Federal Register Vol. 80, No.120,

Federal Register Volume 80, Issue 120 (June 23, 2015)

Page Range35829-36230
FR Document

80_FR_120
Current View
Page and SubjectPDF
80 FR 35953 - Sunshine Act MeetingsPDF
80 FR 35960 - Announcement of Revision to the Department of Health and Human Services Guidance on Procedures for the Provision of Marijuana for Medical Research as Published on May 21, 1999.PDF
80 FR 35996 - Browns Ferry Nuclear Plant, Units 1, 2, and 3PDF
80 FR 35973 - Notice of Availability of a Record of Decision for the White-Tailed Deer Management Plan, Environmental Impact Statement, Cuyahoga Valley National Park, OhioPDF
80 FR 35829 - List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM UMAX Canister Storage System, Certificate of Compliance No. 1040, Amendment No. 1PDF
80 FR 35935 - Foreign-Trade Zone 245-Decatur, Illinois; Authorization of Production Activity; Thyssenkrupp Presta Danville, LLC (Camshafts); Danville, IllinoisPDF
80 FR 35872 - List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM UMAX Canister Storage System, Certificate of Compliance No. 1040, Amendment No. 1PDF
80 FR 35992 - Entergy Nuclear Operations, Inc.; Vermont Yankee Nuclear Power StationPDF
80 FR 35936 - Certain Pasta from Italy: Notice of Preliminary Results of Antidumping Duty Changed Circumstances ReviewPDF
80 FR 35935 - Certain Frozen Warmwater Shrimp From the People's Republic of China: Rescission of Antidumping Duty Administrative Review; 2014-2015PDF
80 FR 35950 - Proposed Information Collection Request; Comment Request; Regulation of Fuels and Fuel Additives: RFS Pathways II, and Technical Amendments to the RFS Standards and E15 Misfueling Mitigation RequirementsPDF
80 FR 35951 - Proposed Consent Decree, Clean Air Act Citizen SuitPDF
80 FR 36040 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel VELA ANDATO; Invitation for Public CommentsPDF
80 FR 36014 - Sunshine Act MeetingPDF
80 FR 35870 - Linear No-Threshold Model and Standards for Protection Against RadiationPDF
80 FR 36041 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel PARADIGM SHIFT; Invitation for Public CommentsPDF
80 FR 36041 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel FORCE; Invitation for Public CommentsPDF
80 FR 36035 - Renewal of the Regional Energy Resource Council CharterPDF
80 FR 36042 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel SIREN; Invitation for Public CommentsPDF
80 FR 36038 - Supplemental Environmental Impact Statement, City of Newport News and City of Hampton to the City of Norfolk, City of Portsmouth, City of Suffolk, and City of Chesapeake, VirginiaPDF
80 FR 35972 - Notice of Availability of a Record of Decision on the Final General Management Plan/Environmental Impact Statement, Ozark National Scenic Riverway, MissouriPDF
80 FR 35953 - Proposed Agency Information Collection Activities; Comment RequestPDF
80 FR 35847 - Safety Zones; Fireworks Events in Captain of the Port New York ZonePDF
80 FR 35844 - Safety Zone; Black River Kayak-a-thon; Black River, Lorain, OHPDF
80 FR 35843 - Regattas and Marine Parades; Great Lakes Annual Marine EventsPDF
80 FR 35892 - Special Local Regulations, Recurring Marine Events in Captain of the Port Long Island Sound ZonePDF
80 FR 36042 - Pipeline Safety: Potential for Damage to Pipeline Facilities Caused by the Passage of HurricanesPDF
80 FR 36044 - Homeless Providers Grant and Per Diem Program; Notice of Funding AvailabilityPDF
80 FR 35970 - Endangered Species; Recovery Permit ApplicationPDF
80 FR 36037 - Notice of Final Federal Agency Actions on Proposed Highways in ColoradoPDF
80 FR 35834 - Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling RequirementsPDF
80 FR 35995 - Information Collection; Physical Protection of Category 1 and Category 2 Quantities of Radioactive MaterialPDF
80 FR 35990 - Information Collection: NRC Request for Sodium Iodide I-131 Treatment and Patient Release InformationPDF
80 FR 35991 - Information Collection: Environmental Protection Regulations for Domestic Licensing and Related Regulatory FunctionsPDF
80 FR 35977 - Information Collection; “Rules of General Applicability to Domestic Licensing of Byproduct Material”PDF
80 FR 35841 - Veterinary Feed Directive; CorrectionPDF
80 FR 35968 - Endangered and Threatened Wildlife and Plants; Receipt of Application for Incidental Take Permit Renewal; Availability of Low-Effect Habitat Conservation Plan and Associated Documents; Charlotte County, FLPDF
80 FR 35967 - Agency Information Collection Activities: Extension, With Change, of an Existing Information Collection; Comment RequestPDF
80 FR 36019 - Academy Funds Trust and Innovator Management LLC; Notice of ApplicationPDF
80 FR 35886 - Energy Efficiency Program for Consumer Products: Energy Conservation Standards for Fluorescent Lamp BallastsPDF
80 FR 36031 - Agency Information Collection Activities: Proposed Request and Comment RequestPDF
80 FR 36030 - Submission for OMB Review; Comment RequestPDF
80 FR 36013 - Submission for OMB Review; Comment RequestPDF
80 FR 35947 - Agency Information Collection Activities: Proposed Collection; Comment Request; Landowner Release for Poles Removed From BPA Transmission SystemPDF
80 FR 35874 - Energy Conservation Program: Test Procedures for Commercial Prerinse Spray ValvesPDF
80 FR 35952 - Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Task Force on Optimal Public Safety Answering Point ArchitecturePDF
80 FR 36039 - Agency Information Collection Activities; Notice of Request for Approval of a New Information CollectionPDF
80 FR 35948 - Agency Information Collection Activities: Proposed Collection; Comment Request; Badge Replacement Request FormPDF
80 FR 36036 - Agency Information Collection Activities; Request for Comments for a New Information CollectionPDF
80 FR 35973 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
80 FR 35941 - 36(b)(1) Arms Sales NotificationPDF
80 FR 35938 - Notice of Availability: Estimated Phthalate Exposure and Risk to Pregnant Women and Women of Reproductive Age as Assessed Using Four NHANES Biomonitoring Data Sets (2005/2006, 2007/2008, 2009/2010, 2011/2012)PDF
80 FR 36028 - Joint Industry Plan; Order Approving Amendment No. 1 to the National Market System Plan Governing the Process of Selecting a Plan Processor and Developing a Plan for the Consolidated Audit Trail by BATS Exchange, Inc., BATS-Y Exchange, Inc., BOX Options Exchange LLC, C2 Options Exchange, Incorporated, Chicago Board Options Exchange, Incorporated, Chicago Stock Exchange, Inc., EDGA Exchange, Inc., EDGX Exchange, Inc., Financial Industry Regulatory Authority, Inc., International Securities Exchange, LLC, ISE Gemini, LLC, Miami International Securities Exchange LLC, NASDAQ OMX BX, Inc., NASDAQ OMX PHLX LLC, The NASDAQ Stock Market LLC, National Stock Exchange, Inc., New York Stock Exchange LLC, NYSE MKT LLC, and NYSE Arca, Inc.PDF
80 FR 36006 - Joint Industry Plan; Notice of Filing of Amendment No. 2 to the National Market System Plan Governing the Process of Selecting a Plan Processor and Developing a Plan for the Consolidated Audit Trail by BATS Exchange, Inc., BATS-Y Exchange, Inc., BOX Options Exchange LLC, C2 Options Exchange, Incorporated, Chicago Board Options Exchange, Incorporated, Chicago Stock Exchange, Inc., EDGA Exchange, Inc., EDGX Exchange, Inc., Financial Industry Regulatory Authority, Inc., International Securities Exchange, LLC, ISE Gemini, LLC, Miami International Securities Exchange LLC, NASDAQ OMX BX, Inc., NASDAQ OMX PHLX LLC, The NASDAQ Stock Market LLC, National Stock Exchange, Inc., New York Stock Exchange LLC, NYSE MKT LLC, and NYSE Arca, Inc.PDF
80 FR 35934 - Tongass National Forest; Alaska; Forest Plan AmendmentPDF
80 FR 35898 - Periodic ReportingPDF
80 FR 35940 - Privacy Act of 1974; System of RecordsPDF
80 FR 35944 - 36(b)(1) Arms Sales NotificationPDF
80 FR 36044 - Quarterly Rail Cost Adjustment FactorPDF
80 FR 35953 - Notice to All Interested Parties of the Termination of the Receivership of 10406, Community Capital Bank, Jonesboro, GAPDF
80 FR 35946 - Agency Information Collection Activities; Comment Request; Income Based Repayment NotificationsPDF
80 FR 35976 - Agency Information Collection Activities: Comment RequestPDF
80 FR 35971 - Proposed Renewal of Information Collection: OMB Control Number 1090-0009, Donor Certification FormPDF
80 FR 36031 - Boathouse Capital II, L.P.; Notice Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of InterestPDF
80 FR 35888 - Regulatory Capital Rules: Regulatory Capital, Implementation of Tier 1/Tier 2 FrameworkPDF
80 FR 35939 - Notice of Availability of Real Property for Public Health Purposes, Including Research, at the Former Walter Reed Army Medical CenterPDF
80 FR 35851 - Suspension of Community EligibilityPDF
80 FR 35966 - Texas; Amendment No. 1 to Notice of a Major Disaster DeclarationPDF
80 FR 35938 - Agency Information Collection Activities Under OMB ReviewPDF
80 FR 35967 - Oklahoma; Amendment No. 5 to Notice of a Major Disaster DeclarationPDF
80 FR 36015 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Disapproving Proposed Rule Change To Remove the Exchange's Quote Mitigation Plan as Provided in Commentary .03 to Exchange Rule 6.86PDF
80 FR 36024 - Self-Regulatory Organizations; NYSEMKT LLC.; Order Disapproving Proposed Rule Change To Remove the Exchange's Quote Mitigation Plan as Provided in Exchange Rule 970.1NYPDF
80 FR 35997 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing of Proposed Rule Change to Rule 1080.07PDF
80 FR 36021 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fees SchedulePDF
80 FR 36008 - American Funds Insurance Series, et al.; Notice of ApplicationPDF
80 FR 35932 - Request for Information: SNAP and WIC Seeking Input Regarding Procurement and Implementation of Electronic Benefit Transfer (EBT) ServicesPDF
80 FR 35964 - Prospective Grant of Start-up Exclusive Evaluation Option License: A Novel HIV-1 Entry InhibitorPDF
80 FR 35975 - Office of Presidential Libraries; Disposal of Presidential RecordsPDF
80 FR 35975 - Importer of Controlled Substances Application: Wildlife Laboratories, Inc.PDF
80 FR 35974 - Importer of Controlled Substances Application: Midas Pharmaceuticals, Inc.PDF
80 FR 35969 - Proposed Information Collection; National Wildlife Refuge Visitor Check-In Permit and Use ReportPDF
80 FR 35842 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation; RepublicationPDF
80 FR 35959 - Determination That ABILIFY (Aripiprazole) Solution Was Not Withdrawn From Sale for Reasons of Safety or EffectivenessPDF
80 FR 35956 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational UsesPDF
80 FR 35957 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug Experience Reporting and Recordkeeping Biological ProductsPDF
80 FR 35890 - Proposed Amendment of Class E Airspace; Tracy, CAPDF
80 FR 35833 - Establishment of Class E Airspace; Cloverdale, CAPDF
80 FR 35964 - National Cancer Institute; Notice of Closed MeetingsPDF
80 FR 35963 - National Institute on Aging; Notice of Closed MeetingPDF
80 FR 35965 - Center for Scientific Review; Notice of Closed Meetings.PDF
80 FR 35962 - Center for Scientific Review; Notice of Closed MeetingPDF
80 FR 35964 - National Institute of Neurological Disorders and Stroke; Notice of Closed MeetingsPDF
80 FR 35961 - National Institute of Environmental Health Sciences; Notice of Closed MeetingsPDF
80 FR 35966 - National Center For Complementary & Integrative Health; Notice of Closed MeetingPDF
80 FR 35961 - National Center For Complementary & Integrative Health; Notice of Closed MeetingPDF
80 FR 35962 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings.PDF
80 FR 35961 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed MeetingPDF
80 FR 35962 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed MeetingPDF
80 FR 35965 - National Library of Medicine; Notice of Closed MeetingPDF
80 FR 35963 - Center For Scientific Review; Notice of Closed MeetingsPDF
80 FR 35916 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to List Leona's Little Blue Butterfly as Endangered or ThreatenedPDF
80 FR 35950 - Bynum Hydro Company, PK Ventures I Limited Partnership; Notice of Application for Transfer of License and Soliciting Comments, Motions to Intervene, and ProtestsPDF
80 FR 35948 - NORCO Pipe Line Company, LLC; Notice of Petition for Declaratory OrderPDF
80 FR 35949 - Combined Notice of Filings #1PDF
80 FR 35889 - Proposed Amendment of Class E Airspace; Douglas, WYPDF
80 FR 35943 - Office of the SecretaryPDF
80 FR 35847 - Military Resale (MR) Commodities; CorrectionPDF
80 FR 35959 - Centers for Disease Control and Prevention (CDC)/Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis and Sexually Transmitted Diseases (STD) Prevention and Treatment; Notice of MeetingPDF
80 FR 35968 - Agency Information Collection Activities: Extension, With Changes, of an Existing Information Collection; Comment RequestPDF
80 FR 35858 - Hybrid III 10-Year-Old Child Test Dummy; Corrections; Incorporation by ReferencePDF
80 FR 35978 - Biweekly Notice Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards ConsiderationsPDF
80 FR 36035 - Policy for Discontinuance of World Aeronautical Chart SeriesPDF
80 FR 35854 - Carriage of Digital Television Broadcast SignalsPDF
80 FR 35899 - Medical Examination of Aliens-Revisions to Medical Screening ProcessPDF
80 FR 35860 - Endangered and Threatened Wildlife and Plants; Technical Corrections for 54 Wildlife and Plant Species on the List of Endangered and Threatened Wildlife and PlantsPDF
80 FR 35848 - National Vaccine Injury Compensation Program: Addition of Intussusception as Injury for Rotavirus Vaccines to the Vaccine Injury TablePDF
80 FR 36164 - Shared Commercial Operations in the 3550-3650 MHz BandPDF
80 FR 36112 - Bus Testing: Establishment of Performance Standards, a Bus Model Scoring System, a Pass/Fail Standard and other Program UpdatesPDF
80 FR 36050 - Federal Motor Vehicle Safety Standards; Electronic Stability Control Systems for Heavy VehiclesPDF

Issue

80 120 Tuesday, June 23, 2015 Contents Agriculture Agriculture Department See

Food and Nutrition Service

See

Forest Service

Army Army Department NOTICES Real Property for Public Health Purposes, Including Research; the Former Walter Reed Army Medical Center, 35939-35940 2015-15347 Bonneville Bonneville Power Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Badge Replacement Request Form, 35948 2015-15370 Landowner Release for Poles Removed from BPA Transmission System, 35947-35948 2015-15377 Coast Guard Coast Guard RULES Regattas and Marine Parades: Great Lakes Annual Marine Events, 35843-35844 2015-15408 Safety Zones: Black River Kayak-a-thon; Black River, Lorain, OH, 35844-35846 2015-15409 Fireworks Events in Captain of the Port New York Zone, 35847 2015-15410 PROPOSED RULES Special Local Regulations: Recurring Marine Events in Captain of the Port Long Island Sound Zone, 35892-35898 2015-15406 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled RULES Military Resale Commodities; Correction, 35847-35848 2015-15284 Commodity Futures Commodity Futures Trading Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35938 2015-15344 Consumer Product Consumer Product Safety Commission NOTICES Estimated Phthalate Exposure and Risk to Pregnant Women and Women of Reproductive Age as Assessed Using Four NHANES Biomonitoring Data Sets, 35938-35939 2015-15366 Defense Department Defense Department See

Army Department

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Independent Review Panel on Military Medical Construction Standards, 35943-35944 2015-15285 Arms Sales, 35941-35946 2015-15358 2015-15367 Privacy Act; Systems of Records, 35940-35941 2015-15360
Drug Drug Enforcement Administration NOTICES Importer of Controlled Substances Application: Midas Pharmaceuticals, Inc., Parsippany, NJ, 35974-35975 2015-15331 Wildlife Laboratories, Inc., Windsor, CO, 35975 2015-15332 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Income Based Repayment Notifications, 35946-35947 2015-15353 Energy Department Energy Department See

Bonneville Power Administration

See

Federal Energy Regulatory Commission

PROPOSED RULES Energy Conservation Programs: Test Procedures for Commercial Prerinse Spray Valves, 35874-35886 2015-15376 Energy Efficiency Programs for Consumer Products: Energy Conservation Standards for Fluorescent Lamp Ballasts, 35886-35888 2015-15383
Environmental Protection Environmental Protection Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Regulation of Fuels and Fuel Additives; RFS Pathways II, and Technical Amendments to the RFS Standards and E15 Misfueling Mitigation Requirements, 35950-35951 2015-15467 Proposed Consent Decree, Clean Air Act Citizen Suit, 35951-35952 2015-15460 Farm Credit Farm Credit Administration PROPOSED RULES Regulatory Capital, Implementation of Tier 1/Tier 2 Framework, 35888-35889 2015-15348 Federal Aviation Federal Aviation Administration RULES Establishment of Class E Airspace: Cloverdale, CA, 35833-35834 2015-15315 PROPOSED RULES Amendments of Class E Airspace: Douglas, WY, 35889-35890 2015-15287 Tracy, CA, 35890-35892 2015-15316 NOTICES Policy for Discontinuance of World Aeronautical Chart Series, 36035-36036 2015-15271 Federal Communications Federal Communications Commission RULES Carriage of Digital Television Broadcast Signals, 35854-35858 2015-15251 Shared Commercial Operations in the 3550-3650 MHz Band, 36164-36230 2015-14494 NOTICES Meetings: Task Force on Optimal Public Safety Answering Point Architecture, 35952-35953 2015-15373 Federal Deposit Federal Deposit Insurance Corporation NOTICES Terminations of Receivership: Community Capital Bank, Jonesboro, GA, 35953 2015-15354 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 2015-15445 35953 2015-15517 Federal Emergency Federal Emergency Management Agency RULES Suspension of Community Eligibility, 35851-35854 2015-15346 NOTICES Major Disaster Declarations: Oklahoma; Amendment No. 5, 35967 2015-15342 Texas; Amendments, 35966-35967 2015-15345 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Bynum Hydro Co.; PK Ventures I LP, 35950 2015-15291 Combined Filings, 35949-35950 2015-15289 Petitions for Declaratory Orders: NORCO Pipe Line Company, LLC, 35948-35949 2015-15290 Federal Highway Federal Highway Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36036-36037, 36039-36040 2015-15369 2015-15371 Environmental Impact Statements; Availability, etc.: Cities of Newport News and Hampton to the Cities of Norfolk, Portsmouth, Suffolk, and Chesapeake, VA, 36038-36039 2015-15419 Final Federal Agency Actions on Proposed Highways in Colorado, 36037 2015-15395 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35953-35956 2015-15412 Federal Transit Federal Transit Administration PROPOSED RULES Bus Testing: Establishment of Performance Standards, Bus Model Scoring System, Pass/Fail Standard and other Program Updates, 36112-36161 2015-14176 Fish Fish and Wildlife Service RULES Endangered and Threatened Wildlife and Plants: 54 Wildlife and Plant Species; Technical Corrections, 35860-35869 2015-15212 PROPOSED RULES Endangered and Threatened Wildlife and Plants: Leona's Little Blue Butterfly; 12-Month Finding on Petition to List, 35916-35931 2015-15296 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Wildlife Refuge Visitor Check-In Permit and Use Report, 35969-35970 2015-15329 Permit Applications: Endangered and Threatened Wildlife and Plants, 35968-35969 2015-15387 Endangered Species; Recovery Applications, 35970-35971 2015-15396 Food and Drug Food and Drug Administration RULES Infant Formula: Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements, 35834-35841 2015-15394 Medical Devices: Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation, 35842-35843 2015-15328 Veterinary Feed Directive; Corrections, 35841-35842 2015-15388 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: New Animal Drugs for Investigational Uses, 35956-35957 2015-15320 Postmarketing Adverse Drug Experience Reporting and Recordkeeping Biological Products, 35957-35958 2015-15319 Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness: ABILIFY (Aripiprazole), 35959 2015-15327 Food and Nutrition Food and Nutrition Service NOTICES Requests for Information: SNAP and WIC Seeking Input Regarding Procurement and Implementation of Electronic Benefit Transfer Services, 35932-35934 2015-15336 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activity Authorizations: Thyssenkrupp Presta Danville, LLC, Foreign-Trade Zone 245, Decatur, IL, 35935 2015-15475 Forest Forest Service NOTICES Environmental Impact Statements; Availability, etc.: Forest Plan Amendment, Tongass National Forest, AK; Corrections, 35934-35935 2015-15362 Health and Human Health and Human Services Department See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

RULES National Vaccine Injury Compensation Program: Addition of Intussusception as Injury for Rotavirus Vaccines to the Vaccine Injury Table, 35848-35851 2015-14771 PROPOSED RULES Medical Screening Process: Medical Examination of Aliens, 35899-35916 2015-15236 NOTICES Guidance for Industry and Staff: Department of Health and Human Services Guidance on Procedures for the Provision of Marijuana for Medical Research; Revision, 35960-35961 2015-15479
Health Resources Health Resources and Services Administration NOTICES Meetings: Centers for Disease Control and Prevention/Health Resources and Services Administration Advisory Committee on HIV, Viral Hepatitis and Sexually Transmitted Diseases Prevention and Treatment, 35959-35960 2015-15283 Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

See

U.S. Immigration and Customs Enforcement

Interior Interior Department See

Fish and Wildlife Service

See

National Park Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Donor Certification Form, 35971-35972 2015-15350
International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Frozen Warmwater Shrimp from the People's Republic of China, 35935-35936 2015-15468 Certain Pasta from Italy, 35936-35938 2015-15471 International Trade Com International Trade Commission NOTICES Complaints: Certain Resealable Packages with Slider Devices, 35973-35974 2015-15368 Justice Department Justice Department See

Drug Enforcement Administration

Maritime Maritime Administration NOTICES Requests for Administrative Waivers of the Coastwise Trade Laws: Vessel FORCE, 36041 2015-15437 Vessel PARADIGM SHIFT, 36041-36042 2015-15439 Vessel SIREN, 36042 2015-15420 Vessel VELA ANDATO, 36040-36041 2015-15457 National Archives National Archives and Records Administration NOTICES Office of Presidential Libraries; Disposal of Presidential Records, 35975-35976 2015-15333 National Highway National Highway Traffic Safety Administration RULES Federal Motor Vehicle Safety Standards: Electronic Stability Control Systems for Heavy Vehicles, 36050-36110 2015-14127 Hybrid III 10-Year-Old Child Test Dummy; Corrections, Incorporation by Reference, 35858-35860 2015-15279 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 2015-15298 2015-15307 35962-35963, 35965-35966 2015-15308 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 35961-35963 2015-15300 2015-15301 National Cancer Institute, 35964 2015-15310 National Center for Complementary and Integrative Health, 35961, 35966 2015-15303 2015-15304 National Heart, Lung, and Blood Institute, 35962 2015-15302 National Institute of Environmental Health Sciences, 35961-35962 2015-15305 National Institute of Neurological Disorders and Stroke, 35964 2015-15306 National Institute on Aging, 35963-35964 2015-15309 National Library of Medicine, 35965 2015-15299 Prospective Grant of Start-up Exclusive Evaluation Option License: A Novel HIV-1 Entry Inhibitor, 35964-35965 2015-15334 National Park National Park Service NOTICES Environmental Impact Statements; Availability, etc.: Ozark National Scenic Riverway, MO, 35972-35973 2015-15417 White-Tailed Deer Management Plan; Cuyahoga Valley National Park, Ohio, 35973 2015-15477 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 35976 2015-15352 Nuclear Regulatory Nuclear Regulatory Commission RULES List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM UMAX Canister Storage System, Certificate of Compliance No. 1040, Amendment No. 1, 35829-35833 2015-15476 PROPOSED RULES Linear No-threshold Model and Standards for Protection against Radiation, 35870-35872 2015-15441 List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM UMAX Canister Storage System, Certificate of Compliance No. 1040, Amendment No. 1, 35872-35874 2015-15474 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions, 35991-35992 2015-15390 NRC Request for Sodium Iodide I-131 Treatment and Patient Release Information, 35990-35991 2015-15391 Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material, 35995-35996 2015-15392 Rules of General Applicability to Domestic Licensing of Byproduct Material, 35977-35978 2015-15389 Applications: Browns Ferry Nuclear Plant, Units 1, 2, and 3, Tennessee Valley Authority; Withdrawal, 35996 2015-15478 Exemptions: Entergy Nuclear Operations, Inc., Vermont Yankee Nuclear Power Station, 35992-35995 2015-15473 Facility Operating Licenses: Applications and Amendments Involving Proposed No Significant Hazards Considerations, etc., 35978-35990 2015-15275 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Pipeline Safety: Potential for Damage to Pipeline Facilities Caused by the Passage of Hurricanes, 36042-36044 2015-15401 Postal Regulatory Postal Regulatory Commission PROPOSED RULES Periodic Reporting, 35898-35899 2015-15361 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36013-36014, 36030-36031 2015-15378 2015-15379 Applications: Academy Funds Trust and Innovator Management, LLC, 36019-36021 2015-15384 American Funds Insurance Series, et al., 36008-36013 2015-15337 Joint Industry Plans: BATS Exchange, Inc., BATS-Y Exchange, Inc., BOX Options Exchange, LLC, et al., 36006-36008, 36028-36030 2015-15364 2015-15365 Meetings; Sunshine Act, 36014-36015 2015-15449 Self-Regulatory Organizations; Proposed Rule Changes: Chicago Board Options Exchange, Inc., 36021-36024 2015-15338 NASDAQ OMX PHLX, LLC, 35997-36006 2015-15339 NYSE Arca, Inc., 36015-36019 2015-15341 NYSEMKT LLC, 36024-36028 2015-15340 Small Business Small Business Administration NOTICES Conflict of Interest Exemptions: Boathouse Capital II, LP, 36031 2015-15349 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36031-36035 2015-15380 Surface Transportation Surface Transportation Board NOTICES Quarterly Rail Cost Adjustment Factor, 36044 2015-15356 Tennessee Tennessee Valley Authority NOTICES Charter Renewals: Regional Energy Resource Council, 36035 2015-15422 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Transit Administration

See

Maritime Administration

See

National Highway Traffic Safety Administration

See

Pipeline and Hazardous Materials Safety Administration

See

Surface Transportation Board

Immigration U.S. Immigration and Customs Enforcement NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2015-15282 35967-35968 2015-15385 Veteran Affairs Veterans Affairs Department NOTICES Funding Availability: Homeless Providers Grant and Per Diem Program, 36044-36047 2015-15397 Separate Parts In This Issue Part II Transportation Department, National Highway Traffic Safety Administration, 36050-36110 2015-14127 Part III Transportation Department, Federal Transit Administration, 36112-36161 2015-14176 Part IV Federal Communications Commission, 36164-36230 2015-14494 Reader Aids

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

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80 120 Tuesday, June 23, 2015 Rules and Regulations NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2015-0067] RIN 3150-AJ58 List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM UMAX Canister Storage System, Certificate of Compliance No. 1040, Amendment No. 1 AGENCY:

Nuclear Regulatory Commission.

ACTION:

Direct final rule.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) is amending its spent fuel storage regulations by revising the Holtec International, Inc. (Holtec), HI-STORM (Holtec International Storage Module) Underground Maximum Capacity (UMAX) Canister Storage System listing within the “List of approved spent fuel storage casks” to add Amendment No. 1 to Certificate of Compliance (CoC) No. 1040. Amendment No. 1 provides a seismically enhanced version of the HI-STORM UMAX Canister Storage System, identified as the “Most Severe Earthquake (MSE)” version, that could be used in areas with higher seismic demands than those analyzed previously. Amendment No. 1 also includes minor physical design changes to help ensure structural integrity of the amended system. These are the addition of a hold-down system to the closure lid; replacing the fill material in the interstitial spaces between the cavity enclosure containers (CECs) surrounding the casks with 3000 psi concrete; strengthening the multi-purpose canister (MPC) guides; and engineering the guides' nominal gap with the MPC to be tighter than the original HI-STORM UMAX Canister Storage System design.

DATES:

The direct final rule is effective September 8, 2015, unless significant adverse comments are received by July 23, 2015. If the direct final rule is withdrawn as a result of such comments, timely notice of the withdrawal will be published in the Federal Register. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date. Comments received on this direct final rule will also be considered to be comments on a companion proposed rule published in the Proposed Rules section of this issue of the Federal Register.

ADDRESSES:

You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):

Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0067. Address questions about NRC dockets to Carol Gallagher, telephone: (301) 415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

Email comments to: [email protected] If you do not receive an automatic email reply confirming receipt, then contact us at (301) 415-1677.

Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at (301) 415-1101.

Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: (301) 415-1677.

For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

Solomon Sahle, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: (301) 415-3781; email: [email protected]

SUPPLEMENTARY INFORMATION:

Table of Contents: I. Obtaining Information and Submitting Comments. II. Procedural Background. III. Background. IV. Discussion of Changes. V. Voluntary Consensus Standards. VI. Agreement State Compatibility. VII. Plain Writing. VIII. Environmental Assessment and Finding of No Significant Environmental Impact. IX. Paperwork Reduction Act Statement. X. Regulatory Flexibility Certification. XI. Regulatory Analysis. XII. Backfitting and Issue Finality. XIII. Congressional Review Act. XIV. Availability of Documents. I. Obtaining Information and Submitting Comments A. Obtaining Information

Please refer to Docket ID NRC-2015-0067 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0067.

NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, (301) 415-4737, or by email to [email protected] For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

B. Submitting Comments

Please include Docket ID NRC-2015-0067 in the subject line of your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

II. Procedural Background

This rule is limited to the changes contained in Amendment No. 1 to CoC No. 1040 and does not include other aspects of the HI-STORM UMAX Canister Storage System. The NRC is using the “direct final rule” procedure to issue this amendment because it represents a limited and routine change to an existing CoC that is expected to be noncontroversial. The amendment to the rule will become effective on September 8, 2015. However, if the NRC receives significant adverse comments on this direct final rule by July 23, 2015, the NRC will publish a document that withdraws this action, and will subsequently address the comments received in a final rule as a response to the companion proposed rule published in the Proposed Rule section of this issue of the Federal Register. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action.

A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3) The comment causes the NRC staff to make a change (other than editorial) to the rule, CoC, or Technical Specifications (TSs).

For detailed instructions on submitting comments, please see the ADDRESSES section of this document.

III. Background

Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that “the Secretary [of the U.S. Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [U.S. Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[t]he Commission shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule which added a new subpart K in part 72 of Title 10 of the Code of Federal Regulations (10 CFR) entitled “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L within 10 CFR part 72 entitled, “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule on March 6, 2015 (80 FR 12073), as corrected on March 25, 2015 (80 FR 15679), that approved the HI-STORM UMAX Canister Storage System design and added it to the list of NRC-approved cask designs in 10 CFR 72.214 as CoC No. 1040.

IV. Discussion of Changes

By letter dated July 11, 2014, and as supplemented on October 31, 2014, Holtec submitted an application to the NRC to amend the HI-STORM UMAX Canister Storage System, CoC No. 1040, under subpart K of 10 CFR part 72. Amendment No. 1 to CoC No. 1040 provides a seismically enhanced version of the HI-STORM UMAX Canister Storage System, identified as the “Most Severe Earthquake (MSE)” version, that could be used in areas with higher seismic demands than those analyzed previously. Amendment No. 1 also includes minor physical design changes to help ensure structural integrity of the amended system. These are the addition of a hold-down system to the closure lid; replacing the fill material in the interstitial spaces between the CECs surrounding the casks with 3000 psi concrete; strengthening the MPC guides; and engineering the guides' nominal gap with the MPC to be tighter than the original HI-STORM UMAX Canister Storage System design.

As documented in the NRC staff's Safety Evaluation Report (SER) (ML15070A149), the NRC staff performed a detailed safety evaluation of the proposed CoC amendment request. This amendment does not reflect a significant change in design or fabrication of the HI-STROM UMAX Canister Storage System cask design previously approved by the NRC (see 80 FR 12073, as corrected 80 FR 15679). Considering the specific design requirements for accident conditions, the NRC staff determined that the design of the cask would continue to prevent loss of confinement, shielding, and criticality control.

This direct final rule revises the Holtec HI-STORM UMAX Canister Storage System listing in 10 CFR 72.214 by adding Amendment No. 1 to CoC No. 1040. The amendment consists of the changes previously described, as set forth in the revised CoC and TSs. The revised TSs are identified in the SER.

The amended Holtec HI-STORM UMAX Canister Storage System, when used under the conditions specified in the CoC, the TSs, and the NRC's regulations, will meet the requirements of 10 CFR part 72; therefore, adequate protection of public health and safety will continue to be ensured. When this direct final rule becomes effective, persons who hold a general license under 10 CFR 72.210 may load spent nuclear fuel into Holtec HI-STORM UMAX Canister Storage Systems that meet the criteria of Amendment No. 1 to CoC No. 1040 under 10 CFR 72.212.

V. Voluntary Consensus Standards

The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC will amend the Holtec HI-STORM UMAX Canister Storage System design listed in 10 CFR 72.214, “List of approved spent fuel storage casks.” This action does not constitute the establishment of a standard that contains generally applicable requirements.

VI. Agreement State Compatibility

Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” approved by the Commission on June 30, 1997, and published in the Federal Register on September 3, 1997 (62 FR 46517), this direct final rule is classified as Compatibility Category “NRC.” Compatibility is not required for Category “NRC” regulations. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the Atomic Energy Act of 1954, as amended, or the provisions of 10 CFR. Although an Agreement State may not adopt program elements reserved to the NRC, it may wish to inform its licensees of certain requirements via a mechanism that is consistent with the particular State's administrative procedure laws, but does not confer regulatory authority on the State.

VII. Plain Writing

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883).

VIII. Environmental Assessment and Finding of No Significant Environmental Impact A. The Action

The action is to amend 10 CFR 72.214 to amend the Holtec HI-STORM UMAX Canister Storage System listing within the “List of approved spent fuel storage casks” to include Amendment No. 1 to CoC No. 1040. Under the National Environmental Policy Act of 1969, as amended, and the NRC's regulations in subpart A of 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” the NRC has determined that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. The NRC has made a finding of no significant impact on the basis of this environmental assessment.

B. The Need for the Action

This direct final rule amends the CoC for the Holtec HI-STORM UMAX Canister Storage System design within the list of approved spent fuel storage casks that power reactor licensees can use to store spent fuel at reactor sites under a general license. Specifically, Amendment No. 1 to CoC No. 1040 provides a seismically enhanced version of the HI-STORM UMAX Canister Storage System, identified as the “Most Severe Earthquake (MSE)” version that could be used in areas with higher seismic demands than those analyzed previously. Amendment No. 1 also includes minor physical design changes to help ensure the structural integrity of the amended system. These are the addition of a hold-down system to the closure lid; replacing the fill material in the interstitial spaces between the CECs surrounding the casks with 3000 psi concrete; strengthening MPC guides; and engineering the guides' nominal gap with the MPC to be tighter than the original HI-STORM UMAX Canister Storage System.

C. Environmental Impacts of the Action

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent fuel under a general license in cask designs approved by the NRC. The potential environmental impact of using NRC-approved storage casks was initially analyzed in the environmental assessment for the 1990 final rule. The environmental assessment for this amendment tiers off of the environmental assessment for the July 18, 1990, final rule. Tiering on past environmental assessments is a standard process under the National Environmental Policy Act.

Holtec HI-STORM UMAX Canister Storage Systems are designed to mitigate the effects of design basis accidents that could occur during storage. Design basis accidents account for human-induced events and the most severe natural phenomena reported for the site and surrounding area. Postulated accidents analyzed for an Independent Spent Fuel Storage Installation, the type of facility at which a holder of a power reactor operating license would store spent fuel in casks in accordance with 10 CFR part 72, include tornado winds and tornado-generated missiles, a design basis earthquake, a design basis flood, an accidental cask drop, lightning effects, fire, explosions, and other incidents.

Considering the specific design requirements for accident conditions, the design of the storage system would prevent loss of containment, shielding, and criticality control. If there is no loss of containment, shielding, or criticality control, the environmental impacts would be insignificant. There are no significant changes to cask design requirements in the proposed CoC amendment. In addition, because there are no significant design or process changes, any resulting occupational exposure or offsite dose rates from the implementation of Amendment No.1 would remain well within the 10 CFR part 20 limits. Therefore, the proposed CoC amendment will not result in any radiological or non-radiological environmental impacts that significantly differ from the environmental impacts evaluated in the environmental assessment supporting the July 18, 1990, final rule. There will be no significant change in the types or significant revisions in the amounts of any effluent released, no significant increase in the individual or cumulative radiation exposure, and no significant increase in the potential for or consequences from radiological accidents. The NRC staff documented its safety findings in the SER for this amendment.

D. Alternative to the Action

The alternative to this action is to deny approval of Amendment No. 1 and terminate the direct final rule. Consequently, any 10 CFR part 72 general licensee that seeks to load spent nuclear fuel into Holtec HI-STORM UMAX Canister Storage Systems in accordance with the changes described in proposed Amendment No. 1 would have to request an exemption from the requirements of 10 CFR 72.212 and 72.214. Under this alternative, interested licensees would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee. Therefore, the environmental impacts of the alternative to the action would be the same or more than the impacts of the action.

E. Alternative Use of Resources

Approval of Amendment No.1 to CoC No. 1040 would result in no irreversible commitments of resources.

F. Agencies and Persons Contacted

No agencies or persons outside the NRC were contacted in connection with the preparation of this environmental assessment.

G. Finding of No Significant Impact

The environmental impacts of the action have been reviewed under the requirements in 10 CFR part 51. Based on the foregoing environmental assessment, the NRC concludes that this direct final rule entitled, “List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM UMAX Canister Storage System, Certificate of Compliance No. 1040, Amendment No. 1,” will not have a significant effect on the human environment. Therefore, the NRC has determined that an environmental impact statement is not necessary for this direct final rule.

IX. Paperwork Reduction Act Statement

This direct final rule does not contain any information collection requirements and, therefore, is not subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Public Protection Notification.

The NRC may not conduct or sponsor, and a person is not required to respond to a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

X. Regulatory Flexibility Certification

Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this rule will not, if issued, have a significant economic impact on a substantial number of small entities. This direct final rule affects only nuclear power plant licensees and Holtec. These entities do not fall within the scope of the definition of small entities set forth in the Regulatory Flexibility Act or the size standards established by the NRC (10 CFR 2.810).

XI. Regulatory Analysis

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent nuclear fuel under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store spent nuclear fuel if it notifies the NRC in advance, the spent fuel is stored under the conditions specified in the cask's CoC, and the conditions of the general license are met. A list of NRC-approved cask designs is contained in 10 CFR 72.214.

On March 6, 2015 (80 FR 12073), as corrected on March 25, 2015 (80 FR 15679), the NRC issued an amendment to 10 CFR part 72 that approved the Holtec HI-STORM UMAX Canister Storage System design by adding it to the list of NRC-approved cask designs in 10 CFR 72.214. On July 11, 2014, and as supplemented on October 31, 2014, Holtec submitted an application to amend the HI-STORM UMAX Canister Storage System as described in Section IV, “Discussion of Changes,” of this document.

The alternative to this action is to withhold approval of Amendment No.1 and to require any 10 CFR part 72 general licensees seeking to load spent nuclear fuel into the Holtec HI-STORM UMAX Canister Storage System under the changes described in Amendment No. 1 to request an exemption from the requirements of 10 CFR 72.212 and 72.214. Under this alternative, each interested 10 CFR part 72 licensee would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee.

Approval of this direct final rule is consistent with previous NRC actions. Further, as documented in the SER and the environmental assessment, the direct final rule will have no adverse effect on public health and safety or the environment. This direct final rule has no significant identifiable impact or benefit on other Government agencies. Based on this regulatory analysis, the NRC concludes that the requirements of the direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory, and therefore, this action is recommended.

XII. Backfitting and Issue Finality

The NRC has determined that the backfit rule (10 CFR 72.62) does not apply to this direct final rule. Therefore, a backfit analysis is not required. This direct final rule amends CoC No. 1040 for the Holtec HI-STORM UMAX Canister Storage System, as currently listed in 10 CFR 72.214, “List of approved spent fuel storage casks.” Amendment No. 1 provides a seismically enhanced version of the HI-STORM UMAX Canister Storage System, identified as the “Most Severe Earthquake (MSE)” version that could be used in areas with higher seismic demands than those analyzed previously. It also includes minor physical design changes to help ensure structural integrity of the amended system.

Amendment No. 1 of CoC No. 1040 for the Holtec HI-STORM UMAX Canister Storage System was initiated by Holtec and was not submitted in response to new NRC requirements, or an NRC request for amendment. Holtec, as the CoC holder, is not protected by the backfitting provisions under 10 CFR 72.62.

In addition, the changes in Amendment No. 1 do not apply to casks which were manufactured to the initial CoC 1040. Amendment No. 1 applies only to new casks fabricated and used under Amendment No. 1. Therefore, these changes do not affect existing users of the Holtec UMAX Canister Storage System. For these reasons, Amendment No. 1 to CoC No. 1040 does not constitute backfitting under 10 CFR 72.62, 10 CFR 50.109(a)(1), or otherwise represent an inconsistency with the issue finality provisions applicable to combined licenses in 10 CFR part 52. Accordingly, no backfit analysis or additional documentation addressing the issue finality criteria in 10 CFR part 52 has been prepared by the staff.

XIII. Congressional Review Act

This action is not a rule as defined in the Congressional Review Act (5 U.S.C. 801-808).

XIV. Availability of Documents

The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

Document ADAMS
  • Accession No./
  • Web link/
  • Federal Register
  • citation
  • Proposed CoC No. 1040, Amendment No. 1 ML15070A151 Appendix A of Proposed TSs ML15070A153 Appendix B of Proposed TS ML15070A152 Preliminary SER ML15070A149 Request for Amendment Application dated July 11, 2014 ML14202A029 Supplemental Information for Proposed Action, dated October 31, 2014 ML14308A164

    The NRC may post materials related to this document, including public comments, on the Federal Rulemaking Web site at http://www.regulations.gov under Docket ID NRC-2015-0067. The Federal Rulemaking Web site allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC-2015-0067); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

    List of Subjects in 10 CFR Part 72

    Administrative practice and procedure, Criminal penalties, Manpower training programs, Nuclear materials, Occupational safety and health, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Spent fuel, Whistleblowing.

    For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR part 72.

    PART 72—LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE 1. The authority citation for part 72 continues to read as follows: Authority:

    Atomic Energy Act secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2232, 2233, 2234, 2236, 2237, 2239, 2273, 2282, 2021); Energy Reorganization Act secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act sec. 102 (42 U.S.C. 4332); Nuclear Waste Policy Act secs. 131, 132, 133, 135, 137, 141, 148 (42 U.S.C. 10151, 10152, 10153, 10155, 10157, 10161, 10168); Government Paperwork Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. 109-58, 119 Stat. 788 (2005).

    Section 72.44(g) also issued under Nuclear Waste Policy Act secs. 142(b) and 148(c), (d) (42 U.S.C. 10162(b), 10168(c), (d)).

    Section 72.46 also issued under Atomic Energy Act sec. 189 (42 U.S.C. 2239); Nuclear Waste Policy Act sec. 134 (42 U.S.C. 10154).

    Section 72.96(d) also issued under Nuclear Waste Policy Act sec. 145(g) (42 U.S.C. 10165(g)).

    Subpart J also issued under Nuclear Waste Policy Act secs. 117(a), 141(h) (42 U.S.C. 10137(a), 10161(h)).

    Subpart K also issued under Nuclear Waste Policy Act sec. 218(a) (42 U.S.C. 10198).

    2. In § 72.214, Certificate of Compliance No. 1040 is revised to read as follows:
    § 72.214 List of approved spent fuel storage casks.

    Certificate Number: 1040.

    Initial Certificate Effective Date: April 6, 2015.

    Amendment No. 1 Effective Date: September 8, 2015.

    SAR Submitted by: Holtec International, Inc.

    SAR Title: Final Safety Analysis Report for the Holtec International HI-STORM UMAX Canister Storage System.

    Docket Number: 72-1040.

    Certificate Expiration Date: April 6, 2035.

    Model Number: MPC-37, MPC-89.

    Dated at Rockville, Maryland, this 11th day of June, 2015.

    For the Nuclear Regulatory Commission.

    Mark A. Satorius, Executive Director for Operations.
    [FR Doc. 2015-15476 Filed 6-22-15; 8:45 am] BILLING CODE 7590-01-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2014-0457; Airspace Docket No. 14-AWP-4] Establishment of Class E Airspace; Cloverdale, CA AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This action establishes Class E airspace at Cloverdale Municipal Airport, Cloverdale CA. to accommodate Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Cloverdale Municipal Airport. This action enhances the safety and management of IFR operations at the airport.

    DATES:

    Effective 0901 UTC, August 20, 2015. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.

    ADDRESSES:

    FAA Order 7400.9Y, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. The Order 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.

    FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15. For further information, you can contact the Airspace Policy and ATC Regulations Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 29591; telephone: 202-267-8783.

    FOR FURTHER INFORMATION CONTACT:

    Richard Roberts, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4517.

    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 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 establishes controlled airspace at Cloverdale Municipal Airport, Cloverdale, CA.

    History

    On September 2, 2014 the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to establish Class E airspace extending upward from 700 feet above the surface at Cloverdale Municipal Airport, Cloverdale, CA. (79 FR 51919). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

    Class E airspace designations are published in paragraph 6005, of FAA Order 7400.9Y, dated August 6, 2014, and effective September 15, 2014, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

    Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Y, airspace Designations and Reporting Points, dated August 6, 2014, and effective September 15, 2014. FAA Order 7400.9Y is publicly available as listed in the ADDRESSES section of this final rule. FAA Order 7400.9Y lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface at Cloverdale, CA, with a segment that extends 6.3 miles south of the airport. Controlled airspace is needed for the RNAV (GPS) standard instrument approaches and departures at the airport.

    Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. 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 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

    Lists of Subjects in 14 CFR Part 71:

    Airspace, Incorporation by reference, Navigation (air).

    Adoption of the Amendment:

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Y, Airspace Designations and Reporting Points, dated August 6, 2014, and effective September 15, 2014, is amended as follows: Paragraph 6005 Class E airspace areas extending upward from 700 feet or more above the surface of the earth. AWP CA E5 Cloverdale, CA [New] Cloverdale Municipal Airport, CA (lat. 38°46′34″ N., long. 122°59′33″ W.)

    That airspace extending upward from 700 feet above the surface within a 3.5-mile radius of Cloverdale Municipal Airport and 2 miles either side of the 152° radial from the 3.5-mile radius to 6.3 miles south of the airport.

    Issued in Seattle, Washington, on June 15, 2015. Christopher Ramirez, Acting Manager, Operations Support Group, Western Service Center.
    [FR Doc. 2015-15315 Filed 6-22-15; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 107 [Docket No. FDA-2013-N-0067] Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is amending the regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula.

    DATES:

    This final rule is effective June 22, 2016. See section VII of this document for information on the filing of objections. Submit either electronic or written objections and requests for a hearing by July 23, 2015.

    ADDRESSES:

    You may submit either electronic or written objections and/or requests for a hearing, identified by Docket No. FDA-2013-N-0067, by any of the following methods:

    Electronic Submissions

    Submit electronic objections in the following way:

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

    Written Submissions

    Submit written objections in the following ways:

    Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Instructions: All submissions received must include the Docket No. FDA-2013-N-0067 for this rulemaking. All objections received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting objections, see the “Objections” heading of the SUPPLEMENTARY INFORMATION section of this document.

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

    FOR FURTHER INFORMATION CONTACT:

    Leila Beker, Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1451.

    SUPPLEMENTARY INFORMATION:

    I. What is the background and legal authority of this final rule? A. Background

    Section 412(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350a(i)) establishes requirements for the nutrient content of infant formulas. Under section 412(i)(2) of the FD&C Act, the Secretary of Health and Human Services (the Secretary) is authorized to revise the list of required nutrients and the required level for any required nutrient. This authority has been delegated to the Commissioner of Food and Drugs (the Commissioner). The table in section 412(i) of the FD&C Act, and in FDA regulations at § 107.100(a) (21 CFR 107.100(a)), specifies that infant formulas must contain 29 nutrients; minimum levels for each nutrient and maximum levels for 9 of the nutrients are also specified. In 1989, the Food and Nutrition Board of the National Research Council established a Recommended Dietary Allowance for selenium for infants 0 to 6 months of age of 10.0 micrograms per day (μg/day), a level extrapolated from adult values on the basis of body weight and with a factor allowed for growth (Ref. 1).

    In the Federal Register of April 16, 2013 (78 FR 22442), we proposed to amend the nutrient specifications for infant formula to include selenium as a required nutrient in § 107.100(a). We also proposed to establish minimum and maximum levels for selenium in infant formulas because evidence exists for both deficiency and toxicity of selenium. We proposed 2.0 μg selenium per 100 kilocalories (/100 kcal) as the minimum level of selenium in infant formulas and 7.0 μg/100 kcal as the maximum level of selenium in infant formulas.

    Scientific evidence from multiple sources supported the proposed levels. Specifically, for the proposed requirements, we considered scientific evidence in: (1) The Institute of Medicine's (IOM) “Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids” (Ref. 2); (2) the Life Sciences Research Office's “Assessment of Nutrient Requirements for Infant Formulas” by Raiten et al. (Ref. 3); (3) “Global Standard for the Composition of Infant Formula. Recommendations of an ESPGHAN [European Society for Paediatric Gastroenterology, Hepatology and Nutrition] Coordinated International Expert Group” by Koletzko et al. (Ref. 4); and (4) “Selenium Status of Term Infants Fed Selenium-Supplemented Formula in a Randomized Dose-Response Trial” by Daniels et al. (Ref. 5). We also searched the scientific literature from 1998 through 2012 for published studies not included in these reports.

    In addition, we proposed to amend the labeling requirements for infant formula in § 107.10(a)(2) to add selenium to the list of nutrients along with the requirement to list the amount of selenium per 100 kcal in the formula.

    B. Legal Authority

    Section 412(i) of the FD&C Act contains a table of nutrients (including minimum and, in some cases, maximum levels for nutrients) that are required to be in an infant formula. Section 412(i)(2) of the FD&C Act authorizes the Secretary to revise the statutory table of nutrients and to revise the level of any required nutrient. The Secretary has delegated this authority to the Commissioner. Our regulations establishing the table of nutrients are codified at § 107.100.

    The final rule amends § 107.100 to add selenium to the list of nutrients required for infant formula. The legal authority for the amendment to § 107.100 comes from section 412(i)(2) of the FD&C Act.

    The final rule also requires adding selenium to the statement of the amounts of nutrients required for infant formula labeling in § 107.10(a)(2). “Infant formula” is defined as a food for “special dietary use” under section 201(z) of the FD&C Act (21 U.S.C. 321(z)). Under sections 403(j) and 701(e) of the FD&C Act (21 U.S.C. 343(j) and 21 U.S.C. 371(e)), the Secretary, and by delegation the Commissioner, may prescribe regulations concerning the vitamin and mineral content of foods for special dietary uses to fully inform purchasers as to the value of the food for such uses. As such, FDA has the authority to revise the statement of the amounts of nutrients required for infant formula labeling in § 107.10(a)(2) under sections 201(z), 403(j), 412(i), and 701(e) of the FD&C Act.

    II. What issues did the comments raise? What are FDA's responses to the comments?

    We invited public comment on the proposed rule. The comment period closed on July 1, 2013. We received fewer than 20 comments. Overall, the comments supported the addition of selenium to infant formula and agreed that selenium is an essential nutrient. We summarize and respond to the comments on the proposed rule and describe the final rule in this section. For ease of reading, we preface each comment discussion with a numbered “Comment,” and each response by a corresponding numbered “Response.” We have numbered each comment to help distinguish among different topics. The number assigned is for organizational purposes only and does not signify the comment's value, importance, or the order in which it was received.

    A. The Addition of Selenium to the Statement of the Amounts of Nutrients (§ 107.10(a)(2))

    The proposed rule would amend the infant formula nutrient labeling and nutrient specification regulations at §§ 107.10 and 107.100, respectively. Proposed § 107.10(a)(2) would add selenium to the statement of the amounts of nutrients required for infant formula labeling.

    We did not receive any comments on proposed § 107.10(a)(2). However, we note that we have revised § 107.10(a)(2) in this final rule to correspond to changes resulting from an interim final rule that appeared in the Federal Register on February 10, 2014 (79 FR 7934), and later affirmed in a final rule that appeared in the Federal Register on June 10, 2014 (79 FR 33057). In brief, § 107.10(a)(2) was reworded by replacing “A statement of the amount of each of the following nutrients supplied by 100 kilocalories” with “A statement of the amount, supplied by 100 kilocalories, of each of the following nutrients and of any other nutrient added by the manufacturer.”

    B. Minimum and Maximum Levels of Selenium (§ 107.100)

    Proposed § 107.100(a) would add selenium to the list of required nutrients in infant formula. The proposal also would establish minimum and maximum levels for selenium in infant formula because evidence exists for both deficiency and toxicity of selenium, and there is no room for error in production of a food that serves as the sole source of nutrition for infants. We proposed to set 2.0 μg selenium/100 kcal as the minimum level of selenium in infant formulas and 7.0 μg/100 kcal as the maximum level of selenium in infant formulas. Since the publication of the proposed rule, we have conducted a search of the scientific literature to identify whether additional studies on selenium requirements of infants were published after we issued our proposal. We did not find any relevant studies in our search.

    (Comment 1) One comment suggested we decrease the minimum level of selenium to 1.6 μg/100 kcal. The comment pointed to analytical variability that can occur between laboratories when testing the levels of selenium. According to the comment, due to this analytical variability, a minimum selenium level of 1.6 μg/100 kcal will likely result in manufacturers' formulating to deliver selenium levels close to 2.0 μg/100 kcal to ensure products do not fall below the minimum.

    (Response 1) We decline to lower the minimum level of selenium in infant formula to 1.6 μg/100 kcal to accommodate analytical variability that can occur between laboratories as the comment suggested. The level of any substance (including nutrients, food additives, or contaminants) established for regulatory purposes must be a value that is based on and true to the available scientific evidence. We recognize that analytical variability is always present and manage this matter under our compliance program. We also note that lowering the minimum level of selenium would not change the analytical variability, and the tested level of selenium might fall below whatever minimum level is set, due to analytical variability. For example, if the minimum level was lowered to 1.6 μg/100 kcal, the tested level of selenium might fall below 1.6 μg/100 kcal due to analytical variability. However, on our own initiative we have revised proposed § 107.100(a) to insert the word “level” between the words “minimum” and “specified” in light of an inadvertent omission in the proposed rule.

    (Comment 2) One comment said that the minimum level of selenium should be in the range reported in breast milk and specifically recommended the level of 1.6 μg selenium/100 kcal, consistent with the mean concentration of selenium in breast milk reported by Daniels et al. (2008). The comment continued, saying it was not aware of any reports of selenium deficiency in breast-fed infants or at this concentration of selenium in infant formula. The comment also stated that we did not consider the data from the breast-fed control group in the Daniels et al. study.

    (Response 2) With regard to this comment suggesting that the selenium concentration in human milk (and more specifically, the level of 1.6 μg/100 kcal reported in the Daniels et al. study) be used as the basis for the required minimum selenium level in infant formula, the scientific evidence we discussed in the proposed rule (78 FR 22442 at 22444) was more broadly based. The discussion in the proposed rule considered the levels of selenium in human milk from the studies used to establish the adequate intake (AI) for selenium by the IOM and the levels of selenium in infant formulas fed in the randomized and double-blinded dose-response study in infants by Daniels et al. (2008).

    Specifically, as discussed in the proposed rule (78 FR 22442 at 22444), the IOM established an AI for selenium of 15.0 μg/day (approximately 2.1 μg/kg body weight/day) for infants 0 to 6 months of age based on the average concentration of selenium in human milk from healthy women from 2 to 6 months of lactation as reported in four studies. The study by Daniels et al. was published after the IOM established the AI for selenium for infants 0 to 6 months of age, and the concentration of selenium in human milk reported in that study was not among the studies considered in the establishment of the AI. We note that the mean concentration of selenium in human milk in the studies included by the IOM in setting the AI for infants 0 to 6 months of age was 18 μg/L and that reported by Daniels et al. was 10.7 μg/L.

    The study by Daniels et al. provides direct evidence of the effect of selenium concentration of infant formula on the circulating biochemical indicators of selenium status in infants. As described in the proposed rule (78 FR 22442 at 22444), this study included a control formula that contained 0.9 μg selenium/100 kcal (considered by the investigators to be a low-selenium formula) and two test formulas that contained 1.9 μg selenium/100 kcal or 3.1 μg selenium/100 kcal. The level of selenium in the formula containing 1.9 μg/100 kcal was somewhat higher than the level in human milk reported in the Daniels et al. study and close to the AI set by the IOM. In our consideration of the study by Daniels et al., we regarded the data from the human milk-fed infants as reference data, with the direct comparators being the indicators of selenium status of infants fed the formulas containing the three levels of selenium. The plasma and erythrocyte indicators of selenium status for both test formulas did not differ from each other but differed with statistical significance from the control formula. Compared to the infants fed the formula containing 1.9 μg selenium/100 kcal, infants fed the formula containing 3.1 μg selenium/100 kcal excreted more selenium in the urine. This increase in urinary selenium was found to be statistically significant. Combined with the finding of no dose-related changes in the circulating indicators of selenium status in infants fed formulas containing 1.9 μg selenium/100 kcal or 3.1 μg selenium/100 kcal, this dose-related increase in urinary selenium suggests that infants fed the formula containing a level of 1.9 μg selenium/100 kcal received sufficient selenium to meet their nutritional needs. Much of the selenium intake above the level of 1.9 μg selenium/100 kcal was apparently eliminated from the body through the body's homeostatic mechanisms.

    As effects on indicators of selenium status have not been evaluated in infants fed formulas with concentrations of selenium between 0.9 μg selenium/100 kcal and 1.9 μg selenium/100 kcal, there are no data to support lowering the minimum level of selenium in infant formula from 2.0 μg/100 kcal to 1.6 μg/100 kcal. The scientific evidence discussed previously and in section III.A. of the proposed rule (78 FR 22442 at 22443) continues to justify 2.0 μg selenium/100 kcal as the minimum level for selenium in infant formulas.

    (Comment 3) In support of a lower minimum level for selenium in infant formula, one comment pointed out that the Codex Alimentarius infant formula standard and the European Union Directive on Infant Formulae and Follow-On Formulae recommend a minimum level of selenium in infant formula of 1.0 μg selenium/100 kcal.

    (Response 3) The level of 1.0 μg/100 kcal as the minimum level for selenium in infant formula was adopted by the Codex Alimentarius in 2007 for its Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Codex Stan 72-1981) (Ref. 6) based on recommendation of this level by an International Expert Group (IEG) of the ESPGHAN (Ref. 4). The IEG recommended 1.0 μg selenium/100 kcal for infant formula based on the median selenium content of human milk and an established history of apparent safe use. However, as described in the proposed rule (78 FR 22442 at 22444), no information was provided regarding the details of how such information was used in making the recommendation for 1.0 μg selenium/100 kcal in infant formula. In addition, the recommendation of the IEG was made in 2005 before the dose-response study of Daniels et al. was published in 2008, and data from that study suggest that a level of 1.9 μg selenium/100 kcal in infant formula meets infants' selenium needs. Further, although, as noted in the comment, the level of 1.0 μg/100 kcal was also adopted as the minimum level for selenium by the European Union in 2006 for its Directive on Infant Formulae and Follow-On Formulae (Commission Directive 2006/141/EC), identification of a scientific basis for the selection of 1.0 μg selenium/100 kcal was not included in the European Union Commission Directive.

    (Comment 4) One comment suggested raising the maximum level of selenium added to infant formula to 9.0 μg/100 kcal. The comment said that the 9.0 μg selenium/100 kcal would align the maximum level of selenium with the upper levels recommended in the Codex Alimentarius Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants, and with the European Union Directive on Infant Formulae and Follow-on Formulae. The comment also stated that 9.0 μg selenium/100 kcal is more aligned with the use of 8.0 μg/100 kcal as the maximum value for selenium in the FDA Compliance Program Guidance Manual (CPGM).

    (Response 4) We decline to increase the maximum level of selenium in infant formula to 9.0 μg selenium/100 kcal as the comment suggested. As noted in the response to comment 1 concerning the minimum level of selenium in infant formula, the maximum level of any substance (including nutrients, food additives, or contaminants) established for regulatory purposes must also be a value that is based on and true to the available scientific evidence.

    The level of 9.0 μg selenium/100 kcal suggested in the comment is the maximum level recommended by the ESPGHAN IEG for infant formula. The report of the IEG stated that its recommendation was based on a history of safe use (not further described) and did not identify scientific data or other information relied upon for its recommendation for a maximum level of 9.0 μg selenium/100 kcal that was subsequently adopted by Codex Alimentarius in 2007 for its Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Codex Stan 72-1981). The level of 9.0 μg selenium/100 kcal was also listed in the European Union Directive on Infant Formulae and Follow-on Formulae. We considered the level of 9.0 μg selenium/100 kcal; however, we could not determine the scientific basis for this level.

    Although we expressly invited comment regarding the proposed maximum level in infant formula of 7.0 μg selenium/100 kcal, including whether such a maximum level is needed and the scientific data or information that form the basis of any comments (78 FR 22442 at 22445), we did not receive any comments that disagreed with the need for a maximum level or that provided a scientific basis that would support a change from the proposed level. The report of the IOM, which we relied upon to propose the maximum level of 7.0 μg selenium/100 kcal, identified the data (concentration of selenium in human milk not associated with known adverse effects) and the method of calculation used to estimate a Tolerable Upper Intake Level (UL) of 7.0 μg/kg body weight/day for selenium intake of infants from 0 to 6 months of age. (As explained in the proposed rule (78 FR 22442 at 22444), a level of intake expressed as μg/kg body weight/day is consistent with an infant formula concentration expressed in μg/100 kcal.)

    With regard to the use of 8.0 μg/100 kcal as a maximum in our CPGM, this level was incorporated into the CPGM when infant formula manufacturers in the United States began adding selenium to infant formulas starting as early as 1990 and preceded the establishment of the UL for infants 0 to 6 months of age by the IOM. We will update the minimum and maximum values for selenium in infant formula in our CPGM to align with the final rule.

    (Comment 5) One comment said that setting 7.0 μg selenium/100 kcal as the maximum level of selenium, which is the amount we proposed, would mean some manufacturers would need to reformulate their products that currently meet the 8.0 μg selenium/100 kcal level that is listed in the FDA CPGM.

    (Response 5) Although the comment said that some manufacturers whose products currently meet the 8.0 μg selenium/100 kcal level listed in the FDA CPGM would need to reformulate, it did not specify how many manufacturers or products would likely be affected or whether label changes would be required following any reformulations. It also did not provide estimates of possible costs resulting from establishing a maximum of 7.0 μg selenium/100 kcal. Other comments indicated that any formula changes could be made in a cost effective and timely manner with an effective date 12 months after publication of the final rule (see comment 7).

    If some manufacturers who currently meet the 8.0 μg selenium/100 kcal level need to reformulate their products to avoid exceeding a selenium level of 7.0 μg/100 kcal, such a reformulation would involve only a small reduction in the amount of selenium added to the formula. Manufacturers routinely make such small changes in the rates of addition of ingredients (which may or may not result in the need for label changes) as a fundamental part of their current good manufacturing practices and quality control programs to ensure the consistent production of infant formulas of high quality. These types of changes are generally not considered to be major changes and are reported to FDA in a “before first processing” submission by the manufacturers if the change may adulterate the product, as required by section 412(d)(3) of the FD&C Act and our regulations in 21 CFR 106.140.

    C. Allowance for Analytical Variability

    (Comment 6) One comment suggested that, in the absence of setting a higher maximum selenium level, FDA would need to establish a specific allowance for method bias to ensure that manufacturers can meet both the minimum and maximum selenium levels. The comment suggested an allowance of 30 percent to account for analytical variability.

    (Response 6) As noted in the response to comment 4, the maximum level of any substance must be a value that is based on and true to the available scientific evidence. For this reason, we are not setting a higher maximum value that would include an allowance for analytical variability or method bias. We are not aware of method bias (consistent over- or under-measurement of the actual concentration) in the analysis of selenium in infant formula. We acknowledge that analytical variability occurs between laboratories when testing the levels of nutrients in infant formula, and we manage this matter under our compliance program as necessary. Further, we decline to set a 30 percent allowance for analytical variation for the chemical analysis of selenium in infant formula. The comment did not provide a reason for setting such a high allowance for analytical variation, and 30 percent variability is much higher than performance requirements for commonly used methods for chemical analysis of minerals in infant formula, which typically is about 10 to 15 percent.

    D. Effective Date

    In the Regulatory Impact Analysis of the proposed rule, we analyzed three options with respect to an effective date: (1) Take no new regulatory action (baseline); (2) require the provisions of this proposed rule and make the provisions of the rule effective 180 days after publication; and (3) require the provisions of this proposed rule, but make the provisions of the rule effective 12 months after publication (78 FR 22442 at 22446).

    (Comment 7) Two comments supported FDA's option 3 in the proposed rule to make the final rule effective 12 months after publication to allow for cost effective and timely changes with no anticipated impact on infant health. One comment explained that because there have been no reports of full-term, breast-fed infants in the United States with evidence of selenium deficiency, there would be no anticipated impact to infant health due to a 6-month delay in the rule's effective date (from 6 months in option 2 to 12 months in option 3 of the Regulatory Impact Analysis of the proposed rule).

    (Response 7) The final rule will be effective 12 months after publication of this document (see DATES). This will allow the industry to make any needed reformulations and label changes to their infant formula products in the 12-month period that the comment identified as cost effective and timely for needed changes.

    E. Miscellaneous Comments

    Several comments addressed matters that were not specific to a particular provision in the proposed rule and/or that were not covered by the rule. We summarize and address those comments here.

    (Comment 8) One comment suggested that FDA recommend or encourage the use of the organic form of selenium, selenomethionine, rather than the inorganic forms, sodium selenite or sodium selenate. The comment explained that selenomethionine is the selenium compound incorporated into body proteins and is available in dietary supplements or from brewer's yeast.

    (Response 8) FDA's specifications for infant formula composition in § 107.100 identify nutrients that must be included in the formula. The regulations do not specify ingredients that can serve as sources of the nutrients, except for vitamin K in § 107.100(c). We decline to specify the form of selenium in infant formula because we do not have information that indicates that any specific source of selenium should be used in infant formula. Our recently published current good manufacturing practices for infant formulas require that ingredients used in infant formulas be safe and suitable for use in infant formula. Specifically, under § 106.40(a), the only substances that may be used in an infant formula are substances that are safe and suitable for use in infant formula under the applicable food safety provisions of the FD&C Act; that is, a substance is used in accordance with the Agency's food additive regulations, is generally recognized as safe for such use, or is authorized by a prior sanction.

    (Comment 9) One comment agreed with the proposed selenium levels “unless a pediatrician otherwise recommends an alternative dosage because of a peculiar deficiency of selenium.” The comment did not explain the circumstances under which a pediatrician would recommend an “alternative dosage.”

    (Response 9) The final rule adds selenium to the list of required nutrients in infant formula and establishes minimum and maximum levels of selenium in infant formula. Manufacturers will be required to add selenium to infant formula within the established bounds as of the effective date of this rule. The rule does not apply to what physicians may do within the practice of medicine. Thus, matters pertaining to the practice of pediatric medicine are outside the scope of this rulemaking.

    (Comment 10) Another comment suggested that FDA consider establishing a higher maximum for vitamin D based on recent American Academy of Pediatrics and IOM recommendations.

    (Response 10) The final rule adds selenium to the list of required nutrients in infant formula and establishes minimum and maximum levels of selenium in infant formula. With respect to vitamin D and infant formula, we may, as resources permit, reevaluate all the minimum and maximum required nutrient levels for infant formula in separate rulemakings.

    (Comment 11) One comment supported the proposal to require the addition of selenium in infant formula. The comment stated that a child that does not receive enough selenium in the diet is at risk of developing Keshan disease.

    (Response 11) FDA agrees that Keshan disease is linked to selenium deficiency. The preamble to the proposed rule discussed the known biological functions of selenium and Keshan disease (a cardiomyopathy that occurs almost exclusively in children) (see 78 FR 22442 at 22443).

    III. What is the environmental impact of this final rule?

    FDA has determined under 21 CFR 25.32(n) 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.

    IV. Federalism

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

    V. Executive Order 12866 and Executive Order 13563: Cost Benefit Analysis

    On April 16, 2013, we proposed to amend our regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula (78 FR 22442). The Economic Impact Analysis in the proposed rule explained the economic impact of the changes to regulations at part 107. We did not receive any comments on the economic analysis of the proposed rule.

    FDA has examined the impacts of this final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct 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). FDA has developed a regulatory impact analysis that presents the benefits and costs of this proposed rule (Ref. 7). We believe that the final rule will not be a significant regulatory action as defined by Executive Order 12866.

    VI. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the annual 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.

    Title: Third-Party Disclosure Requirements for Selenium in Infant Formula

    Description of Respondents: The respondents to this information collection are manufacturers of infant formula marketed in the United States.

    Description: The final rule revises § 107.10(a)(2) to require that selenium be listed in the nutrient list on the label for all infant formulas. In particular, in the nutrient list, selenium must be listed between iodine and sodium and the amount per 100 calories declared; and because selenium is a required ingredient in infant formula, selenium is required to be declared in the formula's ingredient statement by its common or usual name and positioned according to the descending order of its predominance in the formula, under § 101.4 (21 CFR 101.4). The present version of § 107.10(a)(2) is approved by OMB in accordance with the PRA and has been assigned OMB control number 0910-0256. This final rule modifies the information collection associated with the present version of § 107.10(a)(2) by adding 23 hours to the burden associated with the collection. A manufacturer not in compliance with the new minimum and maximum levels for selenium in infant formula would be required to make a one-time change to the nutrient list information disclosed to consumers on the label of its infant formula, to account for the required change in the amount of selenium in its products. The nutrient information disclosed by manufacturers on the infant formula label is necessary to inform purchasers of the value of the infant formula. As discussed previously in this document, FDA has the authority to revise the statement of the amounts of nutrients required for infant formula labeling in § 107.10(a)(2).

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

    Table 1—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 Total capital cost
    § 107.10(a)(2)—Nutrient labeling for infant formula 1 46 46 0.5 (30 minutes) 23 $792,439 1 There are no operating and maintenance costs associated with this collection of information.

    FDA concludes that there will be no additional burden associated with the requirement to disclose selenium in the ingredient statement as required under § 101.4 because all infant formula manufacturers currently add selenium as an ingredient to their infant formula products that are sold in the United States, and all manufacturers currently disclose selenium in the ingredient statement, as specified by § 101.4. Additionally, all manufacturers currently disclose selenium in the nutrient list, as required by § 107.10(b)(5). Under § 107.10(a)(2), only one manufacturer would need to make a one-time labeling change to modify the amount of selenium shown in the nutrient list on the labels of its infant formula.

    The third-party disclosure burden consists of the setup time required to design a revised label and incorporate it into the manufacturing process. Based upon our knowledge of food and dietary supplement labeling, we estimate that the affected manufacturer would require less than 0.5 hour per product to modify the label's nutrient list to reflect the addition of more selenium to the product. We estimate that this manufacturer produces 46 separate infant formulas that would require relabeling. The one-time third-party disclosure burden is estimated in table 1 of this document.

    The final column of table 1 gives the estimated capital cost associated with relabeling. This is the cost of designing a revised label and incorporating it into the manufacturing process. The cost stated in table 1, $792,439, is estimated based on an effective date of 1 year after publication. These costs are based on the cost model estimate that, over a longer period of time, any labeling change is more likely to be coordinated with a change in a label that may already be scheduled, and will diminish the need to, for example, purchase and apply stickers to packages affected by the change.

    The information collection provisions in this final rule have been submitted to OMB for review as required by section 3507(d) of the PRA. The requirements were approved and assigned OMB control number 0910-0256. This approval expires on 04/30/2018.

    An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    VII. Objections

    This rule is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Division of Dockets Management (see ADDRESSES) either electronic or written objections. You must number each objection separately, and, within each numbered objection, you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, we will consider the absence of such a request as waiving the right to a hearing on that objection. If you request a hearing, your objection should include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held.

    It is only necessary to send one set of documents. Identify documents with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register.

    VIII. 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 are available electronically at http://www.regulations.gov.

    1. Food and Nutrition Board, National Research Council, “Recommended Dietary Allowances,” 10th ed., Washington, DC: The National Academies Press, p. 221, 1989.

    2. Food and Nutrition Board, Institute of Medicine, “Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids,” Washington, DC: The National Academies Press, pp. 21-33; 292-299; 315-316, 2000.

    3. Raiten, D. J., J. M. Talbot, and J. H. Waters, “Assessment of Nutrient Requirements for Infant Formulas,” Journal of Nutrition, 128:2059S-2249S, 1998.

    4. Koletzko, B., S. Baker, G. Cleghorn, U.F. Neto, et al., “Global Standard for the Composition of Infant Formula. Recommendations of an ESPGHAN Coordinated International Expert Group,” Journal of Pediatric Gastroenterology and Nutrition, 41:584-599, 2005.

    5. Daniels, L., R. A. Gibson, K. Simmer, P. Van Dael, and M. Makrides, “Selenium Status of Term Infants Fed Selenium-Supplemented Formula in a Randomized Dose-Response Trial,” American Journal of Clinical Nutrition, 88:70-76, 2008.

    6. Codex Alimentarius Commission, “Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants, Codex Stan 72-1981,” 1981. Revised 2007.

    7. FDA/Center for Food Safety and Applied Nutrition, “Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements, Final Regulatory Impact Analysis and Regulatory Flexibility Analysis,” 2015. Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.

    List of Subjects in 21 CFR Part 107

    Food labeling, Infants and children, Nutrition, Reporting and recordkeeping requirements, Signs and symbols.

    For the reasons discussed in the preamble, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, the Food and Drug Administration amends 21 CFR part 107 as follows:

    PART 107—INFANT FORMULA 1. The authority citation for 21 CFR part 107 continues to read as follows: Authority:

    21 U.S.C. 321, 343, 350a, 371.

    2. In § 107.10, revise paragraph (a)(2) to read as follows:
    § 107.10 Nutrient information.

    (a) * * *

    (2) A statement of the amount, supplied by 100 kilocalories, of each of the following nutrients and of any other nutrient added by the manufacturer:

    Nutrients Unit of measurement Protein Grams Fat Do. Carbohydrate Do. Water Do. Linoleic acid Milligrams Vitamins Vitamin A International Units Vitamin D Do. Vitamin E Do. Vitamin K Micrograms Thiamine (Vitamin B1) Do. Riboflavin (Vitamin B2) Do. Vitamin B6 Do. Vitamin B12 Do. Niacin Do. Folic acid (Folacin) Do. Pantothenic acid Do. Biotin Do. Vitamin C (Ascorbic acid) Milligrams Choline Do. Inositol Do. Minerals Calcium Milligrams Phosphorus Do. Magnesium Do. Iron Do. Zinc Do. Manganese Micrograms Copper Do. Iodine Do. Selenium Do. Sodium Milligrams Potassium Do. Chloride Do.
    3. In § 107.100, revise paragraph (a) to read as follows:
    § 107.100 Nutrient specifications.

    (a) An infant formula shall contain the following nutrients at a level not less than the minimum level specified and not more than the maximum level specified for each 100 kilocalories of the infant formula in the form prepared for consumption as directed on the container:

    Nutrients Unit of measurement Minimum level Maximum level Protein Grams 1.8 4.5 Fat Do. 3.3 6.0 Percent calories 30 54 Linoleic acid Milligrams 300 Percent calories 2.7 Vitamins Vitamin A International Units 250 750 Vitamin D Do. 40 100 Vitamin E Do. 0.7 Vitamin K Micrograms 4 Thiamine (Vitamin B1) Do. 40 Riboflavin (Vitamin B2) Do. 60 Vitamin B6 Do. 35 Vitamin B12 Do. 0.15 Niacin 1 Do. 250 Folic acid (Folacin) Do. 4 Pantothenic acid Do. 300 Biotin 2 Do. 1.5 Vitamin C (Ascorbic acid) Milligrams 8 Choline 2 Do. 7 Inositol 2 Do. 4 Minerals Calcium Do. 60 Phosphorus Do. 30 Magnesium Do. 6 Iron Do. 0.15 3.0 Zinc Do. 0.5 Manganese Micrograms 5 Copper Do. 60 Iodine Do. 5 75 Selenium Do. 2 7 Sodium Milligrams 20 60 Potassium Do. 80 200 Chloride Do. 55 150 1 The generic term “niacin” includes niacin (nicotinic acid) and niacinamide (nicotinamide). 2 Required only for non-milk-based infant formulas.
    Dated: June 17, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-15394 Filed 6-22-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2010-N-0155] RIN 0910-AG95 Veterinary Feed Directive; Correction AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule; correction.

    SUMMARY:

    The Food and Drug Administration (FDA) is correcting a final rule entitled “Veterinary Feed Directive” that appeared in the Federal Register of June 3, 2015 (80 FR 31708). The rule amended FDA's animal drug regulations regarding veterinary feed directive (VFD) drugs. The document published with typographical and formatting errors. This document corrects those errors.

    DATES:

    Effective: October 1, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Sharon Benz, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5939, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    In FR Doc. 2015-13393, appearing on page 31708 in the Federal Register of Wednesday, June 3, 2015, the following corrections are made:

    § 558.6 [Corrected]
    1. On page 31734, in the second column, in § 558.6 Veterinary feed directive drugs, in paragraph (b)(5), remove “(b)(2)(vi),” and add in its place “(b)(3)(vi),”. 2. On page 31734, in the third column, in § 558.6 Veterinary feed directive drugs, the introductory text of paragraph (c) “Responsibilities of any person who distributes an animal feed containing a VFD drug or a combination VFD drug:” is corrected as a paragraph heading to read “Responsibilities of any person who distributes an animal feed containing a VFD drug or a combination VFD drug.
    Dated: June 18, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-15388 Filed 6-22-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 876 [Docket No. FDA-2015-N-1297] Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation; Republication AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order; republication.

    SUMMARY:

    The Food and Drug Administration (FDA) is republishing in its entirety a final order entitled “Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation” that published in the Federal Register on May 28, 2015 (80 FR 30353). FDA is republishing to correct an inadvertent omission of information. FDA is classifying the vibrator for climax control of premature ejaculation into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the classification of the vibrator for climax control of premature ejaculation. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

    DATES:

    This order is effective June 23, 2015. The classification was applicable on March 20, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Tuan Nguyen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G118, Silver Spring, MD 20993-0002, 301-796-5174, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

    In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. On November 21, 2013, Auris Medtech Europe, Ltd., submitted a request for classification of the ProlongTM under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). On June 17, 2014, the request for classification of ProlongTM was transferred from Auris Medtech Europe, Ltd., to Ergon Medical, Ltd., through an amendment to the request (Ref. 2).

    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

    Therefore, on March 20, 2015, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 876.5025.

    Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a vibrator for climax control of premature ejaculation will need to comply with the special controls named in this final order. The device is assigned the generic name vibrator for climax control of premature ejaculation, and it is identified as a device used for males who suffer from premature ejaculation. It is designed to increase the time between arousal and ejaculation using the stimulating vibratory effects of the device on the penis.

    FDA has identified the following risks to health associated specifically with this type of device, as well as the measures required to mitigate these risks in table 1.

    Table 1—Vibrator for Climax Control of Premature Ejaculation Risks and Mitigation Measures Identified risk Mitigation measures Pain or Discomfort due to Misuse of Device Labeling. Burns Electrical and Thermal Safety Testing Labeling. Electrical Shock Electrical Safety Testing Labeling. Adverse Skin Reactions Biocompatibility Testing. Patient Injury due to Device Breakage or Failure Mechanical Safety Testing Labeling. Interference With Other Devices/Electrical Equipment Electromagnetic Compatibility Testing Labeling.

    FDA believes that the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness:

    • The labeling must include specific instructions regarding the proper placement and use of the device.

    • The portions of the device that contact the patient must be demonstrated to be biocompatible.

    • Appropriate analysis/testing must demonstrate electromagnetic compatibility safety, electrical safety, and thermal safety of the device.

    • Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.

    Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the vibrator for climax control of premature ejaculation they intend to market.

    II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) 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.

    III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485.

    IV. References

    The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov.

    1. DEN130047: De Novo Request per 513(f)(2) from Auris Medtech Europe Ltd., dated November 21, 2013.

    2. Amendment to De Novo Request from Auris Medtech Europe Ltd., dated June 17, 2014.

    List of Subjects in 21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:

    PART 876—GASTROENTEROLOGY-UROLOGY DEVICES 1. The authority citation for 21 CFR part 876 continues to read as follows: Authority:

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

    2. Republish § 876.5025 to read as follows:
    § 876.5025 Vibrator for climax control of premature ejaculation.

    (a) Identification. A vibrator for climax control of premature ejaculation is used for males who suffer from premature ejaculation. It is designed to increase the time between arousal and ejaculation using the stimulating vibratory effects of the device on the penis.

    (b) Classification. Class II (special controls). The special controls for this device are:

    (1) The labeling must include specific instructions regarding the proper placement and use of the device.

    (2) The portions of the device that contact the patient must be demonstrated to be biocompatible.

    (3) Appropriate analysis/testing must demonstrate electromagnetic compatibility safety, electrical safety, and thermal safety of the device.

    (4) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.

    Dated: June 16, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-15328 Filed 6-22-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2013-0103] RIN 1625-AA08 Regattas and Marine Parades; Great Lakes Annual Marine Events AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of enforcement of regulation.

    SUMMARY:

    The Coast Guard will enforce various special local regulations for annual regattas and marine parades in the Captain of the Port Detroit zone from 9 a.m. on June 26, 2015 through 7 p.m. on August 23, 2015. Enforcement of these regulations is necessary and intended to ensure safety of life on the navigable waters immediately prior to, during, and immediately after these regattas or marine parades. During the aforementioned period, the Coast Guard will enforce restrictions upon, and control movement of, vessels in a specified area immediately prior to, during, and immediately after regattas or marine parades.

    DATES:

    The regulations in 33 CFR 100.914, 100.915, 100.918, 100.919, and 100.920 will be enforced at specified dates and times between June 26, 2015 and August 23, 2015.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this document, call or email Petty Officer First Class Todd Manow, Prevention Department, U.S. Coast Guard Sector Detroit, 110 Mount Elliot Ave., Detroit MI, 48207; telephone (313)568-9580, email [email protected].

    SUPPLEMENTARY INFORMATION:

    The Coast Guard will enforce the following special local regulations listed in 33 CFR part 100, Safety of Life on Navigable Waters, on the following dates and times, which are listed in chronological order:

    (1) § 100.919 International Bay City River Roar, Bay City, MI. This special local regulation will be enforced from 9 a.m. to 6 p.m. on June 26, 27, and 28, 2015. A regulated area is established to include all waters of the Saginaw River bounded on the north by the Liberty Bridge, located at 43°36.3′ N, 083°53.4′ W, and bounded on the south by the Veterans Memorial Bridge, located at 43°35.8′ N, 083°53.6′ W. In case of rain on any of the race days, this special local regulation may be enforced an additional day on June 29, 2015 from 9 a.m. until 6 p.m.

    (2) § 100.920 Tug Across the River, Detroit, MI. This special local regulation will be enforced from 6 p.m. to 6:45 p.m. on July 10, 2015. A regulated area is established to include all waters of the Detroit River, Detroit, Michigan, bounded on the south by the International boundary, on the west by 083°03′ W, on the east by 083°02′ W, and on the north by the U.S. shoreline. This position is located on the Detroit River in front of Hart Plaza, Detroit, MI.

    (3) § 100.914 Trenton Rotary Roar on the River, Trenton, MI. This special local regulation will be enforced from 8 a.m. to 8 p.m. on July 17, 18, and 19, 2015. The regulated area is established to include all waters of the Detroit River, Trenton, Michigan, bounded by an east/west line beginning at a point of land at the northern end of Elizabeth Park in Trenton, MI, located at position 42°8.2′ N; 083°10.6′ W, extending east to a point near the center of the Trenton Channel located at position 42°8.2′ N; 083°10.4′ W, extending south along a north/south line to a point at the Grosse Ile Parkway Bridge located at position 42°7.7′ N; 083°10.5′ W, extending west along a line bordering the Grosse Ile Parkway Bridge to a point on land located at position 42°7.7′ N; 083°10.7′ W, and along the shoreline to the point of origin. This area is in the Trenton Channel between Trenton and Grosse Isle, MI.

    (4) § 100.915 St. Clair River Classic Offshore Race, St. Clair, MI. This special local regulation will be enforced from 10 a.m. to 7 p.m. each day from July 20, 2015 through July 26, 2015. A regulated area is established to include all waters of the St. Clair River, St. Clair, Michigan, bounded by latitude 42°52′00″ N to the north; latitude 42°49′00″ N to the south; the shoreline of the St. Clair River on the west; and the international boundary line on the east.

    Special Local Regulations:

    (1) In accordance with § 100.901, entry into, transiting, or anchoring within these regulated areas is prohibited unless authorized by the Coast Guard patrol commander (PATCOM). The PATCOM may restrict vessel operation within the regulated area to vessels having particular operating characteristics.

    (2) Vessels permitted to enter this regulated area must operate at a no wake speed and in a manner that will not endanger race participants or any other craft.

    (3) The PATCOM may direct the anchoring, mooring, or movement of any vessel within this regulated area. A succession of sharp, short signals by whistle or horn from vessels patrolling the area under the direction of the PATCOM shall serve as a signal to stop. Vessels so signaled shall stop and shall comply with the orders of the PATCOM. Failure to do so may result in expulsion from the area, a Notice of Violation for failure to comply, or both.

    (4) If it is deemed necessary for the protection of life and property, the PATCOM may terminate at any time the marine event or the operation of any vessel within the regulated area.

    (5) In accordance with the general regulations in § 100.35 of this part, the Coast Guard will patrol the regatta area under the direction of a designated Coast Guard Patrol Commander (PATCOM). The PATCOM may be contacted on Channel 16 (156.8 MHz) by the call sign “Coast Guard Patrol Commander.”

    (6) The rules in this section shall not apply to vessels participating in the event or to government vessels patrolling the regulated area in the performance of their assigned duties.

    This document is issued under authority of 33 CFR 100.35 and 5 U.S.C. 552(a). If the Captain of the Port determines that any of these special local regulations need not be enforced for the full duration stated in this document, he may suspend such enforcement and notify the public of the suspension via a Broadcast Notice to Mariners.

    Dated: June 8, 2015. Scott B. Lemasters, Captain, U. S. Coast Guard, Captain of the Port Detroit.
    [FR Doc. 2015-15408 Filed 6-22-15; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2015-0496] RIN 1625-AA00 Safety Zone; Black River Kayak-a-thon; Black River, Lorain, OH AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone on Black River, Lorain, OH. This safety zone is intended to restrict vessels from a portion of the Black River during the Black River Kayak-a-thon. This temporary safety zone is necessary to protect participants and mariners from the navigational hazards associated with a paddle sport regatta.

    DATES:

    This rule is effective from 7:45 a.m. until 2:15 p.m. on June 27, 2015.

    ADDRESSES:

    Documents mentioned in this preamble are part of docket [USCG-2015-0496]. 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, call LT Stephanie Pitts, Chief of Waterways Management, U.S. Coast Guard Marine Safety Unit Cleveland; telephone 216-937-0128. If you have questions on viewing the docket, call Ms. Cheryl Collins, Program Manager, Docket Operations, telephone 202-366-9826 or 1-800-647-5527.

    SUPPLEMENTARY INFORMATION:

    Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking TFR Temporary Final Rule A. Regulatory History and Information

    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 a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be impracticable because it would inhibit the Coast Guard's ability to protect spectators and vessels from the hazards associated with a paddle sport regatta. Therefore, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary rule effective less than 30 days after publication in the Federal Register. For the same reasons discussed in the preceding paragraph, waiting for a 30 day notice period to run would be impracticable.

    B. Basis and Purpose

    The legal basis and authorities for this rule are found in 33 U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish and define regulatory safety zones.

    Between 7:45 a.m. and 2:15 p.m. on June 27, 2015, a paddle sport regatta will be held on the Black River, Lorain, OH, from French Creek at river mile marker 5.0 to the Bascule Bridge at river mile marker 0.3. It is anticipated that up to 75 paddle craft will participate in the event. The Captain of the Port Buffalo has determined that such a gathering of watercraft poses a significant risk to public safety and property. Such hazards include vessels restricted in maneuverability, vessels with low visibility, and high traffic congestion within a narrow channel.

    C. Discussion of the Final Rule

    With the aforementioned hazards in mind, the Captain of the Port Buffalo has determined that this temporary safety zone is necessary to ensure the safety of spectators and vessels during the Black River Kayak-a-thon. This zone will be enforced from 7:45 a.m. until 2:15 p.m. on June 27, 2015. This zone will encompass all waters of Black River; Lorain, OH from position 41°27′28″ N and 082°06′10″ W (NAD 83) in the vicinity of French Creek at river mile marker 5.0 to position 41°28′11″ N and 082°10′32″ W (NAD 83) in the vicinity of the Bascule Bridge at river mile marker 0.3.

    Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

    D. Regulatory Analyses

    We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.

    1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

    We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for a relatively short time. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

    2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered the impact of this rule on small entities. 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. 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 rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in a portion of Black River on the morning of June 27, 2015.

    This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This safety zone would be effective, and thus subject to enforcement, for only six and a half hours. Traffic may be allowed to pass through the zone with the permission of the Captain of the Port. The Captain of the Port can be reached via VHF channel 16. Before the enforcement of the zone, we would issue local Broadcast Notice to Mariners.

    3. Assistance for Small Entities

    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 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 rule or any policy or action of the Coast Guard.

    4. 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).

    5. Federalism

    A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

    6. 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.

    7. 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.

    8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

    9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

    10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

    11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

    12. Energy Effects

    This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

    13. Technical Standards

    This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

    14. 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 (NEPA) (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 the establishment of a safety zone and, therefore 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 are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

    List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard amends 33 CFR parts 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; 46 U.S.C. Chapters 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.

    2. Add temporary § 165.T09-0496 to read as follows:
    § 165.T09-0496 Safety Zone; Black River Kayak-a-thon; Black River, Lorain, OH.

    (a) Location. This zone will encompass all waters of Black River; Lorain, OH from position 41°27′28″ N. and 082°06′10″ W. (NAD 83) in the vicinity of French Creek at river mile marker 5.0 to position 41°28′11″ N. and 082°10′32″ W. (NAD 83) in the vicinity of the Bascule Bridge at river mile marker 0.3.

    (b) Enforcement period. This regulation will be enforced on June 27, 2015 from 7:45 a.m. until 2:15 p.m.

    (c) Regulations. (1) In accordance with the general regulations in § 165.23 of this part, entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative.

    (2) This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Buffalo or his designated on-scene representative.

    (3) The “on-scene representative” of the Captain of the Port Buffalo is any Coast Guard commissioned, warrant or petty officer who has been designated by the Captain of the Port Buffalo to act on his behalf.

    (4) Vessel operators desiring to enter or operate within the safety zone must contact the Captain of the Port Buffalo or his on-scene representative to obtain permission to do so. The Captain of the Port Buffalo or his on-scene representative may be contacted via VHF Channel 16. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port Buffalo, or his on-scene representative.

    Dated: June 8, 2015. B.W. Roche, Captain, U.S. Coast Guard, Captain of the Port Buffalo.
    [FR Doc. 2015-15409 Filed 6-22-15; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2015-0393] Safety Zones; Fireworks Events in Captain of the Port New York Zone AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of enforcement of regulation.

    SUMMARY:

    The Coast Guard will enforce various safety zones within the Captain of the Port New York Zone on the specified dates and times. This action is necessary to ensure the safety of vessels and spectators from hazards associated with fireworks displays. During the enforcement period, no person or vessel may enter the safety zones without permission of the Captain of the Port (COTP).

    DATES:

    The regulation for the safety zones described in 33 CFR 165.160 will be enforced on the dates and times listed in the table below.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this notice, call or email Lieutenant Douglas Neumann, Coast Guard; telephone 718-354-4154, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Coast Guard will enforce the safety zones listed in 33 CFR 165.160 on the specified dates and times as indicated in Table 1 below. This regulation was published in the Federal Register on November 9, 2011 (76 FR 69614).

    Table 1 1. Brooklyn Law School, Ellis Island Safety Zone, 33 CFR 165.160(2.2) • Launch site: A barge located between Federal Anchorages 20-A and 20-B, in approximate position 40°41′45″ N. 074°02′09″ W. (NAD 1983) about 365 yards east of Ellis Island. This Safety Zone is a 360-yard radius from the barge.
  • • Date: June 11, 2015.
  • • Time: 10:10 p.m.-11:20 p.m.
  • 2. Bronx Salutes America, Orchard Beach, The Bronx Safety Zone, 33 CFR 165.160(3.11) • Launch site: All waters of Long Island Sound in an area bound by the following points: 40°51′43.5″ N. 073°47′36.3″ W.; thence to 40°52′12.2″ N. 073°47′13.6″ W.; thence to 40°52′02.5″ N. 073°46′47.8″ W.; thence to 40°51′32.3″ N. 073°47′09.9″ W. (NAD 1983), thence to the point of origin.
  • • Date: June 25, 2015.
  • • Time: 08:50 p.m.-10:10 p.m.
  • 3. City of Poughkeepsie Independence Day Celebration, Poughkeepsie, NY, Hudson River Safety Zone, 33 CFR 165.160(5.13) • Launch site: A barge located in approximate position 41°42′24.50″ N. 073°56′44.16″ W. (NAD 1983), approximately 420 yards north of the Mid Hudson Bridge. This Safety Zone is a 300-yard radius from the barge.
  • • Date: July 04, 2015.
  • • Time: 9:00 p.m.-10:00 p.m.
  • 4. City of Yonkers July 4th Celebration, Yonkers, NY, Hudson River Safety Zone, 33 CFR 165.160(5.5) • Launch site: A barge located in approximate position 40°56′14.5″ N. 073°54′33″ W. (NAD 1983), approximately 475 yards northwest of the Yonkers Municipal Pier, New York. This Safety Zone is a 360-yard radius from the barge.
  • • Date: July 04, 2015.
  • • Time: 08:45 p.m.-10:15 p.m.
  • 5. Peekskill July 4th Celebration, Peekskill Bay, Hudson River Safety Zone, 33 CFR 165.160(5.10) • Launch site: A barge located in approximate position 41°17′16″ N. 073°56′18″ W. (NAD 1983), approximately 670 yards north of Travis Point. This Safety Zone is a 360-yard radius from the barge.
  • • Date: July 04, 2015.
  • • Rain Date: July 05, 2015.
  • • Time: 08:30 p.m.-10:30 p.m.
  • Under the provisions of 33 CFR 165.160, vessels may not enter the safety zones unless given permission from the COTP or a designated representative. Spectator vessels may transit outside the safety zones but may not anchor, block, loiter in, or impede the transit of other vessels. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.

    This notice is issued under authority of 33 CFR 165.160(a) and 5 U.S.C. 552(a). In addition to this notice in the Federal Register, the Coast Guard will provide mariners with advanced notification of enforcement periods via the Local Notice to Mariners and marine information broadcasts. If the COTP determines that a safety zone need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the safety zone.

    Dated: May 11, 2015. G. Loebl, Captain, U.S. Coast Guard, Captain of the Port New York.
    [FR Doc. 2015-15410 Filed 6-22-15; 8:45 am] BILLING CODE 9110-04-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED 41 CFR 51-6 Military Resale (MR) Commodities; Correction AGENCY:

    Committee for Purchase From People Who Are Blind or Severely Disabled.

    ACTION:

    Correcting amendments.

    SUMMARY:

    The Committee published a Final Rule in the Federal Register of June 5, 2015, adding MR numbers to a series of MR numbers that already exist. In the Final Rule, new MR series 11000 and 12000 were designated as “Exclusive”. This document removes MR series 11000 and 12000 from being designated as “Exclusive”. All other parameters of the Final Rule remain the same as published on June 5, 2015.

    DATES:

    Effective June 23, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Barry S. Lineback, Telephone: (703) 603-2118.

    SUPPLEMENTARY INFORMATION:

    This document corrects § 51-6.4 by removing MR series 11000 and 12000 from paragraphs (b), (c)(4), and (d) so the series are no longer designated as “Exclusive”. All other parameters of the Final Rule remain the same as published on June 5, 2015.

    List of Subjects in 41 CFR Part 51-6 Procurement procedures.

    For the reasons set out in the preamble, the Committee amends 41 CFR part 51-6 as follows:

    PART 51-6—PROCUREMENT PROCEDURES 1. The authority citation for part 51-6 continues to read as follows: Authority:

    41 U.S.C. 8501-8506.

    § 51-6.4 [Amended]
    2. In § 51-6.4, in paragraphs (b), (c)(4), and (d), remove “, 11000 (11000-11999); 12000 (12000-12999)”.
    Dated: June 17, 2015. Barry S. Lineback, Director, Business Operations.
    [FR Doc. 2015-15284 Filed 6-22-15; 8:45 am] BILLING CODE 6353-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 100 RIN 0906-AB00 National Vaccine Injury Compensation Program: Addition of Intussusception as Injury for Rotavirus Vaccines to the Vaccine Injury Table AGENCY:

    Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

    ACTION:

    Final rule.

    SUMMARY:

    On July 24, 2013, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) proposing changes to the regulations governing the National Vaccine Injury Compensation Program (VICP). Specifically, the Secretary proposed revisions to the Vaccine Injury Table (Table). The basis for this change is consistent with the Secretary's findings that intussusceptions can reasonably be determined in some circumstances to be caused by rotavirus vaccines. The Secretary is now making this amendment to the Table and to the Qualifications and Aids to Interpretation (QAI), described below under Background Information, as proposed in the NPRM. These regulations will apply only to petitions for compensation under the VICP filed after this final rule becomes effective.

    DATES:

    This final rule is effective July 23, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Avril M. Houston, Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, HRSA, Parklawn Building, Room 11C-06, 5600 Fishers Lane, Rockville, MD 20857, or by telephone: (800) 338-2382. This is a toll-free number.

    SUPPLEMENTARY INFORMATION: I. Background Information

    Under Title XXI of the Public Health Service Act, as amended (PHS Act), individuals who demonstrate a vaccine-related injury or death may receive compensation through the VICP. To be eligible for compensation from the VICP, a petitioner must demonstrate that the injured or deceased individual received a vaccine set forth in the Table (a “covered vaccine”) and sustained a vaccine-related injury or death. A petitioner can prove a vaccine-related injury or death in three ways. First, the petitioner can show, by a preponderance of the evidence, that the vaccine recipient suffered an injury listed in the Table corresponding with the vaccine received, that the onset of such injury occurred within the timeframe specified in the Table, and that the injury meets the requirements set forth in the Table's QAI. A Table injury or death is given the legal presumption that it was caused by the vaccination. Sections 2111(c)(1)(C)(i), 2113(a)(1)(B), and 2114(a) of the PHS Act. Second, if the petitioner cannot demonstrate a Table injury, the petitioner can prevail by proving, by a preponderance of the evidence, that the vaccine caused the injury or death (off-Table injury). Third, a petitioner can prevail by proving, by a preponderance of the evidence, that the vaccine significantly aggravated a pre-existing condition. In all three cases, a petitioner must also show that the injury was sufficiently severe by demonstrating that such person suffered the residual effects of the injury for more than 6 months; died from the administration of the vaccine; or that the alleged injury resulted in inpatient hospitalization and surgical intervention. Section 2111(c)(1)(D) of the PHS Act. If the petitioner can prove a Table injury, off-Table injury, or significant aggravation of a pre-existing condition, the petitioner is entitled to compensation unless it is affirmatively shown that the injury was caused by some factor unrelated to the vaccination.

    Under section 2114(e)(2) of the PHS Act, when the Centers for Disease Control and Prevention (CDC) recommends a vaccine for routine administration to children, the Secretary is required to amend the Table to include such vaccine. Coverage becomes effective when an excise tax is imposed on the vaccine. Additionally, the Secretary is authorized to include specific injuries on the Table with respect to each covered vaccine, including the timeframe when the first symptom or manifestation of the onset of such adverse event may occur. The Secretary may also define such injuries through the QAI. Under section 2114(c) of the PHS Act, the Secretary may make such modifications to the Table by promulgating regulations, with notice and opportunity for a public hearing, and at least 180 days of public comment.

    II. Discussion of the Final Rule

    As discussed in the NPRM (78 FR 44512, July 24, 2013), the Secretary has reviewed the currently available data regarding the Rotarix and RotaTeq vaccines and the risk of intussusception. The background of the RotaShield experience in the U.S. and the published literature from Mexico, Brazil, Australia, and the U.S. supports a small attributable risk of intussusception after the first and second doses of Rotarix and RotaTeq (with a greater amount of data supporting an association with the first dose of both vaccines). Evidence shows the increased risk within the 1-7 days following immunization with peaks in the fourth and fifth days. As a consequence, the Secretary is amending the Table to add the injury of intussusception to the general Table category of “rotavirus vaccines” to allow a presumption of causation for claims that meet the requirements set forth in the Table for that injury. To allow for a generous timeframe that will capture any cases related to the vaccine after day 7, the Secretary has assigned an onset interval of 1-21 days under sections 2114(c) and (e) of the PHS Act.

    The Secretary will stay informed of new information in the scientific and medical field about intussusception and rotavirus vaccines and may propose changes in the future if such information warrants changes to the Table. In addition, the Secretary recognizes that one goal of the VICP is to provide compensation to petitioners harmed by vaccines through a less adversarial system. Therefore, the Secretary feels that adding the Table injury of intussusception after the first and second doses of rotavirus vaccines with a window of 1-21 days is appropriate.

    The QAI section of the Table defines the injury of “intussusception” as the invagination of a segment of intestine into the next segment of intestine, resulting in bowel obstruction, diminished arterial blood supply, and blockage of the venous blood flow. This is characterized by a sudden onset of abdominal pain that may be manifested by anguished crying, irritability, vomiting, abdominal swelling, and/or passing of stools mixed with blood and mucus. The definition for presumption of vaccine causation only applies to the first and second dose of vaccine, and excludes intussusception occurring with or after the third dose. The third dose of rotavirus vaccines lacks sufficient evidence showing risk.

    The definition also delineates the alternative causes of intussusception which, if present in a case, would prevent it from qualifying as a Table injury. The alternative causes were classified into four categories: infectious diseases; anatomic lead points; anatomic bowel abnormalities; and underlying gastrointestinal or systemic diseases. Cases of intussusception where the onset was within 14 days after an infectious disease secondary to non-enteric or enteric adenovirus, other enteric viruses (such as Enterovirus), enteric bacteria (such as Campylobacter jejuni), or enteric parasites (such as Ascaris lumbricoides) would not qualify as a Table injury. Proof of these alternate causes may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing.

    Cases of intussusception in a person with a pre-existing condition identified as the lead point for intussusception, such as intestinal masses and cystic structures (e.g., polyps; tumors; Meckel's diverticulum; lymphoma; or duplication cysts), would not qualify as a Table injury. Additionally, cases of intussusception in a person with abnormalities of the bowel, including congenital anatomic abnormalities, anatomic changes after abdominal surgery, and other anatomic bowel abnormalities caused by mucosal hemorrhage, trauma, or abnormal intestinal blood vessels (such as Henoch Scholein purpura, hematoma, or hemangioma); or in a person with underlying conditions or systemic diseases associated with intussusception (such as cystic fibrosis, celiac disease, or Kawasaki disease) would not qualify as a Table injury.

    Petitioners may be eligible for compensation for vaccine-related cases of intussusception in which the onset is before 1 day or beyond 21 days, or where the condition does not satisfy the criteria under the QAI for intussusception (an “off-Table” claim); however, the petitioners will be required to prove causation-in-fact. Regardless of whether the claim satisfies the criteria in the Table, all petitioners must demonstrate sufficient severity of the injury by proving that the injured person: 1) suffered the residual effects or complications of the alleged vaccine-related injury for more than 6 months after vaccine's administration; 2) died from administration of the vaccine; or 3) sustained inpatient hospitalization and surgery as a result of the alleged vaccine-related injury. Section 2111(c)(1)(D), PHS Act (42 U.S.C. 300aa-11(c)(1)(D)). In the case of rotavirus vaccine administration and subsequent intussusception, the Secretary does not consider a reduction of intussusception with therapeutic enemas to be “surgical intervention.”

    Petitions must also be filed within the applicable statute of limitations. The general statute of limitations applicable to petitions filed with the VICP, set forth in section 2116(a) of the PHS Act (42 U.S.C. 300aa-16(a)), continues to apply. In addition, section 2116(b) of the PHS Act identifies a specific exception to this statute of limitations that applies when the effect of a revision to the Table makes a previously ineligible person eligible to receive compensation or when an eligible person's likelihood of obtaining compensation significantly increases. Under this section, individuals who may be eligible to file petitions based on the revised Table may file a petition for compensation not later than two years after the effective date of the revision if the injury or death occurred not more than eight years before the effective date of the revision of the Table (42 U.S.C. 300aa-16(b)).

    III. Comments and Responses

    The comment period for this regulation ran for 6 months (July 24, 2013-January 21, 2014) and included two public hearings that were held on January 13, 2014, and April 28, 2014. The Secretary received ten comments as a result of this process. None of the commenters objected to the Secretary's proposal to add intussusception as an injury for rotavirus vaccines to the Table, and the overwhelming majority of commenters expressed their support for the proposal. In addition, commenters raised four additional points. Below is a summary of those points and the Secretary's responses to them.

    1. Notice to Potential Petitioners

    COMMENT: A commenter suggested that the Secretary make additional efforts to increase public awareness about expanding the Table and to increase the general public awareness about the VICP.

    RESPONSE: The Secretary will continue efforts to increase the general public's awareness about the VICP, including revisions to the Table.

    2. Demonstrating Severity of Injury

    COMMENT: One commenter suggested that the definition of surgical intervention be broadened to include therapeutic enema treatment.

    RESPONSE: Defining the term “surgical intervention” is beyond the scope of the Table amendments. While the preamble to both the NPRM and final rule includes the Secretary's view that a reduction of intussusception with an enema is not a “surgical intervention,” such language is not included in the regulatory text. Further, the definition of “surgical intervention” is decided by the court.

    3. Onset Time Frame

    COMMENT: A commenter stated that none of the data for either vaccine supports an association with intussusception for days 8-21 after dose 2 and suggested that the Secretary consider revising the time frame for qualification as a Table injury after dose 2 to 1-7 days.

    RESPONSE: The Secretary has considered the approach suggested by the commenter and also the recommendation of the Advisory Commission on Childhood Vaccines (ACCV). The ACCV unanimously recommended the proposed change of 1-21 days for all rotavirus vaccines.

    The ACCV's “Guiding Principles for Recommending Changes to the Vaccine Injury Table,” consist of two overarching principles: (1) the Table should be scientifically and medically credible; and (2) where there is credible scientific and medical evidence both to support and to reject a proposed change (addition or deletion) to the Table, the change should, whenever possible, be made to the benefit of petitioners. The Guiding Principles were established in 2006 to assist the ACCV in evaluating proposed Table revisions and determining whether to recommend Table changes to the Secretary. The ACCV followed these Guiding Principles in making its recommendations to the Secretary for revising this Table. Therefore, the Secretary has decided that the 1-21 day timeframe for both vaccines is the best approach to capture any cases related to the vaccine after day 7.

    4. Published Studies since the Publication of the NPRM

    COMMENT: A commenter identified studies that have been published since the initial NPRM was published.

    RESPONSE: The Secretary has reviewed these studies and found that the most recent data have shown a small but statistically significant increased risk of intussusception within 7 days after the first and second doses of the licensed rotavirus vaccines. However, as discussed above, following the Guiding Principles, the ACCV unanimously recommended the proposed change of 1-21 days for all rotavirus vaccines. Therefore, the Secretary has decided that the 1-21 day timeframe for both vaccines is the best approach to capture any cases related to the vaccine after day 7.

    IV. Regulatory Impact Analysis

    HHS has examined the impact of this rulemaking as required by Executive Order 12866 on Regulatory Planning and Review, Executive Order 13563 on Improving Regulation and Regulatory Review, the Congressional Review Act (5 U.S.C. 804(2)), the Regulatory Flexibility Act (RFA), section 202 of the Unfunded Mandates Reform Act of 1995, section 654(c) of the Treasury and General Government Appropriations Act of 1999, and Executive Order 13132 on Federalism.

    Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits (including potential economic, environmental, public health, safety, distributive, and equity effects). In addition, under the Regulatory Flexibility Act, if a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule.

    Executive Order 12866 requires that all regulations reflect consideration of alternatives, costs, benefits, incentives, equity, and available information. Regulations must meet certain standards, such as avoiding an unnecessary burden. Regulations that are “significant” because of cost, adverse effects on the economy, inconsistency with other agency actions, effects on the budget, or novel legal or policy issues, require special analysis.

    The Secretary has determined that no resources are required to implement the requirements in this rule. Compensation will be made in the same manner used prior to the revisions of this final rule. The only purpose of this rule is to lessen the burden of proof for potential petitioners. Therefore, in accordance with the Regulatory Flexibility Act of 1980 (RFA) and the Small Business Regulatory Enforcement Act of 1996, which amended the RFA, the Secretary certifies that this rule will not have a significant impact on a substantial number of small entities.

    The Secretary has also determined that this rule does not meet the criteria for a major rule as defined by Executive Order 12866, and it would not have a major effect on the economy or federal expenditures. The Secretary has determined that this rule is not a “major rule” within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, it will not have effects on State, local, and tribal governments, or on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995.

    The Secretary finds that the provisions of this rule will not have an adverse effect on family well-being, because this rule does not affect the following family elements: family safety; family stability; marital commitment; parental rights in the education, nurture, and supervision of their children; family functioning; disposable income or poverty; or the behavior and personal responsibility of youth, as determined under section 654(c) of the Treasury and General Government Appropriations Act of 1999.

    This rule is not being treated as a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget. As stated above, this rule would modify the Table based on legal authority.

    Impact of the New Rule

    This rule will have the effect of making it easier for future VICP petitioners alleging the injury of intussusception as the result of a rotavirus vaccine that meets the criteria in the Table to receive the Table's presumption of causation (which relieves them of having to prove that the vaccine actually caused or significantly aggravated the injury).

    Paperwork Reduction Act of 1995

    This final rule has no information collection requirements.

    List of Subjects in 42 CFR Part 100

    Biologics, Health insurance, and Immunization.

    Dated: May 27, 2015. James Macrae, Acting Administrator, Health Resources and Services Administration. Approved: June 5, 2015. Sylvia M. Burwell, Secretary.

    Therefore, for the reasons stated in the preamble, the Department of Health and Human Services amends 42 CFR part 100 as follows:

    PART 100—VACCINE INJURY COMPENSATION 1. The authority citation for part 100 is revised to read as follows: Authority:

    Secs. 312 and 313 of Public Law 99-660 (42 U.S.C. 300aa-1 note); 42 U.S.C. 300aa-10 to 300aa-34; 26 U.S.C. 4132(a); and sec. 13632(a)(3) of Public Law 103-66.

    2. Amend § 100.3 as follows: a. Amend paragraph (a) by revising Item XI in the table. b. Add paragraph (b)(3).

    The revision and addition read as follows:

    § 100.3 Vaccine injury table.

    (a) * * *

    Vaccine Illness, disability, injury or condition covered Time period for first symptom or manifestation of onset or of significant aggravation after
  • vaccine administration
  • *         *         *         *         *         *         * XI. Rotavirus vaccines A. Intussusception
  • B. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed
  • 1-21 days
  • Not applicable
  • *         *         *         *         *         *         *

    (b) * * *

    (3) Intussusception. (i) For purposes of paragraph (a) of this section, intussusception means the invagination of a segment of intestine into the next segment of intestine, resulting in bowel obstruction, diminished arterial blood supply, and blockage of the venous blood flow. This is characterized by a sudden onset of abdominal pain that may be manifested by anguished crying, irritability, vomiting, abdominal swelling, and/or passing of stools mixed with blood and mucus.

    (ii) For purposes of paragraph (a) of this section, the following shall not be considered to be a Table intussusception:

    (A) Onset that occurs with or after the third dose of a vaccine containing rotavirus;

    (B) Onset within 14 days after an infectious disease associated with intussusception, including viral disease (such as those secondary to non-enteric or enteric adenovirus, or other enteric viruses such as Enterovirus), enteric bacteria (such as Campylobacter jejuni), or enteric parasites (such as Ascaris lumbricoides), which may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing;

    (C) Onset in a person with a pre-existing condition identified as the lead point for intussusception such as intestinal masses and cystic structures (such as polyps, tumors, Meckel's diverticulum, lymphoma, or duplication cysts);

    (D) Onset in a person with abnormalities of the bowel, including congenital anatomic abnormalities, anatomic changes after abdominal surgery, and other anatomic bowel abnormalities caused by mucosal hemorrhage, trauma, or abnormal intestinal blood vessels (such as Henoch Scholein purpura, hematoma, or hemangioma); or

    (E) Onset in a person with underlying conditions or systemic diseases associated with intussusception (such as cystic fibrosis, celiac disease, or Kawasaki disease).

    [FR Doc. 2015-14771 Filed 6-22-15; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket ID FEMA-2015-0001; Internal Agency Docket No. FEMA-8385] Suspension of Community Eligibility AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Final rule.

    SUMMARY:

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

    DATES:

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

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

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

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

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

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

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

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

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

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

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

    List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

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

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

    § 64.6 [Amended]
    2. The tables published under the authority of § 64.6 are amended as follows: State and location Community No. Effective date authorization/cancellation of sale of flood insurance in community Current effective map date Date certain Federal
  • assistance
  • no longer
  • available in SFHAs
  • Region I Maine: Belfast, City of, Waldo County 230129 July 8, 1975, Emerg; May 3, 1990, Reg; July 6, 2015, Susp. July 6, 2015 July 6, 2015 Brooks, Town of, Waldo County 230253 July 23, 1975, Emerg; September 18, 1985, Reg; July 6, 2015, Susp. ......do   Do. Burnham, Town of, Waldo County 230130 November 3, 1977, Emerg; June 3, 1991, Reg; July 6, 2015, Susp. Frankfort, Town of, Waldo County 230254 June 5, 1975, Emerg; May 17, 1990, Reg; July 6, 2015, Susp. ......do   Do. Freedom, Town of, Waldo County 230255 October 1, 1975, Emerg; September 27, 1985, Reg; July 6, 2015, Susp. ......do   Do. Isleboro, Town of, Waldo County 230256 May 30, 1975, Emerg; May 15, 1991, Reg; July 6, 2015, Susp. ......do   Do. Knox, Town of, Waldo County 230258 July 30, 1975, Emerg; September 27, 1985, Reg; July 6, 2015, Susp. ......do   Do. Liberty, Town of, Waldo County 230259 July 23, 1975, Emerg; September 27, 1985, Reg; July 6, 2015, Susp. ......do   Do. Lime Island, Waldo County 230985 April 4, 1979, Emerg; April 30, 1984, Reg; July 6, 2015, Susp. ......do   Do. Lincolnville, Town of, Waldo County 230172 October 1, 1975, Emerg; May 3, 1990, Reg; July 6, 2015, Susp. ......do   Do. Little Bermuda Island, Waldo County 230984 April 4, 1979, Emerg; April 30, 1984, Reg; July 6, 2015, Susp. ......do   Do. Monroe, Town of, Waldo County 230260 May 22, 1975, Emerg; September 27, 1985, Reg; July 6, 2015, Susp. ......do   Do. Montville, Town of, Waldo County 230261 October 2, 2008, Emerg; April 1, 2009, Reg; July 6, 2015, Susp. ......do   Do. Morrill, Town of, Waldo County 230262 July 16, 1975, Emerg; September 18, 1985, Reg; July 6, 2015, Susp. ......do   Do. Northport, Town of, Waldo County 230179 July 23, 1975, Emerg; May 15, 1991, Reg; July 6, 2015, Susp. ......do   Do. Palermo, Town of, Waldo County 230263 July 15, 1975, Emerg; March 1, 1987, Reg; July 6, 2015, Susp. ......do   Do. Searsmont, Town of, Waldo County 230265 July 16, 1975, Emerg; September 27, 1985, Reg; July 6, 2015, Susp. ......do   Do. Searsport, Town of, Waldo County 230185 July 2, 1975, Emerg; May 17, 1990, Reg; July 6, 2015, Susp. ......do   Do. Stockton Springs, Town of, Waldo County 230266 July 30, 1975, Emerg; February 4, 1987, Reg; July 6, 2015, Susp. ......do   Do. Swanville, Town of, Waldo County 230267 June 11, 1975, Emerg; February 4, 1987, Reg; July 6, 2015, Susp. ......do   Do. Thorndike, Town of Waldo County 230268 June 14, 1976, Emerg; September 27, 1985, Reg; July 6, 2015, Susp. ......do   Do. Troy, Town of, Waldo County 230269 March 15, 1976, Emerg; April 17, 1987, Reg; July 6, 2015, Susp. ......do   Do. Unity, Town of, Waldo County 230131 July 15, 1975, Emerg; September 27, 1985, Reg; July 6, 2015, Susp. ......do   Do. Winterport, Town of, Waldo County 230271 October 1, 1975, Emerg; May 3, 1990, Reg; July 6, 2015, Susp. ......do   Do. Region III Virginia: Charles City County, Unincorporated Areas 510198 October 20, 1975, Emerg; September 5, 1990, Reg; July 6, 2015, Susp. ......do   Do. Region IV Florida: Clewistown, City of, Hendry County 120108 September 29, 1972, Emerg; March 15, 1977, Reg; July 6, 2015, Susp. ......do   Do. Hendry County, Unincorporated Areas 120107 August 27, 1974, Emerg; May 17, 1982, Reg; July 6, 2015, Susp. ......do   Do. LaBelle, City of, Hendry County 120109 July 30, 1974, Emerg; January 20, 1982, Reg; July 6, 2015, Susp. ......do   Do. Region V Michigan: Fruitland, Township of, Muskegon County 260265 December 11, 1973, Emerg; September 1, 1986, Reg; July 6, 2015, Susp. ......do   Do. Montague, City of, Muskegon County 260160 April 12, 1974, Emerg; May 1, 1978, Reg; July 6, 2015, Susp. ......do   Do. Muskegon, Charter Township, Muskegon County 260163 September 6, 1974, Emerg; August 1, 1977, Reg; July 6, 2015, Susp. ......do   Do. Muskegon, City of, Muskegon County 260161 May 25, 1973, Emerg; June 1, 1977, Reg; July 6, 2015, Susp. ......do   Do. Muskegon Heights, City of, Muskegon County 260162 May 9, 1975, Emerg; February 18, 1981, Reg; July 6, 2015, Susp. ......do   Do. North Muskegon, City of, Muskegon County 260164 December 11, 1973, Emerg; May 2, 1977, Reg; July 6, 2015, Susp. ......do   Do. Norton Shores, City of, Muskegon County 260162 May 9, 1975, Emerg; February 18, 1981, Reg; July 6, 2015, Susp. ......do   Do. Muskegon Heights, City of, Muskegon County 260162 May 9, 1975, Emerg; February 18, 1981, Reg; July 6, 2015, Susp. ......do   Do. North Muskegon, City of, Muskegon County 260164 December 11, 1973, Emerg; May 2, 1977, Reg; July 6, 2015, Susp. ......do   Do. Norton Shores, City of, Muskegon County 260165 April 6, 1973, Emerg; September 15, 1977, Reg; July 6, 2015, Susp. ......do   Do. Ravenna, Township of, Muskegon County 260731 October 6, 1982, Emerg; May 17, 1989, Reg; July 6, 2015, Susp. ......do   Do. White River, Township of, Muskegon County 260299 June 21, 1974, Emerg; January 16, 1981, Reg; July 6, 2015, Susp. ......do   Do. Whitehall, City of, Muskegon County 260166 May 13, 1975, Emerg; October 15, 1980, Reg; July 6, 2015, Susp. ......do   Do. Region VI Arkansas: Alexander, Town of, Pulaski and Saline Counties. 050377 September 26, 1980, Emerg; January 20, 1982, Reg; July 6, 2015, Susp. ......do   Do. Jacksonville, City of, Pulaski County 050180 November 26, 1973, Emerg; September 29, 1978, Reg; July 6, 2015, Susp. ......do   Do. Little Rock, City of, Pulaski County 050181 March 16, 1973, Emerg; March 4, 1980, Reg; July 6, 2015, Susp. ......do   Do. Maumelle, City of, Pulaski County 050577 March 6, 1979, Emerg; February 29, 1988, Reg; July 6, 2015, Susp. ......do   Do. North Little Rock, City of, Pulaski County 050182 January 17, 1974, Emerg; July 16, 1980, Reg; July 6, 2015, Susp. ......do   Do. Pulaski County, Unincorporated Areas 050179 March 6, 1979, Emerg; July 16, 1981, Reg; July 6, 2015, Susp. ......do   Do. Sherwood, City of, Pulaski County 050235 February 15, 1974, Emerg; October 17, 1978, Reg; July 6, 2015, Susp. ......do   Do. Louisiana: Campti, Town of, Natchitoches Parish 220401 August 28, 1992, Emerg; July 3, 2003, Reg; July 6, 2015, Susp. ......do   Do. Clarence, Village of, Natchitoches Parish 220130 March 8, 1976, Emerg; September 18, 1987, Reg; July 6, 2015, Susp. ......do   Do. Goldonna, Village of, Natchitoches Parish 220290 April 2, 1981, Emerg; June 29, 1982, Reg; July 6, 2015, Susp. ......do   Do. Natchez, Village of, Natchitoches Parish 220370 September 29, 1975, Emerg; September 18, 1987, Reg; July 6, 2015, Susp. ......do   Do. Natchitoches, City of, Natchitoches Parish 220131 April 17, 1974, Emerg; September 18, 1987, Reg; July 6, 2015, Susp. ......do   Do. Natchitoches Parish, Unincorporated Areas 220129 May 10, 1973, Emerg; September 18, 1987, Reg; July 6, 2015, Susp. ......do   Do. Provencal, Village of, Natchitoches Parish. 220132 June 27, 1975, Emerg; November 1, 1992, Reg; July 6, 2015, Susp. ......do   Do. Robeline, Village of, Natchitoches Parish. 220133 August 11, 1975, Emerg; August 5, 1985, Reg; July 6, 2015, Susp. ......do   Do. Region VIII Montana: Missoula, City of, Missoula County 300049 March 14, 1975, Emerg; January 6, 1983, Reg; July 6, 2015, Susp. ......do   Do. Missoula County, Unincorporated Areas 300048 January 15, 1975, Emerg; August 15, 1983, Reg; July 6, 2015, Susp. ......do   Do. * do = Ditto. Code for reading third column: Emerg.—Emergency; Reg.—Regular; Susp.—Suspension.
    Dated: April 22, 2015. Roy E. Wright, Deputy Associate Administrator, Federal Insurance and Mitigation Administration, Department of Homeland Security, Federal Emergency Management Agency.
    [FR Doc. 2015-15346 Filed 6-22-15; 8:45 am] BILLING CODE 9110-12-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 76 [CS Docket No. 98-120; FCC 15-65] Carriage of Digital Television Broadcast Signals AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule.

    SUMMARY:

    The Federal Communications Commission (Commission) adopts a proposal filed jointly by the American Cable Association and the National Association of Broadcasters that modifies and extends the exemption from the requirement to carry high definition (“HD”) broadcast signals under “material degradation” provisions of the Communications Act of 1934, as amended (“the Act”) that the Commission granted to certain small cable systems in 2012 (“HD carriage exemption”).

    DATES:

    Effective July 23, 2015, except for the requirement described in paragraph III.4.b of the Supplementary Information. That paragraph contains information collection requirements that have not been approved by the Office of Management and Budget (OMB). The Commission will publish a document in the Federal Register announcing OMB approval and the effective date of that paragraph.

    FOR FURTHER INFORMATION CONTACT:

    Raelynn Remy, [email protected], Federal Communications Commission, Media Bureau, (202) 418-2936.

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's Sixth Report and Order, CS Docket No. 98-120, FCC 15-65, which was adopted and released on June 10, 2015. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Center, Federal Communications Commission, 445 12th Street SW., Room CY-A257, Washington, DC 20554. This document will also be available via ECFS at http://fjallfoss.fcc.gov/ecfs/. Documents will be available electronically in ASCII, Microsoft Word, and/or Adobe Acrobat. Alternative formats are available for people with disabilities (Braille, large print, electronic files, audio format), by sending an email to [email protected] or calling the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

    Paperwork Reduction Act of 1995 Analysis

    This document contains new information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. It will be submitted to OMB for review under Section 3507(d) of the PRA. OMB, the general public, and other Federal agencies are invited to comment on the new information collection requirements contained in this proceeding. In addition, we note that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), we previously sought specific comment on how the Commission might further reduce the information collection burden for small business concerns with fewer than 25 employees.

    I. Introduction

    1. In this Sixth Report and Order, we adopt a proposal filed jointly by the American Cable Association (“ACA”) and the National Association of Broadcasters (“NAB”) 1 that modifies and extends the exemption from the requirement to carry high definition (“HD”) broadcast signals under “material degradation” provisions of the Communications Act of 1934, as amended (“the Act”) 2 that the Commission granted to certain small cable systems in 2012 (“HD carriage exemption”).3 As discussed below, we find that the joint proposal strikes a reasonable balance between the interests of broadcast stations in having their HD signals transmitted without material degradation and the technical and financial constraints that some small cable operators continue to experience. We set forth below a brief history of the HD carriage exemption and explain the basis for our decision.

    1See Letter from Ross Lieberman, Senior Vice President of Government Affairs, American Cable Association and Erin L. Dozier, Senior Vice President and Deputy General Counsel, National Association of Broadcasters, to Marlene H. Dortch, Secretary, FCC, in CS Docket No. 98-120 (filed May 14, 2015) (“Joint Proposal”); Letter from Ross Lieberman, Senior Vice President of Government Affairs, American Cable Association and Erin L. Dozier, Senior Vice President and Deputy General Counsel, National Association of Broadcasters, to Marlene H. Dortch, Secretary, FCC, in CS Docket No. 98-120 (filed May 27, 2015) (clarifying two points in the joint proposal) (“Joint Clarification”).

    2See 47 U.S.C. 534(b)(4)(A), 535(g)(2) (material degradation requirements relating to signals of local commercial and noncommercial television stations, respectively).

    3See Carriage of Digital Television Broadcast Signals: Amendment to Part 76 of the Commission's Rules, CS Docket No. 98-120, Fifth Report and Order, 77 FR 36178 (2012) (“Fifth Report and Order”).

    II. Background

    2. Sections 614(b)(4)(A) and 615(g)(2) of the Act require that cable operators carry signals of commercial and noncommercial broadcast television stations, respectively, “without material degradation.” In the context of the carriage of digital signals, the Commission has interpreted this requirement: (i) To prohibit cable operators from discriminating in their carriage between broadcast and non-broadcast signals; and (ii) to require cable operators to carry HD broadcast signals to their viewers in HD. To address concerns expressed by small cable operators about cost and technical capacity, the Commission in 2008 granted a three-year exemption from the HD carriage requirement to certain small cable systems. In particular, the Commission applied the exemption to small cable systems with 2,500 or fewer subscribers that are not affiliated with a cable operator serving more than 10 percent of all MVPD subscribers, and those with an activated channel capacity of 552 MHz or less. In 2012, the Commission extended the HD carriage exemption for those cable systems until June 12, 2015.

    3. In January 2015, ACA filed a Petition for Rulemaking asking the Commission: (i) To commence a rulemaking proceeding to extend for an additional three years the HD carriage exemption; and (ii) to clarify that analog-only cable systems are not subject to the HD carriage requirement because carriage of HD signals by such systems is not “technically feasible” under Section 614(b)(4)(A) of the Act. On March 12, 2015, the Commission issued a Fifth Further Notice of Proposed Rulemaking in this proceeding that, among other things, proposed to extend the HD carriage exemption for three more years.4 In their initial pleadings responsive to the Fifth Further Notice, multichannel video programming distributors (“MVPDs”) supported the Commission's proposal to extend the HD carriage exemption and broadcasters opposed it. After a series of discussions aimed at resolving their differences, ACA and NAB, on May 14, 2015, filed the joint proposal with the Commission.5

    4See Carriage of Digital Television Broadcast Signals: Amendment to Part 76 of the Commission's Rules, CS Docket No. 98-120, Fifth Further Notice of Proposed Rulemaking, 80 FR 16347 (2015) (“Fifth Further Notice”).

    5See Joint Proposal. See also Joint Clarification; Letter from Erin L. Dozier, Senior Vice President and Deputy General Counsel, National Association of Broadcasters, and Ross Lieberman, Senior Vice President of Government Affairs, American Cable Association, to Marlene H. Dortch, Secretary, FCC, in CS Docket No. 98-120 (filed May 13, 2015).

    III. Discussion

    4. We conclude that it would serve the public interest to adopt the joint proposal put forth by ACA and NAB. Throughout the course of this proceeding, ACA and NAB have expressed differing views about the appropriate scope and duration of the HD carriage exemption, among other issues. We find that the compromise reached by ACA and NAB as reflected in the joint proposal reasonably balances the interest of broadcast stations in having their HD signals transmitted in HD and the interest of small cable operators in upgrading their systems to carry HD broadcast signals in a manner that is cost efficient. We note that no industry commenter has lodged any objection to the joint proposal. We, therefore, find that the public interest would be served by adopting ACA and NAB's joint proposal, as set forth below: 6

    6See Joint Proposal; Joint Clarification. We need not resolve in this order the issue whether analog-only cable systems are subject to the HD carriage requirement under Section 614(b)(4)(A) of the Act because under the terms of the joint proposal, cable systems that do not offer any programming in HD, including analog-only systems, will be exempt from the HD carriage requirement. See Joint Proposal at 1. Thus, our adoption of the joint proposal renders this issue moot.

    a. HD Carriage Exemption Eligibility after June 12, 2015: A small cable system not offering any programming in HD is exempt from the HD carriage requirement. Beginning December 12, 2016, a system utilizing the HD carriage exemption shall no longer be eligible to use it once the system offers any programming in HD.

    b. Notice: Beginning December 12, 2016, at the time a small cable system utilizing the HD carriage exemption offers any programming in HD, the system must give notice that it is offering HD programming to all broadcast stations in its market that are carried on its system.

    c. Transition for Some Systems: A cable system utilizing the HD carriage exemption on June 12, 2015 that does not qualify for the HD carriage exemption on or after June 13, 2015 must come into compliance by December 12, 2016. A cable system that becomes ineligible for the HD carriage exemption after December 12, 2016 would be expected to come into compliance promptly.

    d. Revisions to Definition of “Small” Cable System: “Small” cable systems eligible for the HD carriage exemption would be redefined as those: (i) Serving 1,500 (rather than 2,500) or fewer subscribers, and not affiliated with a cable operator serving more than 2 percent (rather than 10 percent) of all MVPD subscribers, or (ii) having an activated channel capacity of 552 MHz or less.

    IV. Procedural Matters A. Regulatory Flexibility Act

    5. Final Regulatory Flexibility Analysis. As required by the Regulatory Flexibility Act of 1980, as amended (“RFA”) 7 an Initial Regulatory Flexibility Act Analysis (“IRFA”) was incorporated in the Fifth Further Notice in this proceeding.8 The Commission sought written public comment on the proposals in the Fifth Further Notice, including comment on the IRFA. The Commission received no comments on the IRFA. This Final Regulatory Flexibility Act Analysis (“FRFA”) conforms to the RFA.9

    7See 5 U.S.C. 603. The RFA, see 5 U.S.C. 601-612, has been amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (“SBREFA”), Pub. L. 104-121, Title II, 110 Stat. 847 (1996). The SBREFA was enacted as Title II of the Contract With America Advancement Act of 1996 (“CWAAA”).

    8See Fifth Further Notice, Appendix.

    9See 5 U.S.C. 604.

    1. Need for, and Objectives of, the Sixth Report and Order

    6. This proceeding stems from a Petition for Rulemaking filed by the American Cable Association in January 2015 principally requesting that the Commission extend the exemption from the requirement to carry high definition (“HD”) broadcast signals under the “material degradation” provisions of the Communications Act of 1934, as amended, that it granted to certain small cable systems in the 2012 Fifth Report and Order (“HD carriage exemption”). The HD carriage exemption will expire on June 12, 2015 without action by the Commission.

    7. In the accompanying Sixth Report and Order, the Commission adopts a proposal filed jointly by the American Cable Association (“ACA”) and the National Association of Broadcasters (“NAB”) that modifies and extends the HD carriage exemption. The joint proposal reflects a compromise between ACA and NAB on issues concerning, among other things, the appropriate scope and duration of the HD carriage exemption. The Sixth Report and Order concludes that the joint proposal strikes a reasonable balance between the interests of broadcast stations in having their HD signals transmitted without material degradation and the interests of small cable operators in upgrading their systems to provide HD broadcast signals in a manner that is cost efficient.

    8. In particular, the Sixth Report and Order adopts the following provisions that are set forth in the joint proposal:

    HD Carriage Exemption Eligibility after June 12, 2015: A small cable system not offering any programming in HD is exempt from the HD carriage requirement. Beginning December 12, 2016, a system utilizing the HD carriage exemption shall no longer be eligible to use it once the system offers any programming in HD.

    Notice: Beginning December 12, 2016, at the time a small cable system utilizing the HD carriage exemption offers any programming in HD, the system must give notice that it is offering HD programming to all broadcast stations in its market that are carried on its system.

    Transition for Some Systems: A cable system utilizing the HD carriage exemption on June 12, 2015 that does not qualify for the HD carriage exemption on or after June 13, 2015 must come into compliance by December 12, 2016. A cable system that becomes ineligible for the HD carriage exemption after December 12, 2016 would be expected to come into compliance promptly.

    Revisions to Definition of “Small” Cable System: “Small” cable systems eligible for the HD carriage exemption would be redefined as those: (i) Serving 1,500 (rather than 2,500) or fewer subscribers, and not affiliated with a cable operator serving more than 2 percent (rather than 10 percent) of all MVPD subscribers, or (ii) having an activated channel capacity of 552 MHz or less.

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

    9. The Commission did not receive any comments in response to the IRFA.

    3. Description and Estimate of the Number of Small Entities to Which the Rules Will Apply

    10. The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the proposed actions if adopted.10 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” 11 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.12 A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).13 The action taken in the accompanying Sixth Report and Order will affect small cable system operators and small television broadcast stations. A description of these small entities, as well as an estimate of the number of such small entities, is provided below.

    10 5 U.S.C. 603(b)(3).

    11 5 U.S.C. 601(b).

    12 5 U.S.C. 601(3) (incorporating by reference the definition of “small-business concern” in the Small Business Act, 15 U.S.C. 632). Pursuant to 5 U.S.C. 601(3), the statutory definition of a small business applies “unless an agency, after consultation with the Office of Advocacy of the Small Business Administration and after opportunity for public comment, establishes one or more definitions of such term which are appropriate to the activities of the agency and publishes such definition(s) in the Federal Register.”

    13 15 U.S.C. 632.

    11. Cable Companies and Systems. The Commission has developed its own small business size standards for the purpose of cable rate regulation. Under the Commission's rules, a “small cable company” is one serving 400,000 or fewer subscribers nationwide.14 Industry data indicate that there are currently 660 cable operators.15 Of this total, all but ten cable operators nationwide are small under this size standard.16 In addition, under the Commission's rate regulation rules, a “small system” is a cable system serving 15,000 or fewer subscribers.17 Current Commission records show 4,629 cable systems nationwide.18 Of this total, 4,057 cable systems have less than 20,000 subscribers, and 572 systems have 20,000 or more subscribers, based on the same records. Thus, under this standard, we estimate that most cable systems are small entities.

    14 47 CFR 76.901(e).

    15 NCTA, Industry Data, Number of Cable Operators and Systems, http://www.ncta.com/Statistics.aspx (visited October 13, 2014).

    16See SNL Kagan, “Top Cable MSOs—12/12 Q”; available at http://www.snl.com/InteractiveX/TopCableMSOs.aspx?period=2012Q4&sortcol=subscribersbasic&sortorder=desc.

    17 47 CFR 76.901(c).

    18 The number of active, registered cable systems comes from the Commission's Cable Operations and Licensing System (COALS) database on October 10, 2014. A cable system is a physical system integrated to a principal headend.

    12. Cable System Operators (Telecom Act Standard). The Communications Act of 1934, as amended, also contains a size standard for small cable system operators, which is “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than 1 percent of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenues in the aggregate exceed $250,000,000.” 19 There are approximately 54 million cable video subscribers in the United States today.20 Accordingly, an operator serving fewer than 540,000 subscribers shall be deemed a small operator if its annual revenues, when combined with the total annual revenues of all its affiliates, do not exceed $250 million in the aggregate.21 Based on available data, we find that all but ten incumbent cable operators are small entities under this size standard.22 We note that the Commission neither requests nor collects information on whether cable system operators are affiliated with entities whose gross annual revenues exceed $250 million.23 Although it seems certain that some of these cable system operators are affiliated with entities whose gross annual revenues exceed $250,000,000, we are unable at this time to estimate with greater precision the number of cable system operators that would qualify as small cable operators under the definition in the Communications Act.

    19 47 U.S.C. 543(m)(2); see 47 CFR 76.901(f) & nn. 1-3.

    20See NCTA, Industry Data, Cable's Customer Base, http://www.ncta.com/industry-data (visited October 13, 2014).

    21 47 CFR 76.901(f).

    22See NCTA, Industry Data, Top 25 Multichannel Video Service Customers (2012), http://www.ncta.com/industry-data (visited Aug. 30, 2013).

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

    13. Open Video Systems. The open video system (OVS) framework was established in 1996, and is one of four statutorily recognized options for the provision of video programming services by local exchange carriers.24 The OVS framework provides opportunities for the distribution of video programming other than through cable systems. Because OVS operators provide subscription services,25 OVS falls within the SBA small business size standard covering cable services, which is “Wired Telecommunications Carriers.” 26 The SBA has developed a small business size standard for this category, which is: all such businesses having 1,500 or fewer employees.27 Census data for 2007 shows that there were 3,188 firms that operated for that entire year.28 Of this total, 2,940 firms had fewer than 100 employees, and 248 firms had 100 or more employees.29 Therefore, under this size standard, we estimate that the majority of these businesses can be considered small entities.

    24 47 U.S.C. 571(a)(3)-(4).

    25See 47 U.S.C. 573.

    26 See 13 CFR 121.201, 2012 NAICS code 517110. This category of Wired Telecommunications Carriers is defined in part as follows: “This industry comprises establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or a combination of technologies. Establishments in this industry use the wired telecommunications network facilities that they operate to provide a variety of services, such as wired telephony services, including VoIP services; wired (cable) audio and video programming distribution; and wired broadband Internet services.” U.S. Census Bureau, 2012 NAICS Definitions, “517110 Wired Telecommunications Carriers,” at http://www.census.gov/cgi-bin/sssd/naics/naicsrch.

    27 13 CFR 121.201; 2012 NAICS code 517110.

    28 U.S. Census Bureau, 2007 Economic Census. See U.S. Census Bureau, American FactFinder, “Information: Subject Series—Estab and Firm Size: Employment Size of Establishments for the United States: 2007—2007 Economic Census,” NAICS code 517110, Table EC0751SSSZ5; available at http://factfinder2.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ5&prodType=table.

    29Id.

    14. Television Broadcasting. This economic Census category “comprises establishments primarily engaged in broadcasting images together with sound.” 30 The SBA has created the following small business size standard for such businesses: those having $38.5 million or less in annual receipts.31 The 2007 U.S. Census indicates that 808 firms in this category operated in that year. Of that number, 709 had annual receipts of $25,000,000 or less, and 99 had annual receipts of more than $25,000,000.32 Because the Census has no additional classifications that could serve as a basis for determining the number of stations whose receipts exceeded $38.5 million in that year, we conclude that the majority of television broadcast stations were small under the applicable SBA size standard.

    30 U.S. Census Bureau, 2012 NAICS Definitions, “515120 Television Broadcasting,” at http://www.census.gov./cgi-bin/sssd/naics/naicsrch.

    31 13 CFR 121.201; 2012 NAICS code 515120.

    32 U.S. Census Bureau, Table No. EC0751SSSZ4, Information: Subject Series—Establishment and Firm Size: Receipts Size of Firms for the United States: 2007 (515120), http://factfinder2.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ4&prodType=table.

    15. Apart from the U.S. Census, the Commission has estimated the number of licensed commercial television stations to be 1,387 stations.33 Of this total, 1,221 stations (or about 88 percent) had revenues of $38.5 million or less, according to Commission staff review of the BIA Kelsey Inc. Media Access Pro Television Database (BIA) on July 2, 2014. In addition, the Commission has estimated the number of licensed noncommercial educational (NCE) television stations to be 395.34 NCE stations are non-profit, and therefore considered to be small entities.35 Based on these data, we estimate that the majority of television broadcast stations are small entities.

    33 See Broadcast Station Totals as of June 30, 2014, Press Release (MB rel. July 9, 2014) (Broadcast Station Totals) at https://apps.fcc.gov/edocs_public/attachmatch/DOC-328096A1.pdf.

    34 See Broadcast Station Totals, supra.

    35See generally 5 U.S.C. 601(4), (6).

    16. We note, however, that in assessing whether a business concern qualifies as “small” under the above definition, business (control) affiliations 36 must be included. Because we do not include or aggregate revenues from affiliated companies in determining whether an entity meets the revenue threshold noted above, our estimate of the number of small entities affected is likely overstated. In addition, we note that one element of the definition of “small business” is that an entity not be dominant in its field of operation. We are unable at this time to define or quantify the criteria that would establish whether a specific television broadcast station is dominant in its field of operation. Accordingly, our estimate of small television stations potentially affected by the proposed rules includes those that could be dominant in their field of operation. For this reason, such estimate likely is over-inclusive.

    36 “[Business concerns] are affiliates of each other when one concern controls or has the power to control the other or a third party or parties controls or has the power to control both.” 13 CFR 21.103(a)(1).

    4. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements for Small Entities

    17. In this section, we describe the reporting, recordkeeping, and other compliance requirements that the Commission adopts in the Sixth Report and Order.

    18. Reporting Requirements. The Sixth Report and Order does not adopt reporting requirements.

    19. Recordkeeping Requirements. The joint proposal adopted in the Sixth Report and Order requires that, “[b]eginning December 12, 2016, at the time a small cable system utilizing the HD carriage exemption offers any programming in HD, the system must give notice that it is offering HD programming to all broadcast stations in its market that are carried on its system.” This requirement obligates certain small cable operators to notify broadcast stations, and thus, to make and keep records of such notification.

    20. Other Compliance Requirements. The joint proposal adopted in the Sixth Report and Order:

    • Requires “[a] cable system utilizing the HD carriage exemption on June 12, 2015 that does not qualify for the HD carriage exemption on or after June 13, 2015 [to] come into compliance [with the HD carriage requirement] by December 12, 2016. A cable system that becomes ineligible for the HD carriage exemption after December 12, 2016 would be expected to come into compliance promptly.”

    • Requires that “[b]eginning December 12, 2016, a system utilizing the HD carriage exemption shall no longer be eligible to use it once the system offers any programming in HD.”

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

    21. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.37 We seek comment on the applicability of any of these alternatives to affected small entities.

    37 5 U.S.C. 603(c)(1)-(c)(4).

    22. The HD carriage exemption, as modified in the Sixth Report and Order, provides continued regulatory relief to operators of certain small cable systems, i.e., those that (i) serve 1,500 or fewer subscribers and are not affiliated with a cable operator serving more than two percent of all MVPD subscribers; or (ii) have an activated channel capacity of 552 MHz or less. Although some eligible cable systems will no longer qualify for the exemption as a result of the Sixth Report and Order, the joint proposal adopted in the order gives such systems until December 12, 2016 to come into compliance with the HD carriage requirement. We note that the modifications made to the exemption in the Sixth Report and Order were an outgrowth of discussions between ACA and NAB and thus reflect the interests of both small cable operators and broadcasters (including small broadcasters), respectively. The HD carriage exemption has a positive economic impact on any cable system operator that takes advantage of the exemption, and imposes no significant burdens on small television stations.

    6. Report to Congress

    23. The Commission will send a copy of this Sixth Report and Order, including this FRFA, in a report to be sent to Congress pursuant to the SBREFA.38 In addition, the Commission will send a copy of this Sixth Report and Order, including the FRFA, to the Chief Counsel for Advocacy of the SBA. A copy of this Sixth Report and Order and the FRFA (or summaries thereof) also will be published in the Federal Register.39

    38See id. 801(a)(1)(A).

    39 See id. 604(b).

    B. Paperwork Reduction Act

    24. This Sixth Report and Order contains new information collection requirements subject to the Paperwork Reduction Act of 1995. It will be submitted to the Office of Management and Budget (OMB) for review under Section 3507(d) of the PRA. OMB, the general public, and other Federal agencies are invited to comment on the new or modified information collection requirements contained in this proceeding. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), we previously sought specific comment on how the Commission might further reduce the information collection burden for small business concerns with fewer than 25 employees.

    C. Congressional Review Act

    25. The Commission will send a copy of this Sixth Report and Order in a report to be sent to Congress and the Government Accountability Office, pursuant to the Congressional Review Act.40

    40See 5 U.S.C. 801(a)(1)(A).

    D. Additional Information

    26. For more information, contact Raelynn Remy, [email protected], Policy Division, Media Bureau, (202) 418-2936.

    V. Ordering Clauses

    27. Accordingly, it is ordered that, pursuant to the authority found in sections 4, 303, 614, and 615 of the Communications Act of 1934, as amended, 47 U.S.C. 154, 303, 534, and 535, this Sixth Report and Order is adopted and will become effective July 23, 2015, except that the requirement described in paragraph III.4.b of the Supplementary Information, which contains new or modified information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13, will not become effective until the Federal Communications Commission publishes a notice in the Federal Register announcing OMB approval and the effective date of that rule.

    28. It is further ordered that, pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A), the Commission will send a copy of this Sixth Report and Order in CS Docket No. 98-120 in a report to Congress and the Government Accountability Office.

    29. It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, will send a copy of this Sixth Report and Order in CS Docket No. 98-120, including the Final Regulatory Flexibility Act Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2015-15251 Filed 6-22-15; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 572 [Docket No. NHTSA-2011-0175] RIN 2127-AJ49 Hybrid III 10-Year-Old Child Test Dummy; Corrections; Incorporation by Reference AGENCY:

    National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).

    ACTION:

    Technical amendments.

    SUMMARY:

    NHTSA published a document in the Federal Register on February 27, 2012 (77 FR 11651), establishing specifications and qualification requirements for a Hybrid III 10-year-old child size test dummy. The regulatory text adopted by that document contained errors, as did some of the drawings of the test dummy and other materials incorporated by reference pertaining to the test dummy. This document corrects those errors by revising regulatory text and incorporating by reference a corrected drawing package. We have also made conforming changes to the parts list and users' manual for the dummy, which this document also incorporates by reference.

    DATES:

    Effective date: June 23, 2015. The incorporation by reference of the publications listed in this document has been approved by the Director of the Federal Register as of June 23, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Peter Martin, NHTSA Office of Crashworthiness Standards, 1200 New Jersey Avenue SE., Washington, DC 20590, telephone (202) 366-5668, fax (202) 493-2990, or Deirdre Fujita, NHTSA Office of Chief Counsel, 1200 New Jersey Avenue SE., Washington, DC 20590, telephone (202) 366-2992, fax (202) 366-3820.

    SUPPLEMENTARY INFORMATION:

    This document corrects 49 CFR part 572, “Anthropomorphic Test Devices,” Subpart T, “Hybrid III 10-Year-Old Child Test Dummy (HIII-10C).” NHTSA published a final rule on February 27, 2012 (77 FR 11651), establishing Subpart T, which contains specifications and qualification requirements for the HIII-10C. The regulatory text adopted by that document contains errors, as do some of the drawings and other materials incorporated by reference pertaining to the test dummy. This document corrects those errors by revising regulatory text and incorporating by reference a corrected drawing package, parts list and users' manual.

    Need for Correction Corrected Regulatory Text

    The following corrections are made to the regulatory text.

    a. Sections 572.170 and 572.171 of subpart T incorporate by reference a drawings and inspection package, a parts/drawing list, and a users' manual (“Procedures for Assembly, Disassembly and Inspection” (“PADI”)) for the HIII-10C by name and by date. NHTSA is correcting several drawings in the package, and is making conforming changes to the parts list and to several figures in the PADI. For ease of use, rather than switch out individual drawings from the previous drawings package and individual pages from the original PADI and risk confusion by users in the future about which drawings and pages were replaced, NHTSA is incorporating by reference a new set of materials. We are referencing a new drawings and inspection package that has the corrected drawings, a new parts/drawing list, and a new PADI. All these new materials are dated March 2015. We are amending § 572.170 and § 572.171 to reference the new versions of the materials.

    b. The February 2012 final rule incorrectly specifies in 49 CFR 572.177(a)(1) that the thorax impact probe mass is 6.89 ± 0.012 kilograms (kg) (15.2 ± 0.05 pounds (lb)). Figure T4 of subpart T correctly lists the thorax impact probe mass as “6.89 ± 0.05 kg (15.2 ± 0.1 lb).” We are correcting the second sentence of 49 CFR 572.177(a)(1) so that it refers to “6.89 ± 0.05 kg (15.2 ± 0.1 lb).”

    Likewise, the February 2012 final rule incorrectly specifies in § 572.177(a)(2) that the knee impact probe mass is 1.91 ± 0.01 kg (4.21 ± 0.02 lb). Figure T6 of subpart T correctly lists the knee impact probe mass as “1.91 ± 0.05 kg (4.2 ± 0.1 lb).” We are correcting the second sentence of 49 CFR 572.177(a)(2) to reference a mass of 1.91 ± 0.05 kg (4.21 ± 0.1 lb).

    c. The February 2012 final rule inadvertently excluded a specification for the filter class used for the knee probe acceleration and for the thorax probe acceleration. The filter class used for the knee probe acceleration is SAE International (SAE) Channel Frequency Class (CFC) 600. CFC 600 has historically been applied to other dummy knee probe accelerations and NHTSA used CFC 600 in developmental testing of the HIII-10C. The filter class used for the thorax probe acceleration is CFC 180. NHTSA specifies the CFC 180 filter class with other test dummies and used it in developing the HIII-10C. Accordingly, NHTSA corrects 49 CFR 572.177(c) by adding the filter classes for the knee and thorax probe accelerations.

    Corrected Drawings Drawing 420-5120, Upper Leg Flesh

    In the revisions table for this drawing, in Rev F, the overall Upper Leg Flesh height dimension is correctly specified as “4.50 +.06/−.18 (was 4.5 +.16/−.13).” Elsewhere on the drawing, the height dimension next to the part does not match this value in the table. We have corrected the height dimension next to the part to match that of the table.

    In Drawing 420-5120, the dimension for the overall Upper Leg Flesh width is correctly listed, next to the part, as “4.92 +.05/−.20.” In the revisions table, Rev F, the width dimension is different and incorrect. We have corrected the revisions table to match the dimension listed next to the part.

    Drawing 420-4300, Abdomen

    In the revision history table, Rev F, the width of the abdomen pocket is correctly stated as (3.77) and the depth is correctly stated as (2.14). Elsewhere on the drawing, the dimensions listed for those parts do not match those correct dimensions in the revision history table. We have corrected the drawing to match the correct dimensions in the table.

    In the revision history table, Rev E, Note #2 had read: “All Dimensional Tolerances Are ±0.12 inch.” The note was incorrectly removed, and in Rev F, a ±0.06 inch tolerance was incorrectly added to two dimensions (0.75 ±0.06 and 0.62 ±0.06). The ±0.06 inch tolerance is in error; it is an unrealistic dimensional requirement for a molded part. We have revised the drawing to reestablished the ±0.12 inch tolerance for this part.

    Drawing 420-1001, Skull, Machining, 6-Axis

    The drawing package incorporated by the February 2012 final rule had drawing 880105-102, which had an error with respect to the dimensions called out for the center of gravity (CG) location of the skull. The correct CG dimensions for the head assembly are in drawing 420-0000, Sheet 4 of 5, as follows: CGx = 2.330 ± 0.100 inch and CGz = 1.200 ± 0.100 inch. We have removed drawing 880105-102 and have revised drawing 420-1001 (Rev D) to add information on the CG location.

    Revisions Relating to Shoulder Assembly Drawings

    Some of the drawings of the HIII-10C's shoulder area are incorrect because they depict the design of the dummy at the time of our publication of the notice of proposed rulemaking (NPRM) 1 preceding the February 2012 final rule, and not the design of the HIII-10C as it was adopted by the final rule. As adopted by the final rule, the HIII-10C has a shoulder assembly design that can be modified by switching a part of the shoulder assembly (the shoulder yoke), to enable the dummy shoulder to accommodate either a load cell or a structural replacement (SR) in place of a load cell. The drawings adopted by the final rule show the shoulder yoke that accommodates an SR, but we inadvertently did not include drawings showing the HIII-10C with the shoulder yoke assembly that accommodates a load cell. We have corrected this oversight by including in the new drawing package drawings of the alternate shoulder yoke assembly that accommodates a load cell, and drawings of the load cell and assorted hardware.

    1 70 FR 40281, July 13, 2005, Docket No. NHTSA-2004-21247.

    Corrected PADI

    We have revised various figures in the PADI to conform the manual to the changes discussed above. Most of the revisions relate to using the shoulder yoke assembly when using the HIII-10C with a shoulder load cell. The revised figures are: 12, 21, 22, 24, 29, 82 and 83.

    List of Subjects in 49 CFR Part 572

    Motor vehicle safety, Incorporation by reference.

    Accordingly, 49 CFR part 572 is corrected by making the following correcting amendments:

    PART 572—ANTHROPOMORPHIC TEST DUMMIES 1. The authority citation for Part 572 is revised to read as follows: Authority:

    49 U.S.C. 322, 30111, 30115, 30117 and 30166; delegation of authority at 49 CFR 1.95

    Subpart T—Hybrid III 10-Year-Old Child Test Dummy (HIII-10C) 2. Section 572.170 is amended by revising paragraph (b)(1), the introductory text of paragraph (b)(2), and paragraph (b)(3), to read as follows:
    § 572.170 Incorporation by reference.

    (b) * * *

    (1) A parts/drawing list entitled, “Parts/Drawing List, Part 572 Subpart T, Hybrid III 10 Year Old Child Test Dummy (HIII-10C), March, 2015,” IBR approved for § 572.171.

    (2) A drawings and inspection package entitled, “Parts List and Drawings, Part 572 Subpart T, Hybrid III 10 Year Old Child Crash Dummy (HIII-10C), March 2015,” IBR approved for § 572.171, including:

    (3) A procedures manual entitled “Procedures for Assembly, Disassembly, and Inspection (PADI) of the Hybrid III 10 Year Old Child Test Dummy (HIII-10C), March 2015”; IBR approved for §§ 572.171 and 572.177.

    3. Section 572.171 is amended by revising paragraphs (a)(1) and (a)(2), and the introductory text of paragraph (a)(3), to read as follows:
    § 572.171 General description.

    (a) * * *

    (1) The parts enlisted in “Parts/Drawing List, Part 572 Subpart T, Hybrid III 10 Year Old Child Test Dummy (HIII-10C), March, 2015” (incorporated by reference, see § 572.170),

    (2) The engineering drawings and specifications contained in “Parts List and Drawings, Part 572 Subpart T, Hybrid III 10 Year Old Child Crash Dummy (HIII-10C), March 2015,” which includes the engineering drawings and specifications described in Drawing 420-0000, the titles of the assemblies of which are listed in Table A, and,

    (3) A manual entitled “Procedures for Assembly, Disassembly, and Inspection (PADI) of the Hybrid III 10 Year Old Child Test Dummy (HIII-10C), March 2015.”

    4. Section 572.177 is amended by revising the second sentence in paragraph (a)(1) and the second sentence in paragraph (a)(2), and by adding paragraphs (c)(18) and (c)(19), to read as follows:
    § 572.177 Test conditions and instrumentation.

    (a) * * *

    (1) * * * It has a mass of 6.89 ± 0.05 kg (15.2 ± 0.1 lb) and a minimum mass moment of inertia of 2040 kg-cm2 (1.81 lbf-in-sec2) in yaw and pitch about the CG. * * *

    (2) * * * It has a mass of 1.91 ± 0.05 kg (4.21 ± 0.1 lb) and a minimum mass moment of inertia of 140 kg-cm2 (0.124 lbf-in-sec2) in yaw and pitch about the CG. * * *

    (c) * * *

    (18) Thorax probe acceleration, CFC 180,

    (19) Knee probe acceleration, CFC 600.

    Issued May 22, 2015. Raymond R. Posten, Associate Administrator For Rulemaking.
    [FR Doc. 2015-15279 Filed 6-22-15; 8:45 am] BILLING CODE 4910-59-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-R1-ES-2015-0031; FXES11130900000C6-156-FF09E42000] RIN 1018-BA89 Endangered and Threatened Wildlife and Plants; Technical Corrections for 54 Wildlife and Plant Species on the List of Endangered and Threatened Wildlife and Plants AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Direct final rule.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), announce the revised taxonomy of 4 wildlife species and 50 plant species under the Endangered Species Act of 1973, as amended (Act). We are revising the List of Endangered and Threatened Wildlife and the List of Endangered and Threatened Plants to reflect the current scientifically accepted taxonomy and nomenclature of these species.

    DATES:

    This rule is effective September 21, 2015 without further action, unless significant adverse comment is received by July 23, 2015. If significant adverse comment is received regarding taxonomic changes for any of these species, we will publish in the Federal Register a timely withdrawal of the rule.

    ADDRESSES:

    You may submit comments by one of the following methods:

    Electronically: Go to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments to FWS-R1-ES-2015-0031, which is the docket number for this rulemaking.

    By hard copy: Submit comments by U.S. mail or hand-delivery to: Public Comments Processing, Attn: FWS-R1-ES-2015-0031; Division of Policy, Performance, and Management Programs; U.S. Fish and Wildlife Service; 5275 Leesburg Pike MS: BPHC, Falls Church, VA 22041-3803.

    See Public Comments in SUPPLEMENTARY INFORMATION for more information about submitting comments.
    FOR FURTHER INFORMATION CONTACT:

    Marilet Zablan, Program Manager for Restoration and Endangered Species Classification, U.S. Fish and Wildlife Service, Pacific Regional Office, Ecological Services, 911 NE 11th Avenue, Portland, OR 97232; telephone 503-231-6131. Individuals who are hearing impaired or speech impaired may call the Federal Relay Service at 800-877-8337 for TTY (telephone typewriter or teletypewriter) assistance 24 hours a day, 7 days a week.

    SUPPLEMENTARY INFORMATION:

    Purpose of Direct Final Rule and Final Action

    The purpose of this direct final rule is to notify the public that we are revising the List of Endangered and Threatened Wildlife in title 50 of the Code of Federal Regulations (50 CFR 17.11(h)) and the List of Endangered and Threatened Plants (50 CFR 17.12(h)) to reflect the scientifically accepted taxonomy and nomenclature of 4 wildlife species and 50 plant species listed under section 4 of the Act (16 U.S.C. 1531 et seq.). These changes to the List of Endangered and Threatened Wildlife and the List of Endangered and Threatened Plants reflect the most recently accepted scientific names in accordance with 50 CFR 17.11(b) and 50 CFR 17.12(b).

    We are publishing this rule without a prior proposal because this is a noncontroversial action that is in the best interest of the public and should be undertaken in as timely a manner as possible. This rule will be effective, as published in this document, on the effective date specified in DATES, unless we receive significant adverse comments on or before the comment due date specified in DATES. Significant adverse comments are comments that provide strong justifications as to why this rule should not be adopted or why it should be changed.

    If we receive significant adverse comments regarding the taxonomic changes for any of these species, we will publish a document in the Federal Register withdrawing this rule before the effective date, and we will publish a proposed rule to initiate promulgation of those changes to 50 CFR 17.11 or 50 CFR 17.12.

    Public Comments

    You may submit your comments and materials regarding this direct final rule by one of the methods listed in ADDRESSES. Please include sufficient information with your comments that allows us to verify any scientific or commercial information you include. We will not consider comments sent by email or fax, or to an address not listed in ADDRESSES.

    We will post all comments on http://www.regulations.gov. Before including your address, phone number, email address, or other personal information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Comments and materials we receive, as well as supporting documentation we use in preparing this direct final rule, will be available for public inspection on the Internet at http://www.regulations.gov or by appointment, during normal business hours at the U.S. Fish and Wildlife Service office listed in the ADDRESSES section. Please note that comments posted to http://www.regulations.gov are not immediately viewable. When you submit a comment, the system receives it immediately. However, the comment will not be publicly viewable until we post it, which might not occur until several days after submission. Information regarding this rule is available in alternative formats upon request (see FOR FURTHER INFORMATION CONTACT). For information pertaining to specific species, please contact our Ecological Services field offices as follows:

    Species Contact person, phone, Email Contact address Hawaiian plants Kristi Young, Fish and Wildlife Biologist; 808-792-9400, [email protected] Pacific Islands Fish and Wildlife Office, U.S. Fish and Wildlife Service, 300 Ala Moana Blvd., Room 3-122, Honolulu, HI 96813. Guam and Hawaiian birds Kristi Young, Fish and Wildlife Biologist; 808-792-9400, [email protected] Pacific Islands Fish and Wildlife Office, U.S. Fish and Wildlife Service, 300 Ala Moana Blvd., Room 3-122, Honolulu, HI 96813. Willamette daisy and large-flowered woolly meadowfoam Jeff Dillon, Fish and Wildlife Biologist; 503-231-6179, [email protected] Oregon Fish and Wildlife Office, U.S. Fish and Wildlife Service, 2600 SE 98th Avenue, Portland, OR 97266. Northern Idaho ground squirrel Kim Garner, Fish and Wildlife Biologist; 208-378-5243, [email protected] Idaho Fish and Wildlife Office, U.S. Fish and Wildlife Service, 1387 S. Vinnell Way, Room 368, Boise, ID 83709. Background

    Sections 17.11(b) and 17.12(b) of title 50 of the Code of Federal Regulations (CFR) requires us to use the most recently accepted scientific name of any wildlife or plant species that we have determined to be an endangered or threatened species. Using the best available scientific information, this direct final rule documents taxonomic changes of the scientific names to 4 entries on the List of Endangered and Threatened Wildlife (50 CFR 17.11(h)) and 31 entries on the List of Endangered and Threatened Plants (50 CFR 17.12(h)). The basis for these taxonomic changes is supported by published studies in peer-reviewed journals. Accordingly, we revise the scientific names of these species under section 4 of the Act (16 U.S.C. 1531 et seq.) as follows: northern Idaho ground squirrel (Urocitellus brunneus); Hawaiian common gallinule (Gallinula galeata sandvicensis); Guam kingfisher (Todiramphus cinnamominus); Hawaiian petrel (Pterodroma sandwichensis); Cyanea crispa (haha); Cyanea rivularis (haha); Cyperus fauriei (no common name); Erigeron decumbens (Willamette daisy); Euphorbia celastroides var. kaenana (`akoko); Euphorbia deppeana (`akoko); Euphorbia eleanoriae (`akoko); Euphorbia halemanui (`akoko); Euphorbia herbstii (`akoko); Euphorbia kuwaleana (`akoko); Euphorbia remyi var. kauaiensis (`akoko); Euphorbia remyi var. remyi (`akoko); Euphorbia rockii (`akoko); Euphorbia skottsbergii var. skottsbergii (`Ewa Plains `akoko); Kadua cookiana (`awiwi); Kadua st-johnii (no common name); Limnanthes pumila ssp. grandiflora (large-flowered woolly meadowfoam); Lobelia koolauensis (no common name); Polyscias bisattenuata (no common name); Polyscias flynnii (no common name); Polyscias gymnocarpa (`ohe`ohe); Polyscias lydgatei (no common name); Polyscias racemosa (no common name); Pritchardia maideniana (lo`ulu); Schiedea lychnoides (kuawawaenohu); Schiedea viscosa (no common name); Sicyos albus (`anunu); Asplenium dielfalcatum (no common name); Asplenium dielmannii (no common name); Asplenium dielpallidum (no common name); and Asplenium unisorum (no common name). We make these changes to the List of Endangered and Threatened Wildlife and the List of Endangered and Threatened Plants to reflect the most recently accepted scientific names in accordance with 50 CFR 17.11(b) and 50 CFR 17.12(b).

    Additionally, common names of 3 additional species (Cyanea platyphylla (`aku`aku), Dubautia latifolia (koholapehu), and Geranium arboreum (nohoanu)) are revised to reflect currently accepted usage. And family assignments of 16 species (Flueggea neowawraea (mehamehame), Korthalsella degeneri (hulumoa), Lysimachia daphnoides (lehua makanoe), L. iniki (no common name), L. pendens (no common name), L. scopulensis (no common name), L. venosa (no common name), Myrsine juddii (kolea), M. knudsenii (kolea), M. linearifolia (kolea), M. mezii (kolea), M. vaccinioides (kolea), Pleomele hawaiiensis (hala pepe), Xylosma crenatum (no common name), Adenophorus periens (pendent kihi fern), and Diplazium molokaiense (no common name)) are also revised.

    Taxonomic Classification Northern Idaho ground squirrel

    The northern Idaho ground squirrel was originally listed as threatened on April 5, 2000, under the scientific name Spermophilus brunneus brunneus (65 FR 17779). At that time this taxon and the southern Idaho ground squirrel (S. b. endemicus) were both considered to be subspecies of the Idaho ground squirrel, Spermophilus brunneus (Thorington and Hoffmann 2005, p. 805). Helgen et al. (2009, pp. 270-305) split the genus Spermophilus into eight genera: Urocitellus (including the Idaho ground squirrel), Notocitellus, Otospermophilus, Callospermophilus, Spermophilus, Ictidomys, Poliocitellus, and Xerospermophilus, based on skull morphology, pelage characteristics, and mitochondrial DNA analyses (Herron et al. 2004, pp. 1015-1030). The northern Idaho ground squirrel and the southern Idaho ground squirrel differ in pelage, life-history timing, and skull and bacular morphology (Yensen and Sherman 1997, pp. 1-3), and analysis of microsatellite and mitochondrial DNA shows no evidence of recent genetic exchange between the two taxa (Hoisington-Lopez et al. 2012, pp. 589-604). Consequently, Hoisington-Lopez et al. (2012, pp. 595-599) elevated both taxa to species rank, as Urocitellus brunneus and U. endemicus. This taxonomic change does not affect the range or threatened status of the northern Idaho ground squirrel. The Service has used the updated scientific name U. endemicus for the southern Idaho ground squirrel (currently a candidate for listing under the Endangered Species Act) since publication of the candidate notice of review on November 22, 2013 (78 FR 70104).

    Hawaiian common gallinule

    This subspecies was originally listed as endangered on March 11, 1967, under the name of Hawaiian common gallinule (Gallinula chloropus sandvicensis) (32 FR 4001). At that time, the range of Gallinula chloropus was considered to include both the Old World and New World, with the common name of “common gallinule” in American usage (American Ornithologists' Union [AOU] 1957, pp. 160-161) and “moorhen” or “common moorhen” in British usage (e.g., Dudley et al. 2006, p. 537). Subsequently the AOU (1982, p. 5CC) changed the common name of the species to “common moorhen” for consistency with international usage. The current List of Endangered and Threatened Wildlife is consistent with this approach, listing the species as “Hawaiian common moorhen”. However, more recent research indicates that the New World and Old World populations are separate species, based on differences in vocalizations and morphology of the bill and frontal shield (Constantine and the Sound Approach 2006, pp. 138-139) and mitochondrial DNA (Groenenberg et al. 2008, pp. 1-8). Based on this research, AOU accepts the two populations as distinct species (Chesser et al. 2011, p. 603), splitting them into the common gallinule (Gallinula galeata) of North and South America and the common moorhen (Gallinula chloropus) of Eurasia. Chesser et al. (2011, p. 603) includes the Hawaiian Islands within the range of the common gallinule. Data from Hawaiian birds were not analyzed by Constantine and the Sound Approach (2006, pp. 138-139) or Groenenberg et al. (2008, pp. 1-8); however, specimens from the Hawaiian Islands are similar to New World birds in frontal shield morphology, and a mitochondrial DNA sequence from a Hawaiian specimen is identical to those of New World specimens (T. Chesser in litt. 2012). Consequently, the Hawaiian subspecies is now classified as Gallinula galeata sandvicensis, and returns to its original common name of “Hawaiian common gallinule”. The taxonomic change does not affect the range or endangered status of the Hawaiian common gallinule.

    The taxonomic position of the Mariana common moorhen, listed as endangered on August 27, 1984 (49 FR 33881) under the scientific name of Gallinula chloropus guami, has not been studied in detail; however, its frontal shield morphology appears more similar to Old World specimens (T. Chesser in litt. 2012). Consequently, the best available information indicates that its common and scientific names are still appropriate.

    Guam kingfisher

    This bird was originally listed as endangered within its range on Guam on August 27, 1984, under the name of Micronesian kingfisher (Halcyon cinnamomina cinnamomina) (49 FR 33881). The Service's critical habitat designation (69 FR 62944; October 28, 2004) revised the common name of this taxon in the List of Endangered and Threatened Wildlife to “Guam Micronesian kingfisher”, given that two other subspecies of Micronesian kingfisher occur outside Guam.

    At the time this taxon was listed, the genus Halcyon encompassed several dozen kingfisher species ranging from Africa to Australasia and the Pacific islands (Forshaw 1983; Fry et al. 1992, as cited in Moyle 2006, p. 496; Howard and Moore 1991, pp. 168-169). The Australasian and Pacific species within this group are distinctive based on plumage pattern, myology, osteology, feather proteins, and DNA hybridization data (Sibley and Monroe 1990, pp. 89-90; Woodall 2001; Christidis and Boles 2008, p. 169). Analysis of nuclear and mitochondrial DNA (Moyle 2006, pp. 487-499) further indicates that the group of species originally classified under the genus Halcyon is not monophyletic (a monophyletic group consists of an ancestral species and all its descendants, typically being characterized by shared derived characteristics). Consequently most recent authorities (e.g., Woodall 2001, p. 134; Dickinson 2003) have restricted Halcyon to the African species; other species in the group have been classified under the genera Todiramphus (including the Micronesian kingfisher), Pelargopsis, and Syma. When the Micronesian kingfisher was classified within Todiramphus, its specific epithet was changed to cinnamominus for consistency with the gender of the new genus name. Del Hoyo et al. (2014, p. 606) reviewed the three subspecies of Micronesian kingfisher (T. cinnamominus on Guam, T. pelewensis on Palau, and T. reichenbachi on Pohnpei) under the species delimitation criteria of Tobias et al. (2010, pp. 1-23), and concluded that they were distinct at the species level based on differences in plumage pattern, wing and tail proportions, body size, and voice. Consequently, the listed population on Guam is now classified as a full species, Guam kingfisher (Todiramphus cinnamominus). The taxonomic change does not affect the range or endangered status of the taxon.

    Hawaiian petrel

    This bird was originally listed as endangered on March 11, 1967, under the name of Hawaiian dark-rumped petrel (Pterodroma phaeopygia sandwichensis) (32 FR 4001). At that time, the dark-rumped petrel (Pterodroma phaeopygia) was considered to include two subspecies: P. sandwichensis, which breeds on the Hawaiian Islands; and P. phaeopygia, which breeds on the Galapagos Islands and is not known to occur in the United States (AOU 1983, p. 16). More recently, study of the morphology and vocalizations of these two taxa (Tomkins and Milne 1991, pp. 1-35; Browne et al. 1997, pp. 812-815) indicates that they are distinct at a level comparable to other species in the genus. Consequently, the AOU has split them into two species, the Hawaiian petrel (Pterodroma sandwichensis) and the Galapagos petrel (Pterodroma phaeopygia) (Banks et al. 2002, p. 898). On January 5, 2010, the Galapagos petrel was also listed (as threatened), under the now accepted scientific name of Pterodroma phaeopygia (75 FR 235). The taxonomic change does not affect the range or endangered status of the Hawaiian petrel, nor does it affect the range or threatened status of the Galapagos petrel.

    Erigeron decumbens (Willamette daisy)

    The Willamette daisy was listed as endangered on January 25, 2000, under the scientific name Erigeron decumbens var. decumbens (65 FR 3875). At that time E. decumbens was considered to include two varieties, decumbens and robustior. Nesom (2004, pp. 19-39) elevated var. robustior to full species status, finding that the taxon was distinctive in morphology (involucre size, shape of phyllaries, length of corollas and cypselae) and soil habitat preference at a level similar to that of other species of Erigeron. Since var. decumbens was thus the only remaining variety within the species, rendering designation of a nominate variety superfluous, the taxon was renamed as the full species E. decumbens. This treatment has been adopted by the Flora of North America (Nesom 2006, pp. 274-279) and the Oregon Flora Project (Cook et al. 2014a, p. 64). Consequently, the current scientific name of the Willamette daisy is Erigeron decumbens. This taxonomic change does not affect the range or endangered status of the Willamette daisy.

    Limnanthes pumila ssp. grandiflora (large-flowered woolly meadowfoam)

    The large-flowered woolly meadowfoam was listed as endangered on November 7, 2002, under the scientific name Limnanthes floccosa ssp. grandiflora (67 FR 68004). At that time the species L. floccosa was considered to include five subspecies: L. f. ssp. bellingeriana, L. f. ssp. californica, L. f. ssp. floccosa, L. f. ssp. grandiflora, and L. f. ssp. pumila (Arroyo 1973, pp. 177-191; Ornduff 1993, pp. 736-738; Morin 2010, pp. 174-183). Meyers (2010) analyzed chloroplast, mitochondrial, and nuclear DNA of these subspecies and found they represented two clades: ssp. grandiflora and ssp. pumila in one, and ssp. bellingeriana, ssp. californica, and ssp. floccosa in the other; moreover, ssp. grandiflora and ssp. floccosa showed pre- and post-zygotic reproductive isolation from one another when crossed by hand. Consequently, Meyers (2010, pp. 1-121) and Chambers and Meyers (2011, pp. 621-622) reclassified ssp. grandiflora and ssp. pumila within a separate species L. pumila. This treatment has been adopted by the Oregon Flora Project (Cook et al. 2014b, pp. 1-2). Consequently, the current scientific name of the large-flowered woolly meadowfoam is Limnanthes pumila ssp. grandiflora. This taxonomic change does not affect the range or endangered status of the large-flowered woolly meadowfoam.

    Schiedea species

    The Hawaiian plants Alsinidendron lychnoides (kuawawaenohu) and A. viscosum (no common name) were listed as endangered on October 10, 1996 (61 FR 53070). At that time Alsinidendron was considered to be a genus of four species distinct from Schiedea (Wagner et al. 1999, pp. 499-502). However, analysis of nuclear DNA sequence data and morphology by Wagner et al. (2005, pp. 1-169) showed that the Alsinidendron clade is nested within Schiedea, as a sister group to Schiedea verticillata; thus the species in Alsinidendron were reassigned to Schiedea. The specific epithet viscosum was changed to viscosa to conform to the gender of the new generic name. These changes have been accepted in the most recent update to the Manual of the Flowering Plants of Hawaii (Wagner et al. 2012, p. 26). Consequently, the current scientific names of these species are Schiedea lychnoides and Schiedea viscosa. This taxonomic change does not affect the range or endangered status of either of these species.

    The scientific names of Alsinidendron trinerve and A. obovatum (listed as endangered on October 29, 1991 (56 FR 55770)), were revised on the List of Endangered and Threatened Plants to their updated names of Schiedea trinervis and S. obovata when critical habitat was designated on September 18, 2012 (77 FR 57648); thus no further changes in nomenclature are needed for these two species.

    Euphorbia species (`akoko)

    The `Ewa Plains `akoko, a plant endemic to southwestern Oahu, was originally listed under the scientific name Euphorbia skottsbergii var. kalaeloana on August 24, 1982 (47 FR 36846), based on the taxonomy of Sherff (1938, pp. 1-94). Degener and Degener (1959, page unnumbered) moved this species to the genus Chamaesyce, as C. skottsbergii var. kalaeloana. Koutnik (1987, pp. 356-360; 1999, pp. 614-615) synonymized var. kalaeloana with var. skottsbergii, treating var. skottsbergii with a range including southwestern Oahu and northwestern Molokai. Morden and Gregoritza (2005, pp. 969-979) found that the Oahu and Molokai populations of var. skottsbergii differed genetically, and recommended treating them as separate varieties: var. audens on Molokai, and var. skottsbergii on Oahu (including the same range as the originally listed entity). Consequently, the Service revised the List of Endangered and Threatened Plants to refer to the `Ewa Plains `akoko as Chamaesyce skottsbergii var. skottsbergii when critical habitat was designated on September 18, 2012 (77 FR 57648); however, current research supports classifying this plant in the genus Euphorbia as discussed below.

    Several other endangered Hawaiian plants are classified in the genus Chamaesyce as recognized by Degener and Degener (1959). Chamaesyce celastroides var. kaenana and C. kuwaleana were listed as endangered on October 29, 1991 (56 FR 55770); C. halemanui was listed as endangered on May 13, 1992 (57 FR 20580); C. deppeana was listed as endangered on March 28, 1994 (59 FR 14482); C. herbstii and C. rockii were listed as endangered on October 10, 1996 (61 FR 53089); C. eleanoriae, C. remyi var. kauaiensis, and C. remyi var. remyi were listed as endangered on April 13, 2010 (75 FR 18960). No common name was given for Chamaesyce halemanui when it was listed; the other species above were listed with the common name of `akoko.

    Phylogenetic analysis of nuclear and chloroplast DNA sequence data for species in the tribe Euphorbieae (Steinmann and Porter 2002, pp. 453-490; Yang and Berry 2011, pp. 1486-1503) indicate that the genus Euphorbia was paraphyletic (i.e., consisting of all the descendants of the last common ancestor of the group's members except for a small number of monophyletic groups of descendants), with Chamaesyce and several other genera nested within it. Steinman and Porter (2002, pp. 479-480) recommended expanding Euphorbia to include Chamaesyce and the other genera in the subtribe Euphorbiinae. This approach has been accepted in the most recent update to the Manual of the Flowering Plants of Hawaii (Wagner et al. 2012, pp. 31-34). Consequently, the current scientific names of the listed Chamaesyce species are now Euphorbia celastroides var. kaenana, E. deppeana, E. eleanoriae, E. halemanui, E. herbstii, E. kuwaleana, E. remyi var. kauaiensis, E. remyi var. remyi, E. rockii, and E. skottsbergii var. skottsbergii. Although no common name was designated for E. halemanui when it was listed, the common name of `akoko is also appropriate for this species (Wagner et al. 1999, p. 607). These taxonomic changes do not affect the range or endangered status of any of these species.

    Euphorbia haeleeleana (`akoko), which was listed as endangered on October 10, 1996 (61 FR 53108), is not a member of the Chamaesyce group (Wagner et al. 1999, p. 619), and its taxonomy has not changed.

    Cyanea species (haha)

    The Hawaiian plant Rollandia crispa (haha) was listed as endangered on March 28, 1994 (59 FR 14482). Phylogenetic analyses of chloroplast DNA indicated that the species classified in Rollandia were nested within the paraphyletic genus Cyanea (Lammers et al. 1993, pp. 437-441), and the species in Rollandia were, therefore, merged into Cyanea; however, Wagner et al. (1999, pp. 480-481) continued to recognize Rollandia as a genus, including Rollandia crispa. When the Service designated critical habitat for the species on June 17, 2003 (68 FR 35950), the scientific name in the List of Endangered and Threatened Plants was revised to read “Cyanea (=Rollandia) crispa”. The merger of Rollandia into Cyanea has since been accepted in the most recent update to the Manual of the Flowering Plants of Hawaii (Wagner et al. 2012, p. 24); because Rollandia is no longer a recognized genus, the parenthetical reference to it as an alternative name is unnecessary. Consequently the current scientific name of the species, as it should read in the List of Endangered and Threatened Plants, is Cyanea crispa. The current listing of “Cyanea (=Rollandia) crispa” indicates that no common name exists; this is erroneous as the common name is haha. Therefore, we are correcting this error in this rule. These changes do not affect the range or endangered status of the species.

    Cyanea platyphylla was listed as endangered on October 10, 1996 (61 FR 53137), with the common name of haha. Although this common name is generally used for species in the genus Cyanea, Wagner et al. (1999, p. 459) specifically identified `aku`aku as the appropriate common name for Cyanea platyphylla. This change in common name does not affect the range or endangered status of the species.

    Delissea rivularis (oha) was listed as endangered on October 10, 1996 (61 FR 53070). However, Lammers (2005, p. 13) found that the morphology of its leaves, flowers, and seeds is more similar to Cyanea and that molecular data indicate it is more closely related to Cyanea coriacea than to species in Delissea and, therefore, recommended transferring the species to Cyanea. This change has been accepted in the most recent update to the Manual of the Flowering Plants of Hawaii (Wagner et al. 2012, p. 23). Consequently, the current scientific name of this species is Cyanea rivularis. The common name is also changed to haha to correspond with the generally used common name for other species in Cyanea (Wagner et al. 1999, p. 437). This taxonomic change does not affect the range or endangered status of the species.

    On June 11, 2012, a proposed critical habitat rule for multiple Hawaiian species (77 FR 34464) also included proposed scientific name changes for two additional Cyanea species: Cyanea dunbarii (changed to C. dunbariae) and C. macrostegia ssp. gibsonii (changed to C. gibsonii). We expect these changes to be finalized when the final critical habitat rule is published.

    Dubautia latifolia (koholapehu)

    The Hawaiian plant Dubautia latifolia was listed as endangered on May 13, 1992 (57 FR 20580), with the common name of na`ena`e. Although this common name is generally used for species in the genus Dubautia, Wagner et al. (1999, p. 299) specifically identified koholapehu as the appropriate common name for D. latifolia. This change in common name does not affect the range or endangered status of the species.

    Geranium arboreum (nohoanu)

    The Hawaiian plant Geranium arboreum was listed as endangered on May 13, 1992 (57 FR 20589), with the common name of Hawaiian red-flowered geranium. This common name was not historically used prior to listing of the species; however, Wagner et al. (1999, p. 729) identified nohoanu or hinahina as accepted common names for native Hawaiian species of Geranium, including G. arboreum. Use of the common name nohoanu is consistent with Service practice for other listed species of Hawaiian Geranium. This change in common name does not affect the range or endangered status of the species.

    Kadua species

    The Hawaiian plant Hedyotis cookiana (`awiwi) was listed as endangered on February 25, 1994 (59 FR 9304). Hedyotis st.-johnii (Na Pali Beach hedyotis) was listed as endangered on September 30, 1991 (56 FR 49639). Terrell et al. (2005, pp. 818-833) reviewed seed and fruit morphology and floral characteristics of Hawaiian and South Pacific Hedyotis species and found that they were distinct from the Asian and North American species, reassigning them to the genus Kadua. This change has been accepted in the most recent update to the Manual of the Flowering Plants of Hawaii (Wagner et al. 2012, pp. 63-65). Consequently, the current scientific names of these species are Kadua cookiana and Kadua st.-johnii. The common name given for K. st.-johnii in the List of Endangered and Threatened Plants, Na Pali Beach hedyotis, was not historically used prior to listing of the species. Because Wagner et al. (1999, p. 1150) did not identify an independently accepted common name for this species, we are revising the List of Endangered and Threatened Plants to indicate that no common name exists. These taxonomic changes do not affect the range or endangered status of either of these species.

    On June 11, 2012, a proposed critical habitat rule for multiple Hawaiian species (77 FR 34464) also included proposed scientific name changes for two additional Hedyotis species: Hedyotis schechtendahliana var. remyi (changed to Kadua cordata ssp. remyi) and Hedyotis mannii (changed to Kadua laxiflora). We expect these changes to be finalized when the final critical habitat rule is published.

    Lobelia koolauensis

    The Hawaiian plant Lobelia gaudichaudii ssp. koolauensis (no common name) was listed as endangered on October 10, 1996 (61 FR 53089). While Wagner et al. (1999, p. 476) recognized two subspecies of L. gaudichaudii (ssp. koolauensis and ssp. gaudichaudii), differing in corolla color and branching of inflorescences, Lammers (2007, p. 797) determined that they do not interbreed where sympatric and elevated both taxa to full species status. This change has been accepted in the most recent update to the Manual of the Flowering Plants of Hawaii (Wagner et al. 2012, p. 24). Consequently, the current scientific name of this species is Lobelia koolauensis. This taxonomic change does not affect the range or endangered status of the species.

    Cyperus fauriei

    The Hawaiian sedge species Mariscus fauriei (no common name) was listed as endangered on March 4, 1994 (59 FR 10305). Historically, the genus Mariscus has also been recognized as a subgenus of Cyperus, but taxonomists have noted that no consistent characters (e.g., leaf anatomy, spikelet structure, photosynthetic metabolism type) separate the Mariscus group from other species in Cyperus, and recommend merging it within Cyperus subg. Cyperus (Lye 1981, p. 57; Tucker 1994, p. 10; Strong and Wagner 1997, p. 39). This change has been accepted in the most recent update to the Manual of the Flowering Plants of Hawaii (Wagner et al. 2012, p. 81). Consequently, the current scientific name of this species is Cyperus fauriei. This taxonomic change does not affect the range or endangered status of the species.

    Polyscias species

    The Hawaiian plant Munroidendron racemosum (no common name) was listed as endangered on February 25, 1994 (59 FR 9304). Tetraplasandra gymnocarpa (`ohe`ohe) was listed as endangered on March 28, 1994 (59 FR 14482). Tetraplasandra bisattenuata (no common name) and T. flynnii (no common name) were listed as endangered on April 13, 2010 (75 FR 18960). Tetraplasandra lydgatei (no common name) was listed as endangered on September 18, 2012 (77 FR 57648).

    Lowry and Plunkett (2010, pp. 55-84) determined, based on molecular phylogenetic studies (phylogenetics is the study of evolutionary relationships among groups of organisms that are discovered through molecular sequencing data and morphological data matrices) (Plunkett et al. 2001, pp. 213-230; 2004, pp. 861-873), that the genus Polyscias, as previously circumscribed, is paraphyletic, with six traditionally recognized genera (Arthrophyllum, Cuphocarpus, Gastonia, Munroidendron, Reynoldsia, and Tetraplasandra) nested within it. They recommended combining all of these genera into Polyscias. Species in the genera Munroidendron and Tetraplasandra were thus assigned to the genus Polyscias, subgenus Tetraplasandra. The specific epithet racemosum was changed to racemosa to conform with the gender of the new genus name. These changes have been accepted in the most recent update to the Manual of the Flowering Plants of Hawai`i (Wagner et al. 2012, pp. 7-8). Consequently, the current scientific names of these species are P. racemosa, P. gymnocarpa, P. bisattenuata, P. flynnii, and P. lydgatei. These taxonomic changes do not affect the range or endangered status of any of these species.

    Pritchardia maideniana (lo`ulu)

    The Hawaiian palm tree Pritchardia affinis (lo`ulu) was listed as endangered on March 4, 1994 (59 FR 10305). This listing followed the taxonomy of Beccari and Rock (1921, pp. 37-41), who described P. affinis, including three additional varieties (var. gracilis, var. halophila, and var. rhopalocarpa) from localities on the island of Hawai`i. Previously, Beccari (1913, pp. 213-216) had described P. maideniana from cultivated plants in the Royal Botanic Gardens, Sydney, Australia, although the geographic origin of those individuals was unclear and no wild specimens had been located (Beccari and Rock 1921, p. 23). Hodel (2007, pp. S26-S27) examined an extant cultivated plant at the Royal Botanic Gardens, plants in Hawaii grown from its seeds, living plants within the native range of P. affinis on the island of Hawai`i, and photographs of type specimens attributed to both species, and found no differences between P. affinis and P. maideniana. Because P. affinis was the more recently described, Hodel reassigned the species (including all varieties) to P. maideniana. This change has been accepted in the most recent update to the Manual of the Flowering Plants of Hawai`i (Wagner et al. 2012, p. 76). Consequently, the current scientific name of this species is P. maideniana. This taxonomic change does not affect the range in the wild or the endangered status of the species.

    Sicyos albus (`anunu)

    The Hawaiian plant Sicyos alba (`anunu) was listed as endangered on October 10, 1996 (61 FR 53137). The most recent update to the Manual of the Flowering Plants of Hawai`i (Wagner et al. 2012, p. 30) corrected the specific epithet to albus, making it consistent with the gender of the genus name. Consequently, the current scientific name of the species is Sicyos albus. This correction does not affect the range or endangered status of the species.

    Asplenium species

    The Hawaiian fern Diellia falcata was listed as endangered on October 29, 1991 (56 FR 55770). Diellia pallida was listed as endangered on February 25, 1994 (59 FR 9304). Diellia unisora was listed as endangered on June 27, 1994 (59 FR 32932). Diellia mannii was listed as endangered on April 13, 2010 (75 FR 18960).

    Kramer and Viane (1990, p. 55) and Viane and Reichstein (1991, p. 157) classified all species within the family Aspleniaceae, including the above species of Diellia, under the genus Asplenium. Analysis of molecular data by Schneider et al. (2005, pp. 455-460) indicated that Asplenium is paraphyletic and Diellia is a Hawaiian endemic clade nested within it. Therefore, Snow et al. (2011, p. 12) merged Diellia with Asplenium. Because different species had previously been described under the names A. falcatum, A. mannii, and A. pallidum, these names were not available to designate the respective Hawaiian species after the generic change (Viane and Reichstein 1991; Snow et al. 2011, p. 12). Consequently, D. falcata has been renamed A. dielfalcatum; D. mannii has been renamed A. dielmannii; and D. pallida has been renamed A. dielpallidum (Viane and Reichstein 1991, pp. 159-160; Snow et al. 2011, p. 12). Diellia unisora was also renamed A. unisorum, with the specific epithet changing to conform to the gender of the new genus name (Viane and Reichstein 1991, p. 163; Snow et al. 2011, p. 12). These changes have been accepted in the most recent update to Hawaii's Ferns and Fern Allies (Wagner et al. 2012, pp. 103-104). These taxonomic changes do not affect the range or endangered status of any of these species.

    On June 11, 2012, a proposed critical habitat rule for multiple Hawaiian species (77 FR 34464) also included proposed scientific name changes for two additional fern species: Asplenium fragile var. insulare (changed to A. peruvianum var. insulare) and Diellia erecta (changed to A. dielerectum). We expect these changes to be finalized when the final critical habitat rule is published.

    Family reassignments

    Several genera of Hawaiian plants have been recently reassigned to different families (Wagner et al. 2012, pp. 108-109), based on phylogenetic research summarized by Smith et al. (2006, pp. 705-731), Mabberley (2008, pp. 14, 278, 341, 457, 508, 568, 916), the Angiosperm Phylogeny Group (2009, pp. 105-121), and Stevens (2015). These changes have resulted in a need for revisions in the List of Endangered and Threatened Plants where the family reassignments were not reflected in the original listing rules. Flueggea neowawraea (mehamehame) is listed as a member of the family Euphorbiaceae; this should be revised to Phyllanthaceae. Korthalsella degeneri (hulumoa) is listed as a member of the family Viscaceae; this should be revised to Santalaceae. Lysimachia daphnoides (lehua makanoe), L. iniki (no common name), L. pendens (no common name), L. scopulensis (no common name), L. venosa (no common name), Myrsine juddii (kolea), M. knudsenii (kolea), M. linearifolia (kolea), M. mezii (kolea), and M. vaccinioides (kolea) are listed as members of the family Myrsinaceae; this should be revised to Primulaceae. Pleomele hawaiiensis (hala pepe) is listed as a member of the family Liliaceae; this should be revised to Asparagaceae. Xylosma crenatum (no common name) is listed as a member of the family Flacourtiaceae; this should be revised to Salicaceae. Adenophorus periens (pendent kihi fern) is listed as a member of the family Grammitidaceae; this should be revised to Polypodiaceae. Diplazium molokaiense (no common name) is listed as a member of the family Aspleniaceae; this should be revised to Woodsiaceae. These taxonomic changes do not affect the threatened or endangered status or range of any of these species.

    Required Determinations Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.)

    This rule does not contain any new collections of information that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. This rule will not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    National Environmental Policy Act

    We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), need not be prepared in connection with regulations issued pursuant to section 4(a) of the Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (43 FR 49244).

    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:

    (a) Be logically organized;

    (b) Use the active voice to address readers directly;

    (c) Use clear language rather than jargon;

    (d) Be divided into short sections and sentences; and

    (e) 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 ADDRESSES. To help us to revise this rule, your comments should be as specific as possible.

    References Cited

    A complete list of the referenced materials is available upon request from the U.S. Fish and Wildlife Service (see FOR FURTHER INFORMATION CONTACT).

    List of Subjects in 50 CFR Part 17

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

    Regulation Promulgation

    For the reasons given in the preamble, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

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

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

    2. Amend the List of Endangered and Threatened Wildlife in § 17.11(h) by: a. Revising the entry under MAMMALS for “Squirrel, northern Idaho ground” to read as set forth below; b. Removing the entries under BIRDS for “Kingfisher, Guam Micronesian”, “Moorhen, Hawaiian common”, and “Petrel, Hawaiian dark-rumped”; and c. Adding in alphabetic order under BIRDS entries for “Gallinule, Hawaiian common”, “Kingfisher, Guam”, and “Petrel, Hawaiian” to read as follows:
    § 17.11 Endangered and threatened wildlife.

    (h) * * *

    Species Common name Scientific name Historic range Vertebrate
  • population where
  • endangered or
  • threatened
  • Status When listed Critical
  • habitat
  • Special rules
    Mammals *         *         *         *         *         *         * Squirrel, northern Idaho ground Urocitellus brunneus U.S.A. (ID) Entire T 693 NA NA *         *         *         *         *         *         * Birds *         *         *         *         *         *         * Gallinule, Hawaiian common Gallinula galeata sandvicensis U.S.A. (HI) Entire E 1 NA NA *         *         *         *         *         *         * Kingfisher, Guam Todiramphus cinnamominus Western Pacific Ocean, U.S.A. (Guam) Entire E 156 17.95(b) NA *         *         *         *         *         *         * Petrel, Hawaiian Pterodroma sandwichensis U.S.A. (HI) Entire E 1 NA NA *         *         *         *         *         *         *
    3. Amend the List of Endangered and Threatened Plants in § 17.12(h) by: a. Removing the entries under FLOWERING PLANTS for “Alsinidendron lychnoides,” “Alsinidendron viscosum,” Chamaesyce celastroides var. kaenana,” “Chamaesyce deppeana,” “Chamaesyce eleanoriae,” “Chamaesyce halemanui,” “Chamaesyce herbstii,” “Chamaesyce kuwaleana,” “Chamaesyce remyi var. kauaiensis,” “Chamaesyce remyi var. remyi,” “Chamaesyce rockii,” “Chamaesyce skottsbergii var. skottsbergii,” and “Cyanea (=Rollandia) crispa”; b. Adding an entry in alphabetic order under FLOWERING PLANTS for “Cyanea crispa”; c. Revising the entry under FLOWERING PLANTS for “Cyanea platyphylla”; d. Adding entries in alphabetic order under FLOWERING PLANTS for “Cyanea rivularis” and “Cyperus fauriei”; e. Removing the entry under FLOWERING PLANTS for “Delissea rivularis”; f. Revising the entry under FLOWERING PLANTS for “Dubautia latifolia”; g. Adding an entry in alphabetic order under FLOWERING PLANTS for “Erigeron decumbens”; h. Removing the entry under FLOWERING PLANTS for “Erigeron decumbens var. decumbens”; i. Adding entries in alphabetic order under FLOWERING PLANTS for “Euphorbia celastroides var. kaenana,” “Euphorbia deppeana,” “Euphorbia eleanoriae,” “Euphorbia halemanui,” “Euphorbia herbstii,” “Euphorbia kuwaleana,” “Euphorbia remyi var. kauaiensis,” “Euphorbia remyi var. remyi,” “Euphorbia rockii,” and “Euphorbia skottsbergii var. skottsbergii”; j. Revising the entries under FLOWERING PLANTS for “Flueggea neowawraea” and “Geranium arboreum”; k. Removing the entries under FLOWERING PLANTS for “Hedyotis cookiana” and “Hedyotis st-johnii”; l. Adding entries in alphabetic order under FLOWERING PLANTS for “Kadua cookiana” and “Kadua st-johnii”; m. Revising the entry under FLOWERING PLANTS for “Korthalsella degeneri”; n. Removing the entry under FLOWERING PLANTS for “Limnanthes floccosa ssp. grandiflora”; o. Adding an entry in alphabetic order under FLOWERING PLANTS for “Limnanthes pumila ssp. grandiflora”; p. Removing the entry under FLOWERING PLANTS for “Lobelia gaudichaudii ssp. koolauensis”; q. Adding an entry in alphabetic order under FLOWERING PLANTS for “Lobelia koolauensis”; r. Revising the entries under FLOWERING PLANTS for “Lysimachia daphnoides,” “Lysimachia iniki,” “Lysimachia pendens,” “Lysimachia scopulensis,” and “Lysimachia venosa”; s. Removing the entries under FLOWERING PLANTS for “Mariscus fauriei” and “Munroidendron racemosum”; t. Revising the entries under FLOWERING PLANTS for “Myrsine juddii,” “Myrsine knudsenii,” “Myrsine linearifolia,” “Myrsine mezii,” and “Myrsine vaccinioides”; u. Revising the entry under FLOWERING PLANTS for “Pleomele hawaiiensis”; v. Adding entries in alphabetic order under FLOWERING PLANTS for “Polyscias bisattenuata,” “Polyscias flynnii,” “Polyscias gymnocarpa,” “Polyscias lydgatei,” and “Polyscias racemosa”; w. Removing the entry under FLOWERING PLANTS for “Pritchardia affinis”; x. Adding entries in alphabetic order under FLOWERING PLANTS for “Pritchardia maideniana,” “Schiedea lychnoides,” and “Schiedea viscosa”; y. Removing the entry under FLOWERING PLANTS for “Sicyos alba”; z. Adding an entry in alphabetic order under FLOWERING PLANTS for “Sicyos albus”; aa. Removing the entries under FLOWERING PLANTS for “Tetraplasandra bisattenuata,” “Tetraplasandra flynnii,” “Tetraplasandra gymnocarpa,” and “Tetraplasandra lydgatei”; bb. Revising the entry under FLOWERING PLANTS for “Xylosma crenatum” and the entry under FERNS AND ALLIES for “Adenophorus periens”; cc. Adding entries in alphabetic order under FERNS AND ALLIES for “Asplenium dielfalcatum,” “Asplenium dielmannii,” “Asplenium dielpallidum,” and “Asplenium unisorum”; dd. Removing the entries under FERNS AND ALLIES for “Diellia falcata,” “Diellia mannii,” “Diellia pallida,” and “Diellia unisora”; and ee. Revising the entry under FERNS AND ALLIES for “Diplazium molokaiense”.

    The additions and revisions read as follows:

    § 17.12 Endangered and threatened plants.

    (h) * * *

    Species Scientific name Common name Historic range Family Status When listed Critical
  • habitat
  • Special rules
    Flowering Plants *         *         *         *         *         *         * Cyanea crispa Haha U.S.A. (HI) Campanulaceae E 536 17.99(i) NA *         *         *         *         *         *         * Cyanea platyphylla ‘Aku‘aku U.S.A. (HI) Campanulaceae E 595 17.99(k) NA *         *         *         *         *         *         * Cyanea rivularis Haha U.S.A. (HI) Campanulaceae E 590 17.99(a)(1) NA *         *         *         *         *         *         * Cyperus fauriei None U.S.A. (HI) Cyperaceae E 532 17.99(c) and (k) NA *         *         *         *         *         *         * Dubautia latifolia Koholapehu U.S.A. (HI) Asteraceae E 464 17.99(a)(1) NA *         *         *         *         *         *         * Erigeron decumbens Willamette daisy U.S.A. (OR) Asteraceae E 679 17.96(a) NA *         *         *         *         *         *         * Euphorbia celastroides var. kaenana ‘Akoko U.S.A. (HI) Euphorbiaceae E 448 17.99(i) NA Euphorbia deppeana ‘Akoko U.S.A. (HI) Euphorbiaceae E 536 17.99(i) NA Euphorbia eleanoriae ‘Akoko U.S.A. (HI) Euphorbiaceae E 765 17.99(a) NA *         *         *         *         *         *         * Euphorbia halemanui ‘Akoko U.S.A. (HI) Euphorbiaceae E 464 17.99(a)(1) NA Euphorbia herbstii ‘Akoko U.S.A. (HI) Euphorbiaceae E 591 17.99(i) NA Euphorbia kuwaleana ‘Akoko U.S.A. (HI) Euphorbiaceae E 448 17.99(i) NA Euphorbia remyi var. kauaiensis ‘Akoko U.S.A. (HI) Euphorbiaceae E 765 17.99(a) NA Euphorbia remyi var. remyi ‘Akoko U.S.A. (HI) Euphorbiaceae E 765 17.99(a) NA Euphorbia rockii ‘Akoko U.S.A. (HI) Euphorbiaceae E 591 17.99(i) NA Euphorbia skottsbergii var. skottsbergii ‘Ewa Plains ‘akoko U.S.A. (HI) Euphorbiaceae E 120 17.99(i) NA *         *         *         *         *         *         * Flueggea neowawraea Mehamehame U.S.A. (HI) Phyllanthaceae E 559 17.99(a)(1), (c), (e)(1), (i) and (k) NA *         *         *         *         *         *         * Geranium arboreum Nohoanu U.S.A. (HI) Geraniaceae E 465 17.99(e)(1) NA *         *         *         *         *         *         * Kadua cookiana ‘Awiwi U.S.A. (HI) Rubiaceae E 530 17.99(a)(1) NA *         *         *         *         *         *         * Kadua st.-johnii None U.S.A. (HI) Rubiaceae E 441 17.99(a)(1) NA *         *         *         *         *         *         * Korthalsella degeneri Hulumoa U.S.A. (HI) Santalaceae E 806 17.99(i) NA *         *         *         *         *         *         * Limnanthes pumila ssp. Grandiflora Large-flowered woolly meadowfoam U.S.A. (OR) Limnanthaceae E 733 17.96(a) NA *         *         *         *         *         *         * Lobelia koolauensis None U.S.A. (HI) Campanulaceae E 591 17.99(i) NA *         *         *         *         *         *         * Lysimachia daphnoides Lehua makanoe U.S.A. (HI) Primulaceae E 765 17.99(a) NA *         *         *         *         *         *         * Lysimachia iniki None U.S.A. (HI) Primulaceae E 765 17.99(a) NA *         *         *         *         *         *         * Lysimachia pendens None U.S.A. (HI) Primulaceae E 765 17.99(a) NA Lysimachia scopulensis None U.S.A. (HI) Primulaceae E 765 17.99(a) NA Lysimachia venosa None U.S.A. (HI) Primulaceae E 765 17.99(a) NA *         *         *         *         *         *         * Myrsine juddii Kolea U.S.A. (HI) Primulaceae E 591 17.99(i) NA Myrsine knudsenii Kolea U.S.A. (HI) Primulaceae E 765 17.99(a) NA Myrsine linearifolia Kolea U.S.A. (HI) Primulaceae T 590 17.99(a)(1) NA Myrsine mezii Kolea U.S.A. (HI) Primulaceae E 765 17.99(a) NA Myrsine vaccinioides Kolea U.S.A. (HI) Primulaceae E 815 NA NA *         *         *         *         *         *         * Pleomele hawaiiensis Hala pepe U.S.A. (HI) Asparagaceae E 595 17.99(k) NA *         *         *         *         *         *         * Polyscias bisattenuata None U.S.A. (HI) Araliaceae E 765 17.99(a) NA Polyscias flynnii None U.S.A. (HI) Araliaceae E 765 17.99(a) NA Polyscias gymnocarpa ‘Ohe‘ohe U.S.A. (HI) Araliaceae. E 536 17.99(i) NA Polyscias lydgatei None U.S.A. (HI) Araliaceae E 806 17.99(i) NA Polyscias racemosa None U.S.A. (HI) Araliaceae E 530 17.99(a)(1) NA *         *         *         *         *         *         * Pritchardia maideniana Lo‘ulu U.S.A. (HI) Arecaceae E 532 NA NA *         *         *         *         *         *         * Schiedea lychnoides Kuawawaenohu U.S.A. (HI) Caryophyllaceae E 590 17.99(a)(1) NA *         *         *         *         *         *         * Schiedea viscosa None U.S.A. (HI) Caryophyllaceae E 590 17.99(a)(1) NA *         *         *         *         *         *         * Sicyos albus ‘Anunu U.S.A. (HI) Cucurbitaceae E 595 17.99(k) NA *         *         *         *         *         *         * Xylosma crenatum None U.S.A. (HI) Salicaceae E 464 17.99(a)(1) NA *         *         *         *         *         *         * Ferns and Allies Adenophorus periens Pendent kihi fern U.S.A. (HI) Polypodiaceae E 559 17.99(a)(1), (c), (i), and (k) NA *         *         *         *         *         *         * Asplenium dielfalcatum None U.S.A. (HI) Aspleniaceae E 448 17.99(i) NA Asplenium dielmannii None U.S.A. (HI) Aspleniaceae E 765 17.99(a) NA Asplenium dielpallidum None U.S.A. (HI) Aspleniaceae E 530 17.99(a)(1) NA Asplenium unisorum None U.S.A. (HI) Aspleniaceae E 541 17.99(i) NA *         *         *         *         *         *         * Diplazium molokaiense None U.S.A. (HI) Woodsiaceae E 553 17.99(a)(1), (c), (e)(1), and (i) NA *         *         *         *         *         *         *
    Dated: June 9, 2015. Stephen Guertin, Acting Director, U.S. Fish and Wildlife Service.
    [FR Doc. 2015-15212 Filed 6-22-15; 8:45 am] BILLING CODE 4310-55-P
    80 120 Tuesday, June 23, 2015 Proposed Rules NUCLEAR REGULATORY COMMISSION 10 CFR Part 20 [Docket Nos. PRM-20-28, PRM-20-29, and PRM-20-30; NRC-2015-0057] Linear No-Threshold Model and Standards for Protection Against Radiation AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Petition for rulemaking; notice of docketing and request for comment.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) has received three petitions for rulemaking (PRM) requesting that the NRC amend its “Standards for Protection Against Radiation” regulations and change the basis of those regulations from the Linear No-Threshold (LNT) model of radiation protection to the radiation hormesis model. The radiation hormesis model provides that exposure of the human body to low levels of ionizing radiation is beneficial and protects the human body against deleterious effects of high levels of radiation. Whereas, the LNT model provides that radiation is always considered harmful, there is no safety threshold, and biological damage caused by ionizing radiation (essentially the cancer risk) is directly proportional to the amount of radiation exposure to the human body (response linearity). The petitions were submitted by Carol S. Marcus, Mark L. Miller, and Mohan Doss (the petitioners), dated February 9, 2015, February 13, 2015, and February 24, 2015, respectively. These petitions were docketed by the NRC on February 20, 2015, February 27, 2015, and March 16, 2015, and have been assigned Docket Numbers. PRM-20-28, PRM-20-29, and PRM-20-30, respectively. The NRC is examining the issues raised in these petitions to determine whether they should be considered in rulemaking. The NRC is requesting public comments on these petitions for rulemaking.

    DATES:

    Submit comments by September 8, 2015. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date.

    ADDRESSES:

    You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0057. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Email comments to: [email protected] If you do not receive an automatic email reply confirming receipt, then contact us at 301-415-1677.

    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.

    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: 301-415-1677.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Solomon Sahle, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-3781, email: [email protected]

    SUPPLEMENTARY INFORMATION: I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2015-0057 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    Federal rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0057.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in the SUPPLEMENTARY INFORMATION section.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    B. Submitting Comments

    Please include Docket ID NRC-2015-0057 in the subject line of your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

    II. The Petitioners

    On February 9, 2015, Dr. Carol S. Marcus, a Professor of Radiation Oncology, of Molecular and Medical Pharmacology (Nuclear Medicine), and of Radiological Sciences at the David Geffen School of Medicine at the University of California-Los Angeles, filed a petition for rulemaking with the Commission, PRM-20-28 (ADAMS Accession No. ML15051A503). Dr. Marcus was a member of the NRC's Advisory Committee on the Medical Uses of Isotopes from 1990 to 1994. The petitioner indicated that “[t]here has never been scientifically valid support for this LNT hypothesis since its use was recommended by the U.S. National Academy of Sciences Committee on Biological Effects of Atomic Radiation (BEAR I)/Genetics Panel in 1956” and that “[t]he costs of complying with these LNT based regulations are enormous.”

    On February 13, 2015, Mr. Mark L. Miller, a Certified Health Physicist, filed a petition for rulemaking with the Commission, PRM-20-29 (ADAMS Accession No. ML15057A349). The petitioner indicated that “[t]here has never been scientifically valid support for this LNT hypothesis” and that “[t]he costs of complying with these LNT-based regulations are incalculable.” In addition, the petitioner suggests that the use of the LNT hypothesis has “led to persistent radiophobia [radiation-phobia].”

    On February 24, 2015, Dr. Mohan Doss, filed a petition for rulemaking with the Commission, PRM-20-30 (ADAMS Accession No. ML15075A200). Dr. Doss filed this petition on behalf of Scientist for Accurate Radiation Information, whose mission is to “help prevent unnecessary, radiation-phobia-related deaths, morbidity, and injuries associated with distrust of radio-medical diagnostics/therapies and from nuclear/radiological emergencies through countering phobia-promoting misinformation spread by alarmists via the news and other media including journal publications.”

    III. The Petition

    The petitioners request that the NRC amend part 20 of title 10 of the Code of Federal Regulations (10 CFR), “Standards for Protection Against Radiation,” based on new science and evidence that contradicts the LNT hypothesis and request that the NRC greatly simplify and change 10 CFR part 20 to take into account the “vast literature demonstrating no effects or protective effects at relatively low doses of radiation.” The NRC has determined that the petitions met the threshold sufficiency requirements for a petition for rulemaking under § 2.802, “Petition for rulemaking,” and the petitions have been docketed as PRM-20-28, PRM-20-29, and PRM-20-30.

    IV. Discussion of the Petitions A. PRM-20-28

    The petitioner, Dr. Carol S. Marcus, requests that the NRC amend its regulations in 10 CFR part 20 that are based on the LNT hypothesis. The petitioner states that “[t]his ultra-simplistic concept assumes that all radiation absorbed doses, no matter how small, have a finite probability of causing a fatal cancer.” The petitioner further indicates that the “[u]se of the LNT assumption enables regulators to feel justified in ratcheting down permissible worker and public radiation levels, either through actual dose limits or use of the `as low as reasonably achievable' (ALARA) principle, giving the illusion that they are making everyone safer (and creating ever increasing workload for themselves and their licensees).” However, the petitioner suggests that “there has never been scientifically valid support for this LNT hypothesis since its use was recommended by the U.S. National Academy of Sciences Committee on Biological Effects of Atomic Radiation (BEAR I)/Genetics Panel in 1956” and that the “costs of complying with these LNT based regulations are enormous.”

    The petitioner suggests that there is “vast literature” that demonstrates that low doses of radiation have no deleterious effect, and some studies even suggest that low doses of radiation may have protective effects. The petitioner writes, “[t]he literature showing protective effects supports the concept of hormesis, in which low levels of potentially stressful agents, such as toxins, other chemicals, ionizing radiation, etc., protect against the deleterious effects that high levels of these stressors produce and result in beneficial effects (e.g., lower cancer rates).” On May 16, 2015, the petitioner submitted an additional reference to the NRC providing technical information supporting her requests.1

    1 Siegel, Jeffry A., and Welsh, James S.: Does Imaging Technology Cause Cancer? Debunking the Linear No-Threshold Model of Radiation Carcinogenesis. Technology in Cancer Research & Treatment 1533034615578011, first published on March 30, 2015 doi:10.1177/1533034615578011.

    The petitioner recommends the following changes to 10 CFR part 20:

    (1) Worker doses should remain at present levels, with allowance of up to 100 mSv (10 rem) effective dose per year if the doses are chronic.

    (2) ALARA should be removed entirely from the regulations. The petitioner argues that “it makes no sense to decrease radiation doses that are not only harmless but may be hormetic.”

    (3) Public doses should be raised to worker doses. The petitioner notes that “these low doses may be hormetic. The petitioner goes on to ask, “why deprive the public of the benefits of low dose radiation?”

    (4) End differential doses to pregnant women, embryos and fetuses, and children under 18 years of age.

    B. PRM-20-29

    Similarly, the petitioner, Mr. Mark L. Miller, requests that the NRC amend its regulations in 10 CFR part 20 that are based on the LNT hypothesis. The petitioner used much of the same information used in Dr. Marcus' petition for rulemaking. However, Mr. Miller only requests that the following changes be made to 10 CFR part 20:

    (1) Worker doses should remain at present levels, with allowance of up to 100 mSv (10 rem) effective dose per year if the doses are chronic.

    (2) ALARA should be removed entirely from the regulations. The petitioner argues that “it makes no sense to decrease radiation doses that are not only harmless but may be hormetic.”

    (3) Public doses should be raised to worker doses. The petitioner notes that “these low doses may be hormetic. The petitioner states, “[l]ow-dose limits for the public perpetuates radiophobia.”

    C. PRM-20-30

    The petition for rulemaking was submitted by Dr. Mohan Doss, on behalf of Scientist for Accurate Radiation Information, and “supports and supplements” petition PRM-20-28. This petitioner provides additional information suggesting that “low-dose radiation reduces cancer risk” (i.e., has a hormetic [beneficial] effect) and suggests that the “LNT model is no longer justifiable.” The petitioner further states that the use of the LNT hypothesis in the NRC's regulations has “had a major detrimental effect on public health, since they have prevented the study of LDR [low-dose radiation] for controlling aging-related diseases such as cancer, Alzheimer's disease, Parkinson's disease, etc. in spite of studies showing the promise of LDR for the diseases.” The petitioner suggests that “urgency of action on this petition” is necessary because “any potential future accident involving release of radioactive materials in the USA would likely result in panic evacuation because of the LNT—model-based cancer fears and concerns, resulting in considerable casualties and economic damage such as have occurred in Fukushima.” The petitioner further suggests that the “recognition of a threshold dose by NRC would obviate the need for such panic evacuations, associated casualties, and economic harm” when radiation is released in the environment.

    For additional information, see the filed petitions for rulemaking in ADAMS under Accession Nos. ML15051A503, ML15057A349, and ML15075A200.

    V. Conclusion

    The NRC will examine the issues raised in PRM-20-28, PRM-20-29, and PRM-20-30 to determine whether they should be considered in rulemaking. The NRC is requesting public comments on these petitions for rulemaking.

    Dated at Rockville, Maryland, this 16th day of June, 2015.

    For the Nuclear Regulatory Commission.

    Annette L. Vietti-Cook, Secretary of the Commission.
    [FR Doc. 2015-15441 Filed 6-22-15; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 [NRC-2015-0067] RIN 3150-AJ58 List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM UMAX Canister Storage System, Certificate of Compliance No. 1040, Amendment No. 1 AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its spent fuel storage regulations by revising the Holtec International, Inc. (Holtec), HI-STORM (Holtec International Storage Module) Underground Maximum Capacity (UMAX) Canister Storage System listing within the “List of approved spent fuel storage casks” to add Amendment No. 1 to Certificate of Compliance (CoC) No. 1040. Amendment No. 1 provides a seismically enhanced version of the HI-STORM UMAX Canister Storage System, identified as the “Most Severe Earthquake (MSE)” version that could be used in areas with higher seismic demands than those analyzed previously. Amendment No. 1 also includes minor physical design changes to help ensure structural integrity of the amended system. These are the addition of a hold-down system to the closure lid; replacing the fill material in the interstitial spaces between the cavity enclosure containers (CECs) surrounding the casks with plain concrete with a minimum comprehensive strength of 3000 psi concrete; strengthening the multi-purpose canister (MPC) guides; and engineering the guides' nominal gap with the MPC to be tighter than the original HI-STORM UMAX Canister Storage System design.

    DATES:

    Submit comments by July 23, 2015. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.

    ADDRESSES:

    You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):

    Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0067. Address questions about NRC dockets to Carol Gallagher; telephone: (301) 415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Email comments to: [email protected] If you do not receive an automatic email reply confirming receipt, then contact us at (301) 415-1677.

    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at (301) 415-1101.

    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone: (301) 415-1677.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Solomon Sahle, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: (301) 415-3781; email: [email protected]

    SUPPLEMENTARY INFORMATION: I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2015-0067 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0067.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may access publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, (301) 415-4737, or by email to [email protected] For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    B. Submitting Comments

    Please include Docket ID NRC-2015-0067 in the subject line of your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

    II. Procedural Background

    This proposed rule is limited to the changes contained in Amendment No. 1 to CoC No. 1040 and does not include other aspects of the Holtec HI-STORM UMAX Canister Storage System. Because the NRC considers this action noncontroversial and routine, the NRC is publishing this proposed rule concurrently with a direct final rule in the Rules and Regulations section of this issue of the Federal Register. The direct final rule will become effective on September 8, 2015. However, if the NRC receives significant adverse comments on this proposed rule by July 23, 2015, then the NRC will publish a document that withdraws the direct final rule. If the direct final rule is withdrawn, the NRC will address the comments received in response to these proposed revisions in a subsequent final rule. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action in the event the direct final rule is withdrawn.

    A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

    (1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

    (a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

    (b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

    (c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

    (2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

    (3) The comment causes the NRC staff to make a change (other than editorial) to the rule, CoC, or Technical Specifications (TSs).

    For additional procedural information and the regulatory analysis, see the direct final rule published in the Rules and Regulations section of this issue of the Federal Register.

    III. Background

    Section 218(a) of the Nuclear Waste Policy Act (NWPA) of 1982, as amended, requires that “the Secretary [of the U.S. Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [U.S. Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[t]he Commission shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

    To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule which added a new subpart K in part 72 of Title 10 of the Code of Federal Regulations (10 CFR) entitled, “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L in 10 CFR part 72 entitled, “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule on March 6, 2015 (80 FR 12073), as corrected on March 25, 2015 (80 FR 15679), that approved the HI-STORM UMAX Canister Storage System design and added it to the list of NRC-approved cask designs in 10 CFR 72.214 as CoC No. 1040.

    IV. Plain Writing

    The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, well-organized manner that also follows other best practices appropriate to the subject or field and the intended audience. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883). The NRC requests comment on the proposed rule with respect to clarity and effectiveness of the language used.

    V. Availability of Documents

    The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

    Document Adams accession No./
  • Web link/
  • Federal Register
  • citation
  • Proposed CoC No. 1040, Amendment No. 1 ML15070A151 Appendix A of Proposed TS ML15070A153 Appendix B of Proposed TS ML15070A152 Preliminary SER ML15070A149 Request for Amendment Application dated July 11, 2014 ML14202A029 Supplemental Information for Proposed Action dated October 31, 2014 ML14308A164

    The NRC may post materials related to this document, including public comments, on the Federal Rulemaking Web site at http://www.regulations.gov under Docket ID NRC-2015-0067. The Federal Rulemaking Web site allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC-2015-0067); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

    List of Subjects in 10 CFR Part 72

    Administrative practice and procedure, Criminal penalties, Manpower training programs, Nuclear materials, Occupational safety and health, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Spent fuel, Whistleblowing.

    For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is proposing to adopt the following amendments to 10 CFR part 72.

    PART 72—LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE 1. The authority citation for part 72 continues to read as follows: Authority:

    Atomic Energy Act secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2232, 2233, 2234, 2236, 2237, 2239, 2273, 2282, 2021); Energy Reorganization Act secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act sec. 102 (42 U.S.C. 4332); Nuclear Waste Policy Act secs. 131, 132, 133, 135, 137, 141, 148 (42 U.S.C. 10151, 10152, 10153, 10155, 10157, 10161, 10168); Government Paperwork Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. 109-58, 119 Stat. 788 (2005).

    Section 72.44(g) also issued under Nuclear Waste Policy Act secs. 142(b) and 148(c), (d) (42 U.S.C. 10162(b), 10168(c), (d)).

    Section 72.46 also issued under Atomic Energy Act sec. 189 (42 U.S.C. 2239); Nuclear Waste Policy Act sec. 134 (42 U.S.C. 10154).

    Section 72.96(d) also issued under Nuclear Waste Policy Act sec. 145(g) (42 U.S.C. 10165(g)).

    Subpart J also issued under Nuclear Waste Policy Act secs. 117(a), 141(h) (42 U.S.C. 10137(a), 10161(h)).

    Subpart K also issued under Nuclear Waste Policy Act sec. 218(a) (42 U.S.C. 10198).

    2. In § 72.214, Certificate of Compliance No. 1040 is revised to read as follows:
    § 72.214 List of approved spent fuel storage casks.

    Certificate Number: 1040.

    Initial Certificate Effective Date: April 6, 2015.

    Amendment No. 1 Effective Date: September 8, 2015.

    SAR Submitted by: Holtec International, Inc.

    SAR Title: Final Safety Analysis Report for the Holtec International HI-STORM UMAX Canister Storage System.

    Docket Number: 72-1040.

    Certificate Expiration Date: April 6, 2035.

    Model Number: MPC-37, MPC-89.

    Dated at Rockville, Maryland, this 11th day of June, 2015.

    For the Nuclear Regulatory Commission.

    Mark A. Satorius, Executive Director for Operations.
    [FR Doc. 2015-15474 Filed 6-22-15; 8:45 am] BILLING CODE 7590-01-P
    DEPARTMENT OF ENERGY 10 CFR Parts 429 and 431 [Docket No. EERE-2014-BT-TP-0055] RIN 1904-AD41 Energy Conservation Program: Test Procedures for Commercial Prerinse Spray Valves AGENCY:

    Office of Energy Efficiency and Renewable Energy, Department of Energy.

    ACTION:

    Notice of proposed rulemaking and announcement of public meeting.

    SUMMARY:

    The U.S. Department of Energy (DOE) proposes to amend the test procedures for commercial prerinse spray valves to consider the latest version of the industry standard that is incorporated by reference and to consider a procedure for measuring the spray force. DOE also proposes to revise the definition of commercial prerinse spray valve and the current test procedure as they relate to various spray valves currently on the market, including those with multiple spray patterns. DOE does not believe the proposed changes will affect the measured water use. As part of this proposal, DOE is announcing a public meeting to collect comments and data on its proposal.

    DATES:

    DOE will hold a public meeting on Tuesday, July 28, 2015 from 9:00 a.m. to 12:00 p.m., in Washington, DC. The meeting will also be broadcast as a webinar. See section V, “Public Participation,” for instructions and information concerning meeting attendance and webinar participation.

    DOE will accept comments, data, and information regarding this proposed rulemaking before and after the public meeting, but no later than September 8, 2015. See section V, “Public Participation,” for details.

    ADDRESSES:

    The public meeting will be held at the U.S. Department of Energy, Forrestal Building, Room 8E-089, 1000 Independence Avenue SW., Washington, DC 20585.

    Any comments submitted must identify the NOPR for test procedures for commercial prerinse spray valves, and provide docket number EERE-2014-BT-TP-0055 and/or Regulation Identifier Number (RIN) number 1904-AD41. Comments may be submitted using any of the following methods:

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

    2. Email: [email protected] Include the docket number and/or RIN in the subject line of the message.

    3. Mail: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies office, Mailstop EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. If possible, please submit all items on a compact disk (CD), in which case it is not necessary to include printed copies.

    4. Hand Delivery/Courier: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Office, 950 L'Enfant Plaza SW., Suite 600, Washington, DC 20024. Telephone: (202) 586-2945. If possible, please submit all items on a CD, in which case it is not necessary to include printed copies.

    For detailed instructions on submitting comments and additional information on the rulemaking process, see section V of this document (Public Participation).

    Docket: The docket, which includes Federal Register notices, public meeting attendee lists and transcripts, comments, and other supporting documents/materials, is available for review at www.regulations.gov. All documents in the docket are listed in the regulations.gov index. However, some documents listed in the index, such as those containing information that is exempt from public disclosure, may not be publicly available.

    A link to the docket Web page can be found at: www1.eere.energy.gov/buildings/appliance_standards/product.aspx/productid/54. This Web page will contain a link to the docket for this notice on the www.regulations.gov site. The www.regulations.gov Web page will contain simple instructions on how to access all documents, including public comments, in the docket. See section V for information on how to submit comments through regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Mr. James Raba, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-8654. Email: [email protected]

    Ms. Johanna Hariharan, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 287-6307. Email: [email protected]

    For further information about how to submit a comment, review other public comments and the docket, or participate in the public meeting, contact Ms. Brenda Edwards at (202) 586-2945 or by email: [email protected]

    SUPPLEMENTARY INFORMATION:

    DOE intends to incorporate by reference the following industry standards into 10 CFR part 431: ASTM Standard F2324-13, (“ASTM F2324-13”), “Standard Test Method for Prerinse Spray Valves”, approved June 1, 2013.

    Copies of ASTM Standard F2324-13 can be obtained from ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428, or by going to http://www.astm.org/Standard/standards-and-publications.html.

    For further discussion of this standard, see III.B and IV.M of this proposed rule.

    Table of Contents I. Authority and Background II. Summary of the Notice of Proposed Rulemaking III. Discussion A. Definitions 1. Commercial Prerinse Spray Valve 2. Normally-Closed Valve 3. Spray Force B. Industry Standards Incorporated by Reference C. Proposed Additional Test Methods 1. Adding Test Method To Measure Spray Force 2. Multiple Spray Patterns: Adding a Requirement To Measure Flow Rate and Spray Force of Each Spray Pattern D. Rounding Requirements 1. Flow Rate 2. Spray Force E. Certification, Compliance, and Enforcement 1. Selection of Units to Test 2. Representative Value Formula F. Effective and Compliance Date IV. Procedural Issues and Regulatory Review A. Review Under Executive Order 12866 B. Review Under the Regulatory Flexibility Act C. Review Under the Paperwork Reduction Act of 1995 D. Review Under the National Environmental Policy Act of 1969 E. Review Under Executive Order 13132 F. Review Under Executive Order 12988 G. Review Under the Unfunded Mandates Reform Act of 1995 H. Review Under the Treasury and General Government Appropriations Act, 1999 I. Review Under Executive Order 12630 J. Review Under Treasury and General Government Appropriations Act, 2001 K. Review Under Executive Order 13211 L. Review Under Section 32 of the Federal Energy Administration Act of 1974 M. Description of Materials Incorporated by Reference V. Public Participation A. Attendance at Public Meeting B. Procedure for Submitting Prepared General Statement for Distribution C. Conduct of Public Meeting D. Submission of Comments E. Issues on Which DOE Seeks Comment VI. Approval of the Office of the Secretary I. Authority and Background

    Title III of the Energy Policy and Conservation Act of 1975 (42 U.S.C. 6291, et seq.; “EPCA” or, “the Act”) sets forth a variety of provisions designed to improve energy efficiency.1 Part B of title III, which for editorial reasons was redesignated as Part A upon incorporation into the U.S. Code (42 U.S.C. 6291-6309, as codified), establishes the “Energy Conservation Program for Consumer Products Other Than Automobiles.” The Energy Policy Act of 2005, Public Law 109-58 (August 8, 2005) amended EPCA to add “Energy Conservation Standards For Additional Products,” which includes commercial prerinse spray valves (CPSV), and provided the definitions under 42 U.S.C. 6291(33), test procedures under 42 U.S.C. 6293(b)(14), and energy conservation standards for flow rate under 42 U.S.C. 6295(dd).

    1 All references to EPCA refer to the statute as amended through the American Energy Manufacturing Technical Corrections Act (AEMTCA), Public Law 112-210 (December 18, 2012).

    Under EPCA, this program consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy and water conservation standards, and (4) compliance certification and enforcement procedures. The testing requirements consist of test procedures that manufacturers of covered products must use as the basis for (1) certifying to DOE that their products comply with the applicable energy conservation standards adopted under EPCA, and (2) making representations about the efficiency of those products. (42 U.S.C. 6293(c), 6295(s)) Similarly, DOE uses these test procedures to determine compliance with relevant standards established under EPCA.2

    2 Because Congress included CPSV in Part A of Title III of EPCA, the consumer product provisions of Part A (not the industrial equipment provisions of Part A-1) apply to commercial prerinse spray valves. However, because commercial prerinse spray valves are more commonly considered to be commercial equipment, as a matter of administrative convenience and to minimize confusion among interested parties, DOE adopted CPSV provisions into subpart O of 10 CFR part 431 [71 FR 71340, 71374 (Dec. 8, 2006)]. Part 431 contains DOE regulations for commercial and industrial equipment. The location of provisions within the CFR does not affect either their substance or applicable procedure, and DOE refers to CPSV as either “products” or “equipment.”

    General Test Procedure Rulemaking Process

    Under 42 U.S.C. 6293, EPCA sets forth criteria and procedures that DOE is required to follow when prescribing or amending test procedures for covered products. EPCA provides in relevant part that any test procedures prescribed or amended under this section shall be reasonably designed to produce test results which measure energy efficiency, energy use, or estimated annual operating cost of a covered product during a representative average use cycle or period of use and shall not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))

    In addition, if DOE determines that a test procedure amendment is warranted, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments. (42 U.S.C. 6293(b)(2)) Finally, in any rulemaking to amend a test procedure, EPCA requires DOE to determine to what extent, if any, the proposed test procedure would alter the measured energy efficiency of any covered product as determined under the existing test procedure. (42 U.S.C. 6293(e)(1)) If DOE determines that the amended test procedure would alter the measured efficiency of a covered product, DOE must amend the applicable energy conservation standard accordingly. (42 U.S.C. 6293(e)(2))

    EPCA, as amended, sets forth the current maximum flow rate of not more than 1.6 gallons per minute for commercial prerinse spray valves. (42 U.S.C. 6295(dd)) EPCA also requires DOE to use the American Society for Testing and Materials (ASTM) Standard F2324 as a basis for the test procedure for measuring flow rate. (42 U.S.C. 6293(b)(14))

    In the December 8, 2006 final rule, DOE incorporated by reference ASTM Standard F2324-03 into regulatory text (10 CFR 431.263), and prescribed it as the uniform test method to measure flow rate of commercial prerinse spray valves under 10 CFR 431.264. 71 FR 71340, 71374. Later, on October 23, 2013, DOE incorporated by reference ASTM Standard F2324-03 (2009) for testing commercial prerinse spray valves, which updated the 2003 version. 78 FR 62970, 62980.

    II. Summary of the Notice of Proposed Rulemaking

    In this notice of proposed rulemaking (NOPR), DOE proposes to update 10 CFR 431.264, “Uniform test method for the measurement of flow rate for commercial prerinse spray valves,” as follows:

    (1) Incorporate by reference certain provisions (sections: 6.1-6.9, 9.1-9.5.3.2, 10.1-10.2.5, 10.3.1-10.3.8, and 11.3.1) of the current revision to the applicable industry standard—ASTM Standard F2324-13, “Standard Test Method for Prerinse Spray Valves”—pertaining to flow rate and spray force measurement;

    (2) Modify the current definition of the term “commercial prerinse spray valve,” and add definitions for the terms “normally-closed valve” and “spray force;”

    (3) Modify the current test method for measuring flow rate to reference sections 10.1-10.2.5 and 11.3.1 of ASTM Standard F2324-13;

    (4) Add a test method for measuring spray force that references sections 10.3.1-10.3.8 of ASTM Standard F2324-13;

    (5) Add a requirement for measuring flow rate and spray force of each spray pattern for commercial prerinse spray valves with multiple spray patterns;

    (6) Modify the rounding requirement for flow rate measurement and specify the rounding requirement for spray force measurement; and

    (7) Modify the current CPSV sampling requirements to remove the provisions related to determining represented values where consumers would favor higher values.

    DOE's proposed actions are addressed in detail in section III of this NOPR.

    III. Discussion

    The following sections focus on DOE's proposed changes to the test procedure, including definitions, industry standards incorporated by reference, modifications to the test procedure, additional test measurements, rounding requirements, and certification and compliance requirements.

    A. Definitions

    In this document, DOE proposes to amend the existing definition for commercial prerinse spray valve and add definitions for the terms “normally closed valve” and “spray force.” A detailed discussion of these terms follows.

    1. Commercial Prerinse Spray Valve

    According to EPCA, a commercial prerinse spray valve is a handheld device designed and marketed for use with commercial dishwashing and ware washing equipment that sprays water on dishes, flatware, and other food service items for the purpose of removing food residue before cleaning the items. (42 U.S.C. 6291(33)(A), 10 CFR 431.262) EPCA allows DOE to modify the CPSV definition to include products: (1) That are used extensively in conjunction with commercial dishwashing and ware washing equipment; (2) to which the application of standards would result in significant energy savings; and (3) to which the application of standards would not be likely to result in the unavailability of any covered product type currently available on the market. 42 U.S.C. 6291(33)(B) EPCA also allows DOE to modify the CPSV definition to exclude products: (1) That are used for special food service applications; (2) that are unlikely to be widely used in conjunction with commercial dishwashing and ware washing equipment; and (3) to which the application of standards would not result in significant energy savings.

    As a companion to this test procedure rulemaking, on September 11, 2014, DOE published in the Federal Register a notice of public meeting and availability of the Framework document to initiate a rulemaking to consider amending the energy conservation standards for commercial prerinse spray valves. 79 FR 54213 (Sept. 11, 2014).3 In the Framework document, DOE explained that it was considering modifying the CPSV definition to change the scope of the products subject to regulation. (Framework document, pp. 2-3) DOE received several comments in response to the Framework document about potential modifications to the current CPSV definition.

    3See Notice of Public Meeting and Availability of Framework document, 79 FR 54213 (Sept. 11, 2014). See also Docket No. EERE-2014-BT-STD-0027, Framework document, No. 1, available at www.regulations.gov/contentStreamer?objectId=0900006481864b06&disposition=attachment&contentType=pdf (hereinafter “Framework document”).

    Alliance for Water Efficiency (AWE) commented that prerinse spray valves are used in non-prerinse activities (e.g., supermarket vegetable displays, pet grooming, etc.), and suggested that non-prerinse applications be considered separately from the current CPSV rulemaking. (Docket No. EERE-2014-BT-STD-0027, AWE, No. 8 at p. 2) Similarly, T&S Brass and Bronze Works, Inc. (T&S Brass) commented that the CPSV definition should remain specific to the commercial applications currently defined, noting that similar equipment used in non-CPSV applications may not satisfy CPSV performance requirements. (Docket No. EERE-2014-BT-STD-0027, T&S Brass, No. 12 at p. 2) As discussed in the following paragraphs, DOE is proposing to modify the CPSV definition to redefine the scope of coverage for equipment used in conjunction with commercial dishwashing and ware washing, as authorized under 42 U.S.C. 6291(33)(B).

    EPCA's definition includes three key elements: “a handheld device,” “sprays water,” and “purpose of removing food residue.” Consider a commercial dishwasher, which might spray water on items that are placed inside for the purpose of removing food residue. This would not be covered under this definition because it is not a handheld device. Only a handheld device that sprays water for the purpose of removing food residue before cleaning the items would be covered.

    DOE has observed the existence of products distributed in U.S. commerce with brochures describing them as “prerinse spray” or “prerinse spray valve,” and that are marketed (often by third parties) to rinse dishes before washing, to make a difference in washing dirty dishes, to pre-rinse items in a dish room in preparation for running them through a commercial dishwasher, or to be used with pre-rinse assemblies and/or as ware washing equipment. DOE has also observed products marketed as “pull-down kitchen faucet” or “commercial style prerinse,” which generally speaking are handheld devices that can be used for commercial dishwashing or ware washing regardless of installation location. DOE proposes to modify the definition such that these categories of products would meet the definition of commercial prerinse spray valve and would be subject to the associated regulations. Installation location is not a factor in determining whether a given model meets the definition of commercial prerinse spray valve. Although DOE understands that manufacturers may market different categories of prerinse spray valves for various uses such as cleaning floors or walls or filling glasses, DOE proposes that any such device that is suitable for use in conjunction with commercial dishwashing and ware washing equipment to spray water for the purpose of removing food residue, falls within the CPSV definition. This also includes commercial prerinse spray valves with multiple spray patterns.

    However, spray valves used only for other purposes, such as spray valves designed and marketed for use only in cleaning custodial materials or washing walls and floors would not be covered under the definition of commercial prerinse spray valves, if they are not suitable for using in conjunction with dishwashing or ware washing equipment to remove food residue.

    Therefore, after reviewing the current CPSV definition and products currently being distributed in the market as appropriate for dishwashing and ware washing applications, DOE is proposing to replace the phrase “designed and marketed for use” with the phrase “suitable for use.” DOE believes products that are intended for and/or actually are used to remove food residue in dishwashing and ware washing applications should be subject to DOE standards and certification requirements even if they are marketed without the term “commercial dishwashing and ware washing equipment.”

    DOE also reviewed the prerinse spray valve definition in ASTM Standard F2324-13, which defines the term “prerinse spray valve” as “a handheld device containing a release to close mechanism [sic] that is used to spray water on dishes, flatware, etc.” DOE believes that the “release-to-close” mechanism included in the ASTM definition means a manually actuated, normally closed valve. DOE believes that this is a typical feature of commercial prerinse spray valves. DOE has considered whether to include this feature in the definition or whether this would then create a market-incentive to create commercial prerinse spray valves that do not normally, fully, close. If DOE were to include this feature in the definition, DOE prefers the term “normally closed,” because it refers to a physical characteristic of the internal valve within a CPSV, which is intrinsic to its operation; whereas, “release-to-close” refers to a manual action required to operate a CPSV, which could create ambiguity when considering a CPSV with an atypical design for manually activating the spray valve. Therefore, DOE, in the alternative, proposes to include the term “normally closed” in an amended CPSV definition.

    In summary, DOE proposes to define “commercial prerinse spray valve” as “a handheld device suitable for use with commercial dishwashing and ware washing equipment for the purpose of removing food residue before cleaning the items.” In the alternative, DOE would consider defining “commercial prerinse spray valve” as “a handheld device containing a normally closed valve that is suitable for use with commercial dishwashing and ware washing equipment for the purpose of removing food residue before cleaning the items.”

    DOE preliminarily concludes that this proposed definition would satisfy the requirements at 42 U.S.C. 6291(33)(B) because (1) the products covered by this definition are used extensively in conjunction with commercial dishwashing and ware washing equipment; (2) the application of standards to such products would result in significant energy savings; and (3) the application of standards to such products would not be likely to result in the unavailability of any covered product type currently available on the market.4 To the extent that the definition change would change the scope of products subject to standards, DOE proposes that any products that would be newly within the scope of coverage would be subject to standards concurrent with the compliance date of any standards established or revised in the companion standards rulemaking proceeding currently underway. DOE seeks comment on the potential for an expanded scope of coverage resulting from this proposed definition and, should DOE determine that additional products would be subject to standards, DOE would include regulatory text in a final rule in this proceeding making clear that expanded scope and the future compliance date.

    4 The analyses of the energy savings potential of standards and the impact of standards on the availability of any covered product type currently on the market are being conducted as part of DOE's concurrent energy conservation standards rulemaking for commercial prerinse spray valves.

    DOE invites comments from interested parties about this proposed definition. See section V.E.1.a of this NOPR.

    2. Normally-Closed Valve

    If DOE were to adopt a definition of commercial prerinse spray valve that included the term “normally-closed valve,” DOE would also add a definition of the term “normally-closed valve.” In the ASTM Standard F2324-13 definition of a commercial prerinse spray valve, the phrase “. . .containing a release to close mechanism. . .” is included. DOE believes that a release to close mechanism is a common feature of commercial prerinse spray valves that is better described by the term “normally-closed valve.” Unlike the term “release-to-close,” the term “normally-closed valve” is more commonly used in hydraulic engineering and characterizes the valve itself, rather than the actuation mechanism.

    Therefore, DOE proposes to define “normally-closed valve” as “a valve that opens when an external force is exerted upon it and automatically closes when the external force is removed.”

    DOE invites comments about the proposed definition. See section V.E.1.b of this NOPR.

    3. Spray Force

    In this NOPR, DOE also proposes to add a definition for the term “spray force.” Currently, all commercial prerinse spray valves belong to one product class and are subject to a single standard. (10 CFR 431.266) As part of the ongoing CPSV standards rulemaking (Docket No. EERE-2014-BT-STD-0027), DOE is considering whether to retain the single product class or to establish separate product classes, in view of the statutory criteria in 42 U.S.C. 6295(o)(4) and (q). (Framework document, pp. 17-18)

    In particular, DOE is considering using spray force to delineate potential product classes when proposing flow rate standards. As addressed earlier, DOE proposes to incorporate by reference ASTM Standard F2324-13, which prescribes a test method for measuring spray force.

    ASTM Standard F2324-13 amends ASTM Standard F2324-03 (2009), in part, by replacing the cleanability test with a spray force test. As previously mentioned, DOE proposes in this NOPR to incorporate by reference ASTM Standard F2324-13 and to add spray force testing to the test procedure both to be consistent with current industry practice and support potential amended CPSV standards. The term “spray force” is defined in ASTM Standard F2324-13 as “the amount of force exerted onto the spray disc.” DOE proposes to adopt this definition. Water measurements for force typically use kilogram-force. However, kilograms are not a common unit of measurement in the United States and are too large for the spray force exerted by a CPSV. In addition, ASTM Standard F2324 uses ounce-force. Thus, DOE proposes to specify this measurement unit.

    DOE invites comments about the proposed definition. See section V.E.1.c of this NOPR.

    B. Industry Standards Incorporated by Reference

    EPCA prescribes that the test procedure for measuring flow rate for commercial prerinse spray valves be based on ASTM Standard F2324, “Standard Test Method for Pre-Rinse Spray Valves.” (42 U.S.C. 6293(14)) Pursuant to this statutory requirement, DOE incorporated by reference ASTM Standard F2324-03 in a final rule published on December 8, 2006. 71 FR 71340, 71374. DOE last updated its CPSV test procedure to reference the updated ASTM Standard F2324-03 (2009) in a final rule published on October 23, 2013. 78 FR 62970, 62980.

    EPCA directs the Secretary of Energy to review test procedures for all covered products at least once every 7 years, and either to (1) amend a test procedure if the Secretary determines that the amended test procedure would more accurately or fully produce test results which measure energy efficiency, energy use, water use, or estimated annual operating cost during a representative average use cycle, and shall not be unduly burdensome to conduct; or (2) publish a notice in the Federal Register of any determination not to amend a test procedure. (42 U.S.C. 6293(b)(1)(A))

    In 2013, ASTM amended Standard F2324-03 (2009) to replace the cleanability test with a spray force test, based on research conducted by the U.S. Environmental Protection Agency's (EPA's) WaterSense® program.5 Where the cleanability test evaluated cleaning time of a standard dinner plate, the current ASTM Standard F2324-13 prescribes spray force, measured in ounce-force (ozf).6 In addition, where ASTM Standard F2324-03 (2009) required measuring the prerinse spray valve flow rate at water pressures of both 60 ± 1 pounds per square inch (psi) and 60 ± 2 psi (in sections 4.2 and 10.2.2, respectively), ASTM Standard F2324-13 requires measuring commercial prerinse spray valve flow rate only at 60 ± 2 psi.

    5 EPA WaterSense program, September 19, 2013. WaterSense Specification for Commercial Pre-Rinse Spray Valves Supporting Statement, Version 1.0. (see: www.epa.gov/watersense/partners/prsv_final.html).

    6 The cleanability test and its results were not repeatable and reproducible. There also was low user satisfaction with valves that scored well on the cleanability test. Users indicated that spray force may be a better metric for assessing product effectiveness.

    In that rulemaking, DOE received a number of comments related to the test procedure in response to the September 2014 Framework document. A joint comment submitted by the Natural Resources Defense Council (NRDC), Appliance Standards Awareness Project (ASAP), and Alliance to Save Energy (ASE) (collectively referred to as “Advocates”) expressed concern that commercial prerinse spray valves designed “to the test” to meet efficiency standards at 60 psi may perform below user expectations at locations where only 40 or 35 psi is available. (Docket No. EERE-2014-BT-STD-0027, Advocates, No. 11 at p. 2) 7 Similarly, AWE suggested that 50 percent of all DOE testing of commercial prerinse spray valves be conducted on food service installations, to account for various supply pressures. (Docket No. EERE-2014-BT-STD-0027, AWE, No. 8 at p. 4). Nevertheless, AWE also supported use of the ASTM Standard F2324-13 test procedure and testing at a supply pressure of 60 psi. (Docket No. EERE-2014-BT-STD-0027, AWE, No. 8 at p. 2)

    7 A notation in this form provides a reference for information that is in the docket of DOE's rulemaking to develop energy conservation standards for commercial prerinse spray valves (Docket No. EERE-2014-BT-STD-0027), which is maintained at www.regulations.gov. This notation indicates that the statement preceding the reference is document number 11 in the docket for the CPSV energy conservation standards rulemaking, and appears at page 2 of that document.

    DOE understands that supply pressures vary across the country. Some pressures are lower and some are higher than the 60 psi test pressure prescribed in ASTM Standard F2324-13. Limited research by DOE suggests that supply pressures vary at the municipal level across the nation, and at the facility level within a building. Typical range of acceptable water pressure is between 35 psi to 80 psi.8 9 DOE also notes that facilities in a field study conducted by WaterSense in support of their specification for commercial prerinse spray valves showed a pressure range between 38 psi and 83 psi.10

    8 Friedman et.al. 2010. Criteria for Optimized Distribution Systems. Water Research Foundation. Denver, CO.

    9 International Association of Plumbing and Mechanical Officials. Uniform Plumbing Code. 2012. Ontario, Canada.

    10 U.S. Environmental Protection Agency's (EPA's) WaterSense Program. Pre-Rinse Spray Valves Field Study Report. 2011. pp. 16-17. http://www.epa.gov/watersense/docs/final_epa_prsv_study_report_033111v2_508.pdf.

    DOE understands that supply pressures affect the flow rate of a commercial prerinse spray valve once installed. Typically, lower pressures result in lower flow rates of the commercial prerinse spray valves, and higher pressures result in higher flow rates. Nevertheless, testing at a single specific supply pressure to demonstrate compliance with the maximum allowable flow rate would enable a user to compare different commercial prerinse spray valves at this pressure, thus reducing testing burden. DOE has also reviewed the American Society of Mechanical Engineers (ASME) Standard A112.18.1-2012, “Plumbing Supply Fittings,” which contains testing parameters for other plumbing products, such as faucets and showerheads, and found that it requires testing at lower supply pressures only when determining a minimum flow rate. In contrast, ASTM Standard F2324-13 prescribes the commercial prerinse spray valve flow rate to be measured at a supply pressure of 60 ± 2 psi to determine only the maximum flow rate. DOE proposes to test commercial prerinse spray valves at a flowing supply pressure of 60 ± 2 psi, as required by ASTM Standard F2324-13.

    DOE has also identified other differences between ASTM Standard F2324-03 (2009) and ASTM Standard F2324-13, which include: (1) Minimum flow rate of flex tubing, (2) water temperature for testing, and (3) length of water pipe required to be insulated. Table III.1 summarizes changes between ASTM Standard F2324-03 (2009) and 2013 that apply to DOE's test procedure.

    Table III.1—Changes to ASTM Standard F2324 ASTM Standard F2324-2003 (2009) ASTM Standard
  • F2324-2013
  • Flow rate of flex tubing 7 gpm 3.5 gpm. Water temperature for testing 120 ± 4 °F 60 ± 10 °F. Length of water pipe to be insulated Any insulation to have a thermal resistance (R) of 4 °F × ft 2 × h/Btu for the entire length of the water pipe, from the mixing valve to the inlet of the flex tubing No requirement.

    Section 9.1 of ASTM Standard F2324-13 reduced the minimum required flow rate of the flex tubing when no commercial prerinse spray valve is connected from 7 gpm to 3.5 gpm. ASTM Standard F2324-13 includes a note (#3) that a minimum flow rate for the tubing is specified to prevent the flexible tubing from dictating the flow rate of the prerinse spray valve. The required flow rate for commercial prerinse spray valves under 10 CFR 431.266 is less than the flow rate of the flex tubing specified in the ASTM standards. Therefore, because the test procedure measures the flow rate of the commercial prerinse spray valve, which is connected after the tubing, the flow rate of the tubing should not affect the measurement of the flow rate of the commercial prerinse spray valve. DOE believes that the flex tubing flow rate change from 7 gpm to 3.5 gpm (ATSM Standard F2324-2003 (2009) and 2013, respectively) will have no effect on the measured water consumption under the DOE test procedure. Accordingly, DOE proposes to adopt section 9.1 of ASTM Standard F2324-13 for a 3.5 gpm flow rate for flex tubing when not connected to the CPSV.

    ASTM Standard F2324-03 (2009) required the water temperature for testing to be 120 ± 4 °F. ASTM Standard F2324-13 reduces to 60 °F with an increased tolerance of ± 10 °F. DOE believes that this difference may reflect removal of the cleanability test because water temperature affects cleanability under the old approach/standard but not measuring force under the new approach/standard. DOE's research indicates that measurements of flow rate and spray force will be the same under either water temperature. Because the temperature will not affect these measurements, DOE proposes to incorporate the temperature requirements from ASTM Standard F2324-13 (section 10.2.2) into the DOE test procedure for commercial prerinse spray valves.

    Additionally, ASTM Standard F2324-13 removes the ASTM Standard F2324-03 (2009) requirement for any insulation to have a thermal resistance (R) of 4 °F × ft2 × h/Btu for the entire length of the water pipe, from the mixing valve to the inlet of the flex tubing. ASTM Standard F2324-03 required using 120 °F water; however, ASTM Standard F2324-13 requires using 60 °F water. DOE believes ASTM removed the insulation requirement in 2013 in conjunction with the water temperature reduction because the insulation is unnecessary when the test water temperature is 60 °F. Insulating the water pipe from the mixing valve to the inlet of the flex tubing is not required with 60 °F water because the water is below room temperature. DOE believes that removing the requirement to insulate the water pipe will have no effect on the measurement of either the flow rate or spray force because insulation only affects temperature, not water flow rate. DOE thus proposes to adopt the change not to require insulation.

    Finally, Section 4.1 Summary of Test Method, of ASTM Standard F2324-13 states, “If the measured flow rate is not within 5 percent of the rated flow rate, all further testing ceases and the manufacturer is contacted. The manufacturer may make appropriate changes or adjustments to the prerinse spray valve.” DOE notes that it is not incorporating this section of ASTM Standard F2324-13 into the DOE test procedure.

    In view of all the above, to align with current industry practice and to be consistent with test procedure requirements under EPCA, DOE proposes to incorporate by reference the following sections of ASTM Standard F2324-13: 6.1-6.9, 9.1-9.5.3.2, 10.1-10.2.5, 10.3.1-10.3.8, and 11.3.1 (replacing the plural “nozzles” with “nozzle”), and excluding references to the “Annex.” When ASTM Standard F2324-03 (2009) was updated to the current 2013 version, certain sections for measuring flow rate were renumbered. To reflect this renumbering, DOE is proposing to update the current flow rate test method to reference the appropriate sections of ASTM Standard F2324-13. The referenced sections describe the testing apparatus, test method, and calculations pertaining to flow-rate measurement.

    C. Proposed Additional Test Methods 1. Adding Test Method To Measure Spray Force

    As described previously, ASTM Standard F2324-13 includes a test for measuring the spray force of a commercial prerinse spray valve. The test is conducted by mounting a 10-inch rigid disc to a force gauge, located eight inches from the prerinse spray valve, as shown in Figure 4 in section 9.5.2 of ASTM Standard F2324-13. The plate is mounted in a vertical orientation parallel to the face of the commercial prerinse spray valve. After water flow is initiated, the water exits the commercial prerinse spray valve and strikes the disc, creating a force on the disc, which in turn depresses the force gauge. The average force gauge measurement over a 15-second period is recorded.

    During the September 30, 2014 Framework public meeting regarding the energy conservation standards for commercial prerinse spray valves, DOE invited comment on using spray force as a potential characteristic by which to separate product classes (Framework document, pp.17-18; Docket No. EERE-2014-BT-STD-0027, Public Meeting Transcript, No. 6 at p.38). DOE also invited comments about an alternative metric for spray force, gallons per minute divided by ounce-force (gpm/ozf). (Framework Document, p. 3)

    Comments from interested parties during the Framework public meeting, comments submitted to the EPA WaterSense program, and other research by DOE indicate that spray force is an important characteristic in defining the performance of a commercial prerinse spray valve because it relates to the product's application and user satisfaction. During the Framework public meeting, T&S Brass stated that the maximum technologically feasible model (max-tech model) performance should not be evaluated solely based on flow rate, but should include at least one other variable. T&S Brass mentioned that, depending on application, spray force is a characteristic that is considered when determining commercial prerinse spray valve performance. (Docket No. EERE-2014-BT-STD-0027, T&S Brass, Public Meeting Transcript, No. 6 at p.52)

    DOE also found through research that spray force is related to the utility of commercial prerinse spray valves.11 For example, a high spray force is required to clean heavy stains, such as baked-on foods, from silverware, dishes, pots, and pans. By contrast, a commercial prerinse spray valve with lower spray force may be sufficient for food service establishments where baked-on foods are less common. T&S Brass stated that applications of commercial prerinse spray valves range from light rinsing to heavy-duty cleaning. Heavy-duty cleaning applications require more spray force than light rinsing. (Docket No. EERE-2014-BT-STD-0027, T&S Brass, Public Meeting Transcript, No. 6 at p. 40-41)

    11 EPA WaterSense. Response to Public Comments Received on February 2013 WaterSense Draft Specification for Commercial Pre-Rinse Spray Valves, 5-7. September 19, 2013. United States Environmental Protection Agency http://www.epa.gov/watersense/docs/prsv_finalspec_publiccommentresponse_09.19.13_final_508.pdf (accessed May. 20, 2015).

    Spray force also is important because a WaterSense field study found that low water pressure, or spray force, is a source of user dissatisfaction. WaterSense evaluated 14 commercial prerinse spray valve models and collected 56 customer satisfaction reviews, of which nine were unsatisfactory. Seven of the nine unsatisfactory scores were attributed, among other factors, to the pressure (here, the subjective, user-perceived force) of the spray.12 DOE, however, proposes to measure spray force objectively, as in ASTM Standard F2324-13.

    12 EPA WaterSense. Pre-Rinse Spray Valves Field Study Report, pages 24-25. March 31, 2011. United States Environmental Protection Agency www.epa.gov/watersense/docs/final_epa_prsv_study_report_033111v2_508.pdf (accessed Oct. 31, 2014).

    In summary, spray force is a characteristic essential to evaluating the performance of commercial prerinse spray valves because there is a relationship between spray force and both the application of a commercial prerinse spray valve and user satisfaction. As a result, DOE proposes to incorporate by reference the spray force test method contained in sections 10.3.1-10.3.8 of ASTM Standard F2324-14 into the DOE commercial prerinse spray valve test procedure. DOE seeks comment on the addition of the spray force test method. See section V.E.2 of this NOPR.

    2. Multiple Spray Patterns: Adding a Requirement To Measure Flow Rate and Spray Force of Each Spray Pattern

    DOE has identified several commercial prerinse spray valves on the market with multiple spray patterns. On average, these prerinse spray valves provide up to three spray patterns. DOE's research showed a maximum number of five spray patterns for commercial prerinse spray valves. Each spray pattern is obtained by turning the adjustable spray head to select one of the available spray patterns at a time.

    For these commercial prerinse spray valves, each spray pattern can be used in distinct prerinsing applications. The applications range from washing off baked-on food to light washing, as each spray pattern can provide different flow rates and spray forces.

    Because a commercial prerinse spray valve with multiple spray patterns can give different flow rates and spray forces, DOE proposes to test each spray pattern using the flow rate and spray force test methods described in sections III.B and III.C.1, respectively. Additionally, section 10.3.7 from ASTM Standard F2324-13, which is incorporated by reference in this NOPR, also specifies that force shall be tested for each mode (i.e. spray pattern). DOE seeks comment about whether manufacturers should be required to test commercial prerinse spray valves with multiple spray patterns in all spray pattern modes. See section V.E.3 of this NOPR.

    D. Rounding Requirements 1. Flow Rate

    DOE proposes to change the rounding requirements for recording flow rate measurements from one decimal place to two decimal places. Currently, 10 CFR 431.264(b) requires rounding to one decimal place. However, the current WaterSense standard for commercial prerinse spray valves is rounded to two decimal places (1.28 gpm).13 DOE believes that rounding to one decimal place is insufficiently precise for the low magnitude flow rate measurements that may be needed for the forthcoming energy conservation standard. Therefore, DOE proposes to amend the flow rate measurement rounding requirements to two decimal places.

    13 U.S. Environmental Protection Agency's (EPA's) WaterSense program, September 9, 2013. WaterSense Specification for Commercial Pre-Rinse Spray Valves Supporting Statement, Version 1.0.

    2. Spray Force

    Section 11.4.2 of the ASTM Standard F2324-13 specifies that the spray force is rounded to one decimal place. DOE proposes to adopt the same spray force rounding requirements (i.e., one decimal place) in newly created 10 CFR 431.264(b)(2).

    DOE seeks comment about the proposed rounding requirements for flow rate and spray force. See section V.E.4 of this NOPR.

    E. Certification, Compliance, and Enforcement 1. Selection of Units to Test

    DOE proposes to retain the existing CPSV sampling plan at 10 CFR 429.51(a). CPSV testing is subject to DOE's general certification regulations at 10 CFR 429.11. These require a manufacturer to randomly select and test a sample of sufficient size to ensure that the represented value of water consumption adequately represents performance of all of the units within the basic model, but no fewer than two units. 429.11(b). The purposes of these requirements are to achieve a realistic representation of the water consumption of the basic model and to mitigate the risk of noncompliance, without imposing undue test burden.

    Section 8.1 of ASTM Standard F2324-13 requires three representative production units to be selected for all performance testing. DOE is not proposing to adopt this requirement. DOE is only proposing to adopt the testing methodology (i.e., applicable to testing of a unit)—not the rating methodology (i.e., applicable to a basic model)—found in ASTM Standard F2324-13. Accordingly, where ASTM Standard F2324-13 references testing of multiple units, DOE proposes to incorporate by reference the standard subject to the limitation that the DOE test procedure applies to testing of one unit in each sample set (e.g., product class).

    2. Representative Value Formula

    DOE proposes to revise the statistical methods for certification, compliance, and enforcement for commercial prerinse spray valves in 10 CFR 429.51(a)(2). Currently, 10 CFR 429.51(a)(2)(i) and (ii) provide that for any represented value of water consumption of a basic model for which consumers would favor lower values, the upper confidence level (UCL) is used and where consumers would favor higher values, the lower confidence limit (LCL) is used. Where the standard for commercial prerinse spray valves is expressed as a maximum rate of water consumption (gpm) rather than water efficiency, customers would favor a lower value. Therefore, the LCL formula in 10 CFR 429.51(a)(2)(ii) is unnecessary. DOE proposes to remove the LCL formula from the sampling plan for the selection of units for testing and retain only the provision for a UCL under 10 CFR 429.51(a)(2)(i). DOE seeks comment about amending 10 CFR 429.51(a)(2)(ii) by removing the formula for LCL. See section V.E.5 of this NOPR.

    F. Effective and Compliance Date

    In view of the above, any amendments to the commercial prerinse spray valve test procedure, under 10 CFR 431.264, would become effective 30 days after the date of the final rule. Representations would be required to be based on the amended test procedure 180 days after the effective date.

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

    The Office of Management and Budget (OMB) has determined that test procedure rulemakings do not constitute “significant regulatory actions” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (Oct. 4, 1993). Accordingly, this action was not subject to review by the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget.

    B. Review Under the Regulatory Flexibility Act

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

    The potential burden on manufacturers related to commercial prerinse spray values has been analyzed in previous rules. The following analysis is informed by previous rules, but also includes additional analysis.

    When the DOE test procedure was initially adopted in 2006, the test procedure was identical to ENERGY STAR's test procedure. DOE stated in the 2006 test procedure final rule that many manufacturers had been redesigning the products covered under that final rule. These products were tested for compliance with existing voluntary performance standards such as ENERGY STAR program requirements, using industry-developed test procedures that were the basis for the test procedures in the Energy Policy Act of 2005 (EPAct 2005). DOE stated that manufacturers would experience no additional burdens if DOE adopted the test procedure (ASTM Standard F2324-03) referenced in EPAct 2005. 71 FR 71340, 71363 (Dec. 8, 2006). In the final rule that last updated DOE's test procedure, DOE did not adopt any changes to the referenced test procedure, thus DOE determined that there was no incremental cost burden to manufacturers of commercial prerinse spray valves. 78 FR 62970, 62983 (Oct. 23, 2013). Historically, when DOE has adopted the industry's test procedure, it has not resulted in any incremental cost burden to manufacturers of commercial prerinse spray valves.

    For this proposed rule, DOE made inquiry into small business manufacturers of commercial prerinse spray valves. In its market assessment, DOE used public information to identify potential small manufacturers. DOE reviewed the Department of Energy Compliance Database, individual company Web sites, and various marketing research tools (e.g., Dun and Bradstreet reports, Manta) to create a list of companies that import or otherwise manufacture commercial prerinse spray valves covered by this rulemaking.14 DOE identified 11 distinct manufacturers of commercial prerinse spray valves—the smallest business had two employees and the largest had 237 employees.

    14 The Certification Database is part of DOE's Compliance Certification Management System. See www.regulations.doe.gov/certification-data/ (last accessed November 10, 2014).

    In view of the collected data, DOE considered what manufacturers met the Small Business Administration's (SBA's) definition of the term “small business” as it relates to the North American Industry Classification System (NAICS) code 332919 (SBA sets the size standard of 500 or fewer employees),15 and to screen out (1) companies that do not offer commercial prerinse spray valves covered by this rulemaking, (2) do not meet the definition of the term “small business,” or (3) are foreign owned and operated. As a result of its review, DOE identified eight manufacturers that would be considered small businesses. The number of small businesses and the applicable NAICS code 332919 are consistent with the Certification, Compliance, and Enforcement final rule at 76 FR 12422, 12488 (March 7, 2011). Thus, DOE has determined that amending the test procedures under 10 CFR 431.264 would have minimal, if any, effect on covered small businesses, and that an IRFA was not needed.

    15 U.S. Small Business Administration Table of Small Business Size Standards Matched to North American Industry Classification System Codes. See www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf (last accessed February 13, 2015).

    Table IV.1 lists the eight small businesses covered by this proposed rulemaking, according to the number of employees. DOE estimated that the average revenue per small business is approximately $21 million and the combined total annual revenues associated with these small businesses is about $124 million. Further, DOE analyzed the CPSV industry to determine what manufacturers would be covered under a test procedure rulemaking, and determined that 8 of the 11 CPSV manufacturers, or 72 percent, may qualify as a “small business” under SBA classification guidelines.

    Table IV.1—Small Business Size by Number of Employees Number of
  • employees
  • Number of small
  • businesses
  • Percentage of small
  • businesses
  • 1-10 1 12.5 21-30 1 12.5 31-40 1 12.5 41-50 2 25 61-70 1 12.5 101-150 2 25

    DOE estimated the labor burden associated with testing, in view of the 2012 (most recent) median annual pay for (1) environmental engineering technicians ($45,350), (2) mechanical engineering technicians ($51,980), and (3) plumbers, pipefitters, and steamfitters ($49,140) for an average annual salary of $48,823.16 17 DOE divided the average by 1,920 hours per year (40 hours per week for 48 weeks per year) to develop an hourly rate of $25.43. DOE adjusted the hourly rate by 31 percent to account for benefits, resulting in an estimated total hourly rate of $33.31.18 19 DOE used this hourly rate to assess the labor costs for testing units according to the proposed amendments to the test procedures.

    16 U.S. Department of Labor Bureau of Labor Statistics. Occupational Outlook Handbook, Architecture and Engineering. www.bls.gov/ooh/Architecture-and-Engineering/home.htm (last accessed November 4, 2014).

    17 U.S. Department of Labor Bureau of Labor Statistics. Occupational Outlook Handbook, Construction and Extraction Occupations. www.bls.gov/ooh/construction-and-extraction/home.htm (last accessed November 4, 2014).

    18 Obtained from the Bureau of Labor Statistics. News Release: Employer Cost For Employee Compensation—December 2012, December 2012. U.S. Department of Labor. www.bls.gov/news.release/ecec.nr0.htm.

    19 Additional benefits include paid leave, supplemental pay, insurance, retirement and savings, Social Security, Medicare, unemployment insurance, and workers compensation.

    Currently, 10 CFR 431.264 prescribes measurements for a flow rate, but does not address testing flow rate for commercial prerinse spray valves with multiple spray patterns. Instead, it requires testing to be repeated three times for the same unit. As such, DOE believes that testing could be completed in less than an hour per commercial prerinse spray valve. To assess the potential burden of the proposed amended test procedures, DOE rounds the current duration for testing up to a whole hour, for cases where the testing technician needs to document the results or cannot allot his or her labor hours. In view of the foregoing, DOE believes that the current testing process costs, on average, are $66.62 for labor for a total of two basic models to meet the testing requirements of 10 CFR 429.11 and 429.51.

    The proposed amendments to the test procedures include an additional test for spray force. DOE believes that the additional time required to test spray force is not significant but, understandably, the number of spray patterns could potentially increase any testing time. DOE's review of commercial prerinse spray valves yielded an average of three patterns per commercial prerinse spray valve. DOE estimates that the time to measure both flow rate and spray force for all three spray patterns to be greater than one hour but typically less than two hours. DOE again presumes that testing staff may not easily apportion their testing time between product, and rounds the total testing time to two hours per unit tested. Thus, DOE estimates the total labor time to test for two basic models of commercial prerinse spray valves each with multiple spray patterns to be $133.24.20

    20Basic model means all units of a given type of covered product (or class thereof) manufactured by one manufacturer, having the same primary energy source, and which have essentially identical electrical, physical, and functional (or hydraulic) characteristics that affect energy consumption, energy efficiency, water consumption, or water efficiency. (10 CFR 431.262)

    DOE examined the CPSV industry to identify the manufacturers of commercial prerinse spray valves covered in this NOPR, and determined that 72 percent of all CPSV manufacturers could be classified as small entities according to SBA classification guidelines. Although 72 percent of the market could be considered a significant portion of the overall industry, DOE believes that small manufacturers would not be substantially affected by the proposed amendments to the test procedure, because there would be no significant incremental costs to any entity. The cost of testing for each small business analyzed was less than or equal to 0.01 percent of revenue for a sample size of two commercial prerinse spray valves. The current industry standard used for commercial prerinse spray valves (ASTM Standard F2324-13) requires three representative production models be selected for performance testing. However, the DOE sample size of a minimum of two units remains unchanged with this proposed rule. Therefore, DOE concludes that the cost effects accruing from the proposed rule would not have a “significant economic impact on a substantial number of small entities,” and that the preparation of an IRFA is not warranted. DOE will submit a certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the Small Business Administration for review under 5 U.S.C. 605(b).

    DOE seeks comments about whether the proposed test procedure amendments would have a significant economic impact on a substantial number of small entities. See section V.E.6 of this NOPR.

    C. Review Under the Paperwork Reduction Act of 1995

    Manufacturers of commercial prerinse spray valves must certify to DOE that their products comply with any applicable energy conservation standards. In certifying compliance, manufacturers must test their products according to the DOE test procedures for commercial prerinse spray valves, including any amendments adopted for those test procedures. DOE has established regulations for the certification and recordkeeping requirements for all covered consumer products and commercial equipment, including commercial prerinse spray valves. (76 FR 12422 (March 7, 2011)). The collection-of-information requirement for the certification and recordkeeping is subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been approved by OMB under OMB control number 1910-1400. Public reporting burden for the certification is estimated to average 30 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

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

    D. Review Under the National Environmental Policy Act of 1969

    In this proposed rule, DOE proposes test procedure amendments that it expects will be used to develop and implement future energy conservation standards for commercial prerinse spray valves. DOE has determined that this rule falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and DOE's implementing regulations at 10 CFR part 1021. Specifically, this proposed rule would amend the existing test procedures without affecting the amount, quality or distribution of energy usage, and, therefore, would not result in any environmental impacts. Thus, this rulemaking is covered by Categorical Exclusion A5 under 10 CFR part 1021, subpart D, which applies to any rulemaking that interprets or amends an existing rule without changing the environmental effect of that rule. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

    E. Review Under Executive Order 13132

    Executive Order 13132, “Federalism,” 64 FR 43255 (Aug. 4, 1999) imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE has examined this proposed rule and has determined that it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of this proposed rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297(d)) No further action is required by Executive Order 13132.

    F. Review Under Executive Order 12988

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

    G. Review Under the Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a proposed regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820; also available at http://energy.gov/gc/office-general-counsel. DOE examined this proposed rule according to UMRA and its statement of policy and determined that the rule contains neither an intergovernmental mandate, nor a mandate that may result in the expenditure of $100 million or more in any year, so these requirements do not apply.

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

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

    I. Review Under Executive Order 12630

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

    J. Review Under Treasury and General Government Appropriations Act, 2001

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

    K. Review Under Executive Order 13211

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

    This regulatory action to amend the test procedure for measuring the energy efficiency of commercial prerinse spray valves is not a significant regulatory action under Executive Order 12866. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, it is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects.

    L. Review Under Section 32 of the Federal Energy Administration Act of 1974

    Under section 301 of the Department of Energy Organization Act (Pub. L. 95-91; 42 U.S.C. 7101), DOE must comply with section 32 of the Federal Energy Administration Act of 1974, as amended by the Federal Energy Administration Authorization Act of 1977. (15 U.S.C. 788; FEAA) Section 32 essentially provides in relevant part that, where a proposed rule authorizes or requires use of commercial standards, the notice of proposed rulemaking must inform the public of the use and background of such standards. In addition, section 32(c) requires DOE to consult with the Attorney General and the Chairman of the Federal Trade Commission (FTC) concerning the impact of the commercial or industry standards on competition.

    The proposed rule incorporates testing methods contained in the following commercial standards: ASTM F2324-13, Standard Test Method for Prerinse Spray Valves, sections 6.1-6.9, 9.1-9.5.3.2, 10.1-10.2.5, 10.3.1-10.3.8, 11.3.1 (replacing “nozzles” with “nozzle”), and disregarding references to the Annex. DOE has evaluated these standards and is unable to conclude whether they fully comply with the requirements of section 32(b) of the FEAA, (i.e., that they were developed in a manner that fully provides for public participation, comment, and review). DOE will consult with the Attorney General and the Chairman of the FTC concerning the impact of these test procedures on competition prior to prescribing a final rule.

    M. Description of Materials Incorporated by Reference

    In this NOPR, DOE proposes to incorporate by reference the test standard published by ASTM, titled, “Standard Test Method for Prerinse Spray Valves,” ASTM Standard F2324-2013. ASTM Standard F2324-2013 is an industry-accepted test procedure that measures water flow rate and spray force for prerinse spray valves, and is applicable to product sold in North America. ASTM Standard F2324-2013 specifies testing conducted in accordance with other industry accepted test procedures (already incorporated by reference). The test procedure proposed in this NOPR references various sections of ASTM Standard F2324-2013 that address test setup, instrumentation, test conduct, and calculations. ASTM Standard F2324-2013 is readily available at ASTM's Web site at www.astm.org/Standard/standards-and-publications.html.

    V. Public Participation A. Attendance at Public Meeting

    The time, date, and location of the public meeting are listed in the DATES and ADDRESSES sections at the beginning of this document. If you plan to attend the public meeting, please notify Ms. Brenda Edwards at (202) 586-2945 or [email protected]

    Please note that foreign nationals participating in the public meeting are subject to advance security screening procedures which require advance notice prior to attendance at the public meeting. Any foreign national wishing to participate in the public meeting should advise DOE as soon as possible by contacting [email protected] to initiate the necessary procedures. Please also note that any person wishing to bring a laptop into the Forrestal Building will be required to obtain a property pass. Visitors should avoid bringing laptops, or allow an extra 45 minutes. Persons may also attend the public meeting via webinar.

    Because of the REAL ID Act implemented by the Department of Homeland Security (DHS), there have been recent changes regarding identification (ID) requirements for individuals wishing to enter Federal buildings from specific States and U.S. territories. As a result, driver's licenses from the following States or territory will not be accepted for building entry, and instead, one of the alternate forms of ID listed below will be required.

    DHS has determined that regular driver's licenses (and ID cards) from the following jurisdictions are not acceptable for entry into DOE facilities: Alaska, American Samoa, Arizona, Louisiana, Maine, Massachusetts, Minnesota, New York, Oklahoma, and Washington. Acceptable alternate forms of Photo-ID include: U.S. Passport or Passport Card; an Enhanced Driver's License or Enhanced ID-Card issued by the States of Minnesota, New York or Washington (Enhanced licenses issued by these States are clearly marked Enhanced or Enhanced Driver's License); a military ID or other Federal government-issued Photo-ID card.

    In addition, you can attend the public meeting via webinar. Webinar registration information, participant instructions, and information about the capabilities available to webinar participants will be published on DOE's Web site www1.eere.energy.gov/buildings/appliance_standards/product.aspx/productid/54. Participants are responsible for ensuring that their systems are compatible with the webinar software.

    B. Procedure for Submitting Prepared General Statement for Distribution

    Any person who has plans to present a prepared general statement may request that copies of his or her statement be made available at the public meeting. Such persons may submit requests, along with an advance electronic copy of their statement in portable document format (PDF) (preferred), Microsoft Word or Excel, WordPerfect, or text in American Standard Code for Information Interchange (ASCII) file format, to the appropriate address shown in the ADDRESSES section at the beginning of this document. The request and advance copy of statements must be received at least one week before the public meeting and may be emailed, hand-delivered, or sent by mail. DOE prefers to receive requests and advance copies via email. Please include a telephone number to enable DOE staff to make a follow-up contact, if needed.

    C. Conduct of Public Meeting

    DOE will designate a DOE official to preside at the public meeting and may also use a professional facilitator to aid discussion. The meeting will not be a judicial or evidentiary-type public hearing, but DOE will conduct it in accordance with EPCA. (42 U.S.C. 6306) A court reporter will be present to record the proceedings and prepare a transcript. DOE reserves the right to schedule the order of presentations and to establish the procedures governing the conduct of the public meeting. After the public meeting, interested parties may submit further comments on the proceedings as well as on any aspect of the rulemaking until the end of the comment period.

    The public meeting will be conducted in an informal, conference style. DOE will present summaries of comments received before the public meeting, allow time for prepared general statements by participants, and encourage all interested parties to share their views on issues affecting this rulemaking. Each participant will be allowed to make a general statement (within time limits determined by DOE), before the discussion of specific topics. DOE will allow, as time permits, other participants to comment briefly on any general statements.

    At the end of all prepared statements on a topic, DOE will permit participants to clarify their statements briefly and comment on statements made by others. Participants should be prepared to answer questions by DOE and by other participants concerning these issues. DOE representatives may also ask questions of participants concerning other matters relevant to this rulemaking. The official conducting the public meeting will accept additional comments or questions from those attending, as time permits. The presiding official will announce any further procedural rules or modification of the above procedures that may be needed for the proper conduct of the public meeting.

    A transcript of the public meeting will be included in the docket, which can be viewed as described in the DOCKET section at the beginning of this proposed rule. In addition, any person may buy a copy of the transcript from the transcribing reporter.

    D. Submission of Comments

    DOE will accept comments, data, and information regarding this proposed rule not later than the date provided in the DATES section at the beginning of this proposed rule. Interested parties may submit comments using any of the methods described in the ADDRESSES section at the beginning of this proposed rule.

    Submitting comments via regulations.gov. The regulations.gov Web page will require you to provide your name and contact information. Your contact information will be viewable to DOE Building Technologies staff only. Your contact information will not be publicly viewable except for your first and last names, organization name (if any), and submitter representative name (if any). If your comment is not processed properly because of technical difficulties, DOE will use this information to contact you. If DOE cannot read your comment due to technical difficulties and cannot contact you for clarification, DOE may not be able to consider your comment.

    However, your contact information will be publicly viewable if you include it in the comment or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.

    Do not submit to regulations.gov information for which disclosure is restricted by statute, such as trade secrets and commercial or financial information (hereinafter referred to as Confidential Business Information (CBI)). Comments submitted through regulations.gov cannot be claimed as CBI. Comments received through the Web site will waive any CBI claims for the information submitted. For information on submitting CBI, see the Confidential Business Information section.

    DOE processes submissions made through regulations.gov before posting. Normally, comments will be posted within a few days of being submitted. However, if large volumes of comments are being processed simultaneously, your comment may not be viewable for up to several weeks. Please keep the comment tracking number that regulations.gov provides after you have successfully uploaded your comment.

    Submitting comments via email, hand delivery, or postal mail. Comments and documents submitted via email, hand delivery, or postal mail also will be posted to regulations.gov. If you do not want your personal contact information to be publicly viewable, do not include it in your comment or any accompanying documents. Instead, provide your contact information on a cover letter. Include your first and last names, email address, telephone number, and optional mailing address. The cover letter will not be publicly viewable as long as it does not include any comments.

    Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery, please provide all items on a CD, if feasible. It is not necessary to submit printed copies. No facsimiles (faxes) will be accepted.

    Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English and free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.

    Campaign form letters. Please submit campaign form letters by the originating organization in batches of between 50 to 500 form letters per PDF or as one form letter with a list of supporters' names compiled into one or more PDFs. This reduces comment processing and posting time.

    Confidential Business Information. According to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email, postal mail, or hand delivery two well-marked copies: one copy of the document marked confidential including all the information believed to be confidential, and one copy of the document marked non-confidential with the information believed to be confidential deleted. Submit these documents via email or on a CD, if feasible. DOE will make its own determination about the confidential status of the information and treat it according to its determination.

    Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person which would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest.

    It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).

    E. Issues on Which DOE Seeks Comment

    Although DOE welcomes comments on any aspect of this proposal, DOE is particularly interested in receiving comments and views of interested parties concerning the following issues:

    1. Definitions Discussed and Proposed a. Commercial Prerinse Spray Valve DOE seeks comments on its proposal to revise the definition of “commercial prerinse spray valve” in this NOPR; see section III.A.1. b. Normally-Closed Valve DOE seeks comment on its tentative proposal to add a definition for “normally-closed valve” in this NOPR; see section III.A.2. c. Spray Force DOE seeks comments on its proposal add the definition of “spray force” in this NOPR; see section III.A.3. 2. DOE seeks comment on the addition of the spray force test method; see section III.C.1. 3. Spray Patterns DOE seeks comment on whether manufacturers should be required to test commercial prerinse spray valves with multiple spray patterns in all spray pattern modes, see section III.C.2. 4. DOE seeks comment on changing the flow rate measurement rounding requirements from one decimal place to two decimal places, see section III.D. 5. DOE seeks comment on the removal of 10 CFR 429.51(a)(2)(ii), see section III.E. 6. Small Entities DOE seeks comments on its reasoning that the proposed test procedures will not have a significant economic impact on a substantial number of small entities; see section IV.B. VI. Approval of the Office of the Secretary

    The Secretary of Energy has approved publication of this proposed rule.

    List of Subjects 10 CFR part 429

    Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Reporting and recordkeeping requirements.

    10 CFR part 431

    Administrative practice and procedure, Confidential business information, Energy conservation test procedures, Incorporation by reference, and Reporting and recordkeeping requirements.

    Issued in Washington, DC, on June 5, 2015. Kathleen B. Hogan, Deputy Assistant Secretary for Energy Efficiency, Energy Efficiency and Renewable Energy.

    For the reasons stated in the preamble, DOE is proposing to amend parts 429 and 431 of Chapter II of Title 10, Code of Federal Regulations as set forth below.

    PART 429—CERTIFICATION, COMPLIANCE, AND ENFORCEMENT FOR CONSUMER PRODUCTS AND COMMERCIAL AND INDUSTRIAL EQUIPMENT 1. The authority citation for part 429 continues to read as follows: Authority:

    42 U.S.C. 6291-6317.

    2. In § 429.51, paragraph (a) is revised to read as follows:
    § 429.51 Commercial prerinse spray valves.

    (a) Sampling plan for selection of units for testing. (1) The requirements of § 429.11 apply to commercial prerinse spray valves; and

    (2) For each basic model of commercial prerinse spray valves, a sample of sufficient size must be randomly selected and tested to ensure that any represented value of water consumption or other measure of water consumption of a basic model for which consumers would favor lower values must be greater than or equal to the higher of:

    (i) The mean of the sample, where:

    EP23JN15.022 and, x is the sample mean; n is the number of samples; and xi is the ith sample; Or,

    (ii) The upper 95 percent confidence limit (UCL) of the true mean divided by 1.10, where:

    EP23JN15.023 and, x is the sample mean; s is the sample standard deviation; n is the number of samples; and t0.95 is the t statistic for a 95 percent two-tailed confidence interval with n-1 degrees of freedom (from Appendix A of this subpart).
    PART 431—ENERGY EFFICIENCY PROGRAM FOR CERTAIN COMMERCIAL AND INDUSTRIAL EQUIPMENT 3. The authority citation for part 431 continues to read as follows: Authority:

    42 U.S.C. 6291-6317.

    4. Section 431.262 is revised to read as follows:
    § 431.262 Definitions.

    Basic model means all units of a given type of covered product (or class thereof) manufactured by one manufacturer, having the same primary energy source, and which have essentially identical electrical, physical, and functional (or hydraulic) characteristics that affect energy consumption, energy efficiency, water consumption, or water efficiency.

    Commercial prerinse spray valve means a handheld device, containing a normally-closed valve, suitable for use with commercial dishwashing and ware washing equipment for the purpose of removing food residue before cleaning the items.

    Normally-closed valve means a valve that opens when an external force is exerted upon it and automatically closes when the external force is removed.

    Spray force means the amount of force exerted onto the spray disc, measured in ounce-force (ozf).

    5. Section 431.263 is amended by revising paragraph (b)(1) to read as follows:
    § 431.263 Materials incorporated by reference.

    (b) * * *

    (1) ASTM Standard F2324-13, (“ASTM F2324-13”), Standard Test Method for Prerinse Spray Valves, approved June 1, 2013; IBR approved as follows, sections: 6.1—6.9, 9.1-9.5.3.2, 10.1-10.2.5, 10.3.1-10.3.8, and 11.3.1 (replacing “nozzles” with “nozzle”), excluding reference to the Annex, IBR approved for § 431.264.

    6. Section 431.264 is revised to read as follows:
    § 431.264 Uniform test method to measure flow rate and spray force of commercial prerinse spray valves.

    (a) Scope. This section provides the test procedure to measure the water consumption flow rate and spray force of a commercial prerinse spray valve.

    (b) Testing and Calculations.—(1) Flow rate. Test a sample unit in accordance with the requirements of sections 6.1 through 6.9 (Apparatus) except 6.4 and 6.7, 9.1 through 9.4 (Preparation of Apparatus), and 10.1 through 10.2.5 (Procedure), and perform calculations in accordance with section 11.3.1 (Calculation and Report) of ASTM F2324-13, (incorporated by reference, see § 431.263). Disregard any references to the Annex. Record flow rate measurements at the resolutions of the test instrumentation. For the sample unit, calculate the mean of the flow rate measurements. Round the final value for flow rate to two decimal places.

    (2) Spray force. Test each sample unit in accordance with the test requirements specified in sections 6.2 and 6.4 through 6.9 (Apparatus), 9.1 through 9.5.3.2 (Preparation of Apparatus), and 10.3.1 through 10.3.8 (Procedure) of ASTM F2324-13. Disregard any references to the Annex. Record spray force measurements at the resolution of the test instrumentation. For each sample unit, calculate the mean of the spray force measurements. Round the spray force to one decimal place.

    (3) Multiple spray patterns. If a sample unit has multiple spray patterns, for each possible spray pattern:

    (i) Measure both the flow rate and spray force according to paragraphs (b)(1) and (b)(2) of this section (including calculating the mean flow rate and spray force for each spray pattern); and

    (ii) Record the mean flow rate for each spray pattern, rounded to two decimal places. Record the mean spray force for each spray pattern, rounded to one decimal place.

    [FR Doc. 2015-15376 Filed 6-22-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY 10 CFR Part 430 [Docket No. EERE-2015-BT-STD-0006] RIN 1904-AD51 Energy Efficiency Program for Consumer Products: Energy Conservation Standards for Fluorescent Lamp Ballasts AGENCY:

    Office of Energy Efficiency and Renewable Energy, Department of Energy.

    ACTION:

    Notice of public meeting and availability of the Framework Document.

    SUMMARY:

    The U.S. Department of Energy (DOE) is initiating this rulemaking and data collection process to consider amending energy conservation standards for fluorescent lamp ballasts. To inform interested parties and to facilitate this process, DOE has prepared a Framework Document that details the analytical approach and scope of coverage for the rulemaking, and identifies several issues on which DOE is particularly interested in receiving comments. DOE will hold a public meeting to discuss and receive comments on its planned analytical approach and issues it will address in this rulemaking proceeding. DOE welcomes written comments and relevant data from the public on any subject within the scope of this rulemaking. A copy of the Framework Document is available at: http://www1.eere.energy.gov/buildings/appliance_standards/rulemaking.aspx?ruleid=110.

    DATES:

    Comments: DOE will accept written comments, data, and information regarding the Framework Document before and after the public meeting, but no later than August 7, 2015.

    Meeting: DOE will hold a public meeting on Friday, July 17, 2015, from 9:00 a.m. to 4:00 p.m. in Washington, DC. Additionally, DOE plans to conduct the public meeting via webinar. You may attend the public meeting via webinar, and registration information, participant instructions, and information about the capabilities available to webinar participants will be published on DOE's Web site at: http://www1.eere.energy.gov/buildings/appliance_standards/rulemaking.aspx?ruleid=110. Participants are responsible for ensuring their systems are compatible with the webinar software.

    DOE must receive requests to speak at the public meeting before 4:00 p.m., July 6, 2015. DOE must receive an electronic copy of the statement with the name and, if appropriate, the organization of the presenter to be given at the public meeting before 4:00 p.m., July 10, 2015.

    ADDRESSES:

    The public meeting will be held at the U.S. Department of Energy, Forrestal Building, Room 8E-089, 1000 Independence Avenue SW., Washington, DC 20585-0121. Please note that foreign nationals participating in the public meeting are subject to advance security screening procedures which require advance notice prior to attendance at the public meeting. If a foreign national wishes to participate in the public meeting, please inform DOE as soon as possible by contacting Ms. Regina Washington at (202) 586-1214 or by email: [email protected] so that the necessary procedures can be completed. Please note that any person wishing to bring a laptop computer into the Forrestal Building will be required to obtain a property pass. Visitors should avoid bringing laptops, or allow an extra 45 minutes. As noted above, persons may also attend the public meeting via webinar.

    Interested parties are encouraged to submit comments electronically. However, comments may be submitted by any of the following methods:

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

    Email: [email protected] Include docket number EERE-2015-BT-STD-0006 and/or regulatory identification number (RIN) 1904-AD51 in the subject line of the message. All comments should clearly identify the name, address, and, if appropriate, organization of the commenter. Submit electronic comments in WordPerfect, Microsoft Word, PDF, or ASCII file format, and avoid the use of special characters or any form of encryption.

    Postal Mail: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Program, Mailstop EE-5B, Framework Document for Fluorescent Lamp Ballasts, Docket No. EERE-2015-BT-STD-0006 and/or RIN 1904-AD51, 1000 Independence Avenue SW., Washington, DC 20585-0121. If possible, please submit all items on a compact disc (CD), in which case it is not necessary to include printed copies. [Please note that comments sent by mail are often delayed and may be damaged by mail screening processes.]

    Hand Delivery/Courier: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Program, Sixth Floor, 950 L'Enfant Plaza SW., Washington, DC 20024. Telephone: (202) 586-2945. If possible, please submit all items on a CD, in which case it is not necessary to include printed copies.

    Instructions: All submissions received must include the agency name and docket number and/or RIN for this rulemaking. No telefacsimilies (faxes) will be accepted.

    Docket: The docket is available for review at http://www.regulations.gov, and will include Federal Register notices, framework document, notice of proposed rulemaking, public meeting attendee lists and transcripts, comments, and other supporting documents/materials throughout the rulemaking process. The regulations.gov Web page contains simple instructions on how to access all documents, including public comments, in the docket. The docket can be accessed by searching for docket number EERE-2015-BT-STD-0006 on the regulations.gov Web site. All documents in the docket are listed in the www.regulations.gov index. However, not all documents listed in the index may be publicly available, such as information that is exempt from public disclosure.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Lucy deButts, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 287-1604. Email: [email protected]

    Ms. Sarah Butler, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-1777. Email: [email protected]

    For information on how to submit or review public comments and on how to participate in the public meeting, contact Ms. Brenda Edwards, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone (202) 586-2945. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Title III, Part Ba of the Energy Policy and Conservation Act of 1975 (EPCA or the Act), Public Law 94-163, (42 U.S.C. 6291-6309, as codified) sets forth a variety of provisions designed to improve energy efficiency and established the Energy Conservation Program for Consumer Products Other Than Automobiles, a program covering major household appliances (collectively referred to as “covered products”).b Part C of title III (42 U.S.C. 6311-6317) establishes an energy conservation program for certain industrial and commercial equipment. EPCA authorizes DOE to establish technologically feasible, economically justified energy conservation standards for covered products or equipment that would be likely to result in significant national energy savings. (42 U.S.C. 6295(o)(2)(B)(i)(I)-(VII))

    a For editorial reasons, upon codification in the U.S. Code, Part B was redesignated Part A.

    b All references to EPCA in this document refer to the statute as amended through the American Energy Manufacturing Technical Corrections Act (AEMTCA), Public Law 112-210 (Dec. 18, 2012).

    Additional amendments to EPCA have given DOE the authority to regulate the energy efficiency of several products, including certain fluorescent lamp ballasts—the products that are the subject of this document. Amendments to EPCA in the National Appliance Energy Conservation Amendments of 1988 (NAECA 1988), Public Law 100-357, established energy conservation standards for fluorescent lamp ballasts. (42 U.S.C. 6295(g)(5)) These same amendments also required that DOE: (1) Conduct two rulemaking cycles to determine whether these standards should be amended; and (2) for each rulemaking cycle, determine whether the standards in effect for fluorescent lamp ballasts should be amended so that they would be applicable to additional fluorescent lamp ballasts. (42 U.S.C. 6295(g)(7)(A)-(B)) DOE completed these two rulemaking cycles in 2000 and 2011. 65 FR 56740 (Sept. 19, 2000) and 76 FR 70548 (Nov. 14, 2011).

    EPCA mandates that within six years of the publication of the previous final rule, DOE is required to publish either a notice of determination that standards do not need to be amended or a notice of proposed rulemaking including new proposed standards. (42 U.S.C. 6295(m)) This notice and the associated public meeting represent the first step in the process to consider whether to amend energy conservation standards for fluorescent ballasts in that six year review process.

    DOE has prepared the Framework Document to explain the relevant issues, analyses, and processes it anticipates using when considering new or amended energy conservation standards for fluorescent lamp ballasts. The focus of the public meeting noted above will be to discuss the information presented and issues identified in the Framework Document. At the public meeting, DOE will make presentations and invite discussion on the rulemaking process as it applies to fluorescent lamp ballasts. DOE will also solicit comments, data, and information from participants and other interested parties.

    DOE is planning to conduct in-depth technical analyses in the following areas: (1) Engineering; (2) energy use; (3) product price; (4) life-cycle cost and payback period; (5) national impacts; (6) manufacturer impacts; (7) emission impacts; (8) utility impacts; (9) employment impacts; and (10) regulatory impacts. DOE will also conduct several other analyses that support those previously listed, including the market and technology assessment, the screening analysis (which contributes to the engineering analysis), and the shipments analysis (which contributes to the national impact analysis).

    DOE encourages those who wish to participate in the public meeting to obtain the Framework Document and to be prepared to discuss its contents. A copy of the Framework Document is available at: http://www1.eere.energy.gov/buildings/appliance_standards/rulemaking.aspx?ruleid=110.

    Public meeting participants need not limit their comments to the issues identified in the Framework Document. DOE is also interested in comments on other relevant issues that participants believe would affect energy conservation standards for these products, applicable test procedures, or the preliminary determination on the scope of coverage. DOE invites all interested parties, whether or not they participate in the public meeting, to submit in writing by August 7, 2015, comments and information on matters addressed in the Framework Document and on other matters relevant to DOE's consideration of coverage of and standards for fluorescent lamp ballasts.

    The public meeting will be conducted in an informal, facilitated, conference style. There shall be no discussion of proprietary information, costs or prices, market shares, or other commercial matters regulated by U.S. antitrust laws. A court reporter will record the proceedings of the public meeting, after which a transcript will be available for purchase from the court reporter and placed on the DOE Web site at: http://www1.eere.energy.gov/buildings/appliance_standards/rulemaking.aspx?ruleid=110.

    After the public meeting and the close of the comment period on the Framework Document, DOE will collect data, conduct the analyses as discussed in the Framework Document and at the public meeting, and review the public comments it receives.

    DOE considers public participation to be a very important part of the process for determining whether to establish or amend energy conservation standards and, if so, in setting those new or amended standards. DOE actively encourages the participation and interaction of the public during the comment period at each stage of the rulemaking process. Beginning with the Framework Document, and during each subsequent public meeting and comment period, interactions with and among members of the public provide a balanced discussion of the issues to assist DOE in the standards rulemaking process. Accordingly, anyone who wishes to participate in the public meeting, receive meeting materials, or be added to the DOE mailing list to receive future notices and information about this rulemaking should contact Ms. Brenda Edwards at (202) 586-2945, or via email at [email protected]

    Issued in Washington, DC, on June 17, 2015. Kathleen B. Hogan, Deputy Assistant Secretary for Energy Efficiency, Energy Efficiency and Renewable Energy.
    [FR Doc. 2015-15383 Filed 6-22-15; 8:45 am] BILLING CODE 6450-01-P
    FARM CREDIT ADMINISTRATION 12 CFR Parts 607, 614, 615, 620 and 628 RIN 3052-AC81 Regulatory Capital Rules: Regulatory Capital, Implementation of Tier 1/Tier 2 Framework AGENCY:

    Farm Credit Administration.

    ACTION:

    Proposed rule; reopening of comment period.

    SUMMARY:

    The Farm Credit Administration (FCA or we) is reopening the comment period on the proposed rule that would revise our regulatory capital requirements for Farm Credit System (System) institutions to include tier 1 and tier 2 risk-based capital ratio requirements, a tier 1 leverage requirement, a capital conservation buffer, revised risk weightings, and additional public disclosure requirements.

    DATES:

    You may send us comments from June 26, 2015, through July 10, 2015.

    ADDRESSES:

    For accuracy and efficiency reasons, please submit comments by email or through the FCA's Web site. We do not accept comments submitted by facsimile (fax), as faxes are difficult for us to process in compliance with section 508 of the Rehabilitation Act. Please do not submit your comment multiple times via different methods. You may submit comments by any of the following methods:

    Email: Send us an email at [email protected].

    FCA Web site: http://www.fca.gov. Select “Public Commenters,” then “Public Comments,” and follow the directions for “Submitting a Comment.”

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

    Mail: Barry F. Mardock, Deputy Director, Office of Regulatory Policy, Farm Credit Administration, 1501 Farm Credit Drive, McLean, VA 22102-5090.

    You may review copies of all comments we receive at our office in McLean, Virginia, or from our Web site at http://www.fca.gov. Once you are in the Web site, select “Public Commenters,” then “Public Comments,” and follow the directions for “Reading Submitted Public Comments.” We will show your comments as submitted, but for technical reasons we may omit items such as logos and special characters. Identifying information you provide, such as phone numbers and addresses, will be publicly available. However, we will attempt to remove email addresses to help reduce Internet spam.

    FOR FURTHER INFORMATION CONTACT: J.C. Floyd, Associate Director, Finance and Capital Markets Team, Office of Regulatory Policy, Farm Credit Administration, McLean, VA 22102-5090, (720) 213-0924, TTY (703) 883-4056; or Rebecca S. Orlich, Senior Counsel, or Jennifer A. Cohn, Senior Counsel, Office of General Counsel, Farm Credit Administration, McLean, VA 22102-5090, (703) 883-4020, TTY (703) 883-4056.
    SUPPLEMENTARY INFORMATION:

    On September 4, 2014, FCA published a proposed rule to revise our regulatory capital requirements for Farm Credit System (System) institutions to establish tier 1/tier 2 risk-based capital ratio requirements (replacing core surplus and total surplus ratios), a tier 1 leverage ratio requirement (replacing a net collateral requirement for System banks), a capital conservation buffer, revised risk weightings, and additional publish disclosure requirements.1 The revisions to the risk weightings would include replacing references to credit ratings with alternative risk measurements, as required by the Dodd-Frank Wall Street Reform and Consumer Protection Act. The comment period on the proposed rule, after an extension, closed February 16, 2015.2

    1 79 FR 52814 (September 4, 2014).

    2 The original comment period of 120 days was extended an additional 45 days. See 79 FR 76927 (December 23, 2014).

    FCA received a letter dated March 30, 2015, from the Farm Credit Council, a trade association representing System institutions, requesting FCA to reopen the comment period. The Farm Credit Council stated that the reason for its request was to give System institutions the opportunity to meet with FCA Board members that joined the FCA Board on March 13 and 17, 2015, in order to discuss the proposed rule.

    In response to this request, we are reopening the comment period on June 26 through July 10, 2015. Because the proposed rule contains significant revisions to the regulatory capital framework in existing FCA regulations, we believe it is important to give interested parties additional time to provide comments to the FCA Board. Reopening the comment period will ensure transparency in the process.

    Dated: June 17, 2015. Dale L. Aultman, Secretary, Farm Credit Administration Board.
    [FR Doc. 2015-15348 Filed 6-22-15; 8:45 am] BILLING CODE 6705-01-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2015-1089; Airspace Docket No. 15-ANM-11] Proposed Amendment of Class E Airspace; Douglas, WY AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to modify Class E airspace at Converse County Airport, Douglas, WY. After a review of the airspace, the FAA found it necessary to modify the airspace to enhance the safety and management of Instrument Flight Rules (IFR) operations for Standard Instrument Approach Procedures (SIAPs) at the airport and to address inaccuracy identified by FAA Airspace Policy and Support that V-19, which is no longer located in the area, is used in the legal description of the airspace.

    DATES:

    Comments must be received on or before August 7, 2015.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone (202) 366-9826. You must identify FAA Docket No. FAA-2015-1089; Airspace Docket No. 15-ANM-11, at the beginning of your comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone 1-800-647-5527), is on the ground floor of the building at the above address.

    FAA Order 7400.9Y, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. The Order 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.

    FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15. For further information, you can contact the Airspace Policy and Regulations Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC, 20591; telephone: 202-267-8783.

    FOR FURTHER INFORMATION CONTACT:

    Steve Haga, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4563.

    SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority for the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend controlled airspace at Converse County Airport, Douglas, WY.

    Comments Invited

    Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2015-1089; Airspace Docket No. 15-ANM-11.” The postcard will be date/time stamped and returned to the commenter.

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA 98057.

    Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

    Availability and Summary of Documents Proposed for Incorporation by Reference

    This document proposes to amend FAA Order 7400.9Y, Airspace Designations and Reporting Points, dated August 6, 2014, and effective September 15, 2014. FAA Order 7400.9Y is publicly available as listed in the ADDRESSES section of this proposed rule. FAA Order 7400.9Y lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace extending upward from 700 feet above the surface at Converse County Airport, Douglas, WY. The airspace would be modified to within a 4-mile radius of Converse County Airport, with a segment extending from the 4-mile radius to the 7-mile radius east to southwest of the airport, and a segment extending from the 4-mile radius to 7 miles northwest of the airport. The geographic coordinates of the airport would be updated to coincide with the FAA's aeronautical database. The lateral boundary for that airspace extending from 1,200 feet above the surface would be defined utilizing latitudinal and longitudinal reference points instead of Federal airway V-19, and would not change the lateral boundaries or operating requirements of the 1,200 foot airspace. This action is necessary for the safety and management of IFR operations for SIAPs at the airport.

    Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Y, dated August 6, 2014, and effective September 15, 2014, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

    The FAA has determined this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation: (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 will only affect air traffic procedures and air navigation, it is certified this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    Environmental Review

    This proposal will be subject to an environmental analysis in accordance with FAA

    Order 1050.1E, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

    PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for 14 CFR part 71 continues to read as follows: Authority:

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Y, Airspace Designations and Reporting Points, dated August 6, 2014, and effective September 15, 2014, is amended as follows: Paragraph 6005 Class E Airspace areas extending upward from 700 feet or more above the surface of the earth. ANM WY E5 Douglas, WY [Modified] Converse County Airport, WY (Lat. 42°47′50″ N., long. 105°23′09″ W.)

    That airspace extending upward from 700 feet above the surface within a 4-mile radius of Converse County Airport beginning at lat. 42°50′30″ N., long. 105°27′11″ W., clockwise along the 4-mile radius of the airport to the 065° bearing from the airport, and that airspace within a 7-mile radius of the airport from the 065° bearing from the airport clockwise to the 226° bearing, thence northeast to lat. 42°48′41″ N., long. 105°28′28″ W., and that airspace 1 mile either side of the 297° bearing from airport extending from the 4-mile radius to 7 miles northwest of the airport, thence to the point of beginning That airspace extending upward from 1,200 feet above the surface bounded by a line beginning at lat. 43°05′27″ N., long. 106°16′37″ W.; to lat. 43°35′23″ N., long. 104°30′02″ W.; to lat. 43°00′00″ N., long. 104°30′02″ W.; to lat. 43°00′00″ N., long. 104°03′16″ W.; to lat. 41°53′15″ N., long. 104°03′15″ W.; to lat. 41°51′54″ N., long. 105°17′18″ W.; thence to the point of beginning.

    Issued in Seattle, Washington, on June 11, 2015. Christopher Ramirez, Acting Manager, Operations Support Group, Western Service Center.
    [FR Doc. 2015-15287 Filed 6-22-15; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2015-1623; Airspace Docket No. 15-AWP-10] Proposed Amendment of Class E Airspace; Tracy, CA AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to modify Class E airspace extending upward from 700 feet above the surface, at Tracy Municipal Airport, Tracy, CA. After a review, and the decommissioning of the Manteca VHF omnidirectional radio range and distance measuring equipment (VOR/DME), the FAA found it necessary to amend the airspace areas for the safety and management of Instrument Flight Rules (IFR) operations for Standard Instrument Approach Procedures at the airport.

    DATES:

    Comments must be received on or before August 7, 2015.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone (202) 366-9826. You must identify FAA Docket No. FAA-2015-1623; Airspace Docket No. 15-AWP-10, at the beginning of your comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone 1-800-647-5527), is on the ground floor of the building at the above address.

    FAA Order 7400.9Y, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. The Order 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.

    FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15. For further information, you can contact the Airspace Policy and Regulations Group, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone: (202) 267-8783.

    FOR FURTHER INFORMATION CONTACT:

    Rob Riedl, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4534.

    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 airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace at Tracy Municipal Airport, Tracy, CA.

    Comments Invited

    Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2015-1623/Airspace Docket No. 15-AWP-10.” The postcard will be date/time stamped and returned to the commenter.

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA 98057.

    Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

    Availability and Summary of Documents Proposed for Incorporation by Reference

    This document proposes to amend FAA Order 7400.9Y, Airspace Designations and Reporting Points, dated August 6, 2014, and effective September 15, 2014. FAA Order 7400.9Y is publicly available as listed in the ADDRESSES section of this proposed rule. FAA Order 7400.9Y lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace extending upward from 700 feet above the surface at Tracy Municipal Airport, Tracy, CA. Decommissioning of the Manteca VOR/DME and subsequent review of the airspace revealed that airspace redesign is necessary for the safety and management of IFR operations for standard instrument approach procedures at the airport. Class E airspace extending upward from 700 feet above the surface would be modified to within a 3.9-mile radius of Tracy Municipal Airport with segments extending from the 3.9-mile radius to 11 miles northwest, 6.4 miles east, and 9 miles southeast, of the airport.

    Class E airspace designations are published in paragraph 6005, respectively, of FAA Order 7400.9Y, dated August 6, 2014, and effective September 15, 2014, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

    The FAA has determined this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation; (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 will only affect air traffic procedures and air navigation, it is certified this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    Environmental Review

    This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

    PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for 14 CFR part 71 continues to read as follows: Authority:

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Y, Airspace Designations and Reporting Points, dated August 6, 2014, and effective September 15, 2014, is amended as follows:

    Paragraph 6005 Class E Airspace areas extending upward from 700 feet or more above the surface of the earth.

    AWP CA E5 Tracy, CA (Modified) Tracy Municipal Airport, CA (lat. 37°41′21″ N., long. 121°26′31″ W.)

    That airspace extending upward from 700 feet above the surface within a 3.9-mile radius of Tracy Municipal Airport, and within 2 miles each side of the 326° bearing from the airport extending from the 3.9-mile radius to 11 miles northwest of the airport, and that airspace 1.8 miles either side of the airport 132° bearing from the 3.9-mile radius to 9 miles southeast of the airport, and that airspace 2.2 miles either side of the airport 097° bearing from the 3.9-mile radius to 6 miles east of the airport.

    Issued in Seattle, Washington, on June 11, 2015. Christopher Ramirez, Acting Manager, Operations Support Group, Western Service Center.
    [FR Doc. 2015-15316 Filed 6-22-15; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Parts 100 [Docket Number USCG-2015-0100] RIN 1625-AA08 Special Local Regulations, Recurring Marine Events in Captain of the Port Long Island Sound Zone AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to add, delete, and modify special local regulations for annual marine events in the Sector Long Island Sound Captain of the Port (COTP) Zone. When enforced, these regulated areas would restrict vessels from portions of water areas during certain annually recurring events. The proposed special local regulations are intended to expedite public notification and ensure the protection of the maritime public and event participants from the hazards associated with certain maritime events.

    Comments and related material must be received by the Coast Guard on or before July 23, 2015.

    Requests for public meetings must be received by the Coast Guard on or before July 14, 2015.

    You may submit comments identified by docket number USCG-2015-0100 using any one of the following methods:

    (1) Federal eRulemaking Portal: http://www.regulations.gov.

    (2) Fax: 202-493-2251.

    (3) Mail or Delivery: Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries accepted between 9 a.m. and 5 p.m., Monday through Friday, except federal holidays. The telephone number is 202-366-9329.

    See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section below for instructions on submitting comments. To avoid duplication, please use only one of these four methods.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, contact Petty Officer Ian M. Fallon, U.S. Coast Guard Waterways Management Division Sector Long Island Sound; telephone (203) 468-4565, or 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:

    Table of Acronyms COTP Captain of the Port FR Federal Register NPRM Notice of Proposed Rulemaking A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

    1. Submitting Comments

    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. You may submit your comments and material online at http://www.regulations.gov, or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

    To submit your comment online, go to http://www.regulations.gov, type the docket number [USCG-2015-0100] in the “SEARCH” box and click “SEARCH.” Click on “Submit a Comment” on the line associated with this rulemaking.

    If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change the rule based on your comments.

    2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type the docket number [USCG-2015-0100] 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.

    3. Privacy Act

    Anyone can search the electronic form of 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 a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

    4. Public meeting

    We do not plan to hold a public meeting. But you may submit a request for one, using one of the methods specified under ADDRESSES. Please explain why you believe a public meeting would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register.

    B. Regulatory History and Information

    Previously, the Coast Guard promulgated either safety zones or special local regulations for most of the events associated with this proposed rule and received no public comments. The most recent promulgated rulemaking was on May 24, 2013 when the Coast Guard published a Final Rule, entitled, “Safety Zones and Special Local Regulations; Recurring Marine Events in Captain of the Port Sector Long Island Sound Zone” in the Federal Register (78 FR 31402).

    C. Basis and Purpose

    The legal basis for this rulemaking is 33 U.S.C. 1233, which authorizes the Coast Guard to establish special local regulations.

    This proposed regulation carries out two related actions: (1) Establishing necessary special local regulations; and (2) updating and reorganizing existing regulations for ease of use and reduction of administrative overhead.

    D. Discussion of Proposed Rule

    The Coast Guard proposes to amend 33 CFR 100.100 “Special Local Regulations; Regattas and Boat Races in the Coast Guard Sector Long Island Sound Captain of the Port Zone” by establishing 16 permanent marine events regulated areas, removing five, and modifying three marine event special local regulations. By proposing these permanent regulation updates, we are providing the public with an opportunity to comment on these changes. This rulemaking limits the unnecessary burden of establishing temporary rules for events that occur on an annual basis.

    (1) Establishing New Marine Event Regulated Areas

    This rulemaking proposes to establish 16 permanent marine event special local regulations under 33 CFR 100.100. These events include fireworks displays, swimming events, and regattas that take place throughout the Long Island Sound COTP Zone. Event locations and details are listed below in the text of the regulation. Because large numbers of spectator vessels are expected to congregate around the location of these events, these regulated areas are needed to protect both spectators and participants from the safety hazards associated with marine events, including large numbers of swimmers, hard to see and unstable small boats, unexpected pyrotechnics detonation, and burning debris. This rule would permanently establish regulated areas that restrict vessel movement around the location of each marine event to reduce the associated safety.

    During the enforcement period of the regulated areas, persons and vessels would be prohibited from entering, transiting through, remaining, anchoring, or mooring within the regulated area unless specifically authorized by the COTP or the designated representative. Persons and vessels would be able to request authorization to enter, transit through, remain, anchor, or moor within the regulated areas by contacting the COTP Sector Long Island Sound, or designated representative, by telephone at (203) 468-4401 or via VHF radio on channel 16. If authorization to enter, transit through, remain, anchor, or moor within any of the regulated areas is granted, all persons and vessels receiving authorization would be required to comply with the instructions of the COTP or designated representative.

    The Coast Guard COTP Sector Long Island Sound or designated representative would enforce the regulated areas. These designated representatives are comprised of commissioned, warrant, and petty officers of the Coast Guard. The Coast Guard may be assisted by other federal, state and local agencies in the enforcement of these regulated areas.

    Certain special local regulations are listed without known dates or times. Coast Guard Sector Long Island Sound will cause notice of the enforcement of these regulated areas to be made by all appropriate means to affect the widest publicity among the effected segments of the public, including publication in the Federal Register as a Notice of Enforcement, Local Notice to Mariners, and Broadcast Notice to Mariners.

    (2) Remove old Special Local Regulations That Are no Longer Needed

    This rulemaking proposes to remove five special local regulations from the TABLE to § 100.100: (1) 1.3 Head of the Connecticut Regatta, Connecticut River, CT as the event has not been held since 2012 and the sponsoring organization, the City of Middletown, has confirmed that they do not intend to hold the event again in the foreseeable future; (2) 1.4 Riverfront Regatta, Hartford, CT as the event's details have significantly changed and is no longer the same event; (3) 1.5 Patchogue Grand Prix, Patchogue, NY as the event has not been held since 2010 and the sponsoring organization, Offshore Powerboat Association, has confirmed that they do not intend to hold the event again in the foreseeable future; (4) 1.6 Riverfront U.S. Title series Powerboat Race, Hartford, CT as the event has not been held since 2011 and the sponsoring organization, Riverfront Recaptured, has confirmed that they do not intend to hold the event again in the foreseeable future; and (5) 1.8 Kayak for a Cause Regatta as the event has not been held since 2012 and the sponsoring organization, Kayak for a Cause, has disbanded.

    (3) Modify and Update Existing Regulated Areas

    This rule proposes to amend the following special local regulations from the TABLE to § 100.100: (1) 1.1 Harvard-Yale Regatta, Thames River, New London, CT is to be moved to 5.1 on the TABLE to § 100.100; (2) 1.2 Great Connecticut River Raft Race, Middletown is to be moved to 7.1 on the TABLE to § 100.100 and the name changed to Connecticut River Raft Race, Middletown, CT; and (3) 1.7 Hartford Dragon Boat Regatta is be renamed the Riverfront Dragon Boat and Asian Festival and to be moved to 8.1 on the TABLE to § 100.100.

    E. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes or executive orders.

    1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

    The Coast Guard determined that this proposed rulemaking is not a significant regulatory action for the following reasons: The regulated areas are of limited duration and vessels may transit the navigable waterways outside of the regulated areas. Persons or vessels requiring entry into the regulated areas may be authorized to do so by the COTP Sector Long Island Sound or designated representative.

    Advanced public notifications will also be made to local mariners through appropriate means, which may include but is not limited to Local Notice to Mariners and Broadcast Notice to Mariners.

    2. 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 proposed rule will not have a significant economic impact on a substantial number of small entities.

    This proposed rule would 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 the regulated areas during the enforcement periods.

    The special local regulations will not have a significant economic impact on a substantial number of small entities for the following reasons: The regulated areas are of short duration, vessels that can safely do so may navigate in all other portions of the waterways except for the areas designated as regulated areas, and vessels requiring entry into the regulated areas may be authorized to do so by the COTP Sector Long Island Sound or designated representative. Additionally, before the enforcement periods, public notifications will be made to local mariners through appropriate means, which may include but is not limited to Local Notice to Mariners and Broadcast Notice to Mariners.

    If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rulemaking would economically affect it.

    3. Assistance for Small Entities

    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. 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.

    4. Collection of Information

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

    5. Federalism

    A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and determined that this rule does not have implications for federalism.

    6. 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.

    7. 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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

    8. Taking of Private Property

    This proposed rule would not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

    9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

    10. Protection of Children from Environmental Health Risks

    We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.

    11. Indian Tribal Governments

    This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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.

    12. Energy Effects

    This proposed rule is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

    13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

    14. Environment

    We have analyzed this proposed 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 (NEPA)(42 U.S.C. 4321-4370f), and have made a preliminary determination 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 proposed rule involves the establishment of special local regulations. This rule may be categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. A preliminary environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

    List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recording requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows:

    PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority:

    33 U.S.C. 1233.

    § 100.100 Special Local Regulations; Regattas and Boat Races in the Coast Guard Sector Long Island Sound Captain of the Port Zone.
    2. Revise the Table to § 100.100 to read as follows: Table to § 100.100 5 May 5.1 Harvard-Yale Regatta, Thames River, New London, CT • Event type: Boat Race.
  • • Date: A single day between the last Saturday in May through second Saturday of June. Rain Date: A single day between the last Saturday in May through second Saturday of June.
  • • Time (Approximate): 8:00 a.m. to 5:00 p.m.
  • • Location: All waters of the Thames River at New London, Connecticut, between the Penn Central Draw Bridge at position 41°21′46.94″ N. 072°5′14.46″ W. to Bartlett Cove at position 41°25′35.9″ N. 072°5′42.89″ W. (NAD 83). All positions are approximate.
  • 5.2 Jones Beach Air Show • Event type: Boat Race. • Date: The Thursday through Sunday before Memorial Day each May. • Time:
  • (1) The “No Entry Area” will be enforced each day from the start of the air show until 30 minutes after it concludes. Exact time will be determined annually.
  • (2) The “Slow/No Wake Area” and the “No Southbound Traffic Area” will be enforced each day for six hours after the air show concludes. Exact time will be determined annually. • Location:
  • (1) “No Entry Area”: Waters of the Atlantic Ocean off Jones Beach State Park, Wantagh, NY contained within the following described area; beginning at a point on land at position 40°34′54″ N., 073°33′21″ W.; then east along the shoreline of Jones Beach State Park to a point on land at position 40°35′53″ N., 073°28′48″ W.; then south to a point in the Atlantic Ocean off of Jones Beach at position 40°35′05″ N., 073°28′34″ W.; then west to position 40°33′15″ N., 073°33′09″ W.; then north to the point of origin (NAD 83). All positions are approximate.
  • (2) “Slow/No Wake Area”: All navigable waters between Meadowbrook State Parkway and Wantagh State Parkway and contained within the following area. Beginning in position 40°35′49.01″ N., 73°32′33.63″ W.; then north along the Meadowbrook State Parkway to its intersection with Merrick Road in position 40°39′14″ N., 73°34′0.76″ W.; then east along Merrick Road to its intersection with Wantagh State Parkway in position 40°39′51.32″ N. 73°30′43.36″ W.; then south along the Wantagh State Parkway to its intersection with Ocean Parkway in position 40°35′47.30″ N. 073°30′29.17″ W.; then west along Ocean Parkway to its intersection with Meadowbrook State Parkway at the point of origin (NAD 83). All positions are approximate. (3) “No Southbound Traffic Area”: All navigable waters of Zach′s Bay south of the line connecting a point near the western entrance to Zach′s Bay at position 40°36′29.20″ N., 073°29′22.88″ W. and a point near the eastern entrance of Zach′s Bay at position 40°36′16.53″ N. 073°28′57.26″ W. (NAD 83). All positions are approximate. 6 June 6.1 Swim Across America Greenwich • Event type: Swimming.
  • • Date: One day in June to be determined annually.
  • • Time (Approximate): 5:30 a.m. until 12:00 p.m. • Location: All navigable waters of Stamford Harbor within an area starting at a point in position 41°01′32.03″ N., 073°33′8.93″ W., then southeast to a point in position 41°01′15.01″ N., 073°32′55.58″ W.; then southwest to a point in position 41°0′49.25″ N., 073°33′20.36″ W.; then northwest to a point in position 41°0′58″ N., 073°33′27″ W., then northeast to a point in position 41°1′15.8″ N., 073°33′9.85″ W., then heading north and ending at point of origin (NAD 83). All positions are approximate. 7 July 7.1 Connecticut River Raft Race, Middletown, CT • Event type: Boat Race.
  • • Date: A day between the last Saturday in July through first Saturday of August.
  • • Time (Approximate): 10:00 a.m. to 2:00 p.m. • Location: All waters of the Connecticut River near Middletown, CT between Gildersleeve Island (Marker no. 99) at position 41°36′02.13″ N., 072°37′22.71″ W. and Portland Riverside Marina (Marker no. 88) at position 41°33′38.3″ N., 072°37′36.53″ W. (NAD 83). All positions are approximate. • Additional Stipulations: Spectators or other vessels shall not anchor, block, loiter, or impede the transit of event participants or official patrol vessels in the regulated areas unless authorized by COTP or designated representative. 7.2 Dolan Family Fourth Fireworks • Event type: Fireworks Display.
  • • Date: July 4.
  • • Rain date: July 5. • Time (Approximate): (1) The “No Entry Area” will be enforced from 8:30 p.m. to 10:30 p.m. (2) The “Slow/No Wake Area” will be enforced from 7:00 p.m. to 12:00 a.m. • Locations: (1) “No Entry Area”: All waters of Oyster Bay Harbor in Long Island Sound off Oyster Bay, NY within a 1000 foot radius of the launch platform in approximate position 40°53′42.50″ N., 073°30′4.30″ W. (NAD 83). (2) “Slow/No Wake Area”: All waters of Oyster Bay Harbor in Long Island Sound off Oyster Bay, NY contained within the following area; beginning at a point on land in position at 40°53′12.43″ N., 073°31′13.05″ W. near Moses Point; then east across Oyster Bay Harbor to a point on land in position at 40°53′15.12″ N., 073°30′38.45″ W. then north along the shoreline to a point on land in position at 40°53′34.43″ N., 073°30′33.42″ W. near Cove Point; then east along the shoreline to a point on land in position at 40°53′41.67″ N., 073°29′40.74″ W. near Cooper Bluff; then south along the shoreline to a point on land in position 40°53′5.09″ N., 073°29′23.32″ W. near Eel Creek; then east across Cold Spring Harbor to a point on land in position 40°53′6.69″N, 073°28′19.9″W; then north along the shoreline to a point on land in position 40°55′24.09″ N., 073°29′49.09″ W. near Whitewood Point, then west across Oyster Bay to a point on land in position 40°55′5.29″ N., 073°31′19.47″ W. near Rocky Point, then south along the shoreline to a point on land in position 40°54′4.11″ N., 073°30′29.18″ W. near Plum Point, then northwest along the shoreline to a point on land in position 40°54′9.06″ N., 073°30′45.71″ W., then southwest along the shoreline to a point on land in position 40°54′3.2″ N., 073°31′1.29″ W., and then south along the shoreline back to point of origin (NAD 83). All positions are approximate. 7.3 Clam Shell Foundation Fireworks • Event type: Fireworks Display.
  • • Date: One day in July to be determined annually.
  • • Time (Approximate): (1) The “No Entry Area” will be enforced from 9:00 p.m. to 10:30 p.m. (2) The “Northbound Traffic Only Area” will be enforced from 10:30 p.m. to 12:00 a.m. • Locations: (1) “No Entry Area”: All waters of Three Mile Harbor, East Hampton, NY within a 1000 foot radius of the launch platform in approximate position 41°1′15.49″ N., 072°11′27.5″ W. (NAD 83). (2) “Northbound Traffic Only Area″: All waters of Three Mile Harbor, East Hampton, NY contained within the following area; beginning at a point in position at 41°2′5.05″ N., 072°11′19.52″ W.; then southeast to a point on land in position at 41°2′2.67″ N., 072°11′17.97″ W.; then south along shoreline to a point on land in position at 41°1′35.26″ N., 072°11′9.56″ W.; then southeast across channel to a point on land in position at 41°1′30.28″ N., 072°10″52.77″ W.; then north along the shoreline to a point on land in position at 41°1′41.35″ N., 072°10′52.57″ W.; then north across channel to a point on land in position at 41°1′44.41″ N., 072°10′52.23″ W. near the southern end of Sedge Island; then north along shoreline of Sedge Island to a point on land in position at 41°1′56.3″ N., 072°10′59.37″ W., near the northern end of Sedge Island; then northwest across the channel to a point on land in position 41°1′56.76″ N., 072°11′0.66″ W.; then northwest along shoreline to a point on land in position 41°1′41.35″ N., 072°10′52.57″ W.; then northwest to position at 41°2′5.92″ N., 072°11′16.73″ W.; and then southwest to point of origin (NAD 83). All positions are approximate. 7.4 Jones Beach State Park Fireworks • Event type: Fireworks Display.
  • • Date: July 4.
  • • Rain date: July 5. • Time: 8:30 p.m. to 10:30 p.m. • Time (Approximate): (1) The “No Entry Area” will be enforced from 8:30 p.m. to 10:30 p.m. (2) The “Slow/No Wake Area” and the “No Southbound Traffic Area” will be enforced from 9:30 p.m. to 12:00 a.m. • Locations: (1) “No Entry Area”: All waters off of Jones Beach State Park, Wantagh, NY within a 1000 foot radius of the launch platform in approximate position 40°34′56.68″ N., 073°30′31.19″ W. (NAD 83). (2) “Slow/No Wake Area”: All navigable waters between Meadowbrook State Parkway and Wantagh State Parkway and contained within the following area. Beginning in position at 40°35′49.01″ N., 073°32′33.63″ W.; then north along the Meadowbrook State Parkway to its intersection with Merrick Road in position at 40°39′14″ N., 073°34′0.76″ W.; then east along Merrick Road to its intersection with Wantagh State Parkway in position at 40°39′51.32″ N., 073°30′43.36″ W.; then south along the Wantagh State Parkway to its intersection with Ocean Parkway in position at 40°35′47.30″ N., 073°30′29.17″ W.; then west along Ocean Parkway to its intersection with Meadowbrook State Parkway at the point of origin (NAD 83). All positions are approximate. (3) “No Southbound Traffic Area”: All navigable waters of Zach's Bay south of the line connecting a point near the western entrance to Zach's Bay in position at 40°36′29.20″ N., 073°29′22.88″ W. and a point near the eastern entrance of Zach's Bay in position at 40°36′16.53″ N., 073°28′57.26″ W. (NAD 83). All positions are approximate. 7.5 Maggie Fischer Memorial Great South Bay Cross Bay Swim • Event type: Swimming.
  • • Date: One day in July to be determined annually.
  • • Time (Approximate): 6:30 a.m. to 12:30 p.m. • Location: Waters of the Great South Bay, NY within 100 yards of the race course. Starting Point at the Fire Island Lighthouse Dock in position at 40°38′01″ N., 073°13′07″ W.; then north-by-northwest to a point in position at 40°38′52″ N., 073°13′09″ W.; then north-by-northwest to a point in position at 40°39′40″ N., 073°13′30″ W.; then north-by-northwest to a point in position at 40°40′30″ N., 073°14′00″ W.; and then north-by-northwest, finishing at Gilbert Park, Brightwaters, NY at position 40°42′25″ N., 073°14′52″ W. (NAD 83). All positions are approximate. 7.6 Aquapalooza, Zach's Bay • Event type: Regatta. • Date: One day in July to be determined annually. • Time (Approximate): 11:30 a.m. to 8:00 p.m. • Location: All navigable waters of Zach's Bay, Wantagh, NY south of the line connecting a point near the western entrance to Zach's Bay in approximate position 40°36′29.20″ N., 073°29′22.88″ W. and a point near the eastern entrance of Zach's Bay in approximate position 40°36′16.53″ N., 073°28′57.26″ W. • Additional stipulations: During the enforcement period vessel speed in the regulated area is restricted to no wake speed or 6 knots, whichever is slower. On the day of the event from 3 p.m. to 5:30 p.m. vessels may only transit the regulated area in the northbound direction or outbound direction. 7.7 Fran Schnarr Open Water Championship Swim • Event type: Swimming.
  • • Date: One day in July to be determined annually.
  • • Time (Approximate): 7:15 a.m. to 1:30 p.m. • Location: Waters of Huntington Bay, NY within 100 yards of the race course. Starting in position at 40°54′25.3″ N., 073°24′27.9″ W.; then northeast to a position at 40°54′32″ N., 73°23′57.7″ W.; then northwest to a position at 40°54′37.9″ N., 073°23′57.2″ W.; then southwest to a position at 40°54′33.2″ N., 073°25′28.1″ W.; then southeast to a position at 40°54′25.5″ N., 073°25′25.7″ W.; and then southeast to point of origin (NAD 83). All positions are approximate. 8 August 8.1 Riverfront Dragon Boat and Asian Festival • Event type: Boat Race.
  • • Dates: Saturday and Sunday during the third weekend of August.
  • • Time (Approximate): 8:00 a.m. until 4:30 p.m. each day. • Regulated area: All waters of the Connecticut River in Hartford, CT between the Bulkeley Bridge at 41°46′10.10″ N., 072°39′56.13″ W. and the Wilbur Cross Bridge at 41°45′11.67″ N., 072°39′13.64″ W. (NAD 83). All positions are approximate. 8.2 Swim Across the Sound • Event type: Swimming.
  • • Date: One day in August determined annually.
  • • Time (Approximate): 8:30 a.m. to 7:30 p.m. • Location: Waters of Long Island Sound from Port Jefferson, NY in approximate position 40°58′11.71″ N., 073°05′51.12″ W., then northwest to Captain's Cove Seaport, Bridgeport, CT in approximate position 41°09′25.07″ N., 073°12′47.82″ W. (NAD 83). 8.3 Stonewall Swim • Event type: Swimming. • Date: One day during a weekend in August determined annually. • Time (Approximate): 8:30 a.m. until 12:30 p.m. • Location: All navigable waters of the Great South Bay within a three miles long and half mile wide box connecting Snedecor Avenue in Bayport, NY to Porgie Walk in Fire Island, NY. Formed by connecting the following points. Beginning at 40°43′40.24″ N., 073°03′41.50″ W.; then to 40°43′40.00″ N., 073°03′13.40″ W.; then to 40°40′04.13 N., 073°03′43.81″ W.; then to 40°40′08.30″ N., 073°03′17.70″ W.; and ending at the beginning point 40°43′40.24″ N., 073°03′41.5″ W. (NAD 83). 8.4 Island Beach Two Mile Swim • Event type: Swimming. • Date: One day in August to be determined annually. • Time (Approximate): 7:30 a.m. to 11:30 a.m. • Location: All waters of Captain Harbor between Little Captain's Island and Bower's Island that are located within the box formed by connecting four points in the following positions. Beginning at 40°59′23.35″ N. 073°36′42.05″ W., then northwest to 40°59′51.04″ N. 073°37′57.32″ W., then southwest to 40°59′45.17″ N. 073°38′01.18″ W., then southeast to 40°59′17.38″ N. 073°36′45.9″ W., then northeast to the point of origin (NAD 83). All positions are approximate. 8.5 Waves of Hope Swim • Event type: Swimming. • Date: One day in August to be determined annually. • Time (Approximate): 9:30 a.m. to 12:30 p.m. • Location: All waters of the Great South Bay off Amityville, NY shoreward of a line created by connecting the following points. Beginning at a point at 40°39′22.38″ N., 073°25′31.63″ W., then south to a point at 40°39′2.18″ N., 073°25′31.63″ W., then east to a point at 40°39′2.18″ N., 073°24′3.81″ W., then north to a point at 40°39′18.27″ N., 073°24′3.81″ W., and then west back to point of origin (NAD 83). All positions are approximate. 8.6 Smith Point Triathlon • Event type: Swimming. • Date: A day during a weekend in August to be determined annually. • Time (Approximate): 6:20 a.m. to 9:30 a.m. • Location: All waters of Narrow Bay near Smith Point Park in Mastic Beach, NY within the area bounded by land along its southern edge and points in position at 40°44′14.28”N 072° 51′40.68”W, then north to a point at position 40°44′20.83”N 072°51′40.68”W, then east to a point at position 40°44′20.83”N 072°51′19.73”W, then south to a point at position 40°44′14.85”N 072°51′19.73”W, and then southwest along the shoreline back to the point of origin (NAD 83). All positions are approximate. 9 September 9.1 Head of the Tomahawk • Event type: Regatta. • Date: A one day event either on a Saturday or Sunday between September 15 and October 15. • Time (Approximate): 7:30 a.m. to 2:30 p.m. • Location: All navigable waters of the Connecticut River off South Glastonbury, CT Beginning at position 41°41′18.88″N; 072°37′16.26″ W., then downriver along the west bank to a point at position 41°38′49.12″ N.; 072°37′32.73″ W., then across the Connecticut River to a point at position 41°38′49.5″ N.; 072°37′19.55″ W., then upriver along the east bank to a point at position 41°41′25.82″ N.; 072°37′9.08″ W., then across the Connecticut River to the point of origin (NAD 83). • Additional Stipulations: Non-event vessels transiting through the area during the enforcement period are to travel at no wake speeds or 6 knots, whichever is slower and that non-event vessels shall not block or impede the transit of event participants, event safety vessels or official patrol vessels in the regulated area unless authorized by COTP or designated representatives. 10 October 10.1 Head of the Riverfront Rowing Regatta, Hartford, CT • Event type: Regatta.
  • • Date: The first Sunday of October, from 8:30 a.m. until 4:30 p.m.
  • • Location: All water of the Connecticut River, Hartford, CT, between at point North of Wethersfield Cove at 41°43′52.17″ N.; 072°38′40.38″ W. and the Riverside Boat House 41°46′30.98″ N.; 072° 39′54.35″ W. (NAD 83).
    Dated: June 8, 2015. E. J. Cubanski, III, Captain, U. S. Coast Guard, Captain of the Port Sector Long Island Sound.
    [FR Doc. 2015-15406 Filed 6-22-15; 8:45 am] BILLING CODE 9110-04-P
    POSTAL REGULATORY COMMISSION 39 CFR Part 3050 [Docket No. RM2015-9; Order No. 2545] Periodic Reporting AGENCY:

    Postal Regulatory Commission.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Commission is noticing a recent Postal Service filing requesting that the Commission initiate an informal rulemaking proceeding to consider changes to analytical principles relating to periodic reports (Proposal One). This notice informs the public of the filing, invites public comment, and takes other administrative steps.

    DATES:

    Comments are due: July 23, 2015. Reply comments are due: August 3, 2015.

    ADDRESSES:

    Submit comments electronically via the Commission's Filing Online system at http://www.prc.gov. Those who cannot submit comments electronically should contact the person identified in the FOR FURTHER INFORMATION CONTACT section by telephone for advice on filing alternatives.

    FOR FURTHER INFORMATION CONTACT:

    David A. Trissell, General Counsel, at 202-789-6820.

    SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. Summary of Proposal III. Initial Commission Action IV. Ordering Paragraphs I. Introduction

    On June 12, 2015, the Postal Service filed a petition pursuant to 39 CFR 3050.11 requesting that the Commission initiate an informal rulemaking proceeding to consider changes to analytical principles relating to periodic reports.1 Text attached to the Petition identifies the proposed analytical method changes filed in this docket as Proposal One, Proposed Change in RPW Methodology for Forever Stamp Usage, Stamp Breakage, and PIHOP. Id. Attachment at 1. The Postal Service concurrently filed a non-public library reference, along with an application for nonpublic treatment.2

    1 Petition of the United States Postal Service Requesting Initiation of a Proceeding to Consider a Proposed Change in Analytical Principles (Proposal One), June 12, 2015 (Petition).

    2 Notice of Filing of USPS-RM2015-9/NP1 and Application for Nonpublic Treatment, June 12, 2015 (Notice). The library reference is USPS-RM2015-9/NP1, Non-Public Material Relating to Proposal One. The Notice incorporates by reference the Application for Non-Public Treatment of Materials contained in Attachment Two to the December 29, 2014, United States Postal Service Fiscal Year 2014 Annual Compliance Report. Notice at 1. See 39 CFR part 3007 for information on access to non-public material.

    II. Summary of Proposal

    The Petition requests a change in methodology for the treatment of revenue, pieces, and weight (RPW) associated with forever stamp usage, breakage, and Postage-in-the-Hands-of-the-Public (PIHOP). Stamp breakage refers to the forever stamps that have been sold by the Postal Service but will never be used due to factors such as lost or damaged stamps and collectables. Id. at 3. PIHOP refers to forever stamps that are being held by purchasers for future use. Id.

    The Postal Service currently estimates forever stamp breakage by assigning stamps a category and an issue year, known as a layer. Id. at 3-4. When a layer of stamps is no longer available for sale and is determined to be at the end of its life cycle, as measured by the Origin Destination Information System (ODIS)-RPW system, the difference between cumulative sales and cumulative usage (calculated as a percentage) is deemed to be breakage and recognized as revenue for the Postal Service. Id. at 4. This breakage percentage is applied to forever stamp sales for that layer and all remaining open forever stamp layers, until the remaining layers expire and become the new basis for estimating the breakage percentage. Id.

    Forever stamp usage is collected by ODIS-RPW data collectors and expanded to national totals. Id. A separate process calculates the value of the layer used, based on the different prices at which it was originally sold. Id. at 5. The estimated forever stamp usage is included in the current Book Revenue Adjustment Factor (BRAF) calculation. Id. at 7. The Postal Service currently estimates PIHOP liability at the end of each accounting period. Id. at 5. PIHOP liability is calculated by subtracting the stamp breakage and stamp usage from stamp sales. Id.

    The proposed changes include using the ODIS-RPW estimates for forever stamps usage directly in the RPW Report. Id. at 9. Under the proposal, two changes would occur in the BRAF formulation: Forever stamp usage would be removed from the ODIS-RPW Single-Piece Sampling Revenue and forever stamp usage and forever stamp and non-forever stamp breakage would be removed from the residual total balance. Id. at 10. In addition, breakage from both forever and non-forever stamps would be assigned to Market Dominant Other Revenue in the RPW Report and PIHOP revenues, including meter PIHOP, will no longer be allocated directly to products. Id. at 11.

    RPW reporting impacts. The Postal Service provides three tables that assess the impact of its proposal. Id. Table 1 shows the BRAF calculations for FY 2014 for current and proposed methodologies; Table 2 shows the FY 2014 RPW report for the current proposed methodologies; and Table 3 shows the same information for Quarter 2 Year-to-Date FY 2015. Id. at 11-12. Library Reference USPS-FY2015-9/NP1 contains non-public versions of Tables 2 and 3. Id. at 12.

    III. Initial Commission Action

    The Commission establishes Docket No. RM2015-9 for consideration of matters raised by the Petition. Additional information concerning the Petition may be accessed via the Commission's Web site at http://www.prc.gov. Interested persons may submit comments on the Petition and Proposal One no later than July 23, 2015. Reply comments are due no later than August 3, 2015. Pursuant to 39 U.S.C. 505, Anne C. O'Connor is designated as officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.

    IV. Ordering Paragraphs

    It is ordered:

    1. The Commission establishes Docket No. RM2015-9 for consideration of the matters raised by the Petition of the United States Postal Service Requesting Initiation of a Proceeding to Consider a Proposed Change in Analytical Principles (Proposal One), filed June 12, 2015.

    2. Comments are due no later than July 23, 2015. Reply comments are due no later than August 3, 2015.

    3. Pursuant to 39 U.S.C. 505, the Commission appoints Anne C. O'Connor to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this docket.

    4. The Secretary shall arrange for publication of this order in the Federal Register.

    By the Commission.

    Shoshana M. Grove, Secretary.
    [FR Doc. 2015-15361 Filed 6-22-15; 8:45 am] BILLING CODE 7710-FW-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 34 [Docket No. CDC-2015-0045] RIN 0920-AA28 Medical Examination of Aliens—Revisions to Medical Screening Process AGENCY:

    Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services (HHS).

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), within the U.S. Department of Health and Human Services (HHS), is issuing this Notice of Proposed Rulemaking (NPRM) to amend its regulations governing medical examinations that aliens must undergo before they may be admitted to the United States. Specifically, HHS/CDC proposes to: revise the definition of communicable disease of public health significance by removing chancroid, granuloma inguinale, and lymphogranuloma venereum as inadmissible health-related conditions for aliens seeking admission to the United States; update the notification of the health-related grounds of inadmissibility to include proof of vaccinations to align with existing requirements established by the Immigration and Nationality Act (INA); revise the definitions and evaluation criteria for mental disorders, drug abuse and drug addiction; clarify and revise the evaluation requirements for tuberculosis; clarify and revise the process for the HHS/CDC-appointed medical review board that convenes to reexamine the determination of a Class A medical condition based on an appeal; and update the titles and designations of federal agencies within the text of the regulation.

    DATES:

    Written comments must be received on or before August 24, 2015.

    ADDRESSES:

    You may submit comments, identified by the Regulatory Information Number (RIN) 0920-AA28 or the Docket Number CDC-2015-0045 in the heading of this document by any of the following methods:

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

    • Mail: Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS E-03, Atlanta, GA 30333, ATTN: Part 34.

    • Hand Delivery/Courier: Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS E-03, Atlanta, GA 30333, ATTN: Part 34.

    • Viewing Comments: Comments may be viewed at www.regulations.gov, Docket Number CDC-2015-0045.

    Instructions: All submissions received must include the agency name and docket number or RIN for this rulemaking. All relevant 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 or to download an electronic version of the NPRM, go to http://www.regulations.gov and refer to Docket Number CDC-2015-0045. Comments will be available for public inspection from Monday through Friday, except for legal holidays, from 9 a.m. until 5 p.m., Eastern Time, at 1600 Clifton Road NE., Atlanta, Georgia 30333. Please call ahead to 1-866-694-4867, and ask for a representative in the Division of Global Migration and Quarantine to schedule your visit.

    FOR FURTHER INFORMATION CONTACT:

    Ashley A. Marrone, J.D., Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS E-03, Atlanta, Georgia 30333; telephone 1-404-498-1600.

    SUPPLEMENTARY INFORMATION:

    The Preamble to this NPRM is organized as follows:

    I. Public Participation II. Legal Authority III. Background A. Inadmissibility and the Medical Examination B. Applicability of part 34 C. Legislative and Regulatory History IV. Rationale for Proposed Regulatory Action A. Section 34.2 Definitions B. Section 34.3 Scope of Examinations C. Section 34.4 Medical Notifications D. Section 34.7 Medical and Other Care; Death E. Section 34.8 Reexamination; Convening of Review Boards; Expert Witnesses, Reports V. Alternatives Considered VI. Required Regulatory Analyses A. Executive Orders 12866 and 13563 B. The Regulatory Flexibility Act C. The Paperwork Reduction Act D. National Environmental Policy Act (NEPA) E. Executive Order 12988: Civil Justice Reform F. Executive Order 13132: Federalism G. The Plain Language Act of 2010 VII. References I. Public Participation

    Interested persons are invited to participate in this rulemaking by submitting written views, opinions, recommendations, and data. Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure.

    Specifically, HHS/CDC seeks comment on:

    (1) Whether infectious Hansen's disease (previously referred to in regulation as infectious leprosy), infectious syphilis and/or gonorrhea should be removed from the definition of communicable disease of public health significance.

    (2) Whether the definition of communicable disease of public health significance and the scope of the medical examination should be revised as proposed in this regulation;

    (3) Whether the statutory requirement that aliens demonstrate proof of vaccinations should be incorporated into the regulations as a notifiable medical condition. Please note when considering this question that HHS/CDC is not requesting comment on the statutory language itself as HHS/CDC does not have the authority to alter statutory language. Rather, we are interested in comment on the advisability of incorporating statutory language into regulations.

    (4) Whether the requirement that immigrants demonstrate proof of vaccination against vaccine-preventable diseases recommended by the Advisory Committee on Immunization Practices (ACIP) should be limited to only those vaccines for which a public health need exists at the time of immigration or adjustment of status. CDC has previously published criteria for determining whether a public health need exists at the time of immigration or adjustment of status. CDC is not seeking comment on the criteria, but rather on the incorporation of this standard into the regulations.

    (5) Whether the definitions and evaluation criteria for mental disorders, drug abuse and drug addiction should be revised as proposed in this regulation

    (6) Whether the requirements for evaluating the presence of tuberculosis in alien applicants should be clarified and revised as proposed in this regulation and;

    (7) Whether the process for the convening of a medical review board and reexamination of an alien by a medical review board should be revised as proposed in this regulation.

    Do not include any information in your comment or supporting materials that you do not wish to be disclosed publicly.

    II. Legal Authority

    HHS/CDC is proposing these revisions under the authority of 42 U.S.C. 252 and 8 U.S.C. 1182 and 1222.

    III. Background A. Inadmissibility and the Medical Examination

    Under section 212(a)(1) of the Immigration and Nationality Act (INA) (8 U.S.C. 1182(a)(1)), any alien who is determined to have a communicable disease of public health significance is inadmissible to the United States. As a result of this statute, aliens outside of the United States who have a communicable disease of public health significance are ineligible to receive a visa for admission into the United States, absent the grant of a waiver. Aliens within the United States who have a communicable disease of public health significance are also ineligible to adjust their status to that of a lawful permanent resident, absent the grant of a waiver.

    In addition to other potential grounds of inadmissibility, an alien is inadmissible if he/she is determined: (1) To have a communicable disease of public health significance (as currently defined by regulations); (2) to pose, or has posed, a threat to the property, safety, or welfare of the alien or others; (3) to have had a history of behavior, which has posed a threat to the property, safety, or welfare of the alien or others and which is likely to recur or lead to other harmful behavior; or (4) to be a drug abuser or addict.

    At present, except for certain adopted children 10 years of age or younger, HHS/CDC requires any alien seeking admission as an immigrant or seeking adjustment of status to that of a lawful permanent resident, to present documentation of vaccination against all vaccine-preventable diseases explicitly listed in section 212(a)(1)(A)(ii) of the INA (mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenzae type B, hepatitis B), and for all other vaccinations recommended by the Advisory Committee for Immunization Practices (ACIP) for which a public health need exists at the time of immigration or adjustment of status.

    To allow HHS/CDC to adapt vaccination requirements for U.S. immigrants based on public health needs, on April 8, 2009, HHS/CDC published a notice in the Federal Register (74 FR 15986) seeking public comment on proposed criteria that HHS/CDC intended to use to determine which vaccines recommended by the ACIP for the general U.S. population should be required for immigrants seeking admission into the United States or seeking adjustment of status to that of an alien lawfully admitted for permanent residence based on public health needs. The proposed criteria are as follows: The vaccine must be an age-appropriate vaccine as recommended by the ACIP for the general U.S. population, and at least one of the following: (i) The vaccine must protect against a disease that has the potential to cause an outbreak; or (ii) the vaccine must protect against a disease that has been eliminated in the United States or is in the process for elimination in the United States. HHS/CDC received public comment on these criteria and after review and consideration, published a final notice on November 13, 2009, adopting the proposed criteria (74 FR 58634). These criteria became effective on December 14, 2009. Since then, HHS/CDC has relied on such criteria to determine which vaccines aliens must receive as part of the immigration medical screening process. The list of the ACIP vaccine recommendations for the U.S. general public can be found at http://www.cdc.gov/vaccines/hcp/acip-recs/index.html, and the list of HHS/CDC required vaccines for immigration purposes can be found at http://www.cdc.gov/immigrantrefugeehealth/exams/ti/panel/vaccination-panel-technical-instructions.html#tbl1. As more vaccines become available, HHS/CDC will continue to apply these criteria to respond to the ACIP vaccination recommendations.

    Any changes to the list of required vaccines, which result from an application of these criteria, will be reflected in HHS/CDC's Technical Instructions, available to the public at http://www.cdc.gov/immigrantrefugeehealth/exams/ti/index.html. While HHS/CDC is not seeking additional comment on these previously published vaccination criteria at this time, we are requesting comment on incorporating the reference to these criteria in this regulation. We note that if there is a future need for HHS/CDC to reconsider these established criteria, HHS/CDC will solicit comments through publication in the Federal Register.

    The Secretary of Health and Human Services (HHS) is authorized to promulgate regulations establishing the requirements for the medical examination of aliens by sections 212(a)(1) and 232 of the INA and section 325 of the Public Health Service Act (42 U.S.C. 252). The regulations, administered by HHS/CDC, are promulgated at 42 CFR part 34. Under current 42 CFR part 34, an alien seeking permanent residence prior to arrival into the U.S. or through an adjustment of status while in the U.S., must undergo a medical examination to determine whether the alien is inadmissible on medical grounds.

    HHS/CDC issues Technical Instructions that provide the technical consultation and guidance to panel physicians and civil surgeons who conduct the medical examinations of aliens. Panel physicians, designated by the U.S. Department of State (DOS), perform medical examinations on those aliens living outside the United States who are seeking to immigrate to the United States. Civil surgeons, designated by the U.S. Citizenship and Immigration Services (USCIS) within the U.S. Department of Homeland Security (DHS), perform medical examinations for aliens who are already present in the United States and are seeking adjustment of status. The CDC Technical Instructions for Medical Examination of Aliens, including the most current updates that panel physicians and civil surgeons must follow in accordance with these regulations, are available to the public on the CDC Web site, located at the following Internet address: http://www.cdc.gov/immigrantrefugeehealth/exams/ti/index.html.

    B. Applicability of Part 34

    The provisions in 42 CFR part 34 apply to the medical examination of (1) aliens outside the United States who are applying for a visa at an embassy or consulate of the United States; (2) aliens arriving in the United States; (3) aliens required by DHS to have a medical examination in connection with determination of their admissibility into the United States; and (4) aliens who apply for adjustment of their immigration status to that of lawful permanent resident. While 42 CFR part 34 can apply to individuals who wish to come to the United States to visit, such as leisure or business travelers, a medical examination is not routinely required as a condition for issuance of non-immigrant visas or entry into the United States.

    Annually, DHS admits more than 1 million aliens to reside permanently in this country (24). Foreign citizens who wish to live permanently in the United States must comply with U.S. immigration law and specific procedures for applying for an immigrant visa or adjustment of status. These applicants are also subject to the medical grounds of inadmissibility. The four main immigrant visa classifications are: (1) Immediate Relatives, that is, the spouse, child (unmarried and under 21 years of age) or parent of a U.S. citizen (a citizen must be at least 21 years old to file a petition for a parent); (2) Family-Based immigrants (adult sons or daughters of citizens, the siblings of citizens who are at least 21 years old, and the spouse, child, or adult sons or daughters of lawful permanent residents); (3) Employment-Based immigrants; and (4) Diversity immigrants who obtain by lottery the ability to seek an immigrant visa.

    Refugees and asylees may also apply to adjust to permanent resident status from inside the United States. INA section 209; 8 U.S.C. 1159. Section 101(a)(42)(A) of the INA generally defines refugees and asylees as persons who cannot return to their country because of persecution or the well-founded fear of persecution based on race, religion, nationality, membership in a particular social group, or political opinion. A refugee applicant is preliminarily approved for refugee status overseas, but is admitted as a refugee upon admission to the United States at a port of entry. An asylee applicant is approved for asylum from within the United States and is not required to undergo a medical examination as part of the application process until he/she seeks adjustment of status. See INA 208 and 8 CFR part 208. A refugee is subject to the medical grounds of inadmissibility and the medical examination requirements. A refugee is not subject to the vaccination requirements until he/she seeks adjustment of status. See INA section 207; 8 U.S.C. 1157; 8 CFR part 207.

    An additional immigration category under the INA is Temporary Protected Status (TPS). This applies to persons who are in the United States lawfully, though temporarily, as a result of ongoing armed conflict, natural disasters, or certain other extraordinary and temporary conditions, and whose countries have been designated as TPS countries under INA section 244; 8 U.S.C. 1255a; 8 CFR part 244. TPS applicants are also subject to the medical grounds of inadmissibility.

    C. Legislative and Regulatory History of Part 34

    Beginning in 1952, the language of the INA mandated that, among other grounds for inadmissibility, aliens “who are afflicted with any dangerous contagious disease” are ineligible to receive a visa and therefore are excluded from admission into the United States. In 1990, Congress amended the INA by revising the classes of excludable aliens to provide that an alien who is determined (in accordance with regulation prescribed by the Secretary of Health and Human Services) to have a communicable disease of public health significance shall be excludable from the United States. Immigration Act of 1990, Public Law 101-649, section 601, 104 Stat. 4978 January 23, 1990; INA section 212(a)(1)(A)(i), 8 U.S.C. 1182(a)(1)(A)(i) (effective June 1, 1991). At the time of the 1990 INA amendments, the following specific communicable illnesses rendered an alien inadmissible: active tuberculosis, infectious syphilis, gonorrhea, infectious leprosy, chancroid, lymphogranuloma venereum, granuloma inguinale, and human immunodeficiency virus (HIV) infection. HHS/CDC subsequently published a proposed rule that would have removed from the list all diseases except for active tuberculosis. 56 FR 2484 (January 23, 1991). Based on the review and consideration of public comments received on this proposal, HHS published an interim final rule retaining all communicable diseases on the list and committed its initial proposal for further study. 56 FR 25000 (May 31, 1991). On October 6, 2008, HHS/CDC published an Interim Final Rule (IFR) announcing a revised definition of communicable disease of public health significance and revised scope of the medical examination in 42 CFR part 34. This IFR addressed concerns regarding emerging and reemerging diseases in alien populations who are bound for the United States. See 73 FR 58047 and 73 FR 62210.

    With the 2008 revision to 42 CFR part 34, the definition of communicable disease of public health significance was modified to include two disease categories: (1) Quarantinable diseases designated by Presidential Executive Order; and (2) a communicable disease that may pose a public health emergency of international concern in accordance with the International Health Regulations (IHR) of 2005, provided the disease meets specified criteria in addition to the list of specific illnesses. Specific illnesses remaining as a communicable disease of public health significance were active tuberculosis, infectious syphilis, gonorrhea, infectious Hansen's disease (previously referred to in regulation as infectious leprosy), chancroid, lymphogranuloma venereum, granuloma inguinale, and HIV infection.

    In response to a 2008 amendment to the INA, on July 2, 2009, HHS/CDC published a Notice of Proposed Rulemaking (NPRM), which proposed two regulatory changes: 1) The removal of HIV infection from the definition of communicable disease of public health significance; and 2) removal of references to serologic testing for HIV from the scope of examinations. On November 2, 2009, HHS/CDC published a final rule, effective on January 4, 2010, that removed HIV infection and testing for HIV infection from part 34 regulations. 74 FR 31798 and 73 FR 56547.

    Through today's NPRM, HHS/CDC is soliciting public comment on the definition of communicable disease of public health significance and the revised scope of medical examination which were initially promulgated as an interim final rule in 2008. Specifically, in addition to the previously updated language, HHS/CDC proposes to further revise the definition of communicable disease of public health significance by removing these three uncommon health conditions: chancroid; granuloma inguinale; and lymphogranuloma venereum. This definition is now proposed to include (1) quarantinable diseases designated by Presidential Executive Order; (2) a communicable disease that may pose a public health emergency of international concern in accordance with the IHR of 2005; and (3) gonorrhea, infectious Hansen's disease, infectious syphilis, and active tuberculosis.

    HHS/CDC is not proposing to remove active tuberculosis from the definition of a communicable disease of public health significance. At this time, HHS/CDC is not proposing to remove infectious leprosy, gonorrhea, or syphilis from the definition but is proposing to replace the term “infectious leprosy” with “infectious Hansen's disease” and to modify “syphilis, infectious stage” to simply “syphilis, infectious” to reflect modern terminology. HHS/CDC will accept public comment on whether these three diseases should remain or be removed from the definition of communicable disease of public health significance. HHS/CDC's rationale for maintaining these three diseases is that continuing to screen for and treat these diseases, when identified in aliens, provides a public health benefit to the United States as well as a personal health benefit to the individual. Further, while infection with these three diseases initially renders an alien inadmissible to the United States, treatment is available upon identification, and once appropriately treated, aliens are no longer inadmissible. Continued screening for these three diseases during the medical examination provides an opportunity to identify and treat disease in alien populations and thus provide a measure of public health protection to the general U.S. population.

    IV. Rationale for Proposed Regulatory Action

    HHS/CDC identified the need for this rulemaking through an annual retrospective review of its regulations. Executive Order 13563 “Improving Regulation and Regulatory Review” requires Federal agencies to periodically review existing regulations to eliminate those regulations that are obsolete, unnecessary, burdensome, or counterproductive or revise regulations to increase their effectiveness, efficiency, and flexibility.

    Through this NPRM, HHS/CDC proposes to update part 34 to reflect modern terminology and plain language commonly used in medicine and science by public health partners in the medical examination of aliens. Likewise, we are proposing to update part 34 so that the text accurately reflects the statutory and administrative changes that have occurred within the Federal Government regarding agencies and/or departments responsible for this process. These updates will ensure regulations that govern the medical examination of aliens are based upon accepted contemporary scientific principles as well as current medical practices.

    The following is a section-by-section analysis of the proposed changes for which HHS/CDC is seeking public comment:

    A. 34.1 Applicability

    HHS/CDC is proposing to replace the acronym “INS” within 34.1(c) with “DHS” to best reflect the administrative changes that have occurred within the Federal Government regarding agencies and/or departments responsible for the medical examination of aliens.

    B. Section 34.2 Definitions

    Current section 34.2 entitled “Definitions” provides information regarding the intent of HHS/CDC regarding certain terms that are used in the regulation. While HHS/CDC is not proposing to revise all of the current terms and definitions, such as medical examiner, we welcome comment on the use of these terms and its definitions. HHS/CDC is proposing to revise the definitions section as specifically described below.

    HHS/CDC proposes to revise the definitions of: CDC, Communicable disease of public health significance, Civil Surgeon, Class A medical notification, Class B medical notification, Director, Drug abuse, Drug addiction, Medical notification, Medical hold document, Medical officer, Mental disorder and Physical disorder.

    Additionally, HHS/CDC is adding definitions for DHS and HHS and removing the definition of INS. To help guide the reader, we have provided a chart to indicate which text is proposed to change and is therefore subject to comments from the public.

    Current Definitions and Corresponding Proposed Changes in Definitions within the NPRM Definitions in 42 CFR part 34 Corresponding, new, or updated definition within NPRM CDC. Centers for Disease Control, Public Health Services, U.S. Department of Health and Human Services CDC. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. Communicable disease of public health significance. Any of the following diseases:
  • (1) Chancroid.
  • (2) Communicable diseases as listed in a presidential Executive Order, as provided under Section 361(b) of the Public Health Service Act. The current revised list of quarantinable communicable diseases is available at http://www.cdc.gov and http://www.archives.gov/federal-register
  • (3) Communicable diseases that may pose a public health emergency of international concern if it meets one or more of the factors listed in in § 34.3(d) and for which the CDC Director has determined (A) a threat exists for importation into the United States, and (B) such disease may potentially affect the health of the American public. The determination will be made consistent with criteria established in Annex 2 of the revised International Health Regulations (http://www.who.int/csr/ihr/en/), as adopted by the Fifty-Eighth World Health Assembly in 2005, and as entered into effect in the United States in July, 2007. Subject to the U.S. Government's reservation and understandings:
  • (i) Any of the communicable diseases for which a single case requires notification to the World Health Organization (WHO) as an event that may constitute a public health emergency of international concern, or,
  • (ii) Any other communicable disease the occurrence of which requires notification to the WHO as an event that may constitute a public health emergency of international concern. HHS/CDC's determinations will be announced by notice in the Federal Register
  • (4) Gonorrhea.
  • (5) Granuloma inguinale.
  • (6) Leprosy, infectious.
  • (7) Lymphogranuloma venereum.
  • (8) Syphilis, infectious stage.
  • (9) Tuberculosis, active.
  • Communicable disease of public health significance. Any of the following diseases:
  • (1) Communicable diseases as listed in a Presidential Executive Order, as provided under Section 361(b) of the Public Health Service Act. The current revised list of quarantinable communicable diseases is available at http://www.cdc.gov and http://www.archives.gov/federal-register.
  • (2) Communicable diseases that may pose a public health emergency of international concern if it meets one or more of the factors listed in in § 34.3(d) and for which the CDC Director has determined (A) a threat exists for importation into the United States, and (B) such disease may potentially affect the health of the American public. The determination will be made consistent with criteria established in Annex 2 of the revised International Health Regulations (http://www.who.int/csr/ihr/en/), as adopted by the Fifty-Eighth World Health Assembly in 2005, and as entered into effect in the United States in July, 2007. Subject to the U.S. Government's reservation and understandings:
  • (i) Any of the communicable diseases for which a single case requires notification to the World Health Organization (WHO) as an event that may constitute a public health emergency of international concern, or,
  • (ii) Any other communicable disease the occurrence of which requires notification to the WHO as an event that may constitute a public health emergency of international concern. HHS/CDC's determinations will be announced by notice in the Federal Register.
  • (3) Gonorrhea.
  • (4) Hansen's disease, infectious.
  • (5) Syphilis, infectious.
  • (6) Tuberculosis, active.
  • Civil surgeon. A physician, with not less than 4 years' professional experience, selected by the District Director of INS to conduct medical examinations of aliens in the United States who are applying for adjustment of status to permanent residence or who are required by the INS to have a medical examination Civil surgeon. A physician selected by DHS to conduct medical examinations of aliens in the United States who are applying for adjustment of status to permanent residence or who are required by DHS to have a medical examination. Class A medical notification Class A medical notification. (1) A communicable disease of public health significance; (1) A communicable disease of public health significance; (2)(i) A physical or mental disorder and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others;
  • (ii) A history of a physical or mental disorder and behavior associated with the disorder, which behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or lead to other harmful behavior; or
  • (3) Drug abuse or addiction.
  • (2) A failure to present documentation of having received vaccination against “vaccine-preventable diseases” for an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, which shall include at least the following diseases: mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenza type B, and hepatitis B, and any other vaccinations against vaccine-preventable diseases recommended by the Advisory Committee on Immunization Practices (ACIP) for which HHS/CDC determines there is a public health need at the time of immigration or adjustment of status.
    Provided, however, that in no case shall a Class A medical notification be issued for an adopted child who is 10 years of age or younger if, prior to the admission of the child, an adoptive parent or prospective adoptive parent of the child, who has sponsored the child for admission as an immediate relative, has executed an affidavit stating that the parent is aware of the vaccination requirement and will ensure that, within 30 days of the child's admission, or at the earliest time that is medically appropriate, the child will receive the vaccinations identified in the requirement. (3)(i) A current disorder and behavior that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others; (ii) A history of behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or lead to other harmful behavior; or (4) Drug abuse or addiction. Class B medical notification. Medical notification of a physical or mental health condition, disease, or disability serious in degree or permanent in nature amounting to a substantial departure from normal well-being Class B medical notification. Medical notification of a physical or mental health condition, disease, or disability serious in degree or permanent in nature. DHS. U.S. Department of Homeland Security. Director. The Director of the Centers for Disease Control Director. The Director, Centers for Disease Control and Prevention, Department of Health and Human Services, or another authorized representative as approved by the CDC Director or the Secretary. Drug abuse. The non-medical use of a substance listed in section 202 of the Controlled Substances Act, as amended (21 U.S.C. 802) which has not necessarily resulted in physical or psychological dependence Drug abuse. Current substance use disorder or substance-induced disorder, mild, as defined in the current edition of the Diagnostic and Statistical Manual for Mental Disorders (DSM) published by the American Psychiatric Association, or in another authoritative source as approved by the Director, of a substance listed in Section 202 of the Controlled Substances Act, as amended (21 U.S.C. 802). Drug addiction. The non-medical use of a substance listed in section 202 of the Controlled Substances Act, as amended (21 U.S.C. 802) which has resulted in physical or psychological dependence Drug addiction. Current substance use disorder or substance-induced disorder, moderate or severe as defined in the current edition of the Diagnostic and Statistical Manual for Mental Disorders (DSM) published by the American Psychiatric Association, or in another authoritative source as approved by the Director, of a substance listed in Section 202 of the Controlled Substances Act, as amended (21 U.S.C. 802). HHS. U.S. Department of Health and Human Services INS. Immigration and Naturalization Service, U.S. Department of Justice Definition Removed. Medical examiner. A panel physician, civil surgeon, or other physician designated by the Director to perform medical examination of aliens No change. Medical hold document. A document issued to the INS by a quarantine inspector of the Public Health Service at a port of entry, which defers the inspection for admission until the cause of the medical hold is resolved Medical hold document. A document issued to DHS by a quarantine officer of HHS/CDC at a port of entry, which defers the inspection for admission until the cause of the medical hold is resolved. Medical notification. A document issued to a consular authority or the INS by a medical examiner, certifying the presence or absence of:
  • (1) A communicable disease of public health significance;
  • (2)(i) A physical or mental disorder and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others;
  • (ii) A history of a physical or mental disorder, which behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or lead to other harmful behavior;
  • (3) Drug abuse or addiction; or
  • (4) Any other physical abnormality, disease, or disability serious in degree or permanent in nature amounting to a substantial departure from normal well-being
  • Medical notification. A document issued to a consular authority or DHS by a medical examiner, certifying the presence or absence of:
  • (1) A communicable disease of public health significance;
  • (2) Documentation of having received vaccination against “vaccine-preventable diseases” for an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, which shall include at least the following diseases: mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenza type B, and hepatitis B, and any other vaccinations against vaccine-preventable diseases recommended by the Advisory Committee on Immunization Practices (ACIP) for which HHS/CDC determines there is a public health need at the time of immigration or adjustment of status.
  • Provided, however, that in no case shall a Class A medical notification be issued for an adopted child who is 10 years of age or younger if, prior to the admission of the child, an adoptive parent or prospective adoptive parent of the child, who has sponsored the child for admission as an immediate relative, has executed an affidavit stating that the parent is aware of the vaccination requirement and will ensure that, within 30 days of the child's admission, or at the earliest time that is medically appropriate, the child will receive the vaccinations identified in the requirement.
  • (3)(i) A behavior that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others; (ii) A history of a behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or lead to other harmful behavior; (4) Drug abuse or addiction; (5) Any other physical or mental condition, disease or disability serious in degree or permanent in nature. Medical officer. A physician of the Public Health Service Commissioned Corps assigned by the Director to conduct physical and mental examinations of aliens Medical officer. A physician assigned by the Director to conduct physical and mental examinations of aliens on behalf of HHS/CDC. Mental disorder. A currently accepted psychiatric diagnosis, as defined by the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association, or by other authoritative sources Mental disorder. A currently accepted psychiatric diagnosis, as defined by the most recent version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) published by the American Psychiatric Association, or by other authoritative sources as approved by the Director. Panel physician. A physician selected by a United States embassy or consulate to conduct medical examinations of aliens applying for visas No change. Physical disorder. A currently accepted medical diagnosis, as defined by the Manual of the International Classification of Diseases, Injuries, and Causes of Death published by the World Health Organization, or by other authoritative sources Physical disorder. A currently accepted medical diagnosis, as defined by the most recent version of the Manual of the International Classification of Diseases (ICD), Injuries, and Causes of Death published by the World Health Organization, or by other authoritative sources as approved by the Director.
    Section 34.2(a) CDC

    We are proposing to update the definition of CDC to reflect the current official title of the Agency: Centers for Disease Control and Prevention, Department of Health and Human Services. In doing so, we are removing “Public Health Services” from the definition.

    Section 34.2(b) Communicable Disease of Public Health Significance

    This provision defines communicable disease of public health significance as both a specific list of diseases and categories of diseases for which all aliens are inadmissible to the United States. HHS/CDC is proposing to remove three uncommon bacterial infections associated with genital ulcer disease: chancroid, granuloma inguinale, and lymphogranuloma venereum, from the specific list of communicable disease of public health significance as provided for in 42 CFR 34.2(b).

    HHS/CDC uses epidemiological principles and current medical practice to assess and revise the list of diseases defined as a communicable disease of public health significance. Guided by such principles and practice, HHS/CDC believes that these three sexually transmitted infections no longer pose such a significant threat to the general U.S. population, that aliens with these infections should not be denied admission to the United States. The three bacterial infections (chancroid, granuloma inguinale and lymphogranuloma venereum), all primarily transmitted through sexual contact, have never been common in the United States and over the past two decades have been observed to be increasingly rare throughout the world (6, 8). Of the three bacterial infections, only laboratory-diagnosed cases of chancroid are reportable conditions in the United States, and since 2005 fewer than 30 chancroid cases annually were reported to CDC from the U.S. states and territories (6-22).

    While some U.S. cities (7) keep records of cases of granuloma inguinale and lymphogranuloma venereum, neither condition is included on the list of diseases reported to HHS/CDC by clinicians and public health departments. Online searches and a few available publications indicate that both conditions most typically occur in tropical and impoverished settings (i.e., with limited access to water, hygiene); and both conditions are increasingly uncommon over time. A review of the literature published during the past five years identified only a handful of case reports on granuloma inguinale, and the vast majority of these cases were cases outside the United States (12-17). Additionally, cases of lymphogranuloma venereum are increasingly rare among women. Although sporadic small outbreaks of lymphogranuloma venereum have occurred over the past 10 years, these have been almost exclusively among men who have sex with men, with disease generally manifested as severe proctitis (inflammation of the anus or rectum) (18-20).

    Internationally, most countries do not track any of the three infections; however, the few publications and records available suggest case rates have declined worldwide over the past 50 years. Declining rates of these conditions are likely due to a variety of factors. Improved living conditions, better sanitation (e.g., availability of soap and water), condom use, and educational efforts are all believed to be important factors (6, 21-23) contributing to the decline in the incidence of these infections. Improved recognition by physicians and treatment based on clinical presentation of sexually transmitted infections, coupled with treatment of sexual partners, also appears to be important in their decline. Increased antibiotic usage for treatment of other unrelated conditions may have contributed to the declining incidence of these infections. Additionally, HIV prevention strategies such as male circumcision may be playing a role, although definitive studies of this effect are still pending.

    Given the low burden of these three infections globally, the potential introduction of additional cases into the United States by aliens is likely to have a negligible impact on the U.S. population for several reasons. As mentioned, these primarily tropical infections can be prevented through improved personal hygiene (11); protected sex (use of a condom); and treatment of sexual partners. Such infections can be effectively treated and cured with relatively uncomplicated courses of antibiotic therapy. None of the three infections is associated with excess mortality (premature death); and most cases do not lead to serious long term consequences, disability or excessive medical costs.

    After careful consideration of epidemiological principles and current medical practice, scientific evidence indicates that chancroid, granuloma inguinale, and lymphogranuloma venereum do not represent a significant risk for introduction, transmission, and spread from foreign countries to the United States population. Therefore, HHS/CDC proposes to remove these three diseases from the specific list of communicable disease of public health significance and is seeking public comment on this proposal.

    Section 34.2(c) Civil Surgeon

    Civil Surgeon is currently defined as a “physician, with not less than 4 years professional experience, selected by the District Director of INS to conduct medical examinations of aliens in the United States who are applying for adjustment of status to permanent residence or who are required by the INS to have a medical examination.” HHS/CDC is proposing to remove the specific language of “District Director” and “INS” from the definition of civil surgeon to align with the specific language of the definition of civil surgeon as provided for in DHS regulations in 8 CFR part 232. HHS/CDC also proposes to remove “with not less than 4 years' professional experience” from the definition of civil surgeon. Through complimentary regulations promulgated by DHS at 8 CFR 232, the requirement of 4 years' professional experience for civil surgeons will remain in effect. We are proposing this change because DHS is responsible for designating civil surgeons and should therefore have the discretion to determine the necessary prerequisites for that position. Thus, CDC is simply proposing to remove a redundancy found in its regulations and is not affecting a substantive change in policy. HHS/CDC will continue to consult with DHS/USCIS as needed, regarding recommendations for civil surgeon requirements. Therefore, HHS/CDC is proposing civil surgeon to mean a physician designated by DHS to conduct medical examinations of aliens in the United States who are applying for adjustment of status to permanent residence or who are required by DHS to have a medical examination.

    Section 34.2(d) Class A Medical Notification

    HHS/CDC is proposing to amend the definition of Class A medical notification by incorporating statutory language requiring documentary proof of vaccination. This requirement is provided by section 341 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA) which amended Section 212 of the INA. HHS/CDC is proposing to update part 34 to explicitly include the requirement for proof of vaccination as previously specified in the IIRIRA. See Public Law 104-208, Div. C, 110 Stat. 3009-546. Lack of proof of vaccination will result in the issuance of a Class A medical notification. This additional language will not change current practices, but is a reflection of updated statutory language. As noted above, HHS/CDC is not authorized to change statutory requirements; thus, CDC is not requesting comment on the statutory language, but on the advisability of incorporating statutory language into regulations. Additionally, CDC seeks to incorporate and is requesting comment on its understanding that the statutory requirement for proof of vaccination in regard to ACIP-recommended vaccines only applies to those vaccines that are appropriate in an immigration context and for which a public health need exists at the time of immigration or adjustment of status.

    The proposed definition also includes the vaccination exemption specifically provided in Section 212 of the INA for an adopted child who is 10 years of age or younger. This exemption is applicable if, prior to the admission of the child, an adoptive or prospective adoptive parent, who has sponsored the child for admission as an immediate relative, has executed an affidavit stating that the parent is aware of the vaccination requirement and will ensure that the child will be vaccinated within 30 days of the child's admission, or at the earliest time that is medically appropriate. Execution of this affidavit will prevent a Class A medical notification from being generated for lack of proof of vaccination. This additional language will not change current practices, but is a reflection of updated statutory language. Again, because HHS/CDC is not authorized to change statutory requirements, HHS/CDC is not requesting comment on the statutory language, but will accept comment on the advisability of incorporating statutory language into regulations. HHS/CDC believes that the inclusion of statutory language promotes greater transparency and a better understanding of immigration requirements. For further information, please visit: http://www.uscis.gov/ilink/docView/SLB/HTML/SLB/0-0-0-1/0-0-0-29/0-0-0-2006.html.

    Section 34.2(f) Director

    We are proposing to update the definition of Director to reflect the current official title of the CDC Director, as well as his/her delegation authorities. Therefore, the definition of Director is proposed as: the Director, Centers for Disease Control and Prevention, Department of Health and Human Services, or another authorized representative as approved by the CDC Director or the Secretary.

    Section 34.2(g) DHS

    We are proposing to add DHS to the definitions in order to best reflect the administrative changes that have occurred within the Federal Government regarding agencies and/or departments responsible for the medical examination of aliens. The definition of DHS is proposed as: U.S. Department of Homeland Security.

    Section 34.2(h) Drug Abuse and Section 34.2(i) Drug Addiction

    HHS/CDC is proposing to revise the definitions of drug abuse and drug addiction by aligning with the definitions of ”substance use disorders” and “substance-induced disorders,” with the definitions provided by the Diagnostic and Statistical Manual for Mental Disorders (DSM) published by the American Psychiatric Association (25). HHS/CDC is taking this approach because the DSM is the medical standard for the diagnosis of mental disorders and substance-related disorders. The DSM provides current diagnostic criteria based on the latest available evidence. As such, HHS/CDC is proposing drug abuse and drug addiction to mean “current substance use disorders or substance-induced disorders” as defined in the current edition of the DSM, or in another authoritative source as approved by the Director, of a substance listed in Section 202 of the Controlled Substances Act, as amended (21 U.S.C. 802). These proposed updated definitions are not a substantive change, as it is the current practice of HHS/CDC to use the definitions found in the DSM. In the unlikely event that another authoritative source becomes more appropriate than the DSM, HHS/CDC would issue a notice in the Federal Register, update our Web site, and list the source in our technical instructions. We would not pursue notice and comment rulemaking unless the reliance on a new source resulted in a substantive change in CDC operations or policy.

    Section 34.2(k) Medical Hold Document

    HHS/CDC is proposing to update the definition of Medical hold document by replacing “INS” with “DHS”, replacing “Public Health Service” with “HHS/CDC” and replacing “quarantine inspector” with “quarantine officer.” HHS/CDC is proposing these changes to reflect the current Federal agency and position names and respective responsibilities and is not seeking public comment on these non-substantive changes.

    Section 34.2(l) Medical Notification

    The medical notification is a medical examination document issued to a consular authority or to DHS by a medical examiner following examination of an applicant for immigration for inadmissible conditions. HHS/CDC is proposing to amend the definition of medical notification by adding proof of vaccination requirements as already provided by section 341 of the IIRIRA which amended Section 212 of the INA. HHS/CDC is proposing this addition to update part 34 to include the requirement for proof of vaccination that is currently specified in statute in the IIRIRA and for those ACIP-recommended vaccinations for which a public health need exists at the time of immigration or adjustment of status. This is not a substantive change to the regulation, as it will not affect current practice.

    Based on this update, medical notification, according to the INA, is proposed to mean a medical examination document issued to a consular authority or the DHS by a medical examiner that will include the following additional language: “(2) Documentation of having received vaccination against “vaccine-preventable diseases” for an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, which shall include at least the following diseases: mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenza type B and hepatitis B, and any other vaccinations against vaccine-preventable diseases recommended by the ACIP for which there is a public health need at the time of immigration or adjustment of status.”

    Section 34.2(m) Medical Officer

    HHS/CDC is proposing to remove “of the Public Health Service Commissioned Corps” from the definition of medical officer to reflect that a medical officer for these purposes is not required to be a member of the U.S. Public Health Service Commissioned Corps. Removing this requirement will best protect public health by broadening the pool of medical professionals qualified and available to provide alien examination services since there are a limited number of physicians within the Public Health Service Commissioned Corps.

    Section 34.2(n) Mental Disorder and 34.2(p) Physical Disorder

    HHS/CDC is proposing to clarify mental disorder as a currently accepted psychiatric diagnosis, as defined by the most recent edition of the DSM published by the American Psychiatric Association (17) or in another authoritative source as approved by the Director. HHS/CDC is proposing to add “most recent” to qualify the version of the DSM referenced in this definition and clarify the intent of CDC that such diagnoses align with current science and medical practice. HHS/CDC is also allowing for the possibility of other authoritative sources in order to rely on the most recent medical science.

    HHS/CDC is proposing physical disorder to mean a currently accepted medical diagnosis, as defined by the most recent edition of the Manual of the International Classification of Diseases, Injuries, and Causes of Death (ICD) published by the World Health Organization (26) or in another authoritative source as approved by the Director. HHS/CDC is proposing to add “most recent version” to qualify the version of the ICD referenced in this definition and to be consistent with the current Section 212 of the INA. HHS/CDC is also allowing for the possibility of other authoritative sources in order to rely on the most recent medical science. In the event that another authoritative source is determined to be more appropriate for immigration medical examination purposes, HHS/CDC will issue updated technical instructions. Again, these are not substantive changes to the regulation as they follow current HHS/CDC practice and protocol.

    ii. Section 34.3 Scope of Examinations

    Current section 34.3 entitled “Scope of Examinations” applies to those aliens who are required to undergo a medical examination for U.S. immigration purposes. The scope of the examination outlines those matters that relate to inadmissible health-related conditions and was revised in 2008 through an interim final rule. The 2008 interim final rule provided specific screening and testing requirements for those diseases that meet the current definition of communicable disease of public health significance in Section 34.2(b) of 42 CFR part 34. HHS/CDC is proposing to further update this section to incorporate statutory language requiring documentation for vaccine-preventable disease and HHS/CDC's understanding that ACIP vaccine recommendations should only be applied in an immigration context when a public health need exists. In subsection (a)(2)(i), we are also proposing to insert the word “current” in front of “physical or mental disorder” as stated in section 212 of INA.

    Specific Proposed Revisions to Section 34.3(a)

    HHS/CDC is proposing to revise 34.3(a)(2) to include proof of vaccination requirements as provided by section 341 of IIRIRA of 1996 which amended Section 212 of the INA. HHS/CDC is proposing this change as previously described in proposed changes to 34.2 Definitions.

    Specific Proposed Revisions to Section 34.3(e)

    HHS/CDC is proposing to amend § 34.3(e)(1) to clarify the scope of examination requirements that apply to anyone who is required by DHS to have a medical examination for the purpose of determining their admissibility. HHS/CDC has added § 34.3(e)(1)(v) “Applicants required by the DHS to have a medical examination in connection with the determination of their admissibility into the United States.”

    HHS/CDC is proposing the following changes to provide consistency in the required evaluation for tuberculosis: replace all references to “chest x-ray” in § 34.3(e) with “chest radiograph”; clarify that § 34.3(e)(3)(ii) applies to aliens in the United States; and to remove the specific size of chest radiograph provided in § 34.3(e)(5). These changes reflect current medical terminology and technical practice.

    HHS/CDC is proposing to amend § 34.3(e)(2)(iii) by removing “and HIV” to correct the typographical error in the current rule language and reflect that testing for HIV is no longer required. The requirement for serologic testing for syphilis will remain and HHS/CDC has included language to allow the Director to test for other communicable diseases of public health significance (as defined) through technical instructions.

    HHS/CDC is proposing to amend § 34.3(e)(3)(i) and (ii) to reflect the scope of currently available medical tests. HHS/CDC proposes to replace “positive tuberculin reaction” with “positive test of immune response to Mycobacterium tuberculosis antigens” in § 34.3(e)(3)(i) and (ii).

    To allow HHS/CDC discretion to apply appropriate medical screening procedures, HHS/CDC is proposing to amend § 34.3(e)(3)(iii) and (iv) regarding application of tests of immune response by adding “as determined by the Director.”

    To allow for additional testing in medically appropriate circumstances, HHS/CDC is proposing to revise § 34.3(e)(4) by removing “subject to the chest radiograph requirement, and for whom the radiograph shows an abnormality suggestive of tuberculosis disease,” replacing “shall” with “may,” and adding “based on medical evaluation.” HHS/CDC is proposing this revision to read: “All applicants may be required to undergo additional testing for tuberculosis based on the results of the medical evaluation.”

    To reflect current practice and INA statutory language, HHS/CDC is also proposing to amend § 34.3(b)(2) by adding “or other relevant records” to ensure that all appropriate available medical documentation may be considered. HHS/CDC is proposing this revision to read: “For the examining physician to reach a determination or conclusion about the presence or absence of a physical or mental abnormality, disease, or disability, the scope of the examination shall include any laboratory or additional studies that are deemed necessary, either as a result of the physical examination or pertinent information elicited from the alien's medical history or other relevant records.”

    HHS/CDC has included language under § 34.3(f), transmission of records, to ensure that electronic submissions may be acceptable as provided by the Director. Finally, HHS/CDC is proposing to amend § 34.3(g)(4) by replacing “excludable” with “inadmissible” in § 34.3(g)(4) to reflect modern terminology.

    iii. Section 34.4 Medical Notifications

    HHS/CDC proposes to revise § 34.4(b)(1)(ii) to include proof of vaccination requirements as provided by section 341 of the IIRIRA of 1996 which amended section 212 of the INA and to reference criteria established by CDC and published in Federal Register Notices to determine which vaccines recommended by the ACIP will be required for U.S. immigration. In addition, HHS/CDC is proposing to add specific language regarding the exemption of vaccination requirements for an adopted child as provided in section 212 of the INA. Again, these changes are not substantive, but reflect current practice and statutory language.

    iv. Section 38.7 Medical and Other Care; Death

    Under this section, HHS/CDC proposes to replace “INS” with “DHS” and replace “Public Health Services” with “HHS” to reflect modern agency titles and appropriate authorities relating to this provision. Although HHS/CDC is not proposing to make any substantive changes to § 38.7, we will accept public comment on updating this section to reflect modern terminology.

    v. Section 34.8 Reexamination; Convening of Review Boards; Expert Witnesses, Reports

    Review boards are convened by the Director to reexamine aliens at the request of DHS and upon appeal to DHS by an alien certified as having a Class A condition. HHS/CDC is proposing changes to this section to clarify the reexamination and review board's process and improve the expediency of the process. The proposed changes include removing the requirement that one medical officer must be a board-certified psychiatrist in cases where the alien's mental health is a basis for inadmissibility. The requirement for a board-certified psychiatrist will be replaced with a requirement that the review board consist of at least one medical officer who is experienced in the diagnosis and treatment of the physical or mental disorder, or substance-related disorder for which the medical notification was made. Additionally, HHS/CDC is proposing to add failure to present documented proof of having been vaccinated against vaccine preventable diseases as a basis for reexamination by the review board and add clarifying language that the reexamination may be conducted, at the board's discretion, based on the written record.

    By removing the requirement that one medical officer must be a board-certified psychiatrist, HHS/CDC will be able to more easily and efficiently comprise the board of case-specific specialists. Removing the requirement for a board-certified psychiatrist also allows the agency to expedite the review board's convening in circumstances where a medical officer who is a board certified psychiatrist is unavailable. By tailoring the board to meet the needs of the alien, HHS/CDC will ensure that the alien has the attention of medical officers who are experienced in the diagnosis and treatment of their specific medical condition.

    V. Alternatives Considered

    This rulemaking is the result of HHS/CDC's annual retrospective regulatory review. Most of the proposed changes are administrative and will result in minor changes to current guidelines for overseas medical examinations required of persons seeking permanent entry to the United States. Therefore, alternatives to these administrative updates were not considered. However, when considering updates to the definition of communicable disease of public health significance, HHS/CDC looked at all of the specific diseases listed in the definition. As stated previously in the Preamble, in this rulemaking, HHS/CDC proposes to revise the definition of communicable disease of public health significance by removing these three uncommon health conditions: chancroid; granuloma inguinale; and lymphogramuloma venereum. We decided not to remove infectious Hansen's disease (leprosy), gonorrhea, and/or infectious syphilis from the definition at this time. Our decision is based on epidemiological principles and current medical practice to assess these three diseases (infectious Hansen's disease, gonorrhea, and infectious syphilis). We believe that the medical examination provides the opportunity to screen for and treat these diseases, and, when identified in immigrants, provides a public health benefit to the United States as well as a health benefit to the individual. Further, while infection with these three diseases initially renders an alien inadmissible to the United States, treatment is available upon identification, and once appropriately treated, aliens are no longer inadmissible. Continued screening for these three diseases during the medical examination provides an opportunity to identify and treat disease in alien populations and thus provide a measure of public health protection to the general U.S. population. HHS/CDC will continue to assess each of these remaining diseases as a communicable disease of public health significance through further scientific review.

    VI. Required Regulatory Analyses A. Executive Orders 12866 and 13563

    HHS/CDC has examined the impacts of the proposed rule under Executive Order 12866, Regulatory Planning and Review (58 FR 51735, October 4, 1993) and Executive Order 13563, Improving Regulation and Regulatory Review, (76 FR 3821, January 21, 2011)(1,2). Both Executive Orders direct agencies to evaluate any rule prior to promulgation to determine the regulatory impact in terms of costs and benefits to United States populations and businesses. Further, together, the two Executive Orders set the following requirements: quantify costs and benefits where the new regulation creates a change in current practice; define qualitative costs and benefits; choose approaches that maximize benefits; support regulations that protect public health and safety; and minimize the impact of regulation. HHS/CDC has analyzed the rule as required by these Executive Orders and has determined that it is consistent with the principles set forth in the Executive Orders and the Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) and that the rule will create minimal impact (3,4).

    This proposed rule is not being treated as a significant regulatory action as defined by Executive Order 12866. As such, it has not been reviewed by the Office of Management and Budget (OMB).

    There are two main impacts of this proposed rule. First, we are proposing updates to the current regulation that reflect modern terminology, plain language, and current practice. Because there is no change in the baseline from these updates, no costs can be associated with these administrative updates to align the regulation with current practice.

    Second, we are proposing to remove three sexually transmitted bacterial infections, chancroid, granuloma inguinale and lymphogranuloma venereum, from the definition of communicable disease of public health significance (5). In doing this, aliens seeking permanent entry to the United States (immigrants, refugees and asylees) will no longer be examined for these diseases during the mandatory medical examinations that are part of the process of admission to the United States. The impact of dropping this portion of the examination is likely to be minimal. On the positive side, the physicians administering the exam will be able to focus on other areas of patient health. On the negative side, there is the potential for a negligible increase in the numbers of disease cases entering the United States. However, as we explain subsequently, this impact is likely to be extremely small. Further, the costs associated with the current disease burden in the United States are also very limited. Therefore, the potential introduction of a very small number of cases will not change the current cost structure associated with the current disease burden.

    The three bacterial infections (chancroid, granuloma inguinale and lymphogranuloma venereum), are transmitted through sexual contact, have never been common in the United States and over the past two decades are observed to be increasingly rare throughout the world. Of the three conditions, only laboratory-diagnosed cases of chancroid are reportable in the United States, and since 2005 fewer than 30 chancroid cases annually were reported to CDC from the U.S. states and territories (6-23). While some U.S. cities (7) keep records of cases of granuloma inguinale and lymphogranuloma venereum, neither condition is included on the list of diseases reported to the CDC by clinicians and public health departments (6). Online searches and a few available publications indicate that both conditions most typically occur in tropical and impoverished settings (i.e., with limited access to water, hygiene); and both conditions have become increasingly uncommon over time. A review of the literature published during the past five years identified only a handful of case reports on granuloma inguinale, and the vast majority of these cases were cases outside the United States (12-17). Sporadic small outbreaks of lymphogranuloma venereum have occurred over the past 10 years in Europe and the United States (18-20). The numbers of lymphogranuloma venereum cases are small, have been almost exclusively among men who have sex with men, and numbers are not systematically collected for country populations (18-20).

    When HHS/CDC originally attempted to estimate the disease impact to calculate the cost associated with removing these three diseases, we tried to examine the disease rates in the regions or countries of origin of aliens seeking entry to the United States. In the most recent report from the DHS, the Annual Yearbook of Immigration Statistics, DHS reports on the regions and countries of origin of aliens (24). Unfortunately, we have been unable to find disease data that correlates with the DHS population data for region of origination of aliens (24). Data on chancroid, granuloma inguinale and lymphogranuloma venereum are not systematically collected by any country outside of the United States either by specific countries or regions listed by DHS for aliens, or from the World Health Organization (WHO) (8, 22, 23). Ultimately, we were unable to correlate the originating regions of aliens entering the United States permanently (immigrants, refugees, and asylees) with the rates of the three diseases in the countries of origin.

    Potential for onward transmission of these infections to the U.S. population is deemed to be extremely low. While we do not have country or region-specific rates for these diseases, our review of the literature supports the supposition that the potential introduction of additional cases into the United States by aliens is likely to have a negligible impact on the U.S. population. These primarily tropical infections can be prevented through improved personal hygiene (11) and protected sex (use of a condom) (12). New infections can be effectively treated and cured with a short, uncomplicated course of antibiotic therapy.

    Economic analysis and cost results. HHS/CDC has determined that the costs associated with chancroid, granuloma inguinale and lymphogranuloma venereum are currently very low. Given the pattern of diminishing caseloads reported in the literature and available data (6-21), HHS/CDC projects that future costs will remain low. A more detailed analysis as required by EO 12866 and 13563 can be found in the docket for this NPRM. A summary follows below.

    Summary. There is no international disease incidence data available for chancroid, granuloma inguinale and lymphogranuloma venereum. There is some data available for numbers of cases of chancroid observed in the United States over a number of years (6) and DHS also provides data regarding the numbers of legal foreign residents in the United States (24). In the full analysis we used the chancroid data to estimate a range of costs to treat chancroid in the United States (6) at the highest and lowest caseloads observed. An estimated component for granuloma inguinale and lymphogranuloma venereum was added by assumption because of lack of either domestic or international data. The costs were then prorated to reflect the foreign population residing in the United States using DHS data (24).

    Cost estimates were derived for three alternatives titled Low, High, and Extreme. The Low and High alternatives were based on the lowest (most recent) and highest reported caseloads of chancroid (6). The Extreme alternative is six times the highest rate of chancroid ever reported in the United States. Finally, often chancroid, Granuloma Inguinale, and Lymphogranuloma Venereum are co-morbid with other STIs, e.g., HIV, syphilis, or gonorrhea (6, 8, 21). Therefore costs are estimated to both treat cases with or without co-morbidity.

    The results of the analysis are reported in Table 1. None of the results are economically significant, e.g., none of the results are more than $100 million a year in costs.

    Table 1—Annual Costs of Chancroid, Granuloma Inguinale, and Lymphogranuloma Venereum in Lawful Permanent Residents: LOW, HIGH, and EXTREMELY HIGH Caseload Alternatives, in 2013 Dollars Notes: (1) Per-case cost $263.51. (2) Assumes LPRs are 0.4% of total population. Alternatives LOW (less than 1 case a year) HIGH EXTREMELY HIGH LPR Total Annual Costs 50% comorbidity $18 $2,122 $12,731 LPR Total Annual Costs NO comorbidity 33 3,858 23,147

    Estimated benefits of this rule. The benefits to this rule are also qualitative. Aliens as well as the panel physicians and civil surgeons inherently benefit from having current, up-to-date regulations with modern terminology that reflects modern practice and plain language. The physicians administering the exam will be able to devote more time and training to other, more common and/or more serious health issues. The proposed changes do not impose any additional costs on aliens, panel physicians, or civil surgeons.

    Comparison of costs and benefits. Given the potential impact of the rulemaking, we conclude that the benefits of the rule justify any costs. See Tables 2 and 3 below.

    Table 2—Summary of the Quantified and Non-Quantified Benefits and Costs for Updates to the Current Regulation that Reflect Modern Terminology, Plain Language, and Current Practice Category Primary
  • estimate
  • Minimum
  • estimate
  • Maximum
  • estimate
  • Source
  • citation
  • (RIA, preamble, etc.)
  • BENEFITS: Monetized benefits NA (7%) NA (7%) NA (7%) RIA. NA (3%) NA (3%) NA (3%) $0 (0%) $0 (0%) $0 (0%) Annualized quantified, but unmonetized, benefits None N/A N/A RIA. Qualitative (unquantified benefits) Aliens as well as the panel physicians and civil surgeons inherently benefit from having current, up-to-date regulations with modern terminology that reflects modern practice and plain language. RIA. COSTS: Annualized monetized costs (discount rate in parenthesis) a NA (7%) NA (7%) NA (7%) RIA. NA (3%) NA (3%) NA (3%) $0 (0%) $0 (0%) $0 (0%) Annualized quantified, but unmonetized, costs None N/A N/A RIA. Qualitative (unquantified) costs None RIA.
    Table 3—Summary of the Quantified and Non-Quantified Benefits and Costs Removing Chancroid, Granuloma Inguinale, and Lymphogranuloma Venereum From the Definition of Communicable Disease of Public Health Significance Category Primary
  • estimate
  • Minimum
  • estimate
  • Maximum
  • estimate
  • Source
  • citation
  • (RIA, preamble, etc.)
  • BENEFITS: Monetized benefits NA (7%) NA (7%) NA (7%) RIA. NA (3%) NA (3%) NA (3%) NA (0%) NA (0%) NA (0%) Annualized quantified, but unmonetized, benefits None N/A N/A RIA. Qualitative (unquantified benefits) The physicians administering the exam will be able to devote more time and training to other, more common and/or more serious health issues. RIA. COSTS: Annualized monetized costs (discount rate in parenthesis) a NA (7%) NA (7%) NA (7%) RIA. NA (3%) NA (3%) NA (3%) $3,858 (0%) 18 (0%) $23,147 (0%) Annualized quantified, but unmonetized, costs None N/A N/A RIA. Qualitative (unquantified) costs None RIA. a All costs of the rule are annual.
    B. The Regulatory Flexibility Act

    Under the Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), agencies are required to analyze regulatory options to minimize significant economic impact of a proposed rule on small businesses, small governmental units, and small not-for-profit organizations. We have analyzed the costs and benefits of this proposed rule, as required by Executive Order 12866, and a preliminary regulatory flexibility analysis that examines the potential economic effects of this rule on small entities, as required by the Regulatory Flexibility Act. Based on the cost benefit analysis, we do expect this proposed rule to have little or no economic impact on small entities.

    C. The Paperwork Reduction Act

    The Paperwork Reduction Act applies to the data collection requirements found in 42 CFR part 34. The U.S. Department of State is responsible for providing forms to panel physicians, and the Department of Homeland Security is responsible for providing forms to civil surgeons to document the medical examination and screening information for aliens. The Office of Management and Budget (OMB) approved this data collection under OMB Control No. 1405-0113, which will expire on September 30, 2017.

    D. National Environmental Policy Act (NEPA)

    HHS/CDC has determined that the proposed amendments to 42 CFR part 34 will not have a significant impact on the human environment.

    E. Executive Order 12988: Civil Justice Reform

    HHS/CDC has reviewed this rule under Executive Order 12988 on Civil Justice Reform and determines that this proposed rule meets the standard in the Executive Order.

    F. Executive Order 13132: Federalism

    Under Executive Order 13132, if the proposed rule would limit or preempt State authorities, then a federalism analysis is required. The agency must consult with State and local officials to determine whether the rule would have a substantial direct effect on State or local Governments, as well as whether it would either preempt State law or impose a substantial direct cost of compliance on them.

    HHS/CDC has determined that this proposed rule will not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

    G. The Plain Language Act of 2010

    Under 63 FR 31883 (June 10, 1998), Executive Departments and Agencies are required to use plain language in all proposed and final rules. HHS/CDC has attempted to use plain language in proposing this rule to make our intentions and rationale clear and welcomes feedback from the public on our attempt to use plain language in this rule.

    VIII. References 1. The President. Presidential documents. Executive Order 12866 of September 30, 1993: Regulatory Planning and Review. Federal Register. Monday, October 4, 1993;58(190). http://www.archives.gov/federal-register/executive-orders/pdf/12866.pdf. Accessed February 2014. 2. The President. Presidential documents. Executive Order 13563 of January 18, 2011: Improving Regulation and Regulatory Review. Federal Register. Friday, January 21, 2011; 76(14). http://www.thefederalregister.org/fdsys/pkg/FR-2011-01-21/pdf/2011-1385.pdf. Accessed February 2014. 3. U. S. Small Business Administration. Regulatory Flexibility Act. http://www.sba.gov/advocacy/823. Accessed February 2014. 4. Summary of the Unfunded Mandates Reform Act. 2 U.S.C. 1501 et seq (1995). http://www2.epa.gov/laws-regulations/summary-unfunded-mandates-reform-act. Accessed February 2014. 5. Tom Lantos and Henry Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, Public Law 110-293, section 305, 122 Stat. 2963 (July 30, 2008). 6. CDC. CDC WONDER: Sexually Transmitted Disease Morbidity, 1984-2008. Available from: http://wonder.cdc.gov/std-v2008.html. Accessed February 2014. 7. New York State Department of Health. Bureau of Sexually Transmitted Disease Prevention and Epidemiology. STD Statistical Abstract 2008. http://www.health.state.ny.us/statistics/diseases/communicable/std/abstracts/docs/2008.pdf Accessed February 2014. 8. Steen, R. (2001). Eradicating chancroid. Bulletin of the World Health Organization 2001. 79: 818-826. 9. Plummer, FA et al. (1983). Epidemiology of chancroid and Haemophilus ducreyi in Nairobi, Kenya. The Lancet. 2(8362): 1293-1295. 10. Hawkes S et al. (1995) Asymptomatic carriage of Haemophilus ducreyi confirmed by the polymerase chain reaction. Genitourinary Medicine. 71 (4): 224-227. 11. O'Farrell, N. (1993) Soap and water prophylaxis for limiting genital ulcer disease and HIV-1 infection in men in sub-Saharan Africa. Genitourinary Medicine. 69 (4): 297-303. 12. O'Farrell, N, & Moi, H. (2010) European guideline for the management of donovanosis, 2010. International Journal of STD & AIDS. 21:609-610. 13. Richens, J. (2006) Donovanosis (Granuloma Inguinale). Sexually Transmitted Infections. 82(Suppl IV):iv21-iv22. 14. Miller, P. Donovanosis: control or eradication? (2001) Office for Aboriginal and Torres Strait Islander Health. 15. Vorvick, LJ., & Storck, S. (2009). Granuloma inguinale (Donovanosis). Medline Plus. http://www.nlm.nih.gov/medlineplus/ency/article/000636.htm. Accessed February 2014. 16. Bowden FJ, on behalf of the National Donovanosis Eradication Advisory Committee. Donovanosis in Australia: going, going . . . Sex Transm Infect 2005. 81:365-366. 17. CDC. Treatment of Sexually Transmitted Diseases. Diseases characterized by genital ulcers—Granuloma inguinale (Donovanosis). 2011. Available from: http://www.cdc.gov/std/treatment/2010/genital-ulcers.htm. Accessed February 2014. 18. CDC. Treatment of Sexually Transmitted Diseases. Diseases characterized by genital ulcers—Lymphogranuloma Venereum. 2011. Available from: http://www.cdc.gov/std/treatment/2010/genital-ulcers.htm. Accessed February 2014. 19. Martin-Iguacel, R., Llibre, J.M., Nielsen, H., Heras, E., Matas, L., Lugo, R., Clotet, B., Siera, G. (2010) Lymphogranuloma venereum proctocolitis: a silent endemic disease in men who have sex with men in industrialized countries. European Journal of Clinical Microbial Infectious Disease. 29:917-925. 20. Blank, S., Schillinger, JA., Harbatkin, D. (2005) Comment: Lymphogranuloma venereum in the industrialized world. The Lancet. 365: 1607-08. 21. Johnson, LF., Coetzee, DJ., & Dorrington, RE. (2005). Sentinel surveillance of sexually transmitted infections in South Africa: a review. Sexually Transmitted Infections. 81: 287-293. 22. WHO, Global incidence and incidence of selected curable sexually transmitted infections 2001. Available from: http://www.who.int/hiv/pub/sti/en/who_hiv_aids_2001.02.pdf. Accessed February 2014 23. WHO, Global incidence and incidence of four curable sexually transmitted infections (STIs): New estimates from WHO. 2009. 24. United States. Department of Homeland Security. Yearbook of Immigration Statistics: 2010. Washington, DC: U.S. Department of Homeland Security, Office of Immigration Statistics, 2011. 25. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Arlington, VA, American Psychiatric Association, 2013. 26. International Classification of Diseases (ICD), Ninth Revision, World Health Organization. List of Subjects in 42 CFR Part 34

    Aliens, Health care, Medical examination, Passports and visas, Public health, Scope of examination.

    For the reasons discussed in the preamble, the Centers for Disease Control and Prevention, Department of Health and Human Services proposes to amend 42 CFR part 34 as follows:

    1. Revise part 34 to read as follows: PART 34—MEDICAL EXAMINATION OF ALIENS Sec. 34.1 Applicability. 34.2 Definitions. 34.3 Scope of examinations. 34.4 Medical notifications. 34.5 Postponement of medical examination. 34.6 Applicability of Foreign Quarantine Regulations. 34.7 Medical and other care; death. 34.8 Reexamination; convening of review boards; expert witnesses; reports. Authority:

    42 U.S.C. 252; 8 U.S.C. 1182 and 1222.

    § 34.1 Applicability.

    The provisions of this part shall apply to the medical examination of:

    (a) Aliens applying for a visa at an embassy or consulate of the United States;

    (b) Aliens arriving in the United States;

    (c) Aliens required by DHS to have a medical examination in connection with the determination of their admissibility into the United States; and

    (d) Aliens applying for adjustment of status.

    § 34.2 Definitions.

    As used in this part, terms shall have the following meanings:

    (a) CDC. Centers for Disease Control and Prevention, Department of Health and Human Services, or an authorized representative acting on its behalf.

    (b) Communicable disease of public health significance. Any of the following diseases:

    (1) Communicable diseases as listed in a Presidential Executive Order, as provided under Section 361(b) of the Public Health Service Act. The current revised list of quarantinable communicable diseases is available at http://www.cdc.gov and http://www.archives.gov/federal-register.

    (2) Communicable diseases that may pose a public health emergency of international concern if it meets one or more of the factors listed in § 34.3(d) and for which the Director has determined (A) a threat exists for importation into the United States, and (B) such disease may potentially affect the health of the American public. The determination will be made consistent with criteria established in Annex 2 of the revised International Health Regulations (http://www.who.int/csr/ihr/en/), as adopted by the Fifty-Eighth World Health Assembly in 2005, and as entered into effect in the United States in July 2007, subject to the U.S. Government's reservation and understandings:

    (i) Any of the communicable diseases for which a single case requires notification to the World Health Organization (WHO) as an event that may constitute a public health emergency of international concern, or

    (ii) Any other communicable disease the occurrence of which requires notification to the WHO as an event that may constitute a public health emergency of international concern. HHS/CDC's determinations will be announced by notice in the Federal Register.

    (3) Gonorrhea.

    (4) Hansen's disease, infectious.

    (5) Syphilis, infectious.

    (6) Tuberculosis, active.

    (c) Civil surgeon. A physician designated by DHS to conduct medical examinations of aliens in the United States who are applying for adjustment of status to permanent residence or who are required by DHS to have a medical examination.

    (d) Class A medical notification. Medical notification of:

    (1) A communicable disease of public health significance;

    (2) A failure to present documentation of having received vaccination against “vaccine-preventable diseases” for an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, which shall include at least the following diseases: Mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenza type B and hepatitis B, and any other vaccinations recommended by the Advisory Committee for Immunization Practices (ACIP) for which there is a public health need at the time of immigration or adjustment of status. Provided, however, that in no case shall a Class A medical notification be issued for an adopted child who is 10 years of age or younger if, prior to the admission of the child, an adoptive parent or prospective adoptive parent of the child, who has sponsored the child for admission as an immediate relative, has executed an affidavit stating that the parent is aware of the vaccination requirement and will ensure that, within 30 days of the child's admission, or at the earliest time that is medically appropriate, the child will receive the vaccinations identified in the requirement.

    (3)(i) A current physical or mental disorder and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others;

    (ii) A history of a physical or mental disorder and behavior associated with the disorder, which behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or lead to other harmful behavior; or

    (4) Drug abuse or addiction.

    (e) Class B medical notification. Medical notification of a physical or mental health condition, disease, or disability serious in degree or permanent in nature.

    (f) DHS. U.S. Department of Homeland Security.

    (g) Director. The Director of the Centers for Disease Control and Prevention or a designee as approved by the Director or Secretary of Health and Human Services.

    (h) Drug abuse. “Current substance use disorder or substance-induced disorder, mild” as defined in the most recent edition of the Diagnostic and Statistical Manual for Mental Disorders (DSM) as published by the American Psychiatric Association, or by another authoritative source as determined by the Director, of a substance listed in Section 202 of the Controlled Substances Act, as amended (21 U.S.C. 802).

    (i) Drug addiction. “Current substance use disorder or substance-induced disorder, moderate or severe” as defined in the most recent edition of the Diagnostic and Statistical Manual for Mental Disorders (DSM), as published by the American Psychiatric Association, or by another authoritative source as determined by the Director, of a substance listed in Section 202 of the Controlled Substances Act, as amended (21 U.S.C. 802).

    (j) Medical examiner. A panel physician, civil surgeon, or other physician designated by the Director to perform medical examinations of aliens.

    (k) Medical hold document. A document issued to the DHS by a quarantine officer of HHS at a port of entry which defers the inspection for admission until the cause of the medical hold is resolved.

    (l) Medical notification. A medical examination document issued to a U.S. consular authority or DHS by a medical examiner, certifying the presence or absence of:

    (1) A communicable disease of public health significance;

    (2) Documentation of having received vaccination against “vaccine-preventable diseases” for an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, which shall include at least the following diseases: mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenza type B and hepatitis B, and any other vaccinations recommended by the Advisory Committee for Immunization Practices (ACIP) for which HHS/CDC determines there is a public health need at the time of immigration or adjustment of status. Provided, however, that in no case shall a Class A medical notification be issued for an adopted child who is 10 years of age or younger if, prior to the admission of the child, an adoptive parent or prospective adoptive parent of the child, who has sponsored the child for admission as an immediate relative, has executed an affidavit stating that the parent is aware of the vaccination requirement and will ensure that, within 30 days of the child's admission, or at the earliest time that is medically appropriate, the child will receive the vaccinations identified in the requirement;

    (3)(i) A current physical or mental disorder and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others;

    (ii) A history of a physical or mental disorder and behavior associated with the disorder, which behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or lead to other harmful behavior;

    (4) Drug abuse or addiction; or

    (5) Any other physical or mental condition, disease, or disability serious in degree or permanent in nature.

    (m) Medical officer. A physician or other medical professional assigned by the Director to conduct physical and mental examinations of aliens on behalf of HHS/CDC.

    (n) Mental disorder. A currently accepted psychiatric diagnosis, as defined by the current edition of the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association or by another authoritative source as determined by the Director.

    (o) Panel physician. A physician selected by a United States embassy or consulate to conduct medical examinations of aliens applying for visas.

    (p) Physical disorder. A currently accepted medical diagnosis, as defined by the current edition of the Manual of the International Classification of Diseases, Injuries, and Causes of Death published by the World Health Organization or by another authoritative source as determined by the Director.

    § 34.3 Scope of examinations.

    (a) General. In performing examinations, medical examiners shall consider those matters that relate to the following:

    (1) Communicable disease of public health significance;

    (2) Documentation of having received vaccination against “vaccine-preventable diseases” for an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, which shall include at least the following diseases: mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenza type B and hepatitis B, and any other vaccinations recommended by the Advisory Committee for Immunization Practices (ACIP) for which HHS/CDC determines there is a public health need at the time of immigration or adjustment of status.

    Provided, however, that in no case shall a Class A medical notification be issued for an adopted child who is 10 years of age or younger if, prior to the admission of the child, an adoptive parent or prospective adoptive parent of the child, who has sponsored the child for admission as an immediate relative, has executed an affidavit stating that the parent is aware of the vaccination requirement and will ensure that, within 30 days of the child's admission, or at the earliest time that is medically appropriate, the child will receive the vaccinations identified in the requirement;

    (3)(i) A current physical or mental disorder and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others;

    (ii) A history of a physical or mental disorder and behavior associated with the disorder, which behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or lead to other harmful behavior;

    (4) Drug abuse or drug addiction; and

    (5) Any other physical or mental health condition, disease, or disability serious in degree or permanent in nature.

    (b) Scope of all medical examinations.

    (1) All medical examinations will include the following:

    (i) A general physical examination and medical history, evaluation for tuberculosis, and serologic testing for syphilis.

    (ii) A physical examination and medical history for diseases specified in § 34.2(b)(1) and (b)(4) through (10).

    (2) For the examining physician to reach a determination and conclusion about the presence or absence of a physical or mental abnormality, disease, or disability, the scope of the examination shall include any laboratory or additional studies that are deemed necessary, either as a result of the physical examination or pertinent information elicited from the alien's medical history or other relevant records.

    (c) Additional medical screening and testing for examinations performed outside the United States. (1) HHS/CDC may require additional medical screening and testing for medical examinations performed outside the United States for diseases specified in § 34.2(b)(2) and (3) by applying the risk-based medical and epidemiologic factors in paragraph (d)(2) of this section.

    (2) Such examinations shall be conducted in a defined population in a geographic region or area outside the United States as determined by HHS/CDC.

    (3) Additional medical screening and testing shall include a medical interview, physical examination, laboratory testing, radiologic exam, or other diagnostic procedure, as determined by HHS/CDC.

    (4) Additional medical screening and testing will continue until HHS/CDC determines such screening and testing is no longer warranted based on factors such as the following: Results of disease outbreak investigations and response efforts; effectiveness of containment and control measures; and the status of an applicable determination of public health emergency of international concern declared by the Director General of the WHO.

    (5) HHS/CDC will directly provide medical examiners information pertaining to all applicable additional requirements for medical screening and testing, and will post these at the following Internet addresses: http://www.cdc.gov/ncidod/dq/technica.htm and http://www.globalhealth.gov.

    (d) Risk-based approach. (1) HHS/CDC will use the medical and epidemiological factors listed in paragraph (d)(2) of this section to determine the following:

    (i) Whether a disease as specified in § 34.2(b)(3)(ii) is a communicable disease of public health significance; and

    (ii) Which diseases in § 34.2(b)(2) and (3) merit additional screening and testing, and the geographic area in which HHS/CDC will require this screening.

    (2) Medical and epidemiological factors include the following:

    (i) The seriousness of the disease's public health impact;

    (ii) Whether the emergence of the disease was unusual or unexpected;

    (iii) The risk of the spread of the disease in the United States;

    (iv) The transmissibility and virulence of the disease;

    (v) The impact of the disease at the geographic location of medical screening; and

    (vi) Other specific pathogenic factors that would bear on a disease's ability to threaten the health security of the United States.

    (e) Persons subject to requirement for chest radiograph examination and serologic testing. (1) As provided in paragraph (e)(2) of this section, a chest radiograph examination and serologic testing for syphilis shall be required as part of the examination of the following:

    (i) Applicants for immigrant visas;

    (ii) Students, exchange visitors, and other applicants for non-immigrant visas required by a U.S. consular authority to have a medical examination;

    (iii) Applicants outside the United States who apply for refugee status;

    (iv) Applicants in the United States who apply for adjustment of their status under the immigration statute and regulations.

    (v) Applicants required by DHS to have a medical examination in connection with determination of their admissibility into the United States.

    (2) Chest radiograph examination and serologic testing. Except as provided in paragraph (e)(2)(iv) of this section, applicants described in paragraph (e)(1) of this section shall be required to have the following:

    (i) For applicants 15 years of age and older, a chest radiograph examination;

    (ii) For applicants under 15 years of age, a chest radiograph examination if the applicant has symptoms of tuberculosis, a history of tuberculosis, or evidence of possible exposure to a transmissible tuberculosis case in a household or other enclosed environment for a prolonged period;

    (iii) For applicants 15 years of age and older, serologic testing for syphilis and other communicable diseases of public health significance as determined by the Director through technical instructions.

    (iv) Exceptions. Serologic testing for syphilis shall not be required if the alien is under the age of 15, unless there is reason to suspect infection with syphilis. An alien, regardless of age, in the United States, who applies for adjustment of status to lawful permanent resident, shall not be required to have a chest radiograph examination unless their tuberculin skin test, or an equivalent test for showing an immune response to Mycobacterium tuberculosis antigens, is positive. HHS/CDC may authorize exceptions to the requirement for a tuberculin skin test, an equivalent test for showing an immune response to Mycobacterium tuberculosis antigens, or chest radiograph examination for good cause, upon application approved by the Director.

    (3) Immune response to Mycobacterium tuberculosis antigens.

    (i) All aliens 2 years of age or older in the United States who apply for adjustment of status to permanent residents, under the immigration laws and regulations, or other aliens in the United States who are required by the DHS to have a medical examination in connection with a determination of their admissibility, shall be required to have a tuberculin skin test or an equivalent test for showing an immune response to Mycobacterium tuberculosis antigens. Exceptions to this requirement may be authorized for good cause upon application approved by the Director. In the event of a positive test of immune response, a chest radiograph examination shall be required. If the chest radiograph is consistent with tuberculosis, the alien shall be referred to the local health authority for evaluation. Evidence of this evaluation shall be provided to the civil surgeon before a medical notification may be issued.

    (ii) Aliens in the United States less than 2 years old shall be required to have a tuberculin skin test, or an equivalent, appropriate test to show an immune response to Mycobacterium tuberculosis antigens, if there is evidence of contact with a person known to have tuberculosis or other reason to suspect tuberculosis. In the event of a positive test of immune response, a chest radiograph examination shall be required. If the chest radiograph is consistent with tuberculosis, the alien shall be referred to the local health authority for evaluation. Evidence of this evaluation shall be provided to the civil surgeon before a medical notification may be issued.

    (iii) Aliens outside the United States required to have a medical examination shall be required to have a tuberculin skin test, or an equivalent, appropriate test to show an immune response to Mycobacterium tuberculosis antigens, and, if indicated, a chest radiograph.

    (iv) Aliens outside the United States required to have a medical examination shall be required to have a tuberculin skin test, or an equivalent, appropriate test to show an immune response to Mycobacterium tuberculosis antigens, and a chest radiograph, regardless of age, if he/she has symptoms of tuberculosis, a history of tuberculosis, or evidence of possible exposure to a transmissible tuberculosis case in a household or other enclosed environment for a prolonged period, as determined by the Director.

    (4) Additional testing requirements. All applicants may be required to undergo additional testing for tuberculosis based on the medical evaluation.

    (5) How and where performed. All chest radiograph images used in medical examinations performed under the regulations to this part shall be large enough to encompass the entire chest.

    (6) Chest x-ray, laboratory, and treatment reports. The chest radiograph reading and serologic test results for syphilis shall be included in the medical notification. When the medical examiner's conclusions are based on a study of more than one chest x-ray image, the medical notification shall include at least a summary statement of findings of the earlier images, followed by a complete reading of the last image, and dates and details of any laboratory tests and treatment for tuberculosis.

    (f) Procedure for transmitting records. For aliens issued immigrant visas, the medical notification and chest radiograph images, if any, shall be placed in a separate envelope, which shall be sealed. When more than one chest radiograph image is used as a basis for the examiner's conclusions, all images shall be included. Records may be transmitted by other means, as approved by the Director.

    (g) Failure to present records. When a determination of admissibility is to be made at the U.S. port of entry, a medical hold document shall be issued pending completion of any necessary examination procedures. A medical hold document may be issued for aliens who:

    (1) Are not in possession of a valid medical notification, if required;

    (2) Have a medical notification which is incomplete;

    (3) Have a medical notification which is not written in English;

    (4) Are suspected to have an inadmissible medical condition.

    (h) The Secretary of Homeland Security, after consultation with the Secretary of State and the Secretary of Health and Human Services, may in emergency circumstances permit the medical examination of refugees to be completed in the United States.

    (i) All medical examinations shall be carried out in accordance with such technical instructions for physicians conducting the medical examination of aliens as may be issued by the Director. Copies of such technical instructions are available upon request to the Director, Division of Global Migration and Quarantine, Mailstop E03, HHS/CDC, Atlanta GA 30333.

    § 34.4 Medical notifications.

    (a) Medical examiners shall issue medical notifications of their findings of the presence or absence of Class A or Class B medical conditions. The presence of such condition must have been clearly established.

    (b) Class A medical notifications. (1) The medical examiner shall report his/her findings to the consular officer or DHS by Class A medical notification which lists the specific condition for which the alien may be inadmissible, if an alien is found to have:

    (i) A communicable disease of public health significance;

    (ii) A lack of documentation, or no waiver, for an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, of having received vaccination against vaccine-preventable diseases which shall include at least the following diseases: Mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenza type B and hepatitis B, and any other vaccinations recommended by the Advisory Committee for Immunization Practices (ACIP) for which HHS/CDC determines there is a public health need at the time of immigration or adjustment of status.

    Provided however, that a Class A medical notification shall in no case be issued for an adopted child who is 10 years of age or younger if, prior to the admission of the child, an adoptive parent or prospective adoptive parent of the child, who has sponsored the child for admission as an immediate relative, has executed an affidavit stating that the parent is aware of the vaccination requirement and will ensure that, within 30 days of the child's admission, or at the earliest time that is medically appropriate, the child will receive the vaccinations identified in the requirement;

    (iii)(A) A current physical or mental disorder, and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others; or

    (B) A history of a physical or mental disorder and behavior associated with the disorder, which behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or lead to other harmful behavior;

    (iv) Drug abuse or drug addiction.

    Provided, however, that a Class A medical notification of a physical or mental disorder, and behavior associated with that disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others, shall in no case be issued with respect to an alien having only mental shortcomings due to ignorance, or suffering only from a condition attributable to remediable physical causes or of a temporary nature, caused by a toxin, medically prescribed drug, or disease.

    (2) The medical notification shall state the nature and extent of the abnormality; the degree to which the alien is incapable of normal physical activity; and the extent to which the condition is remediable. The medical examiner shall indicate the likelihood, that because of the condition, the applicant will require extensive medical care or institutionalization.

    (c) Class B medical notifications. (1) If an alien is found to have a physical or mental abnormality, disease, or disability serious in degree or permanent in nature amounting to a substantial departure from normal well-being, the medical examiner shall report his/her findings to the consular or DHS officer by Class B medical notification which lists the specific conditions found by the medical examiner. Provided, however, that a Class B medical notification shall in no case be issued with respect to an alien having only mental shortcomings due to ignorance, or suffering only from a condition attributable to remediable physical causes or of a temporary nature, caused by a toxin, medically prescribed drug, or disease.

    (2) The medical notification shall state the nature and extent of the abnormality, the degree to which the alien is incapable of normal physical activity, and the extent to which the condition is remediable. The medical examiner shall indicate the likelihood, that because of the condition, the applicant will require extensive medical care or institutionalization.

    (d) Other medical notifications. If as a result of the medical examination, the medical examiner does not find a Class A or Class B condition in an alien, the medical examiner shall so indicate on the medical notification form and shall report his findings to the consular or DHS officer.

    § 34.5 Postponement of medical examination.

    Whenever, upon an examination, the medical examiner is unable to determine the physical or mental condition of an alien, completion of the medical examination shall be postponed for such observation and further examination of the alien as may be reasonably necessary to determine his/her physical or mental condition. The examination shall be postponed for aliens who have an acute infectious disease until the condition is resolved. The alien shall be referred for medical care as necessary.

    § 34.6 Applicability of Foreign Quarantine Regulations.

    Aliens arriving at a port of the United States shall be subject to the applicable provisions of 42 CFR part 71, Foreign Quarantine, with respect to examination and quarantine measures.

    § 34.7 Medical and other care; death.

    (a) An alien detained by or in the custody of DHS may be provided medical, surgical, psychiatric, or dental care by HHS through interagency agreements under which DHS shall reimburse HHS. Aliens found to be in need of emergency care in the course of medical examination shall be treated to the extent deemed practical by the attending physician and if considered to be in need of further care, may be referred to DHS along with the physician's recommendations concerning such further care.

    (b) In case of the death of an alien, the body shall be delivered to the consular or immigration authority concerned. If such death occurs in the United States, or in a territory or possession thereof, public burial shall be provided upon request of DHS and subject to its agreement to pay the burial expenses. Autopsies shall not be performed unless approved by DHS.

    § 34.8 Reexamination; convening of review boards; expert witnesses; reports.

    (a) The Director shall convene a board of medical officers to reexamine an alien:

    (1) Upon the request of DHS for a reexamination by such a board; or

    (2) Upon an appeal to DHS by an alien who, having received a medical examination in connection with the determination of admissibility to the United States (including examination on arrival and adjustment of status as provided in the immigration laws and regulations) has been certified for a Class A condition.

    (b) The board shall reexamine an alien certified as:

    (1) Having a communicable disease of public health significance;

    (2) Lacking documentation of having received vaccination against “vaccine-preventable diseases” for an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, which shall include at least the following diseases: Mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenza type B and hepatitis B, and any other vaccinations recommended by the Advisory Committee for Immunization Practices (ACIP) for which HHS/CDC determines there is a public health need at the time of immigration or adjustment of status.

    Provided, however, that in no case shall a Class A medical notification be issued for an adopted child who is 10 years of age or younger if, prior to the admission of the child, an adoptive or prospective adoptive parent, who has sponsored the child for admission as an immediate relative, has executed an affidavit stating that the parent is aware of the vaccination requirement and will ensure that the child will be vaccinated within 30 days of the child's admission, or at the earliest time that is medically appropriate.

    (3)(i) Having a current physical or mental disorder and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others; or

    (ii) Having a history of a physical or mental disorder and behavior associated with the disorder, which behavior has posed a threat to the property, safety, or welfare of the alien or others and which behavior is likely to recur or lead to other harmful behavior; or

    (iii) Having drug abuse or drug addiction;

    (c) The board shall consist of the following:

    (i) In circumstances covered by paragraph (b)(1) of this section, the board shall consist of at least one medical officer who is experienced in the diagnosis and treatment of the communicable disease for which the medical notification has been made;

    (ii) In circumstances covered by paragraph (b)(2) of this section, the board shall consist of at least one medical officer who is experienced in the diagnosis and treatment of the vaccine-preventable disease for which the medical notification has been made;

    (iii) In circumstances covered by paragraph (b)(3) of this section, the board shall consist of at least one medical officer who is experienced in the diagnosis and treatment of the physical or mental disorder, or substance-related disorder for which medical notification has been made.

    (d) The decision of the majority of the board shall prevail, provided that at least two medical officers concur in the judgment of the board.

    (e) Reexamination shall include:

    (1) Review of all records submitted by the alien, other witnesses, or the board;

    (2) Use of any laboratory or additional studies which are deemed clinically necessary as a result of the physical examination or pertinent information elicited from the alien's medical history;

    (3) Consideration of statements regarding the alien's physical or mental condition made by a physician after his/her examination of the alien; and

    (4) A physical or psychiatric examination of the alien performed by the board, at the board's discretion.

    (f) An alien who is to be reexamined shall be notified of the reexamination not less than 5 days prior thereto.

    (g) The alien, at his/her own cost and expense, may introduce as witnesses before the board such physicians or medical experts as the board may in its discretion permit; provided that the alien shall be permitted to introduce at least one expert medical witness. If any witnesses offered are not permitted by the board to testify (either orally or through written testimony), the record of the proceedings shall show the reason for the denial of permission.

    (h) Witnesses before the board shall be given a reasonable opportunity to review the medical notification and other records involved in the reexamination and to present all relevant and material evidence orally or in writing until such time as the reexamination is declared by the board to be closed. During the course of the reexamination the alien's attorney or representative shall be permitted to question the alien and he/she, or the alien, shall be permitted to question any witnesses offered in the alien's behalf or any witnesses called by the board. If the alien does not have an attorney or representative, the board shall assist the alien in the presentation of his/her case to the end that all of the material and relevant facts may be considered.

    (i) Any proceedings under this section may, at the board's option, be conducted based on the written record, including through written questions and testimony.

    (j) The findings and conclusions of the board shall be based on its medical examination of the alien, if any, and on the evidence presented and made a part of the record of its proceedings.

    (k) The board shall report its findings and conclusions to DHS, and shall also give prompt notice thereof to the alien if his/her reexamination has been based on his/her appeal. The board's report to DHS shall specifically affirm, modify, or reject the findings and conclusions of prior examining medical officers.

    (l) The board shall issue its medical notification in accordance with the applicable provisions of this part if it finds that an alien it has reexamined has a Class A or Class B condition.

    (m) If the board finds that an alien it has reexamined does not have a Class A or Class B condition, it shall issue its medical notification in accordance with the applicable provisions of this part.

    (n) After submission of its report, the board shall not be reconvened, nor shall a new board be convened, in connection with the same application for admission or for adjustment of status, except upon the express authorization of the Director.

    Dated: June 12, 2015. Sylvia M. Burwell, Secretary.
    [FR Doc. 2015-15236 Filed 6-22-15; 8:45 am] BILLING CODE 4150-28-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-R8-ES-2011-0055; 4500030113] Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to List Leona's Little Blue Butterfly as Endangered or Threatened AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of 12-month petition finding.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list Leona's little blue butterfly (Philotiella leona) as an endangered or threatened species under the Endangered Species Act of 1973, as amended (Act). After a review of the best available scientific and commercial information, we find that listing Leona's little blue butterfly is not warranted at this time. However, we ask the public to submit to us any new information that becomes available concerning threats to the species or its habitat at any time.

    DATES:

    The finding announced in this document was made on June 23, 2015.

    ADDRESSES:

    This finding is available on the internet at http://www.regulations.gov under Docket No. FWS-R8-ES-2011-0055 and on the Klamath Falls Fish and Wildlife Office Web site at http://www.fws.gov/klamathfallsfwo/. Supporting documentation we used in preparing this finding is available for public inspection, by appointment, during normal business hours at: U.S. Fish and Wildlife Service; Klamath Falls Fish and Wildlife Office; 1936 California Ave; Klamath Falls, OR 97601; telephone: (541) 885-8481; facsimile (541) 885-7837. Please submit any new information, materials, or questions concerning this finding to the above street address.

    FOR FURTHER INFORMATION CONTACT:

    Laurie Sada, Field Supervisor, U.S. Fish and Wildlife Service, Klamath Falls Fish and Wildlife Office; 1936 California Ave; Klamath Falls, OR 97601; telephone: (541) 885-8481; facsimile (541) 885-7837. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800-877-8339.

    SUPPLEMENTARY INFORMATION:

    Background

    Section 4(b)(3)(B) of the Act (16 U.S.C. 1531 et seq.) requires that, for any petition to revise the Federal Lists of Endangered and Threatened Wildlife and Plants that contains substantial scientific or commercial information that listing the species may be warranted, we make a finding within 12 months of the date of receipt of the petition. As discussed above, in this finding, we have determined that adding Leona's little blue butterfly to the Federal Lists of Endangered or Threatened Wildlife is not warranted.

    This finding is based upon the “Species Report for Leona's Little Blue Butterfly (Philotiella leona),” (Service 2015, entire) (Species Report) and the scientific analyses of available information prepared by Service biologists from the Service's Klamath Falls Fish and Wildlife Office, the Pacific Southwest Regional Office, and the Headquarters Office. The Species Report contains the best scientific and commercial data available concerning the status of Leona's little blue butterfly, including the past, present, and future stressors to the species. As such, the Species Report provides the scientific basis that informs our regulatory decision in this document, which involves the further application of standards within the Act and its implementing regulations and policies.

    Below is a summary of the background information on Leona's little blue butterfly. For additional information and a detailed discussion of the species' description, taxonomy, life history, habitat, soils, distribution, and abundance, please see the Species Report for Leona's Little Blue Butterfly (Philotiella leona) (Service 2015, entire) available under Docket No. FWS-R8-ES-2011-0055 at http://www.regulations.gov, or from the Klamath Falls Fish and Wildlife Office (see ADDRESSES).

    Previous Federal Action

    On May 12, 2010, we received a petition from the Xerces Society, Dr. David McCorkle of Western Oregon University, and Oregon Wild (Petitioners), requesting that Leona's little blue butterfly be listed as endangered (Matheson et al. 2010, entire). On August 17, 2011, we published in the Federal Register (76 FR 50971) a 90-day finding on the petition and found that the petition presented substantial scientific or commercial information indicating that listing Leona's little blue butterfly may be warranted.

    On July 1, 2013, the Petitioners filed an action with the U.S. District Court of Oregon challenging the Service for failure to issue the 12-month finding on the petition (Xerces Society for Invertebrate Conservation, et al., Plaintiffs, v. S.M.R. Jewell, et al.; Case No. 3:13-CV-01103-MO). On July 31, 2014, the parties entered into a stipulated settlement agreement and order in which the Court ordered the Service to make the required finding pursuant to 16 U.S.C. 1533(b)(3)(B) no later than June 30, 2015. This notice constitutes our compliance with the Court Order and completes our review and final action regarding the petition to list Leona's little blue butterfly as endangered or threatened under the Act.

    Species Description

    Leona's little blue butterfly is a member of the butterfly family Lycaenidae (gossamer-winged butterflies) and the tribe Polyommatini (Pyle 2002, p. 222). The species has a wingspan of less than 0.75 to 1.0 inches (in) (1.9 to 2.5 centimeters (cm)) (Pyle 2002, p. 236). The dorsal wing color for males is dark dusky blue with black submargins and is brown for the female. The ventral wing color for both sexes is white with black spots on fore- and hind-wings (Hammond and McCorkle 1999, p. 77). Leona's little blue butterfly may be confused with other co-occurring species of little blue butterflies such as the glaucon blue (Euphilotes glaucon) and the lupine blue (Plebejus lupini) (Ross 2010, pp. 10-12). Additional species description information can be found in the Species Report (Service 2015, pp. 4-7).

    Biological Information

    The biology of Leona's little blue butterfly is very closely tied to its larval annual host plant, Eriogonum spergulinum (spurry buckwheat) (Hammond and McCorkle, 1999 p. 80; James 2012, pp. 93, 95; James et al. 2014, p. 269). Buckwheat species, such as spurry buckwheat, are known to be pioneer plants. Pioneer plants are plants that colonize disturbed sites and other open, less vegetated areas (Meyer 2008, pp. 499-503). Food sources for adult Leona's little blue butterfly include spurry buckwheat as well as other flowering plants that produce nectar (Ross 2009, p. 17; Johnson 2010, p. 5; Johnson 2011, p. 9; James 2012, p. 95; James et al. 2014, pp. 269-271). Adult Leona's little blue butterfly begin flying and mate in mid- to late-June, which coincides with the period when spurry buckwheat is beginning to flower and providing sources of nectar (Ross 2008, p. 5; James et al. 2014, p. 268). The lifespan of adults is thought to be 2 weeks (James et al. 2014, p. 272). The eggs of Leona's little blue butterfly are laid on the host plant in early July and hatch into larvae a few days later (James 2011, p. 19; James 2012, p. 94). The larvae appear to feed only on the bud and flower of spurry buckwheat (James 2011, p. 19; James 2012, p. 94). Larvae continue to mature and develop into pupa before the plants senesce (Holdren and Ehrlich 1981, p. 128; Ehrlich and Murphy 1987, p. 124). The pupa overwinter (some captive bred pupa remained dormant for 2 years) and emerge as adult butterflies to complete the cycle (James 2012, pp. 94-95). Additional biological information on the species can be found in the Species Report (Service 2015, pp. 7-15).

    Population Size and Distribution

    Information provided in the petition stated that Leona's little blue butterfly was known from a single population (estimated at 1,000 to 2,000 individuals) and that its range was limited to a 6-square-mile (sq-mi) (15.5-square-kilometer (sq-km)) area in the rain shadow of the Cascades near Sand and Scott Creek of the Antelope Desert in Klamath County, Oregon (Matheson et al. 2010, pp. 7-8). Additional surveys conducted in 2011 used a predictive habitat model to search 18,654 acres (ac) (7,549 hectares (ha)) in Oregon adjacent to and more distant from the known population (Johnson 2011, p. 5). No other populations were located outside the Sand and Scott Creek area despite other areas seemingly having the appropriate habitat characteristics (Ross 2008, pp. 5-9; Ross 2009, pp. 4, 8-17; Johnson 2010, p. 2; Johnson 2011, p. 5; Chew 2013, p. 2; Johnson and Ross 2013, pp. 2-12). This indicates that new populations of Leona's little blue butterfly are not likely to be discovered based on negative survey results from Oregon and California in habitat having appropriate characteristics and, therefore, a high potential for the species to be present (Johnson and Ross 2013, p. 2).

    Based on a better understanding of habitat requirements, more focused survey efforts, and more rigorous sampling methods for the species between 2009 and 2013, the current known range of the species has doubled in size from 6 sq mi (15.5 sq km) to 12.8 sq mi (33.1 sq km) (James et al. 2014, p. 272; Service 2015, p. 16). Similarly, the population size estimates have increased to approximately 20,000 individuals as a result of the additional survey efforts (James et al. 2014, p. 272). Leona's little blue butterfly occupancy appears to be coincident with the northern edge of the Sand Creek and Scott Creek alluvial fans (fan-shaped deposits of volcanic material) deposited after the eruption of Mt. Mazama (present day Crater Lake, OR) 6,600 to 7,700 years ago (Tilden 1963, pp. 110-111; Hammond 1981, p. 180; Harris 1988, p. 105; U.S. Geological Survey (USGS) 2002, p. 1; Cummings 2007, p. 30; Johnson 2010, p. 4). Additional population size and distribution information can be found in the Species Report (Service 2015, pp. 5, 15-18).

    Habitat Characteristics

    Habitat for Leona's little blue butterfly is influenced by the geology of the Sand and Scott Creek area, characteristics of vegetation and soil distribution and composition, and factors contributing to the area's disturbance regime (i.e., timber management and fire). Leona's little blue butterfly inhabits open and often disturbed areas associated with the distribution of its host plant, spurry buckwheat (Ross 2009, p. 20; Service 2015, p. 11). The unique assemblage of plant species found in the vicinity of Sand and Scott Creeks is not likely to occur outside the ash and pumice fields deposited during the eruption of Mt. Mazama (Johnson 2011, p. 2). One reason for this may be the presence of subsurface moisture present from an alluvial fan (Johnson 2011, p. 2). Sand Creek and Scott Creek alluvial fans are thicker than other alluvial fans immediately to the north of the occupied habitat area (Johnson 2011, p. 7). Sand Creek and Scott Creek have removed most of the fine ash layer from the eruption of Mt. Mazama, improving porosity and permeability of the area (Johnson 2011, p. 2).

    The transition zone between the Bitterbrush/Needlegrass-Sedge and Lodgepole Pine/Bitterbrush/Fescue plant communities coincides with the boundary of Leona's little blue butterfly occupancy (Volland 1988, pp. 29, 39; Johnson 2010, p. 2). Annual and perennial plants occurring within the occupied habitat include, but are not limited to: Spurry buckwheat, Eriogonum umbellatum (sulphur-flower buckwheat), Hemizonella minima (least tarweed), Cistanthe umbellata (Mt. Hood pussypaws), Plagiobothrys hispidus (Cascade popcorn flower), Machaeranthera canescens var. shastensis (hoary aster), Packera cana (woolly groundsel), Gayophytum diffusum (spreading groundsmoke), Phacelia hastata (silverleaf phacelia), Agoseris glauca (pale agoseris), Antennaria rosea (rosy pussytoes), Epilobium spp., Pinus contorta (lodgepole pine), Pinus ponderosa (ponderosa pine), and Populus tremuloides (quaking aspen).

    The habitat is a dry, high desert with a limited ability of the ash-pumice fields to retain moisture (Hammond 1981, pp. 180, 190). Topography of the area occupied by Leona's little blue butterfly is relatively flat, with elevations ranging from 4,530 ft (1,381 m) on the west to 4,660 ft (1,420 m) on the east (Ross 2009, p. 19; Esri, Inc. ArcMap 10.2.2 1999-2014). Most precipitation in the Sand and Scott Creek area falls in non-summer months with annual rain and snowfall totals ranging from 15-30 in (38-76 cm) (Youngberg and Dyrness 1959, p. 111; Dyrness and Youngberg 1966, p. 123). The porous ash-pumice fields fail to retain moisture during the short summer growing season, with the exception of some areas where ground water does come to the surface (Hammond 1981, p. 180; Hammond and Dornfeld 1983, p. 120). However, subsurface moisture in the Sand and Scott Creeks area may be greater than the surrounding area because Sand and Scott Creeks flow year-round (Cummings 2007, pp. 49, 72, 105). Additional information on habitat characteristics can be found in the Species Report (Service 2015, pp. 11-15).

    Land Ownership and Management

    Land ownership in the range of Leona's little blue butterfly includes Federal and private land. The majority of the land is held by a single private landowner and their lands have been managed for commercial timber operations. This property has recently (2015) been sold to another private timber company, and management of the area is expected to continue as commercial timber land. The Federal land is part of the Fremont-Winema National Forest and is managed for conservation of resources, per their Land and Resource Management Plan (USFS 1990, entire). The remaining private lands are made up of many small parcels with multiple land owners. Additional land ownership information can be found in the Species Report (2015, Figure 1). Table 1 identifies the land ownership, approximate amount of land, and percentage of habitat area.

    Table 1—Land Ownership, Area of Land, and Percentage of Leona's Little Blue Butterfly Habitat Within the Species' Range Population name Land ownership Approximate area
  • (acres (hectares))
  • Approximate area of habitat (percent)
    Sand Creek 1 Private Timber Lands 2 7,654 (3,097) 93.7 Fremont-Winema National Forest 120 (48) 1.5 Other Private Lands 396 (160) from a total of 48 parcels. 4.8 1 The species was first described in the vicinity of Sand Creek, and is the name that has been adopted to identify the population. Further surveys expanded the range, and the species is now known from the vicinity of both Sand and Scott Creeks. 2 Private timber lands previously owned by Fidelity National Financial, the property has recently been sold to Whitefish Cascade Forest Resources of Salem, Oregon and Singapore.
    Summary of Factors Affecting the Species

    In development of the Species Report for Leona's little blue butterfly and conducting our status review, we identified those stressors that may potentially impact Leona's little blue butterfly individuals or their habitat. The following sections provide a summary of the current stressors impacting Leona's little blue butterfly. Table 2 below summarizes the stressors identified for the species over time since the species was first petitioned for listing and compares these with the current situation. The stressors are not listed in order of magnitude or level of severity. The level of impact of each stressor on Leona's little blue butterfly or its habitat is provided in the summary for the stressor in both the Species Report and this 12-month finding. Low-level impacts are those that are considered baseline for a species under natural conditions that may cause a minor amount of loss of individuals and/or habitat currently or in the future, but which do not affect the species as a whole. Moderate-level impacts are those that are causing a more than minor but not widespread loss of individuals and/or habitat currently or that may do so in the future. High-level impacts are those that are causing widespread loss of individuals and/or habitat currently or that may do so in the future. In our evaluation, we did not find any high-level impacts affecting the species or its habitat.

    In this document, we discuss those stressors currently identified as potentially impacting Leona's little blue butterfly or its habitat including those stressors that have changed since our August 17, 2011, 90-day finding (76 FR 50971) published in the Federal Register. A complete discussion of stressors can be found in the Species Report (Service 2015, pp. 19-70).

    Table 2—Stressors Identified for Leona's Little Blue Butterfly Over Time Stressor Assessment of the stressor's impact to Leona's little blue butterfly or its habitat 2010 Petition 2011 90-day finding 1 2015 Species report Timber Management −/+ Not substantial Low-level Lodgepole Pine Encroachment Substantial Moderate-level Fire Substantial (catastrophic fire) Low-level Fire Retardant n/a n/a Low-level Fire Suppression n/a 2 n/a 2 Low-level Right-of-Way Maintenance n/a n/a Low-level Cinder Mining Not substantial Not Present Livestock Grazing Not substantial Not Present Herbivory from Native Animals n/a n/a Low-level Herbicides Not substantial Low-level Invasive Plants n/a n/a Low- to moderate-level Insect Collection −/+ Not substantial Low-level Competition with Other Invertebrates n/a n/a Low-level Predation Not substantial Low-level Disease Not substantial Low-level Pesticides Not substantial Low-level Isolated Population (drought, fire, disease, inbreeding) Substantial (catastrophic fire) Low-level Effects of Climate Change n/a n/a Low- to moderate-level Potential Change in Land Ownership Not substantial Not applicable n/a = not addressed; “−” = negative impact; “+” = positive impact; “−/+” positive and negative impact. 1 Service's determination that the petition presented either “Substantial” or “Not substantial” information indicating that listing may be warranted. Substantial stressors are those stressors that necessitated further review in this 12-month finding. 2 Discussed in reference to lodgepole pine encroachment in petition and 90-day finding.

    Section 4 of the Act (16 U.S.C. 1533) and implementing regulations (50 CFR part 424) set forth procedures for adding species to, removing species from, or reclassifying species on the Federal Lists of Endangered and Threatened Wildlife and Plants. Under section 4(a)(1) of the Act, a species may be determined to be endangered or threatened 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; or

    (E) Other natural or manmade factors affecting its continued existence.

    In making our 12-month finding on the petition, we considered and evaluated the best available scientific and commercial information pertaining to Leona's little blue butterfly in relation to the five factors provided in section 4(a)(1) of the Act. In considering what factors (stressors) might constitute threats, we must look beyond the mere exposure of the species to the factor to determine whether the species responds to the factor in a way that causes actual impacts to the species. If there is exposure to a factor, but no response, or only a positive response, that factor is not a threat. If there is exposure and the species responds negatively, the factor may be a threat and we then attempt to determine if that factor rises to the level of a threat, meaning that it may drive or contribute to the risk of extinction of the species such that the species warrants listing as an endangered or threatened species as those terms are defined by the Act. This does not necessarily require empirical proof of a threat. The combination of exposure and some corroborating evidence of how the species is likely impacted could suffice. The mere identification of factors that could impact a species negatively is not sufficient to compel a finding that listing is appropriate; we require evidence that these factors are operative threats that act on the species to the point that the species meets the definition of an endangered or threatened species under the Act.

    Listing actions may be warranted based on any of the above factors, singly or in combination. The information pertaining to the five factors found under section 4(a)(1) of the Act is discussed for the species below. In this notice, we focused our discussion of threats to those stressors currently found to be potentially impacting Leona's little blue butterfly or its habitat (see Table 2 above). A complete discussion of all the stressors identified in Table 2 including how and to what extent they may impact Leona's little blue butterfly or its habitat can be found in the Species Report (Service 2015, pp. 19-70).

    Factor A. The Present or Threatened Destruction, Modification, or Curtailment of Its Habitat or Range

    The stressors that may impact the habitat or range of Leona's little blue butterfly include: Timber management, lodgepole pine encroachment, fire, fire suppression, right-of-way maintenance, herbivory from native animals, herbicide application, invasive plants, and the effects of climate change. Some of the same potential activities that affect the habitat of Leona's little blue butterfly can also affect individuals. While these impacts to Leona's little blue butterfly may better be characterized under Factor E (Other Natural or Manmade Factors Affecting Its Continued Existence), they are included here in the Factor A discussion for ease of discussion and analysis.

    Timber Management

    The majority (93.7 percent) of land occupied by Leona's little blue butterfly is managed for timber production (commercial timber lands). Timber management is a broad term that encompasses many activities associated with the removal of trees for commercial or noncommercial purposes. Activities may include creation of temporary or permanent roads, use of existing roads, creation of new landings for log or equipment staging, use of existing landings, heavy equipment traveling on and off roads, felling of trees, limbing trees, skidding of trees to landings, piling of logging slash by machine or hand, and burning slash piles. Ground disturbance from all of these activities can impact Leona's little blue butterfly habitat through trampling of host and nectar plants thus making them a less viable resource for Leona's little blue butterfly. Similarly, timber management activities that utilize heavy machinery can affect all life stages of individual Leona's little blue butterfly through crushing of eggs, larvae, pupae, and adults. Activities that result in clearing of suitable habitat (e.g., creation of new roads and landings) have a greater potential impact since host and nectar plants are no longer available for use by Leona's little blue butterfly until plants regenerate during the following growing season. However, timber management activities can also be beneficial to Leona's little blue butterfly and its habitat. The removal of trees and ground disturbance provides conditions suitable to colonization by spurry buckwheat.

    Spurry buckwheat is a colonizer plant species and is capable of rapidly inhabiting open areas resulting from timber management that may not have been previously available to Leona's little blue butterfly. As spurry buckwheat and nectar plants become abundant in the open areas, the habitat becomes suitable for Leona's little blue butterfly. Additionally, the removal of trees and logging slash reduces the overall potential risk of wildfire and limits the potential intensity, severity, and rate of spread of wildfire (see Fire discussion below). This stressor has occurred in the past and will occur in the near- and long-term future. See Timber Management section in the Species Report (Service 2015, pp. 20-23) for additional discussion of this stressor.

    As a result, we have determined that timber management acts as a low-level stressor on Leona's little blue butterfly and its habitat because impacts are more likely to affect forested areas that are not suitable habitat and are not occupied by Leona's little blue butterfly. Impacts to existing open areas containing butterflies would be localized and affect few individuals. Beneficial effects from timber management promote the development of new habitat and maintenance of existing habitat. The limited scope and low severity of the stressor suggest that this is not a considerable source of loss of individuals or habitat. Rather, the longer term benefits from timber management promote continued occupancy and habitat for Leona's little blue butterfly. As a result, we have determined that the impacts from timber management do not rise to the level of a threat.

    Lodgepole Pine (Pinus contorta) Encroachment

    Leona's little blue butterflies occupy open habitat areas that are treeless or sparsely treed. In some cases, natural openings are being encroached by lodgepole pine. Encroachment is different from the natural regeneration of previously forested areas. Encroachment occurs when lodgepole pine, for example, gradually expands into open areas where it was previously absent. Natural regeneration occurs when areas that were harvested become forested again through the gradual sprouting of seeds and growth of seedlings over time. Encroachment and natural regeneration may result in the gradual conversion of these open habitat areas to forested habitats.

    Lodgepole pine encroachment is believed to have reduced the extent of openings in areas occupied by Leona's little blue butterfly (Johnson 2010, p. 6). However, other researchers note that “only a small number of trees” have become established in meadows (Hatcher 2014a, p. 3). Despite the documented presence of lodgepole pine and its encroachment or natural regeneration into occupied Leona's little blue butterfly habitat, there are large openings that appear to have never supported lodgepole pine (Ross and Johnson 2012, p. 2; Johnson 2014e, pers. comm.). This may be due to the deep soils that are present within the Sand Creek Basin. Tilden (1963, p. 111) suggests that the recovery of vegetation since the eruption of Mt. Mazama appears to be inversely related to the depth of the pumice. See Lodgepole Pine (Pinus contorta ) Encroachment section in the Species Report (Service 2015, pp. 23-26) for additional discussion of this stressor.

    Lodgepole pine encroachment and natural regeneration is an ongoing stressor affecting the area occupied by Leona's little blue butterfly. The rate of encroachment and regeneration within the range of the butterfly is not known; however, other areas near Sand Creek have shown that the overall amount of encroachment and regeneration of lodgepole pine is increasing (Horn 2009, pp. 200-204). For example, in the Pumice Desert, (a broad flat area north of Crater Lake, Oregon, that is somewhat similar to the Sand Creek area), lodgepole pine encroachment increased threefold over a period of 40 years and was greater near the forest edge (Horn 2009, pp. 200-204). In the Sand Creek area, lodgepole pine encroachment is believed to have reduced the extent of openings in areas occupied by Leona's little blue butterfly (Johnson 2010, p. 6). However, encroachment is absent in areas that appear to lack suitable conditions for lodgepole pine establishment (Cochran 1973, pp. 3-5; Lotan and Critchfield 1990, pp. 307-309), and based on aerial imagery, our review has found openings that were present in 1995 were still present in 2012. Past and current actions on private timber lands and on the Fremont-Winema National Forest are limiting the encroachment and natural regeneration of lodgepole pine in some areas occupied by Leona's little blue butterfly (USFS 2014, p. 2). Land management practices that result in the removal of lodgepole pine by private timber companies and the U.S. Forest Service are expected to maintain and enhance some open patches through expansion of their perimeters.

    Based on this information, we have determined that the effects from lodgepole pine encroachment and natural regeneration are moderate in areas where this is occurring because lodgepole pine has the ability to render as unsuitable the open habitats used by Leona's little blue butterfly. However, large open areas are present that do not show signs of lodgepole pine encroachment; this may be related to the depth of the pumice, which may act as a natural inhibitor to encroachment by lodgepole pine. In addition, only a small number of trees have become established in meadows. Despite the documented presence of lodgepole pine and its encroachment or natural regeneration into occupied Leona's little blue butterfly habitat, there are large openings that appear to have never supported lodgepole pine. As a result, we have determined that the level of encroachment of lodgepole pine into Leona's little blue butterfly habitat under current natural and managed conditions is not a significant concern and does not rise to the level of a threat now or into the future.

    Fire

    There are two types of fires that may impact Leona's little blue butterfly: wildfire and prescribed fire. Wildfires are unplanned and started by natural events (i.e., lightning) or non-natural sources (e.g., arson, machinery, power lines, etc.). Prescribed fires are burn operations that follow a prescription dictating proper fuel and weather conditions that allow for control of fire severity, intensity, and rate of spread per stated management objectives. Prescribed fire can occur in many forms, ranging from burning material piled after timber harvest to broadcast burning in which large areas are burned over a series of days.

    Both types of fire can result in the loss of Leona's little blue butterfly host and nectar plants, but can also create new openings if a fire burns through dense brush or at high severity through dense forest-stands. Fire may completely consume stands of trees or it may creep around in the understory; fire behavior is dependent upon weather conditions and fuel loading. Extreme weather conditions including high temperature, high wind-speed, and low relative-humidity can result in rapid rates of fire spread at higher intensity and severity than would be expected under more normal weather conditions. Areas with light fuel loads are not expected to burn at the same intensity or severity as those with higher fuel loads. Soils within the range of Leona's little blue butterfly are pumice-based and have low productivity for sustaining fire (Dunn 2011a, p. 9). Because of the low productivity, the types of vegetation that grow in the Sand Creek and Scott Creek area (Volland 1988, p. 38) are not the kinds that will carry fire very far (low leaf litter, very little if any duff layer, no or very few ladder fuels) (Simpson 2007, p. 9-5; Dunn 2011a, p. 9). See Fire section in the Species Report (Service 2015, pp. 26-30) for additional discussion of this stressor.

    The forested stands within Leona's little blue butterfly habitat area are at greater risk of high-intensity and severe fires than the more open areas occupied by Leona's little blue butterfly (Blackwell 2006, p. 236; Dunn 2011b p. 12). However, past fires have been small in size, and the presence of fire suppression crews at nearby Sand Creek Guard Station suggest that, while there is risk of fire in Leona's little blue butterfly habitat, the impacts of fire are not expected to encompass large areas or be widespread. The condition of the standing and ground fuels are mixed, and some areas would not be able to carry fire, further increasing the likelihood that if a large fire were to occur, it would burn in a mosaic pattern and open areas could continue to support Leona's little blue butterfly and its habitat. Beneficial effects from wildfire and prescribed fire promote the development of new habitat and maintenance of existing habitat for Leona's little blue butterfly. For example, Dunn (2011a, p. 9) found that fires occurring during the spurry buckwheat growing season (June through August) could result in an initial reduction in plants immediately following fire, but 2 to 3 years later, spurry buckwheat is likely to increase in the fire-affected areas. Fire can result in brush clearing that reduces competition for Leona's little blue butterfly host and nectar plants (Dunn 2011a, p. 9). James et al. (2014, p. 270) provided an anecdotal observation that spurry buckwheat thrives in the footprints of burned slash piles, and Huntzinger (2003, p. 9) found that Leona's little blue butterflies were more frequent in areas that were prescribe-burned, possibly due to increased sunlight.

    Based on this information, we have determined that fire acts as a low-level stressor on Leona's little blue butterfly and its habitat. The low severity of the stressor suggests that, even though this stressor may occur range-wide, this stressor is not a considerable source of loss of individuals or habitat. Additionally, fire benefits the butterfly by creating and maintaining habitat. As a result, we have determined that the impacts from controlled and wildfire on Leona's little blue butterfly habitat under current natural and managed conditions and in the future are not a significant concern individually or in combination and do not rise to the level of a threat.

    Fire Suppression

    The intent of fire suppression is to extinguish fires quickly. Fire suppression, in turn, interrupts historic fire return intervals by not allowing fires to burn to the extent and degree as they may have in the past and changes the habitat from its expected, natural condition (Crawford 2011, p. 3). Suppression allows for vegetation to become denser and more susceptible to disease, and conifer encroachment to occur over time. Fire suppression, consequently, can lead to loss of open areas and also to larger fires. Ground disturbing activities arising from fire suppression efforts have the ability to impact Leona's little blue butterfly habitat and individuals. These activities may include creation of fire lines (areas cleared of vegetation intended to prevent spread of fire) by hand or machinery and vehicle travel on and off roads. Creation of fire lines involves digging down to mineral soil, which may remove host and nectar plants and disrupt the life cycle of Leona's little blue butterfly. Other actions associated with the creation of fire lines include the felling of trees and/or limbing of trees to reduce ladder fuels (e.g. tall shrubs, small-sized trees, dead branches that provide vertical continuity between strata, thereby allowing fire to carry from surface fuels into the crowns of trees or shrubs). Felling and limbing of trees are likely to result in more open areas and more open forest canopy, which can provide new areas for host and nectar plants to colonize. In addition, when machinery is moved from one area to another, there is the potential for the spread of invasive plants. The stressor of Invasive Plants to Leona's little blue butterfly is discussed below.

    The use of fire retardant to suppress fire is also a concern for Leona's little blue butterfly and its habitat. Fire retardant coats and adheres to vegetation, which slows the progression of fires. Any fire retardant exposure is likely to be lethal to Leona's little blue butterfly life forms that are above ground due to its inherent stickiness, which would severely restrict movement and could also result in suffocation (USFS 2011, p. 179). No data are available regarding the toxicity of fire retardant to larvae of invertebrates (USFS 2011, p. 179). Leona's little blue butterfly in the pupa stage may or may not be exposed to fire retardant dependent upon whether they are at or below ground level. Fire retardant would also potentially result in the killing of host and nectar plants if photosynthesis were inhibited; similarly, flowers coated in retardant would not be available for nectaring. Fire retardant may also act as a fertilizer, increasing plant growth of both native and non-native species. The U.S. Forest Service (USFS) uses mapped buffers to avoid the aerial application of fire retardant in waterways and habitats occupied by some, but not all, threatened or endangered species or those proposed for listing under the Act (USFS 2011, p. 3). These mapped avoidance area buffers occur only on National Forest lands. There are no mapped avoidance buffer areas within the range of Leona's little blue butterfly.

    See Fire Suppression in the Species Report (Service 2015, pp. 32-33) for additional discussion of this stressor.

    Fire suppression activities can have positive and negative impacts to Leona's little blue butterfly and its habitat. Habitat and individuals can be destroyed by suppression that removes habitat. Ground disturbance and tree felling can improve habitat for Leona's little blue butterfly. Suppression can result in densely stocked forests, accumulation of fuels, and conifer encroachment in open areas, which can result in impacts to Leona's little blue butterfly from encroachment and fire that are described above. Fire suppression may act as a low-level stressor on Leona's little blue butterfly and its habitat. The low severity of the stressor suggests that, even though this stressor may occur range-wide, it is not a considerable source of loss of individuals or habitat. Beneficial effects from ground disturbance and tree felling will promote colonization of spurry buckwheat, which will create or enhance habitat for Leona's little blue butterfly. As a result, we have determined that the impacts from fire suppression on Leona's little blue butterfly habitat under current natural and managed conditions and in the future is not a significant concern and does not rise to the level of a threat.

    Right-of-Way Maintenance

    Several rights-of-way occur within the range of Leona's little blue butterfly. The rights-of-way are maintained by Bonneville Power Administration (BPA), TransCanada (Pacific Gas Transmission Company), Oregon Department of Transportation (ODOT), Klamath County, and American Tower Corporation (Johnson 2014e, pers. comm.).

    Maintenance of power line and roadway rights-of-way results in the reduction of woody plants and encourages early successional plants (Forrester et al. 2005, p. 489). As a result, the maintenance of rights-of-way may also be beneficial to Leona's little blue butterfly and its habitat because it maintains open areas that are preferred by host and nectar plants. Power line rights-of-way can also be important butterfly habitat and have been correlated with higher butterfly abundance when compared to semi-natural grasslands (pastures) (Berg et al. 2013, pp. 644, 646).

    Habitat loss and potential direct impacts on Leona's little blue butterfly can also be a concern. Vehicles and equipment traveling off roads are assumed to trample host and nectar plants used by Leona's little blue butterfly. Trampling results in loss of habitat for eggs and larvae and a loss of potential nectar sources for Leona's little blue butterfly. Similar effects are expected from the removal or cutting of vegetation. If activities occur during the flight period, adult Leona's little blue butterfly may be killed by vehicles directly.

    The use of biological control agents is not expected to occur within the range of Leona's little blue butterfly. Biological control agents are used only to treat noxious weeds (BPA 2000, p. 3) and are regulated by the Oregon Department of Agriculture (ODOT 2013, pp. 7-8). Noxious weeds have not been documented within the range of Leona's little blue butterfly (Johnson 2011, p. 9).

    Herbicide application may result in changes to plant distribution and abundance. Information is not available to determine the frequency or area impacted by herbicide application within the rights-of-way. ODOT does recommend herbicide application during certain periods. Please see the Herbicide section below for more information on how herbicides may act as a stressor on Leona's little blue butterfly. See Right-of-Way Maintenance section in the Species Report (Service 2015, pp. 34-36) for additional discussion of this stressor.

    Right-of-way maintenance may act as a low-level stressor on Leona's little blue butterfly and its habitat. The limited scope and low severity of the stressor indicate that this is not a considerable source of loss of individuals or habitat, because this stressor is limited to rights-of-way that occur within the Leona's little blue butterfly range and the maintenance of rights-of-way retains open areas beneficial for the species' habitat. As a result, we have determined that the impacts from maintenance of rights-of-way on Leona's little blue butterfly habitat under current natural and managed conditions are not a significant concern and this activity does not rise to the level of a threat.

    Cinder Mining

    Cinder mining activities including exploration, drilling, and expansion of existing sites could remove habitat for Leona's little blue butterfly and may result in mortality of individuals. Mortality of individuals may result from trampling by vehicles or equipment. See Cinder Mining section in the Species Report (Service 2015, p. 37) for additional discussion of this stressor.

    Cinder mines are not currently present within areas occupied by Leona's little blue butterfly. If cinder mining were to occur, it could impact habitat and individuals. The potential for future cinder mines to impact habitat and individuals would be on small, localized scales. Information other than that provided by the petitioner is not available to assess the potential area of impact. Future cinder mining is not planned by the Fremont-Winema National Forest, and no information about plans for future cinder mines is available for private lands. Cinder mining is not currently a stressor acting on Leona's little blue butterfly and its habitat. Cinder mining is not presently affecting the species, and the small, potential scope and low potential severity of the stressor suggest that cinder mining is not expected to be a significant cause of loss of individuals or habitat in the future. As a result, we have determined that the impacts from cinder mining activities on Leona's little blue butterfly habitat under current natural and managed conditions is not a significant concern and does not rise to the level of a threat now or into the future.

    Livestock Grazing

    Livestock grazing can impact both Leona's little blue butterfly habitat and individuals. Habitat effects are through potential shifts in vegetation community (i.e., selective preference of livestock for some plant species over others), consumption of host and nectar plants, and trampling of vegetation (which reduces the potential for flowers to provide nectar). Eggs and larvae may be consumed if spurry buckwheat is consumed. Spurry buckwheat grows in a very open, small-stemmed shape, giving it a very wispy look (Blackwell 2006, p. 236) that is not likely to be favored as a food source for livestock. Other plants in the occupied habitat area have more robust growth forms with dense foliage that could provide better nutritive value, if only based on the sheer volume of material to eat. Adult Leona's little blue butterfly are expected to fly away if livestock approach and, therefore, are not expected to be consumed by livestock. Nectar plants are likely to be eaten by livestock and could result in a reduction of food for adult Leona's little blue butterfly. Grazing, were it to occur, may also result in beneficial effects to the extent that grazing may result in reduced competition for host and nectar plants by creating or maintaining openings.

    There are no grazing allotments on the Fremont-Winema National Forest portion of the occupied habitat; therefore, Leona's little blue butterfly are not affected by livestock grazing in that area. Information is not available on whether livestock grazing is permitted on private lands in the remainder of the occupied habitat area. Livestock use of lands now owned by Whitefish was not observed during fieldwork conducted in 2010 and 2011 (Johnson 2014b, pers. comm.) See Livestock Grazing section in the Species Report (Service 2015, pp. 37-39) for additional discussion of this stressor.

    Livestock grazing of vegetation may benefit Leona's little blue butterfly by reducing competition for host and nectar plants, thus providing more abundant host and nectar plants for the species. Although livestock grazing could have moderately severe impacts on habitat for Leona's little blue butterfly, it does not appear to be a stressor that is acting on the species or its habitat presently. Because this activity is not occurring and is not expected to occur (based on past land use) within the range of Leona's little blue butterfly, this is not a considerable source of loss of individuals or habitat despite a potential moderate severity should land use activities change in the future. As a result, we have determined that the impacts from livestock grazing on Leona's little blue butterfly habitat under current natural and managed conditions is not a significant concern now or in the future and does not rise to the level of a threat.

    Herbivory from Native Animals

    The entire range of Leona's little blue butterfly habitat has the potential to be impacted by herbivory from native animals with few exceptions. Native animals, such as deer and rabbits, may forage on plants that are used by Leona's little blue butterfly as a larval host plant or for nectar. Deer are known to favor bitterbrush, which occurs in Leona's little blue butterfly habitat. Bitterbrush has not been documented as a known nectar plant for Leona's little blue butterfly (Johnson 2011, p. 9). Spurry buckwheat grows in a very open, small-stemmed shape giving it a very wispy shape that is not likely to be a favored food source for herbivores (Blackwell 2006, p. 236). Other plants in the occupied habitat have more robust growth forms with dense foliage that could provide better nutritive value, if only based on the sheer volume of material to eat. Leona's little blue butterfly eggs and larvae are not expected to be consumed by native animals unless spurry buckwheat is consumed incidentally with other vegetation. Adult Leona's little blue butterfly are likely to flee approaching animals and are not expected to be eaten by herbivores.

    Herbivory is a natural condition in which animals and Leona's little blue butterfly have evolved. Herbivory from native animals is most likely to impact Leona's little blue butterfly nectar plants, with a very small potential for impacts to Leona's little blue butterfly eggs, larvae, and host plants. There is no information available that indicates herbivory is adversely impacting Leona's little blue butterfly or its habitat and to what degree. However, if herbivory is occurring, it is occurring at very low levels that are not expected to reduce adult Leona's little blue butterfly fitness because the butterflies are able to utilize a variety of plants for nectaring and because herbivory would likely not focus on the species' host plant. In addition, Leona's little blue butterfly has evolved with this stressor and there is no information to suggest that the pressure from herbivory has changed. See Herbivory from Native Animals section in the Species Report (Service 2015, pp. 39-40) for additional discussion of this stressor.

    The low severity and natural condition of the stressor indicates that, even though this stressor may occur range-wide, it is not a considerable source of loss of individuals or habitat. As a result, we have determined that the impacts from herbivory from native animals on Leona's little blue butterfly habitat under current and future conditions is not a significant concern and does not rise to the level of a threat.

    Invasive Plants

    Within the range of Leona's little blue butterfly, Bromus tectorum (cheatgrass) is the only known invasive species. Cheatgrass germinates in the fall in arid portions of the Great Basin (Young et al. 1987, p. 266), but may germinate in the spring if fall moisture is not sufficient (Stewart and Hull 1949, p. 58). Invasive or nonnative plants, such as cheatgrass can outcompete native plants for resources. Competition with nonnative plants can result in reduced native plant vigor and distribution. This, in turn, can reduce growth and abundance of host and nectar plants used by Leona's little blue butterfly. Over time, the distribution and abundance of invasive plants may alter the species composition within Leona's little blue butterfly habitat. Changes to species composition may result in starvation of larvae and adults if they are not able to find adequate sources for oviposition and nectar.

    Invasive plants are not known to occur in the Fremont-Winema National Forest portion of the Leona's little blue butterfly range (USFS 2014, p. 4). Surveys of the vegetation community of Sand and Scott Creeks were conducted to determine plant species presence (Johnson 2011, p. 9). Cheatgrass, an invasive plant, is known to occur within the Whitefish portion of the Leona's little blue butterfly range (Johnson 2012, pers. comm.). Cheatgrass occurrences within the range of Leona's little blue butterfly have not been mapped, but these occurrences are not widespread (Johnson 2014c, pers. comm.).

    Based on the information above, we have determined that the severity of invasive plants acting as a stressor on Leona's little blue butterfly and its habitat is low. The severity is low because, while cheatgrass is present, there is no information to suggest that cheatgrass has overrun suitable habitat for Leona's little blue butterfly, nor has it contributed to spread of fire. As a result, the impact of invasive plants is low and does not rise to the level of a threat.

    Combination of Stressors Under Factor A: As discussed above, we have determined that the above identified stressors individually are not acting on Leona's little blue butterfly or its habitat to the extent that they would be considered threats. We now also determine that these stressors collectively or cumulatively do not rise to the level of a threat. See the Cumulative, Synergistic, and Beneficial Effects section below for additional discussion.

    Factor B. Overutilization for Commercial, Recreational, Scientific, or Educational Purposes

    Based on the best available scientific and commercial information, insect collection for commercial, recreational, scientific, or educational purposes is the only known stressor under Factor B and is discussed below.

    Insect Collection

    There is potential for insect collection within the range of Leona's little blue butterfly. The Sand Creek area has been a popular location for insect collection over the last half-century (Ross and Johnson 2012, p. 9). The area is popular because it supports a unique assemblage of rare invertebrate species. However, there is no information regarding which species may be favored by collectors, and there is no available information regarding unauthorized insect collection within the range of Leona's little blue butterfly. Leona's little blue butterfly is similar in appearance to two other species in the Sand Creek area—the glaucon blue butterfly (Euphilotes glaucon) and the lupine blue butterfly (Plebejus lupini). It is not known if these similar-appearing species are sought for collection in the range of Leona's little blue butterfly. Some collection for scientific research on Leona's little blue butterfly has been conducted within the range of the species in the past and at least 579 adult Leona's little blue butterflies, seven eggs, and one fourth instar larva have been collected since 1996. See Insect Collection section in the Species Report (Service 2015, pp. 43-45) for additional discussion of this stressor.

    However, permission is needed to collect butterflies for non-recreational or commercial purposes on lands owned by Fremont-Winema National Forest. Ongoing collection is currently limited by a lack of accessibility to the private timber lands (Lidell 2012, pers. comm.) and permissions required by the Fremont-Winema National Forest (Callaghan 2014, pers. comm.). We are not aware of unauthorized insect collection within the range of Leona's little blue butterfly. We have no information to indicate that collection of insects on other small private lands (likely associated with residences) is allowed, but even if such collection occurs, it is unlikely it would result in collections of large numbers of individuals. All known collections for Leona's little blue butterfly have been limited in scope and associated with a specific purpose (description of species, life history study, mark-release-capture study), and we would not expect two of the studies (description of species, life-history study) to be repeated (Hammond and McCorkle 1999, p. 77; Ross 2009, p. 1; James 2012, p. 93; James et al. 2014, pp. 264, 269). The lack of public access to lands in the majority of the species' range will most likely continue into the future. The lack of access to private lands and permitting requirements by the USFS limits the impact of collection on the species.

    Even though collection may occur range-wide, this stressor has not been shown to be a great source of loss of individuals. This is based on the limited extent of collection for research purposes, no known commercial or recreational collection, and lack of permitted access to a majority of the species' range. As a result, the best available scientific and commercial information indicates that this level of collection is not a current or expected future threat to Leona's little blue butterfly.

    Because collection is the only known commercial, recreational, scientific, or educational use of Leona's little blue butterfly, we have determined, based on the information above that there are no stressors under Factor B that are now or are likely in the near future to rise to the level of a threat.

    Factor C. Disease or Predation Disease

    Butterflies are susceptible to infections from parasites, viruses, bacteria, and fungi as part of the natural conditions in which they have evolved (Davis and Lawrence 2006, p. 1; Altizer and de Roode 2010, p. 18). Viruses and bacteria can be common in butterfly larvae, which ingest capsules or spores incidentally (Davis and Lawrence 2006, p. 1; Altizer and de Roode 2010, p. 20). Fungi can grow on the outside or inside of infected caterpillars, ultimately killing the caterpillar (Altizer and de Roode 2010, p. 21). Symptoms of disease include changes in color, size, shape, and movement (Davis and Lawrence 2006, p. 2). Specific investigations into disease have not been conducted for Leona's little blue butterfly; however, exposure to disease and disease vectors is part of the natural conditions in which Leona's little blue butterfly likely evolved. There is no information on diseases affecting Leona's little blue butterfly from wild or captive-reared individuals (Ross and Johnson 2012, pp. 27, 42-46. See Disease section in the Species Report (Service 2015, pp. 47-48) for additional discussion of this stressor.

    The low severity and natural condition of the stressor suggests that even though disease may occur range-wide, we have no information that indicates losses of individuals are occurring from this potential stressor. As a result, the best available scientific and commercial information indicates that this level of disease is not a current or expected future threat to Leona's little blue butterfly.

    Predation

    We assume that Leona's little blue butterfly and its predators evolved together. Limited information exists on actual predation events of Leona's little blue butterfly. If it occurs, predation on Leona's little blue butterfly could result in reduced numbers of eggs, larvae, and adults. A study conducted in 2011 identified hornets (Vespidae), dragonflies (Odanata), damselflies (Odanata), robberflies (Asilidae), stiltbugs (Berytidae), and spiders (Arachnid) as potential predators of Leona's little blue butterfly (Ross and Johnson 2012, pp. 16-17). The authors of the study concluded that predators are relatively rare within the range of Leona's little blue butterfly. The Asian lady beetle (Harmonia axyridis), suggested as a predator of Leona's little blue butterfly by the Xerces Society for Invertebrate Conservation (Matheson et al. 2010, p. 16), is not known to occur within the range of Leona's little blue butterfly (Ross and Johnson 2012, pp. 33-48). Leona's little blue butterfly lay eggs on or very near flower buds and do not attempt to hide them (e.g., laying on underside of leaves). This behavior suggests that there may be a low relative risk of predation on eggs (Henry and Schultz 2013, p. 190). However, Leona's little blue butterfly larva are typically pink and white, which blends in with the colors of the host plant and may provide camouflage from predators. James et al. (2014, pp. 271-272) suggest that Leona's little blue butterfly mortality from predation is likely very low, as this was not observed during a 3-year study. See Predation section in the Species Report (Service 2015, pp. 46-47) for additional discussion of this stressor.

    Predation can reduce overall abundance of Leona's little blue butterfly. While potential predators are present when Leona's little blue butterfly are active, predation has not been observed. Similarly, pressure from predation is likely one that Leona's little blue butterfly evolved with and to which it has adapted. Predation may be a low-level stressor acting on Leona's little blue butterfly. The low severity and natural condition of the stressor suggests that, even though predation may occur range-wide, this stressor is unlikely to be a considerable source of loss of individuals. As a result, the best available scientific and commercial information indicates that this level of predation is not a current or expected future threat to Leona's little blue butterfly.

    Combination of Stressors Under Factor C: As discussed above, we have determined that disease and predation individually are not acting on Leona's little blue butterfly to the extent that they would be considered threats. Based on the limited known instances of disease or predation, we also determine that disease or predation collectively or cumulatively do not rise to the level of a threat. See the Cumulative, Synergistic, and Beneficial Effects section below for additional discussion.

    Factor D. The Inadequacy of Existing Regulatory Mechanisms

    The Act requires that the Secretary assess available regulatory mechanisms in order to determine whether existing regulatory mechanisms may be inadequate as designed to address threats to the species being evaluated (Factor D). Under this factor, we examine whether existing regulatory mechanisms are inadequate to address the potential threats to Leona's little blue butterfly discussed under other factors. We consider relevant Federal, State, and tribal laws and regulations when evaluating the status of a species. Regulatory mechanisms, if they exist, may preclude the need for listing if we determine that such mechanisms adequately address the threats to the species such that listing is not warranted. Only existing ordinances, regulations, and laws that have a direct connection to a stressor are applicable. Under this factor, we analyze statutes and their implementing regulations, and management direction that stems from those laws and regulations. Such laws and regulations are nondiscretionary and enforceable, and are considered a regulatory mechanism under this analysis. Examples include State government actions enforced under a State statute or constitution, or Federal action under statute. We do not consider the lack of any regulatory mechanisms addressing a specific threat that we identified under one of the other factors as a rationale to conclude that the existing regulatory mechanisms are inadequate for a species under Factor D.

    The Species Report includes a discussion of regulatory mechanisms applicable to Leona's little blue butterfly. In the Species Report (Service 2015, pp. 71-72), we examine the applicable Federal, State, and other statutory and regulatory mechanisms to determine whether these mechanisms are operating as designed to provide conservation for Leona's little blue butterfly or its habitat.

    Federal Regulatory Mechanisms: There are no Federal regulatory mechanisms in place that are specifically designed to ameliorate or reduce stressors on Leona's little blue butterfly or its habitat. However, Leona's little blue butterfly was added to the USFS Region 6 list of Sensitive Species on December 1, 2011 (USFS 2014, p. 1). With this status, Leona's little blue butterfly is required to be considered in USFS Region 6 biological evaluations when proposed projects have the potential to affect the species or its habitat. The objective of this status is to avoid project impacts that result in a loss of viability or contribute toward trends for listing under the Act (USFS and Bureau of Land Management (BLM) 2002, pp. 2, 4). According to USFS Forest Service Manual (FSM) 2670, “[t]here must be no impacts to sensitive species without an analysis of the significance of adverse effects on the populations, its habitat, and on the viability of the species as a whole. It is essential to establish population viability objectives when making decisions that would significantly reduce sensitive species numbers.” The loss of population viability is a concern, when evidenced by either a significant current or predicted downward trend in population numbers or density; or a significant current or predicted downward trend in habitat capability that would reduce a species' existing distribution. Proposed activities that occur within the Fremont-Winema National Forest portion of Leona's little blue butterfly range will include measures to avoid or minimize project-related impacts to Leona's little blue butterfly and its habitat. This status as a sensitive species will continue regardless of Federal listing status under the Act.

    State Regulatory Mechanisms: Oregon State agencies do not have responsibilities for the conservation of invertebrates. The Oregon State Endangered Species Act also does not include protections for invertebrates. Scientific taking permits are required only for birds, mammals, amphibians, and reptiles in the State of Oregon.

    The State of Oregon through the Oregon Department of Agriculture is responsible for pesticide use and application. The Oregon Department of Agriculture helps protect endangered and threatened species in a number of ways including helping educate pesticide users on current application standards and pesticide label language designed to protect waterways, endangered fish and aquatic organisms, plants, insects, and animal species, and critical habitats and makes referrals to wildlife agencies or other agencies in the case of an incident. These standards for application and use of pesticides would benefit Leona's little blue butterfly and its habitat as they are designed to limit impacts to nontarget species and curtail drift of pesticide during application. See Pesticides discussion below or Pesticides section in the Species Report (Service 2015, pp. 48-50) for additional discussion of this stressor.

    The Oregon Biodiversity Information Center (ORBIC) is the State agency responsible for tracking rare invertebrates in Oregon. The Oregon Natural Areas Program has limited authority to assist in the conservation of Oregon's invertebrate species, and via Section 6 of the Endangered Species Act they can receive funding from the U.S. Fish and Wildlife Service to help conserve listed and candidate species. This cooperation between the Oregon Natural Areas Program and the U.S. Fish and Wildlife Service provides opportunities to gather information that can be used to help understand and conserve invertebrates in Oregon (Oregon Biodiversity Information Center 2013, p. 6). The 2013 book of Rare, Threatened, and Endangered Species of Oregon identifies and categorizes species (including Leona's little blue butterfly) into several levels of regulatory or conservation status based on various factors (e.g., Federal or State listed, NatureServe/Natural Heritage ranking, ORBIC list) (Oregon Biodiversity Information Center 2013, entire).

    The ORBIC list identifies species on a scale of 1 to 4 with 1 having the most conservation concern (Oregon Biodiversity Information Center 2013, p. 4). Leona's little blue butterfly has an ORBIC list value of 1. ORBIC list 1 species are defined as those “taxa that are threatened with extinction or presumed to be extinct throughout their entire range” (Oregon Biodiversity Information Center 2013, pp. 4, 32). The NatureServe/Natural Heritage ranking is divided into five categories (identified as 1 again having the most conservation concern) on both a Statewide (S) and global (G) scale. Leona's little blue butterfly is considered an S1, G1 species with “1” defined as species that are “[c]ritically imperiled because of extreme rarity or because it is somehow especially vulnerable to extinction or extirpation, typically with 5 or fewer occurrences” (Oregon Biodiversity Information Center 2013, pp. 5, 32). However, the document further explains that the compilation of information on invertebrates has been difficult due to the acknowledgement that “[l]ittle is known about the status and distribution of most invertebrate taxa found in Oregon, especially those which appear to be rare, threatened or otherwise vulnerable.” The document then further qualifies its rankings by stating that “[a]s a result state ranks may not accurately reflect the true population status for some species” (Oregon Biodiversity Information Center 2013, p. 6).

    Summary of the Inadequacy of Existing Regulatory Mechanisms: We have assessed the available regulatory mechanisms in order to determine whether any are inadequate as designed to address threats to Leona's little blue butterfly. The only mechanism in place is the designation of Leona's little blue butterfly as sensitive species by the USFS which requires that USFS consider any impacts to the species or its habitat in their biological evaluations of potential projects. The objective of this status is to avoid project impacts that result in a loss of viability or contribute toward trends for listing under the Act. In the only project currently proposed for the area occupied by Leona's little blue butterfly on the Fremont-Winema National Forest, the USFS has initiated a habitat improvement project for the species that will implement conservation measures specific to the butterfly. No other Federal regulatory mechanisms specifically apply to the management and/or protection of Leona's little blue butterfly or its habitat. There are no State or private regulatory mechanisms that specifically apply to the management and/or protection of Leona's little blue butterfly or its habitat. Based on the information contained within the Species Report and outlined above on the existing regulatory mechanisms for Leona's little blue butterfly, we conclude that the best available scientific and commercial information does not indicate that the existing regulatory mechanisms are inadequate as designed to address impacts to the species or its habitat.

    Factor E. Other Natural or Manmade Factors Affecting Its Continued Existence

    For ease of discussion, the impacts to individual Leona's little blue butterfly from habitat disturbance activities are discussed under Factor A. For a complete discussion of potential impacts to both habitat and individuals from these activities, see our Factor A discussion, above.

    Competition with Other Invertebrates

    Limited information exists on potential competitive interactions between Leona's little blue butterfly and other species that occur within its range. A study conducted in 2011 identified 37 species of butterflies and 159 species of moths as potential competitors for nectar (Ross and Johnson 2012, p. 8). Competition between species is considered to be a natural condition under which Leona's little blue butterfly evolved. Competitors are relatively abundant in the Leona's little blue butterfly range (Ross and Johnson 2012, p. 24). There is no information to suggest that populations of competitors have increased. The only insect identified using spurry buckwheat as an herbivore is the stiltbug, which uses piercing mouthparts to suck nutrients from plants (Ross and Johnson 2012, pp. 17, 41).

    Competition with other invertebrates may be a low-level stressor acting on Leona's little blue butterfly. The severity is low because Leona's little blue butterfly evolved with competitors, utilizes a wide variety of nectar plants, and is reasonably expected to be able to find food resources when competitors are present. Similarly, the host plant is not known to be used as a larval host plant by other species within the range of the Leona's little blue butterfly. See Competition with Other Invertebrates section in the Species Report (Service 2015, pp. 45-46) for additional discussion of this stressor.

    The low severity and the natural condition of the stressor indicate that, even though competition may occur range-wide, this stressor is not a considerable source of loss of individuals. As a result, the best available scientific and commercial information does not indicate that competition with other invertebrates is now, or will be in the future, a threat to Leona's little blue butterfly.

    Pesticides

    Pesticides may be acting as a low-level stressor on Leona's little blue butterfly. Pesticides are a potential stressor to Leona's little blue butterfly and its habitat, but exposure to pesticides is only likely from sources outside the range of the species; further, the forested habitat surrounding Leona's little blue butterfly habitat forms a barrier to wind and potential pesticide drift into these areas. In addition, the Oregon Department of Agriculture oversees the implementation of the Oregon State Pesticide Control Act for the proper application and use of pesticides (Legislative Counsel Committee 2014, Chapter 634). The Oregon Department of Agriculture is also responsible for ensuring that sensitive species and their environments are protected from improper pesticide use and application through education and reporting (Oregon Department of Agriculture 2015, entire). The proper application and use of pesticides according to the Oregon Department of Agriculture guidelines will limit potential exposure of pesticides to nontarget species and their habitat, including Leona's little blue butterfly. The Fremont-Winema National Forest does not use pesticides in the area occupied by Leona's little blue butterfly and the Animal and Plant Health Inspection Service (APHIS) is not expected to implement grasshopper control on rangelands in the range of the species. The Service's Klamath Marsh National Wildlife Refuge, located 3 mi (4.8 km) east of occupied Leona's little blue butterfly habitat, has used pesticides for grasshopper control (Service 2010b, p. 68). However, drift is unlikely due to the prevailing winds occurring from west to east, and Service personnel follow standard application and use restrictions for drift. See Pesticides section in the Species Report (Service 2015, pp. 48-50) for additional discussion of this stressor.

    As a result, the best available scientific and commercial information does not indicate that pesticide use and application is a threat to Leona's little blue butterfly or its habitat now or in the future.

    Stressors on Isolated Populations

    Leona's little blue butterfly is an endemic species known from one geographic area. Because Leona's little blue butterfly is known from only this one location, the population is confined, or isolated, by the elements that compose suitable habitat. Isolated populations of species with specific habitat requirements may be more vulnerable to effects from disease, inbreeding, and habitat loss because individuals are not replaced through immigration from other populations and are not always able to occupy new areas. Thus isolated populations may be less able to recover from widespread loss of individuals and habitat. Because Leona's little blue butterfly is known from only one population, it may be more susceptible to events related to inbreeding or stochastic events such as drought or catastrophic fire. See Stressors on Isolated Populations in the Species Report (Service 2015, pp. 50-55) for additional discussion of this stressor.

    Stochastic events. Stochastic events (e.g., drought and catastrophic fire) as identified by the petitioner (Matheson et al. 2010, p. 17), may act as a stressor on Leona's little blue butterfly. Leona's little blue butterfly is currently known from one population. Random events in small populations may have a large impact on population dynamics and persistence for a species. If the rate of population growth varies from one generation to the next, random stochastic events in successive generations can lead to population declines even if the population is growing, on average (Holsinger 2000, pp. 55-74; Holsinger 2013, pp. 1-8).

    Drought. Drought over a prolonged period can alter the species composition, relative abundance, and growing season of plants. Drought may result in indirect impacts to individuals using these plants if they are less abundant or have reduced vigor due to competition for resources (Ehrlich et al. 1980, p. 101). Drought may shorten the period of growth for plants due to diminished water availability resulting in early senescence. Early plant senescence can limit the amount of time butterfly larvae have to reach pupa diapause (the period during which growth or development is suspended preceding development into a butterfly) (Holdren and Ehrlich 1981, p. 128; Ehrlich and Murphy 1987, p. 124). However, there is no information on drought relating directly to Leona's little blue butterfly population size or apparent geographic isolation. The available literature does contain information on drought response from other butterfly species. In two species of checkerspot butterflies (Euphydryas editha and Euphydryas chalcedona) from California, drought effects were observed in relationships with the host plant and competition for food (Ehrlich et al. 1980, p. 101). While the life-history traits and habitats of these two species are dissimilar from Leona's little blue butterfly, the study suggests that drought-resistant host plants and the use of a variety of food plants provide protection from the harmful effects of drought (Ehrlich et al. 1980, p. 105). Spurry buckwheat is a desert-restricted annual (James 2012, p. 93) that grows in dry conditions (Hickman 1993, p. 879) and is locally abundant within the range of Leona's little blue butterfly and are very likely to be adapted to drought conditions. Similarly, nectar plants used by Leona's little blue butterfly occurring in this area likely also are adapted to dry conditions.

    Drought has the potential for widespread impacts to many plant species. However, Leona's little blue butterfly occupies a desert ecosystem that is composed of drought-tolerant plants. Because the plants are drought tolerant, they are expected to survive drought years and continue to provide resources for Leona's little blue butterfly. Droughts follow cyclic patterns and are not a persistent stressor for Leona's little blue butterfly habitat, and, therefore, we find that drought does not rise to the level of a threat.

    Catastrophic Fire. The area within the range of Leona's little blue butterfly is a fire-adapted ecosystem with a mixed-severity fire regime (Dunn 2011a, pp. 1, 4). The potential for catastrophic fire events is limited by the mix of forested, recently logged, and non-forested areas contained with the range of Leona's little blue butterfly. There is no information to suggest that catastrophic fires have occurred within the range of Leona's little blue butterfly. Catastrophic fires could result in the widespread loss of forested habitats adjacent to areas occupied by Leona's little blue butterfly. However, given the mixed-severity fire regime of Leona's little blue butterfly range, catastrophic fire is not expected to occur in the near-term. If forest management practices change so that there is an increase in forest cover or fewer open areas between forested patches, the potential for catastrophic fire could increase.

    The potential rates of fire spread and intensity vary widely based on fuel loading. Open areas occupied by Leona's little blue butterfly are not as likely to be subject to catastrophic fire, and Leona's little blue butterfly are expected to persist in these areas after fire (Dunn 2011b p. 12). Therefore, based on current habitat conditions and the use of open areas less susceptible to catastrophic fire by Leona's little blue butterfly, we conclude that catastrophic fire is not a threat to the species now or into the future.

    Inbreeding. Inbreeding is most common in small or isolated populations where immigration and emigration are not occurring regularly enough to maintain genetic variability. Inbreeding can result in changes to morphology, survival, lifespan, and sterility in invertebrates (Frankham and Ralls 1998, p. 441; Lande 1988, p. 1456). Inbreeding in small populations of butterflies has not been a sole factor associated with butterfly extinction; rather, extinction is more likely from other sources such as demographic effects from habitat loss or environmental factors. There is no available information to indicate that inbreeding is a threat to Leona's little blue butterfly, and if it is occurring, the literature suggest that demography and environmental factors are more likely to contribute to a species' extinction than inbreeding alone (Lande 1988, p. 1457). As a result, we have determined that inbreeding is not a concern and does not rise to the level of a threat.

    Summary of Isolated Populations Stressors

    Drought may be acting as a low-level stressor on Leona's little blue butterfly and its habitat, but no information is available to indicate that catastrophic fire or inbreeding are occurring or likely to occur. Recent population estimates by James et al. (2014, p. 272) indicate that there may be 20,000 Leona's little blue butterflies, which is larger than the original population estimates of 1,000 to 2,000 (Ross 2008, p. 4) known at the time of receipt of the petition. The difference in population estimates is a result of a more thorough search of potential habitat and more rigorous sampling methods. The severity of the stressors is low because, even though these stressors may occur across the species' range, they are not a considerable source of loss of individuals or habitat individually or in combination. As a result, the best available scientific and commercial information does not indicate that stressors on isolated populations pose a significant impact to Leona's little blue butterfly or its habitat and do not rise to the level of a threat.

    The Effects of Climate Change

    The effects of climate change may be affecting both Leona's little blue butterfly habitat (Factor A) and individuals (Factor E) through several means. For the ease of analysis, the discussion of the effects of climate change on both individuals and habitat is discussed below.

    Various changes in climate may have direct or indirect effects on species. These effects 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 phenomena (for example, habitat fragmentation) (IPCC 2014, pp. 4-11). 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 (IPCC 2013b, pp. 15-16). 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). With regard to our analysis for Leona's little blue butterfly, downscaled projections are available for the Klamath Basin. See The Effects of Climate Change in the Species Report (Service 2015, pp. 55-59) for additional discussion of this stressor.

    Climate change is an ongoing stressor with projections into the future indicating trends towards warmer temperatures, highly variable precipitation alternating between drier and wetter conditions than had been previously experienced, and less precipitation as snowfall in the Klamath Basin. The entire Leona's little blue butterfly range is subject to impacts from climate change. Negative impacts to Leona's little blue butterfly habitat arise from shifts in plant growing season, diversity, distribution, and abundance (Kittel 1998, p. 79). In turn, Leona's little blue butterfly larvae and adults may have a reduced ability to complete lifecycle events relating to development and egg laying. However, it is expected that the butterfly will continue to follow external cues of temperature and humidity for emergence from pupa such that nectar resources will be available when they emerge (Caldas 2011, p. 80). Potential increases in wildfires as a result of drier conditions may benefit Leona's little blue butterfly by maintaining open habitat areas used by the species. Because of the variable precipitation patterns associated with the effects of climate change, we cannot determine the likely effects of a potential change in precipitation patterns in either the near- or long-term future.

    Because of the uncertainty of information related to the effects of climate change, we cannot conclude it is a threat to Leona's little blue butterfly or its habitat.

    Fire Retardant

    Fire retardant is a substance or chemical agent that reduces the flammability of combustibles and is typically applied by aircraft (National Wildfire Coordinating Group 2014, p. 150). Fire retardant used by the USFS is approximately 85 percent water mixed with inorganic fertilizers (ammonia polyphosphate makes up 60-90 percent of the remaining 15 percent), thickeners, suspending agents, dyes, and corrosion inhibitors (USFS 2011, pp. 15-16). Fire retardant coats and adheres to vegetation, which slows the progression of fires. Fire retardant can be applied during direct attack or indirect attack fire suppression activities. Fire retardant is not used on every fire event; its use is dependent upon the values at risk (human safety, natural resources, and commercial or private property) and the potential for rapid fire growth (USFS 2011, p. 8). Fire retardant exposure is likely to be lethal to Leona's little blue butterfly life forms that are above ground due to its inherent stickiness, which would severely restrict movement and could also result in suffocation (USFS 2011, p. 179). No data are available regarding the toxicity of fire retardant to larvae of invertebrates (USFS 2011, p. 179). Leona's little blue butterfly in the pupa stage may or may not be exposed to fire retardant dependent upon whether they are at or below ground level. Fire retardant would also potentially result in the killing of host and nectar plants if photosynthesis was inhibited; similarly, flowers coated in retardant would not be available for nectaring. Fire retardant may also act as a fertilizer, increasing plant growth of both native and nonnative species.

    The USFS uses mapped buffers to avoid the aerial application of fire retardant in waterways and habitats occupied by some, but not all, threatened and endangered species, or those proposed for listing under the Act. These mapped avoidance area buffers occur only on USFS lands. There are no mapped avoidance buffer areas within the range of Leona's little blue butterfly.

    Exposure to fire retardant can result in lethal impacts to Leona's little blue butterfly and the plants it depends upon to complete its lifecycle. Aerial application of fire retardant generally has a relatively small footprint and would not result in widespread loss of Leona's little blue butterfly or its habitat. Further, fires in the area have historically been small in size and few in number, indicating that this stressor has low potential for widespread impacts to Leona's little blue butterfly or its habitat. Fire retardant may act as a low-level stressor on Leona's little blue butterfly and its habitat currently or in the future. The low severity of the stressor indicates that even though this stressor may occur range-wide, it is not a considerable source of loss of individuals or habitat. Use of fire retardant can slow or inhibit the progression of fire spread in areas occupied by Leona's little blue butterfly. As a result, the best available scientific and commercial information does not indicate that use of fire retardant is a threat to Leona's little blue butterfly or its habitat.

    Change in Land Ownership

    The Mazama Forest has recently been sold by Fidelity National Financial to the Whitefish Cascade Forest Resources of Salem, Oregon, and Singapore. The lands that have been sold overlap the range of Leona's little blue butterfly. There is uncertainty about how the area may be managed into the future; however, we have no information to suggest that the management of the area would change. We would expect the operations to manage timber are likely to continue much as they have in the past. A rotation of harvest and non-harvest would probably be followed to allow for tree growth to sizes desirable for the timber products the company produces. As a result, the best available scientific and commercial information does not indicate that the change in ownership is a threat currently or in the future to Leona's little blue butterfly or its habitat. See Potential Change in Land Ownership in the Species Report (Service 2015, pp. 59-60) for additional discussion of this stressor.

    Cumulative, Synergistic, and Beneficial Effects

    Stressors may combine and interact, resulting in impacts to species not accounted for when stressors are analyzed individually. Stressors that appear minor when viewed individually may have greater impacts when analyzed cumulatively with other stressors. Furthermore, some stressors may act synergistically to cause impacts greater than the sum of the individual stressors. Beneficial effects from stressors (for example, the beneficial effect of wildfire maintaining open areas used by Leona's little blue butterfly) may outweigh the potential negative effects from that stressor or others. When conducting our analysis about the potential threats affecting Leona's little blue butterfly, we also assessed whether the species may be affected by a combination of factors. In the Species Report, we identified multiple potential stressors that may have interrelated impacts on the species or its habitat.

    Cumulative Effects: Potential cumulative effects to Leona's little blue butterfly habitat may occur when lodgepole pine encroachment and invasive plant stressors are viewed together. The larval host plant, spurry buckwheat, grows in open areas, making openings an essential component to the survival of Leona's little blue butterfly. Lodgepole pine encroachment gradually converts open areas with forested habitats. One invasive plant, cheatgrass, is known to occur in a portion of the area occupied by Leona's little blue butterfly. This plant has the ability to rapidly colonize open areas and outcompete native plant species. The combination of lodgepole pine encroachment and invasion by cheatgrass has the potential to create unsuitable habitat conditions for Leona's little blue butterfly.

    Synergistic Effects: When stressors occur together, one stressor may exacerbate the effects of another stressor, causing effects not accounted for when stressors are analyzed individually. Synergistic effects can be observed in a short amount of time. If stressors hinder Leona's little blue butterfly ability to lay eggs in one year, the number of adult butterflies that emerge the following year will be reduced. Stressors that act on the ability of larvae to reach the diapause stage successfully will also reduce the number of adult butterflies that emerge the following year. Stressors that could contribute to synergistic effects for Leona's little blue butterfly are insect collection, pesticides, predation, disease, competition, drought, and climate change. Even when considered together, the severity of these stressors is low or uncertain. The severity is low because even though these stressors may be acting on the population, the observed impact has been very low in the past and under current conditions. In the long term, synergistic effects may increase if the models for climate change are correct. For example, it is conceivable that Leona's little blue butterfly will not be able to adapt its life cycle to changes in plant growing seasons if growing seasons are altered too much. However, the information available at this time is not sufficient to determine if change in growing seasons would be of such magnitude that Leona's little blue butterfly would not be able to adapt.

    Beneficial Effects: A number of the stressors discussed above have the potential to reduce habitat for Leona's little blue butterfly. In particular, timber management activities can remove habitat when new roads or landings are constructed in suitable habitat; vegetation may also be trampled, resulting in damage to host and nectar plants. However, these activities can also create or maintain more habitat for Leona's little blue butterfly than remove or damage it. Based on past timber harvest practices in the range of Leona's little blue butterfly, the amount of forested area that is harvested does not include all of the butterfly's habitat within the area, but is selective. These newly open areas have the potential to become the next area of suitable habitat for Leona's little blue butterfly and may be much greater than the amount of habitat damaged or removed. The creation of new habitat through timber management can occur over large areas in short periods of time and be very effective at offsetting the potential loss of habitat from lodgepole pine encroachment and timber harvest. See Stressors on Isolated Populations and Cumulative, Synergistic, and Beneficial Effects section of the Species Report (Service 2015, pp. 50-55, pp. 61-62) for further discussion.

    Summary of Cumulative, Synergistic, and Beneficial Effects: All or some of the potential stressors could also act in concert as a cumulative threat to Leona's little blue butterfly. Of the stressors reviewed, lodgepole pine encroachment and invasive plants can result in considerable loss of habitat and ultimately individuals of Leona's little blue butterfly. The impacts of climate change are less certain, but, if models are correct, this factor could also interfere with the ability of Leona's little blue butterfly to reproduce. However, the best available scientific and commercial information currently does not indicate that these stressors singularly or cumulatively are causing now or will cause in the future a substantial decline of the total extant population of the species or have large impacts to Leona's little blue butterfly at the species level. Therefore, we do not consider the cumulative or synergistic impacts of these stressors to Leona's little blue butterfly to be a threat at this time, nor into the future.

    Available Conservation Measures

    The only example of conservation measures specific to Leona's little blue butterfly are included in a USFS proposal to improve habitat for the butterfly. The Fremont-Winema National Forest has initiated a habitat improvement project for Leona's little blue butterfly that will implement conservation measures specific to the butterfly. Because Leona's little blue butterflies are known to occupy the project area, project operations will occur over frozen ground or snow in winter to minimize the potential for crushing pupae. Logging slash is to be piled at least 50 feet (ft) (15 meters (m)) from occupied habitat and, to the extent possible, where timber operations just occurred to avoid piling and burning of this material in areas with a high likelihood of occupancy by Leona's little blue butterfly. Similarly, staging areas for equipment will be coordinated to minimize the potential for impacts to Leona's little blue butterfly or its habitat. The Oregon Biodiversity Information Center identifies and categorizes Leona's little blue butterfly as a level 1 species. The level 1 value indicates “taxa that are threatened with extinction or presumed to be extinct throughout their entire range” (Oregon Biodiversity Information Center 2013, pp. 4, 32). Occurring on this list does not necessitate the use of any conservation measures for actions that may impact species identified on this list, but may provide educational information or lead to voluntary conservation for or management of the species or its habitat.

    Finding

    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.” After review of the best available scientific and commercial information pertaining to Leona's little blue butterfly and its habitat, we have determined that the ongoing stressors (identified in Table 2 above) are not of sufficient imminence, intensity, or magnitude to manifest as threats to Leona's little blue butterfly such that it would be presently in danger of extinction throughout all of the species' range, or likely to become so in the foreseeable future. As stated in the Species Report (Service 2015, pp. 15-17), the location, distribution, and abundance of Leona's little blue butterfly populations have been shown to be greater than at the time of the petition. We have determined that the risk and severity of stressors acting on the population are minimal. For Leona's little blue butterfly, we evaluated the potential past, ongoing, and future stressors that may be acting on Leona's little blue butterfly and its habitat and defined the time periods and the foreseeable future of each stressor in the Species Report (Service 2015, pp. 19-20). The time periods identified for each stressor are based on the timeframes associated with known impacts for the stressor on which we can reasonably rely for predictions regarding the future populations, status, trends, and impacts to the species and its habitat. Some stressors may be affecting the species currently, but they have not had measureable effects on the species. In addition, available information does not support a conclusion that potential future stressors are likely to significantly affect Leona's little blue butterfly to an extent that they would have population-level impacts.

    Significant Portion of the Range Determination

    Under the Act and our implementing regulations, a species may warrant listing if it is an endangered or a threatened species throughout all or a significant portion of its range. The Act defines “endangered species” as any species which is “in danger of extinction throughout all or a significant portion of its range,” and “threatened species” as any species which is “likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” The term “species” includes “any subspecies of fish or wildlife or plants, and any distinct population segment [DPS] of any species of vertebrate fish or wildlife which interbreeds when mature.” We published a final policy interpreting the phrase “significant portion of its range” (SPR) (79 FR 37578; July 1, 2014). The final policy states that (1) if a species is found to be an endangered or a threatened species throughout a significant portion of its range, the entire species is listed as an endangered or a threatened species, respectively, and the Act's protections apply to all individuals of the species wherever found; (2) a portion of the range of a species is “significant” if the species is not currently an endangered or a threatened species throughout all of its range, but the portion's contribution to the viability of the species is so important that, without the members in that portion, the species would be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range; (3) the range of a species is considered to be the general geographical area within which that species can be found at the time the Service or the National Marine Fisheries Service makes any particular status determination; and (4) if a vertebrate species is an endangered or a threatened species throughout an SPR, and the population in that significant portion is a valid DPS, we will list the DPS rather than the entire taxonomic species or subspecies.

    The SPR policy is applied to all status determinations, including analyses for the purposes of making listing, delisting, and reclassification determinations. The procedure for analyzing whether any portion is an SPR is similar, regardless of the type of status determination we are making. The first step in our analysis of the status of a species is to determine its status throughout all of its range. If we determine that the species is in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range, we list the species as an endangered (or threatened) species, and no SPR analysis will be required. If the species is neither an endangered nor a threatened species throughout all of its range, we determine whether the species is an endangered or a threatened species throughout a significant portion of its range. If it is, we list the species as an endangered or a threatened species, respectively; if it is not, we conclude that listing the species is not warranted.

    When we conduct an SPR analysis, we first identify any portions of the species' range that warrant further consideration. The range of a species can theoretically be divided into portions in an infinite number of ways. However, there is no purpose to analyzing portions of the range that are not reasonably likely to be significant for either an endangered or a threatened species. To identify only those portions that warrant further consideration, we determine whether there is substantial information indicating that (1) the portions may be significant and (2) the species may be in danger of extinction in those portions or likely to become so within the foreseeable future. We emphasize that answering these questions in the affirmative is not a determination that the species is an endangered or a threatened species throughout a significant portion of its range—rather, it is a step in determining whether a more detailed analysis of the issue is required. In practice, a key part of this analysis is whether the threats are geographically concentrated in some way. If the threats to the species are affecting it uniformly throughout its range, no portion is likely to warrant further consideration. Moreover, if any concentration of threats apply only to portions of the range that clearly do not meet the biologically based definition of “significant” (i.e., the loss of that portion clearly would not be expected to increase the vulnerability to extinction of the entire species), those portions will not warrant further consideration.

    If we identify any portions that may be both (1) significant and (2) endangered or threatened, we engage in a more detailed analysis to determine whether these standards are indeed met. The identification of an SPR does not create a presumption, prejudgment, or other determination as to whether the species in that identified SPR is an endangered or a threatened species. We must go through a separate analysis to determine whether the species is an endangered or a threatened species in the SPR. To determine whether a species is an endangered or a threatened species throughout an SPR, we will use the same standards and methodology that we use to determine if a species is an endangered or a threatened species throughout its range.

    Depending on the biology of the species, its range, and the threats it faces, it may be more efficient to address the “significant” question first, or the status question first. Thus, if we determine that a portion of the range is not “significant,” we do not need to determine whether the species is an endangered or a threatened species there; if we determine that the species is not an endangered or a threatened species in a portion of its range, we do not need to determine if that portion is “significant.”

    We consider the “range” of Leona's little blue butterfly to include the entire population within the Sand and Scott Creek area in South Eastern Oregon. This is the only known population for the current and known historical distribution of the species.

    In considering any significant portion of the range of this species, we evaluated whether the stressors facing Leona's little blue butterfly might be geographically concentrated in any one portion of its range and whether these stressors manifest as threats to Leona's little blue butterfly such that it would be presently in danger of extinction throughout all of the species' range. We examined stressors from timber management, lodgepole pine encroachment, fire, fire retardant, fire suppression, right-of-way maintenance, cinder mining, livestock grazing, herbivory from native animals, herbicides, invasive plants, insect collection, competition with other invertebrates, predation, disease, pesticides, isolated population effects, effects of climate change, change in land ownership, and the inadequacy of existing regulatory mechanisms. We found no concentration of stressors that suggests that Leona's little blue butterfly may be in danger of extinction in a portion of its range. We also found no portion of its range where the stressors are significantly concentrated or substantially greater than in any other portion of its range (Service 2015, pp. 19-70). Therefore, we find that factors affecting Leona's little blue butterfly are essentially uniform throughout its range, indicating no portion of the range warrants further consideration of possible endangered or threatened status under the Act.

    Our review of the best available scientific and commercial information indicates that Leona's little blue butterfly is not in danger of extinction (an endangered species) nor likely to become endangered within the foreseeable future (a threatened species), throughout all or a significant portion of its range. Therefore, we find that listing Leona's little blue butterfly as an endangered or threatened species under the Act is not warranted at this time.

    We request that you submit any new information concerning the status of, or threats to, Leona's little blue butterfly to our Klamath Falls Fish and Wildlife Office (see ADDRESSES) whenever it becomes available. New information will help us monitor the species and encourage its conservation. If an emergency situation develops for the species, we will act to provide immediate protection as required under the Act.

    References Cited

    A complete list of all references cited in this finding is available on the Internet at http://www.regulations.gov under Docket No. FWS-R8-ES-2011-0055 or upon request from the Field Supervisor, Klamath Falls Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT).

    Authors

    The primary authors of this finding are staff from the Pacific Southwest Regional Office in Sacramento, California, in coordination with staff from the Klamath Falls Fish and Wildlife Office in Klamath Falls, Oregon.

    Authority

    The authority for this action is section 4 of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).

    Dated: June 11, 2015. Stephen Guertin, Acting Director, U.S. Fish and Wildlife Service.
    [FR Doc. 2015-15296 Filed 6-22-15; 8:45 am] BILLING CODE 4310-55-P
    80 120 Tuesday, June 23, 2015 Notices DEPARTMENT OF AGRICULTURE Food and Nutrition Service Request for Information: SNAP and WIC Seeking Input Regarding Procurement and Implementation of Electronic Benefit Transfer (EBT) Services AGENCY:

    Food and Nutrition Service (FNS), USDA.

    ACTION:

    Notice; Request for Information.

    SUMMARY:

    The Food and Nutrition Service (FNS) is interested in identifying ways to stimulate increased competition in the Electronic Benefit Transfer (EBT) marketplace and identify procurement or systems features that are barriers to new entrants. FNS is also seeking suggestions which will improve procurement of the delivery of EBT transaction processing services through modifications to, or replacement of, the existing business model. The procurement and implementation of EBT systems by State agencies administering the Supplemental Nutrition Assistance Program (SNAP) and Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) needs to be sustainable for all parties involved.

    The landscape of EBT is in a heightened state of change, due in part to the recent decision by one of three primary companies providing EBT transaction processing services for SNAP and WIC to no longer solicit or accept any new prepaid card business, including for SNAP and WIC EBT services. In addition, there are numerous EBT projects moving toward the October 1, 2020, statutorily-mandated deadline for WIC Program implementation.

    This Request for Information (RFI) seeks to obtain input from EBT stakeholders and other financial payment industry members and interested parties, regarding options and alternatives available to improve the procurement and current operational aspects of EBT. In this document, FNS has posed various questions to prompt stakeholder responses. We intend to consider and follow up on the alternatives and suggestions that appear to be most viable from both a technical and a cost/benefit standpoint.

    Interested stakeholders are invited to respond to any or all of the questions that follow, and to identify issues which may not be listed.

    DATES:

    Comments must be submitted on or before August 24, 2015.

    ADDRESSES:

    Comments may be submitted through the Federal eRulemaking Portal at www.regulations.gov. Follow the online instructions for submitting comments electronically. Comments can also be mailed or delivered to: Andrea Gold, Director, Retailer Policy and Management Division, Supplemental Nutrition Assistance Program, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Room 424, Alexandria, Virginia, 22302.

    All comments submitted in response to this notice will be included in the record and will be made available to the public at www.regulations.gov. Please be advised that the substance of the comments and the identity of the individuals or entities commenting will be subject to public disclosure.

    FOR FURTHER INFORMATION CONTACT:

    Andrea Gold, Director, Retailer Policy and Management Division, Supplemental Nutrition Assistance Program, (703) 305-2434, or via email at [email protected]

    Background

    All SNAP State agencies and some WIC State agencies conduct EBT using magnetic stripe cards similar to debit or credit cards. Almost all EBT systems today are integrated such that all of the service requirements are provided within a single system to the relevant State agencies, often referred to as a turnkey system. Over the years, some States have obtained SNAP EBT services by contracting for individual EBT service components to one or more service providers (such as authorization platform, retailer management, transaction switching, client help desk services, and card production). A few State agencies have performed certain EBT services themselves, to control costs or meet the needs of State operations. These State-operated services may include such functions as transaction authorization, retailer training and management, EBT card distribution, and management and customer service. In the WIC Program, several of the State agencies use smart card or chip card systems, sometimes referred to as off-line systems, while others have chosen an on-line system using a magnetic stripe reader. The trend in WIC, for State agencies choosing both mag-stripe and smart card solutions, is toward contracted EBT services via a turnkey processor.

    Contractors compete for State EBT business in a comparatively small marketplace. FNS has long encouraged healthy competition in this marketplace because the Agency believes it helps to control costs, ensures a level playing field for businesses who are interested in supporting EBT delivery processes, and encourages innovation. Two of the biggest concerns for FNS and State agencies with the limited competition within the EBT market, are the increased risk for sustainability of the industry over time, and the impact limited competition could have on pricing.

    Up until most recently, in the SNAP EBT environment, there have been three dominant primary EBT contractors with State agency EBT contracts. In the WIC EBT environment, these same three on-line EBT SNAP contractors have also provided EBT on-line services for WIC. There are also two other off-line EBT contractors for WIC.

    In January 2014, one of the primary contractors announced that the firm would no longer solicit or accept any new prepaid card business, which includes their EBT services. The firm is in the process of fulfilling its existing contracts but is not pursuing any further business in this area. As a result, only two of those three active primary EBT contractors remain in the market. There has been a new entrant to the SNAP market, a company that has been active in the WIC market; however, at this time, it is unclear whether any other firms will choose to enter this market.

    State agencies have acquired EBT service through one of two major approaches: Procurements dedicated to a single State agency, and multi-state procurements. The latter approach leverages pricing through economies of scale and standardizes requirements and contract provisions in a way that can reduce the burden on contractors of responding to separate contract solicitations by many State agencies. Typical contracts have a base period such as 5 years with several optional extension years, but there are situations where State procurement rules dictate a shorter timeframe with limited renewals. Due to the burden to develop re-procurements and manage the potential transition to a new contractor when an incumbent does not win award, it is not unusual to see a State agency choose to exercise the optional years, resulting in contract lengths of 7-10 years. It is safe to say that FNS and State agencies are interested in the best value and service for EBT projects regardless of the size of a specific State agency.

    The Agricultural Act of 2014, Public Law 113-79 (the Act) has also brought important changes to the SNAP EBT landscape that impacts States and SNAP EBT contractors looking forward.

    That legislation removed the requirement for States and their contractors to provide no cost point-of-sale (POS) devices to all authorized SNAP retailers who were not already using a commercial payment provider. The Act also changed manual voucher processing used when retailer sales do not warrant the cost to receive a POS device from the government and for back up during system outages and disasters.

    On the WIC side, while there is no new legislation at play, most of the 90 WIC State agencies are beginning to convert to an EBT delivery model to meet the October 1, 2020, deadline mandated by the Healthy Hunger-Free Kids Act of 2010, Public Law 111-296. These State agencies are acquiring services from the on-line and off-line contractors.

    In sum, EBT services have developed a pricing model that has evolved since the early projects were initiated in the 1980s. Currently, contractors will bid to provide all the services, including cards, benefit account management, purchase authorization, customer service, retailer equipage and settlement to food retailers for a single cost for each household or case served in a month. Sometimes retailer equipage, pay-phone surcharges for toll-free calls and other fees have been separated from the case-month price. This pricing model allows for fluctuations in caseload related to economic changes or other growth factors. To the degree other pricing models exist, they have not taken root within either SNAP or WIC to date. Pricing can be, and often is, set up in tiers to reduce the case-month fee when certain caseload thresholds are reached either due to increases (or decreases) in household participation or if multiple State agencies have contracted together for economies of scale with the same requirements and contract standards.

    The major functional components of on-line EBT for SNAP and WIC are outlined in Appendix A, and off-line smart card WIC EBT is described in Appendix B.

    Request for Information

    This RFI seeks to obtain input from EBT stakeholders, other financial payments industry members and other interested parties regarding options and alternatives available to improve the procurement and operational aspects of EBT. FNS has posed various questions below to prompt stakeholder responses, and, before those, has also noted a few primary concerns and key objectives for this effort.

    Primary Concerns

    • Less available competition and potential that smaller State agencies may not receive affordable proposals, or even any proposals, in response to State agency solicitations.

    • An increase in procurement activity and system conversions by SNAP State agencies as those using the services of the departing company migrate to the remaining processors.

    • Significant increase in procurement activity and system implementation by WIC State agencies leading up to the October 1, 2020, deadline for WIC State agencies to convert to an EBT delivery system.

    • Management of risks associated with greater activity in a shorter period of time.

    Main Objectives

    FNS is inviting stakeholder input on how the opportunities and risks associated with these changes can best be recognized and managed. There are two main objectives:

    1. Increased competition for EBT services, including that which can possibly be achieved through changes or alternatives to the current business model.

    2. More stability and sustainability for this market, including that which can possibly be achieved through alternative pricing models and contract terms.

    Questions

    The Agency will consider all comments, and plans to follow up on alternatives and suggestions that appear to be most viable from both a technical and a cost/benefit standpoint. Responses will help inform any future actions or guidance issued by the Agency, including guidance to States on issuing EBT Requests for Proposals (RFPs).

    Interested stakeholders are invited to respond to any or all of the following questions, and to identify other issues which may not be listed. Responses which clearly reference the pertinent question below would facilitate FNS' review of the stakeholder feedback.

    Procurement

    1. Do State agency procurements provide sufficient information about the operational characteristics of their EBT projects for new entrants to the EBT market? If not, are there alternatives for potential vendors to obtain the information needed?

    2. How do State Agency requirements, (such as call center response standards, transaction processing requirements, card issuance timeframes and adjustment policies), compare to commercial practices? Would adjusting some of these requirements to closely resemble the commercial world increase the interest of potential new vendors, or impact contract costs or willingness of current vendors to bid? If so, what requirements or practices should be considered?

    3. Are the amounts for liquated damages and penalty clauses currently required by State agencies reasonable? If not, what would be more reasonable amounts or ways for State agencies to safeguard against such problems as project delays, unscheduled system downtime, and below-standard processing times, etc.?

    4. Can more economies of scale be realized without increasing complexity through any of the following:

    a. Multi-state shared services for commercial call center services, card production and delivery, training and other services?

    b. The inclusion of more agencies/programs?

    5. Are there requirements for vendor experience that are necessary to establish minimum qualifications to bid to provide EBT services? Are there requirements you have seen that should not be used because you believe that they unnecessarily limit competition?

    6. Would any vendors be interested in providing select service components (i.e. call centers, transaction processing, training, etc.) if there were an option to offer proposals for one or some rather than all of the service components? What pricing model(s) would work best for separate services when not bundled into the cost per case month pricing (CPCM)?

    7. What alternative procurement models might State Agencies consider to ensure they receive viable competitive bids?

    8. Should State agencies pursue coalition procurements with the benefits they bring, such as economies of scale, or does it tend to limit competition or discourage new entrants into the marketplace?

    Pricing

    9. Does the impact of the EBT vendor assuming development and implementation costs before they begin processing transactions pose a major barrier to entering the market?

    10. Are there ways to separate EBT system development/startup costs from operational costs to reduce risk for new entrants when bidding on a project? If so, what are they? 1

    1 SNAP procurements involve acquiring an operational process with costs for start-up activities included in the monthly operational cost-per-case-month. WIC procurements are conversions from paper to electronic delivery with deliverables and milestones for start-up that may be priced separately.

    11. Are there other changes to the CPCM pricing model that would encourage potential vendors to enter the EBT market?

    12. The tiered pricing model involves tiers within the CPCM pricing model, adjusted at smaller or larger intervals for different caseload levels. How can State consortia which want to procure together better realize economies of scale given their varying caseload sizes, and still benefit from a blended CPCM price based on their collective caseload volumes?

    13. Are there pricing models other than the CPCM model that would be advantageous in reducing pricing risk to the vendor and still maintain sustainable prices for the State agencies? How can the disadvantages to State agencies in forecasting expenses be overcome, if costs are no longer tied to caseload levels?

    Managing Risk

    Several stakeholders have advised FNS that too many procurements occurring in close succession may increase the risk that smaller State Agencies may receive fewer or even no bids, as vendors will devote scarce resources to preparing proposals for the most potentially profitable customers. Similarly, if too many implementations or conversions are scheduled in close succession, it may mean that vendors will not have sufficient technical resources to assign their top team to each one. Both of these situations represent risks which FNS would like to help State Agencies manage and mitigate.

    14. Besides sharing known and estimated RFP release dates and conversion dates, what can FNS do to help State Agencies manage these risks and ensure smooth transitions?

    Other Questions

    15. Are there other areas or issues that we have not specifically asked for a response on which you would like to offer comment related to the two main objectives of this RFI?

    Dated: June 10, 2015. Jeffrey J. Tribiano, Acting Administrator, Food and Nutrition Service.

    Attached: Appendix A: EBT Functions for Online SNAP and WIC EBT

    Appendix B: EBT Functions for Offline WIC EBT Cards (Smart Cards)

    Appendix C: Web sites to RFP and other EBT information:

    Appendix A EBT Functions for On-line SNAP and WIC EBT

    (1) Account setup and benefit authorization—support for on-line accounts for SNAP or WIC households authorized to receive benefits;

    (2) Card issuance and participant training—provide cards, equipment (PIN pads, card readers and training materials);

    (3) Participant account maintenance—receive daily and monthly benefit updates from State agency systems, aging benefits and reporting;

    (4) Transaction processing—approval or denial of food purchases made at authorized SNAP and WIC retailers/vendors; WIC processing includes, but is not limited to, matching of food item UPC, price and quantity;

    (5) Customer service—24x7 toll-free call support with help desk customer service representatives and Interactive Voice Response and web portal services inquiries related to purchase activities and balances from cardholders, merchants and State agency staff;

    (6) Retailer participation—support commercial third party switching services and installation and maintenance of payment terminals in smaller retail locations. Manual backup vouchers for authorizations during system interruptions or for low volume SNAP merchants;

    (7) EBT settlement—daily payment to authorized retailers for approved purchases; reconciliation via reports and data file exchanges, WIC also includes food item detail;

    (8) EBT reporting—administrative and batch data exchange for reporting card account activities by card number and retail location; daily financial settlement reporting and reconciliation; and,

    (9) Disaster Benefit Services (SNAP only)—providing card and benefit services for natural disasters.

    Appendix B EBT Functions for Offline WIC EBT (Smart Cards)

    WIC off-line EBT processing relies on State agencies to load a smart card chip with WIC food balances that can be read in grocery store lanes. Card and Personal Identification Number (PIN) support is provided by the State agency using the clinic system that tracks and determines participant benefits. Purchases are authorized off-line in the grocery lane (without an on-line authorization) and a daily claim file is sent to the WIC EBT host for processing payment to the WIC vendors. A hot card file, reconciliation file and authorized product list (APL) (containing the list of approved Universal Product Codes (UPC) and price look-up (PLU) codes called the APL file) are provided to the WIC grocer via the EBT host (an FTP server).

    (1) EBT host processing—processing of daily WIC claim files containing WIC transaction purchases, editing for Not-to-Exceed price limits, and pick-up of hot card, APL and reconciliation files to authorized WIC retail vendors.

    (2) Retail vendor equipage & integrated support (State agency option)

    (3) Customer Service (State agency option)—toll-free call center support including customer service representatives, Interactive Voice Response (IVR) and/or web portal services for cardholder and retailer and State agency staff inquiries.

    (4) EBT Reporting—administrative and batch data to support all processing and authorization activities.

    (5) Settlement and Reconciliation—similar to SNAP settlement but also includes food product information.

    Appendix C Web sites to RFP and other EBT information

    SNAP EBT Status—http://www.fns.usda.gov/ebt/general-electronic-benefit-transfer-ebt-information

    WIC EBT Status—http://www.fns.usda.gov/wic/wic-ebt-activities

    WIC Technology Partners (Provides links to new and updated solicitations)—http://www.wictechnologypartners.com/solicitations/RFP-B2Z12017/index.php

    [FR Doc. 2015-15336 Filed 6-22-15; 8:45 am] BILLING CODE 3410-30-P
    DEPARTMENT OF AGRICULTURE Forest Service Tongass National Forest; Alaska; Forest Plan Amendment AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of Intent to prepare an environmental impact statement; correction.

    SUMMARY:

    A Notice of Intent (NOI) to prepare an Environmental Impact Statement to amend the 2008 Tongass National Forest Land and Resource Management Plan (Forest Plan) was published in the Federal Register (79 FR 30074) on May 27, 2014. The Tongass National Forest is publishing this corrected NOI due to changes in the anticipated dates for the draft environmental impact statement (DEIS) and Record of Decision (ROD, to designate a new responsible official for the plan amendment, and to clarify the pre-decisional administrative review process. The 2012 Planning Rule (36 CFR part 219) includes subpart B, which establishes a pre-decisional administrative review (hereinafter referred to as “objection”) process for plan amendments giving an individual or entity an opportunity for an independent Forest Service review and resolution of issues before the approval of a plan amendment documented with a ROD (reference 36 CFR part 219, subpart B). This Forest Plan Amendment is subject to the objection process.

    FOR FURTHER INFORMATION CONTACT:

    Susan Howle, Project Manager, Tongass National Forest, Ketchikan, AK 99901, (907) 228-6340.

    Corrections

    In the Federal Register (79 FR 30074) of May 27, 2014 on page 30074, in the third column under the “Dates” caption, correct the second and fourth sentences to read:

    The draft environmental impact statement is expected to be published in October 2015, which will begin a 90-day public comment period.

    The Record of Decision is expected to be signed in October 2016.

    In the Federal Register (79 FR 30074) of May 27, 2014 on page 30075, in the third column under “Scoping Process” caption, correct by adding the following as a third paragraph:

    Forest Service regulations at 36 CFR 219, subpart B; published April 9, 2012 (77 FR 21162) include an objection process that applies to plan amendments. This proposed plan amendment is subject to 36 CFR 219, subpart B. There will be an objection process before the final decision is made, and after the final environmental impact statement and draft Record of Decision are made available to the public. Individuals and entities as defined in 36 CFR 219.53 who have submitted substantive formal comments related to the plan amendment during the opportunities for public comment as provided in subpart A (reference 36 CFR 219.16) may file an objection. Objections will be accepted only from those who have previously submitted substantive formal comments related to the plan amendment during scoping, the 90-day DEIS comment period, or other public involvement opportunity where comments are requested by the responsible official in accordance with 36 CFR 219.16.

    In the Federal Register (79 FR 30074) of May 27, 2014 on page 30075, in the third column at bottom, correct the name and title “Forrest Cole, Tongass Forest Supervisor” to read:

    M. Earl Stewart, Tongass Forest Supervisor

    Dated: June 16, 2015. M. Earl Stewart, Forest Supervisor, Tongass National Forest.
    [FR Doc. 2015-15362 Filed 6-22-15; 8:45 am] BILLING CODE 3410-11-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-10-2015] Foreign-Trade Zone 245—Decatur, Illinois; Authorization of Production Activity; Thyssenkrupp Presta Danville, LLC (Camshafts); Danville, Illinois

    On February 18, 2015, the Economic Development Corporation of Decatur & Macon County, grantee of FTZ 245, submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board on behalf of Thyssenkrupp Presta Danville, LLC, within Subzone 245C, in Danville, Illinois.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (80 FR 9693, 2-24-2015). The FTZ Board has determined that no further review of the activity is warranted at this time. The production activity described in the notification is authorized, subject to the FTZ Act and the Board's regulations, including Section 400.14.

    Dated: June 18, 2015. Elizabeth Whiteman, Acting Executive Secretary.
    [FR Doc. 2015-15475 Filed 6-22-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-893] Certain Frozen Warmwater Shrimp From the People's Republic of China: Rescission of Antidumping Duty Administrative Review; 2014-2015 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (“the Department”) is rescinding the administrative review of the antidumping duty order on certain frozen warmwater shrimp (“shrimp”) from the People's Republic of China (“PRC”) for the period February 1, 2014 through January 31, 2015.

    DATES:

    Effective Date: June 23, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Annathea Cook, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-7425.

    SUPPLEMENTARY INFORMATION:

    Background

    On April 3, 2015, based on a timely request for review on behalf of the Ad Hoc Shrimp Trade Action Committee (“Petitioner”) 1 and the American Shrimp Processors Association (“Domestic Processors”),2 the Department published in the Federal Register a notice of initiation of an administrative review of the antidumping duty order on shrimp from the PRC covering the period February 1, 2014, through January 31, 2015.3 The review covers sixty two companies.4 On April 16, 2015, and May 1, 2015, respectively, Petitioner and Domestic Processors withdrew their requests for an administrative review on all of the sixty two companies listed in the Initiation Notice. 5 No other party requested a review of these companies or any other exporters of subject merchandise.

    1See Letter to the Secretary of Commerce from the Ad Hoc Shrimp Trade Action Committee (“AHSTAC”) “Certain Frozen Warmwater Shrimp from the People's Republic of China: Request for Administrative Reviews” (February 27, 2015).

    2See Letter to the Secretary of Commerce from the American Shrimp Processors Association (“ASPA”) “Administrative Review of the Antidumping Duty Order Covering Frozen Warmwater Shrimp From the People's Republic of China (POR 10:2/1/14-1/31/15): American Shrimp Processors Association's Request for an Administrative Review” (February 27, 2015).

    3See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 80 FR 18202, 18208 (April 3rd, 2015) (“Initiation Notice”).

    4See id.

    5See Letter to the Secretary of Commerce from Petitioner “Certain Frozen Warmwater Shrimp from the People's Republic of China: Domestic Producers' Withdrawal of Review Requests” (April 16, 2015); Letter to the Secretary of Commerce from Domestic Processors “Administrative Review of Antidumping Duty Order Covering Certain Frozen Warmwater Shrimp From the People's Republic of China: Withdrawal of Review Request on Behalf of the American Shrimp Processors Association” (May 1, 2015).

    Rescission of Review

    Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if the party that requested the review withdraws its request within 90 days of the publication of the notice of initiation of the requested review. In this case, Petitioner and Domestic Processors timely withdrew their request by the 90-day deadline, and no other party requested an administrative review of the antidumping duty order. As a result, pursuant to 19 CFR 351.213(d)(1), we are rescinding the administrative review of shrimp from the PRC for the period February 1, 2014, through January 31, 2015, in its entirety.

    Assessment

    The Department will instruct U.S. Customs and Border Protection (“CBP”) to assess antidumping duties on all appropriate entries. Because the Department is rescinding this administrative review in its entirety, the entries to which this administrative review pertained shall be assessed antidumping duties at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions to CBP 15 days after the publication of this notice in the Federal Register, if appropriate.

    Notifications

    This notice serves as a final 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 the antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

    This notice also serves as a final reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).

    Dated: June 17, 2015. Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2015-15468 Filed 6-22-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-475-818] Certain Pasta from Italy: Notice of Preliminary Results of Antidumping Duty Changed Circumstances Review AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    On August 12, 2014, the Department of Commerce (the Department) initiated a changed circumstances review of the antidumping duty order on certain pasta from Italy in order to determine whether La Molisana S.p.A. (La Molisana) is the successor-in-interest to La Molisana Industrie Alimentari, S.p.A. (LMI), a respondent in the investigation and several administrative reviews.1 We preliminarily determine that La Molisana is not the successor-in-interest to LMI. We invite interested parties to comment on these preliminary results.

    1See Certain Pasta from Italy: Initiation of Changed Circumstances Review, 79 FR 47090 (August 12, 2014) (Initiation Notice).

    DATES:

    Effective date June 23, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Stephanie Moore, Office III, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3962.

    SUPPLEMENTARY INFORMATION:

    Background

    On July 24, 1996, the Department published in the Federal Register the antidumping duty order on pasta from Italy.2 The most recently completed administrative review for LMI was for the July 1, 1998 to June 30, 1999 period.3 Pursuant to Section 129 of the Uruguay Round Agreements Act, the Department recalculated the cash deposit rate for LMI and assigned it a de minimis margin.4

    2See Notice of Antidumping Duty Order and Amended Final Determination of Sales at Less Than Fair Value: Certain Pasta From Italy, 61 FR 38547 (July 24, 1996); see also Notice of Second Amendment to the Final Determination and Antidumping Duty Order: Certain Pasta From Italy; 61 FR 42231 (August 14, 1996).

    3See Certain Pasta From Italy: Final Results of Antidumping Duty Administrative Review, 65 FR 77852 (December 13, 2000).

    4See Notice of Implementation of Determination Under Section 129 of the Uruguay Round Agreements Act: Stainless Steel Plate in Coils From Belgium, Steel Concrete Reinforcing Bars From Latvia, Purified Carboxymethylcellulose From Finland, Certain Pasta From Italy, Purified Carboxymethylcellulose From the Netherlands, Stainless Steel Wire Rod From Spain, Granular Polytetrafluoroethylene Resin From Italy, Stainless Steel Sheet and Strip in Coils From Japan, 77 FR 36257 (June 18, 2012) (Notice of Section 129 Implementation).

    On June 23, 2014, La Molisana requested a changed circumstances review. On August 12, 2014, the Department initiated this review.5 On October 20, 2014, New World Pasta Company and Dakota Growers Pasta Company (hereinafter referred to as Petitioners) submitted comments on La Molisana's request for a changed circumstance review. On December 3, 2014, the Department requested additional information from La Molisana, which was submitted, in part, on January 9, 2015, and after an extension was granted, the remainder was submitted on January 28, 2015 (hereinafter referred to as the Supplemental Response).

    5See Initiation Notice.

    On February 6, 2015, Petitioners submitted comments on La Molisana's Supplemental Response. On February 11, 2015, La Molisana objected to Petitioners' February 6, 2015, submission and requested that the Department reject it because it contained untimely filed, uncertified, new factual information. On February 20, 2015, the Department decided not to reject Petitioners' February 6, 2015 submission.6 La Molisana filed comments on February 27, 2015, regarding the Department's decision. On March 4, 2015, the Department requested additional information from La Molisana, which was provided on March 24, 2015 (hereinafter referred to as Second Supplemental Response).

    6See letter from Eric B. Greynolds, Program Manager, Office III, AD/CVD Operations, dated February 20, 2015.

    On April 27, 2015, we extended the time period for issuing the final results of this changed circumstance review by 90 days.7

    7See Letter from Melissa G. Skinner, Director Office III, Antidumping and Countervailing Duty Operations to La Molisana, dated April 7, 2015.

    Scope of the Order

    Imports covered by this order are shipments of certain non-egg dry pasta in packages of five pounds four ounces or less, whether or not enriched or fortified or containing milk or other optional ingredients such as chopped vegetables, vegetable purees, milk, gluten, diastasis, vitamins, coloring and flavorings, and up to two percent egg white. The pasta covered by this scope is typically sold in the retail market, in fiberboard or cardboard cartons, or polyethylene or polypropylene bags of varying dimensions.

    For a full description of the scope, see the Preliminary Results of Changed Circumstances Review Regarding Successor-In-Interest Analysis: Certain Pasta from Italy memorandum dated concurrently with and hereby adopted by this notice.8 The Preliminary Results of Changed Circumstances Review memorandum is a business proprietary document of which the public version 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 it is available to all parties in the Central Records Unit, room 7046, of the main Department of Commerce building. In addition, a complete version of the Preliminary Results of Changed Circumstances Review memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/. The signed Preliminary Results of Changed Circumstances Review memorandum and the electronic version of the Preliminary Results of Changed Circumstances Review memorandum are identical in content.

    8See Memorandum to Paul Piquado, Assistant Secretary for Enforcement and Compliance from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, titled “Preliminary Results of Changed Circumstances Review Regarding Successor-In-Interest Analysis: Certain Pasta from Italy” dated concurrently with this notice (Preliminary Results of Changed Circumstances Review memorandum).

    Preliminary Results of Changed Circumstances Review

    In this changed circumstances review, pursuant to section 751(b) of the Tariff Act of 1930, as amended (the Act), the Department conducted a successor-in-interest analysis. In making such a successor-in-interest determination, the Department examines several factors including, but not limited to, changes in: (1) Management; (2) production facilities; (3) supplier relationships; and (4) customer base.9 While no one or combination of these factors will necessarily provide a dispositive indication, the Department will generally consider the new company to be the successor to the previous company if its resulting operation is not materially dissimilar to that of its predecessor.10 Thus, if the evidence demonstrates that, with respect to the production and sale of the subject merchandise, the new company operates as the same business entity as the former company, the Department will assign the new company the cash deposit rate of its predecessor.11

    9See, e.g., Pressure Sensitive Plastic Tape from Italy: Preliminary Results of Antidumping Duty Changed Circumstances Review, 75 FR 8925 (February 26, 2010), unchanged in Pressure Sensitive Plastic Tape From Italy: Final Results of Antidumping Duty Changed Circumstances Review, 75 FR 27706 (May 18, 2010); and Brake Rotors From the People's Republic of China: Final Results of Changed Circumstances Antidumping Duty Administrative Review, 70 FR 69941 (November 18, 2005) (Brake Rotors), citing Brass Sheet and Strip from Canada: Final Results of Antidumping Duty Administrative Review, 57 FR 20460 (May 13, 1992), and Certain Pasta From Italy: Notice of Final Results of Antidumping Duty Changed Circumstances Review, 79 FR 56339 (September 19, 2014) (Delverde).

    10See, e.g., Brake Rotors. See also Delverde.

    11Id.; see also, e.g., Notice of Initiation and Preliminary Results of Antidumping Duty Changed Circumstances Review: Certain Frozen Warmwater Shrimp From India, 77 FR 64953 (October 24, 2012), unchanged in Final Results of Antidumping Duty Changed Circumstances Review: Certain Frozen Warmwater Shrimp From India, 77 FR 73619 (December 11, 2012).

    Based on the totality of the record evidence and on comments from interested parties, we preliminarily determine that La Molisana is materially dissimilar to LMI in terms of management, production facilities, and supplier relationships. Therefore, we preliminarily find that La Molisana is not the successor-in-interest to LMI.12

    12See Preliminary Results in Changed Circumstances Review memorandum.

    Consequently, we preliminarily determine that La Molisana should not be given the same antidumping duty treatment as LMI. This determination will apply to all entries of the subject merchandise entered or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this changed circumstances review.13 If we reach the same conclusion in the final results, then the cash deposit for La Molisana will continue to be 15.45 percent, the all-others rate established in the antidumping duty investigation, as modified by the section 129 determination.14 This cash deposit requirement will remain in effect until a company-specific rate is calculated for La Molisana.15

    13See Granular Polytetrafluoroethylene Resin from Italy: Final Results of Changed Circumstances Review, 68 FR 25327 (May 12, 2003). See also Delverde.

    14See Notice of Implementation of Section 129.

    15 La Molisana is currently being reviewed in an administrative review covering the period July 1, 2013 through June 30, 2014. See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 79 FR 51548 (August 29, 2014).

    Public Comment

    Pursuant to 19 CFR 351.309(c), interested parties may submit cases briefs not later than 10 days after the date of publication of this notice via ACCESS. ACCESS is available to registered users at http://access.trade.gov and is available to all parties in the Central Records Unit, room 7046, of the main Department of Commerce building. 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. Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically filed document must be received successfully in its entirety by ACCESS, no later than 5:00 p.m. Eastern Time within 10 days after the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in case briefs.

    Consistent with 19 CFR 351.216(e), we will issue the final results of this changed circumstances review no later than 270 days after the date on which this review was initiated, or within 45 days after the publication of the preliminary results if all parties in this review agree to our preliminary results.

    We are issuing and publishing this determination and notice in accordance with sections 751(b) and 777(i)(1) of the Act and 19 CFR 351.216 and 351.221.

    Dated: June 10, 2015. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix List of Topics Discussed in the Preliminary Changed Circumstances Review Decision Memorandum I. Summary II. Background III. Scope of the Order IV. Discussion of Methodology V. Analysis 1. Management 2. Production Facilities 3. Supplier Relationship 4. Customer Base
    [FR Doc. 2015-15471 Filed 6-22-15; 8:45 am] BILLING CODE 3510-DS-P
    COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities Under OMB Review AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995 (“PRA”), this notice announces that the Information Collection Request (“ICR”) abstracted below has been forwarded to the Office of Management and Budget (“OMB”) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.

    DATES:

    Comments must be submitted on or before July 23, 2015.

    ADDRESSES:

    Comments regarding the burden estimated or any other aspect of the information collection, including suggestions for reducing the burden, may be submitted directly to the Office of Information and Regulatory Affairs in OMB, within 30 days of the notice's publication, by email at [email protected] Please identify the comments by OMB Control No. 3038-0013. Please provide the Commodity Futures Trading Commission (“Commission”) with a copy of all submitted comments at the address listed below. Please refer to OMB Reference No. 3038-0013, found on http://reginfo.gov. Comments may also be mailed to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Commodity Futures Trading Commission, 725 17th Street NW., Washington, DC 20503, and Hannah Ropp, Surveillance Analyst, Division of Market Oversight, Commodity Futures Trading Commission, 1155 21st Street NW., Washington, DC 20581.

    Comments may also be submitted by any of the following methods:

    • The Agency's Web site, via its Comments Online process: http://comments.cftc.gov. Follow the instructions for submitting comments through the Web site.

    • Mail: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581.

    • Hand Delivery/Courier: Same as Mail above.

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

    A copy of the supporting statements for the collection of information discussed above may be obtained by visiting RegInfo.gov. All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to http://www.cftc.gov.

    FOR FURTHER INFORMATION CONTACT:

    Hannah Ropp, Surveillance Analyst, Division of Market Oversight; Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581; phone: (202) 418-5228; fax: (202) 418-5507; email: [email protected], and refer to OMB Control No. 3038-0013.

    SUPPLEMENTARY INFORMATION:

    Title: “Exemptions from Speculative Limits (OMB Control No. 3038-0013).” This is a request for extension of a currently approved information collection.

    Abstract: Section 4a(a) of the Commodity Exchange Act (“Act”) allows the Commission to set speculative limits in any commodity for future delivery in order to prevent excessive speculation. Certain sections of the Act and the Commission's Regulations allow exemptions from the speculative limits for persons using the market for hedging and, under certain circumstances, for commodity pool operators and similar traders. This information collection contains the recordkeeping and reporting requirements needed to ensure regulatory compliance with Commission rules relating to this issue.

    Burden Statement: The respondent burden for this collection is estimated to be 3 hours per response. These estimates include the time to locate the information related to the exemptions and to file necessary exemption paperwork.

    Respondents/Affected Entities: Swap Dealers, Large Traders, and other entities affected by Rules 1.47 and 1.48 and Part 150 of the Commission's regulations.

    Estimated number of respondents: 9.

    Estimated total annual burden on respondents: 48 hours.

    Frequency of collection: 1-2 reports annually.

    There are no capital costs or operating and maintenance costs associated with this collection.

    Authority:

    44 U.S.C. 3501 et seq.

    Dated: June 17, 2015. Robert N. Sidman, Deputy Secretary of the Commission.
    [FR Doc. 2015-15344 Filed 6-22-15; 8:45 am] BILLING CODE 6351-01-P
    CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC- 2014-0033] Notice of Availability: Estimated Phthalate Exposure and Risk to Pregnant Women and Women of Reproductive Age as Assessed Using Four NHANES Biomonitoring Data Sets (2005/2006, 2007/2008, 2009/2010, 2011/2012) AGENCY:

    U.S. Consumer Product Safety Commission.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Consumer Product Safety Commission (“Commission,” or “CPSC”) is announcing the availability of a document titled, “Estimated Phthalate Exposure and Risk to Pregnant Women and Women of Reproductive Age as Assessed Using Four NHANES Biomonitoring Data Sets (2005/2006, 2007/2008, 2009/2010, 2011/2012).”

    DATES:

    Submit comments by August 7, 2015.

    ADDRESSES:

    You may submit comments, identified by Docket No. CPSC- 2014-0033, by any of the following methods:

    Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: http://www.regulations.gov. Follow the instructions for submitting comments. The Commission does not accept comments submitted by electronic mail (email), except through www.regulations.gov. The Commission encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above.

    Written Submissions: Submit written submissions by mail/hand delivery/courier to: Office of the Secretary, Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7923.

    Instructions: All submissions received must include the agency name and docket number for this notice. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to: http://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If furnished at all, such information should be submitted in writing.

    Docket: For access to the docket to read background documents or comments received, go to: http://www.regulations.gov, and insert the docket number CPSC- 2014-0033, into the “Search” box, and follow the prompts.

    FOR FURTHER INFORMATION CONTACT:

    Kent R. Carlson, Ph.D., Toxicologist, Division of Toxicology & Risk Assessment, Directorate for Health Sciences, U.S. Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850-3213; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    On December 30, 2014, the Commission issued a notice of proposed rulemaking (“NPR”) that would prohibit children's toys and child care articles containing specified phthalates. 79 FR 78324 (December 30, 2014). As provided in section 108 of the Consumer Product Safety Improvement Act of 2008 (“CPSIA”), the NPR was based on a report to the Commission (“CHAP Report”) from a Chronic Hazard Advisory Panel (“CHAP”) that the CPSIA directed the Commission to convene. The CHAP report is available at http://www.cpsc.gov/PageFiles/169902/CHAP-REPORT-With-Appendices.pdf.

    As stated in the NPR, the CHAP used several data sources for human biomonitoring analysis, including data from the National Human Health and Nutrition Survey (“NHANES”). See 79 FR at 78327. Specifically, the CHAP used biomonitoring data from the 2005/2006 NHANES data set, which was the most recent data available at the time of the CHAP's analysis.

    CPSC staff has reviewed subsequent NHANES data sets that were released after the CHAP's analysis. Staff also reviewed the 2005/2006 data set to replicate the CHAP's methodology. CPSC staff has prepared a document titled, “Estimated Phthalate Exposure and Risk to Pregnant Women and Women of Reproductive Age as Assessed Using Four NHANES Biomonitoring Data Sets (2005/2006, 2007/2008, 2009/2010, 2011/2012)” reflecting the staff's analysis. The document is available on the Commission's Web site at: http://www.cpsc.gov/Global/Regulations-Laws-and-Standards/CPSIA/CHAP/NHANES-Biomonitoring-analysis-for-Commission.pdf and from the Commission's Office of the Secretary at the location listed in the ADDRESSES section of this notice.

    The Commission invites comment on the document, “Phthalate Exposure and Risk to Pregnant Women and Women of Reproductive Age as Assessed Using Four NHANES Biomonitoring Data Sets (2005/2006, 2007/2008, 2009/2010, 2011/2012).” Comments should be submitted by August 7, 2015. Information on how to submit comments can be found in the ADDRESSES section of this notice.

    Dated: June 18, 2015. Todd A. Stevenson, Secretary, Consumer Product Safety Commission.
    [FR Doc. 2015-15366 Filed 6-22-15; 8:45 am] BILLING CODE 6355-01-P
    DEPARTMENT OF DEFENSE Department of the Army Notice of Availability of Real Property for Public Health Purposes, Including Research, at the Former Walter Reed Army Medical Center AGENCY:

    Department of the Army, DoD.

    ACTION:

    Notice of availability of real property.

    SUMMARY:

    Notice is hereby given that a portion of the former Walter Reed Army Medical Center (WRAMC), located at Alaska Avenue NW., and Fern Street NW., Washington, DC is available for conveyance to authorized recipients for the purpose of permitting the recipient to use the property for the protection of public health, including research. Interested authorized recipients must submit a written notice. The written notice shall disclose the contemplated use of the property, which must be associated with protection of public health, including research. Upon receipt of a written notice from an authorized recipient, the Army will promptly provide the interested party an application package and establish a date for submission of a formal application.

    DATES:

    Interested authorized recipients must submit a written notice, within 30 days of publication of this notice in the Federal Register.

    ADDRESSES:

    Submit written notice to the Chief, Real Estate Division, Baltimore District, U.S. Army Corps of Engineers, Mailing address: P.O. Box 1715, Attn: CENAB-RE-M, Baltimore, MD 21201-1715, Street address: 10 South Howard Street, Room 7600, Attn: CENAB-RE-M, Baltimore, MD 21201.

    FOR FURTHER INFORMATION CONTACT:

    More information about the property, including arrangements to tour the property, may be obtained by contacting Mr. Markus Craig, ACSIM BRAC Division, 2530 Crystal Drive, Room 5136C, Arlington, VA 22202, telephone (703)545-2474, or by email [email protected]

    SUPPLEMENTARY INFORMATION:

    The property consists of approximately 11 acres, more or less, improved with buildings and structures as follows:

    —Building 3, parking structure, approximately 341,000 gross square feet (gsf) —Building 52, former warehouse and outpatient clinic, approximately 31,700 gsf —Building 53, former post theater, approximately 17,400 gsf —Building 54, former Armed Forces Institute of Pathology and Military Medical Museum, approximately 400,000 gsf —Offsite utility infrastructure serving the site together with access and utility easements as necessary.

    The property is available for disposal under the authority of section 2834(b) of the National Defense Authorization Act for Fiscal Year 2015, Public Law 113-291. Authorized recipients are the District of Columbia, a political subdivision or instrumentality of the District of Columbia, a tax-supported medical institution, or a hospital or similar institution not operated for profit that has been exempt from taxation under section 501(c) of the Internal Revenue Code of 1986. The Army intends to convey all of the Government's right, title and interest in the property by quitclaim deed; disposal of a lesser interest will not be considered.

    The property is offered “AS IS” and “WHERE IS” without representation, warranty, or guaranty as to quantity, title, character, condition, size, or kind, or that the same is in condition or fit to be used for the purpose for which intended. The buildings contain asbestos and lead based paint. The property has been determined to be suitable for transfer in accordance with the Comprehensive Environmental Response, Compensation & Liability Act (CERCLA). All necessary remediation under CERCLA of hazardous substance releases has been taken.

    Buildings 52, 53 and 54 are considered contributing elements to the Walter Reed Historic District as nominated to both the National Register and District of Columbia Historic Listings. Building 54 is considered individually eligible for listing due to its significance as a cold war relic. Applicable preservation laws apply. The District of Columbia Historic Preservation Act (DC Code §§ 6-1101 et seq.) requires the Mayor's Office to approve permits to demolish, subdivide, or alter a historic landmark or a building in a historic district or to construct a new structure on the site of a landmark or in a historic district. The property will be conveyed without consideration; however, the recipient shall pay the costs incurred by the Army to carry out this conveyance including survey costs, costs for environmental documentation (but not costs for Army environmental remediation of the property), and any other Army administrative costs related to the conveyance.

    Dated: June 4, 2015. Paul D. Cramer, Deputy Assistant Secretary of the Army, (Installations, Housing & Partnerships).
    [FR Doc. 2015-15347 Filed 6-22-15; 8:45 am] BILLING CODE 3710-08-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DoD-2015-OS-0061] Privacy Act of 1974; System of Records AGENCY:

    Defense Contract Audit Agency, DoD.

    ACTION:

    Notice to add a new System of Records.

    SUMMARY:

    The Defense Contract Audit Agency (DCAA) proposes a new system of records notice, RDCAA 366.4, entitled “DCAA Telework Program Records,” in its existing inventory of record systems subject to the Privacy Act of 1974, as amended. This system will be used to collect employee telework agreements to assure compliance with Department of Defense and Defense Contract Audit Agency regulations.

    DATES:

    Comments will be accepted on or before July 23, 2015. This proposed action will be effective the date following the end of the comment period unless comments are received which result in a contrary determination.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

    * Federal Rulemaking Portal: http://www.regulations.gov.

    Follow the instructions for submitting comments.

    * Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.

    Instructions: All submissions received must include the agency name and docket number for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Keith Mastromichalis, DCAA FOIA/Privacy Act Management Analyst, 8725 John J. Kingman Road, Suite 2135, Fort Belvoir, VA 22060-6219, Telephone number: (703) 767-1022.

    SUPPLEMENTARY INFORMATION:

    The Defense Contract Audit Agency system of records notices subject to the Privacy Act of 1974, as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT or from the Defense Privacy and Civil Liberties Division Web site at http://dpcld.defense.gov/privacy.

    The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on May 12, 2015, to the House Committee on Oversight and Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

    Dated: June 18, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. RDCAA 366.4 System name:

    DCAA Telework Program Records.

    System Location:

    Records are maintained by the Human Resources Management Division, Office of the Defense Contract Audit Agency, 8725 John J. Kingman Road, Suite 2133, Fort Belvoir, VA 22060-6219.

    Categories of individuals covered by the system:

    Employees participating in the DCAA Telework Program.

    Categories of records in the system:

    Records include individual's name; position title, grade, and job series; duty station address and telephone number; telework address, telephone number(s), telework request forms (Telework Agreement, Self-Certification Home Safety Checklist, and Employee Checklist).

    Authority for maintenance of the system:

    5 U.S.C. 65, Chapter 65, Telework; DoD Instruction 1035.01, Subject Telework Policy; DCAA Instruction 1035.01, DCAA Telework Policy; and DCAA National Collective Bargaining Agreement.

    Purpose(s):

    Records may be used by DCAA management, human resources offices, and program coordinator for managing and reporting Telework Program participation. DCAA may need to extract Agency-wide data and submit this data as part of the Agency's Annual Telework Report to DoD, Office of Personnel Management (OPM), and/or Congress.

    Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

    In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, these records contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

    To the Department of Labor when an employee is injured while teleworking, i.e., telework address and safety checklists may be disclosed.

    The DoD Blanket Routine Uses set forth at the beginning of the DCAA's compilation of systems of records notices may apply to this system. The complete list of DoD blanket routine uses can be found online at: http://dpcld.defense.gov/Privacy/SORNsIndex/BlanketRoutineUses.aspx.

    Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Storage:

    Paper and electronic storage media.

    Retrievability:

    Records are retrieved by name.

    Safeguards:

    Electronic records are maintained in a password-protected network and accessible only to DCAA management on a need-to-know basis to perform their duties. Access to the network where records are maintained requires a valid Common Access Card (CAC). Paper records are secured in locked cabinets, offices, or buildings during non-duty hours. The same security standards currently applied to individually-issued CAC card are applicable to paper compilations.

    Retention and disposal:

    Records are destroyed one (1) year after employee's participation in the program ends.

    System manager(s) and address:

    Human Resources Manager, Human Resources Management Division, Office of the Defense Contract Audit Agency, 8725 John J. Kingman Road, Suite 2133, Fort Belvoir, VA 22060-6219.

    Notification procedure:

    Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the Privacy Act Officer, Headquarters, Defense Contract Audit Agency, ATTN: CMR, 8725 John J. Kingman Road, Suite 2135, Fort Belvoir, VA 22060-6219.

    Individual should provide full name and organizational information.

    Records access procedures:

    Individuals seeking access to information about themselves contained in this system should address written inquiries to the Privacy Act Officer, Headquarters, Defense Contract Audit Agency, ATTN: CMR, 8725 John J. Kingman Road, Suite 2135, Fort Belvoir, VA 22060-6219.

    Individual should provide full name and organizational information.

    Contesting record procedures:

    DCAA's rules for accessing records, for contesting contents and appealing initial agency determinations are published in DCAA Instruction 5410.10; 32 CFR part 317; or may be obtained from the system manager.

    Record source categories:

    Data is supplied by the subordinate employees submitted to the first level supervisor.

    Exemptions claimed for the system:

    None.

    [FR Doc. 2015-15360 Filed 6-22-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Transmittal No. 15-13] 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:

    Ms. B. English, DSCA/DBO/CFM, (703) 601-3740.

    The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 15-13 with attached Policy Justification and Sensitivity of Technology.

    Dated: June 18, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. EN23JN15.020 Transmittal No. 15-13 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as amended

    (i) Prospective Purchaser: Lebanon

    (ii) Total Estimated Value:

    Major Defense Equipment * $224 million Other $238 million Total $462 million

    (iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase: Six (6) A-29 Super Tucano aircraft, eight (8) PT6A-68A Turboprop engines (6 installed and 2 spares), eight (8) ALE-47 Countermeasure Dispensing Systems, two thousand (2000) Advanced Precision Kill Weapon Systems, eight (8) AN/AAR-60(V)2 Missile Launch Detection Systems, non-SAASM Embedded Global Positioning System/Initial Navigation System (EGIs), spare and repair parts, flight testing, maintenance support, support equipment, publications and technical documentation, ferry support, personnel training and training equipment, U.S. Government and contractor engineering and logistics support services, and other related elements of logistics support.

    (iv) Military Department: Air Force (SAF)

    (v) Prior Related Cases, if any: FMS case WFB-$18M-12Nov14

    (vi) Sales Commission, Fee, etc., Paid, Offered, or Agreed 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: 05 JUNE 2015

    * as defined in Section 47(6) of the Arms Export Control Act.

    POLICY JUSTIFICATION Lebanon—A-29 Super Tucano Aircraft

    The Government of Lebanon has requested a possible sale of six (6) A-29 Super Tucano aircraft, eight (8) PT6A-68A Turboprop engines (6 installed and 2 spares), eight (8) ALE-47 Countermeasure Dispensing Systems, two thousand (2000) Advanced Precision Kill Weapon Systems, eight (8) AN/AAR-60(V)2 Missile Launch Detection Systems, non-SAASM Embedded Global Positioning System/Initial Navigation System (EGIs), spare and repair parts, flight testing, maintenance support, support equipment, publications and technical documentation, ferry support, personnel training and training equipment, U.S. Government and contractor engineering and logistics support services, and other related elements of logistics support. The estimated cost is $462 million.

    This proposed sale serves U.S. national, economic, and security interests by providing Lebanon with airborne capabilities needed to maintain internal security, enforce United Nation's Security Council Resolutions 1559 and 1701, and counter terrorist threats.

    The proposed sale of these aircraft will provide Lebanon with a much needed Close Air Support (CAS) platform to meet present and future challenges posed by internal and border security threats. Lebanon should have no difficulty absorbing these additional aircraft into its armed forces.

    The proposed sale of this equipment and support will not alter the basic military balance in the region.

    The principal contractors will be:

    Sierra Nevada Corporation Centennial, Colorado BAE Systems Nashua, New Hampshire Pratt & Whitney East Hartford, Connecticut Terma North America Arlington, Virginia L-3COM Systems West Salt Lake City, Utah

    There are no known offset agreements proposed in connection with this potential sale.

    Implementation of this proposed sale will not require any additional U.S. Government or U.S. contractor personnel in Lebanon. However, periodic travel will be required on a temporary basis for program reviews and technical support.

    There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.

    Transmittal No. 15-13 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act Annex Item No. vii

    (vii) Sensitivity of Technology:

    1. The A-29 is a light attack aircraft which will provide Close Air Support (CAS), Intelligence Surveillance Reconnaissance (ISR), Counter Terrorism/Counter Insurgency (CT/COIN), and Border Security to the Lebanese Air Force. It is equipped with an integrated MX-15 Electro-Optical Infrared (EO/IR) Laser sensor suite, which gives day/night Intelligence Surveillance Reconnaissance (ISR) capability and includes a laser illuminator/range finder/designator to allow employment of the AGM-114 Hellfire missile and GBU-12/58 Laser Guided Bomb (LGB). The aircraft has six external hard points for weapons and fuel carriage. The Lebanon variant will be capable of carrying:

    —AGM-114M3, N3, & R5 missiles, classified as Secret —External fuel tanks, classified as Unclassified —2.75″ rockets (MK4, MK40, MK 66, Hydra 70), classified as Unclassified —GBU-12, classified as Confidential —GBU-58, classified at Confidential —Advanced Precision Kill Weapon System, classified as Secret —HMP-400 .50 caliber gun pods, classified as Unclassified

    The ISR package is compatible with the current Lebanese ISR assets. Critical cockpit, fuel system and engine components will have aircraft armor able to withstand small arms fire. Technical data and documentation to be provided are Unclassified.

    2. The MX-15 EO/IR sensor is a gyro-stabilized, multi-spectral, multi field of view EO/IR system. The system provides ISR capability and laser designation via an externally mounted turret sensor. Sensor video imagery is displayed in the aircraft real time and may be recorded for subsequent ground analysis. The hardware and technical data and documentation to be provided is Unclassified.

    3. The AN/ALE-47 Counter-Measures Dispensing System (CMDS) is an integrated, threat-adaptive, software-programmable dispensing system capable of dispensing chaff and flares. The threats countered by the CMDS include radar-directed anti-aircraft artillery (AAA), radar command-guided missiles, radar homing-guided missiles, and infrared (IR) guided missiles. The system is internally mounted and may be operated as a stand-alone system. The AN/ALE-47 uses threat data received over the aircraft interfaces to assess the threat situation and to determine a response. The hardware and technical data and documentation to be provided is Unclassified.

    4. The AN/AAR-60 Missile Warning System is an electronic warfare system designed to protect aircraft against infrared-guided (IR) missile threats, laser-guided/laser-aided threats, and unguided munitions. Upon detection of the threat, the system will provide an audio and visual sector warning to the pilot. For IR missile threats, the system automatically initiates countermeasures by sending a command signal to the countermeasures dispensing unit. The AAR-60 is Unclassified.

    5. The APKWS II All-Up-Round (AUR) is an air to ground weapon that consists of an APKWS II Guidance Section (GS), Legacy 2.75 inch MK 66 Mod 4 Rocket Motor and legacy MK 152 and MK455/436 warhead/fuze. The APKWS II GS is installed between the rocket motor and warhead and provides a Semi-Active Laser (SAL) precision capability to the legacy unguided 2.75″ rocket. The APKWS II guidance section is procured as an individual component and mated with the rocket motor and warhead/fuze to create an AUR. Hardware is Unclassified; information related to performance, effectiveness, vulnerabilities and counter-measure is classified up to Secret.

    6. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures which might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.

    7. A determination has been made that the recipient country can provide the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.

    8. All defense articles and services listed in this transmittal have been authorized for release and export to Lebanon.

    [FR Doc. 2015-15367 Filed 6-22-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Independent Review Panel on Military Medical Construction Standards; Notice of Federal Advisory Committee Meeting AGENCY:

    Department of Defense (DoD).

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Department of Defense is publishing this notice to announce the following Federal Advisory Committee meeting of the Independent Review Panel on Military Medical Construction Standards (“the Panel”).

    DATES:

    Tuesday, July 14, 2015 8:00 a.m.-9:00 a.m. EDT (Administrative Working Meeting) 9:00 a.m.-11:30 a.m. EDT (Open Session) 11:30 a.m.-1:30 p.m. EDT (Administrative Working Meeting) ADDRESSES:

    Defense Health Headquarters (DHHQ), Pavilion Salons B-C, 7700 Arlington Blvd., Falls Church, Virginia 22042 (escort required; see guidance in SUPPLEMENTARY INFORMATION, “Public's Accessibility to the Meeting”).

    FOR FURTHER INFORMATION CONTACT:

    The Executive Director and Designated Federal Officer is Ms. Christine Bader, 7700 Arlington Boulevard, Suite 5101, Falls Church, Virginia 22042, [email protected], (703) 681-6653, Fax: (703) 681-9539. For meeting information, please contact Ms. Kendal Brown, 7700 Arlington Boulevard, Suite 5101, Falls Church, Virginia 22042, [email protected], (703) 681-6670, Fax: (703) 681-9539.

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.

    Purpose of the Meeting

    At this meeting, the Panel will address the Ike Skelton National Defense Authorization Act (NDAA) for Fiscal Year 2011 (Pub. L. 111-383), Section 2852(b) requirement to provide the Secretary of Defense independent advice and recommendations regarding a construction standard for military medical centers to provide a single standard of care, as set forth below:

    a. Reviewing the unified military medical construction standards to determine the standards consistency with industry practices and benchmarks for world class medical construction;

    b. Reviewing ongoing construction programs within the DoD to ensure medical construction standards are uniformly applied across applicable military centers;

    c. Assessing the DoD approach to planning and programming facility improvements with specific emphasis on facility selection criteria and proportional assessment system; and facility programming responsibilities between the Assistant Secretary of Defense for Health Affairs and the Secretaries of the Military Departments;

    d. Assessing whether the Comprehensive Master Plan for the National Capital Region Medical (“the Master Plan”), dated April 2010, is adequate to fulfill statutory requirements, as required by section 2714 of the Military Construction Authorization Act for Fiscal Year 2010 (division B of Pub. L. 111-84; 123 Stat. 2656), to ensure that the facilities and organizational structure described in the Master Plan result in world class military medical centers in the National Capital Region; and

    e. Making recommendations regarding any adjustments of the Master Plan that are needed to ensure the provision of world class military medical centers and delivery system in the National Capital Region.

    Agenda

    Pursuant to 5 U.S.C. 552b, as amended, and 41 CFR 102-3.140 through 102-3.165 and subject to availability of space, the Panel meeting is open to the public from 9:00 a.m. to 11:30 a.m. on July 14, 2015, as the Panel will meet in an open forum to deliberate the findings and recommendations that will be contained in the Panel's final report to the Secretary of Defense.

    Availability of Materials for the Meeting

    A copy of the agenda or any updates to the agenda for the July 14, 2015 meeting, as well as any other materials presented, may be obtained at the meeting.

    Public's Accessibility to the Meeting

    Pursuant to 5 U.S.C. 552b, as amended, and 41 CFR 102-3.140 through 102-3.165 and subject to availability of space, this meeting is open to the public. Seating is limited and is on a first-come basis. All members of the public who wish to attend the public meeting must contact Ms. Kendal Brown at the number listed in the section FOR FURTHER INFORMATION CONTACT no later than 12:00 p.m. on Wednesday, July 8, 2015, to register and make arrangements for an escort, if necessary. Public attendees requiring escort should arrive with sufficient time to complete security screening no later than 30 minutes prior to the start of the meeting. To complete security screening, please come prepared to present two forms of identification and one must be a picture identification card.

    Special Accommodations

    Individuals requiring special accommodations to access the public meeting should contact Ms. Kendal Brown at least five (5) business days prior to the meeting so that appropriate arrangements can be made.

    Written Statements

    Any member of the public wishing to provide comments to the Panel may do so in accordance with 41 CFR 102-3.105(j) and 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act, and the procedures described in this notice.

    Individuals desiring to provide comments to the Panel may do so by submitting a written statement to the Executive Director (see FOR FURTHER INFORMATION CONTACT). Written statements should address the following details: The issue, discussion, and a recommended course of action. Supporting documentation may also be included, as needed, to establish the appropriate historical context and to provide any necessary background information.

    If the written statement is not received at least five (5) business days prior to the meeting, the Executive Director may choose to postpone consideration of the statement until the next open meeting.

    The Executive Director will review all timely submissions with the Panel Chairperson and ensure they are provided to members of the Panel before the meeting that is subject to this notice. After reviewing the written comments, the Panel Chairperson and the Executive Director may choose to invite the submitter to orally present their issue during an open portion of this meeting or at a future meeting. The Executive Director, in consultation with the Panel Chairperson, may allot time for members of the public to present their issues for review and discussion by the Panel.

    Dated: June 17, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-15285 Filed 6-22-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Transmittal No. 15-24] 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:

    Ms. B. English, DSCA/DBO/CFM, (703) 601-3740.

    The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 15-24 with attached Policy Justification and Sensitivity of Technology.

    Dated: June 18, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. EN23JN15.021 Transmittal No. 15-24 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act

    (i) Prospective Purchaser: Republic of Korea

    (ii) Total Estimated Value:

    Major Defense Equipment * $1.21 billion Other $0.70 billion TOTAL $1.91 billion

    (iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase: 3 Aegis Shipboard Combat Systems, 3 MK-41 Vertical Launching Systems, 3 Common Data Link Management Systems, 3 AN/UPX-29(V) Identification Friend or Foe Interrogators, spare and repair parts, support equipment, publications and technical documentation, personnel training and training equipment, tool and test equipment, U.S. Government and contractor technical, engineering, and logistics support services, and other related elements of logistics support.

    (iv) Military Department: Navy (LQI)

    (v) Prior Related Cases, if any: FMS case LPN-$1.06B-10Aug02

    (vi) Sales Commission, Fee, etc., Paid, Offered, or Agreed 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: 09 JUNE 2015

    * as defined in Section 47(6) of the Arms Export Control Act.

    POLICY JUSTIFICATION Republic of Korea—Aegis Combat System

    The Republic of Korea (ROK) has requested a possible sale of 3 Aegis Shipboard Combat Systems, 3 MK-41 Vertical Launching Systems, 3 Common Data Link Management Systems, 3 AN/UPX-29(V) Identification Friend or Foe Interrogators, spare and repair parts, support equipment, publications and technical documentation, personnel training and training equipment, tool and test equipment, U.S. Government and contractor technical, engineering, and logistics support services, and other related elements of logistics support. The total estimated cost is $1.91 billion.

    This proposed sale will contribute to the foreign policy and national security objectives of the United States by meeting the legitimate security and defense needs of an ally and partner nation. The ROK is one of the major political and economic powers in East Asia and the Western Pacific and a key partner of the United States in ensuring peace and stability in that region. It is vital to the U.S. interest to assist our Korean ally in developing and maintaining a strong and ready self-defense capability.

    The Aegis Combat System will provide enhanced capabilities on the ROK's naval ships to defend against possible aggression and protect sea lines of communications. Aegis is the keystone in the ROK Navy's efforts to upgrade its shipboard combat and ballistic missile defense capability. The ROK will have no difficulty integrating this system into its armed forces.

    The proposed sale of this equipment and support will not alter the basic military balance in the region.

    The principal contractors will be Lockheed Martin Maritime Systems and Training in Morristown, New Jersey; Raytheon Company in Andover, Massachusetts; General Dynamics Armament Systems in Burlington, Vermont. Although offsets are requested, they are unknown this time and will be determined during negotiations between the ROK and contractors.

    Implementation of this proposal sale will not require any additional U.S. government or U.S. contractor personnel in Korea. However, U.S. Government or contractor personnel in-country visits will be required on a temporary basis in conjunction with program technical oversight and support requirements for approximately five years.

    There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.

    Transmittal No. 15-24 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act Annex Item No. vii

    (vii) Sensitivity of Technology:

    1. Aegis Weapon System (AWS) hardware is Unclassified, with the exception of the RF oscillator used in the Fire Control transmitter, which is classified Confidential. Aegis document in general is unclassified. However, seven operation and maintenance manuals are classified Confidential, and there is also a classified Secret supplement to the Aegis Combat System Maintenance Manual. The manuals and technical documents are limited to those necessary for operational use and organizational maintenance.

    2. While the hardware associated with the SPY-1D radar is Unclassified, the computer programs are classified Secret. It is the combination of the SPY-1D hardware and the computer program for the SPY-1D radar that constitutes the technology sensitive aspects of the AWS. SPY-1D radar hardware design and computer program documentation will not be released.

    3. The AN/UPX-29(V) AIMS MK XIIA Identification Friend or Foe (IFF) system, includes the AN/UPX-41(C) Interrogator Set. The AN/UPX-29(V) IFF includes new waveforms that improve identification coverage, enhances the ability to discriminate between closely spaced platforms, is compatible with civilian air traffic control, and provides enhanced security. The equipment has embedded communication security and is protected internal to Unclassified equipment.

    4. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures which might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.

    5. A determination has been made that the recipient country can provide the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.

    6. All defense articles and services listed in this transmittal have been authorized for release and export to the Republic of Korea.

    [FR Doc. 2015-15358 Filed 6-22-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2015-ICCD-0080] Agency Information Collection Activities; Comment Request; Income Based Repayment Notifications AGENCY:

    Federal Student Aid (FSA), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before August 24, 2015.

    ADDRESSES:

    Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting Docket ID number ED-2015-ICCD-0080 or via postal mail, commercial delivery, or hand delivery. If the regulations.gov site is not available to the public for any reason, ED will temporarily accept comments at [email protected] Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted; ED will ONLY accept comments during the comment period in this mailbox when the regulations.gov site is not available. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Mailstop L-OM-2-2E319, Room 2E103, Washington, DC 20202.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Income Based Repayment Notifications.

    OMB Control Number: 1845-0114.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: Private Sector, State, Local and Tribal Governments.

    Total Estimated Number of Annual Responses: 2,894,005.

    Total Estimated Number of Annual Burden Hours: 231,520.

    Abstract: The Higher Education Act of 1965, as amended (HEA), established the Federal Family Education Loan (FFEL) Program under Title IV, Part B. Section 493C [20 U.S.C. 1098e] of the HEA authorizes income based repayment for Part B borrowers who have a partial financial hardship. The regulations in 34 CFR 682.215(e)(2) require notifications to borrowers from the loan holders once a borrower establishes a partial financial hardship and is placed in an income based repayment (IBR) plan by the loan holder. The regulations identify information the loan holder must provide to the borrower to continue to participate in an IBR plan. This is a request for extension of the current information collection 1845-0114.

    Dated: June 18, 2015. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2015-15353 Filed 6-22-15; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Bonneville Power Administration Agency Information Collection Activities: Proposed Collection; Comment Request; Landowner Release for Poles Removed From BPA Transmission System AGENCY:

    Bonneville Power Administration (BPA), Department of Energy.

    ACTION:

    Proposed information collection and request for comments.

    SUMMARY:

    BPA is seeking comments on a proposed submission to the Office of Management and Budget (OMB) for clearance of a collection of information under the Paperwork Reduction Act of 1995. BPA collects information from landowners or other members of the public who accept treated wood utility transmission poles. These poles are removed from the transmission system when they are no longer of use to BPA. The information collected will document and facilitate transfer of the poles, which minimizes BPA's environmental liability. At the time of information collection, BPA also provides the recipients with consumer information regarding treated wood and use restrictions required by the U.S. Environmental Protection Agency (EPA).

    DATES:

    Comments must be received on or before August 24, 2015.

    ADDRESSES:

    Written comments may be submitted by mail to Christopher M. Frost, CGC-7, Bonneville Power Administration, 905 NE. 11th Avenue, Portland, Oregon 97232, or by email at [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Additional information may be requested from Christopher M. Frost at the mailing address above or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    A recent internal audit of PRA compliance determined that this existing collection does not have an OMB number. BPA collects information from landowners or other members of the public who accept treated wood utility transmission poles. These poles are removed from the transmission system when they are no longer of use to BPA. The information collected will document and facilitate transfer of the poles, which minimizes BPA's environmental liability. At the time of information collection, BPA also provides the recipients with consumer information regarding treated wood and use restrictions required by the U.S. Environmental Protection Agency (EPA). The relevant form, Form BPA F 4300.07d, collects the following information: Intended use for poles (fence post, retaining wall, or landscaping), acknowledgement of receipt of consumer information sheet, acknowledgement of use limitations, acknowledgement of wood treatment type (creosote, pentachlorophenol, copper napthanate, or other as specified), and name and contact information. No third party notification or public disclosure burden is associated with this collection.

    II. Request for Comments

    BPA requests that you send your comments to the location listed in the ADDRESSES section above. Your comments should address:

    (a) The necessity of the information collection for the proper performance of BPA's functions, including whether the information will have practical utility;

    (b) The accuracy of our estimate of the burden (hours and costs) of the collection of information;

    (c) Ways we could enhance the quality, utility, and clarity of the information to be collected; and

    (d) Ways we could minimize the burden of the collection of information, such as through the use of automated collection techniques or other forms of information technology.

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number. Comments may be made available to the public, including your address, phone number, and email address. You may request that we withhold your personally identifiable information, but we cannot guarantee that we will be able to do so.

    III. Data

    OMB Control Number: New.

    Information Collection Request Title: Landowner Release for Poles Removed from BPA Transmission System.

    Type of Request: New.

    Respondents: Landowners and other members of the public accepting poles.

    Annual Estimated Number of Respondents: 120-150.

    Annual Estimated Number of Total Responses: 120-150.

    Average Minutes per Response: 5.

    Annual Estimated Number of Burden Hours: 12.5.

    Annual Estimated Reporting and Recordkeeping Cost Burden: $0.

    Issued in Portland, Oregon, on June 12, 2015. Christopher M. Frost, Agency Records Officer, FOIA/Privacy Officer, Governance and Internal Controls.
    [FR Doc. 2015-15377 Filed 6-22-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Bonneville Power Administration Agency Information Collection Activities: Proposed Collection; Comment Request; Badge Replacement Request Form AGENCY:

    Bonneville Power Administration (BPA), Department of Energy.

    ACTION:

    Proposed information collection and request for comments.

    SUMMARY:

    BPA is seeking comments on a proposed submission to the Office of Management and Budget (OMB) for clearance of a collection of information under the Paperwork Reduction Act of 1995. BPA proposes to collect information on lost, stolen, or damaged badges that control access to BPA facilities. The information collected will help BPA control access to BPA facilities and track identification badges issued under the authority of BPA's Personnel Security office.

    DATES:

    Comments must be received on or before August 24, 2015.

    ADDRESSES:

    Written comments may be submitted by mail to Christopher M. Frost, CGC-7, Bonneville Power Administration, 905 NE 11th Avenue, Portland, Oregon 97232, or by email at [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Additional information may be requested from Christopher M. Frost at the mailing address above or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    A recent internal audit of PRA compliance determined that this existing collection does not have an OMB number. BPA is seeking approval for an information collection on lost, stolen, or damaged badges that control access to BPA facilities. This information collection helps BPA control access to BPA facilities and track identification badges issued by BPA's Personnel Security office. The relevant form, Form BPA F 5632.27e, will collect the following information: type of badge (standard, smart card, proximity access), date of report, date lost, stolen or damaged, name and work phone number of reporting contractor or federal employee, and a brief description of either the type of damage or the incident resulting in loss. No third party notification or public disclosure burden is associated with this collection.

    II. Request for Comments

    BPA requests that you send your comments to the location listed in the ADDRESSES section above. Your comments should address:

    (a) The necessity of the information collection for the proper performance of BPA's functions, including whether the information will have practical utility;

    (b) The accuracy of our estimate of the burden (hours and costs) of the collection of the information;

    (c) Ways we could enhance the quality, utility and clarity of the information to be collected; and

    (d) Ways we could minimize the burden of the collection of the information, such as through the use of automated collection techniques or other forms of information technology.

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number. Comments may be made available to the public, including your address, phone number, and email address. You may request that we withhold your personally identifiable information, but we cannot guarantee that we will be able to do so.

    III. Data

    OMB Control Number: New

    Information Collection Request Title: Badge Replacement Request Form

    Type of Request: New

    Respondents: BPA employees and contractors seeking replacement ID badges.

    Annual Estimated Number of Respondents: 75

    Annual Estimated Number of Total Responses: 75

    Average Minutes per Response: 10

    Annual Estimated Number of Burden Hours: 12.5

    Annual Estimated Reporting and Recordkeeping Cost Burden: $0

    Issued in Portland, Oregon, on June 12, 2015. Christopher M. Frost, Chief Records Officer, FOIA/Privacy Officer, Governance and Internal Controls.
    [FR Doc. 2015-15370 Filed 6-22-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. OR15-27-000] NORCO Pipe Line Company, LLC; Notice of Petition for Declaratory Order

    Take notice that on June 1, 2015, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2014), NORCO Pipe Line Company, LLC (NORCO) filed a petition for a declaratory order seeking a declaratory order approving the overall tariff and rate structure for a new interstate common carrier pipeline to receive reformulated regular gasoline blendstock and ultra-low sulfur diesel at Hammond, Indiana and transport such products to either Argo or Des Plaines, Illinois, all as more fully explained in the petition.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426

    This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern time on July 2, 2015.

    Dated: June 9, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-15290 Filed 6-22-15; 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: ER10-2211-004.

    Applicants: Vandolah Power Company, L.L.C.

    Description: Supplement to December 24, 2014 Triennial Compliance Filing of Vandolah Power Company, L.L.C.

    Filed Date: 06/08/2015.

    Accession Number: 20150608-5264.

    Comment Date: 5 p.m. ET 6/29/15.

    Docket Numbers: ER10-2231-004; ER10-1511-004; ER10-1714-004.

    Applicants: Kentucky Utilities Company, LG&E Energy Marketing Inc., PPL EnergyPlus LLC, Louisville Gas and Electric Company.

    Description: Fourth Supplement to June 30, 2014 Triennial Market Power Update of the PPL Southeast Companies.

    Filed Date: 06/05/2015.

    Accession Number: 20150605-5244.

    Comment Date: 5 p.m. ET 6/26/15.

    Docket Numbers: ER10-2265-005; ER12-21-016; ER11-2211-005; ER11-2209-005; ER11-2210-005; ER11-2207-005; ER11-2206-005; ER13-1150-003; ER13-1151-003; ER10-2783-011; ER10-2784-011 ; ER11-2855-016 ; ER10-2791-011; ER10-2333-004; ER10-2792-011; ER14-1818-005; ER12-1238-004; ER10-2260-003; ER10-2261-003; ER10-2337-006; ER14-1668-002; ER14-1669-002 ; ER14-1674-002; ER14-1670-002; ER14-1671-002; ER14-1675-002; ER14-1673-002; ER14-1676-002; ER14-1677-002; ER14-1678-002; ER14-1679-002; ER14-1672-002; ER10-2795-011; ER10-2798-011; ER10-1575-009; ER10-2339-007; ER10-2338-007; ER10-2340-007; ER12-1239-004; ER10-2336-004; ER10-2335-004; ER10-2799-011; ER10-2801-011; ER10-2385-005; ER11-3727-011; ER10-2262-002; ER12-2413-009; ER11-2062-014; ER10-2346-006; ER10-2812-010; ER10-1291-015; ER10-2843-009; ER11-2508-013; ER11-2863-008; ER11-4307-014; ER10-2347-004; ER10-2348-004; ER12-1711-011; ER10-2350-004; ER10-2846-011; ER12-261-013.

    Applicants: NRG Power Marketing LLC, Agua Caliente Solar, LLC, Alta Wind I, LLC, Alta Wind II, LLC, Alta Wind III, LLC, Alta Wind IV, LLC, Alta Wind V, LLC, Alta Wind X, LLC, Alta Wind XI, LLC, Arthur Kill Power LLC, Astoria Gas Turbine Power LLC, Avenal Park LLC, Bayou Cove Peaking Power, LLC, Bendwind, LLC, Big Cajun I Peaking Power LLC, Boston Energy Trading and Marketing LLC, Broken Bow Wind, LLC, Cabrillo Power I LLC, Cabrillo Power II LLC, CL Power Sales Eight, L.L.C., Community Wind North 1 LLC, Community Wind North 2 LLC, Community Wind North 3 LLC, Community Wind North 5 LLC, Community Wind North 6 LLC, Community Wind North 7 LLC, Community Wind North 8 LLC, Community Wind North 9 LLC, Community Wind North 10 LLC, Community Wind North 11 LLC, Community Wind North 13 LLC, Community Wind North 15 LLC, Conemaugh Power LLC, Connecticut Jet Power LLC, Cottonwood Energy Company LP, CP Power Sales Seventeen, L.L.C., CP Power Sales Nineteen, L.L.C., CP Power Sales Twenty, L.L.C., Crofton Bluffs Wind, LLC, DeGreeff DP, LLC, DeGreeffpa, LLC, Devon Power LLC, Dunkirk Power LLC, Elkhorn Ridge Wind, LLC, El Segundo Energy Center LLC, El Segundo Power, LLC, Energy Alternatives Wholesale, LLC, Energy Plus Holdings LLC, Forward WindPower LLC, GenConn Devon LLC, GenConn Energy LLC, GenConn Middletown LLC, GenOn Energy Management, LLC, GenOn Mid-Atlantic, LLC, Green Mountain Energy Company, Groen Wind, LLC, High Lonesome Mesa, LLC, High Plains Ranch II, LLC, Hillcrest Wind, LLC, Huntley Power LLC, Independence Energy Group LLC.

    Description: Notice of Non-Material Change in Status of NRG MBR Sellers [Part 1].

    Filed Date: 6/8/15.

    Accession Number: 20150608-5265.

    Comments Due: 5 p.m. ET 6/29/15.

    Docket Numbers: ER11-2777-003.

    Applicants: Midcontinent Independent System Operator, Inc., Ameren Illinois Company.

    Description: Offer of Settlement [including Pro Forma sheets] of Ameren Services Company on behalf of Ameren Illinois Company, et al.

    Filed Date: 06/08/2015.

    Accession Number: 20150608-5258.

    Comment Date: 5 p.m. ET 6/29/15.

    Docket Numbers: ER13-104-007.

    Applicants: Florida Power & Light Company.

    Description: Compliance filing per 35: FPL Order No. 1000 Further Regional Compliance Filings to be effective 1/1/2015.

    Filed Date: 6/9/15.

    Accession Number: 20150609-5070.

    Comments Due: 5 p.m. ET 6/29/15.

    Docket Numbers: ER14-1934-004; ER14-1935-004.

    Applicants: Rising Tree Wind Farm LLC, Rising Tree Wind Farm II LLC.

    Description: Notice of Non-Material Change in Status of Rising Tree Wind Farm LLC, et al.

    Filed Date: 6/9/15.

    Accession Number: 20150609-5080.

    Comments Due: 5 p.m. ET 6/30/15.

    Docket Numbers: ER15-1542-001.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Compliance filing per 35: 2015-06-09_SA 2779 Compliance ATC-Wisconsin Electric CFA to be effective N/A.

    Filed Date: 6/9/15.

    Accession Number: 20150609-5027.

    Comments Due: 5 p.m. ET 6/30/15.

    Take notice that the Commission received the following electric reliability filings.

    Docket Numbers: RD15-5-000.

    Applicants: North American Electric Reliability Corporation.

    Description: Petition of the North American Electric Reliability Corporation for Approval of Proposed Reliability Standards PRC-004-5 and PRC-010-2.

    Filed Date: 06/08/2015.

    Accession Number: 20150608-5260.

    Comment Date: 5 p.m. ET 7/9/15.

    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: June 9, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-15289 Filed 6-22-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 4093-036] Bynum Hydro Company, PK Ventures I Limited Partnership; Notice of Application for Transfer of License and Soliciting Comments, Motions to Intervene, and Protests

    On January 16, 2015, Commission staff directed PK Ventures I Limited Partnership (PK Ventures) to file documentation of project ownership and an application to transfer the license for the Bynum Project No. 4093 from Bynum Hydro Company, the licensee of record, to PK Ventures, the owner of the project facilities. On February 18, 2015, PK Ventures filed a response, including among other things, documentation of its ownership of the project and a copy of an earlier filing with the Commission in which it seeks to transfer the license from Bynum Hydro to it. The project is located on the Haw River in Chatham County, North Carolina.

    Contact: Mr. Robert L. Rose, PK Ventures I Limited Partnership, P.O. Box 35236, Sarasota, FL 34242; Phone: (941) 312-0303; Email: [email protected]

    FERC Contact: Patricia W. Gillis, (202) 502-8735.

    Deadline for filing comments, motions to intervene, and protests: 30 days from the date that the Commission issues this notice. The Commission strongly encourages electronic filing. Please file motions to intervene, comments, and protests 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-4093-036.

    Dated: June 9, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-15291 Filed 6-22-15; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2012-0401; FRL-9929-55-OAR] Proposed Information Collection Request; Comment Request; Regulation of Fuels and Fuel Additives: RFS Pathways II, and Technical Amendments to the RFS Standards and E15 Misfueling Mitigation Requirements AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “Regulation of Fuels and Fuel Additives: RFS Pathways II, and Technical Amendments to the RFS Standards and E15 Misfueling Mitigation Requirement” (EPA ICR No. 2520.01., OMB Control No. 2060-NEW to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a request for approval of a new collection. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Comments must be submitted on or before August 24, 2015.

    ADDRESSES:

    Submit your comments, referencing Docket ID No. EPA-HQ-OAR-2012-0401, online using www.regulations.gov (our preferred method), or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Geanetta Heard, Fuels Compliance Center, 6406J, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-343-9017; fax number: 202-565-2085; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

    Abstract: In the final rule, EPA finalized the renewable fuels standard (RFS) program regulations at 40 CFR part 80, subpart M. We believe these provisions will facilitate the introduction of new renewable fuels as well as improve implementation of the program. These provisions includes various changes related to biogas including changes to the revised compressed natural gas (CNG)/liquefied natural gas (LNG) pathway and amendments to various associated registration, recordkeeping, and reporting provisions. The final regulation includes a lifecycle greenhouse gas emissions analysis for renewable electricity, renewable diesel and naphtha produced from landfill biogas. Adding these new pathways will enhance the ability of the biofuels industry to supply advanced biofuels, including cellulosic biofuels, which greatly reduce the greenhouse gas emissions (GHG) compared to the petroleum-based fuels they replace. It also addresses “nameplate capacity” issues for certain production facilities that do not claim exemption from the 20 percent GHG reduction threshold. In the accompanying final rule for this ICR, EPA addressed issues related to crop residue and corn kernel fiber and finalized an approach to determining the volume of cellulosic Renewable Identification Numbers (RIN's) produced from various cellulosic feedstocks. We also included a lifecycle analysis of advanced butanol and discussed the potential to allow for commingling of compliant products at the retail facility level as long as the environmental performance of the fuels would not be detrimental. Several other amendments to the RFS2 program were included.

    In the final rule, EPA also amended various changes to the E15 (gasoline containing up to 15 volume percent ethanol) mis-fueling mitigation regulations (MMR) at 40 CFR part 80, subpart N. Among the E15 changes finalized were technical corrections and amendments to sections dealing with labeling, E15 surveys, product transfer documents, and prohibited acts. Technical amendments and corrections for this regulations had no bearings on the industry estimates.

    Lastly, EPA finalized changes to the survey requirements associated with the ultra-low sulfur diesel (ULSD) program. This change is not addressed here because there are fewer than nine respondents.

    Form Numbers: 2

    RFS1700-RFS2 Renewable Fuel Producers—Cellulosic Converted Fraction—5900-362 RFS1300-RFS2 Renewable Fuel Producers Using Crop Residue as a Feedstock Report—5900-262

    Respondents/affected entities: Producers of renewable fuels, Producers of renewable electricity, Importers of renewable fuels, Feedstock producers from waste treatment plants, Feedstock producers from landfills, Parties who own RINS's.

    Respondent's obligation to respond: Mandatory.

    Estimated number of respondents: 60 (total).

    Frequency of response: Quarterly, annually, on occasion.

    Total estimated burden: 8,889 hours (per year). Burden is defined at 5 CFR 1320.03(b).

    Total estimated cost: $1,081,415 (per year), includes $0 annualized capital or operation & maintenance costs.

    Changes in Estimates EPA estimates yearly 60 respondents and 8,889 burden hours which will cost industry $1,081,415. This is a new collection with no industry cost for comparison.

    Dated: June 15, 2015. Byron Bunker, Director, Compliance Division, Office of Transportation and Air Quality, Office of Air and Radiation.
    [FR Doc. 2015-15467 Filed 6-22-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9929-53-OGC] Proposed Consent Decree, Clean Air Act Citizen Suit AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of proposed consent decree; request for public comment.

    SUMMARY:

    In accordance with section 113(g) of the Clean Air Act, as amended (“CAA” or the “Act”), notice is hereby given of a proposed consent decree to address a lawsuit filed by the Environmental Integrity Project: Environmental Integrity Project v. McCarthy, No. 1:14-cv-2106 (RC) (D. D.C.). On December 12, 2014, Plaintiff filed a complaint alleging that Gina McCarthy, in her official capacity as Administrator of the United States Environmental Protection Agency (“EPA”), failed to perform a non-discretionary duty to grant or deny within 60 days two petitions submitted by the Environmental Integrity Project on May 19, 2014, requesting that EPA object to two CAA Title V permits issued by the Texas Commission on Environmental Quality (“TCEQ”) to the Shell Chemical Company and the Shell Oil Company authorizing the operation of the Deer Park Chemical Plant and the Deer Park Refinery, respectively, located in Harris County, Texas. The proposed consent decree would establish a deadline of August 21, 2015, for EPA to take such action.

    DATES:

    Written comments on the proposed consent decree must be received by July 23, 2015.

    ADDRESSES:

    Submit your comments, identified by Docket ID number EPA-HQ-OGC-2015-0364, online at www.regulations.gov (EPA's preferred method); by email to [email protected]; by mail to EPA Docket Center, Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; or by hand delivery or courier to EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be formatted in Word or ASCII file, avoiding the use of special characters and any form of encryption, and may be mailed to the mailing address above.

    FOR FURTHER INFORMATION CONTACT:

    Richard H. Vetter, Air and Radiation Law Office, Office of General Counsel, U.S. Environmental Protection Agency, c/o US/EPA/OAQPS/SPPD/IO D205-01, Research Triangle Park, North Carolina 27711; telephone: (919) 541-2127; fax number (919) 541-4991; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Additional Information About the Proposed Consent Decree

    The proposed consent decree would resolve a lawsuit filed by the Environmental Integrity Project seeking to compel the Administrator to take actions under CAA section 505(b)(2). Under the terms of the proposed consent decree, EPA would agree to sign its response granting or denying the petitions filed by the Environmental Integrity Project regarding Shell Chemical Company's Deer Park Chemical Plant and Shell Oil Company's Deer Park Refinery, both located in Harris County, Texas, pursuant to section 505(b)(2) of the CAA, on or before August 21, 2015.

    Under the terms of the proposed consent decree, EPA would expeditiously deliver notice of EPA's response to the Office of the Federal Register for review and publication following signature of such response. In addition, the proposed consent decree outlines the procedure for the Plaintiffs to request costs of litigation, including attorney fees.

    For a period of thirty (30) days following the date of publication of this notice, EPA will accept written comments relating to the proposed consent decree from persons who are not named as parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act. Unless EPA or the Department of Justice determines that consent to this consent decree should be withdrawn, the terms of the consent decree will be affirmed.

    II. Additional Information About Commenting on the Proposed Consent Decree A. How can I get a copy of the consent decree?

    The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2015-0364) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.

    An electronic version of the public docket is available through www.regulations.gov. You may use www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, key in the appropriate docket identification number then select “search.”

    It is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing online at www.regulations.gov without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. Information claimed as CBI and other information whose disclosure is restricted by statute is not included in the official public docket or in the electronic public docket. EPA's policy is that copyrighted material, including copyrighted material contained in a public comment, will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the EPA Docket Center.

    B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

    If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment and with any disk or CD ROM you submit. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

    Use of the www.regulations.gov Web site to submit comments to EPA electronically is EPA's preferred method for receiving comments. The electronic public docket system is an “anonymous access” system, which means EPA will not know your identity, email address, or other contact information unless you provide it in the body of your comment. In contrast to EPA's electronic public docket, EPA's electronic mail (email) system is not an “anonymous access” system. If you send an email comment directly to the Docket without going through www.regulations.gov, your email address is automatically captured and included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

    Dated: June 15, 2015. Lorie J. Schmidt, Associate General Counsel.
    [FR Doc. 2015-15460 Filed 6-22-15; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Task Force on Optimal Public Safety Answering Point Architecture AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act (FACA), this notice advises interested persons that the Federal Communications Commission's (FCC) Task Force on Optimal Public Safety Answering Point (PSAP) Architecture (Task Force) will hold its third meeting.

    DATES:

    July 27, 2015.

    ADDRESSES:

    Federal Communications Commission, Room TW-C305 (Commission Meeting Room), 445 12th Street SW., Washington, DC 20554.

    FOR FURTHER INFORMATION CONTACT:

    Timothy May, Federal Communications Commission, Public Safety and Homeland Security Bureau, 202-418-1463, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The meeting will be held on July 27, 2015, from 1:00 p.m. to 4:00 p.m. in the Commission Meeting Room of the FCC, Room TW-305, 445 12th Street SW., Washington, DC 20554. The Task Force is a Federal Advisory Committee that studies and will report findings and recommendations on PSAP structure and architecture to determine whether additional consolidation of PSAP infrastructure and architecture improvements would promote greater efficiency of operations, safety of life, and cost containment, while retaining needed integration with local first responder dispatch and support. On December 2, 2014, pursuant to the FACA, the Commission established the Task Force charter for a period of two years, through December 2, 2016. At this meeting, the Task Force will vote on the recommendations and report of Working Group 3, “Optimal Approach to Next-Generation 911 Resource Allocation for PSAPs.”

    Members of the general public may attend the meeting. The FCC will attempt to accommodate as many attendees as possible; however, admittance will be limited to seating availability. The Commission will provide audio and/or video coverage of the meeting over the Internet from the FCC's Web page at http://www.fcc.gov/live.

    Open captioning will be provided for this event. Other reasonable accommodations for people with disabilities are available upon request. Requests for such accommodations should be submitted via email to [email protected] or by calling the Consumer & Governmental Affairs at (202) 418-0432 (TTY). Such requests should include a detailed description of the accommodation requested. In addition, please include a way the FCC may contact you if it needs more information. Please allow at least five days' advance notice; last minute requests will be accepted, but may be impossible to fill.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2015-15373 Filed 6-22-15; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of the Termination of the Receivership of 10406, Community Capital Bank, Jonesboro, GA

    Notice is hereby given that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for Community Capital Bank, Jonesboro, GA (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of Community Capital Bank on October 21, 2011. The liquidation of the receivership assets has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

    Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 32.1, 1601 Bryan Street, Dallas, TX 75201.

    No comments concerning the termination of this receivership will be considered which are not sent within this time frame.

    Dated: June 18, 2015.

    Federal Deposit Insurance Corporation

    Robert E. Feldman, Executive Secretary.
    [FR Doc. 2015-15354 Filed 6-22-15; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meetings Federal Register Citation of Previous Announcement: 80 FR 33265, June 11, 2015 PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING:

    Tuesday June 16, 2015 at 10:00 a.m. and Thursday, June 18, 2015 at the conclusion of the open meeting.

    PLACE:

    999 E Street NW., Washington, DC.

    STATUS:

    This meeting will be closed to the public.

    CHANGES IN THE MEETING:

    This meeting will be continued at 10:00 a.m. on Tuesday, June 23, 2015.

    CONTACT PERSON FOR MORE INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Shelley E. Garr, Deputy Secretary of the Commission.
    [FR Doc. 2015-15517 Filed 6-19-15; 4:15 pm] BILLING CODE 6715-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meetings Federal Register Notice of Previous Announcement:

    80 FR 34157, June 15, 2015.

    PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING:

    Thursday, June 18, 2015 at 10:00 a.m.

    CHANGES IN THE MEETING:

    This item was also discussed:

    Motion to Authorize the Publication of, and Expenses for, a Forty Year Report

    CONTACT PERSON FOR MORE INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Shawn Woodhead Werth, Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.

    Shawn Woodhead Werth, Secretary and Clerk of the Commission.
    [FR Doc. 2015-15445 Filed 6-19-15; 11:15 am] BILLING CODE 6715-01-P
    FEDERAL RESERVE SYSTEM Proposed Agency Information Collection Activities; Comment Request AGENCY:

    Board of Governors of the Federal Reserve System.

    SUMMARY:

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board of Governors of the Federal Reserve System (Board) its approval authority under the Paperwork Reduction Act (PRA), to approve of and assign OMB numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the PRA Submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB number.

    DATES:

    Comments must be submitted on or before August 24, 2015.

    ADDRESSES:

    You may submit comments, identified by FR 4027 or FR 4029, by any of the following methods:

    • Agency Web site: http://www.federalreserve.gov. Follow the instructions for submitting comments at http://www.federalreserve.gov/apps/foia/proposedregs.aspx.

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

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

    • FAX: (202) 452-3819 or (202) 452-3102.

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

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

    Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503 or by fax to (202) 395-6974.

    FOR FURTHER INFORMATION CONTACT:

    A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public Web site at: http://www.federalreserve.gov/apps/reportforms/review.aspx or may be requested from the agency clearance officer, whose name appears below.

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    SUPPLEMENTARY INFORMATION:

    Request for Comment on Information Collection Proposals

    The following information collections, which are being handled under this delegated authority, have received initial Board approval and are hereby published for comment. At the end of the comment period, the proposed information collections, along with an analysis of comments and recommendations received, will be submitted to the Board for final approval under OMB delegated authority. Comments are invited on the following:

    a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;

    b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, 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 information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and

    e. Estimates of capital or start up costs and costs of operation, maintenance, and purchase of services to provide information.

    Proposal To Approve Under OMB Delegated Authority the Extension for Three Years, Without Revision, of the Following Reports

    1. Report title: Recordkeeping Requirements Associated with the Guidance on Sound Incentive Compensation Policies.

    Agency form number: FR 4027.

    OMB control number: 7100-0327.

    Frequency: On occasion.

    Reporters: State member banks, U.S. bank holding companies, savings and loan holding companies, Edge Act and agreement corporations, and the U.S. operations of foreign banks with a branch, agency, or commercial lending company in the United States.

    Estimated annual reporting hours: One-time implementation: Large institutions—2,400 hours and small institutions—400 hours; Ongoing maintenance—228,400 hours.

    Estimated average hours per response: One-time implementation: Large institutions—480 hours and small institutions—80 hours; Ongoing maintenance—40 hours.

    Number of respondents: One-time implementation: Large institutions—5 respondents and small institutions—5 respondents; Ongoing maintenance—5,710 respondents.

    General description of report: This information collection is authorized pursuant to sections 9, 11(a), 11(i), 25, and 25A of the Federal Reserve Act (12 U.S.C. 248(a), 248(i), 324, 602, and 625), section 5 of the Bank Holding Company Act (12 U.S.C. 1844), section 10(b)(2) of the Home Owners' Loan Act (12 U.S.C. 1467a(b)(2)), and section 7(c) of the International Banking Act (12 U.S.C. 3105(c)). Because the recordkeeping requirements are contained within guidance (and not a statute or regulation) they are voluntary. Because the records will be maintained by each banking institution, the Freedom of Information Act (FOIA) would only be implicated if the Board's examiners retained a copy of the records as part of an examination or supervision of the banking institution. To the extent the Board collects this information during the course of an examination or supervision of a banking institution, the information is considered confidential under exemption 8 of the FOIA (5 U.S.C. 552(b)(8)). In addition, the information may also be kept confidential under exemption 4 of the FOIA which protects commercial or financial information obtained from a person that is privileged or confidential (5 U.S.C. 552(b)(4)).

    Abstract: Incentive compensation practices in the financial services industry were one of many factors contributing to the financial crisis that began in 2007. Banking organizations too often rewarded employees for increasing the firm's short-term revenue or profit without adequate recognition of the risks the employees' activities posed for the firm. More importantly, problematic compensation practices were not limited to the most senior executives at financial firms. Compensation practices can encourage employees at various levels of a banking organization, either individually or as a group, to undertake imprudent risks that can significantly and adversely affect the risk profile of the firm.

    The Sound Incentive Compensation Policies (the Guidance) was developed to help protect the safety and soundness of banking organizations and promote the prompt improvement of incentive compensation practices throughout the banking industry. In addition, the guidance is consistent with the Principles for Sound Compensation Practices adopted by the Financial Stability Board (FSB) in April 2009, as well as the Implementation Standards for those principles issued by the FSB in September 2009.

    Compatibility With Effective Controls and Risk Management

    Principle 2 of the Guidance states that a banking organization should have strong controls governing its process for designing, implementing, and monitoring incentive compensation arrangements. An organization's policies and procedures should:

    • Identify and describe the role(s) of the personnel, business units, and control units authorized to be involved in the design, implementation, and monitoring of incentive compensation arrangements;

    • identify the source of significant risk-related inputs into these processes and establish appropriate controls governing the development and approval of these inputs to help ensure their integrity; and

    • identify the individual(s) and control unit(s) whose approval is necessary for the establishment of new incentive compensation arrangements or modification of existing arrangements. Banking organizations also should create and maintain sufficient documentation to permit an audit of the organization's processes for establishing, modifying, and monitoring incentive compensation arrangements.

    The Guidance also states that a banking organization should conduct regular internal reviews to ensure that its processes for achieving and maintaining balanced incentive compensation arrangements are consistently followed. Such reviews should be conducted by audit, compliance, or other personnel in a manner consistent with the organization's overall framework for compliance monitoring. An organization's internal audit department also should separately conduct regular audits of the organization's compliance with its established policies and controls relating to incentive compensation arrangements. The results should be reported to appropriate levels of management and, where appropriate, the organization's board of directors.

    Strong Corporate Governance

    Principle 3 of the Guidance states that the board of directors should review and approve the overall goals and purposes of the firm's incentive compensation system. The board of directors should provide clear direction to management to ensure that its policies and procedures are carried out in a manner that achieves balance and is consistent with safety and soundness.

    The board of directors should approve and document any material exceptions or adjustments to the incentive compensation arrangements established for senior executives and should carefully consider and monitor the effects of any approved exceptions or adjustments on the balance of the arrangement, the risk-taking incentives of the senior executive, and the safety and soundness of the organization.

    The board of directors should receive and review, on an annual or more frequent basis, an assessment by management, with appropriate input from risk management personnel, of the effectiveness of the design and operation of the organization's incentive compensation system in providing risk taking incentives that are consistent with the organization's safety and soundness. These reports should include an evaluation of whether or how incentive compensation practices may be encouraging excessive risk taking. These reviews and reports should be appropriately scoped to reflect the size and complexity of the banking organization's activities and the prevalence and scope of its incentive compensation arrangements. In addition, at banking organizations that are significant users of incentive compensation arrangements, the board should receive periodic reports that review incentive compensation awards and payments relative to risk outcomes on a backward-looking basis to determine whether the organization's incentive compensation arrangements may be promoting excessive risk-taking.

    2. Report title: Interagency Guidance on Managing Compliance and Reputation Risks for Reverse Mortgage Products.

    Agency form number: FR 4029.

    OMB control number: 7100-0330.

    Frequency: On occasion.

    Reporters: State member banks that originate proprietary and Home Equity Conversion Program (HECM) reverse mortgages.

    Estimated annual reporting hours: Implementation of policies and procedures, 680 hours; Review and maintenance of policies and procedures, 136 hours.

    Estimated average hours per response: Implementation of policies and procedures, 40 hours; Review and maintenance of policies and procedures, 8 hours.

    Number of respondents: Implementation of policies and procedures, 17 respondents; Review and maintenance of policies and procedures, 17 respondents.

    General description of report: Previously, the Board's Legal Division determined that the Board was authorized to issue this guidance pursuant to its authority under section 18(f) of the Federal Trade Commission Act, which authorized the Board to prescribe regulations regarding unfair or deceptive acts or practice by banks (15 U.S.C. 57a(f)) and section 105 of the Truth in Lending Act, which authorized the Board to prescribe regulations to carry out the purposes of the Truth in Lending Act (TILA) (15 U.S.C. 1604). However, under the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) much of the Board's authority under these laws was transferred to the Consumer Financial Protection Bureau. Nonetheless, we continue to believe that the Board has the authority to issue this guidance pursuant to its authority under section 39 of the Federal Deposit Insurance Act (FDI Act), which generally authorizes the Board to establish safety and soundness standards for depository institutions supervised by the Board (12 U.S.C. 1381p-1(a)). Financial institutions' obligation under this guidance is voluntary. Because the documentation required by the guidance is maintained by each institution, the Freedom of Information Act (FOIA) would only be implicated if the Board's examiners retained a copy of this information as part of an examination or supervision of a bank. However, records obtained as a part of an examination or supervision of a bank are exempt from disclosure under FOIA exemption (b)(8), for examination material (5 U.S.C. 552(b)(8)). In addition, the information may also be kept confidential under exemption 4 of the FOIA which protects commercial or financial information obtained from a person that is privileged or confidential (5 U.S.C. 552(b)(4)).

    Abstract: Reverse mortgages are home-secured loans typically offered to elderly consumers. Financial institutions currently provide two types of reverse mortgage products: The lenders' own proprietary reverse mortgage products and reverse mortgages insured by the Department of Housing and Urban Development's Federal Housing Administration (FHA). Reverse mortgage loans insured by the FHA are made pursuant to the guidelines and rules established by HUD's HECM program. HECM loans and proprietary reverse mortgages are also subject to the rules that implement consumer protection laws such as the Real Estate Settlement Procedures Act (RESPA) and TILA.

    In August 2010, the Federal Financial Institutions Examination Council, on behalf of its member agencies,1 published a Federal Register notice adopting supervisory guidance titled “Reverse Mortgage Products: Guidance for Managing Compliance and Reputation Risks.” 2 The guidance is designed to help financial institutions with risk management and assist financial institutions' efforts to ensure that their reverse mortgage lending practices adequately address consumer compliance and reputation risks.

    1 The Board, the Federal Deposit Insurance Corporation, the National Credit Union Administration, the Office of the Comptroller of the Currency, and the Office of Thrift Supervision.

    2 75 FR 50801.

    The guidance describes reporting, recordkeeping, and disclosures for both proprietary and HECM reverse mortgages. A number of these disclosures are “usual and customary” business practices for proprietary and HECM reverse mortgages, and these would not meet the PRA's definition of “paperwork.” Other included disclosure requirements are currently mandated by RESPA or TILA for all reverse mortgage loans and information collections required by HUD's rules for HECM loans.3 Discussion of these requirements in the guidance is also not considered additional paperwork burden imposed by the guidance.

    3 OMB Control No. 2502-0524.

    Proprietary reverse mortgage products, however, are not subject to HUD's rules for HECM loans. To the extent that the interagency guidance applies HECM requirements to proprietary loans, this would meet the PRA's definition of paperwork burden.

    There are also additional provisions in the guidance that apply to both proprietary and HECM reverse mortgages that do not meet the “usual and customary” standard, are not covered by already approved information collections and, therefore, likewise meet the PRA's definition of paperwork burden.

    Proprietary Reverse Mortgages

    Financial institutions offering proprietary reverse mortgages are encouraged under the guidance to follow or adopt relevant HECM requirements for mandatory counseling, disclosures, affordable origination fees, restrictions on cross-selling of ancillary products, and reliable appraisals.

    Proprietary and HECM Reverse Mortgages

    Financial institutions offering either proprietary or HECM reverse mortgages are encouraged to develop clear and balanced product descriptions and make them available to consumers shopping for a mortgage. They should set forth a description of how disbursements can be received and include timely information to supplement disclosures mandated by TILA and other disclosures. Promotional materials and product descriptions should include information about the costs, terms, features, and risks of reverse mortgage products.

    Financial institutions should adopt policies and procedures that prohibit directing a consumer to a particular counseling agency or contacting a counselor on the consumer's behalf. They should adopt clear written policies and establish internal controls specifying that neither the lender nor any broker will require the borrower to purchase any other product from the lender in order to obtain the mortgage. Policies should be clear so that originators do not have an inappropriate incentive to sell other products that appear linked to the granting of a mortgage. Legal and compliance reviews should include oversight of compensation programs so that lending personnel are not improperly encouraged to direct consumers to particular products.

    Financial institutions making, purchasing, or servicing reverse mortgages through a third party should conduct due diligence and establish criteria for third-party relationships and compensation. They should set requirements for agreements and establish systems to monitor compliance with the agreement and applicable laws and regulations. They should also take corrective action if a third party fails to comply. Third-party relationships should be structured in a way that does not conflict with RESPA.

    Board of Governors of the Federal Reserve System, June 18, 2015. Robert deV. Frierson, Secretary of the Board.
    [FR Doc. 2015-15412 Filed 6-22-15; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0481] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Uses AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by July 23, 2015.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-0117. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    New Animal Drugs for Investigational Uses—21 CFR Part 511 OMB Control Number 0910-0117—Extension

    FDA has the authority under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to approve new animal drugs. Section 512(j) of the FD&C Act (21 U.S.C. 360b(j)) authorizes FDA to issue regulations relating to the investigational use of new animal drugs. The regulations setting forth the conditions for investigational use of new animal drugs have been codified at part 511. If the new animal drug is only for tests in vitro or in laboratory research animals, the person distributing the new animal drug must maintain records showing the name and post office address of the expert or expert organization to whom it is shipped and the date, quantity, and batch or code mark of each shipment and delivery for a period of 2 years after such shipment or delivery. Before shipping a new animal drug for clinical investigations in animals, a sponsor must submit to FDA a Notice of Claimed Investigational Exemption (NCIE). The NCIE must contain, among other things, the following specific information: (1) Identity of the new animal drug, (2) labeling, (3) statement of compliance of any non-clinical laboratory studies with good laboratory practices, (4) name and address of each clinical investigator, (5) the approximate number of animals to be treated or amount of new animal drug(s) to be shipped, and (6) information regarding the use of edible tissues from investigational animals. Part 511 also requires that records be established and maintained to document the distribution and use of the investigational new animal drug to assure that its use is safe, and that the distribution is controlled to prevent potential abuse. The Agency uses these required records under its Bioresearch Monitoring Program to monitor the validity of the studies submitted to FDA to support new animal drug approval and to assure that proper use of the drug is maintained by the investigator.

    Investigational new animal drugs are used primarily by drug industry firms, academic institutions, and the government. Investigators may include individuals from these entities, as well as research firms and members of the medical professions. Respondents to this collection of information are the persons who use new animal drugs for investigational purposes.

    In the Federal Register of April 2, 2015 (80 FR 17758), FDA published a 60-day notice requesting public comment on the proposed collection of information. Two comments were received but neither responded to any of the four information collection topics solicited and are therefore not addressed by the Agency.

    FDA estimates the burden of this information collection as follows:

    Table 1—Estimated Annual Reporting Burden 1 21 CFR section Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average burden per response Total hours
    511.1(b)(4) 263 5.30 1,395 1 1,395 511.1(b)(5) 263 .26 69 8 552 511.1(b)(6) 263 .01 2 1 2 511.1(b)(8)(ii) 263 .06 15 2 30 511.1(b)(9) 263 .06 15 8 120 Total 2,099 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 2—Estimated Annual Recordkeeping Burden 1 21 CFR section Number of
  • recordkeepers
  • Number of records per
  • recordkeeper
  • Total annual records Average burden per
  • recordkeeping
  • Total hours
    511.1(a)(3) 263 2.07 545 1 545 511.1(b)(3) 263 5.30 1,395 1 1,395 511.1(b)(7)(ii) 263 5.30 1,395 3.5 4,882.5 511.1(b)(8)(i) 263 5.30 1,395 3.5 4,882.5 Total 11,705 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimate of the time required for reporting requirements, record preparation, and maintenance for this collection of information is based on informal Agency communication with industry. Based on the number of sponsors subject to animal drug user fees, FDA estimates that there are 263 respondents. We use this estimate consistently throughout the table and calculate the “annual frequency per respondent” by dividing the total annual responses by number of respondents. Additional information needed to make a final calculation of the total burden hours (i.e., the number of respondents, the number of recordkeepers, the number of NCIEs received, etc.) is derived from Agency records.

    Dated: June 17, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-15320 Filed 6-22-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0253] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug Experience Reporting and Recordkeeping Biological Products AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by July 22, 2015.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-0230. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Postmarketing Adverse Drug Experience Reporting OMB Control Number 0910-0230—(Extension)

    Sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 352, 355, and 371) require that marketed drugs be safe and effective. In order to know whether drugs that are not safe and effective are on the market, FDA must be promptly informed of adverse experiences associated with the use of marketed drugs. In order to help ensure this, FDA issued regulations at §§ 310.305 and 314.80 (21 CFR 310.305 and 314.80) to impose reporting and recordkeeping requirements on the drug industry that would enable FDA to take the action necessary to protect the public health from adverse drug experiences.

    All applicants who have received marketing approval of drug products are required to report to FDA serious, unexpected adverse drug experiences (“15-day Alert reports”), as well as follow up reports (§ 314.80(c)(1)). This includes reports of all foreign or domestic adverse experiences as well as those based on information from applicable scientific literature and certain reports from postmarketing studies. Section 314.80(c)(1)(iii) pertains to such reports submitted by non-applicants.

    Under § 314.80(c)(2), applicants must provide periodic reports of adverse drug experiences. A periodic report includes, for the reporting interval, reports of serious, expected adverse drug experiences and all nonserious adverse drug experiences and an index of these reports, a narrative summary and analysis of adverse drug experiences, an analysis of the 15-day Alert reports submitted during the reporting interval, and a history of actions taken because of adverse drug experiences. Under § 314.80(i), applicants must keep for 10 years records of all adverse drug experience reports known to the applicant.

    For marketed prescription drug products without approved new drug applications or abbreviated new drug applications, manufacturers, packers, and distributors are required to report to FDA serious, unexpected adverse drug experiences as well as follow-up reports (§ 310.305(c)). Section 310.305(c)(5) pertains to the submission of follow-up reports to reports forwarded to the manufacturers, packers, and distributors by FDA. Under § 310.305(f), each manufacturer, packer, and distributor shall maintain for 10 years records of all adverse drug experiences required to be reported.

    The primary purpose of FDA's adverse drug experience reporting system is to enable identification of signals for potentially serious safety problems with marketed drugs. Although premarket testing discloses a general safety profile of a new drug's comparatively common adverse effects, the larger and more diverse patient populations exposed to the marketed drug provide the opportunity to collect information on rare, latent, and long-term effects. Signals are obtained from a variety of sources, including reports from patients, treating physicians, foreign regulatory agencies, and clinical investigators. Information derived from the adverse drug experience reporting system contributes directly to increased public health protection because the information enables FDA to make important changes to the product's labeling (such as adding a new warning), decisions about risk evaluation and mitigation strategies or the need for postmarket studies or clinical trials, and when necessary, to initiate removal of a drug from the market.

    In the Federal Register of March 12, 2015 (80 FR 13009), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

    Table 1—Estimated Annual Reporting Burden 12 21 CFR section No. of
  • respondents
  • No. of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • Total hours
    310.305(c)(5) 3 1 3 1 3 314.80(c)(1)(iii) 5 1 5 1 5 314.80(c)(2) 724 19.33 13,996 60 839,760 Total 839,768 1 The reporting burden for § 310.305(c)(1), (c)(2), and (c)(3), and § 314.80(c)(1)(i) and (c)(1)(ii) is covered under OMB Control No. 0910-0291. 2 The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.
    Table 2—Estimated Annual Recordkeeping Burden 12 21 CFR section No. of
  • recordkeepers
  • No. of records per
  • recordkeeper
  • Total annual records Average
  • burden per
  • recordkeeping
  • Total hours
    310.305(f) 25 1 25 16 400 314.80(i) 724 508 367,959 16 5,887,344 Total 5,887,744 1 There are no capital costs or operating costs associated with this collection of information. 2 There are maintenance costs of approximately $22,000 annually.
    Dated: June 17, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-15319 Filed 6-22-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0002] Determination That ABILIFY (Aripiprazole) Solution Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) has determined that the drug product listed in this document was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

    FOR FURTHER INFORMATION CONTACT:

    Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363, [email protected]

    SUPPLEMENTARY INFORMATION:

    In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

    The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

    Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.

    FDA has become aware that the drug product listed in the table is no longer being marketed.

    Application No. Drug Applicant NDA 021713 ABILIFY (aripiprazole) Solution; Oral, 1 milligram/1 milliliter Otsuka Pharmaceutical Development and Commercialization Inc., 2440 Research Blvd., Rockville, MD 20850.

    FDA has reviewed its records and, under § 314.161, has determined that the drug product listed in this document was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug product listed in this document in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.

    Approved ANDAs that refer to the NDA listed in this document are unaffected by the discontinued marketing of the products subject to that NDA. Additional ANDAs that refer to this product may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

    Dated: June 16, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-15327 Filed 6-22-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Centers for Disease Control and Prevention (CDC)/Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis and Sexually Transmitted Diseases (STD) Prevention and Treatment; Notice of Meeting

    In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting:

    Name: CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT).

    Date and Time: July 28, 2015, 3:00 p.m.-4:00 p.m.

    Place: This meeting is accessible via audio conference call and Adobe Connect Pro.

    Status: This meeting is open to the public. The virtual meeting is available via teleconference line and Adobe Connect Pro Meeting and will accommodate approximately 100 people. Join the meeting by:

    1. (Audio Portion) Calling the Toll-free Phone Number 1-800-369-3340 and providing the Public Participant Pass Code 8527572; and

    2. (Visual Portion) Connecting to the Advisory Committee Adobe Connect Pro Meeting using the following URL: https://hrsa.connectsolutions.com/cdc-hrsa_AC/. (Copy and paste the above link into your browser if it does not work directly). Participants should call and connect 15 minutes prior to the meeting in order for logistics to be set up. Call (301) 443-9684 or send an email to [email protected] if you have any questions, or send an email to [email protected] if you are having trouble connecting to the meeting site.

    Purpose: This Committee is charged with advising the Director, CDC, and the Acting Administrator, HRSA, regarding activities related to prevention and control of HIV/AIDS, Viral Hepatitis and other STDs, the support of health care services to persons living with HIV/AIDS, and the education of health professionals and the public about HIV/AIDS, Viral Hepatitis, and other STDs.

    Agenda: Agenda items include: (1) Discuss and vote on the “Resolution to express CHACHSPT's recognition on the 25th Anniversary of the Ryan White CARE Act”; and (2) hear the orientation session and discuss the purpose and role of the CHACHSPT. Agenda items are subject to change as priorities dictate.

    FOR FURTHER INFORMATION CONTACT:

    Shelley B. Gordon, Senior Public Health Analyst, Health Resources and Services Administration, HIV/AIDS Bureau, Division of Policy and Data, 5600 Fishers Lane, Room 7C-26, Rockville, Maryland 20857, telephone (301) 443-9684, fax (301) 443-3343, or email [email protected]

    Jackie Painter, Director, Division of the Executive Secretariat.
    [FR Doc. 2015-15283 Filed 6-22-15; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcement of Revision to the Department of Health and Human Services Guidance on Procedures for the Provision of Marijuana for Medical Research as Published on May 21, 1999. AGENCY:

    Office of the Secretary, Office of the Assistant Secretary for Health, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    Announcement of the elimination of the Public Health Service (PHS) review of non-federally funded research protocols involving marijuana and the utilization of the existing Food and Drug Administration (FDA) Investigational New Drug (IND) process for drug development.

    DATES:

    Effective June 2015.

    ADDRESSES:

    Not applicable.

    FOR FURTHER INFORMATION CONTACT:

    Christine Cichetti, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services; telephone (202) 619-0242; email: [email protected].

    SUPPLEMENTARY INFORMATION:

    On May 21, 1999, the PHS review process was established in response to enhanced interest by the biomedical research community in determining the potential therapeutic benefits of marijuana. The original notice of policy change can be found at http://grants.nih.gov/grants/guide/notice-files/not99-091.html. The PHS review process, which includes a committee review of study protocols, helped create a pathway for non-federally funded researchers to conduct these studies. In order to further facilitate research, HHS recently re-evaluated the PHS review procedures to identify opportunities for increased efficiency. The Office of the Assistant Secretary for Health (OASH), in consultation with the National Institutes of Health (NIH) and FDA, determined that the PHS review overlaps in several important ways with FDA's IND process and is no longer necessary to support the conduct of scientifically-sound studies into the potential therapeutic uses of marijuana. The PHS review committee considers the following: Research quality; incorporation of elements of good clinical and laboratory research practices; emphasis on adequate and well-controlled clinical studies; and development of dosage forms of marijuana that would be an alternative to smoked marijuana. The FDA's IND review process considers similar research characteristics: Adherence to good clinical and laboratory practices; whether pivotal clinical trials to support the marketing of proposed drug products are adequate and well-controlled; and the therapeutic benefits and risks to study subjects, favoring dosage forms that would provide measured and consistent dosing to patients as well as reduced exposure to potentially harmful constituents. Therefore, while not identical, the two processes have similar goals (e.g., guiding research on drug development and assuring appropriate treatment of human subjects), share similar criteria for protocol reviews, and possess similar capacity to engage with federal experts for consultation. Based on these considerations, and in order to streamline the application and approval processes for cannabis research, the committee that conducts the PHS review shall be eliminated. Below are instructions for researchers interested in the acquisition of cannabis for medical research. Complete guidance can be found on the NIH/National Institute on Drug Abuse (NIDA) Web site: (http://www.drugabuse.gov/researchers/research-resources/nida-drug-supply-program).

    Background

    Under the 1961 international Single Convention on Narcotic Drugs (amended in 1972), cannabis is designated a Schedule I substance, and participating countries are required to restrict production, manufacture, possession, and distribution of marijuana except for medical and scientific purposes. The Drug Enforcement Administration (DEA) regulates the cultivation of marijuana for research purposes through licensing requirements and establishment of annual aggregate production quotas under the authority of the 1970 Controlled Substances Act (CSA), which implements the Single Convention.

    Marijuana for use in research can be obtained through the NIDA Drug Supply Program. All applicants must fulfill the following criteria:

    For non-NIH funded human research projects:

    1. Demonstrate scientific validity and ethical soundness through review by the FDA's IND process. Research protocols will undergo a scientific review which assures the safety and rights of subjects and the scientific quality of the clinical investigations, and assesses the likelihood that investigations will yield data capable of meeting the statutory standards for drug marketing approval; and

    2. Possess a DEA registration for marijuana, a Schedule I controlled substance under the CSA.

    For NIH-funded projects:

    1. Demonstrate scientific validity and ethical soundness through the NIH grant review process which consists of three steps: (1) The NIH peer review system, which assesses the scientific and technical merit of all grant applications; (2) the National Advisory Council of the funding institute, comprising eminent scientists as well as public members; and (3) the funding institute's Director