0.08 percent of carbon, not more than 1.0 percent of aluminum, and no other element in an amount that would give the steel the characteristics of another alloy steel, in coils or in straight lengths.”

    • Non-Oriented Electrical Steels (NOES), as defined in the antidumping orders issued by the U.S. Department of Commerce in Non-Oriented Electrical Steel From the People's Republic of China, Germany, Japan, the Republic of Korea, Sweden, and Taiwan. 5

    5Non-Oriented Electrical Steel From the People's Republic of China, Germany, Japan, the Republic of Korea, Sweden, and Taiwan: Antidumping Duty Orders, 79 FR 71,741, 71,741-42 (Dep't of Commerce, Dec. 3, 2014). The orders define NOES as “cold-rolled, flat-rolled, alloy steel products, whether or not in coils, regardless of width, having an actual thickness of 0.20 mm or more, in which the core loss is substantially equal in any direction of magnetization in the plane of the material. The term `substantially equal' means that the cross grain direction of core loss is no more than 1.5 times the straight grain direction (i.e., the rolling direction) of core loss. NOES has a magnetic permeability that does not exceed 1.65 Tesla when tested at a field of 800 A/m (equivalent to 10 Oersteds) along (i.e., parallel to) the rolling direction of the sheet (i.e., B800 value). NOES contains by weight more than 1.00 percent of silicon but less than 3.5 percent of silicon, not more than 0.08 percent of carbon, and not more than 1.5 percent of aluminum. NOES has a surface oxide coating, to which an insulation coating may be applied.”

    The products subject to this investigation are currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under item numbers: 7209.15.0000, 7209.16.0030, 7209.16.0060, 7209.16.0070, 7209.16.0091, 7209.17.0030, 7209.17.0060, 7209.17.0070, 7209.17.0091, 7209.18.1530, 7209.18.1560, 7209.18.2510, 7209.18.2520, 7209.18.2580, 7209.18.6020, 7209.18.6090, 7209.25.0000, 7209.26.0000, 7209.27.0000, 7209.28.0000, 7209.90.0000, 7210.70.3000, 7211.23.1500, 7211.23.2000, 7211.23.3000, 7211.23.4500, 7211.23.6030, 7211.23.6060, 7211.23.6075, 7211.23.6085, 7211.29.2030, 7211.29.2090, 7211.29.4500, 7211.29.6030, 7211.29.6080, 7211.90.0000, 7212.40.1000, 7212.40.5000, 7225.50.6000, 7225.50.8015, 7225.50.8085, 7225.99.0090, 7226.92.5000, 7226.92.7050, and 7226.92.8050. The products subject to the investigation may also enter under the following HTSUS numbers: 7210.90.9000, 7212.50.0000, 7215.10.0010, 7215.10.0080, 7215.50.0016, 7215.50.0018, 7215.50.0020, 7215.50.0061, 7215.50.0063, 7215.50.0065, 7215.50.0090, 7215.90.5000, 7217.10.1000, 7217.10.2000, 7217.10.3000, 7217.10.7000, 7217.90.1000, 7217.90.5030, 7217.90.5060, 7217.90.5090, 7225.19.0000, 7226.19.1000, 7226.19.9000, 7226.99.0180, 7228.50.5015, 7228.50.5040, 7228.50.5070, 7228.60.8000, and 7229.90.1000.

    The HTSUS subheadings above are provided for convenience and U.S. Customs purposes only. The written description of the scope of the investigation is dispositive.

    [FR Doc. 2015-32218 Filed 12-21-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-821-823] Countervailing Duty Investigation of Certain Cold-Rolled Steel Flat Products From the Russian Federation: Preliminary Affirmative Countervailing Duty Determination, Preliminary Negative Critical Circumstances Determination, and Alignment of Final Determination With Final Antidumping Duty Determination AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that countervailable subsidies are being provided to producers/exporters of certain cold-rolled steel flat products (cold-rolled steel) from the Russian Federation (Russia). The period of investigation is January 1, 2014, through December 31, 2014. We invite interested parties to comment on this preliminary determination.

    DATES:

    Effective Date: December 22, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Kristen Johnson (the NLMK Companies) and Stephanie Moore (the Severstal Companies), AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4793 and (202) 482-3692, respectively.

    SUPPLEMENTARY INFORMATION: Scope of the Investigation

    The products covered by this investigation are cold-rolled steel flat products from Russia. For a complete description of the scope of the investigation, see Appendix II.

    Methodology

    The Department is conducting this countervailing duty (CVD) investigation in accordance with section 701 of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, we preliminarily determine that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific.1 For a full description of the methodology underlying our preliminary conclusions, see the Preliminary Decision Memorandum.2 A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix I to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and is available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the Internet at http://enforcement.trade.gov/frn/index.html. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content.

    1See sections 771(5)(B) and (D) of the Act regarding financial contribution; section 771(5)(E) of the Act regarding benefit; and section 771(5A) of the Act regarding specificity.

    2See Memorandum from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance, “Decision Memorandum for the Preliminary Affirmative Determination, Preliminary Negative Critical Circumstances Determination, and Alignment of Final Determination With Final Antidumping Determination in the Countervailing Duty Investigation of Certain Cold-Rolled Steel Flat Products from the Russian Federation,” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    New Subsidy Allegation

    On November 4, 2015, ArcelorMittal USA LLC, a petitioner in the investigation,3 timely filed a new subsidy allegation regarding a value added tax (VAT) exemption for steel scrap.4 The Department determined that Petitioners did not satisfy the initiation standard for a VAT program and, therefore, did not initiate an investigation of the program.5

    3 In addition to ArcelorMittal USA LLC, Petitioners in this investigation are United States Steel Corporation, Nucor Corporation, Steel Dynamics, Inc., California Steel Industries, and AK Steel Corporation.

    4See Letter from ArcelorMittal USA LLC, “Petitioners' New Subsidy Allegation,” dated November 4, 2015.

    5See Department Memorandum, “Decision Memorandum on New Subsidy Allegation,” dated December 15, 2015.

    Alignment

    As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), we are aligning the final CVD determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of cold-rolled steel from Russia based on a request made by Petitioners.6 Consequently, the final CVD determination will be issued on the same date as the final AD determination, which is currently scheduled to be issued no later than May 8, 2016,7 unless postponed.

    6See Letter from Petitioners, “Countervailing Duty Investigations of Certain Cold-Rolled Steel Flat Products from Brazil, India, the People's Republic of China, the Republic of Korea, and the Russian Federation—Petitioners' Request to Align Final Determinations in Countervailing and Antidumping Duty Investigations,” dated December 14, 2015.

    7 We note that the current deadline for the final AD determination is May 8, 2016, which is a Sunday. Pursuant to Department practice, the signature date will be the next business day, which is Monday, May 9, 2016. See Notice of Clarification: Application of “Next Business Day” Rule for Administrative Determination Deadlines Pursuant to the Tariff Act of 1930, As Amended, 70 FR 24533 (May 10, 2005).

    Preliminary Negative Determination of Critical Circumstances

    On October 30, 2015, Petitioners filed a timely critical circumstances allegation, pursuant to section 773(e)(1) of the Act and 19 CFR 351.206(c)(1), alleging that critical circumstances exist with respect to imports of cold-rolled steel from Russia.8 We preliminarily determine that critical circumstances do not exist for the NLMK Companies, the Severstal Companies, and all other producers/exporters of subject merchandise in Russia. A discussion of our preliminary negative determination of critical circumstances can be found in the Preliminary Decision Memorandum at the section, “Preliminary Negative Determination of Critical Circumstances.”

    8See Letter from Petitioners, “Critical Circumstances Allegation,” dated October 30, 2015.

    Preliminary Determination and Suspension of Liquidation

    In accordance with section 703(d)(1)(A)(i) of the Act, we calculated a CVD rate for each individually-investigated producer/exporter of the subject merchandise. We preliminarily determine that countervailable subsidies are being provided with respect to the manufacture, production, or exportation of the subject merchandise. We preliminarily determine the countervailable subsidy rates to be:

    Company Subsidy rate Novolipetsk Steel OJSC, Novex Trading (Swiss) S.A., Altai-Koks OJSC, Dolomite OJSC, Stoilensky OJSC, Studenovskaya (Stagdok) OJSC, Trading House LLC, Vtorchermet NLMK LLC, Vtorchermet OJSC, and Vtorchermet NLMK Center LLC (collectively, the NLMK Companies) 6.33 percent ad valorem. PAO Severstal, Severstal Export GmbH, JSC Karelsky Okatysh, AO OLKON, AO Vorkutaugol, and JSC Vtorchermet (collectively, the Severstal Companies) 0.01 percent ad valorem (de minimis). All Others 6.33 percent ad valorem.

    In accordance with section 703(d)(1)(B) and (d)(2) of the Act, we are directing U.S. Customs and Border Protection to suspend liquidation of all entries of cold-rolled steel from Russia that are entered, or withdrawn from warehouse, for consumption on or after the date of the publication of this notice in the Federal Register and require a cash deposit for such entries of the merchandise in the amounts indicated above for all companies other than the Severstal Companies.

    In accordance with sections 703(d) and 705(c)(5)(A) of the Act, for companies not investigated, we apply an “all others” rate, which is normally calculated by weighting the subsidy rates of the individual companies as respondents by those companies' exports of the subject merchandise to the United States. Under section 705(c)(5)(A)(i) of the Act, the all others rate should exclude zero and de minimis rates or any rates based entirely on facts otherwise available. In this investigation, the only rate that is not de minimis or based entirely on facts otherwise available is the rate calculated for the NLMK Companies. Consequently, the rate calculated for the NLMK Companies is assigned as the all others rate.

    Verification

    As provided in section 782(i)(1) of the Act, we intend to verify the information submitted by the respondents prior to making our final determination.

    International Trade Commission Notification

    In accordance with section 703(f) of the Act, we will notify the International Trade Commission (ITC) of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information relating to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order, without the written consent of the Assistant Secretary for Enforcement and Compliance.

    In accordance with section 705(b)(2) of the Act, if our final determination is affirmative, the ITC will make its final determination within 45 days after the Department makes its final determination.

    Disclosure and Public Comment

    The Department intends to disclose to interested parties the calculations performed in connection with this preliminary determination within five days of its public announcement.9 Interested parties may submit case and rebuttal briefs, as well as request a hearing.10 For a schedule of the deadlines for filing case briefs, rebuttal briefs, and hearing requests, see the Preliminary Decision Memorandum.

    9See 19 CFR 351.224(b).

    10See 19 CFR 351.309(c)-(d), 19 CFR 351.310(c).

    This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).

    Dated: December 15, 2015. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope Comments IV. Scope of the Investigation V. Preliminary Negative Determination of Critical Circumstances VI. Alignment VII. Injury Test VIII. Subsidies Valuation IX. Analysis of Programs X. Disclosure and Public Comment XI. Conclusion Appendix II Scope of the Investigation

    The products covered by this investigation are certain cold-rolled (cold-reduced), flat-rolled steel products, whether or not annealed, painted, varnished, or coated with plastics or other non-metallic substances. The products covered do not include those that are clad, plated, or coated with metal. The products covered include coils that have a width or other lateral measurement (“width”) of 12.7 mm or greater, regardless of form of coil (e.g., in successively superimposed layers, spirally oscillating, etc.). The products covered also include products not in coils (e.g., in straight lengths) of a thickness less than 4.75 mm and a width that is 12.7 mm or greater and that measures at least 10 times the thickness. The products covered also include products not in coils (e.g., in straight lengths) of a thickness of 4.75 mm or more and a width exceeding 150 mm and measuring at least twice the thickness. The products described above may be rectangular, square, circular, or other shape and include products of either rectangular or non-rectangular cross-section where such cross-section is achieved subsequent to the rolling process, i.e., products which have been “worked after rolling” (e.g., products which have been beveled or rounded at the edges). For purposes of the width and thickness requirements referenced above:

    (1) Where the nominal and actual measurements vary, a product is within the scope if application of either the nominal or actual measurement would place it within the scope based on the definitions set forth above, and

    (2) where the width and thickness vary for a specific product (e.g., the thickness of certain products with non-rectangular cross-section, the width of certain products with non-rectangular shape, etc.), the measurement at its greatest width or thickness applies.

    Steel products included in the scope of this investigation are products in which: (1) Iron predominates, by weight, over each of the other contained elements; (2) the carbon content is 2 percent or less, by weight; and (3) none of the elements listed below exceeds the quantity, by weight, respectively indicated:

    • 2.50 percent of manganese, or • 3.30 percent of silicon, or • 1.50 percent of copper, or • 1.50 percent of aluminum, or • 1.25 percent of chromium, or • 0.30 percent of cobalt, or • 0.40 percent of lead, or • 2.00 percent of nickel, or • 0.30 percent of tungsten (also called wolfram), or • 0.80 percent of molybdenum, or • 0.10 percent of niobium (also called columbium), or • 0.30 percent of vanadium, or • 0.30 percent of zirconium

    Unless specifically excluded, products are included in this scope regardless of levels of boron and titanium.

    For example, specifically included in this scope are vacuum degassed, fully stabilized (commonly referred to as interstitial-free (IF)) steels, high strength low alloy (HSLA) steels, motor lamination steels, Advanced High Strength Steels (AHSS), and Ultra High Strength Steels (UHSS). IF steels are recognized as low carbon steels with micro-alloying levels of elements such as titanium and/or niobium added to stabilize carbon and nitrogen elements. HSLA steels are recognized as steels with micro-alloying levels of elements such as chromium, copper, niobium, titanium, vanadium, and molybdenum. Motor lamination steels contain micro-alloying levels of elements such as silicon and aluminum. AHSS and UHSS are considered high tensile strength and high elongation steels, although AHSS and UHSS are covered whether or not they are high tensile strength or high elongation steels.

    Subject merchandise includes cold-rolled steel that has been further processed in a third country, including but not limited to annealing, tempering, painting, varnishing, trimming, cutting, punching, and/or slitting, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the cold-rolled steel.

    All products that meet the written physical description, and in which the chemistry quantities do not exceed any one of the noted element levels listed above, are within the scope of these investigation unless specifically excluded. The following products are outside of and/or specifically excluded from the scope of these investigation:

    • Ball bearing steels; 11

    11 Ball bearing steels are defined as steels which contain, in addition to iron, each of the following elements by weight in the amount specified: (i) Not less than 0.95 nor more than 1.13 percent of carbon; (ii) not less than 0.22 nor more than 0.48 percent of manganese; (iii) none, or not more than 0.03 percent of sulfur; (iv) none, or not more than 0.03 percent of phosphorus; (v) not less than 0.18 nor more than 0.37 percent of silicon; (vi) not less than 1.25 nor more than 1.65 percent of chromium; (vii) none, or not more than 0.28 percent of nickel; (viii) none, or not more than 0.38 percent of copper; and (ix) none, or not more than 0.09 percent of molybdenum.

    • Tool steels; 12

    12 Tool steels are defined as steels which contain the following combinations of elements in the quantity by weight respectively indicated: (i) More than 1.2 percent carbon and more than 10.5 percent chromium; or (ii) not less than 0.3 percent carbon and 1.25 percent or more but less than 10.5 percent chromium; or (iii) not less than 0.85 percent carbon and 1 percent to 1.8 percent, inclusive, manganese; or (iv) 0.9 percent to 1.2 percent, inclusive, chromium and 0.9 percent to 1.4 percent, inclusive, molybdenum; or (v) not less than 0.5 percent carbon and not less than 3.5 percent molybdenum; or (vi) not less than 0.5 percent carbon and not less than 5.5 percent tungsten.

    • Silico-manganese steel; 13

    13 Silico-manganese steel is defined as steels containing by weight: (i) Not more than 0.7 percent of carbon; (ii) 0.5 percent or more but not more than 1.9 percent of manganese, and (iii) 0.6 percent or more but not more than 2.3 percent of silicon.

    • Grain-oriented electrical steels (GOES) as defined in the final determination of the U.S. Department of Commerce in Grain-Oriented Electrical Steel From Germany, Japan, and Poland. 14

    14See Grain-Oriented Electrical Steel From Germany, Japan, and Poland: Final Determinations of Sales at Less Than Fair Value and Certain Final Affirmative Determination of Critical Circumstances, 79 FR 42,501, 42,503 (Dep't of Commerce, July 22, 2014). This determination defines grain-oriented electrical steel as “a flat-rolled alloy steel product containing by weight at least 0.6 percent but not more than 6 percent of silicon, not more than 0.08 percent of carbon, not more than 1.0 percent of aluminum, and no other element in an amount that would give the steel the characteristics of another alloy steel, in coils or in straight lengths.”

    • Non-Oriented Electrical Steels (NOES), as defined in the antidumping orders issued by the U.S. Department of Commerce in Non-Oriented Electrical Steel From the People's Republic of China, Germany, Japan, the Republic of Korea, Sweden, and Taiwan. 15

    15See Non-Oriented Electrical Steel From the People's Republic of China, Germany, Japan, the Republic of Korea, Sweden, and Taiwan: Antidumping Duty Orders, 79 FR 71,741, 71,741-42 (Dep't of Commerce, Dec. 3, 2014). The orders define NOES as “cold-rolled, flat-rolled, alloy steel products, whether or not in coils, regardless of width, having an actual thickness of 0.20 mm or more, in which the core loss is substantially equal in any direction of magnetization in the plane of the material. The term `substantially equal' means that the cross grain direction of core loss is no more than 1.5 times the straight grain direction (i.e., the rolling direction) of core loss. NOES has a magnetic permeability that does not exceed 1.65 Tesla when tested at a field of 800 A/m (equivalent to 10 Oersteds) along (i.e., parallel to) the rolling direction of the sheet (i.e., B800 value). NOES contains by weight more than 1.00 percent of silicon but less than 3.5 percent of silicon, not more than 0.08 percent of carbon, and not more than 1.5 percent of aluminum. NOES has a surface oxide coating, to which an insulation coating may be applied.”

    The products subject to these investigation are currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under item numbers: 7209.15.0000, 7209.16.0030, 7209.16.0060, 7209.16.0070, 7209.16.0091, 7209.17.0030, 7209.17.0060, 7209.17.0070, 7209.17.0091, 7209.18.1530, 7209.18.1560, 7209.18.2510, 7209.18.2520, 7209.18.2580, 7209.18.6020, 7209.18.6090, 7209.25.0000, 7209.26.0000, 7209.27.0000, 7209.28.0000, 7209.90.0000, 7210.70.3000, 7211.23.1500, 7211.23.2000, 7211.23.3000, 7211.23.4500, 7211.23.6030, 7211.23.6060, 7211.23.6075, 7211.23.6085, 7211.29.2030, 7211.29.2090, 7211.29.4500, 7211.29.6030, 7211.29.6080, 7211.90.0000, 7212.40.1000, 7212.40.5000, 7225.50.6000, 7225.50.8015, 7225.50.8085, 7225.99.0090, 7226.92.5000, 7226.92.7050, and 7226.92.8050. The products subject to the investigation may also enter under the following HTSUS numbers: 7210.90.9000, 7212.50.0000, 7215.10.0010, 7215.10.0080, 7215.50.0016, 7215.50.0018, 7215.50.0020, 7215.50.0061, 7215.50.0063, 7215.50.0065, 7215.50.0090, 7215.90.5000, 7217.10.1000, 7217.10.2000, 7217.10.3000, 7217.10.7000, 7217.90.1000, 7217.90.5030, 7217.90.5060, 7217.90.5090, 7225.19.0000, 7226.19.1000, 7226.19.9000, 7226.99.0180, 7228.50.5015, 7228.50.5040, 7228.50.5070, 7228.60.8000, and 7229.90.1000.

    The HTSUS subheadings above are provided for convenience and U.S. Customs purposes only. The written description of the scope of the investigation is dispositive.

    [FR Doc. 2015-32223 Filed 12-21-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-580-882] Countervailing Duty Investigation of Certain Cold-Rolled Steel Flat Products From the Republic of Korea: Preliminary Negative Determination and Alignment of Final Determination With Final Antidumping Duty Determination AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that de minimis countervailable subsidies are being provided to producers/exporters of certain cold-rolled steel flat products (cold-rolled steel) from the Republic of Korea (Korea). The period of investigation is January 1, 2014, through December 31, 2014. We invite interested parties to comment on this preliminary determination.

    DATES:

    Effective Date: December 22, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Yasmin Bordas or Emily Maloof, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-3813 or (202) 482-5649, respectively.

    SUPPLEMENTARY INFORMATION: Scope of the Investigation

    The products covered by this investigation are certain cold-rolled steel flat products from Korea. For a complete description of the scope of this investigation, see Appendix II.

    Methodology

    The Department is conducting this countervailing duty (CVD) investigation in accordance with section 701 of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, we preliminarily determine that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific.1 For a full description of the methodology underlying our preliminary conclusions, see the Preliminary Decision Memorandum.2 A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix I to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    1See sections 771(5)(B) and (D) of the Act regarding financial contribution; section 771(5)(E) of the Act regarding benefit; and section 771(5A) of the Act regarding specificity.

    2See Memorandum from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary of Enforcement and Compliance, “Decision Memorandum for the Preliminary Negative Determination: Countervailing Duty Investigation of Certain Cold-Rolled Steel Flat Products from the Republic of Korea,” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    In making this preliminary determination, the Department relied, in part, on facts otherwise available.3 For further information, see “Use of Facts Otherwise Available” in the accompanying Preliminary Decision Memorandum.

    3See section 776(a) of the Act.

    Alignment

    As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), we are aligning the final CVD determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of cold-rolled steel from Korea based on a request made by Petitioners.4 Consequently, the final CVD determination will be issued on the same date as the final AD determination, which is currently scheduled to be issued no later than May 8, 2016,5 unless postponed.

    4 AK Steel Corporation, ArcelorMittal USA LLC, Nucor Corporation, Steel Dynamics Inc., and the United States Steel Corporation (collectively, Petitioners).

    5 The current deadline for the final AD determination, May 8, 2016, is a Sunday. Pursuant to Department practice, the signature date will be the next business day, which is Monday, May 9, 2016. See Notice of Clarification: Application of “Next Business Day” Rule for Administrative Determination Deadlines Pursuant to the Tariff Act of 1930, As Amended, 70 FR 24533 (May 10, 2005).

    Preliminary Determination

    In accordance with section 703(d)(1)(A)(i) of the Act, we calculated a CVD rate for each individually investigated producer/exporter of the subject merchandise. We preliminarily determine that de minimis countervailable subsides are being provided with respect to the manufacture, production or exportation of the subject merchandise, and, thus, this preliminary determination is negative. Consistent with section 703(b)(4)(A) of the Act, we have disregarded de minimis rates. Consistent with section 703(d) of the Act, we have not calculated an all-others rate because we have not reached an affirmative preliminarily determination. We preliminarily determine the countervailable subsidy rates to be:

    Company Subsidy rate
  • (percent)
  • POSCO and Daewoo International Corporation 0.18 Hyundai Steel Co., Ltd 0.61 De minimis.

    Because we preliminarily determine that the CVD rates in this investigation are de minimis, at this time, we will not direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise.

    Verification

    As provided in section 782(i)(1) of the Act, we intend to verify the information submitted by the respondents prior to making our final determination.

    International Trade Commission Notification

    In accordance with section 703(f) of the Act, we will notify the International Trade Commission (ITC) of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information relating to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order, without the written consent of the Assistant Secretary for Enforcement and Compliance.

    In accordance with section 705(b)(3) of the Act, if our final determination is affirmative, the ITC will make its final determination within 75 days after the Department makes its final determination.

    Disclosure and Public Comment

    The Department intends to disclose to interested parties the calculations performed in connection with this preliminary determination within five days of its public announcement.6 Interested parties may submit case and rebuttal briefs, as well as request a hearing.7 For a schedule of the deadlines for filing case briefs, rebuttal briefs, and hearing requests, see the Preliminary Decision Memorandum.

    6See 19 CFR 351.224(b).

    7See 19 CFR 351.309(c)-(d), 19 CFR 351.310(c).

    This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).

    Dated: December 15, 2015. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope Comments IV. Scope of the Investigation V. Alignment VI. Injury Test VII. Use of Facts Otherwise Available VIII. Subsidies Valuation IX. Analysis of Programs X. Disclosure and Public Comment XI. Conclusion Appendix II Scope of the Investigation

    The products covered by this investigation are certain cold-rolled (cold-reduced), flat-rolled steel products, whether or not annealed, painted, varnished, or coated with plastics or other non-metallic substances. The products covered do not include those that are clad, plated, or coated with metal. The products covered include coils that have a width or other lateral measurement (“width”) of 12.7 mm or greater, regardless of form of coil (e.g., in successively superimposed layers, spirally oscillating, etc.). The products covered also include products not in coils (e.g., in straight lengths) of a thickness less than 4.75 mm and a width that is 12.7 mm or greater and that measures at least 10 times the thickness. The products covered also include products not in coils (e.g., in straight lengths) of a thickness of 4.75 mm or more and a width exceeding 150 mm and measuring at least twice the thickness. The products described above may be rectangular, square, circular, or other shape and include products of either rectangular or non-rectangular cross-section where such cross-section is achieved subsequent to the rolling process, i.e., products which have been “worked after rolling” (e.g., products which have been beveled or rounded at the edges). For purposes of the width and thickness requirements referenced above:

    (1) Where the nominal and actual measurements vary, a product is within the scope if application of either the nominal or actual measurement would place it within the scope based on the definitions set forth above, and

    (2) Where the width and thickness vary for a specific product (e.g., the thickness of certain products with non-rectangular cross-section, the width of certain products with non-rectangular shape, etc.), the measurement at its greatest width or thickness applies.

    Steel products included in the scope of this investigation are products in which: (1) iron predominates, by weight, over each of the other contained elements; (2) the carbon content is 2 percent or less, by weight; and (3) none of the elements listed below exceeds the quantity, by weight, respectively indicated:

    • 2.50 percent of manganese, or • 3.30 percent of silicon, or • 1.50 percent of copper, or • 1.50 percent of aluminum, or • 1.25 percent of chromium, or • 0.30 percent of cobalt, or • 0.40 percent of lead, or • 2.00 percent of nickel, or • 0.30 percent of tungsten (also called wolfram), or • 0.80 percent of molybdenum, or • 0.10 percent of niobium (also called columbium), or • 0.30 percent of vanadium, or • 0.30 percent of zirconium

    Unless specifically excluded, products are included in this scope regardless of levels of boron and titanium.

    For example, specifically included in this scope are vacuum degassed, fully stabilized (commonly referred to as interstitial-free (IF)) steels, high strength low alloy (HSLA) steels, motor lamination steels, Advanced High Strength Steels (AHSS), and Ultra High Strength Steels (UHSS). IF steels are recognized as low carbon steels with micro-alloying levels of elements such as titanium and/or niobium added to stabilize carbon and nitrogen elements. HSLA steels are recognized as steels with micro-alloying levels of elements such as chromium, copper, niobium, titanium, vanadium, and molybdenum. Motor lamination steels contain micro-alloying levels of elements such as silicon and aluminum. AHSS and UHSS are considered high tensile strength and high elongation steels, although AHSS and UHSS are covered whether or not they are high tensile strength or high elongation steels.

    Subject merchandise includes cold-rolled steel that has been further processed in a third country, including but not limited to annealing, tempering, painting, varnishing, trimming, cutting, punching, and/or slitting, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the cold-rolled steel.

    All products that meet the written physical description, and in which the chemistry quantities do not exceed any one of the noted element levels listed above, are within the scope of this investigation unless specifically excluded. The following products are outside of and/or specifically excluded from the scope of this investigation:

    • Ball bearing steels; 8

    8 Ball bearing steels are defined as steels which contain, in addition to iron, each of the following elements by weight in the amount specified: (i) not less than 0.95 nor more than 1.13 percent of carbon; (ii) not less than 0.22 nor more than 0.48 percent of manganese; (iii) none, or not more than 0.03 percent of sulfur; (iv) none, or not more than 0.03 percent of phosphorus; (v) not less than 0.18 nor more than 0.37 percent of silicon; (vi) not less than 1.25 nor more than 1.65 percent of chromium; (vii) none, or not more than 0.28 percent of nickel; (viii) none, or not more than 0.38 percent of copper; and (ix) none, or not more than 0.09 percent of molybdenum.

    • Tool steels; 9

    9 Tool steels are defined as steels which contain the following combinations of elements in the quantity by weight respectively indicated: (i) more than 1.2 percent carbon and more than 10.5 percent chromium; or (ii) not less than 0.3 percent carbon and 1.25 percent or more but less than 10.5 percent chromium; or (iii) not less than 0.85 percent carbon and 1 percent to 1.8 percent, inclusive, manganese; or (iv) 0.9 percent to 1.2 percent, inclusive, chromium and 0.9 percent to 1.4 percent, inclusive, molybdenum; or (v) not less than 0.5 percent carbon and not less than 3.5 percent molybdenum; or (vi) not less than 0.5 percent carbon and not less than 5.5 percent tungsten.

    • Silico-manganese steel; 10

    10 Silico-manganese steel is defined as steels containing by weight: (i) not more than 0.7 percent of carbon; (ii) 0.5 percent or more but not more than 1.9 percent of manganese, and (iii) 0.6 percent or more but not more than 2.3 percent of silicon.

    • Grain-oriented electrical steels (GOES) as defined in the final determination of the U.S. Department of Commerce in Grain-Oriented Electrical Steel From Germany, Japan, and Poland. 11

    11Grain-Oriented Electrical Steel From Germany, Japan, and Poland: Final Determinations of Sales at Less Than Fair Value and Certain Final Affirmative Determination of Critical Circumstances, 79 FR 42,501, 42,503 (Dep't of Commerce, July 22, 2014). This determination defines grain-oriented electrical steel as “a flat-rolled alloy steel product containing by weight at least 0.6 percent but not more than 6 percent of silicon, not more than 0.08 percent of carbon, not more than 1.0 percent of aluminum, and no other element in an amount that would give the steel the characteristics of another alloy steel, in coils or in straight lengths.”

    • Non-Oriented Electrical Steels (NOES), as defined in the antidumping orders issued by the U.S. Department of Commerce in Non-Oriented Electrical Steel From the People's Republic of China, Germany, Japan, the Republic of Korea, Sweden, and Taiwan. 12

    12Non-Oriented Electrical Steel From the People's Republic of China, Germany, Japan, the Republic of Korea, Sweden, and Taiwan: Antidumping Duty Orders, 79 FR 71,741, 71,741-42 (Dep't of Commerce, Dec. 3, 2014). The orders define NOES as “cold-rolled, flat-rolled, alloy steel products, whether or not in coils, regardless of width, having an actual thickness of 0.20 mm or more, in which the core loss is substantially equal in any direction of magnetization in the plane of the material. The term `substantially equal' means that the cross grain direction of core loss is no more than 1.5 times the straight grain direction (i.e., the rolling direction) of core loss. NOES has a magnetic permeability that does not exceed 1.65 Tesla when tested at a field of 800 A/m (equivalent to 10 Oersteds) along (i.e., parallel to) the rolling direction of the sheet (i.e., B800 value). NOES contains by weight more than 1.00 percent of silicon but less than 3.5 percent of silicon, not more than 0.08 percent of carbon, and not more than 1.5 percent of aluminum. NOES has a surface oxide coating, to which an insulation coating may be applied.”

    The products subject to these investigations are currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under item numbers: 7209.15.0000, 7209.16.0030, 7209.16.0060, 7209.16.0070, 7209.16.0091, 7209.17.0030, 7209.17.0060, 7209.17.0070, 7209.17.0091, 7209.18.1530, 7209.18.1560, 7209.18.2510, 7209.18.2520, 7209.18.2580, 7209.18.6020, 7209.18.6090, 7209.25.0000, 7209.26.0000, 7209.27.0000, 7209.28.0000, 7209.90.0000, 7210.70.3000, 7211.23.1500, 7211.23.2000, 7211.23.3000, 7211.23.4500, 7211.23.6030, 7211.23.6060, 7211.23.6075, 7211.23.6085, 7211.29.2030, 7211.29.2090, 7211.29.4500, 7211.29.6030, 7211.29.6080, 7211.90.0000, 7212.40.1000, 7212.40.5000, 7225.50.6000, 7225.50.8015, 7225.50.8085, 7225.99.0090, 7226.92.5000, 7226.92.7050, and 7226.92.8050.

    The products subject to the investigations may also enter under the following HTSUS numbers: 7210.90.9000, 7212.50.0000, 7215.10.0010, 7215.10.0080, 7215.50.0016, 7215.50.0018, 7215.50.0020, 7215.50.0061, 7215.50.0063, 7215.50.0065, 7215.50.0090, 7215.90.5000, 7217.10.1000, 7217.10.2000, 7217.10.3000, 7217.10.7000, 7217.90.1000, 7217.90.5030, 7217.90.5060, 7217.90.5090, 7225.19.0000, 7226.19.1000, 7226.19.9000, 7226.99.0180, 7228.50.5015, 7228.50.5040, 7228.50.5070, 7228.60.8000, and 7229.90.1000.

    The HTSUS subheadings above are provided for convenience and customs purposes only. The written description of the scope of the investigation is dispositive.

    [FR Doc. 2015-32222 Filed 12-21-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-351-844] Countervailing Duty Investigation of Certain Cold-Rolled Steel Flat Products From Brazil: Preliminary Affirmative Determination and Alignment of Final Determination With Final Antidumping Duty Determination AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (Department) preliminarily determines that countervailable subsidies are being provided to producers and exporters of certain cold-rolled steel flat products (cold-rolled steel) from Brazil. The period of investigation is January 1, 2014, through December 31, 2014. We invite interested parties to comment on this preliminary determination.

    DATES:

    Effective Date: December 22, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Nicholas Czajkowski or Lana Nigro, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-1395 or (202) 482-1779, respectively.

    Scope of the Investigation

    The products covered by this investigation are cold-rolled steel flat products from Brazil. For a complete description of the scope of this investigation, see Appendix II.

    Methodology

    The Department is conducting this countervailing duty (CVD) investigation in accordance with section 701 of the Tariff Act of 1930, as amended (Act). For each of the subsidy programs found countervailable, we preliminarily determine that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific.1 For a full description of the methodology underlying our preliminary conclusions, see the Preliminary Decision Memorandum. A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix I to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    1 See sections 771(5)(B) and (D) of the Act regarding financial contribution; section 771(5)(E) of the Act regarding benefit; and section 771(5A) of the Act regarding specificity.

    In making this preliminary determination, the Department relied, in part, on facts otherwise available.2 For further information, see “Use of Facts Otherwise Available” in the accompanying Preliminary Decision Memorandum.

    2See section 776(a) of the Act.

    Alignment

    As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), we are aligning the final CVD determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of cold-rolled steel from Brazil based on a request made by Petitioners.3 Consequently, the final CVD determination will be issued on the same date as the final AD determination, which is currently scheduled to be issued no later than May 8, 2016,4 unless postponed.

    3 AK Steel Corporation, ArcelorMittal USA LLC, Nucor Corporation, Steel Dynamics Inc., and the United States Steel Corporation (collectively, Petitioners). See letter from Petitioners, “Countervailing Duty Investigations of Certain Cold-Rolled Steel Flat Products from Brazil, India, the People's Republic of China, the Republic of Korea, and the Russian Federation—Petitioners' Request to Align Final Determinations in Countervailing and Antidumping Duty Investigations,” dated December 14, 2015 (Petitioners' Request for Alignment).

    4 The current deadline for the final AD determination, May 8, 2016, is a Sunday. Pursuant to Department practice, the signature date will be the next business day, which is Monday, May 9, 2016. See Notice of Clarification: Application of “Next Business Day” Rule for Administrative Determination Deadlines Pursuant to the Tariff Act of 1930, As Amended, 70 FR 24533 (May 10, 2005).

    Preliminary Determination and Suspension of Liquidation

    In accordance with section 703(d)(1)(A)(i) of the Act, we calculated a CVD rate for each individually investigated respondent company. Section 705(c)(5)(A)(i) of the Act states that, for companies not individually investigated, we will determine an “all others” rate equal to the weighted-average countervailable subsidy rates established for exporters and producers individually investigated, excluding any zero and de minimis countervailable subsidy rates, and any rates determined entirely under section 776 of the Act.

    Consistent with the Department's practice, we normally calculate the all others rate based on the weighted average of the mandatory respondents' calculated subsidy rates.5 In this case however, the two mandatory respondents have the same rate. Therefore, it is unnecessary to calculate an all others rate that is the weighted average of the mandatory respondents' rates. The all others rate is the rate calculated for both mandatory respondents.

    5 See, e.g., Countervailing Duty Investigation of Certain Passenger Vehicle and Light Truck Tires From the People's Republic of China: Final Affirmative Determination, and Final Affirmative Critical Circumstances Determination, in Part, 80 FR 34888 (June 18, 2015).

    We preliminarily determine the countervailable subsidy rates to be:

    Company Subsidy rate
  • (percent)
  • Companhia Siderurgica Nacional (CSN) 7.42 Usinas Siderurgicas de Minas Gerais S.A. (Usiminas) 7.42 All Others 7.42

    In accordance with sections 703(d)(1)(B) and (2) of the Act, we are directing U.S. Customs and Border Protection to suspend liquidation of all entries of cold-rolled steel from Brazil that are entered, or withdrawn from warehouse, for consumption on or after the date of the publication of this notice in the Federal Register, and to require a cash deposit for such entries of merchandise in the amounts indicated above.

    Verification

    As provided in section 782(i)(1) of the Act, we intend to verify the information submitted by the respondents prior to making our final determination.

    International Trade Commission Notification

    In accordance with section 703(f) of the Act, we will notify the International Trade Commission (ITC) of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information relating to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order, without the written consent of the Assistant Secretary for Enforcement and Compliance.

    In accordance with section 705(b)(2) of the Act, if our final determination is affirmative, the ITC will make its final determination within 45 days after the Department makes its final determination.

    Disclosure and Public Comment

    The Department intends to disclose to interested parties the calculations performed in connection with this preliminary determination within five days of its public announcement.6 Interested parties may submit case and rebuttal briefs, as well as request a hearing.7 For a schedule of the deadlines for filing case briefs, rebuttal briefs, and hearing requests, see the Preliminary Decision Memorandum.

    6 See 19 CFR 351.224(b).

    7 See 19 CFR 351.309(c)-(d), 19 CFR 351.310(c).

    This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).

    Dated: December 15, 2015. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope Comments IV. Scope of the Investigation V. Alignment VI. Injury Test VII. Use of Facts Otherwise Available VIII. Subsidies Valuation IX. Analysis of Programs X. Calculation of the All Others Rate XI. ITC Notification XII. Disclosure and Public Comment XIII. Verification XIV. Conclusion Appendix II Scope of the Investigation

    The products covered by this investigation are certain cold-rolled (cold-reduced), flat-rolled steel products, whether or not annealed, painted, varnished, or coated with plastics or other non-metallic substances. The products covered do not include those that are clad, plated, or coated with metal. The products covered include coils that have a width or other lateral measurement (“width”) of 12.7 mm or greater, regardless of form of coil (e.g., in successively superimposed layers, spirally oscillating, etc.). The products covered also include products not in coils (e.g., in straight lengths) of a thickness less than 4.75 mm and a width that is 12.7 mm or greater and that measures at least 10 times the thickness. The products covered also include products not in coils (e.g., in straight lengths) of a thickness of 4.75 mm or more and a width exceeding 150 mm and measuring at least twice the thickness. The products described above may be rectangular, square, circular, or other shape and include products of either rectangular or non-rectangular cross-section where such cross-section is achieved subsequent to the rolling process, i.e., products which have been “worked after rolling” (e.g., products which have been beveled or rounded at the edges). For purposes of the width and thickness requirements referenced above:

    (1) Where the nominal and actual measurements vary, a product is within the scope if application of either the nominal or actual measurement would place it within the scope based on the definitions set forth above, and

    (2) where the width and thickness vary for a specific product (e.g., the thickness of certain products with non-rectangular cross-section, the width of certain products with non-rectangular shape, etc.), the measurement at its greatest width or thickness applies.

    Steel products included in the scope of this investigation are products in which: (1) Iron predominates, by weight, over each of the other contained elements; (2) the carbon content is 2 percent or less, by weight; and (3) none of the elements listed below exceeds the quantity, by weight, respectively indicated:

    • 2.50 percent of manganese, or • 3.30 percent of silicon, or • 1.50 percent of copper, or • 1.50 percent of aluminum, or • 1.25 percent of chromium, or • 0.30 percent of cobalt, or • 0.40 percent of lead, or • 2.00 percent of nickel, or • 0.30 percent of tungsten (also called wolfram), or • 0.80 percent of molybdenum, or • 0.10 percent of niobium (also called columbium), or • 0.30 percent of vanadium, or • 0.30 percent of zirconium

    Unless specifically excluded, products are included in this scope regardless of levels of boron and titanium.

    For example, specifically included in this scope are vacuum degassed, fully stabilized (commonly referred to as interstitial-free (IF)) steels, high strength low alloy (HSLA) steels, motor lamination steels, Advanced High Strength Steels (AHSS), and Ultra High Strength Steels (UHSS). IF steels are recognized as low carbon steels with micro-alloying levels of elements such as titanium and/or niobium added to stabilize carbon and nitrogen elements. HSLA steels are recognized as steels with micro-alloying levels of elements such as chromium, copper, niobium, titanium, vanadium, and molybdenum. Motor lamination steels contain micro-alloying levels of elements such as silicon and aluminum. AHSS and UHSS are considered high tensile strength and high elongation steels, although AHSS and UHSS are covered whether or not they are high tensile strength or high elongation steels.

    Subject merchandise includes cold-rolled steel that has been further processed in a third country, including but not limited to annealing, tempering, painting, varnishing, trimming, cutting, punching, and/or slitting, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the cold-rolled steel.

    All products that meet the written physical description, and in which the chemistry quantities do not exceed any one of the noted element levels listed above, are within the scope of this investigation unless specifically excluded. The following products are outside of and/or specifically excluded from the scope of this investigation:

    • Ball bearing steels; 8

    8 Ball bearing steels are defined as steels which contain, in addition to iron, each of the following elements by weight in the amount specified: (i) Not less than 0.95 nor more than 1.13 percent of carbon; (ii) not less than 0.22 nor more than 0.48 percent of manganese; (iii) none, or not more than 0.03 percent of sulfur; (iv) none, or not more than 0.03 percent of phosphorus; (v) not less than 0.18 nor more than 0.37 percent of silicon; (vi) not less than 1.25 nor more than 1.65 percent of chromium; (vii) none, or not more than 0.28 percent of nickel; (viii) none, or not more than 0.38 percent of copper; and (ix) none, or not more than 0.09 percent of molybdenum.

    • Tool steels; 9

    9 Tool steels are defined as steels which contain the following combinations of elements in the quantity by weight respectively indicated: (i) More than 1.2 percent carbon and more than 10.5 percent chromium; or (ii) not less than 0.3 percent carbon and 1.25 percent or more but less than 10.5 percent chromium; or (iii) not less than 0.85 percent carbon and 1 percent to 1.8 percent, inclusive, manganese; or (iv) 0.9 percent to 1.2 percent, inclusive, chromium and 0.9 percent to 1.4 percent, inclusive, molybdenum; or (v) not less than 0.5 percent carbon and not less than 3.5 percent molybdenum; or (vi) not less than 0.5 percent carbon and not less than 5.5 percent tungsten.

    • Silico-manganese steel; 10

    10 Silico-manganese steel is defined as steels containing by weight: (i) Not more than 0.7 percent of carbon; (ii) 0.5 percent or more but not more than 1.9 percent of manganese, and (iii) 0.6 percent or more but not more than 2.3 percent of silicon.

    • Grain-oriented electrical steels (GOES) as defined in the final determination of the U.S. Department of Commerce in Grain-Oriented Electrical Steel From Germany, Japan, and Poland. 11

    11Grain-Oriented Electrical Steel From Germany, Japan, and Poland: Final Determinations of Sales at Less Than Fair Value and Certain Final Affirmative Determination of Critical Circumstances, 79 FR 42,501, 42,503 (Dep't of Commerce, July 22, 2014). This determination defines grain-oriented electrical steel as “a flat-rolled alloy steel product containing by weight at least 0.6 percent but not more than 6 percent of silicon, not more than 0.08 percent of carbon, not more than 1.0 percent of aluminum, and no other element in an amount that would give the steel the characteristics of another alloy steel, in coils or in straight lengths.”

    • Non-Oriented Electrical Steels (NOES), as defined in the antidumping orders issued by the U.S. Department of Commerce in Non-Oriented Electrical Steel From the People's Republic of China, Germany, Japan, the Republic of Korea, Sweden, and Taiwan. 12

    12Non-Oriented Electrical Steel From the People's Republic of China, Germany, Japan, the Republic of Korea, Sweden, and Taiwan: Antidumping Duty Orders, 79 FR 71,741, 71,741-42 (Dep't of Commerce, Dec. 3, 2014). The orders define NOES as “cold-rolled, flat-rolled, alloy steel products, whether or not in coils, regardless of width, having an actual thickness of 0.20 mm or more, in which the core loss is substantially equal in any direction of magnetization in the plane of the material. The term `substantially equal' means that the cross grain direction of core loss is no more than 1.5 times the straight grain direction (i.e., the rolling direction) of core loss. NOES has a magnetic permeability that does not exceed 1.65 Tesla when tested at a field of 800 A/m (equivalent to 10 Oersteds) along (i.e., parallel to) the rolling direction of the sheet (i.e., B800 value). NOES contains by weight more than 1.00 percent of silicon but less than 3.5 percent of silicon, not more than 0.08 percent of carbon, and not more than 1.5 percent of aluminum. NOES has a surface oxide coating, to which an insulation coating may be applied.”

    The products subject to this investigation are currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under item numbers: 7209.15.0000, 7209.16.0030, 7209.16.0060, 7209.16.0070, 7209.16.0091, 7209.17.0030, 7209.17.0060, 7209.17.0070, 7209.17.0091, 7209.18.1530, 7209.18.1560, 7209.18.2510, 7209.18.2520, 7209.18.2580, 7209.18.6020, 7209.18.6090, 7209.25.0000, 7209.26.0000, 7209.27.0000, 7209.28.0000, 7209.90.0000, 7210.70.3000, 7211.23.1500, 7211.23.2000, 7211.23.3000, 7211.23.4500, 7211.23.6030, 7211.23.6060, 7211.23.6075, 7211.23.6085, 7211.29.2030, 7211.29.2090, 7211.29.4500, 7211.29.6030, 7211.29.6080, 7211.90.0000, 7212.40.1000, 7212.40.5000, 7225.50.6000, 7225.50.8015, 7225.50.8085, 7225.99.0090, 7226.92.5000, 7226.92.7050, and 7226.92.8050. The products subject to the investigation may also enter under the following HTSUS numbers: 7210.90.9000, 7212.50.0000, 7215.10.0010, 7215.10.0080, 7215.50.0016, 7215.50.0018, 7215.50.0020, 7215.50.0061, 7215.50.0063, 7215.50.0065, 7215.50.0090, 7215.90.5000, 7217.10.1000, 7217.10.2000, 7217.10.3000, 7217.10.7000, 7217.90.1000, 7217.90.5030, 7217.90.5060, 7217.90.5090, 7225.19.0000, 7226.19.1000, 7226.19.9000, 7226.99.0180, 7228.50.5015, 7228.50.5040, 7228.50.5070, 7228.60.8000, and 7229.90.1000.

    The HTSUS subheadings above are provided for convenience and U.S. Customs purposes only. The written description of the scope of the investigation is dispositive.

    [FR Doc. 2015-32221 Filed 12-21-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Institute of Standards and Technology Visiting Committee on Advanced Technology AGENCY:

    National Institute of Standards and Technology, Department of Commerce.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    The Visiting Committee on Advanced Technology (VCAT or Committee), National Institute of Standards and Technology (NIST), will meet in an open session on Wednesday, February 3, 2016 from 8:30 a.m. to 3:15 p.m. Eastern Time and Thursday, February 4, 2016 from 8:30 a.m. to 11:00 a.m. Eastern Time. The VCAT is composed of fifteen members appointed by the NIST Director who are eminent in such fields as business, research, new product development, engineering, labor, education, management consulting, environment, and international relations.

    DATES:

    The VCAT will meet on Wednesday, February 3, 2016, from 8:30 a.m. to 3:15 p.m. Eastern Time and Thursday, February 4, 2016, from 8:30 a.m. to 11:00 a.m. Eastern Time.

    ADDRESSES:

    The meeting will be held in the Portrait Room, Administration Building, at NIST, 100 Bureau Drive, Gaithersburg, Maryland, 20899. Please note admittance instructions under the SUPPLEMENTARY INFORMATION section of this notice.

    FOR FURTHER INFORMATION CONTACT:

    Stephanie Shaw, VCAT, NIST, 100 Bureau Drive, Mail Stop 1060, Gaithersburg, Maryland 20899-1060, telephone number 301-975-2667. Ms. Shaw's email address is [email protected]

    SUPPLEMENTARY INFORMATION: Authority:

    15 U.S.C. 278 and the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

    The purpose of this meeting is for the VCAT to review and make recommendations regarding general policy for NIST, its organization, its budget, and its programs within the framework of applicable national policies as set forth by the President and the Congress. The agenda will include updates from the Administration on current research priorities and NIST's role in addressing these areas. NIST workforce engagement and actions to improve the recruitment and retention of high quality staff will also be discussed. The Committee also will present its initial observations, findings, and recommendations for the 2015 VCAT Annual Report. The agenda may change to accommodate Committee business. The final agenda will be posted on the NIST Web site at http://www.nist.gov/director/vcat/agenda.cfm.

    Individuals and representatives of organizations who would like to offer comments and suggestions related to the Committee's affairs are invited to request a place on the agenda.

    On Thursday, February 4, approximately one-half hour in the morning will be reserved for public comments and speaking times will be assigned on a first-come, first-serve basis. The amount of time per speaker will be determined by the number of requests received, but is likely to be about 3 minutes each. The exact time for public comments will be included in the final agenda that will be posted on the NIST Web site at http://www.nist.gov/director/vcat/agenda.cfm. Questions from the public will not be considered during this period. Speakers who wish to expand upon their oral statements, those who had wished to speak but could not be accommodated on the agenda, and those who were unable to attend in person are invited to submit written statements to VCAT, NIST, 100 Bureau Drive, MS 1060, Gaithersburg, Maryland, 20899, via fax at 301-216-0529 or electronically by email to [email protected].

    All visitors to the NIST site are required to pre-register to be admitted. Please submit your name, time of arrival, email address and phone number to Stephanie Shaw by 5:00 p.m. Eastern Time, Wednesday, January 27, 2016. Non-U.S. citizens must submit additional information; please contact Ms. Shaw. Ms. Shaw's email address is [email protected] and her phone number is 301-975-2667. For participants attending in person, please note that federal agencies, including NIST, can only accept a state-issued driver's license or identification card for access to federal facilities if such license or identification card is issued by a state that is compliant with the REAL ID Act of 2005 (Pub. L. 109-13), or by a state that has an extension for REAL ID compliance. NIST currently accepts other forms of federal-issued identification in lieu of a state-issued driver's license. For detailed information please contact Ms. Shaw at 301-975-2667 or visit: http://nist.gov/public_affairs/visitor/.

    Richard R. Cavanagh, Acting Associate Director for Laboratory Programs.
    [FR Doc. 2015-32058 Filed 12-21-15; 8:45 am] BILLING CODE 3510-13-P
    DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Digital Economy Board of Advisors, Extension of Nomination Deadline AGENCY:

    National Telecommunications and Information Administration, U.S. Department of Commerce.

    ACTION:

    Extension of Nomination Deadline for the Digital Economy Board of Advisors.

    SUMMARY:

    NTIA announces that the closing deadline for the submission of nominations for the Digital Economy Board of Advisors is extended to midnight Eastern Standard Time (EST) on January 12, 2016.

    DATES:

    Nominations should be submitted electronically using the online nomination form on or before midnight EST on January 12, 2016.

    ADDRESSES:

    All nominations should be submitted using the online nomination form located at www.ntia.doc.gov/digital-economy.

    FOR FURTHER INFORMATION CONTACT:

    Evelyn Remaley, Designated Federal Officer, at (202) 482-3821 or [email protected]

    SUPPLEMENTARY INFORMATION:

    On November 27, 2015, NTIA published a notice in the Federal Register announcing the establishment of the Digital Economy Board of Advisors and calling for nominations for the Board. (80 FR 74086, Nov. 27, 2015). NTIA requires that all nominations be submitted electronically using the online nomination form located at www.ntia.doc.gov/digital-economy. NTIA established a nomination window through midnight EST on December 23, 2015.

    NTIA extends the nomination deadline to midnight EST on January 12, 2016. NTIA announces this deadline extension in the interest of ensuring that applicants have sufficient time to submit nominations, recognizing the proximity of several Federal holidays to the current nomination deadline. All other requirements for the submission of nominations remain unchanged.

    Dated: December 17, 2015. Kathy D. Smith, Chief Counsel, National Telecommunications and Information Administration.
    [FR Doc. 2015-32115 Filed 12-21-15; 8:45 am] BILLING CODE 3510-60-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Transmittal No. 15-71] 36(b)(1) Arms Sales Notification AGENCY:

    Defense Security Cooperation Agency, Department of Defense.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.

    FOR FURTHER INFORMATION CONTACT:

    Sarah A. Ragan or Heather N. Harwell, DSCA/LMO, (703) 604-1546/(703) 607-5339.

    The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 15-71 with attached Policy Justification and Sensitivity of Technology.

    Dated: December 17, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. BILLING CODE 5001-06-P EN22DE15.000 BILLING CODE 5001-06-C Transmittal No. 15-71 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(l) of the Arms Export Control Act, as amended

    (i) Prospective Purchaser: Kingdom of Morocco

    (ii) Total Estimated Value:

    Major Defense Equipment * $ 96.0 million Other $ 61.0 million Total $157.0 million

    (iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase:

    Major Defense Equipment (MDE):

    Six hundred (600) TOW 2A, Radio Frequency (RF) Missiles (BGM-71E-4B-RF)

    Seven (7) TOW 2A, Radio Frequency (RF) Missile (BGM-71E-4B-RF) Fly-to-Buy Lot Acceptance Missiles

    Three hundred (300) M220A2 TOW Launchers

    Also included with this request are Missile Support Equipment; Government-Furnished Equipment; Technical Manuals/Publications; Spare Parts; Tool and Test Equipment; Training; U.S. Government Technical Support/Logistical Support; Contractor Technical Support; and other associated equipment and services.

    (iv) Military Department: U.S. Army (MO-B-USZ)

    (v) Prior Related Cases, if any: None

    (vi) Sales Commission, Fee, etc., Paid, Offered, or Ag reed to be Paid: None

    (vii) Sensitivity of Technology Contained in the Defense Article or Defense Services Proposed to be Sold: See Attached Annex

    (viii) Date Report Delivered to Congress: 17 NOV 2015

    * As defined in Section 47(6) of the Arms Export Control Act

    POLICY JUSTIFICATION Morocco—Radio Frequency (RF) TOW 2A, Radio Frequency (FR) Missile (BGM-71-4B-RF), M220A2 TOW Launchers, Support and Training

    The Kingdom of Morocco has requested a possible sale of:

    Major Defense Equipment (MDE):

    Six hundred (600) TOW 2A, Radio Frequency (RF) Missiles (BGM-71E-4B-RF)

    Seven (7) TOW 2A, Radio Frequency (RF) Missile (BGM-71E-4B-RF) Fly-to-Buy Lot Acceptance Missiles

    Three hundred (300) M220A2 TOW Launchers

    Also included with this request are Missile Support Equipment; Government-Furnished Equipment; Technical Manuals/Publications; Spare Parts; Tool and Test Equipment; Training; U.S. Government Technical Support/Logistical Support; Contractor Technical Support; and other associated equipment and services. The estimated value of MDE is $96 million. The total estimated value is $157 million.

    This proposed sale will contribute to the foreign policy and national security of the United States by helping to improve the security of a major Non-NATO ally that continues to be an important force for the political stability and economic progress in North Africa.

    The proposed sale of the TOW 2A Missiles, M220A2 Launchers and technical support will advance Morocco's efforts to modernize its ground defense capability.

    The proposed sale of this equipment and support will not alter the basic military balance in the region.

    The principal contractor involved in this program is Raytheon Missile Systems, Tucson, Arizona. There are no known offset agreements proposed in connection with this potential sale.

    Implementation of this proposed sale will require the U.S. Government or contractor representatives to travel to Morocco for multiple periods for equipment deprocessing/fielding, system checkout and new equipment training. There will be no more than six contractor personnel in Morocco at any one time and all efforts will take less than 14 weeks in total.

    There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.

    Transmittal No. 15-71 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as amended Annex Item No. vii

    (vii) Sensitivity of Technology:

    1. The Radio Frequency (RF) TOW 2A Missile (BGM-71E-4B-RF) is a direct attack missile designed to defeat armored vehicles, reinforced urban structures, field fortifications and other such targets. TOW missiles are fired from a variety of TOW launchers in the U.S. Army, USMC, and FMS customer forces. The TOW 2A RF missile can be launched from the same launcher platforms as the existing wire-guided TOW 2A missile without modification to the launcher. The TOW 2A missile (both wire & RF) contains two tracker beacons (xenon and thermal) for the launcher to track and guide the missile in flight. Guidance commands from the launcher are provided to the missile by a RF link contained within the missile case. The hardware, software, and technical publications provided with the sale thereof are unclassified. However, the system itself contains sensitive technology that instructs the system on how to operate in the presence of countermeasures.

    2. If a technology advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.

    [FR Doc. 2015-32077 Filed 12-21-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION Applications for New Awards; Talent Search Program AGENCY:

    Office of Postsecondary Education, Department of Education.

    ACTION:

    Notice.

    Overview Information

    Talent Search Program

    Notice inviting applications for new awards for fiscal year (FY) 2016.

    Catalog of Federal Domestic Assistance (CFDA) Number: 84.044A.

    Dates:

    Applications Available: December 22, 2015.

    Deadline for Transmittal of Applications: February 5, 2016.

    Deadline for Intergovernmental Review: April 20, 2016.

    Full Text of Announcement I. Funding Opportunity Description

    Purpose of Program: The purpose of the Talent Search Program is to identify qualified individuals from disadvantaged backgrounds with potential for education at the postsecondary level and encourage them to complete secondary school and undertake postsecondary education. Talent Search projects publicize the availability of, and facilitate the application for, student financial assistance for persons who seek to pursue postsecondary education, and encourage persons who have not completed programs at the secondary or postsecondary level to enter or reenter and complete these programs.

    Background: The Federal TRIO programs, including the Talent Search Program, represent a national commitment to education for all students regardless of race, ethnic background, disability status, or economic circumstances. Consistent with this mission, the Department has a strong interest in ensuring that students who are low-income, potential first-generation college students, limited English proficient, students from groups that are traditionally underrepresented in postsecondary education, students with disabilities, students who are homeless children and youths, students who are in foster care or are aging out of the foster care system, or other disconnected students receive services provided by Talent Search.

    Priorities: This notice contains two competitive preference priorities. In accordance with 34 CFR 75.105(b)(2)(v), Competitive Preference Priority 1(a) is from allowable activities specified in the statute (see section 402B(c)(1) of the Higher Education Act of 1965, as amended (HEA))(20 U.S.C. 1070a-12(c)(1)). Competitive Preference Priority 1(b) is from 34 CFR 75.226. In accordance with 34 CFR 75.105(b)(2)(iv), Competitive Preference Priority 2(a) is from allowable activities specified in the statute (see section 402B(c)(6) of the HEA)(20 U.S.C. 1070a-12(c)(6)). Competitive Preference Priority 2(b) is from 34 CFR 75.226.

    Applicants must include, in the one-page abstract submitted with the application, a statement indicating which, if any, of the competitive preference priorities are addressed. If the applicant addresses any of the competitive preference priorities, this information must also be listed on the Talent Search Program Profile Form.

    Background on Competitive Preference Priorities: Each competitive preference priority has two parts—(a) and (b)—and the applicant must address both parts to receive consideration for the highest available number of points for that priority.

    Competitive Preference Priority 1(a). Under Competitive Preference Priority 1(a), the Department will award a competitive preference to projects designed to provide academic tutoring, which may include instruction in reading, writing, study skills, mathematics, science, and other subjects. The Department is interested in receiving applications with strong plans to provide effective tutoring programs for students to increase the likelihood that they complete high school and enroll in a postsecondary institution. Applicants addressing this priority should demonstrate how their proposals will improve student outcomes consistent with the Talent Search Program.

    Competitive Preference Priority 2(a). Through Competitive Preference Priority 2(a), the Department encourages applicants to propose strategies focused on developing mentoring programs. Mentoring programs are administered in various forms. Most scholars believe that mentoring is an important complement to other strategies employed to improve student outcomes. Yet, it is less clear which programmatic approaches to mentoring are particularly effective for students with different academic, social, or economic profiles. The Department is interested in receiving applications with strong plans to provide effective mentoring to students to increase the likelihood that they complete high school and enroll in a postsecondary institution. Applicants addressing this priority should demonstrate how their proposals will improve student outcomes consistent with the Talent Search Program.

    Competitive Preference Priorities 1(b) and 2(b). To meet Competitive Preference Priority (1)(b) or (2)(b), applicants must cite research studies that support their proposed tutoring or mentoring strategies. Applicants must address part (a) of each priority to be considered for the points available in part (b) of each priority. In recognition of the growing and emergent body of available research on tutoring and mentoring strategies that improve student success, we will award points for studies with varying levels of methodological rigor: One point for studies that meet Evidence of Promise (as defined in this notice) or two points for studies that meet Moderate Evidence of Effectiveness (as defined in this notice).

    Through Competitive Preference Priorities 1(b) and 2(b), an applicant can earn one additional point for each priority by demonstrating that its strategy is based on research that meets the Evidence of Promise standard or two additional points for each priority by demonstrating that its strategy is based on research that meets the Moderate Evidence of Effectiveness standard. Applicants seeking to address Competitive Preference Priority 1(b) or 2(b) should identify up to two citations for studies that meet the definition of the applicable evidence standard for each priority (a maximum of four citations if addressing both priorities). The Department will review the studies cited by the applicants to determine if they meet the requirements for Evidence of Promise or Moderate Evidence of Effectiveness.

    Cited studies may include those already listed in the Department's What Works Clearinghouse (WWC) Reviewed Studies Database (see http://ies.ed.gov/ncee/wwc/ReviewedStudies.aspx) or those that are not included in that database. Studies listed in the WWC Reviewed Studies Database do not necessarily satisfy any or all of the criteria needed to meet either the Evidence of Promise standard or the Moderate Evidence of Effectiveness standard, as defined in this notice, and therefore it is important that applicants themselves ascertain the suitability of a study for an evidence priority.

    Points will only be awarded if the submitted studies are determined to meet the particular evidence standard, and if a determination is made that the research cited is relevant to the proposed projects. Applicants addressing Competitive Preference Priorities 1(b) or 2(b) should clearly demonstrate the relevance of the cited studies to proposed project activities. Applicants should also clearly demonstrate how the proposed project activities align with the cited study with sufficient fidelity. Where modifications to the cited intervention will be made to account for student or institutional/organizational characteristics, resource limitations, or other special factors, the applicant should provide a justification or basis for the modifications in the narrative response to the priority.

    The link(s) for the citation(s) submitted for Competitive Preference Priority 1(b) or 2(b) should be provided on the abstract, as well as on the Talent Search Program Profile Form. Applicants should specify in their narrative responses to these priorities the findings within the studies cited as evidence in support of their strategies and ensure that the citation(s) and link(s) are from an available source.

    Competitive Preference Priorities: For FY 2016 and any subsequent year for which we make awards from the list of unfunded applicants from this competition, these priorities are competitive preference priorities. Under 34 CFR 75.105(c)(2)(i), we award up to six additional points to an application, depending on how well application meets one or more of these priorities.

    The competitive preference priorities are:

    Competitive Preference Priority 1(a)—Providing Academic Tutoring. The Secretary gives priority to projects designed to provide academic tutoring, which may include instruction in reading, writing, study skills, mathematics, science, and other subjects (1 additional point).

    Competitive Preference Priority 1(b)—Strategies supported by Evidence of Promise (1 additional point) or by Moderate Evidence of Effectiveness (2 additional points).

    Competitive Preference Priority 2(a)—Providing Mentoring Programs (1 additional point). The Secretary gives priority to projects designed to provide mentoring programs involving elementary or secondary school teachers or counselors, faculty members at institutions of higher education, students, or any combination of such persons (1 additional point).

    Competitive Preference Priority 2(b)—Programs supported by Evidence of Promise (1 additional point) or on Moderate Evidence of Effectiveness (2 additional points).

    Definitions:

    The following definitions are from 34 CFR 77.1.

    Evidence of Promise means there is empirical evidence to support the theoretical linkage(s) between at least one critical component and at least one relevant outcome presented in the logic model for the proposed process, product, strategy, or practice. Specifically, Evidence of Promise means the conditions in both paragraphs (i) and (ii) of this definition are met:

    (i) There is at least one study that is a—

    (A) Correlational study with statistical controls for selection bias;

    (B) Quasi-experimental design study that meets the What Works Clearinghouse Evidence Standards with reservations; or

    (C) Randomized controlled trial that meets the What Works Clearinghouse Evidence Standards with or without reservations.

    (ii) The study referenced in paragraph (i) of this definition found a statistically significant or substantively important (defined as a difference of 0.25 standard deviations or larger) favorable association between at least one critical component and one relevant outcome presented in the logic model for the proposed process, product, strategy, or practice.

    Moderate Evidence of Effectiveness means one of the following conditions is met:

    (i) There is at least one study of the effectiveness of the process, product, strategy, or practice being proposed that meets the What Works Clearinghouse Evidence Standards without reservations, found a statistically significant favorable impact on a relevant outcome (with no statistically significant and overriding unfavorable impacts on that outcome for relevant populations in the study or in other studies of the intervention reviewed by and reported on by the What Works Clearinghouse), and includes a sample that overlaps with the populations or settings proposed to receive the process, product, strategy, or practice.

    (ii) There is at least one study of the effectiveness of the process, product, strategy, or practice being proposed that meets the What Works Clearinghouse Evidence Standards with reservations, found a statistically significant favorable impact on a relevant outcome (with no statistically significant and overriding unfavorable impacts on that outcome for relevant populations in the study or in other studies of the intervention reviewed by and reported on by the What Works Clearinghouse), includes a sample that overlaps with the populations or settings proposed to receive the process, product, strategy, or practice, and includes a large sample and a multi-site sample. Note: Multiple studies can cumulatively meet the large and multi-site sample requirements as long as each study meets the other requirements in this paragraph.

    Multi-site sample means more than one site, where site can be defined as an LEA, locality, or State.

    Quasi-experimental design study means a study using a design that attempts to approximate an experimental design by identifying a comparison group that is similar to the treatment group in important respects. These studies, depending on design and implementation, can meet What Works Clearinghouse Evidence Standards with reservations (but not What Works Clearinghouse Evidence Standards without reservations).

    Randomized controlled trial means a study that employs random assignment of, for example, students, teachers, classrooms, schools, or districts to receive the intervention being evaluated (the treatment group) or not to receive the intervention (the control group). The estimated effectiveness of the intervention is the difference between the average outcome for the treatment group and for the control group. These studies, depending on design and implementation, can meet What Works Clearinghouse Evidence Standards without reservations.

    Relevant outcome means the student outcome(s) (or the ultimate outcome if not related to students) the proposed process, product, strategy, or practice is designed to improve; consistent with the specific goals of a program.

    What Works Clearinghouse Evidence Standards means the standards set forth in the What Works Clearinghouse Procedures and Standards Handbook (Version 3.0, March 2014), which can be found at the following link: http://ies.ed.gov/ncee/wwc/DocumentSum.aspx?sid=19.

    Program Authority: 20 U.S.C. 1070a-11 and 1070a-12.

    Applicable Regulations: (a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 74, 75 (except for §§ 75.215 through 75.221), 77, 79, 82, 84, 86, 97, 98, and 99. (b) The Office of Management and Budget Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in 2 CFR part 200, as adopted and amended in 2 CFR part 3474. (d) The regulations for this program in 34 CFR part 643.

    Note:

    The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian tribes.

    Note:

    The regulations in 34 CFR part 86 apply to institutions of higher education only.

    II. Award Information

    Type of Award: Discretionary grants.

    Estimated Available Funds: The Administration has requested $859,752,000 for the Federal TRIO Program for FY 2016, of which we intend to use an estimated $134,662,000 for Talent Search awards. The actual level of funding, if any, depends on final Congressional action. However, we are inviting applications to allow enough time to complete the grant process if Congress appropriates funds for this program.

    Estimated Range of Awards: $230,000-$681,210.

    Estimated Average Size of Awards: $265,754.

    Maximum Award:

    • For an applicant that is not currently receiving a Talent Search Program grant, the maximum award amount is $230,000 for a project that will serve a minimum of 500 participants, based upon a per-participant cost of no more than $460.

    • For an applicant that is currently receiving a Talent Search Program grant, the maximum award amount is the greater of (a) $230,000 or (b) 100 percent of the applicant's base award amount for FY 2015. The minimum number of participants an applicant proposes to serve must be 500 and the project must propose a per-participant cost that does not exceed $460 per participant. For example, an applicant that is eligible for a $460,000 grant, must propose to serve at least 1,000 participants.

    We will reject any application that proposes a budget exceeding the maximum amount listed above for a single budget period of 12 months. We will also reject any application that proposes a budget to serve fewer than 500 participants, and will reject any application that proposes a budget that exceeds the maximum per participant cost of $460.

    Estimated Number of Awards: 451.

    Note:

    The Department is not bound by any estimates in this notice.

    Project Period: Up to 60 months.

    III. Eligibility Information

    1. Eligible Applicants: Institutions of higher education, public and private agencies, and organizations including community-based organizations with experience in serving disadvantaged youth, combinations of such institutions, agencies and organizations, and secondary schools, for planning, developing, or carrying out one or more of the services identified under this program.

    2. Cost Sharing or Matching: This program does not require cost sharing or matching.

    3. Other: An applicant may submit multiple applications if each separate application describes a project that will serve a different target area or different target schools. The term target area is defined as a geographic area served by a project, and the term target school is a school designated by the applicant as a focus of project services (34 CFR 643.7).

    IV. Application and Submission Information

    1. Address to Request Application Package: Craig Pooler, U.S. Department of Education, 1990 K Street NW., Suite 7010, Washington, DC 20006-8510. Telephone: (202) 502-7600; or email: [email protected]

    If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

    Individuals with disabilities can obtain a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) by contacting the contact person listed in this section.

    2. Content and Form of Application Submission: Requirements concerning the content of an application, together with the forms you must submit, are in the application package for this program.

    Page Limit: The application narrative is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. You must limit the project narrative (Part III), which includes the budget narrative, to the equivalent of no more than 65 pages using the following standards. However, any application addressing the competitive preference priorities may include up to two additional pages for each part of each priority (1(a) and (b); 2(a) and (b)), if addressed. Those up to eight additional pages must be used to discuss how the application meets the competitive preference priority (or priorities). The additional pages allotted to address priorities cannot be used for or transferred to the project narrative or any section of the application.

    Note:

    For the purpose of determining compliance with the page limit, each page on which there is text or graphics will be counted as one full page.

    A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides. Page numbers and an identifier may be within the 1″ margin.

    Double space (no more than three lines per vertical inch) all text in the project narrative.

    Single space is appropriate for titles, headings, footnotes, quotations, references, and captions, as well as all text in figures, charts, and graphs.

    You should also include a table of contents in the project narrative, which will not be counted toward the page limit.

    Use a font that is either 12 point or larger, or no smaller than 10 pitch (characters per inch).

    Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman and Arial Narrow) will not be accepted.

    The page limit does not apply to Part I—the Application for Federal Assistance Face Sheet (SF 424); Part II—the budget information summary form (ED Form 524); Part III, the Talent Search Program Profile Form, the one-page Project Abstract form; and Part IV—the Assurances and Certifications. If you include any attachments or appendices, these items will be counted as part of Part III—the Project Narrative, for the purpose of the page-limit requirement. You must include your complete response to the selection criteria and priorities in Part III—the Project Narrative.

    We will reject your application if you exceed the page limit.

    3. Submission Dates and Times:

    Applications Available: December 22, 2015.

    Deadline for Transmittal of Applications: February 5, 2016.

    Applications for grants under this program must be submitted electronically using the Grants.gov Apply site (Grants.gov). For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to section IV. 7. Other Submission Requirements of this notice.

    We do not consider an application that does not comply with the deadline requirements.

    Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under For Further Information Contact in section VII in this notice. If the Department provides an accommodation or auxiliary aid to an individual with a disability in connection with the application process, the individual's application remains subject to all other requirements and limitations in this notice.

    Deadline for Intergovernmental Review: April 20, 2016.

    4. Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this program.

    5. Funding Restrictions: We specify unallowable costs in 34 CFR 643.31. We reference additional regulations outlining funding restrictions in the Applicable Regulations section of this notice.

    6. Data Universal Numbering System Number, Taxpayer Identification Number, and System for Award Management: To do business with the Department of Education, you must—

    a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);

    b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry (CCR)), the Government's primary registrant database;

    c. Provide your DUNS number and TIN on your application; and

    d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.

    You can obtain a DUNS number from Dun and Bradstreet. A DUNS number can be created within one to two business days.

    If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.

    The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data entered into the SAM database by an entity. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.

    Note:

    Once your SAM registration is active, you will need to allow 24 to 48 hours for the information to be available in Grants.gov and before you can submit an application through Grants.gov.

    If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.

    Information about SAM is available at www.SAM.gov. To further assist you with obtaining and registering your DUNS number and TIN in SAM or updating your existing SAM account, we have prepared a SAM.gov Tip Sheet, which you can find at: www2.ed.gov/fund/grant/apply/sam-faqs.html.

    In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page: www.grants.gov/web/grants/register.html.

    7. Other Submission Requirements: Applications for grants under this program must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.

    a. Electronic Submission of Applications.

    Applications for grants under the Talent Search Program, CFDA number 84.044A, must be submitted electronically using the Governmentwide Grants.gov Apply site at www.Grants.gov. Through this site, you will be able to download a copy of the application package, complete it offline, and then upload and submit your application. You may not email an electronic copy of a grant application to us.

    We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement and submit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section under Exception to Electronic Submission Requirement.

    You may access the electronic grant application for the Talent Search Program at www.Grants.gov. You must search for the downloadable application package for this program by the CFDA number. Do not include the CFDA number's alpha suffix in your search (e.g., search for 84.044, not 84.044A).

    Please note the following:

    • When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.

    • Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.

    • The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.

    • You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this program to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page at www.G5.gov.

    • You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.

    • You must submit all documents electronically, including all information you typically provide on the following forms: the Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.

    • You must upload any narrative sections and all other attachments to your application as files in a PDF (Portable Document) read-only, non-modifiable format. Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF or submit a password-protected file, we will not review that material.

    • Your electronic application must comply with any page-limit requirements described in this notice.

    • After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. (This notification indicates receipt by Grants.gov only, not receipt by the Department.) The Department then will retrieve your application from Grants.gov and send a second notification to you by email. This second notification indicates that the Department has received your application and has assigned your application a PR/Award number (an ED-specified identifying number unique to your application).

    • We may request that you provide us original signatures on forms at a later date.

    Application Deadline Date Extension in Case of Technical Issues with the Grants.gov System: If you are experiencing problems submitting your application through Grants.gov, please contact the Grants.gov Support Desk, toll free, at 1-800-518-4726. You must obtain a Grants.gov Support Desk Case Number and must keep a record of it.

    If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.

    If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under For Further Information Contact in section VII of this notice and provide an explanation of the technical problem you experienced with Grants.gov, along with the Grants.gov Support Desk Case Number. We will accept your application if we can confirm that a technical problem occurred with the Grants.gov system and that that problem affected your ability to submit your application by 4:30:00 p.m., Washington, DC time, on the application deadline date. The Department will contact you after a determination is made on whether your application will be accepted.

    Note:

    The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.

    Exception to Electronic Submission Requirement: You qualify for an exception to the electronic submission requirement, and may submit your application in paper format, if you are unable to submit an application through the Grants.gov system because—

    • You do not have access to the Internet; or

    • You do not have the capacity to upload large documents to the Grants.gov system;

    and

    • No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.

    If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.

    Address and mail or fax your statement to: James Davis, U.S. Department of Education, 1990 K Street NW., Room 7007, Washington, DC 20006-8510. FAX: (202) 502-7545.

    Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.

    b. Submission of Paper Applications by Mail.

    If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.044A) LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.

    You must show proof of mailing consisting of one of the following:

    (1) A legibly dated U.S. Postal Service postmark.

    (2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.

    (3) A dated shipping label, invoice, or receipt from a commercial carrier.

    (4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.

    If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:

    (1) A private metered postmark.

    (2) A mail receipt that is not dated by the U.S. Postal Service.

    If your application is postmarked after the application deadline date, we will not consider your application.

    Note:

    The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.

    c. Submission of Paper Applications by Hand Delivery.

    If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.044A), 550 12th Street SW., Room 7039, Potomac Center Plaza, Washington, DC 20202-4260.

    The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.

    Note for Mail or Hand Delivery of Paper Applications:

    If you mail or hand deliver your application to the Department—

    (1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and

    (2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.

    V. Application Review Information

    1. Selection Criteria: The selection criteria for this program competition are in 34 CFR 643.21 and listed in the application package.

    2. Review and Selection Process: We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

    In addition, in making a competitive grant award, the Secretary also requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4,1 08.8, and 110.23).

    For this competition, a panel of three non-Federal reviewers will review each application in accordance with the selection criteria, pursuant to 34 CFR 643.21. The individual scores assigned by the reviewers will be added and the sum divided by the number of reviewers to determine the peer reviewer score received in the review process. Additionally, in accordance with 34 CFR 643.22, the Secretary will award prior experience points to applicants that have conducted a Talent Search project during budget periods 2012-13, 2013-14, 2014-15, based on their documented experience. Prior experience points, if any, will be added to the application's averaged reader score to determine the total score for each application.

    3. Tie-breaker: If there are insufficient funds for all applications with the same total scores, the Secretary will choose among the tied applications so as to serve geographical areas that have been underserved by the Talent Search Program.

    4. Special Conditions: Under 2 CFR 3474.10, the Secretary may impose special conditions and, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

    VI. Award Administration Information

    1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN); or we may send you an email containing a link to access an electronic version of your GAN. We may notify you informally, also.

    If your application is not evaluated or not selected for funding, we notify you.

    2. Administrative and National Policy Requirements:

    We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section in this notice.

    We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

    3. Reporting: At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multi-year award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to www.ed.gov/fund/grant/apply/appforms/appforms.html.

    4. Performance Measures: The success of the Talent Search Program will be measured by secondary school persistence and graduation rates of Talent Search participants, as well as postsecondary enrollment and completion rates. All Talent Search Program grantees will be required to submit an annual performance report documenting secondary school persistence, secondary school graduation and postsecondary enrollment of their participants. Since students may take different amounts of time to complete their postsecondary education, multiple years of performance report data are needed to determine the postsecondary completion rates of Talent Search Program participants. The Department of Education will aggregate the data provided in the annual performance reports from all grantees to determine the accomplishment level.

    5. Continuation Awards: In making a continuation award under 34 CFR 75.253, the Secretary considers, among other things: whether a grantee has made substantial progress in achieving the goals and objectives of the project; whether the grantee has expended funds in a manner that is consistent with its approved application and budget; and, if the Secretary has established performance measurement requirements, the performance targets in the grantee's approved application. In making a continuation grant, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

    VII. Agency Contact FOR FURTHER INFORMATION CONTACT:

    Craig Pooler, U.S. Department of Education, 1990 K Street NW., Suite 7010, Washington, DC 20006-8510. Telephone: (202) 502-7600 or email: [email protected]

    If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.

    VIII. Other Information

    Accessible Format: Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact persons listed under For Further Information Contact in section VII if this notice.

    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 the 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.

    Delegation of Authority: The Secretary of Education has delegated authority to Jamienne S. Studley, Deputy Under Secretary, to perform the functions and duties of the Assistant Secretary for Postsecondary Education.

    Dated: December 16, 2015. Jamienne S. Studley, Deputy Under Secretary.
    [FR Doc. 2015-32089 Filed 12-21-15; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY [OE Docket No. EA-290-C] Application to Export Electric Energy; Ontario Power Generation, Inc. AGENCY:

    Office of Electricity Delivery and Energy Reliability, DOE.

    ACTION:

    Notice of Application.

    SUMMARY:

    Ontario Power Generation, Inc. (Applicant or OPG) has applied to renew its authority to transmit electric energy from the United States to Canada pursuant to section 202(e) of the Federal Power Act.

    DATES:

    Comments, protests, or motions to intervene must be submitted on or before January 21, 2016.

    ADDRESSES:

    Comments, protests, motions to intervene, or requests for more information should be addressed to: Office of Electricity Delivery and Energy Reliability, Mail Code: OE-20, U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585-0350. Because of delays in handling conventional mail, it is recommended that documents be transmitted by overnight mail, by electronic mail to [email protected], or by facsimile to 202-586-8008.

    SUPPLEMENTARY INFORMATION:

    Exports of electricity from the United States to a foreign country are regulated by the Department of Energy (DOE) pursuant to sections 301(b) and 402(f) of the Department of Energy Organization Act (42 U.S.C. 7151(b), 7172(f)) and require authorization under section 202(e) of the Federal Power Act (16 U.S.C. 824a(e)).

    On April 18, 2011, DOE issued Order No. EA-290-B to OPG, which authorized the Applicant to transmit electric energy from the United States to Canada as a power marketer for a five-year term using existing international transmission facilities. That authority expires on June 21, 2016. On December 7, 2015, OPG filed an application with DOE for renewal of the export authority contained in Order No. EA-290 for an additional five-year term.

    In its application, OPG states that it does not own or operate any electric generation or transmission facilities, and it does not have a franchised service area. The electric energy that OPG proposes to export to Canada would be surplus energy purchased from third parties such as electric utilities and Federal power marketing agencies pursuant to voluntary agreements. The existing international transmission facilities to be utilized by OPG have previously been authorized by Presidential permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.

    Procedural Matters: Any person desiring to be heard in this proceeding should file a comment or protest to the application at the address provided above. Protests should be filed in accordance with Rule 211 of the Federal Energy Regulatory Commission's (FERC) Rules of Practice and Procedures (18 CFR 385.211). Any person desiring to become a party to these proceedings should file a motion to intervene at the above address in accordance with FERC Rule 214 (18 CFR 385.214). Five copies of such comments, protests, or motions to intervene should be sent to the address provided above on or before the date listed above.

    Comments and other filings concerning OPG's application to export electric energy to Canada should be clearly marked with OE Docket No. EA-290-C. An additional copy is to be provided directly to both Andrew Barrett, Ontario Power Generation, Inc., 700 University Avenue, Toronto, Ontario M5G 1X6 Canada and Jerry L. Pfeffer, Skadden, Arps, Slate, Meagher & Flom LLP, 1440 New York Avenue NW., Washington, DC 20005.

    A final decision will be made on this application after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after a determination is made by DOE that the proposed action will not have an adverse impact on the sufficiency of supply or reliability of the U.S. electric power supply system.

    Copies of this application will be made available, upon request, for public inspection and copying at the address provided above, by accessing the program Web site at http://energy.gov/node/11845, or by emailing Angela Troy at [email protected]

    Issued in Washington, DC, on December 16, 2015. Christopher Lawrence, Electricity Policy Analyst, Office of Electricity Delivery and Energy Reliability.
    [FR Doc. 2015-32091 Filed 12-21-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Oak Ridge Reservation AGENCY:

    Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Oak Ridge Reservation. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

    DATES:

    Wednesday, January 13, 2016, 6:00 p.m.

    ADDRESSES:

    Department of Energy Information Center, Office of Science and Technical Information, 1 Science.gov Way, Oak Ridge, Tennessee 37830.

    FOR FURTHER INFORMATION CONTACT:

    Melyssa P. Noe, Federal Coordinator, Department of Energy Oak Ridge Operations Office, P.O. Box 2001, EM-90, Oak Ridge, TN 37831. Phone (865) 241-3315; Fax (865) 576-0956 or email: [email protected] or check the Web site at http://energy.gov/orem/services/community-engagement/oak-ridge-site-specific-advisory-board.

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

    Tentative Agenda:

    • Welcome and Announcements • Comments from the Deputy Designated Federal Officer • Comments from the DOE, Tennessee Department of Environment and Conservation, and Environmental Protection Agency Liaisons • Public Comment Period • Briefing on the Proposed Environmental Management Disposal Facility • Additions/Approval of Agenda • Motions/Approval of November 10, 2015 Meeting Minutes • Status of Recommendations with DOE • Committee Reports • Federal Coordinator Report • Adjourn

    Public Participation: The EM SSAB, Oak Ridge, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Melyssa P. Noe at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to the agenda item should contact Melyssa P. Noe at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

    Minutes: Minutes will be available by writing or calling Melyssa P. Noe at the address and phone number listed above. Minutes will also be available at the following Web site: http://energy.gov/orem/services/community-engagement/oak-ridge-site-specific-advisory-board.

    Issued at Washington, DC on December 16, 2015. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2015-32093 Filed 12-21-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Orders Granting Authority To Import and Export Natural Gas, To Import and Export Liquefied Natural Gas, To Export Compressed Natural Gas, and To Vacate Authority During October 2015 FE Docket Nos. PORTLAND GENERAL ELECTRIC COMPANY 15-135-NG CANADA IMPERIAL OIL LIMITED 15-138-NG CROWLEY PETROLEUM DISTRIBUTION, ALASKA LLC 15-133-LNG TIDAL ENERGY MARKETING, INC 15-137-NG PLANET ENERGY CORP 15-136-NG DTE ENERGY TRADING, INC 15-145-NG DIRECT ENERGY MARKETING LIMITED 15-146-NG GREENFIELD ENERGY CENTRE LP 15-148-NG MINNESOTA ENERGY RESOURCES CORPORATION 15-147-NG EXCELERATE LIQUEFACTION SOLUTIONS I, LLC 12-61-LNG 12-146-LNG EMERA CNG, LLC 13-157-CNG TRANSFUELS, LLC d/b/a BLU LNG 15-121-LNG GAS NATURAL CAXITLAN, S. DE. R.L. DE C.V 15-150-NG ENBRIDGE GAS DISTRIBUTION INC 15-152-NG MARITIMES NG SUPPLY LIMITED PARTNERSHIP 15-153-NG DIRECT ENERGY MARKETING, INC 15-151-NG ROCHESTER GAS AND ELECTRIC CORPORATION 15-157-NG VERMONT GAS SYSTEMS, INC 15-154-NG SARANAC POWER PARTNERS L.P 11-155-NG TENASKA MARKETING VENTURES 15-156-NG ENSERCO ENERGY LLC 14-15-NG CPD ALASKA LLC 15-133-LNG AGENCY:

    Office of Fossil Energy, Department of Energy (DOE).

    ACTION:

    Notice of orders.

    SUMMARY:

    The Office of Fossil Energy (FE) of the Department of Energy gives notice that during October 2015, it issued orders granting authority to import and export natural gas, to import and export liquefied natural gas (LNG), to export compressed natural gas (CNG), and to vacate authority. These orders are summarized in the attached appendix and may be found on the FE Web site at http://energy.gov/fe/downloads/listing-doefe-authorizationsorders-issued-2015. They are also available for inspection and copying in the Office of Fossil Energy, Office of Oil and Gas Global Security and Supply, Docket Room 3E-033, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-9478. The Docket Room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.

    Issued in Washington, DC, on December 16, 2015. John A. Anderson, Director, Office of Regulation and International Engagement, Office of Oil and Natural Gas. Appendix—DOE/FE Orders Granting Import/Export Authorizations 3718 15-135-NG 10/05/15 Portland General Electric Company Order granting blanket authority to import/export natural gas from/to Canada. 3719 15-138-NG 10/05/15 Canada Imperial Oil Order granting blanket authority to import/export natural gas from/to Canada. 3720 15-133-LNG 10/05/15 Crowley Petroleum Distribution, Alaska LLC Order granting blanket authority to import LNG from Canada by truck and in ISO Containers on Liner Cargo vessels and Ocean-going vessels. 3721 15-137-NG 10/05/15 Tidal Energy Marketing, Inc Order granting blanket authority to import/export natural gas from/to Canada. 3722 15-136-NG 10/05/15 Planet Energy Corp Order granting blanket authority to import/export natural gas from/to Canada and vacating prior authority. 3723 15-145-NG 10/08/15 DTE Energy Trading, Inc Order granting blanket authority to import/export natural gas from/to Canada. 3724 15-146-NG 10/08/15 Direct Energy Marketing Limited Order granting blanket authority to import natural gas from Canada. 3725 15-148-NG 10/08/15 Greenfield Energy Centre LP Order granting blanket authority to import/export natural gas from/to Canada. 3726 15-147-NG 10/09/15 Minnesota Energy Resources Corporation Order granting blanket authority to import/export natural gas from/to Canada and vacating prior authority. 3128-A 12-61-LNG
  • 12-146-LNG
  • 10/13/15 Excelerate Liquefaction Solutions I, LLC Order vacating long-term, Multi-contract authority to export LNG to Free Trade Agreement Nations, and Notice of Withdrawal of Application Requesting long-term, Multi-contract authority to export LNG to Non-free Trade Agreement Nations.
    3727 13-157-CNG 10/19/15 Emera CNG, LLC Final Opinion and Order granting long-term, Multi-contract authority to export compressed natural gas by vessel from a Proposed CNG Compression and Loading Facility at the Port of Palm Beach, Florida to Non-Free Trade Agreement Nations. 3728 15-121-LNG 10/14/15 Transfuels, LLC d/b/a BLU LNG Order granting blanket authority to export LNG by ISO Containers loaded on vessels to Free Trade Agreement Nations. 3729 15-150-NG 10/26/15 Gas Natural Caxitlan, S. de R.L. de C.V Order granting blanket authority to export natural gas to Mexico. 3730 15-152-NG 10/26/15 Enbridge Gas Distribution Inc Order granting blanket authority to import/export natural gas from/to Canada. 3731 15-153-NG 10/26/15 Maritimes NG Supply Limited Partnership Order granting blanket authority to import natural gas from Canada. 3732 15-151-NG 10/26/15 Direct Energy Marketing, Inc Order vacating blanket authority to import/export natural gas from/to Canada. 3733 15-157-NG 10/26/15 Rochester Gas and Electric Corporation Order granting blanket authority to import natural gas from Canada. 3734 15-154-NG 10/26/15 Vermont Gas Systems, Inc Order granting blanket authority to import natural gas from Canada. 3735 15-155-NG 10/26/15 Saranac Power Partners L.P Order granting blanket authority to import natural gas from Canada. 3736 15-156-NG 10/26/15 Tenaska Marketing Ventures Order granting blanket authority to import/export natural gas from/to Canada/Mexico. 3403-A 14-15-NG 10/26/15 Enserco Energy LLC Order vacating blanket authority to import/export natural gas from/to Canada and to export natural gas to Mexico. 3720-A 15-133-LNG 10/26/15 CPD Alaska LLC Order amending blanket authority to import LNG from Canada by truck, in ISO Containers on Liner Cargo vessels, and on Bulk Ocean-going vessels.
    [FR Doc. 2015-32160 Filed 12-21-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Northern New Mexico AGENCY:

    Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

    DATES:

    Wednesday, January 27, 2016, 1:00 p.m.-5:15 p.m.

    ADDRESSES:

    Ohkay Conference Center, Highway 68, Ohkay Owingeh, New Mexico 87566.

    FOR FURTHER INFORMATION CONTACT:

    Menice Santistevan, Northern New Mexico Citizens' Advisory Board (NNMCAB), 94 Cities of Gold Road, Santa Fe, NM 87506. Phone (505) 995-0393; Fax (505) 989-1752 or Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

    Tentative Agenda • Call to Order • Welcome and Introductions • Approval of Agenda and Meeting Minutes of November 12, 2015, and November 18, 2015 • Old Business • New Business • Update from Co-Deputy Designated Federal Officer(s) • Consideration and Action on Draft Recommendation 2016-01 • Presentation on EM Los Alamos Field Office Budget • Update on the Waste Isolation Pilot Plant • Update from NNMCAB Liaisons • Public Comment Period • Wrap-Up Comments from NNMCAB Members • Adjourn

    Public Participation: The EM SSAB, Northern New Mexico, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Menice Santistevan at least seven days in advance of the meeting at the telephone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Menice Santistevan at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

    Minutes: Minutes will be available by writing or calling Menice Santistevan at the address or phone number listed above. Minutes and other Board documents are on the Internet at: http://energy.gov/em/nnmcab/northern-new-mexico-citizens-advisory-board.

    Issued at Washington, DC, on December 16, 2015. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2015-32094 Filed 12-21-15; 8:45 am] BILLING CODE 6405-01-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Northern New Mexico AGENCY:

    Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a combined meeting of the Environmental Monitoring and Remediation Committee and Waste Management Committee of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico (known locally as the Northern New Mexico Citizens' Advisory Board [NNMCAB]). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

    DATES:

    Wednesday, January 13, 2016, 2:00 p.m.-4:00 p.m.

    ADDRESSES:

    NNMCAB Office, 94 Cities of Gold Road, Santa Fe, NM 87506.

    FOR FURTHER INFORMATION CONTACT:

    Menice Santistevan, Northern New Mexico Citizens' Advisory Board, 94 Cities of Gold Road, Santa Fe, NM 87506. Phone (505) 995-0393; Fax (505) 989-1752 or Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

    Purpose of the Environmental Monitoring and Remediation Committee (EM&R): The EM&R Committee provides a citizens' perspective to NNMCAB on current and future environmental remediation activities resulting from historical Los Alamos National Laboratory (LANL) operations and, in particular, issues pertaining to groundwater, surface water and work required under the New Mexico Environment Department Order on Consent. The EM&R Committee will keep abreast of DOE-EM and site programs and plans. The committee will work with the NNMCAB to provide assistance in determining priorities and the best use of limited funds and time. Formal recommendations will be proposed when needed and, after consideration and approval by the full NNMCAB, may be sent to DOE-EM for action.

    Purpose of the Waste Management (WM) Committee: The WM Committee reviews policies, practices and procedures, existing and proposed, so as to provide recommendations, advice, suggestions and opinions to the NNMCAB regarding waste management operations at the Los Alamos site.

    Tentative Agenda:

    • Call to Order and Introductions • Approval of Agenda • Approval of Minutes from October 14, 2015 • Old Business • New Business • Update from DOE • Presentation by DOE: Los Alamos Transuranic Waste Program Corrective Actions • Public Comment Period • Sub-Committee Breakout Session ○ Election of Fiscal Year 2016 (FY16) EM&R Vice Chair ○ Draft FY16 Committee Work Plans ○ General Committee Business • Adjourn

    Public Participation: The NNMCAB's Committees welcome the attendance of the public at their combined committee meeting and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Menice Santistevan at least seven days in advance of the meeting at the telephone number listed above. Written statements may be filed with the Committees either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Menice Santistevan at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

    Minutes: Minutes will be available by writing or calling Menice Santistevan at the address or phone number listed above. Minutes and other Board documents are on the Internet at: http://energy.gov/em/nnmcab/northern-new-mexico-citizens-advisory-board.

    Issued at Washington, DC, on December 16, 2015. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2015-32092 Filed 12-21-15; 8:45 am] BILLING CODE 6405-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP16-297-000.

    Applicants: Young Gas Storage Company, Ltd.

    Description: Section 4(d) rate filing per 154.204: Average Thermal Content Adjustment Filing—2015 to be effective 12/1/2015.

    Filed Date: 12/11/15.

    Accession Number: 20151211-5091.

    Comments Due: 5 p.m. ET 12/23/15.

    Docket Numbers: RP16-298-000.

    Applicants: Colorado Interstate Gas Company, L.L.C.

    Description: Section 4(d) rate filing per 154.204: Average Thermal Content Adjustment Filing—2015 to be effective 12/1/2015.

    Filed Date: 12/11/15.

    Accession Number: 20151211-5133.

    Comments Due: 5 p.m. ET 12/23/15.

    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: December 16, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-32124 Filed 12-21-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. IC16-1-000] Commission Information Collection Activities (FERC-725K); Comment Request AGENCY:

    Federal Energy Regulatory Commission.

    ACTION:

    Comment request.

    SUMMARY:

    In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory Commission (Commission or FERC) is submitting its information collection FERC-725K (Mandatory Reliability Standards for the SERC Region) to the Office of Management and Budget (OMB) for review of the information collection requirements. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below. The Commission previously issued a Notice in the Federal Register (80 FR 61812, 10/14/2015) requesting public comments. The Commission received no comments on the FERC-725K and is making this notation in its submittal to OMB.

    DATES:

    Comments on the collection of information are due by January 21, 2016.

    ADDRESSES:

    Comments filed with OMB, identified by the OMB Control No. 1902-0260, should be sent via email to the Office of Information and Regulatory Affairs: [email protected] Attention: Federal Energy Regulatory Commission Desk Officer. The Desk Officer may also be reached via telephone at 202-395-4718.

    A copy of the comments should also be sent to the Commission, in Docket No. IC16-1-000, by either of the following methods:

    eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.

    Mail/Hand Delivery/Courier: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street NE., Washington, DC 20426.

    Instructions: All submissions must be formatted and filed in accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support by email at [email protected], or by phone at: (866) 208-3676 (toll-free), or (202) 502-8659 for TTY.

    Docket: Users interested in receiving automatic notification of activity in this docket or in viewing/downloading comments and issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

    FOR FURTHER INFORMATION CONTACT:

    Ellen Brown may be reached by email at [email protected], by telephone at (202) 502-8663, and by fax at (202) 273-0873.

    SUPPLEMENTARY INFORMATION:

    Title: Mandatory Reliability Standards for the SERC Region.

    OMB Control No.: 1902-0260.

    Type of Request: Three-year extension of the FERC-725K information collection requirements with no changes to the reporting requirements.

    Abstract: Section 215 of the Federal Power Act (FPA) requires a Commission-certified Electric Reliability Organization (ERO) to develop mandatory and enforceable Reliability Standards, which are subject to Commission review and approval. Once approved, the Reliability Standards may be enforced by NERC, subject to Commission oversight, or by the Commission independently.

    Reliability Standards that NERC proposes to the Commission may include Reliability Standards that are proposed by a Regional Entity to be effective in that region. In Order No. 672, the Commission noted that:

    As a general matter, we will accept the following two types of regional differences, provided they are otherwise just, reasonable, not unduly discriminatory or preferential and in the public interest, as required under the statute: (1) A regional difference that is more stringent than the continent-wide Reliability Standard, including a regional difference that addresses matters that the continent-wide Reliability Standard does not; and (2) a regional Reliability Standard that is necessitated by a physical difference in the Bulk-Power System.

    When NERC reviews a regional Reliability Standard that would be applicable on an interconnection-wide basis and that has been proposed by a Regional Entity organized on an interconnection-wide basis, NERC must rebuttably presume that the regional Reliability Standard is just, reasonable, not unduly discriminatory or preferential, and in the public interest. In turn, the Commission must give “due weight” to the technical expertise of NERC and of a Regional Entity organized on an interconnection-wide basis.

    On April 19, 2007, the Commission accepted delegation agreements between NERC and each of the eight Regional Entities. In the order, the Commission accepted SERC as a Regional Entity organized on less than an interconnection-wide basis. As a Regional Entity, SERC oversees Bulk-Power System reliability within the SERC Region, which covers a geographic area of approximately 560,000 square miles in a sixteen-state area in the southeastern and central United States (all of Missouri, Alabama, Tennessee, North Carolina, South Carolina, Georgia, Mississippi, and portions of Iowa, Illinois, Kentucky, Virginia, Oklahoma, Arkansas, Louisiana, Texas and Florida). The SERC Region is currently geographically divided into five subregions that are identified as Southeastern, Central, VACAR, Delta, and Gateway.

    Type of Respondents: Entities registered with the North American Electric Reliability Corporation (within the SERC region).

    Estimate of Annual Burden:1 The Commission estimates the annual public reporting burden for the information collection as:

    1 The Commission defines burden as the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For further explanation of what is included in the information collection burden, reference 5 Code of Federal Regulations 1320.3.

    2 The $66.45 hourly cost figure (including benefits) comes from the cost of an engineer as posted on the Bureau of Labor Statistics (BLS) Web site: http://www.bls.gov/oes/current/naics2_22.htm#11-0000 (wage category 17-2071).

    3 Both figures for PC respondents are not to be totaled. They represent the same set of respondents.

    4 The $66.45 hourly cost figure (including benefits) comes from the cost of an engineer as posted on the Bureau of Labor Statistics (BLS) Web site: http://www.bls.gov/oes/current/naics2_22.htm#11-0000 (wage category 17-2071).

    5 Both figures for GO respondents are not to be totaled. They represent the same set of respondents.

    6 The hourly cost for GOs uses the hourly reporting cost of $66.45 per hour is based on the cost (including benefits) of an engineer to implement the requirements of the rule.

    7 The record retention cost of $37.50 per hour (including benefits) comes from Commission staff research on record retention requirements (wage category 43-4199 for information and record clerks).

    FERC-725K—Mandatory Reliability Standard for the SERC Region Number of
  • respondents
  • Annual
  • number of
  • responses per
  • respondent
  • Total number of responses Average
  • burden and cost per
  • response 2
  • Total annual burden hours and total
  • annual cost
  • Cost per
  • respondent
  • ($)
  • (1) (2) (1) * (2) = (3) (4) (3) * (4) = (5) (5) ÷ (1) PCs: Design and Document Automatic UFLS Program 3 21 1 21 8
  • $532
  • 168
  • 4 $11,172
  • $532
    PCs: Provide Documentation and Data to SERC 3 21 1 21 16
  • $1,064
  • 336
  • $22,344
  • 1,064
    GOs: Provide Documentation and Data to SERC 5 104 1 104 16
  • $1,064
  • 6 1,664
  • $110,656
  • 1,064
    GOs: Record Retention 5 104 1 104 4
  • $150
  • 416
  • 7 $15,600
  • 150
    Total 125 2,584
  • $159,772
  • 2,810

    Comments: Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

    Dated: December 16, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-32128 Filed 12-21-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RP15-1022-000] Alliance Pipeline, L.P.; Notice of Informal Settlement Conference

    Take notice that an informal settlement conference will be convened in this proceeding commencing at 10:00 a.m. (EST) on December 21, 2015, at the offices of the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, for the purpose of exploring the possible settlement of the above-referenced docket.

    Any party, as defined by 18 CFR 385.102(c), or any participant as defined by 18 CFR 385.102(b), is invited to attend. Persons wishing to become a party must move to intervene and receive intervenor status pursuant to the Commission's regulations (18 CFR 385.214).

    FERC conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations please send an email to [email protected] or call toll free 1-866-208-3372 (voice) or 202-502-8659 (TTY), or send a FAX to 202-208-2106 with the required accommodations.

    For additional information, please contact Ken Ende, [email protected], at 202-502-6762 or Sharli Silva, [email protected], at 202-502-8719 or Kelsey Bagot at (202) 502-8121, [email protected]

    Dated: December 16, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-32132 Filed 12-21-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP15-525-000] UGI Sunbury, LLC; Revised Notice of Schedule for Environmental Review of the Sunbury Pipeline Project

    This notice identifies the Federal Energy Regulatory Commission (Commission or FERC) staff's revised schedule for the completion of the environmental assessment (EA) for UGI Sunbury LLC's Sunbury Pipeline Project. The previous notice of schedule, issued on November 9, 2015, identified January 7, 2016 as the EA issuance date.

    Schedule for Environmental Review Issuance of EA—December 28, 2015 90-day Federal Authorization Decision Deadline—March 27, 2016

    If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the project's progress.

    Additional Information

    In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: December 16, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-32126 Filed 12-21-15; 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: ER15-2056-001.

    Applicants: Upper Peninsula Power Company.

    Description: Compliance filing: Amendment to Triennial Market Based Rate to be effective 8/28/2015.

    Filed Date: 12/16/15.

    Accession Number: 20151216-5101.

    Comments Due: 5 p.m. ET 1/6/16.

    Docket Numbers: ER16-539-000.

    Applicants: Southwest Power Pool, Inc.

    Description: Section 205(d) Rate Filing: Membership Agreement Amendments for Central Power and Mountrail-Williams to be effective 2/14/2016.

    Filed Date: 12/16/15.

    Accession Number: 20151216-5170.

    Comments Due: 5 p.m. ET 1/6/16.

    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: December 16, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-32123 Filed 12-21-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP16-28-000] National Fuel Gas Supply Corporation; Notice of Application

    Take notice that on December 3, 2015, National Fuel Gas Supply Corporation (National Fuel), 6363 Main Street, Williamsville, New York 14221, filed in the above referenced docket an application pursuant to sections 7(b) and 7(c) of the Natural Gas Act (NGA), and Part 157 of the Commission's regulations requesting authorization for the construction and operation of new Line QP and permission to abandon the Queen Storage Field, including the base gas in the field, the Queen Compressor Station, and a segment of Line Q, all located in Forest and Warren Counties, Pennsylvania, as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site athttp://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at [email protected] or call toll-free, (886) 208-3676 or TYY, (202) 502-8659.

    Any questions concerning this application may be directed to David W. Reitz, Deputy General Counsel for National Fuel, 6363 Main Street, Williamsville, New York 14221; by calling (716) 857-7949; by faxing (716) 857-7206; or by emailing [email protected]

    Specifically, National Fuel proposes to abandon by sale all of the facilities comprising its Queen Storage Field, including an approximately 5.5 mile segment of its Line Q. These facilities are proposed to be sold to EmKey Gathering LLC which plans to operate them as part of its non-jurisdictional gathering facilities. In order to maintain service to existing utility customers, National Fuel seeks authorization to construct and operate approximately 5 miles of new 4-inch diameter plastic pipe traversing along or adjacent to the existing Line Q right-of-way.

    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.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit seven copies of filings made in the proceeding with the Commission and must mail a copy to the applicant and to every other party. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    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 commentors 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 commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors 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 7 copies of the protest or intervention to the Federal Energy regulatory Commission, 888 First Street NE., Washington, DC 20426.

    Comment Date: 5:00 p.m. Eastern Time on January 6, 2016.

    Dated: December 16, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-32127 Filed 12-21-15; 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 rate filings:

    Docket Numbers: ER10-1790-013; ER10-2595-003; ER12-1400-004; ER10-276-004.

    Applicants: BP Energy Company, Flat Ridge Wind Energy, LLC, Flat Ridge 2 Wind Energy LLC, Rolling Thunder I Power Partners, LLC.

    Description: Updated Market Power Analysis for Southwest Power Pool Region of BP Energy Company, et al. under ER10-1790, et al.

    Filed Date: 12/15/15.

    Accession Number: 20151215-5242.

    Comments Due: 5 p.m. ET 2/12/16.

    Docket Numbers: ER15-1345-003.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Compliance filing: 2015-12-15_SMEPA Compliance 2nd Amendment to be effective 6/1/2015.

    Filed Date: 12/16/15.

    Accession Number: 20151216-5043.

    Comments Due: 5 p.m. ET 1/6/16.

    Docket Numbers: ER15-2019-001

    Applicants: Wisconsin Electric Power Company.

    Description: Market-Based Triennial Review Filing: Wisconsin Electric Amended Triennial MBR Filing in ER15-2019-001 to be effective 8/25/2015.

    Filed Date: 12/15/15.

    Accession Number: 20151215-5230.

    Comments Due: 5 p.m. ET 1/5/16.

    Docket Numbers: ER16-534-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Section 205(d) Rate Filing: 2015-12-15_Coordinated Transaction Scheduling Filing to be effective 3/1/2017.

    Filed Date: 12/15/15.

    Accession Number: 20151215-5234.

    Comments Due: 5 p.m. ET 1/5/16.

    Docket Numbers: ER16-535-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Section 205(d) Rate Filing: PJM Revisions to OATT, OA and MISO-PJM JOA re Coordinated Transaction Scheduling to be effective 3/1/2017.

    Filed Date: 12/15/15.

    Accession Number: 20151215-5236.

    Comments Due: 5 p.m. ET 1/5/16.

    Docket Numbers: ER16-536-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Section 205(d) Rate Filing: PJM Revisions to OATT, OA and MISO-PJM JOA re Coordinated Transaction Scheduling to be effective 3/1/2017.

    Filed Date: 12/15/15.

    Accession Number: 20151215-5237.

    Comments Due: 5 p.m. ET 1/5/16.

    Docket Numbers: ER16-537-000.

    Applicants: Wisconsin Electric Power Company.

    Description: Tariff Cancellation: Wisconsin Electric Cancellation of Pending Tariff Record in ER15-2019-000 to be effective 8/25/2015.

    Filed Date: 12/15/15.

    Accession Number: 20151215-5238.

    Comments Due: 5 p.m. ET 1/5/16.

    Docket Numbers: ER16-538-000.

    Applicants: ISO New England Inc., New England Power Pool Participants Committee.

    Description: Section 205(d) Rate Filing: Removal of Requirement to Publish De-List Bid Pricing Information to be effective 2/14/2016.

    Filed Date: 12/16/15.

    Accession Number: 20151216-5028.

    Comments Due: 5 p.m. ET 1/6/16.

    Take notice that the Commission received the following qualifying facility filings:

    Docket Numbers: QF16-245-000.

    Applicants: Graphic Packaging International Inc.

    Description: Form 556 of Graphic Packaging International Inc. [West Monroe].

    Filed Date: 12/15/15.

    Accession Number: 20151215-5240.

    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: December 16, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-32122 Filed 12-21-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP15-144-000] Florida Gas Transmission Company, LLC; Notice of Revised Schedule for Environmental Review of the Jacksonville Expansion Project

    This notice identifies the Federal Energy Regulatory Commission staff's revised schedule for the completion of the environmental assessment (EA) for the Florida Gas Transmission Company, LLC's Jacksonville Expansion Project. The first notice of schedule, issued on November 12, 2015, identified December 18, 2015 as the EA issuance date. However, staff has revised the schedule for issuance of the EA.

    Schedule for Environmental Review Issuance of EA: January 15, 2016 90-day Federal Authorization Decision Deadline: April 14, 2016

    If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.

    Additional Information

    In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription www.ferc.gov/docs-filing/esubscription.asp.

    Dated: December 16, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-32125 Filed 12-21-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14737-000] Energy Resources USA Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications

    On November 26, 2015, Energy Resources USA Inc., filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of a hydropower project to be located at the U.S. Army Corps of Engineers' (Corps) Tom Bevill Lock and Dam on the Tombigbee River near the town of Aliceville in Pickens County, Alabama. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.

    The proposed project would consist of the following: (1) A 770-foot-long, 300-foot-wide intake channel with a 85-foot-long retaining wall; (2) a 131-foot-long, 82-foot-wide powerhouse containing four generating units with a total capacity of 15.5 megawatts; (3) a 1000-foot-long, 220-foot-wide tailrace with a 40-foot-long retaining wall; (4) a 4.16/69 kilo-Volt (kV) substation; and (5) a 3-mile-long, 69 kV transmission line. The proposed project would have an estimated average annual generation of 84,440 megawatt-hours, and operate as directed by the Corps.

    Applicant Contact: Mr. Ander Gonzalez, Energy Resources USA Inc., 2655 Le Jeune Road, Suite 804, Coral Gables, Florida 33134; Phone: (954) 248-8425; Email: [email protected]

    FERC Contact: Christiane Casey, [email protected], (202) 502-8577.

    Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.

    The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-14737-000.

    More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-14737) in the docket number field to access the document. For assistance, contact FERC Online Support.

    Dated: December 16, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.