Federal Register Vol. 80, No.195,

Federal Register Volume 80, Issue 195 (October 8, 2015)

Page Range60795-61086
FR Document

80_FR_195
Current View
Page and SubjectPDF
80 FR 61083 - German-American Day, 2015PDF
80 FR 60936 - Sunshine Act MeetingPDF
80 FR 60931 - Government in the Sunshine Act MeetingPDF
80 FR 60900 - Sunshine Act MeetingPDF
80 FR 60802 - Safety Zone, Chicago Harbor, Navy Pier Southeast, Chicago, ILPDF
80 FR 60876 - Request for Applications: The Community Forest and Open Space Conservation ProgramPDF
80 FR 60928 - Information Collection Activities: Pollution Prevention and Control; Submitted for Office of Management and Budget (OMB) Review; Comment RequestPDF
80 FR 60881 - Certain Cold-Rolled Steel Flat Products From Brazil, India, the People's Republic of China, the Republic of Korea, and the Russian Federation: Postponement of Preliminary Determinations in the Countervailing Duty InvestigationsPDF
80 FR 60881 - Fresh Garlic From the People's Republic of China: Final Rescission of the Semiannual Antidumping Duty New Shipper Review of Jinxiang Kaihua Imp & Exp Co., Ltd.PDF
80 FR 60883 - Certain Preserved Mushrooms From the People's Republic of China: Initiation of Antidumping Duty New Shipper ReviewPDF
80 FR 60937 - Florida Power and Light Company St. Lucie Plant, Unit 2PDF
80 FR 60937 - Vogtle Electric Generating Plant, Units 3 and 4PDF
80 FR 60897 - Pesticide Program Dialogue Committee; Notice of Public MeetingPDF
80 FR 60899 - Receipt of Test Data Under the Toxic Substances Control ActPDF
80 FR 60882 - Utility Scale Wind Towers From the People's Republic of China: Notice of Rescission of Antidumping Duty Administrative Review; 2014-2015PDF
80 FR 60880 - Utility Scale Wind Towers From the Socialist Republic of Vietnam: Notice of Rescission of Antidumping Duty Administrative Review; 2014-2015PDF
80 FR 60884 - Science Advisory Board (SAB)PDF
80 FR 60900 - Privacy Act of 1974; System of RecordsPDF
80 FR 60807 - Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Atka Mackerel in the Bering Sea and Aleutian Islands Management AreaPDF
80 FR 60898 - National and Governmental Advisory Committees to the U.S. Representative to the Commission for Environmental CooperationPDF
80 FR 60818 - Ethylene Glycol Monobutyl Ether; Community Right-To-Know Toxic Chemical Release ReportingPDF
80 FR 60958 - Open Meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project CommitteePDF
80 FR 60879 - Meeting of the United States Manufacturing CouncilPDF
80 FR 60959 - Open Meeting of the Taxpayer Advocacy Panel Special Projects CommitteePDF
80 FR 60958 - Open Meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project CommitteePDF
80 FR 60958 - Open Meeting of the Taxpayer Advocacy Panel Joint CommitteePDF
80 FR 60959 - Open Meeting of the Taxpayer Advocacy Panel Tax Forms and Publications Project CommitteePDF
80 FR 60959 - Open Meeting of the Taxpayer Advocacy Panel Toll-Free Phone Line Project CommitteePDF
80 FR 60901 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMBPDF
80 FR 60956 - Proposed Collection; Comment Request for Electronic License Application FormPDF
80 FR 60924 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
80 FR 60925 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
80 FR 60927 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
80 FR 60926 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
80 FR 60958 - Open Meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project CommitteePDF
80 FR 60950 - Draft Availability Payment Concessions Public-Private Partnership Model Contract GuidePDF
80 FR 60891 - Maricopa West Solar PV, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
80 FR 60893 - Combined Notice of Filings #2PDF
80 FR 60893 - Wheelabrator Saugus Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
80 FR 60894 - Cedar Bluff Wind, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request For Blanket Section 204 AuthorizationPDF
80 FR 60889 - Combined Notice of Filings #1PDF
80 FR 60879 - Advisory Committee MeetingPDF
80 FR 60886 - State Energy Advisory Board (STEAB)PDF
80 FR 60908 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
80 FR 60905 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
80 FR 60906 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
80 FR 60885 - Biological and Environmental Research Advisory CommitteePDF
80 FR 60909 - Submitting Food Canning Establishment Registration Form and Food Process Filing Forms to the Food and Drug Administration in Electronic or Paper Format: Guidance for Industry; AvailabilityPDF
80 FR 60955 - DRV, LLC, Receipt of Petition for Decision of Inconsequential NoncompliancePDF
80 FR 60872 - Privacy Act Systems of Records; Wildlife Services Management Information SystemPDF
80 FR 60888 - PacifiCorp; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and ProtestsPDF
80 FR 60890 - Duke Energy Carolinas, LLC; Notice of Availability of Draft Environmental AssessmentPDF
80 FR 60892 - Transwestern Pipeline Company, LLC; Notice of Request Under Blanket AuthorizationPDF
80 FR 60886 - Notice of ApplicationPDF
80 FR 60895 - Equitrans, L.P.; Notice of ApplicationPDF
80 FR 60895 - DBM Pipeline, LLC; Notice of Staff Protest to Proposed Blanket Certificate ActivityPDF
80 FR 60891 - City of Manitou Springs, Colorado;PDF
80 FR 60896 - Public Citizen, Inc. v. Midcontinent Independent System Operator, Inc., The People of the State of Illinois By Illinois Attorney General Lisa Madigan v. Midcontinent Independent System Operator, Inc., Southwestern Electric Cooperative, Inc. v. Midcontinent Independent System Operator, Inc., Dynegy, Inc., and Sellers of Capacity into Zone 4 of the 2015-2016 MISO Planning Resource Auction, Illinois Industrial Energy Consumers v. Midcontinent Independent System Operator, Inc.; Notice of Technical ConferencePDF
80 FR 60893 - New York Association of Public Power v. Niagara Mohawk Power Corporation and New York Independent System Operator, Inc., New York Association of Public Power v. Niagara Mohawk Power Corporation and New York Independent System Operator, Inc., Municipal Electric Utilities Association of New York v. Niagara Mohawk Power Corporation and New York Independent System Operator, Inc.; Notice of FilingPDF
80 FR 60916 - Integrated Summary of Effectiveness; Guidance for Industry; AvailabilityPDF
80 FR 60901 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
80 FR 60953 - Fiscal Year 2015 Innovative Public Transportation Workforce Development Program Project SelectionsPDF
80 FR 60809 - General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical BassinetPDF
80 FR 60885 - Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Standard for Infant SwingsPDF
80 FR 60911 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substance Notification ProgramPDF
80 FR 60913 - Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act ProductsPDF
80 FR 60918 - Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division LevelPDF
80 FR 60917 - Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; AvailabilityPDF
80 FR 60935 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection; Comments Requested: Generic Clearance for Cognitive, Pilot and Field Studies for Bureau of Justice Statistics Data Collection ActivitiesPDF
80 FR 60934 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension Without Change, of a Previously Approved Collection Federal Firearms License (FFL) RENEWAL ApplicationPDF
80 FR 60957 - Sanctions Actions Pursuant to Executive Order 13224PDF
80 FR 60888 - Pacific Gas and Electric Company; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and ProtestsPDF
80 FR 60894 - Combined Notice of Filings #1PDF
80 FR 60935 - Notice of Lodging Proposed Consent DecreePDF
80 FR 60832 - Federal Acquisition Regulation; Simplified Acquisition Threshold for Overseas Acquisitions in Support of Humanitarian or Peacekeeping OperationsPDF
80 FR 60833 - Federal Acquisition Regulation; Improvement in Design-Build Construction ProcessPDF
80 FR 60947 - Projects Approved for Consumptive Uses of WaterPDF
80 FR 60875 - National Urban and Community Forestry Advisory CouncilPDF
80 FR 60936 - Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978PDF
80 FR 60953 - Petition for Waiver of CompliancePDF
80 FR 60950 - Aviation Rulemaking Advisory Committee Meeting on Transport Airplane and Engine IssuesPDF
80 FR 60797 - Miscellaneous RulesPDF
80 FR 60902 - Wright Medical Group, Inc. and Tornier N.V.; Analysis To Aid Public CommentPDF
80 FR 60931 - Notice of Lodging of Proposed Consent Decree Under the Clean Water ActPDF
80 FR 60946 - Privacy Act of 1974, as Amended; Computer Matching Program (SSA/Office of Personnel Management (OPM))-Match Numbers 1005, 1019, 1020, and 1021PDF
80 FR 60940 - Proposed Collection; Comment RequestPDF
80 FR 60944 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Clearance of New Natural Gas Futures ContractsPDF
80 FR 60941 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing of a Proposed Rule Change Relating To Margin RequirementsPDF
80 FR 60921 - Center for Scientific Review Notice of Closed MeetingsPDF
80 FR 60921 - National Institute of Environmental Health Sciences; Notice of Closed MeetingPDF
80 FR 60920 - National Heart, Lung, and Blood Institute Notice of Closed MeetingsPDF
80 FR 60922 - National Institute of Environmental Health Sciences Notice of Closed MeetingsPDF
80 FR 60825 - Assessment and Collection of Regulatory Fees for Fiscal Year 2015PDF
80 FR 60899 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
80 FR 60805 - Approval and Promulgation of Implementation Plans; Kentucky: New Sources in or Impacting Nonattainment AreasPDF
80 FR 60952 - Positive Train Control Safety Plan for the Southern California Regional Rail AuthorityPDF
80 FR 60803 - Security Zone: Escorted Vessels, Los Angeles-Long Beach, CA, Captain of the Port ZonePDF
80 FR 60795 - Airworthiness Directives; Dassault Aviation AirplanesPDF
80 FR 60797 - Administrative Wage Garnishment ProceduresPDF
80 FR 60950 - Thirty-Sixth Meeting: Special Committee (224) Airport Security Access Control SystemsPDF
80 FR 61029 - Endangered and Threatened Wildlife and Plants; Designation of Critical Habitat for Kentucky Arrow DarterPDF
80 FR 60989 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Sierra Nevada Red Fox as an Endangered or Threatened SpeciesPDF
80 FR 60961 - Endangered and Threatened Wildlife and Plants; Threatened Species Status for Kentucky Arrow Darter With 4(d) RulePDF
80 FR 60850 - Endangered and Threatened Wildlife and Plants; Reclassifying the Columbian White-Tailed Deer From Endangered to Threatened With a Rule Under Section 4(d) of the ActPDF
80 FR 60834 - Endangered and Threatened Wildlife and Plants; 12-Month Findings on Petitions To List 19 Species as Endangered or Threatened SpeciesPDF
80 FR 60923 - Request for Information (RFI): Soliciting Input for the National Center for Advancing Translational Sciences (NCATS) Strategic Planning ProcessPDF

Issue

80 195 Thursday, October 8, 2015 Contents Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

See

Forest Service

See

Grain Inspection, Packers and Stockyards Administration

Animal Animal and Plant Health Inspection Service NOTICES Privacy Act; Systems of Records, 60872-60875 2015-25640 Safety Enviromental Enforcement Bureau of Safety and Environmental Enforcement NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Pollution Prevention and Control, 60928-60930 2015-25707 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 60905-60909 2015-25646 2015-25647 2015-25648 Coast Guard Coast Guard RULES Safety Zones: Chicago Harbor, Navy Pier Southeast, Chicago, IL, 60802-60803 2015-25728 Security Zones: Escorted Vessels, Los Angeles-Long Beach, CA, Captain of the Port Zone, 60803-60805 2015-25557 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Consumer Product Consumer Product Safety Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Safety Standard for Infant Swings, 60885 2015-25626 Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Meetings: Biological and Environmental Research Advisory Committee, 60885-60886 2015-25645 State Energy Advisory Board; Teleconference, 60886 2015-25649
Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Kentucky: New Sources in or Impacting Nonattainment Areas, 60805-60807 2015-25575 PROPOSED RULES Denial of Petition: Ethylene Glycol Monobutyl Ether; Community Right-to-Know Toxic Chemical Release Reporting, 60818-60825 2015-25674 NOTICES Meetings: National and Governmental Advisory Committees to the U.S. Representative to the Commission for Environmental Cooperation, 60898-60899 2015-25675 Pesticide Program Dialogue Committee, 60897-60898 2015-25687 Receipt of Test Data Under the Toxic Substances Control Act, 60899 2015-25686 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Dassault Aviation Airplanes, 60795-60797 2015-25492 NOTICES Meetings: Aviation Rulemaking Advisory Committee, Transport Airplane and Engine Issues, 60950 2015-25608 Special Committee (224) Airport Security Access Control Systems;, 60950 2015-25402 Federal Communications Federal Communications Commission PROPOSED RULES Assessment and Collection of Regulatory Fees for Fiscal Year 2015, 60825-60831 2015-25578 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 60899-60900 2015-25577 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 60900 2015-25736 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Atlantic Coast Pipeline, LLC, Dominion Transmission, Inc., Atlantic Coast Pipeline, LLC and Piedmont Natural Gas Co., Inc, 60886-60888 2015-25636 Equitrans, LP, 60895-60896 2015-25635 Pacific Gas and Electric Co., 60888-60889 2015-25617 PacifiCorp, 60888 2015-25639 Combined Filings, 60889-60890, 60893-60895 2015-25616 2015-25651 2015-25654 Environmental Assessments; Availability, etc.: Duke Energy Carolinas, LLC, 60890-60891 2015-25638 Filings: New York Association of Public Power v. Niagara Mohawk Power Corp. et al, 60893 2015-25631 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Cedar Bluff Wind, LLC, 60894 2015-25652 Maricopa West Solar PV, LLC, 60891 2015-25655 Wheelabrator Saugus Inc., 60893 2015-25653 Qualifying Conduit Hydropower Facilities: Manitou Springs, CO, 60891-60892 2015-25633 Requests Under Blanket Authorizations: Transwestern Pipeline Co., LLC, 60892-60893 2015-25637 Staff Protest to Proposed Blanket Certificate Activities: DBM Pipeline, LLC, 60895 2015-25634 Technical Conferences: Public Citizen, Inc. v. Midcontinent Independent System Operator, Inc., et al, 60896-60897 2015-25632 Federal Highway Federal Highway Administration NOTICES Draft Availability Payment Concessions Public-Private Partnership Model Contract Guide, 60950-60952 2015-25656 Federal Housing Finance Agency Federal Housing Finance Agency NOTICES Privacy Act of 1974; System of Records, 60900-60901 2015-25678 Federal Railroad Federal Railroad Administration NOTICES Petitions for Waivers of Compliance, 60953 2015-25609 Positive Train Control Safety Plan for the Southern California Regional Rail Authority, 60952-60953 2015-25573 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 60901-60902 2015-25664 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 60901 2015-25629 Federal Trade Federal Trade Commission RULES Miscellaneous Rules; Technical Correction, 60797 2015-25605 NOTICES Proposed Consent Agreements: Wright Medical Group, Inc. and Tornier N.V., 60902-60905 2015-25604 Federal Transit Federal Transit Administration NOTICES Innovative Public Transportation Workforce Development Program Project Selections, 60953-60955 2015-25628 Fish Fish and Wildlife Service PROPOSED RULES Endangered and Threatened Wildlife and Plants: 12-Month Finding on a Petition To List Sierra Nevada Red Fox, 60990-61028 2015-25289 12-Month Findings on Petitions to List 19 Species as Endangered or Threatened Species, 60834-60850 2015-25058 Kentucky Arrow Darter; Designation of Critical Habitat, 61030-61081 2015-25290 Reclassifying the Columbian White-tailed Deer from Endangered to Threatened, 60850-60871 2015-25260 Threatened Species Status for Kentucky Arrow Darter with 4(d) Rule, 60962-60988 2015-25278 Food and Drug Food and Drug Administration PROPOSED RULES General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet, 60809-60817 2015-25627 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Food Contact Substance Notification Program, 60911-60913 2015-25625 Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level, 60918-60920 2015-25623 Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products, 60913-60915 2015-25624 Guidance for Industry and Staff: Integrated Summary of Effectiveness, 60916-60917 2015-25630 Guidance: Adverse Event Reporting for Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act, 60917-60918 2015-25622 Submitting Food Canning Establishment Registration Form and Food Process Filing Forms in Electronic or Paper Format, 60909-60911 2015-25642 Foreign Assets Foreign Assets Control Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Electronic License Application Form, 60956-60957 2015-25662 Blocking or Unblocking of Persons and Properties, 60957 2015-25618 Forest Forest Service NOTICES Meetings: National Urban and Community Forestry Advisory Council, 60875-60876 2015-25611 Requests for Applications: Community Forest and Open Space Conservation Program, 60876-60879 2015-25725 General Services General Services Administration PROPOSED RULES Federal Acquisition Regulation: Improvement in Design-Build Construction Process, 60833-60834 2015-25613 Simplified Acquisition Threshold for Overseas Acquisitions in Support of Humanitarian or Peacekeeping Operations, 60832-60833 2015-25614 Grain Inspection Grain Inspection, Packers and Stockyards Administration NOTICES Meetings: Grain Inspection Advisory Committee, 60879 2015-25650 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Food and Drug Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

Homeland Homeland Security Department See

Coast Guard

Interior Interior Department See

Bureau of Safety and Environmental Enforcement

See

Fish and Wildlife Service

Internal Revenue Internal Revenue Service NOTICES Meetings: Taxpayer Advocacy Panel Joint Committee, 60958-60959 2015-25667 Taxpayer Advocacy Panel Notices and Correspondence Project Committee, 60958 2015-25669 Taxpayer Advocacy Panel Special Projects Committee, 60959 2015-25670 Taxpayer Advocacy Panel Tax Forms and Publications Project Committee, 60959 2015-25666 Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee, 60958 2015-25672 Taxpayer Advocacy Panel Taxpayer Communications Project Committee, 60958 2015-25657 Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee, 60959 2015-25665 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Cold-Rolled Steel Flat Products from Brazil, India, the People's Republic of China, the Republic of Korea, and the Russian Federation, 60881 2015-25706 Certain Preserved Mushrooms from the People's Republic of China, 60883-60884 2015-25704 Fresh Garlic from the People's Republic of China, 60881-60882 2015-25705 Utility Scale Wind Towers from the People's Republic of China, 60882-60883 2015-25684 Utility Scale Wind Towers from the Socialist Republic of Vietnam, 60880 2015-25683 Meetings: United States Manufacturing Council, 60879-60880 2015-25671 International Trade Com International Trade Commission NOTICES Meetings; Sunshine Act, 60931 2015-25846 Justice Department Justice Department See

Parole Commission

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Firearms License RENEWAL Application, 60934-60935 2015-25620 Generic Clearance for Cognitive, Pilot and Field Studies for Bureau of Justice Statistics Data Collection Activities, 60935-60936 2015-25621 Proposed Consent Decrees under the Clean Water Act, 60931-60935 2015-25602 2015-25615
Labor Department Labor Department RULES Administrative Wage Garnishment Procedures, 60797-60802 2015-25427 National Highway National Highway Traffic Safety Administration NOTICES Inconsequential Noncompliance; Petitions: DRV, LLC, 60955-60956 2015-25641 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 60921-60922 2015-25584 National Heart, Lung, and Blood Institute, 60920-60921 2015-25582 National Institute of Environmental Health Sciences, 60921-60922 2015-25581 2015-25583 Requests for Information: Soliciting Input for the National Center for Advancing Translational Sciences Strategic Planning Process, 60923-60924 2015-24761 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Atka mackerel in the Bering Sea and Aleutian Islands Management Area; Reallocation, 60807-60808 2015-25676 NOTICES Meetings: Science Advisory Board, 60884-60885 2015-25679 National Science National Science Foundation NOTICES Antarctic Conservation Act Permit Applications, 60936 2015-25610 Nuclear Regulatory Nuclear Regulatory Commission NOTICES License Amendment Applications: Vogtle Electric Generating Plant, Units 3 and 4, 60937-60940 2015-25688 Petitions: Florida Power and Light Company St. Lucie Plant, Unit 2, 60937 2015-25696 Parole Parole Commission NOTICES Meetings; Sunshine Act, 60936 2015-25857 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: German-American Day (Proc. 9343), 61083-61086 2015-25934 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 60940-60941 2015-25600 Self-Regulatory Organizations; Proposed Rule Changes: Chicago Board Options Exchange, Inc., 60941-60944 2015-25598 ICE Clear Europe Limited, 60944-60946 2015-25599 Social Social Security Administration NOTICES Privacy Act; Computer Matching Programs, 60946-60947 2015-25601 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 60924-60928 2015-25658 2015-25659 2015-25660 2015-25661 Susquehanna Susquehanna River Basin Commission NOTICES Projects Approved for Consumptive Uses of Water, 60947-60949 2015-25612 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Railroad Administration

See

Federal Transit Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department See

Foreign Assets Control Office

See

Internal Revenue Service

Separate Parts In This Issue Part II Interior Department, Fish and Wildlife Service, 60962-60988 2015-25278 Part III Interior Department, Fish and Wildlife Service, 60990-61028 2015-25289 Part IV Interior Department, Fish and Wildlife Service, 61030-61081 2015-25290 Part V Presidential Documents, 61083-61086 2015-25934 Reader Aids

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

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

80 195 Thursday, October 8, 2015 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-0934; Directorate Identifier 2014-NM-030-AD; Amendment 39-18287; AD 2015-20-08] RIN 2120-AA64 Airworthiness Directives; Dassault Aviation Airplanes AGENCY:

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

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for all Model FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes; Model MYSTERE-FALCON 200 airplanes; and Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes. This AD was prompted by reports of defective fire extinguisher tubes. It was determined the defects were caused by corrosion. This AD requires repetitive general visual inspections of the fire extinguisher tubes for cracking and corrosion, and replacement of any cracked tube with a serviceable tube, if necessary. We are issuing this AD to detect and correct cracking and corrosion in the fire extinguisher tubes, which could impact the capability to extinguish an engine fire, and possibly result in damage to the airplane and injury to the passengers.

DATES:

This AD becomes effective November 12, 2015.

ADDRESSES:

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-0934; or in person at the Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Dassault Aviation Model FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes; Model MYSTERE-FALCON 200 airplanes; and Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes. The NPRM published in the Federal Register on May 4, 2015 (80 FR 25254).

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued Airworthiness Directive 2013-0299, dated December 19, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Dassault Aviation Model FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes; Model MYSTERE-FALCON 200 airplanes; and Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes. The MCAI states:

Several defective extinguisher tubes have been reported on certain Dassault Aviation Fan Jet Falcon aeroplanes. The results of the investigations concluded that these occurrences were caused by corrosion.

This condition, if not detected and corrected, could impact the capability to extinguish an engine fire, possibly resulting in damage to the aeroplane and injury to the occupants.

For the reason described above, this [EASA] AD requires repetitive [general visual] inspections [for cracking and corrosion] of the fire extinguisher tubes and, depending on findings, the replacement of an affected part with a serviceable part (improved fire extinguisher tube). It also proposes the replacement of those tubes with the “old Part Number” (P/N) with a serviceable part with the new P/N as a terminating action. In addition, this [EASA] AD prohibits installation of an affected tube on an aeroplane.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-0934-0002.

Comments

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 25254, May 4, 2015) or on the determination of the cost to the public.

Conclusion

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

• Are consistent with the intent that was proposed in the NPRM (80 FR 25254, May 4, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 25254, May 4, 2015).

Costs of Compliance

We estimate that this AD affects 170 airplanes of U.S. registry.

We also estimate that it will take about 4 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $57,800, or $340 per product.

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

Authority for This Rulemaking

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

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

Regulatory Findings

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-0934; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2015-20-08 Dassault Aviation: Amendment 39-18287. Docket No. FAA-2015-0934; Directorate Identifier 2014-NM-030-AD. (a) Effective Date

This AD becomes effective November 12, 2015.

(b) Affected ADs

None.

(c) Applicability

This AD applies to Dassault Aviation Model FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes; Model MYSTERE-FALCON 200 airplanes; and Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes, certificated in any category, all manufacturer serial numbers.

(d) Subject

Air Transport Association (ATA) of America Code 26, Fire protection.

(e) Reason

This AD was prompted by reports of defective fire extinguisher tubes. It was determined the defects were caused by corrosion. We are issuing this AD to detect and correct cracking and corrosion in the fire extinguisher tubes, which could impact the capability to extinguish an engine fire, and possibly result in damage to the airplane and injury to the passengers.

(f) Compliance

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

(g) Inspection

For airplanes identified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD: Within 13 months or 450 flight hours, whichever occurs first after the effective date of this AD, do a general visual inspection of the fire extinguisher tubes for cracking and corrosion, in accordance with a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Dassault Aviation's EASA Design Organization Approval (DOA). Repeat the inspection thereafter at intervals not to exceed 13 months.

(1) Model FAN JET FALCON airplanes and Model FAN JET FALCON SERIES C, D, E, F, and G airplanes, equipped with any fire extinguisher tubes having part numbers MY20791-101, MY20791-101-1, MY20791-102, MY20791-102-1, MY20791-117, and MY20791-112.

(2) Model MYSTERE-FALCON 200 airplanes equipped with any fire extinguisher tubes having part numbers M20H791000210B1 and M20H791000240B1.

(3) Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes equipped with any fire extinguisher tubes having part numbers M20R791101, M20R791101A1, and M20R791102.

(h) Corrective Action

If, during any inspection required by paragraph (g) of this AD, any cracking or corrosion is found, before further flight, replace the tube with a serviceable tube having a part number specified in Table 1 to paragraph (h) of this AD, as applicable.

Table 1 to Paragraph (h) of This AD—Serviceable Fire Extinguisher Tubes For model— Equipped with affected pin— Replace with serviceable pin— FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes MY20791-101 MY20791-101-2. FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes MY20791-101-1 MY20791-101-2. FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes MY20791-102 MY20791-102-2. FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes MY20791-102-1 MY20791-102-2. FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes MY20791-117 MY20791-117n-1. FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes MY20791-112 MY20791-112-1. MYSTERE-FALCON 200 airplanes M20H791000210B1 M20H791000210B2. MYSTERE-FALCON 200 airplanes M20H791000240B1 M20H791000240B2. MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes M20R791101 M20R791101A2. MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes M20R791101A1 M20R791101A3. MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes M20R791102 M20R791102A2. (i) Terminating Action for the Repetitive Inspections

Replacement of an affected tube with a serviceable tube, as required by paragraph (h) of this AD, constitutes a terminating action for the repetitive inspections required by paragraph (g) of this AD.

(j) Parts Installation Prohibition

As of the effective date of this AD, no person may install a tube having a part number identified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD, on any airplane.

(k) Other FAA AD Provisions

The following provisions also apply to this AD:

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

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

(l) Related Information

Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2013-0299, dated December 19, 2013, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-0934-0002.

(m) Material Incorporated by Reference

None.

Issued in Renton, Washington, on September 29, 2015. Jeffrey E. Duven, Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2015-25492 Filed 10-7-15; 8:45 am] BILLING CODE 4910-13-P
FEDERAL TRADE COMMISSION 16 CFR Part 4 Miscellaneous Rules AGENCY:

Federal Trade Commission.

ACTION:

Final rules; technical correction.

SUMMARY:

The Federal Trade Commission published final rules on May 6, 2015, revising certain of its rules of practice. This document makes a technical correction to those final rules.

DATES:

Effective October 8, 2015.

FOR FURTHER INFORMATION CONTACT:

Josephine Liu, Attorney, (202) 326-2170, Office of the General Counsel, Federal Trade Commission, 600 Pennsylvania Avenue NW., Washington, DC 20580.

SUPPLEMENTARY INFORMATION:

This document makes a technical correction to two cross-references in Rule 4.4(a)(3).

List of Subjects in 16 CFR Part 4

Administrative practice and procedure, Freedom of information, Public record.

Accordingly, 16 CFR part 4 is corrected by making the following correcting amendment:

PART 4—MISCELLANEOUS RULES 1. The authority citation for part 4 continues to read as follows: Authority:

15 U.S.C. 46, unless otherwise noted.

§ 4.4 [Amended]
2. In § 4.4, amend the first sentence of paragraph (a)(3) by removing “section 20(c)(7) of the FTC Act” and adding in its place “section 20(c)(8) of the FTC Act” and by removing “section 20(c)(8) of the FTC Act” and adding in its place “section 20(c)(9) of the FTC Act”.

By direction of the Commission.

Donald S. Clark, Secretary.
[FR Doc. 2015-25605 Filed 10-7-15; 8:45 am] BILLING CODE 6750-01-P
DEPARTMENT OF LABOR Office of the Secretary 29 CFR Part 20 RIN 1290-AA27 Administrative Wage Garnishment Procedures AGENCY:

Office of the Secretary, Labor.

ACTION:

Interim final rule with request for comments.

SUMMARY:

This rule will allow the U.S. Department of Labor (Department) to garnish the disposable wages of non-federal workers who are indebted to the Department without first obtaining a court order. It implements the administrative wage garnishment provisions contained in the Debt Collection Improvement Act of 1996 (DCIA) in accordance with the regulations issued by the Secretary of the Treasury.

DATES:

This rule is effective October 8, 2015. Comments must be received within 30 days of publication, which is on or before November 9, 2015.

ADDRESSES:

You may submit written comments to the docket using any one of the following methods:

(1) Federal eRulemaking Portal: http://www.regulations.gov.

(2) Mail: Address comments concerning this interim rule to Shelia Alexander, Office of Chief Financial Officer, U.S. Department of Labor, Frances Perkins Building, Room S4030, 200 Constitution Avenue NW., Washington, DC 20210.

(3) Email: Comments may also be submitted by electronic mail to [email protected]

Additionally, any comments that concern information collection may be sent to the Office of Information and Regulatory Affairs, Attention OMB Desk Officer for DOL, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Shelia Alexander, Office of the Chief Financial Officer, (202) 693-4472; or Rachel Rikleen, Office of the Solicitor, (202) 693-5702.

SUPPLEMENTARY INFORMATION: I. Background

Section 31001(o) of the Debt Collection Improvement Act of 1996 (DCIA), which is codified at 31 U.S.C. 3720D, authorizes federal agencies to use administrative procedure to garnish the disposable pay of an individual to collect delinquent non-tax debt owed to the United States in accordance with regulations promulgated by the Secretary of the Treasury. Wage garnishment is a process whereby an employer withholds amounts from an employee's wages and pays those amounts to the employee's creditor pursuant to a withholding order. Under the DCIA, agencies may garnish up to 15% of a delinquent non-tax debtor's disposable wages. Prior to the enactment of the DCIA, agencies were generally required to obtain a court judgment before garnishing the wages of non-Federal employees.

The DCIA requires the Secretary of the Treasury to issue regulations implementing the administrative wage garnishment requirements. These implementing regulations, which are at 31 CFR 285.11, provide for due process for nontax debtors and require agencies to publish regulations for administrative wage garnishment hearings. Pursuant to 31 CFR 285.11(f), federal agencies must either prescribe regulations for the conduct of an administrative wage garnishment hearing consistent with the procedures set forth in section 285.11 or adopt section 285.11 without change by reference. Through this rule, the Department has decided to issue its own regulations consistent with the procedural requirements of section 285.11.

This interim rule governs only administrative wage garnishment. Nothing in this regulation precludes the use of collection remedies not contained in the regulation. The Department and other federal agencies may simultaneously use multiple collection remedies to collect a debt, except as prohibited by law.

The Department may, but is not required to, promulgate additional policies, procedures, and understandings consistent with this regulation and other applicable Federal laws, policies, and procedures, subject to the approval of the Department's Chief Financial Officer or their delegate. The Department does not intend for its components, agencies, and entities to be able to adopt different policies, procedures, or understandings.

II. Public Participation

The Department is issuing this interim final rule to provide the public with an opportunity to comment. The Department must receive comments by the deadline stated above, which is no later than 30 days after this notice appears in the Federal Register.

III. Compliance With the Administraive Procedure Act; The Paperwork Reduction Act; The Regulatory Flexibility Act; The Unfunded Mandates Reform Act; and Executive Orders 12866, 12988, and 13132

For purposes of the Administrative Procedure Act, 5 U.S.C. 551-559, this rule involves an agency procedure or practice, and therefore no notice of proposed rulemaking is required under section 553. Nonetheless, this is an interim rulemaking, with a provision for a 30-day public comment period. The Department will review all comments received during the comment period and will consider any modifications that appear appropriate in adopting these rules as final.

The Department has determined that this rule contains no collection of information subject to the Paperwork Reduction Act, 44 U.S.C. 3501-3521. However, the Department specifically invites comments on this determination. In addition to having an opportunity to file comments with the Department, comments about the paperwork implications of the proposed regulations may be addressed to the Office of Management and Budget (OMB). Comments to the OMB should be directed to: Office of Information and Regulatory Affairs, Attention OMB Desk Officer for the DOL, Office of Management and Budget, Room 10235, Washington, DC 20503; Telephone: 202-395-7316/Fax: 202-395-6974 (these are not toll-free numbers). You can also submit comments to the OMB by email at [email protected] The OMB will consider all written comments that agency receives within 30 days of publication of this rule. (Commenters are encouraged, but not required, to send a courtesy copy of any comments submitted to the OMB regarding the information collections by mail or courier to: U.S. Department of Labor-OASAM, Office of the Chief Information Officer, Attn: Departmental Information Compliance Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210; or by email: [email protected]) As previously indicated, written comments directed to the Department may be submitted within 30 days of publication of this notice. Should a commenter believe this rule contains a covered information collection, then the Department and OMB seek comments that:

(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires administrative agencies to consider the effect of their actions on small entities, including small businesses. Because no notice of proposed rulemaking is required for procedural rules, the requirements of the RFA pertaining to regulatory flexibility analysis do not apply. However, even if the RFA were to apply, the Department certifies that this interim rule will not have a significant impact on a substantial number of small entities. Although the employer of a delinquent debtor would have to certify certain information about the debtor such as the debtor's employment status and earnings, that information is normally in the employer's payroll records. It would not take a significant amount of time or result in a significant cost for an employer to make this certification. An employer is not required to vary its normal pay cycle to comply with a garnishment order issued under these regulations.

For purposes of the Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1501-1516, the Department has determined that the rule contains no Federal mandates, as defined in Title II of UMRA. Therefore the rule is not subject to the requirements of section 202 and 205 of UMRA.

Executive Orders 12866 and 12988 require that each agency write regulations that are easy to understand and specify how individual civil litigation rights will be affected. The Department has determined that this rule is drafted, to the extent practicable, under the standards established in those orders. However, the Secretary invites comments on how to make these proposed regulations easier to understand.

Executive Order 13132 requires us to ensure meaningful and timely input by state and local elected officials in the development of regulatory policies that have federalism implications. The interim rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.

IV. Summary of Key Aspects of the Rule

This rule applies to debts owed to the Department or in connection with any program administered by the Department. The administrative wage garnishment process will be applied consistently throughout the Department.

The Department can enter into agreements, such as memoranda of understanding, with other Federal agencies permitting that agency to administer part or all of the Department's administrative wage garnishment process. Nothing in this regulation requires the Department to duplicate notices or administrative proceedings required by contract, this regulation, or other laws or regulations. Thus, for example, the Department is not required to provide a debtor with two hearings on the same issue merely because two different collection tools are used, each of which requires that the debtor be provided with a hearing.

Section 20.205 lists the notice requirements, which includes an explanation of the debtor's rights. The debtor is allowed to inspect Department records related to the debt, enter into a written repayment agreement, and have a hearing. A debtor can request one of two types of available hearings—a paper hearing or an oral hearing. The format of oral hearings is not limited to in-person and telephone hearings and may include new forms of technology. The hearing official has the authority to determine the kind of hearing and the amount of time allotted each hearing.

If a hearing is held, the Department can meet its initial burden by offering documentation, including a copy of the debt adjudication, which demonstrates the existence of the debt and its amount. Once the Department has established its prima facie case, the debtor can dispute the existence or amount of the debt. For example, the debtor can meet his or her burden by demonstrating that he or she is not the person who owes a debt to the Department, that he or she has not received payments from the Department or has not been fined by the Department, or that he or she has already paid the debt.

Additionally, the Federal Employees Compensation Act (FECA), 5 U.S.C. 8101-8193, contains a provision that precludes administrative and judicial review of agency determinations, which normally includes a repayment schedule. As a result, for hearings related to FECA debts, once the Department has made its prima facie case, the debtor has only two limited grounds on which he or she can demonstrate that an administrative wage garnishment is not appropriate. The debtor may not challenge the underlying merits of the determination that created the debt.

Section 20.209 describes how much the Department can withhold through administrative wage garnishment, which is up to 15%, and the employer's administrative wage garnishment duties. A withholding order for family support would always have priority over an administrative wage garnishment order. If there are multiple federal garnishment orders, priority depends on which garnishment order was first obtained. When a debtor's disposable pay is already subject to one or more withholding orders with higher or equal priority with the Department's administrative wage garnishment order, the amount that the employer must withhold and remit to the Department would not be more than an amount calculated by subtracting the amount(s) withheld under the other withholding order(s) from 25% of the debtor's disposable pay. For example, if the employer is withholding 20% of a debtor's disposable pay for a family support or prior withholding order, the amount withheld for the subsequent withholding order issued under this section is limited to 5% of the debtor's disposable pay. When the family support or prior withholding order terminates, the amount withheld for the subsequent withholding order issued under this section may be increased to 15%.

List of Subjects in 29 CFR Part 20

Administrative wage garnishment, debt collection, Labor.

Signed at Washington, DC, on this 29th day of September, 2015. Thomas E. Perez, U.S. Secretary of Labor.

For the reasons set forth in the preamble, the Department of Labor amends part 20 of title 29 of the Code of Federal Regulations as follows:

PART 20—FEDERAL CLAIMS COLLECTION 1. The authority citation for part 20 is revised to read as follows: Authority:

31 U.S.C. 3711 et seq.; Subpart D is also issued under 5 U.S.C. 5514; Subpart E is also issued under 31 U.S.C. 3720A; Subpart F is also issued under 31 U.S.C. 3720D.

2. Add subpart F to read as follows: Subpart F—Administrative Wage Garnishment Sec. 20.201 Purpose. 20.202 Scope. 20.203 Definitions. 20.204 General rule. 20.205 Notice requirements. 20.206 Hearing. 20.207 Wage garnishment order. 20.208 Certification by employer. 20.209 Amounts withheld. 20.210 Exclusions from garnishment. 20.211 Financial hardship. 20.212 Ending garnishment. 20.213 Actions prohibited by employer. 20.214 Refunds. 20.215 Right of Action.
§ 20.201 Purpose.

This section provides procedures the U.S. Department of Labor may use to collect money from a debtor's disposable pay by means of administrative wage garnishment to satisfy delinquent nontax debt owed to the Department. In accordance with the procedures set forth in 31 U.S.C. 3720D and 31 CFR 285.11, the Department may request that a non-Federal employer garnish the disposable pay of an individual to collect delinquent non-tax debt owed to the Department or in connection with any program administered by the Department.

§ 20.202 Scope.

(a) This subpart applies to any non-tax debt owed to the U.S. Department of Labor or in connection with any program administered by the Department and to any entity that pursues recovery of such debt. The Department can enter into arrangements with other federal agencies to carry out its responsibilities under this part.

(b) This subpart shall apply notwithstanding any provision of State law.

(c) Nothing in this subpart precludes the compromise of a debt or the suspension or termination of a collection action in accordance with applicable law. See, for example, the Federal Claims Collection Standards (FCCS), 31 CFR parts 900-904.

(d) The receipt of payments pursuant to this subpart does not preclude the Department from pursuing other debt collection remedies separately or in conjunction with administrative wage garnishment, including the offset of Federal payments, to satisfy delinquent nontax debt owed to the Department.

(e) This subpart does not apply to the collection of delinquent nontax debt owed to the United States from the wages of Federal employees from their Federal employment. Federal pay is subject to the Federal salary offset procedures set forth in 5 U.S.C. 5514 and other applicable laws.

(f) Nothing in this subpart requires the Department to duplicate notices or administrative proceedings required by contract, this subpart, or other laws, regulations, or procedures.

§ 20.203 Definitions.

As used in this section the following definitions shall apply:

(a) The term business day means Monday through Friday, not including Federal legal holidays. For purposes of computation, the last day of the period will be included unless it is a Federal legal holiday.

(b) The term day means calendar day. For purposes of computation, the last day of the period will be included unless it is a Saturday, a Sunday, or a Federal legal holiday.

(c) The term debt or claim means any amount of money, funds or property that has been determined by an appropriate official of the Federal Government to be owed to the Department by an individual, including debt administered by a third party as an agent for the Federal Government.

(d) The term debtor means an individual who owes a delinquent nontax debt to the Department.

(e) The term delinquent nontax debt means any nontax debt that has not been paid by the date specified in the initial written demand for payment, or applicable agreement, unless other satisfactory payment arrangements have been made. For purposes of this section, the terms “debt” and “claim” are synonymous and refer to delinquent nontax debt.

(f) The term Department means the United States Department of Labor.

(g) The term disposable pay means that part of the debtor's compensation (including, but not limited to, salary, bonuses, commissions, and vacation pay) from an employer remaining after the deduction of health insurance premiums and any amounts required by law to be withheld. For purposes of this subpart, “amounts required by law to be withheld” include amounts for deductions such as social security taxes and withholding taxes but do not include any amount withheld pursuant to a court order.

(h) The term employer means a person or entity that employs the services of others and that pays their wages or salaries. The term employer includes, but is not limited to, State and local Governments but does not include an agency of the Federal Government.

(i) The term evidence of service means information retained by the Department indicating the nature of the document to which it pertains, the date of mailing of the document, and to whom the document is being sent. Evidence of service may be retained electronically so long as the manner of retention is sufficient for evidentiary purposes.

(j) The term garnishment means the process of withholding amounts from an employee's disposable pay and the paying of those amounts to a creditor in satisfaction of a withholding order.

(k) The term hearing official means any qualified individual, as determined by the Department.

(l) The term withholding order means any order for withholding or garnishment of pay issued by the Department. For purposes of this section, the terms “wage garnishment order” and “garnishment order” have the same meaning as “withholding order.”

§ 20.204 General rule.

Whenever the Department determines that a delinquent debt is owed by an individual, to the Department or in connection with any program administered by the Department, the Department may initiate proceedings administratively to garnish the wages of the delinquent debtor.

§ 20.205 Notice requirements.

(a) At least 30 days before the initiation of garnishment proceedings, the Department shall mail, by first class mail to the debtor's last known address a written notice informing the debtor of:

(1) The nature and amount of the debt;

(2) The intention of the Department to initiate proceedings to collect the debt through deductions from pay until the debt and all accumulated interest, penalties and administrative costs are paid in full; and

(3) An explanation of the debtor's rights, including those set forth in paragraph (b) of this section, and the time frame within which the debtor may exercise his or her rights.

(b) The debtor shall be afforded the opportunity:

(1) To inspect and copy the Department's records related to the debt;

(2) To enter into a written repayment agreement with the Department under terms agreeable to the Department; and

(3) For a hearing in accordance with § 20.206 before a hearing official. The debtor is not entitled to a hearing concerning the terms of the proposed repayment schedule if these terms have been established by written agreement under 20.206(b)(2).

(c) The Department will retain evidence of service indicating the date of mailing of the notice.

§ 20.206 Hearing.

(a) Request for hearing. If the debtor submits a written request for a hearing concerning the existence or amount of the debt or the terms of the repayment schedule, the Department shall provide a written or oral hearing in accordance with 31 CFR 285.11(f) before a hearing official.

(b) Type of hearing or review. (1) For purposes of this subpart, whenever the Department is required to afford a debtor a hearing, the Department shall provide the debtor with a reasonable opportunity for an oral hearing when the hearing official determines that the issues in dispute cannot be resolved by review of the documentary evidence, for example, when the validity of the claim turns on the issue of credibility or veracity.

(2) If a hearing official determines that an oral hearing is appropriate, the time and location of the hearing, including the amount of time allotted for the hearing, shall be at the discretion of the hearing official. An oral hearing may, at the discretion of the hearing official, be conducted either in-person, by telephone conference, or by other electronic means. All travel expenses incurred by the debtor in connection with an in-person hearing will be borne by the debtor. All charges incurred during the hearing as a result of the use of telephone conference or other electronic means will be the responsibility of the Department.

(3) In those cases when an oral hearing is not required by this section, a hearing official shall nevertheless accord the debtor a “paper hearing,” that is, a hearing official will decide the issues in dispute based upon a review of the written record. The hearing official will establish a reasonable deadline for the submission of evidence.

(c) Effect of timely request. Subject to § 20.206(k), if the debtor's written request is received by the Department on or before the 15th business day following the mailing of the notice described in § 20.205(a), the Department shall not issue a withholding order under § 20.207 until the debtor has been provided the requested hearing and a decision in accordance with paragraphs (h) and (i) of this section has been rendered.

(d) Failure to timely request a hearing. If the debtor's written request is received by the Department after the 15th business day following the mailing of the notice described in § 20.205(a), the Department shall provide the debtor with a hearing before a hearing official. However, the Department will not delay issuance of a withholding order unless the Department determines that the delay in filing the request was caused by factors beyond the debtor's control or the Department receives information that the Department believes justifies a delay or cancellation of the withholding order.

(e) Procedure. After the debtor requests a hearing, the hearing official shall notify the debtor of:

(1) The date and time of a hearing conducted by telephone conference or other electronic means;

(2) The date, time, and location of an in-person oral hearing; or

(3) The deadline for the submission of evidence for a written hearing.

(f) Burden of proof. (1) The agency will have the burden of going forward to prove the existence or amount of the debt. The Department can satisfy this burden by submitting a certified copy of the adjudication or other document that establishes the existence of the debt and the amount of the debt.

(2) Thereafter, if the debtor disputes the existence or amount of the debt, the debtor must show by a preponderance of the evidence that no debt exists or that the amount of the debt is incorrect. In addition, the debtor may present evidence that:

(i) The terms of the repayment schedule are unlawful;

(ii) The terms would cause a financial hardship to the debtor; or

(iii) The collection of the debt may not be pursued due to operation of law.

(3) Debts that arise under the Federal Employees Compensation Act, 5 U.S.C. 8101-8193, are subject to preclusion of administrative and judicial review, as described at 5 U.S.C. 8128(b). As a result, once the Department meets its burden of showing the existence and amount of a debt under this statute, the debtor must prove by a preponderance of the evidence that:

(i) The documentation put forward by the agency to establish the debt was not authentic; or

(ii) The debt was incurred by someone other than the debtor as a result of identity theft.

(g) Record. The hearing official must maintain a summary record of any hearing provided under this section.

(h) Hearing procedure. A hearing is an informal process and the hearing official is not bound by common law or statutory rules of evidence or by technical or formal rules of procedure. However, witnesses who testify in oral hearings must do so under affirmation, so that 18 U.S.C. 1001 applies.

(i) Date of decision. The hearing official shall issue a written opinion stating his or her decision, as soon as practicable, but not later than 60 days after the date on which the request for such hearing was received. If a hearing official is unable to provide the debtor with a hearing and render a decision within 60 days after the receipt of the request for such hearing:

(1) The Department may not issue a withholding order until the hearing is held and a decision rendered; or

(2) If the Department had previously issued a withholding order to the debtor's employer, the Department must suspend the withholding order beginning on the 61st day after the receipt of the hearing request and continuing until a hearing is held and a decision is rendered.

(j) Content of decision. The written decision shall include:

(1) A summary of the facts presented;

(2) The hearing official's findings, analysis, and conclusions; and

(3) The terms of any repayment schedules, if applicable.

(k) Final agency action. The hearing official's decision will be the final agency action for the purposes of judicial review under the Administrative Procedure Act, 5 U.S.C. 701-706.

(l) Failure to appear. In the absence of good cause shown to the hearing official, a debtor who fails to appear at a hearing scheduled pursuant to this section will be deemed as not having timely filed a request for a hearing.

§ 20.207 Wage garnishment order.

(a) Unless the Department receives information that the Department believes justifies a delay or cancellation of the withholding order, the Department shall send, by first class mail, a withholding order to the debtor's employer:

(1) Within 30 days after the debtor fails to make a timely request for a hearing (i.e., within 15 business days after the mailing of the notice described in § 20.205(a), or,

(2) If a timely request for a hearing is made by the debtor, within 30 days after a final decision is made by the hearing official, or,

(3) As soon as reasonably possible thereafter.

(b) The withholding order sent to the employer under paragraph (a) of this section shall be in the form prescribed by the Secretary of the Treasury. The withholding order shall contain the signature of, or the image of the signature of, the Secretary of Labor or his or her delegatee. The order shall contain only the information necessary for the employer to comply with the withholding order. Such information includes the debtor's name, address, and Employee Identification Number, as well as instructions for withholding and information as to where payments should be sent.

(c) The Department will retain evidence of service indicating the date of mailing of the order.

§ 20.208 Certification by employer.

Along with the withholding order, the agency shall send to the employer a certification in the form prescribed by the Secretary of the Treasury. The employer shall complete and return the certification to the Department within the time frame prescribed in the instructions to the form. The certification will address matters such as information about the debtor's employment status and disposable pay available for withholding.

§ 20.209 Amounts withheld.

(a) After an employer receives a garnishment order, the employer must deduct from all disposable pay paid to the applicable debtor during each pay period the amount of garnishment described in paragraph (b) of this section.

(b) Subject to the provisions in paragraphs (c) and (d) of this section, the amount of garnishment shall be the lesser of:

(1) The amount indicated on the garnishment order up to 15 percent of the debtor's disposable pay; or

(2) The amount set forth in 15 U.S.C. 1673(a)(2) (Restriction on Garnishment). The amount set forth at 15 U.S.C. 1673(a)(2) is the amount by which a debtor's disposable pay exceeds an amount equivalent to thirty times the minimum wage. See 29 CFR 870.10.

(c) When a debtor's pay is subject to withholding orders with priority the following shall apply:

(1) Unless otherwise provided by Federal law, withholding orders issued under this subpart shall be paid in the amounts set forth under paragraph (b) of this section and shall have priority over other withholding orders which are served later in time. However, withholding orders for family support shall have priority over withholding orders issued under this subpart.

(2) If amounts are being withheld from a debtor's pay pursuant to a withholding order served on an employer before a withholding order issued pursuant to this subpart, or if a withholding order for family support is served on an employer at any time, the amounts withheld pursuant to the withholding order issued under this subpart shall be the lesser of:

(i) The amount calculated under paragraph (b) of this section, or

(ii) An amount equal to 25 percent of the debtor's disposable pay less the amount(s) withheld under the withholding order(s) with priority.

(3) If a debtor owes more than one debt to the Department, the Department may issue multiple withholding orders provided that the total amount garnished from the debtor's pay for such orders does not exceed the amount set forth in paragraph (b) of this section.

(d) An amount greater than that set forth in paragraphs (b) and (c) of this section may be withheld upon the written consent of the debtor.

(e) The employer shall promptly pay to the Department all amounts withheld in accordance with the withholding order issued pursuant to this subpart.

(f) An employer shall not be required to vary its normal pay and disbursement cycles in order to comply with the withholding order.

(g) Any assignment or allotment by an employee of his earnings shall be void to the extent it interferes with or prohibits execution of the withholding order issued under this subpart, except for any assignment or allotment made pursuant to a family support judgment or earlier withholding order.

(h) The employer shall withhold the appropriate amount from the debtor's wages for each pay period until the employer receives notification from the Department to discontinue wage withholding. The garnishment order shall indicate a reasonable period of time within which the employer is required to commence wage withholding.

§ 20.210 Exclusions from garnishment.

The Department may not garnish the wages of a debtor who it knows has been involuntarily separated from employment until the debtor has been reemployed continuously for at least 12 months. The debtor has the burden of informing the Department (or any other federal agency exercising the Department's authority under this subpart) of the circumstances surrounding an involuntary separation from employment.

§ 20.211 Financial hardship.

(a) A debtor whose wages are subject to a wage withholding order under this subpart, may, at any time, request a review by the Department of the amount garnished, based on materially changed circumstances such as disability, divorce, or catastrophic illness which result in financial hardship.

(b) A debtor requesting a review under paragraph (a) of this section shall submit the basis for claiming that the current amount of garnishment results in a financial hardship to the debtor, along with supporting documentation. The Department shall consider any information submitted in accordance with procedures and standards established by the agency.

(c) If a financial hardship is found, the Department shall downwardly and temporarily adjust the amount garnished to reflect the debtor's financial condition. The Department will notify the employer of any adjustments to the amounts to be withheld.

§ 20.212 Ending garnishment.

(a) Once the Department has fully recovered the amounts owed by the debtor, including interest, penalties, and administrative costs consistent with the FCCS, the Department shall send the debtor's employer notification to discontinue wage withholding.

(b) At least annually, the Department shall review its debtors' accounts to ensure that garnishment has been terminated for accounts that have been paid in full.

§ 20.213 Actions prohibited by employer.

An employer may not discharge, refuse to employ, or take disciplinary action against the debtor due to the issuance of a withholding order under this subpart.

§ 20.214 Refunds.

(a) If a hearing official, at a hearing held pursuant to § 20.206, determines that a debt is not legally due and owing to the Department, the Department shall promptly refund any amount collected by means of administrative wage garnishment.

(b) Unless required by Federal law or contract, refunds under this section shall not bear interest.

§ 20.215 Right of action.

The Department may sue any employer for any amount that the employer fails to withhold from wages owed and payable to an employee in accordance with §§ 20.207 and 20.209. However, a suit may not be filed before the termination of the collection action involving a particular debtor, unless earlier filing is necessary to avoid expiration of any applicable statute of limitations period. For purposes of this subpart, “termination of the collection action” occurs when the agency has terminated collection action in accordance with the FCCS or other applicable standards. In any event, termination of the collection action will have been deemed to occur if the agency has not received any payments to satisfy the debt from the particular debtor whose wages were subject to garnishment, in whole or in part, for a period of 1 year.

[FR Doc. 2015-25427 Filed 10-7-15; 8:45 am] BILLING CODE 4510-7C-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2013-0320] RIN 1625-AA00 Safety Zone, Chicago Harbor, Navy Pier Southeast, Chicago, IL AGENCY:

Coast Guard, DHS.

ACTION:

Notice of enforcement of regulation.

SUMMARY:

The Coast Guard will enforce the Navy Pier Southeast Safety Zone within the Chicago Harbor during specified periods on from September 12, 2015 through October 31, 2015. This action is necessary and intended to ensure safety of life on the navigable waters of the United States immediately prior to, during, and immediately after multiple firework events. During the enforcement periods listed below, no person or vessel may enter the safety zone without permission of the Captain of the Port Lake Michigan.

DATES:

The regulations in 33 CFR 165.931 will be enforced at specified times between 8:00 p.m. on September 12, 2015 through 10:00 p.m. on October 31, 2015.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this document, call or email LT Lindsay Cook, Waterways Management Division, Marine Safety Unit Chicago, telephone 630-986-2155, email address [email protected].

SUPPLEMENTARY INFORMATION:

The Coast Guard will enforce the Safety Zone; Chicago Harbor, Navy Pier Southeast, Chicago, IL listed in 33 CFR 165.931, on September 12, 2015 at 8:00 p.m. until 9:00 p.m., September 27, 2015 at 7:45 p.m. until 8:30 p.m., and on October 31, 2015 at 9:15 p.m. until 10:00 p.m.

This safety zone encompasses the waters of Lake Michigan within Chicago Harbor bounded by coordinates beginning at 41°53′26.5″ N., 087°35′26.5″ W.; then south to 41°53′7.6″ N., 087°35′26.3″ W.; then west to 41°53′7.6″ N., 087°36′23.2″ W.; then north to 41°53′26.5″ N., 087°36′24.6″ W. then east back to the point of origin (NAD 83). All vessels must obtain permission from the Captain of the Port Lake Michigan, or an on-scene representative to enter, move within or exit the safety zone. Vessels and persons granted permission to enter the safety zone shall obey all lawful orders or directions of the Captain of the Port Lake Michigan, or an on-scene representative.

This document is issued under authority of 33 CFR 165.931 and 5 U.S.C. 552(a). In addition to this publication in the Federal Register, the Coast Guard will provide the maritime community with advance notification of these enforcement periods via broadcast Notice to Mariners or Local Notice to Mariners. If the Captain of the Port Lake Michigan determines that the safety zone need not be enforced for the full duration stated in this notice, he or she may suspend enforcement and provide notice via a Broadcast Notice to Mariners. The Captain of the Port Lake Michigan or an on-scene representative may be contacted via VHF Channel 16.

Dated: September 9, 2015. K.M. Moser, Commander, U.S. Coast Guard, Acting Captain of the Port Lake Michigan.
[FR Doc. 2015-25728 Filed 10-7-15; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2015-0880] RIN 1625-AA87 Security Zone: Escorted Vessels, Los Angeles-Long Beach, CA, Captain of the Port Zone AGENCY:

Coast Guard, DHS.

ACTION:

Interim rule and request for comments.

SUMMARY:

The Coast Guard is establishing a security zone around any vessel escorted by one or more Coast Guard, State, or local law enforcement assets on the navigable waters of the Captain of the Port (COTP) Zone, Los Angeles-Long Beach, California. This action is necessary to protect personnel, vessels, and facilities from sabotage or other subversive acts, accidents, or other events of a similar nature. No vessel or person is allowed in this zone unless authorized by the Captain of the Port or a designated representative.

DATES:

This rule is effective without actual notice from October 8, 2015. For the purposes of enforcement, actual notice will be used from September 18, 2015, until October 8, 2015.

Comments and related material must be received by the Coast Guard on or before December 17, 2015. Requests for public meetings must be received by the Coast Guard on or before November 18, 2015.

ADDRESSES:

You may submit comments identified by docket number USCG-2015-0880 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this rule, call or email LT Jevon James, Waterways Management, U.S. Coast Guard; telephone (310)521-3860, email [email protected].

SUPPLEMENTARY INFORMATION: Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking A. Public Participation and Request for Comments

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086). Documents mentioned in this rule as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

B. Regulatory History and Information

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Publishing a NPRM and delaying the effective date would be impracticable, as publication of an NPRM would delay the effective date of this rule past the time where it was needed. To ensure safe boating and the appropriate distance away from the escorted vessel is maintained, it is imperative that a standard exclusionary zone be broadcast and safe speeds be followed for all escorted vessels.

For the same reason above, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register.

C. Basis and Purpose

The terrorist attacks of September 2001 heightened the need for development of various security measures throughout the seaports of the United States, particularly around vessels and facilities whose presence or movement creates a heightened vulnerability to terrorist acts; or those for which the consequences of terrorist acts represent a threat to national security. The President of the United States has found that the security of the United States is and continues to be endangered following the attacks of September 11 (E.O. 13,273, 67 FR 56215, Sep. 3, 2002 and 79 FR 56475, Sep. 19, 2014).

The Captain of the Port Los Angeles-Long Beach, California conducts port security operations involving vessels that require additional security, including, but not limited to, high capacity passenger vessels, vessels carrying sensitive Department of Defense cargoes, vessels carrying dangerous cargoes, and foreign naval vessels. The Captain of the Port has determined that these vessels have a significant vulnerability to subversive activity by other vessels or persons, or, in some cases, themselves pose a risk to a port and the public within the Captain of the Port Zone, as described in 33 CFR 3.55-10. This rule enables the COTP Los Angeles-Long Beach to provide effective port security, while minimizing the public's confusion and easing the administrative burden of implementing separate temporary security zone rules for each escorted vessel.

D. Discussion of the Interim Rule

This rule establishes a security zone that prohibits persons and vessels from coming within 500 yards of all escorted vessels within navigable waters, as defined in 33 CFR 2.36, of the Captain of the Port Zone Los Angeles-Long Beach, CA, as described in 33 CFR 3.55-10. Persons or vessels that receive permission to enter the security zone must proceed at a minimum safe speed, at a safe distance from the escorted vessel as directed by the on scene Coast Guard, State, or local law enforcement agency, and must comply with all orders issued by the COTP or a designated representative. Outside of this arrangement, no vessel or person may enter within a 500-yard radius of an escorted vessel.

An escorted vessel is defined as a vessel, other than a large U.S. naval vessel as defined in 33 CFR 165.2015, that is accompanied by one or more Coast Guard assets or other Federal, State or local law enforcement agency assets clearly identifiable by lights, vessel markings, or with agency insignia as listed below:

(1) Coast Guard surface or air asset displaying the Coast Guard insignia.

(2) State and/or local law enforcement asset displaying the applicable agency markings and/or equipment associated with the agency.

When escorted vessels are moored, dayboards or other visual indications such as lights or buoys may be used. In all cases, broadcast notice to mariners will be issued to advise mariners of these restrictions.

E. 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

E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget. The limited geographic area impacted by the security zone will not restrict the movement or routine operation of commercial or recreational vessels through the Ports within the Captain of the Port Zone Los Angeles-Long Beach.

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 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 may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit in the vicinity of escorted vessels. This rule would not have a significant impact on a substantial number of small entities because the zones are limited in size, in most cases leaving ample space for vessels to navigate around them. The zones will not significantly impact commercial and passenger vessel traffic patterns, and mariners will be notified of the zones via Broadcast Notice to Mariners. Where such space is not available and security conditions permit, the Captain of the Port will attempt to provide flexibility for individual vessels to transit through the zones as needed.

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, 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.

3. 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).

4. Federalism and Indian Tribal Governments

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

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

5. 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.

6. 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 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.

7. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

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

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

2. Add § 165.11731 to read as follows:
§ 165.11731 Security Zone: Escorted Vessels, Los Angeles-Long Beach, CA, Captain of the Port Zone.

(a) Definitions. The following definitions apply to this section:

COTP means Captain of the Port Los Angeles-Long Beach, CA (LALB).

Designated representatives means Coast Guard Patrol Commanders including Coast Guard coxswains, petty officers and other officers operating Coast Guard vessels, and Federal, State, and local officers designated by or assisting the COTP, in the enforcement of the security zone.

Escorted vessel means a vessel, other than a large U.S. naval vessel as defined in § 165.2015, that is accompanied by one or more Coast Guard assets or other Federal, State or local law enforcement agency assets clearly identifiable by lights, vessel markings, or with agency insignia as listed below:

(1) Coast Guard surface or air asset displaying the Coast Guard insignia.

(2) State and/or local law enforcement asset displaying the applicable agency markings and/or equipment associated with the agency.

(3) When escorted vessels are moored, dayboards or other visual indications such as lights or buoys may be used. In all cases, broadcast notice to mariners will be issued to advise mariners of these restrictions.

Minimum safe speed means the speed at which a vessel proceeds when it is fully off plane, completely settled in the water and not creating excessive wake. Due to the different speeds at which vessels of different sizes and configurations may travel while in compliance with this definition, no specific speed is assigned to minimum safe speed. In no instance should minimum safe speed be interpreted as a speed less than that required for a particular vessel to maintain steerageway. A vessel is not proceeding at minimum safe speed if it is:

(1) On a plane;

(2) In the process of coming up onto or coming off a plane; or

(3) Creating an excessive wake.

(b) Regulated area. All navigable waters, as defined in 33 CFR 2.36, within the Captain of the Port Zone, Los Angeles-Long Beach, California 33 CFR 3.55-10.

(c) Security zone. A 500-yard security zone is established around each escorted vessel within the regulated area described in paragraph (b) of this section. This is a moving security zone when the escorted vessel is in transit and becomes a fixed zone when the escorted vessel is anchored or moored. A security zone will not extend beyond the boundary of the regulated area in this section.

(d) Regulations. (1) The general regulations for security zones contained in § 165.33 apply to this section.

(2) A vessel may request the permission of the COTP LALB or a designated representative to enter the security zone described in paragraph (c) of this section. If permitted to enter the security zone, a vessel must proceed at the minimum safe speed and must comply with the orders of the COTP or a designated representative.

(e) Notice of security zone. The COTP will inform the public of the existence or status of the security zones around escorted vessels in the regulated area by Broadcast Notice to Mariners. Coast Guard assets or other Federal, State or local law enforcement agency assets will be clearly identified by lights, vessel markings, or with agency insignia. When escorted vessels are moored, dayboards or other visual indications such as lights or buoys may be used.

(f) Contact information. The COTP LALB may be reached via phone at (310) 521-3801. Any on scene Coast Guard or designated representative assets may be reached via VHF-FM channel 16.

Dated: September 15, 2015. J. F. Williams, Captain, U.S. Coast Guard, Captain of the Port Los Angeles—Long Beach.
[FR Doc. 2015-25557 Filed 10-7-15; 8:45 am] BILLING CODE 9110-04-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2015-0384; FRL-9935-22-Region 4] Approval and Promulgation of Implementation Plans; Kentucky: New Sources in or Impacting Nonattainment Areas AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

The Environmental Protection Agency (EPA) is taking final action to approve the Commonwealth of Kentucky's September 23, 2011, State Implementation Plan (SIP) revision, submitted through the Kentucky Division for Air Quality (KY DAQ), which modifies the SIP by making changes to Kentucky regulation, “Review of new sources in or impacting upon nonattainment areas.” EPA has determined that Kentucky's requested SIP revision meets the applicable provisions of the Clean Air Act (CAA or Act) and EPA regulations regarding Nonattainment New Source Review (NNSR) permitting.

DATES:

This rule is effective November 9, 2015.

ADDRESSES:

EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2015-0384. All documents in the docket are listed on the www.regulations.gov Web site. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Zuri Farngalo, Air Regulatory Management Section, Air Planning and Implementation Branch, Pesticides and Toxics Management Division, Region 4, U.S. Environmental Protection Agency, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr. Farngalo can be reached by telephone at (404) 562-9152 and via electronic mail at [email protected]

SUPPLEMENTARY INFORMATION: I. Background

On September 23, 2011, KY DAQ submitted a SIP revision to EPA for approval that makes several changes to Kentucky's regulations at 401 Kentucky Administrative Regulations (KAR) 51:052, Review of new sources in or impacting nonattainment areas. These regulations establish air quality permitting requirements for the construction or modification of major stationary sources located within, or impacting upon, areas designated nonattainment for any primary national ambient air quality standard. To ensure improvement of air quality in those areas, the emissions resulting from construction or modification of a major stationary source must be offset with compensating emission reductions.

Kentucky's requested SIP revision would revise 401 KAR 51:052 by: (1) Changing Section 5, paragraph (6)(b) to authorize new or modified sources to offset their emission increases with emission reductions achieved by shutting down an existing unit or curtailing production or operating hours prior to the new source application date (if specified conditions are met), (2) adding new and more comprehensive language to Section 5, paragraph (6)(b) describing how to calculate offsetting emission reductions obtained from a source shutdown or curtailment (3) amending Section 4, paragraph (3)(a) to establish an offset ratio of at least 1:1 for pollutants other than volatile organic compounds and nitrogen oxides, and (4) making changes to the introductory paragraph to 401 KAR 51:052 and Section 5, paragraph (3)(e) that update and clarify these provisions.

In a notice of proposed rulemaking (NPR) published on August 11, 2015, EPA proposed to approve Kentucky's revisions to 401 KAR 51:052, Review of new sources in or impacting nonattainment areas revisions. See 80 FR 48051. The details of Kentucky's submittal and the rationale for EPA's action are provided in the NPR. EPA did not receive any relevant comments on the proposed action.

II. Incorporation by Reference

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of Kentucky Rule 401 KAR 51:052 entitled “Review of new sources in or impacting nonattainment areas,” which became effective in the Commonwealth of Kentucky on August 4, 2011. EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the Region 4 office (see the ADDRESSES section of this preamble for more information).

III. Final Action

EPA is taking final action to approve the Commonwealth of Kentucky's September 23, 2011, SIP revision. EPA has determined that the changes to Kentucky's Rule 401 KAR 51:052, Review of new sources in or impacting nonattainment areas, are approvable because they are consistent with CAA section 110 and EPA's regulations regarding NNSR permitting at 40 CFR 51.165.

IV. Statutory and Executive Order Reviews

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 7, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements and Volatile organic compounds.

Dated: September 24, 2015. Heather McTeer Toney, Regional Administrator, Region 4.

40 CFR parts 52 is amended as follows:

PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for part 52 continues to read as follows: Authority:

42 U.S.C. 7401 et seq.

Subpart S—Kentucky 2. In § 52.920, table 1 in paragraph (c) is amended under Chapter 51 by revising the entry for “401 KAR 51:052” to read of follows:
§ 52.920 Identification of plan.

(c) * * *

Table 1—EPA-Approved Kentucky Regulations State citation Title/subject State effective date EPA approval
  • date
  • Explanation
    *         *         *         *         *         *         * Chapter 51 Attainment and Maintenance of the National Ambient Air Quality Standards *         *         *         *         *         *         * 401 KAR 51:052 Review of new sources in or impacting nonattainment areas 8/4/2011 10/8/2015 [Insert Federal Register citation] *         *         *         *         *         *         *
    [FR Doc. 2015-25575 Filed 10-7-15; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 141021887-5172-02] RIN 0648-XE224 Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Atka Mackerel in the Bering Sea and Aleutian Islands Management Area AGENCY:

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

    ACTION:

    Temporary rule; reallocation.

    SUMMARY:

    NMFS is reallocating the projected unused amount of the 2015 Atka mackerel incidental catch allowance (ICA) for the Bering Sea subarea and Eastern Aleutian district (BS/EAI) to the Amendment 80 cooperative allocations in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to allow the 2015 total allowable catch of Atka mackerel in the BSAI to be fully harvested.

    DATES:

    Effective 12 hrs Alaska local time (A.l.t.), October 5, 2015 through 2400 hrs, A.l.t., December 31, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Steve Whitney, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

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

    The 2015 Atka mackerel ICA for the BS/EAI is 1,000 metric tons (mt) and 2015 Atka mackerel total allowable catch allocated to the Amendment 80 cooperatives is 20,696 mt as established by the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015).

    The Administrator, Alaska Region, NMFS, has determined that 700 mt of the Atka mackerel ICA for the BS/EAI will not be harvested. Therefore, in accordance with § 679.91(f), NMFS reallocates 700 mt of Atka mackerel from the BS/EAI ICA to the Amendment 80 cooperatives in the BSAI. In accordance with § 679.91(f), NMFS will reissue cooperative quota permits for the reallocated Atka mackerel following the procedures set forth in § 679.91(f)(3).

    The harvest specifications for Atka mackerel included in the harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) are revised as follows: 300 mt of Atka mackerel for the BS/EAI ICA and 21,395 mt of Atka mackerel for the Amendment 80 cooperative allocations in the BS/EAI. Table 6 is revised and republished in its entirety as follows:

    Table 6—Final 2015 Seasonal and Spatial Allowances, Gear Shares, CDQ Reserve, Incidental Catch Allowance, and Amendment 80 Allocations of the BSAI Atka Mackerel TAC [Amounts are in metric tons] Sector 1 Season 2 3 4 2015 Allocation by area Eastern Aleutian District/Bering Sea Central Aleutian District 5 Western Aleutian District TAC n/a 27,000 17,000 10,500 CDQ reserve Total 2,889 1,819 1,124 A 1,445 910 562 Critical Habitat n/a 546 337 B 1,445 910 562 Critical Habitat n/a 546 337 ICA Total 300 75 40 Jig 6 Total 116 0 0 BSAI trawl limited access Total 2,301 1,511 0 A 1,150 755 0 Critical Habitat n/a 453 0 B 1,150 755 0 Critical Habitat n/a 453 0 Amendment 80 sectors Total 21,395 13,595 9,337 A 10,697 6,798 4,668 B 10,697 6,798 4,668 Alaska Groundfish Cooperative Total 6 12,030 8,111 5,741 A 6,015 4,056 2,871 Critical Habitat n/a 2,433 1,722 B 6,015 4,056 2,871 Critical Habitat n/a 2,433 1,722 Alaska Seafood Cooperative Total 6 9,365 5,484 3,595 A 4,683 2,742 1,798 Critical Habitat n/a 1,645 1,079 B 4,683 2,742 1,798 Critical Habitat n/a 1,645 1,079 1 Section 679.20(a)(8)(ii) allocates the Atka mackerel TACs, after subtracting the CDQ reserves, jig gear allocation, and ICAs to the Amendment 80 and BSAI trawl limited access sectors. The allocation of the ITAC for Atka mackerel to the Amendment 80 and BSAI trawl limited access sectors is established in Table 33 to part 679 and § 679.91. The CDQ reserve is 10.7 percent of the TAC for use by CDQ participants (see §§ 679.20(b)(1)(ii)(C) and 679.31). 2 Regulations at §§ 679.20(a)(8)(ii)(A) and 679.22(a) establish temporal and spatial limitations for the Atka mackerel fishery. 3 The seasonal allowances of Atka mackerel are 50 percent in the A season and 50 percent in the B season. 4 Section 679.23(e)(3) authorizes directed fishing for Atka mackerel with trawl gear during the A season from January 20 to June 10 and the B season from June 10 to December 31. 5 Section 679.20(a)(8)(ii)(C)(1)(i) limits no more than 60 percent of the annual TACs in Areas 542 and 543 to be caught inside of critical habitat; (a)(ii)(C)(1)(ii) equally divides the annual TACs between the A and B seasons as defined at § 679.23(e)(3); and (a)(8)(ii)(C)(2) requires the TAC in Area 543 shall be no more than 65 percent of ABC. 6 Section 679.20(a)(8)(i) requires that up to 2 percent of the Eastern Aleutian District and the Bering Sea subarea TAC be allocated to jig gear after subtracting the CDQ reserve and ICA. The amount of this allocation is 0.5 percent. The jig gear allocation is not apportioned by season. Note: Seasonal or sector apportionments may not total precisely due to rounding.

    This will enhance the socioeconomic well-being of harvesters dependent upon Atka mackerel in this area. The Regional Administrator considered the following factors in reaching this decision: (1) The current catch of Atka mackerel ICA in the BS/EAI, (2) the harvest capacity and stated intent on future harvesting patterns of the Amendment 80 cooperatives that participate in this BS/EAI fishery.

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the reallocation of Atka mackerel from the BS/EAI ICA to the Amendment 80 cooperatives in the BSAI. Since the fishery is currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of September 25, 2015.

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

    This action is required by § 679.91 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: October 5, 2015 Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-25676 Filed 10-5-15; 4:15 pm] BILLING CODE 3510-22-P
    80 195 Thursday, October 8, 2015 Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 880 [Docket No. FDA-2015-N-0701] General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Food and Drug Administration (FDA) is proposing to rename pediatric hospital beds as pediatric medical cribs and establish special controls for these devices. FDA is also proposing to establish a separate classification regulation for medical bassinets, previously under the pediatric hospital bed classification regulation, as a class II (special controls) device. The proposed regulation for both pediatric medical cribs and medical bassinets would also include the Consumer Product Safety Commission's (CPSC) mattress flammability standards for the mattresses intended for use with these devices. In addition, this proposed rule would require prescription use of pediatric medical cribs and bassinets.

    DATES:

    Submit either electronic or written comments by December 7, 2015. See section VII of this document for the proposed effective date of a final rule based on this proposed rule.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2015-N-0701 for “General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    FOR FURTHER INFORMATION CONTACT:

    Michael J. Ryan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301-796-6283.

    SUPPLEMENTARY INFORMATION:

    I. Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Device Amendments of 1990 (SMDA) (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the FDA Safety and Innovation Act (Pub. L. 112-144), among other amendments, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes three categories (classes) of devices, based on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

    Most generic types of devices that were on the market before May 28, 1976, the date of the 1976 amendments (generally referred to as preamendments devices), have been classified by FDA through the issuance of regulations in accordance with the procedures set forth in section 513(c) and (d) of the FD&C Act into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as post-amendments devices), are classified automatically by statute (section 513(f) of the FD&C Act) into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless FDA initiates one of the following procedures: (1) FDA reclassifies the device into class I or II; (2) FDA issues an order classifying the device into class I or II in accordance with section 513(f)(2) of the FD&C Act; or (3) FDA issues an order finding the device to be substantially equivalent, under section 513(i), to a predicate device that is already legally marketed. The Agency determines whether new devices are substantially equivalent to predicate devices through review of premarket notifications under section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of the FD&C Act and its implementing regulations, codified in Title 21 of the Code of Federal Regulations (21 CFR part 807, subpart E), require persons who intend to market a new device that does not require a premarket approval application under section 515 of the FD&C Act (21 U.S.C. 360e) to submit a premarket notification report (510(k)) containing information that allows FDA to determine whether the new device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval.

    Section 513(a)(1)(B) of the FD&C Act defines class II devices as those devices for which the general controls in section 513(a)(1)(A) by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including the issuance of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and any other appropriate actions the Agency deems necessary to provide such assurance (see also 21 CFR 860.3(c)(2)).

    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements on its own initiative or upon petition of an interested person, if FDA determines that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of the device. Devices under the pediatric hospital bed classification regulation were exempted from premarket notification, subject to certain limitations, in accordance with section 510(m) of the FD&C Act (63 FR 59222 at 59229, November 3, 1998).

    II. Regulatory History and Description of the Devices

    FDA classified pediatric hospital beds (21 CFR 880.5140) as class II devices (45 FR 69678 at 69694, October 21, 1980), and later exempted them from premarket notification (510(k)), in a final rule published in the Federal Register of November 3, 1998 (63 FR 59222 at 59229). In § 880.5140, a pediatric hospital bed is defined as “a device intended for medical purposes that consists of a bed or crib designed for the use of a pediatric patient, with fixed end rails and movable and latchable side rails. The contour of the bed surface may be adjustable.”

    A medical bassinet is a non-powered device that consists of two components: (1) A basket, the sleep or bed component, which is typically made of plastic and (2) a durable frame with wheels, which holds the basket or bed component (FDA refers to this component as a “basket or bed component” in this proposed rule). The basket or bed component is a box-like structure, generally made of a clear, high-impact resistant plastic material, with an open top and four stationary walls to keep the baby in place. Medical bassinets are typically used in hospital settings for infants up to 5 months in age. Medical bassinets currently fall under the pediatric hospital bed classification regulation.

    III. Proposed Regulation

    Pediatric medical cribs that meet the definition of a device in section 201(h) of the FD&C Act (21 U.S.C. 321(h)) are regulated by FDA (referred to as pediatric medical cribs or cribs intended for medical purposes) (product code FMS) and, if this rule is finalized, will have to comply with the special controls identified in the final regulation for pediatric medical cribs. Cribs outside of the device definition (referred to as cribs for non-medical purposes) must meet the CPSC's regulations and guidelines. A crib designed for the use of a pediatric patient may meet the medical device definition if it is intended for use in the cure, mitigation or treatment of disease (see section 201(h) of the FD&C Act).

    In the Federal Register of December 28, 2010 (75 FR 81766), the CPSC issued a final rule prohibiting the use of the drop-side rail design for non-medical cribs in consumer households as of June 28, 2011. Child care facilities, family child care homes, and places of public accommodation (e.g., hotels and motels) had to comply with the rule as of December 28, 2012. CPSC's rule establishes new standards for full-size and non-full-size cribs used for non-medical purposes, which effectively prohibit the manufacture or sale of cribs for non-medical purposes with a drop-side rail design in households, child care facilities, family child care homes, and places of public accommodation. This rule did not affect pediatric medical cribs regulated by FDA, which may contain a drop-side rail design that includes movable and latchable side and end rails.

    Because drop-side rail cribs for non-medical purposes and pediatric medical cribs are regulated by different agencies, CPSC consulted with FDA about the impact their final rule could have on settings, such as nursery schools and day care centers, where pediatric medical cribs with drop-side rails are often used for pediatric patients after they have been discharged from a health care facility. CPSC, which regulates consumer products, including drop-side rail cribs not intended for medical purposes, received reports of deaths of children attributable to entrapment and/or strangulation caused by the malfunctioning of drop-side rail cribs.

    Although drop-side cribs for non-medical purposes are now prohibited, there is still a need for pediatric medical cribs with drop-side rails inside and outside of traditional health care settings. CPSC and FDA have heard from medical device consumers and health care providers that pediatric medical cribs with drop-side rails are extremely helpful for patient care in hospital settings and even outside of traditional health care settings, such as day care centers caring for infants and children with disabilities, because they allow parents and care givers easy access to children to perform routine and emergency medical procedures, including, but not limited to, CPR, blood collection, IV insertion, respiratory care, and skin care. These drop-side rail cribs also make it easier for hospital staff to facilitate safe patient transport and reduce the chance of caregiver injury. Health care workers have stated that they need to have continued access to these medical cribs with drop-side rails (Ref. 1). Therefore, FDA is proposing to permit manufacturers to continue to manufacture and sell medical cribs with the drop-side rail design in traditional health care settings and to permit the use of pediatric medical cribs with drop-side rail designs outside of traditional health care settings through prescription use only (it is noted that State child care licensing agencies are generally responsible for overseeing day care providers while FDA is responsible for medical devices).

    FDA is proposing to revise the identification in § 880.5140 to include only pediatric medical cribs, establish special controls for this device, and change the name of the classification regulation from “pediatric hospital bed” to “pediatric medical crib.” The Agency is taking these actions to clarify the devices that fall under this particular classification regulation and establish special controls the Agency believes are necessary for a reasonable assurance of safety and effectiveness. In addition, FDA is proposing that use of a pediatric medical crib be restricted to prescription use in accordance with 21 CFR 801.109. In order to use or administer use of pediatric medical cribs, authorization must be made by a practitioner licensed by law through a prescription for the device.

    This rule also proposes to create a separate regulation for medical bassinets and establish special controls for this device type to provide a reasonable assurance of safety and effectiveness. In addition, FDA is proposing that use of medical bassinets be restricted to prescription use in accordance with 21 CFR 801.109. In order to use or administer use of medical bassinets, authorization must be made by a practitioner licensed by law through a prescription for the device. FDA proposes not to change the 510(k) exempt status of pediatric medical cribs and medical bassinets.

    Devices currently under the pediatric hospital bed classification regulation include: Open pediatric medical cribs, medical bassinets, pediatric cribs with integrated air mattresses, youth beds, pediatric stretchers, crib enclosure beds, and cuddle-carrier infant beds. If this proposed rule is finalized, devices that do not meet the definition of “pediatric medical crib” will be administratively moved to more appropriate class II regulations, and no longer be under the revised pediatric hospital bed classification regulation. At that time, FDA proposes to send manufacturers of the remaining pediatric hospital beds notices identifying the new classification regulation and product code under which the device will be classified.

    If this proposed rule is finalized, FDA intends to move the following medical devices listed under § 880.5140 to devices with similar intended uses and class II regulations: Pediatric cribs with integrated air mattresses to 21 CFR 890.5170, “Powered flotation therapy bed;” youth beds to either 21 CFR 880.5100, “AC powered adjustable hospital bed,” or 21 CFR 880.5120, “Manual adjustable hospital bed,” depending on whether they are powered or not; pediatric stretchers to 21 CFR 880.6910, “Wheeled stretchers;” and crib enclosure beds to 21 CFR 880.6760, “Protective restraint.” This action would not have any substantive effect on the current marketing status of the devices. However, manufacturers of these devices would need to refer to the new regulation classification and product code provided by the Agency in future interactions with FDA.

    As discussed in section IV, an analysis of Medical Device Reports (MDRs) submitted to the Manufacturer and User Facility Device Experience (MAUDE) database from January 1, 2005, to September 1, 2015, indicated 516 adverse events associated with pediatric medical cribs including 15 serious injuries. The adverse events associated with pediatric medical cribs were assessed to better understand the risks and establish the proposed special controls for this device. FDA believes that sufficient information is available to establish special controls to provide a reasonable assurance of the safety and effectiveness of the device.

    As discussed further in section VI, FDA believes risks to health resulting from use of these cribs would be effectively mitigated by the special controls proposed in this rule, and that these controls, in combination with the general controls, would provide a reasonable assurance of safety and effectiveness for pediatric medical cribs for their intended use. Therefore, FDA is proposing new safety requirements and allowing medical cribs in homes and day cares only when medically necessary.

    FDA is also taking this opportunity to address adverse event reports pertaining to medical bassinets by proposing to establish special controls for these devices to provide a reasonable assurance of safety and effectiveness. FDA has received adverse events from hospitals regarding incidents of medical bassinet tipping and improper cleaning of the basket or bed component that caused cracks and crazing, which have resulted in patient injury. The Agency is proposing to separate medical bassinets from other types of pediatric hospital beds to allow for more targeted postmarket surveillance of these devices. FDA believes the special controls it is proposing here, in combination with the general controls, would provide a reasonable assurance of safety and effectiveness for medical bassinets.

    IV. Risks to Health A. Pediatric Medical Crib

    Between January 1, 2005, and September 1, 2015, FDA received 516 adverse event reports, or MDRs, associated with open pediatric medical cribs, through the Agency's MAUDE database. There were 15 adverse event reports of serious injuries including 6 reports of entrapment, which were predominantly extremity entrapments of legs or arms. The majority of MDRs for medical cribs were for malfunctions such as drop-side rails not latching or lowering, brakes not holding, wheels or casters breaking, and where applicable, scales not reading correct weights. These malfunctions (501 reports) were not associated with any adverse health effects. After considering available information, FDA determined that the following risks to health are associated with the use of pediatric medical cribs:

    Injury resulting from mechanical or structural failure of the device—Mechanical or structural failure of the crib can result in failure of load-bearing components such as the wheels or casters, or failure of the latches or other locking mechanisms that secure the sides of the crib. These failures can result in injuries, as demonstrated by the MDRs received in FDA's database.

    Pinching, laceration, splinters, and foreign body ingestion—Depending on the material of the pediatric crib, certain cribs may peel or crack and may expose pediatric patients to substances or materials that may be toxic or may cause abrasions or lacerations if the surface of the crib material is compromised.

    Entrapment, falls, and strangulation—Pediatric medical cribs may cause entrapment of patient limbs if the width of the side rails are not correct and if there are gaps between the mattress and crib frame that are larger than the width of two fingers. Depending on the height requirements of the rails a pediatric patient may escape or fall from the crib. The term “entrapment” refers to circumstances where a patient is caught, trapped, or entangled in the space in or about the bed rail, mattress, or hospital bed frame.

    Burns—Certain flammable materials used in the construction of pediatric medical cribs may allow for the spread of fire, which may result in serious injuries. Fires can spread easily in hospital rooms with a patient using oxygen. The free-flowing oxygen can intensify a fire, which can rapidly spread to flammable objects in the room, including crib mattresses.

    Use error—Use error may contribute to or exacerbate any of the previously mentioned adverse events. For example, a user may be unaware that a side rail did not latch, or may fail to properly maintain a pediatric medical crib. Therefore, adequate instructions for use and user education are essential to safe device operation.

    B. Medical Bassinet

    Between January 1, 2005, and September 1, 2015, FDA received 40 adverse event reports associated with this device type. The most common MDRs for medical bassinets include reports of malfunctions such as casters or wheels not working, which have caused tipping, and broken bassinet base components, such as doors and drawers, or collapse or breakage of utility shelves or chart holders. There are also reports of the plastic sleep basket or bed component crazing (cracking), resulting in sharp edges and cuts to hospital personnel.

    FDA has considered the available information and determined that the following risks to health are associated with medical bassinets:

    Injury resulting from mechanical or structural failure of the device—Mechanical or structural failure of the bassinet can result in failure of load-bearing components such as the wheels or casters, or failure of the latches or other locking mechanisms that secure the drawers of the bassinet. These failures can result in injuries, particularly if the bassinet tips over, as demonstrated by the MDRs received in FDA's database.

    Burns—Certain flammable materials used in the construction of pediatric medical bassinets may allow for the spread of fire, which may result in serious injuries. Fires can spread easily in hospital rooms with a patient using oxygen. The free-flowing oxygen can intensify a fire, which can rapidly spread to flammable objects in the room, including bassinet mattresses.

    Crazing or cracking of basket or bed component—The basket or bed component of the bassinet that the pediatric patient is placed in may craze or crack due to improper care or handling, such as cleaning the plastic material of the basket or bed component with inappropriate cleaning solutions. Crazing or cracking may result in injuries such as cuts.

    Use error—Use error may contribute to, or exacerbate, any of the previously mentioned risks. For example, a user may accidentally leave a door or drawer in the base component of the bassinet open or place too much weight in a drawer or on a shelf, which may present a tipping hazard. Also, a user may fail to properly maintain a medical bassinet.

    V. Establishment of Special Controls

    Under section 513(a)(1)(B) of the FD&C Act, as amended by the SMDA, class II devices are defined as devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance. Special controls may include the issuance of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the Agency deems necessary to provide such assurance (see also § 860.3(c)(2)).

    Under this authority, FDA is proposing to establish special controls for pediatric medical cribs (§ 880.5140) and pediatric medical bassinets (§ 880. 5145). The Agency believes that the applicable special controls, together with the general controls, would provide reasonable assurance of the safety and effectiveness of these devices.

    VI. Proposed Special Controls A. Pediatric Medical Crib

    FDA consulted with health care providers in children's hospitals, registered nurses in pediatric units, biomedical engineers, and technicians, and analyzed the associated adverse events with pediatric medical cribs. Specifically, FDA consulted with MedSun hospitals regarding their 2011 survey on clinicians' experiences with pediatric medical cribs with drop-side rails used in MedSun's hospitals (Ref. 1). The MedSun survey summary highlights the clinical perspective and the importance of this device in medical and health care settings. The most common issues and concerns in the survey were the lack of understanding of side rail operation and the need for reinforcing patient safety when the side rails are raised or lowered. Many respondents of the survey suggested further improvements for pediatric medical cribs, for instance, improved labeling, specific distance between slats and emergency releases on side rails for faster access to pediatric patients. The adverse events identified in the MedSun survey are similar to the MDRs FDA has received on this device. FDA believes that the special controls proposed in this proposed rule, in combination with the general controls, would provide a reasonable assurance of safety and effectiveness for pediatric medical cribs their intended use.

    Table 1—Health Risks and Mitigation Measures for Pediatric Medical Crib Identified risks to health Mitigation measures Injury Resulting from Mechanical or Structural Failure of the Device Performance Testing.
  • Design Testing.
  • Pinching, Lacerations, Splinters, and Foreign Body Ingestion Appropriate Materials Free From Surface Defects.
  • Labeling.
  • Entrapment, Falls, and Strangulation Performance Testing. Rail and End Panel Design. Side Rail Spacing and Safety Features. Appropriate Fitting of Mattress. Burns CPSC's Mattress Flammability Standard. Use Error Labeling.

    As provided in Table 1, the Agency believes the following special controls, in combination with the general controls, would effectively mitigate the identified risks to health and provide reasonable assurance of the safety and effectiveness of the device:

    1. Design and performance testing must be conducted to ensure the mechanical and structural stability of the crib under expected conditions of use, including the security of latches and other locking mechanisms when engaged. These requirements are derived from sections 6.2 and 6.3 of ASTM (formerly the American Society for Testing and Materials) International Standard F1169-13, entitled “Standard Consumer Safety Specification for Full-Size Baby Cribs” (Ref. 2) and sections 5.7 and 6.3 of ASTM International Standard F2710-13, entitled “Standard Consumer Safety Performance Specification for Commercial Cribs” (Ref. 3), which was developed with input from crib manufacturers.

    2. To reduce possible injury of pinching, lacerations, and crushing, the crib shall be designed and constructed in a manner that eliminates hardware accessible to a child within the crib. This requirement is derived from section 5.10 of ASTM International Standard F1169-13, entitled “Standard Consumer Safety Specification for Full-Size Baby Cribs” (Ref. 2), which was developed with input from crib manufacturers. Also, materials used shall be appropriate for the conditions of use, allow for proper sanitation, and free from surface defects of the device that could result in injuries.

    3. To reduce the risk of head and limb entrapment, the distance between side rail components (such as slats, spindles, corner posts, and rods) shall be designed to reduce potential entrapment of pediatric patients and the distance between such components shall not exceed 23/8 inches (6 centimeters) apart. In addition, the rails and end panels of a crib must be of a height to mitigate the possibility of falls and/or escapes by the patient. These requirements are derived from sections 5.7.2 and 5.8.1 of ASTM International Standard F1169-13, entitled “Standard Consumer Safety Specification for Full-Size Baby Cribs” (Ref. 2), which was developed with input from crib manufacturers.

    4. To reduce the risk of head and limb entrapment, no gap shall exist between the edge of the bottom rail and the top of the mattress surface and the mattress must fit tightly around all four sides of the crib. These requirements are derived from section 5.9 of ASTM International Standard F1169-13, entitled “Standard Consumer Safety Specification for Full-Size Baby Cribs” (Ref. 2), which was developed with input from crib manufacturers.

    5. To reduce flammability and the risk of burns, the mattress for the crib shall meet the CPSC Standard for the Flammability of Mattresses and Mattress Pads and its Standard for the Flammability (Open Flame) of Mattress Sets, 16 CFR parts 1632 and 1633, respectively. This proposed special control would clarify for manufacturers the standards necessary for mattresses intended to be used with pediatric medical cribs to prevent the spread of fires that can easily occur in hospital rooms with a patient using oxygen. The free-flowing oxygen can intensify a fire, which can rapidly spread to most of the flammable objects in the room especially mattresses. The consumer standards for flammability of mattresses in 16 CFR parts 1632 and 1633 are also accepted by the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations). CPSC's mattress and mattress pad flammability standard under 16 CFR part 1632 addresses mattress fires ignited by open flame sources, including matches, candles, lighters, and other related scenarios. It prescribes a test to determine the ignition resistance of a mattress or a mattress pad when exposed to a lighted cigarette. CPSC's standard for the flammability of mattress sets under 16 CFR part 1633 is a broader standard designed to reduce deaths and injuries caused by mattress fires, particularly those fires ignited by, among others things, oxygen use or electrical equipment sources that may occur in a patient's room. In addition, CPSC's regulations require that manufacturers meet an established fire safety performance standard, based on ASTM E2187-09, entitled “International's Standard Test Method for Measuring the Ignition Strength of Cigarettes” (Ref. 4), which was developed with input from crib manufacturers.

    6. To reduce flammability and the risk of burns, the labeling must bear all information required pursuant to the CPSC Standard for the Flammability of Mattresses and Mattress Pads and its Standard for the Flammability (Open Flame) of Mattress Sets, 16 CFR parts 1632 and 1633, respectively.

    7. To reduce the risk of use error, which may result in mechanical or structural failure of the crib due to inadequate care or maintenance, pediatric medical crib labeling must include adequate instructions for users to care for and maintain their crib. These requirements are derived from sections 5.18 of ASTM International Standard F1169-13, entitled “Standard Consumer Safety Specification for Full-Size Baby Cribs” (Ref. 2).

    FDA believes that the special controls proposed in this rule would provide a reasonable assurance of safety and effectiveness of pediatric medical cribs in their intended use. The ASTM and CPSC standards noted above apply to all mattresses and mattress pads intended or promoted for sleeping upon, as defined in 16 CFR 1632.1(a), including medical mattresses that are regulated by FDA as an accessory to medical beds. Therefore, FDA anticipates that manufacturers would be able to meet the requirements imposed by the proposed special controls in this proposed rule without undue burden. FDA invites comments on this conclusion, including comments regarding the types of performance testing manufacturers conduct for pediatric medical cribs, particularly to ensure the performance of medical crib latches on drop-side rails.

    In addition, FDA is proposing to restrict these devices to prescription use under section 520(e) of the FD&C Act (see § 801.109 (prescription devices)). In order to use or administer use of pediatric medical cribs, authorization must be made by a practitioner licensed by law.

    B. Medical Bassinet

    Table 2 lists the risks to health FDA has identified for Medical Bassinets, as described in the Risks to Health, section IV of this proposed rule, along with the corresponding proposed mitigation measures for each risk.

    Table 2—Health Risks and Mitigation Measures for Medical Bassinet Identified risks to health Mitigation measures Injury Resulting from Mechanical or Structural Failure of the Device Performance Testing. Labeling. Burns CPSC's Mattress Flammability Standard. Crazing or Cracking of Basket or Bed Component Performance Testing. Labeling. Use Error Labeling.

    The Agency believes the following special controls, in combination with the general controls, would effectively mitigate the identified risks to health and provide reasonable assurance of the safety and effectiveness of medical bassinets:

    1. To mitigate crazing, cracking, and deterioration of the basket or bed component of the device, the manufacturer must conduct performance testing to determine material compatibility with cleansing products labeled to clean the device.

    2. To reduce flammability and the risk of burns, the bassinet shall meet CPSC's Standard for the Flammability of Mattresses and Mattress Pads and its Standard for the Flammability (Open Flame) of Mattress Sets, 16 CFR parts 1632 and 1633, respectively.

    3. To reduce the risk of injury resulting from mechanical or structural failure of the device, and particularly, device tipping that can result from those failures; manufacturers shall conduct performance testing to ensure the mechanical and structural stability of the bassinet under expected use conditions, including transport of patients in the bassinet.

    4. To reduce the risk of use error, specifically error that may result in bassinet tipping, FDA proposes that manufacturers shall have a label on the front of the bassinet cabinet with the following warning statement:

    WARNING: To avoid tipping hazards of this device, make sure that the basket or bed component sits firmly in the base and that all doors, drawers, and casters are secure.

    The label must be affixed to the front of the bassinet base cabinet and the text shall be in letters not less than 10 millimeters in height.

    FDA believes this warning is necessary because even if performance testing demonstrates that a bassinet does not present a tipping hazard under expected use conditions, users may exceed these expected use conditions, particularly during transport of a patient in the bassinet.

    5. To reduce the risk of use error, which may result in mechanical or structural failure of the bassinet due to inadequate care or maintenance, medical bassinet labeling must include adequate instructions for users to care for and maintain the bassinet.

    FDA believes that the special controls proposed in this rule would provide a reasonable assurance of safety and effectiveness of medical bassinets in their intended use. The CPSC standards noted previously apply to all mattresses and mattress pads intended or promoted for sleeping upon, as defined in 16 CFR 1632.1(a), including medical mattresses that are regulated by FDA as an accessory to medical beds. Therefore, FDA believes most manufacturers are already complying with the proposed special control for mattress flammability set forth in this proposed rule. FDA invites comments on the types of performance testing manufacturers conduct for medical bassinets.

    In addition, FDA is proposing to restrict these devices to prescription use under section 520(e) of the FD&C Act (see § 801.109 (Prescription devices)). In order to use or administer use of medical bassinets, authorization must be made by a practitioner licensed by law.

    VII. Proposed Effective Date

    FDA proposes that any final rule based on this proposal become effective 60 days after its publication in the Federal Register.

    VIII. Environmental Impact, No Significant 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.

    IX. Economic Analysis of Impacts

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

    The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the expected costs associated with this rule are expected to be modest, we propose to certify that this rule would not have a significant economic impact on a substantial number of small entities.

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

    A. Objective of the Rule

    Pediatric hospital beds are classified as class II, 510(k) exempt medical devices intended for the treatment, care, or diagnosis of diseases or illnesses of pediatric patients. In this proposed rule, FDA proposes to amend § 880.5140 by revising the identification and establishing special controls for pediatric medical cribs. This rule would also change the name of the classification regulation from “pediatric hospital bed” to “pediatric medical crib,” and place medical bassinets, previously under the pediatric hospital beds classification regulation, as a separate class II, 510(k) exempt device, subject to its own special controls.

    Pediatric medical cribs used in health care settings contain a drop-side rail design that includes movable and latchable side and end rails. As stated previously, the CPSC issued a final rule prohibiting the use of the drop-side rail design for non-medical cribs in consumer households as of June 28, 2011 (December 28, 2010, 75 FR 81766). CPSC's rule establishes new standards for full-size and non-full-size cribs used for non-medical purposes, which effectively prohibit the manufacture or sale of cribs for non-medical purposes with a drop-side rail design in households, child care facilities, family child care homes, and places of public accommodation. The compliance date for this same rule for child care facilities, family child care homes, and places of public accommodation was December 28, 2012 (75 FR 81766). CPSC's rule was established in response to infant deaths that occurred when the side rail of a crib used for non-medical purposes detached or disengaged. In contrast, there have been no deaths and a few serious injuries reported to FDA associated with pediatric medical cribs, which are made of more durable materials and construction in comparison to cribs used for non-medical purposes. Additionally, FDA has determined that drop-side rails are essential for patient care in hospital settings and even outside of traditional health care settings to allow parents and care givers easy access to their patients in order to perform both routine and emergency medical procedures. To address concerns raised by CPSC's reports on consumer drop-side rail cribs and account for the medical need of this device, FDA is proposing to establish special controls and require a prescription for this device when used outside of traditional health care setting. Thus, FDA has determined that cribs with drop-side rail designs may remain on the market when intended for medical use, and can be used outside of traditional health care settings through prescription use only. In addition, this proposed rule adds specific special controls for medical bassinets to mitigate health risks such as tipping of the device and crazing of the plastic basket or bed component. Regulation of this device under a separate regulation would also allow for more targeted post market surveillance for this device.

    B. Benefits

    FDA's Registration and Listing database identifies 38 manufacturers of medical cribs and bassinets. FDA has reviewed the safety standards of several large pediatric crib and bassinet manufacturers in order to determine the compliance burden associated with the proposed special controls. The Agency concludes that many of the special controls proposed by this rule are consistent with current industry practice among many medical crib and bassinet manufacturers. The proposed special control that is not currently practiced is the warning labeling requirements for medical bassinets. For new pediatric medical crib and bassinet manufacturers entering the market or manufacturers that may not be currently following the practices required by the proposed special controls, if this proposed rule is finalized, its special controls will clarify safety standards and minimize the risk of injury to pediatric patients.

    The beneficial features of medical bassinets are portability, ease of cleaning, and, when it is made of a clear material, the ability to see the baby from all sides. The proposed special controls would require bassinet manufacturers to place labels on their devices warning against device tipping. This requirement would apply to new bassinets; bassinets that have already been sold would not be required to add the new labels to their devices. The warning label is intended to prevent tipping of the device, which may be caused by unlatched drawers, dislodged wheels, or too much weight on the shelves. The Agency has not received any reports of death or serious injury related to medical bassinets, although there have been a small number of reports of malfunctioning casters, which may cause device tipping. The benefits of the new warning label are not readily quantifiable, but it is expected to reduce the risk of the bassinet from tipping and thus, reduce potential injury to pediatric patients.

    The provision allowing for the medical cribs outside of traditional health care settings would benefit pediatric patients who require the specialized care provided by these devices outside of traditional health care settings. Due to the CPSC rule regarding cribs used for non-medical purposes, discussed previously, consumers and child care facilities are restricted from using cribs with a drop-side rail design. If this proposed rule is finalized, it will allow consumers and child care facilities to utilize the pediatric medical cribs if they are prescribed by a health care professional.

    The special controls regarding the mechanical structure of pediatric medical cribs are intended to minimize the risk of injury, including entrapment or strangulation of pediatric patients. The spacing specifications of the side rail components are designed to prevent head or neck entrapment and strangulation incidents in which infants may slip between the openings of the slats, and the performance testing requirements are designed to ensure the side rail latches of pediatric medical cribs will perform as intended and remain secure when the latches are engaged. The special control requiring specific height of the rails and end panels may prevent falls and/or escapes by the patient. Also, by having pediatric medical crib manufacturers use materials that are appropriate for the conditions of use and allow for proper sanitation, these special controls may help mitigate surface defects that can cause injury to the patient.

    Additionally, the mattress size standards for cribs and bassinets are intended to reduce the risk of significant gaps between the mattress and the device structure, which could potentially create an entrapment hazard. The flammability standard is intended to reduce deaths and injuries related to mattress fires, particularly those initially ignited by open flame sources such as lighters, candles, and matches. Although the practices proposed in these special controls are believed to be followed by almost all manufacturers of products currently on the market, the proposed special controls would reinforce safety standards for such manufacturers and ensure that other manufacturers and manufacturers of new products adhere to the same safety standards.

    C. Costs

    The economic impact of the proposed regulation is determined primarily by whether manufacturers currently comply with the proposed special controls. As stated previously, the special controls that are not currently practiced by industry, of which FDA is aware, are the bassinet warning labeling and the performance testing requirements. FDA is also aware that many manufacturers of pediatric medical cribs and medical bassinets registered with the FDA currently conform to the risk mitigations and structural requirements that are being proposed as special controls, and thus conforming to these special controls, if finalized, would not result in an increase in cost to pediatric medical crib manufacturers and only cause a small increase in cost for medical bassinet manufactures. Additionally, the renaming of pediatric medical cribs and redesignation in the CFR for medical bassinets and the remaining devices under the pediatric hospital bed classification are administrative in nature, and are not expected to result in any cost burdens.

    The new warning labeling requirements for medical bassinets will apply to manufacturers of new bassinets only. FDA does not expect bassinets that are currently on the market to be relabeled. If manufacturers of new bassinets add labels to the devices at the time of production, the cost burden to manufacturers would be minimized. Although we do not have direct estimates of labeling costs for these devices, the best estimate of these costs is derived from FDA's labeling cost model. Because FDA would require specific language and format of the labels, we consider this to be a minor labeling change that would not require label design, market tests, or analytical tests. Labeling costs would include labor and material, and are estimated to be, on average, approximately $140 per unit. Then we use the number of live births per year as reported by the Center for Disease Control and Prevention in order to determine the number of bassinets produced per year for medical use (Ref. 5). Using an estimate of 4 million births per year and 11,000 births per day, we estimate that each birth requires an average hospital stay of 3 days. This yields a total supply of approximately 33,000 medical bassinets in the United States. Given an average yearly replacement rate of 20 percent for all medical bassinets, we estimate that approximately 6,600 new bassinets will be produced annually. Applying the $140 per unit labeling cost yields a total yearly cost of $924,000 associated with the new bassinet warning label requirement.

    The special controls require performance testing for medical bassinets to reduce the risk of crazing of the plastic basket or bed component. We assume that the performance testing may be conducted as an extension to current product testing and may be performed at the same testing facilities currently utilized by bassinet manufacturers. FDA projects that a maximum of an additional week of testing would be required. The costs associated with the performance testing include the labor costs of mechanical engineers, who typically perform these tests. The mean 2012 hourly wage for mechanical engineers is $40.75, as reported by the Occupational Employment Statistics provided by the Bureau of Labor Statistics (Ref. 6). Applying a multiplier of 1.45 to adjust for benefits, hourly labor costs are estimated to be approximately $59. Assuming a 40-hour work week, the total maximum estimated cost for each manufacturer to perform these additional tests is approximately $2,360. It is uncertain the exact number of manufacturers that do not currently conduct performance testing and would therefore be required to extend current testing practices. However, given the relatively small number of medical bassinet manufacturers, FDA anticipates that even the upper-bound total cost would be modest.

    The prescription use of pediatric medical cribs outside of traditional health care settings may potentially increase Medicaid spending for eligible pediatric patients. According to our review of Healthcare Common Procedure Coding System billing codes for the Medicaid program, currently, States typically offer Medicaid coverage for prescribed rental or purchase of hospital beds and pediatric cribs (Ref. 7). We estimate the number of additional prescriptions for pediatric medical cribs to be filled annually as a result of this proposed rule would be less than 100. Medicaid expenditure on pediatric medical cribs is estimated to be on average $2,500 per device. This yields a maximum annual total cost of $250,000.

    Although it is unlikely that these devices would require physical modification to meet the standards proposed by the special controls in this proposed rule, there may be manufacturers on the market of which we are unaware that do not conform to the requirements proposed in the special controls. The proposed special controls could have a significant impact on firms that are not currently in compliance with the special controls, as their products may require modifications. The special control that may cause additional costs for manufacturers is the special control concerning the mechanical structure of pediatric medical cribs. We are not able to estimate the actual compliance costs for manufacturers of pediatric medical cribs because such costs may vary by firm size and the amount of modification required. Alternatively, we provide an estimate of the modification cost by using aggregate industry market price information and cost data. The costs associated with these modifications may include the costs associated with product design and testing, labor, material, and production. We use data from the Annual Survey of Manufacturers to calculate aggregate labor and materials costs as a percentage of total sales for manufacturers represented by North American Industry Classification System code 339113 (Ref. 8). The data indicate that labor and materials represent approximately 45 percent of total sales. Allowing market price to represent per unit revenue at the firm level, we estimate the cost of modification to be approximately 45 percent of the average price of a pediatric medical crib. After surveying market prices of pediatric medical cribs, we estimate an average per unit price of $2,500. This yields an average cost of approximately $1,125 to modify a pediatric medical crib to be in compliance with the proposed special controls.

    FDA invites comments on the compliance of manufacturers with the special controls, including the performance testing, mechanical structure, flammability requirements, and bassinet labeling requirements, as well as cost information if modifications are required.

    X. Paperwork Reduction Act of 1995

    The proposed rule refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management Budget (OMB) and the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information, regarding premarket notification submissions (21 CFR part 807, subpart E), are approved under OMB control number 0910-0120. The collections of information, regarding labeling (21 CFR part 801), including prescription device labeling and adequate directions for use, are approved under OMB control number 0910-0485. The collections of information regarding current good manufacturing practice quality systems (21 CFR part 820), including design controls (as referenced in proposed § 880.5140(b)(1) and proposed § 880.5145(b)(1) and (b)(3) of this document), are approved under OMB control number 0910-0073. The collections of information in 16 CFR 1632 and 1633, regarding mattress flammability, are approved under OMB control number 3041-0014.

    In addition, FDA concludes that the warning label for bassinets does not constitute a “collection of information” under the PRA. Rather, the labeling statement is “public disclosure(s) of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public.” (5 CFR 1320.3(c)(2)).

    XI. 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. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)

    1. MedSun: Newsletter #66: “Pediatric Hospital Cribs: MedSun Small Sample Survey Summary” (November 2011), available at http://www.fda.gov/downloads/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/Newsletters/UCM422131.pdf. 2. ASTM International (formerly the American Society for Testing and Materials), “Standard Consumer Safety Specifications for Full-Size Baby Cribs,” Designation: F1169-13, available at http://www.astm.org/Standards/F1169.htm, 2013. 3. ASTM International (formerly the American Society for Testing and Materials), “Standard Consumer Safety Performance Specification for Commercial Cribs,” Designation: F2710-13, available at http://www.astm.org/Standards/F2710.htm, 2013. 4. ASTM International, “Standard Test Method for Measuring the Ignition Strength of Cigarettes,” Designation: E2187-09 Standard, available at http://www.astm.org/Standards/E2187.htm. 5. Centers for Disease Control and Prevention (CDC), National Vital Statistics System, Birth Data, available at http://www.cdc.gov/nchs/births.htm. 6. Occupational Employment Statistics provided by the Bureau of Labor Statistics, May 2012 Occupational Employment Statistics, available at http://www.bls.gov/oes/2012/may/oes_stru.htm. 7. Centers for Medicare & Medicaid Services, HCPCS 2015 Code: E0300, available at http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/index.html?redirect=/medhcpcsgeninfo/. 8. U.S. Census Bureau, 2013 Annual Survey of Manufacturers, available at http://www.census.gov/manufacturing/asm/index.html. List of Subjects in 21 CFR Part 880

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 880 be amended as follows:

    PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES 1. The authority citation for 21 CFR part 880 continues to read as follows: Authority:

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

    2. Revise § 880.5140 to read as follows:
    § 880.5140 Pediatric medical crib.

    (a) Identification. A pediatric medical crib is a prescription device intended for medical purposes for use with a pediatric patient that consists of an open crib, fixed-end rails, movable and latchable side rail components, and possibly an accompanying mattress. The contour of the crib surface may be adjustable.

    (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. The special controls for this device are:

    (1) Crib design and performance testing shall demonstrate the mechanical and structural stability of the crib under expected conditions of use, including the security of latches and other locking mechanisms when engaged;

    (2) Materials used shall be appropriate for the conditions of use, allow for proper sanitation and free from surface defects that could result in injuries;

    (3) Rails and end panels shall be designed taking into account the crib's height at its lowest point to the top of the mattress to prevent patient falls and/or escape. Hardware and fasteners shall be designed and constructed to eliminate mechanical hazards to the patient;

    (4) The distance between components of the side rail (such as slats, spindles, and corner posts) shall not be greater than 23/8 inches (6 centimeters (cm)) apart at any point. Side rails shall contain safety features for locking and adjust the lowest position of the crib to a height that shall be 20 inches (51 cm) above the top of the mattress;

    (5) The device shall not have a gap between the bottom of the rail and the top surface of the mattress and the mattress pad must fit tightly around all four sides of the crib;

    (6) The mattress for the crib shall meet the Consumer Product Safety Commission (CPSC) Standard for the Flammability of Mattresses and Mattress Pads and Standard for the Flammability (Open Flame) of Mattress Sets, 16 CFR parts 1632 and 1633, respectively;

    (7) The labeling must bear all information required pursuant to the CPSC Standard for the Flammability of Mattresses and Mattress Pads and Standard for the Flammability (Open Flame) of Mattress Sets, 16 CFR parts 1632 and 1633, respectively; and

    (8) Pediatric medical crib labeling must include adequate instructions for users to care for and maintain their crib.

    3. Add § 880.5145 to subpart F to read as follows:
    § 880.5145 Medical bassinet.

    (a) Identification. A medical bassinet is a prescription device that is a small bed intended for use with pediatric patients, generally from birth to approximately 5 months of age. It is intended for medical purposes for use in a nursery, labor and delivery unit, or patient room, but may also be used outside of traditional health care settings. A medical bassinet is a non-powered device that consists of two components: The plastic basket or bed component and a durable frame with wheels, which holds the basket or bed component. The basket or bed component is a box-like structure, generally made of a clear, high impact-resistant plastic material, with an open top and four stationary walls to hold the pediatric patient. The frame can include drawers, shelving or cabinetry that provides space to hold baby care items. The wheels or casters allow the bassinet to transport the baby throughout the care setting.

    (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. The special controls for this device are:

    (1) The manufacturer must conduct performance testing to determine material compatibility with cleansing products labeled to clean the device. Testing must demonstrate that the cleaning instructions provided by the manufacturer do not cause crazing, cracking, or deterioration of the device;

    (2) The mattress for the device shall meet the Consumer Product Safety Commission Standard for the Flammability of Mattresses and Mattress Pads and Standard for the Flammability (Open Flame) of Mattress Sets, 16 CFR parts 1632 and 1633, respectively;

    (3) Manufacturers shall conduct performance testing to ensure the mechanical and structural stability of the bassinet under expected use conditions, including transport of patients in the bassinet. Testing must demonstrate that failures such as wheel or caster breakage do not occur, and that the device does not present a tipping hazard due to any mechanical failures, under expected use conditions;

    (4) Each device must have affixed a label on the front of the bassinet cabinet with the following language in text of at least 10 millimeters in height:

    WARNING: To avoid tipping hazards of this device, make sure that the basket or bed component sits firmly in the base and that all doors, drawers, and casters are secure.

    (5) Labeling must include adequate instructions for users to care for and maintain their bassinet.

    Dated: October 2, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-25627 Filed 10-7-15; 8:45 a.m.] BILLING CODE 4164-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 372 [EPA-HQ-TRI-2015-0352; FRL 9935-38-OEI] Ethylene Glycol Monobutyl Ether; Community Right-To-Know Toxic Chemical Release Reporting AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Denial of petition.

    SUMMARY:

    Environmental Protection Agency (EPA) is denying a petition to remove ethylene glycol monobutyl ether (EGBE) from the category Certain Glycol Ethers under the list of chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) of 1990. EPA has reviewed the available data on this chemical and has determined that EGBE does not meet the deletion criterion of EPCRA section 313(d)(3). Specifically, EPA is denying this petition because EPA's review of the petition and available information resulted in the conclusion that EGBE meets the listing criterion of EPCRA section 313(d)(2)(B) due to its potential to cause serious or irreversible chronic health effects in humans, specifically, liver toxicity and concerns for hematological effects.

    DATES:

    EPA denied this petition on September 24, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Daniel R. Bushman, Environmental Analysis Division, Office of Information Analysis and Access (2842T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-566-0743; fax number: 202-566-0677; email: [email protected], for specific information on this notice. For general information on EPCRA section 313, contact the Emergency Planning and Community Right-to-Know Hotline, toll free at (800) 424-9346 (select menu option 3) or (703) 412-9810 in Virginia and Alaska or toll free, TDD (800) 553-7672, http://www.epa.gov/superfund/contacts/infocenter/.

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this notice apply to me?

    You may be potentially affected by this action if you manufacture, process, or otherwise use EGBE. Potentially affected categories and entities may include, but are not limited to:

    Category Examples of potentially affected entities Industry Facilities included in the following NAICS manufacturing codes (corresponding to SIC codes 20 through 39): 311,* 312,* 313,* 314,* 315,* 316, 321, 322, 323,* 324, 325,* 326,* 327, 331, 332, 333, 334,* 335,* 336, 337,* 339,* 111998,* 211112,* 212324,* 212325,* 212393,* 212399,* 488390,* 511110, 511120, 511130, 511140,* 511191, 511199, 512220, 512230,* 519130,* 541712,* or 811490.*
  • *Exceptions and/or limitations exist for these NAICS codes.
  • Facilities included in the following NAICS codes (corresponding to SIC codes other than SIC codes 20 through 39): 212111, 212112, 212113 (correspond to SIC 12, Coal Mining (except 1241)); or 212221, 212222, 212231, 212234, 212299 (correspond to SIC 10, Metal Mining (except 1011, 1081, and 1094)); or 221111, 221112, 221113, 221118, 221121, 221122, 221330 (Limited to facilities that combust coal and/or oil for the purpose of generating power for distribution in commerce) (correspond to SIC 4911, 4931, and 4939, Electric Utilities); or 424690, 425110, 425120 (Limited to facilities previously classified in SIC 5169, Chemicals and Allied Products, Not Elsewhere Classified); or 424710 (corresponds to SIC 5171, Petroleum Bulk Terminals and Plants); or 562112 (Limited to facilities primarily engaged in solvent recovery services on a contract or fee basis (previously classified under SIC 7389, Business Services, NEC)); or 562211, 562212, 562213, 562219, 562920 (Limited to facilities regulated under the Resource Conservation and Recovery Act, subtitle C, 42 U.S.C. 6921 et seq.) (correspond to SIC 4953, Refuse Systems). Federal Government Federal facilities.

    This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Some of the entities listed in the table have exemptions and/or limitations regarding coverage, and other types of entities not listed in the table could also be affected. To determine whether your facility would be affected by this action, you should carefully examine the applicability criteria in part 372 subpart B of Title 40 of the Code of Federal Regulations. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

    B. How can I get copies of this document and other related information?

    1. Docket. EPA has established a docket for this action under Docket ID No. EPA-HQ-TRI-2015-0352. Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy at the OEI Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. This Docket Facility 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.

    2. Electronic Access. You may access this Federal Register document electronically from the Government Printing Office under the “Federal Register” listings at FDSys (http://www.thefederalregister.org/fdsys/browse/collection.action?collectionCode=FR).

    II. Introduction

    Section 313 of EPCRA, 42 U.S.C. 11023, requires certain facilities that manufacture, process, or otherwise use listed toxic chemicals in amounts above reporting threshold levels to report their environmental releases and other waste management quantities of such chemicals annually. These facilities must also report pollution prevention and recycling data for such chemicals, pursuant to section 6607 of the PPA, 42 U.S.C. 13106. Congress established an initial list of toxic chemicals that comprised more than 300 chemicals and 20 chemical categories.

    EPCRA section 313(d) authorizes EPA to add or delete chemicals from the list and sets criteria for these actions. EPCRA section 313(d)(2) states that EPA may add a chemical to the list if any of the listing criteria in Section 313(d)(2) are met. Therefore, to add a chemical, EPA must demonstrate that at least one criterion is met, but need not determine whether any other criterion is met. EPCRA section 313(d)(3) states that a chemical may be deleted if the Administrator determines there is not sufficient evidence to establish any of the criteria described in EPCRA section 313(d)(2)(A)-(C). The EPCRA section 313(d)(2)(A)-(C) criteria are:

    • The chemical is known to cause or can reasonably be anticipated to cause significant adverse acute human health effects at concentration levels that are reasonably likely to exist beyond facility site boundaries as a result of continuous, or frequently recurring, releases. • The chemical is known to cause or can reasonably be anticipated to cause in humans: ○ Cancer or teratogenic effects, or ○ serious or irreversible— reproductive dysfunctions, neurological disorders, heritable genetic mutations, or other chronic health effects. • The chemical is known to cause or can be reasonably anticipated to cause, because of: ○ its toxicity, ○ its toxicity and persistence in the environment, or ○ its toxicity and tendency to bioaccumulate in the environment, a significant adverse effect on the environment of sufficient seriousness, in the judgment of the Administrator, to warrant reporting under this section.

    EPA often refers to the section 313(d)(2)(A) criterion as the “acute human health effects criterion;” the section 313(d)(2)(B) criterion as the “chronic human health effects criterion;” and the section 313(d)(2)(C) criterion as the “environmental effects criterion.”

    Under section 313(e)(1), any person may petition EPA to add chemicals to or delete chemicals from the list. EPA issued a statement of petition policy and guidance in the Federal Register of February 4, 1987 (52 FR 3479) to provide guidance regarding the recommended content and format for submitting petitions. On May 23, 1991 (56 FR 23703), EPA issued guidance regarding the recommended content of petitions to delete individual members of the section 313 metal compounds categories. EPA published in the Federal Register of November 30, 1994 (59 FR 61432) a statement clarifying its interpretation of the section 313(d)(2) and (d)(3) criteria for modifying the section 313 list of toxic chemicals.

    III. What is the description of the petition?

    On January 23, 2015, EPA received a petition from American Chemistry Council (ACC) Ethylene Glycol Ethers Panel requesting EPA to delete EGBE (Chemical Abstracts Service Registry Number (CASRN) 111-76-2) from the list of chemicals subject to reporting under EPCRA section 313 and PPA section 6607 (Reference (Ref. 1)). EGBE is not individually listed under EPCRA section 313 but rather is reportable under the Certain Glycol Ethers category. The petitioner contends that the available scientific data show that EGBE has low potential hazard to human health and the environment. Therefore, the petitioner believes that under EPA's policy for listing decisions under EPCRA section 313, potential exposures should be considered. The petitioner believes that their analysis shows that exposure levels are well below the concern levels for human health and ecological effects.

    IV. What is EPA's evaluation of the toxicity of EGBE?

    EPA's evaluation of the toxicity of EGBE included a review of the human health and ecological effects data. EPA's Integrated Risk Information System (IRIS) toxicological review of EBGE (Ref. 2) was the primary source used to determine the human health effects of EGBE. EPA also prepared an assessment of the chemistry, fate, and ecological effects for EGBE (Ref. 3).

    A. What is EPA's review of the human health toxicity data for EGBE?

    EPA's evaluation of the toxicity of EGBE included a review (Ref. 4) of the IRIS toxicological review of EGBE (Ref. 2). EPA also reviewed the findings of studies published since the IRIS toxicological review of EGBE, but found no data relevant to include in this evaluation. This Unit outlines the evidence of human health toxicity from the 2010 IRIS toxicological review of EGBE. Unit IV.B. below discusses the conclusions regarding EGBE's potential human health toxicity.

    1. Toxicokinetics. In humans, EGBE is absorbed and rapidly distributed following inhalation, ingestion, or dermal exposure (Refs. 5, 6, 7, and 8). Several reviews have described the metabolism of EGBE in detail (Refs. 9, 10, and 11). The principal products from EGBE metabolism are butoxyacetic acid (BAA) (rats and humans) and the glutamine or glycine conjugate of BAA (humans). BAA is excreted in the urine of both rats and humans, which suggests that the creation of BAA through the formation of butoxyacetaldehyde by alcohol dehydrogenase is applicable to rats and humans (Refs. 8, 12, and 13). The other proposed metabolic pathways, however, may only be applicable to rats since the metabolites of these pathways (i.e., ethylene glycol, EGBE glucuronide, and EGBE sulfate) have been observed in the urine of rats (Refs. 14 and 15), but not in humans (Ref. 8). In addition, Corley et al. (Ref. 8) confirmed the finding from Rettenmeier et al. (Ref. 16) that approximately two-thirds of the BAA formed in humans is conjugated with glutamine and glycine. These pathways, however, have not been observed in the rat.

    Several experimental studies have measured the concentration of BAA in human serum and urine following exposure to EGBE. For humans, the elimination kinetics of EGBE and BAA appear to be independent of the route of exposure with an approximate half-life of around one hour for EGBE and an approximate half-life of BAA of 3-4 hours (Refs. 17, 18, and 19).

    Several physiologically based pharmacokinetic models for EGBE have been developed. Some older models have described the kinetics of EGBE for acute human exposure and exposure to rats via the ingestion, inhalation, and dermal routes (Refs. 17 and 20 based on data from Refs. 13, 21, and 22). Newer models, however, have extended upon the work of these previous models. Corley et al. (Ref. 7) described the kinetics of EGBE and BAA in both rats and humans. These authors later validated the human dermal exposure model (Ref. 8). Lee et al. (Ref. 23) modeled the kinetics of EGBE and BAA in mice and rats from a National Toxicology Program (NTP) 2-year inhalation bioassay (based on data from Dill et al. (Ref. 24)). Species, gender, age, and exposure concentration-dependent differences in the kinetics of BAA were observed. Corley et al. (Ref. 12) built on the Lee et al. (Ref. 23) model by replacing some model assumptions with experimental data (Note: The Corley et al. (Ref. 12) model, along with the Lee et al. (Ref. 23) rat and mouse model and Corley et al. (Ref. 8) human model were used by EPA to calculate internal doses of EGBE in the 2010 IRIS toxicological review of EGBE (Ref. 2)).

    2. Effects of Acute and Short-Term Exposure. Hematologic and other effects have been observed in several acute and short-term oral studies of EGBE in rats and mice (Refs. 15, 25, 26, 27, 28, 29, 30, 31, 32, 33, and 34). Varying degrees of hematotoxicity have also been observed in rats and rabbits following dermal application of EGBE (Refs. 14 and 35). Guinea pigs, however, have not demonstrated sensitivity to the hematologic effects of EGBE in acute studies (Refs. 36 and 37). EGBE has also been found to be an ocular irritant when instilled in rabbits (Refs. 38 and 39).

    A few in vitro studies have investigated EGBE's potential hemolytic effects in human red blood cells after acute exposures. Bartnik et al. (Ref. 14) reported no hemolysis of human red blood cells exposed for three hours to BAA levels up to 15 millimolar (mM). Hemolysis was observed in rat red blood cells, however, at BAA levels as low as 1.25 mM. Udden (Ref. 40) incubated human red blood cells with up to 2.0 mM BBA for four hours, and the authors observed none of the morphological changes observed in rat red blood cells at the same concentration. Udden (Ref. 41) reported a significant change in human red blood cell deformability at exposure to 7.5 and 10 mM BAA for 4 hours, whereas deformability in rat red blood cells was significantly increased at 0.05 mM BAA. Mean cellular volume in human blood samples was significantly increased at 10 mM BAA while mean cellular volume in rats was significantly increased at 0.05 mM BAA.

    There are a number of case reports of acute ingestion of EGBE with little or no hematologic effects observed (Refs. 42, 43, 44, 45, 46, 47, 48, and 49). Some other observed effects were likely not directly related to hemolysis; however, the cause of the effects cannot be explained based on the limited data available. Also, hemodialysis was employed to remove un-metabolized EGBE in many of the cases.

    One experimental study in humans (Ref. 50), observed no effects on red blood cell fragility after exposure of two males and one female to up to 195 part per million (ppm) EGBE for 8 hours.

    3. Carcinogenicity and Mutagenicity. Under the Guidelines for Carcinogen Risk Assessment (Ref. 51), there is suggestive evidence of EGBE's carcinogenic potential based on a 2-year NTP bioassay in mice and rats (Ref. 52). EGBE has been tested for its potential for genotoxicity both in vitro and in vivo, and the available data do not demonstrate that EGBE is mutagenic or clastogenic (Refs. 53, 54, 55, 56, 57, and 58).

    4. Reproductive and Developmental Toxicity.The reproductive and developmental toxicity of EGBE has been investigated in a number of oral and inhalation studies in rats, mice, and rabbits. In a two-generation reproductive toxicity study, fertility was reduced in mice at very high maternally toxic doses (>1,000 milligrams/kilogram (mg/kg)) (Ref. 59), but no other significant reproductive effects were reported in any study (Refs. 26, 52, 60, 61, 62, 63, 64, 65, and 66). Maternal toxicity related to the hematologic effects of EGBE and relatively minor developmental effects have been reported in developmental studies (Refs. 67, 68, 69, and 70). No teratogenic effects were noted in any of the studies. As such, EGBE is not reasonably anticipated to be a reproductive or developmental toxicant at moderately low to low doses.

    5. Neurotoxicity. There is no evidence of neurotoxicity in any animal studies of EGBE. One case study patient demonstrated neurologic deficits after ingesting a product with a high dose of EGBE and other chemicals (Ref. 47). Given the general limitations of case studies and the presence of other chemicals, however, EPA cannot draw conclusions about EGBE's potential neurotoxicity from this particular study.

    6. Other Subchronic and Chronic Toxicity. Hematologic effects and liver toxicity have been observed at low doses of EGBE in several animal studies.

    The NTP (Ref. 66) conducted a 13-week study in F344 rats and B6C3F1 mice in which groups of 10 animals/gender/species received EGBE in drinking water at doses of 0, 750, 1,500, 3,000, 4,500, and 6,000 ppm. The corresponding doses based on measured drinking water consumption were: 0, 69, 129, 281, 367, or 452 milligrams/kilogram/day (mg/kg/day) in male rats; 0, 82, 151, 304, 363, or 470 mg/kg/day in female rats; 0, 118, 223, 553, 676, or 694 mg/kg/day in male mice; and 0, 185, 370, 676, 861, or 1,306 mg/kg/day in female mice.

    Indications of mild to moderate anemia were observed in both genders. Statistically significant hematologic effects in female rats included reduced red blood cell counts and hemoglobin concentrations at ≥750 ppm and increased reticulocytes, decreased platelets, and increased bone marrow cellularity at 3,000 ppm. Liver effects including cytoplasmic alterations, hepatocellular degeneration, and pigmentation were reported in the mid- and high-dose groups (≥1,500 ppm for males and females; statistics not reported). Additionally, cytoplasmic alterations of liver hepatocytes were observed in the lowest-dose groups (750 ppm for males and females). The lack of cytoplasmic granularity of the hepatocytes indicates that this response was not due to enzyme induction (Ref. 71). The NTP (Ref. 66) identified a lowest-observed-adverse-effect level (LOAEL) for rats of 750 ppm (approximately 58.6 mg/kg/day calculated using water consumption rates and body weights measured during the last week of exposure and, therefore, slightly different from those reported by the study authors (Ref. 2)) based on decreased red blood cell count and hemoglobin in female rats. A NOAEL was not identified.

    A reduction in body weight gain at ≥3,000 ppm was observed in male and female mice. An increase in relative kidney weight was also observed at all doses in female mice. Body weight reductions followed decreased water consumption. No histopathologic changes were noted at any dose level, however, relative kidney weights showed a statistically significant increase at 750 and 1,500 ppm in the absence of reduction in body weight gain. The NTP (Ref. 66) identified a LOAEL for mice of 3,000 ppm (approximately, 553-676 mg/kg/day calculated using water consumption rates and body weights measured during the last week of exposure and, therefore, slightly different from those reported by the study authors (Ref. 2)) based on reduced body weight and body weight gain.

    Dodd et al. (Ref. 62) conducted a 90-day subchronic inhalation study using F344 rats (16/gender/group) exposed to EGBE for 6 hours/day, 5 days/week at concentrations of 0, 5, 25, and 77 ppm. After 6 weeks, the 77 ppm female rats had statistically significant decreases in red blood cell counts (13%) and hemoglobin concentrations, accompanied by an 11% increase in mean corpuscular hemoglobin. Similar results were observed in males. However, many of these effects had lessened by the end of the study. The authors reported a LOAEL of 77 ppm based on decreases in red blood cell count and hemoglobin concentrations, accompanied by an increase in mean corpuscular hemoglobin in both genders.

    The NTP (Ref. 52) conducted a subchronic inhalation study in F344 rats and B6C3F1 mice (10/gender). Rats and mice were exposed to EGBE concentrations of 0, 31, 62.5, 125, 250, and 500 ppm (0, 150, 302, 604, 1,208, and 2,416 milligrams/cubic meter (mg/m3)) 6 hours/day, 5 days/week for 14 weeks. The NTP (Ref. 52) identified a LOAEL of 31 ppm in female rats based on decreases in hematocrit, hemoglobin, and red blood cell count and a LOAEL of 62.5 ppm in male rats based on a decrease in red blood cell count. Histopathologic effects were observed in male and female rats. Effects reported in female rats included liver necrosis at 250 ppm and centrilobular degeneration and renal tubular degeneration at 500 ppm. Other effects reported in both genders included: Excessive splenic congestion in the form of extramedullary hematopoiesis (at 250 ppm in male rats and 125 ppm in female rats), hemosiderin accumulation in Kupffer cells (at 125 ppm in male rats and 62.5 ppm in female rats), intracytoplasmic hemoglobin (at 125 ppm in male rats and 31 ppm in female rats), hemosiderin deposition (at 125 ppm in male rats and 62.5 ppm in female rats), and bone marrow hyperplasia (at 250 ppm in male rats and 62.5 ppm in female rats). The authors identified a LOAEL of 62.5 ppm for mice based on histopathological changes in the forestomach (including: Necrosis, ulceration, inflammation, and epithelial hyperplasia) in both males and females. Signs consistent with the hemolytic effects of EGBE (including: Decreased red blood cell counts, increased reticulocyte counts, and increased mean corpuscular volume) were also observed at 250 and 500 ppm in male and female mice.

    The NTP (Ref. 52) also completed a 2-year inhalation study on EGBE in both F344 rats and B6C3F1 mice. In this study, animals were exposed to EGBE 6 hours/day, 5 days/week at concentrations of 0, 31, 62.5, and 125 ppm (0, 150, 302, and 604 mg/m3) for groups of 50 F344 rats and 0, 62.5, 125, and 250 ppm (0, 302, 604, and 1,208 mg/m3) for groups of 50 B6C3F1 mice. The authors identified a LOAEL of 31 ppm in rats based on decreases in hematocrit, hemoglobin, and red blood cell count in female rats in a satellite group observed at 3 and 6 months. The authors identified 62.5 ppm as the LOAEL for mice based on hemosiderin deposition.

    One long-term occupational study of EGBE was identified in the literature. Haufroid et al. (Ref. 72) reported a small decrease in hematocrit and increase in mean corpuscular hemoglobin in a cross sectional study of 31 workers exposed to an average concentration of 0.6 ppm EGBE over 1 to 6 years. The biological significance of these findings, however, is unclear as they were within normal clinical ranges and no other measured parameters were affected by EGBE exposure.

    B. What are EPA's conclusions regarding the human hazard potential of EGBE?

    There is evidence to indicate that the human red blood cell response to EGBE exposure is less than that of rodents, however, this conclusion is based on a relatively small number of in vitro and short-term human exposure studies with supporting evidence from pharmacokinetic models (Refs. 7, 8, 14, 40, 41, and 50). Little is known of the long-term or repeated exposure responses in humans to EGBE.

    In 2010, EPA concluded in the IRIS toxicological review of EGBE that human red blood cells do appear capable of responding similarly to the causative EGBE metabolites, albeit at much higher exposures (Ref. 2). The IRIS toxicological review of EGBE employed an interspecies uncertainty factor of 1 to derive the reference values for EGBE in part because there was not a preponderance of toxicodynamic data in both animals and humans describing why humans are less sensitive than rats to the hematologic effects in question (Ref. 2). Also, EPA calculated a human equivalent concentration LOAEL (LOAELHEC) for hematologic effects of 271 mg/m3 (approximately 77 mg/kg/day, assuming constant exposure, an inhalation rate of 20 cubic meters/day (m3/day), and a 70 kg human) using pharmacokinetic model estimates (Refs. 7 and 8) of the human internal dose equivalent of the toxic metabolite BAA to that estimated for female rats exposed to 31 ppm EGBE in the NTP (Ref. 52) study (Ref. 2). In its assessment of EGBE, the European Union carried out a slightly different calculation based on the same underlying data and reported a similar, but slightly higher, human equivalent LOAEL of 474 mg/m3 (approximately 135 mg/kg/day) (Ref. 11).

    Additionally, multiple animal studies by the NTP reported liver toxicity (e.g., cytoplasmic alterations of liver hepatocytes at 750 ppm (approximately 69 mg/kg/day) in male rats and 750 ppm (82 mg/kg/day) in female rats (Ref. 66) and liver necrosis at 250 ppm (approximately 243 mg/kg/day) in female rats (Ref. 52)) to which humans do not demonstrate decreased sensitivity. These findings provide further evidence of EGBE's potential toxicity to humans at moderately low to low doses.

    Therefore, the available evidence is sufficient to conclude that EGBE can be reasonably anticipated to demonstrate moderately high to high chronic toxicity in humans based on the EPCRA Section 313 listing criteria (59 FR 61432, November 30, 1994).

    C. What is EPA's review of the ecological toxicity of EGBE?

    Based on a review of the available aquatic ecological toxicity data, EGBE does not appear to present a significant concern for adverse effects on the environment. Experimentally measured effects occurred at relatively high concentrations indicating low toxicity (Ref. 3). Such high concentrations are not expected to be observed under typical environmental conditions. Table 1 presents some of the available toxicity data for EGBE, the complete listing of the available toxicity data and more details about the studies can be found in the ecological assessment (Ref. 3).

    1. Acute toxicity. Toxicity threshold values (duration not specified) of 900 milligrams/liter (mg/L) and 72-hour EC50 values (i.e., the concentration that is effective in producing a sublethal response in 50% of test organisms) of 911 and 1,840 mg/L for biomass and growth rate, respectively, have been reported for green algae (Refs. 73, 74, and 75). The corresponding 72-hour No-Observed-Effect-Concentration (NOEC) values for biomass and growth rate were 88 and 286 mg/L (Ref. 76). For water fleas (Daphnia magna), 24- or 48-hour EC50 values ranged from 835 to 1,815 mg/L (Refs. 77 and 78). A 48-hour EC50 value of 164 mg/L in rotifers (reproduction) has also been reported (Refs. 74 and 75).

    Acute toxicity values for freshwater fish ranged from an LC50 (i.e., the concentration that is lethal to 50% of test organisms) of 1,395 mg/L for the golden orfe (Leuciscus idus) (duration not specified) (Ref. 79) to a 96-hour LC50 of 2,137 mg/L for the fathead minnow (Pimephales promelas) (Ref. 80). A 96-hour LC50 value of 1,490 mg/L was available for bluegill sunfish (Ref. 81) and 96-hour LC50 values for rainbow trout were 1,474 and 1,700 mg/L (Refs. 74, 75, and 82). An LC50 value (duration not specified) of 1,575 mg/L was also available for golden orfe (Leuciscus idus) (Ref. 79) and a 24-hour LC50 value of 1,700 mg/L was available for goldfish (Carassius auratus) (Ref. 83).

    A study of the invertebrate Artemia salina (brine shrimp) reported a 24-hour LC50 value of 1,000 mg/L (Ref. 84). Also, an embryo-larval test in which Japanese oyster eggs (Crassostrea gigas) were incubated with the test material for 24 hours and then examined for abnormalities indicated an identical 24-hour Lowest-Observed-Effect-Concentration (LOEC) of 1,000 mg/L (Ref. 74). A study of an estuarine/marine fish silverside (Menidia beryllina) reported a 96-hour LC50 value of 1,250 mg/L (Ref. 81).

    2. Chronic toxicity. Values for chronic toxicity in aquatic plants ranged from an 8-day LOEC (inhibition of cell division) of 35 mg/L for the cyanobacteria Microcystis aeruginosa (Refs. 85 and 86) to greater than 1,000 mg/L for a 7-day EC50 (growth rate) for the green alga Selenastrum capricornutum (Ref. 87). Experimental data for the freshwater invertebrate Daphnia magna include values that ranged from 100 mg/L for a 21-day NOEC (reproduction) (Refs. 74, 75, and 77) to an EC50 of 297 mg/L (endpoint not reported) (Ref. 88).

    Table 1—Range of Experimental Ecological Toxicity Values for EGBE on Selected Target Species Species Duration and test endpoint Experiment
  • type a
  • Value
  • (mg/L)
  • Reference
    Acute aquatic toxicity Algae: Green algae (Pseudokirchneriella subcapitata) 72-hour EC50 (growth) S, M 1,840 (Refs. 74 and 75). Green algae (Pseudokirchneriella subcapitata) 72-hour NOEC (biomass) S, M 88 (Ref. 82). Freshwater invertebrate: Water flea (Daphnia magna) 48-hour EC50 S, U, O 1,815 (Ref. 78). Rotifer (Brachionus calyciflorus) 48-hour EC50 (reproduction) S, M 164 (Refs. 74 and 75). Freshwater fish: Golden orfe (Leuciscus idus) LC50 NS 1,395 (Ref. 79). Fathead minnow (Pimephales promelas) 96-hour LC50 S, O 2,137 (Ref. 80). Estuarine/marine invertebrate: Brine shrimp (Artemia salina) 24-hour LC50 S, U, C 1,000 (Ref. 84). Japanese oyster eggs (Crassostrea gigas) 24-hr LOEC (embryotoxicity) S 1,000 (Refs. 74 and 75). Estuarine/marine fish: Silverside (Menidia beryllina) 96-hour LC50 S, U 1,250 (Ref. 81). Chronic aquatic toxicity Algae: Blue-green algae (Microcystis aeruginosa) 8-day LOEC (cell multiplication inhibition) S, U 35 (Refs. 85 and 86). Green algae (Selenastrum capricornutum) 7-day EC50 (growth rate) S, U >1,000 (Ref. 87). Freshwater invertebrate: Water flea (Daphnia magna) 21-day NOEC (reproduction) R, M 100 (Refs. 74 and 75). Water flea (Daphnia magna) 21-day NOEC R, M 100 (Ref. 88). Water flea (Daphnia magna) 21-day EC50 R, M 297 (Ref. 88). Freshwater fish: Zebrafish (Brachydanio rerio) 21-day NOEC (mortality) NS >100 (Ref. 89). a Experiment type: S = static, R = renewal, M = measured, U = unmeasured, O = open test system, NS = not specified
    V. What is EPA's rationale for the denial?

    EPA is denying the petition to delete EGBE from the Certain Glycol Ethers category which is subject to reporting under EPCRA section 313. This denial is based on EPA's conclusion that EGBE can reasonably be anticipated to cause serious or irreversible chronic health effects in humans, specifically, liver toxicity and concerns for hematological effects. While EPA acknowledges that there is evidence to indicate that humans are less sensitive than rodents to the hematological effects associated with acute or short-term exposure to EGBE, little is known of the long-term or repeated exposure responses in humans to EGBE. Thus, some concern remains over the potential for hematological effects following a lifetime of exposure to EGBE. Unlike the hematological effects of EGBE, there is no evidence of humans' decreased sensitivity to the reported liver effects relative to rodents. Therefore, EPA has concluded that EGBE meets the EPCRA section 313(d)(2)(B) listing criteria based on the available human health toxicity data.

    Because EPA believes that EGBE has moderately high to high chronic toxicity, EPA does not believe that an exposure assessment is appropriate for determining whether EGBE meets the criteria of EPCRA section 313(d)(2)(B). This determination is consistent with EPA's published statement clarifying its interpretation of the section 313(d)(2) and (d)(3) criteria for modifying the section 313 list of toxic chemicals (59 FR 61432, November 30, 1994).

    VI. References

    EPA has established an official public docket for this action under Docket ID No. EPA-HQ-TRI-2015-0352. The public docket includes information considered by EPA in developing this action, including the documents listed below, which are electronically or physically located in the docket. In addition, interested parties should consult documents that are referenced in the documents that EPA has placed in the docket, regardless of whether these referenced documents are electronically or physically located in the docket. For assistance in locating documents that are referenced in documents that EPA has placed in the docket, but that are not electronically or physically located in the docket, please consult the person listed in the above FOR FURTHER INFORMATION CONTACT section.

    1. American Chemistry Council. 2014. Petition of the American Chemistry Council's Ethylene Glycol Ethers Panel To Remove Ethylene Glycol Monobutyl Ether From the Toxics Release Inventory Under Section 313 Of The Emergency Planning and Community Right-To-Know Act of 1986. December 29, 2014. 2. U.S. EPA. 2010. Toxicological review of Ethylene Glycol Monobutyl Ether (CASRN 111-76-2) in support of summary information on the Integrated Risk Information System (IRIS). U.S. Environmental Protection Agency. Washington, DC. http://www.epa.gov/iris/toxreviews/0500tr.pdf. 3. U.S. EPA. 2009. Technical Review of Ethylene Glycol Monobutyl Ether (EGBE): Chemistry, Environmental Fate and Ecological Toxicity CAS Registry Number 111-76-2. Office of Environmental Information. September 9, 2009. 4. U.S. EPA. 2015. Memorandum from Jocelyn Hospital, Toxicologist, Environmental Analysis Division to Megan Carroll, Acting Division Director of the Environmental Analysis Division. July 24, 2015. Subject: Review of the Data in the 2010 Integrated Risk Information System (IRIS) Toxicological Review of Ethylene Glycol Monobutyl Ether (EGBE). 5. Kumagai, S., Oda H., Matsunaga I., Kosaka H., Akasaka S. 1999. Uptake of 10 polar organic solvents during short-term respiration. Toxicol. Sci. 48: 255-263. 6. Johanson G., Boman A. 1991. Percutaneous absorption of 2-butoxyethanol vapour in human subjects. Occup. Environ. Med. 48: 788-792. 7. Corley R.A., Bormett G.A., Ghanayem B.I. 1994. Physiologically-based pharmacokinetics of 2-butoxyethanol and its major metabolite 2-butoxyacetic acid, in rats and humans. Toxicol. Appl. Pharmacol. 129: 61-79. 8. Corley R.A., Markham D.A., Banks C., Delorme P., Masterman A., Houle J.M. 1997. Physiologically based pharmacokinetics and the dermal absorption of 2-butoxyethanol vapor by humans. Fundam. Appl. Toxicol. 39: 120-130. 9. Commonwealth of Australia. 1996. National Industrial Chemicals Notification and Assessment Scheme (NICNAS)-priority existing chemical no. 6-2-butoxyethanol in cleaning products. Australian Government Publishing Service. Canberra, Australia. http://www.nicnas.gov.au/__data/assets/pdf_file/0003/4368/PEC_6_2-Butoxyethanol-in-Cleaning-Products_Full_Report_PDF.pdf. 10. ECETOC. 1994. Butoxyethanol criteria document. Special Report No. 7. European Centre for Ecotoxicology and Toxicology of Chemicals. Brussels, Belgium. 11. E.U. 2006. European Union Risk Assessment Report: 2-butoxyethanol. http://echa.europa.eu/documents/10162/e74a38e1-b9e1-4568-92c5-615c4b56f92d. 12. Corley, R.A., Grant, D.M., Farris, E., Weitz, K.K., Soelberg, J.J., Thrall, K.D., Poet, T.S. 2005. Determination of age and gender differences in biochemical processes affecting the disposition of 2-butoxyethanol and its metabolites in mice and rats to improve PBPK modeling. Toxicol. Lett. 156: 127-161. 13. Medinsky, M.A., Singh, G., Bechtold, W.E., Bond, J.A., Sabourin, P.J., Birnbaum, L.S., Henderson, R.F. 1990. Disposition of three glycol ethers administered in drinking water to male F344/N rats. Toxicol. Appl. Pharmacol. 102: 443-455. 14. Bartnik, F.G., Reddy, A.K., Klecak, G., Zimmermann, V., Hostynek, J.J., Kunstler, K. 1987. Percutaneous absorption, metabolism, and hemolytic activity of n-butoxyethanol. Fundam. Appl. Toxicol. 8: 59-70. 15. Ghanayem, B.I., Blair, P.C., Thompson, M.B., Maronpot, R.R., Matthews, H.B. 1987. Effect of age on the toxicity and metabolism of ethylene glycol monobutyl ether (2-butoxyethanol) in rats. Toxicol. Appl. Pharmacol. 91: 222-234. 16. Rettenmeier, A.W., Hennigs, R., Wodarz, R. 1993. Determination of butoxyacetic acid and N-butoxyacetyl-glutamine in urine of lacquerers exposed to 2-butoxyethanol. Int. Arch. Occup. Environ. Health. 65: S151-S153. 17. Johanson, G. 1986. Physiologically based pharmacokinetic modeling of inhaled 2-butoxyethanol in man. Toxicol. Lett. 34: 23-31. 18. Johanson, G., Johnsson, S. 1991. Gas chromatographic determination of butoxyacetic acid in human blood after exposure to 2-butoxyethanol. Arch. Toxicol. 65: 433-435. 19. Johanson, G., Boman, A., Dynesius, B. 1988. Percutaneous absorption of 2-butoxyethanol in man. Scand. J. Work Environ. Health. 14: 101-109. 20. Shyr, L.J., Sabourin, P.J., Medinsky, M.A., Birnbaum, L.S., Henderson, R.F. 1993. Physiologically based modeling of 2-butoxyethanol disposition in rats following different routes of exposure. Environ. Res. 63: 202-218. 21. Sabourin, P.J., Medinsky, M.A., Birnbaum, L.S., Griffith, W.C., Henderson, R.F. 1992. Effect of exposure concentration on the disposition of inhaled butoxyethanol by F344 rats. Toxicol. Appl. Pharmacol. 114: 232-238. 22. Sabourin, P.J., Medinsky, M.A., Thurmond, F., Birnbaum, L.S., Henderson, R.F. 1993. Erratum to: Effect of dose on the disposition of methoxyethanol, ethoxyethanol, and butoxyethanol administered dermally to male F344/N rats. Fundamental and Applied Toxicology 19:124-132. Fundam. Appl. Toxicol. 20: 508-510. 23. Lee, K.M., Dill, J.A., Chou, B.J., Roycroft, J.H. 1998. Physiologically based pharmacokinetic model for chronic inhalation of 2-butoxyethanol. Toxicol. Appl. Pharmacol. 153: 211-226. 24. Dill, J.A., Lee, K.M., Bates, D.J., Anderson, D.J., Johnson, R.E., Chou, B.J., Burka, L.T., Roycroft, J.H. 1998. Toxicokinetics of inhaled 2-butoxyethanol and its major metabolite, 2-butoxyacetic acid, in F344 rats and B6C3F1 mice. Toxicol. Appl. Pharmacol. 153: 227-242. 25. Ghanayem, B.I., Sullivan, C.A. 1993. Assessment of the haemolytic activity of 2-butoxyethanol and its major metabolite, butoxyacetic acid, in various mammals including humans. Hum. Exp. Toxicol. 12: 305-311. 26. Grant, D., Sulsh, S., Jones, H.B., Gangolli, S.D., Butler, W.H. 1985. Acute toxicity and recovery in the hemopoietic system of rats after treatment with ethylene glycol monomethyl and monobutyl ethers. Toxicol. Appl. Pharmacol. 77: 187-200. 27. Ghanayem, B.I., Sanchez, I.M., Matthews, H.B. 1992. Development of tolerance to 2-butoxyethanol-induced hemolytic anemia and studies to elucidate the underlying mechanisms. Toxicol. Appl. Pharmacol. 112: 198-206. 28. Ezov, N., Levin-Harrus, T., Mittelman, M., Redlich, M., Shabat, S., Ward, S.M., Peddada, S., Nyska, M., Yedgar, S., Nyska, A. 2002. A chemically induced rat model of hemolysis with disseminated thrombosis. Cardiovasc. Toxicol. 2: 181-194. 29. Koshkaryev, A., Barshtein, G., Nyska, A., Ezov, N., Levin-Harrus, T., Shabat, S., Nyska, M., Redlich, M., Tsipis, F., Yedgar, S. 2003. 2-Butoxyethanol enhances the adherence of red blood cells. Arch. Toxicol. 77: 465-469. 30. Shabat, S., Nyska, A., Long, P.H., Goelman, G., Abramovitch, R., Ezov, N., Levin-Harrus, T., Peddada, S., Redlich, M., Yedgar, S., Nyska, M. 2004. Osteonecrosis in a chemically induced rat model of human hemolytic disorders associated with thrombosis—a new model for avascular necrosis of bone. Calcif. Tissue Int. 74: 220-228. 31. Redlich, M., Maly, A., Aframian, D., Shabat, S., Ezov, N., Levin-Harrus, T., Nyska, M., Nyska, A. 2004. Histopathologic changes in dental and oral soft tissues in 2-butoxyethanol-induced hemolysis and thrombosis in rats. J. Oral. Pathol. Med. 33: 424-429. 32. Corley, R.A; Weitz, K.K., Mast, T.J., Miller, R.A., Thrall, B.D. 1999. Short-term studies to evaluate the dosimetry and modes of action of EGBE in B6C3F1 mice [final report]. Battelle Memorial Institute. Richland, WA. Battelle Project No. 29753. 33. Poet, T.S., Soelberg, J.J., Weitz, K.K., Mast, T.J., Miller, R.A., Thrall, B.D., Corley, R.A. 2003. Mode of action and pharmacokinetic studies of 2-butoxyethanol in the mouse with an emphasis on forestomach dosimetry. Toxicol. Sci. 71: 176-189. 34. Green, T; Toghill A; Lee R; Moore R; Foster J. 2002. The development of forestomach tumors in the mouse following exposure to 2-butoxyethanol by inhalation: Studies on the mode of action and relevance to humans. Toxicology. 180: 257-273. 35. Tyler, T.R. 1984. Acute and subchronic toxicity of ethylene glycol monobutyl ether. Environ. Health. Perspect. 57: 185-191. 36. Shepard, K.P. 1994. Ethylene glycol monobutyl ether: Acute oral toxicity study in the guinea pig. Eastman Kodak Company for Chemical Manufacturers Association. Rochester, NY and Arlington, VA. 37. Gingell, R., Boatman, R.J., Lewis, S. 1998. Acute toxicity of ethylene glycol mono-n-butyl ether in the guinea pig. Food Chem. Toxicol. 36: 825-829. 38. Jacobs, G.A., Martens, M.A. 1989. An objective method for the evaluation of eye irritation in vivo. Food Chem. Toxicol. 27: 255-258. 39. Kennah, H.E. II., Hignet, S., Laux, P.E., Dorko, J.D., Barrow, C.S. 1989. An objective procedure for quantitating eye irritation based upon changes of corneal thickness. Fundam. Appl. Toxicol. 12: 258-268. 40. Udden, M.M. 2000. Rat erythrocyte morphological changes after gavage dosing with 2-butoxyethanol: A comparison with the in vitro effects of butoxyacetic acid on rat and human erythrocytes. J. Appl. Toxicol. 20: 381-387. 41. Udden, M.M. 2002. In vitro sub-hemolytic effects of butoxyacetic acid on human and rat erythrocytes. Toxicol. Sci. 69: 258-264. 42. Bauer, P., Weber, M., Mur, J.M., Protois, J.C., Bollaert, P.E., Condi, A., Larcan, A., Lambert, H. 1992. Transient non-cardiogenic pulmonary edema following massive ingestion of ethylene glycol butyl ether. Intensive Care Med. 18: 250-251. 43. Gijsenbergh, F.P., Jenco, M., Veulemans, H., Groeseneken, D., Verberckmoes, R., Delooz, H.H. 1989. Acute butylglycol intoxication: A case report. Hum. Toxicol. 8: 243-245. 44. Gualtieri, J.F., Harris, C.R., Roy, R., Corley, R.A., Manderfield, C. 1995. Multiple 2-butoxyethanol intoxications in the same patient: Clinical findings, pharmacokinetics, and therapy. J. Toxicol. Clin. Toxicol. 33: 550-551. 45. Gualtieri, J.F., DeBoer, L., Harris, C.R., Corley, R. 2003. Repeated ingestion of 2-butoxyethanol: Case report and literature review. J. Toxicol. Clin. Toxicol. 41: 57-62. 46. Rambourg-Schepens, M.O., Buffet, M., Bertault. R., Jaussaud, M., Journe, B., Fay, R., Lamiable, D. 1988. Severe ethylene glycol butyl ether poisoning. Kinetics and metabolic pattern. Hum Toxicol, 7: 187-189. 47. Burkhart, K.K., Donovan, J.W. 1998. Hemodialysis following butoxyethanol ingestion. Clin. Toxicol. 36: 723-725. 48. Osterhoudt, K.C. 2002. Fomepizole therapy for pediatric butoxyethanol intoxication. J. Toxicol. Clin. Toxicol. 40: 929-930. 49. Dean, B.S., Krenzelok, E.P. 1991. Critical evaluation of pediatric ethylene glycol monobutyl ether poisonings. Vet. Hum. Toxicol. 33: 362. 50. Carpenter, C.P., Pozzani, U.C., Weil, C.S., Nair III, J.H., Keck, G.A., Smyth Jr., H.F. 1956. The toxicity of butyl cellosolve solvent. AMA Arch. Ind. Health. 14: 114-131. 51. U.S. EPA. 2005. Guidelines for carcinogen risk assessment, Final Report. Risk Assessment Forum, U.S. Environmental Protection Agency. Washington, DC. EPA/630/P-03/001F. http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=116283. 52. NTP. 2000. NTP technical report on the toxicology and carcinogenesis studies of 2 butoxyethanol (CAS No. 111-76-2) in F344/N rats and B6C3F1 mice (inhalation studies). National Toxicology Program. Research Triangle Park, NC. NTP TR 484. http://ntp.niehs.nih.gov/?objectid=070AC403-B110-CA79-3A23AF79DE7B752A. 53. Zeiger, E., Anderson, B., Haworth, S., Lawlor, T., Mortelmans, K. 1992. Salmonella mutagenicity tests: V Results from the testing of 311 chemicals. Environ. Mol. Mutagen. 19: 2-141. 54. Gollapudi, B.B., Barber, E.D., Lawlor, T.E., Lewis, S.A. 1996. Re-examination of the mutagenicity of ethylene glycol monobutyl ether to Salmonella tester strain TA97a. Mutat. Res. 370: 61-64. 55. Chiewchanwit, T., Au, W.W. 1995. Mutagenicity and cytotoxicity of 2-butoxyethanol and its metabolite, 2-butoxyacetaldehyde, in Chinese hamster ovary (CHO-AS52) cells. Mutat. Res. 334: 341-346. 56. Klaunig, J.E., Kamendulis, L.M. 2005. Mode of action of butoxyethanol-induced mouse liver hemangiosarcomas and hepatocellular carcinomas. Toxicol. Lett. 156: 107-115. 57. NTP. 1996. Toxicology and carcinogenesis studies of acetonitrile (CAS No 75-05-8) in F344/N rats and B6C3F1 mice (inhalation studies). National Toxicology Program. Research Triangle Park, NC. http://ehp.niehs.nih.gov/ntp/docs/4004xxdoc.html. 58. Keith, G., Coulais, C., Edorh, A., Bottin, M.C., Rihn, B. 1996. Ethylene glycol monobutyl ether has neither epigenetic nor genotoxic effects in acute treated rats and in subchronic treated v-HA-ras transgenic mice. Occup. Hyg. 2: 237-249. 59. Heindel, J.J., Gulati, D.K., Russell, V.S., Reel, J.R., Lawton, AD., Lamb IV, J.C. 1990. Assessment of ethylene glycol monobutyl and monophenyl ether reproductive toxicity using a continuous breeding protocol in Swiss CD-1 Mice. Fundam. Appl. Toxicol. 15: 683-696. 60. Nagano, K., Nakayama, E., Koyano, M., Oobayashi, H., Adachi, H., Yamada, T. 1979. Testicular atrophy of mice induced by ethylene glycol mono alkyl ethers (author's translation). Sangyo Igaku/Jap. J. Ind. Health. 21: 29-35. 61. Nagano, K., Nakayama, E., Oobayashi, H., Nishizawa, T., Okuda, H., Yamazaki, K. 1984. Experimental studies on toxicity of ethylene glycol alkyl ethers in Japan. Environ. Health. Perspect. 57: 75-84. 62. Dodd, D.E., Snellings, W.M., Maronpot, R.R., Ballantyne, B. 1983. Ethylene glycol monobutyl ether: Acute, 9-day, and 90-day vapor inhalation studies in Fischer 344 rats. Toxicol. Appl. Pharmacol. 68: 405-414. 63. Doe, J.E. 1984. Further studies on the toxicology of the glycol ethers with emphasis on rapid screening and hazard assessment. Environ. Health Perspect. 57: 199-206. 64. Foster, P.M., Lloyd, S.C., Blackburn, D.M. 1987. Comparison of the in vivo and in vitro testicular effects produced by methoxy-, ethoxy- and N-butoxy acetic acids in the rat. Toxicology. 43: 17-30. 65. Exon, J.H., Mather, G.G., Bussiere, J.L., Olson, D.P., Talcott, P.A. 31991. Effects of subchronic exposure of rats to 2-methoxyethanol or 2-butoxyethanol: Thymic atrophy and immunotoxicity. Fundam. Appl. Toxicol. 16: 830-840. 66. NTP. 1993. NTP technical report on toxicity studies of ethylene glycol ethers: 2-methoxyethanol, 2-ethoxyethanol, 2-butoxyethanol (CAS Nos. 109-86-4, 110-80-5, 111-76-2) administered in drinking water to F344/N rats and B6C3F1 mice. National Toxicology Program. Research Triangle Park, NC. 26; NIH Publication 93-3349. 67. Nelson. B.K., Setzer, J.V., Brightwell, W.S., Mathinos, P.R., Kuczuk, M.H., Weaver, T.E., Goad, P.T. 1984. Comparative inhalation teratogenicity of four glycol ether solvents and an amino derivative in rats. Environ. Health Perspect. 57: 261-271. 68. Tyl, R.W., Millicovsky, G., Dodd, D.E., Pritts, I.M., France, K.A., Fisher, L.C. 1984. Teratologic evaluation of ethylene glycol monobutyl ether in Fischer 344 rats and New Zealand white rabbits following inhalation exposure. Environ. Health Perspect. 57: 47-68. 69. Hardin, B.D., Goad, P.T., Burg, J.R. 1984. Developmental toxicity of four glycol ethers applied cutaneously to rats. Environ. Health Perspect. 57: 69-74. 70. Wier, P.J., Lewis, S.C., Traul, K.A. 1987. A comparison of developmental toxicity evident at term to postnatal growth and survival using ethylene glycol monoethyl ether, ethylene glycol monobutyl ether, and ethanol. Teratog. Carcinog. Mutagen. 7: 55-64. 71. Greaves, P. 2000. Hepatocellular hypertrophy and hyperplasia. In Histopathology of preclinical toxicity studies: Interpretation and relevance in drug safety evaluation (pp. 445-448). New York, NY: Elsevier. 72. Haufroid. V., Thirion, F., Mertens, P., Buchet, J.P., Lison, D. 1997. Biological monitoring of workers exposed to low levels of 2-butoxyethanol. Int. Arch. Occup. Environ. Health. 70: 232-236. 73. Bringmann, G., Kuhn, R. 1977. Limiting values for the damaging action of water pollutants to bacteria (Pseudomonas putida) and green algae (Scenedesmus quadricauda) in the cell multiplication inhibition test. Z. Wasser Abwasser Forsch. 10(3/4): 87-98. (In German) 74. Devillers, J., Chezeau, A., Thybaud, E., Poulsen, V., Procher, J.-M., Graff, L., Vasseur, P., Mouchet, F., Ferrier, V., Quiniou, F. 2002. Ecotoxicity of ethylene glycol monobutyl ether and its acetate. Toxicology Mechanisms and Methods, 12: 255-263. 75. Devillers, J., Chezeau, A., Thybaud, E., Poulsen, J.-M., Graff, L., Vasseur, P., Chenon, P., Mouchet, F., Ferrier, V., Quiniou, F. 2002. Ecotoxicity of ethylene glycol monomethyl ether and its acetate. Toxicology Mechanisms and Methods. 12: 241-254. 76. INERIS. 1999. Détermination de la toxicité chronique du 2-butoxyethanol vis-à-vis de l'algue d'eau douce Pseudokirchneriella subcapitata, Ba746d-CGR21427. Verneuil-en-Halatte, France, 14 december 1999, INERIS: 14. As cited in Ref. 77. 77. ECB (European Chemicals Bureau). 2006. European Union Risk Assessment Report for 2-Butoxyethanol (EGBE). Vol. 68. European Commission. 78. Bringmann, G., Kuhn, R. 1982. Results of the toxic action of water pollutants on Daphnia magna in an improved standardized procedure. Z. Wasser Abwasser Forsch. 15(1): 1-6. (In German) 79. Juhnke, I., Luedemann, D. 1978. Results of the study of 200 chemical compounds on acute fish toxicity using the Golden Orfe test. Z. Wasser Abwasser Forsch. 11(5): 161-164. (In German) 80. Dow Chemical Co. 1979. Toxicity of Dowanol EB to freshwater organisms (redactor: Bartlett), 31 August 1979. As cited in Ref. 77. 81. Dawson, G.W., Jennings, A.L., Drozdowski, D., Rider, E. 1975. The acute toxicity of 47 industrial chemicals to fresh and saltwater fishes. Journal of Hazardous Materials. 1: 303-318. 82. INERIS. 1999. Détermination de la toxicité aiguë du 2-butoxyethanol vis-à-vis de Oncorhynchus mykiss, unpublished, Ba746f-CGR21427. Verneuil-en-Halatte, France, 14 december 1999, INERIS: 10. As cited in Ref. 77. 83. Bridie, A.L., Wolff, C.J.M., Winter, M. 1979. The acute toxicity of some petrochemicals to goldfish. Water Res. 13(7): 623-626. 84. Price, K.S., Waggy, G.T., Conway, R.A. 1974. Brine shrimp bioassay and seawater BOD of petrochemicals. Journal WPCF. 46(1): 63-76. 85. Bringmann, G., Kuhn, R. 1978. Threshold Values of Substances Harmful to Water for Blue Algae (Microcystis aeruginosa) and Green Algae (Scenedesmus quadricauda) in Tests Measuring the Inhibition of Cellular Propagation. Vom Wasser. 50:45 60 (in German) (English Abstract), Tr 80 0201, Literature Research Company: 22 p. 86. Bringmann, G., Kuhn, R. 1978. Testing of Substances for Their Toxicity Threshold: Model Organisms Microcystis (Diplocystis) aeruginosa and Scenedesmus quadricauda. Mitt. Int. Ver. Theor. Angew. Limnol. 21: 275 284. 87. Dill, DC, Milazzo, D.P. 1988. Dowanol PM Glycol Ether: Evaluation of the toxicity to the green alga, Selenastrum capricornutum Printz. Dow Chemical Company. EPA Document Control Number 86-890001160. 18 pages. 88. INERIS. 1999. Détermination de la toxicité chronique du 2-butoxyethanol vis-à-vis de Daphnia magna, Ba746a-CGR21427. Verneuil-en-Halatte, France, 15 december 1999, INERIS: 13. As cited in Ref. 77. 89. INERIS. 2001. Essai poisson 21 jours, Danio rerio, unpublished report, N° 22685, 05.11.2001. As cited in Ref. 77. List of Subjects in 40 CFR Part 372

    Environmental protection, Community right-to-know, Reporting and recordkeeping requirements, and Toxic chemicals.

    Dated: September 24, 2015. Arnold E. Layne, Director, Office of Information Analysis and Access.
    [FR Doc. 2015-25674 Filed 10-7-15; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 1 [MD Docket No. 15-121; FCC 15-108] Assessment and Collection of Regulatory Fees for Fiscal Year 2015 AGENCY:

    Federal Communications Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    In this document the Commission revises its Schedule of Regulatory Fees to recover an amount of $339,844,000 that Congress has required the Commission to collect for fiscal year 2015. Section 9 of the Communications Act of 1934, as amended, provides for the annual assessment and collection of regulatory fees under sections 9(b)(2) and 9(b)(3), respectively, for annual “Mandatory Adjustments” and “Permitted Amendments” to the Schedule of Regulatory Fees.

    DATES:

    Comments are due November 9, 2015 and Reply Comments are due December 7, 2015.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's Further Notice of Proposed Rulemaking (FNPRM), FCC 15-108, MD Docket No. 15-121, adopted on September 1, 2015 and released on September 2, 2015.

    I. Administrative Matters A. Initial Regulatory Flexibility Analysis

    1. As required by the Regulatory Flexibility Act of 1980 (RFA),1 the Commission has prepared an Initial Regulatory Flexibility Analysis (FRFA) relating to this Further Notice of Proposed Rulemaking.

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

    B. Initial Paperwork Reduction Act of 1995 Analysis

    2. This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

    C. Filing Instructions

    3. Pursuant to sections 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

    • Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS.

    • Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.

    ○ Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

    ○ All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW., Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.

    ○ Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.

    ○ U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW., Washington, DC 20554.

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

    D. Ex Parte Information

    5. This proceeding shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda, or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with § 1.1206(b). In proceedings governed by § 1.49(f) or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format (e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

    II. Introduction and Executive Summary

    6. In the Further Notice of Proposed Rulemaking in this docket, we seek further comment on changes to our methodology in calculating regulatory fees for AM and FM broadcast radio and on reallocating FTEs from the Wireline Competition Bureau working on numbering and universal service issues.

    III. Background

    7. Congress adopted a regulatory fee schedule in 1993 2 and authorized the Commission to assess and collect annual regulatory fees pursuant to the schedule, as amended by the Commission.3 As a result, the Commission annually reviews the regulatory fee schedule, proposes changes to the schedule to reflect changes in the amount of its appropriation, and proposes increases or decrease to the schedule of regulatory fees.4 The Commission makes changes to the regulatory fee schedule “if the Commission determines that the schedule requires amendment to comply with the requirements” 5 of section 9(b)(1)(A) of the Act.6 The Commission may also add, delete, or reclassify services in the fee schedule to reflect additions, deletions, or changes in the nature of its services “as a consequence of Commission rulemaking proceedings or changes in law.” Thus, for each fiscal year, the proposed fee schedule in the annual Notice of Proposed Rulemaking (NPRM) will reflect changes in the amount appropriated for the performance of the FCC's regulatory activities, changes in the industries represented by the regulatory fee payers, changes in Commission FTE levels, and any other issues of relevance to the proposed fee schedule.7 After receipt and review of comments, the Commission issues a Report and Order adopting the fee schedule for the fiscal year and sets out the procedures for payment of fees.

    2 47 U.S.C. 159 (g) (showing original fee schedule prior to Commission amendment).

    3 47 U.S.C. 159

    4 47 U.S.C. 159(b)(1)(B).

    5 47 U.S.C. 159(b)(2).

    6 47 U.S.C. 159(b)(1)(A).

    7 Section 9(b)(2) discusses mandatory amendments to the fee schedule and Section 9(b)(3) discusses permissive amendments to the fee schedule. Both mandatory and permissive amendments are not subject to judicial review. 47 U.S.C. 159(b)(2) and (3).

    IV. Further Notice of Proposed Rulemaking A. Broadcasters' Regulatory Fees

    8. In the FY 2015 NPRM, we sought comment on whether the Commission should review the apportionment of regulatory fees among broadcasters. We sought comment on whether the Commission should reexamine the number of FTEs devoted to the regulation of radio versus television broadcasters and adjust the fee paid by radio and television broadcasters to more accurately take into account factors related to “the benefits provided to the payor of the fee by the Commission's activities.” 8 NAB filed comments in support of our effort to better align fees with the FTEs working on broadcast issues, but observes that we have not yet provided information about the relevant FTEs.9 We have reviewed the categories of work performed by FTEs in the Media Bureau, in order to provide further information for commenters on this issue. The Media Bureau, consisting of 169 FTEs, develops, recommends, and administers the policy and licensing programs for electronic media, including cable television, broadcast television, and radio in the United States and its territories, and also handles post-licensing matters regarding DBS service. The Media Bureau has 25 FTEs in the bureau front office, (including staff assigned to Bureau-wide administrative support), 51 in the Audio Division, 27 in the Industry Analysis Division, 13 in Engineering Division, 29 in the Policy Division, and 24 in the Video Division. Some of these FTEs may be categorized as auctions-funded, depending on the Commission's auctions schedule. All of the Engineering Division FTEs work on cable issues, and some FTEs from the Policy and Industry Analysis Divisions also work on cable issues. Of the 52 FTEs in the Audio Division, approximately 42 are assigned to FM and 10 to AM. The 25 FTEs in the Video Division work on television issues. We seek further comment on whether and how to reform our regulatory fee assessments for broadcasters.

    8 47 U.S.C. 159(b)(1)(A) (providing for adjustment of the FTE allocation to “take into account factors that are reasonably related to the benefits provided to the payor of the fee by the Commission's activities, including such factors as service area coverage, shared use versus exclusive use, and other factors that the Commission determines are necessary in the public interest.”).

    9 NAB Comments at 2.

    9. The Commission assesses regulatory fees on radio broadcasters based on type and class of service and on the population they serve. Earlier this year we sought comment on whether the dividing points for higher fee levels for both television and radio broadcasters remain appropriate and observed that “no single ratio apportions regulatory fees among AM and FM radio categories.” 10 We seek further comment on rationalizing the regulatory fee table for radio broadcasters. First, we seek input on including a higher population row in the table, dividing radio broadcasters that serve 3,000,001-6,000,000 people from those that serve more. Second, we seek input on standardizing the incremental increase in fees as radio broadcasters increase the population they serve, such as by requiring that fee adjustments between tiers monotonically increase as the population served increases. Third, we seek input on consistently assessing fees based on the relative type and class of service, such as by assessing FM class B, C, C0, C1, & C2 stations at twice the rate of AM class C stations, and FM class A, B1, & C3 stations assessed at 75 percent more than AM class C stations. For AM stations, we seek comment on assessing AM class A stations at 60 percent more, AM class B stations at 15 percent more, and AM class D stations at 10 percent more than AM class C stations (i.e., at roughly the relative rates assessed today). Taking these options together, we seek comment on the following potential table of regulatory fees for radio broadcasters.

    10FY 2015 NPRM, 30 FCC Rcd at 5359, para. 13.

    Proposed Radio Station Regulatory Fees Population served AM Class A AM Class B AM Class C AM Class D FM Classes A, B1 & C3 FM Classes B, C, C0, C1 & C2 <=25,000 $910 $655 $570 $625 $1,000 $1,140 25,001-75,000 1,370 985 855 940 1,495 1,710 75,001-150,000 1,825 1,310 1,140 1,255 1,995 2,280 150,001-500,000 2,735 1,965 1,710 1,880 2,995 3,420 500,001-1,200,000 4,560 3,280 2,850 3,135 4,990 5,700 1,200,001-3,000,000 6,840 4,915 4,275 4,705 7,480 8,550 3,000,001-6,000,000 9,120 6,555 5,700 6,270 9,975 11,400 >6,000,000 11,400 8,195 7,125 7,840 12,470 14,250

    10. The Commission assesses regulatory fees on television broadcasters based on the markets they serve (1-10:11-25:26-50:51-100: Remaining Market). Before the Commission combined the VHF and UHF regulatory fee categories, the ratio of regulatory fees for VHF stations (then considered the most valuable stations) was roughly 14:11:7:4:1. Today, it is roughly 10:9:6:3:1. We seek comment on readjusting the table to restore the traditional determination that Top 10 stations should pay about twice what stations in markets 26-50 pay (that is, the new ratios would be 12:9:6:3:1). With this change, and adjusting to recover the same total regulatory fees as television broadcasters pay today, we seek comment on the following potential table of regulatory fees for television broadcasters.

    Digital TV (47 CFR part 73) VHF and UHF commercial Before After Markets 1-10 $46,825 $55,025 Markets 11-25 43,200 41,270 Markets 26-50 27,625 27,515 Markets 51-100 16,275 13,755 Remaining Markets 4,850 4,585 Construction Permits 4,850 4,585

    11. NAB also observes that after the spectrum incentive auction there may be fewer television stations, resulting in material changes in the regulatory fee apportionment among the remaining stations.11 We seek comment on whether, when, and how the Commission should adjust its methodology for assessing regulatory fees on televisions stations, to respond to such potential changed circumstances consistent with the provisions of Section 9 of the Communications Act.

    11 NAB Comments at 7-9.

    B. ITTA's Proposals To Reallocate FTEs

    12. ITTA has suggested that we should consider all cross-cutting work throughout the Commission, not just in the International Bureau, and we should re-assign certain Wireline Competition Bureau FTEs for regulatory fee purposes.12 ITTA contends that the Commission should make appropriate adjustments to its regulatory fee structure to reflect that the work of the Wireline Competition Bureau is no longer primarily focused on ITSPs.13 According to ITTA, resources expended by Wireline Competition Bureau FTEs increasingly benefit other industry sectors.14 ITTA argues that the Commission's efforts to modernize the Lifeline program and to conduct a comprehensive analysis of the special access marketplace, for example, generate significant benefits for entities that do not pay regulatory fees as ITSPs.15

    12 ITTA Comments at 2-5.

    13Id. at 3-4.

    14Id. at 4.

    15Id. at 4-5.

    13. ITTA has previously proposed that we combine wireless providers into the ITSP fee category so that all voice providers pay regulatory fees on the same basis.16 ITTA continues to endorse this approach and contends that such action would be consistent with the Commission's decision to incorporate interconnected VoIP providers into the ITSP fee category to ensure that such providers are paying their share of regulatory fees in connection with the Commission's oversight of voice services.17

    16Id. at 3.

    17Id.

    14. We recognize that there is substantial convergence in the telecommunications industry and organizational changes in the Commission that may support additional FTE reallocations as ITTA contends. Wireless providers are not subject to all of the regulations and requirements imposed on ITSPs. However, there are certain rules (e.g., universal service), that wireless and wireline services benefit from and the Wireline Competition Bureau FTEs provide the oversight and regulation of the industry in these areas.18 We seek comment on ITTA's proposals to (i) combine wireless voice and wireline services into the ITSP category and, alternatively, to (ii) re-assign certain Wireline Competition Bureau FTEs as indirect for regulatory fee purposes. Concerning any reassignment of direct FTEs, we seek comment on whether it is reasonable and consistent with section 9 of the Act to readjust the assignment of FTEs in the bureau and if the record demonstrates the clearest case for reassignment.19

    18 47 CFR 54.900 et seq.

    19FY 2013 Report and Order, 28 FCC Rcd at 12357-58, para. 19.

    15. Commenters supporting ITTA's proposals should also explain: How wireless voice services and wireline services can be combined (currently wireless regulatory fees are calculated per subscriber and ITSP fees are based on revenues) and how we would determine which and how many Wireline Competition Bureau FTEs to reassign as indirect. We note that, as ITTA observes, certain issues handled in the Wireline Competition Bureau benefit wireless providers, and that argument could support reassigning certain Wireline Competition Bureau FTEs as Wireless Telecommunications Bureau FTEs for regulatory fee purposes.20 For example, given the amount of Universal Service Lifeline Support distributed to wireless providers, should FTEs who work on issues related to such providers be allocated the Wireless Telecommunications Bureau for regulatory fee calculations? 21 Alternatively, we also seek comment on adopting a new fee category for wireless providers, as a subcategory of the ITSP regulatory fee category, based on a percentage Wireline Competition Bureau FTE work devoted to work related to these wireless regulatees.22

    20 Based on staff analysis, approximately 10 FTEs work on high-cost issues, 4 FTEs work on Lifeline issues, 9 FTEs work on E-rate issues, and 4 FTEs work on Rural Health Care issues. In addition approximately 14 FTEs work on numbering issues and/or special access.

    21 Wireless providers received an estimated $1.4 billion in Lifeline disbursements in 2014.

    22See, e.g ., FY 2014 NPRM, 29 FCC Rcd at 10782-84, paras. 38-43.

    V. Regulatory Flexibility Analysis Initial Regulatory Flexibility Analysis

    16. As required by the Regulatory Flexibility Act (RFA),23 the Commission prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on small entities by the policies and rules proposed in the Further Notice of Proposed Rulemaking (Further Notice). Written comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadline for comments on this Further Notice. The Commission will send a copy of the Further Notice, including the IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA).24 In addition, the Further Notice and IRFA (or summaries thereof) will be published in the Federal Register.25

    23 5 U.S.C. 603. The RFA, 5 U.S.C. 601-612 has been amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), Pub. L. 104-121, Title II, 110 Stat. 847 (1996).

    24 5 U.S.C. 603(a).

    25Id.

    A. Need for, and Objectives of, the Notice

    17. The Further Notice seeks comment regarding adjusting the regulatory fees paid by broadcasters, for radio and television. Specifically, the Commission seeks comment on the extent of FTEs that work on video, cable, DBS, and radio services, and whether the current proportion of fees paid by these various fee categories associated with these services are still accurate. The level of FTE activity on these media services determines the proportion of fees to be paid by each media service fee category, which in turn is used to calculate the fee amount for each fee category.

    B. Legal Basis

    18. This action, including publication of proposed rules, is authorized under Sections (4)(i) and (j), 9, and 303(r) of the Communications Act of 1934, as amended.26

    26 47 U.S.C. 154(i) and (j), 159, and 303(r).

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

    19. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the proposed rules and policies, if adopted.27 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” 28 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.29 A “small business concern” is one which: (1) Is independently owned and operated; (2) Is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.30

    27 5 U.S.C. 603(b)(3).

    28 5 U.S.C. 601(6).

    29 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.”

    30 15 U.S.C. 632.

    20. Small Entities. Our actions, over time, may affect small entities that are not easily categorized at present. We therefore describe here, at the outset, three comprehensive small entity size standards that could be directly affected by the proposals under consideration.1 As of 2009, small businesses represented 99.9 percent of the 27.5 million businesses in the United States, according to the SBA.2 In addition, a “small organization is generally any not-for-profit enterprise which is independently owned and operated and not dominant in its field.3 Nationwide, as of 2007, there were approximately 1,621,215 small organizations.4 Finally the term “small governmental jurisdiction” is defined generally as “governments of cities, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.5 Census Bureau data for 2011 indicate that there were 90,056 local governmental jurisdictions in the United States.6 We estimate that, of this total, as many as 89,327 entities may qualify as “small governmental jurisdictions.” 7 Thus, we estimate that most local government jurisdictions are small.

    1See 5 U.S.C. 601(3)-(6).

    2See SBA, Office of Advocacy, “Frequently Asked Questions”, available at http://www.sba.gov/faqs/faqindex.cfm?arealD=24.

    3 5 U.S.C. 601(4).

    4See Independent Sector, The New Nonprofit Almanac and Desk Reference (2010).

    5 5 U.S.C. 601(5).

    6See SBA, Office of Advocacy, “Frequently Asked Questions,” available at http.www.sba.gov/sites/default/files.FAQMarch201_Opdf.

    7 The 2011 Census Data for small governmental organizations are not presented based on the size of the population in each organization. As stated above, there were 90,056 local governmental organizations in 2011. As a basis for estimating how many of these 90,056 local organizations were small, we note that there were a total of 729 cities and towns (incorporated places and civil divisions) with populations over 50,000. See http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?src=bkmk. If we subtract the 729 cities and towns that exceed the 50,000 population threshold, we conclude that approximately 789, 237 are small.

    21. Wired Telecommunications Carriers. The U.S. Census Bureau defines this industry as “establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired communications networks. Transmission facilities may be based on a single technology or a combination of technologies. Establishments in this industry use the wired telecommunications network facilities that they operate to provide a variety of services, such as wired telephony services, including VoIP services, wired (cable) audio and video programming distribution, and wired broadband internet services. By exception, establishments providing satellite television distribution services using facilities and infrastructure that they operate are included in this industry.” 8 The SBA has developed a small business size standard for Wired Telecommunications Carriers, which consists of all such companies having 1,500 or fewer employees.9 Census data for 2007 shows that there were 3,188 firms that operated that year. Of this total, 3,144 operated with fewer than 1,000 employees.10 Thus, under this size standard, the majority of firms in this industry can be considered small.

    8See http://www.census.gov/cgi-bin/sssd/naics/naicsrch.

    9See 13 CFR 120.201, NAICS Code 517110.

    10http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ5&prodType=table.

    22. Local Exchange Carriers (LECs). Neither the Commission nor the SBA has developed a size standard for small businesses specifically applicable to local exchange services. The closest applicable NAICS Code category is for Wired Telecommunications Carriers as defined in paragraph 6 of this IRFA. Under that size standard, such a business is small if it has 1,500 or fewer employees.11 According to Commission data, census data for 2007 shows that there were 3,188 establishments that operated that year. Of this total, 3,144 operated with fewer than 1,000 employees.12 The Commission estimates that most providers of local exchange service are small entities that may be affected by the rules and policies proposed in the Further Notice.

    11 13 CFR 121.201, NAICS code 517110.

    12See id.

    23. Incumbent LECs. Neither the Commission nor the SBA has developed a small business size standard specifically for incumbent local exchange services. The closest applicable NAICS Code category is Wired Telecommunications Carriers, as defined in paragraph 6 of this IRFA. Under that size standard, such a business is small if it has 1,500 or fewer employees.13 According to Commission data, 3,188 firms operated in that year. 1,307 carriers reported that they were incumbent local exchange service providers.14 Of this total, 3,144 operated with fewer than 1,000 employees.15 Consequently, the Commission estimates that most providers of incumbent local exchange service are small businesses that may be affected by the rules and policies proposed in the Further Notice. Three hundred and seven (307) Incumbent Local Exchange Carriers reported that they were incumbent local exchange service providers.16 Of this total, an estimated 1,006 have 1,500 or fewer employees.17

    13 13 CFR 121.201, NAICS code 517110.

    14See Trends in Telephone Service, Federal Communications Commission, Wireline Competition Bureau, Industry Analysis and Technology Division at Table 5.3 (Sept. 2010) (Trends in Telephone Service).

    15See id.

    16See id.

    17Id.

    24. Competitive Local Exchange Carriers (Competitive LECs), Competitive Access Providers (CAPs), Shared-Tenant Service Providers, and Other Local Service Providers. Neither the Commission nor the SBA has developed a small business size standard specifically for these service providers. The appropriate NAICS Code category is Wired Telecommunications Carriers, as defined in paragraph 6 of this IRFA. Under that size standard, such a business is small if it has 1,500 or fewer employees.18 U.S. Census data for 2007 indicate that 3,188 firms operated during that year. Of that number, 3,144 operated with fewer than 1,000 employees.19 Based on this data, the Commission concludes that the majority of Competitive LECs, CAPs, Shared-Tenant Service Providers, and Other Local Service Providers are small entities. According to Commission data, 1,442 carriers reported that they were engaged in the provision of either competitive local exchange services or competitive access provider services.20 Of these 1,442 carriers, an estimated 1,256 have 1,500 or fewer employees. In addition, 17 carriers have reported that they are Shared-Tenant Service Providers, and all 17 are estimated to have 1,500 or fewer employees.21 In addition, 72 carriers have reported that they are Other Local Service Providers.22 Of this total, 70 have 1,500 or fewer employees.23 Consequently, the Commission estimates that most providers of competitive local exchange service, competitive access providers, Shared-Tenant Service Providers, and Other Local Service Providers are small entities that may be affected by rules adopted pursuant to the proposals in this Notice.

    18 13 CFR 121.201, NAICS code 517110.

    19http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ5&prodType=%20table.

    20See Trends in Telephone Service, at Table 5.3.

    21Id.

    22Id.

    23Id.

    25. Interexchange Carriers (IXCs). Neither the Commission nor the SBA has developed a definition for Interexchange Carriers. The closest NAICS Code category is Wired Telecommunications Carriers as defined in paragraph 6 of this IRFA. The applicable size standard under SBA rules is that such a business is small if it has 1,500 or fewer employees.24 According to Commission data, 359 companies reported that their primary telecommunications service activity was the provision of interexchange services.25 Of this total, an estimated 317 have 1,500 or fewer employees and 42 have more than 1,500 employees.26 Consequently, the Commission estimates that the majority of interexchange service providers are small entities that may be affected by rules adopted pursuant to the Further Notice.

    24 13 CFR 121.201, NAICS code 517110.

    25See Trends in Telephone Service, at Table 5.3.

    26Id.

    26. Prepaid Calling Card Providers. Neither the Commission nor the SBA has developed a small business size standard specifically for prepaid calling card providers. The appropriate NAICS Code category for prepaid calling card providers is Telecommunications Resellers. This industry comprises establishments engaged in purchasing access and network capacity from owners and operators of telecommunications networks and reselling wired and wireless telecommunications services (except satellite) to businesses and households. Mobile virtual networks operators (MVNOs) are included in this industry.27 Under the applicable SBA size standard, such a business is small if it has 1,500 or fewer employees.28 U.S. Census data for 2007 show that 1,523 firms provided resale services during that year. Of that number, 1,522 operated with fewer than 1,000 employees.29 Thus, under this category and the associated small business size standard, the majority of these prepaid calling card providers can be considered small entities. According to Commission data, 193 carriers have reported that they are engaged in the provision of prepaid calling cards.30 All 193 carriers have 1,500 or fewer employees.31 Consequently, the Commission estimates that the majority of prepaid calling card providers are small entities that may be affected by rules adopted pursuant to the Further Notice.

    27http://www.census.gov/cgi-bin/ssd/naics/naicsrch.

    28 13 CFR 121.201, NAICS code 517911.

    29http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US_51SSSZ5&prodType=table.

    30See Trends in Telephone Service, at Table 5.3.

    31Id.

    27. Local Resellers. The SBA has developed a small business size standard for the category of Telecommunications Resellers. Under that size standard, such a business is small if it has 1,500 or fewer employees.32 Census data for 2007 show that 1,523 firms provided resale services during that year. Of that number, 1,522 operated with fewer than 1,000 employees.33 Under this category and the associated small business size standard, the majority of these local resellers can be considered small entities. According to Commission data, 213 carriers have reported that they are engaged in the provision of local resale services.34 Of this total, an estimated 211 have 1,500 or fewer employees.35 Consequently, the Commission estimates that the majority of local resellers are small entities that may be affected by rules adopted pursuant to the proposals in this Further Notice.

    32 13 CFR 121.201, NAICS code 517911.

    33Id.

    34See Trends in Telephone Service, at Table 5.3.

    35Id.

    28. Toll Resellers. The Commission has not developed a definition for Toll Resellers. The closest NAICS Code Category is Telecommunications Resellers, and the SBA has developed a small business size standard for the category of Telecommunications Resellers. Under that size standard, such a business is small if it has 1,500 or fewer employees.36 Census data for 2007 show that 1,523 firms provided resale services during that year. Of that number, 1,522 operated with fewer than 1,000 employees.37 Thus, under this category and the associated small business size standard, the majority of these resellers can be considered small entities. According to Commission data, 881 carriers have reported that they are engaged in the provision of toll resale services.38 Of this total, an estimated 857 have 1,500 or fewer employees.39 Consequently, the Commission estimates that the majority of toll resellers are small entities that may be affected by our proposals in the Further Notice.

    36 13 CFR 121.201, NAICS code 517911.

    37Id.

    38See Trends in Telephone Service, at Table 5.3.

    39Id.

    29. Other Toll Carriers. Neither the Commission nor the SBA has developed a size standard for small businesses specifically applicable to Other Toll Carriers. This category includes toll carriers that do not fall within the categories of interexchange carriers, operator service providers, prepaid calling card providers, satellite service carriers, or toll resellers. The closest applicable NAICS Code category is for Wired Telecommunications Carriers, as defined in paragraph 6 of this IRFA. Under that size standard, such a business is small if it has 1,500 or fewer employees.40 Census data for 2007 shows that there were 3,188 firms that operated that year. Of this total, 3,144 operated with fewer than 1,000 employees.41 Thus, under this category and the associated small business size standard, the majority of Other Toll Carriers can be considered small. According to Commission data, 284 companies reported that their primary telecommunications service activity was the provision of other toll carriage.42 Of these, an estimated 279 have 1,500 or fewer employees.43 Consequently, the Commission estimates that most Other Toll Carriers are small entities that may be affected by the rules and policies adopted pursuant to the Further Notice.

    40 13 CFR 121.201, NAICS code 517110.

    41Id.

    42See Trends in Telephone Service, at Table 5.3.

    43Id.

    30. Wireless Telecommunications Carriers (except Satellite). This industry comprises establishments engaged in operating and maintaining switching and transmission facilities to provide communications via the airwaves, such as cellular services, paging services, wireless internet access, and wireless video services.44 The appropriate size standard under SBA rules is that such a business is small if it has 1,500 or fewer employees. For this industry, Census Data for 2007 show that there were 1,383 firms that operated for the entire year. Of this total, 1,368 firms had fewer than 1,000 employees. Thus under this category and the associated size standard, the Commission estimates that the majority of wireless telecommunications carriers (except satellite) are small entities. Similarly, according to internally developed Commission data, 413 carriers reported that they were engaged in the provision of wireless telephony, including cellular service, Personal Communications Service (PCS), and Specialized Mobile Radio (SMR) services.45 Of this total, an estimated 261 have 1,500 or fewer employees.46 Consequently, the Commission estimates that approximately half of these firms can be considered small. Thus, using available data, we estimate that the majority of wireless firms can be considered small.

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

    45See Trends in Telephone Service, at Table 5.3.

    46Id.

    31. Cable Television and other Subscription Programming.47 Since 2007, these services have been defined within the broad economic census category of Wired Telecommunications Carriers. That category is defined as follows: “This industry comprises establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or a combination of technologies.” 48 The SBA has developed a small business size standard for this category, which is: All such firms having 1,500 or fewer employees.49 Census data for 2007 shows that there were 3,188 firms that operated that year. Of this total, 3,144 had fewer than 1,000 employees.50 Thus under this size standard, the majority of firms offering cable and other program distribution services can be considered small and may be affected by rules adopted pursuant to the Further Notice.

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

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

    49 13 CFR 121.201, NAICS code 517110.

    50http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ECN_2007_US-51SSSZ5&prodType=Table.

    32. 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.51 Industry data indicate that there are currently 4,600 active cable systems in the United States.52 Of this total, all but ten cable operators nationwide are small under the 400,000-subscriber size standard.53 In addition, under the Commission's rate regulation rules, a “small system” is a cable system serving 15,000 or fewer subscribers.54 Current Commission records show 4,600 cable systems nationwide.55 Of this total, 3,900 cable systems have less than 15,000 subscribers, and 700 systems have 15,000 or more subscribers, based on the same records.56 Thus, under this standard as well, we estimate that most cable systems are small entities.

    51 47.CFR 76.901(e).

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

    53See SNL KAGAN at www.snl.com/interactiveX/topcableMSOs aspx?period2015Q1&sortcol=subscribersbasic&sortorder=desc.

    54 47 CFR76.901(c).

    55See footnote 2, supra.

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

    33. 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 are approximately 52,403,705 cable video subscribers in the United States today.57 Accordingly, an operator serving fewer than 524,037 subscribers shall be deemed a small operator if its annual revenues, when combined with the total annual revenues of all its affiliates, do not exceed $250 million in the aggregate.58 Based on available data, we find that all but nine incumbent cable operators are small entities under this size standard.59 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.60 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.

    57See SNL KAGAN at www.snl.com/interactivex/MultichannelIndustryBenchmarks.aspx.

    58 47.901(f) and notes ff. 1, 2, and 3.

    59See SNL KAGAN at www.snl.com/Interactivex/TopCable MSOs.aspx.

    60 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 section 76.901(f) of the Commission's rules. See 47 CFR 76.901(f).

    34. All Other Telecommunications. “All Other Telecommunications” is defined as follows: This U.S. industry is comprised of establishments that are primarily engaged in providing specialized telecommunications services, such as satellite tracking, communications telemetry, and radar station operation. This industry also includes establishments primarily engaged in providing satellite terminal stations and associated facilities connected with one or more terrestrial systems and capable of transmitting telecommunications to, and receiving telecommunications from, satellite systems. Establishments providing Internet services or voice over Internet protocol (VoIP) services via client-supplied telecommunications connections are also included in this industry.61 The SBA has developed a small business size standard for “All Other Telecommunications,” which consists of all such firms with gross annual receipts of $32.5 million or less.62 For this category, census data for 2007 show that there were 2,383 firms that operated for the entire year. Of these firms, a total of 2,346 had gross annual receipts of less than $25 million.63 Thus, a majority of “All Other Telecommunications” firms potentially affected by the proposals in the Further Notice can be considered small.

    61http://www.census.gov/cgi-bin/ssssd/naics/naicsrch.

    62 13 CFR 121.201; NAICs Code 517919.

    63http://factfinder.census.gov/faces/tableservices.jasf/pages/productview.xhtml?pid+ECN_2007_US.51SSSZ4&prodType=table.

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

    35. This Further Notice does not propose any changes to the Commission's current information collection, reporting, recordkeeping, or compliance requirements.

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

    36. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its approach, which may include the following four alternatives, among others: (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.64

    64 5 U.S.C. 603(c)(1) through (c)(4).

    37. This Further Notice seeks comment on the Commission's regulatory fee collection for radio and television broadcasters, including comment on exempting smaller broadcasters from regulatory fees. Specifically, the Commission seeks comment on the extent of FTEs that work on video, cable, DBS, and radio services, and whether the current proportion of fees paid by these various fee categories associated with these services are still accurate. The level of FTE activity on these media services determines the proportion of fees to be paid by each media service fee category, which in turn is used to calculate the fee amount for each fee category. Since this determines the fee rate for big and small media companies, the Commission is sensitive to the impact of any changes in the proportion of FTE activity on companies in the media industry.

    F. Federal Rules That May Duplicate, Overlap, or Conflict With the Proposed Rules

    38. None.

    VI. Ordering Clauses

    39. Accordingly, it is ordered that, pursuant to sections 4(i) and (j), 9, and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 159, and 303(r), this Report and Order and Further Notice of Proposed Rulemaking is hereby adopted.

    40. It is further ordered that this Further Notice of Proposed Rulemaking comments are due November 9, 2015 and reply comments are due December 7, 2015.

    41. It is further ordered that the Commission's Consumer & Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Further Notice of Proposed Rulemaking, including the Initial Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the U.S. Small Business Administration.

    Federal Communications Commission. Marlene H. Dortch. Secretary.
    [FR Doc. 2015-25578 Filed 10-7-15; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION 48 CFR Parts 2, 4, 13, 18, and 19 [FAR Case 2015-020; Docket 2015-0020; Sequence 1] RIN 9000-AN09 Federal Acquisition Regulation; Simplified Acquisition Threshold for Overseas Acquisitions in Support of Humanitarian or Peacekeeping Operations AGENCIES:

    Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).

    ACTION:

    Proposed rule.

    SUMMARY:

    DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement a higher simplified acquisition threshold for overseas acquisitions in support of humanitarian or peacekeeping operations.

    DATES:

    Interested parties should submit written comments to the Regulatory Secretariat at one of the addresses shown below on or before December 7, 2015 to be considered in the formulation of a final rule.

    ADDRESSES:

    Submit comments in response to FAR Case 2015-020 by any of the following methods:

    • Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching for “FAR Case 2015-020.” Select the link “Comment Now” that corresponds with FAR Case 2015-020. Follow the instructions provided at the “Comment Now” screen. Please include your name, company name (if any), and “FAR Case 2015-020” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat (MVCB), ATTN: Ms. Flowers, 1800 F Street NW., 2nd Floor, Washington, DC 20405.

    Instructions: Please submit comments only and cite FAR Case 2015-020, in all correspondence related to this case. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Ms. Kathlyn Hopkins, Procurement Analyst, at 202-969-7226, for clarification of content. For information pertaining to status or publication schedules, contact the Regulatory Secretariat at 202-501-4755. Please cite FAR case 2015-020.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The purpose of this rule is to implement 41 U.S.C. 153, which establishes a higher simplified acquisition threshold (SAT) for overseas acquisitions in support of humanitarian or peacekeeping operations. FAR Case 2003-022 was published as an interim rule on February 23, 2004 (69 FR 8312) and as a final rule on December 20, 2004 (69 FR 76350). Drafters of that rule revised the definition for SAT contained at FAR 2.101, Definitions, but also inadvertently deleted the reference to overseas humanitarian or peacekeeping missions and the requisite doubling of the SAT in those circumstances. The civilian statute at the time was numbered 41 U.S.C. 259(d)(1); it is now at 41 U.S.C. 153. The purpose of this rule is to reinstate the increased SAT for overseas acquisitions for peacekeeping or humanitarian operations. Conforming changes are made in FAR parts 4, 13, 18, and 19.

    II. Executive Orders 12866 and 13563

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

    III. Regulatory Flexibility Act

    DoD, GSA, and NASA do not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because the rule merely provides flexibilities associated with contracting under the SAT for overseas acquisitions in support of humanitarian or peacekeeping operations. However, an Initial Regulatory Flexibility Analysis (IRFA) has been performed, and is summarized as follows:

    The purpose of this rule is to implement 41 U.S.C. 153, which establishes a higher SAT for overseas acquisitions in support of humanitarian or peacekeeping operations. The increased threshold is limited to those procurements. In Fiscal Year 2014, 1,545 awards were made in support of humanitarian or peacekeeping operations, and 585 (37.86 percent) of these awards were to small businesses. Additionally, only 81 (5.24 percent) of the awards were valued between $150,000 and $300,000. Therefore, it is not anticipated that this rule will have a significant economic impact on small businesses.

    The rule does not duplicate, overlap, or conflict with any other Federal rules. No alternatives were determined that will accomplish the objectives of the rule.

    The Regulatory Secretariat has submitted a copy of the IRFA to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the IRFA may be obtained from the Regulatory Secretariat. DoD, GSA, and NASA invite comments from small business concerns and other interested parties on the expected impact of this rule on small entities.

    DoD, GSA, and NASA will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (FAR Case 2015-020), in correspondence.

    IV. Paperwork Reduction Act

    This rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

    List of Subjects in 48 CFR Parts 2, 4, 13, 18, and 19

    Government procurement.

    William Clark, Director, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy.

    Therefore, DoD, GSA, and NASA propose amending 48 CFR parts 2, 4, 13, 18, and 19 as set forth below:

    1. The authority citation for 48 CFR parts 2, 4, 13, 18, and 19 continues to read as follows: Authority:

    40 U.S.C. 121(c); 10 U.S.C. chapter 137; and 51 U.S.C. 20113.

    PART 2—DEFINITIONS OF WORDS AND TERMS 2. Amend section 2.101 in paragraph (b)(2), by revising the definition “Simplified acquisition threshold” to read as follows:
    2.101 Definitions.

    (b) * * *

    (2) * * *

    Simplified acquisition threshold means $150,000, except for—

    (1) Acquisitions of supplies or services that, as determined by the head of the agency, are to be used to support a contingency operation or to facilitate defense against or recovery from nuclear, biological, chemical, or radiological attack (41 U.S.C. 1903), the term means—

    (i) $300,000 for any contract to be awarded and performed, or purchase to be made, inside the United States; and

    (ii) $1 million for any contract to be awarded and performed, or purchase to be made, outside the United States.

    (2) Acquisitions of supplies or services that, as determined by the head of the agency, are to be used to support a humanitarian or peacekeeping operation (41 U.S.C. 153 and 10 U.S.C. 2302), the term means $300,000 for any contract to be awarded and performed, or purchase to be made, outside the United States.

    PART 4—ADMINISTRATIVE MATTERS
    4.1102 [Amended]
    3. Amended section 4.1102 by removing from paragraph (a)(3)(i) “10 U.S.C. 2302(7)” and adding “10 U.S.C. 2302(8)” in its place. PART 13—SIMPLIFIED ACQUISITION PROCEDURES
    13.003 [Amended]
    4. Amended section 13.003 by removing from paragraph (b)(1) “described in paragraph (1)” and adding “described in paragraph (1)(i)” in its place. PART 18—EMERGENCY ACQUISITIONS 5. Amend subpart 18.2 by redesignating section 18.204 as section 18.205; and adding a new section 18.204 to read as follows:
    18.204 Humanitarian or peacekeeping operation.

    (a) A humanitarian or peacekeeping operation is defined in 2.101.

    (b) Simplified acquisition threshold. The threshold increases when the head of the agency determines the supplies or services are to be used to support a humanitarian or peacekeeping operation. (See 2.101.)

    PART 19—SMALL BUSINESS PROGRAMS
    19.203 [Amended]
    6. Amended section 19.203 by removing from paragraph (b) “described in paragraph (1)” and adding “described in paragraph (1)(i)” in its place.
    19.502-2 [Amended]
    7. Amended section 19.502-2 by removing from paragraph (a) “described in paragraph (1) of the Simplified Acquisition Threshold” and adding “described in paragraph (1)(i) of the simplified acquisition threshold” in its place.
    [FR Doc. 2015-25614 Filed 10-7-15; 8:45 am] BILLING CODE 6820-EP-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION 48 CFR Part 36 [FAR Case 2015-018; Docket No. 2015-0018; Sequence No. 1] RIN 9000-AN10 Federal Acquisition Regulation; Improvement in Design-Build Construction Process AGENCIES:

    Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).

    ACTION:

    Proposed rule.

    SUMMARY:

    DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement section 814 of the Carl Levin and Howard P. `Buck' McKeon National Defense Authorization Act for Fiscal Year 2015 that requires the head of the contracting activity to approve any determinations to select more than five offerors to submit phase-two proposals for a two-phase design-build construction acquisition that is valued at greater than $4 million.

    DATES:

    Interested parties should submit written comments to the Regulatory Secretariat at one of the addresses shown below on or before December 7, 2015 to be considered in the formulation of a final rule.

    ADDRESSES:

    Submit comments in response to FAR Case 2015-018 by any of the following methods:

    • Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching for “FAR Case 2015-018.” Select the link “Comment Now” that corresponds with FAR Case 2015-018. Follow the instructions provided at the “Comment Now” screen. Please include your name, company name (if any), and “FAR Case 2015-018” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat (MVCB), ATTN: Ms. Flowers, 1800 F Street NW., 2nd Floor, Washington, DC 20405.

    Instructions: Please submit comments only and cite FAR Case 2015-018, in all correspondence related to this case. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Mr. Curtis E. Glover, Sr., Procurement Analyst, at 202-501-1448, for clarification of content. For information pertaining to status or publication schedules, contact the Regulatory Secretariat at 202-501-4755. Please cite FAR case 2015-018.

    SUPPLEMENTARY INFORMATION:

    I. Background

    DoD, GSA, and NASA are proposing to amend the FAR to implement section 814 of the Carl Levin and Howard P. `Buck' McKeon National Defense Authorization Act for Fiscal Year 2015. Section 814 is entitled Improvement in Defense Design-Build Construction Process. Section 814 requires the head of the contracting activity, delegable to a level no lower than the senior contracting official, to approve any determinations to select more than five offerors to submit phase-two proposals for a two-phase design build construction acquisition that is valued at greater than $4 million.

    II. Discussion and Analysis

    This proposed rule does not change the maximum number of offerors, currently five, that may be selected to submit phase-two proposals without a contracting officer determination. However, for acquisitions valued above $4 million, the determination must now have a higher level of approval for the contracting officer to select more than five offerors. A potential offeror may be more inclined to invest their pre-award efforts on solicitations where they have an increased chance of award.

    III. Executive Orders 12866 and 13563

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

    IV. Regulatory Flexibility Act

    This change is not expected to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. Nevertheless, an Initial Regulatory Flexibility Analysis (IRFA) has been prepared, and is summarized as follows:

    This rule implements section 814 of the Carl Levin and Howard P. `Buck' McKeon National Defense Authorization Act for Fiscal Year 2015. Section 814 is entitled Improvement in Defense Design-Build Construction Process. Section 814 requires the head of the contracting activity, delegable to a level no lower than the senior contracting official, to approve any determinations to select more than five offerors to submit phase-two proposals for a two-phase design build construction acquisition that is valued at greater than $4 million.

    The number of design-build construction awards is not currently tracked by the Federal government's business systems. In Fiscal Year 2014, the Federal government awarded 3,666 construction awards to 2,239 unique small business vendors. It is unknown what percentage of these contracts involved design-build construction services.

    This rule does not impose new recordkeeping or reporting requirements. The new approval requirement for advancing more than five contractors to phase two of a two-phase design-build selection procedure only affects the internal procedures of the Government. For acquisitions valued over $4M, the head of the contracting activity (HCA) is required to now make a determination that it is in the best interest of the Government to select more than five offerors to proceed to phase two. Any burden caused by this rule is expected to be minimal and will not be any greater on small businesses than it is on large businesses.

    The rule does not duplicate, overlap, or conflict with any other Federal rules. No alternative approaches were considered. It is not anticipated that the proposed rule will have a significant economic impact on small entities.

    The Regulatory Secretariat has submitted a copy of the IRFA to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the IRFA may be obtained from the Regulatory Secretariat. DoD, GSA, and NASA invite comments from small business concerns and other interested parties on the expected impact of this rule on small entities.

    DoD, GSA, and NASA will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (FAR Case 2015-018), in correspondence.

    V. Paperwork Reduction Act

    The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

    List of Subject in 48 CFR Part 36

    Government procurement.

    William Clark, Director, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy.

    Therefore, DoD, GSA, and NASA propose amending 48 CFR part 36 as set forth below:

    PART 36—CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS 1. The authority citation for 48 CFR part 36 continues to read as follows: Authority:

    40 U.S.C. 121(c); 10 U.S.C. chapter 137; and 51 U.S.C. 20113.

    2. Amend section 36.303-1 by revising paragraph (a)(4) to read as follows:
    36.303-1 Phase One.

    (a) * * *

    (4) A statement of the maximum number of offerors that will be selected to submit phase-two proposals. The maximum number specified in the solicitation shall not exceed five unless the contracting officer determines, for that particular solicitation, that a number greater than five is in the Government's interest and is consistent with the purposes and objectives of the two-phase design-build selection procedures. The contracting officer shall document this determination in the contract file. For acquisitions greater than $4 million, the determination shall be approved by the head of the contracting activity, delegable to a level no lower than the senior contracting official within the contracting activity.

    [FR Doc. 2015-25613 Filed 10-7-15; 8:45 am] BILLING CODE 6820-EP-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-HQ-ES-2015-0143; 4500030113] Endangered and Threatened Wildlife and Plants; 12-Month Findings on Petitions To List 19 Species as Endangered or Threatened Species AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of 12-month petition findings.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service, FWS, or USFWS), announce 12-month findings on petitions to list 19 species as endangered species or threatened species under the Endangered Species Act of 1973, as amended (Act). After review of the best available scientific and commercial information, we find that listing the American eel, Cumberland arrow darter, the Great Basin distinct population segment (DPS) of the Columbia spotted frog, Goose Creek milkvetch, Nevares spring bug, Page springsnail, Ramshaw meadows sand-verbena, Sequatchie caddisfly, Shawnee darter, Siskiyou mariposa lily, Sleeping ute milkvetch, Southern Idaho ground squirrel, Tahoe yellow cress, and six Tennessee cave beetles (Baker Station, Coleman, Fowler's, Indian Grave Point, inquirer, and Noblett's cave beetles) is not warranted at this time. However, we ask the public to submit to us any new information that becomes available concerning the threats to any of the 19 species listed above or their habitat at any time.

    DATES:

    The findings announced in this document were made on October 8, 2015.

    ADDRESSES:

    These findings are available on the Internet at http://www.regulations.gov at Docket Number FWS-HQ-ES-2015-0143. Supporting information used in preparing these findings is available for public inspection, by appointment, during normal business hours by contacting the appropriate person as specified under FOR FURTHER INFORMATION CONTACT. Please submit any new information, materials, comments, or questions concerning these findings to the appropriate person, as specified under FOR FURTHER INFORMATION CONTACT.

    FOR FURTHER INFORMATION CONTACT: Species Contact information American eel Northeast Regional Office, Endangered Species Program, 413-253-8615. Cumberland arrow darter Kentucky Ecological Services Field Office, 502-695-0468. Great Basin DPS of the Columbia spotted frog Nevada Fish and Wildlife Office, 775-861-6300. Goose Creek milkvetch Utah Ecological Services Field Office, 801-975-3330. Nevares spring naucorid bug Carlsbad Fish and Wildlife Office, 760-431-9440. Page springsnail Arizona Ecological Services Field Office, 602-242-0210. Ramshaw meadows sand-verbena Sacramento Fish and Wildlife Office, 916-414-6700. Sequatchie caddisfly Tennessee Ecological Services Field Office, 931-528-6481. Shawnee darter Kentucky Ecological Services Field Office, 502-695-0468. Siskiyou mariposa lily Yreka Fish and Wildlife Office, 530-842-5763. Sleeping ute milkvetch Western Colorado Ecological Services Field Office, 970-628-7184. Southern Idaho ground squirrel Idaho Fish and Wildlife Office, 208-378-5265. Tahoe yellow cress Nevada Fish and Wildlife Office, 775-861-6300. Tennessee cave beetles (Baker Station, Coleman, Fowler's, Indian Grave Point, inquirer, and Noblett's cave beetles) Tennessee Ecological Services Field Office, 931-528-6481.

    If you use a telecommunications device for the deaf (TDD), please 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. 1533) requires that, for any petition to revise the Federal Lists of Endangered and Threatened Wildlife and Plants that contains substantial scientific or commercial information indicating that listing an animal or plant species may be warranted, we make a finding within 12 months of the date of receipt of the petition. In this finding, we determine whether the petitioned actions regarding the American eel, Cumberland arrow darter, the Great Basin distinct population segment (DPS) of the Columbia spotted frog, Goose Creek milkvetch, Nevares spring bug, Page springsnail, Ramshaw meadows sand-verbena, Sequatchie caddisfly, Shawnee darter, Siskiyou mariposa lily, Sleeping ute milkvetch, Southern Idaho ground squirrel, Tahoe yellow cress, and six Tennessee cave beetles (Baker Station, Coleman, Fowler's, Indian Grave Point, inquirer, and Noblett's cave beetles) are: (1) Not warranted, (2) warranted, or (3) warranted, but the immediate proposal of a regulation implementing the petitioned action is precluded by other pending proposals to determine whether species are endangered or threatened species, and expeditious progress is being made to add or remove qualified species from the Federal Lists of Endangered and Threatened Wildlife and Plants (warranted but precluded). Section 4(b)(3)(C) of the Act requires that we treat a petition for which the requested action is found to be warranted but precluded as though resubmitted on the date of such finding, that is, requiring a subsequent finding to be made within 12 months. We must publish these 12-month findings in the Federal Register.

    Summary of Information Pertaining to the Five Factors

    Section 4 of the Act (16 U.S.C. 1533) and the implementing regulations in part 424 of title 50 of the Code of Federal 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 an endangered species or a threatened species based on any of the following five factors:

    (A) The present or threatened destruction, modification, or curtailment of its habitat or range;

    (B) Overutilization for commercial, recreational, scientific, or educational purposes;

    (C) Disease or predation;

    (D) The inadequacy of existing regulatory mechanisms; or

    (E) Other natural or manmade factors affecting its continued existence.

    We summarize below the information on which we based our evaluation of the five factors provided in section 4(a)(1) of the Act in determining whether the American eel, Cumberland arrow darter, the Great Basin DPS of the Columbia spotted frog, Goose Creek milkvetch, Nevares spring bug, Page springsnail, Ramshaw meadows sand-verbena, Sequatchie caddisfly, Shawnee darter, Siskiyou mariposa lily, Sleeping ute milkvetch, Southern Idaho ground squirrel, Tahoe yellow cress, and six Tennessee cave beetles (Baker Station, Coleman, Fowler's, Indian Grave Point, inquirer, and Noblett's cave beetles) are threatened species or endangered species. More detailed information about these species is presented in the species-specific assessment forms found on www.regulations.gov. In considering what factors 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. In that case, we 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 affected could suffice. The mere identification of factors that could affect 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 species or a threatened species under the Act.

    In making our 12-month findings, we considered and evaluated the best available scientific and commercial information.

    American Eel (Anguilla rostrata) Previous Federal Actions

    For a complete petition history for the American eel prior to September 2011, see the Previous Federal Action section of our September 29, 2011, 90-day substantial petition finding. Publication of the 90-day finding in the Federal Register (September 29, 2011; 76 FR 60431) opened a period to solicit new information that was not previously available or was not considered at the time of our previous 2007 status review and not-warranted 12-month finding (February 2, 2007; 72 FR 4967), and initiated a new status review.

    On December 23, 2011, the petitioner (Center for Environmental Science Accuracy and Reliability (CESAR), formerly known as the Council for Endangered Species Act Reliability) filed a Notice of Intent to sue the Service for failure to publish a finding within 12 months of receiving the April 30, 2010, petition. On August 7, 2012, CESAR filed a complaint with the U.S. District Court for the District of Columbia for the Service's failure to meet the petition's statutory timeline. On April 24, 2013, the Service entered into a court-approved settlement agreement with CESAR stipulating that the Service would complete a status review of American eel and deliver a 12-month finding to the Federal Register on or before September 30, 2015 (Stipulated Settlement Agreement, Center for Envt'l Science Accuracy and Reliability v. Salazar, et al. (D.D.C., Case No. 1:12-cv-01311-EGS), Doc. 18, filed April 24, 2013.).

    To ensure the status review was based on the best scientific and commercial information available, the Service, in November 2013 through January 2014, requested any new or updated American eel information since the 2007 status review. The requests were sent to State and Federal agencies, Native American tribes, nongovernmental agencies, and other interested parties. In addition to any new or updated information, the requests specifically sought information related to panmixia, glass eel recruitment, climate change, oceanographic conditions, and eel abundance at fishways. See the lists of references reviewed and cited for a list of agencies, organizations, and parties from which we received information; these reference lists are available at http://www.regulations.gov and at http://www.fws.gov/northeast/newsroom/eels.html.

    Summary of Status Review

    In making our 12-month finding on the petition, we consider and evaluate the best available scientific and commercial information. This evaluation includes information from all sources, including State, Federal, tribal, academic, and private entities and the public. However, because we have a robust history with the American eel and completed a thorough status review for the species in 2007, we are incorporating by reference the February 7, 2007, 12-month finding (72 FR 4967) and using its information as a baseline for our 2015 status review and 12-month petition finding.

    A supporting document entitled, American Eel Biological Species Report (Report) provides a summary of the current (post 2007) literature and information regarding the American eel's distribution, habitat requirements, life-history, and stressors. The Report is available as a Supplemental Document at http://www.fws.gov/northeast/newsroom/eels.html. We describe in the Report or in our 12-month finding document any substantive changes that we identified in the data used in the February 7, 2007, 12-month finding or in conclusions drawn from that data, based upon our review of the best available scientific and commercial information since 2007.

    American eel are a facultative catadromous fish species, meaning they commonly use brackish estuaries or near-shore marine habitats, in addition to the freshwater habitats. After mature eels spawn in the Sargasso Sea, the eggs hatch into “leptocephali,” a larval stage that lasts for about 1 year. Leptocephali are transported by ocean currents from the Sargasso Sea to the Atlantic coast of North America, the Caribbean, Gulf of Mexico, Central America and northern portions of South America. Leptocephali metamorphose into “glass eels” while at sea and then actively swim across the continental shelf to coastal waters. Glass eels transform into small pigmented juvenile eels, commonly called “elvers,” after taking up residence in marine, estuarine, or freshwater rearing habitats in coastal waters. As they grow, the larger juvenile eels are known as “yellow eels.” American eels begin sexual differentiation at a length of about 20 to 25 centimeters (7.9 to 9.8 inches), well in advance of maturation as a “silver eel.” Upon nearing sexual maturity, silver eels begin migration toward the Sargasso Sea, completing sexual maturation en route. In the United States, the American eel is found in fresh, estuarine, and marine waters in 36 States. The upstream extent of eel distribution in freshwater is limited by impassable dams and natural barriers. American eel are ubiquitous in many continental aquatic habitats including marine habitats, estuaries, lakes, ponds, small streams, and large rivers to the headwaters. They may be locally abundant to the extent that they sometimes constitute a large proportion of the total fish biomass in many watersheds.

    The 2007 Status Review and the 2015 Report reviewed a number of stressors (natural or human induced negative pressures affecting individuals or subpopulations of a species) on the American eel, including the effects of climate change; parasites; habitat loss in estuaries, lakes, and rivers; migratory effects from hydroelectric projects; recreational and commercial harvests; and contaminants.

    In terms of climate change, North Atlantic Ocean temperatures may continue to rise as a result of climate change, but a great deal of uncertainty remains regarding changes in physical oceanographic processes and how, or to what extent, those processes will affect eel migration, aggregation for reproduction, and ultimately abundance. The species report discusses in detail the complex subject of climate change and its foreseeable effects on the species. Based on our review of the best available scientific and commercial information, we conclude that climate change, based on its reasonably foreseeable effects, is not a threat to the American eel that puts it in danger of extinction or likely to become so in the foreseeable future, nor is it reasonably foreseeable that it would become such a threat in the future.

    As for parasites, despite the spread of Anguillicoloides crassus and increasing mean infection rates over time, there is no direct evidence to support a conclusion that the parasite causes significant American eel mortality. Nor is there direct evidence to support or refute the hypotheses that A. crassus impairs the silvering process, prevents American eels from completing their spawning migration to the Sargasso Sea, or impairs spawning.

    With regard to habitat loss, American eel have been extirpated from some portions of their historical range, mostly as a result of large hydroelectric and water storage dams built since the early twentieth century. Although dams have extirpated eels from some large rivers and certain headwaters, the species remains widely distributed over the majority of its historical range. We consider habitat loss from barriers to be a historical effect, and any population-level effects likely have already been realized. The extensive range of American eel provides multiple freshwater and estuarine areas that support the species' life stages and thus buffer the species as a whole from stressors affecting individuals or smaller populations in any one area. Currently, ocean habitats and the full range of continental habitats (estuaries, lakes, and rivers) remain available and occupied by the American eel. Some American eels complete their life cycle without ever entering freshwater. Highly fecund females continue to be present in extensive areas of freshwater (lacustrine and riverine), estuarine, and marine habitats; males also continue to be present in these habitats. Recruitment of glass eels continues to occur in these habitats with no evidence of continuing reduction in glass eel recruitment. For these reasons, we conclude that the available freshwater, estuarine, and marine habitats are sufficient to sustain the American eel population.

    With regard to migratory effects from hydroelectric projects, hydroelectric dams are obstacles that may delay the downstream migration of silver eels that mature in riverine habitats, and hydroelectric turbines can cause mortality or injury (eels that mature and migrate from estuary or marine habitats downstream are not affected by hydroelectric dams). The effects of turbine injury, including delayed mortality and possible impaired reproduction and increased predation risk, are poorly understood in the American eel. The best scientific and commercial information available indicates that mortality from hydroelectric turbines can cause significant mortality to downstream-migrating silver eels. The installation of effective downstream passage measures (i.e., bypasses or night spillage) through the Federal Energy Regulatory Commission relicensing process has reduced, and continues to reduce this mortality.

    In terms of recreational and commercial harvest, we continue to acknowledge that sometimes large numbers of individual American eel are recreationally or commercially harvested for food, bait, or aquaculture, but we conclude that harvest and trade are not threats to the American eel. The species is highly resilient, and remains a widely distributed fish species with a relatively stable population despite the levels of historical habitat loss and historical and current commercial and recreational harvest. That harvest is being managed and monitored via existing harvest quotas, licenses, and reporting requirements to ensure the species' conservation.

    In addition, contaminants may affect early life stages of the American eel, but without specific information, we remain cautious in extrapolation of laboratory studies to rangewide population-level effects (e.g., there are no studies showing reduced recruitment of glass eels in the wild, which would be an indicator of decreased outmigration, or decreased egg or leptocephali survival). A correlation between the contamination of the upper Saint Lawrence River/Lake Ontario watershed and the timing of the 1980s decline of American eel in the upper Saint Lawrence River/Lake Ontario watershed is not evident.

    Lastly, there are no individual stressors that rise to the level of a threat to the American eel. Some stressors can have cumulative effects and result in increased mortality. For example, the Report discusses known cumulative and synergistic interactions of various contaminants and known cumulative effects of increased predation and mortality at or below dams that block eel migration. While some individual American eels may be exposed to increased levels of mortality as a result of these contaminant or predation cumulative effects, we have no indication that the species is, or will be, significantly affected at a population level. Therefore, we conclude that there are no cumulative stressors that are a threat to the American eel now, or that will become a threat in the foreseeable future.

    The best available information indicates that, American eel are a single panmictic population that lacks distinct population structure, breeds in the Sargasso Sea, and shares a single common gene pool. Panmixia is central to evaluating stressors to the American eel since, in order for any stressor to rise to the level of a threat (natural or human-induced pressure affecting a species as a whole), it must act upon a large portion of the population at some life-history focal point, or the stressor must be present throughout a large part of the species' range. And the stressor must elicit a response that results in significant mortality, impaired reproduction, or juvenile recruitment failure.

    Several lines of evidence indicate that the American eel population is not subject to threats that would imperil its continued existence. Despite historical habitat losses and a population reduction over the past century, American eels remain widely distributed throughout a large part of their historical range. Glass eels are recruited to North American rivers in large numbers. Elvers are also present in large numbers well inland on some east coast river systems—for example, more than 820,000 eels passed through a new fishway at the Roanoke Rapids Dam, located 137 miles inland on the Roanoke River in 2013, the fourth year of operation. American eels are plastic in their behavior and adaptability, inhabiting a wide range of freshwater, estuarine, and marine habitats over an exceptionally broad geographic range. Because of the species' panmixia, areas that have experienced depletion or extirpation may experience a “rescue effect” allowing for continued or renewed occupation of available areas. Trends in abundance over recent decades vary among locations and life stages, showing decreases in some areas, and increases or no trends in other areas. Limited records of glass eel recruitment do not show trends that would signal recent declines in annual reproductive success or the effect of new or increased stressors. Taken as a whole, a clear trend cannot be detected in species-wide abundance during recent decades, and, while acknowledging that there have been large declines in abundance from historical times, the species currently appears to be depleted but stable. While some eel habitat has been permanently lost and access to freshwater habitats is impaired by dams that lack upstream fish passage, access to freshwater habitat has improved, and continues to improve, in other areas through new or improved eel ladders and removal of barriers. Despite the loss of some freshwater habitat, the American eel population appears to be stable based on young-of-the-year indices and estimates of spawner abundance. In addition, since 2007, newer information indicates that some American eel complete their life cycle in estuarine and marine waters.

    Finding

    Based on our review of the best available scientific and commercial information pertaining to the five factors, we find that the stressors are not of sufficient imminence, intensity, or magnitude to indicate that the American eel is in danger of extinction (an endangered species), or likely to become an endangered species within the foreseeable future (a threatened species), throughout all of its range.

    There are no threats currently affecting the American eel throughout the species' range. There are several stressors that cause individual mortality, including recreational and commercial harvest (Factor B), predation (Factor C), and hydroelectric turbines (Factor E), but none that affect a portion of the species' range more than another. In addition, there are no portions of the species' range that are considered significant given the species' panmictic life-history. Therefore, we find that no portion of the American eel's range warrants further consideration of possible endangered or threatened status under the Act, and we find that listing the American eel as a threatened or endangered species throughout all or a significant portion of its range is not warranted at this time.

    Cumberland Arrow Darter (Etheostoma sagitta) Previous Federal Actions

    The Cumberland arrow darter was first identified as a candidate for protection under the Act through our internal process in the Candidate Notice of Review published in the November 21, 2012, Federal Register (77 FR 69994); the subspecies was identified at the time as E. sagitta sagitta. Threats to the subspecies identified at that time were water pollution from surface coal mining and gas exploration activities; removal of riparian vegetation; stream channelization; increased siltation associated with poor mining, logging, and agricultural practices; and deforestation of watersheds. It was assigned a listing priority number (LPN) of 9. On November 22, 2013 (78 FR 70104), the LPN was changed to 8 due to morphological and genetic analysis resulting in the recognition of Cumberland arrow darter as a species (E. sagitta) as opposed to a subspecies, which it remained until evaluation for listing this year.

    Summary of Status Review

    The following summary is based on information in our files. From 2010 to 2012, the Service and its partners (Kentucky Department of Fish and Wildlife Resources (KDFWR), Kentucky State Nature Preserve Commission (KSNPC), and Tennessee Wildlife Resources Agency (TWRA)) completed a range-wide status assessment for the Cumberland arrow darter (USFWS 2012, pp. 1-2). We first generated a list of historical (pre-2000) records through review of agency databases (KDFWR, KSNPC, and TWRA), museum records (University of Tennessee), and published literature. From 2010 through 2012, surveys were completed at 187 of 202 historical sites and in 124 of 128 historical streams (sites corresponded to individual sampling reaches and more than one could be present on a given stream). Surveys were also conducted at other sites/streams where habitat conditions appeared to be suitable for the species. When first considered for candidate status in early 2012, status surveys were still ongoing, and the species had been observed in 72 of 123 historical sites visited (58 percent) and 60 of 101 historical streams visited (59 percent). More comprehensive surveys in Tennessee in late 2012 and additional surveys in Kentucky in 2013-2014 expanded the species' known range to 98 streams, including 119 of 187 historical sites visited (64 percent), 85 of 128 historical streams visited (66 percent), and 13 new (non-historical) streams (USFWS 2012, pp. 1-2; USFWS unpublished data). New distributional records were obtained during each year of sampling, primarily from the middle and western portions of the species' geographical range. Within Kentucky, the species was observed at 87 of 143 sites (61 percent) and in 61 of 100 streams (61 percent). Within Tennessee, the species was observed at 32 of 44 sites (73 percent) and in 24 of 30 streams (80 percent). [Note that 2 of the historical streams surveyed occur in both Kentucky and Tennessee and are, therefore, included in each of the State totals provided in the previous sentences (i.e., 100 and 30, respectively.] The species' most significant declines were documented within the Poor Fork, Clover Fork, Straight Creek, Clear Creek, and Clear Fork drainages, all of which are located within the eastern half of the species' geographical range. This portion of the upper Cumberland River drainage has less public ownership than the western half of the drainage and has been impacted more extensively by surface coal mining.

    Over the last 3 years, new field surveys and monitoring efforts across the Cumberland arrow darter's range have improved our understanding of the species' distribution and stressors. Based on these findings, we have reexamined the species' status and reevaluated the magnitude and imminence of its stressors. We acknowledge that the species has suffered declines in portions of its range (e.g., it has been extirpated from 43 of 128 historical streams) and portions of the range continue to suffer some level of water quality degradation and habitat disturbance. However, we have determined that the species' overall status is more secure than previously believed, and stressors acting on the species are not of sufficient imminence, intensity, or magnitude to indicate the species is in danger of extinction (an endangered species), or likely to become endangered within the foreseeable future (a threatened species). The Cumberland arrow darter's status is bolstered by its large number of occupied streams (98) and its frequent occurrence in streams on public lands and in streams with listed species (e.g., blackside dace). In support of this not-warranted finding, we offer the following specifics with regard to its status:

    • The species' range (number of extant streams) is larger than first believed. When first identified as a candidate for listing in 2012, the Cumberland arrow darter was known from 72 of 123 historical sites visited (58 percent) and 60 of 101 historical streams visited (59 percent). More comprehensive surveys in Tennessee and additional surveys in Kentucky from 2012 through 2014 expanded the species' known range to 98 streams, including 85 of 128 historical streams (66 percent) and 13 new streams. The species' relatively broad distribution and high number of occupied streams increases its resiliency and redundancy.

    • The species has demonstrated greater persistence in streams with at least 1 listed species (62 streams) or in streams located on public lands (45 streams). When combined, these two groups total 75 streams, or 77 percent of the species' known habitats. Historically, less habitat disturbance has occurred on public lands, and many of the species' best remaining habitats are located in these areas. The Cumberland arrow darter also benefits indirectly from listed species' protections provided by Federal and State statutes and regulations, especially in Kentucky where State water quality regulations (401 Kentucky Administrative Regulations 10:031, Section 8) provide added protections for streams supporting listed species (“Outstanding State Resource Waters”).

    The species utilizes larger streams more frequently than previously believed, bolstering the species' redundancy, resiliency, and representation (capacity of a species to adapt to changing environmental conditions). We have recent records (multiple individuals each) from Capuchin Creek, Elk Fork Creek, Jellico Creek (at Criscillis Branch), Marsh Creek (near mouth), and Roaring Paunch Creek, all of which are fourth-order streams or larger and have watersheds exceeding 65 square kilometers (25 square miles). This information suggests the species utilizes more stream kilometers (miles) than previously believed because most survey efforts have focused on smaller streams (third-order and smaller). The species' presence in these habitats protects against stochastic and catastrophic events (e.g., drying, floods, or pollution events) that can occur across the species' range.

    Finding

    We evaluated the stressors to the Cumberland arrow darter and considered factors that, individually and in combination, presently or potentially could pose a risk to the species and its habitat. Based on our analysis of these stressors and our review of the species' current status, we conclude that listing this species under the Act is not warranted, because this species is not in danger of extinction, and is not likely to become in danger of extinction throughout all of its within the foreseeable future. We evaluated the current range of the Cumberland arrow darter to determine if there is any apparent geographic concentration of potential threats for this species. We examined potential threats, and found that potential impacts (e.g., water quality degradation) associated with surface coal mining and other land uses (e.g., residential development) are greater in the eastern half of the species' geographical range (e.g., water quality degradation is more common within this part of the range, and more extirpations have occurred there).

    To determine if this portion of the range was significant, we evaluated its contribution and importance to the species' overall viability. Even though the species has been extirpated from multiple streams within the eastern half of the geographical range, we do not consider this portion of the range to be so important that, without the members in that portion, the species in the remainder of the range would be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range (i.e., the loss of this portion clearly would not be expected to increase the vulnerability to extinction of the entire species). The species continues to occupy 98 streams across its entire range. A total of 75 of these streams (77 percent) either support a listed species (62 streams) or occur on publicly owned lands (45 streams) where disturbance is minimal (e.g., Daniel Boone National Forest). The eastern half of the species' geographical range continues to support multiple viable populations; 17 occupied streams, 15 of which are in public ownership or are occupied by a listed species. Given the hypothetical loss of the geographical eastern portion of the species range, the Cumberland arrow darter would still occupy 81 streams, 60 of which are in public ownership are occupied by a listed species. Therefore, we do not consider the eastern half of the species geographical range to constitute a significant portion of the species' range. Because this portion of the range is not significant, we conclude that the species 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 the Cumberland arrow darter as an endangered or threatened species under the Act is not warranted at this time. Therefore, we no longer consider it to be a candidate species for listing.

    Great Basin DPS of the Columbia Spotted Frog (Rana luteiventris) Previous Federal Actions

    On May 4, 1989, we received a petition dated May 1, 1989, from Peter Hoving, Chairman, Issues Committee, requesting that the spotted frog be listed as a threatened species under the Act. In 1993, we announced a finding on the petition where we found five populations of the spotted frog warranted listing (58 FR 27260; May 7, 1993). On September 19, 1997, we announced our acceptance of species-specific genetic and geographic differences in spotted frogs and we added the Great Basin distinct population segment of the Columbia spotted frog to the candidate list with a listing priority number (LPN) of 3 (62 FR 49402). In the December 6, 2007,Candidate Notice of Review (CNOR) (72 FR 69039), we announced a change in LPN from 3 to 9 for this entity. In subsequent annual CNOR publications, we maintained our determination of LPN of 9 for this species.

    Summary of Status Review

    The Columbia spotted frog (Great Basin DPS) occurs in Nevada, southwestern Idaho, and southeastern Oregon. The Columbia spotted frog is a slim-waisted, long-legged, smooth-skinned frog measuring between 2 to 4 inches. Dorsal colors and pattern include light brown, dark brown, or gray, with small spots. Ventral coloration can differ among geographic population units and may range from yellow to salmon with mottled throat regions.

    Columbia spotted frogs in the Great Basin have been affected primarily by the remaining effects of past habitat destruction and modification, which caused increased habitat fragmentation and isolation. Livestock grazing, mining activities, beaver management, water development, predation, disease, and the effects of climate change have also been identified as potential threats to the species. Heavy use by livestock has been shown to be detrimental to Columbia spotted frog habitat in localized areas. Livestock grazing and development of springs for livestock and agricultural purposes occur or have occurred throughout the Great Basin and resulted in an unquantifiable loss of riparian and wetland habitats used by the species. However, springs developed into ponds for the purposes of watering livestock have resulted in the creation and maintenance of persistent, high quality breeding and rearing habitat for the species in portions of the species range.. Mining has been shown to have localized impacts to populations but has a relatively low influence on a rangewide basis. Historical trapping nearly extirpated beaver from the Great Basin; however, beaver populations have rebounded and occupy the majority of its historical range but at lower densities. Harvest of beaver continues throughout the Great Basin but does not seem to be negatively impacting the beaver population as a whole within the Great Basin. However, there is little information on the impacts of harvest at the local watershed level to analyze impacts at this finer scale. The ability of beavers to restore degraded stream systems and the resulting habitat modification from their dams which keeps water on the landscape longer is becoming recognized as an important restoration technique (Gibson and Olden 2014, pp. 399-401; Pollack et al. 2014, pp. 284-286).

    Nonnative fish and amphibian predators occur within the range of Columbia spotted frogs. The level of impact from predation is variable across the species' range, and depends on the quality of habitat (availability of cover and shelter). These nonnative predators can also introduce and help spread diseases and pathogens. However, current population-level effects of both predation and disease (pathogens and parasites) have not been documented within the Great Basin; therefore, we conclude that predation and disease are not negatively affecting Columbia spotted frogs in the Great Basin at this time nor do we expect them to in the near future.

    Climate change has affected, and is expected to continue to affect, Great Basin ecosystems; however, the impacts to permanent water sources and to Columbia spotted frog populations are not well documented. The available data does not indicate whether any effects from climate change will have population-level effects within a reasonably foreseeable period of time. Based on this variability and uncertainty of the exact effects of climate change on the Columbia spotted frog Great Basin DPS within its range, we cannot reasonably determine that the effects of climate change are likely to have a population-level impact on the species now or in the foreseeable future.

    Many of the stressors discussed above do not act alone. Multiple stressors can alter the effects of other stressors or act synergistically to affect individuals and populations. For example, Kiesecker and Blaustein (1995, pp. 11050-11051) describe how UV-B acts with a pathogen to increase embryonic mortality above levels shown with either factor alone. Interactions between current land uses and changing climate or other environmental conditions may cause shifts in populations, communities, and ecosystems or may increase an individual's susceptibility to infection, disease, or predation (Hansen et al. 2001, p. 767; IPCC 2002, p. 22). However, the best available scientific information does not indicate that multiple stressors acting in combination or synergistically currently rising to the level of being identified as a stressor to the Great Basin DPS of Columbia spotted frogs and we therefore conclude that they do not cumulatively pose a threat to the species at this time nor do we expect them to do so in the future.

    Conservation efforts are occurring in many areas across the range of the Columbia spotted frog. A 10-year Conservation Agreement and Strategy has been implemented in Nevada since 2003. Due to the success of the Conservation Agreement and Strategy in managing and conserving Columbia spotted frogs in Nevada, a revised 10-year agreement (2015-2024) was signed in February 2015. In 2006, a Candidate Conservation Agreement with Assurances was developed for a population in Idaho. An increase in monitoring has improved our knowledge of the distribution of the species, as well as improved knowledge of demography in several populations. Improved grazing management in some locations has contributed to improved stream and riparian habitat in some areas. Creating ponded habitat has also improved numerous occupied sites throughout the Great Basin, as well as in other parts of the species' range. All three States include Columbia spotted frog on their list of protected species.

    Finding

    Based on our review of the best available scientific and commercial information pertaining to the five factors, we find that the stressors acting on the species and its habitat, either singly or in combination, are not of sufficient imminence, intensity, or magnitude to indicate that the Great Basin DPS of the Columbia spotted frog is in danger of extinction (an endangered species), or likely to become endangered within the foreseeable future (a threatened species), throughout all of its range. This finding is based on additional populations that have been found since the species was first identified as a candidate, the relatively stable population and distribution of the species, and conservation management that is occurring throughout the species' range for impacts to both the habitat and the species. Because the distribution of the species is relatively stable across its range and stressors are similar throughout the species' range, we found no concentration of stressors that suggests that the Great Basin DPS of the Columbia spotted frog may be in danger of extinction in any portion of its range. Therefore, we find that listing the Great Basin DPS of the Columbia spotted frog as a threatened or an endangered species or maintaining the species as a candidate is not warranted throughout all or a significant portion of its range at this time, and consequently we are removing it from candidate status.

    Goose Creek Milkvetch (Astragalus anserinus) Previous Federal Actions

    On February 3, 2004, we received a petition dated January 30, 2004, from Red Willow Research, Inc., and 25 other concerned parties, including the Prairie Falcon Audubon Society Chapter Board, Western Watersheds Project, Utah Environmental Congress, Sawtooth Group of the Sierra Club, and 21 private citizens. The petitioners requested that we list Goose Creek milkvetch as a threatened or an endangered species, emergency list the species, and designate critical habitat concurrently with the listing (Red Willow Research Inc, in litt. 2004). The petition contained information on the natural history of Goose Creek milkvetch, its population status, and potential threats to the species. Potential threats discussed in the petition include the destruction and modification of habitat, disease and predation, inadequacy of existing regulatory mechanisms, and other natural and manmade factors such as exotic and noxious weed invasions and road construction and maintenance. The petition clearly identified itself as a petition, and included the requisite identification information as required in 50 CFR 424.14(a).

    In a February 19, 2004, letter to the petitioners, we responded that our initial review of the petition for Goose Creek milkvetch determined that an emergency listing was not warranted, and that due to court orders and judicially approved settlement agreements for other listing actions, we would not be able to further address the petition to list the species at that time. On August 16, 2007, we published a notice of 90-day finding that the petition presented substantial scientific or commercial information indicating that listing Goose Creek milkvetch may be warranted, and we were initiating a status review of the species (72 FR 46023). A 60-day public comment period followed.

    Our subsequent 12-month finding identified Goose Creek milkvetch as a species for which listing as an endangered species or threatened species was warranted but was precluded due to higher priority listing decisions, and we assigned Goose Creek milkvetch a listing priority number of 5 (74 FR 46521; September 10, 2009). Following the finding, we completed annual Candidate Notices of Review in 2010 (75 FR 69222; November 10, 2010), 2011 (76 FR 66370; October 6, 2011), 2012 (77 FR 69994; November 21, 2012), 2013 (78 FR 70104; November 22, 2013), and 2014 (79 FR 72449; December 5, 2014), all of which maintained the species as a candidate. We assigned the listing priority number of 2 to the species in 2012, and maintained that listing priority through 2014. The change in the listing priority number was based upon information indicating that livestock use and invasive species (cheatgrass) had increased following the 2007 wildfires and that impacts to the species from these stressors were imminent.

    As a result of the Service's 2011 multidistrict litigation settlement with petitioners, a proposed listing rule or a not-warranted 12-month finding is required by September 30, 2016 (In re: Endangered Species Act Section 4 Deadline Litigation, No. 10-377 (EGS), MDL Docket No. 2165 (D.D.C. May 10, 2011)). This 12-month finding satisfies the requirements of that settlement agreement for the Goose Creek milkvetch.

    Summary of Status Review

    Goose Creek milkvetch is a narrow endemic plant in the Goose Creek drainage in Idaho, Nevada, and Utah. The current range of Goose Creek milkvetch is essentially the same as the historical range; however, we continue to identify a greater distribution of the species across its range. Overall, Goose Creek milkvetch occurs in a scattered distribution within five populations. Plants are typically found on sparsely vegetated outcrops of highly weathered volcanic-ash (tuffaceous) soils. The total population size in 2014 is estimated to be approximately 31,648 plants occupying approximately 2,117 acres (857 hectares).

    In our 2009 12-month finding (74 FR 46521; September 10, 2009), we identified the threats to Goose Creek milkvetch to be wildfire, wildfire management (firefighting and post-wildfire emergency stabilization and restoration activities), invasive nonnative plant species (cheatgrass, leafy spurge, crested wheatgrass), livestock use, development, recreation, mining, the inadequacy of regulatory mechanisms, and small population size. In our current candidate assessment, we evaluated available information, and concluded that the species is resilient to these stressors and that current impacts to the species are not as strong as previously believed.

    In 2015 we identified leafy spurge as a future threat to Goose Creek milkvetch, based upon its anticipated future spread and expansion within the species' range containing 64 percent of the total population. Leafy spurge has the ability to increase in density rapidly and displace Goose Creek milkvetch, which may lead to local extirpation of the species in infested areas that are not detected and controlled at early stages of leafy spurge invasion. As a result, our initial finding was that Goose Creek milkvetch warranted listing as a result of the future threat of leafy spurge. However, the Bureau of Land Management (BLM) and the U.S. Fish and Wildlife Service finalized a conservation agreement for the long-term conservation of Goose Creek milkvetch in early 2015 that identifies conservation measures to address the spread and control of leafy spurge in Goose Creek milkvetch habitat. Through our Policy for Evaluation of Conservation Efforts When Making Listing Decisions (PECE) (68 FR 15100; March 28, 2003) analysis, we evaluated the actions in the conservation agreement and concluded that there is sufficient certainty that the actions will be implemented and effective such that leafy spurge will not become a future threat to Goose Creek milkvetch.

    As a result of new information and analysis, the originally identified threats in our previous 12-month finding are no longer considered current or foreseeable threats for the following reasons: (1) The population is stable, the species is persisting at all monitored sites despite disturbance events, and it is occupying its historical range; (2) the species occurs over 216 square miles (559 square kilometers), and currently has adequate representation, resiliency, and redundancy throughout its range; (3) the species appears resilient to the identified stressors based on our evaluation in the 2015 candidate assessment; (4) new monitoring information after recent wildfires indicates that Goose Creek milkvetch was not significantly affected by wildfire and wildfire management (post-wildfire emergency stabilization and restoration activities) as previous information indicated; and (5) expanded commitments in the 2015 BLM/FWS conservation agreement to survey for and annually treat leafy spurge within Goose Creek milkvetch habitat on BLM lands will be effective in controlling the future spread of this noxious weed, and will protect approximately 86 percent of the total known population and 93 percent of the total known habitat of Goose Creek milkvetch.

    Finding

    Based on our review of the best available scientific and commercial information pertaining to the five factors, we find that the current stressors acting on the species and its habitat are not of sufficient imminence, intensity, or magnitude to indicate that the Goose Creek milkvetch is warranted for listing at this time. However, we did find the potential future threat from leafy spurge is of such a magnitude that listing Goose Creek milkvetch may be warranted. We evaluated the actions outlined in the 2015 conservation agreement with the BLM under PECE, and we found sufficient certainty of implementation and effectiveness of the actions such that the potential future threat of the habitat impacts due to the spread of leafy spurge will largely be ameliorated. Therefore, based on the best available information, we find that listing Goose Creek milkvetch is not warranted throughout its range. Because the distribution of the species is relatively stable across its range and stressors are similar throughout the species' range, we found no concentration of stressors that suggests that the Goose Creek milkvetch may be in danger of extinction in any portion of its range. Therefore, we find that listing the Goose Creek milkvetch as a threatened or an endangered species is not warranted throughout all or a significant portion of its range at this time, and consequently we are removing it from candidate status.

    Nevares Spring Naucorid Bug (Ambrysus Funebis) Previous Federal Actions

    On November 15, 1994, we added the Nevares Spring naucorid bug (Amargosa naucorid bug) to the candidate list as a category 2 species on the Candidate Notice of Review (CNOR) (59 FR 59012). Category 2 species were those species for which listing as endangered or threatened species was possibly appropriate, but for which biological information sufficient to support a proposed rule was lacking. However, the February 28, 1996, CNOR (61 FR 7596) discontinued recognition of category 1 and 2 species, so the Nevares Spring naucorid bug was no longer considered a candidate species after that date. On May 4, 2004 (69 FR 24880), we added the species to the candidate list with a listing priority number (LPN) of 5. In our November 21, 2012, CNOR (77 FR 69998), we changed the LPN from 5 to 2. In subsequent annual CNOR publications, we maintained our determination of LPN of 2 for this species.

    Summary of Status Review

    The Nevares Spring naucorid bug is an aquatic invertebrate found only within the Furnace Creek Springs (Nevares, Texas, and Travertine Springs) of Death Valley National Park, California, managed by the National Park Service (NPS). Based on both historical and recent surveys, this narrow endemic species is considered locally abundant where found, but otherwise uncommon in aquatic habitats within the Travertine and Nevares Spring complexes and in areas of the Furnace Creek Wash. The Furnace Creek Springs have been used as a water source (potable and non-potable water) since the 1800s, and the primary threat to the Nevares Spring naucorid bug at the time it was placed on the candidate list (2004) was loss of habitat due to diversion of water.

    Since then, the NPS has rebuilt the Furnace Creek water collection system and has implemented restoration actions within the range of the species. The combined post-pumping flow for affected springs is approximately 80 percent of the estimated pre-pumping flow. While this activity represents a negative factor within one of four of the Travertine Springs springbrooks, we have determined that this stressor is not of significant magnitude to affect the conservation status of the species. Flows from Nevares Springs (occupied by the bug) and Texas Spring (unknown occupation) have not been affected by the groundwater pumping and are not part of the Furnace Creek water collection system. The NPS has also eliminated water diversions and implemented aquatic habitat restoration at Travertine Spring 2, including restoration of its previously dry downstream springbrook. The results have augmented local groundwater, which has reemerged in aquatic habitat in portions of the spring area and downstream areas, including Furnace Creek Wash (occupied by the bug). Similar beneficial restoration actions are planned for other areas. While we believe that these future habitat restoration efforts could enhance the conservation status of the species by providing suitable habitat, these future actions are not factored into our determination.

    We also evaluated potential threats related to nonnative or invasive plants, predation, fire, and the effects of climate change. The impact to the species' habitat from nonnative or invasive plants is minor in scope and is currently being managed by the NPS. Predation is not currently a threat to the species and is not expected to be a threat in the near future. Fire has been a rare event within the Furnace Creek Springs area, and it is not expected to be a threat in the near future due to specific management actions being implemented by the NPS as required by the Death Valley National Park General Management Plan. Based on computer model projections (Fisk 2011, pp. 141-144), potential impacts to the species from the effects of climate change (i.e., changes to groundwater head and spring discharge for the Furnace Creek Springs) also are unlikely to be significant well into the 21st Century.

    Finding

    Based on our review of the best available scientific and commercial information pertaining to the five factors, we find that the stressors acting on the species and its habitat are not of sufficient imminence, intensity, or magnitude to indicate that the Nevares Spring naucorid bug is in danger of extinction (an endangered species), or likely to become endangered within the foreseeable future (a threatened species), throughout all of its range. This finding is based on the relatively stable population and distribution of the species, and the habitat restoration efforts and conservation management that have occurred throughout the species' range to minimize impacts to both the habitat and the species since the species was first identified as a candidate. Because the distribution of the species is narrow and stressors are similar throughout the entire species' range, we found no concentration of stressors that suggests that the Nevares Spring naucorid bug may be in danger of extinction in any portion of its range, or likely to become so in the foreseeable future. Therefore, we find that listing the Nevares Spring naucorid bug as a threatened species or an endangered species or maintaining the species as a candidate throughout all or a significant portion of its range is not warranted at this time, and consequently we are removing it from candidate status.

    Page Springsnail (Pyrgulopsis morrisoni) Previous Federal Actions

    The Service first identified the Page springsnail as a category 2 candidate species on January 6, 1989 (54 FR 554). Category 2 candidates were defined as species for which we had information that proposed listing was possibly appropriate, but conclusive data on biological vulnerability and threats were not available to support a proposed rule at the time. In the February 28, 1996, Candidate Notice of Review (CNOR) (61 FR 7596), we discontinued the designation of Category 2 species as candidates. Page springsnail became a candidate species (formerly known as Category 1 candidate) on February 28, 1996, with a listing priority number of 2 (61 FR 7596). The Page springsnail remained on the candidate list thereafter with no change in listing priority number. On April 12, 2002, we received a petition dated April 11, 2002, from the Center for Biological Diversity, requesting emergency listing and designation of critical habitat for the Page springsnail. We acknowledged receipt of the petition in a letter dated August 8, 2002. In that letter we stated the Service's policy to treat petitions on candidate species as second petitions, and that we consider all candidates as having been subject to both a positive 90-day finding and a warranted-but-precluded 12-month finding under section 4(b)(3)(B)(iii) of the Act. As such we did not make a separate 90-day or 12-month finding in response to the petition.

    In 2011, the Service entered into two settlement agreements regarding species on the candidate list at that time (Endangered Species Act Section 4 Deadline Litigation, No. 10-377 (EGS), MDL Docket No. 2165 (D.D.C. May 10, 2011)). This finding fulfills our obligations regarding the Page springsnail under those settlement agreements.

    Summary of Status Review

    The Page springsnail is a small aquatic snail endemic to 10 populations in a complex of springs along Oak Creek and Spring Creek in Yavapai County, central Arizona. Like other members of the family Hydrobiidae, Page springsnails are strictly aquatic and often occur in abundance within suitable spring habitats. The Page springsnail occurs in springs, seeps, marshes, cienegas, spring brooks, spring pools, outflows, and diverse lotic (flowing) waters, supported by water discharged from a regional aquifer. Eight of the 10 known populations occur on land managed by Arizona Game and Fish Department (AGFD) as a fish hatchery.

    The Page springsnail became a candidate species primarily due to habitat modifications at the springhead and spring run that resulted in changes to the habitat factors listed above, resulting in the extirpation of two populations. Subsequently, AGFD implemented a Candidate Conservation Agreement with Assurances that includes conservation measures that have resulted in the majority of Page springsnail populations being secure from spring modification, aquatic vegetation removal, and water contamination in the future. These management actions include coordinating with the Service and considering the needs of the Page springsnail when conducting aquatic vegetation control, management of nonnative fishes, chemical use, and addition of material into springs. AGFD has also restored much of the spring habitat on their lands; restoration activities include modifying springs, adding substrate preferred by springsnails, and eradicating nonnative species.

    The Page springsnail needs multiple resilient populations distributed across its range to maintain viability into the future and to avoid extinction. In general, the more Page springsnail populations that occur across its range, the higher the viability of the species and the lower the risk of extinction. A number of factors influence whether Page springsnail populations will maximize habitat occupancy, which increases the resiliency of a population to stochastic events. These factors include (1) adequate spring discharge (water quantity), (2) sufficient water quality, (3) free-flowing spring ecosystems, and (4) appropriate substrate and aquatic vegetation within the springs.

    In the future, the primary source of potential habitat loss is groundwater depletion, which may result in reduced or eliminated spring flow. We are relatively certain that climate change and increased water consumption from increased human population levels in the Verde Valley will result in lowered groundwater levels. Though we are not certain of the specific relationship between base flow and spring discharge, it is likely that declines in groundwater levels in the Verde Valley subbasin and base flow in the Verde River will translate to some decline in spring flow. We therefore anticipate that the effect of groundwater declines on future levels of spring discharge is the primary factor influencing the future condition of the Page springsnail.

    Finding

    Our review found that there are currently 10 existing Page springsnail populations, occurring in approximately the same geographic range that the species was known to occupy historically. To assess the current status of these populations, we grouped each of them into three categories of resiliency, which were based on spring flow rate, water quality, free-flowing spring runs, and vegetation and substrate quality. We categorized six populations as currently having high resiliency, three as currently having moderate resiliency, and one as currently having low resiliency. The best available data suggests that populations in high or moderate condition will be resilient populations at low risk of extirpation. In total, nine of the populations rank as high or moderate for the combined evaluation of the elements needed to maintain the species (water flow rate, water quality, free flowing, and aquatic vegetation and substrate). This current number of populations in high or moderate condition existing across the species' range provides resiliency (90 percent of populations considered sufficiently large to withstand stochastic events), redundancy (the populations exist across the historical range, although that range is inherently small, to withstand catastrophic events), and representation (multiple populations continuing to occur across the range of the species to maintain ecological and genetic diversity). Because this estimate of the condition and distribution of populations provides sufficient resiliency, representation, and redundancy for the species, we conclude that the current risk of extinction of the Page springsnail is sufficiently low that it does not meet the definition of an endangered species under the Act.

    Looking into the foreseeable future, and considering that spring flows could decline somewhat by 2065, we forecasted that two populations would continue to have high resiliency, four would have moderate resiliency, and four would have low resiliency (Service 2015, p. 33). The best available data suggests that populations in high or moderate condition will be resilient populations at low risk of extirpation. This forecasted number of populations in good condition existing across the species' range would provide resiliency (60 percent of populations considered sufficiently large to withstand stochastic events), redundancy (the populations would exist across the historical range, although that range is inherently small, to withstand catastrophic events), and representation (multiple populations would continue to occur across the range of the species to maintain ecological and genetic diversity). Therefore, because this forecast of the number and distribution of populations under the spring flow scenario that we expect to occur provides sufficient resiliency, redundancy, and representation for the species, we conclude the species is likely to remain at a sufficiently low risk of extinction that it will not become in danger of extinction in the foreseeable future. Therefore, we find that the Page springsnail does not meet the definition of a threatened species under the Act.

    Having found that the Page springsnail is not an endangered species or a threatened species throughout all of its range, we next consider whether there are any significant portions of its range in which the Page springsnail is in danger of extinction or likely to become so. We found no portions of its range where potential threats are significantly concentrated or substantially greater than in other portions of its range. Therefore, we find that factors affecting the species are essentially uniform throughout its range, indicating that no portion of the range of the Page springsnail warrants further consideration of possible endangered species or threatened species status under the Act.

    In conclusion, because the number and distribution of Page springsnail populations provides sufficient resiliency, redundancy, and representation for the species now and in the foreseeable future, we find that the Page springsnail no longer warrants listing throughout all or a significant portion of its range, and consequently we are removing it from candidate status.

    Ramshaw Meadows Sand-Verbena (Abronia alpina) Previous Federal Actions

    The Act directed the Secretary of the Smithsonian Institution to prepare a report on endangered and threatened plant species, which was published as House Document No. 94-51. We published a notice in the Federal Register on July 1, 1975 (40 FR 27823), in which we announced that we would review more than 3,000 native plant species named in the Smithsonian's report and other species added by the 1975 notice for possible addition to the List of Endangered and Threatened Plants. Ramshaw Meadows sand-verbena was one of those species. In the February 21, 1990, Candidate Notice of Review (CNOR) (55 FR 6186), we identified the species as a category 1 candidate species. In the February 28, 1996, CNOR, we retained the species as a candidate and assigned it a listing priority number (LPN) of 8 (61 FR 7602). In the September 19, 1997, CNOR (62 FR 49404), we changed the LPN to 11. On May 11, 2004, we received a petition dated May 4, 2004, from the Center for Biological Diversity et al. requesting the listing of the Ramshaw Meadows sand-verbena as a threatened species with critical habitat. In subsequent annual CNOR publications, we maintained our determination of LPN of 11 for this species.

    Summary of Status Review

    Abronia alpina is a small perennial herb 1 to 6 inches across forming compact mats with lavender pink, trumpet-shaped, and generally fragrant flowers. The species is known from one main population center at Ramshaw Meadow and a smaller population at the adjacent Templeton Meadow on the Kern River Plateau (8,700-feet elevation) in the Sierra Nevada Mountains, California. The entire range of the species is approximately 15 acres (6.1 hectares) and is administered by the U.S. Forest Service (USFS) (Inyo National Forest, Tulare County, California). The species' population fluctuates from year to year without any clear trends with estimates ranging from approximately 150,000 to 50,000 plants (based on USFS survey results 1985-2012). Abronia alpina is currently categorized by the USFS as a “Sensitive Species” under the 1988 Land and Resource Management Plan (LRMP), but is proposed to be categorized as an “At-Risk Species” under the revised LRMP currently being developed.

    Threats to Abronia alpina and its habitat identified at the time it was determined to be a candidate species included cattle trailing, trampling by campers and packstock, deteriorated watershed conditions, and potential bank cutting of habitat. In response, the USFS has implemented a number of conservation measures that have been effective in reducing these adverse effects, including developing a livestock trailing strategy; exclosure fencing; establishing a monitoring program; discontinuing livestock grazing for a 10-year period (2001-2011); rerouting hiking and packstock trails; and conducting land exchanges of private land so that all A. alpina habitat is on Federal land.

    The stressors currently acting upon Abronia alpina and its habitat include lodgepole pine encroachment; potential bank cutting of habitat; the effects of climate change; recreation (camping, packstock); and cattle trailing within meadow habitats. Past conservation actions by the U.S. Forest Service have reduced or eliminated the effects of most of these stressors on A. alpina and its habitat. In addition, the Inyo National Forest and U.S. Fish and Wildlife Service have developed and signed a conservation agreement to evaluate current stressors for A. alpina and update conservation actions that will be implemented by the Inyo National Forest to continue to protect and manage A. alpina and its habitat (Conservation Agreement and Species Management Guide for Abronia alpina (Ramshaw abronia) Tulare County, California, Dated: April 2015). The conservation agreement addresses ongoing management needs of A. alpina and its habitat, including management or monitoring of past and present stressors that have been identified. The past and current conservation actions and protection provided by the Inyo National Forest have been demonstrated to reduce and ameliorate the effect of stressors acting upon the species, and we anticipate those completed actions to have lasting, positive effects into the near future. While we are not basing our finding on the February 2015 conservation agreement, we anticipate that conservation measures and protections outlined in the Conservation Agreement will continue to build on the success that past actions have had and will continue to benefit Abronia alpina into the future.

    Finding

    Based on our review of the best available scientific and commercial information pertaining to the five factors, we find that the stressors acting on the species and its habitat are not of sufficient imminence, intensity, or magnitude to indicate that Abronia alpina is in danger of extinction (an endangered species), or likely to become endangered within the foreseeable future (a threatened species), throughout all of its range. This finding is based on the past conservation actions and protections provided by the Inyo National Forest that have shown success in reduction and amelioration of the effect of stressors acting upon the species and its habitat. We found no concentration of stressors that suggests that the Abronia alpina may be in danger of extinction in any portion of its range. Therefore, we find that listing A. alpina as a threatened or an endangered species throughout all or a significant portion of its range or maintaining the species as a candidate is not warranted at this time, and we are removing it from candidate status.

    Sequatchie Caddisfly (Glyphopsyche sequatchie) Previous Federal Actions

    The Sequatchie caddisfly was first identified as a candidate for protection under the Act through our internal process in the October 25, 1999, Candidate Notice of Review published in the Federal Register (64 FR 57534), and the Service was subsequently petitioned on May 11, 2004, to list the species although no new information was provided with the petition. Threats to the species identified at that time were siltation; agricultural, chemical, and municipal runoff; vandalism; pollution from trash; and small population size. The Sequatchie caddisfly was assigned a listing priority number (LPN) of 5 (64 FR 57534), and that LPN was maintained until evaluation for listing this year.

    Summary of Status Review

    The Sequatchie caddisfly (Glyphopsyche sequatchie) was discovered in 1994 and first described by Etnier and Hix (1999, entire). This species is a member of the insect order Trichoptera, family Limnephilidae, subfamily Limnephilinae, and tribe Chilostigmini (Wiggins 1996, pp. 270, 310).

    Despite extensive efforts to find additional sites (Moulton and Floyd, 2013, entire), the Sequatchie caddisfly has been observed at only three spring runs in the Sequatchie Valley, all in Marion County, Tennessee: Owen Spring Branch (the type locality); Martin Spring run in the Battle Creek system, and Clear Spring Branch (Etnier and Hix 1999, pp. 629-630; Walton 2011, pers. comm.). In July 2014, biologists with the Service, the Tennessee Department of Environment and Conservation (TDEC), the University of Tennessee, and the Tennessee Wildlife Resources Agency completed quantitative surveys within a 20-meter (66-foot) reach at both the Owen Spring Branch and Martin Spring sites. During the Owen Spring Branch survey, a total of 269 Sequatchie caddisflies were observed within 29 0.25-square-meter (2.7-square-foot) quadrats (USFWS, unpublished data).

    Using these data, we estimated the population size at 5,192-6,273 individuals (95% confidence interval) within the 20-meter (66-foot) sampling reach. Considering the amount of occupied habitat within Owen Spring Branch (approximately 280 meters (919 feet)), we extrapolated that the population size at Owen Spring exceeds 50,000 caddisflies. During the Martin Spring surveys, a total of 260 Sequatchie caddisflies were observed within 30 0.25-square-meter (2.7-square-foot) quadrats (USFWS, unpublished data). Using these data, we estimated the population size at 6,546-10,593 individuals (95% confidence interval) within the 20-meter (66-foot) sampling reach. Considering the amount of occupied habitat within Martin Spring (approximately 660 meters (2,165 feet)), we extrapolated that the population size at Martin Spring exceeds 100,000 caddisflies. Both the Owen Spring Branch and Martin Spring estimates are much larger than previous estimates, which were 1,500 to 3,000 individuals at Owen Spring Branch and characterized as “very rare,” with only 6 individuals found at Martin Spring (Moulton and Floyd (2013, pp. 8-9)). In 2010, a single larva was collected at Clear Spring Branch during routine water quality monitoring by TDEC (Walton 2011, pers. comm.). In subsequent surveys, no individuals were observed at the Clear Spring Branch site (Moulton and Floyd 2013, p. 8; USFWS, unpublished data). It is unclear whether the larva collected in 2010 was the result of a dispersal event or of a population that occurred at very low levels, and the site is now considered unoccupied by the species. Sedimentation, beaver activity, mowing/clearing, trampling/public access, and possibly watershed disturbance are all stressors to habitat (Factor A). All of these stressors occur at both the Owen Spring Branch and Martin Spring sites, except for beaver activity, which is only found at Owen Spring Branch. However, these stressors are largely abated by management practices that have been in place for over 3 years, such as beaver and erosion control measures currently being undertaken by TDEC and other partners. Nevertheless, our not-warranted finding is not based on the implementation of these voluntary efforts.

    Finding

    The Sequatchie caddisfly is found at only two sites in Marion County, Tennessee. However, population sizes are now estimated to be substantially larger than previously thought, and the best available information does not indicate any evidence of declines or inbreeding depression in either of the known populations at this time. Based on our review of the best available scientific and commercial information pertaining to the five factors, we find that there are no stressors of sufficient imminence, intensity, or magnitude to indicate that the Sequatchie caddisfly is in danger of extinction (an endangered species), or likely to become so within the foreseeable future (a threatened species), throughout all of its range.

    We consider the range of the Sequatchie caddisfly to include Martin Spring and Owen Spring in the Sequatchie Valley of Tennessee. We evaluated the current range of Sequatchie caddisfly to determine if there is any apparent geographic concentration of potential threats for this species. We examined potential threats from range curtailment, sedimentation, beaver activity, mowing/clearing, trampling/public access, watershed disturbance, collection, disease, predation by introduced rainbow trout, the inadequacy of existing regulatory mechanisms, and small population size effects and found no concentration that suggests that the Sequatchie caddisfly may be in danger of extinction in a portion of its range. While there is a higher level of trampling and public access at Owen Spring Branch, the best available data do not indicate that this stressor rises to the level of a threat to the species at this site, such that this portion meets the definition of an endangered or a threatened species. Furthermore, we found no other portions of the range where potential threats are significantly concentrated or substantially greater than in other portions of its range. Therefore, we find that the factors affecting Sequatchie caddisfly are essentially uniform throughout its range, indicating no portion of the range warrants further consideration of possible endangered species or threatened species status under the Act.

    Our review of the best available scientific and commercial information indicates that the Sequatchie caddisfly is not in danger of extinction (an endangered species) and is not likely to become an endangered species within the foreseeable future (a threatened species), throughout all or a significant portion of its range. Therefore, we find that listing Sequatchie caddisfly as an endangered or a threatened species under the Act is not warranted at this time, and we are removing it from candidate status.

    Siskiyou Mariposa Lily (Calochortus persistens) Previous Federal Actions

    The Act directed the Secretary of the Smithsonian Institution to prepare a report on endangered and threatened plant species, which was published as House Document No. 94-51. We published a notice in the Federal Register on July 1, 1975 (40 FR 27823), in which we announced that we would review more than 3,000 native plant species named in the Smithsonian's report and other species added by the 1975 notice for possible addition to the List of Endangered and Threatened Plants. Siskiyou mariposa lily was one of those species. In the February 21, 1990, Candidate Notice of Review (CNOR) (55 FR 6192), we first identified the species as a category 2 candidate. However, the February 28, 1996, CNOR (61 FR 7596) discontinued recognition of category 1 and 2 species, so Siskiyou mariposa lily was no longer considered candidate species after that date. On September 10, 2001, we received a petition dated August 24, 2001, from Klamath-Siskiyou Wildlands Center, Oregon Natural Resources Council, and Barbara Knapp requesting that the Siskiyou mariposa lily be listed as an endangered species under the Act and that critical habitat be designated. In the June 13, 2002, CNOR (67 FR 40662), we once again added the species as a candidate with a listing priority number (LPN) of 2. In the May 11, 2005, CNOR, we changed the LPN to 5 (70 FR 24932). In subsequent annual CNOR publications, we maintained our determination of LPN of 5 for this species.

    Summary of Status Review

    Calochortus persistens is a perennial flowering bulb with one to two large showy, pink to lavender, erect, bell-shaped flowers with yellow fringes. Calochortus persistens is restricted to three disjunct areas in the Klamath-Siskiyou Mountain Range at elevations of 4,300 feet (ft) to 6,000 ft, on the California-Oregon border (Gunsight-Humbug Ridge and Cottonwood Peak Area, west of Yreka, Siskiyou County, California (two locations), and Bald Mountain site, west of Ashland, Jackson County, Oregon). Land ownership for the three sites is a combination of U.S. Forest Service (USFS), Bureau of Land Management (BLM), and private lands. Population numbers for the species varies by location and numbers from 5 to 100,000 plants. Past numbers of Calochortus persistens plants in each area may have been underestimated depending on survey timing.

    Between 1982 and 2013, numerous conservation initiatives and management plans have been developed to conserve Calochortus persistens. The most recent is the “Conservation Agreement between the U.S. Fish and Wildlife Service and the U.S. Forest Service and U.S. Bureau of Land Management for Calochortus persistens (Siskiyou mariposa lily)” (Calochortus persistens Conservation Agreement) that was finalized and approved on November 19, 2013. The conservation agreement identifies completed, ongoing, and future actions to remove or reduce the stressors to C. persistens across all occupied Federal lands. The USFS and BLM have also identified Calochortus persistens as a “Sensitive Species.” Based on the successful track record of managing the species as provided for with the conservation initiatives, including the 2013 conservation agreement, we conclude that management of the species will provide for diverse plant communities by maintaining viable populations of plants and for conservation of the species by ensuring continued existence of viable populations that will prevent a trend towards listing under the Act. The USFS has issued management guidelines for C. persistens and has designated 1,005 acres (407 hectares) as a Special Habitat Management Area for the species.

    The major stressor to Calochortus persistens habitat has been competition from the nonnative plant Isatis tinctoria (dyer's woad). Isatis tinctoria was reported to have spread throughout the Gunsight-Humbug Ridge and Cottonwood Peak occurrences to varying degrees. However, surveys have demonstrated that juvenile recruitment is evident and plants of all ages occur in each population. In 2003, the USFS initiated removal of I. tinctoria. In 2006, a second population of C. persistens was found at Cottonwood Peak consisting of more than 15,900 plants. This area does not contain any I. tinctoria. Because the existing occurrences for I. tinctoria are being managed, and some populations or occurrences within populations are not subject to the impacts from I. tinctoria, we have determined that the severity of the impacts from nonnative plants has been greatly decreased and is not resulting in significant impacts to C. persistens at the range wide or local population level at this time nor do we expect it to in the foreseeable future.

    Other stressors identified include fire and fire suppression activities, habitat disturbance activities, roads, off-highway vehicle use, grazing activities, collection, predation, low recruitment, and the species' relatively small, disjunct distribution. In our candidate assessment, we evaluated these stressors and determined that they are not resulting in significant population-level impacts to Calochortus persistens now nor are they likely to do so into the foreseeable future. Our finding is based partly on management activities and because evidence review of the best available data does not suggest that there is a decline in the C. persistens populations at any of the three locations.

    Finding

    Based on our review of the best available scientific and commercial information pertaining to the five factors, we find that the stressors acting on the species and its habitat are not of such imminence, intensity, or magnitude to indicate that Calochortus persistens is in danger of extinction (an endangered species), or likely to become endangered within the foreseeable future (a threatened species), throughout all of its range. We also found no portion of its range where the threats are significantly concentrated or substantially greater than in any other portion of its range. Therefore, we find that listing Calochortus persistens as a threatened or an endangered species or maintaining the species as a candidate is not warranted throughout all or a significant portion of its range at this time, and consequently we are removing it from candidate status.

    Shawnee Darter (Etheostoma tecumsehi) Previous Federal Action

    On April 20, 2010, we received, via email, a petition from the Center for Biological Diversity, Alabama Rivers Coalition, Clinch Coalition, Dogwood Alliance, Gulf Restoration Network, Tennessee Forests Council, West Virginia Highlands Conservancy, Tierra Curry, and Noah Curry, requesting to list 404 aquatic, riparian, and wetland species, including the Shawnee darter, as an endangered or a threatened species and to designate critical habitat concurrent with listing. We subsequently published a notice of a 90-day petition finding in the Federal Register (76 FR 59836; September 27, 2011), concluding that the petition to list the Shawnee darter, among other species, presented substantial scientific or commercial evidence that listing may be warranted.

    Summary of Status Review

    The Shawnee darter occurs within the Pond River system of the Green River in parts of four western Kentucky counties (Christian, Todd, Muhlenberg, and Hopkins). The species is broadly distributed across its range, inhabiting high-gradient headwater streams with abundant sand, gravel, and cobble riffles. Color characteristics of the females and non-breeding males of this species are similar to other members of the orangethroat darter group, and the largest specimens reach over 2 inches for males and up to 1.8 inches for females

    Destruction and modification of habitat have been identified as potential threats to the Shawnee darter. Streams within the Pond River system have been degraded by a variety of past and current activities such as dredging, channelization, impoundment, riparian zone removal and others. Much of the stream modification in the Pond River system occurred decades ago for agricultural and flood control purposes. While these manipulations occurred in the past, the habitat and water quality impacts persist, and siltation/sedimentation is considered a primary source of degradation within the Shawnee darter's range. While there are numerous dams across the range of the Shawnee darter, constructed mostly for flood control in the 1960s and 1970s, only eight occur between known species occurrences.

    Historical and ongoing land uses (e.g., agriculture, natural resource extraction, etc.) have also affected and continue to affect stream habitats as well as water quality. Residential and agricultural land uses may result in increases in nutrients (e.g., fecal coliforms) that can be detrimental to aquatic fauna, and the Shawnee darter is often absent from streams with high nutrient levels. However, these impacts do not appear to be widespread within the species' range. Coal mining historically occurred, to a limited extent, in the northernmost edge of the species' range but has not reduced the species' distribution or occurrences. While oil and gas extraction is widespread within the range, it does not appear to be causing any broad changes to stream habitat or water quality. Reviews of permitted activities (e.g., coal mining) and digital land use coverages over the years do not indicate any significant changes in land use; despite these historical and ongoing impacts, survey efforts in 2007 and 2013 indicate that the Shawnee darter is maintaining its populations and remains one of the most abundant darter species in the streams where it occurs.

    Finding

    Based on our review of the best available scientific and commercial information pertaining to the five factors, we find that the stressors acting on the species and its habitat are not of such imminence, intensity, or magnitude to indicate that the Shawnee darter is in danger of extinction (an endangered species), or likely to become endangered within the foreseeable future (a threatened species), throughout all 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. Therefore, we find that listing the Shawnee darter as a threatened species or an endangered species throughout all or a significant portion of its range is not warranted at this time.

    Sleeping Ute Milkvetch (Astragalus tortipes) Previous Federal Actions

    Sleeping Ute milkvetch became a candidate species in the Candidate Notice of Review (CNOR) of 1996, with a listing priority number (LPN) of 11, after approximately 3 percent of the species' range was disturbed during construction of an irrigation canal (61 FR 7596; February 28, 1996). Between 1997 and 2006, the LPN was changed various times, and ultimately returned to LPN 11, because the threats were considered non-imminent (62 FR 49398, September 19, 1997; 66 FR 54808, October 30, 2001; 71 FR 53756, September 12, 2006). We received a petition in 2004 from the Center for Biological Diversity and others to list 225 species, including Sleeping Ute milkvetch. We reported in the 2005 CNOR that the petition contained no new information regarding Sleeping Ute milkvetch, and maintained it as a candidate (60 FR 24870, May 11, 2005). The species was maintained as a candidate with LPN 11 through the 2014 CNOR (79 FR 72450, December 5, 2014).

    Summary of Status Review

    Sleeping Ute milkvetch is a perennial plant that grows only on the Smokey Hills layer of the Mancos Shale Formation on Ute Mountain Ute Tribal land in Montezuma County, Colorado. Very few formal surveys have been done for Sleeping Ute milkvetch, so we have no information on long-term population trends. However, surveys in 2000 indicated the presence of 3,744 plants at 24 locations covering 500 acres (202 hectares) within an overall range of 6,400 acres (2,590). The Tribe received a grant in 2015 that enabled them to document the current status of the species. The 2015 plant surveys and impact assessment report show that the population has increased to 14,929 individual plants that were counted, plus an additional 5,000 that were estimated to occur within the same range.

    We evaluated all known potential impacts to the plant, including impacts from the Towaoc Highline Canal construction, rifle range use, off-highway vehicles (OHVs), cattle grazing, and a prairie dog colony. While these impacts were previously believed to pose a threat to the species, and some may have caused losses of individual plants or habitat in the past, we received updated information from the Tribe that has improved our understanding of how these factors currently affect the species. For example, there are currently no plans for oil and gas development within the plant's habitat. The design and operation of the canal has not opened the area to increased vehicle use and associated ground disturbance as previously anticipated; the entire length of the canal and its maintenance roads are fenced; and access points from roads are gated and locked. The presence of a rifle range has introduced OHV use and outdoor recreation that has negatively affected individual plants and habitat, but these effects have been limited to one location, while the majority of populations remain unaffected. The Tribe has taken significant steps to reduce the impact of feral livestock, removing more than 400 head of feral livestock in 2013 and 2014, leaving only around 50 head remaining. Herbivory was reported, but the effects on reproduction were not determined.

    Overall, current information indicates an increase in abundance from past surveys; that most stressors are speculative and any actual impacts have been at the individual, not population or species level; and that no impacts individually or cumulatively rise to the level of a threat so significant that it contributes to putting the species in danger of extinction or likely to become so in the foreseeable future. In addition, the Tribe believes that the health and existence of the species is in part due to its location on Tribal land, where all activities are controlled by the Tribe and no public access is allowed without permission.

    Finding

    Based on our review of the best available scientific and commercial information pertaining to the five factors, we find that the stressors acting on the species and its habitat are not of such imminence, intensity, or magnitude to indicate that Sleeping Ute milkvetch is in danger of extinction (an endangered species), or likely to become endangered within the foreseeable future (a threatened species), throughout all 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. Therefore, we find that listing Sleeping Ute milkvetch as a threatened species or an endangered species is not warranted throughout all or a significant portion of its range at this time, and we have removed it from candidate status.

    Southern Idaho Ground Squirrel (Urocitellus Endemicus) Previous Federal Actions

    The southern Idaho ground squirrel was recognized as a Category 2 candidate species in the 1985 Candidate Notice of Review (CNOR) (50 FR 37958; September 18, 1985). Category 2 species were those species for which listing as an endangered species or as a threatened species was possibly appropriate, but for which biological information sufficient to support a proposed rule was lacking. However, the February 28, 1996, CNOR (61 FR 7596) discontinued recognition of category 1 and 2 species, so the southern Idaho ground squirrel was no longer considered a candidate species after that date.

    On January 29, 2001, we received a petition dated January 26, 2001, from Biodiversity Legal Foundation, requesting that the southern Idaho ground squirrel, at the time classified taxonomically as a subspecies, be listed as an endangered or a threatened species under the Act and that critical habitat be designated. Included in the petition was supporting information regarding the species' taxonomy, historical and current distribution, habitat, life history, present status, and threats to the species. We acknowledged the receipt of the petition in a letter to the Biodiversity Legal Foundation, dated February 26, 2001. In that letter we also stated that due to court orders and judicially approved settlement agreements for other listing and critical habitat determinations under the Act that required nearly all of our listing and critical habitat funding for fiscal year (FY) 2001, we would not be able to address the petition further at that time but would complete the action in FY 2002. We also stated that an initial review of the petition did not indicate that an emergency listing was warranted.

    In the October 30, 2001, CNOR (66 FR 54808), we again identified the southern Idaho ground squirrel as a candidate for listing and assigned it a listing priority number (LPN) of 3, which reflects a subspecies facing threats of a high magnitude that are considered imminent.

    On May 4, 2004, we continued to identify the southern Idaho ground squirrel as a candidate for listing in the CNOR (69 FR 24876), but we changed the LPN to 6, which reflects a subspecies facing threats of a high magnitude that are not considered imminent. This change was the result of conservation actions that had been implemented and that had reduced the imminence of threats, along with commitments from various agencies and parties to initiate and implement conservation actions for the squirrel. We acknowledged in this CNOR that although the magnitude of threats was still high, it was trending toward a moderate-to-low range.

    On June 21, 2004, the U.S. District court for the District of Oregon (Center for Biological Diversity v. Norton, Civ. No. 03-1111-AA) found that our resubmitted petition findings for three species, including the southern Idaho ground squirrel, that we published as part of the CNOR on May 4, 2004 (69 FR 24876), were not sufficient because we did not provide adequate information to support our warranted but precluded determinations. The court ordered that we publish updated findings. On December 27, 2004, in response to the court's order, we published a 12-month finding (69 FR 77167) on resubmitted petitions to list the three species. In response to ongoing conservation actions, we also changed the LPN to 9, which reflects a subspecies facing threats of a moderate to low magnitude that are considered imminent.

    On November 22, 2013, we continued to identify the southern Idaho ground squirrel as a candidate for listing in the CNOR (78 FR 70104), but changed the LPN to 8 to reflect a change in taxonomy from subspecies to species. The most recent CNOR dated December 5, 2014 (79 FR 72450), continued to reflect the species' status as a candidate species with an LPN of 8.

    Summary of Status Review

    The southern Idaho ground squirrel is endemic to four counties in southwest Idaho; its total known range is approximately 718,318 acres (290,693 hectares). Threats to southern Idaho ground squirrels identified in the January 26, 2001, listing petition include: Habitat degradation from invasive exotic annual vegetation and future loss of habitat from urban development; direct killing from shooting, trapping, or poisoning; competition with Columbian ground squirrels; inadequacy of existing regulatory mechanisms; and low population numbers.

    Habitat across the range of the southern Idaho ground squirrel is degraded from nonnative vegetation, primarily by nonnative annuals such as Bromus tectorum (cheatgrass) and Taeniatherum caput-medusae (medusahead). Nonnative annuals provide inconsistent forage quality for southern Idaho ground squirrels compared to native vegetation. Although their habitat is degraded, squirrels have been at a peak in their population cycle for the past several years and are well distributed throughout most of their historical range, which has led to an increase in gene flow among populations. Additionally, based on a Geographic Information Systems analysis, we found that the fire-return interval of 80 years has not changed and falls within the range of historical levels.

    The 2001 listing petition cited rapid urban development as a threat to southern Idaho ground squirrels; however, very little urban development has occurred in the range of the squirrel in the past 14 years. Although urban development will likely occur in the future, we are not aware of any large-scale development plans at this time.

    Recreational shooting and other direct killing of southern Idaho ground squirrels is being regulated and monitored. Authorized control actions and trapping/translocation efforts in areas where local abundance is high results in a temporary decrease of the local population, but not the extermination of the population. Competition with Columbian ground squirrels does not result in a substantial impact to the species due to limited overlap in their distributions. Climate change models predict increased temperatures that could have both positive and possibly negative effects on squirrels, and we do not have enough information at this time to determine what the actual impact, if any, will be on this species, although we note there is evidence that southern Idaho ground squirrels may be phenotypically plastic, similar to other species, which should enable them to adapt more readily to a changing climate through changes such as earlier emergence from their burrows.

    A programmatic Candidate Conservation Agreement with Assurances (CCAA) was completed for this species in 2005 and contains conservation measures that minimize ground-disturbing activities, allow for the investigation of methods to restore currently degraded habitat, provide for additional protection to southern Idaho ground squirrels from recreational shooting and other direct killing on enrolled lands, and allow for the translocation of squirrels to or from enrolled lands, if necessary. The acreage enrolled through the programmatic CCAA encompasses approximately 9 percent of the known range of the species. A more recent CCAA is expected to be completed by the fall of 2015.

    Therefore, despite changes in habitat conditions and localized stressors (agricultural control, competition), squirrels continue to persist throughout the majority of their historical range and populations appear stable. Although we recognize that current conditions do not provide ideal habitat for the species, we anticipate that southern Idaho ground squirrels will continue to demonstrate resilience and persist in these degraded habitat conditions in the future.

    Finding

    Based on our review of the best available scientific and commercial information pertaining to the five factors, we find that the stressors acting on the species and its habitat are not of such imminence, intensity, or magnitude to indicate that the southern Idaho ground squirrel is in danger of extinction (an endangered species), or likely to become endangered within the foreseeable future (a threatened species), throughout all 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. Therefore, we find that listing the southern Idaho ground squirrel as a threatened species or an endangered species is not warranted throughout all or a significant portion of its range at this time, and we have removed it from candidate status.

    Tahoe Yellow Cress (Rorippa Subumbellata) Previous Federal Actions

    The Act directed the Secretary of the Smithsonian Institution to prepare a report on endangered and threatened plant species, which was published as House Document No. 94-51. We published a notice in the Federal Register on July 1, 1975 (40 FR 27823), in which we announced that we would review more than 3,000 native plant species named in the Smithsonian's report and other species added by the 1975 notice for possible addition to the List of Endangered and Threatened Plants. Tahoe yellow cress was one of those species. In the September 27, 1985, Candidate Notice of Review (CNOR) (50 FR 39526; supplementary information page 18), Tahoe yellow cress was added to the candidate list as a category 3C species. Category 3C species were those species that were proven to be more abundant or widespread than previously believed or those that are not subject to identifiable threats. In the September 30, 1993, CNOR (58 FR 51184), we changed the candidate status to category 1: Category 2 species were those species for which listing as endangered or threatened species was possibly appropriate, but for which biological information sufficient to support a proposed rule was lacking In the February 28, 1996, CNOR (61 FR 7612), we no longer recognized category 1 and 2 species as candidates and, therefore, most of those species, including Tahoe yellow cress, were removed from candidate status.

    On December 27, 2000, we received a petition from the Southwest Center for Biological Diversity requesting the Tahoe yellow cress be listed as an endangered species with critical habitat. On December 27, 2004 (69 FR 77167), we published a notice of resubmitted petition findings including the Tahoe yellow cress. In that document, we announced the change of LPN from 2 to 8. In subsequent annual CNOR publications, we maintained our determination of LPN of 8 for this species.

    Summary of Status Review

    Tahoe yellow cress is a member of the mustard family (Brassicaceae) known only from the shores of Lake Tahoe in California and Nevada. The species is a low-growing, herbaceous perennial with yellow flowers. Flowering and fruiting occurs between late May and late October.

    Tahoe yellow cress is well adapted to its dynamic shorezone environment and is capable of recolonizing sites after periods of inundation. This ability is evident by the demonstrated natural fluctuations in the number of Tahoe yellow cress that coincide with lake elevation and available habitat. Since 2001, the population numbers (number of stems) have ranged from a low of approximately 4,500 stems in 2006 (high lake level year (1,898-meter (m) elevation)) to more than 30,000 stems in 2014 (low lake level (1,897 m)). At this time, the most significant stressor to Tahoe yellow cress and its habitat is recreational activities on public beaches and adjacent habitat around the shore of Lake Tahoe; however, impacts from this stressor are being addressed by ongoing management actions that include fencing, signage, and adherence to beach-raking guidelines on public lands. Beach raking on private lands remains a concern, because guidelines are voluntary and cannot be enforced. However, this stressor is not of such magnitude as to present a population-level risk to the species. Impacts from shorezone development are being effectively managed by ongoing and effective implementation of applicable shorezone ordinances.

    Since 1999, the Adaptive Management Working Group has developed and implemented conservation actions for Tahoe yellow cress. A conservation strategy coupled with a memorandum of understanding/conservation agreement (MOU/CA) between numerous Federal, State, and local agencies and environmental organizations has been implemented to address the stressor to Tahoe yellow cress. The MOU/CA was again signed in 2013 for a period of 10 years, and an updated conservation strategy is expected in 2015. An annual monitoring plan is in place, and propagation, transplanting, and translocation strategies have been examined and successfully initiated. Based on the successful track record of numerous parties implementing these conservation actions together, we conclude that ongoing implementation of those actions is managing and avoiding or mitigating identified impacts.

    Finding

    Based on our review of the best available scientific and commercial information pertaining to the five factors, we find that the stressors acting on the species and its habitat are not of sufficient imminence, intensity, or magnitude to indicate that Tahoe yellow cress is in danger of extinction (an endangered species), or likely to become endangered within the foreseeable future (a threatened species), throughout all of its range. Because the distribution of the species is limited to the shoreline areas of Lake Tahoe and stressors are similar throughout the species' range, we found no concentration of stressors that suggests that Tahoe yellow cress may be in danger of extinction in any portion of its range. Therefore, we find that listing Tahoe yellow cress as a threatened species or as an endangered species throughout all of or a significant portion of its range is not warranted at this time, and consequently we are removing it from candidate status.

    6 Tennessee Cave Beetles: Baker Station (=Insular) Cave Beetle (Pseudanophthalmus Insularis); Coleman Cave Beetle (Pseudanophthalmus Colemanensis); Fowler's Cave Beetle (Pseudanophthalmus Fowlerae); Indian Grave Point (=Soothsayer) Cave Beetle (Pseudanophthalmus Tiresias); Inquirer Cave Beetle (Pseudanophthalmus Inquisitor); and Noblett's Cave Beetle (Pseudanophthalmus Paulus) Previous Federal Actions

    The Service provided notification letters of status review for the Noblett's Cave beetle on June 22, 1990, and for the Fowler's Cave beetle, inquirer cave beetle, Baker Station Cave beetle, Noblett's Cave beetle, and Indian Grave Point Cave beetle on November 8, 1993. These letters were provided to species experts, representatives of resource agencies, and other interested parties to request information and comments regarding potential listing of the species as endangered species or threatened species.

    Fowler's Cave beetle, inquirer cave beetle, Baker Station Cave beetle, Noblett's Cave beetle, and Indian Grave Point Cave beetle were added to the Federal list of candidate species in the 1991 Candidate Notice of Review (CNOR) (56 FR 58804) as category 2 species. Category 2 species were those species for which listing as an endangered species or a threatened species was possibly appropriate, but for which biological information sufficient to support a proposed rule was lacking. The category 2 status of these five species was confirmed in 1994 (59 FR 58982). However, the February 28, 1996, CNOR (61 FR 7596) discontinued recognition of category 1 and 2 species, so the Fowler's Cave beetle, inquirer cave beetle, Baker Station Cave beetle, Noblett's Cave beetle, and Indian Grave Point Cave beetle were no longer considered candidate species after that date.

    The Service received a petition from the Center for Biological Diversity and others, dated May 4, 2004, to list as endangered species, 225 species, including the inquirer cave beetle, and to designate critical habitat for the species. The Service received another petition on May 11, 2004, to list eight cave beetles, including the inquirer cave beetle. The Service had already determined, in the October 30, 2001, CNOR that the inquirer cave beetle was a candidate for listing (66 FR 54808), and therefore, we did not need to issue a new 90-day or 12-month finding in response to the petition. The Coleman Cave beetle, Fowler's Cave beetle, Baker Station Cave beetle, Indian Grave Point Cave beetle, and Noblett's Cave beetle became candidates for listing in the May 4, 2004, CNOR (69 FR 24876).

    On April 20, 2010, the Center for Biological Diversity and others petitioned the Service to list as threatened or endangered 404 species, including the Coleman Cave beetle, and to designate critical habitat for those species. Because this species was already a candidate for listing, we were not required to issue a new 90-day or 12-month finding in response to the petition.

    Each of the six species addressed in this finding has been included by the Service in every CNOR since the petitions were received in 2004, as species for which listing is warranted but precluded by higher priority listing actions.

    The 2011 Multi-District Litigation (MDL) settlement agreement specified that the Service will systematically, over a period of 6 years, review and address the needs of 251 candidate species to determine if they should be added to the Federal Lists of Endangered and Threatened Wildlife and Plants. The six beetle species included in this finding were on that list of candidate species. This finding completes the Service's requirements under the MDL agreement with respect to these six beetle species.

    Summary of Status Review

    The six species are small (3 to 8 millimeters in length) predatory cave beetles that occupy moist habitats containing organic matter transported from sources outside the inhabited caves. Members of the Pseudanophthalmus genus vary in rarity from fairly widespread species that are found in many caves, to species that are extremely rare and commonly restricted to only one cave or, at most, two or three caves. The six beetles addressed by this finding are found entirely within Tennessee, and two of the species (i.e., inquirer cave beetle and Noblett's Cave beetle) are currently known from only one cave. Fowler's Cave beetle and Indian Grave Point Cave beetle are known to occur in two caves; Baker Station Cave beetle has been documented from three caves; and the Coleman Cave beetle is known from four caves and a possible fifth. Surveys conducted during a status update for the six cave beetles during the period 2013-2015 resulted in findings of three of the beetles that had not been seen in decades (i.e., Fowler's Cave beetle, Baker Station Cave beetle, and Noblett's Cave beetle). Although usually zero to three individuals of any of the six species are found during most surveys, 97 Coleman Cave beetles were also found during a 2013 site visit.

    Various populations of the six cave beetles were historically believed to have been subjected to stressors such as water quality impacts associated with a landfill, erosion due to construction, livestock operations, various aspects of human visitation of caves, and possible impacts to cave food webs resulting from interruption of organic energy inputs. The greatest potential stressors to the beetles appear recently to have been human trampling of beetles and their habitats, curtailing the input of organic materials to caves, excavation of cave habitats, and predation. However, actual impacts from these potential sources appear to be minimal. We have no information indicating that these stressors are adversely affecting the species at this time, either individually or cumulatively, at a level that warrants their listing under the Act.

    Abatement of stressors has been initiated for the Coleman Cave beetle, Fowler's Cave beetle, and inquirer cave beetle through development of cooperative management agreements (CMAs) with private landowners and coordination between State property managers, nongovernmental organizations, and the Service. Implementation of CMAs is likely resulting in reduction of the impacts of potential stressors to these three beetles. However, our not-warranted finding is not based on the implementation of these voluntary efforts. For the Baker Station Cave beetle, Indian Grave Point Cave beetle, and Noblett's Cave beetle, the stressors appear minimal.

    There has been a perception since the 1960s that population trends of the six beetles could possibly be decreasing, but that perception is likely due in part to the low level of survey effort expended for these species and difficulty in collecting them. The recent evidence of continued persistence of these species, in conjunction with the lack of evidence that stressors are negatively affecting these cave beetles, lead us to conclude that these species are more stable than previously thought.

    Finding

    Based on our review of the best available scientific and commercial information pertaining to the five factors, we find that the stressors acting on the species and its habitat are not of sufficient imminence, intensity, or magnitude to conclude that the Coleman Cave beetle, Fowler's Cave beetle, inquirer cave beetle, Baker Station Cave beetle, Indian Grave Point Cave beetle, or Noblett's Cave beetle are in danger of extinction (endangered species), or likely to become endangered within the foreseeable future (threatened species), throughout all of their respective ranges. We evaluated the current range of the six beetles to determine if there is any apparent geographic concentration of stressors for any of the species. The six beetles have relatively small ranges that are limited to the local cave systems where they are currently found. We examined potential stressors including human visitation, livestock grazing, commercial and residential development, disease, predation, and sources of water quality impairment. We found no concentration of stressors that suggests that any of these six species of cave beetles may be in danger of extinction in a portion of their respective ranges. Therefore, we find that listing the Coleman Cave beetle, Fowler's Cave beetle, inquirer cave beetle, Baker Station Cave beetle, Indian Grave Point Cave beetle, or Noblett's Cave beetle as threatened species or endangered species throughout all or a significant portion of their respective ranges is not warranted at this time, and consequently we are removing Coleman Cave beetle, Fowler's Cave beetle, inquirer cave beetle, Baker Station Cave beetle, Indian Grave Point Cave beetle, and Noblett's Cave beetle from candidate status.

    New Information

    We request that you submit any new information concerning the status of, or stressors to, the American eel, Cumberland arrow darter, the Great Basin distinct population segment of the Columbia spotted frog, Goose Creek milkvetch, Nevares spring bug, Page springsnail, Ramshaw meadows sand-verbena, Sequatchie caddisfly, Shawnee darter, Siskiyou mariposa lily, Sleeping ute milkvetch, Southern Idaho ground squirrel, Tahoe yellow cress, and six Tennessee cave beetles (Baker Station, Coleman, Fowler's, Indian Grave Point, inquirer, and Noblett's cave beetles) to the appropriate person, as specified under FOR FURTHER INFORMATION CONTACT, whenever it becomes available. New information will help us monitor these species and encourage their conservation. If an emergency situation develops for any of these species, we will act to provide immediate protection.

    References Cited

    Lists of the references cited in the petition findings are available on the Internet at http://www.regulations.gov and upon request from the appropriate person, as specified under FOR FURTHER INFORMATION CONTACT.

    Author(s)

    The primary author(s) of this notice are the staff members of the Branch of Listing, Ecological Services Program.

    Authority

    The authority for this section is section 4 of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).

    Dated: September 23, 2015. Gary Frazer, Acting Director, U.S. Fish and Wildlife Service.
    [FR Doc. 2015-25058 Filed 10-7-15; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-R1-ES-2014-0045; FXES11130900000C6-156-FF09E42000] RIN 1018-BA30 Endangered and Threatened Wildlife and Plants; Reclassifying the Columbian White-Tailed Deer From Endangered to Threatened With a Rule Under Section 4(d) of the Act AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Proposed rule.

    SUMMARY:

    Under the authority of the Endangered Species Act of 1973, as amended (Act), we, the U.S. Fish and Wildlife Service (Service), propose to reclassify the Columbia River distinct population segment (DPS) of Columbian white-tailed deer (Odocoileus virginianus leucurus) from endangered to threatened, and we propose a rule under section 4(d) of the Act to enhance conservation of the species through range expansion and management flexibility. This proposal is based on a thorough review of the best available scientific data, which indicate that the species' status has improved such that it is not currently in danger of extinction throughout all or a significant portion of its range. We seek information, data, and comments from the public regarding the Columbian white-tailed deer and this proposal.

    DATES:

    We will accept comments received or postmarked on or before December 7, 2015. Please note that if you are using the Federal eRulemaking Portal (see ADDRESSES), the deadline for submitting an electronic comment is 11:59 p.m. Eastern Time on this date. We must receive requests for public hearings, in writing, at the address shown in the FOR FURTHER INFORMATION CONTACT section by November 23, 2015.

    ADDRESSES:

    You may submit comments by one of the following methods:

    (1) Electronically: Go to the Federal eRulemaking Portal: http://www.regulations.gov. In the Search box, enter FWS-R1-ES-2014-0045, which is the docket number for this rulemaking. Then, in the Search panel on the left side of the screen, under the Document Type heading, click on the Proposed Rules link to locate this document. You may submit a comment by clicking on “Comment Now!” Please ensure that you have found the correct rulemaking before submitting your comment.

    (2) By hard copy: Submit by U.S. mail or hand-delivery to: Public Comments Processing, Attn: FWS-R1-ES-2014-0045; U.S. Fish and Wildlife Service, MS: BPHC, 5275 Leesburg Pike, Falls Church, VA 22041-3808.

    We request that you send comments only by the methods described above. We will post all comments on http://www.regulations.gov. This generally means that we will post any personal information you provide us (see the Information Requested section, below, for more information).

    Document availability: The proposed rule is available on http://www.regulations.gov. In addition, the supporting file for this proposed rule will be available for public inspection, by appointment, during normal business hours, at the Oregon Fish and Wildlife Office, 2600 SE 98th Avenue, Portland, OR 97266; telephone 503-231-6179. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Services (FIRS) at 800-877-8339.

    FOR FURTHER INFORMATION CONTACT:

    Paul Henson, State Supervisor, telephone: 503-231-6179. Direct all questions or requests for additional information to: Columbian White-tailed Deer Information Request, U.S. Fish and Wildlife Service, Oregon Fish and Wildlife Office, 2600 SE 98th Avenue, Portland, OR 97266. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION: Executive Summary

    Why we need to publish a rule. Under the Act, a species may warrant reclassification from endangered to threatened if it no longer meets the definition of endangered (in danger of extinction). The Columbia River DPS of Columbian white-tailed deer (CWTD) is listed as endangered, and we are proposing to reclassify the DPS as threatened because we have determined it is no longer in danger of extinction. Reclassifications can only be made by issuing a rulemaking. Furthermore, changes to the take prohibitions in section 9 of the Act, such as those we are proposing for this species under a section 4(d) rule, can only be made by issuing a rulemaking.

    The basis for our action. Under the Act, we may determine that a species is an endangered or threatened species based on any of five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. We have determined that the CWTD is no longer at risk of extinction and therefore does not meet the definition of endangered, but is still impacted by habitat loss and degradation of habitat to the extent that the species meets the definition of a threatened species (a species which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range) under the Act.

    We are proposing to promulgate a section 4(d) rule. We are considering whether to exempt from the Act's take prohibitions (under section 9), certain activities conducted on State, Tribal, and private lands where CWTD occur or where they would occur if we were to reintroduce them to areas of their historic distribution. Under the proposed 4(d) rule, take of CWTD caused by CWTD damage management activities (such as hazing, use of non-lethal projectiles, or lethal control), and accidental misidentification during damage management activities and hunting of Columbian black-tailed deer (Odocoileus hemionus columbianus) (black-tailed deer) would be exempt from section 9 of the Act. The proposed 4(d) rule targets these activities to provide protective mechanisms to private landowners and State and Tribal agencies so they may continue with normal activities in the presence of CWTD and therefore facilitate the natural movement, translocation, and range expansion of CWTD.

    Public Hearing

    Section 4(b)(5)(E) of the Act provides for a public hearing on this proposal, if requested. We must receive a request for a public hearing, in writing, at the address shown in FOR FURTHER INFORMATION CONTACT by the date specified in the DATES section. We will schedule a public hearing on this proposal, if requested, and announce the date, time, and place of the hearing, as well as how to obtain reasonable accommodations, in the Federal Register at least 15 days before the hearing.

    Peer Review

    In accordance with our policy, “Notice of Interagency Cooperative Policy for Peer Review in Endangered Species Act Activities,” which published in the Federal Register on July 1, 1994 (59 FR 34270), we will seek the expert opinion of at least three appropriate independent specialists regarding scientific data and interpretations contained in this proposed rule. We will send copies of this proposed rule to the peer reviewers immediately following publication in the Federal Register. This assessment will be completed during the public comment period. The purpose of such review is to ensure that our decisions are based on scientifically sound data, assumptions, and analysis. Accordingly, the final decision may differ from this proposal.

    Information Requested

    We intend that any final action resulting from this proposal will be based on the best available scientific and commercial data and will be as accurate and as effective as possible. Therefore, we invite Native American Tribes, governmental agencies, the scientific community, industry, or any other interested parties to submit comments or recommendations concerning any aspect of this proposed rule. Comments should be as specific as possible. We are specifically requesting comments on:

    (1) The appropriateness of our proposal to reclassify this CWTD DPS from endangered to threatened.

    (2) The factors that are the basis for making a reclassification determination for a species under section 4(a) of the Act (16 U.S.C. 1531 et seq.), which are:

    (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.

    (3) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to this DPS and existing regulations that may be addressing those threats.

    (4) Additional information concerning the historical and current status, range, distribution, and population size of this species, including the locations of any additional populations of this species.

    (5) Any information on the biological or ecological requirements of the species and ongoing conservation measures for the species and its habitat.

    (6) Any information on foreseeable changes to land use or County land use planning within the boundaries of the DPS that may affect future habitat availability for CWTD.

    (7) The appropriateness of a rule to exempt certain take prohibitions of CWTD under section 4(d) of the Act.

    (8) Any additional information pertaining to the promulgation of a rule to exempt certain take prohibitions of CWTD under section 4(d) of the Act.

    (9) Relevant data on climate change and potential impacts to CWTD and its habitat.

    We will take into consideration all comments and any additional information we receive. Such communications may lead to a final rule that differs from this proposal. All comments, including commenters' names and addresses, if provided to us, will become part of the supporting record. Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include. Please note that submissions merely stating support for or opposition to the action under consideration without providing supporting information, although noted, will not be considered in making a determination, as section 4(b)(1)(A) of the Act directs that determinations as to whether any species is a threatened or endangered species must be made “solely on the basis of the best scientific and commercial data available.”

    You may submit your comments and materials concerning the proposed rule by one of the methods listed in the ADDRESSES section. We request that you send comments only by the methods described in the ADDRESSES section.

    If you submit information via http://www.regulations.gov, your entire submission—including any personal identifying information—will be posted on the Web site. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so.

    We will post all hardcopy submissions on http://www.regulations.gov. Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on http://www.regulations.gov, or by appointment, during normal business hours at the U.S. Fish and Wildlife Service, Oregon Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT).

    Previous Federal Action

    On March 11, 1967, the Secretary of the Interior identified the CWTD as an endangered species (32 FR 4001), under the authority of the Endangered Species Preservation Act of October 15, 1966 (80 Stat. 926; 16 U.S.C. 668aa(c)). On March 8, 1969, the Secretary of the Interior again identified the CWTD as an endangered species (34 FR 5034) under section 1(c) of the Endangered Species Preservation Act of 1966. On August 25, 1970, the Acting Secretary of the Interior proposed to list the CWTD as an endangered subspecies (35 FR 13519) under the authority of the new regulations implementing the Endangered Species Conservation Act (ESCA) of 1969. On October 13, 1970, the Director of the Bureau of Sport Fisheries and Wildlife listed the CWTD as an endangered subspecies (35 FR 16047) under the authority of the new regulations implementing the ESCA of 1969. Species listed as endangered under the ESCA of 1969 were automatically included in the List of Endangered and Threatened Wildlife when the Endangered Species Act was enacted in 1973. In December 1971, the Service established the Julia Butler Hansen Refuge for CWTD (JBHR), in Cathlamet, Washington.

    On October 21, 1976, the Service released the CWTD Recovery Plan. On June 14, 1983, the Service released the Revised CWTD Recovery Plan. The plan addressed the two main populations of CWTD, Columbia River and Douglas County, separately. On July 24, 2003, the Service published a rule (68 FR 43647) that: (1) Recognized the Douglas County and Columbia River populations as DPSs under the Service's 1996 Policy Regarding the Recognition of Distinct Vertebrate Population Segments under the Act (see 61 FR 4722; February 7, 1996), and (2) removed the Douglas County population of CWTD from the List of Endangered and Threatened Wildlife. It was determined that recovery criteria for the Douglas County population had been met, as it achieved benchmarks in both population size and amount of secure habitat.

    A 5-year status review of the Columbia River DPS was completed on November 5, 2013 (U.S. Fish and Wildlife Service 2013a); this review concluded that CWTD's status had substantially improved since listing, that the DPS no longer met the definition of an endangered species under the Act, and recommended the DPS should be downlisted from endangered to threatened.

    Species Information

    The Columbian white-tailed deer is the westernmost representative of 38 subspecies of white-tailed deer in North and Central America (Gavin 1984, p. 6). It resembles other white-tailed deer subspecies, ranging in size from 39 to 45 kilograms (kg) (85 to 100 pounds (lb)) for females and 52 to 68 kg (115 to 150 lb) for males (Oregon Department of Fish and Wildlife 1995, p. 2). Generally, the species displays a red-brown color in summer and gray in winter, with distinct white rings around the eyes and a white ring just behind the nose (Oregon Department of Fish and Wildlife 1995, p. 2). Its tail is relatively long, brown on top with a white fringe and white underneath (Verts and Carraway 1998, p. 479).

    Although white-tailed deer can live up to 20 years, their mean lifespan is probably closer to 6 years, though 9- to 12-year olds are common. One Service study showed a median age at death of 3 years for bucks and 5 years for does (Gavin 1984, p. 490). More recent data from CWTD translocated in 2013 and 2014 showed a median age at death of 5 years for bucks and 9 years for does. Does can reach sexual maturity by 6 months of age or when their weight reaches approximately 36 kg (80 lb), however their maturation and fertility depends on the nutritional quality of available forage (Verme and Ullrey 1984, p. 96). Breeding will occur from mid-September through late February, and the peak of the breeding season, or rut, occurs in November. Fawns are born in the early summer after an approximate 200-day gestation period. In their first pregnancy, does usually give birth to a single fawn, although twins are common in later years if adequate forage is abundant (Verme and Ullrey 1984, p. 96).

    The subspecies was formerly distributed throughout the bottomlands and prairie woodlands of the lower Columbia, Willamette, and Umpqua River basins in Oregon and southern Washington (Bailey 1936, p. 92; Verts and Carraway 1998, p. 479). Although white-tailed deer are considered generalist browsers that also graze on grasses and forbs, Suring and Vohs (1979, p. 616) and Gavin et al. (1984, p. 13) reported that CWTD on the JBHR Mainland Unit were primarily grazers. This probably reflects browse and forage availability rather than a predisposition toward forage. Observations by JBHR biologists suggest fawns on the JBHR Mainland Unit are most often associated with pastures of tall, dense reed canary grass (Phalaris arundinacea L.) and tall fescue (Festuca arundinacea), as well as mixed deciduous and Sitka spruce (Picea sitchensis) forest (U.S. Fish and Wildlife Service 1983, p. 10; Brookshier 2004, p. 2).

    Early accounts indicate that CWTD were locally common, particularly in riparian areas along major rivers (Crews 1939, p. 5). The subspecies occupied a range of approximately 60,000 square kilometers (km2) (23,170 square miles (mi2)) west of the Cascades Mountains: From the Dalles, Oregon, in the east, to the Pacific Ocean in the west; and Lake Cushman in Mason County, Washington, in the north, to Grants Pass, Oregon, in the south (Crews 1939, p. 3; Smithsonian 2014, p. 1). The decline in CWTD numbers was rapid with the arrival and settlement of pioneers in the fertile river valleys (Crews 1939, p. 2). Conversion of brushy riparian land to agriculture, urbanization, uncontrolled sport and commercial hunting, and perhaps other factors apparently caused the extirpation of this deer over most of its range by the early 1900s (Crews 1939, pp. 2, 5). By 1940, a population of 500 to 700 animals along the lower Columbia River in Oregon and Washington, and a disjunct population of 200 to 300 in Douglas County, Oregon, survived (Crews 1939, p. 3; Gavin 1984, p. 487; Verts and Carraway 1998, p. 480). These two remnant populations remain geographically separated by about 320 km (200 mi), much of which is unsuitable or discontinuous habitat. The Columbia River DPS has a discontinuous current range of approximately 240 km2 (93 mi2) or about 24,281 hectares (ha) (60,000 acres (ac)) (Smith 1985, p. 247) (Figure 1) in limited areas of Clatsop and Columbia Counties in Oregon, and Cowlitz, Wahkiakum, and Clark Counties in Washington. Within that range, CWTD currently occupy an area of approximately 6,475 ha (16,000 ac) (U.S. Fish and Wildlife Service 2013a, p. 7), with a 2014 population estimate of about 830 deer (U.S. Fish and Wildlife Service, unpublished data).

    BILLING CODE 4333-15-D EP08OC15.000 BILLING CODE 4333-15-C Review of the Recovery Plan

    Section 4(f) of the Act directs us to develop and implement recovery plans for the conservation and survival of endangered and threatened species unless we determine that such a plan will not promote the conservation of the species. Under section 4(f)(1)(B)(ii), recovery plans must, to the maximum extent practicable, include “objective, measurable criteria which, when met, would result in a determination, in accordance with the provisions of [section 4 of the Act], that the species be removed from the list.” However, revisions to the Lists of Endangered and Threatened Wildlife and Plants (adding, removing, or reclassifying a species) must be based on determinations made in accordance with sections 4(a)(1) and 4(b) of the Act. Section 4(a)(1) requires that the Secretary determine whether a species is endangered or threatened (or not) because of one or more of five threat factors. Section 4(b) of the Act requires that the determination be made “solely on the basis of the best scientific and commercial data available.” While recovery plans provide important guidance to the Service, States, and other partners on methods of minimizing threats to listed species and measurable objectives against which to measure progress towards recovery, they are not regulatory documents and cannot substitute for the determinations and promulgation of regulations required under section 4(a)(1) of the Act. A decision to revise the status of a species on, or to remove a species from, the Federal List of Endangered and Threatened Wildlife (50 CFR 17.11) is ultimately based on an analysis of the best scientific and commercial data then available to determine whether a species is no longer an endangered species or a threatened species, regardless of whether that information differs from the recovery plan.

    There are many paths to accomplishing recovery of a species, and recovery may be achieved without all criteria being fully met. For example, one or more criteria may be exceeded while other criteria may not yet be accomplished. In that instance, we may determine that the threats are minimized sufficiently and the species is robust enough to delist. In other cases, recovery opportunities may be discovered that were not known when the recovery plan was finalized. These opportunities may be used instead of methods identified in the recovery plan. Likewise, information on the species may be learned that was not known at the time the recovery plan was finalized. The new information may change the extent to which criteria need to be met for recognizing recovery of the species. Recovery of a species is a dynamic process requiring adaptive management that may, or may not, fully follow the guidance provided in a recovery plan.

    In the 1983 Revised Recovery Plan for CWTD (U.S. Fish and Wildlife Service 1983), the Service established the following criteria for downlisting the Columbia River DPS from endangered to threatened: (1) Maintain a minimum of at least 400 CWTD across the Columbia River DPS; and (2) maintain 3 viable subpopulations, 2 of which are located on secure habitat (U.S. Fish and Wildlife Service 1983, pp. 31-33). Viable is defined as a minimum November population of 50 individuals or more. Secure habitat is defined as free from adverse human activities in the foreseeable future and relatively safe from natural phenomena that would destroy the habitat's value to CWTD.

    The recovery plan established the following criteria for delisting (i.e., removing the species from the Federal List of Endangered and Threatened Wildlife): (1) Maintain a minimum of at least 400 CWTD across the Columbia River DPS; and (2) maintain 3 viable subpopulations, all located on secure habitat. Recovery actions specified in the recovery plan to achieve the downlisting and delisting goals include management of existing subpopulations and protection of their habitat, establishment of new subpopulations, and public education and outreach to foster greater understanding of CWTD and its place in the natural environment of its historic range (U.S. Fish and Wildlife Service 1983, pp. 31-33).

    Recovery Plan Implementation for the Columbia River DPS. At the time of the Revised Recovery Plan's publication, the JBHR Mainland Unit subpopulation was the only subpopulation considered viable and secure. The Revised Recovery Plan recommended increasing the Tenasillahe Island subpopulation to a minimum viable herd of 50 deer, maintaining a total population minimum of 400 deer, and securing habitat for one additional subpopulation (U.S. Fish and Wildlife Service 1983, p. 31).

    Forty-eight years have passed since the CWTD was federally listed as endangered, and the species is now more abundant and better distributed throughout the lower Columbia River Valley. The improvement is due in part to the support and augmentation of existing subpopulations, and the establishment of new subpopulations via successful translocations within the species' historical range. Currently, there are six main CWTD subpopulations: JBHR Mainland Unit (88 deer), Tenasillahe Island (154 deer), Upper Estuary Islands (39 deer), Puget Island (227 deer), Westport/Wallace Island (154 deer), and Ridgefield National Wildlife Refuge (NWR) (48 deer) (see Table 1, below). Threats to the species have been substantially ameliorated and CWTD have met all of the criteria for downlisting to threatened in the Revised Recovery Plan. A review of the species' current status relative to the downlisting criteria follows.

    Downlisting Criterion 1: Maintain a minimum of at least 400 CWTD across the Columbia River DPS. This criterion has been met. The total population of the Columbia River DPS has been maintained at over 400 deer annually since regular surveys began in 1984, and the population estimate for 2014 is more than double this figure. See Table 1, below, for CWTD subpopulations and their current population sizes.

    Downlisting Criterion 2: Maintain three viable subpopulations, two of which are located on secure habitat. This criterion has been met. There are currently four viable subpopulations of CWTD: Tenasillahe Island at 154 deer, Puget Island at 227 deer, Westport/Wallace Island at 154 deer, and the JBH Mainland Unit at 88 deer (see Table 1, below). The Tenasillahe Island and Puget Island subpopulations are located on secure habitat, as explained in the following status discussion.

    Table 1—Estimated Population Size of the Columbia River DPS of CWTD by Subpopulation [U.S. Fish and Wildlife Service 2013a, p. 7; U.S. Fish and Wildlife Service, unpublished data] Year Puget Island Tenasillahe Island Westport/Wallace
  • Island
  • JBHR
  • Mainland
  • unit
  • Upper
  • Estuary
  • Islands c
  • Ridgefield NWR Total
    1984 170 40 150 360 0 0 720 1985 215 40 125 480 0 0 860 1986 195 55 125 500 0 0 875 1987 185 70 150 500 0 0 905 1988 205 80 150 410 0 0 845 1989 205 90 150 375 0 0 820 1990 200 105 150 345 0 0 800 1991 200 130 150 280 0 0 760 1992 200 165 175 280 0 0 820 1993 200 195 200 175 0 0 770 1994 200 205 225 140 0 0 770 1995 200 205 225 120 0 0 750 1996 200 125 225 51 0 0 610 1997 200 150 200 100 0 0 650 1998 200 200 200 110 0 0 710 1999 150 160 140 110 25 0 585 2000 150 135 150 120 55 0 610 2001 125 135 150 120 55 0 585 2002 125 100 140 125 55 0 545 2003 125 100 140 115 80 0 560 2004 110 100 140 110 95 0 555 2005 125 100 140 100 100 0 565 2006 a n/a 86 104 81 67 0 2007 a n/a 82 n/a 59 e 41 0 2009 a 138 b 97 146 b 74 28 0 d 593 2010 a n/a 143 164 68 39 0 d 630 2011 171 90 n/a 83 f 18 0 d 603 2014 227 154 g 154 88 39 48 d 830 a Estimates from 2006-2010 are derived from Forward-Looking Infrared (FLIR) survey results, but survey results from 2008 produced anomalous data because an alternative technique was used. These data are not considered representative of actual numbers, and are thus not included in this table. b Numbers reflect a post-survey translocation of 16 deer from Tenasillahe Island to the Refuge mainland. c Includes Lord, Walker, Fisher, Hump, and Crims Islands. d Includes estimates from residual populations in Cottonwood Island, Clatskanie Flats, Brownsmead, Willow Grove, Barlow Point, and Rainier. e Does not include Fisher and Hump Islands. f Assuming a white-tailed:black-tailed deer ratio of 20:1; this includes only Crims Island. g Approximate population estimate after 2014 translocation. Note: Totals are not given in 2006 and 2007 due to incomplete data, and no surveys were conducted in 2012 or 2013.

    At the time of the CWTD Revised Recovery Plan publication in 1983, the number of deer in the Columbia River DPS was thought to be 300 to 400. The first comprehensive survey effort in 1984 resulted in an estimate of 720 deer, suggesting that prior estimates were probably low. Beginning in 1996, the Service began using Forward-Looking Infrared (FLIR) thermography camera systems affixed to a helicopter (or, in 2008, a fixed-wing Cessna 206) to conduct aerial CWTD surveys within the Columbia River DPS, in addition to annual fall ground counts. Fall ground counts have been conducted since 1985, and have been used to provide more clarity in establishing long-term population trends by indicating gross population changes. In years when FLIR surveys were not completed, ground counts were used to estimate whether there had been any unusual decrease or increase in a subpopulation. The current estimate (2014) of the Columbia River DPS population is approximately 830 deer (Table 1).

    The JBHR Mainland Unit subpopulation has fluctuated in numbers since regular surveys began, with a high of 500 deer in 1987 to a low of 51 deer in 1996 (after a catastrophic flood event). The declining population trend seen in the JBHR Mainland Unit subpopulation over the last 30 years (Table 1) is likely the result of overpopulation that occurred after the area became a refuge in 1971. With the protected status of the refuge and the cessation of hunting, the deer increased in numbers to levels that were unsustainable given the amount of available habitat, culminating with the peak of 500 CWTD. Refuge biologists established a goal of approximately 125 deer for the JBHR Mainland Unit to maintain long-term stability (U.S. Fish and Wildlife Service 2010, p. 2:62). Flooding on the JBHR Mainland Unit has occurred three times over the history of the refuge, in 1996, 2006 and 2009. Although the refuge saw short-term population declines after each flood, the numbers returned to prior levels within a few years. From 1997 to the present, the JBHR Mainland Unit subpopulation stabilized and consistently maintains population numbers above the recovery criteria minimum of 50 deer (Table 1).

    In March of 2011, JBHR personnel discovered erosion of the dike that protects the Mainland Unit from flooding by the Columbia River. The progressive erosion led to the closure of Steamboat Slough Road, which runs on top of the dike. A geotechnical assessment determined that the dike was at “imminent risk” of failure (U.S. Fish and Wildlife Service 2013b, p. 2) and a breach at that location would result in the flooding of the JBHR Mainland Unit at high tides. In response to this threat, the Service conducted an emergency translocation of 37 CWTD from the JBHR Mainland Unit to unoccupied but suitable habitat at Ridgefield NWR in early 2013 (U.S. Fish and Wildlife Service 2013c, p. 8). The U.S. Army Corps of Engineers subsequently constructed a set-back levee on JBHR to prevent flooding of the refuge and to restore salmonid habitat (U.S. Army Corps of Engineers 2013, p. 11). Though the set-back dike, completed in fall 2014, reduces available CWTD habitat on the JBHR Mainland Unit by approximately 28 ha (70 ac), or approximately 3.5 percent of the total 797 ha (1,970 ac), it will restore the stability of the remaining habitat for the Mainland Unit subpopulation. After the removal of 37 CWTD in 2013, the population of the JBHR Mainland Unit has rebounded quickly to an estimated 88 deer (2014).

    The JBHR also includes Tenasillahe Island in Oregon. The 1983 Revised Recovery Plan recommended increasing the Tenasillahe Island subpopulation to a minimum viable herd of 50 deer. The Service has accomplished this recovery goal through several translocation efforts and habitat enhancement, and the island's subpopulation, though still affected by flood events, has remained relatively stable. The most current FLIR survey at this location (in 2014) estimated the population at 154 deer (Table 1).

    The Revised Recovery Plan identified a series of islands near Longview, Washington, as suitable habitat to create a third subpopulation. These islands, known as the Upper Estuary Islands, included Fisher, Hump, Lord, and Walker, with a total area of 400 ha (989 ac), under a mix of private and State ownership. Fisher Island is a naturally occurring tidal wetland dominated by black cottonwood (Populus trichocarpa), willow (Salix spp.), and dogwood (Cornus nuttallii) (U.S. Fish and Wildlife Service 2005, p. 1). The remaining three islands are dredge material sites with dense cottonwood and shrub habitat. Translocations of CWTD to Fisher/Hump and Lord/Walker Islands began in 2003, and a total of 66 deer (33 to each set of islands) have been relocated there to date (U.S. Fish and Wildlife Service 2013a, p. 23). The population goal for the 4-island complex is at least 50 CWTD (U.S. Fish and Wildlife Service 2005, p. 1), but as a unit, this complex has yet to maintain the target population of 50 deer. The 4-island complex currently contains 10 CWTD. It is suspected that the low numbers of CWTD in the complex are a result of deer finding higher quality habitat in areas adjacent to the island complex. Telemetry data indicate that CWTD frequently move between the island complex and adjacent areas of Willow Grove, the Barlow Point industrial area, and Dibblee Point (U.S. Fish and Wildlife Service 2005, p. 3), so many of the translocated deer may be in these other locations. These adjacent areas averaged 44 CWTD between 2009 and 2011 (U.S. Fish and Wildlife Service 2013a, p. 23). However, further range expansion in this region is limited by its direct proximity to urban development. The potential for problems associated with translocations, particularly damage to private gardens and commercial crops, remains an issue with local landowners and therefore limits CWTD range expansion at this time.

    Crims Island was also designated in the Revised Recovery Plan as a suitable translocation site and has subsequently been added to the Upper Estuary Islands subpopulation for recovery purposes. Crims Island lies 1.6 km (1 mi) downstream from the original Upper Estuary Islands, and contributes to the interchange among CWTD of neighboring islands and mainland subpopulations (U.S. Fish and Wildlife Service 2005, p. 4). It was secured for CWTD recovery in a 1999 agreement between the Bonneville Power Administration, the Columbia Land Trust, and the Service (U.S. Fish and Wildlife Service 2010, p. 1:19). Crims Island has received 66 CWTD through several translocation efforts (U.S. Fish and Wildlife Service 2013a, p. 21). The protected portion of the island (approximately 191 ha (473 ac)) contains about 121 ha (300 ac) of deciduous forest (black cottonwood, Oregon ash (Fraxinus latifolia), and willow), pasture, and marsh. Crims Island was formerly grazed but remains undeveloped. This area was originally considered able to support 50 to 100 deer (U.S. Fish and Wildlife Service 2000, p. 2) but has only supported between 8 and 33 deer since 2000, with the latest population estimate at 29 deer in 2014.

    Puget Island has supported one of the largest and most stable subpopulations of CWTD. While densities have historically been lower than refuge lands, the size of Puget Island (about 2,023 ha (5,000 ac)) has enabled it to support a healthy number of deer. Since regular surveys began in 1984, the population at Puget Island has averaged between 175 and 200 deer. The latest survey (2014) estimated the population at a high of 227 deer. Eleven deer were removed from the area for the 2014 translocation to Ridgefield NWR. Puget Island is a mix of private and public land. The private land consists mainly of pasture for cattle and goats, residential lots, and hybrid cottonwood plantations that provide food and shelter for the deer. Farmers and ranchers on the island often implement predator (coyote, Canis latrans) control on their lands to protect poultry and livestock, and this management activity likely benefits the CWTD population on the island.

    The Westport/Wallace Island subpopulation has also been stable and relatively abundant since regular surveys began. After reaching a peak of approximately 225 deer in 1995, the subpopulation's last estimate from 2010 was 164 deer (Table 1). However, 10 deer were removed from the area for the 2014 translocation to Ridgefield NWR, so the most current estimate is approximately 154 deer. Habitat in the Westport area consists mainly of cottonwood/willow swamp and scrub-shrub tidal wetlands. In 1995, Wallace Island, Oregon, was purchased by the Service for CWTD habitat. Though the habitat is now protected for the recovery of CWTD, the 227-ha (562-ac) island alone is considered too small to support a viable population (U.S. Fish and Wildlife Service 2010, p. 4:39). Because it is located adjacent to Westport, Oregon, Wallace Island is considered part of the Westport/Wallace Island CWTD subpopulation. Acquisitions by JBHR also include a 70-ha (173-ac) area of Westport called the Westport Unit.

    Ridgefield NWR is located in Clark County, Washington, approximately 108 km (67 mi) southeast of JBHR, and is comprised of 2,111 ha (5,218 ac) of marshes, grasslands, and woodlands with about 1,537 ha (3,800 ac) of upland terrestrial habitat. As part of the 2013 emergency translocation, the Service moved 37 deer from the JBHR Mainland Unit to Ridgefield NWR in Clark County, Washington (U.S. Fish and Wildlife Service 2013c, p. 8). Eleven of the deer suffered either capture-related mortality or post-release mortality within 2 months, mainly due to predation (U.S. Fish and Wildlife Service, unpublished data). In 2014, another 21 deer were translocated to Ridgefield NWR from Puget Island and Westport, and the current estimated population based on FLIR surveys is 48 deer (Table 1).

    Cottonwood Island lies approximately 1.6 km (1 mi) upriver from Dibblee Point on the Washington side of the Columbia River. The 384-ha (948-ac) island was considered in the Revised Recovery Plan as a potential relocation site; it was thought that the island could support up to 50 deer. The island is a recreational site for camping and fishing with the surrounding waters used for waterfowl hunting. Cottonwood Island has multiple landowners, primarily a coalition of ports administered by the Port of Portland, but there are no people living on the island and no commercial interests (U.S. Fish and Wildlife Service 2013b, p. 15). In the fall of 2010, 15 deer were moved to Cottonwood Island from the Westport population in Oregon (Cowlitz Indian Tribe 2010, p. 1). Seven confirmed mortalities resulted from vehicle collisions as CWTD dispersed off the island (Cowlitz Indian Tribe 2010, p. 3). Telemetry monitoring by Washington Department of Fish and Wildlife (WDFW) personnel in the spring of 2011 detected three radio-collared CWTD on Cottonwood Island and two on the Oregon mainland near Rainier, Oregon. A second translocation of 12 deer to Cottonwood Island (from Puget Island) occurred in conjunction with the 2013 emergency translocation effort (U.S. Fish and Wildlife Service 2013a, p. 24). All but four of these new CWTD subsequently died or moved off the island, with five deer dying from vehicle strikes (U.S. Fish and Wildlife Service, unpublished data). Habitat quality may be a factor in the movement of CWTD off the island, so habitat restoration of about 6 ha (15 ac) was conducted in 2013. Staff at JBHR and the Cowlitz Indian Tribe are conducting periodic monitoring of CWTD translocated to Cottonwood Island.

    While the overall population trend for the Columbia River DPS appears to decline over time along a similar trajectory as the JBHR Mainland Unit subpopulation until 2006, closer examination reveals that the overall trend is strongly influenced by the decline of the unsustainable highs that the JBHR Mainland Unit experienced in the late 1980s. The other subpopulations did not undergo a similar decline, and when the JBHR Mainland Unit is left out of the analysis, the overall Columbia River DPS population demonstrates a more positive trend.

    Page 37 of the Revised Recovery Plan states, “. . . protection and enhancement (of off-refuge CWTD habitat) can be secured through local land use planning, zoning, easement, leases, agreements, and/or memorandums of understanding” (U.S. Fish and Wildlife Service 1983, p. 37). In the 30 years following the development of the Revised Recovery Plan, the Service interpreted this to mean that the only acceptable methods of securing habitat in order to meet recovery criteria were the ones listed in the above citation. This led the Service to focus most CWTD recovery efforts on increasing and maintaining the subpopulations within the boundaries of the JBHR rather than working in areas that did not meet the narrow interpretation of “secure” habitat. These efforts resulted in some successful recovery projects such as growing and stabilizing the subpopulation on Tenasillahe Island, which is part of JBHR and currently one of the largest subpopulations in the Columbia River DPS. However, it also led the Service to put significant resources and time toward efforts that have shown less consistent success, such as establishing viable and stable herds on the Upper Estuary islands. At present, a total of 314 deer have been translocated in an effort to move CWTD to “secure” habitats. As discussed earlier in this section, some translocations yielded success (Ridgefield) and some failed to increase subpopulation numbers (Cottonwood Island and the Upper Estuary Islands).

    Two subpopulations, Puget Island and Westport/Wallace Island, have maintained relatively large and stable numbers over the last 3 decades even though these areas are not under conservation ownership or agreement. The number of CWTD in these two areas clearly demonstrates a measure of security in the habitat regardless of the ownership of the land. If we look at population trends and stability, these two locations have provided more biological security to CWTD than the flood prone JBHR Mainland Unit, which is protected for the conservation of CWTD.

    The 30-year population trends from Puget Island and Westport/Wallace Island make it clear that CWTD can maintain secure and stable populations on suitable habitat that is not formally set aside by acquisition, conservation easement, or agreement for the protection of the species. Within this context, we have re-evaluated the current status of CWTD under a broadened framework for what constitutes “secure” habitat. This now includes locations that, regardless of ownership status, have supported viable subpopulations of CWTD for 20 or more years, and have no anticipated change to land management in the foreseeable future that would make the habitat less suitable to CWTD.

    While Puget Island and Westport/Wallace Island had previously not been considered “secure” habitat, they have been supporting two of the largest and most stable subpopulations in the Columbia River DPS since listing. Although CWTD numbers at these 2 locations have fluctuated, the Westport/Wallace Island subpopulation had 150 deer in 1984 and 164 deer in 2010, and the Puget Island population had 170 deer in 1984 and 227 deer in 2014 (Table 1). The Revised Recovery Plan identified Puget Island and the Westport area as suitable sources for CWTD translocations due in large part to their population stability. Subsequently, these two locations have been the donor source for numerous translocations over the last 30 years, including the removal of 23 deer from Puget Island and 10 deer from Westport as part of the 2013-2014 translocation effort. Removal of CWTD from these two locations on multiple occasions for the purpose of translocation has not resulted in any decrease in donor population numbers.

    Since the late 1980s, the total acreage of tree plantations on Puget Island decreased by roughly half (Stonex 2012, pers. comm.). However, a proportional decrease in the numbers of CWTD did not occur. Furthermore, though Puget Island has experienced changes in land use and increases in development over time, such as the break-up of large agricultural farms into smaller hobby farms, the changes have not inhibited the ability of CWTD to maintain a very stable population on the island. The Wahkiakum Comprehensive Plan (2006) anticipates that future development on Puget Island will continue to be tree farms, agricultural farms, and rural residential (both low density with 1- to 2-ha (2.5- to 5-ac) lots and medium density with 0.4- to 1-ha (1- to 2.5-ac) lots), with a goal of preserving the rural character of the area (Wahkiakum County 2006, p. 392). Puget Island's population has grown at a nominal rate of 1 to 1.5 percent over the past 15 years; that past rate along with building permit growth over the last 5 years leads Wahkiakum County to project a population growth rate on the island of 1.5 percent through the 20-year “plan horizon” that extends through the year 2025 (Wahkiakum County 2006, p. 379). Because CWTD have demonstrated the ability to adapt to the type of development on the island, continued development of this type is not expected to impact CWTD on the island in the foreseeable future (Meyers 2013, pers. comm.). Therefore, the Service considers Puget Island secure habitat.

    Apart from Wallace Island and the Westport Unit, most of the area where the Westport/Wallace Island subpopulation is located is under private ownership and a large portion of that land is owned and managed by one individual family. The family has managed the land for duck hunting for many years, implementing intensive predator control and maintaining levees as part of their land management activities. The Service suspects that CWTD reproduction in the Westport/Wallace Island subpopulation has benefited from this intensive predator control (Meyers 2013, pers. comm.). If the property owners alter the management regime or the property should change hands, the Westport/Wallace Island subpopulation could be negatively affected, particularly if the owners decide to remove the current levees, thereby inundating some of the CWTD habitat (Meyers 2013, pers. comm.). Because the stability of CWTD in this area appears to be so closely tied to one private landowner and their land management choices, there is less certainty as to the long-term security of this subpopulation and its associated habitat. As a result, although a small portion of the habitat for this subpopulation is protected for CWTD, the Service does not currently recognize Westport/Wallace Island as secure habitat. However, given that the area has supported a healthy subpopulation of CWTD for several decades, the Service should consider securing this property through purchase or conservation agreement to ensure a stable management regime, thereby increasing recovery prospects for the Columbia River DPS.

    With respect to the species' recovery criteria (U.S. Fish and Wildlife Service 1983, pp. 31-33), we currently have 4 viable subpopulations of CWTD: (1) Tenasillahe Island at 154 deer, (2) Puget Island at approximately 227 deer, (3) Westport/Wallace Island at 154 deer, and (4) the JBHR Mainland Unit at 88 deer (Table 1). Furthermore, because two of these viable subpopulations, Tenasillahe Island and Puget Island, are now considered secure, the Columbia River DPS has met the recovery criteria for downlisting to threatened status under the Act. The Westport/Wallace Island subpopulation has shown consistent stability over the last 30 years, on par with Puget Island and Tenasillahe Island, but its long-term security is less certain. The JBHR Mainland Unit has already rebounded in numbers to over 50 animals (2014 population estimate was 88 deer), and the set-back dike is in place to restore the stability of the habitat. In order for the Service to determine that the population has regained its secure status, several years of monitoring will be necessary to accurately assess the long-term response of the JBHR Mainland Unit population to both the removal of half its numbers in 2013, and the reduction in habitat from the construction of the setback dike.

    Summary of Factors Affecting the Species

    Section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for listing species, reclassifying species, or removing species from listed status. “Species” is defined by the Act as including any species or subspecies of fish or wildlife or plants, and any distinct vertebrate population segment of vertebrate fish or wildlife that interbreeds when mature (16 U.S.C. 1532(16)). A species may be determined to be an endangered or threatened species due to one or more of the five factors described in section 4(a)(1) of the Act: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. We must consider these same five factors in reclassifying (i.e., downlisting) a species. We may downlist a species if the best available scientific and commercial data indicate that the species no longer meets the definition of endangered, but instead meets the definition of threatened due to: (1) The species' status has improved to the point that it is not in danger of extinction throughout all or a significant portion of its range, but the species is not recovered (as is the case with the CWTD); or (2) the original scientific data used at the time the species was classified were in error.

    Determining whether a species has improved to the point that it can be downlisted requires consideration of whether the species is endangered or threatened because of the same five categories of threats specified in section 4(a)(1) of the Act. For species that are already listed as endangered or threatened, this analysis of threats is an evaluation of both the threats currently facing the species and the threats that are reasonably likely to affect the species in the foreseeable future following the delisting or downlisting and the removal or reduction of the Act's protections.

    A species is “endangered” for purposes of the Act if it is in danger of extinction throughout all or a “significant portion of its range” and is “threatened” if it is likely to become endangered within the foreseeable future throughout all or a “significant portion of its range.” The word “range” in the significant portion of its range (SPR) phrase refers to the general geographical area in which the species occurs at the time a status determination is made. We published a final policy interpreting the phrase “Significant Portion of its Range” (SPR) (79 FR 37578). The final policy states that (1) if a species is found to be endangered or threatened throughout a significant portion of its range, the entire species is listed as an endangered species 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 endangered or threatened 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 Service or the National Marine Fisheries Service makes any particular status determination; and (4) if a vertebrate species is endangered or threatened 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. For the purposes of this analysis, we will evaluate whether the currently listed species, the Columbia River DPS of CWTD, continues to meet the definition of endangered or threatened.

    In considering what factors might constitute threats, we must look beyond the exposure of the species to a particular factor to evaluate whether the species may respond to the factor in a way that causes actual impacts to the species. If there is exposure to a factor and the species responds negatively, the factor may be a threat, and during the five-factor analysis, we attempt to determine how significant a threat it is. The threat is significant if it drives or contributes to the risk of extinction of the species, such that the species warrants listing as endangered or threatened as those terms are defined by the Act. However, the identification of factors that could impact a species negatively may not be sufficient to compel a finding that the species warrants listing. The information must include evidence sufficient to suggest that the potential threat is likely to materialize and that it has the capacity (i.e., it should be of sufficient magnitude and extent) to affect the species' status such that it meets the definition of endangered or threatened under the Act.

    In the following analysis, we evaluate the status of the Columbia River DPS of CWTD throughout all its range as indicated by the five-factor analysis of threats currently affecting, or that are likely to affect, the species within the foreseeable future.

    A. The Present or Threatened Destruction, Modification, or Curtailment of Its Habitat or Range.

    CWTD evolved as a prairie edge/woodland-associated species with historically viable populations that were not confined to river valleys (Bailey 1936, pp. 92-93). CWTD were then extirpated in all but two areas of their historical range: the Columbia River DPS area and the Douglas County DPS area. The remnant Columbia River DPS population was forced by anthropogenic factors (residential and commercial development, roads, agriculture, etc., causing fragmentation of natural habitats) into the lowland areas it now inhabits. Urban, suburban, and agricultural areas now limit population expansion, and existing occupied areas support densities of CWTD indicative of low-quality habitats, particularly lower lying and wetter habitat than where the species would typically be found.

    Loss of habitat is suspected as a key factor in historical CWTD declines; 12,140 ha (30,000 ac) of habitat along the lower Columbia River were converted for residential and large-scale agricultural use from 1870 to 1970 (Northwest Power and Conservation Council 2004, p. B4:13). Over time, CWTD were forced into habitat that was fragmented, wetter, and more lowland than what would be ideal for the species. The recovery of the Douglas County DPS reflects the availability of more favorable habitat (a mix of conifer and hardwood-dominated vegetation communities, including oak woodlands and savannah) and compatible land use practices, such as intensive sheep grazing (Franklin and Dyrness 1988, p. 110).

    Though limited access to high-quality upland habitat in the Columbia River DPS remains the most prominent hindrance to CWTD dispersal and recovery today, the majority of habitat loss and fragmentation has already occurred. The most dramatic land use changes occurred during the era of hydroelectric and floodplain development in the Columbia River basin, beginning with the construction of Willamette Falls Dam in 1888 and continuing through the 1970s (Northwest Power and Conservation Council 2013, p. 1). Compared to the magnitude of change that occurred to CWTD habitat through activities associated with these types of development (e.g., dredging, filling, diking, and channelization) (Northwest Power and Conservation Council 2004, p. III, 13-15), significant future changes to currently available habitat for the Columbia River DPS are not anticipated.

    Recovery efforts for CWTD have, in large part, focused on formally protecting land for the recovery of the species through acquisitions and agreements such as JBHR, Crims Island, Cottonwood Island, and Wallace Island, as well as restoration activities to increase the quality of existing available habitat. To date, the Service has worked to conserve 3,604 ha (8,918 ac) of habitat for the protection of CWTD (U.S. Fish and Wildlife Service 2013, p. 20). Habitat restoration and enhancement activities on JBHR have improved the quality of habitat since the publication of the Revised Recovery Plan in 1983, and Ridgefield NWR now has an active habitat enhancement program in place to support the translocated CWTD. These efforts have added to the available suitable habitat for the Columbia River DPS and helped to offset some of the impacts from previous habitat loss.

    Though much of the occupied habitat in the Columbia River DPS is fragmented, wetter than the species prefers, and more vulnerable to flooding, many variables influence CWTD survival. A mosaic of ownerships and protection levels does not necessarily hinder the existence of CWTD when land-use is compatible with the habitat needs of the deer. For example, on Puget Island, which is not formally set aside for the protection of CWTD, the fawn:doe (F:D) ratios are higher than on the protected JBHR Mainland Unit, and the area has supported a stable CWTD population without active management in the midst of continued small-scale development for several decades. Additionally, the Westport/Wallace Island subpopulation has long maintained stable numbers, even though most of the area is not managed for the protection of CWTD. The level of predation, level of disturbance, and condition of habitat all influence how CWTD can survive in noncontiguous habitats.

    Flooding is a threat to CWTD habitat when browsing and fawning grounds become inundated for prolonged periods. In the past, significant flooding events have caused large-scale CWTD mortality and emigration from the JBHR Mainland Unit (U.S. Fish and Wildlife Service 2007, p. 1). The JBHR Mainland Unit experienced three major storm-related floods in 1996, 2006, and 2009. These flooding events were associated with a sudden drop in population numbers, followed by population recovery in the next few years. During some historical flooding events, CWTD abandoned and have not returned to low-lying areas that became inundated, particularly areas that continued to sustain frequent flooding such as Karlson Island.

    A large proportion of all occupied CWTD habitat is land that was reclaimed from tidal inundation in the early 20th century by construction of dikes and levees for agricultural use (U.S. Fish and Wildlife Service 2010, p. 1:17). In recent years, there has been interest in restoring the natural tidal regime to some of this land, mainly for fish habitat enhancement. This restoration could reduce habitat for CWTD in certain areas where the majority of the subpopulation relies upon the reclaimed land. Since 2009, three new tide gates were installed on the JBHR Mainland Unit to improve fish passage and facilitate drainage in the event of large-scale flooding. When the setback levee on the refuge was completed in fall 2014, the original dike under Steamboat Slough Road was breached and the estuarine buffer created now provides additional protection from flooding to the JBHR Mainland Unit. However, it has also resulted in the loss or degradation of about 28 ha (70 ac) of CWTD habitat, which amounts to approximately 3.5 percent of the total acreage of the JBHR Mainland Unit.

    The persistence of invasive species, especially reed canary grass, has reduced forage quality over much of CWTD's range, but it remains unclear as to how much this change in forage quality is affecting the overall status of CWTD. While CWTD will eat the grass, it is only palatable during early spring growth, or about 2 months in spring, and it is not a preferred forage species (U.S. Fish and Wildlife Service 2010, p. 3:12). Cattle grazing and mowing are used on JBHR lands to control the growth of reed canary grass along with tilling and planting of pasture grasses and forbs. This management entails a large effort that will likely be required in perpetuity unless other control options are discovered. Reed canary grass is often mechanically suppressed in agricultural and suburban landscapes, but remote areas, such as the upriver islands, experience little control. Reed canary grass thrives in wet soil and excludes the establishment of other grass or forb vegetation that is likely more palatable to CWTD. Increased groundwater due to sea level rise or subsidence of diked lands may exacerbate this problem by extending the area impacted by reed canary grass. However, where groundwater levels rise high enough and are persistent, reed canary grass will be drowned out and may be eradicated, though this rise in water level may also negatively affect CWTD. The total area occupied by reed canary grass in the future may therefore decrease, remain the same, or increase, depending on topography, land management, or both.

    Competition with elk (Cervus canadensis) for forage on the JBHR Mainland Unit has historically posed a threat to CWTD (U.S. Fish and Wildlife Service 2004, p. 5). To address these concerns, JBHR staff trapped and removed 321 elk during the period from 1984 to 2001. Subsequently, JBHR staff conducted two antlerless elk hunts, resulting in a harvest of eight cow elk (U.S. Fish and Wildlife Service 2004, p. 13). The combination of these efforts and elk emigration reduced the elk population to fewer than 20 individuals. The JBHR considers their elk reduction goal to have been met. Future increases in the population above 20 individuals may be controlled with a limited public hunt (U.S. Fish and Wildlife Service 2010, p. B-20). In a related effort, JBHR personnel have constructed roughly 4 miles (6.4 km) of fencing to deter elk immigration onto the JBHR (U.S. Fish and Wildlife Service 2004, p. 10).

    Climate Change

    Our analyses under the Act include consideration of ongoing and projected changes in climate. The terms “climate” and “climate change” are defined by the Intergovernmental Panel on Climate Change (IPCC). “Climate” refers to the mean and variability of different types of weather conditions over time, with 30 years being a typical period for such measurements, although shorter or longer periods also may be used (Intergovernmental Panel on Climate Change 2013, p. 1450). The term “climate change” thus refers to a change in the mean or variability of one or more measures of climate (e.g., temperature or precipitation) that persists for an extended period, typically decades or longer, whether the change is due to natural variability, human activity, or both (Intergovernmental Panel on Climate Change 2013, p. 1450). Various types of changes in climate can 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 the effects of interactions of climate with other variables (e.g., habitat fragmentation) (Intergovernmental Panel on Climate Change 2007, pp. 8-14, 18-19). In our analyses, we use our expert judgment to weigh relevant information, including uncertainty, in our consideration of various aspects of climate change.

    Environmental changes related to climate change could potentially affect CWTD occupying low-lying habitat that is not adequately protected by well-maintained dikes. Furthermore, even in areas that have adequate dikes built, the integrity of those dikes could be at risk of failure from climate change. Climatic models have predicted significant sea-level rise over the next century (Mote et al. 2014, p. 492). Rising sea levels could degrade or inundate current habitat, forcing some subpopulations of CWTD to move out of existing habitat along the Columbia River into marginal or more developed habitat. A rise in groundwater levels could alter vegetation regimes, lowering forage quality of CWTD habitat and allowing invasive plants to expand their range into new areas of CWTD habitat. The increase in ground water levels due to sea-level rise could also allow the threat of hoof rot to persist or increase.

    Maintaining the integrity of existing flood barriers that protect CWTD habitat will be important to the recovery of the Columbia River DPS until greater numbers of CWTD can occupy upland habitat through recruitment, additional translocations, and natural range expansion. The JBHR Mainland Unit has experienced three major storm-related floods since 1996. While this could be a cluster of storms in the natural frequency of occurrence, it could also indicate increased storm intensity and frequency due to climate change effects. These flooding events have been associated with a sudden drop in the CWTD population (Table 1), which then slowly recovers. An increased rate of occurrence of these events, however, could permanently reduce the size of this subpopulation. The potential for increased numbers of flood events could also lead to increases in the occurrence of hoof rot and other deer maladies.

    The National Wildlife Federation has employed a model to predict changes in sea level in Puget Sound, Washington, and along areas of the Oregon and Washington coastline. The study predicted an average rise of 0.28 m (0.92 ft) by 2050, and 0.69 m (2.26 ft) by 2100, in the Columbia River region (Glick et al. 2007, p. 73). A local rise in sea level would translate into the loss of some undeveloped dry land and tidal and inland fresh marsh habitats. By 2100, projections show that these low-lying habitats could lose from 17 to 37 percent of their current area due to an influx of saltwater. In addition, since the JBHR Mainland Unit and Tenasillahe Island were diked in the early 1900s, the land within the dikes has subsided and dropped to a level near or below groundwater levels. This in turn has degraded CWTD habitat quality in some areas. Although salt-water intrusion does not extend this far inland, the area experiences 2- to 2.5-m (7- to 8-ft) tidal shifts due to a backup of the Columbia River. Sea-level rise may further increase groundwater levels on both of these units, as levees do not provide an impermeable barrier to groundwater exchange.

    Due to the reasons listed above, we find the effects of climate change to be a potential threat to some subpopulations of CWTD in the future, particularly the JBHR Mainland Unit and Tenasillahe Island subpopulations, but not the entire Columbia River DPS. Because of the low-lying nature of some currently occupied CWTD habitat in the Columbia River DPS, the long-term stability of the subpopulations in those areas may rely on the availability of and access to high-quality upland habitat protected from the effects of projected sea-level rise. The Columbia River DPS would benefit from the identification of additional suitable high-quality upland habitat and the development of partnerships with State wildlife agencies to facilitate the translocation of CWTD to these areas, as well as securing land with existing stable subpopulations, such as the Westport area.

    Summary of Factor A

    Habitat loss still remains a threat today, though a greater understanding of CWTD adaptation and persistence clearly indicates that the severity of the threat is less than previously thought. Stable populations of the species do persist in habitat that was previously dismissed as inadequate for long-term survival such as the subpopulations on Puget Island, Washington, and in Westport, Oregon (Westport/Wallace Island subpopulation). Historical habitat loss was largely a result of development and while this activity is still a limiting factor, we now understand that the type of development influences how CWTD respond. Areas such as Puget Island have been and are expected to continue experiencing the breakup of large agricultural farms into smaller hobby farms with a continued focus on low- to medium-density rural residential development. This type of change has not inhibited the ability of CWTD to maintain a stable population on Puget Island. Therefore, this type of development is not expected to impact CWTD on Puget Island in the foreseeable future. In contrast, areas like Willow Grove will likely see a continued change from an agricultural to a suburban landscape; this type of development may have a negative impact on CWTD depending on the density of development.

    The Service`s recovery efforts involving habitat acquisition and restoration have led to a corresponding increase in the amount and quality of habitat specifically protected for the benefit of CWTD. Habitat enhancement efforts have been focused primarily on the JBHR Mainland Unit, followed by Tenasillahe Island and Crims Island where attention has been focused on increasing the quality of browse, forage, and cover. There is also a new habitat enhancement program at Ridgefield NWR that is focused on increasing the amount of browse and forage available to CWTD. Finally, CWTD now have access to the upland areas at Ridgefield NWR, and it is expected that they will respond positively to the higher quality habitat.

    The rise in sea level predicted by climate change models could threaten any low-lying habitat of the Columbia River DPS not adequately protected by dikes, and also threaten the integrity of dikes providing flood control to certain subpopulations of CWTD. Therefore, the effects of climate change could potentially impact certain subpopulations of CWTD in the future, but climate change does not constitute a threat to the entire DPS now or in the foreseeable future. Overall, although the threat of habitat loss and modification still remains, it is lower than thought at the time the Recovery Plan was developed; this is due to habitat acquisition and enhancement efforts, as well as an overall better understanding of the influence of different types of development on CWTD populations.

    B. Overutilization for Commercial, Recreational, Scientific, or Educational Purposes

    Overutilization for commercial, scientific, or educational purposes is not a threat to CWTD. While historical overharvest of CWTD contributed to population decline, all legal harvest of CWTD in the Columbia River DPS ceased when CWTD was federally listed as endangered. Just after the establishment of the JBHR, poaching was not uncommon. Public understanding and views of CWTD have gradually changed however, and poaching is no longer considered a threat. Regulations and enforcement are in place to protect CWTD from overutilization, and a downlisting (and associated 4(d) rule) would not change this. There have only been a few cases of intentional shooting of CWTD through poaching in the 48 years since CWTD were first listed (Bergh 2014, pers. comm.). Though poaching cannot be completely ameliorated, this current level of poaching is not considered a threat. If subpopulations should decline, poaching could have a greater impact on CWTD numbers and would need to be monitored. Though overutilization was a factor that led to the listing of CWTD as federally endangered in 1967, it does not constitute a threat now or in the foreseeable future.

    C. Disease or Predation Disease

    The Revised Recovery Plan lists necrobacillosis (hoof rot) as a primary causal factor in CWTD mortality on the JBHR (U.S. Fish and Wildlife Service 1983, p. 13). Fusobacterium necrophorum is identified as the etiological agent in most cases of hoof rot, although concomitant bacteria such as Arcanobacterium pyogenes may also be at play (Langworth 1977, p. 383). Damp soil or inundated pastures increase the risk of hoof rot among CWTD with foot injuries (Langworth 1977, p. 383). Among 155 carcasses recovered from 1974 to 1977, hoof rot was evident in 31 percent (n=49) of the cases, although hoof rot only attributed directly to 3 percent (n=4) of CWTD mortalities (Gavin et al. 1984, pp. 30-31). Currently, CWTD on the JBHR Mainland Unit have occasionally displayed visible evidence of hoof rot, and recent cases have been observed on Puget Island, but its prevalence is not known to be a limiting factor in population growth (U.S. Fish and Wildlife Service 2010, p. 4:53). Of the 49 CWTD captured from the JBHR Mainland Unit and Puget Island in 2013, none displayed evidence of hoof rot at the time of capture (U.S. Fish and Wildlife Service, unpublished data).

    Deer hair loss syndrome (DHLS) was documented in black-tailed deer in northwest Oregon from 2000 to 2004 (Biederbeck 2004, p. 4). DHLS results when a deer with an immune system weakened by internal parasites is plagued with ectoparasites such as deer lice (Damalinia (Cervicola) spp.). The weakened deer suffer increased inflammation and irritation, which result in deer biting, scratching, and licking affected areas and, ultimately, removing hair in those regions. This condition is found most commonly among deer occupying low-elevation agricultural areas (below 183 m (600 ft) elevation). While the study found a higher instance in black-tailed deer, cases in CWTD have also been observed. Most cases (72 percent) of DHLS detected at the Saddle Mountain Game Management Unit in northwest Oregon were associated with black-tailed deer. Twenty-six percent of black-tailed deer surveyed in the Saddle Mountain Game Management Unit showed symptoms of DHLS, while only 7 percent of CWTD were symptomatic (Biederbeck 2004, p. 4). Additionally, cases were identified in CWTD in 2002 and 2003, but none of the CWTD surveyed in 2004 showed evidence of the disease (Biederbeck 2004, p. 4). CWTD captured during translocations in recent years have occasionally exhibited evidence of hair loss. Mild hair loss has been observed in a few fawns and yearlings (U.S. Fish and Wildlife Service 2010, p. 4:53).

    DHLS is not thought to be highly contagious, nor is it considered to be a primary threat to CWTD survival, although it has been associated with deer mortality (Biederbeck 2002, p. 11; 2004, p. 7). Reports of DHLS among black-tailed deer in Washington have indicated significant mortality associated with the condition. In 2006, a high number of Yakima area mule deer (Odocoileus hemionus) mortalities were reported with symptoms of DHLS (Washington Department of Fish and Wildlife 2010, p. 1), although their mortality may be more related to a significant outbreak of lice in the population at the time. With respect to CWTD, however, there has been no documented mortality associated with the disease on the JBHR Mainland Unit (U.S. Fish and Wildlife Service 2010, p. 4:53) and DHLS is not a current or foreseeable threat.

    Parasite loads were tested in 16 CWTD on the JBHR Mainland Unit and Tenasillahe Island in February of 1998 (Creekmore and Glaser 1999, p. 3). All CWTD tested via fecal samples showed evidence of the stomach worm Haemonchus contortus. Lung worm (Parelaphostrongylus spp.) and trematode eggs, possibly from liver flukes (Fascioloides spp.), were also detected. These results are generally not a concern among healthy populations, and even though the Columbia River DPS of CWTD has less than optimal forage and habitat quality available in some subpopulations, their relatively high parasite load has never been linked to mortality in the DPS. Parasites are not a current or future threat to CWTD, as the parasite load appears to be offset by a level of fecundity that supports stable or increasing populations.

    Predation

    Coyote predation on CWTD has been a problem for the Columbia River DPS, but careful attention to predator control has demonstrated that predation can be managed. Since 1983, studies have been conducted to determine the primary factors affecting fawn survival throughout the range of the Columbia River DPS of CWTD (U.S. Fish and Wildlife Service, unpublished data), and coyote predation is thought to be the most significant impact on fawn recruitment. On the JBHR Mainland Unit, Clark et al. (2010, p. 1) fitted 131 fawns with radio collars and tracked them for the first 150 days of age from 1978 to 1982, and then again from 1996 to 2000 (16 deer were dropped from the analyses due to collar issues). The authors found only a 23 percent survival rate. Coyote predation was determined to be the primary cause of fawn mortality, accounting for 69 percent (n=61) of all documented mortalities. In comparison, disease and starvation accounted for 16 percent of known fawn mortalities. The cause(s) of the remaining 15 percent of mortalities was unknown.

    Between 1997 and 2008, 46 coyotes were removed from the JBHR Mainland Unit by the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (U.S. Fish and Wildlife Service 2010, p. 4:62). In some cases, removal has been correlated with an increase in fawn survival. In 1996, the estimated JBHR Mainland Unit Fawn:Doe (F:D) ratio was 15:100. The following year, after 9 coyotes were removed, the F:D ratio increased to 61:100 (U.S. Fish and Wildlife Service 2010, p. 4:54). On Tenasillahe Island, the average F:D ratio between 2001 and 2003 was 6:100. No coyotes were removed during that time. Over the next 5 years (2004 to 2008), 31 coyotes were removed, and the F:D ratio improved and averaged 37:100. Clark et al. (2010, p. 14) suggested shifting the timing of coyote removal from winter/early spring to the critical fawning period of June to September. This suggestion has been included in the comprehensive conservation plan for the JBHR and has been implemented since 2008. Since shifting the timing of predator control, a F:D ratio of 37:100 has been maintained on the JBHR Mainland Unit. Due to the evident success of predator control efforts at JBHR, Ridgefield NWR began implementing a coyote control program in May 2013, to support the newly translocated CWTD.

    It is common for private landowners in the region to practice predator control on their property, and we have no information that leads us to anticipate a change in the level of predator control on these lands in the foreseeable future (Meyers 2013, pers. comm.). Additionally, coyote control has been in practice on refuge lands for some time and will continue to be implemented on both JBHR and Ridgefield NWR to support the translocated populations. While coyote control efforts in the Columbia River DPS have met with some success, there may be other factors, such as habitat enhancement, also influencing increased ratios in certain CWTD subpopulations. Doe survival in the DPS has been shown to rely more heavily on the availability of nutritious forage than predation pressures, even though fawn predation within subpopulations is most likely influenced by coyote population cycles (Phillips 2009, p. 20). Furthermore, deer and elk populations can be depressed by the interplay between various factors such as habitat quality and predation pressures (Oregon Department of Fish and Wildlife 2013, p. 8).

    As CWTD move towards full recovery and increase in numbers as well as occupation of higher quality habitat such as Ridgefield NWR, predation will be offset by increased fecundity. Also, the rate of predator control currently in place is not anticipated to change in the foreseeable future. An intermediate focus on coyote control for the translocated populations on refuge lands (and monitoring of predation by other species such as bobcat), used in conjunction with long-term improvement of habitat conditions, is anticipated to yield fecundity increases that will lead to self-sustaining population levels. While predator control is in practice in some subpopulations, predation at the DPS scale is not a threat.

    Summary of Factor C

    Diseases naturally occur in wild ungulate populations. Diseases such as hoof rot, DHLS, and parasite loads can often work through a population without necessarily reducing the overall population abundance. Even though the relatively high parasite load in the Columbia River DPS of CWTD is compounded by the additional stressor of suboptimal forage and habitat quality for some subpopulations, the load itself has never been linked to mortality in the DPS. Disease in the Columbia River DPS of CWTD is not a threat now or in the foreseeable future.

    Predation in the Columbia River DPS of CWTD is not a threat now or in the foreseeable future. Depredation of fawns by coyotes is common in the Columbia River DPS; however many factors work in conjunction with each other to determine overall level of fawn recruitment. Coyote control is in practice on some private lands in the region as well as both JBHR and Ridgefield NWR, and the level of control is not anticipated to change in the foreseeable future. As CWTD increase in numbers through continued recovery efforts, population increases will offset the impact of predation.

    D. The Inadequacy of Existing Regulatory Mechanisms

    Under this factor, we examine whether existing regulatory mechanisms are inadequate to address the threats to the CWTD discussed under other factors. Section 4(b)(1)(A) of the Act requires the Service to take into account “those efforts, if any, being made by any State or foreign nation, or any political subdivision of a State or foreign nation, to protect such species. . . .” In relation to Factor D under the Act, we interpret this language to require the Service to consider relevant Federal, State, and Tribal laws, regulations, and other such mechanisms that may minimize any of the threats we describe in threat analyses under the other four factors, or otherwise enhance conservation of the species. We give strongest weight to statutes and their implementing regulations and to management direction that stems from those laws and regulations. An example would be State governmental actions enforced under a State statute or constitution, or Federal action under statute.

    The following section includes a discussion of State, local, or Federal laws, regulations, or treaties that apply to CWTD. It includes legislation for Federal land management agencies and State and Federal regulatory authorities affecting land use or other relevant management. Before CWTD was federally listed as endangered in 1967, the species had no regulatory protections. Existing laws were considered inadequate to protect the subspecies. The CWTD was not officially recognized by Oregon or Washington as needing any special protection or given any special consideration under other environmental laws when project impacts were reviewed.

    The CWTD is now designated as “State Endangered” by the WDFW. Although there is no State Endangered Species Act in Washington, the Washington Fish and Wildlife Commission has the authority to list species (Revised Code of Washington (RCW) 77.12.020), and they listed CWTD as endangered in 1980. State listed species are protected from direct take, but their habitat is not protected (RCW 77.15.120). Under the Washington State Forest Practices Act, the Washington State Forest Practices Board has the authority to designate critical wildlife habitat for State-listed species affected by forest practices (Washington Administrative Code (WAC) 222-16-050, WAC 222-16-080), though there is no critical habitat designated for CWTD.

    The WDFW's hunting regulations remind hunters that CWTD are listed as endangered by the State of Washington (Washington Department of Fish and Wildlife 2015, pp. 18, 20). This designation means it is illegal to hunt, possess, or control CWTD in Washington. There has been one documented case of an accidental shooting of CWTD by a black-tailed deer hunter due to misidentification, and a few cases of intentional shooting of CWTD through poaching in the 48 years since CWTD were first listed (Bergh 2014, pers. comm.). The State endangered designation adequately protects individual CWTD from direct harm, but offers no protection to CWTD habitat.

    The Washington State Legislature established the authority for Forest Practices Rules (FPR) in 1974. The Forest Practices Board established rules to implement the Forest Practices Act in 1976, and has amended the rules continuously over the last 30 years. The WDNR is responsible for implementing the FPR and is required to consult with the WDFW on matters relating to wildlife, including CWTD. The FPR do not specifically address CWTD, but they do address endangered and threatened species under their “Class IV-Special” rules (WAC 222-10-040). If a landowner's forestry-related action would “reasonably . . . be expected, directly or indirectly, to reduce appreciably the likelihood of the survival or recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of that species,” the landowner would be required to comply with the State's Environmental Policy Act guidelines before they could perform the action in question. The guidelines can require the landowner to employ mitigation measures, or they may place conditions on the action such that any potentially significant adverse impacts would be reduced. Compliance with the FPR does not substitute for or ensure compliance with the Federal Endangered Species Act. A permit system for the scientific taking of State-listed endangered and threatened wildlife species is managed by the WDFW.

    Though CWTD (Columbia River DPS) are not listed as endangered or threatened by the State of Oregon, they are classified as a “protected mammal” by the State of Oregon because of their federally endangered designation, and this will not change if CWTD are federally downlisted to threatened (Oregon Department of Fish and Wildlife 2012, p. 1). The CWTD is designated as “Sensitive-Vulnerable” by the Oregon Department of Fish and Wildlife (ODFW). The “Sensitive” species classification was created under Oregon's Sensitive Species Rule (Oregon Administrative Rules (OAR) 635-100-040) to address the need for a proactive species conservation approach. The Sensitive Species List is a nonregulatory tool that helps focus wildlife management and research activities, with the goal of preventing species from declining to the point of qualifying as “endangered” or “threatened” under the Oregon Endangered Species Act (Oregon Revised Statutes (ORS) 496.171, 496.172, 496.176, 496.182 and 496.192). Species designated as Sensitive-Vulnerable are those facing one or more threats to their populations, habitats, or both. Vulnerable species are not currently imperiled with extirpation from a specific geographic area or the State, but could become so with continued or increased threats to populations, habitats, or both. This designation encourages but does not require the implementation of any conservation actions for the species. The ODFW does not allow hunting of CWTD, except for controlled hunt of the federally delisted Douglas County DPS in areas near Roseburg, Oregon (Oregon Department of Fish and Wildlife 2015, p. 39). There have been no documented cases of accidental or intentional killing of CWTD in Oregon (Boechler 2014, pers. comm.).

    The State may authorize a permit for the scientific taking of a federally endangered or threatened species for “activities associated with scientific resource management such as research, census, law enforcement, habitat acquisition and maintenance, propagation and transplantation.” An incidental taking permit or statement issued by a Federal agency for a species listed under the Federal Endangered Species Act “shall be recognized by the state as a waiver for any state protection measures or requirements otherwise applicable to the actions allowed under the federal permit” (ORS 96.172(4)).

    The Oregon Forest Practices Act (ORS 527.610 to 527.992 and OAR Chapter 629, Divisions 600 to 665) lists protection measures specific to private and State-owned forested lands in Oregon. These measures include specific rules for overall maintenance of fish and wildlife, and specifically federally endangered and threatened species including the collection and analysis of the best available information and establishing inventories of these species (ORS 527.710 section 3(a)(A)). Compliance with the forest practice rules does not substitute for or ensure compliance with the Endangered Species Act.

    The Oregon Department of Forestry recently updated their Northwest Oregon Forest Plan (Oregon Department of Forestry 2010). There is no mention of CWTD in their Forest Plan, but they do manage for elk and black-tailed deer. Landowners and operators are advised that Federal law prohibits a person from taking certain endangered or threatened species that are protected under the Endangered Species Act (Act) (OAR 629-605-0105).

    Federal status under the Act continues to provide additional protections to CWTD not available under State laws. Other than the “take” that would be allowed for the specific activities outlined in the accompanying proposed 4(d) rule, “take” of CWTD is prohibited on all lands without a permit or exemption from the Service. Furthermore, the National Wildlife Refuge System Improvement Act of 1997 (16 U.S.C. 668dd et seq.) provides additional protection to CWTD. Where CWTD occur on NWR lands (JBHR and Ridgefield NWR), this law protects CWTD and their habitats from large-scale loss or degradation due to the Service's mission “to administer a national network of lands . . . for the conservation, management, and where appropriate, restoration of the fish, wildlife, and plant resources and their habitats.”

    The JBHR was established in Washington in 1971, specifically to protect and manage the endangered CWTD. The JBHR includes several subpopulations (Mainland Unit, Tenasillahe Island, and a portion of Westport/Wallace Island), supporting a total of approximately one third of the DPS population of CWTD. The JBHR's CCP includes goals for the following: (1) Protecting, maintaining, enhancing, and restoring habitats for CWTD; (2) contributing to the recovery of CWTD by maintaining minimum population sizes on JBHR properties; and (3) conducting survey and research activities, assessments, and studies to enhance species protection and recovery (U.S. Fish and Wildlife Service 2010, pp. 2:48-76). The JBHR implements habitat improvement and enhancement actions on a regular basis as well as predator management. As of early 2013, Ridgefield NWR is home to a new subpopulation of CWTD. Habitat conditions on Ridgefield NWR are favorable for CWTD, and predator control is being implemented. Regular monitoring will occur to assess the viability of the subpopulation over time. Both JBHR and Ridgefield NWR must conduct section 7 consultations under the Act for any refuge activity that may result in adverse effects to CWTD.

    Summary of Factor D

    Although additional regulatory mechanisms have been developed for the Columbia River DPS since its listing under the Act and these mechanisms are working as designed and help to minimize threats, they do not fully ameliorate the threats to the species and its habitat. At present without the protections of the Act, the existing regulatory mechanisms for the Columbia River DPS remain inadequate.

    E. Other Natural or Manmade Factors Affecting Its Continued Existence Hybridization

    Hybridization with black-tailed deer was not considered a significant threat to the Columbia River DPS of CWTD at the time of the development of the Revised Recovery Plan (U.S. Fish and Wildlife 1983, p. 40). Later studies raised some concern over the presence of black-tailed deer genes in the isolated Columbia River DPS population. Gavin and May (1988, p. 1) found evidence of hybridization in 6 of 33 samples of CWTD on the JBHR Mainland Unit and surrounding area. A subsequent study revealed evidence of hybridization on Tenasillahe Island, but not the JBHR Mainland Unit (Piaggio and Hopken 2009, p. 18). On Tenasillahe Island, 32 percent (8) of the 25 deer tested and identified as CWTD contained genes from black-tailed deer. Preliminary evidence shows no morphological differences in CWTD/black-tailed deer hybrids, suggesting molecular analysis may be the only analytic tool in tracking hybridization. These data suggest that these genes may have been due to a single hybridization event that is being carried through the Tenasillahe Island population.

    Translocation efforts have at times placed CWTD in areas that support black-tailed deer populations. While few black-tailed deer inhabit the JBHR Mainland Unit or Tenasillahe Island, the Upper Estuary Islands population may experience more interspecific interactions. Aerial FLIR survey results in 2006 detected 44 deer on the 4-island complex of Fisher/Hump and Lord/Walker. Based upon the proportion of CWTD to black-tailed deer sightings using trail cameras on these islands, Service biologists estimated that, at most, 14 of those detected were CWTD (U.S. Fish and Wildlife Service 2007, p. 1). A study conducted in 2010 by the JBHR and the National Wildlife Research Center using fecal samples collected on Crims, Lord, and Walker Islands showed no hybridization in any of the samples collected, suggesting a low tendency to hybridize even in island situations (Piaggio and Hopken 2010, p. 14). The actual magnitude of hybridization has probably not changed since the listing of CWTD; however there is not enough data available to confirm this assumption. Hybridization might affect the genetic viability of the Columbia River DPS, and additional research regarding hybridization could give broader insight to the implications and occurrence of this phenomenon, and how it may influence subspecies designation. Although a more complete data set would provide more conclusive information regarding hybridization in CWTD, based upon the minor level of detections of black-tailed deer genetic material and the complete lack of any evidence of hybridization on several islands, we find that hybridization is not a threat to the Columbia River DPS.

    Vehicle Collisions

    Because deer are highly mobile, collisions between CWTD and vehicles do occur, but the number of collisions in the Columbia River DPS has not prevented the DPS population from increasing over time and meeting some recovery criteria. The frequency of collisions is dependent on the proximity of a subpopulation to roads with high traffic levels, and collisions with CWTD have been most frequent among deer that have been translocated to areas that are relatively close to high trafficked roads. In 2010, 15 deer were translocated to Cottonwood Island, Washington, from Westport, Oregon. Seven of those translocated deer swam off the island and were killed by collisions with vehicles on U.S. Highway 30 in Oregon, and on Interstate 5 in Washington (Cowlitz Indian Tribe 2010, p. 3). By contrast, of the 58 deer that were translocated to Ridgefield NWR in 2013 and 2014, only 3 have been struck by vehicles, and all 3 were struck after wandering off refuge land. Because of its proximity to Highway 4 in Washington, JBHR sees occasional collisions between vehicles and CWTD on or near the refuge. Refuge personnel recorded four CWTD killed by vehicle collisions in 2010, along Highway 4 and on the JBHR Mainland Unit. These were deer that were either observed by Service personnel or reported directly to the JBHR.

    The Washington Department of Transportation removes road kills without reporting species details to the JBHR, so the actual number of CWTD struck by cars in Washington is probably slightly higher than the number of cases of which JBHR staff is aware. Since the 2013 translocation, ODFW has an agreement with the Oregon Department of Transportation (ODOT) that ODOT personnel assigned to stations along Highway 30 will report any CWTD mortalities. So far, they have been contacting the Oregon State Police and occasionally ODFW staff when they find a mortality with a collar or ear tags. It is uncertain if the ODOT staff report unmarked CWTD mortalities (VandeBergh 2013, pers. comm.).

    Although the number of deer collisions may increase over time as CWTD populations expand in both numbers and range, the rate of collisions in proportion to the Columbia River DPS population size is not currently a problem and is not expected to rise in the future. Therefore, vehicle collisions are unlikely to ever be a threat to the Columbia River DPS.

    Summary of Factor E

    Low levels of hybridization have recently been detected between black-tailed deer and CWTD on JBHR (Piaggio and Hopken 2010, p. 15). Future genetics work could give a broader insight into the implications and occurrence of this phenomenon. Piaggio and Hopken revealed a low genetic diversity among CWTD, which compounds the threat of hybridization (2010, pp. 16-17). An increase in the incidence of hybridization beyond current levels could potentially affect the subspecies designation of CWTD. However, Piaggio and Hopken concluded that although hybridization can occur between CWTD and black-tailed deer, it is not a common or current event (2010, p. 16). The two species will preferentially breed within their own taxa, and their habitat preferences differ somewhat. Therefore, hybridization does not constitute a threat now or in the foreseeable future. The number of deer/vehicle collisions may increase over time as CWTD expand in numbers and range, but the overall rate of collisions is not expected to increase. Therefore, vehicle collisions do not constitute a threat now or in the foreseeable future.

    Overall Summary of Factors Affecting CWTD

    Based on the most recent comprehensive survey data from 2011 and 2014, the Columbia River DPS has approximately 830 CWTD, with 4 viable subpopulations, 2 of which are considered secure (Tenasillahe Island and Puget Island). The current range of CWTD in the lower Columbia River area has been expanded approximately 80.5 km (50 mi) upriver from its easternmost range of Wallace Island in 1983, to Ridgefield, Washington, presently. The Ridgefield NWR population is expected to grow and represent an additional viable subpopulation, as defined in the recovery plan. Furthermore, the JBHR Mainland unit has returned to a level above 50 animals and will likely regain its secure status in the near future. The Columbia River DPS has consistently exceeded the minimum population criteria of 400 deer over the past 2 decades, and though the JBHR Mainland Unit subpopulation has experienced a decline from the unsustainable levels of the late 1980s, it has stabilized to population levels at or near the carrying capacity of the habitat.

    Threats to the Columbia River DPS from habitat loss or degradation (Factor A) still remain and will likely continue into the foreseeable future in the form of habitat alteration, but are less severe than previously thought due to a greater understanding of the effects of land use and habitat management on CWTD. Overutilization (Factor B) is not a threat. Predation and disease (Factor C) in the Columbia River DPS of CWTD are not threats. Depredation of fawns by coyotes does occur in the Columbia River DPS; however many factors work in conjunction with each other to determine overall level of fawn recruitment. Without the protections of the Act, the existing regulatory mechanisms for the Columbia River DPS remain inadequate (Factor D). Vehicle collisions, disease, and hybridization (Factor E) are not threats.

    Proposed Determination

    As required by the Act, we considered the five factors in assessing whether the Columbia River DPS of CWTD is endangered or threatened throughout all or a significant portion of its range. We carefully examined the best scientific and commercial information available regarding the past, present, and future threats faced by the DPS. We reviewed the information available in our files and other available published and unpublished information, and we consulted with recognized experts and State and Tribal agencies. During this process, we found the Columbia River DPS is still affected by habitat loss and degradation, and some subpopulations may potentially be affected in the future by habitat changes resulting from the effects of climate change, but we did not identify any factors that are likely to reach a magnitude that currently threatens the continued existence of the DPS.

    Our analysis indicates that the Columbia River DPS of CWTD is not in danger of extinction throughout all of its range and does not, therefore, meet the definition of an endangered species. 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.” Furthermore, as described in our 2014 policy (79 FR 37578, July 1, 2014), a portion of the range of a species is `significant' (SPR) if the species is not currently endangered or threatened 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. Because we find the CWTD is threatened (still in danger of extinction in the foreseeable future) based on its status throughout all its range due to the continued threat of habitat loss, that ends the SPR inquiry. Therefore, we propose to reclassify the Columbia River DPS of CWTD from an endangered species to a threatened species under the Act. Additionally, although the DPS has yet to fully meet the Recovery Plan criteria for delisting, it now meets the definition of a threatened species.

    Effects of the Proposed Rule

    This proposal, if made final, would revise 50 CFR 17.11(h) to reclassify the Columbia River DPS of CWTD from endangered to threatened. Reclassification of CWTD from endangered to threatened would provide recognition of the substantial efforts made by Federal, State, and local government agencies; Tribes; and private landowners to recover the species. Adoption of this proposed rule would formally recognize that this species is no longer at risk of extinction and therefore does not meet the definition of endangered, but is still impacted by habitat loss and degradation of habitat to the extent that the species meets the definition of a threatened species (a species which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range) under the Act. However, this proposed reclassification would not significantly change the protection afforded this species under the Act. Other than the “take” that would be allowed for the specific activities outlined in the accompanying proposed 4(d) rule, the regulatory protections of the Act would remain in place. Anyone taking, attempting to take, or otherwise possessing a CWTD, or parts thereof, in violation of section 9 of the Act would still be subject to a penalty under section 11 of the Act, except for the actions that would be covered under the 4(d) rule. Whenever a species is listed as threatened, the Act allows promulgation of a rule under section 4(d). These rules may prescribe conditions under which take of the threatened species would not be a violation of section 9 of the Act. A 4(d) rule is proposed for CWTD.

    4(d) Rule

    The purposes of the Act are to provide a means whereby the ecosystems upon which endangered species and threatened species depend may be conserved, to provide a program for the conservation of endangered species and threatened species, and to take such steps as may be appropriate to achieve the purposes of the treaties and conventions set forth in the Act. When a species is listed as endangered, certain actions are prohibited under section 9 of the Act, as specified in 50 CFR 17.21. These include, among others, prohibitions on take within the United States, within the territorial seas of the United States, or upon the high seas; import; export; and shipment in interstate or foreign commerce in the course of a commercial activity.

    The Act does not specify particular prohibitions and exceptions to those prohibitions for threatened species. Instead, under section 4(d) of the Act, the Secretary is authorized to issue regulations deemed necessary and advisable to provide for the conservation of threatened species. The Secretary also has the discretion to prohibit by regulation with respect to any threatened species any act prohibited under section 9(a)(1) of the Act. Exercising this discretion, the Service has by regulation applied those prohibitions to threatened species unless a special rule is promulgated under section 4(d) of the Act (“4(d) rule”) (50 CFR 17.31(c)). Under 50 CFR 17.32, permits may be issued to allow persons to engage in otherwise prohibited acts for certain purposes unless a special rule provides otherwise.

    A 4(d) rule may include some or all of the prohibitions and authorizations set out at 50 CFR 17.31 and 17.32, but also may be more or less restrictive than those general provisions. For the Columbia River DPS of CWTD, the Service has determined that a 4(d) rule is appropriate. As a means to facilitate conservation of CWTD in the Columbia River DPS and expansion of their range by increasing flexibility in management activities for our State and Tribal partners and private landowners, we propose to issue a rule for this species under section 4(d) of the Act. This 4(d) rule would only apply if and when the Service finalizes the reclassification of the Columbia River DPS of CWTD as threatened.

    Under the proposed 4(d) rule, the following forms of take would not be prohibited:

    • Take by landowners or their agents conducting intentional harassment not likely to cause mortality if they have obtained a permit from the applicable State conservation agency;

    • Take of problem CWTD (as defined under Provisions of the 4(d) Rule, below) by Federal or State wildlife management agency or private landowners acting in accordance with a permit obtained from a State conservation agency;

    • Take by private landowners that is accidental and incidental to an otherwise permitted and lawful activity to control damage by black-tailed deer, and if reasonable due care was practiced to avoid such taking;

    • Take by black-tailed deer hunters if the take was accidental and incidental to hunting done in full compliance with the State hunting rules, and if reasonable due care was practiced to avoid such taking;

    • Take by designated Tribal employees and State and local law enforcement officers to deal with sick, injured, or orphaned CWTD;

    • Take by State-licensed wildlife rehabilitation facilities when working with sick, injured, or orphaned CWTD; and

    • Take under permits issued by the Service under 50 CFR 17.32. Other than these exceptions, the provisions of 50 CFR 17.31(a) and (b) would apply.

    The proposed 4(d) rule targets these activities to facilitate conservation and management of CWTD where they currently occur through increased flexibility for State wildlife management agencies, and to encourage landowners to facilitate the expansion of CWTD's range by increasing the flexibility of management of the deer on their property (see Justification, below). Activities on Federal lands or with any Federal agency involvement will still need to be addressed through consultation under section 7 of the Act. Take of CWTD in defense of human life in accordance with 50 CFR 17.21(c)(2) or by the Service or designated employee of a State conservation agency responding to a demonstrable but nonimmediate threat to human safety in accordance with 50 CFR 17.21(c)(3)(iv) (primarily in the event that a deer interferes with traffic on a highway) is not prohibited. Any deterence activity that does not create a likelihood of injury by significantly disrupting normal CWTD behavioral patterns such as breeding, feeding, or sheltering is not take and is therefore not prohibited under section 9. Noninjurious deterrence activities for CWTD damage control may include yelling at the deer, use of repellants, fencing and other physical barriers, properly deployed noise-making devices (including explosive devices such as propane cannons, cracker shells, whistlers, etc.), scarecrows, plant protection devices (bud caps, netting, tree tubes, etc.), and artificial lighting.

    If there is potential that an activity would interrupt normal CWTD behavior to the point where the animal would stop feeding or not find adequate cover, creating a likelihood of injury, then the activity would have the potential to cause take in the form of harassment. Under this proposed 4(d) rule, if the activity is not likely to be lethal to CWTD, it would be classified as intentional harassment not likely to cause mortality and would be allowed if the activity is carried out under and according to a legally obtained permit from the Oregon or Washington State conservation agency. Actions that may create a likelihood of injury, but are determined by State wildlife biologists not likely to cause mortality, may include the use of nonlethal projectiles (including paintballs, rubber bullets, pellets or “bb's” from spring- or air-propelled guns, etc.) or herding or harassing with dogs, and would only be allowed if the activity is carried out under and according to a legally obtained permit from the Oregon or Washington State conservation agency.

    This proposed 4(d) rule would also allow a maximum of 5 percent of the DPS to be lethally taken annually for the following activities combined: (1) Damage management of problem CWTD, (2) misidentification during black-tailed deer damage management, and (3) misidentification during black-tailed deer hunting. The identification of a problem CWTD will occur when the State conservation agency or Service determines in writing that: (1) A CWTD is causing more than de minimus negative economic impact to a commercial crop; (2) previous efforts to alleviate the damage through nonlethal methods have been ineffective; and (3) there is a reasonable certainty that additional property losses will occur in the near future if a lethal control action is not implemented.

    The current estimated population of the DPS is 850 deer; therefore 5 percent would currently equate to 43 deer. We would set the annual allowable take at 5 percent of the most current annual population estimate of the DPS to provide sufficient flexibility to our State wildlife agency partners in the management of CWTD and to strengthen our partnership in the recovery of the DPS. Although the fecundity and overall recruitment rate is strong and will allow the DPS to persist and continue to recover even with take up to the maximum allowable 5 percent, we do not expect that the number of deer taken per year will ever exceed 2 percent of the DPS per year for the reasons detailed in the following paragraph.

    In 2013 and 2014, the Service conducted an exceptional amount of direct management on CWTD populations through translocation events; during that time, out of the 47 CWTD that were translocated, only 3 were injured or killed during capture or release. Because no damage management activities have been required for successfully translocated CWTD, no CWTD have been injured or killed as a result of damage management activities. Furthermore, the Service expects that most CWTD will respond to noninjurious or nonlethal means of dispersal and that take of problem CWTD will not often be necessary. We are, therefore, confident that the amount of CWTD taken under this proposed 4(d) rule during CWTD damage management actions would be relatively low. Additionally, the Service expects that the potential for accidental shooting by mistaking a CWTD for a black-tailed deer would be quite low because there has been only one documented case of an accidental shooting of CWTD by a black-tailed deer hunter due to misidentification (Bergh 2014, pers. comm.) and there are no documented accidental shootings of CWTD during black-tailed deer damage management. The 2015 big game hunting regulations in both Oregon and Washington provide information on distinguishing between black-tailed deer and CWTD and make it clear that shooting CWTD is illegal under State law (Oregon Department of Fish and Wildlife 2015, p. 39; Washington Department of Fish and Wildlife 2015, pp. 18, 20). Even with this proposed 4(d) rule in place, a hunter who shot a CWTD due to misidentification would still be required under the Act to report the incident to the Service, required under State law to report the incident to State authorities, and would still be subject to potential prosecution under State law.

    Because the maximum amount of take allowed for these activities would be a percentage of the DPS population in any given year, the exact number of CWTD allowed to be taken would vary from year to year in response to each calendar year's most current estimated population. As mentioned above, we do not expect that the number of deer taken would ever exceed 2 percent of the DPS per year. If take does go beyond 2 percent of the DPS population in a given year, the Service would convene a meeting with the Oregon Department of Fish and Wildlife and the Washington Department of Fish and Wildlife to discuss CWTD management and strategies to minimize further take from these activities for the rest of the year. If take should exceed 5 percent of the total DPS population in any given year, no further take would be allowed for these activities in the DPS as a whole, and, should any further take occur, it would be subject to potential prosecution under the Act.

    Justification

    As the Columbia River DPS of CWTD grows in number and range, the deer are facing increased interaction and potential conflict with the human environment. If finalized, the reclassification of the Columbia River DPS of CWTD would allow employees of State conservation agencies operating a conservation program pursuant to the terms of a cooperative agreement with the Service in accordance with section 6(c) of the Act, and who are designated by their agencies for such purposes, and who are acting in the course of their official duties, to take CWTD to carry out conservation programs (see 50 CFR 17.31(b)). However, there are many activities carried out or managed by the States, Tribes, and private landowners that help reduce conflict with CWTD and thereby facilitate the movement of CWTD across the landscape, but would not be afforded take allowance under reclassification alone. These activities include CWTD damage management, black-tailed deer damage management, and black-tailed deer hunting. The proposed 4(d) rule would provide incentive to States, Tribes, and private landowners to support the movement of CWTD across the landscape by alleviating concerns about unauthorized take of CWTD.

    One of the limiting factors in the recovery of the Columbia River DPS has been the concern of landowners regarding CWTD on their property due to the potential property damage from the species. Landowners express concern over their inability to prevent or address the damage because of the threat of penalties under the Act. Furthermore, State wildlife agencies expend resources addressing landowner complaints regarding potential CWTD damage to their property, or concerns from black-tailed deer hunters who are hunting legally but might accidentally shoot a CWTD even after reasonable due care was practiced to avoid such taking. By providing more flexibility to the States, Tribes, and landowners regarding management of CWTD, we would enhance support for both the movement of CWTD within areas where they already occur, as well as the expansion of the subspecies' range into additional areas of Washington and Oregon through translocations.

    The proposed 4(d) rule would address intentional CWTD damage management by private landowners and State and Tribal agencies; black-tailed deer damage management and hunting; and management of sick, injured, and orphaned CWTD by Tribal employees, State and local law enforcement officers, and State licensed wildlife rehabilitation facilities. Addressing these targeted activities that may normally result in take under section 9 of the Act would increase the incentive for landowners and land managers to allow CWTD on their property, and provide enhanced options for State wildlife agencies with respect to CWTD damage management and black-tailed deer management, thereby encouraging the States' participation in recovery actions for CWTD.

    We believe the actions and activities that would be allowed under the 4(d) rule, while they may have some minimal level of harm or disturbance to individual CWTD in the Columbia River DPS, would not be expected to adversely affect efforts to conserve and recover the DPS and, in fact, should facilitate these efforts. The take of CWTD from these activities would be strictly limited to a maximum of 5 percent of the most current annual DPS population estimate in order to have a negligible impact on the overall DPS population. Though there would be a chance for lethal take to occur, recruitment rates are high enough in the DPS to allow for continued population growth despite the take that would be allowed in this proposed rule. This proposed special rule would not be made final until we have reviewed and fully considered comments from the public and peer reviewers.

    Provisions of the 4(d) Rule

    The increased interaction of CWTD with the human environment increases the potential for property damage caused by CWTD, as well as the potential for conflict with legal black-tailed deer management activities. Therefore, this proposed 4(d) rule would increase the flexibility of CWTD management for the States, Tribes, and private landowners by allowing take of CWTD resulting from CWTD damage management, and black-tailed deer damage management and hunting. The maximum allowable annual take per calendar year for these activities combined would be 5 percent of the most current annual CWTD DPS population estimate.

    A State conservation agency would be able to issue permits to landowners or their agents to harass CWTD on lands they own, rent, or lease if the State conservation agency determines in writing that such action is not likely to cause mortality of CWTD. The techniques employed in this harassment must occur only as specifically directed or restricted by the State permit in order to avoid causing CWTD mortality. The State conservation agency would also be able to issue a permit to landowners or their agents to take problem CWTD on lands they own, rent, or lease. A CWTD would only be identified as a problem deer if the State conservation agency or Service determines in writing that: (1) The CWTD are causing more than de minimus negative economic impact to a commercial crop; (2) previous efforts to alleviate the damage through nonlethal methods have been ineffective; and (3) there is a reasonable certainty that additional property losses will occur in the near future if a lethal control action is not implemented. Take of problem CWTD would have to be implemented only as directed and allowed in the permit obtained from the State conservation agency. Additionally, any employee or agent of the Service or the State conservation agency, who is designated by their agency for such purposes and when acting in the course of their official duties, would be able to take problem CWTD.

    Take of CWTD in the course of carrying out black-tailed deer damage control would be a violation of this rule unless: The taking was accidental; reported within 72 hours; reasonable care was practiced to avoid such taking; and the person causing the take was in possession of a valid black-tailed deer damage control permit from a State conservation agency. Take of CWTD in the course of hunting black-tailed deer would be a violation of this rule unless: The take was accidental; reported within 72 hours; the take was in the course of hunting black-tailed deer under a lawful State permit; and reasonable due care was exercised to avoid such taking.

    The increased interaction of CWTD with the human environment increases the likelihood of encounters with injured or sick CWTD. Therefore, take of CWTD would also be allowed by Tribal employees, State and local government law enforcement officers, and State-licensed wildlife rehabilitation facilities to provide aid to injured or sick CWTD. Tribal employees and local government law enforcement officers would be allowed take of CWTD for the following purposes: Aiding or euthanizing sick, injured, or orphaned CWTD; disposing of a dead specimen; and salvaging a dead specimen that may be used for scientific study. State-licensed wildlife rehabilitation facilities would also be allowed to take CWTD for the purpose of aiding or euthanizing sick, injured, or orphaned CWTD.

    Required Determinations Clarity of This Proposed 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 better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

    National Environmental Policy Act

    We have determined that an environmental assessment or an environmental impact statement, 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 adopted 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 (48 FR 49244).

    Government-to-Government Relationship With Tribes

    In accordance with the President's memorandum of April 29, 1994, Government-to-Government Relations with Native American Tribal Governments (59 FR 22951), E.O. 13175, and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that Tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes.

    We have coordinated the proposed rule with the Cowlitz Indian Tribe who manages land where one subpopulation of CWTD population is located, Cottonwood Island. Biologists from the Cowlitz Indian Tribe are members of the CWTD Working Group and have worked with the Service, WDFW, and ODFW to incorporate conservation measures to benefit CWTD into their management plan for the island.

    References Cited

    A complete list of all references cited in this proposed rule is available at http://www.regulations.gov at Docket No. FWS-R1-ES-2014-0045, or upon request from the Oregon Fish and Wildlife Office (see ADDRESSES).

    Authors

    The primary authors of this document are staff members of the Oregon Fish and Wildlife Office in Portland, Oregon (see FOR FURTHER INFORMATION CONTACT).

    List of Subjects in 50 CFR Part 17

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

    Proposed Regulation Promulgation

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

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

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

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

    (h) * * *

    Species Common name Scientific name Historic range Vertebrate
  • population where
  • endangered or threatened
  • Status When listed Critical
  • habitat
  • Special rules
    Mammals *         *         *         *         *         *         * Deer, Columbian white-tailed Odocoileus virginianus leucurus U.S.A. (WA, OR) Columbia River (Clark, Cowlitz, Pacific, Skamania and Wahkiakum Counties, WA, and Clatsop, Columbia and Multnomah Counties, OR) T 1, 738 NA 17.40(r) *         *         *         *         *         *         *
    3. Amend § 17.40 by adding a paragraph (r) to read as follows:
    § 17.40 Special rules—mammals.

    (r) Columbian white-tailed deer (Odocoileus virginianus leucurus) (CWTD), the Columbia River distinct population segment.

    (1) General requirements. Other than as expressly provided at paragraph (r)(3) of this section, the provisions of § 17.31(a) apply to the CWTD.

    (2) Definitions. For the purposes of this entry:

    (i) CWTD means the Columbia River distinct population segment (DPS) of Columbian white-tailed deer.

    (ii) Intentional harassment means an intentional act which creates the likelihood of injury to wildlife by annoying it to such an extent as to significantly disrupt normal behavior patterns which include, but are not limited to, breeding, feeding, or sheltering. Intentional harassment may include prior purposeful actions to attract, track, wait for, or search out CWTD, or purposeful actions to deter CWTD.

    (iii) Problem CWTD means a CWTD that has been identified in writing by a State conservation agency or the Service as meeting the following criteria:

    (A) The CWTD is causing more than de minimus negative economic impact to a commercial crop;

    (B) Previous efforts to alleviate the damage through nonlethal methods have been ineffective; and

    (C) There is a reasonable certainty that additional property losses will occur in the near future if a lethal control action is not implemented.

    (iv) Commercial crop means commercially raised horticultural, agricultural, or forest products.

    (v) State conservation agency means the State agency in Oregon or Washington operating a conservation program for CWTD pursuant to the terms of a cooperative agreement with the Service in accordance with section 6(c) of the Endangered Species Act.

    (3) Allowable forms of take of CWTD. Take of CWTD resulting from the following legally conducted activities is allowed:

    (i) Intentional harassment not likely to cause mortality. A State conservation agency may issue permits to landowners or their agents to harass CWTD on lands they own, rent, or lease if the State conservation agency determines in writing that such action is not likely to cause mortality of CWTD. The techniques employed in this harassment must occur only as specifically directed or restricted by the State permit in order to avoid causing CWTD mortality.

    (ii) Take of problem CWTD. Take of problem CWTD is authorized under the following circumstances.

    (A) Any employee or agent of the Service or the State conservation agency, who is designated by their agency for such purposes, may, when acting in the course of their official duties, take problem CWTD. This take must occur in compliance with all other applicable Federal, State, and local laws and regulations.

    (B) The State conservation agency may issue a permit to landowners or their agents to take problem CWTD on lands they own, rent, or lease. Such take must be implemented only as directed and allowed in the permit obtained from the State conservation agency.

    (iii) Accidental take of CWTD when carrying out State-permitted black-tailed deer damage control. Take of CWTD in the course of carrying out black-tailed deer damage control will be a violation of this rule unless the taking was accidental; reasonable care was practiced to avoid such taking; and the person causing the take was in possession of a valid black-tailed deer damage control permit from a State conservation agency. When issuing black-tailed deer damage control permits, the State conservation agency will provide education regarding identification of target species. The exercise of reasonable care includes, but is not limited to, the review of the educational material provided by the State conservation agency and identification of the target before shooting.

    (iv) Accidental take of CWTD when carrying out State-permitted black-tailed deer hunting. Take of CWTD in the course of hunting black-tailed deer will be a violation of this rule unless the take was accidental; the take was in the course of hunting black-tailed deer under a lawful State permit; and reasonable due care was exercised to avoid such taking. The State conservation agency will provide educational material to hunters regarding identification of target species when issuing hunting permits. The exercise of reasonable care includes, but is not limited to, the review of the educational materials provided by the State conservation agency and identification of the target before shooting.

    (4) Take limits. The amount of take of CWTD allowed for the activities in subparagraphs (r)(3)(ii), (r)(3)(iii), and (r)(3)(iv) of this section will not exceed 5 percent of the CWTD population during any calendar year as determined by the Service. By December 31 of each year, the Service will use the most current annual DPS population estimate to set the maximum allowable take for these activities for the following calendar year. If take exceeds 2 percent of the DPS population in a given calendar year, the Service will convene a meeting with the Oregon Department of Fish and Wildlife and the Washington Department of Fish and Wildlife to discuss CWTD management and strategies to minimize further take from these activities for the rest of the year. If take exceeds 5 percent of the CWTD population in any given calendar year, no further take under subparagraphs (r)(3)(ii), (r)(3)(iii), and (r)(3)(iv) will be allowed during that year and any further take that does occur may be subject to prosecution under the Endangered Species Act.

    (5) Reporting and disposal requirements. Any injury or mortality of CWTD associated with the actions authorized under paragraphs (r)(3) and (r)(7) of this section must be reported to the Service within 72 hours, and specimens may be disposed of only in accordance with directions from the Service. Reports should be made to the Service's Law Enforcement Office at (503) 231-6125, or the Service's Oregon Fish and Wildlife Office at (503) 231-6179. The Service may allow additional reasonable time for reporting if access to these offices is limited due to closure.

    (6) Additional taking authorizations for Tribal employees, State and local law enforcement officers, and State-licensed wildlife rehabilitation facilities.

    (i) Tribal employees and State and local government law enforcement officers. When acting in the course of their official duties, both Tribal employees designated by the Tribe for such purposes, and State and local government law enforcement officers working in the States of Oregon or Washington, may take CWTD for the following purposes:

    (A) Aiding or euthanizing sick, injured, or orphaned CWTD;

    (B) Disposing of a dead specimen; and

    (C) Salvaging a dead specimen that may be used for scientific study.

    (ii) Such take must be reported to the Service within 72 hours, and specimens may be disposed of only in accordance with directions from the Service.

    (7) Wildlife rehabilitation facilities licensed by the States of Oregon or Washington. When acting in the course of their official duties, a State-licensed wildlife rehabilitation facility may take CWTD for the purpose of aiding or euthanizing sick, injured, or orphaned CWTD. Such take must be reported to the Service within 72 hours as required by paragraph (r)(5) of this section, and specimens may be retained and disposed of only in accordance with directions from the Service.

    (8) Take authorized by permits. Any person with a valid permit issued by the Service under § 17.32 may take CWTD, pursuant to the special terms and conditions of the permit.

    Dated: September 11, 2015. James W. Kurth, Acting Director, U.S. Fish and Wildlife Service.
    [FR Doc. 2015-25260 Filed 10-7-15; 8:45 am] BILLING CODE 4333-15-P
    80 195 Thursday, October 8, 2015 Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2014-0036] Privacy Act Systems of Records; Wildlife Services Management Information System AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Notice; revision of a system of records.

    SUMMARY:

    The Animal and Plant Health Inspection Service proposes to revise an existing system of records in its inventory of record systems subject to the provisions of the Privacy Act of 1974, as amended. The Animal and Plant Health Inspection Service is revising Wildlife Services Management Information System, USDA-APHIS-9, to revise the routine uses, expand the categories of records in the system, and the location of the system. This notice is necessary to meet the requirements of the Privacy Act to publish in the Federal Register notice of the existence and character of record systems maintained by the agency.

    DATES:

    Effective Date: This system will be adopted without further notice on November 17, 2015 unless modified to respond to comments received from the public and published in a subsequent notice.

    Comment date: Comments must be received, in writing, on or before November 9, 2015.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0036.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2014-0036, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

    Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0036 or in our reading room, which is located in Room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Robert P. Myers, Staff Officer, Wildlife Services, APHIS, 4700 River Road Unit 87, Riverdale, MD 20737; (301) 851-2499.

    SUPPLEMENTARY INFORMATION:

    The Privacy Act of 1974, as amended (5 U.S.C. 552a), requires agencies to publish in the Federal Register notice of new or revised systems of records. A system of records is a group of any records under the control of any agency, from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to an individual.

    The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) is proposing to revise a system of records, entitled Wildlife Services (WS) Management Information System (MIS), which is used to maintain a record of activities conducted by the agency pursuant to its mission and responsibilities authorized by the Act of March 2, 1931, as amended (7 U.S.C. 426 and 426(b)), and the Act of December 22, 1987 (7 U.S.C. 426(c)).

    Within this area of responsibility, WS provides wildlife damage management services to Federal, State, Tribal, and local governments; private sector entities within the United States; foreign partners; and cooperators. Individuals and cooperators may include farmers, ranchers, livestock dealers (including agents and brokers), airport employees, representatives of condominium associations, representatives of homeowners associations, golf course owners, pest control operators, contract personnel engaged in program activities, private homeowners, and other individuals. Wildlife damage management services include services to control wildlife diseases and invasive species and to protect livestock, aquaculture, agricultural resources, natural resources, and property.

    The WS MIS contains personally identifiable information about persons who acquire wildlife damage management services from APHIS. The information includes a name, telephone number, mailing address, physical location address, and, when necessary, Global Positioning System (GPS) coordinates. (GPS aids in tracking wildlife damage management devices and to locate entry points where WS has approval to enter lands.) For cooperators for whom WS provides services on specific wildlife damage projects, an identifying number may be issued, which may be a Federal tax identification number, an employer identification number, and for individual citizens who are the primary contact in a funded cooperative agreement relationship, a social security number. In these instances, WS collects social security numbers or other identifying numbers, such as tax identification numbers or employer identification numbers, in compliance with the Debt Collection Improvement Act of 1996 (Pub. L. 104-134). The WS MIS may also include information relating to adverse human or animal incidents, indemnity, agreements, or insurance claims. In addition, the WS MIS includes information about WS employees, such as names, duty stations, user names, passwords, telephone numbers (home and work), email addresses (personal and work), and MIS-specific employee identification numbers.

    Agency procedure requires that WS employees obtain permission to enter the property of cooperators. Information collected about cooperators will be used to document authority and license to enter premises to conduct wildlife damage management activities, pursuant to requests from cooperators for services to be conducted on their behalf. In addition, WS will use the information to help evaluate the effectiveness of program activities.

    Also in support of the APHIS mission, WS conducts surveys by selecting cooperators to provide information about various facets of program activities related to the services provided. Information provided by the cooperator during the course of business enables WS to contact them and request voluntary participation in a survey, as well as use the information volunteered by the cooperator to make determinations about how and when work will be performed, what methods will be used, what information will be provided to the cooperator about the methodology, process, frequency, results, and time lines to be used in program activities, and to assist in developing safety measures and protocols.

    The system of records notice for this system was previously published in the Federal Register on April 30, 2008 (73 FR 23404-23406, APHIS-2006-0018). To the extent that disclosure will not violate 7 U.S.C. 8791, and any amendments thereto, the system is amended to add new Routine Uses 7 through 10 and to revise Routine Uses 1 and 2. Routine Uses 3, 4, 5, 6, and 11 (formerly Routine Use 7) remain the same. In addition, this notice updates the system location and manager, categories of records, storage, retention and disposal, and record source categories.

    Proposed New Routine Uses Proposed New Routine Use 7

    APHIS is adding new routine use 7 to establish that APHIS will disclose the records to agencies that APHIS has interagency agreements or memoranda of understanding with, such as the Bureau of Land Management and the U.S. Fish and Wildlife Service, for cases in which a cooperator has a grazing allotment and the agencies require information about wildlife damage management actions performed on the agencies' managed land.

    Proposed New Routine Use 8

    APHIS is adding new routine use 8 to establish that APHIS will disclose the records to consumer reporting agencies in accordance with section 31 U.S.C. 3711(e) for cases in which WS provides services under a funded cooperative agreement. APHIS is also updating the “Disclosure to Consumer Reporting Agencies” section of the notice to reflect this new routine use.

    Proposed New Routine Use 9

    APHIS is adding new routine use 9 to establish that APHIS will disclose the records to Federal, State, Tribal, and local regulatory agencies and their employees and contractors who collaborate with WS.

    Proposed New Routine Use 10

    APHIS is adding new routine use 10 to establish that APHIS will disclose the records to State- or Federal Government-level representatives of the U.S. Environmental Protection Agency to comply with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) mandate (FIFRA Sec. 8, 7 U.S.C. 136f, and FIFRA 7 U.S.C. 136i-l) as to application or deployment of regulated pesticides and regulated pesticide devices.

    Revised Routine Uses

    Routine Use 1 and Routine Use 2 are being revised by APHIS to add reference to Tribal governments because some WS projects may take place on Tribal lands.

    A complete listing of routine uses of records maintained in the system is included in the document published with this notice.

    System Location and Manager

    APHIS is amending the system location to reflect that the electronic component of the system and its back up are housed on secure USDA-owned and operated systems in Riverdale, MD, and Ft. Collins, CO, and are not located at USDA's National Information Technology Center (NITC) in Kansas City, MO. However, an APHIS mandate scheduled for implementation in Fiscal Year 2015, may dictate that the system be relocated to NITC in Kansas City, MO, possibly with a mirror image stored at the NITC-managed, Enterprise Data Center, St. Louis, MO. APHIS is also updating the title of the system manager.

    Categories of Records

    In addition to the personally identifiable information previously listed in this notice, APHIS is also adding customer resource information, such as the numbers of animals WS may protect on a given property, because WS reports to customers the quantities and types of resources it protects over time and uses summarized date to report the resources it is protecting. This information will also include resources that were threatened, damaged, or destroyed by wildlife. In addition, we are adding information for WS collaborators and some WS contract pilots similar to the information maintained in the system for WS employees.

    Storage

    APHIS is amending this section to agree with the “System Location” section of the notice and to add that documents that are executed originals will be maintained in State or regional WS offices that are locked during non-business hours and require employee identification for admittance at all times.

    Retention and Disposal

    APHIS is amending this section to add that, in addition to Federal and State employee information remaining active in the system as long as the individual works for WS, information may remain active for as long as an employee's project-related work history is retained in the system. In addition, APHIS is adding that WS has developed record retention schedules for electronic information, but until they are approved by the National Archives and Records Administration (NARA), electronic records will be classified as permanent. Lastly, APHIS is adding that record retention schedules for WS paper-based records will be in accordance with NARA and existing APHIS policy.

    Record Source Categories

    APHIS is clarifying that WS employees enter data submitted by cooperators (customers) and that WS may add information to the system that consists of reference and lookup data about pesticide registration, wildlife laws, and permits obtained from Federal, State, Tribal, and local authorities.

    Miscellaneous

    The information collection requests associated with this system have been approved by the Office of Management and Budget under the Paperwork Reduction Act.

    A report on the revised system of records, required by 5 U.S.C. 552a(r), as implemented by Office of Management and Budget Circular A-130, was sent to the Chairman, Committee on Homeland Security and Governmental Affairs, United States Senate; the Chairman, Committee on Oversight and Government Reform, House of Representatives; and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget.

    Done in Washington, DC, this 28th day of September 2015. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. USDA-APHIS-9 System name:

    Wildlife Services Management Information System

    Security classification:

    None.

    System location:

    The files (paper-based component) for the Wildlife Services (WS) Management Information System (MIS) are maintained in the offices of Wildlife Services, Riverdale, MD; Wildlife Services Information Technology Support Center, Ft. Collins, CO; Federal and State area offices; and Federal regional offices. The electronic component of the system is housed on secure USDA-owned and operated systems in Riverdale, MD, and Ft. Collins, CO. A backup site for the data is also located at Riverdale, MD and Ft. Collins, CO. However, an APHIS mandate scheduled for implementation in fiscal year 2016, may dictate that the system be relocated to USDA's National Information Technology Center (NITC) in Kansas City, MO, possibly with a mirror image stored at the NITC-managed, Enterprise Data Center, St. Louis, MO.

    Categories of individuals covered by the system:

    Individuals who participate in depredation activities, including ranchers, farmers, livestock dealers (including agents and brokers) handling livestock covered by the program, airport employees, representatives of condominium associations, representatives of homeowner associations, private homeowners, golf course owners, employees of the Federal Government, employees of State and Tribal governments, pest control operators, contract personnel engaged in program activities, and other entities.

    Categories of records in the system:

    The records consist of agreements for services; description of property; names and addresses of those entering the agreement; contact information, including names and telephone numbers; property locations and descriptions, which may include Global Positioning System coordinates and customer resource information; resources that were threatened, damaged, or destroyed by wildlife; adverse human or animal incidents information; and insurance, appraisals, indemnity, and property damage information. In addition, for cooperators for whom WS provides services on specific wildlife damage projects, an identifying number, which may be a Federal tax identification number, an employer identification number, or for individual citizens who are the primary contact in a funded cooperative agreement relationship, a social security number. (Identifying numbers are recorded only on the paper-based component of the system.)

    The system also includes information about WS employees, WS collaborators, and some WS contract pilots, such as names, duty stations, user names, passwords, telephone numbers (home and work), email addresses (personal and work), and MIS-specific employee identification numbers.

    Purpose(s) of the system:

    This system will be used to maintain a record of activities conducted by the agency pursuant to its mission and responsibilities for providing services necessary to manage wildlife damage to agriculture, human health and safety, natural resources, and human property.

    Authority for maintenance of the system:

    The Act of March 2, 1931, as amended (7 U.S.C. 426 and 426(b)), and the Act of December 22, 1987 (7 U.S.C. 426(c)).

    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, records maintained in the system may be disclosed outside USDA, to the extent that disclosure will not violate 7 U.S.C. 8791, and any amendments thereto, as follows:

    (1) To cooperative Federal, State, Tribal, and local government officials, employees, or contractors, and other parties as necessary to carry out the program; and other parties engaged to assist in administering the program. Such contractors and other parties will be bound by the nondisclosure provisions of the Privacy Act. This routine use assists the agency in carrying out the program, and thus is compatible with the purpose for which the records are created and maintained;

    (2) To the appropriate agency, whether Federal, State, local, Tribal, or foreign, charged with responsibility of investigating or prosecuting a violation of law or of enforcing, implementing, or complying with a statute, rule, regulation, or order issued pursuant thereto, of any record within this system when information available indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and either arising by general statute or particular program statute, or by rule, regulation, or court order issued pursuant thereto;

    (3) To the Department of Justice when the agency, or any component thereof, or any employee of the agency in his or her official capacity, or any employee of the agency in his or her individual capacity where the Department of Justice has agreed to represent the employee, or the United States, in litigation, where the agency determines that litigation is likely to affect the agency or any of its components, is a party to litigation or has an interest in such litigation, and the use of such records by the Department of Justice is deemed by the agency to be relevant and necessary to the litigation; provided, however, that in each case, the agency determines that disclosure of the records to the Department of Justice is a use of the information contained in the records that is compatible with the purpose for which the records were collected;

    (4) For use in a proceeding before a court or adjudicative body before which the agency is authorized to appear, when the agency, or any component thereof, or any employee of the agency in his or her official capacity, or any employee of the agency in his or her individual capacity where the agency has agreed to represent the employee, or the United States, where the agency determines that litigation is likely to affect the agency or any of its components, is a party to litigation or has an interest in such litigation, and the agency determines that use of such records is relevant and necessary to the litigation; provided, however, that in each case, the agency determines that disclosure of the records to the court is a use of the information contained in the records that is compatible with the purpose for which the records were collected;

    (5) To appropriate agencies, entities, and persons when the agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; the agency has determined that as a result of the suspected or confirmed compromise, there is a risk of harm to economic or property interests, a risk of identity theft or fraud, or a risk of harm to the security of integrity of this system or other systems or programs (whether maintained by the agency or another agency or entity) that rely upon the compromised information; and the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the agency's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm;

    (6) To USDA contractors, partner agency employee or contractors, or private industry employed to identify patterns, trends, or anomalies indicative of fraud, waste, or abuse;

    (7) To land management agencies, such as the Bureau of Land Management and the U.S. Fish and Wildlife Service relating to wildlife damage on grazing allotments;

    (8) To consumer reporting agencies in accordance with section 31 U.S.C. 3711(e);

    (9) To Federal, State, Tribal, and local regulatory agencies and their employees and contractors who collaborate with Wildlife Services in implementation of, or agencies that regulate, wildlife management projects or programs, or who have an interest in, or regulate, animal or public health, or national security;

    (10) To State- or Federal Government-level representatives of the U.S. Environmental Protection Agency, in compliance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) mandate (FIFRA Sec. 8, 7 U.S.C. 136f, and FIFRA 7 U.S.C. 136i-l), of the location on a cooperator's property where certain regulated pesticide devices are deployed or regulated pesticides are applied; and

    (11) To the National Archives and Records Administration (NARA) or to the General Services Administration for records management inspections conducted under 44 U.S.C. 2904 and 2906.

    Disclosure to consumer reporting agencies:

    In accordance with section 31 U.S.C. 3711(e).

    Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:

    Policies for storing, retrieving, accessing, retaining, and disposing of records in the system are outlined in the Wildlife Services Information and Data Management Handbook and the APHIS Records Management Handbook and are summarized below.

    Storage:

    The WS MIS records will be maintained in USDA-owned server storage. Documents that are executed originals will be maintained in State or regional Wildlife Services offices that are locked during non-business hours and require employee identification for admittance at all times.

    Retrievability:

    Under this system, data may be retrieved and organized by agreement number, name of cooperator, or agreement holder. Retrieval permissions for employees who have access to the system are determined by the data usage role of the employee and are compliant with the APHIS “least privilege” rule.

    Safeguards:

    Control measures designed to prevent misuse of accessible data include unique user identification, a password protection protocol, and limitation of user roles through compartmentalization of allowed access. Agency implemented cybersecurity measures and firewalls are built into the application user interface, and monitoring of use of the MIS for profiles of misuse is possible. The hard copy components of the system, and computer files, tapes, and disks are kept in a safeguarded environment with access only by authorized personnel.

    Retention and disposal:

    Information identifying cooperators is kept in the system as long as a cooperator retains an active agreement with WS. Federal and State employee information is kept active in the system as long as the individual works for WS or as long as their project-related work history is retained in the system. WS has developed record retention schedules for electronic information, but until they are approved by NARA, electronic records will be classified as permanent. Record retention schedules for WS paper-based records are in accordance with NARA and existing APHIS policy.

    System manager(s) and address:

    Director, Applications Development, Information Technology Support Center, Wildlife Services, USDA/APHIS, NRRC, 2150 Centre Avenue, Building A, Suite 143, Fort Collins, CO 80526.

    Notification procedure:

    Any individual may request general information regarding this system of records or information as to whether the system contains records pertaining to him/her from the system manager at the address above. All inquiries pertaining to this system should be in writing, must name the system of records as set forth in the system notice, and must contain the individual's name, telephone number, address, and email address.

    Record access procedures:

    Any individual may obtain information from a record in the system that pertains to him or her. Requests for hard copies of records should be in writing, and the request must contain the requesting individual's name, address, name of the system of records, timeframe for the records in question, any other pertinent information to help identify the file, and a copy of his/her photo identification containing a current address for verification of identification. All inquiries should be addressed to the Freedom of Information and Privacy Act Staff, Legislative and Public Affairs, APHIS, 4700 River Road Unit 50, Riverdale, MD 20737-1232.

    Contesting record procedures:

    Any individual may contest information contained within a record in the system that pertains to him/her by submitting a written request to the system manager at the address above. Include the reason for contesting the record and the proposed amendment to the information with supporting documentation to show how the record is inaccurate.

    Record source categories:

    WS users generate data about the work performed by WS. Additional data is collected is voluntarily submitted by cooperators (customers) and entered into the system by WS employees. In addition, reference and lookup data about pesticide registration, wildlife laws, and permits are obtained from Federal, State, Tribal, and local authorities.

    Exemptions claimed for the system:

    None.

    [FR Doc. 2015-25640 Filed 10-7-15; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Forest Service National Urban and Community Forestry Advisory Council AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The National Urban and Community Forestry Advisory Council (Council) will meet in Denver, Colorado. The Council is authorized under section 9 of the Cooperative Forestry Assistance Act, as amended by title XII, section 1219 of Public Law 101-624 (the Act) (16 U.S.C. 2105g) and the Federal Advisory Committee Act (FACA) (5 U.S.C. App. II). Additional information concerning the Council, can be found by visiting the Council's Web site at: http://www.fs.fed.us/ucf/nucfac.shtml.

    DATES:

    The meeting will be held on Monday, November 16, 2015 from 9:00 a.m. to 5:00 p.m. PDT or until Council business is completed. All meetings are subject to cancellation. For updated status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Webb Municipal Office Building, Conference Room 1.D.1, 201 West Colfax Avenue, Denver, Colorado. Written comments concerning this meeting should be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses, when provided, are placed in the record and available for public inspection and copying. The public may inspect comments received at the USDA Forest Service, Sidney Yates Building, Room 3SC-01C, 201 14th Street SW., Washington DC 20024. Please call ahead at 202-205-7829 to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Nancy Stremple, Executive Staff, National Urban and Community Forestry Advisory Council, Sidney Yates Building, Room 3SC-01C, 201 14th Street SW., Washington, DC 20024, by telephone at 202-205-7829, or by email at [email protected], or by cell phone at 202-309-9873, or via facsimile at 202-690-5792.

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to:

    1. Introduce new members;

    2. Develop the 2016 Work Plan;

    3. Develop the 2017 grant categries;

    4. Listen to local constituents urban forestry concerns;

    5. Prepare to present the 10-year action plan (2016-2026);

    6. Receive Forest Service budget and program updates; and

    7. Finalize the 2015 Accomplishments/Recommendations report.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should submit a request in writing by November 2, 2015, to be scheduled on the agenda. Council discussion is limited to Forest Service staff and Council members, however anyone who would like to bring urban and community forestry matters to the attention of the Council may file written statements with the Council's staff before or after the meeting. Written comments and time requests for oral comments must be sent to Nancy Stemple, Executive Staff, National Urban and Community Forestry Advisory Council, Sidney Yates Building, Room 3SC-01C, 201 14th Street SW., Washington, DC 20024, or by email at [email protected]

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled For Further Information Contact. All reasonable accommodation requests are managed on a case by case basis.

    Dated: October 2, 2015. Patti Hirami, Associate Deputy Chief, State & Private Forestry.
    [FR Doc. 2015-25611 Filed 10-7-15; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Request for Applications: The Community Forest and Open Space Conservation Program AGENCY:

    Forest Service, USDA.

    ACTION:

    Request for applications.

    SUMMARY:

    The U.S. Department of Agriculture, Forest Service, State and Private Forestry, Cooperative Forestry staff, requests applications for the Community Forest and Open Space Conservation Program (CFP). This is a competitive grant program whereby local governments, qualified nonprofit organizations, and Indian Tribes are eligible to apply for grants to establish community forests through fee simple acquisition of private forest land from a willing seller. The purpose of the program is to establish community forests by protecting forest land from conversion to non-forest uses and provide community benefits such as sustainable forest management, environmental benefits including clean air, water, and wildlife habitat; benefits from forest-based educational programs; benefits from serving as models of effective forest stewardship; and recreational benefits secured with public access.

    Eligible lands for grants funded under this program are private forests that are at least five acres in size, suitable to sustain natural vegetation, and at least 75 percent forested. The lands must also be threatened by conversion to non-forest uses, must not be held in trust by the United States on behalf of any Indian Tribe, must not be Tribal allotment lands, must be offered for sale by a willing seller, and if acquired by an eligible entity, must provide defined community benefits under CFP and allow for public access.

    DATES:

    Interested local government and nonprofit applicants must submit applications to the State Forester. Tribal applicants must submit applications to the appropriate Tribal government officials. All applications, either hardcopy or electronic, must be received by State Foresters or Tribal governments by January 15, 2016. State Foresters or Tribal government officials must forward applications to the Forest Service Region, Northeastern Area or International Institute of Tropical Forestry by February 19, 2016.

    ADDRESSES:

    All local government and qualified nonprofit organization applications must be submitted to the State Forester of the State where the property is located. All Tribal applications must be submitted to the equivalent Tribal government official. Applicants are encouraged to contact and work with the Forest Service Region, Northeastern Area or International Institute of Tropical Forestry, and State Forester or equivalent Tribal government official when developing their proposal. Applicants must consultant with the State Forester and equivalent Tribal government official prior to requesting technical assistance for a project. The State Forester's member roster may be found on http://www.fs.fed.us/spf/coop/programs/loa/cfp.shtml. All applicants must also send an email to [email protected] to confirm an application has been submitted for funding consideration.

    State Foresters and Tribal government officials shall submit applications, either electronic or hardcopy, to the appropriate Forest Service Regional/Area/Institute contact noted below.

    Northern and Intermountain Regions Regions 1 and 4 (ID, MT, ND, NV, UT) Janet Valle, U.S. Forest Service, 324 25th St., Ogden, UT 84401, 801-625-5258 (phone), 801-625-5716 (fax), [email protected] Rocky Mountain Region Region 2 (CO, KS, NE, SD, WY) Claire Harper, U.S. Forest Service, 740 Simms Street, Golden, CO 80401, 303-275-5239 (phone), 303-275-5754 (fax), [email protected] Southwestern Region Region 3 (AZ, NM) Alicia San Gil, U.S. Forest Service, 333 Broadway SE., Albuquerque, NM 87102, 505-842-3881 (phone), 505-842-3165 (fax), [email protected] Pacific Southwest Region Region 5 (CA, HI, Guam, American Samoa, Federated States of Micronesia and Other Pacific Islands) Chris Fischer, U.S. Forest Service, 1323 Club Drive, Vallejo, CA 94592, 707-562-8921 (phone), 707-562-9054 (fax), [email protected] Pacific Northwest, and Alaska Regions Regions 6 and 10 (AK, OR, WA) Karl Dalla Rosa, U.S. Forest Service, 120 Southwest 3rd Ave., Portland, OR 97204 or P.O. Box 3623, Portland, OR 97208-3623, 503-808-2913 (phone), 503-808-2469 (fax), [email protected] Southern Region Region 8 (AL, AR, FL, GA, KY, LA, MS, NC, OK, SC, TN, TX, VA) Mike Murphy, U.S. Forest Service, 1720 Peachtree Rd., NW., Suite 700B 850S North, Atlanta, GA 30309, 404-347-5214 (phone), 404-347-2776 (fax), [email protected] International Institute of Tropical Forestry (PR, VI) Magaly Figueroa, U.S. Forest Service, Jardin Botanico Sur, 1201 Calle Ceiba, San Juan, PR 00926-1119, 787-766-5335 x 222 (phone), 787-766-6263 (fax), [email protected] Northeastern Area (CT, DC, DE, IA, IL, IN, MA, MD, ME, MI, MN, MO, NH, NJ, NY, OH, PA, RI, VT, WI, WV) Neal Bungard, U.S. Forest Service, 271 Mast Road, Durham, NH 03824-4600, 603-868-7719 (phone), 603-868-7604 (fax), [email protected] FOR FURTHER INFORMATION CONTACT:

    For questions regarding the grant application or administrative regulations, contact Maya Solomon, Program Coordinator, 202-205-1376, [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 twenty-four hours a day, every day of the year, including holidays.

    SUPPLEMENTARY INFORMATION:

    CFDA number 10.689: To address the goals of Section 7A of the Cooperative Forestry Assistance Act of 1978 (16 U.S.C. 2103d) as amended, the Forest Service is requesting proposals for community forest projects that protect forest land that has been identified as a national, regional, or local priority for protection and to assist communities in acquiring forestland that will provide public recreation, environmental and economic benefits, and forest-based educational programs.

    Detailed information regarding what to include in the application, definitions of terms, eligibility, and necessary prerequisites for consideration can be found in the final program rule, published October 20, 2011 (76 FR 65121-65133), which is available at www.fs.fed.us/spf/coop/programs/loa/cfp.shtml and at www.grants.gov (Opportunity number CFP-FS-1002016).

    Grant Application Requirements 1. Eligibility Information

    a. Eligible Applicants. A local governmental entity, Indian Tribe (including Alaska Native Corporations), or a qualified nonprofit organization that is qualified to acquire and manage land (see § 230.2 of the final rule). Individuals are not eligible to receive funds through this program.

    b. Cost Sharing (Matching Requirement). All applicants must demonstrate a 50 percent match of the total project cost. The match can include cash, in-kind services, or donations, which shall be from a non-Federal source. For additional information, please see § 230.6 of the final rule at www.fs.fed.us/spf/coop/programs/loa/cfp.shtml.

    c. DUNS Number. All applicants shall include a Data Universal Numbering System (DUNS) number in their application. For this requirement, the applicant is the entity that meets the eligibility criteria and has the legal authority to apply for and receive the grant. For assistance in obtaining a DUNS number at no cost, call the DUNS number request line 1-866-705-5711 or register on-line at http://fedgov.dnb.com/webform.

    d. System for Award Management. All prospective awardees shall be registered in the System for Award Management prior to award, during performance, and through final payment of any grant resulting from this solicitation. Further information can be found at www.sam.gov. For assistance, contact Federal Service Desk 1-866-606-8220.

    2. Award Information

    The Administration proposed to fund the CFP at $1.683 million for fiscal year 2016. Individual grant applications may not exceed $400,000, which does not include technical assistance requests. The Federal Government's obligation under this program is contingent upon the availability of appropriated funds.

    No legal liability on the part of the Government shall be incurred until funds are committed by the grant officer for this program to the applicant in writing. The initial grant period shall be for 2 years, and acquisition of lands should occur within that timeframe. Lands acquired prior to the grant award are not eligible for CFP funding. The grant may be reasonably extended by the Forest Service when necessary to accommodate unforeseen circumstances in the land acquisition process. Written annual financial performance reports and semi-annual project performance reports shall be required and submitted to the appropriate grant officer.

    Technical assistance funds, totaling not more than 10 percent of all funds, may be allocated to State Foresters and equivalent officials of the Indian tribe. Technical assistance, if provided, will be awarded at the time of the grant. Applicants shall work with State Foresters and equivalent officials of the Indian tribe to determine technical assistance needs and include the technical assistance request in the project's budget.

    As funding allows, applications submitted through this request may be funded in future years, subject to the availability of funds and the continued feasibility and viability of the project.

    3. Application Information

    Application submission. All local governments and qualified nonprofit organizations' applications must be submitted to the State Forester where the property is located by January 15, 2016. All Tribal applications must be submitted to the equivalent Tribal government official by January 15, 2016. Applications may be submitted either electronic or hardcopy to the appropriate official. The State Forester's contact information may be found at http://www.fs.fed.us/spf/coop/programs/loa/cfp.shtml.

    All applicants must also send an email to [email protected] to confirm an application has been submitted to the State Forester or equivalent Tribal government official for funding consideration.

    All State Foresters and Tribal government officials must forward applications to the Forest Service by February 19, 2016.

    4. Application Requirements

    The following section outlines grant application requirements:

    a. The application can be no more than eight pages long, plus no more than two maps (eight and half inches by eleven inches in size), the grant forms specified in (b), and the draft community forest plan specified in (d).

    b. The following grant forms and supporting materials must be included in the application:

    (1) An Application for Federal Assistance (Standard Form 424);

    (2) Budget information (Standard Form SF 424c—Construction Programs); and

    (3) Assurances of compliance with all applicable Federal laws, regulations, and policies (Standard Form 424d— Construction Programs).

    c. Documentation verifying that the applicant is an eligible entity and that the land proposed for acquisition is eligible (see § 230.2 of the final rule).

    d. Applications must include the following, regarding the property proposed for acquisition:

    (1) A description of the property, including acreage and county location;

    (2) A description of current land uses, including improvements;

    (3) A description of forest type and vegetative cover;

    (4) A map of sufficient scale to show the location of the property in relation to roads and other improvements as well as parks, refuges, or other protected lands in the vicinity;

    (5) A description of applicable zoning and other land use regulations affecting the property;

    (6) A description of the type and extent of community benefits, including to underserved communities (selection criteria outlined below);

    (7) A description of relationship of the property within and its contributions to a landscape conservation initiative; and

    (8) A description of any threats of conversion to non-forest uses, including any encumbrances on the property that prevent conversion to nonforest uses.

    e. Information regarding the proposed establishment of a community forest, including:

    (1) A description of the benefiting community, including demographics, and the associated benefits provided by the proposed land acquisition;

    (2) A description of community involvement to-date in the planning of the community forest acquisition and of community involvement anticipated in long-term management of the property;

    (3) An identification of persons and organizations that support the project and their specific role in establishing and managing the community forest; and

    (4) A draft community forest plan. The eligible entity is encouraged to work with the State Forester or equivalent Tribal government official for technical assistance when developing or updating the Community Forest Plan. In addition, the eligible entity is encouraged to work with technical specialists, such as professional foresters, recreation specialists, wildlife biologists, or outdoor education specialists, when developing the Community Forest Plan.

    f. Information regarding the proposed land acquisition, including:

    (1) A proposed project budget not exceeding $400,000 and technical assistance needs as coordinated with the State Forester or equivalent Tribal government official (section § 230.6 of the final program rule);

    (2) The status of due diligence, including signed option or purchase and sale agreement, title search, minerals determination, and appraisal;

    (3) Description and status of cost share (secure, pending, commitment letter, etc. (section § 230.6 of the final rule) ;

    (4) The status of negotiations with participating landowner(s) including purchase options, contracts, and other terms and conditions of sale;

    (5) The proposed timeline for completing the acquisition and establishment of the community forest; and

    (6) Long term management costs and funding source(s).

    g. Applications must comply with the U. S. Department of Agriculture's Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards also referred to as the Omni Circular (2 CFR 400).

    h. Applications must also include the forms required to process a Federal grant. Section 6 Grant Requirements references the grant forms that must be included in the application and the specific administrative requirements that apply to the type of Federal grant used for this program.

    A sample grant outline, scoring guidance, the final rule, and required forms can be found on the CFP Web site at: http://www.fs.fed.us/spf/coop/programs/loa/cfp.shtml.

    5. Forest Service's Project Selection Criteria

    a. Using the criteria described below, to the extent practicable, the Forest Service will give priority to applications that maximize the delivery of community benefits, as defined in the final rule (see § 230.2 of the final rule).; and

    b. The Forest Service will evaluate all applications received by the State Foresters or equivalent Tribal government officials and award grants based on the following criteria:

    (1) Type and extent of community benefits provided, including to underserved communities. Community benefits are defined in the final program rule as:

    (i) Economic benefits, such as timber and non-timber products;

    (ii) Environmental benefits, including clean air and water, stormwater management, and wildlife habitat;

    (iii) Benefits from forest-based experiential learning, including K-12 conservation education programs; vocational education programs in disciplines such as forestry and environmental biology; and environmental education through individual study or voluntary participation in programs offered by organizations such as 4-H, Boy or Girl Scouts, Master Gardeners, etc.;

    (iv) Benefits from serving as replicable models of effective forest stewardship for private landowners; and

    (v) Recreational benefits, such as hiking, hunting and fishing secured through public access.

    (2) Extent and nature of community engagement in the establishment and long-term management of the community forest;

    (3) Amount of cost share leveraged;

    (4) Extent to which the community forest contributes to a landscape conservation initiative;

    (5) Extent of due diligence completed on the project, including cost share committed and status of appraisal;

    (6) Likelihood that, if unprotected, the property would be converted to non-forest uses; and

    (7) Costs to the Federal Government.

    6. Grant Requirements

    a. Once an application is selected, funding will be obligated to the grant recipient through a grant.

    b. Local and Indian tribal governments should refer to 2 CFR part 225, Cost Principles for State,

    Local, and Indian Tribal Governments (OMB Circular A-87) and 7 CFR part 3016 (Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments) for directions.

    c. Nonprofit organizations should refer to 2 CFR part 215 Uniform Administrative Requirements for Grants and Other Agreements With Institutions of Higher Education, Hospitals and Other Nonprofit Organizations (OMB Circular A-110) and 7 CFR part 3019 Uniform Administrative Requirements for Grants and Cooperative Agreements With Institutions of Higher Education, Hospitals, and other Nonprofit Organizations for directions.

    d. Forest Service must approve any amendments to a proposal or request to reallocate funding within a grant proposal. If negotiations on a selected project fail, the applicant cannot substitute an alternative site.

    e. The grant recipient must comply with the requirements in section § 230.8 in the final rule before funds will be released.

    f. After the project has closed, as a requirement of the grant, grant recipients will be required to provide the Forest Service with a Geographic Information System (GIS) shapefile: A digital, vector-based storage format for storing geometric location and associated attribute information, of CFP project tracts and cost share tracts, as applicable.

    g. Any funds not expended within the grant period must be de-obligated and returned to the Forest Service.

    h. All media, press, signage, and other documents discussing the creation of the community forest must reference the partnership and financial assistance by the Forest Service through the CFP.

    Additional information may be found in section § 230.9 of the final rule.

    Dated: October 2, 2015. Patricia F. Hirami, Associate Deputy Chief, State and Private Forestry.
    [FR Doc. 2015-25725 Filed 10-7-15; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration Advisory Committee Meeting AGENCY:

    Grain Inspection, Packers and Stockyards Administration, USDA.

    ACTION:

    Notice of advisory committee meeting.

    SUMMARY:

    Pursuant to the Federal Advisory Committee Act, this constitutes notice of the upcoming meeting of the Grain Inspection, Packers and Stockyards Administration (GIPSA) Grain Inspection Advisory Committee (Advisory Committee). The Advisory Committee meets annually to advise the GIPSA Administrator on the programs and services that GIPSA delivers under the U.S. Grain Standards Act. Recommendations by the Advisory Committee help GIPSA better meet the needs of its customers who operate in a dynamic and changing marketplace.

    DATES:

    October 27, 2015, 8:00 a.m. to 4:30 p.m.; and October 28, 2015, 8:00 a.m. to Noon.

    ADDRESSES:

    The Advisory Committee meeting will take place at GIPSA's National Grain Center, 10383 N. Ambassador Drive, Kansas City, Missouri 64153.

    Requests to orally address the Advisory Committee during the meeting or written comments may be sent to: Administrator, GIPSA, U.S. Department of Agriculture, 1400 Independence Avenue SW., STOP 3601, Washington, DC 20250-3601. Requests and comments may also be faxed to (202) 690-2173.

    FOR FURTHER INFORMATION CONTACT:

    Terri L. Henry by phone at (202) 205-8281 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    The purpose of the Advisory Committee is to provide advice to the GIPSA Administrator with respect to the implementation of the U.S. Grain Standards Act (7 U.S.C. 71-87k). Information about the Advisory Committee is available on the GIPSA Web site at http://www.gipsa.usda.gov/fgis/adcommit.html.

    The agenda will include service delivery overview, quality updates, field management overview, international program updates, and technology and science initiatives.

    For a copy of the agenda please contact Terri L. Henry by phone at (202) 205-8281 or by email at [email protected]

    Public participation will be limited to written statements unless permission is received from the Committee Chairperson to orally address the Advisory Committee. The meeting will be open to the public.

    Persons with disabilities who require alternative means of communication of program information or related accommodations should contact Terri L. Henry at the telephone number listed above.

    Larry Mitchell, Administrator, Grain Inspection, Packers and Stockyards Administration.
    [FR Doc. 2015-25650 Filed 10-7-15; 8:45 am] BILLING CODE 3410-KD-P
    DEPARTMENT OF COMMERCE International Trade Administration Meeting of the United States Manufacturing Council AGENCY:

    International Trade Administration, Commerce.

    ACTION:

    Notice of an open meeting.

    SUMMARY:

    The United States Manufacturing Council (Council) will hold an open meeting on Friday, October 23, 2015. The Council was established in April 2004 to advise the Secretary of Commerce on matters relating to the U.S. manufacturing industry. The purpose of the meeting is for Council members to review and deliberate on recommendations developed by the Workforce Development subcommittee looking at issues of shifting the image of manufacturing and high school educational approach enhancements for consideration by the Manufacturing Council. The agenda may change to accommodate Council business. The final agenda will be posted on the Department of Commerce Web site for the Council at http://trade.gov/manufacturingcouncil, at least one week in advance of the meeting.

    DATES:

    Friday, October 23, 2015, 8:00 a.m.-2:00 p.m. The deadline for members of the public to register, including requests to make comments during the meetings and for auxiliary aids, or to submit written comments for dissemination prior to the meeting, is 5 p.m. EDT on October 13, 2015.

    ADDRESSES:

    The meeting will be held at 1651 Wilkening Road in Schaumburg, Ilinois. Requests to register (including to speak or for auxiliary aids) and any written comments should be submitted to: U.S. Manufacturing Council, U.S. Department of Commerce, Room 4043, 1401 Constitution Avenue NW., Washington, DC 20230, [email protected] Members of the public are encouraged to submit registration requests and written comments via email to ensure timely receipt.

    FOR FURTHER INFORMATION CONTACT:

    Archana Sahgal, the United States Manufacturing Council, Room 4043, 1401 Constitution Avenue NW., Washington, DC 20230, telephone: 202-482-4501, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background: The Council advises the Secretary of Commerce on matters relating to the U.S. manufacturing industry.

    Public Participation: The meeting will be open to the public and will be accessible to people with disabilities. All guests are required to register in advance by the deadline identified under the DATES caption. Seating is limited and will be on a first come, first served basis. Requests for sign language interpretation or other auxiliary aids must be submitted by the registration deadline. Last minute requests will be accepted, but may be impossible to fill. There will be fifteen (15) minutes allotted for oral comments from members of the public. To accommodate as many speakers as possible, the time for public comments may be limited to three (3) minutes per person. Individuals wishing to reserve speaking time during the meeting must submit a request at the time of registration, as well as the name and address of the proposed speaker. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, the International Trade Administration may conduct a lottery to determine the speakers. Speakers are requested to submit a written copy of their prepared remarks by 5:00 p.m. on Tuesday, October 13, 2015, for inclusion in the meeting records and for circulation to the members of the Manufacturing Council. Speakers additionally are requested to bring at least 25 copies of their oral comments for distribution to the members of the Manufacturing Council and to the public at the meeting. In addition, any member of the public may submit pertinent written comments concerning the Council's affairs at any time before or after the meeting. Comments may be submitted to Archana Sahgal at the contact information indicated above. To be considered during the meeting, comments must be received no later than 5:00 p.m. EDT on October 13, 2015, to ensure transmission to the Council prior to the meeting. Comments received after that date and time will be distributed to the members but may not be considered during the meeting. Copies of Council meeting minutes will be available within 90 days of the meeting.

    Dated: October 2, 2015. Archana Sahgal, Executive Secretary, United States Manufacturing Council.
    [FR Doc. 2015-25671 Filed 10-5-15; 4:15 pm] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-552-814] Utility Scale Wind Towers From the Socialist Republic of Vietnam: Notice of 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 its administrative review of utility scale wind towers (“wind towers”) from the Socialist Republic of Vietnam (“Vietnam”) for the period February 1, 2014 through January 31, 2015 (“POR”), based on the withdrawal of request for review.

    DATES:

    Effective date: October 8, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Robert Galantucci, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2923.

    SUPPLEMENTARY INFORMATION: Background

    On February 2, 2015, the Department published the notice of opportunity to request an administrative review of the antidumping duty order on wind towers from Vietnam for the POR.1 On February 25, 2015, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the “Act”), and 19 CFR 351.213(b), the Department received a timely request from the Wind Tower Trade Coalition (“Petitioner”) to conduct an administrative review.2

    1See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 80 FR 5509 (February 2, 2015).

    2See Letter from Petitioner, “Utility Scale Wind Towers from the Socialist Republic of Vietnam: Request for Administrative Review,” dated February 25, 2015.

    Pursuant to this request and in accordance with 19 CFR 351.221(c)(1)(i), on April 3, 2015, the Department published a notice of initiation of an administrative review of the antidumping duty order on wind towers from Vietnam.3 On July 1, 2015, Petitioner withdrew its request for an administrative review.4

    3See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 80 FR 18202 (April 3, 2015) (“Initiation Notice”).

    4See Letter from Petitioner, “Utility Scale Wind Towers from the Socialist Republic of Vietnam: Withdrawal of Request for Administrative Review,” dated July 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 the request within 90 days of the publication date of the notice of initiation of review. As noted above, Petitioner withdrew its request for review within 90 days of the publication date of the Initiation Notice. No other parties requested an administrative review of the order. Therefore, in accordance with 19 CFR 351.213(d)(1), we are rescinding this review in its entirety.

    Assessment

    The Department will instruct U.S. Customs and Border Protection (“CBP”) to assess antidumping duties on all appropriate entries of wind towers from Vietnam. Antidumping duties shall be assessed 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 date of publication of this notice of rescission of administrative review.

    Notifications

    This notice also serves as a final reminder to importers for whom this review is being rescinded 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 Secretary's presumption that reimbursement of the antidumping duties occurred and the subsequent assessment of double antidumping duties.

    This notice also serves as a reminder to parties subject to administrative protective orders (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/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 published in accordance with section 751 of the Act, and 19 CFR 351.213(d)(4).

    Dated: October 1, 2015. Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2015-25683 Filed 10-7-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-351-844, C-533-866, C-570-030, C-580-882, C-821-823] Certain Cold-Rolled Steel Flat Products From Brazil, India, the People's Republic of China, the Republic of Korea, and the Russian Federation: Postponement of Preliminary Determinations in the Countervailing Duty Investigations AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    FOR FURTHER INFORMATION CONTACT:

    Sergio Balbontin at (202) 482-6478 (Brazil); Robert Bolling at (202) 482-3434 and Erin Kearney at (202) 482-0167 (India); Yasmin Nair at (202) 482-3813 (the People's Republic of China and the Republic of Korea); and Kristen Johnson at (202) 482-4793 (the Russian Federation), AD/CVD Operations, Enforcement and Compliance, International Trade Administration, Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.

    SUPPLEMENTARY INFORMATION: Background

    On August 17, 2015, the Department of Commerce (the Department) initiated countervailing duty investigations on certain cold-rolled steel flat products from Brazil, India, the People's Republic of China, the Republic of Korea, and the Russian Federation.1 Currently, the preliminary determinations are due no later than October 21, 2015.

    1See Certain Cold-Rolled Steel Flat Products From Brazil, India, the People's Republic of China, the Republic of Korea, and the Russian Federation: Initiation of Countervailing Duty Investigations, 80 FR 51206 (August 24, 2015).

    Postponement of the Preliminary Determinations

    Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires the Department to issue the preliminary determination in a countervailing duty investigation within 65 days after the date on which the Department initiated the investigation. However, if the petitioner makes a timely request for an extension in accordance with 19 CFR 351.205(e), section 703(c)(1)(A) of the Act allows the Department to postpone the preliminary determination until no later than 130 days after the date on which the Department initiated the investigation.

    On September 23, 2015, Petitioners 2 submitted timely requests pursuant to section 703(c)(1)(A) of the Act and 19 CFR 351.205(e) to postpone the preliminary determinations.3 For the reasons stated above and because there are no compelling reasons to deny the requests, the Department, in accordance with section 703(c)(1)(A) of the Act, is postponing the deadline for the preliminary determinations to no later than 120 days after the day on which the investigation was initiated. In accordance with section 735(a)(1) of the Act, the deadline for the final determinations of these investigations will continue to be 75 days after the date of the preliminary determinations, unless postponed at a later date.

    2 AK Steel Corporation, ArcelorMittal USA EEC, Nucor Corporation, Steel Dynamics, Inc., and the United States Steel Corporation (collectively, Petitioners).

    3See Letters from Petitioners, entitled “Cold-Rolled Steel Flat Products from Brazil, India, the People's Republic of China, the Republic of Korea, and the Russian Federation: Petitioners' Request to Extend the Countervailing Duty Preliminary Determination,” dated September 23, 2015.

    This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).

    Dated: October 1, 2015. Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2015-25706 Filed 10-7-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-831] Fresh Garlic From the People's Republic of China: Final Rescission of the Semiannual Antidumping Duty New Shipper Review of Jinxiang Kaihua Imp & Exp Co., Ltd. AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (“the Department”) is conducting a new shipper review (“NSR”) of Jinxiang Kaihua Imp & Exp Co., Ltd. (Kaihua) regarding the antidumping duty order on fresh garlic from the People's Republic of China (“the PRC”). On June 5, 2015, the Department published the preliminary results in which it found that Kaihua's new shipper sale is not bona fide. As a result, we preliminarily rescinded the NSR of Kaihua1 and we invited interested parties to comment. Based on our analysis of the comments received, we continue to find Kaihua's new shipper sale is not bona fide. Consequently, the Department is rescinding this NSR.

    1See Fresh Garlic From the People's Republic of China: Preliminary Intent To Rescind the New Shipper Review of Jinxiang Kaihua Imp & Exp Co., Ltd., 70 FR 32092 (June 5, 2015) (Preliminary Results) and accompanying Issues and Decision Memorandum (PDM).

    DATES:

    Effective Date: October 8, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Milton Koch, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2584.

    Background

    On June 5, 2015, the Department published the preliminary results of this new shipper review.2 The review covers the new shipper Kaihua. The period of review (POR) is November 1, 2013, through April 30, 2014. A summary of the events that occurred since the Department published the Preliminary Results, as well as a full discussion of the issues raised by parties for this final determination, may be found in the Issues and Decision Memorandum, dated concurrently with, and hereby adopted by, this notice.3

    2Id.

    3See Memorandum from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance, regarding “Issues and Decision Memorandum for the Final Results of Antidumping Duty Semiannual New Shipper Review on Fresh Garlic from the People's Republic of China: Jinxiang Kaihua Imp & Exp Co., Ltd.” issued concurrently with this notice (Issues and Decision Memorandum).

    The Issues and Decision Memorandum is a public document and is made available to the public via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://iaaccess.trade.gov, and is available to all parties in the Department's Central Records Unit, located in Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be found at http://enforcement.trade.gov/frn/. The signed and the electronic versions of the Issues and Decision Memorandum are identical in content.

    Scope of the Order

    The merchandise covered by this order is all grades of garlic, whether whole or separated into constituent cloves. The subject merchandise is currently classifiable under the Harmonized Tariff Schedule of the United States (“HTSUS”) subheadings: 0703.20.0000, 0703.20.0005, 0703.20.0010, 0703.20.0015, 0703.20.0020, 0703.20.0090, 0710.80.7060, 0710.80.9750, 0711.90.6000, 0711.90.6500, 2005.90.9500, 2005.90.9700, and 2005.99.9700. A full description of the scope of the order is contained in the Issues and Decision Memorandum.4 Although the HTSUS subheadings are provided for convenience and customs purposes, the written product description is dispositive.

    4See the Issues and Decision Memorandum.

    Final Rescission of New Shipper Review

    As we explain in the Issues and Decision Memorandum and in the proprietary Kaihua Bona Fides Memorandum 5 issued with the Preliminary Results, due to the totality of circumstances, including the price, discrepancies relating to expenses arising from the transaction, lack of definitive proof of payment, and pattern of inconsistencies in Kaihua's submissions, we continue to find that Kaihua's sale is not bona fide. As a result, we are rescinding the new shipper review of Kaihua.

    5See Memorandum to Edward Yang, Office Director, AD/CVD Operations Office VII, “Bona Fide Nature of the Sales in the Antidumping Duty New Shipper Review of Fresh Garlic from the People's Republic of China (PRC): Jinxiang Kaihua Imp & Exp Co., Ltd.” dated June 3, 2015.

    Analysis of Comments Received

    All issues raised in the case and rebuttal briefs are addressed in the Issues and Decision Memorandum. A list of the issues that are raised in the briefs and addressed in the Issues and Decision Memorandum is in the appendix of this notice.

    Cash Deposit Requirements

    Effective upon publication of the final rescission of the NSR of Kaihua, the Department will instruct CBP to discontinue the option of posting a bond or security in lieu of a cash deposit for entries of subject merchandise by Kaihua. Cash deposits will be required for exports of subject merchandise by Kaihua entered, or withdrawn from warehouse, for consumption on or after the publication date, at the PRC-wide rate.

    Assessment Instructions

    As the result of this rescission of the NSR of Kaihua, the entries of Kaihua covered by this NSR will be assessed at the PRC-wide rate.

    Notification to Importers

    This notice serves as 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 POR. Failure to comply with this requirement could result in the Secretary of Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Return or Destruction of Proprietary Information

    This notice serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of business proprietary information disclosed under the APO in accordance with 19 CFR 351.305(a)(3). We request timely written notification of return or destruction of APO materials or conversion to judicial protective order. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

    This notice is issued and published this notice in accordance with sections 751(a)(2)(B) and 777(i) of the Tariff Act of 1930, as amended, and 19 CFR 351.214.

    Dated: October 1, 2015. Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance. Appendix List of Topics Discussed in the Issues and Decision Memorandum 1. Summary 2. Background 3. Scope of the Order 4. Discussion of the Issues Comment 1: Whether The Price Of Kaihua's Garlic Was Bona Fide Comment 2: Whether The Comparison Of Single-Clove Garlic With Multi-Clove Garlic Comports With Recent Decisions Comment 3: Whether CBP Data Contains Errors Comment 4: Whether Kaihua Reported Accurate And Actual Expense And Accounting Data Comment 5: Whether Kaihua Provided Proof Of Payment Comment 6: Whether There Is A Pattern Of Inconsistencies With Kaihua's Submissions 5. Recommendation
    [FR Doc. 2015-25705 Filed 10-7-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-981] Utility Scale Wind Towers From the People's Republic of China: Notice of 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 its administrative review of utility scale wind towers (“wind towers”) from the People's Republic of China (“PRC”) for the period February 1, 2014 through January 31, 2015 (“POR”), based on the withdrawal of request for review.

    DATES:

    Effective Date: October 8, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Robert Galantucci, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2923.

    SUPPLEMENTARY INFORMATION: Background

    On February 2, 2015, the Department published the notice of opportunity to request an administrative review of the antidumping duty order on wind towers from the PRC for the POR.1 On February 25, 2015, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the “Act”), and 19 CFR 351.213(b), the Department received a timely request from the Wind Tower Trade Coalition (“Petitioner”) to conduct an administrative review.2

    1See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 80 FR 5509 (February 2, 2015).

    2See Letter from Petitioner, “Utility Scale Wind Towers from the People's Republic of China: Request for Administrative Review,” dated February 25, 2015.

    Pursuant to this request and in accordance with 19 CFR 351.221(c)(1)(i), on April 3, 2015, the Department published a notice of initiation of an administrative review of the antidumping duty order on wind towers from the PRC.3 On July 1, 2015, Petitioner withdrew its request for an administrative review.4

    3See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 80 FR 18202 (April 3, 2014) (“Initiation Notice”).

    4See Letter from Petitioner, “Utility Scale Wind Towers from the People's Republic of China: Withdrawal of Request for Administrative Review,” dated July 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 a review withdraws the request within 90 days of the publication date of the notice of initiation of the requested review. As noted above, Petitioner withdrew its request for review within 90 days of the publication date of the Initiation Notice. No other parties requested an administrative review of the order. Therefore, in accordance with 19 CFR 351.213(d)(1), we are rescinding this review in its entirety.

    Assessment

    The Department will instruct U.S. Customs and Border Protection (“CBP”) to assess antidumping duties on all appropriate entries of wind towers from the PRC. Antidumping duties shall be assessed 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 date of publication of this notice of rescission of administrative review.

    Notifications

    This notice also serves as a final reminder to importers for whom this review is being rescinded 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 Secretary's presumption that reimbursement of the antidumping duties occurred and the subsequent assessment of double antidumping duties.

    This notice also serves as a reminder to parties subject to administrative protective orders (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/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 published in accordance with section 751 of the Act, and 19 CFR 351.213(d)(4).

    Dated: October 1, 2015. Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2015-25684 Filed 10-7-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-851] Certain Preserved Mushrooms From the People's Republic of China: Initiation of Antidumping Duty New Shipper Review AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    DATES:

    Effective Date: October 8, 2015.

    SUMMARY:

    The Department of Commerce (the Department) is initiating a new shipper review of the antidumping duty order on certain preserved mushrooms (mushrooms) from the People's Republic of China (PRC) involving Linyi Yuqiao International Trade Co., Ltd. (Yuqiao). The period of review (POR) of this new shipper review is February 1, 2015, through July 31, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Michael J. Heaney or Robert James, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, telephone: (202) 482-4475 or (202) 482-0649, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On February 19, 1999, the Department published the antidumping duty order on mushrooms from the PRC.1 Pursuant to section 751(a)(2)(B)(i) of the Tariff Act of 1930, as amended (the Act), we received a timely request for a new shipper review of the order from Yuqiao.2 In its request for review, Yuqiao identified itself as the exporter of the subject merchandise, while listing the producer as Linyi City Kangfa Foodstuff Drinkable Co., Ltd. (Kangfa).

    1See Notice of Amendment of Final Determination of Sales at Less Than Fair Value and Antidumping Duty Order: Certain Preserved Mushrooms From the People's Republic of China, 64 FR 8308 (February 19, 1999).

    2See Letter from Yuqiao to Secretary of Commerce, dated August 28, 2015 (Yuqiao Request).

    Pursuant to the requirements set forth in section 751(a)(2)(B)(i) of the Act and 19 CFR 351.214(b)(2), Yuqiao certified that: (1) It did not export subject merchandise to the United States during the period of investigation (POI) (see section 751(a)(2)(B)(i)(I) of the Act and 19 CFR 351.214(b)(2)(ii)(A)); (2) since the initiation of the investigation it has never been affiliated with any exporter or producer that exported subject merchandise to the United States during the POI, including those companies not individually examined during the investigation (see section 751(a)(2)(B)(i)(II) of the Act and 19 CFR 351.214(b)(2)(iii)(A)); and (3) its export activities are not controlled by the central government of the PRC (see 19 CFR 351.214(b)(2)(iii)(B)). Kangfa also certified that: (1) It did not export the subject merchandise to the United States during the POI (see 19 CFR 351.214(b)(2)(ii)(B)); and (2) since the initiation of the investigation, Kangfa has never been affiliated with any exporter or producer that exported subject merchandise during the POI, including those companies not individually examined during the investigation.3

    3Id. at Attachment 1.

    Moreover, in accordance with 19 CFR 351.214(b)(2)(iv), Yuqiao submitted documentation establishing the following: (1) The date on which it first entered merchandise into the United States; (2) the volume of its first shipment and a statement that it had no subsequent shipments; and (3) the date of its first sale to an unaffiliated customer in the United States.4

    4Id. at Attachment 2.

    Finally, the Department conducted a U.S. Customs and Border Protection (CBP) database query and confirmed the price, quantity, and date of entry of the sale at issue.5 Notably, the CBP data indicate that Yuqiao's sale and entry of subject merchandise occurred during the POR and the entry was suspended for antidumping duties.

    5Id.; see also Memorandum to the File from the Case Analyst, “Certain Preserved Mushrooms from the People's Republic of China: Customs Data for NSR”, dated September 14, 2015, and herein incorporated by reference.

    Period of Review

    Pursuant to 19 CFR 351.214(g)(1)(i)(B), the POR for new shipper reviews initiated in the month immediately following the semiannual anniversary month will be the six month period immediately preceding the semiannual anniversary month. Therefore, because the semiannual anniversary month of this order is August, the POR for this new shipper review is February 1, 2015, through July 31, 2015.

    Initiation of New Shipper Review

    Pursuant to section 751(a)(2)(B) of the Act and 19 CFR 351.214(b), the Department finds that Yuqiao's request meets the statutory and regulatory requirements for initiation of a new shipper review.6 Accordingly, the Department is initiating a new shipper review of the antidumping duty order on mushrooms from the PRC for subject merchandise produced by Kangfa and exported by Yuqaio. Absent a determination that the case is extraordinarily complicated, the Department intends to issue the preliminary results of this review within 180 days after the date on which this review is initiated and the final results within 90 days after the date on which the Department issues the preliminary results.7

    6See Memorandum from Michael J. Heaney to the File through Scot T. Fullerton entitled, “Initiation of Antidumping Duty New Shipper Review: Certain Preserved Mushrooms from the People's Republic of China (A-570-851),” dated September xx, 2015.

    7See section 751(a)(2)(B)(iv) of the Act and 19 CFR 351.214(h)(i).

    In cases involving non-market economies, the Department requires that a company seeking to establish eligibility for an antidumping duty rate separate from the country-wide rate provide evidence of de jure and de facto absence of government control over the company's export activities.8 Accordingly, the Department will issue a questionnaire to Yuqiao that will include a separate rates section. This review may proceed if the response provides sufficient indication that Yuqiao is not subject to either de jure or de facto government control with respect to its exports of mushrooms.

    8See, e.g., Wooden Bedroom Furniture from the People's Republic of China: Preliminary Results of Antidumping Duty New Shipper Reviews, 75 FR 72794, 72796 (November 26, 2010), unchanged in Wooden Bedroom Furniture from the People's Republic of China: Final Results of Antidumping Duty New Shipper Reviews, 76 FR 9747 (February 22, 2011).

    The Department will instruct CBP to allow (at the option of the importer) the posting, until the completion of the review, of a bond or security in lieu of a cash deposit for each entry of subject merchandise exported by Yuqiao and produced by Kangfa in accordance with section 751(a)(2)(B)(iii) of the Act and 19 CFR 351.214(e). Because Kangfa certified that the sales which form the basis for its request were produced by Kangfa, the Department will instruct CBP to permit the use of a bond only for entries of subject merchandise produced by Kangfa and exported by Yuqiao.

    To assist in its analysis of the bona fides of Yuqiao's sales, upon initiation of this new shipper review, the Department will require the company to submit on an ongoing basis complete transaction information concerning any sales of subject merchandise to the United States that were made subsequent to the POR.

    Interested parties requiring access to business proprietary information in this new shipper review should submit applications for disclosure under administrative protective order, in accordance with 19 CFR 351.305 and 351.306.

    This initiation and notice are published in accordance with section 751(a)(2)(B) of the Act, 19 CFR 351.214, and 19 CFR 351.221(c)(1)(i).

    Dated: October 1, 2015. Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2015-25704 Filed 10-7-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Science Advisory Board (SAB) AGENCY:

    Office of Oceanic and Atmospheric Research (OAR), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).

    ACTION:

    Notice of open meeting.

    SUMMARY:

    The Science Advisory Board (SAB) was established by a Decision Memorandum dated September 25, 1997, and is the only Federal Advisory Committee with responsibility to advise the Under Secretary of Commerce for Oceans and Atmosphere on strategies for research, education, and application of science to operations and information services. SAB activities and advice provide necessary input to ensure that National Oceanic and Atmospheric Administration (NOAA) science programs are of the highest quality and provide optimal support to resource management.

    Time and Date: The meeting will be held Thursday, October 29, 9:45 a.m. EDT to 5:45 p.m. EDT and on Friday, October 30, from 8:15 a.m. EDT to 1:00 p.m. EDT. These times and the agenda topics described below are subject to change. Please refer to the Web page http://www.sab.noaa.gov/Meetings/meetings.html for the most up-to-date meeting times and agenda.

    Place: The meeting will be held at the Hamilton Hotel Ballroom, 1001 14th Street Northwest, Washington, DC. Please check the SAB Web site http://www.sab.noaa.gov/Meetings/meetings.html for directions to the meeting location.

    Status: The meeting will be open to public participation with a 15-minute public comment period on October 29 from 5:30-5:45 p.m. EDT (check Web site to confirm time). The SAB expects that public statements presented at its meetings will not be repetitive of previously submitted verbal or written statements. In general, each individual or group making a verbal presentation will be limited to a total time of two (2) minutes. Individuals or groups planning to make a verbal presentation should contact the SAB Acting Executive Director by October 22, 2015 to schedule their presentation. Written comments should be received in the SAB Executive Director's Office by October 22, 2015, to provide sufficient time for SAB review. Written comments received by the SAB Executive Director after October 22, 2015, will be distributed to the SAB, but may not be reviewed prior to the meeting date. Seating at the meeting will be available on a first-come, first-served basis.

    Special Accommodations: These meetings are physically accessible to people with disabilities. Requests for special accommodations may be directed no later than 12:00 p.m. on October 22, 2015, to Dr. Elizabeth Turner, Acting SAB Executive Director, Room 146 Gregg Hall, 35 Colovos Road, Durham, NH 03824; Email: [email protected]

    Matters To Be Considered: The meeting will include the following topics: (1) Review Report for the Joint Institute on Marine and Atmospheric Research (JIMAR); (2) Review Report for the Cooperative Institute on Mesoscale Meteorological Studies (CIMMS); (3) Gulf Coast Ecosystem Restoration Program Advisory Working Group Report on the RESTORE Act Science Program's Performance Metrics Plan and Coordination Plan; (4) SAB Strategy Discussion; (5) Updates from the NOAA Administrator and Chief Scientist; (6) Discussion on Optimizing SAB Working Group Operations and (7) Working Group Issues for Discussion.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Elizabeth Turner, Acting Executive Director, Science Advisory Board, NOAA, Room 146 Gregg Hall, 35 Colovos Road, Durham, NH 03824. Email: [email protected]; or visit the NOAA SAB Web site at http://www.sab.noaa.gov.

    Dated: October 1, 2015. Jason Donaldson, Chief Financial Officer, Office of Oceanic and Atmospheric Research, National Oceanic and Atmospheric Administration.
    [FR Doc. 2015-25679 Filed 10-7-15; 8:45 am] BILLING CODE 3510-KD-P
    CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC-2013-0025] Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Standard for Infant Swings AGENCY:

    Consumer Product Safety Commission.

    ACTION:

    Notice.

    SUMMARY:

    As required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Consumer Product Safety Commission (“CPSC” or “Commission”) requests comments on a proposed extension of approval of a collection of information under the safety standard for swings, approved previously under OMB Control No. 3041-0155. The Commission will consider all comments received in response to this notice before requesting an extension of this collection of information from the Office of Management and Budget (“OMB”).

    DATES:

    Submit written or electronic comments on the collection of information by December 7, 2015.

    ADDRESSES:

    You may submit comments, identified by Docket No. CPSC-2013-0025, 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-2013-0025, into the “Search” box, and follow the prompts.

    FOR FURTHER INFORMATION CONTACT:

    Robert H. Squibb, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; (301) 504-7815, or by email to: [email protected]

    SUPPLEMENTARY INFORMATION:

    CPSC seeks to renew the following currently approved collection of information:

    Title: Safety Standard for Infant Swings.

    OMB Number: 3041-0155.

    Type of Review: Renewal of collection.

    Frequency of Response: On occasion.

    Affected Public: Manufacturers and importers of infant swings.

    Estimated Number of Respondents: 9 firms that supply infant swings to the United States market have been identified; there are approximately 5 models per firm annually.

    Estimated Time per Response: 1 hour/model associated with marking and labeling.

    Total Estimated Annual Burden: 45 hours (9 firms × 5 models × 1 hour).

    General Description of Collection: The Commission revised the CPSC standard for the safety standard for infant swings (16 CFR part 1223) on June 24, 2013 (78 FR 37706). The standard is intended to address hazards to children associated with infant swings. Among other requirements, the standard requires manufacturers, including importers, to meet the collection of information requirements for marking and labeling for infant swings.

    Request for Comments

    The Commission solicits written comments from all interested persons about the proposed collection of information. The Commission specifically solicits information relevant to the following topics:

    —Whether the collection of information described above is necessary for the proper performance of the Commission's functions, including whether the information would have practical utility; —Whether the estimated burden of the proposed collection of information is accurate; —Whether the quality, utility, and clarity of the information to be collected could be enhanced; and —Whether the burden imposed by the collection of information could be minimized by use of automated, electronic or other technological collection techniques, or other forms of information technology. Dated: October 5, 2015. Todd A. Stevenson, Secretary, Consumer Product Safety Commission.
    [FR Doc. 2015-25626 Filed 10-7-15; 8:45 am] BILLING CODE 6355-01-P
    DEPARTMENT OF ENERGY Biological and Environmental Research Advisory Committee AGENCY:

    Office of Science, Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Biological and Environmental Research Advisory Committee (BERAC). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of these meetings be announced in the Federal Register.

    DATES:

    Wednesday, October 28, 2015—9:00 a.m. to 6:00 p.m.

    Thursday, October 29, 2015—8:30 a.m. to 12:00 p.m.

    ADDRESSES:

    Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Boulevard, Gaithersburg, Maryland 20878.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Sharlene Weatherwax, Designated Federal Officer, BERAC, U.S. Department of Energy, Office of Science, Office of Biological and Environmental Research, SC-23/Germantown Building, 1000 Independence Avenue SW., Washington, DC 20585-1290; Telephone: (301) 903-3251; Fax (301) 903-5051 or email: [email protected] The most current information concerning this meeting can be found on the Web site: http://science.energy.gov/ber/berac/meetings/.

    SUPPLEMENTARY INFORMATION:

    Purpose of the Committee: To provide advice on a continuing basis to the Director, Office of Science of the Department of Energy, on the many complexes scientific and technical issues that arises in the development and implementation of the Biological and Environmental Research Program.

    Tentative Agenda Topics • Report from the Under Secretary for Science and Energy • Report from the Office of Science • Report from the Office of Biological and Environmental Research • News from the Biological Systems Science and Climate and Environmental Sciences Divisions • Report on the Biological Systems Science Division Strategic Plan • Briefings on the Industrialization of Biology and the Advanced Research Projects Agency—Energy (ARPA-E) • Environmental Molecular Sciences Laboratory update • Integrated Field Laboratory workshop report and discussion • Science Talk • New Business • Public Comment

    Public Participation: The day and a half meeting is open to the public. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any of the items on the agenda, you should contact Sharlene Weatherwax at: [email protected] (email) or (301) 903-5051 (fax). You must make your request for an oral statement at least five business days before the meeting. Reasonable provision will be made to include the scheduled oral statements on the agenda. The Chairperson of the Committee will conduct the meeting to facilitate the orderly conduct of business. Public comment will follow the 10-minute rule.

    Minutes: The minutes of this meeting will be available for public review and copying within 45 days at the BERAC Web site: http://science.energy.gov/ber/berac/meetings/berac-minutes/.

    Issued in Washington, DC, on October 2, 2015. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2015-25645 Filed 10-7-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY State Energy Advisory Board (STEAB) AGENCY:

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

    ACTION:

    Notice of Open Teleconference.

    SUMMARY:

    This notice announces a teleconference call of the State Energy Advisory Board (STEAB). The Federal Advisory Committee Act (Pub. L. 92-463; 86 Stat.770) requires that public notice of these meetings be announced in the Federal Register.

    DATES:

    Thursday, November 19, 2015 from 3:30 p.m. to 4:00 p.m. (EDT). To receive the call-in number and passcode, please contact the Board's Designated Federal Officer at the address or phone number listed below.

    FOR FURTHER INFORMATION CONTACT:

    Michael Li, Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy, 1000 Independence Ave. SW., Washington, DC 20585. Phone number 202-287-5718, and email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: To make recommendations to the Assistant Secretary for the Office of Energy Efficiency and Renewable Energy regarding goals and objectives, programmatic and administrative policies, and to otherwise carry out the Board's responsibilities as designated in the State Energy Efficiency Programs Improvement Act of 1990 (Pub. L. 101-440).

    Tentative Agenda: Receive STEAB Task Force updates on action items and revised objectives for FY 2016, discuss follow-up opportunities and engagement with EERE and other DOE staff as needed to keep Task Force work moving forward, continue engagement with DOE, EERE and EPSA staff regarding energy efficiency and renewable energy projects and initiatives, and receive updates on member activities within their states.

    Public Participation: The meeting is open to the public. Written statements may be filed with the Board either before or after the meeting. Members of the public who wish to make oral statements pertaining to agenda items should contact Michael Li at the address or telephone number listed above. Requests to make oral comments must be received five days prior to the meeting; reasonable provision will be made to include requested topic(s) on the agenda. The Chair of the Board is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business.

    Minutes: The minutes of the meeting will be available for public review and copying within 60 days on the STEAB Web site at: http://www.energy.gov/eere/steab/state-energy-advisory-board.

    Issued at Washington, DC, on October 2, 2015. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2015-25649 Filed 10-7-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Application Docket Nos. Atlantic Coast Pipeline, LLC CP15-554-000
  • PF15-6-000
  • Dominion Transmission, Inc CP15-555-000
  • PF15-5-000
  • Atlantic Coast Pipeline, LLC and Piedmont Natural Gas Company, Inc CP15-556-000

    Take notice that on September 18, 2015, Atlantic Coast Pipeline, LLC (ACP), 120 Tredgar Street, Richmond, Virginia 23219 filed an application under section 7(c) of the Natural Gas Act and Part 157 of the Commission's regulations requesting authorization to install, construct, own, operate and maintain certain natural gas pipeline facilities for its Atlantic Coast Pipeline project consisting of: (i) Approximately 564.1 miles of various diameter pipeline; (ii) three greenfield compressor stations totaling 117,545 horsepower (HP) of compression; and (iii) various appurtenant and auxiliary facilities designed to transport up to approximately 1.5 million dekatherms per day (MMDth/d) of natural gas. Facilities to be constructed are located in Harrison, Lewis, Upshur, Randolph, and Pocahontas Counties, West Virginia; Highland, Augusta, Nelson, Buckingham, Cumberland, Prince Edward, Nottoway, Dinwiddie, Brunswick, Greensville and Southampton Counties and the Cities of Suffolk and Chesapeake, Virginia; and Northampton, Halifax, Nash, Wilson, Johnston, Sampson, Cumberland and Robeson Counties, North Carolina. Additionally, ACP is seeking Blanket Certificates of public convenience and necessity pursuant to Part 284, Subpart G authorizing the transportation of natural gas for others, and Part 157, Subpart F authorizing certain facility construction, operation and abandonment activities, all as more fully described in the application.

    In a related filing, on September 18, 2015, Dominion Transmission, Inc. (DTI), 707 East Main Street, Richmond, Virginia 23219, filed under sections 7(b) and 7(c) of the Natural Gas Act and Part 157 of the Commission's regulations requesting authorization to abandon, install, construct, own, operate and maintain certain natural gas pipeline facilities for its Supply Header Project (Supply Header) located in Westmoreland and Greene Counties, Pennsylvania; and Harrison, Doddridge, Tyler, Wetzel, and Marshall Counties, West Virginia. The Supply Header would provide transportation service of approximately 1.5 MMDth/d from supply areas on the DTI system for delivery to the ACP. The Supply Header facilities would consist of: (i) Two pipeline loops of 30-inch diameter pipeline totaling 37.5 miles; ii) added compression at three existing compressor stations totaling 70,530 HP; and iii) various appurtenant and auxiliary facilities. DTI also proposes to abandon two compressor units in Wetzel County, West Virginia, all as more fully described in the application.

    Finally, on September 18, 2015, ACP and Piedmont Natural Gas Company, Inc. (Piedmont), 4720 Piedmont Row Drive, Charlotte, North Carolina 28210, filed a joint application under section 7(c) of the NGA and Part 157 of the Commission's regulations seeking authorization of a lease pursuant to which ACP will lease capacity (Lease) on Piedmont's system for use by ACP in providing service under its FERC Gas Tariff, primarily for the Public Service Company of North Carolina, Inc. Piedmont, a local distribution company (LDC), also requests a limited jurisdiction certificate in order to enter into the Lease with ACP for the interstate transportation of gas through Piedmont's facilities. Piedmont also requests a determination that the Lease will not affect its status and a LDC not otherwise subject to Commission regulation, all as more fully described in the application.

    The filings may also be viewed on the web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC at [email protected] or toll free at (866) 208-3676, or TTY, (202) 502-8659.

    Any questions regarding ACP's or DTI's projects should be directed to Angela Woolard, Gas Transmission Certificates, Dominion Transmission, Inc., 701 East Cary Street, Richmond, Virginia 23219; telephone: 866-319-3382.

    Any questions regarding the ACP—Piedmont Lease should be directed to Matthew Bley, Director, Gas Transmission Certificates, Dominion Transmission, Inc., 701 East Cary Street, Richmond, Virginia 23219; telephone: 866-319-3382.

    On November 13, 2014, the Commission staff granted ACP's and DTI's requests to utilize the National Environmental Policy Act (NEPA) Pre-Filing Process and assigned Docket Nos. PF15-6-000 and PF15-5-000, respectively to staff activities involving the combined Atlantic Coast Pipeline and Supply Header projects. Now, as of the filing of the applications on September 18, 2015, the NEPA Pre-Filing Process for this project has ended. From this time forward, this proceeding will be conducted in Docket No. CP15-554-000 for the Atlantic Coast Pipeline and CP15-555-000 for DTI's Supply Header project, as noted in the caption of this Notice.

    Within 90 days after the Commission issues a Notice of Application for the ACP, Supply Header and ACP—Piedmont Lease projects, the Commission staff will issue a Notice of Schedule for Environmental Review that will indicate the anticipated date for the Commission's staff issuance of the final EIS analyzing both the three proposals. The issuance of a Notice of Schedule for Environmental Review will also serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's final EIS.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 7 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy regulatory Commission, 888 First Street NE., Washington, DC 20426.

    Comment Date: 5:00 p.m. Eastern Time on October 23, 2015.

    Dated: October 2, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-25636 Filed 10-7-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 4580-006] PacifiCorp; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:

    a. Types of Application: Amendment of Exemption.

    b. Project Nos.: 4580-006.

    c. Date Filed: September 21, 2015.

    d. Applicant: PacifiCorp.

    e. Name of Projects: Last Chance Canal Hydroelectric Project.

    f. Location: The project is located at the Last Chance Canal, a diversion from the Bear River in Caribou County, Idaho.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.

    h. Applicant Contact: Roger L. Raeburn, Chief Dam Safety Engineer, PacifiCorp, 825 NE. Multnomah Street, Suite 1500, Portland, OR 97232; (503) 813-6667 or [email protected]

    i. FERC Contact: B. Peter Yarrington, (202) 502-6129 or [email protected]

    j. Deadline for filing comments, motions to intervene, and protests is 15 days from the issuance date of this notice by the Commission. The Commission strongly encourages electronic filing. Please file motions to intervene, protests, or comments 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. Please include the project number (P-4580-006) on any comments, motions to intervene, or protests filed.

    k. Description of Request: The applicant proposes to replace the project's wood-crib diversion dam, and parts of the canal intake structure. An engineering inspection in April 2015 found significant deterioration of the diversion dam, which is over 100 years old, in addition to seepage where the intake structure meets the dam. The existing diversion dam would be replaced with a new structure of reinforced concrete and roller-compacted concrete. The work would not result in any changes to dam height, dam width, associated water levels, or project operation.

    l. Locations of the Application: A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street NE., Room 2A, Washington, DC 20426, or by calling (202) 502-8371. This filing may also be viewed on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits in the docket number field to access the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, call 1 (866) 208-3676 or email [email protected], for TTY, call (202) 502-8659. A copy is also available for inspection and reproduction at the address in item (h) above.

    m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.

    n. Comments, Protests, or Motions to Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.

    o. Filing and Service of Responsive Documents: Any filing must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). All comments, motions to intervene, or protests should relate to project works which are the subject of the amendment application. Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. If an intervener files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: October 2, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-25639 Filed 10-7-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 77-276] Pacific Gas and Electric Company; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:

    a. Type of Application: Application for Temporary Variance of Minimum Flow Requirement.

    b. Project No.: 77-276.

    c. Date Filed: September 30, 2015.

    d. Applicant: Pacific Gas and Electric Company (licensee).

    e. Name of Project: Potter Valley Project.

    f. Location: Eel River and East Fork Russian River in Lake and Mendocino Counties, California.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).

    h. Applicant Contact: Mr. Matthew Joseph, License Coordinator, Pacific Gas and Electric Company, Mail Code: N13E, P.O. Box 770000, San Francisco, CA 94177, (415) 973-8616.

    i. FERC Contact: Mr. John Aedo, (415) 369-3335, or [email protected]

    j. Deadline for filing comments, motions to intervene, protests, and recommendations is October 19, 2015. The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, or recommendations 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. Please include the project number (P-77-276) on any comments, motions to intervene, protests, or recommendations filed.

    k. Description of Request: The licensee requests a temporary variance of the minimum flow requirement in the East Branch Russian River. The licensee states that it is planning to conduct repairs to reconstruct the lower woodstave conduit and replace some adjoining piping above the Potter Valley powerhouse. The licensee states that it needs to dewater the lower portion of the water conveyance system to conduct this work. In order to complete the work, the licensee is requesting a temporary variance of its Normal water year minimum flow requirement of 35 cubic feet per second (cfs) between November 1, 2015 and March 15, 2016. During this time, the licensee proposes to release flows through a conduit into a seasonal creek that is a tributary to the East Branch Russian River immediately downstream of the project powerhouse. The licensee states that during the repair period, it would release a minimum flow of 20 cfs from the conduit into the East Branch Russian River, which would include the release of up to 5 cfs for the Potter Valley Irrigation District. The licensee states that if site conditions reach a Critically Dry water year status, it would instead, maintain the license-required minimum flow of 5 cfs. Finally, the licensee proposes to regularly monitor the interim flows in the seasonal tributary. Upon completion of construction, the licensee states that it would notify the resource agencies and return to the license-required flows.

    l. Locations of the Application: A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street NE., Room 2A, Washington, DC 20426, or by calling (202) 502-8371. This filing may also be viewed on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits in the docket number field to access the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, call 1-866-208-3676 or email [email protected], for TTY, call (202) 502-8659. A copy is also available for inspection and reproduction at the address in item (h) above.

    m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.

    n. Comments, Protests, or Motions to Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.

    o. Filing and Service of Responsive Documents: Any filing must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). All comments, motions to intervene, or protests should relate to project works which are the subject of the license surrender. Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. If an intervener files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: October 2, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-25617 Filed 10-7-15; 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 exempt wholesale generator filings:

    Docket Numbers: EG15-132-000.

    Applicants: CED Alamo 5, LLC.

    Description: Self-certification as an exempt wholesale generator of CED Alamo 5, LLC.

    Filed Date: 9/29/15.

    Accession Number: 20150929-5130.

    Comments Due: 5 p.m. ET 10/20/15.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-1817-010; ER10-1820-014; ER10-1819-011; ER10-1818-009.

    Applicants: Southwestern Public Service Company.

    Description: Supplement to June 30, 2015 Triennial Market Power Analysis of Southwestern Public Service Company, et al.

    Filed Date: 9/25/15.

    Accession Number: 20150925-5301.

    Comments Due: 5 p.m. ET 10/16/15.

    Docket Numbers: ER15-1473-002.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Report Filing: 2015-09-29_SA 2771 Refund Report of ATC-Cloverland CFA to be effective N/A.

    Filed Date: 9/29/15.

    Accession Number: 20150929-5111.

    Comments Due: 5 p.m. ET 10/20/15.

    Docket Numbers: ER15-1861-000.

    Applicants: Tucson Electric Power Company.

    Description: Report Filing: Refund Report to be effective N/A.

    Filed Date: 9/29/15.

    Accession Number: 20150929-5002.

    Comments Due: 5 p.m. ET 10/20/15.

    Docket Numbers: ER15-1862-000.

    Applicants: Tucson Electric Power Company.

    Description: Report Filing: Refund Report to be effective N/A.

    Filed Date: 9/29/15.

    Accession Number: 20150929-5003.

    Comments Due: 5 p.m. ET 10/20/15.

    Docket Numbers: ER15-2720-001; ER15-2689-001; ER15-2688-001.

    Applicants: WestRock CP, LLC, MeadWestvaco Coated Board, LLC, MeadWestvaco Virginia Corporation.

    Description: Notice of Non-Material Change in Status of the WestRock MBR Sellers.

    Filed Date: 9/28/15.

    Accession Number: 20150928-5344.

    Comments Due: 5 p.m. ET 10/19/15.

    Docket Numbers: ER15-2736-000.

    Applicants: PJM Interconnection, L.L.C., Commonwealth Edison Company.

    Description: § 205(d) Rate Filing: ComEd submits Amended Facilities, Interconnection, and Easement Agreement 4266 to be effective 9/28/2015.

    Filed Date: 9/28/15.

    Accession Number: 20150928-5305.

    Comments Due: 5 p.m. ET 10/19/15.

    Docket Numbers: ER15-2737-000.

    Applicants: Beethoven Wind, LLC.

    Description: Tariff Cancellation: Notice of cancellation to be effective 9/29/2015.

    Filed Date: 9/28/15.

    Accession Number: 20150928-5308.

    Comments Due: 5 p.m. ET 10/19/15.

    Docket Numbers: ER15-2738-000.

    Applicants: Sierra Pacific Power Company.

    Description: Initial rate filing: Rate Schedule No. 68—SPPC Concurrence with PG&E Service Agreement 84 to be effective 10/31/2015.

    Filed Date: 9/28/15.

    Accession Number: 20150928-5310.

    Comments Due: 5 p.m. ET 10/19/15.

    Docket Numbers: ER15-2739-000.

    Applicants: PJM Interconnection, L.L.C., Trans-Allegheny Interstate Line Company, West Penn Power Company, The Potomac Edison Company, Pennsylvania Electric Company, Metropolitan Edison Company, Monongahela Power Company.

    Description: § 205(d) Rate Filing: Trans-Allegheny, et al. submits service agreement nos. 2149, 3743, and 3818 to be effective 10/1/2015.

    Filed Date: 9/29/15.

    Accession Number: 20150929-5090.

    Comments Due: 5 p.m. ET 10/20/15.

    Docket Numbers: ER15-2740-000.

    Applicants: Central Hudson Gas & Electric Corporation.

    Description: § 205(d) Rate Filing: Revision to FERC Rate Schedule 206 to be effective 7/1/2015.

    Filed Date: 9/29/15.

    Accession Number: 20150929-5101.

    Comments Due: 5 p.m. ET 10/20/15.

    Take notice that the Commission received the following electric securities filings:

    Docket Numbers: ES15-66-000.

    Applicants: El Paso Electric Company.

    Description: Supplement to September 9, 2015 Application of El Paso Electric Company for FPA Section 204 authorization.

    Filed Date: 9/16/15.

    Accession Number: 20150916-5070.

    Comments Due: 5 p.m. ET 10/13/15.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: September 29, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-25651 Filed 10-7-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2503-154] Duke Energy Carolinas, LLC; Notice of Availability of Draft Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office of Energy Projects has reviewed the application for a new license for the Keowee-Toxaway Hydroelectric Project, located on the Toxaway, Keowee, and Little Rivers in Oconee County and Pickens County, South Carolina and Transylvania County, North Carolina, and has prepared a draft Environmental Assessment (EA) for the project. The project does not occupy federal land.

    The draft EA contains staff's analysis of the potential environmental impacts of the project and concludes that relicensing the project, with appropriate environmental measures, would not constitute a major federal action that would significantly affect the quality of the human environment.

    A copy of the draft EA is on file with the Commission and is available for public inspection. The draft EA may also be viewed on the Commission's Web site at http://www.ferc.gov using the “eLibrary” link. Enter the docket number, excluding the last three digits in the docket number field, to access the document. For assistance, contact FERC Online Support at [email protected] or toll-free at 1-866-208-3676, or for TTY, (202) 502-8659. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    Any comments should be filed within 30 days from the date of this notice. Comments may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site 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. Although the Commission strongly encourages electronic filing, documents may also be paper-filed. To paper-file, mail comments to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-2503-154.

    For further information, contact Rachel McNamara at (202) 502-8340 or [email protected]

    Dated: October 1, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-25638 Filed 10-7-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER15-2728-000] Maricopa West Solar PV, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Maricopa West Solar PV, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is October 19, 2015.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic 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.

    Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-25655 Filed 10-7-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CD15-34-000] City of Manitou Springs, Colorado; Notice of Preliminary Determination of a Qualifying Conduit Hydropower Facility and Soliciting Comments and Motions To Intervene

    On September 24, 2015, the City of Manitou Springs, Colorado, filed a notice of intent to construct a qualifying conduit hydropower facility, pursuant to section 30 of the Federal Power Act (FPA), as amended by section 4 of the Hydropower Regulatory Efficiency Act of 2013 (HREA). The proposed Manitou Springs WTP Hydro Project would have an installed capacity of 40 kilowatts (kW), and would be located along an existing 16-inch-diameter raw water pipeline supplying water to the city's water treatment plant. The project would be located in the City of Manitou Springs in El Paso County, Colorado.

    Applicant Contact: Jason Wells, City Administrator, 606 Manitou Ave., Manitou Springs, CO 80829, Phone No. (719) 685-2626.

    FERC Contact: Christopher Chaney, Phone No. (202) 502-6778, email: [email protected]

    Qualifying Conduit Hydropower Facility Description: The proposed project would consist of: (1) A proposed powerhouse, approximately 12.5 feet by 23 feet, adjacent to the existing water treatment plant building; (2) a short, 6-inch-diameter penstock teeing off the existing 16-inch-diameter raw water supply pipeline; (3) one vertical in-line Francis turbine/generator unit with an installed capacity of 40 kilowatts (kW); (4) a short, 6-inch-diameter discharge returning water to the existing 16-inch-diameter raw water pipeline; and (5) appurtenant facilities.

    The proposed project would have a total installed capacity of 40 kW.

    A qualifying conduit hydropower facility is one that is determined or deemed to meet all of the criteria shown in the table below.

    Table 1—Criteria for Qualifying Conduit Hydropower Facility Statutory provision Description Satisfies
  • (Y/N)
  • FPA 30(a)(3)(A), as amended by HREA The conduit the facility uses is a tunnel, canal, pipeline, aqueduct, flume, ditch, or similar manmade water conveyance that is operated for the distribution of water for agricultural, municipal, or industrial consumption and not primarily for the generation of electricity Y FPA 30(a)(3)(C)(i), as amended by HREA The facility is constructed, operated, or maintained for the generation of electric power and uses for such generation only the hydroelectric potential of a non-federally owned conduit Y FPA 30(a)(3)(C)(ii), as amended by HREA The facility has an installed capacity that does not exceed 5 megawatts Y FPA 30(a)(3)(C)(iii), as amended by HREA On or before August 9, 2013, the facility is not licensed, or exempted from the licensing requirements of Part I of the FPA Y

    Preliminary Determination: Based upon the above criteria, Commission staff preliminarily determines that the proposal satisfies the requirements for a qualifying conduit hydropower facility, which is not required to be licensed or exempted from licensing.

    Comments and Motions to Intervene: Deadline for filing comments contesting whether the facility meets the qualifying criteria is 45 days from the issuance date of this notice.

    Deadline for filing motions to intervene is 30 days from the issuance date of this notice.

    Anyone may submit comments or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210 and 385.214. Any motions to intervene must be received on or before the specified deadline date for the particular proceeding.

    Filing and Service of Responsive Documents: All filings must (1) bear in all capital letters the “COMMENTS CONTESTING QUALIFICATION FOR A CONDUIT HYDROPOWER FACILITY” or “MOTION TO INTERVENE,” as applicable; (2) state in the heading the name of the applicant and the project number of the application to which the filing responds; (3) state the name, address, and telephone number of the person filing; and (4) otherwise comply with the requirements of sections 385.2001 through 385.2005 of the Commission's regulations.1 All comments contesting Commission staff's preliminary determination that the facility meets the qualifying criteria must set forth their evidentiary basis.

    1 18 CFR 385.2001-2005 (2015).

    The Commission strongly encourages electronic filing. Please file motions to intervene and comments 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. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Locations of Notice of Intent: Copies of the notice of intent can be obtained directly from the applicant or such copies can be viewed and reproduced at the Commission in its Public Reference Room, Room 2A, 888 First Street NE., Washington, DC 20426. The filing may also be viewed on the web at http://www.ferc.gov/docs-filing/elibrary.asp using the “eLibrary” link. Enter the docket number (i.e., CD15-34) in the docket number field to access the document. For assistance, call toll-free 1-866-208-3676 or email [email protected] For TTY, call (202) 502-8659.

    Dated: October 1, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-25633 Filed 10-7-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP15-559-000] Transwestern Pipeline Company, LLC; Notice of Request Under Blanket Authorization

    Take notice that on September 25, 2015, Transwestern Pipeline Company, LLC (Transwestern), 1300 Main Street, Houston, Texas 77002, filed a prior notice application pursuant to sections 157.205, 157.208, and 157.210 of the Federal Energy Regulatory Commission's (Commission) regulations under the Natural Gas Act (NGA), and Transwestern's blanket certificate issued in Docket No. CP82-534-000. Transwestern seeks authorization to: (1) Modify the existing compressor units at its P-1 Compressor Station located in Roosevelt County, New Mexico, and at its P-2 Compressor Station located in Deaf Smith County, Texas; and (2) increase the certificated capacity of its Panhandle Lateral to flow an additional 22,000 million cubic feet per day, all as more fully set forth in the application, which is open to the public for inspection. The filing may also be viewed on the web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at [email protected] or call toll-free, (866) 208-3676 or TTY, (202) 502-8659.

    Any questions regarding this application should be directed to Mr. Kelly Allen, Manager, Regulatory Affairs Department, Transwestern Pipeline Company, LLC, 1300 Main Street, Houston, Texas 77002 or phone (713) 989-2606, or fax (713) 989-1205 or by email [email protected]

    Any person or the Commission's staff may, within 60 days after issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and pursuant to section 157.205 of the regulations under the NGA (18 CFR 157.205), a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for filing a protest. If a protest is filed and not withdrawn within 30 days after the allowed time for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding, or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenter will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    Dated: October 2, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-25637 Filed 10-7-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. EL12-101-000; EL14-29-000; EL13-16-000] New York Association of Public Power v. Niagara Mohawk Power Corporation and New York Independent System Operator, Inc., New York Association of Public Power v. Niagara Mohawk Power Corporation and New York Independent System Operator, Inc., Municipal Electric Utilities Association of New York v. Niagara Mohawk Power Corporation and New York Independent System Operator, Inc.; Notice of Filing

    Take notice that on September 30, 2015, Niagara Mohawk Power Corporation submitted tariff filing: Refund Report to be effective N/A.

    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. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.

    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 October 21, 2015.

    Dated: October 1, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-25631 Filed 10-7-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER15-2722-000] Wheelabrator Saugus Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Wheelabrator Saugus Inc.'s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is October 19, 2015.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic 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.

    Dated: September 29, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-25653 Filed 10-7-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #2

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC15-157-000.

    Applicants: Pennsylvania Electric Company, Metropolitan Edison Company, Jersey Central Power & Light Co., FirstEnergy Transmission, LLC, Mid-Atlantic Interstate Transmission, LL.

    Description: Response of Pennsylvania Electric Company, et al., to August 28, 2015 Commission letter requesting additional information.

    Filed Date: 9/28/15.

    Accession Number: 20150928-5341.

    Comments Due: 5 p.m. ET 10/19/15.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER13-948-007.

    Applicants: Entergy Services, Inc., Entergy Arkansas, Inc., Entergy Gulf States Louisiana, L.L.C., Entergy Louisiana, LLC, Entergy Mississippi, Inc., Entergy New Orleans, Inc., Entergy Texas, Inc.

    Description: Entergy Services, Inc., on behalf of the Entergy Operating Companies, submits transmission formula rate implementation timeline and deadlines for 2015-16 rate year.

    Filed Date: 9/28/15.

    Accession Number: 20150928-5345.

    Comments Due: 5 p.m. ET 10/19/15.

    Docket Numbers: ER15-2741-000.

    Applicants: Arizona Public Service Company.

    Description: § 205(d) Rate Filing: Service Agreement No. 346—City of Williams to be effective 12/1/2015.

    Filed Date: 9/29/15.

    Accession Number: 20150929-5190.

    Comments Due: 5 p.m. ET 10/20/15.

    Docket Numbers: ER15-2742-000.

    Applicants: Panda Patriot LLC.

    Description: Baseline eTariff Filing: FERC Electric Tariff, Volume No. 1 (MBR Application) to be effective 11/13/2015.

    Filed Date: 9/29/15.

    Accession Number: 20150929-5221.

    Comments Due: 5 p.m. ET 10/20/15.

    Take notice that the Commission received the following land acquisition reports:

    Docket Numbers: LA15-3-000.

    Applicants: Consolidated Edison Company of New York, Inc., Consolidated Edison Energy, Inc, Consolidated Edison Solutions, Inc., Orange and Rockland Utilities, Inc., CED White River Solar, LLC, CED White River Solar 2, LLC, Alpaugh North, LLC, Alpaugh 50, LLC, Broken Bow Wind II, LLC, Copper Mountain Solar 2, LLC, Copper Mountain Solar 3, LLC, Mesquite Solar 1, LLC, Campbell County Wind Farm, LLC.

    Description: Quarterly Land Acquisition Report of Consolidated Edison Company of New York, Inc., et. al.

    Filed Date: 9/29/15.

    Accession Number: 20150929-5153.

    Comments Due: 5 p.m. ET 10/20/15.

    Take notice that the Commission received the following electric reliability filings:

    Docket Numbers: RR15-16-000.

    Applicants: North American Electric Reliability Corporation.

    Description: Response of North American Electric Reliability Corporation's to September 15, 2015 Commission letter requesting additional information.

    Filed Date: 9/29/15.

    Accession Number: 20150929-5218.

    Comments Due: 5 p.m. ET 10/13/15.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: September 29, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-25654 Filed 10-7-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER15-2676-000] Cedar Bluff Wind, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request For Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Cedar Bluff Wind, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is October 19, 2015.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic 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.

    Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-25652 Filed 10-7-15; 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: ER13-1053-001.

    Applicants: Switch Energy LLC.

    Description: Notice in Change in Status of Switch Energy LLC.

    Filed Date: 10/1/15.

    Accession Number: 20151001-5432.

    Comments Due: 5 p.m. ET 10/22/15.

    Docket Numbers: ER15-2534-000.

    Applicants: Saddleback Ridge Wind, LLC.

    Description: Supplement to August 26, 2015 Saddleback Ridge Wind, LLC tariff filing.

    Filed Date: 10/1/15.

    Accession Number: 20151001-5411.

    Comments Due: 5 p.m. ET 10/22/15.

    Docket Numbers: ER15-2705-000.

    Applicants: Southwest Power Pool, Inc.

    Description: Report Filing: Seams Transmission Projects-Re-Submission of Transmittal Letter in ER15-2705 to be effective N/A.

    Filed Date: 10/2/15.

    Accession Number: 20151002-5080.

    Comments Due: 5 p.m. ET 10/23/15.

    Docket Numbers: ER16-3-000.

    Applicants: Southwest Power Pool, Inc.

    Description: Southwest Power Pool, Inc.'s Informational Filing to Notify the Commission of Implementation of Year-Four Reallocation of Revenue Requirements Pursuant to Attachments J and O for the Balanced Portfolio.

    Filed Date: 10/1/15.

    Accession Number: 20151001-5136.

    Comments Due: 5 p.m. ET 10/22/15.

    Docket Numbers: ER16-11-000.

    Applicants: Sierra Pacific Power Company.

    Description: § 205(d) Rate Filing: Rate Schedule No. 27—Annual BPA-GTA Update 2015 to be effective 10/31/2015.

    Filed Date: 10/1/15.

    Accession Number: 20151001-5407.

    Comments Due: 5 p.m. ET 10/22/15.

    Docket Numbers: ER16-12-000.

    Applicants: LRI Renewable Energy LLC.

    Description: § 205(d) Rate Filing: Emerald City Amendment to LRI to be effective 10/2/2015.

    Filed Date: 10/2/15.

    Accession Number: 20151002-5083.

    Comments Due: 5 p.m. ET 10/23/15.

    Docket Numbers: ER16-13-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: Revisions to Attach AE Regarding Annual Auction Revenue Right Allocation to be effective 1/28/2016.

    Filed Date: 10/2/15.

    Accession Number: 20151002-5106.

    Comments Due: 5 p.m. ET 10/23/15.

    Docket Numbers: ER16-14-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2015-10-02_MISO-SPP JOA Section 8.1.2 Amendment M2M to be effective 3/1/2015.

    Filed Date: 10/2/15.

    Accession Number: 20151002-5124.

    Comments Due: 5 p.m. ET 10/23/15.

    Docket Numbers: ER16-15-000.

    Applicants: R.E. Ginna Nuclear Power Plant, LLC.

    Description: § 205(d) Rate Filing: 2015 normal Oct to be effective 10/2/2015.

    Filed Date: 10/2/15.

    Accession Number: 20151002-5125.

    Comments Due: 5 p.m. ET 10/23/15.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 2, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-25616 Filed 10-7-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP15-537-000] DBM Pipeline, LLC; Notice of Staff Protest to Proposed Blanket Certificate Activity

    Commission staff (Protestor) hereby protests the prior notice request filed under the provisions of part 157, subpart F, of the Commission's regulations, by DBM Pipeline, LLC (DBM Pipeline) on July 27, 2015 in the above referenced docket. Pursuant to its part 157, subpart F, blanket certificate authority, DBM Pipeline proposes to construction and operate approximately 9 miles of 20-inch-diameter pipeline in Reeves and Culberson Counties, Texas, and Eddy County, New Mexico. Protestor seeks to have this prior notice request processed as a case-specific application filed under section 7(c) of the Natural Gas Act and part 157, subpart A, of the Commission's regulations.1

    1 Section 157.205(f) provides that a protested prior notice filing shall be treated as though it had filed a case-specific application under National Gas Act section 7, unless, pursuant to section 157.205(g) the protestor withdraws its protest within 30 days after protests were due.

    Protestor notes that on September 28, 2015, DBM Pipeline filed a data response which described a mitigation plan instead of an avoidance plan for historic properties. Mitigation plans do not comply with the National Historic Preservation Act under the Commission's regulations for blanket projects. DBM Pipeline must file with the Commission construction plan to avoid historic properties (exceed 25 feet from any of the historic properties). In addition, DBM Pipeline must file with the FERC complete responses to the FERC Environmental Data Request dated September 23, 2015.

    Without this information, environmental concerns cannot be adequately addressed within the 30 day period after the protest deadline.

    Dated: October 2, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-25634 Filed 10-7-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP15-553-000] Equitrans, L.P.; Notice of Application

    Take notice that on September 18, 2015, Equitrans, L.P. (“Equitrans”), pursuant to section 7(c) of the Federal Energy Regulatory Commission's (FERC) regulations under the Natural Gas Act (NGA), filed in Docket No. CP15-553-000, application for all authorizations necessary for it to restate the certificated capacities for the Allegheny Valley Connector (AVC) storage facilities located in Cambria, Clarion, Allegheny and Westmoreland Counties, Pennsylvania to reflect actual operations. The new collective storage deliverability will be adjusted to 246 MMcf/d from 260 MMcf/d and the new working gas capacity will be adjusted to 11.2 Bcf from 15.1 Bcf. The filing may also be viewed on the web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at [email protected] or call toll-free, (866) 208-3676 or TTY, (202) 502-8659.

    Any questions concerning this application may be directed to Matthew Eggerding, Counsel—Midstream, EQT Corporation, 625 Liberty Avenue, Suite 1700, Pittsburgh, PA 15222 by calling (412) 553-5786; by faxing (412) 553-7781; or by emailing [email protected]

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 5 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests, and interventions via the internet in lieu of paper. See 18 CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web site (www.ferc.gov) under the “e-Filing” link. 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.

    Comment Date: 5:00 p.m. Eastern Time on October 23, 2015.

    Dated: October 2, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-25635 Filed 10-7-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. EL15-70-000; EL15-71-000; EL15-72-000; EL15-82-000] Public Citizen, Inc. v. Midcontinent Independent System Operator, Inc., The People of the State of Illinois By Illinois Attorney General Lisa Madigan v. Midcontinent Independent System Operator, Inc., Southwestern Electric Cooperative, Inc. v. Midcontinent Independent System Operator, Inc., Dynegy, Inc., and Sellers of Capacity into Zone 4 of the 2015-2016 MISO Planning Resource Auction, Illinois Industrial Energy Consumers v. Midcontinent Independent System Operator, Inc.; Notice of Technical Conference

    Take notice that a staff-led conference will be held on October 20, 2015, at the offices of the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, between 9:00 a.m. and 4:15 p.m. (EST). The purpose of the conference is to obtain further information concerning the above referenced complaints.1

    1 As noted in its order issued October 1, 2015 in Docket No. IN15-10-000, the Commission's Office of Enforcement is conducting a non-public investigation under Part 1b of the Commission's regulations into whether market manipulation or other potential violations of Commission orders, rules and regulations occurred before or during the Auction conducted by MISO in April 2015. This technical conference will not address the current investigation.

    The technical conference will be transcribed. Transcripts will be available for a fee from Ace-Federal Reports, Inc. (202-347-3700).

    There will be a free webcast of the conference. The webcast will allow persons to listen to the technical conference, but not participate. Anyone with internet access who wants to listen to the conference can do so by navigating to the Calendar of Events at www.ferc.gov and locating the technical conference in the Calendar. The technical conference will contain a link to its webcast. The Capitol Connection provides technical support for the webcast and offers the option of listening to the meeting via phone-bridge for a fee. If you have any questions, visit www.CapitolConnection.org or call 703-993-3100. The webcast will be available on the Calendar of Events on the Commission's Web site www.ferc.gov for three months after the conference.

    Advance registration is not required but is highly encouraged. Attendees may register at the following Web page: https://www.ferc.gov/whats-new/registration/10-20-15-form.asp. Attendees should allow time to pass through building security procedures before the 9:00 a.m. (EST) start time of the technical conference. In addition, information on this event will be posted on the Calendar of Events on the Commission's Web site, www.ferc.gov, prior to the event.

    Discussions at the conference may address matters at issue in the following Commission proceeding(s) that are either pending or within their rehearing period: Midcontinent Independent System Operator, Inc., Docket No. ER11-4081-000, et al.

    Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations, please send an email to [email protected] or call toll free (866) 208-3372 (voice) or (202) 502-8659 (TTY), or send a FAX to (202) 208-2106 with the required accommodations.

    The technical conference will consist of four sessions and focus on the issues raised in the complaints, as detailed below. Commissioners may attend and ask questions. The times given below are approximate and may change, as needed.

    Conference Introduction: Commission Staff (9:00 a.m.-9:15 a.m.) Session 1: Market Power Mitigation (9:15 a.m.-12:15 p.m.) Panel 1: Implementation of the Current Mitigation Procedures and Reference Level Calculations (90 mins)

    Staff will lead a discussion to obtain information on the current market power mitigation procedures, including Initial Reference Levels, the transmission availability from MISO to PJM Interconnection, L.L.C. (PJM), PJM's market for replacement capacity, opportunity costs, and the Conduct Threshold for capacity market offer mitigation. Panelists should also be prepared to answer questions including, but not limited to, the following: For the 2014/15 and 2015/16 delivery years, how much PJM replacement capacity was procured after PJM's third incremental auction, and of that, how much was from MISO resources, and for what prices and durations were these MISO resources contracted? How much total transmission capability was available between MISO and PJM during the 2014/15 and 2015/16 MISO and PJM delivery years, and how much of that transmission capacity was subscribed as of the PJM third Incremental Auction for each delivery year? How much total transmission capability is expected between MISO and PJM for the 2016/17 and 2017/18 delivery years, and how much of that transmission capability is already subscribed?

    Panel 2: Alternatives to the Current Mitigation Procedures and Reference Level Calculation (90 mins)

    Panelists should be prepared to discuss possible alternatives to the current market power mitigation procedures and calculations. Panelists should also be prepared to answer questions including, but not limited to, the following: How should opportunity cost underlying reference levels consider physical or economic limitations of capacity sales? Should individual reference levels be developed for market participants that are pivotal suppliers in the capacity market? If so, how should they be determined? What are alternatives to PJM replacement capacity sales for determining the opportunity costs used to establish mitigation reference levels?

    Lunch Break: (12:15 p.m.-1:15 p.m.) Session 2: Local Requirements (1:15 p.m.-2:15 p.m.)

    Panelists should be prepared to describe the calculations of Auction parameters such as Local Reliability Requirements, Capacity Import Limits, Capacity Export Limits, and Local Clearing Requirements, and to answer questions including, but not limited to, the following: What was the rationale behind the methodological change to examine constraints below 200 kV in the calculation of Capacity Import Limits and Capacity Export Limits? How does MISO's calculation of zonal Capacity Import Limits and Capacity Export Limits reflect counter-flows from or into neighboring regions?

    Session 3: Zonal Boundaries (2:15 p.m.-3:00 p.m.)

    Panelists should be prepared to discuss the current zonal boundaries in MISO and the criteria used to establish zonal configuration. Panelists should also be prepared to answer questions including, but not limited to, the following: Have the six criteria in the Tariff established a zonal configuration that reflects the physical constraints on the MISO transmission system? If there is little or no congestion between adjacent zones, what are the reasons for and against combining the zones? What changes to the criteria and/or zonal configuration are currently being considered by MISO?

    Break: (3:00 p.m.-3:15 p.m.) Session 4: Wrap Up (3:15 p.m.-4:00 p.m.)

    Panelists should be prepared to answer questions including, but not limited to, the following: What changes to the Tariff, including those not discussed in the first three sessions, might be necessary to ensure just and reasonable outcomes going forward, and, of these changes, which can be implemented for the 2016/17 Auction?

    Conference Conclusion: Next Steps (4:00 p.m.-4:15 p.m.)

    Following the technical conference, the Commission will consider post-technical conference comments regarding the matters discussed at the conference submitted on or before November 4, 2015.

    For more information about this technical conference, please contact Elizabeth Shen, 202-502-6545, [email protected], regarding legal issues; or Angelo Mastrogiacomo, 202-502-8689, angelo.mastrog[email protected], and Emma Nicholson, 202-502-8846, [email protected], regarding technical issues; or Sarah McKinley, 202-502-8368, [email protected], regarding logistical issues.

    Dated: October 1, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-25632 Filed 10-7-15; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2015-0669; FRL-9934-99] Pesticide Program Dialogue Committee; Notice of Public Meeting AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    Pursuant to the Federal Advisory Committee Act, the Environmental Protection Agency's Office of Pesticide Programs is announcing a public meeting of the Pesticide Program Dialogue Committee (PPDC) on October 21-22, 2015. In addition, EPA is announcing meetings on October 20, 2015, of the following PPDC Workgroups: Integrated Pest Management, Comparative Safety Statements, 21st Century Toxicology/New Integrated Testing Strategies, and Pesticide Incidents. These meetings provide advice and recommendations to the EPA Administrator on issues associated with pesticide regulatory development and reform initiatives, evolving public policy and program implementation issues, and science issues associated with evaluating and reducing risks from use of pesticides.

    DATES:

    The PPDC meeting will be held on Wednesday, October 21, 2015, from 9 a.m. to 5:00 p.m. and Thursday, October 22, 2015, from 9 a.m. to 12:00 p.m.

    Work Group Meetings: On Tuesday, October 20, 2015, PPDC Work Group meetings are scheduled as follows: Integrated Pest Management Work Group, 1:00 p.m. to 3:00 p.m., Comparative Safety Statements Work Group, 2:00 p.m. to 4:00 p.m., 21st Century Toxicology/New Integrated Testing Strategies Work Group, 1:00 p.m. to 3:00 p.m., and Pesticide Incidents Work Group, 1:30 p.m. to 4:00 p.m.

    Agenda: A draft agenda will be posted on or before October 7, 2015.

    Accommodations requests: To request accommodation of a disability, please contact the person listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request.

    ADDRESSES:

    The PPDC Meeting and PPDC Work Group meetings will be held at 1 Potomac Yard South, 2777 S. Crystal Drive, Arlington, VA. The PPDC meeting will be held in the lobby-level Conference Center. The PPDC Work Group meetings will be held as follows: Integrated Pest Management Work Group in the fourth floor conference room number N4850-70, Comparative Safety Statements Work Group in the lobby-level Conference Center; 21st Century Toxicology/New Integrated Testing Strategies Work Group in the ninth floor conference room number 9100; and Pesticide Incidents Work Group in the fourth floor conference room number N4830.

    EPA's Potomac Yard South Building is approximately 1 mile from the Crystal City Metro Station.

    FOR FURTHER INFORMATION CONTACT:

    Dea Zimmerman, Office of Pesticide Programs (LC-8J), Environmental Protection Agency, 77 W. Jackson Boulevard, Chicago, IL 60604; telephone number: (312) 353-6344; email address: [email protected]

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

    You may be potentially affected by this action if you work in agricultural settings or if you are concerned about implementation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the Federal Food, Drug, and Cosmetic Act (FFDCA); and the amendments to both of these major pesticide laws by the Food Quality Protection Act (FQPA) of 1996; the Pesticide Registration Improvement Act, and the Endangered Species Act. Potentially affected entities may include, but are not limited to: Agricultural workers and farmers; pesticide industry and trade associations; environmental, consumer, and farm worker groups; pesticide users and growers; animal rights groups; pest consultants; state, local, and tribal governments; academia; public health organizations; and the public. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

    B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0669 is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    II. Background

    The PPDC is a Federal advisory committee chartered under the Federal Advisory Committee Act (FACA), Public Law 92-463. EPA established the PPDC in September 1995 to provide advice and recommendations to the EPA Administrator on issues associated with pesticide regulatory development and reform initiatives, evolving public policy and program implementation issues, and science issues associated with evaluating and reducing risks from use of pesticides. The following sectors are represented on the current PPDC: Environmental/public interest and animal rights groups; farm worker organizations; pesticide industry and trade associations; pesticide user, grower, and commodity groups; Federal and state/local/tribal governments; the general public; academia; and public health organizations.

    III. How can I request to participate in this meeting?

    PPDC meetings are free, open to the public, and no advance registration is required. Public comments may be made during the public comment session of each meeting or in writing to the person listed under FOR FURTHER INFORMATION CONTACT.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: October 2, 2015. Marty Monell, Acting Director, Office of Pesticide Programs.
    [FR Doc. 2015-25687 Filed 10-7-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OA-2015-0210; FRL 9935-35-OARM] National and Governmental Advisory Committees to the U.S. Representative to the Commission for Environmental Cooperation AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of Advisory Committee meeting teleconference call.

    SUMMARY:

    Under the Federal Advisory Committee Act, Public Law 92-463, EPA gives notice of a meeting of the National Advisory Committee (NAC) and Governmental Advisory Committee (GAC) to the U.S. Representative to the North American Commission for Environmental Cooperation (CEC). The National and Governmental Advisory Committees advise the EPA Administrator in her capacity as the U.S. Representative to the CEC Council. The Committees are authorized under Articles 17 and 18 of the North American Agreement on Public Law 103-182, and as directed by Executive Order 12915, entitled “Federal Implementation of the North American Agreement on Environmental Cooperation.” The NAC is composed of 14 members representing academia, environmental non-governmental organizations, and private industry. The GAC consists of 15 members representing state, local, and Tribal governments. The Committees are responsible for providing advice to the U.S. Representative on a wide range of strategic, scientific, technological, regulatory, and economic issues related to implementation and further elaboration of the NAAEC.

    The purpose of this meeting is to provide advice on a variety of trade and environment issues in North America. The meeting will also include a public comment session. The agenda, meeting materials, and general information about NAC and GAC will be available at http://www2.epa.gov/faca/nac-gac.

    DATES:

    The NAC/GAC will hold a public teleconference on October 23, 2015, from 1:00 p.m. to 5:30 p.m. Eastern Standard Time.

    ADDRESSES:

    The meeting will be held at the U.S. EPA William Jefferson Clinton East Building, 1201 Constitution Avenue NW., Room 1132, Washington, DC 20004

    FOR FURTHER INFORMATION CONTACT:

    Oscar Carrillo, Designated Federal Officer, [email protected], 202-564-0347, U.S. EPA, Office of Diversity, Advisory Committee Management and Outreach (1601-M), 1200 Pennsylvania Avenue NW., Washington, DC 20004.

    SUPPLEMENTARY INFORMATION:

    Requests to make oral comments or to provide written comments to NAC/GAC should be sent to Oscar Carrillo at [email protected] by Wednesday, October 14, 2015. The meeting is open to the public, with limited seating on a first-come, first-served basis. Members of the public wishing to participate in the teleconference should contact Oscar Carrillo at [email protected] or (202) 564-0347 by October 14, 2015.

    Meeting Access: For information on access or services for individuals with disabilities, please contact Oscar Carrillo at 202-564-0347 or [email protected] To request accommodation of a disability, please contact Oscar Carrillo, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request.

    Dated: September 17, 2015. Oscar Carrillo, Designated Federal Officer.
    [FR Doc. 2015-25675 Filed 10-7-15; 8:45 am] BILLING CODE 6560-50-P
    Environmental Protection Agency [EPA-HQ-OPPT-2013-0677; FRL-9934-79] Receipt of Test Data Under the Toxic Substances Control Act AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    EPA is announcing its receipt of test data submitted pursuant to a test rule issued by EPA under the Toxic Substances Control Act (TSCA). As required by TSCA, this document identifies each chemical substance and/or mixture for which test data have been received; the uses or intended uses of such chemical substance and/or mixture; and describes the nature of the test data received. Each chemical substance and/or mixture related to this announcement is identified in Unit I. under SUPPLEMENTARY INFORMATION.

    FOR FURTHER INFORMATION CONTACT:

    For technical information contact: Kathy Calvo, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-8089; email address: calvo,[email protected]

    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected].

    SUPPLEMENTARY INFORMATION: I. Chemical Substances and/or Mixtures

    Information about the following chemical substances and/or mixtures is provided in Unit IV.:

    1H,3H-Benzo[1,2-c:4,5-c′]difuran-1,3,5,7-tetrone (aka PMDA) (CAS RN 89-32-7). II. Federal Register Publication Requirement

    Section 4(d) of TSCA (15 U.S.C. 2603(d)) requires EPA to publish a notice in the Federal Register reporting the receipt of test data submitted pursuant to test rules promulgated under TSCA section 4 (15 U.S.C. 2603).

    III. Docket Information

    A docket, identified by the docket identification (ID) number EPA-HQ-OPPT-2013-0677, has been established for this Federal Register document that announces the receipt of data. Upon EPA's completion of its quality assurance review, the test data received will be added to the docket for the TSCA section 4 test rule that required the test data. Use the docket ID number provided in Unit IV. to access the test data in the docket for the related TSCA section 4 test rule.

    The docket for this Federal Register document and the docket for each related TSCA section 4 test rule is available electronically at http://www.regulations.gov or in person at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    IV. Test Data Received

    This unit contains the information required by TSCA section 4(d) for the test data received by EPA.

    1H,3H-Benzo[1,2-c:4,5-c′]difuran-1,3,5,7-tetrone (aka PMDA) (CAS RN 89-32-7).

    1. Chemical Use(s): Epoxy curing and cross-linking agent; plasticizer and synthetic intermediate.

    2. Applicable Test Rule: Chemical testing requirements for second group of high production volume chemicals (HPV2), 40 CFR 799.5087.

    3. Test Data Received: The following listing describes the nature of the test data received. The test data will be added to the docket for the applicable TSCA section 4 test rule and can be found by referencing the docket ID number provided. EPA reviews of test data will be added to the same docket upon completion.

    Reproduction Developmental Toxicity Screening Test (F1). The docket ID number assigned to this data is EPA-HQ-OPPT-2007-0531.

    Authority:

    15 U.S.C. 2601 et seq.

    Dated: October 1, 2015. Maria J. Doa, Director, Chemical Control Division, Office of Pollution Prevention and Toxics.
    [FR Doc. 2015-25686 Filed 10-7-15; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0286] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written PRA comments should be submitted on or before December 7, 2015. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control No.: 3060-0286.

    Title: Section 80.302, Notice of Discontinuance, Reduction, or Impairment of Service Involving a Distress Watch.

    Form No.: N/A.

    Type of Review: Extension of a currently approved collection.

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

    Number of Respondents and Responses: 160 respondents and 160 responses.

    Estimated Time per Response: 1 hour.

    Frequency of Response: Third party disclosure requirement.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection 47 U.S.C. 154, 303, 307(e), 309 and 332, unless noted.

    Total Annual Burden: 160 hours.

    Annual Cost Burden: No cost.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Needs and Uses: The reporting requirement contained in section 80.302 is necessary to ensure that the U.S. Coast Guard is timely notified when a coast station, which is responsible for maintaining a listening watch on a designated marine distress and safety frequency discontinues, reduces or impairs its communications services. This notification allows the Coast Guard to seek an alternate means of providing radio coverage to protect the safety of life and property at sea or object to the planned diminution of service. The information is used by the U.S. Coast Guard district office nearest to the coast station. Once the Coast Guard is aware that such a situation exists, it is able to inform the maritime community that radio coverage has or will be affected and/or seek to provide coverage of the safety watch via alternate means.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2015-25577 Filed 10-7-15; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meeting AGENCY:

    Federal Election Commission.

    DATE AND TIME:

    Monday, October 5, 2015 at 2:30 p.m.

    PLACE:

    999 E Street NW., Washington, DC.

    STATUS:

    This meeting was closed to the public.

    ITEMS DISCUSSED:

    Compliance matters pursuant to 52 U.S.C. 30109.

    Internal personnel decisions, or internal rules and practices.

    PERSON TO CONTACT FOR INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Shawn Woodhead Werth, Secretary and Clerk of the Commission.
    [FR Doc. 2015-25736 Filed 10-6-15; 11:15 am] BILLING CODE 6715-01-P
    FEDERAL HOUSING FINANCE AGENCY [No. 2015-N-09] Privacy Act of 1974; System of Records AGENCY:

    Federal Housing Finance Agency.

    ACTION:

    Notice of Revisions to Existing Systems of Records Notices.

    SUMMARY:

    In accordance with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a (Privacy Act), notice is hereby given that the Federal Housing Finance Agency (FHFA) is revising its existing Systems of Records Notices (SORN) to change and/or add to the System Location Address; the System Manager Address; and the Address for where to direct inquiries and requests.

    The proposed revisions are to the following systems: Federal Home Loan Bank System Directory (FHFA-1); Financial Management System (FHFA-2); Correspondence Tracking System (FHFA-3); Compensation Information Provided by the Regulated Entities (FHFA-4); Mail, Contact, Telephone, and Other Lists (FHFA-7); Federal Home Loan Bank Directors (FHFA-8); Administrative Grievance Records (FHFA-9); Employee Benefits Records (FHFA-10); Transit Subsidy Program Records (FHFA-11); Parking Program Records (FHFA-12); Freedom of Information Act and Privacy Act Records (FHFA-13); Emergency Notification System (FHFA-14); Payroll, Retirement, Time and Attendance, and Leave Records (FHFA-15); and Personnel Investigative Files (FHFA-16).

    Since the revisions to these existing systems of records are purely administrative in nature, they will become effective upon publication in the Federal Register.

    DATES:

    These revisions are effective October 8, 2015. See SUPPLEMENTARY INFORMATION for additional information.

    FOR FURTHER INFORMATION CONTACT:

    Stacy Easter, Privacy Act Officer, [email protected] or (202) 649-3803; or David A. Lee, Senior Agency Official for Privacy, [email protected] or (202) 649-3803 (not toll-free numbers), Federal Housing Finance Agency, Eighth Floor, 400 Seventh Street SW., Washington, DC 20024. The telephone number for the Telecommunications Device for the Deaf is 800-877-8339.

    SUPPLEMENTARY INFORMATION: I. Introduction

    This notice satisfies the Privacy Act requirement that an agency publishes a system of records notice in the Federal Register when there is an addition or change to the agency's systems of records. Although Congress established general exemptions and specific exemptions that could be used to exempt records from provisions of the Privacy Act, the Director of FHFA has determined that records and information in this system of records are not exempt from the requirements of the Privacy Act.

    Pursuant to paragraph 4.c.(1) of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (61 FR 6428, 6435 February 20, 1996), FHFA has not submitted a report describing the system of records covered by this notice to the Committee on Oversight and Government Reform of the House of Representatives, the Committee on Homeland Security and Governmental Affairs of the Senate, and the Office of Management and Budget, because the changes to the systems are minor and administrative and changes of this nature are not required to be reported.

    II. Notice of Amendment of Systems of Records

    The following systems of records, Federal Home Loan Bank System Directory (FHFA-1), Financial Management System (FHFA-2), and Correspondence Tracking System (FHFA-3), all established at 74 FR 31949 (Jul. 6, 2009); Compensation Information Provided by the Regulated Entities (FHFA-4), established at 75 FR 35028 (Jun. 21, 2010); Mail, Contact, Telephone, and Other Lists (FHFA-7), Federal Home Loan Bank Directors (FHFA-8), Administrative Grievance Records (FHFA-9), Employee Benefits Records (FHFA-10), Transit Subsidy Program Records (FHFA-11), Parking Program Records (FHFA-12), and Freedom of Information Act and Privacy Act Records (FHFA-13), all established at 76 FR 33286 (Jun. 8, 2011); and Emergency Notification System (FHFA-14), Payroll, Retirement, Time and Attendance, and Leave Records (FHFA-15), and Personnel Investigative Files (FHFA-16), all established at 77 FR 499 (Jan. 5, 2012), are hereby revised as follows:

    SYSTEM LOCATIONS:

    Federal Housing Finance Agency, 400 Seventh Street SW., Washington, DC 20024; and any alternate work site utilized by employees of the Federal Housing Finance Agency (FHFA) or by individuals assisting such employees.

    For the Payroll, Retirement, Time and Attendance, and Leave Records (FHFA-15) system only, add the following under System Locations: Department of the Interior, Interior Business Center, 7301 W. Mansfield Avenue, Lakewood, CO 80235.

    SYSTEM MANAGER(S) AND ADDRESS:

    Federal Housing Finance Agency, 400 Seventh Street SW., Washington, DC 20024, and any alternate work site utilized by FHFA employees or by individuals assisting such employees.

    For the Payroll, Retirement, Time and Attendance, and Leave Records (FHFA-15) system only, add the following under System Address: Department of the Interior, Interior Business Center, 7301 W. Mansfield Avenue, Lakewood, CO 80235.

    NOTIFICATION AND RECORD ACCESS PROCEDURES:

    Direct inquiries and requests to the Privacy Act Officer by mail at Federal Housing Finance Agency, 400 Seventh Street SW., Washington, DC 20024, or electronically at http://www.fhfa.gov/AboutUs/FOIAPrivacy/Pages/Privacy.aspx in accordance with the procedures set forth in 12 CFR part 1204.

    CONTESTING RECORD PROCEDURES:

    Direct requests to the Privacy Act Appeals Officer by mail at Federal Housing Finance Agency, 400 Seventh Street SW., Washington, DC 20024, or electronically at http://www.fhfa.gov/AboutUs/FOIAPrivacy/Pages/Privacy.aspx in accordance with the procedures set forth in 12 CFR part 1204.

    Dated: September 29, 2015. Melvin L. Watt, Director, Federal Housing Finance Agency.
    [FR Doc. 2015-25678 Filed 10-7-15; 8:45 am] BILLING CODE 8070-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 2, 2015.

    A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:

    1. First Merchants Corporation, Muncie, Indiana; to merge with Ameriana Bancorp, and thereby indirectly acquire Ameriana Bank, both in New Castle, Indiana.

    Board of Governors of the Federal Reserve System, October 5, 2015. Michael J. Lewandowski, Associate Secretary of the Board.
    [FR Doc. 2015-25629 Filed 10-7-15; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB AGENCY:

    Board of Governors of the Federal Reserve System.

    SUMMARY:

    Notice is hereby given of the final approval of proposed information collections by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) 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 control number.

    FOR FURTHER INFORMATION CONTACT:

    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.

    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.

    Final approval under OMB delegated authority of the extension, without revision, of the following report:

    Report title: Registration of a Securities Holding Company.

    Agency form number: FR 2082.

    OMB control number: 7100-0347.

    Frequency: On occasion.

    Reporters: Securities holding companies.

    Estimated annual reporting hours: 40 hours.

    Estimated average hours per response: 8 hours.

    Number of respondents: 5.

    General description of report: The FR 2082 is authorized pursuant to Section 618 of the Dodd-Frank Act (12 U.S.C. 1850a). The institutions' obligation to report is mandatory for companies that elect to register under Section 618. The confidentiality of the forms required to be filed pursuant to section 241.3(b)(3)(i) is covered in specific memoranda relating to those forms. With respect to the “Registration of a Securities Holding Company” form required pursuant to section 241.3(a)(1), the information submitted on and with the form is normally public. However, a company may seek confidential treatment for any such information that it believes is exempt from disclosure under FOIA (5 U.S.C. 552(b)(1)-(9)). A determination of confidentiality would be made on a case-by-case basis.

    Abstract: On June 4, 2012, the Federal Reserve published a final rulemaking for Securities Holding Companies (Regulation OO) in the Federal Register (77 FR 32881). Regulation OO implements section 618 of the Dodd-Frank Act, which permits nonbank companies that own at least one registered securities broker or dealer, and that are required by a foreign regulator or provision of foreign law to be subject to comprehensive consolidated supervision, to register with the Board and subject themselves to supervision by the Board.

    Current Actions: On July 23, 2015, the Federal Reserve published a notice in the Federal Register (80 FR 43777) requesting public comment on the proposed extension, without revision, of the FR 2082. The comment period for the notice expired on September 21, 2015. The Federal Reserve did not receive any comments on the proposal, and the FR 2082 will be extended without revision as proposed.

    Final approval under OMB delegated authority of the extension, with revision, of the following report:

    Report title: Request for Proposal and Request for Price Quotations.

    Agency form number: RFP and RFPQ.

    OMB control number: 7100-0180.

    Frequency: On occasion.

    Reporters: Vendors of goods and services.

    Estimated annual reporting hours: RFP: 17,500 hours; RFPQ: 4,400 hours; Subcontractor report: 50 hours.

    Estimated average hours per response: RFP: 50 hours; RFPQ: 2 hours; Subcontractor report: 20 minutes.

    Number of respondents: RFP: 350; RFPQ: 2,200; Subcontractor report: 150.

    General description of report: The RFP and RFPQ are required to obtain a benefit and are authorized by Sections 10(3), 10(4), and 11(1) of the Federal Reserve Act (12 U.S.C. 243, 244, and 248(l)). With regard to the Subcontracting Report, Section 342(c) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) requires the Federal Reserve to develop and implement standards and procedures to assess the diversity policies and practices in all business and activities of the agency at all levels, including procurement, insurance, and all types of contracts. (12 U.S.C. 5452(c)(1)). “Such procedure shall include a written statement, in a form and with such content as the Director [of OMWI] shall prescribe . . . that a contractor shall ensure . . . the fair inclusion of women and minorities in the workforce of the contractor and, as applicable, subcontractors.” (12 U.S.C. 5452(c)(2)).

    Proposals from vendors that are not accepted and incorporated into contracts with the Federal Reserve would be protected from Freedom of Information (FOIA) disclosure by 41 U.S.C. 4702, which expressly prohibits FOIA disclosure of these proposals. Moreover, during the solicitation process vendors are permitted to mark information contained in their proposals that is proprietary or confidential with the label RESTRICTED DATA. For information so marked, the Federal Reserve also may determine on a case-by-case basis whether FOIA exemption 4, which applies to “trade secrets and commercial or financial information,” would protect information from disclosure pursuant to a FOIA request (5 U.S.C. 552(b)(4)).

    Abstract: The Federal Reserve uses the RFP and the RFPQ as appropriate to obtain competitive proposals and contracts from approved vendors of goods and services. This information collection is required to collect data on prices, specifications of goods and services, and qualifications of prospective vendors.

    Current Actions: On July 23, 2015, the Federal Reserve published a notice in the Federal Register (80 FR 43777) requesting public comment on the proposed extension, with revision, of the RFP and RFPQ. In connection with the RFP and RFPQ process, the Federal Reserve proposed to require prime contractors to submit a Subcontracting Report that would collect information about their subcontractors' commitments toward diversity and inclusion of minority-owned and women-owned vendors in the subcontractor's activities. The comment period for the notice expired on September 21, 2015. The Federal Reserve received one comment, which stated that contracting programs should be open to all and that no one should be discriminated against nor granted preferential treatment because of skin color, national origin, or sex. The RFP and RFPQ will be extended with revision as proposed.

    Board of Governors of the Federal Reserve System, October 5, 2015. Robert deV. Frierson, Secretary of the Board.
    [FR Doc. 2015-25664 Filed 10-7-15; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL TRADE COMMISSION [File No. 151 0018] Wright Medical Group, Inc. and Tornier N.V.; Analysis To Aid Public Comment AGENCY:

    Federal Trade Commission.

    ACTION:

    Proposed consent agreement.

    SUMMARY:

    The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.

    DATES:

    Comments must be received on or before October 30, 2015.

    ADDRESSES:

    Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/wrighttornierconsent online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write “Wright Medical Group, Inc. and Tornier N.V.—Consent Agreement; File No. 151 0018” on your comment and file your comment online at https://ftcpublic.commentworks.com/ftc/wrighttornierconsent by following the instructions on the web-based form. If you prefer to file your comment on paper, write “Wright Medical Group, Inc. and Tornier N.V.—Consent Agreement; File No. 151 0018” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024.

    FOR FURTHER INFORMATION CONTACT:

    Aylin M. Skroejer (202-326-2459), Bureau of Competition, 600 Pennsylvania Avenue NW., Washington, DC 20580.

    SUPPLEMENTARY INFORMATION:

    Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for September 30, 2015), on the World Wide Web, at http://www.ftc.gov/os/actions.shtm.

    You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before October 30, 2015. Write “Wright Medical Group, Inc. and Tornier N.V.—Consent Agreement; File No. 151 0018” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

    Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which . . . is privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

    If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).1 Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest.

    1 In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c), 16 CFR 4.9(c).

    Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/wrighttornierconsent by following the instructions on the web-based form. If this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that Web site.

    If you file your comment on paper, write “Wright Medical Group, Inc. and Tornier N.V.—Consent Agreement; File No. 151 0018” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

    Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before October 30, 2015. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

    Analysis of Agreement Containing Consent Order To Aid Public Comment Introduction

    The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an Agreement Containing Consent Order (“Consent Agreement”) from Wright Medical Group, Inc. (“Wright”) and Tornier N.V. (“Tornier”) designed to remedy the anticompetitive effects resulting from the proposed merger of Wright and Tornier. Under the terms of the proposed Decision and Order (“Order”) contained in the Consent Agreement, the parties are required to divest to Integra Lifesciences Corporation (“Integra”) all of Tornier's rights and assets related to the following reconstructive joint markets: (1) Total ankle replacements; (2) total silastic big toe joint replacements; and (3) total silastic toe joint replacements for the second through fifth “lesser” toes.

    The proposed Consent Agreement has been placed on the public record for thirty days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty days, the Commission will again review the Consent Agreement and the comments received, and decide whether it should withdraw from the Consent Agreement, modify it, or make it final.

    Pursuant to an Agreement and Plan of Merger dated October 27, 2014, Wright and Tornier propose to merge in an all-stock transaction valued at approximately $3.3 billion (the “Proposed Merger”). The Commission's Complaint alleges that the Proposed Merger, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45, by substantially lessening competition in the U.S. markets for total ankle replacements and total silastic toe joint replacements. The proposed Consent Agreement will remedy the alleged violations by preserving the competition that otherwise would be lost in these markets as a result of the Proposed Merger.

    The Parties

    Headquartered in Memphis, Tennessee, Wright is a global orthopedic company that divides its business into three categories: foot and ankle hardware; upper extremity reconstructive devices; and biologics products.

    Tornier is a global medical device company based in Amsterdam, the Netherlands, with U.S. operations headquartered in Bloomington, Minnesota. Tornier's U.S. products include those for the upper extremity joints; lower extremity joints; sports medicine; and biologics.

    The Relevant Products and Structure of the Markets I. Total Ankle Replacements

    Total ankle replacements are used to treat end-stage ankle arthritis, which develops when cartilage on the bones of the ankle joint wears away and causes bone-on-bone grinding down of the joint surface. Patients with end-stage ankle arthritis experience pain and swelling at the ankle along with difficulty walking. Total ankle replacements reduce the pain while maintaining the motion at the ankle joint. They replace damaged bone and cartilage with a metal tibial tray, a metal talar dome, and a polyethylene bearing. In a fixed bearing total ankle replacement, the polyethylene bearing is locked to the tibial component, while in a mobile bearing system it moves independently. Physicians and their patients would not switch to an alternative product or therapy in response to a small but significant increase in the price of total ankle replacements.

    Wright, Tornier, and Stryker Corporation (“Stryker”) are the only significant suppliers in the U.S. market for total ankle replacements, accounting for 44%, 19%, and 31% of 2014 sales, respectively. Wright and Tornier are each other's closest competitor. These companies both offer fixed bearing technologies and the only options for revision surgeries, i.e., surgeries to redo a prior total ankle replacement procedure. The other leading supplier, Stryker, supplies the only mobile bearing system in the United States, making it a more distant competitor to Wright and Tornier. The only other U.S. supplier of total ankle replacements, Zimmer Holdings, Inc. (“Zimmer”) offers a technology that typically is used only in specialized cases. Zimmer maintains a fringe position in the market.

    II. Total Silastic Toe Joint Replacements

    Total big toe joint replacements treat severe cases of hallux rigidus, an arthritic condition in the first metatarsophalangeal (“MTP”) joint of the big toe. Pain and inflammation at the first MTP joint restricts movement of the big toe and leads to difficulty walking. Total big toe joint replacements relieve pain and preserve motion in the big toe.

    There are two types of total big toe joint replacements: Metal and silastic. Total silastic big toe joint replacements are a distinct antitrust market. Surgeons that favor total silastic big toe joint replacements over metal implants do so for the silastic implants' flexibility and longevity. The silastic implants are also significantly less expensive than total metal big toe joint replacements. Physicians and patients do not view total silastic and total metal big toe joint replacements as reasonably interchangeable. A small but significant increase in the price of total silastic big toe joint replacements would not cause physicians or patients to switch to other products or therapies.

    The U.S. market for total silastic big toe joint replacements is highly concentrated. Wright and Tornier are the only significant suppliers of the product, accounting for approximately 60% and 38% of the market, respectively. The next closest competitor to Wright and Tornier—Sgarlato Med LLC—accounts for a nominal share of the market.

    Although more rare than in the big toes, severe arthritis also occurs in the MTP joints of the lesser toes. Physicians and patients who use total silastic lesser toe joint replacements would not switch to any other product or procedure in response to a small but significant increase in the price of the total silastic toe joint implants. Wright, Tornier, and OsteoMed supply total silastic lesser toe joint replacements in the United States, and Wright and Tornier are each other's closest competitor. The Proposed Merger would result in a combined market share of approximately 76%.

    The relevant geographic market for total ankle replacements and total silastic toe joint replacements is the United States. These products are medical devices regulated by the U.S. Food and Drug Administration (“FDA”). Medical devices sold outside of the United States, but not approved for sale in the United States, do not provide viable competitive alternatives for U.S. consumers.

    Entry Conditions

    Entry in the relevant markets would not be timely, likely, or sufficient in magnitude, character, and scope to deter or counteract the anticompetitive effects of the Proposed Merger. To enter or effectively expand in any of the relevant markets successfully, a supplier would need to design and manufacture an effective product, obtain FDA approval, and develop clinical history supporting the long-term efficacy of its product. The new entrant or expanding firm would also need to develop and foster product loyalty and establish a nationwide sales network capable of marketing the product and providing on-site service at hospitals nationwide. Establishing a track record for quality, service, and consistency is difficult, expensive, and typically spans several years.

    Competitive Effects of the Merger

    The Proposed Merger would likely result in significant competitive harm to consumers in the markets for total ankle replacements and total silastic toe joint replacements. As particularly close substitutes in each relevant market, Wright and Tornier respond directly to competition from each other with improved products, better service, and lower prices. By eliminating this direct and substantial head-to-head competition, the Proposed Merger likely would allow the combined firm to exercise market power unilaterally, resulting in less innovation and higher prices for consumers.

    The Consent Agreement

    The Consent Agreement eliminates the competitive concerns raised by the Proposed Merger by requiring the parties to divest to Integra all of the rights and assets needed for it to become an independent, viable, and effective competitor in the U.S. markets for total ankle replacements and total silastic toe joint replacements. The divestitures will maintain the competition that currently exists in each of the relevant markets.

    Integra is well positioned to restore the competition that otherwise would be lost through the Proposed Merger. Headquartered in Plainsboro, New Jersey, Integra is a global medical device company that has experience manufacturing, marketing, and distributing orthopedic devices in the United States, and a track record for quality, service, and consistency. Integra's lower extremity product portfolio is also highly complementary to Tornier's total ankle replacements and total silastic toe joint replacements.

    The Order requires Tornier to divest all U.S. assets and rights related to the relevant products, including intellectual property, manufacturing technology, and existing inventory. In order to ensure continuity of supply, the Order requires that the parties supply Integra with total ankle replacements for up to three years and total silastic toe joint replacements for up to one year while Integra transitions to independent manufacturing and works to obtain FDA approval.

    To ensure that the divestitures are successful, the Order requires the parties to enter into a transitional services agreement with Integra to assist the company in establishing its manufacturing capabilities and securing all necessary FDA approvals. Further, the Order requires that the parties transfer all confidential business information to Integra, as well as provide access to employees who possess or are able to identify such information. Integra also will have the right to interview and offer employment to employees associated with the relevant products.

    The parties must accomplish these divestitures and relinquish their rights to Integra no later than ten days after the Proposed Merger is consummated. If the Commission determines that Integra is not an acceptable acquirer, or that the manner of the divestitures is not acceptable, the proposed Order requires the parties to unwind the sale of rights to Integra and then divest the products to a Commission-approved acquirer within six months of the date the Order becomes final. The proposed Order further allows the Commission to appoint a trustee in the event the parties fail to divest the products as required.

    The Order also requires the parties to appoint Quantic Regulatory Services, LLC as interim monitor to ensure the parties comply with the obligations pursuant to the Consent Agreement and to keep the Commission informed about the status of the transfer of the assets and rights to Integra.

    The purpose of this analysis is to facilitate public comment on the Consent Agreement, and it is not intended to constitute an official interpretation of the proposed Order or to modify its terms in any way.

    By direction of the Commission.

    Donald S. Clark, Secretary.
    [FR Doc. 2015-25604 Filed 10-7-15; 8:45 am] BILLING CODE 6750-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-15BHD; Docket No. CDC-2016-0088] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Congenital Heart Surveillance to Recognize Outcomes, Needs and well-being (CHSTRONG). CDC seeks to collect data for the purpose of providing insight into the public health questions that remain for the population and to develop services and allocate resources to improve long-term health and wellbeing.

    DATES:

    Written comments must be received on or before December 7, 2015.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2016-0088 by any of the following methods:

    Federal eRulemaking Portal: Regulation.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on 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. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    Proposed Project

    Congenital Heart Surveillance To Recognize Outcomes, Needs, and Well-being (CHSTRONG)—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Congenital heart defects (CHDs) are the most common type of structural birth defects, affecting approximately 1 in 110 live-born children. In prior decades, many CHDs were considered fatal during infancy or childhood, but with tremendous advances in pediatric cardiology and cardiac surgery, at least 85% of patients now survive to adulthood and there are approximately 1.5 million adults with CHD living in the United States. With vast declines in mortality from pediatric heart disease over the past 30 years, it is vital to evaluate long term outcomes and quality of life issues for adults with CHD. However, U.S. data on long term outcomes, quality of life issues, and comorbidities of adults born with CHD are lacking. U.S. data is needed to provide insight into the public health questions that remain for this population and to develop services and allocate resources to improve long-term health and wellbeing.

    For this one-year project, we will use data from U.S. state birth defect surveillance systems to identify a population-based sample of individuals 18 to 45 years of age born with CHD. We will then use state databases and online search engines to find current addresses for those individuals and mail surveys to them inquiring about their barriers to health care, quality of life, social and educational outcomes, and transition of care from childhood to adulthood. The information collected from this population-based survey will be used to inform current knowledge, allocate resources, develop services, and, ultimately, improve long-term health of adults born with CHD.

    We estimate identifying 7,500 individuals with CHD in the birth defects surveillance systems, obtaining current addresses and sending surveys to 5,625 individuals with CHD (75%), and receiving completed surveys from 4,500 individuals (80%). The survey takes approximately 25 minutes to complete, which includes 5 minutes to read the informed consent and 20 minutes to answer survey questions. Therefore, we estimate the total burden hours are 1,875.

    There are no costs to participants other than their time.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden
  • hours
  • Individuals with CHD Informed consent 4,500 1 5/60 375 Individuals with CHD Survey 4,500 1 20/60 1,500 Total 1,875
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2015-25647 Filed 10-7-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day-16-15BHH; Docket No. CDC-2016-0087] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Personal Protective Equipment Information (PPE-Info) Database which is a compendium of personal protective equipment (PPE) Federal regulations and consensus standards.

    DATES:

    Written comments must be received on December 7, 2015.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2016-0087 by any of the following methods:

    Federal eRulemaking Portal: Regulation.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

    Please note:

    All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on 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. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    Proposed Project

    PPE-Info Database—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    The mission of the National Institute for Occupational Safety and Health (NIOSH) is to promote safety and health at work for all people through research and prevention. Under Public Law 91-173 as amended by Public Law 95-164 (Federal Mine Safety and Health Act of 1977), NIOSH is proposing a three-year study to conduct research to advance the health and safety of workers.

    National Personal Protective Technology Laboratory (NPPTL) developed the NIOSH PPE-Info Database in response to recommendations from the Institute of Medicine (IOM) in its report, Certifying Personal Protective Technologies (PPT): Improving Worker Safety. The report recommended that NPPTL “expand its efforts to become a national clearinghouse for information on all types of PPT.”

    In its current application, the database provides standards developers, manufacturers, purchasers, and end users of PPE with a comprehensive tool which allows general or advanced criteria searches of relevant standards, target occupational groups, basic conformity assessment specifications, accredited lab information, and standard connections.

    The CDC is currently updating its PPE selection guidance related to the Ebola response. This guidance, Guidance on Personal Protective Equipment To Be Used by Healthcare Workers During Management of Patients with Ebola Virus Disease in U.S. Hospitals, Including Procedures for Putting On (Donning) and Removing (Doffing) (hereafter referred to as the “CDC Ebola Response PPE Guidance”) will provide recommendations, in the form of protection standards, for PPE selection and use for the Ebola response.

    The NIOSH PPE-Info Database is being expanded as a tool to connect the protection standards that already exist in the database, with relevant PPE information as identified through the updated CDC Ebola Response PPE Guidance. This new aspect of the NIOSH PPE-Info Database allows end users (e.g., healthcare workers) to find products (e.g., gowns and coveralls) that are compliant (as verified by manufacturer) with the protection standards outlined by the CDC Ebola Response PPE Guidance. The initial information in the NIOSH PPE-Info Database will only offer guidance on gowns and coveralls, but is intended to expand to all PPE types associated with the official CDC Ebola Response PPE Guidance in the future. Since there is no single source of this information, NOISH is requesting that Manufactures provide it directly for input into the Ebola PPE selection guidance portion of the database.

    NIOSH is requesting that a Memorandum of Understanding (MOU) be developed with Ebola response PPE manufacturers to facilitate cooperation and collaboration on the provision of product information. The primary focus of the collaboration will be the exchange of manufacturer product information to be aggregated and displayed in the NIOSH PPE-Info Database.

    The nature and use of this information exchange includes the (1) provision of product information regarding compliance (as verified by manufacturers) with designated protection standards related to CDC guidance for personal protective equipment (PPE) used by healthcare workers during management of patients with confirmed or suspected Ebola Virus Disease (“Ebola”) and (2) the verification, by manufacturers, of product information displayed in the NIOSH PPE-Info Database.

    Once the MOU is signed, the manufacturer will be sent a product information sheet. Using he product information sheet, NIOSH collects manufacturer-specific product information such as; product category (e.g., gown or coverall), standards that the product claim complies with, product model number, product name, link to product specification sheet from manufacturer, and designation of whether third-party testing was performed. Once this information is completed, the product information sheet is electronically signed and returned by email to NIOSH. The NIOSH project officer will then upload the information into a PPE-Info sub database, which acts as an interim point for review. The manufacturer is then sent a link to the sub database to review their products. The manufacturer has one week to make objections. If no objections are made, the information in the sub-database gets published to the live NIOSH PPE-Info database.

    Quarterly, manufacturer products will be pulled from the database and sent through a pre generated product information sheet to the manufacturer POC. Manufacturers are required through the MOU to complete and return the PPE Information Sheet within two weeks of receipt along with the electronic verification form.

    NIOSH will be soliciting information from manufacturers and manufacturer POCs. For products that comply with gown and coverall standards, we estimate that seven manufacturers will need to supply product information. The amount of time for manufacturers to complete the initial product information sheets and make quarterly updated will be no more than 3 hours for the initial product information and one hour for the quarterly updates. The total estimated burden hours are 42. There are no costs to respondents other than their time.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Number
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total
  • burden
  • hours
  • Manufacturer Initial Product Info Sheet 7 1 3 Manufacturer POC Quarterly product Info Sheet 7 3 1 21 Total 42
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2015-25646 Filed 10-7-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-0234; Docket No. CDC-2015-0086] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the National Ambulatory Medical Care Survey (NAMCS). The purpose of NAMCS is to meet the needs and demands for statistical information about the provision of ambulatory medical care services in the United States.

    DATES:

    Written comments must be received on or before December 7, 2015.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2016-0026 by any of the following methods:

    Federal eRulemaking Portal: Regulation.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on 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. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    Proposed Project

    The National Ambulatory Medical Care Survey (NAMCS), (OMB No. 0920-0234, expires 12/31/2017)—Revision — National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Section 306 of the Public Health Service (PHS) Act (42 U.S.C. 242k), as amended, authorizes that the Secretary of Health and Human Services, acting through NCHS, shall collect statistics on the utilization of health care provided by non-federal office-based physicians in the United States. On December 19, 2014, the OMB approved data collection for three years from 2015 to 2017. This revision is to request approval to continue NAMCS data collection activities for three years from 2016-2018 and to add questions to the physician interview that pertain to policies, services, and experiences related to the prevention and treatment of sexually transmitted infections (STIs) and HIV prevention among adolescents and others. Small modifications will also be made to questions on the use of electronic health records. This notice also covers a decrease in the sample size resulting from smaller budget allocations. Due to this decrease, selected state estimates will not be available for 2016-2018 data.

    The National Ambulatory Medical Care Survey (NAMCS) has been conducted intermittently from 1973 through 1985, and annually since 1989. The purpose of NAMCS, a voluntary survey, is to meet the needs and demands for statistical information about the provision of ambulatory medical care services in the United States. Ambulatory services are rendered in a wide variety of settings, including physicians' offices and hospital outpatient and emergency departments.

    The NAMCS target universe consists of all office visits made by ambulatory patients to non-Federal office-based physicians (excluding those in the specialties of anesthesiology, radiology, and pathology) who are engaged in direct patient care. In 2006, physicians and mid-level providers (i.e., nurse practitioners, physician assistants, and nurse midwives) practicing in community health centers (CHCs) were added to the NAMCS sample, and these data will continue to be collected.

    To complement NAMCS data, NCHS initiated the National Hospital Ambulatory Medical Care Survey (NHAMCS, OMB No. 0920-0278, expires 02/28/18) in 1992 to provide data concerning patient visits to hospital outpatient and emergency departments. NAMCS and NHAMCS are the principal sources of data on ambulatory care provided in the United States.

    There is no cost to the respondents other than their time.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average burden
  • per response
  • (in hrs.)
  • Total
  • burden
  • (in hrs.)
  • Office-based physicians Physician Induction Interview (NAMCS-1) 2,590 1 45/60 1,943 Patient Record form (NAMCS-30) (Physician abstracts) 259 30 14/60 1,813 Prepare and transmit EHR (MU On-Boarding) 130 1 1 130 Pulling, refiling medical record forms (FR abstracts) 2,201 30 1/60 1,101 Community Health Centers Induction Interview—service delivery site (NAMCS-201) 104 1 30/60 52 Induction Interview—Providers (NAMCS-1) 234 1 30/60 117 Patient Record form (NAMCS-30) (Provider abstracts) 23 30 14/60 161 Pulling, refiling medical record forms (FR abstracts) 211 30 1/60 106 Reabstraction study Pulling, refiling medical record forms abstracts) 72 10 1/60 12 Total 5,435
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2015-25648 Filed 10-7-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1622] Submitting Food Canning Establishment Registration Form and Food Process Filing Forms to the Food and Drug Administration in Electronic or Paper Format: Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled “Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format: Guidance for Industry.” This guidance describes the administrative procedures to be used by commercial processors that manufacture, process, or pack acidified foods (“AF”) and/or thermally processed low-acid foods packaged in hermetically sealed containers (historically referred to as “low-acid canned foods” or “LACF”). These changes include new registration and food process filing forms and a new “smart form” system for electronic submission of the process filing forms. Registration and process filing are required by the AF and LACF provisions of our regulations. This guidance also provides general information about how to use FDA's systems for electronic submission of the applicable forms. In addition, this guidance describes administrative procedures for voluntary registration and voluntary submissions when a commercial processor has determined that its product is not an acidified food or a low-acid canned food, and is therefore not subject to our regulations for AF and LACF. Further, this guidance describes a voluntary process whereby, upon request, we review data and other information that relate to a new processing method or new equipment.

    DATES:

    Submit either electronic or written comments on FDA guidances at any time.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions: Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions: Submit written/paper submissions as follows:

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

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2013-D-1622 for Submitting Food Canning Establishment Registration Form and Food Process Filing Forms to the Food and Drug Administration in Electronic or Paper Format: Guidance for Industry; Availability. Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    Submit written requests for single copies of the guidance entitled “Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format: Guidance for Industry” to Office of Food Safety, Center for Food Safety and Applied Nutrition (HFS-HFS-302), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.

    FOR FURTHER INFORMATION CONTACT:

    Susan Brecher, Center for Food Safety and Applied Nutrition (HFS-302), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1781.

    SUPPLEMENTARY INFORMATION: I. Background

    We are announcing the availability of a guidance for industry entitled “Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format: Guidance for Industry.” This guidance is being issued consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents our current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

    This guidance supersedes the previous guidance entitled “Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format.” Among other things, it provides guidance on administrative procedures related to new process filing forms (Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g) that will replace the current process filing forms (Forms FDA 2541a and 2541c). The process filing regulations in 21 CFR 108.25(c)(2) and 108.35(c)(2) currently specify Form FDA 2541a (food canning establishment process filing for all methods except aseptic) or Form FDA 2541c (food canning establishment process filing for aseptic systems). We intend to update these regulations to specify the new form numbers, and to provide information about how to access the online system for electronic submission of these forms, as soon as possible.

    This guidance describes: (1) Administrative procedures relating to the registration requirements of 21 CFR 108.25(c)(1) (for AF) using Form FDA 2541 in both electronic and paper format; (2) administrative procedures relating to the registration requirements of § 108.35(c)(1) (for LACF) using Form FDA 2541 in both electronic and paper format; (3) administrative procedures relating to the process filing requirements of § 108.25(c)(2) (for AF) using Form FDA 2541e in both electronic and paper format; (4) administrative procedures relating to the process filing requirements of § 108.35(c)(2) (for LACF) using Forms FDA 2541d, FDA 2541f, and FDA 2541g in both electronic and paper format; (5) administrative procedures for voluntary registration and voluntary process filing submissions when a commercial processor has determined that its product is not an acidified food (or a low-acid canned food), and is therefore not subject to 21 CFR part 113, 21 CFR part 114, or part 108; and (6) a voluntary process whereby, upon request, we review data and other information that relate to a new processing method or new equipment.

    In the Federal Register of January 14, 2014 (79 FR 2448), we made available a draft guidance entitled “Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format” and gave interested parties an opportunity to submit comments by March 17, 2014, for us to consider before beginning work on the final version of the guidance. We received a few comments on the draft guidance, largely directed to the specific content of the forms discussed in the guidance rather than to the procedures described in the guidance, and have not made any modifications to the final guidance as a result of these comments. We have, however, modified the content of the forms where appropriate. We have deleted information, which we had included in the draft guidance, explaining how the draft guidance would eventually supersede previous administrative guidance associated with previous editions of the forms, which are now obsolete. We also have modified the Appendix of the final guidance to include additional resources—e.g., instructions for submitting process filing forms electronically. The guidance announced in this notice finalizes the draft guidance dated January 2014.

    II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in parts 108, 113, and 114 have been approved under OMB control number 0910-0037. The collections of information related to 21 CFR 1.230 through 1.233 and section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) have been approved under OMB control number 0910-0502.

    III. Electronic Access

    Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/FoodGuidances, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/AcidifiedLACF/default.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.

    Dated: October 5, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-25642 Filed 10-7-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0294] Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substance Notification Program AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information associated with the Food Contact Substance Notification Program.

    DATES:

    Submit either electronic or written comments on the collection of information by December 7, 2015.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2012-N-0294 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substance Notification Program.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of the proposed collection of information set forth in this document.

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

    Food Contact Substance Notification Program—21 CFR 170.101, 170.106, and 171.1 OMB Control Number 0910-0495—Extension

    Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(h)) establishes a premarket notification process for food contact substances. Section 409(h)(6) of the FD&C Act defines a “food contact substance” as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.” Section 409(h)(3) of the FD&C Act requires that the notification process be used for authorizing the marketing of food contact substances except when: (1) We determine that the submission and premarket review of a food additive petition (FAP) under section 409(b) of the FD&C Act is necessary to provide adequate assurance of safety, or (2) we and the manufacturer or supplier agree that an FAP should be submitted. Section 409(h)(1) of the FD&C Act requires that a notification include: (1) Information on the identity and the intended use of the food contact substance, and (2) the basis for the manufacturer's or supplier's determination that the food contact substance is safe under the intended conditions of use.

    Sections 170.101 and 170.106 of FDA's regulations (21 CFR 170.101 and 170.106) specify the information that a notification must contain and require that: (1) A food contact substance notification (FCN) includes Form FDA 3480, and (2) a notification for a food contact substance formulation includes Form FDA 3479. These forms serve to summarize pertinent information in the notification. The forms facilitate both preparation and review of notifications because the forms will serve to organize information necessary to support the safety of the use of the food contact substance. The burden of filling out the appropriate form has been included in the burden estimate for the notification.

    Currently, interested persons transmit an FCN submission to the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition using Form FDA 3480 whether it is submitted in electronic or paper format. We estimate that the amount of time for respondents to complete Form FDA 3480 will continue to be the same.

    In addition to its required use with FCNs, Form FDA 3480 is recommended to be used to organize information within a Pre-notification Consultation or Master File submitted in support of an FCN according to the items listed on the form. Master Files can be used as repositories for information that can be referenced in multiple submissions to FDA, thus minimizing paperwork burden for food contact substance authorizations. We estimate that the amount of time for respondents to complete the Form FDA 3480 for these types of submissions is 0.5 hours.

    Section 171.1 of FDA's regulations (21 CFR 171.1) specifies the information that a petitioner must submit in order to: (1) Establish that the proposed use of an indirect food additive is safe, and (2) secure the publication of an indirect food additive regulation in parts 175 through 178 (21 CFR parts 175 through 178). Parts 175 through 178 describe the conditions under which the additive may be safely used.

    In addition, FDA's guidance document entitled “Use of Recycled Plastics in Food Packaging: Chemistry Considerations,” provides assistance to manufacturers of food packaging in evaluating processes for producing packaging from post-consumer recycled plastic. The recommendations in the guidance address the process by which manufacturers certify to us that their plastic products are safe for food contact.

    Description of Respondents: The respondents to this information collection are manufacturers of food contact substances.

    We estimate the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 21 CFR section or other category FDA form
  • No.
  • Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Average
  • burden per
  • response
  • Total
  • hours
  • 170.106 2 (Category A) FDA 3479 10 2 20 2 40 170.101 3 7 (Category B) FDA 3480 6 1 6 25 150 170.101 4 7 (Category C) FDA 3480 6 2 12 120 1,440 170.101 5 7 (Category D) FDA 3480 42 2 84 150 12,600 170.101 6 7 (Category E) FDA 3480 38 1 38 150 5,700 Pre-notification Consultation or Master File (concerning a food contact substance)8 FDA 3480 190 1 190 0.5 95 Amendment to an existing notification (170.101), amendment to a Pre-notification Consultation, or amendment to a Master File (concerning a food contact substance)9 FDA 3480A 100 1 100 0.5 50 171.1 Indirect Food Additive Petitions N/A 1 1 1 10,995 10,995 Use of Recycled Plastics in Food Packaging: Chemistry Considerations N/A 10 1 10 25 250 Total 31,320 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Notifications for food contact substance formulations and food contact articles. These notifications require the submission of Form FDA 3479 (“Notification for a Food Contact Substance Formulation”) only. 3 Duplicate notifications for uses of food contact substances. 4 Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions. 5 Notifications for uses that are the subject of moderately complex food additive petitions. 6 Notifications for uses that are the subject of very complex food additive petitions. 7 These notifications require the submission of Form FDA 3480. 8 These notifications recommend the submission of Form FDA 3480. 9 These notifications recommend the submission of Form FDA 3480A.

    The estimates in table 1 are based on our current experience with the food contact substance notification program and informal communication with industry.

    Beginning in row 1, we estimate 10 respondents will submit 2 notifications annually for food contact substance formulations (Form FDA 3479), for a total of 20 responses. We calculate a reporting burden of 2 hours per response, for a total of 40 hours. In row 2 we estimate six respondents. We believe the hourly burden for preparing these notifications will primarily consist of the manufacturer or supplier completing Form FDA 3480, verifying that a previous notification is effective, and preparing necessary documentation. We estimate one submission for each respondent, for a total of six responses. We calculate a reporting burden of 25 hours per response, for a total of 150 hours.

    In rows 3, 4, and 5, we identify three tiers of FCNs that reflect different levels of burden applicable to the respective information collection items (denoted as Categories C, D, and E). We estimate 6 respondents will submit 2 Category C submissions annually, for a total of 12 responses. We calculate a reporting burden of 120 hours per response, for a total burden of 1,440 hours. We estimate 42 respondents will submit 2 Category D submissions annually, for a total of 84 responses. We calculate a reporting burden of 150 hours per response, for a total burden of 12,600 hours. We estimate 38 respondents will submit 1 Category E submission annually, for a total of 38 responses. We calculate a reporting burden of 150 hours per response, for a total burden of 5,700 hours.

    In row 6, we estimate 190 respondents will submit information to a pre-notification consultation or a master file in support of FCN submission using Form FDA 3480. We calculate a reporting burden of 0.5 hours per response, for a total burden of 95 hours. In row 7 we estimate 100 respondents will submit an amendment (Form FDA 3480A) to a substantive or non-substantive request of additional information to an incomplete FCN submission, an amendment to a pre-notification consultation, or an amendment to a master file in support of an FCN. We calculate a reporting burden of 0.5 hours per response, for a total burden of 50 hours.

    In row 8, we estimate one respondent will submit one indirect food additive petition under § 171.1, for a total of one response. We calculate a reporting burden of 10,995 hours per response, for a total burden of 10,995 hours.

    Finally, in row 9, we estimate 10 respondents will utilize the recommendations in the guidance document entitled, “Use of Recycled Plastics in Food Packaging: Chemistry Considerations,” to develop the additional information for one such submission annually, for a total of 10 responses. We calculate a reporting burden of 25 hours per response, for a total burden of 250 hours.

    Dated: October 2, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-25625 Filed 10-7-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0247] Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act 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 November 9, 2015.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2012-N-0247 for “Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Formal Meetings With Sponsors and Applicants for PDUFA Products.”

    Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    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 0910-0429.

    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.

    Guidance for Industry on Formal Meetings With Sponsors and Applicants for PDUFA Products—OMB Control Number 0910-0429—Extension

    This information collection approval request is for FDA guidance on the procedures for formal meetings between FDA and sponsors or applicants regarding the development and review of PDUFA products. The guidance describes procedures for requesting, scheduling, conducting, and documenting such formal meetings. The guidance provides information on how the Agency will interpret and apply section 119(a) of the Food and Drug Administration Modernization Act (FDAMA) (Pub. L. 105-115), specific PDUFA goals for the management of meetings associated with the review of human drug applications for PDUFA products, and provisions of existing regulations describing certain meetings (§§ 312.47 and 312.82 (21 CFR 312.47 and 312.82)).

    The guidance describes two collections of information: The submission of a meeting request containing certain information and the submission of an information package in advance of the formal meeting. Agency regulations at §§ 312.47(b)(1)(ii), (1)(iv), and (2) describe information that should be submitted in support of a request for an end-of-phase 2 meeting and a pre-NDA meeting. The information collection provisions of § 312.47 have been approved by OMB control number 0910-0014. However, the guidance provides additional recommendations for submitting information to FDA in support of a meeting request. As a result, FDA is submitting additional estimates for OMB approval.

    I. Request for a Meeting

    Under the guidance, a sponsor or applicant interested in meeting with the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) should submit a meeting request to the appropriate FDA component as an amendment to the underlying application. FDA regulations (§§ 312.23, 314.50, and 601.2 (21 CFR 312.23, 314.50, and 601.2)) state that information provided to the Agency as part of an investigational new drug application (IND), new drug application (NDA), or biological license application (BLA) must be submitted with an appropriate cover form. Form FDA 1571 must accompany submissions under INDs and Form FDA 356h must accompany submissions under NDAs and BLAs. Both forms have valid OMB control numbers as follows: Form FDA 1571—OMB control number 0910-0014 and Form FDA 356h—OMB control number 0910-0338.

    In the guidance document, CDER and CBER ask that a request for a formal meeting be submitted as an amendment to the application for the underlying product under the requirements of §§ 312.23, 314.50, and 601.2; therefore, requests should be submitted to the Agency with the appropriate form attached, either Form FDA 1571 or Form FDA 356h. The Agency recommends that a request be submitted in this manner for two reasons: (1) To ensure that each request is kept in the administrative file with the entire underlying application, and (2) to ensure that pertinent information about the request is entered into the appropriate tracking databases. Use of the information in the Agency's tracking databases enables the Agency to monitor progress on the activities attendant to scheduling and holding a formal meeting and to ensure that appropriate steps will be taken in a timely manner.

    Under the guidance, the Agency requests that sponsors and applicants include in meeting requests certain information about the proposed meeting. Such information includes:

    • Information identifying and describing the product;

    • the type of meeting being requested;

    • a brief statement of the purpose of the meeting;

    • a list of objectives and expected outcomes from the meeting;

    • a preliminary proposed agenda;

    • a draft list of questions to be raised at the meeting;

    • a list of individuals who will represent the sponsor or applicant at the meeting;

    • a list of Agency staff requested to be in attendance;

    • the approximate date that the information package will be sent to the Agency; and

    • suggested dates and times for the meeting.

    This information will be used by the Agency to determine the utility of the meeting, to identify Agency staff necessary to discuss proposed agenda items, and to schedule the meeting.

    II. Information Package

    A sponsor or applicant submitting an information package to the Agency in advance of a formal meeting should provide summary information relevant to the product and supplementary information pertaining to any issue raised by the sponsor, applicant, or Agency. The Agency recommends that information packages generally include:

    • Identifying information about the underlying product;

    • a brief statement of the purpose of the meeting;

    • a list of objectives and expected outcomes of the meeting;

    • a proposed agenda for the meeting;

    • a list of specific questions to be addressed at the meeting;

    • a summary of clinical data that will be discussed (as appropriate);

    • a summary of preclinical data that will be discussed (as appropriate); and

    • chemistry, manufacturing, and controls information that may be discussed (as appropriate).

    The purpose of the information package is to provide Agency staff the opportunity to adequately prepare for the meeting, including the review of relevant data concerning the product. Although FDA reviews similar information in the meeting request, the information package should provide updated data that reflect the most current and accurate information available to the sponsor or applicant. The Agency finds that reviewing such information is critical to achieving a productive meeting.

    The collection of information described in the guidance reflects the current and past practice of sponsors and applicants to submit meeting requests as amendments to INDs, NDAs, and BLAs and to submit background information prior to a scheduled meeting. Agency regulations currently permit such requests and recommend the submission of an information package before an end-of-phase 2 meeting (§§ 312.47(b)(1)(ii) and (iv)) and a pre-NDA meeting (§ 312.47(b)(2)).

    Description of Respondents: A sponsor or applicant for a drug or biological product who requests a formal meeting with the Agency regarding the development and review of a PDUFA product.

    Burden Estimate: Provided in this document is an estimate of the annual reporting burden for the submission of meeting requests and information packages under the guidance.

    III. Request for a Formal Meeting

    Based on data collected from the review divisions and offices within CDER and CBER, FDA estimates that approximately 1,099 sponsors and applicants (respondents) request approximately 2,366 formal meetings with CDER annually and approximately 175 respondents request approximately 264 formal meetings with CBER annually regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information to be submitted with a meeting request in accordance with the guidance, is estimated to be approximately 10 hours. Based on FDA's experience, the Agency expects it will take respondents this amount of time to gather and copy brief statements about the product and a description of the purpose and details of the meeting.

    IV. Information Package

    Based on data collected from the review divisions and offices within CDER and CBER, FDA estimates that approximately 959 respondents submitted approximately 1,901 information packages to CDER annually and approximately 142 respondents submitted approximately 193 information packages to CBER annually prior to a formal meeting regarding the development and review of a PDUFA product. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information package in accordance with the guidance, is estimated to be approximately 18 hours. Based on FDA's experience, the Agency expects it will take respondents this amount of time to gather and copy brief statements about the product, a description of the details for the anticipated meeting, and data and information that generally would already have been compiled for submission to the Agency.

    In the Federal Register of May 20, 2015 (80 FR 29010), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

    As stated earlier, the guidance provides information on how the Agency will interpret and apply section 119(a) of FDAMA, specific PDUFA goals for the management of meetings associated with the review of human drug applications for PDUFA products, and provisions of existing regulations describing certain meetings (§§ 312.47 and 312.82). The information collection provisions in § 312.47 concerning end-of-phase 2 meetings and pre-NDA meetings have been approved by OMB control number 0910-0014. However, the guidance provides additional recommendations for submitting information to FDA in support of a meeting request. As a result, FDA is submitting for OMB approval these additional estimates.

    Table 1—Estimated Annual Reporting Burden 1 Meeting requests and information packages Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    Meeting Requests: CDER 1,099 2.15 2,366 10 23,660 CBER 175 1.51 264 10 2,640 Total 26,300 Information Packages: CDER 959 1.99 1,901 18 34,218 CBER 142 1.36 193 18 3,474 Total 37,692 Grand Total 63,992 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Dated: October 2, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-25624 Filed 10-7-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0449] Integrated Summary of Effectiveness; Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Integrated Summary of Effectiveness.” This guidance describes how an integrated summary of effectiveness (ISE) should be prepared by industry for new drug applications (NDAs) and biologics license applications (BLAs). This guidance is intended to improve the quality of drug applications by describing what efficacy information should be submitted so that FDA can make a regulatory decision on an application. This guidance finalizes the draft guidance issued August 28, 2008.

    DATES:

    Submit either electronic or written comments on Agency guidances at any time.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2008-D-0449 for Integrated Summary of Effectiveness; Guidance for Industry; Availability. Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of Communication, Training, and Manufacturers Assistance, Center for Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. The guidance may also be obtained from the Center for Biologics Evaluation and Research by mail by calling 1-800-835-4709 or 240-402-7800. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Helen Sile, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6462, Silver Spring, MD 20993-0002, 301-796-4123; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a guidance for industry entitled “Integrated Summary of Effectiveness.” This guidance describes how an ISE should be prepared by industry for NDAs and BLAs. The ISE has been required as part of an NDA submission since 1985 (21 CFR 314.50(d)(5)(v)), but the regulation does not describe the specific components of the ISE. The guidance for industry “Guideline for the Format and Content of the Clinical and Statistical Sections of an Application” (Clin-Stat guidance) provides a description of what FDA recommends for inclusion in an ISE. However, since the Clin-Stat guidance was published, several International Conference on Harmonisation guidances, including the ICH guidances for industry “E3 Structure and Content of Clinical Study Reports,” “E10 Choice of Control Group and Related Issues in Clinical Trials,” and “M4E The CTD—Efficacy,” have provided additional recommendations for describing individual trials and providing results of efficacy analyses.

    This guidance supersedes section II.G., Integrated Summary of Effectiveness Data, of the Clin-Stat guidance to reflect FDA's current thinking regarding the format and content of the ISE to provide a truly integrated analysis, rather than a summary of efficacy results from individual clinical trials, and to satisfy FDA regulatory requirements. This guidance also incorporates the conceptual framework of section 2.7.3, Summary of Clinical Efficacy, from ICH M4E. Although there are no corresponding regulations requiring an ISE for BLA submissions, applicants are encouraged to provide these analyses.

    The focus of the ISE is not on the detailed results of individual studies, which are described in individual study reports, but a comprehensive, detailed, integrated analysis that goes beyond individual study results to examine all sources of information concerning effectiveness to provide further insight into the efficacy of the study drug. Integrated analyses included in an ISE generally fall into two broad categories: (1) Comparing the individual studies to better understand the overall results; and (2) using the greater power of pooled analyses to gain insight into the nature of the drug's effectiveness in demographic (e.g., age, sex, race, and ethnicity) and other subpopulations, dose-response, and onset and duration of effect, among others.

    A draft of this guidance was published for comment in the Federal Register on August 28, 2008 (73 FR 50825). Comments received on the draft guidance have been considered and the guidance has been revised as follows: (1) Clarification on the difference between the document included in Module 2, section 2.7.3, Summary of Clinical Efficacy, from ICH M4E, and the ISE has been provided; (2) the definition of integrated analyses has been revised and the components that constitute an integrated analyses have been clarified; (3) pooled analyses has been defined; and (4) the recommendations for when it is appropriate to pool data has been included.

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on preparing an ISE. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001. The collections of information for submission of data in a BLA under 21 CFR 601.2 have been approved under OMB control number 0910-0338.

    III. Electronic Access

    Persons with access to the Internet may obtain the guidance at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov.

    Dated: October 2, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-25630 Filed 10-7-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-2138] Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must submit adverse event reports to FDA. This guidance explains FDA's current thinking on adverse event reporting for these outsourcing facilities.

    DATES:

    Submit either electronic or written comments on Agency guidances at any time.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2014-D-2138 for Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability. Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    Submit written requests for single copies of the guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Sara Rothman, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3110.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a final guidance for industry entitled “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA) into law (Pub. L. 113-54). The DQSA added a new section, 503B, to the FD&C Act (21 U.S.C. 353b). Under section 503B(b), a compounder can register as an outsourcing facility with FDA. Section 503B(d)(4) of the FD&C Act defines an outsourcing facility, in part, as a facility that complies with all of the requirements of section 503B, including registering with FDA as an outsourcing facility and paying associated fees. If the conditions outlined in section 503B(a) of the FD&C Act are satisfied, a drug compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility is exempt from certain sections of the FD&C Act, including section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use) and section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)). Drugs compounded in outsourcing facilities are not exempt from the requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice for drugs).

    Under section 503B(b)(5), an outsourcing facility must submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under 21 CFR 310.305 (or any successor regulations). This guidance explains how FDA intends to implement § 310.305 with respect to outsourcing facilities.

    In the Federal Register of February 19, 2015 (80 FR 8872), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on May 20, 2015. FDA received seven comments on the draft guidance.

    In response to received comments or on its own initiative, FDA made several changes to clarify particular points and to provide updated information.

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents FDA's current thinking on this topic. It does not create any rights for any person and is not binding on FDA or the public. An alternative approach can be used if such approach satisfies the requirements of the applicable statutes and regulations.

    II. Paperwork Reduction Act

    This guidance contains collections of information that are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information have been approved under OMB control number 0910-0800.

    III. Electronic Access

    Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: October 2, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-25622 Filed 10-7-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0248] Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level 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 November 9, 2015.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations .gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2012-N-0248 for “Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

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

    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 0910-0430.

    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.

    Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level OMB Control Number 0910-0430—Extension

    This information collection approval request is for FDA guidance on the process for formally resolving scientific and procedural disputes in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that cannot be resolved at the division level. The guidance describes procedures for formally appealing such disputes to the office or center level and for submitting information to assist center officials in resolving the issue(s) presented. The guidance provides information on how the Agency will interpret and apply provisions of the existing regulations regarding internal Agency review of decisions (§ 10.75 (21 CFR 10.75)) and dispute resolution during the investigational new drug (IND) process (§ 312.48 (21 CFR 312.48)) and the new drug application/abbreviated new drug application (NDA/ANDA) process (§ 314.103 (21 CFR 314.103)). In addition, the guidance provides information on how the Agency will interpret and apply the specific Prescription Drug User Fee Act (PDUFA) goals for major dispute resolution associated with the development and review of PDUFA products.

    Existing regulations, which appear primarily in parts 10, 312, and 314 (21 CFR parts 10, 312, and 314), establish procedures for the resolution of scientific and procedural disputes between interested persons and the Agency, CDER, and CBER. All Agency decisions on such matters are based on information in the administrative file (§ 10.75(d)). In general, the information in an administrative file is collected under existing regulations in part 312 (OMB control number 0910-0014), part 314 (OMB control number 0910-0001), and part 601 (21 CFR part 601) (OMB control number 0910-0338), which specify the information that manufacturers must submit so that FDA may properly evaluate the safety and effectiveness of drugs and biological products. This information is usually submitted as part of an IND, NDA, or biologics license application (BLA), or as a supplement to an approved application. While FDA already possesses in the administrative file the information that would form the basis of a decision on a matter in dispute resolution, the submission of particular information regarding the request itself and the data and information relied on by the requestor in the appeal would facilitate timely resolution of the dispute. The guidance describes the following collection of information not expressly specified under existing regulations: The submission of the request for dispute resolution as an amendment to the application for the underlying product, including the submission of supporting information with the request for dispute resolution.

    Agency regulations (§§ 312.23(a)(11) and (d), 314.50, 314.94, and 601.2) state that information provided to the Agency as part of an IND, NDA, ANDA, or BLA is to be submitted in triplicate and with an appropriate cover form. Form FDA 1571 must accompany submissions under INDs and Form FDA 356h must accompany submissions under NDAs, ANDAs, and BLAs. Both forms have valid OMB control numbers as follows: FDA Form 1571—OMB control number 0910-0014, and FDA Form 356h—OMB control number 0910-0338.

    In the guidance document, CDER and CBER ask that a request for formal dispute resolution be submitted as an amendment to the application for the underlying product and that it be submitted to the Agency in triplicate with the appropriate form attached, either Form FDA 1571 or Form FDA 356h. The Agency recommends that a request be submitted as an amendment in this manner for two reasons: To ensure that each request is kept in the administrative file with the entire underlying application and to ensure that pertinent information about the request is entered into the appropriate tracking databases. Use of the information in the Agency's tracking databases enables the appropriate Agency official to monitor progress on the resolution of the dispute and to ensure that appropriate steps will be taken in a timely manner.

    CDER and CBER have determined and the guidance recommends that the following information should be submitted to the appropriate center with each request for dispute resolution so that the Center may quickly and efficiently respond to the request: (1) A brief but comprehensive statement of each issue to be resolved, including a description of the issue, the nature of the issue (i.e., scientific, procedural, or both), possible solutions based on information in the administrative file, whether informal dispute resolution was sought prior to the formal appeal, whether advisory committee review is sought, and the expected outcome; (2) a statement identifying the review division/office that issued the original decision on the matter and, if applicable, the last Agency official that attempted to formally resolve the matter; (3) a list of documents in the administrative file, or additional copies of such documents, that are deemed necessary for resolution of the issue(s); and (4) a statement that the previous supervisory level has already had the opportunity to review all of the material relied on for dispute resolution. The information that the Agency suggests submitting with a formal request for dispute resolution consists of: (1) Statements describing the issue from the perspective of the person with a dispute, (2) brief statements describing the history of the matter, and (3) the documents previously submitted to FDA under an OMB approved collection of information.

    Based on FDA's experience with dispute resolution, the Agency expects that most persons seeking formal dispute resolution will have gathered the materials listed previously when identifying the existence of a dispute with the Agency. Consequently, FDA anticipates that the collection of information attributed solely to the guidance will be minimal.

    Description of Respondents: A sponsor, applicant, or manufacturer of a drug or biological product regulated by the Agency under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act who requests formal resolution of a scientific or procedural dispute.

    In the Federal Register of June 2, 2015 (80 FR 31386), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

    Burden Estimate: Provided in this document is an estimate of the annual reporting burden for requests for dispute resolution. Based on data collected from review divisions and offices within CDER and CBER, FDA estimates that approximately eight sponsors and applicants (respondents) submit requests for formal dispute resolution to CDER annually and approximately one respondent submits requests for formal dispute resolution to CBER annually. The total annual responses are the total number of requests submitted to CDER and CBER in 1 year, including requests for dispute resolution that a single respondent submits more than one time. FDA estimates that CDER receives approximately 31 requests annually and CBER receives approximately 1 request annually. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a request for formal dispute resolution in accordance with this guidance, including the time it takes to gather and copy brief statements describing the issue from the perspective of the person with the dispute, brief statements describing the history of the matter, and supporting information that has already been submitted to the Agency. Based on experience, FDA estimates that approximately 8 hours on average would be needed per response. Therefore, FDA estimates that 8 hours will be spent per year by respondents requesting formal dispute resolution under the guidance.

    Table 1—Estimated Annual Reporting Burden 1 Requests for formal dispute resolution Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • Total hours
    CDER 8 2 31 8 248 CBER 1 1 1 8 8 Total 256 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Dated: October 2, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-25623 Filed 10-7-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Lung Imaging Phase 2.

    Date: November 2, 2015.

    Time: 9:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The River Inn, 924 25th Street NW., Washington, DC 20037.

    Contact Person: Stephanie L. Constant, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7189, Bethesda, MD 20892, 301-443-8784, [email protected]

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; SBIR Phase IIB Small Market Awards.

    Date: November 4, 2015.

    Time: 8:30 a.m. to 10:00 a.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Crystal City, 2399 Jefferson Davis Hwy., Arlington, VA 22202.

    Contact Person: Tony L. Creazzo, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892-7924, 301-435-0725, [email protected]

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI SBIR Phase IIB Bridge Awards (R44).

    Date: November 4, 2015.

    Time: 10:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Crystal City, 2399 Jefferson Davis Hwy., Arlington, VA 22202.

    Contact Person: Susan Wohler Sunnarborg, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National, Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7182, Bethesda, MD 20892, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: October 2, 2015. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-25582 Filed 10-7-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Training for Career Independence in Environmental Health Sciences.

    Date: November 2, 2015.

    Time: 11:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute of Environmental Health Sciences, Keystone Building, Room 1003A, 530 Davis Drive, Research Triangle Park, NC 27709 (Telephone Conference Call).

    Contact Person: Linda K. Bass, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat'l Institute Environmental Health Sciences, P.O. Box 12233, MD EC-30, Research Triangle Park, NC 27709, (919) 541-1307.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS)
    Dated: October 2, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-25583 Filed 10-7-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Therapeutic Strategies for Lysosomal Storage and Amino; Acid Metabolism Disorders.

    Date: November 3, 2015.

    Time: 11:00 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call).

    Contact Person: Alessandra C Rovescalli, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Rm 5205 MSC7846, Bethesda, MD 20892, (301) 435-1021, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Laboratory for Fluorescence Dynamics.

    Date: November 8-10, 2015.

    Time: 9:00 a.m. to 11:00 a.m.

    Agenda: To review and evaluate grant applications.

    Place: Atrium Hotel, 18700 MacArthur Blvd., Irvine, CA 92612.

    Contact Person: Mike Radtke, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4176, MSC 7806, Bethesda, MD 20892, 301-435-1728, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Informatics.

    Date: November 9, 2015.

    Time: 9:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Claire E Gutkin, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3106, MSC 7808, Bethesda, MD 20892, 301-594-3139, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Clinical Neurophysiology, Devices, Neuroprosthetics, and Biosensors.

    Date: November 12-13, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: J.W. Marriott Hotel, JW Marriott Hotel New Orleans, 614 Canal Street, New Orleans, LA 70130.

    Contact Person: Cristina Backman, Ph.D., Scientific Review Officer, ETTN IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5211, MSC 7846, Bethesda, MD 20892, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Non-HIV Anti Infective Therapeutics.

    Date: November 12-13, 2015.

    Time: 8:00 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Garden Inn Bethesda, 7301 Waverly Street, Bethesda, MD 20814.

    Contact Person: Neerja Kaushik-Basu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3198 MSC 7808, Bethesda, MD 20892, (301) 435-2306, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Biomaterials, Delivery, and Nanotechnology.

    Date: November 12, 2015.

    Time: 8:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: David Filpula.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Brain Disorders and Related Neurosciences.

    Date: November 12-13, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Nikko San Francisco, 222 Mason Street, San Francisco, CA 94102.

    Contact Person: Vilen A Movsesyan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040M, MSC 7806, Bethesda, MD 20892, 301-402-7278, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Risk, Prevention and Health Behavior.

    Date: November 12-13, 2015.

    Time: 9:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Claire E Gutkin, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3106, MSC 7808, Bethesda, MD 20892, 301-594-3139, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Nutrition and Metabolic Processes Topics.

    Date: November 12, 2015.

    Time: 2:00 p.m. to 4:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call).

    Contact Person: Hui Chen, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301-435-1044, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Topics in Drug Discovery and Mechanisms of Antimicrobial Resistance.

    Date: November 13, 2015.

    Time: 8:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Guangyong Ji, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3211, MSC 7808, Bethesda, MD 20892, 301-435-1146, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Muscle Physiology and Disease.

    Date: November 13, 2015.

    Time: 10:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

    Contact Person: Maria Nurminskaya, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892, (301) 435-1222, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: October 2, 2015. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-25584 Filed 10-7-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Environmental Health Sciences Review Committee.

    Date: November 4, 2015.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Sheraton Chapel Hill Hotel, 1 Europa Drive, Chapel Hill, NC 27517.

    Contact Person: Linda K Bass, Ph.D., Scientific Review Administrator, Scientific Review Branch, Division of Extramural Research and Training, Nat'l Institute of Environmental Health Sciences, P.O. Box 12233, MD EC-30, Research Triangle Park, NC 27709 (919) 541-1307.

    Name of Committee: Environmental Health Sciences Review Committee.

    Date: November 5-6, 2015.

    Time: 8:30 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Sheraton Chapel Hill Hotel, 1 Europa Drive, Chapel Hill, NC 27517.

    Contact Person: Linda K Bass, Ph.D., Scientific Review Administrator, Scientific Review Branch, Division of Extramural Research and Training, Nat'l Institute of Environmental Health Sciences, P.O. Box 12233, MD EC-30, Research Triangle Park, NC 27709 (919) 541-1307.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS)
    Dated: October 2, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-25581 Filed 10-7-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Request for Information (RFI): Soliciting Input for the National Center for Advancing Translational Sciences (NCATS) Strategic Planning Process SUMMARY:

    The National Center for Advancing Translational Sciences (NCATS) seeks input on the development of a five-year strategic plan. We invite input from any and all interested parties.

    DATES:

    To ensure consideration, responses must be submitted by Jan. 8, 2016, 11:59:59 p.m. EST.

    ADDRESSES:

    Comments must be submitted electronically using the web-based form available at http://grants.nih.gov/grants/rfi/rfi.cfm?ID=50.

    FOR FURTHER INFORMATION CONTACT:

    Specific questions about this notice should be sent via email to: [email protected]

    SUPPLEMENTARY INFORMATION: Background

    Several thousand diseases affect humans of which only about 500 have any treatment. Thanks to our growing understanding of human biology, along with the increased availability of innovative technologies, there is an unprecedented opportunity to translate scientific discoveries more efficiently into new, more effective and safer health interventions. Currently, a novel intervention can take about 14 years and $2 billion to develop, with a failure rate exceeding 95 percent.

    To address the challenges, NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational science process in an effort to speed the delivery of interventions (e.g. drugs, diagnostics and medical devices) to patients. Rather than targeting a particular disease or fundamental science, NCATS focuses on what is common across diseases and the translational process. The Center emphasizes innovation and deliverables, relying on the power of data and new technologies to develop, demonstrate and disseminate improvements in translational science that bring about tangible improvements in human health. NCATS' current programs focus on pre-clinical innovation to drive advances in early stages of the translational process, from target validation to first-in-human studies; clinical innovation to support clinical and translational research, creating and sharing expertise, tools and training needed to develop and deploy effective treatments in people; and reengineering translational science through cross-cutting programs that address common scientific and organizational barriers to enable faster and more effective interventions that tangibly improve human health.

    For more information about NCATS, visit https://ncats.nih.gov.

    Translation and Translational Science

    NCATS defines translation as the process of turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and the public—from diagnostics and therapeutics to medical procedures and behavioral changes. Translational science is defined as the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process.

    The translational science process can be envisioned as a spectrum (https://ncats.nih.gov/translation/spectrum) encompassing each stage of research along the path from the biological basis of health and disease to interventions that improve the health of individuals and the public. The spectrum is not linear or unidirectional; rather, each of the five stages (Basic Research, Pre-Clinical Research, Clinical Research, Clinical Implementation, and Public Health) builds upon and informs the others. Patient Involvement plays a central role in the entire process.

    Basic Research, while not typically conducted at NCATS, reveals fundamental mechanisms of biology, disease or behavior that inform and can be informed by each of the other stages. Pre-clinical Research connects those basic discoveries made in the laboratory or clinic to a new medical intervention. Clinical Research tests the safety and effectiveness of those interventions in human subjects, and also can include behavioral and observational studies, outcomes and health services research, and the testing and refinement of new technologies. Research on the adoption of medical interventions into routine clinical care for the general population, the evaluation of clinical trial results, and the identification of new clinical questions and gaps in care occur in the Clinical Implementation stage. The Public Health stage of translation includes studies on health outcomes at the population level to determine the effects of diseases and efforts to prevent, diagnose and treat them. Central to the translational science spectrum is Patient Involvement in which NCATS researchers collaborate and engage with patients and community members to better identify and understand public health needs and develop useful medical interventions. For more information, including a graphical depiction of the translational science spectrum, visit https://ncats.nih.gov/translation/spectrum.

    At all stages of the spectrum, NCATS develops new approaches, demonstrates their usefulness, disseminates the findings, and engages with patients and community members to better identify and understand public health needs.

    Strategic Planning Process

    NCATS is in the process of developing its first strategic plan to set the goals and priorities of the Center over the next five years. We anticipate that the strategic plan will outline and provide a roadmap of translational research priorities and the most pressing scientific and operational opportunities and challenges in translation; emerging research needs; barriers to progress; and the resources, infrastructure, or tools needed to catalyze major scientific advances in translation.

    NCATS is soliciting stakeholder input through this Request for Information and through a series of webinars (details at https://ncats.nih.gov/strategicplan) to ensure that members of the community and our partners have a voice in framing the Center's future scientific direction.

    Information Requested

    NCATS seeks input on the scientific and operational opportunities, challenges and research needs in translational science to help set the Center's strategic priorities and inform the development of a five-year strategic plan.

    Some examples of particular issues of interest that apply across the translational science spectrum include:

    • Breaking down professional, cultural and scientific silos across the translational science spectrum

    • Focusing on inter-operability of data systems (such as integrating patient data and electronic health records into pre-clinical research)

    • Expanding research efforts at NCATS into new therapeutic modalities

    • Focusing on patient-driven research and patient/community engagement

    • Forming innovative partnerships with a wide variety of stakeholders

    • Identifying skillsets and competencies needed for training the next generation of translational scientists

    • Utilizing modern communication and dissemination tools to expand awareness of translational science to a wide variety of stakeholders

    NCATS encourages stakeholders from all sectors to provide input on these and any other relevant issues. Stakeholders include, but are not limited to: Patients and members of the health advocacy community; basic, translational and clinical scientists at universities and research institutions; health care providers; biotechnology, venture capital and pharmaceutical industry members; colleagues at other NIH institutes, centers and offices; partners at other government agencies (e.g. the Food and Drug Administration, other agencies of the Department of Health and Human Services, the Environmental Protection Agency, and the Department of Defense); policy makers and funders; as well as the general public. Organizations are encouraged to submit a single response that reflects the views of their organization and membership as a whole.

    To respond to this RFI, please go to http://grants.nih.gov/grants/rfi/rfi.cfm?ID=50. To ensure consideration, responses must be submitted by Jan. 8, 2016, 11:59:59 p.m. EST.

    General Information

    Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret or sensitive information in your response. Respondents are advised that the U.S. Government is under no obligation to acknowledge receipt of the information provided and will not provide feedback to respondents. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH Web sites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

    This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers. The Government will not pay for the preparation of any information submitted or for the Government's use of such information. No basis for claims against the Government shall arise as a result of a response to this request for information or from the Government's use of such information.

    NCATS looks forward to your input and encourages you to share this RFI document and the information about the upcoming webinars with your colleagues.

    Dated: September 25, 2015. Christopher P. Austin, Director, National Center for Advancing Translational Sciences (NCATS).
    [FR Doc. 2015-24761 Filed 10-7-15; 8:45 am] BILLING CODE P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request

    In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276-1243.

    Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

    Proposed Project: Violence Intervention to Enrich Lives (VITEL) Supplement—NEW

    This data collection is to study the intersection of intimate partner violence (IPV) and trauma for women with HIV, at risk for HIV, and at risk for substance use disorders (SUDs). VITEL provides supplemental funding to existing SAMHSA Targeted Capacity Expansion: Substance Abuse Treatment for Racial/Ethnic Minority Women at High Risk for HIV/AIDS (TCE-HIV: Minority Women) grantees. The goals of the VITEL program are (1) reduce IPV through screening and referrals, (2) reduce risky behaviors that lead to new HIV infections and SUDs, (3) increase access to care and improve health outcomes for people living with HIV and AIDS, (4) reduce HIV-related health disparities resultant from IPV screening tool implementation, and (5) determine the feasibility of integrating IPV screening in behavioral health settings. A multi-stage approach has been used to develop the appropriate theoretical framework, conceptual model, evaluation design and protocols, and data collection instrumentation. Process and outcome measures have been developed to fully capture community and contextual conditions, the scope of the VITEL program implementation and activities, and client outcomes. A mixed-method approach (e.g., surveys, semi-structured interviews, focus groups) will be used, for example, to examine collaborative community linkages established between grantees and other service providers (e.g., primary health care, SUD recovery), determine which program models and what type and amount of client exposure to services contribute to significant changes in IPV, SUD, and HIV risk behaviors of the targeted populations, and determine the impact of VITEL services on providers, clients, and communities.

    The data collection for this program will be conducted quarterly (during this one year supplemental period) and the client outcome data collection will be ongoing throughout the program and will be collected at baseline, discharge and 6-months post baseline for all treatment clients. The respondents are clinic-based social workers and counselors, clinic-based administrators and clinic-based clients. The estimated annualized burden is summarized below:

    Instrument/activity Number of
  • respondents
  • Responses per
  • respondent
  • Total
  • response
  • numbers
  • Total
  • response
  • numbers
  • Hours per
  • response
  • Total
  • burden
  • hours
  • Baseline data collection (Clients) 500 1 500 500 .42 210 Discharge data collection (Clients) 500 1 500 500 .42 210 6-month post Baseline data collection (Clients) 500 1 500 500 .42 210 Interaction Form (Client) 500 1 500 500 .42 210 Treatment Focus Group (Client) 45 2 90 90 1.0 90 Client Sub-total 2,045 930 Executives and Project Director/Program Manager (Semi-Structured Interviews) 10 1 10 10 .75 7.5 Executives and Project Director/Program Manager (Progress Report) 5 1 5 5 3.0 15 Direct Staff (Semi-Structured Interviews) 10 1 10 10 .75 7.5 Community Collaborators (Semi-Structured Interviews) 10 1 10 10 1.0 5 Staff Sub-total 35 40 Total 2,080 970

    Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 2-1057, One Choke Cherry Road, Rockville, MD 20857 OR email her a copy at [email protected]. Written comments should be received by December 7, 2015.

    Summer King, Statistician.
    [FR Doc. 2015-25661 Filed 10-7-15; 8:45 am] BILLING CODE 4162-20-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.

    Project: Behavioral Health Information Technologies and Standards—In-Depth Qualitative Data Collection Activity—NEW

    The Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Treatment (CSAT) and Center for Behavioral Health Statistics and Quality (CBHSQ) are proposing to conduct qualitative data collection activities (i.e., focus group and site visits) to assess health information technology (HIT) adoption practices among SAMHSA grantees. As part of its Strategic Initiative to advance the use of health information technologies to support integrated behavioral health care, SAMHSA has been working to develop questions that will examine HIT adoption by behavioral health service providers who are implementing SAMHSA grant programs. The selected programs are funded by the by the Cente