Federal Register Vol. 80, No.96,

Federal Register Volume 80, Issue 96 (May 19, 2015)

Page Range28537-28805
FR Document

80_FR_96
Current View
Page and SubjectPDF
80 FR 28803 - Continuation of the National Emergency With Respect to BurmaPDF
80 FR 28762 - Sunshine Act Meetings; Unified Carrier Registration Plan Board of DirectorsPDF
80 FR 28737 - Sunshine Act MeetingPDF
80 FR 28614 - Sunshine Act MeetingsPDF
80 FR 28764 - Proposed Information Collection; Comment RequestPDF
80 FR 28569 - Special Local Regulations: 86th Major League Baseball (MLB) All-Star Week/Game, Ohio River Mile 469.5 to 471.2; Cincinnati, OHPDF
80 FR 28559 - Safety Zone; Agat Marina, Agat, GuamPDF
80 FR 28561 - Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal BoardPDF
80 FR 28558 - Drawbridge Operation Regulation; Long Island, New York Inland Waterway From East Rockaway Inlet to Shinnecock Canal, NYPDF
80 FR 28629 - National Committee on Vital and Health Statistics: MeetingPDF
80 FR 28629 - Meetings of the Advisory Group on Prevention, Health Promotion, and Integrative and Public HealthPDF
80 FR 28556 - Safety Zones and Special Local Regulations; Recurring Marine Events in Captain of the Port Long Island Sound ZonePDF
80 FR 28613 - Public Availability of Environmental Protection Agency FY 2014 Service Contract InventoryPDF
80 FR 28571 - Electronic Reporting and Recordkeeping Requirements for New Source Performance Standards; Extension of Comment PeriodPDF
80 FR 28609 - Strategic Environmental Research and Development Program, Scientific Advisory Board; Notice of Federal Advisory Committee MeetingPDF
80 FR 28582 - Taking of Marine Mammals Incidental to Specified Activities; Anacortes Tie-Up Slips Dolphin and Wingwall ReplacementPDF
80 FR 28620 - Proposed Information Collection Activity; Comment RequestPDF
80 FR 28618 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
80 FR 28615 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
80 FR 28609 - Submission for OMB Review; Comment RequestPDF
80 FR 28608 - Fishing Capacity Reduction Program for the Southeast Alaska Purse Seine Salmon FisheryPDF
80 FR 28760 - Petition for Exemption; Summary of Petition Received; Gus Christopher ToulatosPDF
80 FR 28713 - Comment Request: National Science Foundation Proposal/Award; Information-NSF Proposal and Award Policies and Procedures GuidePDF
80 FR 28716 - President's Commission on White House Fellowships Advisory Committee: Closed MeetingPDF
80 FR 28581 - Wooden Bedroom Furniture From the People's Republic of China: Notice of Court Decision Not in Harmony With Final Results of Administrative Review and Notice of Second Amended Final Results of Administrative Review Pursuant to Court DecisionPDF
80 FR 28710 - Kelly Services Working On-Site Kraft Foods Group Global, Inc. Woburn, Massachusetts; Amended Certification Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
80 FR 28710 - Notice of Revised Determination on ReconsiderationPDF
80 FR 28613 - Southline Transmission, L.L.C., SU FERC, L.L.C.; Notice of Petition for Declaratory OrderPDF
80 FR 28636 - The U.S. Customs and Border Protection Airport and Seaport Inspections User Fee Advisory Committee (UFAC); CorrectionPDF
80 FR 28621 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and MonitoringPDF
80 FR 28610 - Notice of Public Hearing and Business MeetingPDF
80 FR 28567 - Proposed Amendments to the Rules of Practice and Procedure To Allow Each Signatory Party and the DRBC To Administer a Single Process for the Review and Adjudication of ProjectsPDF
80 FR 28612 - Environmental Management Site-Specific Advisory Board, HanfordPDF
80 FR 28612 - Agency Information Collection Activities; Comment Request; Graduate Assistance in Areas of National Need (GAANN) Performance ReportPDF
80 FR 28579 - Notice of Request for Extension of Approval of an Information Collection; Importation of Christmas Cactus and Easter Cactus in Growing Media From the Netherlands and DenmarkPDF
80 FR 28762 - Petition for Exemption From the Vehicle Theft Prevention Standard; Jaguar Land Rover North America, LLCPDF
80 FR 28639 - Trinity River Adaptive Management Working Group; Public MeetingPDF
80 FR 28613 - Update to Notice of Financial Institutions for Which the Federal Deposit Insurance Corporation Has Been Appointed Either Receiver, Liquidator, or ManagerPDF
80 FR 28539 - Fisheries of the Exclusive Economic Zone Off Alaska; Bering Sea and Aleutian Islands Crab Rationalization Program; Amendment 45; Pacific Cod Sideboard Allocations in the Gulf of AlaskaPDF
80 FR 28707 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension Without Change of a Previously Approved Collection; September 11th Victim Compensation Fund Claimant Eligibility and Compensation FormPDF
80 FR 28717 - Self-Regulatory Organizations; NYSE MKT, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Modifying the NYSE Amex Options Fee Schedule Related to Fees and Credits Associated With the Customer Best Execution AuctionPDF
80 FR 28735 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending the NYSE Arca Equities Schedule of Fees and Charges for Exchange Services To Reduce Fees for Routing Certain Retail Orders to Away Market CentersPDF
80 FR 28621 - Exploring Naloxone Uptake and Use; Public Meeting; Request for CommentsPDF
80 FR 28575 - Fisheries of the Northeastern United States; Atlantic Mackerel, Squid, and Butterfish Fisheries; Framework Adjustment 9PDF
80 FR 28617 - Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)PDF
80 FR 28617 - World Trade Center Health Program Scientific/Technical Advisory Committee: Notice of Charter RenewalPDF
80 FR 28619 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or Institute)PDF
80 FR 28615 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial ReviewPDF
80 FR 28618 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial ReviewPDF
80 FR 28620 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial ReviewPDF
80 FR 28638 - Proposed Information Collection; National Initiative To Understand and Connect Americans and NaturePDF
80 FR 28709 - Eaton Corporation, Cooper Power Systems, Power Delivery Division, Including On-Site Leased Workers From Adecco Employment, Olean, New York; Amended Certification Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
80 FR 28709 - Amended Certification Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
80 FR 28711 - Hewlett Packard Company, HP Enterprise Services, America Sales Operations, Omaha, Nebraska; Hewlett Packard Company, Order Management, America Sales Operations, Omaha, Nebraska; Hewlett Packard Company, Technology & Operations, Sales Operations, Ww Sales Transformation, Quote To Order, Quote And Configuration Including Remote Workers From Arkansas, California, Colorado, Florida, Idaho, Massachusetts And Texas And Including Leased Workers From Modis Omaha, Nebraska; Amended Certification Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
80 FR 28637 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; Horseshoe Crab Tagging ProgramPDF
80 FR 28538 - Prohibition of Fixed-Wing Special Visual Flight Rules Operations at Washington-Dulles International Airport; WithdrawalPDF
80 FR 28707 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection; Semi-Annual Progress Report for Grantees From the Enhanced Training and Services To End Violence Against and Abuse of Women Later in Life Program (Training Program)PDF
80 FR 28708 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved CollectionPDF
80 FR 28667 - JM Pharmacy Group, Inc., d/b/a Farmacia Nueva and Best Pharma Corp; Decision and OrderPDF
80 FR 28759 - Interagency Task Force on Veterans Small Business Development; Federal Register Meeting NoticePDF
80 FR 28580 - Notice of Public Meeting of the Idaho Advisory Committee for Members of the Committee To Receive Member Orientation and Discuss Civil Rights Issues in the StatePDF
80 FR 28611 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 2015-16 National Postsecondary Student Aid Study (NPSAS:16) Full Scale Institution Contacting And Enrollment List CollectionPDF
80 FR 28643 - Bobby D. Reynolds, N.P., Tina L. Killebrew, N.P. and David R. Stout, N.P.; Decision and OrdersPDF
80 FR 28759 - Meeting of the Advisory Committee on Veterans Business AffairsPDF
80 FR 28695 - Annicol Marrocco, M.D.; Decision and OrderPDF
80 FR 28614 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
80 FR 28614 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
80 FR 28733 - Self-Regulatory Organizations; ICE Clear Europe Limited; Order Approving Proposed Rule Change Relating to Collateral and Haircut PolicyPDF
80 FR 28739 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Designation of Longer Period for Commission Action on Proposed Rule Change To Amend and Restate Certain Rules That Govern the NASDAQ PSXPDF
80 FR 28740 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to the Reporting Requirements of FINRA Rule 4530(a)(1)(H)PDF
80 FR 28738 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Adjust the Preferred Market Maker Quoting ObligationsPDF
80 FR 28721 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change Adopting New Equity Trading Rules Relating to Trading Sessions, Order Ranking and Display, and Order Execution To Reflect the Implementation of Pillar, the Exchange's New Trading Technology PlatformPDF
80 FR 28742 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Fees for Use of EDGX Exchange, Inc.PDF
80 FR 28639 - National Register of Historic Places; Notification of Pending Nominations and Related ActionsPDF
80 FR 28693 - Sharad C. Patel, M.D.; Decision and OrderPDF
80 FR 28689 - Maryanne Phillips-Elias, M.D.; Decision and OrderPDF
80 FR 28745 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing of Proposed Rule Change To Establish Rules Governing the Trading of Options on the EDGX Options ExchangePDF
80 FR 28761 - Manual for Assessing Safety Hardware (MASH) TransitionPDF
80 FR 28640 - Karen S. Dunning, N.P.; Decision and OrderPDF
80 FR 28537 - Modification of Class D and Class E Airspace; Pasco, WAPDF
80 FR 28714 - Information Collection: Disposal of High-Level Radioactive Wastes in Geologic RepositoriesPDF
80 FR 28715 - Information Collection: Destinations of Released Patients Following Treatment with Iodine-131 and Estimation of Doses to Members of the Public at Locations other than Conventional Residences Receiving Such PatientsPDF
80 FR 28719 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related To Fees for Use of EDGA Exchange, Inc.PDF
80 FR 28757 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify NASDAQ Rule 7018 Governing Fees and Credits Assessed For Execution and RoutingPDF
80 FR 28634 - Center for Scientific Review; Notice of Closed MeetingsPDF
80 FR 28633 - National Institute on Aging; Notice of Closed MeetingsPDF
80 FR 28632 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed MeetingsPDF
80 FR 28636 - National Institute on Drug Abuse Amended; Notice of MeetingPDF
80 FR 28630 - Center for Scientific Review; Notice of Closed MeetingsPDF
80 FR 28636 - Center For Scientific Review; Amended Notice of MeetingPDF
80 FR 28632 - National Institute of Mental Health; Notice of Closed MeetingPDF
80 FR 28635 - National Institute of Mental Health; Notice of Closed MeetingsPDF
80 FR 28633 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
80 FR 28633 - Prospective Grant of Exclusive License: Biomarkers for Acute Ischemic StrokePDF
80 FR 28765 - Proposed Collection; Comment Request for Form 5452PDF
80 FR 28763 - Proposed Collection; Comment Request for Form 3949-APDF
80 FR 28588 - Takes of Marine Mammals Incidental to Specified Activities; Construction Activities at the Children's Pool Lifeguard Station at La Jolla, CaliforniaPDF
80 FR 28572 - International Fisheries; Pacific Tuna Fisheries; Establishment of Tuna Vessel Monitoring System in the Eastern Pacific OceanPDF
80 FR 28716 - New Postal ProductPDF
80 FR 28712 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; General Inquiries to State Agency ContactsPDF
80 FR 28622 - List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Request for NominationsPDF
80 FR 28624 - Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Withdrawal of Compliance Policy Guide; Section 608.400 Compounding of Drugs for Use in AnimalsPDF
80 FR 28580 - Submission for OMB Review; Comment RequestPDF
80 FR 28545 - Law Enforcement ReportingPDF
80 FR 28555 - Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972PDF
80 FR 28767 - Rules of Practice and Procedure for Administrative Hearings Before the Office of Administrative Law JudgesPDF

Issue

80 96 Tuesday, May 19, 2015 Contents Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

Animal Animal and Plant Health Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Importation of Christmas Cactus and Easter Cactus in Growing Media from the Netherlands and Denmark, 28579 2015-12073 Army Army Department RULES Law Enforcement Reporting, 28545-28555 2015-11943 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 28615-28619 2015-12094 2015-12095 Charter Renewals: World Trade Center Health Program Scientific/Technical Advisory Committee, 28617 2015-12058 Meetings: Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health, 28617 2015-12059 Disease, Disability, and Injury Prevention and Control Special Emphasis Panel, 28615, 28618, 28620 2015-12053 2015-12054 2015-12056 2015-12055 Safety and Occupational Health Study Section, National Institute for Occupational Safety and Health, 28619-28620 2015-12057 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 28620 2015-12096 Civil Rights Civil Rights Commission NOTICES Meetings: Idaho Advisory Committee; Teleconference, 28580 2015-12041 Coast Guard Coast Guard RULES Drawbridge Operation Regulations: Long Island, New York Inland Waterway from East Rockaway Inlet to Shinnecock Canal, NY, 28558 2015-12112 Safety Zones and Special Local Regulations Recurring Marine Events in Captain of the Port Long Island Sound Zone, 28556-28558 2015-12103 Safety Zones: Agat Marina, Agat, Guam, 28559-28561 2015-12121 PROPOSED RULES Special Local Regulations: 86th Major League Baseball All-Star Week/Game, Ohio River Mile 469.5 to 471.2; Cincinnati, OH, 28569-28571 2015-12122 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

Patent and Trademark Office

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 28580-28581 2015-11979
Defense Department Defense Department See

Army Department

See

Navy Department

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 28609 2015-12093 Meetings: Strategic Environmental Research and Development Program, Scientific Advisory Board, 28609-28610 2015-12098
Delaware Delaware River Basin Commission PROPOSED RULES Meetings: Amendments to the Rules of Practice and Procedure, 28567-28568 2015-12076 NOTICES Meetings: Delaware River Basin Commission, 28610-28611 2015-12077 Drug Drug Enforcement Administration NOTICES Decisions and Orders: Annicol Marrocco, 28695-28706 2015-12035 Bobby D. Reynolds, et al., 28643-28667 2015-12038 JM Pharmacy Group, Inc., d/b/a Farmacia Nueva and Best Pharma Corp., 28667-28689 2015-12043 Karen S. Dunning, 28640-28643 2015-12020 Maryanne Phillips-Elias, M.D., 28689-28693 2015-12023 Sharad C. Patel, M.D., 28693-28695 2015-12025 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: 2015-16 National Postsecondary Student Aid Study; Full Scale Institution Contacting and Enrollment List Collection, 28611-28612 2015-12040 Graduate Assistance in Areas of National Need Performance Report, 28612 2015-12074 Employment and Training Employment and Training Administration NOTICES Worker Adjustment Assistance Eligibility; Amended Certifications: Eaton Corp., Cooper Power Systems, Olean, NY, 28709 2015-12051 Worker Adjustment Assistance; Amended Certifications: Hewlett Packard Co., HP Enterprise Services, Omaha, NE, et al., 28711-28712 2015-12049 Kelly Services; Kraft Foods Group Global, Woburn, MA, 28710 2015-12083 Southern California Edison, a subsidiary of Edison International, Irwindale, CA, et al., 28709-28710 2015-12050 Worker and Alternative Trade Adjustment Assistance; Revised Determinations: San Bernardino Sun, a Subsidiary of California Newspapers Partnership, San Bernardino, CA, and Inland Valley Daily Bulletin, a Subsidiary of California Newspapers Partnership, Ontario, CA, 28710-28711 2015-12082 Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Meetings: Environmental Management Site-Specific Advisory Board, 28612-28613 2015-12075
Environmental Protection Environmental Protection Agency PROPOSED RULES Electronic Reporting and Recordkeeping Requirements for New Source Performance Standards, 28571-28572 2015-12100 NOTICES Fiscal Year 2014 Service Contract Inventory, 28613 2015-12102 Federal Aviation Federal Aviation Administration RULES Modification of Class D and Class E Airspace: Pasco, WA, 28537-28538 2015-12019 Prohibition of Fixed-Wing Special Visual Flight Rules Operations at Washington-Dulles International Airport; Withdrawal, 28538-28539 2015-12047 NOTICES Petitions for Exemptions; Summaries: Gus Christopher Toulatos, 28760 2015-12089 Federal Deposit Federal Deposit Insurance Corporation NOTICES Updated Listing of Financial Institutions in Liquidation, 28613-28614 2015-12069 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 28614 2015-12159 Federal Energy Federal Energy Regulatory Commission NOTICES Petitions for Declaratory Orders: Southline Transmission, LLC; SU FERC, LLC, 28613 2015-12080 Federal Highway Federal Highway Administration NOTICES Manual for Assessing Safety Hardware Transition, 28761-28762 2015-12021 Federal Motor Federal Motor Carrier Safety Administration NOTICES Meetings; Sunshine Act, 28762 2015-12209 Federal Reserve Federal Reserve System NOTICES Change in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 28614-28615 2015-12034 Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 28614 2015-12033 Fish Fish and Wildlife Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Horseshoe Crab Tagging Program, 28637-28638 2015-12048 National Initiative to Understand and Connect Americans and Nature, 28638-28639 2015-12052 Meetings: Trinity River Adaptive Management Working Group, 28639 2015-12070 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring, 28621 2015-12078 Guidance for Industry and Staff: Compounding Animal Drugs From Bulk Drug Substances; Withdrawal of Compliance Policy Guide on Compounding of Drugs for Use in Animals, 28624-28629 2015-11982 List of Bulk Drug Substances That May be Used by an Outsourcing Facility to Compound Drugs for Use in Animals; Request for Nominations, 28622-28624 2015-11983 Meetings: Exploring Naloxone Uptake and Use, 28621-28622 2015-12061 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Children and Families Administration

See

Food and Drug Administration

See

National Institutes of Health

NOTICES Meetings: Advisory Group on Prevention, Health Promotion, and Integrative and Public Health, 28629-28630 2015-12104 National Committee on Vital and Health Statistics, 28629 2015-12106
Homeland Homeland Security Department See

Coast Guard

See

U.S. Customs and Border Protection

Interior Interior Department See

Fish and Wildlife Service

See

National Park Service

Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 28764-28765 2015-12002 2015-12127 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Form 3949-A, 28763-28764 2015-11998 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Wooden Bedroom Furniture from the People's Republic of China, 28581-28582 2015-12084 Justice Department Justice Department See

Drug Enforcement Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 28708-28709 2015-12045 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Semi-Annual Progress Report for Grantees from the Enhanced Training and Services to End Violence Against and Abuse of Women Later in Life Program, 28707-28708 2015-12046 September 11th Victim Compensation Fund Claimant Eligibility and Compensation Form, 28707 2015-12065
Labor Department Labor Department See

Employment and Training Administration

RULES Rules of Practice and Procedure for Administrative Hearings Before the Office of Administrative Law Judges, 28768-28802 2015-11586 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: General Inquiries to State Agency Contacts, 28712-28713 2015-11984
National Highway National Highway Traffic Safety Administration NOTICES Petitions for Exemptions: Jaguar Land Rover North America, LLC; Vehicle Theft Prevention Standard, 28762-28763 2015-12072 National Institute National Institutes of Health NOTICES Exclusive Licenses: Biomarkers for Acute Ischemic Stroke, 28633-28634 2015-12005 Meetings: Center for Scientific Review, 28630-28632, 28634-28636 2015-12009 2015-12010 2015-12014 National Institute of Allergy and Infectious Diseases, 28633 2015-12006 National Institute of Mental Health, 28632, 28635-28636 2015-12007 2015-12008 National Institute on Aging, 28633 2015-12013 National Institute on Alcohol Abuse and Alcoholism, 28632-28633 2015-12012 National Institute on Drug Abuse, 28636 2015-12011 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone off Alaska: Bering Sea and Aleutian Islands Crab Rationalization Program; Amendment 45; Pacific Cod Sideboard Allocations in the Gulf of Alaska, 28539-28545 2015-12066 PROPOSED RULES Fisheries of the Northeastern United States: Atlantic Mackerel, Squid, and Butterfish Fisheries; Framework Adjustment 9, 28575-28578 2015-12060 International Fisheries: Pacific Tuna Fisheries; Establishment of Tuna Vessel Monitoring System in the Eastern Pacific Ocean, 28572-28575 2015-11991 NOTICES Fee Rate Adjustments: Fishing Capacity Reduction Program; Southeast Alaska Purse Seine Salmon Fishery, 28608-28609 2015-12092 Takes of Marine Mammals Incidental to Specified Activities: Anacortes Tie-up Slips Dolphin and Wingwall Replacement, 28582-28588 2015-12097 Construction Activities at the Children's Pool Lifeguard Station at La Jolla, CA, 28588-28608 2015-11994 National Park National Park Service NOTICES National Register of Historic Places: Pending Nominations and Related Actions, 28639-28640 2015-12026 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Foundation Proposal/Award Information -- NSF Proposal and Award Policies and Procedures Guide, 28713 2015-12086 Navy Navy Department RULES Certifications and Exemptions under the International Regulations for Preventing Collisions at Sea, 1972, 28555 2015-11908 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Destinations of Released Patients Following Treatment with Iodine-131 and Estimation of Doses to Members of the Public at Locations Other than Conventional Residences Receiving Such Patients, 28715-28716 2015-12017 Disposal of High-Level Radioactive Wastes in Geologic Repositories, 28714-28715 2015-12018 Patent Patent and Trademark Office RULES Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board, 28561-28566 2015-12117 Personnel Personnel Management Office NOTICES Meetings: Presidents Commission on White House Fellowships Advisory Committee, 28716 2015-12085 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 28716-28717 2015-11990 Presidential Documents Presidential Documents ADMINISTRATIVE ORDERS Burma; Continuation of National Emergency (Notice of May 15, 2015), 28803-28805 2015-12290 Securities Securities and Exchange Commission NOTICES Meetings; Sunshine Act, 28737 2015-12183 Self-Regulatory Organizations; Proposed Rule Changes: BOX Options Exchange, LLC, 28738-28739 2015-12029 EDGA Exchange, Inc., 28719-28721 2015-12016 EDGX Exchange, Inc., 28742-28757 2015-12022 2015-12027 Financial Industry Regulatory Authority, Inc., 28740-28742 2015-12030 ICE Clear Europe, Ltd., 28733-28735 2015-12032 NASDAQ OMX PHLX, LLC, 28739-28740 2015-12031 NASDAQ Stock Market, LLC, 28757-28759 2015-12015 NYSE Arca, Inc., 28721-28733, 28735-28737 2015-12028 2015-12062 NYSE MKT, LLC, 28717-28719 2015-12063 Small Business Small Business Administration NOTICES Meetings: Advisory Committee On Veterans Business Affairs, 28759-28760 2015-12037 Interagency Task Force on Veterans Small Business Development, 28759 2015-12042 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Motor Carrier Safety Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department See

Internal Revenue Service

Customs U.S. Customs and Border Protection NOTICES Meetings: U.S. Customs and Border Protection Airport and Seaport Inspections User Fee Advisory Committee; Correction, 28636-28637 2015-12079 Separate Parts In This Issue Part II Labor Department, 28768-28802 2015-11586 Part III Presidential Documents, 28803-28805 2015-12290 Reader Aids

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80 96 Tuesday, May 19, 2015 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2014-0279; Airspace Docket No. 14-ANM-3] Modification of Class D and Class E Airspace; Pasco, WA AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action modifies the Class D and Class E airspace at Tri-Cities Airport, Pasco, WA. Controlled airspace is necessary to accommodate the new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at the airport. This action, initiated by the biennial review of the Pasco, WA, enhances the safety and management of IFR operations at the airport.

DATES:

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

ADDRESSES:

FAA Order 7400.9Y, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

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

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION: History

On July 3, 2014, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to modify controlled airspace at Tri-Cities Airport, Pasco, WA (79 FR 37967). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class D airspace and Class E airspace designations are published in paragraphs 5000, 6004 and 6005, respectively, of FAA Order 7400.9Y, dated August 6, 2014, and effective September 15, 2014, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in that Order. Except for editorial corrections this rule is the same as published in the NPRM.

Availability and Summary of Documents for Incorporation by Reference

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

The Rule

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class D airspace, Class E surface airspace, and Class E airspace extending upward from 700 feet above the surface at Tri-Cities Airport, Pasco, WA. After a biennial review of the airspace, the FAA found modification of the airspace necessary for the safety and management of aircraft departing and arriving under IFR operations at the airport. The Class D airspace area is expanded from the existing 4.3 miles to 4.8 miles, west of the airport, from the 255° radial to the 12° radial, and two segments extending 5.8 miles southwest and northeast of the airport is added. The cutout of the Class D airspace area for Vista Airport is eliminated, as Vista Airport is closed. The Class E surface airspace is adjusted to coincide with the dimensions of the Class D airspace area. Class E airspace designated as an extension to the Class D and Class E surface area is removed as it is no longer needed for IFR operations. The Class E airspace extending 700 feet above the surface is decreased to an 11-mile radius of the airport with segments extending from the 11-mile radius to 13 miles northeast and southeast of the airport, and a segment 4 miles south and 9 miles north of a 226° bearing from the airport extending to 15 miles southwest of the airport. These actions are necessary to accommodate RNAV (GPS) standard instrument approach procedures at the airport.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at Tri-Cities Airport, Pasco, WA.

Environmental Review

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment

Lists of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment:

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

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

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

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Y, Airspace Designations and Reporting Points, dated August 6, 2014, and effective September 15, 2014, is amended as follows: Paragraph 5000 Class D Airspace. ANM WA D Pasco, WA [Modified] Pasco, Tri-Cities Airport, WA (Lat. 46°15′53″ N., long. 119°07′09″ W.) That airspace extending upward from the surface to and including 2,900 feet MSL within a 4.3-mile radius of Tri-Cities Airport, and that airspace within a 4.8-mile radius of the airport from the 256° bearing from the airport clockwise to the 11° bearing from the airport, and that airspace within a 5.8-mile radius of the airport from the 11° bearing from the airport clockwise to the 83° bearing from the airport, and within a 5.8-mile radius of the airport from the 213° bearing clockwise to the 256° bearing from the airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory. Paragraph 6002 Class E airspace designated as surface areas. ANM WA E2 Pasco, WA [Modified] Pasco, Tri-Cities Airport, WA (Lat. 46°15′53″ N., long. 119°07′09″ W.)

That airspace extending upward from the surface within a 4.3-mile radius of Tri-Cities Airport and that airspace within 4.8-mile radius of the airport from the 256° bearing from the airport clockwise to the 11° bearing from the airport and that airspace within a 5.8-mile radius of the airport from the 11° bearing from the airport clockwise to the 83° bearing from the airport and within 5.8-mile radius of the airport from 213° bearing clockwise to the 256° bearing from the airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.

Paragraph 6004 Class E airspace areas designated as an extension to Class D or Class E surface area. ANM WA E4 Pasco, WA [Removed] Paragraph 6005 Class E airspace areas extending upward from 700 feet or more above the surface of the earth. ANM WA E5 Pasco, WA [Modified] Pasco, Tri-Cities Airport, WA (Lat. 46°15′53″ N., long. 119°07′09″ W.)

That airspace extending upward from 700 feet above the surface within 7.8-mile radius of the Tri-Cities Airport, and that airspace within an 11-mile radius of the airport from the 265° bearing from the airport clockwise to 16° bearing from the airport, and that airspace from the 54° bearing from the airport clockwise to the 112° from the airport, and that airspace 3.5 miles either side of the 35° bearing of the airport extending from the 11-mile radius to 13 mile northeast of the airport, and that airspace and that airspace 4.0 miles either side of the 133° bearing extending from the airport to 13 miles southeast of the airport, and that airspace 4 miles southeast and 9 miles northwest of the 226° bearing from the airport extending from the airport 15 miles southwest; that airspace extending upward from 1,200 feet above the surface bounded by a line beginning at lat. 45°49′00″ N., long. 118°00′00″ W.; to lat. 45°49′00″ N., long. 119°45′00″ W.; to lat. 47°00′00″ N., long. 119°45′00″ W.; to lat. 47°00′00″ N., long. 118°00′00″ W.; thence to the point of origin.

Issued in Seattle, Washington, on May 8, 2015. Christopher Ramirez, Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2015-12019 Filed 5-18-15; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 91 [Docket No. FAA-2015-0190; Amdt. No. 91-337] RIN 2120-AK69 Prohibition of Fixed-Wing Special Visual Flight Rules Operations at Washington-Dulles International Airport; Withdrawal AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Direct final rule; withdrawal.

SUMMARY:

The FAA is withdrawing a previously published direct final rule that would have prohibited fixed-wing special visual flight rules operations at Washington-Dulles International Airport. The FAA is withdrawing this action because it has received an adverse comment.

DATES:

The direct final rule published on March 26, 2015, at 80 FR 15887, is withdrawn, effective May 19, 2015.

FOR FURTHER INFORMATION CONTACT:

For technical questions concerning this action, contact David Maddox, Airspace Policy and Regulation Group, AJV-113, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone (202) 267-8783; email [email protected]

For legal questions concerning this action, contact Robert Frenzel, Office of the Chief Counsel, AGC-200, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone (202) 267-3073; email [email protected]

SUPPLEMENTARY INFORMATION:

Background

On March 26, 2015 (80 FR 15887), the FAA published in the Federal Register a direct final rule prohibiting fixed-wing special visual flight rules (SVFR) operations at Washington-Dulles International Airport (IAD). The direct final rule was to become effective on May 26, 2015.

Reason for Withdrawal

The FAA is withdrawing the direct final rule because the agency received an adverse comment to the rule and is required by 14 CFR 11.31(c) to withdraw a direct final rule if the agency receives any adverse comment or notice of intent to file any adverse comment. We received a comment from an individual pilot who objected to the prohibition of fixed-wing SVFR operations at IAD. The commenter stated that the blanket prohibition of SVFR was inappropriate and unnecessary. The commenter further stated that he had personally used SVFR twice in the last few years to land at IAD to participate in an event at the Smithsonian National Air and Space Museum's Steven F. Udvar-Hazy Center, which is located adjacent to IAD. The commenter further suggested that the IAD control tower should approve or disapprove SVFR operations on a case-by-case basis.

The FAA has determined that the comment meets the requirements for consideration as an adverse comment per § 11.31(a). In accordance with the provisions of § 11.31(c), the FAA withdraws the direct final rule.

Conclusion

Withdrawal of Amendment No. 91-337 does not preclude the FAA from issuing rulemaking on the subject in the future, nor does it commit the agency to any future course of action. The agency may also make any future necessary changes to the Code of Federal Regulations through a notice of proposed rulemaking with opportunity for public comment. Therefore, the FAA withdraws Amendment No. 91-337 published at 80 FR 15887, March 26, 2015.

Issued under authority provided by 49 U.S.C. 106(f), 44701(a), and 44703 in Washington, DC, on May 13, 2015.

Jodi S. McCarthy, Director, Airspace Services.
[FR Doc. 2015-12047 Filed 5-18-15; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 15 CFR Part 902 50 CFR Part 680 [Docket No. 130820737-5408-02] RIN 0648-BD61 Fisheries of the Exclusive Economic Zone Off Alaska; Bering Sea and Aleutian Islands Crab Rationalization Program; Amendment 45; Pacific Cod Sideboard Allocations in the Gulf of Alaska AGENCY:

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

ACTION:

Final rule.

SUMMARY:

NMFS publishes regulations to implement Amendment 45 to the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner Crabs (Crab FMP). Amendment 45 establishes, for a limited period of time, a process for NMFS to permanently remove Pacific cod catch limits, known as sideboard limits, which are applicable to certain hook-and-line catcher/processors in the Central and Western Gulf of Alaska (GOA) Regulatory Areas. This action authorizes NMFS to remove these Pacific cod sideboard limits in the Central and/or Western GOA if each eligible participant in the hook-and-line catcher/processor sector in a regulatory area signs and submits a request that NMFS remove the sideboard limit. Each eligible participant will be required to submit the request to NMFS within 1 year of the date of publication of this final rule. This action is necessary to provide participants in the Central and Western GOA hook-and-line catcher/processor sectors with an opportunity to cooperatively coordinate harvests of Pacific cod through private arrangement to the participants' mutual benefit, which would remove the need for sideboard limits in these regulatory areas. This action is intended to promote the goals and objectives of the Crab FMP, the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), and other applicable law.

DATES:

Effective June 18, 2015.

ADDRESSES:

Electronic copies of the following documents may be obtained from http://www.regulations.gov or from the NMFS Alaska Region Web site at http://alaskafisheries.noaa.gov:

• The Regulatory Impact Review/Initial Regulatory Flexibility Analysis (RIR/IRFA), and the Categorical Exclusion prepared for this action (collectively referred to as the “Analysis”);

• The Harvest Specifications Supplemental Information Report (SIR) prepared for the final 2015 and 2016 harvest specifications;

• The Final Environmental Assessment/Final RIR/IRFA for Amendment 83 to the Fishery Management Plan for Groundfish of the Gulf of Alaska (GOA FMP) Allocation of Pacific Cod Among Sectors in the Western and Central GOA; and

• The Alaska Groundfish Harvest Specifications Final Environmental Impact Statement (Harvest Specifications EIS).

Written comments regarding the burden-hour estimates or other aspects of the collection of information requirements contained in this final rule may be submitted by mail to NMFS, Alaska Region, P.O. Box 21668, Juneau, AK 99802-1668, Attn: Ellen Sebastian, Records Officer; in person at NMFS, Alaska Region, 709 West 9th Street, Room 420A, Juneau, AK; or by email to [email protected] or fax to 202-395-5806.

FOR FURTHER INFORMATION CONTACT:

Rachel Baker, 907-586-7228

SUPPLEMENTARY INFORMATION:

This final rule implements Amendment 45 to the Crab FMP. The king and Tanner crab fisheries in the exclusive economic zone (EEZ) of the Bering Sea and Aleutian Islands are managed under the Crab FMP. While the groundfish fisheries in the EEZ of the Gulf of Alaska are managed primarily under the Fishery Management Plan for Groundfish of the Gulf of Alaska (GOA FMP), some aspects of groundfish fishing in the Gulf of Alaska are managed under the Crab FMP.

NMFS published the Notice of Availability for Amendment 45 in the Federal Register on February 2, 2015 (80 FR 5499), with a 60-day comment period that ended April 3, 2015. The Secretary approved Amendment 45 on April 29, 2015, after accounting for information from the public, and determining that Amendment 45 is consistent with the Crab FMP, the Magnuson-Stevens Act, and other applicable law. NMFS published a proposed rule for Amendment 45 on February 12, 2015 (80 FR 7817). The 30-day comment period on the proposed rule ended March 16, 2015. NMFS received one comment letter during the comment periods on Amendment 45 and the proposed rule. A summary of the comment and NMFS' response is provided in the Comment and Response section of this preamble.

Background

A detailed review of the provisions of Amendment 45, the implementing regulations, and the rationale for these regulations is provided in the preamble to the proposed rule (79 FR 36702, June 30, 2014) and is not repeated here. The proposed rule is available from the NMFS Alaska Region Web site (see ADDRESSES).

This final rule establishes, for a limited period of time, a regulatory process for NMFS to permanently remove Pacific cod catch limits, known as sideboard limits, that are applicable to some participants in the Central GOA Regulatory Area (Central GOA) and Western GOA Regulatory Area (Western GOA) hook-and-line catcher/processor sectors. This final rule preamble provides a brief description of Pacific cod fishery management for the Central and Western GOA hook-and-line catcher/processor sectors and the management provisions that apply to Amendment 45 and this final rule.

Management of Pacific Cod in the Central and Western GOA

NMFS implements conservation and management measures, such as catch limits, to prevent overfishing while achieving the optimum yield in federally managed fisheries. Catch limits for GOA Pacific cod are established as part of the annual harvest specifications process for GOA groundfish. The North Pacific Fishery Management Council (Council) annually recommends, and NMFS specifies, an amount of catch at which overfishing is occurring (i.e., overfishing limit or OFL), an acceptable biological catch (ABC), and a total allowable catch (TAC) for each stock or stock complex (i.e., species or species group). Separate TACs are calculated using the apportionment of TAC for specific regulatory areas to limit catch and ensure that fisheries can be effectively managed. Specific to this final rule, the Council recommends, and NMFS implements an OFL and ABC for Pacific cod in the GOA, and separate TACs for the Eastern, Central, and Western GOA Pacific cod fisheries. NMFS apportions each TAC among various gear types (e.g., pot or trawl gear), operation types (e.g., catcher vessels and catcher/processors), and sectors (e.g., hook-and-line catcher/processors) as required by regulation (see regulations at § 680.20(a)). Similarly, the Council recommends and NMFS establishes sideboard limits as part of the harvest specifications process. Sideboard limits constrain harvests by specific vessels based on regulatory requirements established under various management programs. Sideboard limits are calculated as a portion of the TACs for some groundfish species and established in the annual harvest specifications. The resulting sideboard limits for Pacific cod, expressed in metric tons, are published in the annual GOA groundfish harvest specification notices (for the most recent example, see 80 FR 10250, February 25, 2015).

Under this final rule, the GOA Pacific cod OFL, ABC, TACs, and sector allocations will continue to be established through the annual GOA harvest specifications process. NMFS will continue to manage Pacific cod in the GOA by limiting harvests to the established TACs and sector allocations. Therefore, this final rule does not increase the likelihood that an OFL, ABC, TAC, or sector catch limit will be exceeded. See the preamble to the proposed rule and sections 1.5.2 and 3.2 of the Analysis for additional details.

NMFS also manages Pacific cod fisheries through the License Limitation Program (LLP). A vessel is required to be named on an LLP license before it can be deployed to directed fish (i.e., specifically target) for Pacific cod in Federal waters of the GOA. NMFS has issued a specific number of LLP licenses, which establish an upper limit on the total number of potential participants in GOA Pacific cod fisheries. LLP licenses must have the necessary endorsements to directed fish for Pacific cod in the GOA. Specific to this final rule, participants in the Central GOA and Western GOA hook-and-line catcher/processor sectors must have an LLP license with endorsements assigned for (1) Central GOA or Western GOA, (2) hook-and-line gear, (3) catcher/processor, and (4) Pacific cod.

GOA Pacific Cod Sideboard Limits Established Under the BSAI Crab Rationalization Program

The Bering Sea and Aleutian Islands (BSAI) Crab Rationalization Program (CR Program) was implemented in 2005 and established a catch share program that allocates BSAI crab resources among harvesters, processors, and coastal communities. As part of the CR Program, eligible vessel owners and vessel captains were allocated quota share (QS) in several valuable crab fisheries, including the Bering Sea snow crab (Chionoecetes opilio) fishery. The CR Program provides increased flexibility for crab fishermen to choose when and where to fish or whether to lease their crab QS and fish for species other than crab. The Council and NMFS recognized that the benefits of the CR Program could create incentives for recipients of snow crab QS to increase their level of participation in groundfish fisheries, especially Pacific cod fisheries in the Central and Western GOA. Therefore, Federal regulations implementing the CR Program established CR Program GOA sideboards to limit the potential adverse effects of the CR Program on GOA groundfish fisheries. These sideboards prevent CR Program participants from preempting fishermen in the GOA that did not receive benefits from the CR Program.

During a fishing year, NMFS manages CR Program GOA Pacific cod sideboard limits by tracking all catch of vessels subject to a sideboard limit to make sure the sideboard limits are not exceeded. NMFS will prohibit directed fishing for GOA Pacific cod in a specific regulatory area by vessels subject to the CR Program GOA Pacific cod sideboard limit through the annual harvest specifications if NMFS determines at the start of the fishing year that the CR Program GOA Pacific cod sideboard limit is insufficient to support a directed fishery by those vessels (see regulations at § 680.22(e)(2) and (3)).

The preamble to the proposed rule and section 1.6 of the Analysis describe that some of the vessels and LLP licenses active in the hook-and-line catcher/processor sector are subject to CR Program GOA Pacific cod sideboard limits. The hook-and-line catcher/processor sector operating in the EEZ off Alaska currently consists of 36 vessels. NMFS has determined that eight of these 36 vessels are subject to the CR Program GOA Pacific cod sideboard limits. The Federal Fisheries Permit (FFP) issued by NMFS to each of these eight vessels includes a designation indicating that the vessel is subject to the CR Program GOA Pacific cod sideboard limits. Of the LLP licenses that authorize a vessel to participate in the Central and/or Western GOA Pacific cod hook-and-line catcher/processor sector, NMFS has determined that five LLP licenses are subject to the CR Program GOA Pacific cod sideboard limits. These five LLP licenses include a designation indicating that the license is subject to the CR Program GOA Pacific cod sideboard limits.

Allocations of Pacific Cod in the GOA

CR Program GOA Pacific cod sideboard limits constrain the harvest of GOA Pacific cod by vessels and holders of license limitation program (LLP) licenses that were used to harvest specific amounts of Pacific cod in the GOA and snow crab in the Bering Sea and Aleutian Islands Management Area. Originally, the CR Program GOA Pacific cod sideboard limits for the Eastern, Central, and Western GOA were calculated using the Pacific cod TACs for each area. With the implementation of Amendment 83 to the Fishery Management Plan for Gulf of Alaska Groundfish in 2012, the CR Program GOA Pacific cod sideboard limits in the Central and Western GOA are calculated using the apportionment of Pacific cod TAC established for specific gear types (e.g., hook-and-line gear, pot gear) and by operation type (i.e., catcher/processor vessels, catcher vessels). CR Program GOA Pacific cod sideboard limits in the Central and Western GOA for vessels using hook-and-line gear and operating as catcher/processors (the hook-and-line catcher/processor sector) are now much smaller than they were prior to Amendment 83. As a result, NMFS prohibits directed fishing for Pacific cod in the Central and Western GOA by participants in the hook-and-line catcher/processor sector who are subject to CR Program GOA Pacific cod sideboard limits so that these small sideboard limits are not exceeded. The proposed rule preamble describes that Amendment 83 did not change Pacific cod management in the Eastern GOA because the same level of competition, or race for fish, did not exist in the Eastern GOA compared to the Central and Western GOA. As a result, the CR Program GOA Pacific cod sideboard limits in the Eastern GOA were not recalculated for gear and operation type.

The Effect of Pacific Cod Sideboard Limits on Hook-and-Line Catcher/Processors in the Central and Western GOA

The CR Program GOA Pacific cod sideboard limits affected the eight vessels and the five LLP licenses subject to the sideboard limits differently starting in 2012 under Amendment 83 than under management provisions when the CR Program was first implemented in 2006 through 2011. Since the implementation of Amendment 83, NMFS has prohibited directed fishing by participants subject to CR Program GOA Pacific cod sideboard limits in the hook-and-line catcher/processor sector in the Central and Western GOA. NMFS has made this determination each year based on the small amount of the sideboard limits, the need to account for incidental catch of Pacific cod by sideboarded hook-and-line catcher/processors in other groundfish fisheries in the Central and Western GOA, and the potential catch rates of Pacific cod by sideboarded hook-and-line catcher/processors relative to the sideboard limits. The proposed rule preamble and sections 1.5 and 1.6 of the Analysis provide additional detail on the impacts of Amendment 83 on participants in the Central and Western GOA hook-and-line catcher/processor sectors who are subject to CR Program GOA Pacific cod sideboard limits.

Implementation of This Action

This final rule is necessary to provide participants in the Central and Western GOA hook-and-line catcher/processor sectors with an opportunity to cooperatively coordinate harvests of Pacific cod through private arrangement to the participants' mutual benefit, which would remove the need for current regulations that impose sideboard harvest restrictions on some participants in the sectors. This final rule establishes regulatory conditions that must be met prior to the removal of CR Program GOA Pacific cod sideboard limits for the hook-and-line catcher/processor sectors in the Central and/or Western GOA. NMFS will remove the sideboard limits if each person holding an LLP license or LLP licenses with endorsements that authorize directed fishing for Pacific cod as a hook-and-line catcher/processor in the Central or Western GOA (i.e., eligible participants) provides NMFS with a signed form requesting that NMFS remove the Pacific cod sideboard limit for that regulatory area.

Under this final rule, NMFS will not remove the Pacific cod sideboard limit for the Central or Western GOA unless each eligible participant in the Central or Western GOA submits to NMFS a completed Request to Extinguish Pacific Cod Sideboard Limit in the Central or Western GOA. As described in the preamble to the proposed rule, the holders of LLP licenses with the necessary endorsements, rather than vessels owners, represent the universe of eligible fishery participants in the Central and Western GOA hook-and-line catcher/processor sectors. This final rule adds Table 10 to Part 680 to identify the 23 LLP licenses with endorsements that authorize a vessel to catch and process Pacific cod at-sea using hook-and-line gear in the Central GOA, and the 18 LLP licenses with endorsements that authorize a vessel to catch and process Pacific cod at-sea using hook-and-line gear in the Western GOA. The holders of the LLP licenses listed in Table 10 to Part 680 comprise the universe of participants eligible to request removal of a GOA Pacific cod sideboard limit. Each holder of an LLP license with Central GOA endorsements listed in Table 10 to Part 680 will be required to complete and submit to NMFS the form requesting removal of the CR Program GOA Pacific cod sideboard limit in the Central GOA. Similarly, each holder of an LLP license with Western GOA endorsements listed in Table 10 to Part 680 will be required to complete and submit to NMFS the form requesting removal of the CR Program GOA sideboard limit in the Western GOA.

This final rule modifies regulations at 50 CFR 680.22(e) that require NMFS to establish Pacific cod sideboard limits for hook-and-line catcher/processors during the annual harvest specification process. Under this final rule, NMFS will not establish these sideboard limits for the Central or Western GOA if all participants eligible to use a hook-and-line catcher/processor to fish for Pacific cod in the regulatory area sign and submit to NMFS a request that NMFS remove the sideboard limit for that regulatory area.

Each eligible participant will be required to submit that request to NMFS on or before May 18, 2016. Each eligible participant in the Central and/or Western GOA must sign an affidavit, included on a form, to request that NMFS no longer establish Pacific cod sideboard limits for the hook-and-line catcher/processor sector in the Central and/or Western GOA. If NMFS receives the required affidavits during the 1-year period, NMFS will announce the permanent removal of the Central and/or Western GOA sideboard limits during the annual GOA groundfish specification process and will no longer establish Pacific cod sideboard limits for the hook-and-line catcher/processor sector in the Central and/or Western GOA. If NMFS does not receive the required affidavits on or before May 18, 2016, NMFS will continue to establish GOA Pacific cod sideboard limits for the hook-and-line catcher/processor sectors through the annual GOA groundfish specification process and the opportunity to remove them will expire.

Although this final rule is intended to provide an opportunity for coordination and cooperation among all eligible participants in both the Central and Western GOA, this final rule allows the eligible participants to submit requests for each regulatory area separately. Therefore, a CR Program GOA Pacific cod sideboard limit could be removed for one regulatory area without requiring all eligible participants in both areas to agree.

This final rule adds regulations at § 680.22(e)(1)(ii) to clarify that NMFS will not establish CR Program GOA Pacific cod sideboard limits for the hook-and-line catcher/processor sector in a regulatory area through the annual harvest specification process if NMFS receives completed request forms from all eligible participants in a regulatory area by the deadline. CR Program GOA Pacific cod sideboard limits are currently implemented through the annual harvest specification process; therefore, CR program GOA Pacific cod sideboard limits could not be removed immediately upon receipt by NMFS of the required forms. NMFS will remove a CR Program GOA Pacific cod sideboard limit for the hook-and-line catcher/processor sector during the next annual harvest specification cycle for GOA groundfish.

This final rule does not require eligible participants to enter into a private contractual agreement to coordinate fishing practices within that regulatory area prior to submitting to NMFS the required forms requesting removal of a CR Program GOA Pacific cod sideboard limit. If the holders of the LLP licenses listed in Table 10 to Part 680 are unable, or unwilling, to agree to request that NMFS remove a CR Program GOA Pacific cod sideboard limit in a regulatory area within the time provided, the sideboard limit for that regulatory area will continue to apply. Maintaining the CR Program GOA Pacific cod sideboard limits—if unanimous agreement for their removal is not reached by the eligible participants—is consistent with the objectives of sideboard management as established by the CR Program and the sideboard limit calculation method established under regulations implementing Amendment 83. Removing sideboard limits without unanimous agreement of all of the eligible participants could indicate that eligible participants have not agreed to coordinate harvests. This could increase the likelihood of a race for fish and could allow those who received QS under the CR Program to expand their efforts in the GOA Pacific cod fisheries. Such a result would not be consistent with the goals of the CR Program or the Council's objectives for this action.

This final rule does not modify the CR Program GOA Pacific cod sideboard limits for hook-and-line catcher/processors in the Eastern GOA. As explained in the preamble to the proposed rule, this action does not remove the sideboard designations on the FFPs for the eight sideboarded vessels or the five sideboarded LLP licenses, and these vessels and LLP licenses will still be subject to a CR Program Pacific cod sideboard limit if they are used in the Eastern GOA.

Changes From the Proposed Rule

NMFS made no changes from the proposed to final rule.

OMB Revisions to Paperwork Reduction Act References in 15 CFR 902.1(b)

Section 3507(c)(B)(i) of the PRA requires that agencies inventory and display a current control number assigned by the Director, OMB, for each agency information collection. Section 902.1(b) identifies the location of NOAA regulations for which OMB approval numbers have been issued. Because this final rule revises and adds data elements within a collection-of-information for recordkeeping and reporting requirements, 15 CFR 902.1(b) is revised to reference correctly the sections resulting from this final rule.

Comment and Response

During the public comment periods for the Notice of Availability for Amendment 45 and the proposed rule to implement Amendment 45, NMFS received one comment letter that did not support Amendment 45 and the proposed rule. A summary of the comment received and NMFS' response follows.

Comment: Amendment 45 is not consistent with National Standard 1 of the Magnuson-Stevens Act because it does not prevent overfishing while achieving the optimum yield of fish stocks. Under Amendment 45, industry participants would utilize self-regulation and private contractual agreements to limit GOA Pacific cod harvests if all operations consent to eliminating GOA Pacific cod sideboard limits. This self-regulation would lead to overfishing because industry participants do not have sufficient biological information to establish sustainable catch limits. Furthermore, individual fishing operations have a significant economic incentive to agree to eliminate the Pacific cod sideboard catch limits and then engage in overfishing in order to increase fishing revenue.

Response: NMFS has determined that Amendment 45 and this final rule are consistent with the Magnuson-Stevens Act, the Crab FMP, and other applicable law. Under Amendment 45 and this final rule, the Council and NMFS will continue to manage the Pacific cod fisheries in the GOA to prevent overfishing while achieving, on a continuing basis, the optimum yield from each fishery, consistent with National Standard 1 of the Magnuson-Stevens Act and the GOA FMP. Section 3.2.1 of the GOA FMP defines the OFL as the level above which overfishing is occurring for a species or species group. NMFS manages fisheries in an effort to ensure that no OFLs are exceeded in any year. Section 3.2.4.3 of the GOA FMP clarifies that if catch is approaching an OFL, NMFS will prevent overfishing by closing specific fisheries identified by gear and area that incur the greatest catch. Closures expand to other fisheries if the rate of take is not sufficiently slowed. Regulations at § 679.20(d)(1), (d)(2), and (d)(3) define the process NMFS uses to limit or prohibit fishing to prevent overfishing and maintain total catch at or below the OFL.

Amendment 45 and this final rule establish a process for NMFS to remove GOA Pacific cod sideboard limits. The GOA Pacific cod sideboard limits are an additional level of harvest limits within the GOA Pacific cod sector allocations. Removal of sideboard limits does not mean the GOA Pacific cod fisheries will not have a harvest limit. The proposed rule preamble and sections 1.5.2 and 3.2 of the Analysis describe that Pacific cod OFLs, ABCs, TACs, and sector allocations will continue to be established through the annual GOA harvest specifications process. Amendment 45 and this final rule do not change or otherwise supersede that process. NMFS will continue to manage Pacific cod in the GOA by limiting harvests to the established TACs and sector allocations as specified in regulations at § 679.20. Therefore, this final rule does not increase the likelihood that an OFL, ABC, TAC, or sector catch limit will be exceeded. A detailed description of the annual harvest specification process is provided in the Harvest Specifications SIR prepared for the final 2015 and 2016 harvest specifications and the Alaska Groundfish Harvest Specifications EIS (see ADDRESSES).

The Council determined, and NMFS agrees, that Amendment 45 and this final rule are necessary to provide participants in the Central and Western GOA hook-and-line catcher/processor sectors with an opportunity to cooperatively coordinate harvests of Pacific cod through private arrangement to the participants' mutual benefit, which would remove the need for sideboard limits in these regulatory areas. The preamble to the proposed rule (79 FR 36702, June 30, 2014) and section 1.4 of the Analysis describe that Amendment 45 and this final rule are intended to balance the Council's competing objectives: (1) To relieve the CR Program GOA Pacific cod sideboard limits for some vessels and LLP licenses that benefitted from allocations under the CR program, and (2) to protect the GOA-only participants from adverse impacts that may result from removal of those sideboard limits.

Classification

The Administrator, Alaska Region, NMFS, determined that Amendment 45 to the Crab FMP is necessary for the conservation and management of the GOA groundfish fishery and that it is consistent with the Crab FMP, GOA FMP, the Magnuson-Stevens Act, and other applicable laws.

Small Entity Compliance Guide

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a final regulatory flexibility analysis (FRFA), the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. The preamble to the proposed rule and this final rule serve as the small entity compliance guide. This action does not require any additional compliance from small entities that is not described in the preambles. Copies of this final rule are available from NMFS at the following Web site: http://alaskafisheries.noaa.gov.

Executive Order 12866

This rule has been determined to be not significant for purposes of Executive Order 12866.

Final Regulatory Flexibility Analysis

Section 604 of the Regulatory Flexibility Act (RFA) requires that, when an agency promulgates a final rule under section 553 of Title 5 of the U.S. Code, after being required by that section, or any other law, to publish a general notice of proposed rulemaking, the agency shall prepare a final regulatory flexibility analysis.

Section 604 describes the contents of a FRFA: (1) A statement of the need for, and objectives of, the rule; (2) a statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments; (3) the response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments; (4) a description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available; (5) a description of the projected reporting, recordkeeping and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and (6) a description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.

The “universe” of entities to be considered in a FRFA generally includes only those small entities that can reasonably be expected to be directly regulated by the final rule. If the effects of the rule fall primarily on a distinct segment of the industry, or portion thereof (e.g., user group, gear type, geographic area), that segment would be considered the universe for purposes of this analysis.

The Small Business Administration (SBA) has established size standards for all major industry sectors in the U.S., including commercial finfish harvesters (NAICS code 114111), commercial shellfish harvesters (NAICS code 114112), other commercial marine harvesters (NAICS code 114119), for-hire businesses (NAICS code 487210), marinas (NAICS code 713930), seafood dealers/wholesalers (NAICS code 424460), and seafood processors (NAICS code 311710). A business primarily involved in finfish harvesting is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual gross receipts not in excess of $20.5 million, for all its affiliated operations worldwide. For commercial shellfish harvesters, the same qualifiers apply, except the combined annual gross receipts threshold is $5.5 million. For other commercial marine harvesters, for-hire fishing businesses, and marinas, the same qualifiers apply, except the combined annual gross receipts threshold is $7.5 million.

A business primarily involved in seafood processing is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual employment, counting all individuals employed on a full-time, part-time, or other basis, not in excess of 500 employees for all its affiliated operations worldwide. For seafood dealers/wholesalers, the same qualifiers apply, except the employment threshold is 100 employees. In determining a concern's number of employees, SBA counts all individuals employed on a full-time, part-time, or other basis. This includes employees obtained from a temporary employee agency, professional employee organization or leasing concern. SBA will consider the totality of the circumstances, including criteria used by the Internal Revenue Service (IRS) for Federal income tax purposes, in determining whether individuals are employees of a concern. Volunteers (i.e., individuals who receive no compensation, including no in-kind compensation, for work performed) are not considered employees. Where the size standard is number of employees, the method for determining a concern's size includes the following principles: (1) The average number of employees of the concern used (including the employees of its domestic and foreign affiliates) based upon numbers of employees for each of the pay periods for the preceding completed 12 calendar months; (2) part-time and temporary employees are counted the same as full-time employees.

Need for and Objectives of This Action

A statement of the need for, and objectives of, the rule is contained in the preamble to this final rule and is not repeated here.

Summary of Significant Issues Raised During Public Comment

NMFS published a proposed rule on February 12, 2015 (80 FR 7817). An initial regulatory flexibility analysis (IRFA) was prepared and summarized in the “Classification” section of the preamble to the proposed rule. The comment period closed on March 16, 2015. NMFS received one letter of public comment on the proposed rule. This comment letter did not address the IRFA or the economic impacts of the rule generally. The Chief Counsel for Advocacy of the SBA did not file any comments on the proposed rule.

Number and Description of Small Entities Regulated by This Action

This action would directly regulate eight entities. These eight entities include the owners of the eight vessels, and the holders of the five LLP licenses currently subject to CR Program GOA Pacific cod sideboard limits in the Central and Western GOA hook-and-line catcher/processor sectors. The owners of the eight vessels and holders of the five LLP licenses directly regulated by this action are affiliated through their membership in the Freezer Longline Conservation Cooperative (FLCC). The FLCC represents LLP holders and the owners and operators of vessels that participate in the Pacific cod hook-and-line catcher/processor sector in the Federal waters of the BSAI. The FLCC is comprised of businesses that are engaged in the harvesting and processing of finfish. The annual revenue of members of the FLCC has exceeded $130 million per year since its formation, and $172 million in 2012, the most recent year of available revenue data (see Table 1-14 in Section 1.6 of the Analysis for additional detail). Members of the FLCC are not considered small entities because the annual revenue of the cooperative exceeds the size standards for small entities.

Three entities hold LLP licenses and own vessels that operate only in the GOA as hook-and-line catcher/processors. These three entities are not directly regulated by the CR Program GOA Pacific cod sideboard limits, and are not members of the FLCC. One entity owns a vessel named on an LLP license with Central GOA Pacific cod hook-and-line catcher/processor endorsements; the other two entities each own a vessel named on LLP licenses with Western GOA Pacific cod hook-and-line catcher/processor endorsements. These three entities are not directly regulated by this action because this action would not impose regulations on these vessels or the associated LLP licenses, or relieve them from regulation. These three entities may voluntarily choose to submit a request for removal of the sideboard limits under this action, but are not required to do so.

Reporting, Recordkeeping, and Other Compliance Requirements

The reporting, recordkeeping, and other compliance requirements will increase slightly under the action if eligible participants in the Central or Western GOA agree to submit an affidavit to NMFS requesting removal of the CR Program GOA sideboard limits. The reporting, recordkeeping, and other compliance requirements will not change under the action if eligible participants in the Central or Western GOA do not submit an affidavit to NMFS requesting removal of the CR Program GOA sideboard limits.

Description of Significant Alternatives That Minimize Adverse Impacts on Small Entities

A FRFA also requires a description of the steps the agency has taken to minimize the significant impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative (Alternative 2 as modified by Option 1, described below) adopted in the final rule and why each of the other significant alternatives to the rule considered by the agency that affect the economic impact on small entities was rejected. The suite of potential actions includes two alternatives, one associated option, and one associated suboption. A detailed description of these alternatives and options is provided in section 1.6 of the Analysis prepared for this action.

The Council considered two alternatives for this action. Alternative 1 is the status quo, which does not meet the objectives of the action. Alternative 2 would remove the CR Program GOA Pacific cod sideboard limits in either the Central GOA, Western GOA, or both regulatory areas. As part of Alternative 2, the Council and NMFS also considered an option and a suboption for removing the CR Program GOA Pacific cod sideboard limits. The option (i.e., this action) removes the CR Program GOA Pacific cod sideboard limits for the hook-and-line catcher/processor sector permanently if certain conditions are met by a specified date. The sub-option would have suspended the CR Program GOA Pacific cod sideboard limits for the hook-and-line catcher/processor sector on an annual basis if certain conditions are met annually.

The option requires all hook-and-line catcher/processor LLP license holders that are authorized to target Pacific cod in the Central or Western GOA (i.e., eligible participants) to submit a form to NMFS requesting the permanent removal of the GOA Pacific cod sideboard limit in that regulatory area on a one-time basis. The option also requires the request to be submitted within one year of the date of publication in the Federal Register of the final rule implementing Amendment 45, if approved by the Secretary.

The sub-option would have required all eligible participants to annually submit a form to NMFS requesting removal of the GOA Pacific cod sideboard limit in that regulatory area for the upcoming fishing year. Under the sub-option, if the annual form is not received by NFMS, the sideboard limits would not be removed for the following fishing year (i.e., January 1 through December 31).

This action implements Alternative 2 with the option to permanently remove the CR Program GOA sideboard limits if each eligible participant in a regulatory area submits to NMFS a form requesting removal and provides that form to NMFS within the required timeline. The Council rejected the sub-option because the annual suspension of sideboards could create uncertainty for participants, result in additional administrative burden and costs, and potentially create management instability. Although this action does not directly regulate small entities, the preferred alternative is the only alternative in the suite of options and alternatives considered that reduces the burden on directly regulated entities and best meets the purpose and need for this action.

Collection-of-Information Requirements

This rule contains a collection-of-information requirement subject to the Paperwork Reduction Act (PRA) and which has been approved by Office of Management and Budget (OMB) under control number 0648-0334. Public reporting burden for the Request to Extinguish Pacific Cod Sideboard Limits for Hook-and-Line Catcher/Processors in the Western or Central GOA is estimated to average 30 minutes per individual response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments on this burden estimate or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES), and by email to [email protected], or fax to 202-395-5806.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number. All currently approved NOAA collections of information may be viewed at: http://www.cio.noaa.gov/services_programs/prasubs.html.

List of Subjects 15 CFR Part 902

Reporting and recordkeeping requirements.

50 CFR Part 680

Alaska, Fisheries, Reporting and recordkeeping requirements.

Dated: May 11, 2015. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

For the reasons set out in the preamble, NMFS amends 15 CFR part 902 and 50 CFR part 680 as follows:

Title 15—Commerce and Foreign Trade PART 902—NOAA INFORMATION COLLECTION REQUIREMENTS UNDER THE PAPERWORK REDUCTION ACT: OMB CONTROL NUMBERS 1. The authority citation for part 902 continues to read as follows: Authority:

44 U.S.C. 3501 et seq.

2. In § 902.1, in the table in paragraph (b), under the entry “50 CFR”,add an entry in alphanumeric order for “680.22” to read as follows:
§ 902.1 OMB control numbers assigned pursuant to the Paperwork Reduction Act.

(b) * * *

CFR part or section where the information
  • collection requirement is located
  • Current OMB Control No.
  • (all numbers begin with 0648-)
  • *    *    *    *    * 50 CFR: *    *    *    *    * 680.22 -0334 *    *    *    *    *
    Title 50—Wildlife and Fisheries PART 680—SHELLFISH FISHERIES OF THE EXCLUSIVE ECONOMIC ZONE OFF ALASKA 3. The authority citation for part 680 continues to read as follows: Authority:

    16 U.S.C. 1862; Pub. L. 109-241; Pub. L. 109-479.

    4. In § 680.22, revise paragraph (e) heading and introductory text, and paragraph (e)(1) to read as follows:
    § 680.22 Sideboard protections for GOA groundfish fisheries.

    (e) Conversion of sideboard ratios into annual sideboard harvest limits. NMFS will convert sideboard ratios into annual sideboard harvest limits according to the following procedures.

    (1) Annual sideboard harvest limits. (i) Except as provided in paragraph (e)(1)(ii) of this section, annual sideboard harvest limits for each groundfish species, except fixed-gear sablefish, will be established by multiplying the sideboard ratios calculated under paragraph (d) of this section by the proposed and final TACs in each area for which a TAC is specified. If a TAC is further apportioned by season, the sideboard harvest limit also will be apportioned by season in the same ratio as the overall TAC. The resulting harvest limits expressed in metric tons will be published in the annual GOA groundfish harvest specification notices.

    (ii) NMFS will not establish an annual sideboard harvest limit for Pacific cod for vessels that catch and process Pacific cod using hook-and-line gear in the Central GOA Regulatory Area if all eligible participants request that the sideboard harvest limit be removed in accordance with the requirements of paragraph (e)(1)(ii)(A) of this section. NMFS will not establish an annual sideboard harvest limit for Pacific cod for vessels that catch and process Pacific cod using hook-and-line gear in the Western GOA Regulatory Area if all eligible participants request that the sideboard harvest limit be removed in accordance with the requirements of paragraph (e)(1)(ii)(B) of this section. NMFS will publish notification of the removal of the sideboard harvest limit for Pacific cod for vessels that catch and process Pacific cod using hook-and-line gear in the Central GOA Regulatory Area or the Western GOA Regulatory Area through the annual GOA groundfish harvest specifications (see § 679.20(c)(1)(iii) and (c)(3)(ii)).

    (A) Central GOA. For the Central GOA Regulatory Area (Statistical Areas 620 and 630; see Figure 3 to 50 CFR part 679), the holders of all LLP licenses listed in Column A of Table 10 to this part must submit to NMFS a completed Request to Extinguish Pacific Cod Sideboard Limits for Hook-and-Line Catcher/Processors in the Western or Central GOA, and the request must be received by NMFS on or before May 18, 2016.

    (B) Western GOA. For the Western GOA Regulatory Area (Statistical Area 610; see Figure 3 to 50 CFR part 679), the holders of all LLP licenses listed in Column B of Table 10 to this part must submit to NMFS a completed Request to Extinguish Pacific Cod Sideboard Limits for Hook-and-Line Catcher/Processors in the Western or Central GOA, and the request must be received by NMFS on or before May 18, 2016.

    5. Add Table 10 to part 680 to read as follows: Table 10 to Part 680—License Limitation Program License Numbers That Authorize the Owners and Operators of Catcher/Processors to Directed Fish for Pacific Cod With Hook-and-Line Gear in the Central Gulf of Alaska Regulatory Area (Column A) and in the Western Gulf of Alaska Regulatory Area (Column B) Column A: Column B: LLG1125 LLG1400. LLG1128 LLG1401. LLG1400 LLG1576. LLG1576 LLG1578. LLG1713 LLG1785. LLG1785 LLG1916. LLG1916 LLG1917. LLG1917 LLG2026. LLG1989 LLG2081. LLG2081 LLG2112. LLG2112 LLG2892. LLG2238 LLG2935. LLG2705 LLG3090. LLG2783 LLG3602. LLG2892 LLG3617. LLG2958 LLG3676. LLG3609 LLG4004. LLG3616 LLG4823. LLG3617. LLG3676. LLG3681. LLG3973. LLG4823.
    [FR Doc. 2015-12066 Filed 5-18-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF DEFENSE Department of the Army 32 CFR Part 635 RIN 0702-AA62 [Docket No. USA-2010-0020] Law Enforcement Reporting AGENCY:

    Department of the Army, DoD.

    ACTION:

    Interim rule; request for comments.

    SUMMARY:

    The Department of the Army amends its regulation concerning law enforcement reporting for a number of statutory requirements to better coordinate law enforcement work and personnel both within the Department of the Army, across DoD, and with other Federal, State, and local law enforcement officials. It meets law enforcement reporting requirements for selected criminal and national security incidents and provides law enforcement agencies, such as the Department of Homeland Security and Transportation Security Administration, with the most current information available. It also provides the Army chain of command with timely criminal information to respond to queries from the Department of Defense, the news media, and others. The rule establishes policies and procedures for offense and serious-incident reporting with the Army; for reporting to the Department of Defense and the Department of Justice, as appropriate; and for participating in the Federal Bureau of Investigation's National Crime Information Center, the Department of Justice's Criminal Justice Information System, the National Law Enforcement Telecommunications System, and State criminal justice systems. It also updates various reporting requirements described in various Federal statutes.

    DATES:

    Effective May 22, 2015. Consideration will be given to all comments received by: July 20, 2015.

    ADDRESSES:

    You may submit comments, identified by 32 CFR part 635, Docket No. USA-2010-0020 and or RIN 0702-AA62, by any of the following methods:

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

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.

    Instructions: All submissions received must include the agency name and docket number or Regulatory Information Number (RIN) for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Katherine Brennan, (703) 692-6721.

    SUPPLEMENTARY INFORMATION: Justification for Interim Final Rule

    Publication of this rule as interim is necessary to maintain national security, ensure the safety and wellbeing of the Soldiers, and/or to avoid legal action against the DOD. While DOD and the Army have implemented many of these requirements through official messages and memorandum, they are not yet published in the internal Army Regulation until this rule becomes final.

    For example, until this rule is published:

    • Army law enforcement does not have a regulation directing them to report Suspicious activity to the FBI's threat reporting system, eGuardian.

    • Sexual assaults are not properly reported using the 2012 National Defense Authorization Act Sexual Assault definition.

    • Offense codes used by Army law enforcement to describe the complaint or offense as used in reports to congress are not adequately updated.

    • Changes to the restricted sexual assault evidence kits retention schedule from one year to 5 years per the most recent version of the NDAA is causing confusion regarding proper procedures which could result in inconsistency in retaining sexual assault evidence.

    In addition, the rule adds the requirement to report positive drug urinalysis tests to the National Instant Checks System (NICS) under the authority of the Brady Handgun Violence Prevention Act of 1993 as amended (18 U.S.C. 922). While the United States Army Criminal Records Center is currently providing these reports to NICS, it may be happening inconsistently.

    The Lautenberg Amendment to the Gun Control Act of 1968, requires commanders and family advocacy programs report all domestic violence incidents to the local Installation Provost Marshal Office/Directorate of Emergency Services (PMO/DES). This rule provides guidance to Army Commanders on reporting domestic violence to the PMO/DES in accordance with the Lautenberg Amendment. Without this rule in place, it is possible for a soldier who is prohibited from carrying a weapon due to a qualifying conviction not being properly identified and continuing in assignments and missions which are prohibited.

    The rule ensures crime victims and witness are notified about their rights according to the Victim Rights and Restitution Act (42 U.S.C. 10601) and Victim and Witness Protection Act (Sections 1512-1514 of Title 18, U.S.C.). The Army currently must advise the victim or witness of their rights using the Department of Defense Form 2701 (Initial Information for Victims and Witnesses of Crime) in accordance with Army Regulation (AR) 190-45. This rule requires victim witness notifications to be reported on the Department of the Army Form 3975 which feeds into the Army's law enforcement records management system, Centralized Operations Police Suite (COPS). This provides the Army an ability to query the number of victim witness notifications for congressional inquiries.

    The rule adds the requirement to input Army crime data into the Defense Incident-Based Reporting System (DIBRS) to comply with the Uniform Federal Crime Reporting Act, Section 534 note of title 28, U.S.C.

    The rule adds registration of sex offenders on Army installation to effectuate federal and state registration requirements including the Sex Offender Registration and Notification Act (SORNA), 42 U.S.C. 16901 et seq,. This ensures all registered sex offenders who reside or are employed on an Army installation register with the installation PMO or DES. This allows the Army to track or monitor sex offender registration compliance on Army installations which impacts the safety of all personnel residing on Army installations.

    The rule ensures compliance with the requirement from the Protecting the Force: Lessons from Ft. Hood, report of the DoD Independent Review, January 2010, which requires reporting of Suspicious Activity to the FBI's eGuardian.

    I. Purpose of the Regulatory Action

    a. The publication of this rule will ensure the Army is in compliance with multiple Department of Defense and Federal requirements.

    This regulatory action will add policy pertaining to the collection of fingerprints and DNA from individuals suspected of certain offenses through the Department of the Defense Instruction 5505.14, Deoxyribonucleic Acid (DNA) collection requirements for criminal investigations, found at: http://www.dtic.mil/whs/directives/corres/pdf/550514p.pdf and Department of Defense Instruction 5505.11, Fingerprint Card and Final Disposition Report Submission Requirements, found at: http://www.dtic.mil/whs/directives/corres/pdf/550511p.pdf.

    This rule adds policy on sex offenders on Army Installations and thus ensures the safety of our Soldiers, family members, and civilians that live and work on Army installation through identifying, monitoring and tracking sex offenders on Army installations.

    This rule includes policy pertaining to the release of Military Police (MP) records by adding reporting requirement of domestic incidents to the Army Family Advocacy Program. This rule authorizes the limited use of the Federal Bureau of Investigations (FBI), National Crime Information Center (NCIC) pursuant to FBI regulations and policy to conduct checks of visitors to an installation.

    The rule implements the reporting requirements of DODD 7730.47, Defense Incident-Based Reporting System (DIBRS), found at http://www.dtic.mil/whs/directives/corres/pdf/773047p.pdf, by mandating the use of the Centralized Operations Police Suite (COPS) Military Police Reporting System. This implements reporting requirements of Section 534 of Title 28, United States Code (also known as “The Uniform Federal Crime Reporting Act of 1988”), the victim and witness assistance notifications of Sections 10607 10608 of Title 42 (also known as “The Victims' Rights and Restitution Act of 1990”), Section 922 of Title 18, United States Code (also known as “The Brady Handgun Violence Prevention Act and The Lautenberg Amendment to the Gun Control Act”), Sections 16901 through 16928 of Title 42, United States Code (Sex Offender Registration and Notification Act (SORNA)), Section 1701, NDAA FY 14, DoDD 1030.01, DoDI 1030.2. and Public Law 107-188, “Public Health Security and Bioterrorism Preparedness and Response Act of 2002,” June 12, 2002.

    The rule implements the sex offender registration requirements of DODI 1325.07, Administration of Military Correctional Facilities and Clemency and Parole Authority, found at http://dtic.mil/whs/directives/corres/pdf/132507p.pdf. The rule's registration requirements allow the Provost Marshal or Director of Emergency Services to provide all military sex offenders with the “State registration” document(s) and direct Soldiers to the local or State law enforcement agency, which will register them based on their physical residence address. If a MOU/MOA exists with the local or State law enforcement agency, they will notify the installation. Installation PMs and DESs in the United States will provide written notice of the conviction or transfer to the offender's gaining unit commander, the State's chief LE officer, the chief LE officer of the local jurisdiction in which the accused will reside, the State or local agency responsible for the receipt or maintenance of a sex offender registration where the person will reside, and upon request, governmental officials of foreign countries. Installation PM and DES notifications to State and local officials are described in DODI 1325.07, Administration of Military Correctional Facilities and Clemency and Parole Authority, found at http://dtic.mil/whs/directives/corres/pdf/132507p.pdf.

    The rule implements the victim/witness requirements contained in DODI 1030.2, Victim and Witness Assistance Procedures, found at http://dtic.mil/whs/directives/corres/pdf/103002p.pdf, which implements Sections 1512-1514 of Title 18, United States Code and Sections 113 (note), 1058, 1059 and 1408 of Title 10, United States Code by providing guidance on assisting victims and witnesses of crime from initial contact through investigation, prosecution, and confinement.

    The Army will use eGuardian to report, share and analyze unclassified suspicious activity information regarding potential threats or suspicious activities affecting DOD personnel, facilities, or forces in transit in both CONUS and OCONUS. eGuardian is the Federal Bureau of Investigation's (FBI) sensitive-but-unclassified web-based platform for reporting, and in some instances, sharing, suspicious activity and threat related information with other federal, state, tribal, and territorial law enforcement and force protection entities. Information entered into eGuardian by the Army may be either shared with all eGuardian participants or reported directly to the FBI. All information entered into eGuardian by the Army will comply with the policy framework for the system and any existing agency agreements, which incorporate privacy protections.

    Analysis of Suspicious Activity Reporting (SARs) will assist Criminal Intelligence analysts and commanders in mitigating potential threats and vulnerabilities, and developing annual threat assessments.

    b. The Department is issuing this interim final rule pursuant to its authority under 28 U.S.C. 534, Acquisition, preservation, and exchange of identification records and information, 42 U.S.C. 10607, Services to Victims, 18 U.S.C. 922, Unlawful Act,, 10 U.S.C. 1562, Database on domestic violence incidents, 10 U.S.C. Chap. 47, Uniform Code of Military Justice, Section 1701, National Defense Authorization Act for Fiscal Year 2014, Sexual Assault Prevention and Response and Related Reforms, DoDD 1030.01, Victim and Witness Assistance, and DoDI 1030.2, Victim and Witness Assistance Procedures. Implements crime reporting requirements of the Uniform Federal Crime Reporting Act (Title 10, United States Code, Section 534), the Brady Handgun Violence Prevention Act (18 U.S.C. 922), and the Victim Rights and Restitution Act (42 U.S.C. 10607).

    II. Summary of the Major Provisions of the Regulatory Action in Question

    The major provisions of this regulatory action include: Records administration, release of information, offense reporting, victim and witness assistance procedures, and the National Crime Information Center policy.

    The records administration section includes procedures for safeguarding official information, special requirements of the Privacy Act of 1974 to protect personal information, purpose of gathering police intelligence/criminal information, name checks for criminal background check purposes using the Army's law enforcement databases, registration of sex offenders on Army Installations in the Continental United States and Outside the Continental United States (CONUS and OCONUS), and collection by law enforcement officials of deoxyribonucleic acid (DNA) from subjects of certain offenses. The System of Records Notice, SORN A0190-45, Military Police Reporting Program Records (MRRP) describes the policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system, it can be found at: http://dpcld.defense.gov/Privacy/SORNsIndex/DODwideSORNArticleView/tabid/6797/Article/569993/a0190-45-opmg.aspx The Privacy Impact Assessment can be found at: http://ciog6.army.mil/Portals/1/PIA/2014/CIMS-CID.pdf.

    The release of information section discusses release of information from Army records, under the Freedom of Information Act (FOIA) and Privacy Act of 1974, and release of law enforcement information furnished by foreign governments or international organizations. The section also contains procedures for requesting amendment of records and accounting for military police record disclosure.

    The section on offense reporting provides information on completing the DA Form 4833 (Commander's Report of Disciplinary or Administrative Action), found at: http://www.apd.army.mil/pub/eforms/pdf/a4833.pdf, for civilian subjects, requirements for submitting fingerprint card and final disposition reports, releasing of domestic incidents reports to the Army Family Advocacy Program (FAP). This section also includes reporting of domestic violence incidents to law enforcement, issuing of protective orders, procedures for establishing Memoranda of Understanding with civilian law enforcement agencies, and reporting of Suspicious Activity to the FBI's eGuardian.

    The victim and witness assistance procedures ensure Army personnel involved in the detection, investigation, and prosecution of crimes protect victims and witnesses rights. The National Crime Information Center (NCIC) policy section authorizes NCIC checks, pursuant to FBI regulations and policy, of visitors to a military installation.

    III. Cost and Benefits

    This rule will not have a monetary effect upon the public. This rule facilitates information sharing between authorized agencies to enhance protection of personnel and resources critical to DoD mission assurance.

    IV. Retrospective Review

    The revisions to this rule will be reported in future status updates as part of DoD's retrospective plan under Executive Order 13563 completed in August 2011. DoD's full plan can be accessed at: http://www.regulations.gov/#!docketDetail;D=DOD-2011-OS-0036.

    V. Regulatory Procedures A. Regulatory Flexibility Act

    The Department of the Army has determined that the Regulatory Flexibility Act does not apply because the rule does not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601-612.

    B. Unfunded Mandates Reform Act

    The Department of the Army has determined that the Unfunded Mandates Reform Act does not apply because the rule does not include a mandate that may result in estimated costs to State, local or tribal governments in the aggregate, or the private sector, of $100 million or more.

    C. National Environmental Policy Act

    The Department of the Army has determined that the National Environmental Policy Act does not apply because the rule does not have an adverse impact on the environment.

    D. Paperwork Reduction Act

    The Department of the Army has determined that the Paperwork Reduction Act (PRA) does apply to this rule's sex offender registration requirement; all other requirements are exempted since it is information collected during a criminal investigation.

    DoD has submitted the sex offender registration requirement to OMB under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35). Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; (b) the accuracy of the estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology.

    Title: Army Sex Offender Information.

    Type of Request: New.

    Number of Respondents: 550.

    Responses per Respondent: 1.

    Annual Responses: 550.

    Average Burden per Response: 20 minutes.

    Annual Burden Hours: 183 hours.

    Needs and Uses: The Army requires tracking and management of sex offenders that reside or are employed on an Army installation due to the transient nature of the Army community. Without such a requirement, the Army would have difficulty tracking sex offenders once they transfer to other states or overseas without anyone's knowledge. All registered sex offenders who reside or are employed on an Army installation will submit their registration information with the installation Provost Marshal Office (PMO).

    Affected Public: Individuals or households.

    Frequency: On occasion.

    Respondent's Obligation: Voluntary.

    OMB Desk Officer:

    Written comments and recommendations on the proposed information collection should be sent to Ms. Jasmeet Seehra at the Office of Management and Budget, DoD Desk Officer, Room 10102, New Executive Office Building, Washington, DC 20503, with a copy to the Department of Defense, Office of the Deputy Chief Management Officer, Directorate of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.. Comments can be received from 30 to 60 days after the date of this notice, but comments to OMB will be most useful if received by OMB within 30 days after the date of this notice.

    You may also submit comments, identified by docket number and title, by the following method:

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

    Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Department of Defense, Office of the Deputy Chief Management Officer, Directorate of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.

    E. Executive Order 12630 (Government Actions and Interference With Constitutionally Protected Property Rights)

    The Department of the Army has determined that Executive Order 12630 does not apply because the rule does not impair private property rights.

    F. Executive Order 12866 (Regulatory Planning and Review) and Executive Order 13563 (Improving Regulation and Regulatory Review)

    The Department of the Army has determined that according to the criteria defined in Executive Order 12866 and Executive Order 13563 this rule is a significant regulatory action and has been reviewed by OMB.

    G. Executive Order 13045 (Protection of Children From Environmental Health Risk and Safety Risks)

    The Department of the Army has determined that the criteria of Executive Order 13045 do not apply because this rule does not implement or require actions impacting environmental health and safety risks on children.

    H. Executive Order 13132 (Federalism)

    The Department of the Army has determined that the criteria of Executive Order 13132 do not apply because this rule will not have a substantial 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.

    List of Subjects in 32 CFR Part 635

    Crime, Law, Law enforcement, Law enforcement officers, Military law.

    Thomas Blair Chief, Law Enforcement Branch, Operations Division, Office of the Provost Marshal General, DA.

    For reasons stated in the preamble the Department of the Army revises 32 CFR part 635 to read as follows:

    PART 635—LAW ENFORCEMENT REPORTING Subpart A—Records Administration Sec. 635.1 General. 635.2 Safeguarding official information. 635.3 Special requirements of the Privacy Act of 1974. 635.4 Police Intelligence/Criminal Information. 635.5 Name checks. 635.6 Registration of Sex Offenders on Army Installations (inside and outside the Continental United States). 635.7 Collection of deoxyribonucleic acid. Subpart B—Release of Information 635.8 General. 635.9 Release of information. 635.10 Release of information under the Freedom of Information Act (FOIA). 635.11 Release of information under the Privacy Act of 1974. 635.12 Amendment of records. 635.13 Accounting for military police record disclosure. 635.14 Release of law enforcement information furnished by foreign governments or international organizations. Subpart C—Offense Reporting 635.15 DA Form 4833 (Commander's Report of Disciplinary or Administrative Action) for Civilian Subjects. 635.16 Fingerprint Card and Final Disposition Report Submission Requirements. 635.17 Release of domestic incidents reports to the Army Family Advocacy Program (FAP). 635.18 Domestic violence. 635.19 Protection Orders. 635.20 Establishing Memoranda of Understanding. 635.21 Suspicious Activity Reporting (SAR). Subpart D—Victim and Witness Assistance Procedures 635.22 Procedures. Subpart E—National Crime Information Center Policy 635.23 Standards. Authority:

    28 U.S.C. 534, 42 U.S.C. 10601, 18 U.S.C. 922, 10 U.S.C. 1562, 10 U.S.C. Chap. 47, 42 U.S.C. 16901 et seq., 10 U.S.C. 1565, 42 U.S.C. 14135a.

    Subpart A—Records Administration
    § 635.1 General.

    The proponent of this part is the Provost Marshal General. The proponent has the authority to approve exceptions or waivers to this Part that are consistent with controlling law and regulations. In distributing information on juvenile victims or subjects, the installation Freedom of Information Act (FOIA) Office will ensure that only individuals with a need to know of the personally identifiable information (PII) of a juvenile are provided the identifying information on the juvenile. For example, a community commander is authorized to receive pertinent information on juveniles under their jurisdiction. When a MPR identifying juvenile offenders must be provided to multiple commanders or supervisors, the FOIA Office must sanitize each report to withhold juvenile information not pertaining to that commander's area of responsibility.

    § 635.2 Safeguarding official information.

    (a) Military police records are unclassified except when they contain national security information as defined in AR 380-5 (Available at http://www.apd.army.mil/pdffiles/r380_5.pdf), Department of the Army Information Security Program.

    (b) Military police records will also be released to Federal, state, local or foreign law enforcement agencies as prescribed by 32 CFR part 505, The Army Privacy Program. Expanded markings will be applied to these records.

    § 635.3 Special requirements of the Privacy Act of 1974.

    (a) Certain PII is protected in accordance with the provisions of the Privacy Act of 1974, 5 U.S.C. 552a, as implemented by 32 CFR part 310, DoD Privacy Program, 32 CFR part 505, The Army Privacy Program, and OMB guidance defining PII.

    (b) Pursuant to 5 U.S.C. 552a(e)(3), when an Army activity asks an individual for his or her PII that will be maintained in a system of records, the activity must provide the individual with a Privacy Act Statement (PAS). A PAS notifies individuals of the authority, purpose, and use of the collection, whether the information is mandatory or voluntary, and the effects of not providing all or any part of the requested information.

    (c) Army law enforcement personnel performing official duties often require an individual's PII, including SSN, for identification purposes. This PII can be used to complete MPRs and records. In addition to Executive Order 9397, as amended by Executive Order 13478, the solicitation of the SSN is authorized by paragraph 2.c.(2) of DoD Instruction 1000.30, “Reduction of Social Security Number (SSN) Use Within DoD” (available at http://www.dtic.mil/whs/directives/corres/pdf/100030p.pdf). The purpose is to provide commanders and law enforcement officials with means by which information may accurately be identified. The SSN is used as an additional/alternate means of identification to facilitate filing and retrieval. The following procedures will be used for identification:

    (1) Retired military personnel are required to produce their Common Access Card or DD Form 2 (Ret) (U.S. Armed Forces of the United States General Convention Identification Card), or other government issued identification, as appropriate.

    (2) Family members of sponsors will be requested to produce their DD Form 1173 (Uniformed Services Identification and Privilege Card). Information contained thereon (for example, the sponsor's SSN) will be used to verify and complete applicable sections of MPRs and related forms.

    (3) Non-Department of Defense (DoD) civilians, including military family members and those whose status is unknown, will be advised of the provisions of the Privacy Act Statement when requested to disclose their PII, including SSN, as required.

    (d) Notwithstanding the requirement to furnish an individual with a PAS when his or her PII will be maintained in a system of records, AR 340-21, The Army Privacy Program, http://www.apd.army.mil/pdffiles/r340_21.pdf, provides that records contained in SORN A0190-45, Military Police Reporting Program Records (MRRP), http://dpcld.defense.gov/Privacy/SORNsIndex/tabid/5915/Article/6066/a0190-45-opmg.aspx, that fall within 5 U.S.C. 552a(j)(2) are exempt from the requirement in 5 U.S.C. 552a(e)(3) to provide a PAS.

    § 635.4 Police Intelligence/Criminal Information.

    (a) The purpose of gathering police intelligence is to identify individuals or groups of individuals in an effort to anticipate, prevent, or monitor possible criminal activity. Police intelligence aids criminal investigators in developing and investigating criminal cases. 32 CFR part 633 designates the U.S. Army Criminal Investigation Command (USACIDC) as having the primary responsibility to operate a criminal intelligence program. Criminal Intelligence will be reported through the Army Criminal Investigation and Criminal Intelligence (ACI2) System and other criminal intelligence products. The crimes listed in paragraphs (a)(1)-(9) of this section, as well as the reportable incidents, behavioral threat indicators, and other matters of counterintelligence interest specified by AR 381-12, Threat Awareness and Reporting Program, (available at http://www.apd.army.mil/pdffiles/r381_12.pdf) will be reported to the nearest Army counterintelligence office.

    (1) Sedition;

    (2) Aiding the enemy by providing intelligence to the enemy;

    (3) Spying;

    (4) Espionage;

    (5) Subversion;

    (6) Treason;

    (7) International terrorist activities or material support to terrorism (MST);

    (8) Unreported contacts with foreigners involved in intelligence activities;

    (9) Unauthorized or intentional disclosure of classified info.

    (b) Information on persons and organizations not affiliated with DoD may not normally be acquired, reported, processed or stored. Situations justifying acquisition of this information include, but are not limited to—

    (1) Theft, destruction, or sabotage of weapons, ammunition, equipment facilities, or records belonging to DoD units or installations.

    (2) Protection of Army installations and activities from potential threat.

    (3) Information received from the FBI, state, local, or international law enforcement agencies which directly pertains to the law enforcement mission and activity of the installation Provost Marshal Office/Directorate of Emergency Services (PMO/DES), Army Command (ACOM), Army Service Component Command (ASCC) or Direct Reporting Unit (DRU) PMO/DES, or that has a clearly identifiable military purpose and connection. A determination that specific information may not be collected, retained or disseminated by intelligence activities does not indicate that the information is automatically eligible for collection, retention, or dissemination under the provisions of this part. The policies in this section are not intended and will not be used to circumvent any federal law that restricts gathering, retaining or dissemination of information on private individuals or organizations.

    (c) Retention and disposition of information on non-DoD affiliated individuals and organizations are subject to the provisions of DoD Directive 5200.27 (available at http://www.dtic.mil/whs/directives/corres/pdf/520027p.pd), AR 380-13, Acquisition and Storage of Information Concerning Non-Affiliated Persons and Organizations (available at http://www.apd.army.mil/pdffiles/r380_13.pdf) and AR 25-400-2, The Army Records Information Management System (ARIMS) (available at http://www.apd.army.mil/pdffiles/r25_400_2.pdf).

    (d) Local police intelligence files may be exempt from 32 CFR part 518 and the FOIA's disclosure requirements.

    § 635.5 Name checks.

    (a) Information contained in military police records will be released under the provisions of 32 CFR part 505, The Army Privacy Program, to authorized personnel for valid background check purposes. Examples include child care/youth program providers, sexual assault response coordinator, unit victim advocate, access control, unique or special duty assignments, security clearance procedures and suitability and credentialing purposes. Any information released must be restricted to that necessary and relevant to the requester's official purpose. Provost Marshals/Directors of Emergency Services (PM/DES) will establish written procedures to ensure that release is accomplished in accordance with 32 CFR part 505.

    (b) Checks will be accomplished by a review of the COPS Military Police Reporting System (MPRS). Information will be disseminated according to Subpart B of this part.

    (c) In response to a request for local files or name checks, PM/DES will release only founded offenses with final disposition. Offenses determined to be unfounded will not be released. These limitations do not apply to requests submitted by law enforcement agencies for law enforcement purposes, and counterintelligence investigative agencies for counterintelligence purposes.

    (d) A successful query of COPS MPRS would return the following information:

    (1) Military Police Report Number;

    (2) Report Date;

    (3) Social Security Number;

    (4) Last Name;

    (5) First Name;

    (6) Protected Identity (Y/N);

    (7) A link to view the military police report; and

    (8) Whether the individual is a subject, victim, or a person related to the report disposition.

    (e) Name checks will include the information derived from COPS MPRS and the United States Army Crime Records Center (USACRC). All of the policies and procedures for such checks will conform to the provisions of this part. Any exceptions to this policy must be coordinated with Headquarters Department of the Army (HQDA), Office of the Provost Marshal General (OPMG) before any name checks are conducted. The following are examples of appropriate uses of the name check feature of COPS MPRS:

    (1) Individuals named as the subjects of serious incident reports.

    (2) Individuals named as subjects of investigations who must be reported to the USACRC.

    (3) Individuals seeking employment as child care/youth program providers.

    (4) Local checks of the COPS MPRS as part of placing an individual in the COPS MPRS system.

    (5) Name checks for individuals seeking employment in law enforcement positions.

    § 635.6 Registration of Sex Offenders on Army Installations (inside and outside the Continental United States).

    (a) Sex Offenders on US Army Installations. Garrison Commander's responsibilities: Garrison Commanders will ensure that sex offenders, as defined in paragraph (b) of this section that reside or are employed on an Army Installation register with the installation PM/DES. This includes service members, civilian employees, accompanying dependent family members, and contractors.

    (b) Sex offender is defined as:

    (1) Any person, including but not limited to a Service member, Service member's family member, Civilian employee, Civilian employee's family member, or contractor, who either is registered or required to register as a sex offender by any law, regulation or policy of the United States, the Department of Defense, the Army, a State, the District of Columbia, the Commonwealth of Puerto Rico, Guam, America Samoa, The Northern Mariana Islands, the United States Virgin Islands, or a Federally recognized Indian tribe. This definition is not limited to persons convicted for felony sex offenses but includes all persons who are registered or required to register as a sex offender regardless of the classification of their offenses, including felonies, misdemeanors, and offenses not classified as a felony or misdemeanor.

    (2) The persons who are sex offenders as defined in paragraph (b)(1) include those convicted by a foreign government of an offense equivalent or closely analogous to a covered offense under the Uniform Code of Military Justice as provided in AR 27-10, Military Justice (available at http://www.apd.army.mil/pdffiles/r27_10.pdf), Chapter 24.” See 42 U.S.C. 16911(5)(B) and U.S. Department of Justice, Office of the Attorney General, The National Guidelines for Sex Offender Registration and Notification, Final Guidelines, 73 FR 38030, 38050-1 (July 2, 2008) for guidelines and standards. Contact the servicing Office of the Staff Judge Advocate for assistance in interpreting or applying this provision.

    (c) Sex Offender Registration Requirements. Sex offenders, as defined in paragraph (b)(1) of this section must register with the installation PMO/DES within three working days of first arriving on an installation. Sex offenders must provide the installation PMO/DES with evidence of the qualifying conviction. The PMO/DES will enter the registering sex offender's conviction information on a Department of the Army Form 3975 as an information entry into the Army's Centralized Operations Police Suite (COPS) with the state the sex offender was convicted, date of conviction, and results of conviction, to include length of time required to register and any specific court ordered restrictions. Registration with the PMO/DES does not relieve sex offenders of their legal obligation to comply with applicable state and local registration requirements for the state in which they reside, work, or attend school (see, AR 190-47 (available at http://www.apd.army.mil/pdffiles/r190_47.pdf), chapter 14 and AR 27-10 (available at http://www.apd.army.mil/pdffiles/r27_10.pdf), chapter 24). Registration with the state is also required under the Sex Offender Registration and Notification Act (SORNA), 42 U.S.C. 16901 et seq., and implemented by AR 27-10 (Available at http://www.apd.army.mil/pdffiles/r27_10.pdf), Military Justice, and DoDI 1325.7 (Available at http://www.dtic.mil/whs/directives/corres/pdf/132507p.pdf). In addition, upon assignment, reassignment, or change of address, sex offenders will inform the installation PM/DES within three working days. Failure to comply with registration requirements is punishable under Federal or State law and/or under the UCMJ. “State” in this paragraph includes any jurisdiction listed in paragraph (b)(1) of this section in which a sex offender is required to register.

    (d) Installation PMOs and DESs will maintain and update a monthly roster of current sex offenders names and provide it to the Sexual Assault Review Board; the Army Command PM and DES and the garrison commander.

    (e) Installation PMs and DESs will complete the following procedures for all other sex offenders required to register on the installation—

    (1) Complete a DA Form 3975 as an information entry into COPS.

    (2) Complete “Section III—Subject (1a-7)” on the DA Form 3975 to identify the sex offender. Ensure the sex offender produces either evidence of the qualifying conviction or the sex offender registration paperwork in order to complete “Section VII—Narrative” with the state in which the sex offender was convicted, date of conviction, and results of conviction, to include length of time required to register and any specific court ordered restrictions.

    (f) DoD civilians, contractors, and family members that fail to register at the installation PMO/DES are subject to a range of administrative sanctions, including but not limited to a complete or limited bar to the installation and removal from military housing.

    § 635.7 Collection of deoxyribonucleic acid.

    (a) Army Law Enforcement (LE) personnel will collect deoxyribonucleic acid (DNA) pursuant to DoDI 5505.14 (available at http://www.dtic.mil/whs/directives/corres/pdf/550514p.pdf), DNA Collection Requirements for Criminal Investigations. Per this subpart, a sample of an individual's DNA is to allow for positive identification and to provide or generate evidence to solve crimes through database searches of potentially matching samples. DNA samples will not be collected from juveniles.

    (b) Army LE personnel will obtain a DNA sample from a civilian in their control at the point it is determined there is probable cause to believe the detained person violated a Federal statute equivalent to the offenses identified in DoDI 5505.11 (available at http://www.dtic.mil/whs/directives/corres/pdf/550511p.pdf), Fingerprint Card and Final Disposition Report Submission Requirements, and 32 CFR part 310, Department of Defense Privacy Program, except for the listed violations that are exclusively military offenses. For the purposes of this rule, DNA shall be taken from all civilian drug offenders, except those who are arrested or detained for the offenses of simple possession and personal use.

    (1) When Army LE personnel make a probable cause determination concerning a civilian not in their control, Army LE personnel are not required to collect DNA samples. Likewise, Army LE personnel are not required to obtain DNA samples when another LE agency has, or will, obtain the DNA.

    (2) Army LE personnel will use the U.S. Army Criminal Investigation Laboratory (USACIL) DNA kit which includes a DNA sample card and the USACIL DNA database collection eform. Army LE personnel will forward civilian DNA samples to the USACIL. Army LE personnel will document, in the appropriate case file, when civilian LE agencies handle any aspect of the DNA processing and whether the civilian LE agency forwarded the DNA sample to the FBI laboratory.

    (c) DoD Instruction 5505.14 (available at http://www.dtic.mil/whs/directives/corres/pdf/550514p.pdf) details the procedures former Soldiers and civilians must follow to request expungement of their DNA records. Former Soldiers and civilians from whom DNA samples have been taken, but who were not convicted of any offense giving rise to the collection of DNA, do not submit requests to have their DNA record expunged through installation PMO/DES channels. To request expungement of DNA records for civilians pursuant to Sections 14132 of title 42, United States Code, the requestor or legal representative must submit a written request to: FBI, Laboratory Division, 2501 Investigation Parkway, Quantico, VA 22135, Attention: Federal Convicted Offender Program Manager.

    Subpart B—Release of Information
    § 635.8 General.

    (a) The policy of HQDA is to conduct activities in an open manner and provide the public accurate and timely information. Accordingly, law enforcement information will be released to the degree permitted by law and Army regulations.

    (b) Any release of military police records or information compiled for law enforcement purposes, whether to persons within or outside the Army, must be in accordance with the FOIA and the Privacy Act.

    (c) Requests by individuals for access to military police records about themselves will be processed in compliance with FOIA and the Privacy Act.

    (d) Military police records in the temporary possession of another organization remain the property of the originating law enforcement agency. The following procedures apply to any organization authorized temporary use of military police records:

    (1) Any request from an individual seeking access to military police records will be immediately referred to the originating law enforcement agency for processing. The temporary custodian of military police records does not have the authority to release those records.

    (2) When the temporary purpose of the using organization has been satisfied, the military police records will be returned to the originating law enforcement agency or the copies will be destroyed.

    (3) A using organization may maintain information from military police records in their system of records, if approval is obtained from the originating law enforcement agency. This information may include reference to a military police record (for example, MPR number or date of offense), a summary of information contained in the record, or the entire military police record. When a user includes a military police record in its system of records, the originating law enforcement agency will delete portions from that record to protect special investigative techniques, maintain confidentiality, preclude compromise of an investigation, and protect other law enforcement interests.

    § 635.9 Release of information.

    (a) Release of information from Army records to agencies outside DoD will be governed by 32 CFR part 518, 32 CFR part 505, AR 600-37, Unfavorable Information (Available at http://www.apd.army.mil/pdffiles/r600_37.pdf), and this part. Procedures for release of certain other records and information is contained in AR 20-1, Inspector General Activities and Procedures (available at http://www.apd.army.mil/pdffiles/r20_1.pdf), AR 27-20, Claims (available at http://www.apd.army.mil/pdffiles/r27_20.pdf), AR 27-40, Litigation (available at http://www.apd.army.mil/pdffiles/r27_40.pdf), AR 40-66, Medical Record Administration and Healthcare Documentation (available at http://www.apd.army.mil/pdffiles/r40_66.pdf), AR 195-2, Criminal Investigation Activities (available at http://www.apd.army.mil/pdffiles/r195_2.pdf), AR 360-1, The Army Public Affairs Program (available at http://www.apd.army.mil/pdffiles/r360_1.pdf), and AR 600-85, The Army Substance Abuse Program (available at http://www.apd.army.mil/pdffiles/r600_85.pdf). Installation drug and alcohol offices may be provided an extract of DA Form 3997 (Military Police Desk Blotter) for offenses involving the use of alcohol or drugs (for example, drunk driving, drunk and disorderly conduct, or positive urinalysis).

    (b) Installation PM/DES are the release authorities for military police records under their control. They may release criminal record information to other activities as prescribed in 32 CFR part 518 and 32 CFR part 505, and this part.

    (c) Authority to deny access to criminal records information rests with the initial denial authority (IDA) for the FOIA and the denial authority for Privacy Acts cases, as addressed in 32 CFR part 518 and 32 CFR part 505.

    § 635.10 Release of information under the Freedom of Information Act (FOIA).

    (a) The release and denial authorities for all FOIA requests concerning military police records include PM/DES and the Commander, USACIDC. Authority to act on behalf of the Commander, USACIDC is delegated to the Director, USACRC.

    (b) FOIA requests from members of the press will be coordinated with the installation public affairs officer prior to release of records under the control of the installation PM/DES. When the record is on file at the USACRC the request must be forwarded to the Director, USACRC.

    (c) Requests will be processed as prescribed in 32 CFR part 518 and as follows:

    (1) The installation FOIA Office will review requested reports to determine if any portion is exempt from release.

    (2) Statutory and policy questions will be coordinated with the local staff judge advocate (SJA).

    (3) Coordination will be completed with the local USACIDC activity to ensure that the release will not interfere with a criminal investigation in progress or affect final disposition of an investigation.

    (4) If it is determined that a portion of the report, or the report in its entirety will not be released, the request to include a copy of the Military Police Report or other military police records will be forwarded to the Director, USACRC, ATTN: CICR-FP, 27130 Telegraph Road, Quantico, VA 22134. The requestor will be informed that their request has been sent to the Director, USACRC, and provided the mailing address for the USACRC. When forwarding FOIA requests, the outside of the envelope will be clearly marked “FOIA REQUEST.”

    (5) A partial release of information by an installation FOIA Office is permissible when it is acceptable to the requester. (An example would be the redaction of a third party's social security number, home address, and telephone number, as permitted by law). If the requester agrees to the redaction of exempt information, such cases do not constitute a denial. If the requester insists on the entire report, a copy of the report and the request for release will be forwarded to the Director, USACRC. There is no requirement to coordinate such referrals at the installation level. The request will simply be forwarded to the Director, United States Army Crime Records Center (USACRC) for action.

    (6) Requests for military police records that have been forwarded to USACRC and are no longer on file at the installation PMO/DES will be forwarded to the Director, USACRC for processing.

    (7) Requests concerning USACIDC reports of investigation or USACIDC files will be referred to the Director, USACRC. In each instance, the requestor will be informed of the referral and provided the Director, USACRC address.

    (8) Requests concerning records that are under the supervision of an Army activity, or other DoD agency, will be referred to the appropriate agency for response.

    § 635.11 Release of information under the Privacy Act of 1974.

    (a) Military police records may be released according to provisions of the Privacy Act of 1974, 5 U.S.C. 552a, as implemented by 32 CFR part 310, DoD Privacy Program, 32 CFR part 505, The Army Privacy Program, and this part.

    (b) The release and denial authorities for all Privacy Act cases concerning military police records are provided in § 635.9.

    (c) Privacy Act requests for access to a record, when the requester is the subject of that record, will be processed as prescribed in 32 CFR part 505.

    § 635.12 Amendment of records.

    (a) Policy. An amendment of records is appropriate when such records are established as being inaccurate, irrelevant, untimely, or incomplete. Amendment procedures are not intended to permit challenging an event that actually occurred. Requests to amend reports will be granted only if the individual submits new, relevant and material facts that are determined to warrant their inclusion in or revision of the police report. The burden of proof is on the individual to substantiate the request. Requests to delete a person's name from the title block will be granted only if it is determined that there is not probable cause to believe that the individual committed the offense for which he or she is listed as a subject. It is emphasized that the decision to list a person's name in the title block of a police report is an investigative determination that is independent of whether or not subsequent judicial, non-judicial or administrative action is taken against the individual.

    (b) In compliance with DoD policy, an individual will still remain entered in the Defense Clearance Investigations Index (DCII) to track all reports of investigation.

    § 635.13 Accounting for military police record disclosure.

    (a) 32 CFR part 505 prescribes accounting policies and procedures concerning the disclosure of military police records.

    (b) PM/DES will develop local procedures to ensure that disclosure of military police records as described in 32 CFR part 505 are available on request.

    (c) In every instance where records are disclosed; individuals, agencies or components are reminded that use or further disclosure of any military police reports, Military Police Investigator (MPI) reports, or other information received must be in compliance with DoDI 5505.7 (available at http://www.dtic.mil/whs/directives/corres/pdf/550507p.pdf), paragraph 6.5.2. which states that “judicial or adverse administrative actions shall not be taken against individuals or entities based solely on the fact that they have been titled or indexed due to a criminal investigation.”

    § 635.14 Release of law enforcement information furnished by foreign governments or international organizations.

    (a) Information furnished by foreign governments or international organizations is subject to disclosure, unless exempted by 32 CFR part 518 and 32 CFR part 505, federal statutes or executive orders.

    (b) Release of U.S. information (classified military information or controlled unclassified information) to foreign governments is accomplished per AR 380-10 (available at http://www.apd.army.mil/pdffiles/r380_10.pdf).

    Subpart C—Offense Reporting
    § 635.15 DA Form 4833 (Commander's Report of Disciplinary or Administrative Action) for Civilian Subjects.

    Civilian Subjects titled by Army Law Enforcement. PM/DES and USACIDC will complete and submit disposition reports to USACRC for civilian subjects, not subject to the UCMJ, who are titled by Army law enforcement. PM/DES and USACIDC will complete the DA Form 4833 and submit the form to USACRC for these subjects. PM/DES and USACIDC will not include these completed DA Form 4833 for civilian personnel in reporting compliance statistics for commanders. This ensures records of dispositions of civilian subjects titled by military LE are available in CJIS to support NCIC background checks for firearms purchases, employment, security clearances etc.

    § 635.16 Fingerprint Card and Final Disposition Report Submission Requirements.

    (a) General. This paragraph implements DoDI 5505.11, Fingerprint Card and Final Disposition Report Submission Requirements, which prescribes procedures for Army LE to report offender criminal history data, by submitting FBI Form FD 249 (Suspect Fingerprint Card) to USACRC. USACRC forwards this data to the Criminal Justice Information Services (CJIS) division of the FBI for inclusion in the Next Generation Identification Database. This paragraph does not eliminate other requirements to provide criminal history data, including those concerning the DIBRS.

    (b) Installation PM/DES will submit offender criminal history data to USACRC, based on a probable cause standard determined in conjunction with the servicing SJA or legal advisor for all civilians investigated for offenses equivalent to those listed in DoDI 5505.11. This includes foreign nationals, persons serving with or accompanying an armed force in the field in time of declared war or contingency operations, and persons subject to Public Law 106-523 in accordance with DoDI 5525.11 (Available at http://www.dtic.mil/whs/directives/corres/pdf/552511p.pdf), Criminal Jurisdiction Over Civilians Employed By or Accompanying the Armed Forces Outside the United States, Certain Service Members, and Former Service Members.

    (c) For purposes of this paragraph commanders will notify their installation PMO/DES when they become aware that a non-DoD and/or foreign LE organization has initiated an investigation against a Soldier, military dependent, or DoD civilian employee or contractor, for the equivalent of an offense listed in DoDI 5525.11 (available at http://www.dtic.mil/whs/directives/corres/pdf/552511p.pdf), Enclosure 2, or punishable pursuant to the U.S.C.

    § 635.17 Release of domestic incidents reports to the Army Family Advocacy Program (FAP).

    (a) Installation PM/DES will comply with the reporting requirements set forth in AR 608-18 (available at http://www.apd.army.mil/pdffiles/r608_18.pdf).

    (b) In addition to substantiated incidents of domestic violence, installation PM/DES will notify the Family Advocacy Program Manager (FAPM) and Social Work Services (SWS) of all incidents in which a preponderance of indicators reveal a potential risk of reoccurrence and increasing severity of maltreatment which could lead to domestic violence or child abuse. Installation PM/DES will ensure these notifications are recorded in the official military police journal in COPS. This is to:

    (1) Establish a history of incidents that indicate an emerging pattern of risk of maltreatment/victimization to Soldiers and or Family members. See AR 608-18 for incidents that define maltreatment.

    (2) Develop a trend history of unsubstantiated-unresolved incidents in order to prevent possible violence or maltreatment from occurring.

    § 635.18 Domestic violence.

    (a) Responding to incidents of domestic violence requires a coordinated effort by LE, medical, and social work personnel, to include sharing information and records as permitted by law and regulation. AR 608-18, Chapter 3, contains additional information about domestic violence and protective orders. AR 608-18, Glossary, Section II refers to domestic violence as including the use, attempted use, or threatened use of force or violence against a person or a violation of a lawful order issued for the protection of a person, who is:

    (1) A current or former spouse;

    (2) A person with whom the abuser shares a child in common; or

    (3) A current or former intimate partner with whom the abuser shares or has shared a common domicile.

    (b) All domestic violence incidents will be reported to the local installation PMO/DES.

    § 635.19 Protection Orders.

    (a) A DD Form 2873, Military Protective Order (MPO) is a written lawful order issued by a commander that orders a Soldier to avoid contact with those persons identified in the order. MPOs may be used to facilitate a “cooling-off” period following domestic violence and sexual assault incidents, to include incidents involving children. The commander should provide a written copy of the order within 24 hours of its issuance to the person with whom the member is ordered not to have contact and to the installation LE activity.

    (b) Initial notification. In the event a MPO is issued against a Soldier and any individual involved in the order does not reside on a Army installation at any time during the duration of the MPO, the installation PMO/DES will notify the appropriate civilian authorities (local magistrate courts, family courts, and local police) of:

    (1) The issuance of the protective order;

    (2) The individuals involved in the order;

    (3) Any change made in a protective order;

    (4) The termination of the protective order.

    (c) A Civilian Protective Order (CPO) is an order issued by a judge, magistrate or other authorized civilian official, ordering an individual to avoid contact with his or her spouse or children. Pursuant to the Armed Forces Domestic Security Act, 10 U.S.C. 1561a, a CPO has the same force and effect on a military installation as such order has within the jurisdiction of the court that issued the order.

    § 635.20 Establishing Memoranda of Understanding.

    (a) Coordination between military law enforcement personnel and local civilian law enforcement personnel is essential to improve information sharing, especially concerning investigations, arrests, and prosecutions involving military personnel. PM/DES or other law enforcement officials shall seek to establish formal Memoranda of Understanding (MOU) with their civilian counterparts to establish or improve the flow of information between their agencies, especially in instances involving military personnel. MOUs can be used to clarify jurisdictional issues for the investigation of incidents, to define the mechanism whereby local law enforcement reports involving active duty service members will be forwarded to the appropriate installation law enforcement office, to encourage the local law enforcement agency to refer victims of domestic violence to the installation Family Advocacy office or victim advocate, and to foster cooperation and collaboration between the installation law enforcement agency and local civilian agencies.

    (b) Installation commanders are authorized to contract for local, state, or federal law enforcement services (enforcement of civil and criminal laws of the state) from civilian police departments. (Section 120 of the Water Resources Development Act of 1976). Section 120(a) of the Water Resources Development Act of 1976 authorizes the Secretary of the Army, acting through the Chief of Engineers, to contract with States and their political subdivisions for the purpose of obtaining increased law enforcement services at water resource development projects under the jurisdiction of the Secretary of the Army to meet needs during peak visitation periods.

    (c) MOUs will address the following issues at a minimum:

    (1) A general statement of the purpose of the MOU.

    (2) An explanation of jurisdictional issues that affect respective responsibilities to and investigating incidents occurring on and off the installation. This section should also address jurisdictional issues when a civilian order of protection is violated on military property (see 10 U.S.C. 1561a).

    (3) Procedures for responding to incidents that occur on the installation involving a civilian alleged offender.

    (4) Procedures for local law enforcement to immediately (within 4 hours) notify the installation law enforcement office of incidents/investigations involving service members.

    (5) Procedures for transmitting incident/investigation reports and other law enforcement information involving active duty service members from local civilian law enforcement agencies to the installation law enforcement office.

    (6) Notification that a Solider is required to register as a sex offender either as the result of military judicial proceedings or civilian judicial proceedings.

    (7) Procedures for transmitting civilian protection orders (CPOs) issued by civilian courts or magistrates involving active duty service members from local law enforcement agencies to the installation law enforcement office.

    (8) Designation of the title of the installation law enforcement recipient of such information from the local law enforcement agency.

    (9) Procedures for transmitting military protection orders (MPOs) from the installation law enforcement office to the local civilian law enforcement agency with jurisdiction over the area in which any person named in the order resides.

    (10) Designation of the title of the local law enforcement agency recipient of domestic violence and CPO information from the installation law enforcement agency.

    (11) Respective responsibilities for providing information to victims regarding installation resources when either the victim or the alleged offender is an active duty service member.

    (12) Sharing of information and facilities during the course of an investigation in accordance with the Privacy Act of 1974 (see 5 U.S.C. 552a(b)(7)).

    (13) Regular meetings between the local civilian law enforcement agency and the installation law enforcement office to review cases and MOU procedures.

    § 635.21 Suspicious Activity Reporting (SAR).

    (a) The Army will use eGuardian to report, share and analyze unclassified suspicious activity information regarding potential threats or suspicious activities affecting DoD personnel, facilities, or forces in transit in both CONUS and OCONUS. USACIDC is the Army's eGuardian program manager.

    (b) eGuardian is the Federal Bureau of Investigation's (FBI) sensitive-but-unclassified web-based platform for reporting, and in some instances, sharing, suspicious activity and threat related information with other federal, state, tribal, and territorial law enforcement and force protection entities. Information entered into eGuardian by the Army may be either shared with all eGuardian participants or reported directly to the FBI. All information entered into eGuardian by the Army will comply with the policy framework for the system and any existing agency agreements, which incorporate privacy protections. Analysis of SARs will assist CRIMINTEL analysts and commanders in mitigating potential threats and vulnerabilities, and developing annual threat assessments.

    (c) Any concerned soldier or citizen can submit a SAR to the nearest installation PMO/DES, CI or CID office. The receiving office will then be responsible for reviewing the information and determining whether it is appropriate for submission into eGuardian.

    Subpart D—Victim and Witness Assistance Procedures
    § 635.22 Procedures.

    (a) As required by DoDD 1030.01 (Available at http://www.dtic.mil/whs/directives/corres/pdf/103001p.pdf), Army personnel involved in the detection, investigation, and prosecution of crimes must ensure that victims and witnesses rights are protected. Victim's rights include-

    (1) The right to be treated with fairness, dignity, and a respect for privacy.

    (2) The right to be reasonably protected from the accused offender.

    (3) The right to be notified of court proceedings.

    (4) The right to be present at all public court proceedings related to the offense, unless the court determines that testimony by the victim would be materially affected if the victim heard other testimony at trial, or for other good cause.

    (5) The right to confer with the attorney for the Government in the case.

    (6) The right to restitution, if appropriate.

    (7) The right to information regarding conviction, sentencing, imprisonment, and release of the offender from custody.

    (b) [Reserved]

    Subpart E—National Crime Information Center Policy
    § 635.23 Standards.

    The use of NCIC is limited to authorized criminal justice purposes such as, stolen vehicle checks or wants and warrants. Subject to FBI regulations and policy, NCIC checks of visitors to a military installation may be authorized by the Installation/Garrison Commander as set forth in DoD 5200.08-R (Available at http://www.dtic.mil/whs/directives/corres/pdf/520008r.pdf) and DoDI 5200.08 (Available at http://www.dtic.mil/whs/directives/corres/pdf/520008p.pdf). Visitors to Army installations are non-DoD affiliated personnel.

    [FR Doc. 2015-11943 Filed 5-18-15; 8:45 am] BILLING CODE 3710-08-P
    DEPARTMENT OF DEFENSE Department of the Navy 32 CFR Part 706 Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972 AGENCY:

    Department of the Navy, DoD.

    ACTION:

    Final rule.

    SUMMARY:

    The Department of the Navy (DoN) is amending its certifications and exemptions under the International Regulations for Preventing Collisions at Sea, 1972, as amended (72 COLREGS), to reflect that the Deputy Assistant Judge Advocate General (DAJAG)(Admiralty and Maritime Law) has determined that USS JACKSON (LCS 6) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with certain provisions of the 72 COLREGS without interfering with its special function as a naval ship. The intended effect of this rule is to warn mariners in waters where 72 COLREGS apply.

    DATES:

    This rule is effective May 19, 2015 and is applicable beginning May 7, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Commander Theron R. Korsak, (Admiralty and Maritime Law), Office of the Judge Advocate General, Department of the Navy, 1322 Patterson Ave. SE., Suite 3000, Washington Navy Yard, DC 20374-5066, telephone 202-685-5040.

    SUPPLEMENTARY INFORMATION:

    Pursuant to the authority granted in 33 U.S.C. 1605, the DoN amends 32 CFR part 706.

    This amendment provides notice that the DAJAG (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS JACKSON (LCS 6) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I, paragraph 3(c), pertaining to the task light's horizontal distance from the fore and aft centerline of the vessel in the athwartship direction. The DAJAG (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

    Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

    List of Subjects in 32 CFR Part 706

    Marine safety, Navigation (water), Vessels.

    For the reasons set forth in the preamble, the DoN amends part 706 of title 32 of the Code of Federal Regulations as follows:

    PART 706—CERTIFICATIONS AND EXEMPTIONS UNDER THE INTERNATIONAL REGULATIONS FOR PREVENTING COLLISIONS AT SEA, 1972 1. The authority citation for part 706 continues to read as follows: Authority:

    33 U.S.C. 1605.

    2. Section 706.2 is amended in Table Four, paragraph 15, by revising the entry for USS JACKSON (LCS 6) to read as follows:
    § 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605.

    Table Four

    15. * * * Vessel Number Horizontal distance from the fore and aft centerline of the vessel in the athwartship direction *         *         *         *         *         *         * USS JACKSON LCS 6 Upper—0.10 meters Middle—1.31 meters Lower—1.31 meters
    Approved: May 7, 2015. A.B. Fischer, Captain, JAGC, U.S. Navy, Deputy Assistant Judge Advocate, General (Admiralty and Maritime Law). Dated: May 11, 2015 N.A. Hagerty-Ford Commander, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer.
    [FR Doc. 2015-11908 Filed 5-18-15; 8:45 am] BILLING CODE 3810-FF-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Parts 100 and 165 [Docket No. USCG-2012-1036] Safety Zones and Special Local Regulations; Recurring Marine Events in Captain of the Port Long Island Sound Zone AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of enforcement of regulation.

    SUMMARY:

    The Coast Guard will enforce one special local regulation for a boat race, 16 safety zones for fireworks displays and one safety zone for a swim event in the Sector Long Island Sound area of responsibility on the dates and times listed in the tables below. This action is necessary to provide for the safety of life on navigable waterways during the events. During the enforcement periods, no person or vessel may enter the regulated area or safety zones without permission of the Captain of the Port (COTP) Sector Long Island Sound or designated representative.

    DATES:

    The regulations in 33 CFR 100.100 and 33 CFR 165.151 will be enforced during the dates and times as listed in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this notice, call or email Petty Officer Ian Fallon, Waterways Management Division, U.S. Coast Guard Sector Long Island Sound; telephone 203-468-4565, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Coast Guard will enforce the special local regulation listed in 33 CFR 100.100 and the safety zones listed in 33 CFR 165.151 on the specified dates and times as indicated in the following Tables.

    Table to § 100.100 August 1.1 Harvard-Yale Regatta, Thames River, New London, CT • Event type: Boat Race.
  • • Date: June 7, 2015.
  • • Time: 8:30 a.m. to 12:30 p.m.
  • • Location: All waters of the Thames River at New London, Connecticut, between the Penn Central Draw Bridge 41°21′46.94″ N., 072°5′14.46″ W. to Bartlett Cove 41°25′ 35.9″ N., 072°5′42.89″ W. (NAD 83). • Additional stipulations: Spectator vessels must be at anchor within a designated spectator area or moored to a waterfront facility within the regulated area in such a way that they shall not interfere with the progress of the event at least 30 minutes prior to the start of the races. They must remain moored or at anchor until the men's varsity have passed their positions. At that time, spectator vessels located south of the Harvard Boathouse may proceed downriver at a reasonable speed. Vessels situated between the Harvard Boathouse and the finish line must remain stationary until both crews return safely to their boathouses. If for any reason the men's varsity crew race is postponed, spectator vessels will remain in position until notified by Coast Guard or regatta patrol personnel. The last 1000 feet of the race course near the finish line will be delineated by four temporary white buoys provided by the sponsor. All spectator craft shall remain behind these buoys during the event. Spectator craft shall not anchor: to the west of the race course, between Scotch Cap and Bartlett Point Light, or within the race course boundaries or in such a manner that would allow their vessel to drift or swing into the race course. During the effective period all vessels shall proceed at a speed not to exceed six knots in the regulated area. Spectator vessels shall not follow the crews during the races. Swimming is prohibited in the vicinity of the race course during the races. A vessel operating in the vicinity of the Submarine Base may not cause waves which result in damage to submarines or other vessels in the floating dry-docks.
    Table 1 to § 165.151 6.2 Town of Branford Fireworks • Date: June 27, 2015.
  • • Rain Date: June 28, 2015.
  • • Time: 9:00 p.m. to 10:30 p.m. • Location: Waters of Branford Harbor, Branford, CT in approximate position, 41°15′30″ N., 072°49′22″ W. (NAD 83). 6.3 Vietnam Veterans/Town of East Haven Fireworks • Date: June 27, 2015.
  • • Rain Date: June 29, 2015.
  • • Time: 9:00 p.m. to 11:00 p.m.
  • • Location: Waters off Cosey Beach, East Haven, CT in approximate position, 41°14′19″ N., 072°52′9.8″ W. (NAD 83). 7.1 Point O'Woods Fire Company Summer Fireworks • Date: July 3, 2015.
  • • Rain Date: July 5, 2015.
  • • Time: 9:00 p.m. to 10:00 p.m. • Location: Waters of the Great South Bay, Point O'Woods, NY in approximate position 40°39′18.57″ N., 073°08′5.73″ W. (NAD 83). 7.4 Norwalk Fireworks • Date: July 3, 2015. • Rain Date: July 5, 2015. • Time: 8:30 p.m. to 10:30 p.m. • Location: Waters off Calf Pasture Beach, Norwalk, CT in approximate position, 41°04′50″ N., 073°23′22″ W. (NAD 83). 7.5 Lawrence Beach Club Fireworks • Date: July 3, 2015.
  • • Rain Date: July 5, 2015.
  • • Time: 9:00 p.m. to 10:30 p.m. • Location: Waters of the Atlantic Ocean off Lawrence Beach Club, Atlantic Beach, NY in approximate position 40°34′42.65″ N., 073°42′56.02″ W. (NAD 83). 7.6 Sag Harbor Fireworks • Date: July 4, 2015. • Rain Date: July 5, 2015. • Time: 9:00 p.m. to 10:30 p.m. • Location: Waters of Sag Harbor Bay off Havens Beach, Sag Harbor, NY in approximate position 41°00′26″ N., 072°17′9″ W. (NAD 83). 7.7 South Hampton Fresh Air Home Fireworks • Date: July 3, 2015.
  • • Rain Date: July 5, 2015.
  • • Time: 8:45 p.m. to 10:00 p.m. • Location: Waters of Shinnecock Bay, Southampton, NY in approximate positions, 40°51′48″ N., 072°26′30″ W. (NAD 83). 7.18 Independence Day Celebration Fireworks • Date: July 4, 2015.
  • • Rain Date: July 5, 2015.
  • • Time: 8:30 p.m. to 10:00 p.m. • Location: Waters off of Umbrella Beach, Montauk, NY in approximate position 41°01′44″ N., 071°57′13″ W. (NAD 83). 7.27 City of Long Beach Fireworks • Date: July 10, 2015.
  • • Rain Date: July 11, 2015.
  • • Time: 8:30 p.m. to 10:00 p.m. • Location: Waters off Riverside Blvd, City of Long Beach, NY in approximate position 40°34′38.77″ N., 073°39′41.32″ W. (NAD 83). 7.33 Groton Long Point Yacht Club Fireworks • Date: July 18, 2015.
  • • Rain Date: July 19, 2015.
  • • Time: 9:00 p.m. to 10:30 p.m. • Location: Waters of Long Island Sound, Groton, CT in approximate position 40°59′41.40″ N., 072°06′08.70″ W. (NAD 83). 7.34 Devon Yacht Club Fireworks • Date: July 4, 2015.
  • • Rain Date: July 5, 2015.
  • • Time: 8:45 p.m. to 10:00 p.m. • Location: Waters of Napeague Bay, in Block Island Sound off Amagansett, NY in approximate position 40°59′41.40″ N., 072°06′08.70″ W. (NAD 83). 7.40 Rowayton Fireworks • Date: July 4, 2015. • Rain Date: July 5, 2015. • Time: 9:00 p.m. to 11:00 p.m. • Location: Waters of Long Island Sound south of Bayley Beach Park in Rowayton, CT in approximate position 41°03′11″ N., 073°26′41″ W. (NAD 83). 7.42 Connetquot River Summer Fireworks • Date: July 2, 2015. • Rain Date: July 3, 2015. • Time: 8:45 p.m. to 9:55 p.m. • Location: Waters of the Connetquot River off Snapper Inn Restaurant, Oakdale, NY in approximate position 40°43′32.38″ N., 073°9′02.64″ W. (NAD 83). 8.4 Town of Babylon Fireworks • Date: August 22, 2015. • Rain Date: August 23, 2015. • Time: 8:30 p.m. to 10:00 p.m. • Location: Waters off of Cedar Beach Town Park, Babylon, NY in approximate position 40°37′53″ N., 073°20′12″ W. (NAD 83). 9.1 East Hampton Fire Department Fireworks • Date: August 29, 2015.
  • • Rain Date: August 30, 2015.
  • • Time: 8:45 p.m. to 10:15 p.m. • Location: Waters off Main Beach, East Hampton, NY in approximate position 40°56′40.28″ N., 072°11′21.26″ W. (NAD 83). 9.4 The Creek Fireworks • Date: September 5, 2015. • Rain Date: September 6, 2015. • Time: 7:45 p.m. to 9:15 p.m. • Location: Waters of Long Island Sound off the Creek Golf Course, Lattingtown, NY in approximate position 40°54′13″ N., 073°35′58″ W. W. (NAD 83).
    Table 2 to § 165.151 1.6 Swim Across America Greenwich • Date: June 27, 2015. • Time: 5:30 a.m. to 10:30 a.m. • Location: All navigable waters of Stamford Harbor within a half mile long and 1,000 foot wide polygon shaped box stretching from Dolphin Cove to Rocky Point between Stamford and Greenwich, CT. Formed by connecting the following points. Beginning at point (A) 41°01′32.03″ N., 073°33′8.93″ W., then south east to point (B) 41°01′ 15.01″ N., 073°32′55.58″ W.; then south west to point (C) 41°00′49.25 N., 073°33′ 20.36″ W.; then north west to point (D) 41°00′58.00″ N., 073°33′27.00″ W., then north east to point (E) 41°01′15.80″ N., 073°33′09.85″ W., then heading north and ending at point (A) (NAD 83).

    Under the provisions of 33 CFR 100.100 and 33 CFR 165.151, the regatta, fireworks displays and swim event listed above are established as a special local regulation or safety zone. Under the provisions of 33 CFR 100.100 and 165.151, vessels may not enter the regulated area unless given permission from the COTP or a designated representative. Spectator vessels may transit outside the safety zones but may not anchor, block, loiter in, or impede the transit of other vessels. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.

    This notice is issued under authority of 33 CFR 100, 33 CFR 165 and 5 U.S.C. 552 (a). In addition to this notice in the Federal Register, the Coast Guard will provide the maritime community with advance notification of this enforcement period via the Local Notice to Mariners or marine information broadcasts. If the COTP determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.

    Dated: May 7, 2015. E.J. Cubanski, III, Captain, U.S. Coast Guard, Captain of the Port Sector Long Island Sound.
    [FR Doc. 2015-12103 Filed 5-18-15; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2015-0314] Drawbridge Operation Regulation; Long Island, New York Inland Waterway From East Rockaway Inlet to Shinnecock Canal, NY AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the operation of the Loop Parkway Bridge, mile 0.7, across Long Creek, and the Meadowbrook State Parkway Bridge, mile 12.8, across Sloop Channel, both at Hempstead, New York. This temporary deviation is necessary to facilitate the 2015 Dee Snider's Ride to Fight Hunger on Long Island. This temporary deviation allows two bridges to remain in the closed position during this public event.

    DATES:

    This deviation is effective from 11 a.m. to 1 p.m. on September 20, 2015.

    ADDRESSES:

    The docket for this deviation, [USCG-2015-0314] is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this deviation. You may also visit the Docket Management Facility in Room W12-140, on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC, 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, contact Ms. Judy K. Leung-Yee, Project Officer, First Coast Guard District, telephone (212) 514-4330, [email protected] If you have questions on viewing the docket, call Ms. Cheryl Collins, Program Manager, Docket Operations, telephone (202) 366-9826.

    SUPPLEMENTARY INFORMATION:

    The Loop Parkway Bridge, mile 0.7, across Long Creek has a vertical clearance in the closed position of 21 feet at mean high water and 25 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.799(f).

    The Meadowbrook State Parkway Bridge, mile 12.8, across Sloop Channel has a vertical clearance in the closed position of 22 feet at mean high water and 25 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.799(h). Long Creek and Sloop Channel are transited by commercial fishing and recreational vessel traffic.

    Long Island Cares, Inc. requested and the bridge owner for both bridges, the State of New York Department of Transportation, concurred with this temporary deviation from the normal operating schedule to facilitate a public event, the 2015 Dee Snider's Ride.

    Under this temporary deviation, the Loop Parkway and the Meadowbrook State Parkway Bridges may remain in the closed position between 11 a.m. and 1 p.m. on September 20, 2015.

    There are no alternate routes for vessel traffic; however, vessels that can pass under the closed draws during this closure may do so at any time. The bridges may be opened in the event of an emergency.

    The Coast Guard will inform the users of the waterways through our Local and Broadcast Notice to Mariners of the change in operating schedule for the bridges so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

    In accordance with 33 CFR 117.35(e), the drawbridges must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

    Dated: May 8, 2015. C.J. Bisignano, Supervisory Bridge Management Specialist, First Coast Guard District.
    [FR Doc. 2015-12112 Filed 5-18-15; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2015-0300] RIN 1625-AA00 Safety Zone; Agat Marina, Agat, Guam AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard will establish a safety zone in the waters of Agat Marina, Guam, to be enforced daily during the repairs to the Agat marina channel markers from 7:30 a.m. through 6:00 p.m. from May 25, 2015 through June 8, 2015 while the construction barge is in the channel. The safety zone will encompass all waters within 25 yards of the construction barge in the Agat Marina Channel. This safety zone is necessary to protect the crew working the channel markers, and the mariners from the hazards of the repairs taking place at the Agat Marina.

    DATES:

    This rule is effective from 7:30 a.m. May 25, 2015 through 6:00 p.m., (local Kilo time) on August 8, 2015. This rule is enforced daily Monday through Saturday from 7:30 a.m. to 6:00 p.m. May 25, 2015 through June 8, 2015 (local Kilo time).

    ADDRESSES:

    Documents indicated in this preamble as being available in the docket are part of docket USCG-2015-0300 and are available online by going to http://www.regulations.gov, inserting USCG-2015-0300 in the “Keyword” box, and then clicking “Search.” They are also available for inspection or copying at the Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary rule, call Chief Kristina Gauthier, U.S. Coast Guard Sector Guam at (671) 355-4866.

    If you have questions on viewing the docket, call Cheryl Collins, Program Manager, Docket Operations; telephone 202-366-9826, or 1-800-647-5527.

    SUPPLEMENTARY INFORMATION: Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking COTP Captain of the Port PAG Port Authority Guam Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the official notification of Agat Marina Channel repairs, and the need for this safety zone, was not finalized 60 days prior to the start of the repairs. Publishing an NPRM and delaying the effective date would be contrary to the public interest since the event would occur before the rulemaking process was complete, thereby jeopardizing the safety of the people and property unknowingly transiting or remaining in the area.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for not publishing an NPRM prior to making this rule effective 30 days after publication in the Federal Register. The COTP finds this good cause to be the immediate need for a safety zone to allay the aforementioned safety concerns surrounding the construction work to be undertaken at Agat Marina.

    Basis and Purpose

    The legal basis for this rule is the Coast Guard's authority to establish limited access areas: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-6, 160.5; Public Law 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1.

    A safety zone is a water area, shore area, or water and shore area, for which access is limited to authorized person, vehicles, or vessels for safety or environmental purposes. The purpose of this rulemaking is to protect mariners from the potential hazards associated with the construction barge operating in a narrow channel.

    Discussion of Rule

    In order to protect the public from the hazards of the construction associated with the channel marker replacement, the Coast Guard is establishing a temporary safety zone, enforced daily Monday through Saturday, from 7:30 a.m. to 6:00 p.m. May 25, 2015 through June 8, 2015 (Kilo, Local Time). Enforcement dates may need to be changed or adjusted in the event that sea or weather conditions are not conducive to safe operations. In the event of a change in dates the new dates and times will be broadcast in a Broadcast Notice to Mariners and transmited via email to all port partners. The safety zone is located within the Guam COTP Zone (See 33 CFR 3.70-15), and will cover all waters of the Agat Marina Channel located at 13 degrees 28 minutes 54 seconds North and 144 degrees 47 minutes 30 seconds East (NAD 1983), from the surface of the water to the ocean floor within 25 yards of the construction barge KIWI 1. There will be a no wake zone while transiting the entire channel. The general regulations governing safety zones contained in 33 CFR 165.23 apply. Any Coast Guard commissioned, warrant or petty officer, and any COTP representative permitted by law, may enforce the zone. The COTP may waive any of the requirements of this rule for any person, vessel, or class of vessel upon finding that application of the safety zone is unnecessary or impractical for the purpose of maritime safety. Vessels or persons violating this rule are subject to the penalties set forth in 33 U.S.C. 1232.

    Regulatory Analyses

    We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

    Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

    Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule would affect the following entities, some which might be small entities: The owners or operators of vessels intending to transit the Agat Marina Channel daily from 07:30 a.m. May 25, 2015 through 6 p.m. June 8, 2015. Due to the nature of the work to be undertaken to ensure the proper demarkation of the Agat Marina Channel, the channel will be adversely affected during the anticipated 14 days of construction. The narrowing of the channel in the area around the construction barge will require additional safety precautions be taken by local mariners. The safety zone will not have significant economic impact on a substantial number small entities for the following reasons. The nature of the work and location of the barge may cause some delays in the entering and exiting of the channel by small boat operators berthed in the Agat Marina, however traffic will still be allowed to transit around the construction barge with no wake. Before the activation of the zone, maritime advisories will be widely available to users of the channel.

    Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

    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.

    Collection of Information

    This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

    Federalism

    A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

    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 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.

    Taking of Private Property

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

    Civil Justice Reform

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

    Protection of Children

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

    Indian Tribal Governments

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

    Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

    Technical Standards

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

    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 concluded this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves is categorically excluded from further environmental documentation because it is a regulation establishing a safety zone. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES.

    List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard amends 33 CFR 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. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.

    2. Add § 165.T14-300 to read as follows:
    § 165.T14-300 Safety Zone; Agat Marina, Agat, Guam.

    (a) Location. The following area, within the Guam COTP Zone (See 33 CFR 3.70-15), from the surface of the water to the ocean floor, is a safety zone: 25 yards around the construction barge KIWI 1 in the waters of Agat Marina, Guam located at 13 degrees 28 minutes 54 seconds North and 144 degrees 47 minutes 30 seconds East (NAD 1983). There is a no wake zone established for the entire length of the Agat Channel.

    (b) Effective Dates. This rule is effective from 7:30 a.m. May 25, 2015 through 6:00 p.m. on August 8, 2015 (Kilo, Local Time) while the construction barge KIWI 1 is in the channel.

    (c) Regulations. The general regulations governing safety zones contained in 33 CFR 165.23 apply. Entry into, transit through or anchoring within this zone is prohibited unless authorized by the COTP or a designated representative thereof. Authorization can be requested from PAG Harbor Master via phone at (671) 477-5931 ext 533.

    (d) Enforcement. This rule is enforced daily Monday through Saturday from 7:30 a.m. to 6:00 p.m. May 25, 2015 through June 8, 2015 (Kilo, Local Time) while the construction barge KIWI 1 is in the channel. Any Coast Guard commissioned, warrant, or petty officer, and any other COTP representative permitted by law, may enforce this temporary safety zone.

    (e) Waiver. The COTP may waive any of the requirements of this rule for any person, vessel, or class of vessel upon finding that application of the safety zone is unnecessary or impractical for the purpose of maritime security.

    (f) Penalties. Vessels or persons violating this rule are subject to the penalties set forth in 33 U.S.C. 1232.

    Dated: April 30, 2015. James B. Pruett, Captain, U.S. Coast Guard, Captain of the Port Guam.
    [FR Doc. 2015-12121 Filed 5-18-15; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Patent and Trademark Office 37 CFR Part 42 [Docket No. PTO-P-2015-0032] RIN 0651-AD00 Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board AGENCY:

    Patent Trial and Appeal Board, United States Patent and Trademark Office, U.S. Department of Commerce.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule amends the existing consolidated set of rules relating to the United States Patent and Trademark Office (Office or USPTO) trial practice for inter partes review, post-grant review, the transitional program for covered business method patents, and derivation proceedings that implemented provisions of the Leahy-Smith America Invents Act (“AIA”) providing for trials before the Office.

    DATES:

    Effective Date: This rule is effective May 19, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Susan L. C. Mitchell, Lead Administrative Patent Judge by telephone at (571) 272-9797.

    SUPPLEMENTARY INFORMATION:

    Executive Summary: Purpose: This final rule increases the page limitations for briefing for Patent Owner's motion to amend and for Petitioner's reply brief in response to comments from the public. This final rule also addresses clarifying changes to the rules so that they conform to Office practice in conducting AIA proceedings.

    Summary of Major Provisions: In an effort to gauge the effectiveness of the rules governing AIA trials, the Office conducted a nationwide listening tour in April and May of 2014, and in June 2014, published a Federal Register Notice asking for public feedback about the AIA trial proceedings. The Office has carefully reviewed the comments and, in response to public input, will issue two rules packages; a first, final rule package with more ministerial changes to the rules, and a second, proposed rule package that will issue later to address more involved changes to the rules and the Office Patent Trial Practice Guide. The Office presents the following final rules to address issues concerning Patent Owner's motion to amend and Petitioner's reply brief that involve ministerial changes, and will address public comments relating to those specific issues only, in this first, final rule package. For instance, the following final rules provide ten additional pages for a Patent Owner motion to amend, allow a claims appendix for a motion to amend, and provide ten additional pages for Petitioner's reply brief.

    These final rules also provide changes to conform the rules to the Office's established practices in handling AIA proceedings. For instance, the final rules require a specific font to ensure readability of briefs, clarify that more than one back-up counsel can be named, and clarify how to count challenged claims to calculate fees. The final rules also clarify that providing a statement of material fact by a party is optional and that routine discovery contemplates only cross-examination of affidavit testimony prepared for the proceeding. The final rules further provide that uncompelled direct testimony must be in the form of an affidavit, not a deposition; that motions in limine are not used in AIA practice; that objections to evidence should be made part of the record by filing them; and that only a single request for rehearing may be filed as of right. Finally, with regard to covered business method patent reviews, the final rules clarify, consistent with the AIA, that such reviews may be extended in the case of joinder and that no petition for a covered business method patent review may be filed if the petitioner or real party-in-interest filed a civil action challenging the validity of a claim of the covered business method patent.

    Costs and Benefits: This rulemaking is not economically significant, and is not significant, under Executive Order 12866 (Sept. 30, 1993), as amended by Executive Order 13258 (Feb. 26, 2002) and Executive Order 13422 (Jan. 18, 2007).

    Background Development of the Final Rule

    On September 16, 2011, the AIA was enacted into law (Pub. L. 112-29, 125 Stat. 284 (2011)), and shortly thereafter in 2012, the Office implemented rules to govern Office trial practice for AIA proceedings, including inter partes review, post-grant review, the transitional program for covered business method patents, and derivation proceedings pursuant to 35 U.S.C. 135, 316 and 326 and AIA 18(d)(2). See Rules of Practice for Trials Before the Patent Trial and Appeal Board and Judicial Review of Patent Trial and Appeal Board Decisions, 77 FR 48,612 (Aug. 14, 2012); Changes to Implement Inter Partes Review Proceedings, Post-Grant Review Proceedings, and Transitional Program for Covered Business Method Patents, 77 FR 48,680 (Aug. 14, 2012); Transitional Program for Covered Business Method Patents—Definitions of Covered Business Method Patent and Technological Invention, 77 FR 48,734 (Aug. 14, 2014). Additionally, the Office published a Patent Trial Practice Guide for the rules to advise the public on the general framework of the regulations, including the structure and times for taking action in each of the new proceedings. See Office Patent Trial Practice Guide, 77 FR 48,756 (Aug. 14, 2012).

    In an effort to gauge the effectiveness of the rules governing AIA trials, the Office conducted a nationwide listening tour in April and May of 2014. During the listening tour, the Office focused particularly on transparency and public involvement in making trial proceedings more effective going forward by adjusting the rules and guidance where necessary. As a result, in June of 2014, the Office published a Request for Comments in the Federal Register and, at stakeholder request, extended the period for receiving comments to October 16, 2014. See Request for Comments on Trial Proceedings Under the America Invents Act Before the Patent Trial and Appeal Board, 79 FR 36,474 (June 27, 2014).

    The Request for Comments asked seventeen questions on ten broad topics, including a general catchall question, to elicit any proposed changes to the AIA post-grant program that stakeholders suggest would be beneficial. See Request for Comments, 79 FR at 36,476-77. The Office received thirty-seven comments from bar associations, corporations, law firms, and individuals, encompassing a wide range of issues. The Office expresses its gratitude for the thoughtful and comprehensive comments provided by the public, which are available on the USPTO Web site: http://www.uspto.gov/page/comments-trial-proceedings-under-america-invents-act-patent-trial-and-appeal-board.

    Several commenters expressed satisfaction with the current AIA post-grant programs, and several commenters offered suggestions on how to strengthen the AIA post-grant programs. For example, some suggestions concerned the claim construction standard used by the PTAB, motions to amend, discovery procedures, and handling of multiple proceedings. The Office will address all public comments that do not involve changes to the page limitations for Patent Owner's motion to amend or Petitioner's reply brief in the second, proposed rule package.

    Discussion of Specific Final Rules Subpart A—Trial Practice and Procedure Patent Owner's Motion To Amend a. Amendments to the Rules

    In response to comments received from the public concerning amendment practice in AIA proceedings, the Office is increasing the page limitation for Patent Owner's motion to amend by ten pages and allowing a claims appendix that is not included in the page limitation. To implement this increase in the page limitation for a motion to amend from fifteen to twenty-five pages, exclusive of any claims appendix, with a commensurate increase in the number of pages for an opposition to a motion to amend, the Office amends 37 CFR 42.24(a) and (c), 42.121(b), and 42.221(b) as follows:

    • Amend 37 CFR 42.24(a)(1) to add the phrase “or claim listing” after “or appendix of exhibits.”

    • Amend 37 CFR 42.24(a)(1)(v) to read “Motions (excluding Motions to Amend): 15 pages”; and add (vi) to read “Motions to Amend: 25 pages.”

    • Amend 37 CFR 42.24(c)(2) to read “Replies to oppositions (excluding replies to oppositions to Motions to Amend): 5 pages”; and add (3) to read “Replies to oppositions to Motions to Amend: 12 pages.”

    • Amend 37 CFR 42.121(b) to read “Content. A motion to amend claims must include a claim listing, which claim listing may be contained in an appendix to the motion, show the changes clearly, and set forth . . . .”

    • Amend 37 CFR 42.221(b) to read “Content. A motion to amend claims must include a claim listing, which claim listing may be contained in an appendix to the motion, show the changes clearly, and set forth . . . .”

    b. Response to Comments

    Comments: Although some comments advocated no change to the Office's motion to amend practice in AIA proceedings, numerous comments suggested relaxing the page limitation on Patent Owner's motion to amend. Several comments proposed a specific number of additional pages, and/or permitting the listing of claims in an appendix not counted toward the page limit. One comment suggested a flexible page limit based on the number of substitute claims proposed, and one comment suggested that the Board more freely grant requests for additional pages. Another comment suggested permitting the patent owner to allocate unutilized pages from the patent owner's response to the motion to amend.

    Response: The overall request to relax the page limitation on Patent Owner's motion to amend is adopted. As set forth above, the Office amends 37 CFR 42.24(a) to increase the page limit for motions to amend from 15 pages to 25 pages. Applying the provision of 37 CFR 42.24(b)(3) mandating an equal page limitation for oppositions, the page limit for oppositions to motions to amend also increases from 15 pages to 25 pages. The Office also amends 37 CFR 42.24(c) to increase the page limit for replies to oppositions to motions to amend from 5 pages to 12 pages. Also, the Office amends 37 CFR 42.121(b) and 37 CFR 42.221(b) to permit an appendix for the claim listing accompanying a motion to amend that is not counted toward the 25-page limitation.

    The specific request for a flexible page limit based on the number of substitute claims is not adopted. This procedure is not warranted in light of the above amendments relaxing the page limitation on Patent Owner's motion to amend. In addition, this approach may encourage parties to increase unnecessarily the number of substitute claims presented solely to procure additional pages for the motion. In accord with the specific request that the Board more freely grant requests for additional pages, however, the Board will continue to consider requests for additional pages on a case-by-case basis.

    The specific request that a patent owner be able to allocate pages from the patent owner's response to a motion to amend is not adopted. This procedure is not warranted in light of the above amendments relaxing the page limitation on Patent Owner's motion to amend. In addition, this procedure would be difficult to administer in light of the above amendments, placing an undue administrative burden on the Office to determine and monitor the total number of pages allocated to the patent owner, to the petitioner's opposition to the motion to amend, and to any reply.

    Petitioner's Reply a. Amendments to the Rules

    In response to comments received from the public, the Office is increasing the page limitation for Petitioner's reply brief to Patent Owner's response to petition by 10 pages. To implement this increase in the page limitation for Petitioner's reply brief from fifteen to twenty-five pages, the Office amends 37 CFR 42.24(c)(1) to read: “Replies to patent owner responses to petitions: 25 pages.”

    b. Response to Comments

    Comments: Although at least one commenter wanted no change, several commenters suggested that the fifteen pages afforded for a Petitioner's reply brief is not commensurate with the number of pages afforded to Patent Owner, especially if Patent Owner raises new issues. Commenters suggested that increasing the page limitation for Petitioner's reply brief would allow a more complete record before the Office. One comment suggested that to provide Petitioner with a fair opportunity to respond, the number of pages afforded for Petitioner's reply brief may correspond to the number of pages in Patent Owner's post-institution response that is devoted to new issues.

    Response: The overall request to relax page limitations on Petitioner's reply brief to Patent Owner's response is adopted. As set forth above, the Office amends 37 CFR 42.24(c)(1) to increase the page limit for Petitioner's reply brief from 15 to 25 pages.

    The specific request for a flexible page limit based on new issues raised in Patent Owner's response is not adopted. This procedure is not warranted in light of the above amendment relaxing the page limitation on Petitioner's reply brief. In addition, this procedure would be difficult to administer, placing an undue administrative burden on the Office to determine the total number of pages allocated by Patent Owner to new issues.

    Required Font

    In AIA post-grant proceeding filings, the Office has required either a proportional or monospaced font that is 14-point or larger, with an additional requirement that any monospaced font must not contain more than four characters per centimeter or ten characters per inch. See 37 CFR 42.6(a)(2)(ii). The Office has received briefs from parties that utilize narrow fonts that may be compliant with these requirements, but nevertheless, have proved difficult to read. To address this concern, the Office is amending 37 CFR 42.6(a)(2) to require 14-point, Times New Roman proportional font, with normal spacing, to ensure readability of all briefs.

    Counsel

    To clarify the rule regarding designation of counsel for an AIA proceeding that more than one back-up counsel may be designated, the Office amends 37 CFR 42.10 as follows:

    • Replace the article “a” before “back-up counsel” with “at least one” in 37 CFR 42.10(a).

    Fees

    The Office has explained in the Office Patent Trial Practice Guide that to understand the scope of a dependent claim, the claim(s) from which the dependent claim depends must be construed along with the dependent claim. Therefore, to calculate any fee due under 37 CFR 42.15 that is based on the number of claims, each claim challenged will be counted as well as any claim from which a challenged claim depends, unless the parent claim is also separately challenged. See Rules of Practice for Trials Before the Patent Trial and Appeal Board and Judicial Review of Patent Trial and Appeal Board Decisions; Final Rule, 77 FR 48,612, 48,619 (Aug. 14, 2012).

    To clarify the fees rule to reflect explicitly this requirement to include unchallenged claims from which a challenged claim depends in the claim count for fee calculating purposes, the Office is amending 37 CFR 42.15 as follows:

    • Add the content “, including unchallenged claims from which a challenged claim depends” after the text “each claim in excess of 20” in 37 CFR 42.15(a)(3) and 42.15(b)(3).

    • Delete the first instance of the phrase “request fee” in the following phrase “Post-Grant or Covered Business Method Patent Review request fee Post-Institution request fee” in 42.15(b)(4).

    • Add the content “, including unchallenged claims from which a challenged claim depends” after the text “each claim in excess of 15” in 37 CFR 42.15(a)(4) and 42.15(b)(4).

    Oppositions and Replies and Page Limits for Petitions, Motions, Oppositions, and Replies

    To clarify that supplying a statement of material fact by a party is optional, the Office amends 37 CFR 42.23 and 42.24 as follows:

    • Replace the phrase “and must include a statement identifying material facts in dispute” from the first sentence of 37 CFR 42.23(a) with “and, if the paper to which the opposition or reply is responding contains a statement of material fact, must include a listing of facts that are admitted, denied, or cannot be admitted or denied.”

    • Replace the phrase “the required” with “any” in the first sentence of 37 CFR 42.24(c).

    Discovery

    To clarify that routine discovery includes only the cross-examination of affidavit testimony prepared for the proceeding, the Office amends 37 CFR 42.51(b)(1)(ii) to add the phrase “prepared for the proceeding” after “affidavit testimony.”

    Taking Testimony

    Because uncompelled direct testimony must be submitted in the form of an affidavit, the Office is amending 37 CFR 42.53(c)(2) as follows:

    • Delete the word “deposition” from the phrase “uncompelled direct deposition testimony.”

    To clarify that either party is permitted to file testimony as an exhibit, the Office amends 37 CFR 42.53(f)(7) to delete the phrase “by proponent” in the second sentence.

    Motion in Limine

    The term motion in limine is included in the title for 37 CFR 42.64, but the rule does not provide for a motion in limine. To clarify the rule, the Office amends 37 CFR 42.64 to delete “motion in limine” from the title of the rule.

    Objection

    The Office amends 37 CFR 42.64(b)(1) for consistency with the Office Patent Trial Practice Guide. The Office Patent Trial Practice Guide requires that a party wishing to challenge admissibility of evidence must object timely to the evidence. Therefore, the Office Patent Trial Practice Guide states that a motion to exclude evidence requires a party to identify where in the record the objection originally was made, but 37 CFR 42.64(b)(1) merely requires service of objections to evidence, which does not make such objections part of the record. Therefore, the Office amends the first and second sentences of 37 CFR 42.64(b)(1) to replace “served” with “filed” so as to require filing of objections, which also requires service under 37 CFR 42.6(e)(2).

    Decision on Petition or Motions

    To clarify that a party may file only a single request for rehearing as of right, the Office amends 37 CFR 42.71(d) to add “single” before “request for rehearing” in the first sentence.

    Subpart D—Transitional Program for Covered Business Method Patents Procedure and Pendency

    To clarify that the pendency of a covered business method patent review proceeding can be extended in the case of joinder and to harmonize the rule with similar rules in other post grant proceedings, the Office amends 37 CFR 42.300(c) to add “, or adjusted by the Board in the case of joinder” at the end of the second sentence after “Chief Administrative Patent Judge.”

    Who May Petition for a Covered Business Method Patent Review

    The Office may not institute a covered business method patent review of a challenged patent when the petitioner filed a civil action challenging the validity of a claim of the patent before filing the petition. See AIA section 18(a)(1); 35 U.S.C. 325(a)(1); SecureBuy, LLC v. CardinalCommerce Corp., Case CBM2014-00035 (PTAB Apr. 25, 2014) (Paper 12) (precedential). To state this prohibition explicitly, the Office amends 37 CFR 42.302 to add a section (c) as set forth in the regulatory text of this rule.

    Rulemaking Considerations

    A. Administrative Procedure Act (APA): This final rule revises the consolidated set of rules relating to Office trial practice for inter partes review, post-grant review, the transitional program for covered business method patents, and derivation proceedings. The changes being adopted in this rule do not change the substantive criteria of patentability. These changes involve rules of agency practice. See, e.g., 35 U.S.C. 316(a)(5), as amended. http://www.cruiseamerica_.com/rent/our_vehicles/ These rules are procedural and/or interpretive rules. See Bachow Commc'ns Inc. v. F.C.C., 237 F.3d 683, 690 (D.C. Cir. 2001) (rules governing an application process are procedural under the Administrative Procedure Act); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001) (rules for handling appeals were procedural where they did not change the substantive requirements for reviewing claims); Nat'l Org. of Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (rule that clarifies interpretation of a statute is interpretive); JEM Broad. Co. v. F.C.C., 22 F.3d 320, 328 (D.C. Cir. 1994) (rules are not legislative because they do not “foreclose effective opportunity to make one's case on the merits”).

    Accordingly, prior notice and opportunity for public comment are not required pursuant to 5 U.S.C. 553(b) or (c) (or any other law), and thirty-day advance publication is not required pursuant to 5 U.S.C. 553(d) (or any other law). See Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), do not require notice and comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice”) (quoting 5 U.S.C. 553(b)(A)); U.S. v. Gould, 568 F.3d 459, 476 (4th Cir. 2009) (“The APA also requires publication of any substantive rule at least 30 days before its effective date, 5 U.S.C. 553(d), except where the rule is interpretive . . . .”).

    B. Regulatory Flexibility Act: As prior notice and an opportunity for public comment are not required pursuant to 5 U.S.C. 553 or any other law, neither a regulatory flexibility analysis nor a certification under the Regulatory Flexibility Act (5 U.S.C. 601-612) is required. See 5 U.S.C. 603.

    C. Executive Order 12866 (Regulatory Planning and Review): This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993).

    D. Executive Order 13563 (Improving Regulation and Regulatory Review): The Office has complied with Executive Order 13563. Specifically, the Office has, to the extent feasible and applicable: (1) Made a reasoned determination that the benefits justify the costs of the rule; (2) tailored the rule to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector and the public as a whole, and provided on-line access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.

    E. Executive Order 13132 (Federalism): This rulemaking does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).

    F. Executive Order 13175 (Tribal Consultation): This rulemaking will not: (1) Have substantial direct effects on one or more Indian tribes; (2) impose substantial direct compliance costs on Indian tribal governments; or (3) preempt tribal law. Therefore, a tribal summary impact statement is not required under Executive Order 13175 (Nov. 6, 2000).

    G. Executive Order 13211 (Energy Effects): This rulemaking is not a significant energy action under Executive Order 13211 because this rulemaking is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211 (May 18, 2001).

    H. Executive Order 12988 (Civil Justice Reform): This rulemaking meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden as set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996).

    I. Executive Order 13045 (Protection of Children): This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (Apr. 21, 1997).

    J. Executive Order 12630 (Taking of Private Property): This rulemaking will not affect a taking of private property or otherwise have taking implications under Executive Order 12630 (Mar. 15, 1988).

    K. Congressional Review Act: Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), prior to issuing any final rule, the United States Patent and Trademark Office will submit a report containing the rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this final rule are not expected to result in an annual effect on the economy of 100 million dollars or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this final rule is not a “major rule” as defined in 5 U.S.C. 804(2).

    L. Unfunded Mandates Reform Act of 1995: The changes set forth in this rulemaking do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of 100 million dollars (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of 100 million dollars (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.

    M. National Environmental Policy Act: This rulemaking will not have any effect on the quality of the environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq.

    N. National Technology Transfer and Advancement Act: The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this rulemaking does not contain provisions which involve the use of technical standards.

    O. Paperwork Reduction Act: The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3549) requires that the Office consider the impact of paperwork and other information collection burdens imposed on the public. This final rule involves information collection requirements which are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3549). This rulemaking does not add any additional information requirements or fees for parties before the Board. Therefore, the Office is not resubmitting information collection packages to OMB for its review and approval because the revisions in this rulemaking do not materially change the information collections approved under OMB control number 0651-0069.

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

    List of Subjects in 37 CFR Part 42

    Administrative practice and procedure, inventions and patents.

    For the reasons set forth in the preamble, 37 CFR part 42 is amended as follows.

    PART 42—TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD 1. The authority citation for 37 CFR part 42 continues to read as follows: Authority:

    35 U.S.C. 2(b)(2), 6, 21, 23, 41, 135, 311, 312, 316, 321-326 and Public Law 112-29.

    Subpart A—Trial Practice and Procedure 2. Section 42.6 is amended by revising paragraph (a)(2)(ii) to read as follows:
    § 42.6 Filing of documents, including exhibits; service.

    (a) * * *

    (2) * * *

    (ii) 14-point, Times New Roman proportional font, with normal spacing, must be used;

    3. Section 42.10 is amended by revising paragraph (a) to read as follows:
    § 42.10 Counsel.

    (a) If a party is represented by counsel, the party must designate a lead counsel and at least one back-up counsel who can conduct business on behalf of the lead counsel.

    4. Section 42.15 is amended by revising paragraphs (a)(3), (a)(4), (b)(3), and (b)(4) to read as follows:
    § 42.15 Fees.

    (a) * * *

    (3) In addition to the Inter Partes Review request fee, for requesting review of each claim in excess of 20, including unchallenged claims from which a challenged claim depends: $200.00.

    (4) In addition to the Inter Partes Post-Institution request fee, for requesting review of each claim in excess of 15, including unchallenged claims from which a challenged claim depends: $400.00.

    (b) * * *

    (3) In addition to the Post-Grant or Covered Business Method Patent Review request fee, for requesting review of each claim in excess of 20, including unchallenged claims from which a challenged claim depends: $250.00.

    (4) In addition to the Post-Grant or Covered Business Method Patent Review Post-Institution request fee, for requesting review of each claim in excess of 15, including unchallenged claims from which a challenged claim depends: $550.00.

    5. Section 42.23 is amended by revising the first sentence of paragraph (a) to read as follows:
    § 42.23 Oppositions and replies.

    (a) Oppositions and replies must comply with the content requirements for motions and, if the paper to which the opposition or reply is responding contains a statement of material fact, must include a listing of facts that are admitted, denied, or cannot be admitted or denied. * * *

    6. Section 42.24 is amended by revising paragraphs (a)(1) introductory text and (a)(1)(v), the first sentence of paragraph (c) introductory text, and paragraphs (c)(1) and (c)(2), and adding paragraphs (a)(1)(vi) and (c)(3) to read as follows:
    § 42.24 Page limits for petitions, motions, oppositions, and replies.

    (a) Petitions and motions.

    (1) The following page limits for petitions and motions apply and include any statement of material facts to be admitted or denied in support of the petition or motion. The page limit does not include a table of contents, a table of authorities, a certificate of service, or appendix of exhibits or claim listing.

    (v) Motions (excluding Motions to Amend): 15 pages.

    (vi) Motions to Amend: 25 pages.

    (c) Replies. The following page limits for replies apply and include any statement of facts in support of the reply. * * *

    (1) Replies to patent owner responses to petitions: 25 pages.

    (2) Replies to oppositions (excluding replies to oppositions to Motions to Amend): 5 pages.

    (3) Replies to oppositions to Motions to Amend: 12 pages.

    7. Section 42.51 is amended by revising paragraph (b)(1)(ii) to read as follows.
    § 42.51 Discovery.

    (b) * * *

    (1) * * *

    (ii) Cross examination of affidavit testimony prepared for the proceeding is authorized within such time period as the Board may set.

    8. Section 42.53 is amended by revising paragraphs (c)(2) and (f)(7) to read as follows:
    § 42.53 Taking testimony.

    (c) * * *

    (2) Unless stipulated by the parties or ordered by the Board, cross-examination, redirect examination, and re-cross examination for uncompelled direct testimony shall be subject to the follow time limits: Seven hours for cross-examination, four hours for redirect examination, and two hours for re-cross examination.

    (f) * * *

    (7) Except where the parties agree otherwise, the proponent of the testimony must arrange for providing a copy of the transcript to all other parties. The testimony must be filed as an exhibit.

    9. Section 42.64 is amended by revising the section heading and the first two sentences of paragraph (b)(1) to read as follows.
    § 42.64 Objection; motion to exclude.

    (b) * * *

    (1) Objection. Any objection to evidence submitted during a preliminary proceeding must be filed within ten business days of the institution of the trial. Once a trial has been instituted, any objection must be filed within five business days of service of evidence to which the objection is directed. * * *

    10. Section 42.71 is amended by revising the first sentence of paragraph (d) to read as follows:
    § 42.71 Decisions on petitions or motions.

    (d) Rehearing. A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. * * *

    Subpart B—Inter Partes Review 11. Section 42.121 is amended by revising paragraph (b) introductory text to read as follows:
    § 42.121 Amendment of the patent.

    (b) Content. A motion to amend claims must include a claim listing, which claim listing may be contained in an appendix to the motion, show the changes clearly, and set forth:

    Subpart C—Post-Grant Review 12. Section 42.221 is amended by revising paragraph (b) introductory text to read as follows:
    § 42.221 Amendment of the patent.

    (b) Content. A motion to amend claims must include a claim listing, which claim listing may be contained in an appendix to the motion, show the changes clearly, and set forth:

    Subpart D—Transitional Program for Covered Business Method Patents 13. Section 42.300 is amended by revising paragraph (c) to read as follows:
    § 42.300 Procedure; pendency.

    (c) A covered business method patent review proceeding shall be administered such that pendency before the Board after institution is normally no more than one year. The time can be extended by up to six months for good cause by the Chief Administrative Patent Judge, or adjusted by the Board in the case of joinder.

    14. Section 42.302 is amended by adding paragraph (c) to read as follows:
    § 42.302 Who may petition for a covered business method patent review.

    (c) A petitioner may not file a petition to institute a covered business method patent review of the patent where, before the date on which the petition is filed, the petitioner or real party-in-interest filed a civil action challenging the validity of a claim of the patent.

    Dated: May 14, 2015. Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.
    [FR Doc. 2015-12117 Filed 5-18-15; 8:45 am] BILLING CODE 3510-16-P
    80 96 Tuesday, May 19, 2015 Proposed Rules DELAWARE RIVER BASIN COMMISSION 18 CFR Part 410 Proposed Amendments to the Rules of Practice and Procedure To Allow Each Signatory Party and the DRBC To Administer a Single Process for the Review and Adjudication of Projects AGENCY:

    Delaware River Basin Commission.

    ACTION:

    Proposed rule; notice of public hearing.

    SUMMARY:

    The Commission will hold a public hearing to receive comments on proposed amendments to its Administrative Manual Part III—Rules of Practice and Procedure (18 CFR part 401) to provide for DRBC and each of the parties to the Delaware River Basin Compact (United States Public Law 87-328, Approved September 27, 1961, 75 Statutes at Large 688; 53 Delaware Laws, Chapter 71, Approved May 26, 1961; New Jersey Laws of 1961, Chapter 13, Approved May 1, 1961; New York Laws of 1961, Chapter 148, Approved March 17, 1961; and Pennsylvania Acts of 1961, Act No. 268, Approved July 7, 1961 (“the Compact”)—Delaware, New Jersey, New York, Pennsylvania and the federal government (“Signatory Parties”)—to coordinate and collaborate in the administration of a single process for the review and adjudication of projects. The program, called “One Process/One Permit,” (also herein, “the Program”) will allow DRBC and administrative agencies of the Signatory Parties participating in the Program to incorporate the requirements and determinations of both DRBC and the Signatory Party agency into a single permit or other approval instrument.

    DATES:

    The public hearing will start on or around 2 p.m. on Tuesday, June 9, 2015, during the Commission's regularly scheduled public hearing. The hearing will continue until all those wishing to testify have had an opportunity to do so. Depending upon the number of people wishing to speak, the hearing officer may impose time limits on speakers. Written comments will be accepted by any of the means described below and must be received by 5:00 p.m. on Wednesday, July 1, 2015. More information regarding the procedures for the hearing and comments is set forth in the section “Oral Testimony and Written Comments.”

    ADDRESSES:

    The public hearing will be held at the Washington Crossing Historic Park Visitor's Center at 1112 River Road in Washington Crossing, Pennsylvania. Please check washingtoncrossingpark.org/contact/ for directions, as Internet mapping services provide unreliable directions to this location.

    Oral Testimony and Written Comments: Persons wishing to testify at the hearing are asked to register in advance by contacting Paula Schmitt at 609-883-9500, ext. 224 or [email protected] Written comments may be submitted as follows: If by email (preferred), to [email protected]; by fax, to Commission Secretary at 609-883-9522; by U.S. Mail, to Commission Secretary, DRBC, P.O. Box 7360, West Trenton, NJ 08628-0360; or by overnight mail, to Commission Secretary, DRBC, 25 State Police Drive, West Trenton, NJ 08628-0360. Comments also may be delivered by hand at any time during DRBC's regular office hours (Monday through Friday, 8:30 a.m. through 5:00 p.m. except on national holidays) until the close of the comment period. In all cases, please include the commenter's name, address and affiliation, if any, in the comment document and “One Process/One Permit” or “OPOP” in the subject line.

    FOR FURTHER INFORMATION CONTACT:

    The rule text is available on the DRBC Web site, DRBC.net. Also posted to the Web site are an extensive FAQ document; DRBC Resolution No. 2015-4, authorizing the Executive Director to initiate rulemaking and enter into an administrative agreement with the New Jersey Department of Environmental Protection (NJDEP) for demonstration of the Program; and the administrative agreement between DRBC and the NJDEP to provide for the demonstration program, which includes provisions for fully implementing One Process/One Permit once a final rule has been adopted. Detailed procedures of the DRBC for public hearings, public meetings and “Public Dialogue” are available on the web at: http://www.state.nj.us/drbc/library/documents/procedures120414.pdf. For further information, please contact Commission Secretary Pamela M. Bush, 609-477-7203.

    SUPPLEMENTARY INFORMATION: Background

    Because DRBC and its Signatory Parties share common water resource management objectives, sponsors of many water resource-related projects in the Delaware River Basin are currently required to apply to both the DRBC and a state agency, among others, for approvals. The proposed rule provides for DRBC and the administrative agencies of the Signatory Parties to identify regulatory programs that by mutual agreement will be managed through a single process resulting in one decision or approval. Agreements between DRBC and federal agencies are possible under the rule, but none are currently contemplated.

    One Process/One Permit is intended to promote interagency cooperation and collaboration on shared mission objectives, achieve regulatory program efficiencies, avoid unnecessary duplication of effort, and reduce the potential for confusion on the part of regulated entities and the public. The regulatory standards and authorities of the DRBC and each of its Signatory Parties are expressly preserved by the Program, including in the proposed rule. The more protective of the applicable DRBC or Signatory Party agency's requirements will be included in each permit or approval issued under the Program.

    The proposed rule provides for DRBC and each Signatory Party agency choosing to implement One Process/One Permit to enter into an administrative agreement that identifies the types of projects and approvals to be covered. Initially, the Program is expected to be implemented for (a) withdrawals of basin waters subject to both DRBC review and state allocation programs; and (b) wastewater discharges subject to DRBC review and the state-administered National Pollutant Discharge Elimination System (NPDES) program. For water withdrawals, the lead agency under One Process/One Permit may be the state or the DRBC, depending upon current state programs. The delegated state environmental agencies will be lead agencies for the review of wastewater discharges. Other regulatory programs, such as programs relating to floodplain management, could be included in the future. All administrative agreements between DRBC and agencies of the Signatory Parties for implementing One Process/One Permit will be subject to Commission approval following a public hearing.

    Authority

    Sections 1.5 and 3.9 of the Compact and existing DRBC rules allow and encourage the Commission to use the agencies of the Signatory Parties wherever feasible and advantageous consistent with the Compact. Accordingly, under the proposed rule, permits issued by Signatory Party agencies may include a finding required by Section 3.8 of the Compact. Specifically, after the rule and amended agreements are in place, based on the appropriate level of review and a recommendation by the DRBC staff, approvals issued under the Program may include the finding that when operated in accordance with the terms and conditions of the approval, the activities regulated by the approval will not substantially impair or conflict with DRBC's comprehensive plan.

    Operation of the Program

    Under the proposed rule, an application for initial approval, renewal or revision of project activities subject to the One Process/One Permit program will be filed only with the lead agency. This does not mean that the DRBC or others will not be involved in the review of applications for new and renewal water withdrawal and discharge projects. Rather, DRBC and the Signatory Party agency will follow a single process, and reviews will be performed more efficiently and more collaboratively.

    Consistent with the proposed rule, the agreements between DRBC and Signatory Party agencies will provide for a level of DRBC review appropriate to the circumstances. Some reviews, such as those for simple and standard renewals of existing permits, may be significantly streamlined or subject to inter-agency notifications only. Others, including to implement standards for which the DRBC staff have special expertise, will involve substantial DRBC staff effort. For example, under the wastewater discharge program, DRBC staff will continue to perform modeling to determine “No Measurable Change” requirements for the Commission's Special Protection Waters program and to calculate an alternative mixing zone for a discharge of treated industrial wastewater to the Delaware Estuary. For certain projects, DRBC staff also will continue to identify conditions of approval to ensure that projects subject to review under the Compact and implementing regulations do not impair or conflict with the Commission's comprehensive plan. The purpose of One Process/One Permit is to eliminate unnecessary effort, not to eliminate effort needed to fully review a project under all applicable standards and rules. Under the Program, each party continues to recognize the authority of the other to promulgate rules, regulations and standards. The rule does not change that authority.

    Notably, a separate DRBC review and decision for water withdrawal and discharge activities will still be required in certain cases, such as when a new project must be incorporated into the Commission's comprehensive plan. Both parties also will retain the right to act separately, such as in the instances, anticipated to be rare, where the parties cannot agree on the terms and conditions of approval. Certain categories of projects that are subject to DRBC review will not be covered by the Program, and the Executive Director and Commissioners will have the ability to remove a project from the Program. However, the objective of One Process/One Permit is to encompass most, if not all, elements of the review and approval for covered projects.

    The proposed rule does not modify the existing project review fee schedule of the DRBC or that of any Signatory Party agency. Although One Process/One Permit is expected to improve process efficiency, in many instances as described above, the DRBC will devote significant resources and work effort to review projects and support its regulatory programs. Accordingly, the DRBC regulatory program will continue for the present to be supported by its existing regulatory program fees. The Commission's fee schedule set forth in Resolution No. 2009-2 will remain in effect unless and until the Commission amends it through rulemaking or a comparable public process. Under One Process/One Permit, all DRBC fees applicable under current practices will continue to be paid directly to the Commission.

    The proposed rule provides that persons aggrieved by the final action of a state agency on behalf of the Commission under One Process/One Permit must exhaust their administrative remedies under the law of the Signatory Party agency that issued the decision.

    New Jersey Demonstration Program

    By Resolution No. 2015-4 approved by the Commission on March 11, 2015, DRBC and NJDEP have agreed to “practice” using new collaborative processes between the two agencies for the review of wastewater discharge applications, pending the adoption of a new rule such as the one proposed today. The agreement between DRBC and NJDEP provides for the demonstration program and sets forth provisions needed to fully implement One Process/One Permit once a final rule has been adopted. In the event that a project reviewed under the New Jersey Demonstration Program reaches the stage where it is ready for final approval before DRBC has adopted a final rule, the application will be acted upon by DRBC and the NJDEP independently. As explained above, additional information about the New Jersey Demonstration Program is available on the Commission's Web site.

    Preservation of the 1954 Supreme Court Decree

    In accordance with Sections 3.3(a) and 3.5 of the Compact, the proposed rule expressly provides that it does not grant authority to any Signatory Party agency to impair, diminish or otherwise adversely affect the diversions, compensating releases, rights, conditions, obligations and provisions for administration thereof provided in the United States Supreme Court decree in New Jersey v. New York, 347 U.S. 995 (1954) (“Decree”). The rule further reiterates that any such action may be taken only by the Commission with the unanimous consent of the parties to the Decree or upon unanimous consent of the members of the Commission following a declaration of a state of emergency in accordance with Section 3.3(a) of the Compact.

    No Effect on Section 401 State Water Quality Certification Programs

    The proposed rule also does not affect the authority of Signatory Party states to issue water quality certifications under Section 401 of the Clean Water Act.

    Dated: May 13, 2015. Pamela M. Bush, Commission Secretary.
    [FR Doc. 2015-12076 Filed 5-18-15; 8:45 am] BILLING CODE 6360-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2015-0219] RIN 1625-AA08 Special Local Regulations: 86th Major League Baseball (MLB) All-Star Week/Game, Ohio River Mile 469.5 to 471.2; Cincinnati, OH AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to establish a special local regulation for all waters of the Ohio River, surface to bottom, extending from Ohio River mile 469.5 to 471.2 at Cincinnati, OH July 10, 2015 through July 14, 2015. This special local regulation is necessary to protect persons and property from potential damage and safety hazards during the “86th Major League Baseball (MLB) All-Star Week/Game”, an event which will likely involve a high density of boater traffic in the river miles specified. This proposed special local regulation is intended to temporarily restrict vessel traffic in a portion of the Ohio River during this event and implement a moving security zone for certain vessel traffic within the special local regulated zone.

    DATES:

    Comments and related material must be received by the Coast Guard on or before June 1, 2015.

    ADDRESSES:

    You may submit comments identified by docket number using any one of the following methods:

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

    (2) Fax: 202-493-2251.

    (3) Mail or Delivery: Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries accepted between 9 a.m. and 5 p.m., Monday through Friday, except federal holidays. The telephone number is 202-366-9329.

    See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section below for further instructions on submitting comments. To avoid duplication, please use only one of these three methods.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email Petty Officer James Robinson, Sector Ohio Valley, U.S. Coast Guard; telephone (502) 779-5432, email [email protected] or Petty Officer Caloeb Gandy, Sector Ohio Valley, U.S. Coast Guard; telephone (502) 779-5346, email [email protected] If you have questions on viewing or submitting material to the docket, call Cheryl Collins, Program Manager, Docket Operations, telephone (202) 366-9826.

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

    We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

    1. Submitting Comments

    If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online at http://www.regulations.gov, or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

    To submit your comment online, go to http://www.regulations.gov, type the docket number [USCG-2015-0219] in the “SEARCH” box and click “SEARCH.” Click on “Submit a Comment” on the line associated with this rulemaking.

    If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change the rule based on your comments.

    2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type the docket number (USCG-2015-0219) in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rulemaking. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    3. Privacy Act

    Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

    4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a request for one, using one of the methods specified under ADDRESSES. Please explain why you believe a public meeting would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register.

    B. Regulatory History and Information

    The Captain of the Port (COTP) Ohio Valley is proposing to establish a special local regulation for all waters of the Ohio River, surface to bottom, extending from Ohio River mile 469.5 to 471.2 at Cincinnati, OH July 10, 2015 through July 14, 2015. This special local regulation is necessary to protect persons and property from potential damage and safety hazards during the “86th MLB All-Star Week/Game”, which may involve high density of boater traffic in the river miles specified. This proposed special local regulation is intended to temporarily restrict vessel traffic in a portion of the Ohio River during this event and implement a moving security zone for certain vessel traffic within the special local regulated zone. There is no regulatory history related to this proposed special local regulation or the event triggering a need for the proposed special local regulation.

    C. Basis and Purpose

    The Coast Guard's authority for establishing a special local regulation for marine events is contained at 33 U.S.C. 1233.

    Major League Baseball is holding the “86th All-Star Week/Game” July 10, 2015 through July 14, 2015. This event is planned to take place at the Great American Ballpark in the vicinity of the waters of the Ohio River, at Cincinnati, OH. Based on the need for additional safety measures to protect persons and property during this event on the waterway, the Coast Guard proposes to establish a special local regulation on specified waters of the Ohio River. The proposed special local regulation would be in effect from July 10, 2015 through July 14, 2015 and would encompass all waters of the Ohio River, mile 469.5-471.2.

    D. Discussion of Proposed Rule

    The Captain of the Port (COTP) Ohio Valley is proposing to establish a special local regulation for all waters of the Ohio River, surface to bottom, extending from Ohio River mile 469.5 to 471.2 at Cincinnati, OH July 10, 2015 through July 14, 2015. This special local regulation is necessary to protect persons and property from potential damage and safety hazards during the “86th MLB All-Star Week/Game”, an event which will likely involve a high density of boater traffic in the river miles specified. This proposed special local regulation is intended to temporarily restrict vessel traffic in a portion of the Ohio River and implement a moving security zone for certain vessel traffic within the special local regulated zone during this event in order to promote the safety of life and property on the navigable waterway. There is no regulatory history related to this proposed special local regulation or the event triggering a need for the proposed special local regulation.

    The effect of this proposed rule will be to restrict general navigation during the event. Vessels intending to transit the Ohio River through the designated mile markers will only be allowed to transit the area when the COTP Ohio Valley, or a designated representative, has deemed it safe to do so or at the completion of the event each day.

    E. Regulatory Analyses

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

    1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. This proposed special local regulation restricts transit on the Ohio River from mile 469.5 to 471.2, for a short duration of four days; Broadcast Notices to Mariners and Local Notices to Mariners will also inform the community of this special local regulation so that they may plan accordingly for this short restriction on transit. Vessel traffic may request permission from the COTP Ohio Valley or a designated representative to enter the restricted area.

    2. Impact on Small Entities

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

    This proposed rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit mile marker 469.5 to 471.2 on the Ohio River, from July 10, 2015 through July 14, 2015. The special local regulation will not have a significant economic impact on a substantial number of small entities for the following reasons. This special local regulation will be in effect for a limited duration for a period of four days. Although, the regulation would apply to the entire width of the river, traffic would be allowed to pass through the regulated area with the permission of the COTP Ohio Valley or a designated representative or at the completion of the event each day. Broadcast Notices to Mariners will also inform the community of this special local regulation so that they may plan accordingly for temporary restrictions on transit.

    If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

    3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

    4. Collection of Information

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

    5. Federalism

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

    6. Protest Activities

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

    7. Unfunded Mandates Reform Act

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

    8. Taking of Private Property

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

    9. Civil Justice Reform

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

    10. Protection of Children From Environmental Health Risks

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

    11. Indian Tribal Governments

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

    12. Energy Effects

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

    13. Technical Standards

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

    14. Environment

    We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a special local regulation involving a high media event and the potential for high boating traffic. This rule is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. A preliminary environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

    List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the U.S. Coast Guard proposes to amend 33 CFR part 100 as follows:

    PART 100—SAFETY OF LIFE ON NAVIGABLE WATERWAYS 1. The authority citation for part 100 continues to read as follows: Authority:

    33 U.S.C. 1233.

    2. Section 100.35T08-0219 is added to read as follows:
    § 100.35T08-0219 Special Local Regulation; Ohio River, Miles 469.5 to 471.2, Cincinnati, OH.

    (a) Location. The following area is a special local regulation: All waters of the Ohio River, beginning at mile marker 469.5 to mile 471.2 at Cincinnati, OH.

    (b) Enforcement date. This section is enforceable from: July 10, 2015 through July 14, 2015.

    Dated: April 22, 2015. R.V. Timme, Captain, U.S. Coast Guard, Captain of the Port Ohio Valley.
    [FR Doc. 2015-12122 Filed 5-18-15; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 60 [EPA-HQ-OAR-2009-0174; FRL-9927-80-OAR] RIN 2060-AP63 Electronic Reporting and Recordkeeping Requirements for New Source Performance Standards; Extension of Comment Period AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule; extension of public comment period.

    SUMMARY:

    The Environmental Protection Agency (EPA) is announcing that the period for providing public comments on the March 20, 2015, proposed “Electronic Reporting and Recordkeeping Requirements for New Source Performance Standards” is being extended by 30 days.

    DATES:

    Comments. The public comment period for the proposed rule published March 20, 2015 (80 FR 15100), is being extended by 30 days to June 18, 2015, in order to provide the public additional time to submit comments and supporting information.

    ADDRESSES:

    Comments. Written comments on the proposed rule may be submitted to the EPA electronically, by mail, by facsimile or through hand delivery/courier. Please refer to the proposal (80 FR 15100) for the addresses and detailed instructions.

    Docket. Publicly available documents relevant to this action are available for public inspection either electronically at http://www.regulations.gov or in hard copy at the EPA Docket Center, EPA WJC West Building, Room 3334, 1301 Constitution Ave. NW., Washington, DC 20004. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. A reasonable fee may be charged for copying. The EPA has established the official public docket for this rulemaking under Docket ID No. EPA-HQ-OAR-2009-0174.

    World Wide Web. The EPA Web site containing information for this rulemaking is at http://www.epa.gov/ttn/atw/eparules.html.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Gerri Garwood, Measurement Policy Group (MPG), Sector Policies and Programs Division (D243-05), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, telephone number: (919) 541-2406; fax number: (919) 541-1039; and email address: [email protected]

    SUPPLEMENTARY INFORMATION: Comment Period

    After considering a request submitted by the Air Permitting Forum to extend the public comment period, the EPA has decided to extend the public comment period for an additional 30 days. Therefore, the public comment period will end on June 18, 2015, rather than May 19, 2015. This extension will ensure that the public has sufficient time to review and comment on all of the information available, including the proposed rule and other materials in the docket.

    Dated: May 8, 2015. Stephen D. Page, Director.
    [FR Doc. 2015-12100 Filed 5-18-15; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 300 [Docket No. 130722646-5430-02] RIN 0648-BD54 International Fisheries; Pacific Tuna Fisheries; Establishment of Tuna Vessel Monitoring System in the Eastern Pacific Ocean AGENCY:

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

    ACTION:

    Supplemental proposed rule; request for comments.

    SUMMARY:

    NMFS revises a proposed rule published on February 6, 2014, to implement Inter-American Tropical Tuna Commission (IATTC) Resolution C-04-06. Under the original proposed rule Vessel Monitoring Systems (VMS) would be required for any U.S. commercial fishing vessels that are 24 meters (78.74 feet) or more in overall length and used to target tuna in the eastern Pacific Ocean. After publication of the proposed rule on February 6, 2014, the IATTC adopted Resolution C-14-02, which expands the applicability of the VMS requirements to vessels engaged in fishing activities for either tuna or tuna-like species; this action would implement that expanded application. This action would also revise the original proposed rule by allowing additional conditions to authorize a vessel owner or operator to shut down a VMS unit, and in a few non-substantive ways as described below. This rule is intended to ensure full U.S. compliance with its international obligations under the IATTC Convention.

    DATES:

    Written comments on this supplemental proposed rule must be received on or before June 18, 2015.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2013-0117, by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2013-0117, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Rachael Wadsworth, NMFS West Coast Region, 501 W. Ocean Blvd., Suite 4200, Long Beach, CA 90802. Include the identifier “NOAA-NMFS-2013-0117” in the comments.

    Public Hearing: The public is welcome to attend a public hearing and offer comments on this supplemental proposed rule from 1 p.m. to 4 p.m. PST, June 9, 2015, at 501 W. Ocean Boulevard, Suite 4200, Long Beach, CA 90802. The public may also participate in the public hearing via conference line: 888-790-6181; participant passcode: 64120.

    Instructions: Comments must be submitted by one of the above methods to ensure they are received, documented, and considered by NMFS. Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.) submitted voluntarily by the sender will be publicly accessible. Do not submit confidential business information, or otherwise sensitive or protected information. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    Copies of the draft Regulatory Impact Review (RIR) and other supporting documents prepared for the original proposed rule are available via the Federal eRulemaking Portal: http://www.regulations.gov, docket NOAA-NMFS-2013-0117 or by contacting the Regional Administrator, William W. Stelle, Jr., NMFS West Coast Region, 7600 Sand Point Way NE., Bldg 1, Seattle, WA 98115-0070 or by email to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Rachael Wadsworth, NMFS West Coast Region, 562-980-4036.

    SUPPLEMENTARY INFORMATION:

    NMFS published a proposed rule in the Federal Register (79 FR 7152) on February 6, 2014, to broaden the existing Vessel Monitoring System (VMS) requirements in the Pacific Ocean and to clarify the applicability of VMS requirements to U.S. commercial fishing vessels, 24 meters (78.74 feet) or more in overall length, used to target tuna (i.e., any fish of the genus Thunnus or of the species Euthynnus (Katsuwonus) pelamis (skipjack tuna)) in the waters of the Convention Area. The Convention Area is bounded by the west coast of the Americas and on the north, south, and west respectively, by the 50° N. and 50° S. parallels, and the 150° W. meridian. The original proposed rule was intended to ensure full U.S. implementation of Resolution C-04-06, adopted by the Inter-American Tropical Tuna Commission (IATTC) at its 72nd Meeting in June 2004.

    After publication of the original proposed rule, the IATTC adopted Resolution C-14-02 at its 87th Meeting in July 2014, which amends and replaces Resolution C-04-06. This supplemental proposed rule revises the applicability of the VMS requirements to reflect Resolution C-14-02 and updates other sections of the regulatory text that was published in the original proposed rule. The regulatory text of the original proposed rule is republished in this supplemental proposed rule with the changes described above and in more detail below.

    Background and Need for Action

    A detailed description of the original proposed rule was published in the preamble to that rule, which is available online (https://federalregister.gov/a/2014-02598) and from NMFS (see ADDRESSES). The VMS requirements from the original proposed rule are briefly summarized here.

    Commercial fishing vessels that are 24 meters or more in overall length are required to install, activate, carry and operate VMS units (also known as “mobile transmitting units”). The VMS units and mobile communications service providers must be type-approved by NOAA for fisheries in the IATTC Convention Area. Information for current NOAA type-approved VMS units can be obtained from: NOAA, Office of Law Enforcement (OLE), 1315 East-West Hwy, Suite 3301, Silver Spring, MD 20910-3282; telephone at (888) 210-9288; fax at (301) 427-0049. Or, by contacting NOAA OLE VMS Helpdesk: telephone: (888) 219-9228; email: [email protected]; or online by going to http://www.nmfs.noaa.gov/ole/about/our_programs/vessel_monitoring.html, and click “approved VMS units.” The business hours of the VMS Helpdesk are: Monday through Friday, except Federal holidays, 7 a.m. to 11 p.m., Eastern Time.

    Compliance with the existing VMS requirements at 50 CFR 300.219, 50 CFR 660.712, 50 CFR 660.14, or 50 CFR 665.19 would satisfy these new requirements relating to the installation, carrying, and operation of VMS units, provided that the VMS unit and mobile communications service provider are type-approved by NOAA for fisheries in the Convention Area, and the VMS unit is operated continuously at all times while the vessel is at sea unless the Special-Agent-In-Charge, NOAA Office of Law Enforcement, Pacific Islands Division (or designee) (SAC) authorizes a VMS unit to be shut down and the same requirements proposed for the case of VMS unit failure are followed.

    This supplemental proposed rule would revise the proposed rule in the following ways: (1) Expand the applicability of the VMS requirements to include fishing activities for tuna-like species in the Convention Area; (2) additional conditions to allow the SAC to authorize a vessel owner or operator to shut down a VMS unit; (3) update the address for the SAC; (4) update the definition of “Convention Area;” (5) revise the description of the purpose and scope of part 300, subpart C, section 300.20 of Title 50 of the Code of Federal Regulations (CFR); and (6) make minor revisions to the regulatory text for punctuation and clarify circumstances when a vessel owner or operator is responsible for an action. These changes are described in greater detail below.

    First, IATTC Resolution C-14-02 expanded the scope of the initial IATTC Resolution. The original proposed rule would have applied only to commercial fishing vessels that are 24 meters or more in overall length and used to target tuna in the Convention Area. This supplemental proposed rule would apply to commercial fishing vessels engaging in fishing activities for tuna or tuna-like species, including those managed under the Fishery Management Plan for U.S. West Coast Fisheries for Highly Migratory Species, in conformance with Resolution C-14-02. Therefore, this supplemental proposed rule would apply to any commercial fishing vessel of the United States that is 24 meters or more in overall length and engaging in fishing activities for tuna or tuna-like species in the Convention Area, and for which any of the following permits is required: Pacific highly migratory species permit under 50 CFR 660.707, or high seas fishing permit under 50 CFR 300.13.

    Second, the supplemental proposed rule would allow additional conditions for the SAC to authorize a vessel owner or operator to shut down a VMS unit. Vessel owners or operators must submit requests to shut down their VMS unit to the SAC. See the regulatory text for more details on the specific conditions and procedures for obtaining SAC authorization for shutting down VMS units.

    Third, the supplemental proposed rule would update the address for the SAC of the Pacific Islands Division, reflecting an address change that occurred after the publication of the original proposed rule.

    Fourth, this supplemental proposed rule would also update the regulatory definition of the Convention Area, which is currently defined as the waters within the area bounded by the mainland of the Americas, lines extending westward from the mainland of the Americas along the 40° N. latitude and 40° S. latitude, and 150° W. longitude. The current regulatory definition would be updated to be consistent with the definition described in the preamble of the original proposed rule, and the Convention for the Strengthening of the Inter-American Tropical Tuna Commission (Antigua Convention). The Antigua Convention entered into force in 2010 and all IATTC resolutions adopted subsequent to 2010, such as Resolution C-14-02, are premised on the definition of “Convention Area” in the Antigua Convention. Accordingly, this supplemental proposed rule would define the Convention Area as all waters of the eastern Pacific Ocean within the area bounded by the west coast of the Americas and by the following lines: The 50° N. parallel from the coast of North America to its intersection with the 150° W. meridian; the 150° W. meridian to its intersection with the 50° S. parallel; and the 50° S. parallel to its intersection with the coast of South America.

    If the proposed update to the regulatory definition of the Convention Area becomes effective, there would be no additional impacts to vessels. Although NMFS relied on the current definition (40° N. latitude and 40° S. latitude, and 150° W. longitude) of the Convention Area to modify the procedures and requirements for the Regional Vessel Register for the IATTC (74 FR 1607, January 13, 2009), NMFS uses permits rather than fishing area as a basis for providing the IATTC a list of U.S. vessels to be placed on the Regional Vessel Register. Specifically, NMFS considers vessels that are authorized to fish for highly migratory species in the Convention Area under the following fishing permits: Pacific highly migratory species permit under 50 CFR 660.707, and high seas fishing permit under 50 CFR 300.13. Therefore, the proposed update to the regulatory definition of the Convention Area would not affect the current process NMFS uses to provide the IATTC a list of U.S. vessels to place on the Regional Vessel Register.

    Lastly, the supplemental proposed rule would update the purpose and scope of Title 50, part 300, subpart C, section 300.20 of the CFR for consistency with the updated definition for the Convention Area.

    Classification

    The NMFS Assistant Administrator has determined that this supplemental proposed rule is consistent with the Tuna Conventions Act of 1950 and other applicable laws, subject to further consideration after public comment.

    National Environmental Policy Act

    This action is categorically excluded from the requirement to prepare an environmental assessment in accordance with NAO 216-6. A memorandum for the file has been prepared that sets forth the decision to use a categorical exclusion.

    Executive Order 12866

    This supplemental proposed rule has been determined to be not significant for purposes of Executive Order 12866.

    Regulatory Flexibility Act

    An Initial Regulatory Flexibility Analysis (IRFA) was prepared for the original proposed rule (79 FR 7152), published on February 6, 2014, as required by section 604 of the Regulatory Flexibility Act (RFA) and is not repeated here. As described above, this supplemental proposed rule would not result in different impacts than those described in the IRFA for the original proposed rule.

    As discussed in the preamble, this supplemental proposed rule would expand the applicability of the VMS requirements to commercial fishing vessels that are 24 meters or more in overall length and engaging in fishing activities for tuna or tuna-like species in the Convention Area. To estimate the number of affected entities for the original proposed rule, the number of vessels authorized to fish for highly migratory species in the Convention Area through fishing permits was considered a reasonable proxy. The permits used to estimate affected entities were those issued under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.) through regulations codified at 50 CFR 660.707 or under the authority of the High Seas Fishing Compliance Act of 1995 (16 U.S.C. 5501 et seq.) through regulations codified at 50 CFR 300.13. NMFS also considers these fishing permits a reasonable proxy for estimating the number of vessels used to fish for tuna or tuna-like species in the Convention Area. Copies of the IRFA, prepared for the original proposed rule, are available from NMFS (see ADDRESSES).

    Paperwork Reduction Act Collections of Information

    This supplemental proposed rule contains a collection-of-information requirement subject to the Paperwork Reduction Act (PRA) and approved by OMB under control number (0648-0690) for the original proposed rule (79 FR 7152), published on February 6, 2014. This supplemental proposed rule does not result in changes to the burden hour estimates prepared for the original proposed rule. Public comment regarding the burden-hour estimates or other aspects of the collection-of-information requirements was requested in the original proposed rule.

    List of Subjects in 50 CFR Part 300

    Administrative practice and procedure, Fish, Fisheries, Fishing, Marine resources, Reporting and recordkeeping requirements, Treaties.

    Dated: May 11, 2015. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 300 is proposed to be amended as follows:

    PART 300—INTERNATIONAL FISHERIES REGULATIONS Subpart C—Eastern Pacific Tuna Fisheries 1. The authority citation for 50 CFR part 300, subpart C continues to read as follows: Authority:

    16 U.S.C. 951-961 et seq.

    2. Section 300.20 is revised to read as follows:
    § 300.20 Purpose and scope.

    The regulations in this subpart are issued under the authority of the Tuna Conventions Act of 1950 (Act) and apply to persons and vessels subject to the jurisdiction of the United States. The regulations implement resolutions of the Inter-American Tropical Tuna Commission (IATTC) for the conservation and management of stocks of highly migratory fish resources in the Convention Area.

    3. In § 300.21, the definition for “Convention Area” is revised and the definitions for “Commercial”, “Vessel monitoring system (VMS)”, and “VMS unit” are added, in alphabetical order, to read as follows:
    § 300.21 Definitions.

    Commercial with respect to commercial fishing, means fishing in which the fish harvested, either in whole or in part, are intended to enter commerce through sale, barter or trade.

    Convention Area or IATTC Convention Area, means all waters of the eastern Pacific Ocean within the area bounded by the west coast of the Americas and by the following lines: The 50° N. parallel from the coast of North America to its intersection with the 150° W. meridian; the 150° W. meridian to its intersection with the 50° S. parallel; and the 50° S. parallel to its intersection with the coast of South America.

    Vessel monitoring system (VMS) means an automated, remote system that provides information about a vessel's identity, location and activity, for the purposes of routine monitoring, control, surveillance and enforcement of area and time restrictions and other fishery management measures.

    VMS unit, sometimes known as a “mobile transmitting unit,” means a transceiver or communications device, including all hardware and software that is carried and operated on a vessel as part of a VMS.

    4. In § 300.24, paragraphs (y) through (bb) are added to read as follows:
    § 300.24 Prohibitions.

    (y) Fail to install, activate, or operate a VMS unit as required in § 300.26(c).

    (z) In the event of VMS unit failure or interruption; fail to repair or replace a VMS unit; fail to notify the Special-Agent-In-Charge, NOAA Office of Law Enforcement, Pacific Islands Division (or designee); and follow the instructions provided; or otherwise fail to act as provided in § 300.26(c)(4).

    (aa) Disable, destroy, damage or operate improperly a VMS unit installed under § 300.26, or attempt to do any of the same, or fail to ensure that its operation is not impeded or interfered with, as provided in § 300.26(e).

    (bb) Fail to make a VMS unit installed under § 300.26 or the position data obtained from it available for inspection, as provided in § 300.26(f) and (g).

    5. Section 300.26 is added to read as follows:
    § 300.26 Vessel monitoring system (VMS).

    (a) Special-Agent-In-Charge (SAC), NOAA Office of Law Enforcement, Pacific Islands Division (or designee) and VMS Helpdesk contact information and business hours:

    (1) The contact information for the SAC for the purpose of this section: 1845 Wasp Blvd., Building 176, Honolulu, HI 96818; telephone: (808) 725-6100; facsimile: 808-725-6199; email: [email protected]; business hours: Monday through Friday, except Federal holidays, 8 a.m. to 4:30 p.m., Hawaii Standard Time.

    (2) The contact information for the NOAA Office of Law Enforcement's VMS Helpdesk is telephone: (888) 219-9228; email: [email protected] The business hours of the VMS Helpdesk are Monday through Friday, except Federal holidays, 7 a.m. to 11 p.m., Eastern Time.

    (b) Applicability. This section applies to any U.S. commercial fishing vessel that is 24 meters or more in overall length and engaging in fishing activities for tuna or tuna-like species in the Convention Area, and for which either of the following permits is required: Pacific highly migratory species permit under § 660.707, or high seas fishing permit under § 300.13 of this part.

    (c) Provisions for Installation, Activation and Operation—(1) VMS Unit Installation. The vessel owner or operator must obtain and have installed on the fishing vessel, in accordance with instructions provided by the SAC and the VMS unit manufacturer, a VMS unit that is type-approved by NOAA for fisheries in the IATTC Convention Area. The vessel owner or operator shall arrange for a NOAA-approved mobile communications service provider to receive and relay transmissions from the VMS unit to NOAA. The vessel owner or operator shall authorize NOAA OLE, the U.S. Coast Guard (USCG) and other authorized entities to receive and relay position reports. The owner or operator must authorize NOAA to set up the reporting interval of the VMS unit as once per hour. The NOAA OLE VMS Helpdesk is available to provide instructions for VMS installation and a list of the current type-approved VMS units and mobile communication service providers.

    (2) VMS Unit Activation. If the VMS unit has not yet been activated as described in this paragraph, or if the VMS unit has been newly installed or reinstalled, or if the mobile communications service provider has changed since the previous activation, or if directed by the SAC, the vessel owner or operator must, prior to leaving port:

    (i) Turn on the VMS unit to make it operational;

    (ii) Submit a written activation report to the SAC, via mail, facsimile or email, that includes the vessel's name; the vessel's official number; the VMS unit manufacturer and identification number; and telephone, facsimile or email contact information for the vessel owner or operator; and

    (iii) Receive verbal or written confirmation from the SAC that the proper VMS unit transmissions are being received from the VMS unit.

    (3) VMS Unit Operation. The vessel owner and operator shall continuously operate the VMS unit at all times, except that the VMS unit may be shut down while the vessel is in port or otherwise not at sea, or if, after the end of the fishing season, the vessel will no longer be engaging in fishing activities in the Convention Area for which either a Pacific highly migratory species permit or a high seas fishing permit is required, provided that the owner or operator:

    (i) Prior to shutting down the VMS unit, reports to the SAC or the NOAA Office of Law Enforcement's VMS Helpdesk via facsimile, email, or web-form the following information: The intent to shut down the VMS unit; the vessel's name; the vessel's official number; an estimate for when the vessel's VMS may be turned back on; and telephone, facsimile or email contact information for the vessel owner or operator. In addition, the vessel owner or operator shall receive verbal or written confirmation from the SAC before shutting down the VMS unit after the end of the fishing season; and

    (ii) When turning the VMS unit back on, report to the SAC or the NOAA Office of Law Enforcement's VMS Helpdesk, via mail, facsimile or email, the following information: That the VMS unit has been turned on; the vessel's name; the vessel's official number; and telephone, facsimile or email contact information for the vessel owner or operator; and

    (iii) Prior to leaving port, receive verbal or written confirmation from the SAC that proper transmissions are being received from the VMS unit.

    (4) Failure of VMS unit. If the VMS unit has become inoperable or transmission of automatic position reports from the VMS unit has been interrupted, or if notified by NOAA or the USCG that automatic position reports are not being received from the VMS unit or that an inspection of the VMS unit has revealed a problem with the performance of the VMS unit, the vessel owner or operator shall comply with the following requirements:

    (i) If the vessel is at port: The vessel owner or operator shall repair or replace the VMS unit and ensure it is operable before the vessel leaves port.

    (ii) If the vessel is at sea: The vessel owner, operator, or designee shall contact the SAC by telephone, facsimile, or email at the earliest opportunity during the SAC's business hours and identify the caller and vessel. The vessel operator shall follow the instructions provided by the SAC which could include, but are not limited to, ceasing fishing, stowing fishing gear, returning to port, and/or submitting periodic position reports at specified intervals by other means; and repair or replace the VMS unit and ensure it is operable before starting the next trip.

    (5) Related VMS Requirements. Installing, carrying and operating a VMS unit in compliance with the requirements in 50 CFR 300.219, 50 CFR 660.712, 50 CFR 660.14, or 50 CFR 665.19 relating to the installation, carrying, and operation of VMS units shall be deemed to satisfy the requirements of paragraph (c) of this section, provided that the VMS unit is operated continuously and at all times while the vessel is at sea, unless the SAC authorizes a VMS unit to be shut down as described in paragraph (c)(3), the VMS unit and mobile communications service providers are type-approved by NOAA for fisheries in IATTC Convention Area, the owner or operator has authorized NOAA to receive and relay transmissions from the VMS unit, and the specific requirements of paragraph (c)(4) of this section are followed. If the VMS unit is owned by NOAA, the requirement under paragraph (c)(4) of this section to repair or replace the VMS unit will be the responsibility of NOAA, but the vessel owner and operator shall be responsible for ensuring that the VMS unit is operable before leaving port or starting the next trip.

    (d) Costs. The vessel owner and operator shall be responsible for all costs associated with the purchase, installation and maintenance of the VMS unit and for all charges levied by the mobile communications service provider as necessary to ensure the transmission of automatic position reports to NOAA as required in paragraph (c) of this section. However, if NOAA is paying for the VMS-associated costs because the VMS unit is carried and operated under a requirement of 50 CFR 300.219, 50 CFR 660.712, or 50 CFR 665.19, the vessel owner and operator shall not be responsible to pay the costs.

    (e) Tampering. The vessel owner and operator must ensure that the VMS unit is not tampered with, disabled, destroyed, damaged or maintained improperly, and that its operation is not impeded or interfered with.

    (f) Inspection. The vessel owner and operator must make the VMS unit, including its antenna, connectors and antenna cable, available for inspection by authorized officers.

    (g) Access to data. The vessel owner and operator must make the vessel's position data obtained from the VMS unit or other means immediately and always available for inspection by NOAA personnel, USCG personnel, and authorized officers.

    [FR Doc. 2015-11991 Filed 5-18-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 150401329-5437-01] RIN 0648-BF00 Fisheries of the Northeastern United States; Atlantic Mackerel, Squid, and Butterfish Fisheries; Framework Adjustment 9 AGENCY:

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

    ACTION:

    Proposed rule, request for comments.

    SUMMARY:

    Framework Adjustment 9 proposes management measures to further enhance catch monitoring and address discarding catch before it has been sampled by observers (known as slippage), in the Atlantic mackerel fishery. Framework 9 would implement slippage consequence measures, and a requirement that slippage events be reported via the vessel monitoring system. For allowable slippage events, due to safety, mechanical failure, or excess catch of spiny dogfish, vessels must move 15 nm from the location of the slippage event. For non-allowable slippage events, due to reasons other than those listed previously, vessels must terminate their fishing trip. Slippage events have the potential to substantially affect analysis or extrapolations of incidental catch, including river herring and shad, these proposed measures are designed to address this issue.

    DATES:

    Public comments must be received by June 18, 2015.

    ADDRESSES:

    Copies of supporting documents used by the Mid-Atlantic Fishery Management Council, including the Environmental Assessment (EA) and Regulatory Impact Review (RIR)/Initial Regulatory Flexibility Analysis (IRFA), are available from: Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, 800 North State Street, Suite 201, Dover, DE 19901, telephone (302) 674-2331. The EA/RIR/IRFA is also accessible via the Internet at http://www.greateratlantic.fisheries.noaa.gov.

    You may submit comments, identified by NOAA-NMFS-2015-0049, by any one of the following methods:

    • Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2015-0049, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to NMFS, Northeast Regional Office, 55 Great Republic Drive, Gloucester, MA 01930. Mark the outside of the envelope “Comments on Framework 9.”

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    FOR FURTHER INFORMATION CONTACT:

    Carly Bari, Fishery Policy Analyst, (978) 281-9224, fax (978) 281-9135.

    SUPPLEMENTARY INFORMATION: Background

    NMFS implemented measures to improve catch monitoring of the mackerel, squid, and butterfish fisheries through Amendment 14 to the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan (FMP) (79 FR 10029, February 24, 2014). The focus of Amendment 14 was to improve evaluation of the incidental catch of river herring (alewife and blueback herring) and shad (American shad and hickory shad), and to address incidental catch of river herring and shad. NMFS disapproved three measures that were initially included in Amendment 14 including: A dealer reporting requirement; a cap that, if achieved, would require vessels discarding catch before it had been sampled by observers (known as slippage) to return to port; and a recommendation of 100-percent observer coverage on midwater trawl vessels and 100-, 50-, and 25-percent observer coverage on bottom trawl mackerel vessels, with the industry contributing $325 per day toward observer costs.

    Currently, slippage events are prohibited for vessels issued a limited access mackerel permit or a longfin squid/butterfish moratorium permit and carrying a NMFS-approved observer except in circumstances which allow slippage events including: Safety; mechanical failure; and excess catch of spiny dogfish. Additionally, following a slippage event, vessels are currently required to submit a Released Catch Affidavit within 48 hours of the end of the fishing trip. In response to the disapproval of the slippage measures in Amendment 14, the Mid-Atlantic Fishery Management Council developed Framework Adjustment 9 to the Atlantic Mackerel, Squid, and Butterfish FMP to further enhance catch monitoring and to address slippage in the Atlantic mackerel fishery. Framework 9 would add slippage consequence measures and slippage reporting requirements to build upon the current measures and to address monitoring the catch of river herring and shad.

    Framework 9 would require Tier 1, 2, and 3 mackerel vessels on observed trips to move 15 nm following an excepted slippage event, which includes safety, mechanical failure, or excess catch of spiny dogfish. These vessels would also be required to terminate a fishing trip and immediately return to port following a non-excepted slippage event, which would be due to any reason other than those listed above. In addition to submitting a Released Catch Affidavit, vessels carrying an observer would also be required to report all slippage events through the vessel monitoring system daily catch report for mackerel and longfin squid.

    Corrections

    This proposed rule also contains an additional regulation change that was mistakenly omitted in the 2015-2017 Atlantic mackerel, squid, and butterfish specifications final rule (80 FR 14870, March 20, 2015). This regulation change would prohibit all vessels with a valid mackerel permit from fishing for, possessing, transferring, receiving, or selling more than 20,000 lb (9.07 mt) of mackerel per trip or per day after 95 percent of the river herring and shad catch cap has been harvested. This change in the regulations was identified, described, and made available for public comment in the proposed rule for the 2015-2017 Atlantic mackerel, squid, and butterfish specifications (79 FR 68202, November 14, 2014).

    Classification

    Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the NMFS Assistant Administrator has determined that this proposed rule is consistent with the Atlantic Mackerel, Squid, and Butterfish FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.

    This proposed rule has been determined to be not significant for purposes of Executive Order 12866.

    An IRFA was prepared, as required by section 603 of the Regulatory Flexibility Act (RFA). The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. A summary of the analysis follows.

    Description of the Reasons Why Action by the Agency Is Being Considered

    This action proposes management measures for the slippage consequences to better monitor catch of river herring and shad in the Atlantic mackerel fishery. The preamble to this proposed rule includes a complete description of the reasons why the Council and NMFS are considering this action and these are not repeated here.

    Statement of the Objectives of, and Legal Basis for, This Proposed Rule

    The purpose of this proposed action is to minimize slippage, which will improve observer data, and should in turn improve decision-making that uses observer data. Failure to implement the measures described in this proposed rule could result in biased observer data. The preamble to this proposed rule includes a complete description of the objectives of and legal basis for this action and these are not repeated here.

    Description and Estimate of the Number of Small Entities to Which This Proposed Rule Would Apply

    The proposed alternative applies to mackerel limited access permits. Based on permit data for 2013, 150 separate vessels hold mackerel limited access permits, 114 entities own those vessels, and, based on current Small Business Administration (SBA) definitions, 107 of these are small entities. Of the 107 small entities, 4 had no revenue in 2013 and those entities with no revenue are considered small entities for the purpose of this analysis. All of the entities that had revenue fell into the finfish or shellfish categories, and the SBA definitions for those categories for 2014 are $20.5 million for finfish fishing and $5.5 million for shellfish fishing. Of the entities with revenues, their average revenues in 2013 were $1,201,419. 70 had primary revenues from finfish fishing and 33 had their primary revenues from shellfish fishing.

    Description of the Projected Reporting, Record-Keeping, and Other Compliance Requirements of This Proposed Rule

    The proposed action contains collection-of-information requirements subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). This requirement has been submitted to OMB for approval under Control Number 0648-0679.

    Under the proposed action, all limited access mackerel vessels carrying an observer would be required to report all slippage events on the VMS mackerel and longfin squid daily catch report. This information collection is intended to improve monitoring the catch of river herring and shad in the Atlantic mackerel fishery. The burden estimates for these new requirements apply to all limited access mackerel vessels. In a given fishing year, NMFS estimates that these additionally reporting requirements will not cause any additional time or cost burden from that which was previously approved under OMB Control Number 0648-0679.

    Public comment is sought regarding: Whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the burden estimate; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information to the Regional Administrator (see ADDRESSES), and email to [email protected], or fax to (202) 395-5806.

    Notwithstanding any other provisions of the law, no person is required to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number. All currently approved NOAA collections of information may be viewed at: http://www.cio.noaa.gov/services_programs/prasubs.html.

    Federal Rules Which May Duplicate, Overlap, or Conflict With This Proposed Rule

    This action contains no other compliance costs. It does not duplicate, overlap, or conflict with any other Federal law.

    Description of Significant Alternatives to the Proposed Action Which Accomplish the Stated Objectives of Applicable Statues and Which Minimize Any Significant Economic Impact on Small Entities

    The proposed alternative should not have more than minimal impact on the affected small entities compared to recent operation of the fishery (2011-2013, and 2014 landings to date appear similar to 2013). First, the primary impact should only be that vessels will not slip catches before observers have a chance to observe/sample them, which should have almost no economic impact on vessels. Slippage for reasons besides safety, mechanical issues, and spiny dogfish are already prohibited, and this proposed action would require vessels to move 15 nm before fishing again if a slippage for those excepted reasons occurs (vessels could not fish within 15 nm of the slippage event for the remainder of the trip). Total small entity mackerel revenues over 2011-2013 averaged $2.0 million, for an average of approximately $19,000 per affected small entity (107), compared to their average revenues of $1,201,419 in 2013 as described above. Given the small relative value of mackerel for most affected entities, the infrequency of slippage, and given the consequence of excepted slippages is only to move 15 nm, it seems likely that the economic impacts should be minimal for affected small entities. This is especially true since only a small portion of trips are observed, and the measures only apply to observed trips.

    If slippages have been masking higher river herring and shad landings, it is possible that prohibiting slippages could lead to the mackerel fishery closing earlier (because of the river herring and shad cap) than it otherwise would if more slippages were occurring. However, given the very low mackerel catches in recent years (less than 20 percent of the quota), it is more likely that catch increases might be limited rather than actually having decreased catches, so small entities should not be more than minimally impacted compared to recent fishery operations. In addition, if vessels are prohibited from targeting mackerel due to the cap, they will likely partially mitigate any foregone revenue by fishing for other species (e.g. squid, butterfish, herring, etc.).

    List of Subjects in 50 CFR Part 648

    Fisheries, Fishing, Recordkeeping and reporting requirements.

    Dated: May 13, 2015. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 648 is proposed to be amended as follows:

    PART 648—FISHERIES OF THE NORTHEASTERN UNITED STATES 1. The authority citation for part 648 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq.

    2. In § 648.11, paragraph (n)(3)(ii) is revised and paragraph (n)(3)(iii) is added to read as follows:
    § 648.11 At-sea sea sampler/observer coverage.

    (n) * * *

    (3) * * *

    (ii) If fish are released prior to being brought on board the vessel due to any of the exceptions in paragraphs (n)(3)(i)(A)-(C) of this section, the vessel operator must move at least 15 nm from the location of release before fishing again, and must stay at least 15 nm from the slippage event location for the remainder of the fishing trip. The vessel operator must also complete and sign a Released Catch Affidavit detailing the vessel name and permit number; the VTR serial number; where, when, and for what reason the catch was released; the estimated weight of each species brought on board (if only part of the tow was released) or released on that tow. A completed affidavit must be submitted to NMFS within 48 hr of the end of the trip. The vessel operator must also report a slippage event on the VMS mackerel and longfin squid daily catch report.

    (iii) If fish are released prior to being brought on board the vessel due to any reason other than the exceptions in paragraphs (n)(3)(i)(A)-(C) of this section, the vessel operator must immediately terminate the trip and return to port. No fishing activity may occur during the return to port. The vessel operator must also complete and sign a Released Catch Affidavit detailing the vessel name and permit number; the VTR serial number; where, when, and for what reason the catch was released; the estimated weight of each species brought on board (if only part of the tow was released) or released on that tow. A completed affidavit must be submitted to NMFS within 48 hr of the end of the trip. The vessel operator must also report the slippage event on the VMS mackerel and longfin squid daily catch report.

    3. In § 648.14, paragraph (g)(2)(ii)(G) is added, paragraphs (g)(2)(vi) and (vii) are revised and paragraphs (g)(2)(viii), (ix), and (x) are added to read as follows:
    § 648.14 Prohibitions.

    (g) * * *

    (2) * * *

    (ii) * * *

    (G) Fish for, possess, transfer, receive, or sell; or attempt to fish for, possess, transfer, receive, or sell; more than 20,000 lb (9.07 mt) of mackerel per trip; or land, or attempt to land more than 20,000 lb (9.07 mt) of mackerel per day after 95 percent of the river herring and shad cap has been harvested, if the vessel holds a valid mackerel permit.

    (vi) Release fish from codend of the net, transfer fish to another vessel that is not carrying a NMFS-approved observer, or otherwise discard fish at sea before bringing the fish aboard and making it available to the observer for sampling, unless subject to one of the exceptions defined at § 648.11(n)(3) if issued a Limited Access Atlantic mackerel permit, or a longfin squid/butterfish moratorium permit.

    (vii) Fail to move 15 nm, as specified at § 648.11(n)(3)(ii).

    (viii) Fail to immediately return to port as specified at § 648.11(n)(3)(iii).

    (ix) Fail to complete, sign, and submit a Released Catch Affidavit if fish are released pursuant to the requirements at § 648.11(n)(3).

    (x) Fail to report a slippage event on the VMS mackerel and longfin squid daily catch report.

    [FR Doc. 2015-12060 Filed 5-18-15; 8:45 am] BILLING CODE 3510-22-P
    80 96 Tuesday, May 19, 2015 Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2015-0032] Notice of Request for Extension of Approval of an Information Collection; Importation of Christmas Cactus and Easter Cactus in Growing Media From the Netherlands and Denmark AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Extension of approval of an information collection; comment request.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with regulations for the importation of Christmas cactus and Easter cactus in growing media from the Netherlands and Denmark.

    DATES:

    We will consider all comments that we receive on or before July 20, 2015.

    ADDRESSES:

    You may submit comments by either of the following methods:

    • Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0032.

    • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2015-0032, 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-2015-0032 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:

    For information on the importation of Christmas cactus and Easter cactus in growing media from the Netherlands and Denmark, contact Mr. William Aley, Senior Regulatory Specialist, PPP, RPM, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737; (301) 851-2130. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

    SUPPLEMENTARY INFORMATION:

    Title: Importation of Christmas Cactus and Easter Cactus in Growing Media From the Netherlands and Denmark.

    OMB Control Number: 0579-0266.

    Type of Request: Extension of approval of an information collection.

    Abstract: Under the Plant Protection Act (7 U.S.C. 7701 et seq.), the Secretary of Agriculture is authorized to restrict the importation, entry, or interstate movement of plants, plant products, and other articles to prevent the introduction of plant pests into the United States or their dissemination within the United States. The Secretary has delegated this authority to the Animal and Plant Health Inspection Service (APHIS).

    The regulations contained in “Subpart—Plants for Planting” (7 CFR 319.37 through 319.37-14) prohibit or restrict, among other things, the importation of living plants, plant parts, and seeds for propagation. These regulations are intended to ensure that imported plants for planting do not serve as a host for plant pests, such as insects or pathogens, that can cause damage to U.S. agricultural and environmental resources.

    Under these regulations, Christmas cactus and Easter cactus in approved growing media may be imported into the United States from the Netherlands and Denmark under certain conditions, which require the use of a phytosanitary certificate and declaration stating the plants were grown in accordance with specific conditions, an agreement between APHIS and the plant protection service of the country where the plants are grown, and an agreement between the foreign plant protection service and the grower.

    We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for an additional 3 years.

    The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

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

    (2) Evaluate the accuracy of our estimate of the burden of the 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, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

    Estimate of burden: The public reporting burden for this collection of information is estimated to average 0.57 hours per response.

    Respondents: Foreign plant protection service officials and growers in the Netherlands and Denmark.

    Estimated annual number of respondents: 20.

    Estimated annual number of responses per respondent: 10.5.

    Estimated annual number of responses: 210.

    Estimated total annual burden on respondents: 120 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

    All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

    Done in Washington, DC, this 13th day of May 2015. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2015-12073 Filed 5-18-15; 8:45 am] BILLING CODE 3410-34-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Idaho Advisory Committee for Members of the Committee To Receive Member Orientation and Discuss Civil Rights Issues in the State AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Idaho Advisory Committee (Committee) to the Commission will be held on Friday, June 5, 2015, for the purpose of discussing project proposals on equity in school spending and state compliance with the Supreme Court Olmsted decision. The meeting will be held by teleconference.

    DATES:

    Friday, June 5, 2015 from 3:30 p.m. to 4:30 p.m. MST.

    FOR FURTHER INFORMATION CONTACT:

    Peter Minarik, DFO, at (213) 894-3437 or [email protected]

    SUPPLEMENTARY INFORMATION:

    This meeting is available to the public through the following toll-free call-in number: 888-437-9455 conference ID: 6159656. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.

    Members of the public are also entitled to submit written comments. The comments must be received in the Western Regional Office of the Commission by July 6, 2015. The address is Western Regional Office, U.S. Commission on Civil Rights, 300 N. Los Angeles Street, Suite 2010, Los Angeles, CA 90012. Persons wishing to email their comments may do so by sending them to Angelica Trevino, Civil Rights Analyst, Western Regional Office, at [email protected] Persons who desire additional information should contact the Western Regional Office, at (213) 894-3437, (or for hearing impaired TDD 913-551-1414), or by email to [email protected] Hearing-impaired persons who will attend the meeting and require the services of a sign language interpreter should contact the Regional Office at least ten (10) working days before the scheduled date of the meeting.

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at http://facadatabase.gov/committee/meetings.aspx?cid=245 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Western Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Western Regional Office at the above email or street address.

    Agenda:

    Election of vice-chair Discussion of proposal on equity in school district spending Discussion of proposal on state compliance with Olmsted decision Adjournment

    Public Call Information:

    Dial: 888-437-9445 Conference ID: 6159656 Dated: May 13, 2015. David Mussatt, Chief, Regional Programs Coordination Unit.
    [FR Doc. 2015-12041 Filed 5-18-15; 8:45 am] BILLING CODE 6335-01-P
    DEPARTMENT OF COMMERCE Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

    Agency: U.S. Census Bureau.

    Title: Current Population Survey, Basic Demographic Items.

    OMB Control Number: 0607-0049.

    Form Number(s): There are no forms. We conduct all interviews on computers.

    Type of Request: Regular.

    Number of Respondents: 708,000.

    Average Hours Per Response: 0.0273.

    Burden Hours: 19,347.

    Needs and Uses: The Census Bureau plans to request clearance from the Office of Management and Budget (OMB) for the collection of same sex marriage data as part of the basic demographic information on the Current Population Survey (CPS) beginning in June 2015. The current clearance expires July 31, 2017. The CPS has been the source of official government statistics on employment and unemployment for over 50 years. The Bureau of Labor Statistics (BLS) and the Census Bureau jointly sponsor the basic monthly survey. The Census Bureau also prepares and conducts all the field work. At the OMB's request, the Census Bureau and the BLS divide the clearance request in order to reflect the joint sponsorship and funding of the CPS program. The BLS submits a separate clearance request for the portion of the CPS that collects labor force information for the civilian noninstitutional population. Some of the information within that portion includes employment status, number of hours worked, job search activities, earnings, duration of unemployment, and the industry and occupation classification of the job held the previous week.

    The justification that follows is in support of the demographic data. The demographic information collected in the CPS provides a unique set of data on selected characteristics for the civilian noninstitutional population. Some of the demographic information we collect are age, marital status, gender, Armed Forces status, education, race, origin, and family income. We use these data in conjunction with other data, particularly the monthly labor force data, as well as periodic supplement data. We also use these data independently for internal analytic research and for evaluation of other surveys. In addition, we use these data as a control to produce accurate estimates of other personal characteristics.

    Affected Public: Individuals or Households.

    Frequency: Monthly.

    Respondent's Obligation: Voluntary.

    Legal Authority: Title 13, United States Code, Section 182; and Title 29, United States Code, Sections 1-9.

    This information collection request may be viewed at www.reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202)395-5806.

    Dated: May 13, 2015. Glenna Mickelson, Management Analyst, Office of the Chief Information Officer.
    [FR Doc. 2015-11979 Filed 5-18-15; 8:45 am] BILLING CODE 3510-07-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-890] Wooden Bedroom Furniture From the People's Republic of China: Notice of Court Decision Not in Harmony With Final Results of Administrative Review and Notice of Second Amended Final Results of Administrative Review Pursuant to Court Decision AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    On April 21, 2015, the United States Court of International Trade (“CIT”) issued its final judgment in Home Meridian Int'l, Inc. v. United States, Consol. Court No. 11-00325,1 and sustained the Department of Commerce's (“the Department”) third remand redetermination.2 Consistent with the decision of the United States Court of Appeals for the Federal Circuit (“CAFC”) in Timken Co. v. United States, 893 F.2d 337 (Fed. Cir. 1990) (“Timken”), as clarified by Diamond Sawblades Mfrs. Coalition v. United States, 626 F.3d 1374 (Fed. Cir. 2010) (“Diamond Sawblades”), the Department is notifying the public that the final judgment in this case is not in harmony with the Department's Amended Final Results. 3 The Department is amending its Amended Final Results with regard to the calculation of the weighted average dumping margin applied to the mandatory respondent, Dalian Huafeng Furniture Group Co., Ltd. (“Huafeng”), and the two separate rate respondents included in this decision: Nanhai Baiyi Woodwork Co. Ltd. (“Nanhai”) and Dongguan Liaobushangdun Huada Furniture Factory and Great Rich (HK) Enterprise Co., Ltd. (“Dongguan”).

    1See Home Meridian Int'l, Inc. v. United States, Consol. Court No. 11-00325, Slip Op. 15-34 (April 21, 2015) (“Home Meridian III”).

    2See Final Results of Third Redetermination Pursuant to Court Order,” Court No. 14-1251, (March 27, 2015) (“Remand Redetermination III”) available at http://enforcement.trade.gov/remands/cafc-1415-1251.pdf.

    3See Wooden Bedroom Furniture From the People's Republic of China: Notice of Court Decision Not in Harmony With Final Results of Administrative Review and Notice of Amended Final Results of Administrative Review Pursuant to Court Decision, 78 FR 72862 (December 4, 2013) (“Amended Final Results”).

    DATES:

    Effective Date: May 1, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Patrick O'Connor, 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) 482-0989.

    SUPPLEMENTARY INFORMATION:

    Background

    In the Final Results, the Department valued certain wood inputs used by the respondent, Huafeng, with surrogate values and used Insular Rattan and Native Products Corporation's (“Insular Rattan”) 2009 financial statements, among others, to calculate surrogate financial ratios.4 The CIT twice remanded issues involving the Final Results to the Department, and, in its second redetermination, the Department valued certain wood inputs used by Huafeng with market economy purchase prices and revised the calculation of the surrogate financial ratios by excluding Insular Rattan's financial statements from the calculation.5 On November 14, 2013, the CIT sustained the final results of the Department's second redetermination and, in accordance with Timken, the Department published a notice of Amended Final Results. 6 The American Furniture Manufacturers Committee for Legal Trade and Vaughan-Bassett Furniture Company, Inc. appealed the valuation of wood inputs, but not the issue of excluding Insular Rattan's financial statements, to the CAFC. On December 1, 2014, the CAFC reversed the CIT's decision and vacated the Department's redetermination results in which it used market economy purchase prices, rather than surrogate values, to value certain of Huafeng's wood inputs. The CAFC directed the CIT to reinstate the Department's wood valuation in the first redetermination (using surrogate values for Huafeng's wood inputs). On January 28, 2015, the CIT ordered the Department to file a redetermination with the Court in which it continued to exclude Insular Rattan's financial statements from its calculations and reinstated the wood valuation from the first redetermination. Pursuant to the CIT's order, the Department filed the final results of its third redetermination with the CIT on March 27, 2015 in which it valued Huafeng's wood inputs using surrogate values and continued to exclude Insular Rattan's financial statements from its calculations.7 On April 21, 2015, the CIT sustained the Department's Remand Redetermination III. 8

    4See Wooden Bedroom Furniture from the People's Republic of China: Final Results and Final Rescission in Part, 76 FR 49729 (Aug. 11, 2011) (“Final Results”).

    5See Second Redetermination Pursuant to Court Order, Court No. 11-00325, dated August 26, 2013 (“Remand Redetermination II”).

    6See Amended Final Results.

    7See Remand Redetermination III.

    8See Home Meridian III.

    Timken Notice

    In its decision in Timken, 893 F.2d at 341, as clarified by Diamond Sawblades, the CAFC held that, pursuant to section 516A(e) of the Tariff Act of 1930, as amended (“the Act”), the Department must publish a notice of a court decision that is not “in harmony” with a Department determination and must suspend liquidation of entries pending a “conclusive” court decision. The CIT's April 21, 2015, judgment sustaining the Department's Remand Redetermination III in which it valued certain wood inputs using surrogate values, rather than market economy purchase prices, constitutes a final decision of that court that is not in harmony with the Department's Amended Final Results. This notice is published in fulfillment of the publication requirements of Timken. Accordingly, the Department will continue the suspension of liquidation of the subject merchandise pending the expiration of the period of appeal, or if appealed, pending a final and conclusive court decision.

    Amended Final Results

    Because there is now a final court decision with respect to this case, the Department is amending its Amended Final Results with respect to Huafeng's weighted-average dumping margin for the period January 1, 2009 through December 31, 2009. In addition, the Department has amended the Amended Final Results for Nanhai and Dongguan, the separate rate respondents included in this final court decision. The remaining weighted-average dumping margins from the Final Results, as subsequently amended,9 remain unchanged.

    9See Wooden Bedroom Furniture From the People's Republic of China: Amended Final Results of Antidumping Duty Administrative Review, 76 FR 57713 (September 16, 2011).

    Manufacturer/exporter Weighted-average dumping margin
  • (percent)
  • Dalian Huafeng Furniture Group Co., Ltd 45.83 Nanhai Baiyi Woodwork Co. Ltd 45.83 Dongguan Liaobushangdun Huada Furniture Factory 45.83 Great Rich (HK) Enterprise Co., Ltd

    In the event the CIT's ruling is not appealed or, if appealed, upheld by the CAFC, the Department will instruct CBP to liquidate entries of subject merchandise based on the revised assessment rates calculated by the Department.

    This notice is issued and published in accordance with sections 516A(e)(1), 751(a)(1), and 777(i)(1) of the Act.

    Dated: May 11, 2015. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2015-12084 Filed 5-18-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XD741 Taking of Marine Mammals Incidental to Specified Activities; Anacortes Tie-Up Slips Dolphin and Wingwall Replacement AGENCY:

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

    ACTION:

    Notice; issuance of an incidental take authorization.

    SUMMARY:

    In accordance with the Marine Mammal Protection Act (MMPA) regulations, notification is hereby given that NMFS has issued an Incidental Harassment Authorization (IHA) to the Washington State Department of Transportation (WSDOT) to take, by harassment, small numbers of 11 species of marine mammals incidental to construction activities for a tie-up slips dolphin and wingwall replacement project in Anacortes, Washington State, between September 1, 2015, and August 31, 2016.

    DATES:

    Effective September 1, 2015, through August 31, 2016.

    ADDRESSES:

    Requests for information on the incidental take authorization should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910. A copy of the application containing a list of the references used in this document, NMFS' Environmental Assessment (EA), Finding of No Significant Impact (FONSI), and the IHA may be obtained by writing to the address specified above or visiting the Internet at: http://www.nmfs.noaa.gov/pr/permits/incidental/. Documents cited in this notice may be viewed, by appointment, during regular business hours, at the aforementioned address.

    FOR FURTHER INFORMATION CONTACT:

    Shane Guan, Office of Protected Resources, NMFS, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    Background

    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

    An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

    Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the U.S. can apply for a one-year authorization to incidentally take small numbers of marine mammals by harassment, provided that there is no potential for serious injury or mortality to result from the activity. Section 101(a)(5)(D) establishes a 45-day time limit for NMFS review of an application followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of marine mammals. Within 45 days of the close of the comment period, NMFS must either issue or deny the authorization.

    Summary of Request

    On April 1, 2014, WSDOT submitted a request to NOAA requesting an IHA for the possible harassment of small numbers of 11 marine mammal species incidental to construction associated with the Anacortes Tie-up Slips Dolphin and Wingwall Replacement in the city of Anacortes, on Fidalgo Island, adjacent to Guemes Channel, Skagit County, Washington, between September 1, 2015, and February 15, 2016. NMFS determined that the IHA application was complete on July 1, 2014.

    Description of the Specified Activity

    A detailed description of the WSDOT's Anacortes tie-up slips dolphin and wingwall project is provided in the Federal Register notice for the proposed IHA (80 FR 11648; March 4, 2015). Since that time, no changes have been made to the proposed construction activities. Therefore, a detailed description is not provided here. Please refer to that Federal Register notice for the description of the specific activity.

    Comments and Responses

    A notice of NMFS' proposal to issue an IHA to WSDOT was published in the Federal Register on March 4, 2015. That notice described, in detail, WSDOT's activity, the marine mammal species that may be affected by the activity, and the anticipated effects on marine mammals. During the 30-day public comment period, NMFS received comments from the Marine Mammal Commission (Commission). Specific comments and responses are provided below.

    Comment 1: The Commission notes that the construction would be conducted in December and January, however, WSDOT's ambient noise measurements were conducted in March and showed that median ambient noise level at the proposed construction area is 123 dB re 1 µPa. The Commission states that the ambient noise levels would be lower in winter (December and January) than those were collected in March when vessel traffic is greater. Therefore, the Commission recommends that NMFS either (1) require WSDOT to measure ambient sound levels during winter and adjust the Level B harassment zones accordingly or (2) base the Level B harassment zones on the 120-dB re 1 µPa threshold and adjust the zones to ensure adequate protection for southern resident killer whales.

    Response: NMFS worked with WSDOT and its acoustic consultant regarding the ambient noise levels in the vicinity of the construction area. In general, doubling the number of boats would only increase the background sound levels by about 3 decibels so adding or subtracting one boat will not have a substantial effect on the overall background sound levels. The ferry vessels dominate the sound levels in the areas around the terminals where WSDOT's measurement was collected. It is only expected a slight increase in sound levels in the summer months due to more recreational boats in the area. Both NMFS and WSDOT's acoustic consultant considers that sound levels between about September to May should be consistent from month to month and representative of the work period.

    Nevertheless, WSDOT agreed that modeled 120 dB isopleths to be used as the threshold for Level B takes for vibratory pile driving and pile removal activities and submitted a updated monitoring plan to encompass this larger zone of influence (ZOI). The updated monitoring measures are discussed in details below in the “Mitigation Measure” and “Monitoring and Reporting” sections.

    In addition, WSDOT is considering getting new winter background data prior to the start of the project. If the measurement shows smaller ZOI, WSDOT will inform NMFS with another revised monitoring plan that reflects the updated ZOI based on onsite measurements.

    The revised ZOI does not change the number of marine mammals takes, because all animals within the general vicinity of the project are being considered for potential takes.

    Description of Marine Mammals in the Area of the Specified Activity

    The marine mammal species under NMFS jurisdiction most likely to occur in the proposed construction area include Pacific harbor seal (Phoca vitulina richardsi), northern elephant seal (Mirounga angustirostris), California sea lion (Zalophus californianus), Steller sea lion (Eumetopias jubatus), killer whale (Orcinus orca) (transient and Southern Resident stocks), gray whale (Eschrichtius robustus), humpback whale (Megaptera novaeangliae), minke whale (Balaenoptera acutorostrata), harbor porpoise (Phocoena phocoena), Dall's porpoise (P. dali), and Pacific white-sided dolphin (Lagenorhynchus obliquidens). A list of the species and their status are provided in Table 1.

    Table 1—Marine Mammal Species Potentially Present in Region of Activity Species ESA status MMPA status Occurrence Harbor Seal Not listed Non-depleted Frequent. California Sea Lion Not listed Non-depleted Frequent. Northern Elephant Seal Not listed Non-depleted Occasional. Steller Sea Lion (eastern DPS) Not listed Under review Rare. Harbor Porpoise Not listed Non-depleted Frequent. Dall's Porpoise Not listed Non-depleted Occasional. Pacific White-sided dolphin Not listed Non-depleted Occasional. Killer Whale Endangered (S. Resident) Depleted Occasional. Gray Whale Delisted Unclassified Occasional. Humpback Whale Endangered Depleted Rare. Minke Whale Not listed Non-depleted Rare.

    General information on the marine mammal species found in Washington coastal waters can be found in Caretta et al. (2014), which is available at the following URL: http://www.nmfs.noaa.gov/pr/sars/pdf/po2013.pdf. Refer to that document for information on these species. A list of marine mammals in the vicinity of the action and their status are provided in Table 3. Specific information concerning these species in the vicinity of the proposed action area is provided in detail in the WSDOT's IHA application.

    Potential Effects of the Specified Activity on Marine Mammals

    The effects of underwater noise from in-water pile removal and pile driving associated with the construction activities for a tie-up slips dolphin and wingwall replacement project in Anacortes has the potential to result in behavioral harassment of marine mammal species and stocks in the vicinity of the action area. The Notice of Proposed IHA included a discussion of the effects of anthropogenic noise on marine mammals, which is not repeated here. No instances of hearing threshold shifts, injury, serious injury, or mortality are expected as a result of WSDOT's activities given the strong likelihood that marine mammals would avoid the immediate vicinity of the pile driving area.

    Potential Effects on Marine Mammal Habitat

    The primary potential impacts to marine mammals and other marine species are associated with elevated sound levels, but the project may also result in additional effects to marine mammal prey species and short-term local water turbidity caused by in-water construction due to pile removal and pile driving. These potential effects are discussed in detail in the Federal Register notice for the proposed IHA and are not repeated here.

    Mitigation Measures

    In order to issue an incidental take authorization under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses.

    For WSDOT's proposed Anacortes tie-up slips dolphin and wingwall replacement project, NMFS is requiring WSDOT to implement the following mitigation measures to minimize the potential impacts to marine mammals in the project vicinity as a result of the in-water construction activities.

    No Impact Pile Driving

    To avoid potential injury to marine mammals, only vibratory pile hammer will be used for pile removal and pile driving.

    Time Restriction

    Work would occur only during daylight hours, when visual monitoring of marine mammals can be conducted. In addition, all in-water construction will be limited to the period between September 1, 2015, and February 15, 2016.

    Establishment of Level B Harassment Zones of Influence

    Because WSDOT will not use impact pile driving for the proposed construction work, no Level A exclusion zone exists for marine mammals. NMFS currently uses received level of 120 dB as the onset of Level B harassment from non-impulse sources such as vibratory pile driving and pile removal. Although ambient measurement during March at the vicinity of Anacortes Ferry Terminal showed that the median ambient noise level is at 123 dB re 1 µPa, WSDOT will use 120 dB re 1 µPa as the isopleths for modeling its Level B harassment zone. WSDOT is considering collecting ambient noise data before in-water construction and adjust the Level B behavioral harassment zone based on measurements.

    The 120-dB Level B harassment ZOIs from in-water vibratory pile removal and pile driving are modeled based on in-water measurements at the WSDOT Port Townsend Ferry Terminal (Laughlin 2011) and Friday Harbor Ferry Terminal (Laughlin 2010) constructions. These modeled results are presented in Table 2 below.

    Table 2—Modeled ZOI Distances to Level B Behavioral Harassment From the Pile Driving and Pile Removal at WSDOT's Anacortes Project Area Vibratory pile type/method Threshold In-water ZOI
  • (km)
  • In-air ZOI
  • (m)
  • 12-inch timber removal 120 dBRMS re 1 µPa 2.3 24-inch steel removal/driving 120 dBRMS re 1 µPa 6.3 30-inch steel driving 120 dBRMS re 1 µPa 39.8 36-inch steel driving 120 dBRMS re 1 µPa 63.1 All piles/in-air (harbor seals) 90 dBRMS re 20 µPa 30 All piles/in-air (other pinnipeds) 100 dBRMS re 20 µPa 10
    Soft Start

    WSDOT will implement “soft start” (or ramp up) to reduce potential startling behavioral responses from marine mammals. Soft start requires contractors to initiate noise from the vibratory hammer for 15 seconds at reduced energy followed by a 1-minute waiting period. The procedure will be repeated two additional times. Each day, WSDOT will use the soft-start technique at the beginning of pile driving, or if pile driving has ceased for more than one hour.

    Shutdown Measures

    WSDOT shall implement shutdown measures if southern resident killer whales are sighted within the vicinity of the project area and are approaching the Level B harassment zone (zone of influence, or ZOI) during in-water construction activities.

    If a killer whale approaches the ZOI during pile driving or removal, and it is unknown whether it is a Southern Resident killer whale or a transient killer whale, it shall be assumed to be a Southern Resident killer whale and WSDOT shall implement the shutdown measure.

    If a Southern Resident killer whale or an unidentified killer whale enters the ZOI undetected, in-water pile driving or pile removal shall be suspended until the whale exits the ZOI to avoid further level B harassment.

    Further, WSDOT shall implement shutdown measures if the number of any allotted marine mammal takes reaches the limit under the IHA (if issued), if such marine mammals are sighted within the vicinity of the project area and are approaching the Level B harassment zone during in-water construction activities.

    Coordination With Local Marine Mammal Research Network

    Prior to the start of pile driving, the Orca Network and/or Center for Whale Research will be contacted to find out the location of the nearest marine mammal sightings. The Orca Sightings Network consists of a list of over 600 (and growing) residents, scientists, and government agency personnel in the U.S. and Canada. Sightings are called or emailed into the Orca Network and immediately distributed to other sighting networks including: the Northwest Fisheries Science Center of NOAA Fisheries, the Center for Whale Research, Cascadia Research, the Whale Museum Hotline and the British Columbia Sightings Network.

    `Sightings' information collected by the Orca Network includes detection by hydrophone. The SeaSound Remote Sensing Network is a system of interconnected hydrophones installed in the marine environment of Haro Strait (west side of San Juan Island) to study orca communication, in-water noise, bottom fish ecology and local climatic conditions. A hydrophone at the Port Townsend Marine Science Center measures average in-water sound levels and automatically detects unusual sounds. These passive acoustic devices allow researchers to hear when different marine mammals come into the region. This acoustic network, combined with the volunteer (incidental) visual sighting network allows researchers to document presence and location of various marine mammal species.

    With this level of coordination in the region of activity, WSDOT will be able to get real-time information on the presence or absence of whales before starting any pile driving.

    Mitigation Conclusions

    NMFS has carefully evaluated the mitigation measures and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another:

    • The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals

    • The proven or likely efficacy of the specific measure to minimize adverse impacts as planned

    • The practicability of the measure for applicant implementation.

    Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:

    (1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).

    (2) A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to received levels of pile driving and pile removal or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

    (3) A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to received levels of pile driving and pile removal, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

    (4) A reduction in the intensity of exposures (either total number or number at biologically important time or location) to received levels of pile driving, or other activities expected to result in the take of marine mammals (this goal may contribute to a, above, or to reducing the severity of harassment takes only).

    (5) Avoidance or minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.

    (6) For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

    Based on our evaluation of the prescribed mitigation measures, NMFS has determined the measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

    Monitoring and Reporting

    In order to issue an incidental take authorization (ITA) for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth, “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for ITAs must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. WSDOT submitted a marine mammal monitoring plan as part of the IHA application, and updated the plan based on comments received from the Commission. The updated monitoring plan can be found at http://www.nmfs.noaa.gov/pr/permits/incidental.htm. The plan may be modified or supplemented based on comments or new information received from the public during the public comment period.

    Monitoring measures prescribed by NMFS should accomplish one or more of the following general goals:

    (1) An increase in the probability of detecting marine mammals, both within the mitigation zone (thus allowing for more effective implementation of the mitigation) and in general to generate more data to contribute to the analyses mentioned below;

    (2) An increase in our understanding of how many marine mammals are likely to be exposed to levels of pile driving that we associate with specific adverse effects, such as behavioral harassment, TTS, or PTS;

    (3) An increase in our understanding of how marine mammals respond to stimuli expected to result in take and how anticipated adverse effects on individuals (in different ways and to varying degrees) may impact the population, species, or stock (specifically through effects on annual rates of recruitment or survival) through any of the following methods:

    Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);

    Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);

    Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli;

    (4) An increased knowledge of the affected species; and

    (5) An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.

    Monitoring Measures

    WSDOT shall employ NMFS-approved protected species observers (PSOs) to conduct marine mammal monitoring for its Anacortes tie-up dolphins and wingwall replacement project. The PSOs will observe and collect data on marine mammals in and around the project area for 30 minutes before, during, and for 30 minutes after all pile removal and pile installation work. If a PSO observes a marine mammal within a ZOI that appears to be disturbed by the work activity, the PSO will notify the work crew to initiate shutdown measures.

    Monitoring of marine mammals around the construction site shall be conducted using high-quality binoculars (e.g., Zeiss, 10 × 42 power). Due to the different sizes of ZOIs from different pile sizes, two different ZOIs and monitoring protocols corresponding to a specific pile size will be established. Specifically, during vibratory timber removal, and 24″ steel vibratory pile driving and removal, one land-based PSO will monitor the area from the terminal work site, and one boat with a driver and a PSO will travel through the monitoring area. During 30/36″ vibratory pile driving, one land-based PSO will monitor the area from the terminal work site, and two boats with two drivers and two PSOs will travel through the monitoring area (see Figures 2 and 3 in WSDOT's updated Marine Mammal Monitoring Plan).

    Data collection during marine mammal monitoring will consist of a count of all marine mammals by species, a description of behavior (if possible), location, direction of movement, type of construction that is occurring, time that pile replacement work begins and ends, any acoustic or visual disturbance, and time of the observation. Environmental conditions such as weather, visibility, temperature, tide level, current, and sea state would also be recorded.

    Reporting Measures

    WSDOT is required to submit a final monitoring report within 90 days after completion of the construction work or the expiration of the IHA (if issued), whichever comes earlier. This report shall detail the monitoring protocol, summarize the data recorded during monitoring, and estimate the number of marine mammals that may have been harassed. NMFS shall have an opportunity to provide comments on the report, and if NMFS has comments, WSDOT shall address the comments and submit a final report to NMFS within 30 days.

    In addition, NMFS requires WSDOT to notify NMFS' Office of Protected Resources and NMFS' Stranding Network within 48 hours of sighting an injured or dead marine mammal in the vicinity of the construction site. WSDOT shall provide NMFS with the species or description of the animal(s), the condition of the animal(s) (including carcass condition, if the animal is dead), location, time of first discovery, observed behaviors (if alive), and photo or video (if available).

    In the event that WSDOT finds an injured or dead marine mammal that is not in the vicinity of the construction area, WSDOT would report the same information as listed above to NMFS as soon as operationally feasible.

    Estimated Take by Incidental Harassment

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].

    As discussed above, in-water pile removal and pile driving (vibratory and impact) generate loud noises that could potentially harass marine mammals in the vicinity of WSDOT's proposed Anacortes Ferry Terminal tie-up slip dolphin and wingwall replacement project.

    As mentioned earlier in this document, currently NMFS uses 120 dB re 1 µPa and 160 dB re 1 µPa at the received levels for the onset of Level B harassment from non-impulse (vibratory pile driving and removal) and impulse sources (impact pile driving) underwater, respectively. Table 3 summarizes the current NMFS marine mammal take criteria.

    Table 3—Current Acoustic Exposure Criteria for Non-explosive Sound Underwater Criterion Criterion definition Threshold Level A Harassment (Injury) Permanent Threshold Shift (PTS) (Any level above that which is known to cause TTS) 180 dB re 1 µPa (cetaceans).
  • 190 dB re 1 µPa (pinnipeds)
  • root mean square (rms).
  • Level B Harassment Behavioral Disruption (for impulse noises) 160 dB re 1 µPa (rms). Level B Harassment Behavioral Disruption (for non-impulse noise) 120 dB re 1 µPa (rms).

    As explained above, ZOIs will be established that encompass the areas where received underwater sound pressure levels (SPLs) exceed the applicable thresholds for Level B harassment. In the case of WSDOT's proposed Anacortes construction project, the Level B harassment ZOI for non-impulse noise sources will be at the received level at 120 dB. This level may be revised and the Level B ZOI reestablished if WSDOT conduct an ambient noise measurement during the time of construction. There will not be a zone for Level A harassment in this case, because source levels from vibratory hammer do not exceed the threshold for Level A harassment, and no impact hammer will be used in the proposed project.

    Sound Levels From Proposed Construction Activity

    As mentioned earlier, the revised 120-dB Level B harassment ZOIs are modeled based on in-water measurements at the WSDOT Port Townsend Ferry Terminal (Laughlin 2011) and Friday Harbor Ferry Terminal (Laughlin 2010) constructions (Table 2). Incidental take is calculated for each species by estimating the likelihood of a marine mammal being present within a ZOI during active pile removal/driving. Expected marine mammal presence is determined by past observations and general abundance near the Anacortes ferry terminal during the construction window. Ideally, potential take is estimated by multiplying the area of the ZOI by the local animal density. This provides an estimate of the number of animals that might occupy the ZOI at any given moment. However, there are no density estimates for any Puget Sound population of marine mammal.

    As a result, the take requests were estimated using local marine mammal data sets, and information from state and federal agencies. All haulout and observation data available are summarized in Section 3 of WSDOT's IHA application. Project duration is presented in Section 2 of WSDOT's IHA application.

    The calculation for marine mammal exposures is estimated by:

    Exposure estimate = N (number of animals in the area) * Number of days of pile removal/driving activity.

    Estimates include Level B acoustical harassment during vibratory pile removal and driving. All estimates are conservative, as pile removal/driving will not be continuous during the work day. Using this approach, a summary of estimated takes of marine mammals incidental to WSDOT's Anacortes Ferry Terminal tip-up dolphins and wingwall replacement work are provided in Table 4.

    Table 4—Estimated Numbers of Marine Mammals That May Be Exposed to Received Pile Removal Levels Above 120 dB re 1 μPa (rms) Species Estimated marine mammal takes Abundance Percentage Pacific harbor seal 900 14,612 6.0 California sea lion 180 296,750 0.06 Steller sea lion 360 52,847 0.7 Northern elephant seal 72 124,000 0.06 Harbor porpoise 612 10,682 5.7 Dall's porpoise 108 42,000 0.3 Killer whale, transient 70 354 20 Killer whale, Southern Resident 4 81 5.0 Pacific white-sided dolphin 360 25,233 1.4 Gray whale 36 18,017 0.2 Humpback whale 30 2,043 1.5 Minke whale 10 202-600 1.7-5 Analysis and Determinations Negligible Impact

    Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of Level B harassment takes, alone, is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through behavioral harassment, NMFS must consider other factors, such as the likely nature of any responses (their intensity, duration, etc.), the context of any responses (critical reproductive time or location, migration, etc.), as well as the number and nature of estimated Level A harassment takes, the number of estimated mortalities, and effects on habitat.

    WSDOT's Anacortes Ferry Terminal tie-up dolphins and wingwall replacement project would involve vibratory pile removal and pile driving activities. Elevated underwater noises are expected to be generated as a result of these activities; however, these noises are expected to result in no mortality or Level A harassment and limited Level B harassment of marine mammals. WSDOT will not use impact hammer for pile driving, thus eliminating the potential for injury (including PTS) and TTS from noise impact. For vibratory pile removal and pile driving, noise levels are not expected to reach the level that may cause TTS, injury (including PTS), or mortality to marine mammals. Therefore, NMFS does not expect that any animals would experience Level A harassment (including injury or PTS) or Level B harassment in the form of TTS from being exposed to in-water pile removal and pile driving associated with WSDOT's construction project.

    Additionally, the sum of noise from WSDOT's proposed Anacortes Ferry Terminal tie-up dolphins and wingwall replacement construction activities is confined to a limited area by surrounding landmasses; therefore, the noise generated is not expected to contribute to increased ocean ambient noise. In addition, due to shallow water depths in the project area, underwater sound propagation of low-frequency sound (which is the major noise source from pile driving) is expected to be poor.

    In addition, WSDOT's proposed activities are localized and of short duration. The entire project area is limited to WSDOT's Anacortes Ferry Terminal construction work. The entire project would involve the removal of 272 existing piles and installation of 81 piles. The duration for the construction would involve 68 hours in 9 days for pile removal and 27 hours in 27 days for pile installation. These low-intensity, localized, and short-term noise exposures may cause brief startle reactions or short-term behavioral modification by the animals. These reactions and behavioral changes are expected to subside quickly when the exposures cease. Moreover, the proposed mitigation and monitoring measures are expected to reduce potential exposures and behavioral modifications even further. Additionally, no important feeding and/or reproductive areas for marine mammals are known to be near the proposed action area. Therefore, the take resulting from the proposed Anacortes Ferry Terminal tie-up dolphins and wingwall replacement work is not reasonably expected to, and is not reasonably likely to, adversely affect the marine mammal species or stocks through effects on annual rates of recruitment or survival.

    The project area is not a prime habitat for marine mammals, nor is it considered an area frequented by marine mammals. Therefore, behavioral disturbances that could result from anthropogenic noise associated with WSDOT's construction activities are expected to affect only a small number of marine mammals on an infrequent and limited basis.

    The project also is not expected to have significant adverse effects on affected marine mammals' habitat, as analyzed in detail in the “Anticipated Effects on Marine Mammal Habitat” section. The project activities would not modify existing marine mammal habitat. The activities may cause some fish to leave the area of disturbance, thus temporarily impacting marine mammals' foraging opportunities in a limited portion of the foraging range; but, because of the short duration of the activities and the relatively small area of the habitat that may be affected, the impacts to marine mammal habitat are not expected to cause significant or long-term negative consequences.

    Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS finds that the total marine mammal take from WSDOT's Anacortes Ferry Terminal tie-up dolphins and wingwall replacement project will have a negligible impact on the affected marine mammal species or stocks.

    Small Number

    Based on analyses provided above, it is estimated that approximately 900 harbor seals, 180 California sea lions, 360 Steller sea lions, 72 northern elephant seals, 612 harbor porpoises, 108 Dall's porpoises, 70 transient killer whales, 4 Southern Resident killer whales, 360 Pacific white-sided dolphins, 36 gray whales, 30 humpback whales, and 10 minke whales could be exposed to received noise levels that could cause Level B behavioral harassment from the proposed construction work at the Anacortes Ferry Terminal in Washington State. These numbers represent approximately 0.06% to 20% of the populations of these species that could be affected by Level B behavioral harassment, respectively (see Table 5 above), which are small percentages relative to the total populations of the affected species or stocks.

    Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, which are expected to reduce the number of marine mammals potentially affected by the proposed action, NMFS finds that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.

    Impact on Availability of Affected Species for Taking for Subsistence Uses

    There are no subsistence uses of marine mammals in the proposed project area; and, thus, no subsistence uses impacted by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

    Endangered Species Act (ESA)

    The humpback whale and the Southern Resident stock of killer whale are the only marine mammal species currently listed under the ESA that could occur in the vicinity of WSDOT's proposed construction projects. Under section 7 of the ESA, the Federal Highway Administration (FHWA) and WSDOT have consulted with NMFS West Coast Regional Office (WCRO) on the proposed WSDOT Anacortes Ferry Terminal tie-up slip dolphins and wingwall replacement project. WCRO issued a Biological Opinion on July 15, 2014, which concludes that the proposed Anacortes Ferry Terminal tie-up slip dolphins and wingwall replacement project may affect, but is not likely to adversely affect the listed marine mammal species and stocks.

    The issuance of an IHA to WSDOT constitutes an agency action that authorizes an activity that may affect ESA-listed species and, therefore, is subject to section 7 of the ESA. As the effects of the activities on listed marine mammals were analyzed during a formal consultation between the FHWA and NMFS, and as the underlying action has not changed from that considered in the consultation, the discussion of effects that are contained in the Biological Opinion and accompanying memo issued to the FHWA on July 15, 2014, pertains also to this action. Therefore, NMFS has determined that issuance of an IHA for this activity would not lead to any effects to listed marine mammal species apart from those that were considered in the consultation on FHWA's action.

    National Environmental Policy Act (NEPA)

    NMFS prepared an Environmental Assessment (EA) and analyzed the potential impacts to marine mammals that would result from WSDOT's Anacortes Ferry Terminal tie-up slip dolphins and wingwall replacement project. A Finding of No Significant Impact (FONSI) was signed in May 2015. A copy of the EA and FONSI is available upon request (see ADDRESSES).

    Authorization

    NMFS has issued an IHA to WSDOT for the potential harassment of small numbers of 11 marine mammal species incidental to the Anacortes Ferry Terminal tie-up slip dolphins and wingwall replacement construction in Washington State, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.

    Dated: May 12, 2015. Donna S. Wieting, Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2015-12097 Filed 5-18-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XD807 Takes of Marine Mammals Incidental to Specified Activities; Construction Activities at the Children's Pool Lifeguard Station at La Jolla, California AGENCY:

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

    ACTION:

    Notice; proposed Incidental Harassment Authorization (IHA); request for comments.

    SUMMARY:

    NMFS has received an application from the City of San Diego for an IHA to take small numbers of marine mammals, by Level B harassment, incidental to construction activities at the Children's Pool Lifeguard Station in La Jolla, California. NMFS has reviewed the IHA application, including all supporting documents, and determined that it is adequate and complete. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an IHA to the City of San Diego to take, by Level B harassment only, three species of marine mammals during the specified activities.

    DATES:

    Comments and information must be received no later than June 18, 2015.

    ADDRESSES:

    Comments on the IHA application should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910. The mailbox address for providing email comments is [email protected] Please include 0648-XD807 in the subject line. NMFS is not responsible for email comments sent to addresses other than the one provided here. Comments sent via email, including all attachments, must not exceed a 25-megabyte size.

    All comments received are a part of the public record and will generally be posted to http://www.nmfs.noaa.gov/pr/permits/incidental/ without change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.

    An electronic copy of the IHA application containing a list of the references used in this document may be obtained by writing to the address specified above, telephoning the contact listed below (see FOR FURTHER INFORMATION CONTACT), or visiting the Internet at: http://www.nmfs.noaa.gov/pr/permits/incidental/. Documents cited in this notice, including the IHA application, may also be viewed, by appointment, during regular business hours, at the aforementioned address.

    FOR FURTHER INFORMATION CONTACT:

    Howard Goldstein or Jolie Harrison, Office of Protected Resources, NMFS, 301-427-8401.

    SUPPLEMENTARY INFORMATION:

    Background

    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.), directs the Secretary of Commerce (Secretary) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals, by United States citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

    Authorization for the incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring, and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

    Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the United States can apply for an authorization to incidentally take small numbers of marine mammals by harassment. Section 101(a)(5)(D) of the MMPA establishes a 45-day time limit for NMFS's review of an application followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of small numbers of marine mammals. Within 45 days of the close of the public comment period, NMFS must either issue or deny the authorization.

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].

    Summary of Request

    On February 25, 2015, NMFS received an application from the City of San Diego, Engineering and Capital Projects Department, requesting an IHA for the taking of marine mammals incidental to construction activities. NMFS determined that the IHA application was adequate and complete on April 9, 2015.

    The City of San Diego would undertake the proposed construction activities between June 2015 and June 2016 at the Children's Pool Lifeguard Station in La Jolla, California. In-air noise generated from equipment used during the construction activities is likely to result in the take of marine mammals. The requested IHA would authorize the take, by Level B (behavioral) harassment, of small numbers of Pacific harbor seals (Phoca vitulina richardii), California sea lions (Zalophus californianus), and northern elephant seals (Mirounga angustirostris) incidental to construction activities of the Children's Pool Lifeguard Station at La Jolla, CA. Because the proposed construction activities were subject to delays and cannot be completed by June 27, 2015, the City of San Diego has requested a renewal of the 2014 to 2015 IHA for an additional year. The construction activities are planned to take place during June 2015 to June 2016 in La Jolla, CA. Regarding the previous IHA, NMFS published a notice in the Federal Register (79 FR 8160) on February 11, 2014, making preliminary determinations and proposing to issue an IHA. The notice initiated a 30-day public comment period. On June 6, 2014, NMFS published a notice in the Federal Register (79 FR 32699) announcing the issuance of an IHA. Additional information on the construction activities at the Children's Pool Lifeguard Station is contained in the IHA application, which is available upon request (see ADDRESSES).

    Also, NMFS issued the City of San Diego an IHA in 2013 (78 FR 40705, July 8, 2013) for demolition and construction activities at the Children's Pool Lifeguard Station that were scheduled to be completed in 2013. Because the construction activities were subject to delays (e.g., nesting migratory birds, unexpected drainage pipes, unexpected demolition and construction planning, etc.) and could not be completed by December 15, 2013, the City of San Diego requested a renewal of the 2013 IHA for an additional year. Additional information on the construction activities at the Children's Pool Lifeguard Station is contained in the IHA application, which is available upon request (see ADDRESSES).

    Description of the Proposed Specified Activity Overview

    The City of San Diego plans to conduct construction activities at the Children's Pool Lifeguard Station in La Jolla, CA in order to meet the needs of the lifeguards at Children's Pool and the demand for lifeguard services. The overall project includes the demolition of the existing lifeguard station and construction of a new, three-story, lifeguard station on the same site. Demolition of the existing lifeguard station was completed in 2013 to 2014 and construction of the new lifeguard station is expected to be completed in 2015 to 2016. Because the previously existing lifeguard station was demolished and closed to entry, a temporary lifeguard tower was moved onto the bluff near the previous lifeguard station.

    Proposed Dates and Duration

    The City of San Diego is planning to begin/resume the project at the Children's Pool in La Jolla, CA on June 1, 2015, (see page 30 to 31 of the Negative Declaration in the IHA application) with completion of the new lifeguard station to be completed by December 15, 2015. The City of San Diego and NMFS are requiring a moratorium on all construction activities during harbor seal pupping and weaning (i.e., December 15th to May 30th; see page 5 of the Mitigated Negative Declaration in the IHA application). Therefore, work on this project can only be performed between June 1st and December 14th of any year.

    Proposed construction activities would generally occur Monday through Friday (no work will occur on holidays) during daylight hours only, as stipulated in the “Mitigated Negative Declaration” included in the IHA application and local ordinances. As a modification to the original IHA, the City of San Diego has requested that planned construction activities be allowed on weekends (i.e., Saturday and Sunday to ensure completion of the project during 2015. The exact dates of the proposed activities depend on logistics and scheduling. The IHA is valid through June 2016 to allow for construction delays.

    Proposed Specific Geographic Region

    The La Jolla Children's Pool Lifeguard Station is located at 827 1/2 Coast Boulevard, La Jolla, CA 92037 (32° 50′ 50.02″ North, 117° 16′ 42.8″ West). The locations and distances (in ft) from the construction site to the Children's Pool haul-out area, breakwater ledge/rocks haul-out area, reef haul-out area, and Casa Beach haul-out area can be found in the City of San Diego's IHA application.

    Detailed Description of the Proposed Specified Activities

    The Children's Pool was created in 1931 by building a breakwater wall which created a protected pool for swimming. Although partially filled with sand, the Children's Pool still has open water for swimming and a beach for sunbathing and beachcombing. The Children's Pool and nearby shore areas (i.e., shoreline, beaches, and reefs of La Jolla) are used by swimmers, sunbathers, SCUBA divers and snorkelers, shore/surf fishermen, school classes, tide pool explorers, kayakers, surfers, boogie and skim boarders, seal, sea lion, bird and nature watchers, and for other activities by the general public. Over the last three years (2010 through 2012), an average of 1,556,184 people have visited the Children's Pool annually, and lifeguards have taken an average of 8,147 preventive actions and 86 water rescues annually (CASA, 2010; 2011; 2012).

    The previous lifeguard facility at Children's Pool, built in 1967, was old, deteriorating from saltwater intrusion, and no longer served the needs of the lifeguard staff or the beach-going public. The structure was condemned on February 22, 2008 due to its deteriorated condition and lack of structural integrity. Because the existing building was no longer viable, a temporary lifeguard tower was moved in. However, a new lifeguard station is required to meet the needs of the lifeguards and the demand for lifeguard services.

    The overall project includes the demolition of the existing lifeguard station and construction of a new, three-story, lifeguard station on the same site. Demolition and removal of the existing lifeguard station was completed in 2013 to 2014 and construction of the new lifeguard station is expected to be completed in 2015 to 2016. The building contractor utilized excavators, backhoes, concrete saws, and jackhammers for demolishing the previous structure and has hauled the waste materials to an offsite landfill where it was separated into recycled content and waste. During the second year of construction (2014 to 2015) and in the same footprint as the old lifeguard station, the new lifeguard station is being constructed within and adjacent to the previous facility. Rough plumbing and electrical have been laid; the foundation has been poured and some of the steel structure has been erected. The new lifeguard facility is in an optimal location to provide lifeguard service to the community. The new, three-story, building will contain a lower level with beach access level public restrooms and showers, lifeguard lockers, and sewage pump room; a second level with two work stations, ready/observation room, kitchenette, restroom, and first aid station; and a third “observation” level (with a 270° view of the beach and nearby reef areas) with a single occupancy observation space, radio storage closet, and exterior catwalk. Interior stairs will link the floors. The existing below grade retaining walls will remain in place and new retaining walls will be constructed for a ramp from street level to the lower level for emergency vehicle beach access and pedestrian access to the lower level restrooms and showers. A 5.6 m (18. 5 ft) wall will be located along the north end of the lower level. The walls will be designed for a minimum design life of 50 years and will not be undermined from ongoing coastal erosion. The walls will not be readily viewed from Coast Boulevard, the public sidewalks or the surrounding community. Enhanced paving, seating and viewing space, drinking fountains, adapted landscaping, and water efficient irrigation will also be included.

    The City of San Diego has divided the demolition and construction activities are divided into phases:

    (1.) Mobilization and temporary facilities;

    (2.) Demolition and site clearing;

    (3.) Site preparation and utilities;

    (4.) Building foundation;

    (5.) Building shell;

    (6.) Building exterior;

    (7.) Building interior;

    (8.) Site improvements; and

    (9.) Final inspection and demobilization.

    Demolition and construction of the new lifeguard station was initially estimated to take approximately 7 months (148 actual demolition and construction days) and be completed by December 15, 2013; however, demolition and construction did not start until later than previously planned in June 2013 and June 2014 due to the presence of nesting migratory birds (i.e., Western seagulls [Larus occidentalis] and eggs/chicks). There were additional unexpected delays in the demolition due to unforeseen underground structures at the site making it impossible to finish the project by December 15, 2013 or 2014. The City of San Diego completed phases 1 to 4 during 2013 and 2014. During the 2013 to 2014 construction window, the temporary on-site tower was removed and two temporary towers were installed nearby (one about 500 m [1,640.4 ft] south of the construction site and another about 1,000 m [3,280.8 ft] east of the construction site to serve citizens utilizing the beaches and ocean waters nearby. Construction of phases 5 to 9 would commence in June 2015, thereby necessitating a renewal of the previous IHA.

    The notice of the final IHA for the City of San Diego's demolition and construction activities that was published in the Federal Register on July 8, 2013 (78 FR 40705) provides a detailed summary on phases 1 to 4 (i.e., mobilization and temporary facilities, demolition and site clearing, site preparation and utilities, and building foundation). Phases 5 to 9 include (phases overlap in time):

    (5.) Building shell:

    Pre-cast concrete panel walls, panel walls, rough carpentry and roof framing, wall board, cable railing, metal flashing, and roofing.

    Equipment—crane, truck, fork lift, and hand/power tools.

    Timeframe—Approximately 35 days.

    This phase will be completed in 2015 and has a maximum source level of 100 dB.

    (6.) Building exterior:

    Doors and windows, siding paint, light fixtures, and plumbing fixtures.

    Equipment—truck, hand/power tools, and chop saw.

    Timeframe—Approximately 4 weeks.

    This phase will be completed in 2015 and has a maximum source level of 100 dB.

    (7.) Building interiors:

    Walls, sewage lift station, rough and finish mechanical electrical plumbing structural (MEPS), wall board, door frames, doors and paint.

    Equipment—truck, hand/power tools, and chop saw.

    Timeframe—Approximately 37 days.

    This phase will be completed in 2015 and has a maximum source level of 100 dB.

    (8.) Site improvements:

    Modify storm drain, concrete seat walls, curbs, and planters, fine grade, irrigation, hardscape, landscape, hand rails, plaques, and benches.

    Equipment—backhoe, truck, hand/power tools, concrete pump/truck, and fork lift.

    Timeframe—Approximately 37 days.

    This phase will be completed in 2015 and has a maximum source level of 110 dB.

    (9.) Final inspection and demobilization:

    System testing, remove construction equipment, inspection, and corrections.

    Equipment—truck, and hand/power tools.

    Timeframe—Approximately 41 days.

    This phase will be completed in 2015 and has a maximum source level of 100 dB.

    The exact dates of the planned activities depend on logistics and scheduling.

    Sound levels during all phases of the project would not exceed 110 dB re 20 μPa at five feet from the sound sources. The 110 dB estimate is based on equipment manufacturers' estimates obtained by the construction contractor. The City of San Diego utilized published or manufacturers' measurement data based on the proposed equipment (i.e., a backhoe, dump truck, cement pump, air compressor, electric screw guns, jackhammers, concrete saw, chop saw, and hand tools) to be utilized on the project site. Operation of the equipment is the primary activity within the range of construction activities that is likely to affect marine mammals by potentially exposing them to in-air (i.e., airborne or sub-aerial) noise. During the working day, the City of San Diego estimates there would be sound source levels above 90 dB re 20 μPa, including 65 days of 100 to 110 dB re 20 μPa at the construction site.

    On average, pinnipeds will be about 30.5 meters (m) (100 feet [ft]) or more from the construction site with a potential minimum of about 15.2 m (50 ft). During 2013 and 2014, measured sound levels from the demolition equipment reaching the pinnipeds did not exceed approximately 90 dB re 20 μPa at the haul-out area closest to the demolition and construction and a peak of about 83 dB re 20 μPa at the mean hauling-out distance (30.5 m). The City of San Diego used the formula and online calculator on the Web site: http://sengpielaudio.com/calculator-distance.htm and measured distances from the sound source to determine the area of potential impacts from in-air sound. Table 1 of the City of San Diego's monitoring report provides mean sound and mean distance from sound sources by the type of equipment and monitoring location. The City of San Diego intends to continue to measure in-air background noise levels in the days immediately prior to, during, and after the construction activities.

    Additional details regarding the proposed construction activities of the Children's Pool Lifeguard Station can be found in the City of San Diego's IHA application. The IHA application can also be found online at: http://www.nmfs.noaa.gov/pr/permits/incidental/construction.htm.

    Description of Marine Mammals in the Specified Geographic Area of the Proposed Specified Activity

    Three species of pinnipeds are known to or could occur in the Children's Pool proposed action area and off the Pacific coastline (see Table 1 below). Pacific harbor seals, California sea lions, and northern elephant seals are the three species of marine mammals that occur and are likely to be found within the immediate vicinity of the activity area. Therefore, these three species are likely to be exposed to effects of the proposed specified activities. A variety of other marine mammals have on occasion been reported in the coastal waters off southern California. These include gray whales, killer whales, bottlenose dolphins, Steller sea lions, northern fur seals, and Guadalupe fur seals. However, none of these species have been reported to occur in the immediate proposed action area of the Children's Pool beach. Therefore, NMFS does not expect, and is not authorizing, incidental take of other marine mammal species from the proposed specified activities. Table 1 below identifies the cetacean and pinnipeds species, their habitat, and conservation status in the nearshore area of the general region of the proposed project area.

    Table 1—The Habitat, Abundance, and Conservation Status of Marine Mammals Inhabiting the General Region of the Action Area in the Pacific Ocean Off the Southern Coast of California Species Habitat Occurrence Range Best
  • population
  • estimate
  • (minimum) 1
  • ESA 2 MMPA 3
    Mysticetes Gray whale (Eschrichtius robustus) Coastal and shelf Transient during season migrations North Pacific Ocean, Gulf of California to Arctic—Eastern North Pacific stock 20,990 (20,125) DL—Eastern Pacific stock
  • EN—Western Pacific stock
  • NC—Eastern North Pacific stock
  • D—Western North Pacific stock.
  • Odontocetes Killer whale (Orcinus orca) Widely distributed Varies on inter-annual basis Cosmopolitan 354 (354)—West Coast Transient stock NL
  • EN—Southern resident population
  • NC
  • D—Southern Resident and AT1 Transient populations.
  • Bottlenose dolphin (Tursiops truncatus) Offshore, inshore, coastal, estuaries Limited, small population within 1 km of shore Tropical and temperate waters between 45° North and South 323 (290)—California Coastal stock NL NC. Long-beaked common dolphin (Delphinus capensis) Inshore Common, more inshore distribution, year-round presence Nearshore and tropical waters 107,016 (76,224)—California stock NL NC. Pinnipeds Pacific harbor seal (Phoca vitulina richardii) Coastal Common Coastal temperate to polar regions in Northern Hemisphere 30,968 (27,348)—California stock NL NC. Northern elephant seal (Mirounga angustirostris) Coastal, pelagic when not migrating Common Eastern and Central North Pacific—Alaska to Mexico 179,000 (81,368)—California breeding stock NL NC. California sea lion (Zalophus californianus) Coastal, shelf Common Eastern North Pacific Ocean—Alaska to Mexico 296,750 (153,337)—U.S. stock NL NC. Steller sea lion (Eumetopias jubatus) Coastal, shelf Rare North Pacific Ocean—Central California to Korea 72,223 (52,847)—Eastern U.S. stock DL—Eastern U.S. stock
  • EN—Western U.S. stock
  • D.
    Northern fur seal (Callorhinus ursinus) Pelagic, offshore Rare North Pacific Ocean—Mexico to Japan 12,844 (6,722)—California stock NL NC—California stock. Guadalupe fur seal (Arctocephalus townsendi) Coastal, shelf Rare California to Baja California, Mexico 7,408 (3,028)—Mexico to California T D. NA = Not available or not assessed. 1 NMFS Marine Mammal Stock Assessment Reports 2 U.S. Endangered Species Act: EN = Endangered, T = Threatened, DL = Delisted, and NL = Not listed. 3 U.S. Marine Mammal Protection Act: D = Depleted, S = Strategic, and NC = Not classified.

    The rocks and beaches at or near the Children's Pool in La Jolla, CA, are almost exclusively Pacific harbor seal hauling-out sites. On infrequent occasions, one or two California sea lions or a single juvenile northern elephant seal have been observed on the sand or rocks at or near the Children's Pool (i.e., breakwater ledge/rocks haul-out area, reef haul-out area, and Casa Beach haul-out area). These sites are not usual haul-out locations for California sea lions and/or northern elephant seals. The City of San Diego commissioned two studies of harbor seal abundance trends at the Children's Pool. Both studies reported that appearances of California sea lions and northern elephant seals are infrequent, but not rare at Children's Pool (Yochem and Stewart, 1998; Hanan, 2004; Hanan & Associates, 2011). During 2013, the City of San Diego observed one juvenile and three adult California sea lions and two juvenile northern elephant seals at the Children's Pool. During 2014, the City of San Diego observed 22 California sea lions (during 19 days) and 30 juvenile elephant seals (during 29 days) at the Children's Pool. Adult sea lions were also observed hauling out on rocks and cliffs near the Children's Pool.

    Pacific Harbor Seal

    Harbor seals are widely distributed in the North Atlantic and North Pacific. Two subspecies exist in the Pacific Ocean: P. v. stejnegeri in the western North Pacific near Japan, and P. v. richardii in the eastern North Pacific. The subspecies in the eastern North Pacific Ocean inhabits near-shore coastal and estuarine areas from Baja California, Mexico, to the Pribilof Islands in Alaska. These seals do not make extensive pelagic migrations, but do travel 300 to 500 kilometers (km) (162 to 270 nautical miles [nmi]) on occasion to find food or suitable breeding areas (Herder, 1986; Harvey and Goley, 2011). Previous assessments of the status of harbor seals have recognized three stocks along the west coast of the continental U.S.: (1) California, (2) Oregon and Washington outer coast waters, and (3) inland waters of Washington. An unknown number of harbor seals also occur along the west coast of Baja California, at least as far south as Isla Asuncion, which is about 100 miles south of Punta Eugenia. Animals along Baja California are not considered to be a part of the California stock because it is not known if there is any demographically significant movement of harbor seals between California and Mexico and there is no international agreement for joint management of harbor seals. Harbor seal presence at haul-out sites is seasonal with peaks in abundance during their pupping and molting periods. Pupping and molting periods are first observed to the south and progress northward up the coast with time (e.g., January to May near San Diego, April to June in Oregon and Washington) (Jeffries, 1984; Jeffries, 1985; Huber et al., 2001; Hanan, 2004; Hanan & Associates, 2011).

    In California, approximately 400 to 600 harbor seal haul-out sites are distributed along the mainland coast and on offshore islands, including intertidal sandbars and ledges, rocky shores and islets, and beaches (Harvey et al., 1995; Hanan, 1996; Lowry et al., 2008). Preferred haul-out sites are those that are protected from the wind and waves, and allow access to deep water for foraging (Perrin et al., 2008). Of the known haul-out sites, 14 locations are rookeries (2 locations have multiple sites, for a total of 17 sites) on or near the mainland of California. The population of harbor seals has grown off the U.S. west coast and has led to new haul-out sites being used in California (Hanan, 1996). Harbor seals are one of the most common and frequently observed marine mammals along the coastal environment.

    Harbor seals have been observed hauling-out and documented giving birth at the Children's Pool since the 1990's (Yochem and Stewart, 1998; Hanan & Associates, 2004). Pacific harbor seals haul-out year-round on beaches and rocks (i.e., breakwater ledge/rocks haul-out area, reef haul-out area, and Casa Beach haul-out area) below the lifeguard tower at Children's Pool. According to Yochem (2005), the Children's Pool beach site is used by harbor seals at all hours of the day and at all tides with the exception of occasional high tide/high swell events in which the entire beach is awash. It is one of the three known haul-out sites for this species in San Diego County. These animals have been observed in this area moving to/from the Children's Pool, exchanging with the rocky reef directly west of and adjacent to the breakwater and with Seal Rock, which is about 150 m (492 ft) west of the Children's Pool. Harbor seals have also been reported on the sandy beach just southwest of the Children's Pool. At low tide, additional space for hauling-out is available on the rocky reef areas outside the retaining wall and on beaches immediately southward. Haul-out times vary by time of year, from less than an hour to many hours. There have been no foraging studies at this site, but harbor seals have been observed in nearshore waters and kelp beds nearby, including La Jolla Cove.

    The Children's Pool area is the only rookery in San Diego County and the only mainland rookery on the U.S. west coast between the border of Mexico and Point Mugu in Ventura County, CA (321.9 km [200 miles]). The number of harbor seals in this area has increased since 1979, and seals are documented to give birth on these beaches during December through May (Hanan, 2004; Hanan & Associates, 2011). The official start to pupping season is December 15. Females in an advanced stage of pregnancy begin to show up on the Children's Pool beach by late October to early November. Several studies have identified harbor seal behavior and estimated harbor seal numbers including patterns of daily and seasonal area use (Yochem and Stewart, 1998; Hanan & Associates, 2011; Linder, 2011). Males, females, and pups (in season) of all ages and stages of development are observed at the Children's Pool and adjacent areas.

    In southern California, a considerable amount of information is known about the movements and ecology of harbor seals, but population structure in the region is not as well known (Stewart and Yochem, 1994, 2000; Keper et al., 2005; Hanan & Associates, 2011). Linder (2011) suggests that this population moves along the California coast and the beach at Children's Pool is part of a “regional network of interconnected” haul-out and pupping sites. Harbor seals often haul-out in protected bays, inlets, and beaches (Reeves et al., 1992). At and near the Children's Pool, harbor seals haul-out on the sand, rocks, and breakwater base in numbers of 0 to 15 harbor seals to a maximum of about 150 to 250 harbor seals depending on the time of day, season, and weather conditions (Hanan, 2004, Hanan & Associates, 2011; Linder, 2011). Because space is limited behind the breakwater at the Children's Pool, Linder (2011) predicted that it is unlikely that numbers will exceed 250 harbor seals. Based on monitoring from a camera, Western Alliance for Nature (WAN) reported that during the month of May 2013 up to 302 harbor seals were documented resting on the Children's Pool beach at any given time, with additional harbor seals on the rocks and in the water (Wan, personal communication). Almost every day, except for weekends, over 250 individual harbor seals were present on the beach. During the months of September 2012 to January 2013, the average number of harbor seals on the beach varied from 83 to 120 animals before people entered the beach or when people were behind the rope. During this same period, when people were on the beach and/or across the rope, the average number of harbor seals varied from 7 to 27. The City of San Diego observed 12 counts totaling more than 200 and a maximum of 238 animals during the 2014 to 2015 construction window. The weather (i.e., wind and/or rain) and the proximity of humans to the beach likely affect the presence of harbor seals on the beach.

    Radio-tagging and photographic studies have revealed that only a portion of seals utilizing a hauling-out site are present at any specific moment or day (Hanan, 1996, 2005; Gilbert et al., 2005; Harvey and Goley, 2011; and Linder, 2011). These radio-tagging studies indicate that harbor seals in Santa Barbara County haul-out about 70 to 90% of the days annually (Hanan, 1996). The City of San Diego expects harbor seals to behave similarly at the Children's Pool. Tagged and branded harbor seals from other haul-out sites have been observed by Dr. Hanan at the Children's Pool. For example, harbor seals with red-stained heads and coats, which are typical of some harbor seals in San Francisco Bay have been observed at Children's Pool, indicating that seals tagged at other locations and haul-out sites visit the site. A few seals have been tagged at the Children's Pool and there are no reports of these tagged animals at other sites (probably because of very low re-sighting efforts and a small sample size [10 individuals radio-tagged]), which may indicate a degree of site-fidelity (Yochem and Stewart, 1998). These studies further indicate that seals are constantly moving along the coast including to/from the offshore islands and that there may be as many as 600 individual harbor seals using Children's Pool during a year, but certainly not all at one time.

    The City of San Diego has fitted a polynomial curve to the number of expected harbor seals hauling-out at the Children's Pool by month (see Figure 1 of the IHA application and Figure 2 below) based on counts at the Children's Pool by Hanan (2004), Hanan & Associates (2011), Yochem and Stewart (1998), and the Children's Pool docents (Hanan, 2004). A three percent annual growth rate of the population was applied to Yochem and Stewart (1998) counts to normalize them to Hanan & Associates and docent counts in 2003 to 2004. Based on monitoring during 2013 to 2014, Dr. Hanan estimates that similar numbers of harbor seals hauling-out at Children's Pool during 2011 and would expect similar numbers in 2015 to 2016.

    A complete count of all harbor seals in California is impossible because some are always away from the haul-out sites. A complete pup count (as is done for other pinnipeds in California) is also not possible because harbor seals are precocial, with pups entering the water almost immediately after birth. Population size is estimated by counting the number of seals ashore during the peak haul-out period (May to July) and by multiplying this count by a correction factor equal to the inverse of the estimated fraction of seals on land. Based on the most recent harbor seal counts (2009) and including a revised correction factor, the estimated population of harbor seals in California is 30,196 individuals (NMFS, 2011), with an estimated minimum population of 26,667 for the California stock of harbor seals. Counts of harbor seals in California increased from 1981 to 2004. The harbor seal is not listed under the ESA and the California stock is not considered depleted or strategic under the MMPA (Carretta et al., 2010).

    California Sea Lion

    The California sea lion is a full species, separate from the Galapagos sea lion (Zalophus wollebaeki) and the extinct Japanese sea lion (Zalophus japonicus) (Brunner, 2003; Wolf et al., 2007; Schramm et al., 2009). This species of sea lion is found from southern Mexico to southwestern Canada. The breeding areas of the California sea lion are on islands located in southern California, western Baja California, and the Gulf of California. A genetic analysis of California sea lions identified five genetically distinct geographic populations: (1) Pacific Temperate, (2) Pacific Subtropical, (3) Southern Gulf of California, (4) Central Gulf of California, and (5) Northern Gulf of California (Schramm et al., 2009). In that study, the Pacific Temperate population included rookeries within U.S. waters and the Coronados Islands just south of U.S./Mexico border. Animals from the Pacific Temperate population range north into Canadian waters, and movement of animals between U.S. waters and Baja California waters has been documented, though the distance between the major U.S. and Baja California rookeries is at least 740.8 km (400 nmi). Males from western Baja California rookeries may spend most of the year in the United States.

    The entire California sea lion population cannot be counted because all age and sex classes are never ashore at the same time. In lieu of counting all sea lions, pups are counted during the breeding season (because this is the only age class that is ashore in its entirety), and the numbers of births is estimated from the pup count. The size of the population is then estimated from the number of births and the proportion of pups in the population. Censuses are conducted in July after all pups have been born. There are no rookeries at or near the Children's Pool, although in the past two years births have been reported at La Jolla Cove (about 0.75 km [0.47 miles] east of Children's Pool). Population estimates for the U.S. stock of California sea lions range from a minimum of 153,337 to an average estimate of 296,750 animals. They are considered to be at carrying capacity of the environment. The California sea lion is not listed under the ESA and the U.S. stock is not considered depleted or strategic under the MMPA.

    Northern Elephant Seal

    Northern elephant seals breed and give birth in California (U.S.) and Baja California (Mexico), primarily on offshore islands (Stewart et al., 1994) from December to March (Stewart and Huber, 1993). Spatial segregation in foraging areas between males and females is evident from satellite tag data (Le Beouf et al., 2000). Males migrate to the Gulf of Alaska and western Aleutian Islands along the continental shelf to feed on benthic prey, while females migrate to pelagic areas in the Gulf of Alaska and the central North Pacific to feed on pelagic prey (Le Beouf et al., 2000). Adults return to land between March and August to molt, with males returning later than females. Adults return to their feeding areas again between their spring/summer molting and their winter breeding seasons.

    Populations of northern elephant seals in the U.S. and Mexico have recovered after being nearly hunted to extinction (Stewart et al., 1994). Northern elephant seals underwent a severe population bottleneck and loss of genetic diversity when the population was reduced to an estimated 10 to 30 individuals (Hoelzel et al., 2002). However, movement and genetic exchange continues between rookeries when they start breeding (Huber et al., 1991). The California breeding population is now demographically isolated from the Baja California population. The California breeding population is considered in NMFS's stock assessment report to be a separate stock.

    A complete population count of elephant seals is not possible because all age classes are not ashore simultaneously. Elephant seal population size is typically estimated by counting the number of pups produced and multiplying by the inverse of the expected ratio of pups to total animals (McCann, 1985). Based on counts of elephant seals at U.S. rookeries in 2010, Lowry et al. (2014) reported that 40,684 pups were born. Lowry et al. (2014) applied a multiplier of 4.4 to extrapolate from total pup counts to a population estimate of approximately 179,000 elephant seals. This multiplier is derived from life tables based on published elephant seal fecundity and survival rates, and reflects a population with approximately 23% pups (Cooper and Stewart, 1983; Le Boeuf and Reiter, 1988; Hindell 1991; Huber et al., 1991; Reiter and Le Boeuf, 1991; Clinton and Le Boeuf, 1993; Le Boeuf et al., 1994; Pistorius and Bester, 2002; McMahon et al., 2003; Pistorius et al., 2004; Condit et al., 2014). The minimum population size for northern elephant seals in 2010 can be estimated very conservatively as 81,368, which is equal to twice the observed pup count (to account for the pups and their mothers). The population is reported to have grown at 3.8% annually since 1988 (Lowry et al., 2014). Northern elephant seals are not listed under the ESA and are not considered as depleted or a strategic stock under the MMPA.

    Further information on the biology and local distribution of these marine mammal species and others in the region can be found in the City of San Diego's IHA application, which is available upon request (see ADDRESSES), and the NMFS Marine Mammal Stock Assessment Reports, which are available online at: http://www.nmfs.noaa.gov/pr/sars/.

    Potential Effects of the Proposed Specified Activity on Marine Mammals

    This section includes a summary and discussion of the ways that the types of stressors associated with the proposed specified activity (e.g., construction equipment and activities) have been observed to impact marine mammals. This discussion may also include reactions that we consider to rise to the level of a take and those that we do not consider to rise to the level of take (for example, with acoustics), we may include a discussion of studies that showed animals not reacting at all to sound or exhibiting barely measureable avoidance). This section is intended as a background of potential effects and does not consider either the specific manner in which this activity will be carried out or the mitigation that will be implemented, or how either of those will shape the anticipated impacts from this specific activity. The “Estimated Take by Incidental Harassment” section later in this document will include a quantitative analysis of the number of individuals that are expected to be taken by this activity. The “Negligible Impact Analysis” section will include the analysis of how this specific activity will impact marine mammals and will consider the content of this section, the “Estimated Take by Incidental Harassment” section, the “Proposed Mitigation” section, and the “Anticipated Effects on Marine Mammal Habitat” section to draw conclusions regarding the likely impacts of this activity on the reproductive success or survivorship of individuals and from that on the affected marine mammal populations or stocks.

    When considering the influence of various kinds of sound on the marine environment, it is necessary to understand that different kinds of marine life are sensitive to different frequencies of sound. Based on available behavioral data, audiograms have been derived using auditory evoked potentials, anatomical modeling, and other data, Southall et al. (2007) designate “functional hearing groups” for marine mammals and estimate the lower and upper frequencies of functional hearing of the groups. The functional groups and the associated frequencies are indicated below (though animals are less sensitive to sounds at the outer edge of their functional range and most sensitive to sounds of frequencies within a smaller range somewhere in the middle of their functional hearing range):

    • Low-frequency cetaceans (13 species of mysticetes): functional hearing is estimated to occur between approximately 7 Hz and 30 kHz;

    • Mid-frequency cetaceans (32 species of dolphins, six species of larger toothed whales, and 19 species of beaked and bottlenose whales): functional hearing is estimated to occur between approximately 150 Hz and 160 kHz;

    • High-frequency cetaceans (eight species of true porpoises, six species of river dolphins, Kogia spp., the franciscana (Pontoporia blainvillei), and four species of cephalorhynchids): functional hearing is estimated to occur between approximately 200 Hz and 180 kHz; and

    • Phocid pinnipeds in water: functional hearing is estimated to occur between approximately 75 Hz and 100 kHz;

    • Otariid pinnipeds in water: functional hearing is estimated to occur between approximately 100 Hz and 40 kHz.

    As mentioned previously in this document, 3 marine mammal species (0 cetacean and 3 pinniped species) are likely to occur in the proposed action area. Of the 3 pinniped species likely to occur in the City of San Diego's proposed action area, 2 are classified as phocid pinnipeds (i.e., Pacific harbor seal and northern elephant seal) and, 1 is classified as an otariid pinniped (i.e., California sea lion) (Southall et al., 2007). The City of San Diego requests authorization for Level B harassment of these 3 species of marine mammals (i.e., Pacific harbor seals, California sea lions, and northern elephant seals) incidental to the use of equipment and its propagation of in-air noise from various acoustic mechanisms associated with the construction activities of the Children's Pool Lifeguard Station at La Jolla, CA discussed above. NMFS considers a species' functional hearing group when we analyze the effects of exposure to sound on marine mammals.

    The notice of the proposed IHA (79 FR 8160, February 11, 2014) included a discussion of the effects of in-air sounds from construction activities on pinnipeds, which included tolerance, behavioral disturbance, and hearing impairment. NMFS refers readers to the City of San Diego's IHA application and NMFS's EA for additional information on the behavioral reactions (or lack thereof) by all types of marine mammals to high levels of in-air sounds.

    The potential effects to marine mammals described in this section of the document generally do not take into consideration the monitoring and mitigation measures described later in this document (see the “Proposed Mitigation” and “Proposed Monitoring and Reporting” sections), which are designed to effect the least practicable impact on affected marine mammal species or stocks.

    Anticipated Effects on Marine Mammal Habitat

    The rocks and beaches at or near the Children's Pool in La Jolla, CA, are almost exclusively Pacific harbor seal hauling-out sites. Harbor seals have been observed hauling-out and documented giving birth at the Children's Pool since the 1990's (Yochem and Stewart, 1998; Hanan & Associates, 2004). It is one of the three known haul-out sites for this species in San Diego County and is the only rookery in San Diego County and the only mainland rookery on the U.S. west coast between the border of Mexico and Point Mugu in Ventura County, CA. More information on this population of Pacific harbor seals can be found in the “Description of Marine Mammals in the Specified Geographic Area of the Proposed Specified Activity.”

    The primary anticipated adverse impacts upon habitat consist of temporary changes to the in-air acoustic environment, as detailed in the notice of the proposed IHA (79 FR 8160, February 11, 2014). These changes are minor, temporary, and limited in duration to the period of the construction activities. The temporary impacts on the acoustic environment are not expected to have any permanent effects on the species or stock populations of marine mammals occurring at the Children's Pool.

    All proposed construction activities are beyond or outside the habitat areas where harbor seals and other pinnipeds are found. Visual barriers would be erected to shield construction activities from the visual perception and potentially dampen acoustic effects on pinnipeds. Because the public occasionally harasses the harbor seals with various activities, the NMFS-qualified PSO monitoring the site would make observations and attempt to distinguish and attribute any observed harassment to the public or to the proposed construction activities and give all details in the observation report. If any short-term, temporary impacts to habitat due to sounds or visual presence of equipment and workers did occur, the City of San Diego would expect pinniped behavior to return to pre-construction conditions soon after the activities are completed, which is anticipated to occur before the next pupping season (Hanan & Associates, 2011).

    The area of habitat affected is small and the effects are localized and temporary; thus there is no reason to expect any significant reduction in habitat available for foraging and other habitat uses. No aspect of the project is anticipated to have any permanent effect on the location or use of pinniped haul-outs or related habitat features in the area (Hanan & Associates, 2011). Further, the site is already very disturbed by member of the public who come to the area during the day and night to view the pinnipeds. The City of San Diego and NMFS do not project any loss or modification of physical habitat for these species. Any potential temporary loss or modification of habitat due to in-air noise or visual presence of equipment and workers during the proposed construction activities is expected by the City of San Diego and NMFS to be quickly restored after construction activities end and all equipment and barriers are removed.

    For these reasons, NMFS anticipates that the proposed action would result in no impacts to marine mammal habitat beyond rendering the areas immediately around the Children's Pool less desirable during construction activities.

    Proposed Mitigation

    In order to issue an Incidental Take Authorization (ITA) under section 101(a)(5)(D) of the MMPA, NMFS must prescribe, where applicable, the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (where relevant).

    The City of San Diego has established the Children's Pool as a shared beach for pinnipeds and people (except during pupping season when the beach has been closed to the public). In the past, during the pupping season, a rope was placed along the upper part of the beach with signage to inform and designate how close people can come to the haul-out area and the pinnipeds. The timeframe for the rope has been extended so that it is now present year-round. The construction activities are planned to occur outside the harbor seal pupping and weaning periods.

    The City of San Diego would implement the following proposed mitigation measures to help ensure the least practicable impact on marine mammals:

    (1) Prohibition of construction during pupping season;

    (2) Daily construction timing;

    (3) Construction of visual and acoustic barriers;

    (4) Use of Protected Species Observers;

    (5) Establishment of buffer zones; and

    (6) Potential abandonment survey.

    Visual and acoustic barriers were constructed in 2013 to mitigate the effects of the construction activities. The visual and acoustic barriers were constructed of plywood, 1.2 to 2.4 m (4 to 8 ft) tall stood on end and held up by wood posts. The sheets of plywood were stood upright and held up with two wooden two by fours hinged to the top of the frame, so they could be collapsed and moved depending on the location and need for access by demolition and construction equipment. The barriers were placed at the site with input from NMFS Southwest Regional Office (SWRO) personnel so that they will hide as advantageously as possible the construction activities that may be seen by pinnipeds. The barriers appear to dampen the acoustic sound sources, but do not prevent sound from permeating the environment. The barriers also appear to hide and reduce visual cues that may stimulate behavioral reactions from the pinnipeds on the beach below. As the site is a beach with construction along the cliff and on flat areas above the cliff, a complete barrier cannot be constructed to hide all construction activities for the project. Once the walls of the lifeguard station's building are in place, much of the construction activities will take place above the Children's Pool beach (i.e., out of sight) as well as inside the building (i.e., a visual and partial sound barrier). There would be no activities in the ocean or closer to the water's edge and since harbor seals mate underwater in the ocean, there will be no impacts on mating activities. California sea lions and northern elephant seals are such infrequent users of this area and their rookeries are so far away (at least 104.6 km [65 miles] at offshore islands) that there will be no adverse impact on these species.

    As part of the public comment process for the issuance of the previous 2013 IHA, NMFS modified several of the monitoring and mitigation measures included in the proposed IHA (78 FR 25958, May 3, 2013) for practicability reasons, and also included several additional measures in the final IHA (78 FR 40705, July 8, 2013). These included changing the pupping season from December 15th to May 15th and prohibiting construction activities during this time; extending construction activities from 7:00 a.m. to 7:00 p.m. to help assure that more work would be completed during the 2013 construction window; continuing monitoring for 60 days following the end of construction activities; and triggering a shut-down of construction activities in the unexpected event of abandonment of the Children's Pool site. The mitigation measure on scheduling the heaviest construction activities (with the highest sound levels) during the annual period of lowest haul-out occurrence (October to November) was originally included in the City of San Diego's Mitigated Negative Declaration when it was anticipated that the City of San Diego would obtain an IHA in the summer of 2012 and begin demolition and construction activities in the fall of 2012. This requirement has been removed because it is no longer practicable due to logistics, scheduling and to allow the planned activities to be completed before the next pupping season.

    The activities proposed by the applicant includes a variety of measures calculated to minimize potential impacts on marine mammals, including:

    Prohibition of Construction During Pupping Season

    Construction shall be prohibited during the Pacific harbor seal pupping season (December 15th to May 15th) and for an additional two weeks thereafter to accommodate lactation and weaning of late season pups. Thus, construction shall be prohibited from December 15th to June 1st.

    Daily Construction Timing

    Construction activities shall be scheduled, to the maximum extent practicable, during the daily period of lowest haul-out occurrence, from approximately 8:30 a.m. to 3:30 p.m. However, construction activities may be extended from 7 a.m. to 7 p.m. to help assure that the project can be completed during the 2015 construction window. Harbor seals typically have the highest daily or hourly haul-out period during the afternoon from 3 p.m. to 6 p.m.

    Construction of Visual and Acoustic Barriers

    A visual and acoustic barrier would be erected and maintained for the duration of the project to shield construction activities from beach view. The temporary barrier shall consist of 1/2 to 3/4 inch (1.3 to 1.9 centimeters [cm]) plywood constructed 1.8 to 2.4 m (6 to 8 ft) high depending on the location. The City of San Diego does not believe that a complete barrier can be constructed to hide all of the proposed construction activities. Once the walls of the lifeguard station building are in place, much of the proposed construction activities would take place on the bluff above the beach (thus out of sight) and inside the building, which would provide a visual and partial sound barrier.

    Protected Species Observers

    Trained PSOs would be used to detect, document, and minimize impacts (i.e., possible shut-down of noise-generating operations [turning off the equipment so that in-air sounds associated with construction no longer exceed levels that are potentially harmful to marine mammals]) to marine mammals. More information about this measure is contained in the “Proposed Monitoring” section (below).

    Establishment of Buffer Zones

    The City of San Diego shall establish buffer zones (i.e., where sound pressure levels are at or above 90 dB re 20 μPa for harbor seals and/or at or above 100 dB re 20 μPa for all pinniped species except harbor seals [for in-air noise]) around the construction activities so that in-air sounds associated with the construction activities no longer exceed levels that are potentially harmful to marine mammals.

    Timing Constraints for In-Air Noise

    To minimize in-air noise impacts on marine mammals, construction activities shall be limited to the period when the species of concern would be least likely to be in the project area. The construction window for construction activities shall be from June 1 to December 15, 2015. The IHA may extend to June 1 through June 27, 2016 to finish the construction activities if needed. Avoiding periods when the highest number of marine mammal individuals are in the action area is another mitigation measure to protect marine mammals from the proposed construction activities.

    Potential Abandonment Survey

    After the first two months of monitoring during construction activities, the City of San Diego will take the mean number of observed harbor seals at the Children's Pool in a 24-hour period across that two months and compare it to the mean of the lower 95 percent confidence interval in Figure 1 (see below). If the observed mean is lower, the City of San Diego would shut-down construction activities and work with NMFS and other harbor seal experts (e.g., Mark Lowry, Dr. Sarah Allen, Dr. Pamela Yochem, and/or Dr. Brent Stewart) to develop and implement a revised mitigation plan to further reduce the number of takes and potential impacts. Once a week every week thereafter, the City of San Diego will take the same mean of observed harbor seals across the previous three tide cycles (a tide cycle is approximately 2 weeks) and compare it to the 95% lower confidence interval in Figure 1 for the same time period. If the observed mean is lower, the City of San Diego would shut-down and take the action described above. If abandonment of the site is likely, monitoring would be expanded away from the Children's Pool to determine if animals have been temporarily displaced to known haul-out sites in the southern California area (e.g., north end of Torrey Pines, cave on the exposed ocean side of Point Loma, etc.). For the purpose of this action, NMFS will consider the Children's Pool site to possibly be abandoned if zero harbor seals are present each day during the daytime and nighttime hours for at least three tide cycles (a tide cycle is approximately 2 weeks), but this cannot be confirmed until observations continue to be zero during a full pupping and molting season.

    EN19MY15.000

    More information regarding the City of San Diego's monitoring and mitigation measures for the proposed construction activities at the Children's Pool Lifeguard Station can be found in the IHA application.

    Proposed Mitigation Conclusions

    NMFS has carefully evaluated the applicant's mitigation measures and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. NMFS's evaluation of potential measures included consideration of the following factors in relation to one another:

    • The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals;

    • The proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and

    • The practicability of the measure for applicant implementation, including consideration of personnel safety, practicality of implementation, and impact on the effectiveness of the activity.

    Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:

    (1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).

    (2) A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to received levels from construction equipment, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

    (3) A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to received levels from construction equipment, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

    (4) A reduction in the intensity of exposures (either total number or number at biologically important time or location) to received levels from construction equipment, or other activities expected to result in the take of marine mammals (this goal may contribute to a, above, or to reducing the severity of harassment takes only).

    (5) Avoidance of minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.

    (6) For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

    Based on NMFS's evaluation of the applicant's proposed measures, as well as other measures considered by NMFS or recommended by the public, NMFS has determined that the mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

    Proposed Monitoring and Reporting

    In order to issue an ITA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must, where applicable, set forth “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104 (a)(13) require that requests for ITAs include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area.

    Monitoring measures prescribed by NMFS should accomplish one or more of the following general goals:

    (1) An increase in the probability of detecting marine mammals, both within the mitigation zone (thus allowing for more effective implementation of the mitigation) and in general to generate more data to contribute to the analyses mentioned below;

    (2) An increase in our understanding of how many marine mammals are likely to be exposed to levels from construction equipment that we associate with specific adverse effects, such as behavioral harassment, TTS or PTS;

    (3) An increase in our understanding of how marine mammals respond to stimuli expected to result in take and how anticipated adverse effects on individuals (in different ways and to varying degrees) may impact the population, species, or stock (specifically through effects on annual rates of recruitment or survival) through any of the following methods:

    • Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);

    • Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict receive level, distance from the source, and other pertinent information);

    • Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli;

    (4) An increased knowledge of the affected species; and

    (5) An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.

    Proposed Monitoring

    The City of San Diego has developed a monitoring plan (see Appendix I, Mitigated Negative Declaration in the IHA application) based on discussions between the project biologist, Dr. Doyle Hanan, and NMFS biologists. The plan has been vetted by City of San Diego planners and reviewers. The plan has been formally presented to the public for review and comment. The City of San Diego has responded in writing and in public testimony (see City of San Diego Council Hearing, December 14, 2011) to all public concerns.

    The monitoring plan involves surveying prior to construction activities, monitoring during construction activities by NMFS-approved PSOs with high-resolution binoculars and handheld digital sound level meters (measuring devices in the 30 to 130 dB re 20 µPa range), and post-construction monitoring. The City of San Diego would include sound measurements at and near the construction site in their initial survey prior to the activities as a background and baseline for the project. While no specific acoustic study is planned, the City of San Diego's Mitigated Negative Declaration states that marine mammal monitoring shall be conducted for three to five days prior to construction and shall include hourly systematic counts of pinnipeds using the beach, Seal Rock, and associated reef areas. Monitoring three to five days prior to construction will provide baseline data regarding recent haul-out behavior and patterns as well as background noise levels near the time of the proposed construction activities.

    During the proposed construction activities, monitoring shall assess behavior and potential behavioral responses to construction noise and activities. PSOs would observe the proposed construction activities from a station along the breakwater wall and from the base of the cliff below the construction area. PSOs would be on site approximately 30 minutes before the start of proposed construction activities and would remain on site until 30 minutes after activities have ceased. Visual digital recordings and photographs shall be used to document individuals and behavioral responses to construction. The City of San Diego (i.e., PSOs) plans to make hourly counts of the number of pinnipeds present and record sound or visual events that result in behavioral responses and changes, whether during construction or from public stimuli. During these events, pictures and video will also be taken when possible. The “Mitigated Negative Declaration” states “monitoring shall assess behavior and potential behavioral responses to construction noise and activities. Visual digital recordings and photographs shall be used to document individuals and behavioral responses to construction.”

    Monitors would have authority to stop construction as necessary depending on sound levels, pinniped presence, and distance from sound sources. Daily monitoring reports would be maintained for periodic summary reports to the City of San Diego and to NMFS. Observations would be entered into and maintained on Hanan & Associates computers. The City of San Diego plans to follow the reporting requirements in the Mitigated Negative Declaration, which states that “the biologist shall document field activity via the Consultant Site Visit Record. The Consultant Site Visit Record shall be either emailed or faxed to the City of San Diego's Mitigation Monitoring Coordination process (MMC) on the 1st day of monitoring, the 1st week of each month, the last day of monitoring, and immediately in the case of any undocumented discovery. The project biologist shall submit a final construction monitoring report to MMC within 30 days of construction completion.” The MMC “coordinates the monitoring of development projects and requires that changes are approved and implemented to be in conformance with the permit requirements and to minimize any damage to the environment.” These documents will also be sent to NMFS. Finally, the City of San Diego has modified its monitoring program to include 60 days of monitoring post-construction activities. Following construction, the City of San Diego would have a program of onsite PSOs that would randomly select a day per week to monitor.

    NMFS notes that the WAN's La Jolla Harbor Seal Webcam was attached to the old (now demolished) lifeguard station and is no longer available online (http://www.wanconservancy.org/la_jolla_harbor_seal_earthcam.htm). The City of San Diego has stated that there is no suitable place to mount the camera at the construction site. Therefore, the City of San Diego cannot do periodic checks using the webcam for monitoring purposes as required by the 2013 IHA. However, the camera was not expected to replace NMFS-qualified PSOs at the site making accurate counts, measuring sound levels and observing the public and the construction, as well as the harbor seals. In the old camera view, a person may have been able to see visual evidence of Level B harassment but probably would not have been able to distinguish between harassment from construction activities and harassment from the public since the camera had a limited scope and only showed the Children's Pool beach and pinnipeds (usually a specific portion of the beach, but not the reef nor nearby beaches).

    Consistent with NMFS procedures, the following marine mammal monitoring and reporting shall be performed for the proposed action:

    (1) The PSO shall be approved by NMFS prior to construction activities.

    (2) The NMFS-approved PSO shall attend the project site prior to, during, and after construction activities cease each day throughout the construction window.

    (3) The PSO shall search for marine mammals within the Children's Pool area.

    (4) The PSO shall be present during construction activities to observe for the presence of marine mammals in the vicinity of the specified activity. All such activity would occur during daylight hours (i.e., 30 minutes after sunrise and 30 minutes before sunset). If inclement weather limits visibility within the area of effect, the PSO would perform visual scans to the extent conditions allow.

    (5) If marine mammals are sighted by the PSO within the acoustic threshold areas, the PSO shall record the number of marine mammals within the area of effect and the duration of their presence while the noise-generating activity is occurring. The PSO would also note whether the marine mammals appeared to respond to the noise and, if so, the nature of that response. The PSO shall record the following information: Date and time of initial sighting, tidal stage, weather conditions, Beaufort sea state, species, behavior (activity, group cohesiveness, direction and speed of travel, etc.), number, group composition, distance to sound source, number of animals impacted, construction activities occurring at time of sighting, and monitoring and mitigation measures implemented (or not implemented). The observations would be reported to NMFS.

    (6) A final report would be submitted summarizing all in-air acoustic effects from construction activities and marine mammal monitoring during the time of the authorization, and any long term impacts from the project.

    A written log of dates and times of monitoring activity will be kept. The log shall report the following information:

    • Time of observer arrival on site;

    • Time of the commencement of in-air noise generating activities, and description of the activities;

    • Distances to all marine mammals relative to the sound source;

    • Distances from the sound meter to each sound-producing activity when conducting sound measurements;

    • For harbor seal observations, notes on seal behavior during noise-generating activity, as described above, and on the number and distribution of seals observed in the project vicinity;

    • For observations of all marine mammals other than harbor seals, the time and duration of each animal's presence in the project vicinity; the number of animals observed; the behavior of each animal, including any response to noise-generating activities;

    • Time of the cessation of in-air noise generating activities; and

    • Time of observer departure from site.

    All monitoring data collected during construction would be included in the biological monitoring notes to be submitted. A final report summarizing the construction monitoring and any general trends observed would also be submitted to NMFS within 90 days after monitoring has ended during the period of the lifeguard station construction.

    Proposed Reporting

    The City of San Diego would notify NMFS Headquarters and the NMFS Southwest Regional Office prior to initiation of the construction activities. A draft final report must be submitted to NMFS within 90 days after the conclusion of the construction activities of the Children's Pool Lifeguard Station. The report would include a summary of the information gathered pursuant to the monitoring requirements set forth in the IHA, including dates and times of operations and all marine mammal sightings (dates, times, locations, species, behavioral observations [activity, group cohesiveness, direction and speed of travel, etc.], tidal stage, weather conditions, Beaufort sea state and wind force, associated construction activities). A final report must be submitted to the Regional Administrator within 30 days after receiving comments from NMFS on the draft final report. If no comments are received from NMFS, the draft final report would be considered to be the final report.

    While the IHA does not authorize injury (i.e., Level A harassment), serious injury, or mortality, should the applicant, contractor, monitor or any other individual associated with the construction project observe an injured or dead marine mammal, the incident (regardless of cause) will be reported to NMFS as soon as practicable. The report should include species or description of animal, condition of animal, location, time first found, observed behaviors (if alive) and photo or video, if available.

    In the unanticipated event that the City of San Diego discovers a live stranded marine mammal (sick and/or injured) at Children's Pool, they shall immediately contact Sea World's stranded animal hotline at 1-800-541-7235. Sea World shall also be notified if a dead stranded pinniped is found so that a necropsy can be performed. In all cases, NMFS shall be notified as well, but for immediate response purposes, Sea World shall be contacted first.

    Reporting Prohibited Take—In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by this IHA, such as an injury (Level A harassment), serious injury, or mortality, the City of San Diego shall immediately cease the specified activities and immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401 and/or by email to [email protected], [email protected], and the West Coast Regional Stranding Coordinator (562-980-3230). The report must include the following information:

    • Time, date, and location (latitude/longitude) of the incident;

    • The type of activity involved;

    • Description of the circumstances during and leading up to the incident;

    • Status of all sound source use in the 24 hours preceding the incident; water depth; environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

    • Description of marine mammal observations in the 24 hours preceding the incident; species identification or description of the animal(s) involved;

    • The fate of the animal(s); and photographs or video footage of the animal (if equipment is available).

    Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS shall work with the City of San Diego to determine the action necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. The City of San Diego may not resume its activities until notified by NMFS via letter, email, or telephone.

    Reporting an Injured or Dead Marine Mammal with an Unknown Cause of Death—In the event that the City of San Diego discovers an injured or dead marine mammal, and the lead PSO determines that the cause of the injury or death is unknown and the death is relatively recent (i.e., in less than a moderate state of decomposition as described in the next paragraph), the City of San Diego would immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401, and/or by email to [email protected], [email protected], and the NMFS West Coast Regional Office (1-866-767-6114), and/or to the West Coast Regional Stranding Coordinator (562-980-3230). The report must include the same information identified above. Activities may continue while NMFS reviews the circumstances of the incident. NMFS would work with the City of San Diego to determine whether modification of the activities is appropriate.

    Reporting an Injured or Dead Marine Mammal Not Related to the Activities—In the event that the City of San Diego discovers an injured or dead marine mammal, and the lead PSO determines that the injury or death is not associated with or related to the activities authorized (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), the City of San Diego shall report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401, and/or by email to [email protected], [email protected], and the NMFS West Coast Regional Office (1-866-767-6114) and/or to the West Coast Regional Stranding Coordinator (562-980-3230) within 24 hours of the discovery. The City of San Diego shall provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS and the Marine Mammal Stranding Network. Activities may continue while NMFS reviews the circumstances of the incident.

    Monitoring Results From Previously Authorized Activities 2013 to 2014

    Hanan & Associates, Inc., on behalf of the City of San Diego, conducted marine mammal and in-air sound monitoring at six locations during demolition and construction activities at the Children's Pool Lifeguard Station in La Jolla, California from June 3, 2013 to February 12, 2014. Demolition and construction activities began on July 10, 2013 and were halted for the Pacific harbor seal pupping season (December 15, 2013 to June 1, 2014). During 115 days of visual and acoustic observations, Hanan & Associates counted a total of 61,631 Pacific harbor seals and 26,037 people. During the 2013 demolition and construction activities, Hanan & Associates observed a total of 15,673 takes by Level B harassment (i.e., alerts, movements, and flushes) that could be attributed to demolition and construction activities (5,095 takes), the general public (8,639 takes), and other sources (1,939 takes). As of April 15, 2014, at least 60 harbor seal pups (including 2 still births) have been born at the Children's Pool and there has been no indication of abandonment. In addition to the Pacific harbor seal sightings, PSOs recorded 11 sightings of cetaceans (gray whales and bottlenose dolphins), 4 sightings of California sea lions (1 juvenile, 3 adult), and 2 northern elephant seals (both juveniles) at the Children's Pool.

    Hanan & Associates recorded mean in-air sound levels of 69.2 dB re 20 μPa (range of 55.6 to 93.7 dB re 20 μPa) during non-demolition and construction activities and 70.3 dB re 20 μPa (range of 50.7 to 103.1 dB re 20 μPa) during demolition and construction activities. During 2013, measured sound levels from the demolition equipment reaching the pinnipeds did not exceed approximately 90 dB re 20 μPa at the haul-out area closest to the demolition and construction activities, nor did they exceed a peak of about 83 dB re 20 μPa at the mean hauling-out distance (30.5 m).

    2014 to 2015

    Hanan & Associates, Inc., on behalf of the City of San Diego, conducted marine mammal and in-air sound monitoring at seven locations during demolition and construction activities at the Children's Pool Lifeguard Station in La Jolla, California from August 6, 2014 to March 15, 2015. Construction activities began on August 6, 2014 and were halted for the Pacific harbor seal pupping season (December 15, 2014 to June 1, 2015). During 127 days of visual and acoustic observations, Hanan & Associates counted a total of 63,598 Pacific harbor seals and 27,844 people. During the 2014 demolition and construction activities, Hanan & Associates observed a total of 20,259 takes by Level B harassment (i.e., alerts, movements, and flushes) that could be attributed to demolition and construction activities (7,424 takes), the general public (10,000 takes), and other sources (2,835 takes). As of March 13, 2015, at least 60 harbor seal pups (including 6 still or premature births) have been born at the Children's Pool and there has been no indication of abandonment. In addition to the Pacific harbor seal sightings, PSOs recorded 24 sightings of cetaceans (gray whales, common and bottlenose dolphins), 366 sightings of California sea lions (at Seal Rock, Children's Pool beach, South Casa Beach, and on the reef), and 1 northern elephant seals (1 juvenile on Children's Pool beach) at the Children's Pool. One dead adult and one dead juvenile California sea lion were sighted on the Children's Pool beach after the start of the beach closure and after the construction activities stopped for the pupping season. These strandings were reported to NMFS.

    Hanan & Associates recorded mean in-air sound levels of 68.9 dB re 20 μPa (range of 51.5 to 97.2 dB re 20 μPa) during non-construction activities and 71.3 dB re 20 μPa (range of 49.4 to 102.7 dB re 20 μPa) during construction activities. During 2014, measured sound levels from the construction equipment reaching the pinnipeds did not exceed approximately 90 dB re 20 μPa at the haul-out area closest to the construction activities.

    More information on the monitoring results from the City of San Diego's previous demolition and construction activities at the La Jolla Children's Pool Lifeguard Station can be found in the final monitoring reports. The 2013 to 2014 and 2014 to 2015 monitoring reports can be found online at: http://www.nmfs.noaa.gov/pr/permits/incidental/construction.htm#childrenspool.

    EN19MY15.001 Estimated Take by Incidental Harassment

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].

    Table 2—NMFS's Current Underwater and In-Air Acoustic Exposure Criteria Criterion Criterion definition Threshold Underwater Impulsive (Non-Explosive) Sound Level A harassment (injury) Permanent threshold shift (PTS) (Any level above that which is known to cause TTS) 180 dB re 1 μPa-m (root means square [rms]) (cetaceans).
  • 190 dB re 1 μPa-m (rms) (pinnipeds).
  • Level B harassment Behavioral disruption (for impulsive noise) 160 dB re 1 μPa-m (rms). Level B harassment Behavioral disruption (for continuous noise) 120 dB re 1 μPa-m (rms). In-Air Sound Level A harassment NA NA. Level B harassment Behavioral disruption 90 dB re 20 μPa (harbor seals).
  • 100 dB re 20 μPa (all other pinniped species).
  • NA (cetaceans).
  • NA = Not available or not assessed.

    The City of San Diego and NMFS anticipate takes of Pacific harbor seals, California sea lions, and northern elephant seals by Level B (behavioral) harassment only incidental to the construction project at the Children's Pool. No takes by injury (Level A harassment), serious injury, or mortality are expected. NMFS will consider pinnipeds behaviorally reacting to the construction activities by flushing into the water, moving more than 1 m (3.3 ft), but not into the water; becoming alert and moving, but not moving more than 1 m; and changing direction of current movements by individuals as behavioral criteria for take by Level B harassment.

    With proposed construction activities scheduled to begin in June 2015, the City of San Diego expects a range of 0 to 190 harbor seals to be present daily during June and a seasonal decline through November to about 0 to 50 harbor seals present daily. If all of the estimated harbor seals present are taken by incidental harassment each day, there could be a maximum of 10,000 takes (i.e., approximately 2,947 adult males and 2,211 juvenile males, 2,842 adult females and 2,000 juvenile females based on age and sex ratios presented in Harkonen et al., 1999) over the entire duration of the activities. An unknown portion of the incidental takes will be from repeated exposures as harbor seals leave and return to the Children's Pool area. A polynomial curve fit to counts by month was used by the City of San Diego to estimate the number of harbor seals expected to be hauled-out by day (see below and Figure 2 of the IHA application).

    EN19MY15.002

    Assuming the total seals predicted to haul-out daily at the Children's Pool are exposed to sound levels that are considered Level B harassment during days where sound is predicted to exceed 90 dB at the construction site (65 days), there could be a maximum of approximately 10,000 incidental takes (i.e., exposures) of approximately up to 600 individual Pacific harbor seals over the duration of the activities. The estimated 600 individual Pacific harbor seals would be taken by Level B harassment multiple times during the proposed construction activities.

    Very few California sea lions and/or northern elephant seals are ever observed at the Children's Pool (i.e., one or two individuals). The City of San Diego requests the authority to incidentally take (i.e., exposures) 10,000 Pacific harbor seals, 100 California sea lions, and 25 northern elephant seals, which will equate to 600, 2, and 1 individuals, respectively, being exposed multiple times. More information on the number of takes authorized, and the approximate percentage of the stock for the three species in the proposed action area can be found in Table 3 (below).

    Table 3—Summary of the Authorized Incidental Take by Level B Harassment of Pinnipeds for the City of San Diego's Proposed Construction Activities Generating In-Air Noise at the Children's Pool Lifeguard Station in La Jolla, CA Species Take
  • authorization
  • (number of
  • exposures)
  • Estimated
  • number of
  • individuals
  • taken
  • Abundance Approximate
  • percentage of
  • estimated stock
  • (individuals)
  • Population trend
    Pacific harbor seal 10,000 600 30,968—California stock 1.93 Increased in California 1981 to 2004. California sea lion 100 2 296,750—U.S. stock <0.01 Increasing. Northern elephant seal 25 1 179,000—California breeding stock <0.01 Increasing 3.8% annually since 1988.
    Encouraging and Coordinating Research

    Each construction phase and potential harassment activity will be evaluated as to observed sound levels and any pinniped reaction by type of sound source. Flushing would be documented by sex and age class. These data will provide information for IHA permitting in future projects. Potential additional mitigation (other than what is already required) will be discussed and suggested in the final report. NMFS has encouraged the City of San Diego to review and analyze any available data to determine baseline information as well as evaluate the impacts from the construction activities on the pinnipeds at the Children's Pool.

    Impact on Availability of Affected Species or Stock for Taking for Subsistence Uses

    Section 101(a)(5)(D) of the MMPA requires NMFS to determine that the authorization will not have an unmitigable adverse effect on the availability of marine mammal species or stocks for subsistence use. There are not relevant subsistence uses of marine mammals implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for subsistence purposes.

    Analysis and Preliminary Determinations Negligible Impact

    Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of Level B harassment takes, alone, is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through behavioral harassment, NMFS must consider other factors, such as the likely nature of any responses (their intensity, duration, etc.), the context of any responses (critical reproductive time or location, migration, etc.), as well as the number and nature of estimated Level A harassment takes, the number of estimated mortalities, and effects on habitat.

    In making a negligible impact determination, NMFS evaluated factors such as:

    (1) The number of anticipated injuries, serious injuries, or mortalities;

    (2) The number, nature, and intensity, and duration of Level B harassment; and

    (3) The context in which the takes occur (i.e., impacts to areas of significance, impacts to local populations, and cumulative impacts when taking into account successive/contemporaneous actions when added to baseline data);

    (4) The status of the stock or species of marine mammals (i.e., depleted, not depleted, decreasing, increasing, stable, impact relative to the size of the population);

    (5) Impacts on habitat affecting rates of recruitment/survival; and

    (6) The effectiveness of monitoring and mitigation measures.

    No injuries (Level A harassment), serious injuries, or mortalities are anticipated to occur as a result of the City of San Diego's construction activities, and none are authorized by NMFS. The proposed activities are not expected to result in the alteration of reproductive behaviors, and the potentially affected species would be subjected to only temporary and minor behavioral impacts.

    Behavioral disturbance may potentially occur incidental to the visual presence of humans and construction activities; however, pinnipeds at this site have likely adapted or become acclimated to human presence at this site. These “urbanized” harbor seals do not exhibit sensitivity at a level similar to that noted in harbor seals in some other regions affected by human disturbance (Allen et al., 1984; Suryan and Harvey, 1999; Henry and Hammil, 2001; Johnson and Acevedo-Gutierrez, 2007; Jansen et al., 2006; Hanan & Associates, 2011). Therefore, there is a high likelihood that many of the harbor seals present during the proposed construction activities would not be flushed off of the beach or rocks, as pinnipeds at this site are conditioned to human presence and loud noises (Hanan, 2004; Hanan & Associates, 2011) (see http://www.youtube.com/watch?v=4IRUYVTULsg).

    As discussed in detail above, the proposed project scheduling avoids sensitive life stages for Pacific harbor seals. Proposed project activities producing in-air noise will commence in June and end by December 15. The commencement date occurs after the end of the pupping season, affords additional time to accommodate lactation and weaning of season pups, and takes into account periods of lowest haul-out occurrence. The end date falls approximately two weeks prior to January 1, the time after which most births occur, providing protection for pregnant and nursing harbor seals that may give birth before January 1.

    Table 3 of this document outlines the number of Level B harassment takes that are anticipated as a result of these proposed activities. Due to the nature, degree, and context of Level B (behavioral) harassment anticipated and described (see “Potential Effects on Marine Mammals” section above) in this notice, this activity is not expected to impact rates of annual recruitment or survival for the affected species or stock (i.e., California stock of Pacific harbor seals, U.S. stock of California sea lions, and California breeding stock of northern elephant seals), particularly given the proposed mitigation, monitoring, and reporting measures that would be implemented to minimize impacts to marine mammals.

    The Children's Pool is one of the three known haul-out sites for Pacific harbor seal in San Diego County and the only rookery in San Diego County and the only mainland rookery on the U.S. west coast for this species between the border of Mexico and Point Mugu in Ventura County, CA. For the other marine mammal species that may occur within the action area (i.e., California sea lions and northern elephant seals), there are no known designated or important feeding and/or reproductive areas. Many animals perform vital functions, such as feeding, resting, traveling, and socializing, on a diel cycle (i.e., 24 hour cycle). Behavioral reactions to noise exposure (such as disruption of critical life functions, displacement, or avoidance of important habitat) are more likely to be significant if they last more than one diel cycle or recur on subsequent days (Southall et al., 2007). However, Pacific harbor seals have been hauling-out at Children's Pool during the year for many years (including during pupping season and while females are pregnant) while being exposed to anthropogenic sound sources such as vehicle traffic, human voices, etc. and other stimuli from human presence. While studies have shown the types of sound sources used during the construction activities have the potential to displace marine mammals from breeding areas for a prolonged period (e.g., Lusseau and Bejder, 2007; Weilgart, 2007), based on the best available information, this does not seem to be the case for the Pacific harbor seals at the Children's Pool. The Pacific harbor seals have repeatedly hauled-out to pup over many years and the NMFS Stock Assessment Reports (NMFS, 2011) for this stock have shown that the population is increasing and is considered stable. Additionally, the proposed construction activities would increase sound levels in the environment in a relatively small area surrounding the lifeguard station (compared to the range of the animals), and some animals may only be exposed to and harassed by sound for less than a day.

    NMFS's practice has been to apply the 90 dB re 20 µPa and 100 dB re 20 µPa received level threshold for in-air sound levels to determine whether take by Level B harassment occurs. Southall et al. (2007) provide a severity scale for ranking observed behavioral responses of both free-ranging marine mammals and laboratory subjects to various types of anthropogenic sound (see Table 4 in Southall et al. [2007]). NMFS has not established a threshold for Level A harassment (injury) for marine mammals exposed to in-air noise, however, Southall et al. (2007) recommends 149 dB re 20 µPa (peak flat) as the potential threshold for injury from in-air noise for all pinnipeds. No in-air sounds from proposed construction activities would exceed 110 dB at the source and no measured sounds approached that sound level in 2013.

    Of the 3 marine mammal species under NMFS jurisdiction that may or are known to likely occur in the action area, none are listed as threatened or endangered under the ESA. No incidental take has been requested to be authorized for ESA-listed species as none are expected to be within the action area. To protect these animals (and other marine mammals in the action area), the City of San Diego shall schedule construction activities with highest sound levels during the daily period of lowest haul-out occurrence; limit activities to the hours of daylight; erect a temporary visual and acoustic barrier; use PSOs and prohibit construction activities during harbor seal pupping season. No injury, serious injury, or mortality is expected to occur and due to the nature, degree, and context of the Level B harassment anticipated, the proposed activity is not expected to impact rates of recruitment or survival.

    Although behavioral modifications, including temporarily vacating the area during the proposed construction activities, may be made by these species to avoid the resultant acoustic disturbance, the availability of alternate areas within these areas for species and the short and sporadic duration of the activities, have led NMFS to determine that the taking by Level B harassment from the specified activity would have a negligible impact on the affected species in the specified geographic region. NMFS believes that the time period of the proposed construction activities, the requirement to implement mitigation measures (e.g., prohibiting construction activities during pupping season, scheduling operations to periods of the lowest haul-out occurrence, visual and acoustic barriers, and the addition of a new measure that helps protect against unexpected abandonment of the site), and the inclusion of the monitoring and reporting measures, will reduce the amount and severity of the potential impacts from the activity to the degree that will have a negligible impact on the species or stocks in the action area.

    Based on the analysis contained herein of the likely effects of the proposed specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS finds that the total marine mammal take from the City of San Diego's activities would have a negligible impact on the affected marine mammal species or stocks.

    Small Numbers

    As mentioned previously, NMFS estimates that 3 species of marine mammals under its jurisdiction could be potentially affected by Level B harassment over the course of the IHA. It is estimated that up to 600 individual Pacific harbor seals, 2 individual California sea lions, and 1 northern elephant seal would be taken (multiple times) by Level B harassment, which would be approximately 1.93, less than 0.01, and less than 0.01% of the respective California, U.S., and California breeding stocks. The population estimates for the marine mammal species that may be taken by Level B harassment were provided in Table 2 of this document.

    NMFS has determined, provided that the aforementioned proposed mitigation and monitoring measures are implemented, that the impact of the proposed construction activities at the Children's Pool Lifeguard Station in La Jolla, CA, June 2015 to June 2016, may result, at worst, in a temporary modification in behavior and/or low-level physiological effects (Level B harassment) of small numbers of certain species of marine mammals. Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed mitigation and monitoring measures, NMFS preliminarily finds that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks. See Table 2 for the proposed authorized take numbers of marine mammals.

    Endangered Species Act

    NMFS (Permits and Conservation Division) has determined that an ESA section 7 consultation for the issuance of an IHA under section 101(a)(5)(D) of the MMPA for this activity is not necessary for any ESA-listed marine mammal species under its jurisdiction, as the proposed action would not affect ESA-listed species.

    National Environmental Policy Act

    To meet NMFS's National Environmental Policy Act (NEPA; 42 U.S. C. 4321 et seq.) requirements for the issuance of an IHA to the City of San Diego, NMFS prepared an Environmental Assessment (EA) in 2013 for a similar activity titled Environmental Assessment on the Issuance of an Incidental Harassment Authorization to the City of San Diego to Take Marine Mammals by Harassment Incidental to Demolition and Construction Activities at the Children's Pool Lifeguard Station in La Jolla, California to comply with the Council of Environmental Quality (CEQ) regulations and NOAA Administrative Order (NAO) 216-6. NMFS will evaluate the proposed action to determine whether the 2013 EA supports the City of San Diego's 2015 IHA request.

    Proposed Authorization

    As a result of these preliminary determinations, NMFS proposed to issue an IHA to the City of San Diego for conducting construction activities at the Children's Pool Lifeguard Station in La Jolla, CA, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. The duration of the IHA would not exceed one year from the date of its issuance. The proposed IHA language is provided below:

    The City of San Diego, Public Works Department, Engineering and Capital Projects Branch, Architectural Engineering and Parks Division, 525 B Street, Suite 750, MS 908A, San Diego, California 92101, is hereby authorized under section 101(a)(5)(D) of the Marine Mammal Protection Act (16 U.S.C. 1371(a)(5)(D)), to harass small numbers of marine mammals incidental to the construction activities at the Children's Pool Lifeguard Station, June 2015 through June 2016, contingent upon the following conditions:

    1. Effective Dates

    This Authorization is valid from June 28, 2015 through June 27, 2016.

    2. Specified Geographic Region

    This Authorization is valid only for the construction activities at the Children's Pool Lifeguard Station that shall occur in the following specified geographic area:

    The La Jolla Children's Pool Lifeguard Station at 827 1/2 Coast Boulevard, La Jolla, California 92037 (32° 50′50.02″ North, 117°16′42.8″ West), as specified in the City of San Diego's IHA application.

    3. Species Authorized and Level of Takes

    (a) The incidental taking of marine mammals, by Level B harassment only, is limited to the following species in the La Jolla, California area:

    (i) Pinnipeds—see Table 2 (above) for authorized species and take numbers.

    (ii) If any marine mammal species are encountered during construction activities that are not listed in Table 3 (above) for authorized taking and are likely to be exposed to sound pressure levels (SPLs) at or above 90 decibels (dB) re 20 µPa for harbor seals and/or at or above 100 dB re 20 µPa for all pinniped species except harbor seals (for in-air noise), then the City of San Diego must shut-down operations to avoid take.

    (b) The taking by injury (Level A harassment), serious injury, or death of any of the species listed in Condition 3(a) above, or the taking of any kind of any other species of marine mammal, is prohibited and may result in the modification, suspension or revocation of this Authorization.

    4. The methods authorized for taking by Level B harassment are limited to acoustic-generating equipment sources (e.g., backhoe, dump truck, cement truck, air compressor, electric screw guns, jackhammer, concrete saw, chop saw, and hand tools) without an amendment to this Authorization:

    5. Prohibited Take

    The taking of any marine mammal in a manner prohibited under this Authorization must be reported immediately to the Office of Protected Resources, National Marine Fisheries Service (NMFS), at 301-427-8401.

    6. Mitigation and Monitoring Requirements

    The City of San Diego is required to implement the following mitigation and monitoring requirements when conducting the specified activities in order to achieve the least practicable adverse impact on affected marine mammal species or stocks:

    Construction Prohibited During Pupping Season

    (a) The construction activities shall be prohibited during the Pacific harbor seal pupping season at Children's Pool (December 15th to May 15th) and for an additional two weeks to accommodate lactation and weaning of late season pups. Thus, construction shall be prohibited from December 15th to June 1st.

    Daily Construction Timing

    (b) The construction activities shall be scheduled Monday through Friday; however, they may continue on weekends to ensure completion of the project in 2015. To the maximum extent practicable, the construction activities shall be conducted from approximately 8:30 a.m. to 3:30 p.m., during the daily period of lowest haul-out occurrence; however, construction activities may be extended from 7 a.m. to 7 p.m. (i.e., daylight hours) to help assure that the project is completed during the 2015 construction window. Harbor seals typically have the highest daily or hourly haul-out period during the afternoon from 3 p.m. to 6 p.m.

    Visual and Acoustic Barriers

    (c) A visual and acoustic barrier will be erected and maintained for the duration of the project to shield construction activities from beach view. The temporary barrier shall consist of 1.3 to 1.9 centimeter (1/2 to 3/4 inch) plywood constructed 1.2 to 2.4 meters (4 to 8 feet) high depending on the location. The barriers will be placed at the site with input from NMFS West Coast Regional Office personnel so that they will hide as advantageously as possible the construction activities that may be seen by pinnipeds.

    Protected Species Observers

    (d) A NMFS-qualified, trained Protected Species Observer (PSO) shall be used to detect, document, and minimize potential impacts from construction activities. The PSO shall attend the project site 30 minutes prior until 30 minutes after construction activities cease each day throughout the construction window. The PSO shall be approved by NMFS prior to construction activities. The PSO shall search for marine mammals using binoculars and/or the naked eye within the Level B (behavioral) harassment zones, which may vary upon the type of in-air sound being produced by the construction activities. The PSO will observe from a station along the breakwater wall as well as the base of the cliff below the construction area. If inclement weather limits visibility within the area of effect, the PSO will perform visual scans to the extent conditions allow. The PSO will not have to monitor on days or portions of days when there will be little chance of disturbance from construction activities (e.g., nothing visual, sound levels at source less than 90 dB re 20 µPa, or all work activities inside the building).

    (e) The PSO shall visually scan the action area for the presence of marine mammals at least 30 minutes prior to the start-up and continuously throughout periods of in-air noise-generating activities. Visual scans shall continue for at least 30 minutes after each noise-generating episode has ceased.

    (f) The PSO shall use visual digital recordings and photographs to document individuals and behavioral responses to the construction activities. The PSO shall make hourly counts of the number of pinnipeds present and record sound or visual events that result in behavioral responses and changes, whether during construction activities or from public stimuli. During these events, pictures and videos will be taken when possible to document individuals and behavioral responses.

    (g) A PSO shall record the following information when a marine mammal is sighted:

    (i) Species, group size, age/size/sex categories (if determinable), behavior when first sighted and after initial sighting, heading (if consistent), distribution, bearing and distance relative to the sound source(s), group cohesiveness, duration of presence, apparent reaction to the construction activities (e.g., none, avoidance, approach, etc.), direction and speed of travel, duration of presence, and if there are other causes of potential disturbance occurring;

    (ii) Date, time, location, activity of construction operations, monitoring and mitigation measures implemented (or not implemented), tidal stage, weather conditions, Beaufort sea state, wind speed, visibility, and sun glare; and

    (iii) The data listed under Condition 6(g)(ii) shall also be recorded at the start and end of each observation watch and during a watch whenever there is a change in one or more variables.

    (h) A PSO shall also record the time of arrival and departure on site, commencement and cessation of in-air noise construction activities, and presence of humans on the beach. Whenever possible, the PSO should determine as to whether or not the harassment or pinnipeds is attributable to the construction activities and/or the presence of the public on the beach and around the Children's Pool area. A PSO shall record the number of people on the beach and surrounding areas as well as their location relative to the animals.

    Buffer Zones

    (i) Buffer zones shall be established (i.e., where sound pressure levels [SPLs] are at or above 90 decibels (dB) re 20 µPa for harbor seals and/or at or above 100 dB re 20 µPa for all pinniped species except harbor seals [for in-air noise]) around the construction activities so that in-air sounds associated with the construction activities no longer exceed levels that are potentially harmful to marine mammals.

    In-Air Noise Monitoring

    (j) In-air noise monitoring and reporting shall be performed during the construction activities at and near the Children's Pool Lifeguard Station. The PSO shall have access to handheld digital sound level measuring devices. The study will characterize in-air sound levels in the area related to (e.g., construction equipment including backhoe, dump truck, cement truck, air compressor, electric screw guns, jackhammer, concrete saw, chop saw, and hand tools) and in the absence (as a background and baseline [i.e., ambient] for the project) of all construction activities, and confirm or identify harassment isopleths for all types of and construction activities conducted. To better assess in-air sound propagation and source levels, the distance from the sound meter to each sound-producing activity when conducting sound measurements shall be noted. Monitoring shall be conducted three to five days prior to construction activities and shall include hourly systematic counts of pinnipeds using the beach, Seal Rock, and associated reef areas to provide baseline data regarding recent haul-out behavior and patterns as well as background noise levels near the time and construction activities. Monitoring shall continue for 60 days following the end of demolition and construction activities. Following construction, the City of San Diego will have a program where a PSO that will randomly select a day per week to visit the Children's Pool.

    Potential Abandonment Survey

    (k) After the first two months of monitoring during construction activities, the City of San Diego shall take the mean number of observed harbor seals at the Children's Pool in a 24-hour period across the two months and compare it to the mean of the lower 95 percent confidence interval in Figure 3 (see above). If the observed mean is lower, the City of San Diego shall shut-down construction activities and work with NMFS and other harbor seal experts (e.g., Mark Lowry, Dr. Sarah Allen, Dr. Pamela Yochem, and/or Dr. Brent Stewart) to develop and implement a revised mitigation plan to further reduce the number of takes and potential impacts. Once a week every week thereafter, the City of San Diego shall take the same mean of observed harbor seals across the previous three tide cycles (a tide cycle is approximately 2 weeks) and compare it to the 95% lower confidence interval in Figure 3 for the same time period. If the observed mean is lower, the City of San Diego shall shut-down and take the action described above. If abandonment of the site is likely, monitoring shall be expanded away from the Children's Pool to determine if animals have been temporarily displaced to haul-out sites in the southern California area (e.g., Torrey Pines, Point Loma, etc.).

    7. Reporting Requirements

    The City of San Diego is required to:

    (a) Submit a draft report on all activities and monitoring results to the Office of Protected Resources, NMFS, within 90 days of the completion of the construction activities at the Children's Pool Lifeguard Station. This report must contain and summarize the following information:

    (i) Dates, times, locations, weather, sea conditions (including Beaufort sea state and wind speed), and associated activities during all construction activities and marine mammal sightings;

    (ii) Species, number, location, distance from the PSO, and behavior of any marine mammals, as well as associated construction activities, observed throughout all monitoring activities.

    (iii) An estimate of the number (by species) of marine mammals that: (A) are known to have been exposed to the construction activities (based on visual observation) at received levels greater than or equal 90 dB re 20 μPa for harbor seals and 100 dB re 20 μPa for all other pinniped species for in-air noise with a discussion of any specific behaviors those individuals exhibited; and (B) may have been exposed (based on reported values and modeling measurements for the construction equipment) to the construction activities in-air noise at received levels greater than or equal 90 dB re 20 μPa for harbor seals and 100 dB re 20 μPa for all other pinniped species with a discussion of the nature of the probable consequences of that exposure on the individuals that have been exposed. NMFS will consider pinnipeds flushing into the water; moving more than 1 m (3.3 ft), but not into the water; becoming alert and moving, but not moving more than 1 m; and changing direction of current movement by individuals as behavioral criteria for take by Level B harassment.

    (iii) A description of the implementation and effectiveness of the: monitoring and mitigation measures of the IHA.

    (b) Submit a final report to the Chief, Permits and Conservation Division, Office of Protected Resources, NMFS, within 30 days after receiving comments from NMFS on the draft report. If NMFS decides that the draft report needs no comments, the draft report shall be considered to be the final report.

    8. In the unanticipated event that the City of San Diego discovers a live stranded marine mammal (sick and/or injured) at Children's Pool, they shall immediately contact Sea World's stranded animal hotline at 1-800-541-7235. Sea World shall also be notified for dead stranded pinnipeds so that a necropsy can be performed. In all cases, NMFS shall be notified as well, but for immediate responses purposes, Sea World shall be contacted first.

    Reporting Prohibited Take

    In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by this Authorization, such as an injury (Level A harassment), serious injury or mortality, the City of San Diego shall immediately cease the specified activities and immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401 and/or by email to [email protected] and [email protected] and the West Coast Regional Stranding Coordinator (562-980-3230). The report must include the following information:

    (a) Time, date, and location (latitude/longitude) of the incident; the type of activity involved; description of the circumstances during and leading up to the incident; status of all sound source use in the 24 hours preceding the incident; water depth; environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility); description of marine mammal observations in the 24 hours preceding the incident; species identification or description of the animal(s) involved; the fate of the animal(s); and photographs or video footage of the animal (if equipment is available).

    Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS shall work with the City of San Diego to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. The City of San Diego may not resume their activities until notified by NMFS via letter or email, or via telephone.

    Reporting an Injured or Dead Marine Mammal with an Unknown Cause of Death

    In the event that the City of San Diego discovers an injured or dead marine mammal, and the lead PSO determines that the cause of the injury or death is unknown and the death is relatively recent (i.e., in less than a moderate state of decomposition as described in the next paragraph), the City of San Diego will immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401, and/or by email to [email protected] and [email protected], and the NMFS West Coast Regional Office (1-866-767-6114) and/or the West Coast Regional Stranding Coordinator (562-980-3230). The report must include the same information identified in the Condition 8(a) above. Activities may continue while NMFS reviews the circumstances of the incident. NMFS will work with the City of San Diego to determine whether modifications in the activities are appropriate.

    Reporting an Injured or Dead Marine Mammal Not Related to the Activities

    In the event that the City of San Diego discovers an injured or dead marine mammal, and the lead PSO determines that the injury or death is not associated with or related to the activities authorized in Condition 2 to 4 of this Authorization (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), the City of San Diego shall report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401, and/or by email to [email protected] and [email protected], and the NMFS West Coast Regional Office (1-866-767-6114) and/or the West Coast Regional Stranding Coordinator (562-980-3230), within 24 hours of the discovery. The City of San Diego shall provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS and the Marine Mammal Stranding Network. Activities may continue while NMFS reviews the circumstances of the incident.

    9. A copy of this Authorization must be in the possession of all contractors and PSOs operating under the authority of this IHA.

    Request for Public Comments

    NMFS requests comment on our analysis, the draft authorization, and any other aspect of the preliminary determinations and notice of the proposed IHA for the City of San Diego's construction activities at the La Jolla Children's Pool Lifeguard Station. Please include with your comments any supporting data or literature citations to help inform our final decision on the City of San Diego's request for an MMPA authorization. Concurrent with the publication of this notice in the Federal Register, NMFS is forwarding copies of this IHA application to the Marine Mammal Commission and its Committee of Scientific Advisors.

    Dated: May 11, 2015. Perry F. Gayaldo, Deputy Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2015-11994 Filed 5-18-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XD943 Fishing Capacity Reduction Program for the Southeast Alaska Purse Seine Salmon Fishery AGENCY:

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

    ACTION:

    Notice of fee rate adjustment.

    SUMMARY:

    NMFS issues this notice to decrease the fee rate to repay the $13,133,030 reduction loan for the fishing capacity reduction program in the Southeast Alaska purse seine salmon fishery.

    DATES:

    The fee rate decrease is effective June 1, 2015.

    ADDRESSES:

    Send questions about this notice to Paul Marx, Chief, Financial Services Division, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910-3282.

    FOR FURTHER INFORMATION CONTACT:

    Paul Marx, (301) 427-8771.

    SUPPLEMENTARY INFORMATION:

    I. Background

    NMFS' authority to make the loan resides in sections 1111 and 1112 of the Merchant Marine Act, 1936 (46 App. U.S.C. 1279(f) and 1279(g)(MMA)(title XI)).

    The Program was authorized in the Consolidated Appropriations Act of 2005 (Section 209 of Title II of Division B of Pub. L. 108-447) and waives all of the fishing capacity reduction program requirements of the Magnuson-Stevens Act (Sections 312(b)-(e)) codified at 16 U.S.C. 1801 et seq. except for Sections (b)(1)(C) and (d) which state: (1) It must be cost-effective; and (2) it is subject to a referendum approved by a majority of permit holders.

    NMFS published proposed program regulations on May 23, 2011 (76 FR 29707), and final program regulations on October 6, 2011 (76 FR 61985), to implement the reduction program. Subsequently, the Southeast Revitalization Association submitted a capacity reduction plan to NMFS. NMFS approved the plan on February 24, 2012. NMFS published the list of eligible voters on March 1, 2012 (77 FR 12568) and the notice of referendum period on March 29, 2012 (77 FR 19004). Interested persons should review these for further program details.

    NMFS conducted a referendum where the majority of permit holders voted to repay a fishing capacity reduction loan to purchase the permits identified in the reduction plan.

    On May 7, 2012, NMFS published another Federal Register document (77 FR 26744) advising the public that NMFS would tender the program's reduction payments to the 64 selected bidders who would permanently stop fishing with the permits they had relinquished in return for reduction payments. Subsequently, NMFS disbursed $13,133,030 in reduction payments to the 64 selected bidders.

    NMFS published a Federal Register notice on July 16, 2012 (77 FR 41754) informing the public that fee collection would begin on July 22, 2012. Since then all harvesters of Southeast Alaska purse seine salmon must pay the fee and all fish buyers of Southeast Alaska purse seine salmon must collect the fee in accordance with the applicable regulations.

    NMFS published a notice in the Federal Register on June 5, 2013 (78 FR 33810) to decrease the fee rate from 3.0% of landed value and any subsequent bonus payments to 1.5%, effective June 1, 2013.

    II. Purpose

    The purpose of this notice is to adjust the fee rate for the reduction fishery in accordance with the framework rule's § 600.1013(b). Section 600.1013(b) directs NMFS to recalculate the fee to a rate that will be reasonably necessary to ensure reduction loan repayment within the specified 40-year term.

    The initial fee applicable to the Southeast Alaska purse seine salmon program's reduction fishery was 3.0% of landed value and any subsequent bonus payments, which was decreased in June 2013 to 1.5%. NMFS has determined this fee rate is more than is needed to service the loan. Therefore, NMFS is decreasing the fee rate to 1.0% of landed value and any subsequent bonus payments which NMFS has determined is sufficient to ensure timely loan repayment. Fish buyers may continue to use Pay.gov to disburse collected fee deposits at: http://www.pay.gov/paygov/. Please visit the NMFS Web site for additional information at: http://www.nmfs.noaa.gov/mb/financial_services/buyback.htm.

    III. Notice

    The new fee rate for the Southeast Alaska purse seine salmon fishery is effective June 1, 2015.

    Fish sellers and fish buyers must pay and collect the fee in the manner set out in 50 CFR 600.1107 and the framework rule. Consequently, all harvesters and fish buyers should read subpart L to 50 CFR 600.1013 to understand how fish harvesters must pay and fish buyers must collect the fee.

    Dated: May 14, 2015. Basil Brown, Acting Director, Office of Management and Budget, National Marine Fisheries Service.
    [FR Doc. 2015-12092 Filed 5-18-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DoD-2015-HA-0009] Submission for OMB Review; Comment Request ACTION:

    Notice.

    SUMMARY:

    The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

    DATES:

    Consideration will be given to all comments received by June 18, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Fred Licari, 571-372-0493.

    SUPPLEMENTARY INFORMATION:

    Title, Associated Form and OMB Number: TRICARE Young Adult Application; DD Form 2947; OMB Control Number 0720-0049.

    Type of Request: Reinstatement.

    Number of Respondents: 16,000.

    Responses per Respondent: 2.

    Annual Responses: 32,000.

    Average Burden per Response: 15 minutes.

    Annual Burden Hours: 8,000.

    Needs and Uses: The information collection requirement is necessary to evaluate eligibility and qualifications of former young adult dependents applying for extended dependent coverage under the TRICARE Young Adult program.

    Affected Public: Individuals or households.

    Frequency: On occasion.

    Respondent's Obligation: Required to obtain or retain benefits.

    OMB Desk Officer: Ms. Meredith DeDona.

    Written comments and recommendations on the proposed information collection should be sent to Ms. Meredith DeDona at the Office of Management and Budget, Desk Officer for DoD, Room 10236, New Executive Office Building, Washington, DC 20503.

    You may also submit comments, identified by docket number and title, by the following method:

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

    Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    DOD Clearance Officer: Mr. Frederick Licari.

    Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.

    Dated: May 14, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-12093 Filed 5-18-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Strategic Environmental Research and Development Program, Scientific Advisory Board; Notice of Federal Advisory Committee Meeting AGENCY:

    Department of Defense.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Defense is publishing this notice to announce an open meeting of the Strategic Environmental Research and Development Program, Scientific Advisory Board (SAB). This meeting will be open to the public.

    DATES:

    Tuesday, June 16, 2015, from 8:00 a.m. to 4:50 p.m.

    ADDRESSES:

    Renaissance Portsmouth-Norfolk Waterfront Hotel, 425 Water Street, Portsmouth, Virginia 23704.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Anne Andrews, SERDP Office, 4800 Mark Center Drive, Suite 17D08, Alexandria, VA 22350-3605; or by telephone at (571) 372-6565.

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150. This notice is published in accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463).

    Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is on a first-come basis.

    The purpose of the June 16, 2015 meeting is to review research and development projects requesting Strategic Environmental Research and Development Program funds as required by the SERDP Statute, U.S. Code ‐ Title 10, Subtitle A, Part IV, Chapter 172, § 2904. The full agenda follows:

    8:00 a.m. Convene/Opening Remarks, Approval of October 2014 Minutes; Dr. Joseph Hughes, Chair. 8:05 a.m. Program Update; Dr. Anne Andrews, Acting Executive Director. 8:20 a.m. Munitions Response Overview; Dr. Herb Nelson, Munitions Response, Program Manager. 8:30 a.m. 15 MR01-039 (MR-2545): Sediment Volume Search Sonar Development, (FY15 New Start); Mr. Daniel Brown, Applied Research Laboratory, The Pennsylvania State University, State College, PA. 9:15 a.m. Break 9:30 a.m. Resource Conservation and Climate Change Overview; Dr. John Hall, Resource Conservation and Climate Change, Program Manager. 9:50 a.m. RC-2245: Defense Coastal/Estuarine Research Program (DCERP) Overview, (FY16 Continuing); Dr. Patricia Cunningham, RTI International, Research Triangle Park, NC. 10:05 a.m. RC-2245: CB-4 Title: Predicting Sustainability of Coastal Military Training Environments; Dr. Jesse McNinch, ERDC Coastal Hydraulics Lab, Duck, NC. 10:35 a.m. RC-2245: CC-1 Title: Development of Uniform Historical and Projected Climate to Support Integrated Coastal Ecosystem Research; Dr. Ryan Boyles, North Carolina State University, Raleigh, NC. 11:20 a.m. RC-2245: Development of Empirical Carbon Budget; Dr. Craig Tobias, University of Connecticut, Groton, CT. 12:05 p.m. Lunch 1:05 p.m. RC-2245: Translating Science into Practice; Dr. Mike Piehler, University of North Carolina, Morehead City, NC. 1:35 p.m. RC-2245: TAC Comments and Project Management; Dr. Patricia Cunningham, RTI International, Research Triangle Park, NC. 2:20 p.m. FY16 Statements of Need—Summaries in Preparation of New Start Projects to be Presented in September and October; SERDP Program Managers. 3:25 p.m. Break 3:40 p.m. FY17 SON—Board Input; All. 4:05 p.m. Scenarios for Sea Level Rise and Extreme Water Levels: Building on SERDP Research; Dr. John Hall, Resource Conservation and Climate Change, Program Manager. 4:50 p.m. Public Discussion/Adjourn

    Pursuant to 41 CFR 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written statements to the Strategic Environmental Research and Development Program, Scientific Advisory Board. Written statements may be submitted to the committee at any time or in response to an approved meeting agenda.

    All written statements shall be submitted to the Designated Federal Officer (DFO) for the Strategic Environmental Research and Development Program, Scientific Advisory Board. The DFO will ensure that the written statements are provided to the membership for their consideration. Contact information for the DFO can be obtained from the GSA's FACA Database at http://www.facadatabase.gov/. Time is allotted at the close of the meeting day for the public to make comments. Oral comments are limited to 5 minutes per person.

    Dated: May 14, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-12098 Filed 5-18-15; 8:45 am] BILLING CODE 5001-06-P
    DELAWARE RIVER BASIN COMMISSION Notice of Public Hearing and Business Meeting June 9-10, 2015.

    Notice is hereby given that the Delaware River Basin Commission will hold a public hearing on Tuesday, June 9, 2015. A business meeting will be held the following day on Wednesday, June 10, 2015. The hearing and business meeting are open to the public and will be held at the Washington Crossing Historic Park Visitor Center, 1112 River Road, Washington Crossing, Pennsylvania.

    Public Hearing. The public hearing on June 9, 2015 will begin at 1:30 p.m. Hearing items will include: Draft dockets for the withdrawals, discharges and other water-related projects subject to the Commission's review; a resolution apportioning among the signatory parties the amounts required for support of the current expense and capital budgets for the fiscal year ending June 30, 2016; a resolution approving the annual current expense and capital budgets for the fiscal year ending June 30, 2016; and a proposed rule, published elsewhere in this issue of the Federal Register, amending DRBC's Administrative Manual Part III—Rules of Practice and Procedure to provide for the One Process/One Permit Program.

    The list of projects scheduled for hearing, including project descriptions, will be posted on the Commission's Web site, www.drbc.net, in a long form of this notice at least ten days before the hearing date. Draft resolutions scheduled for hearing also will be posted at www.drbc.net ten or more days prior to the hearing. Additional information related to the proposed rule to provide for the One Process/One Permit Program can be found in separate notices of proposed rulemaking in the Federal Register, the register publications of each of the Commission's member states, and at www.drbc.net.

    Written comments on draft dockets and resolutions scheduled for hearing on June 9 will be accepted through the close of the hearing that day. After the hearing on all scheduled matters has been completed, and as time allows, an opportunity for public dialogue will also be provided.

    The public is advised to check the Commission's Web site periodically prior to the hearing date, as items scheduled for hearing may be postponed if additional time is deemed necessary to complete the Commission's review, and items may be added up to ten days prior to the hearing date. In reviewing docket descriptions, the public is also asked to be aware that project details commonly change in the course of the Commission's review, which is ongoing.

    Public Meeting. The public business meeting on June 10, 2015 will begin at 1:30 p.m. and will include: Adoption of the Minutes of the Commission's March 11, 2015 business meeting, announcements of upcoming meetings and events, a report on hydrologic conditions, reports by the Executive Director and the Commission's General Counsel, and consideration of any items for which a hearing has been completed or is not required.

    There will be no opportunity for additional public comment at the June 10 business meeting on items for which a hearing was completed on June 9 or a previous date. Commission consideration on June 10 of items for which the public hearing is closed may result in either approval of the item (by docket or resolution) as proposed, approval with changes, denial, or deferral. When the Commissioners defer an action, they may announce an additional period for written comment on the item, with or without an additional hearing date, or they may take additional time to consider the input they have already received without requesting further public input. Any deferred items will be considered for action at a public meeting of the Commission on a future date. Items heard during the March 10, 2015 Public Hearing on which the Commission has not yet acted include draft dockets D-2014-008-1 for the Columbia Gas Transmission Corporation, and D-2014-022-1 for the Trancontinental Pipeline Company, LLC.

    Advance Sign-Up for Oral Comment. Individuals who wish to comment for the record at the public hearing on June 9 or to address the Commissioners informally during the public dialogue portion of the meeting that day as time allows, are asked to sign up in advance by contacting Ms. Paula Schmitt of the Commission staff, at [email protected] or by phoning Ms. Schmitt at 609-883-9500 ext. 224.

    Addresses for Written Comment. Written comment on items scheduled for hearing may be delivered by hand at the public hearing or in advance of the hearing, either: By hand, U.S. Mail or private carrier to: Commission Secretary, P.O. Box 7360, 25 State Police Drive, West Trenton, NJ 08628; by fax to Commission Secretary, DRBC at 609-883-9522; or by email (preferred) to [email protected] If submitted by email in advance of the hearing date, written comments on a docket should also be sent to Mr. William Muszynski, Manager, Water Resources Management at [email protected]

    Accommodations for Special Needs. Individuals in need of an accommodation as provided for in the Americans with Disabilities Act who wish to attend the informational meeting, conference session or hearings should contact the Commission Secretary directly at 609-883-9500 ext. 203 or through the Telecommunications Relay Services (TRS) at 711, to discuss how we can accommodate your needs.

    Updates. Items scheduled for hearing are occasionally postponed to allow more time for the Commission to consider them. Other meeting items also are subject to change. Please check the Commission's Web site, www.drbc.net, closer to the meeting date for changes that may be made after the deadline for filing this notice.

    Additional Information, Contacts. The list of projects scheduled for hearing, with descriptions, will be posted on the Commission's Web site, www.drbc.net, in a long form of this notice at least ten days before the hearing date. Draft dockets and resolutions for hearing items will be available as hyperlinks from the posted notice. Additional public records relating to hearing items may be examined at the Commission's offices by appointment by contacting Carol Adamovic, 609-883-9500, ext. 249. For other questions concerning hearing items, please contact Project Review Section assistant Victoria Lawson at 609-883-9500, ext. 216.

    Dated: May 13, 2015. Pamela M. Bush, Commission Secretary and Assistant General Counsel.
    [FR Doc. 2015-12077 Filed 5-18-15; 8:45 am] BILLING CODE 6360-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2015-ICCD-0065] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 2015-16 National Postsecondary Student Aid Study (NPSAS:16) Full Scale Institution Contacting And Enrollment List Collection AGENCY:

    Institute of Education Sciences/National Center for Education Statistics (IES), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before June 18, 2015.

    ADDRESSES:

    Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting Docket ID number ED-2015-ICCD-0065 or via postal mail, commercial delivery, or hand delivery. If the regulations.gov site is not available to the public for any reason, ED will temporarily accept comments at [email protected] Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted; ED will ONLY accept comments during the comment period in this mailbox when the regulations.gov site is not available. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Mailstop L-OM-2-2E319, Room 2E103, Washington, DC 20202.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Kashka Kubzdela, 202-502-7411.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: 2015-16—National Postsecondary Student Aid Study (NPSAS:16) Full Scale Institution Contacting And Enrollment List Collection.

    OMB Control Number: 1850-0666.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 4,478.

    Total Estimated Number of Annual Burden Hours: 4,081.

    Abstract: The National Postsecondary Student Aid Study (NPSAS), a nationally representative study of how students and their families finance postsecondary education, was first implemented by the National Center for Education Statistics (NCES) in 1987 and has been fielded every 3 to 4 years since. The next major data collection will occur in 2016 following a field test collection in 2015. This submission is for the ninth cycle in the series, NPSAS:16, which will also serve as the base year study for the 2016 Baccalaureate and Beyond Longitudinal Study (B&B) which provides data on the various paths of recent college graduates into employment and additional education. The NPSAS:16 sample will include about 2,000 institutions and about 128,000 students. Institution contacting will begin in October 2015 and student data collection will be conducted from January through September 2016. A separate package to request clearance for student data collection (interviews and institution record data) will be submitted in the fall 2015. This submission includes contacting materials and collection of enrollment lists from institutions selected to participate in the full-scale study.

    Dated: May 13, 2015. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2015-12040 Filed 5-18-15; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2015-ICCD-0066] Agency Information Collection Activities; Comment Request; Graduate Assistance in Areas of National Need (GAANN) Performance Report AGENCY:

    Department of Education (ED), Office of Postsecondary Education (OPE).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before July 20, 2015.

    ADDRESSES:

    Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting Docket ID number ED-2015-ICCD-0066 or via postal mail, commercial delivery, or hand delivery. If the regulations.gov site is not available to the public for any reason, ED will temporarily accept comments at [email protected] Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted; ED will ONLY accept comments during the comment period in this mailbox when the regulations.gov site is not available. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Mailstop L-OM-2-2E319, Room 2E103, Washington, DC 20202.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Rebecca Ell, (202) 502-7779.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Graduate Assistance in Areas of National Need (GAANN) Performance Report.

    OMB Control Number: 1840-0748.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: Private Sector, State, Local and Tribal Governments.

    Total Estimated Number of Annual Responses: 291.

    Total Estimated Number of Annual Burden Hours: 3,273.

    Abstract: Graduate Assistance in Areas of National Need (GAANN) grantees must submit a performance report annually. The reports are used to evaluate grantee performance. Further, the data from the reports will be aggregated to evaluate the accomplishments and impact of the GAANN Program as a whole. Results will be reported to the Secretary in order to respond to GPRA requirements.

    Dated: May 14, 2015. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2015-12074 Filed 5-18-15; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Hanford AGENCY:

    Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Hanford. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

    DATES:

    Wednesday, June 10, 2015, 8:30 a.m.-5:00 p.m. Thursday, June 11, 2015, 9:00 a.m.-12:00 p.m. ADDRESSES:

    Red Lion Hanford House, 802 George Washington Way, Richland, WA 99352.

    FOR FURTHER INFORMATION CONTACT:

    Kristen Skopeck, Federal Coordinator, Department of Energy Richland Operations Office, 825 Jadwin Avenue, P.O. Box 550, A7-75, Richland, WA 99352; Phone: (509) 376-5803; or Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

    Tentative Agenda:

    • Potential Draft Advice Budget Priorities • Discussion Topics Tank Vapor Implementation Plan Phoenix Tool—Tank Farm Application Tri-Party Agreement Agencies' Updates Hanford Advisory Board Committee Reports Board Business

    Public Participation: The meeting is open to the public. The EM SSAB, Hanford, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kristen Skopeck at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Kristen Skopeck at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

    Minutes: Minutes will be available by writing or calling Kristen Skopeck's office at the address or phone number listed above. Minutes will also be available at the following Web site: http://www.hanford.gov/page.cfm/hab.

    Issued at Washington, DC, on May 13, 2015. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2015-12075 Filed 5-18-15; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL15-65-000] Southline Transmission, L.L.C., SU FERC, L.L.C.; Notice of Petition for Declaratory Order

    Take notice that on May 11, 2015, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2014), Southline Transmission, L.L.C. (Southline) and SU FERC, L.L.C. (SU FERC), filed a petition for declaratory order requesting that the Commission: (1) Find that Southline Transmission is a passive entity and therefore not a public utility within the meaning of the Federal Power Act or an electric utility company under the Public Utility Holding Company Act of 2005, (2) grant SU FERC negotiated rate authority, (3) approve SU FERC's capacity allocation methodology, and (4) grant certain waivers of FERC's regulations.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426

    This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern time on June 10, 2015.

    Dated: May 13, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-12080 Filed 5-18-15; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OARM-2015-0283; FRL-9927-88-OARM] Public Availability of Environmental Protection Agency FY 2014 Service Contract Inventory AGENCY:

    Environmental Protection Agency

    ACTION:

    Notice.

    SUMMARY:

    In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), the Environmental Protection Agency is publishing this notice to advise the public of the availability of the FY 2014 Service Contract Inventory. This inventory provides information on service contract actions over $25,000 that were made in FY 2014. The information is organized by function to show how contracted resources are distributed throughout the Agency. The inventory has been developed in accordance with guidance issued by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP), Service Contract Inventories (December 19, 2011). The Environmental Protection Agency has posted its inventory and a summary of the inventory on the EPA's homepage at the following link: http://www.epa.gov/oam/inventory/inventory.htm.

    FOR FURTHER INFORMATION CONTACT:

    Questions regarding the service contract inventory should be directed to Linear Cherry in the Office of Acquisition Management, Policy, Training, and Oversight Division (3802R), Financial Analysis and Oversight Service Center, Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: (202) 564-4403; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    General Information How can I get copies of this docket and other related information?

    1. The EPA has established a docket for this action under Docket ID No. EPA-HQ-OARM-2015-0283. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the FY 2014 Service Contract Inventory Docket in the EPA Docket Center, (EPA/DC) EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the FY 2014 Service Contract Inventory Docket is (202) 566-1752.

    2. Electronic Access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/.

    Dated: May 14, 2015. John R. Bashista, Director, Office of Acquisition Management.
    [FR Doc. 2015-12102 Filed 5-18-15; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Update to Notice of Financial Institutions for Which the Federal Deposit Insurance Corporation Has Been Appointed Either Receiver, Liquidator, or Manager AGENCY:

    Federal Deposit Insurance Corporation.

    ACTION:

    Update listing of financial institutions in liquidation.

    SUMMARY:

    Notice is hereby given that the Federal Deposit Insurance Corporation (Corporation) has been appointed the sole receiver for the following financial institutions effective as of the Date Closed as indicated in the listing. This list (as updated from time to time in the Federal Register) may be relied upon as “of record” notice that the Corporation has been appointed receiver for purposes of the statement of policy published in the July 2, 1992 issue of the Federal Register (57 FR 29491). For further information concerning the identification of any institutions which have been placed in liquidation, please visit the Corporation Web site at www.fdic.gov/bank/individual/failed/banklist.html or contact the Manager of Receivership Oversight in the appropriate service center.

    Dated: May 11, 2015. Federal Deposit Insurance Corporation. Pamela Johnson, Regulatory Editing Specialist. Institutions in Liquidation [In alphabetical order] FDIC Ref. No. Bank name City State Date closed 10514 Edgebrook Bank Chicago IL 5/8/2015
    [FR Doc. 2015-12069 Filed 5-18-15; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meetings AGENCY:

    Federal Election Commission.

    DATE and TIME:

    Thursday, May 21, 2015 At 10:00 a.m.

    PLACE:

    999 E Street NW., Washington, DC (Ninth Floor).

    STATUS:

    This meeting will be open to the public.

    ITEMS TO BE DISCUSSED:

    Correction and Approval of Minutes for March 19, 2015 Audit Division Recommendation Memorandum on the Oakland County Democratic Party (OCDP) (A12-02) Audit Division Recommendation Memorandum on Kevin McCarthy for Congress (KMFC) (A13-02) Audit Division Recommendation Memorandum on New American City, Inc. (NAC) Presentation by the FEC Staff on Enhanced Engagement with the Public and Stakeholders Notice to Respondents of Information Sharing by the Commission Proposed Statement of Policy Regarding the Public Disclosure of Closed Enforcement Files Motion to Open a Rulemaking in Response to Comments and Testimony on the McCutcheon v. FEC ANPRM Proposed Directive 74 on the Timely Resolution of Enforcement Matters Management and Administrative Matters

    Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Shawn Woodhead Werth, Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.

    PERSON TO CONTACT FOR INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Shawn Woodhead Werth, Secretary and Clerk of the Commission.
    [FR Doc. 2015-12159 Filed 5-15-15; 11:15 am] BILLING CODE 6715-01-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 June 11, 2015.

    A. Federal Reserve Bank of Atlanta (Chapelle Davis, Assistant Vice President) 1000 Peachtree Street, NE., Atlanta, Georgia 30309:

    1. United Community Banks, Inc., Blairsville, Georgia; to merge with Palmetto Bancshares, Inc., and thereby acquire The Palmetto Bank, both of Greenville, South Carolina.

    Board of Governors of the Federal Reserve System, May 13, 2015. Michael J. Lewandowski, Associate Secretary of the Board.
    [FR Doc. 2015-12033 Filed 5-18-15; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than June 2, 2015.

    A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:

    1. David L. Johnson and Sandra L. Castetter, both of Kansas City, Missouri; each individually to acquire over 10 percent; and David L. Johnson and Sandra L. Castetter, together with Park GP, LLC, North Kansas City, Missouri, acting in concert to acquire up to 24.99 percent of the voting shares CCSB Financial Corp., parent of Clay County Savings Bank, both of Liberty, Missouri.

    Board of Governors of the Federal Reserve System, May 13, 2015. Michael J. Lewandowski, Assistant Secretary of the Board.
    [FR Doc. 2015-12034 Filed 5-18-15; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review

    The meeting announced below concerns Building Local Community Health Leadership for Action on Preventing Chronic Disease, SIP 15-006, initial review.

    SUMMARY:

    This document corrects a notice that was published in the Federal Register on May 5, 2015, Volume 80, Number 86, Page 25692. The time and date should have read as follows:

    TIME AND DATE:

    11:00 a.m.-6:00 p.m., May 28, 2015 (Closed).

    FOR FURTHER INFORMATION CONTACT:

    Brenda Colley Gilbert, Ph.D., M.S.P.H., Director, Extramural Research Program Operations and Services, CDC, 4770 Buford Highway NE., Mailstop F-80, Atlanta, Georgia 30341, Telephone: (770) 488-6295, [email protected].

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2015-12054 Filed 5-18-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review

    In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces a meeting for the initial review of applications in response to Funding Opportunity Announcement (FOA) PS15-1505, Enhancing HIV Prevention Communication and Mobilization Efforts through Strategic Partnerships.

    Time and Date: 10:00 a.m.-1:00 p.m., EDT, Panels 1-5; June 9, 2015 (CLOSED).

    Place: Teleconference.

    Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463.

    Matters for Discussion: The meeting will include the initial review, discussion, and evaluation of applications received in response to “Enhancing HIV Prevention Communication and Mobilization Efforts through Strategic Partnerships” FOA PS15-1505.

    Contact Person for more Information: Lisa R. Williams, Public Health Analyst, CDC, 1600 Clifton Road, NE., Mailstop E07, Atlanta, Georgia 30333, Telephone: (404) 639-1877.

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2015-12056 Filed 5-18-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-15-15AIS; Docket No. CDC-2015-0037] 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 information collection entitled CDC Burden of Canine Brucellosis Information Collection. This information collection will help to estimate canine brucellosis disease burden in dogs, which will aid in the determination of the public health importance of human B. canis infections, and the potential for zoonotic transmission.

    DATES:

    Written comments must be received on or before July 20, 2015.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2015-0037 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

    CDC Burden of Canine Brucellosis Information Collection—New—National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Canine brucellosis is a bacterial infection caused by the organism Brucella canis. Few seroprevalence studies have been done to estimate the prevalence of canine brucellosis, most of which were conducted over 25 years ago. Two recent reports from Oklahoma and Wisconsin describe increasing prevalence in dogs; however, the national burden is not known. B. canis is also pathogenic to humans, although human infections are thought to be rare in the United States.

    Unlike Brucella abortus, B. melitensis, and B. suis, B. canis is not classified as a select agent. As a result, laboratory identification of the organism in humans does not require reporting to the Laboratory Response Network. Brucella species-specific data are not collected in the Nationally Notifiable Disease Surveillance System at CDC, and there are no validated Brucella canis serological tests to diagnose disease in humans. For these reasons, there are no national estimates of B. canis prevalence in humans or canines.

    Additionally, canine infections with other Brucella species have been reported in the literature. Zoonotic transmission is a concern with all Brucella species pathogenic to humans, and at least one human infection with B. suis related to canine contact has been reported. Neither the prevalence of canine brucellosis nor the potential risk of zoonotic spread to humans is known.

    There has been interest in human brucellosis caused by B. canis among the public health community. However, the degree of public health importance of human B. canis infections has not yet been ascertained. The Council of State and Territorial Epidemiologists approved a position statement in 2012 that recommends increased focus on B. canis, and urges CDC to support the development of a human diagnostic assay.

    The purpose of this information collection request is to estimate the burden of canine brucellosis in the United States, which will aid in the determination of the level of public health importance of human B. canis infections, and the potential for transmission of brucellosis from dogs. An estimate of disease burden in dogs will provide an idea of potential transmission between dogs and humans, and determine the need for future human public health studies, which is critical during this time of scarce resources.

    Veterinary diagnostic laboratories throughout the United States will be solicited to provide information on the quantity of test requests and positive results for Brucella spp. in canines, outsourcing of clinical testing, state-wide policies for reporting of positive results, and policies for human exposure to clinical specimens or isolates.

    The laboratories were identified through multiple sources: A review of the Animal and Plant Health Inspection Service-approved Brucella diagnostic laboratories, the National Animal Health Laboratory Network laboratories, the American Association of Veterinary Laboratory Diagnosticians (AAVLD), and an Internet search.

    The outcomes of this information collection are to assess the burden of disease in the animal host (dogs, in this case), as well as evaluate the knowledge and practices of occupational exposures to the organism. The information collected will be used to guide a longer term strategy for identification of human cases, understanding risk factors and activities associated with zoonotic transmission, and eventually validation of a human diagnostic assay. These strategies will be implemented using other mechanisms.

    The total annual burden is 129 hours.

    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.)
  • Veterinary diagnostic laboratory staff Burden of Canine Brucellosis Information Collection 119 1 1 119 Other laboratories Burden of Canine Brucellosis Information Collection 10 1 1 10 Total 129
    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. 2015-12094 Filed 5-18-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)

    In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), and pursuant to the requirements of 42 CFR 83.15(a), the Centers for Disease Control and Prevention (CDC), announces the following meeting of the aforementioned committee:

    Time and Date: 11:00 a.m.-2:00 p.m. EDT, Tuesday, June 9, 2015.

    Place: Audio Conference Call via FTS Conferencing. The USA toll-free, dial-in number is 1-866-659-0537 and the pass code is 9933701.

    Status: Open to the public. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference at the USA toll-free, dial-in number, 1-866-659-0537 and the passcode is 9933701.

    Background: The Advisory Board was established under the Energy Employees Occupational Illness Compensation Program Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the new compensation program. Key functions of the Advisory Board include providing advice on the development of probability of causation guidelines, which have been promulgated by the Department of Health and Human Services (HHS) as a final rule; advice on methods of dose reconstruction, which have also been promulgated by HHS as a final rule; advice on the scientific validity and quality of dose estimation and reconstruction efforts being performed for purposes of the compensation program; and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC).

    In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to the CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, most recently, August 3, 2013, and will expire on August 3, 2015.

    Purpose: This Advisory Board is charged with (a) providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179; (b) providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and (c) upon request by the Secretary, HHS, advising the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class.

    Matters for Discussion: The agenda for the conference call includes: NIOSH evaluation of SEC Petition for Westinghouse Electric Corp. facility in Bloomfield, New Jersey (January 1, 1950-March 1, 2011); Work Group and Subcommittee Reports; SEC Petitions Update for the July 2015 Advisory Board Meeting; Plans for the July 2015 Advisory Board Meeting; and Advisory Board Correspondence.

    The agenda is subject to change as priorities dictate.

    Contact Person for More Information: Theodore M. Katz, M.P.A., Designated Federal Officer, NIOSH, CDC, 1600 Clifton Rd. NE., Mailstop: E-20, Atlanta, Georgia 30333, Telephone (513) 533-6800, Toll Free 1-800-CDC-INFO, Email [email protected]

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2015-12059 Filed 5-18-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention World Trade Center Health Program Scientific/Technical Advisory Committee: Notice of Charter Renewal

    This gives notice under Public Law 111-347 (The James Zadroga 9/11 Health and Compensation Act of 2010) and the Federal Advisory Committee Act (Pub. L. 92-463) of October 6, 1972, that the World Trade Center Health Program Scientific/Technical Advisory Committee, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through May 12, 2017.

    For information, contact person for more information: Paul J. Middendorf, Ph.D., Designated Federal Officer, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Department of Health and Human Services, 2400 Century Parkway NE., Mail Stop E-20, Atlanta, Georgia 30345, telephone 1 (888) 982-4748; email: [email protected]

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2015-12058 Filed 5-18-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review

    In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces a meeting for the initial review of applications in response to Funding Opportunity Announcement (FOA), RFA-CE-15-001, Research Grants for Preventing Violence and Violence related Injury (R01).

    Times and Dates: 08:30 a.m.-5:00 p.m., EDT, June 17-18, 2015 (Closed).

    Place: Georgian Terrace, 659 Peachtree Road NE., Room 4, Atlanta, Georgia 30308. This meeting will also be held by teleconference.

    Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463.

    Matters for Discussion: The meeting will include the initial review, discussion, and evaluation of applications received in response to “Research Grants for Preventing Violence and Violence Related Injury (R01)”, FOA Number: CE-15-001.

    Contact Person for More Information: M. Chris Langub, Ph.D., Scientific Review Officer, CDC, 4770 Buford Hwy., NE., Mailstop E63, Atlanta, Georgia 30341-3724, Telephone: 770-488-4334.

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2015-12055 Filed 5-18-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-15-0822; Docket No. CDC-2015-0035] 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 a proposed revision to the approved information collection project entitled “The National Intimate Partner and Sexual Violence Survey (NISVS)”. This project collects information about individual's experiences of sexual violence, stalking and intimate partner violence.

    DATES:

    Written comments must be received on or before July 20, 2015.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2015-0035 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

    National Intimate Partner and Sexual Violence Survey (NISVS)—Revision—(OMB Control No. 0920-0822, Expiration—6/30/2016), National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    In 2010, the National Intimate Partner and Sexual Violence Surveillance System (NISVSS) reported that approximately 6.9 million women and 5.6 million men experienced rape, physical violence and/or stalking by an intimate partner within the last year. The health care costs of Intimate Partner Violence (IPV) exceed $5.8 billion each year, nearly $3.9 billion of which is for direct medical and mental health care services.

    In order to address this important public health problem, CDC implemented, beginning in 2010, the National Intimate Partner and Sexual Violence Surveillance System that produces national and state level estimates of Intimate Partner Violence (IPV), Sexual Violence (SV) and stalking on an annual basis.

    This revision request is multi-faceted. CDC is requesting a continuation of data collection among non-institutionalized adult men and women aged 18 years or older in the United States assessing lifetime experiences of IPV, SV and stalking with a new and improved data collection tool. The revisions to the survey are aimed at reducing the time and complexity of the instrument, thus reducing the burden on the respondent. The simplified structure of the instrument will also reduce the complexity of the data set, making it more assessable for public use. Additionally, in collaboration with the Department of Defense (DoD), NISVS will collect information regarding the experiences of IPV, SV and stalking among active duty women and men in the military and wives of active duty men. This data collection will take place during the first three months of data collection.

    To comply with OMB requirements, CDC is in the process of developing an expert panel to address methodological issues with the NISVS survey. The panel will meet multiple times over the course of the next year. The members of this panel will provide guidance on how to improve both survey design (methods, sampling frame, recruitment, mode of administration) and content/question wording with the goals of increasing response rates, reducing non-response bias, and maximizing the opportunities across Federal surveys for covering populations of interest. This change request also encompasses the implementation of the panel's recommendations to improve the survey.

    In the bi-annual data collection periods, total of 170,000 households will be screened. After determining eligibility and consent, 25,000 will complete the survey. The average burden per screened respondent remains at three minutes (total burden in hours equals 8,500) while the average burden per surveyed respondent is 25 minutes (total burden in hours equals 10,417). The survey will be conducted among English or Spanish speaking male and female adults (18 years and older) living in the United States.

    There are no costs to respondents 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
  • Non-Participating Individuals (Screened) NISVS Survey Instrument 170,000 1 3/60 8,500 Eligible Individuals (Surveyed) NISVS Survey Instrument 25,000 1 25/60 10,417 Total 18,917
    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. 2015-12095 Filed 5-18-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or Institute)

    In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the following committee meeting.

    Times and Dates:

    8:00 a.m.-5:00 p.m., June 16, 2015 (Closed) 8:00 a.m.-5:00 p.m., June 17, 2015 (Closed)

    Place: Embassy Suites, 1900 Diagonal Road, Alexandria, Virginia 22314, Telephone: 703-684-5900, Fax: 703-684-0653.

    Purpose: The Safety and Occupational Health Study Section will review, discuss, and evaluate grant application(s) received in response to the Institute's standard grants review and funding cycles pertaining to research issues in occupational safety and health, and allied areas.

    It is the intent of NIOSH to support broad-based research endeavors in keeping with the Institute's program goals. This will lead to improved understanding and appreciation for the magnitude of the aggregate health burden associated with occupational injuries and illnesses, as well as to support more focused research projects, which will lead to improvements in the delivery of occupational safety and health services, and the prevention of work-related injury and illness. It is anticipated that research funded will promote these program goals.

    Matters for Dicussion: The meeting will convene to address matters related to the conduct of Study Section business and for the study section to consider safety and occupational health-related grant applications.

    These portions of the meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, Centers for Disease Control and Prevention, pursuant to Section 10(d) Public Law 92-463.

    Agenda items are subject to change as priorities dictate.

    Contact Person for More Information: Price Connor, Ph.D., NIOSH Health Scientist, CDC, 2400 Executive Parkway, Mailstop E-20, Atlanta, Georgia 30345, Telephone: (404) 498-2511, Fax: (404) 498-2571.

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry.

    Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2015-12057 Filed 5-18-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review

    The meeting announced below concerns Integrating Self-Management Education with Cancer Survivorship Care Planning, SIP 15-001, and Using Cancer Registry Data to Promote Proactive Tobacco Cessation among Adult Cancer Survivors, SIP 15-003, initial review.

    SUMMARY:

    This document corrects a notice that was published in the Federal Register on April 14, 2015 Volume 80, Number 86, Page 19990. The time and date should have read as follows:

    DATES:

    Time and Date: 11:00 a.m.-6:00 p.m., May 12, 2015 (Closed).

    FOR FURTHER INFORMATION CONTACT:

    Brenda Colley Gilbert, Ph.D., M.S.P.H., Director, Extramural Research Program Operations and Services, CDC, 4770 Buford Highway NE., Mailstop F-80, Atlanta, Georgia 30341, Telephone: (770) 488-6295, [email protected].

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2015-12053 Filed 5-18-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects

    Title: Assets for Independence Program Performance Progress Report.

    OMB No.: New.

    Description

    The Assets for Independence (AFI) Act (Title IV of the Community Opportunities, Accountability, and Training and Educational Services Act of 1998, Pub. L. 105-285, [42 U.S.C. 604 note]) requires that organizations operating AFI projects submit annual progress reports.

    This request is to create an AFI program specific Performance Progress Report (PPR) to replace the semiannual standard form performance progress report (SF-PPR) and the annual data report. The AFI PPR will collect data on project activities and attributes similar to the reports that it is replacing. The Office of Community Services (OCS) in the Administration for Children and Families (ACF) will use the data collected in the AFI PPR to prepare the annual AFI Report to Congress, to evaluate and monitor the performance of the AFI program overall and of individual projects, and to inform and support technical assistance efforts. The AFI PPR would fulfill AFI Act reporting requirements and program purposes.

    The AFI PPR will be submitted quarterly: Three times per year using an abbreviated short form and one time using a long form. Both draft data collection instruments are available for review online at https://idaresources.acf.hhs.gov/AFIPPR.

    Note: This request does not affect financial reporting requirements for AFI grantees. The SF-425 will still be required semiannually throughout the grant project period with a final report due 90 days after the grant project period ends.

    Respondents: Assets for Independence (AFI) program grantees.

    Annual Burden Estimates Instrument Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden
  • hours per
  • response
  • Total burden hours
    AFI PPR Short Form 300 3 0.5 450 AFI PPR Long Form 300 1 4 1200

    Estimated Total Annual Burden Hours: 1,650.

    In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address: [email protected] All requests should be identified by the title of the information collection.

    The Department specifically requests comments 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) 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

    Karl Koerper, Reports Clearance Officer.
    [FR Doc. 2015-12096 Filed 5-18-15; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0998] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a collection of information entitled, “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    On January 08, 2015, the Agency submitted a proposed collection of information entitled, “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0409. The approval expires on April 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: May 13, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-12078 Filed 5-18-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0802] Exploring Naloxone Uptake and Use; Public Meeting; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public meeting; request for comments.

    The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, in collaboration with the National Institutes on Drug Abuse, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Health Resources and Services Administration, will hold a public meeting to discuss increasing the use of naloxone to reduce the incidence of opioid drug overdose fatalities. During the meeting, academic and government experts, industry representatives, and patient advocates will discuss which populations are at-risk for opioid drug overdose and how we can work together to encourage the use of naloxone to reduce the risk of overdose from opioid drugs.

    Date and Time: The public meeting will be held on July 1, 2015, from 8 a.m. to 5 p.m. and on July 2, 2015, from 8 a.m. to 3 p.m. The open public hearing will be held between 1 p.m. and 2 p.m. on July 1, 2015, and between 1 p.m. and 2 p.m. on July 2, 2015, during which speaker testimony will be accepted. We will try to accommodate all persons who wish to testify; however, the duration of each speaker's testimony may be limited by time constraints. Those wishing to participate in the open public hearing should limit their remarks to issues related to the uptake of naloxone both in conventional medical settings and outside of those settings to reduce the incidence of opioid drug overdose fatalities.

    Location: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002.

    Contact Person: Mary Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3519, [email protected]; or Georgiann Ienzi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3515, [email protected]

    Registration: If you wish to attend the public meeting or provide testimony during the open public hearing, please email your registration to [email protected] by June 22, 2015. Those without email access may register by contacting one of the contact persons (see Contact Persons). When registering, please provide complete contact information for each attendee, including name, title, affiliation, address, email address, and telephone number. Registration is free and will be on a first-come, first-served basis. Early registration is recommended because seating is limited. Registrants will receive confirmation once they have been accepted for the public meeting. Onsite registration on the day of the public meeting will be permitted based on space availability. If registration reaches maximum capacity, FDA will post a notice closing registration for the public meeting at: http://www.fda.gov/Drugs/NewsEvents/ucm442236.htm.

    Comments: Submit either electronic or written comments by September 1, 2015. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. If you need special accommodations due to a disability, contact Mary Gross or Georgiann Ienzi (see Contact Persons) at least 7 days in advance of the meeting.

    SUPPLEMENTARY INFORMATION: I. Introduction

    The number of prescriptions filled for opioid drugs has increased drastically in recent years. In 2009 nearly 257 million prescriptions were written for opioid drugs in the United States. This number rose to nearly 260 million in 2012. The increased availability of opioid drugs appears to be contributing significantly to abuse and overdose in the United States. In 2013 there were approximately 16,235 deaths from overdose involving opioid drugs. That same year, there were 8,257 deaths from overdose involving heroin.

    Naloxone, a mu-opioid antagonist, is a medication that can rapidly reverse the overdose of both prescription opioid drugs (e.g., OxyContin) and illicit opioid drugs (e.g., heroin). It is currently the standard treatment for those experiencing overdose and is commonly used by trained medical personnel in emergency departments and on ambulances. Its use among nonmedical personnel has also increased in recent years. The purpose of the public meeting is to explore issues surrounding the uptake of naloxone to treat opioid drug overdose. The meeting agenda will include topics on the clinical, regulatory, and legal implications of making naloxone more widely available. FDA will post the agenda and additional public meeting material approximately 2 days before the workshop at: http://www.fda.gov/Drugs/NewsEvents/ucm442236.htm.

    II. Transcripts

    A transcript will be made available approximately 45 days after the public meeting. It will be accessible at http://www.regulations.gov and may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: May 13, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-12061 Filed 5-18-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-1196] List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Request for Nominations AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; request for nominations.

    SUMMARY:

    The Food and Drug Administration (FDA) intends to develop a list of bulk drug substances that may be used by outsourcing facilities registered under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to compound animal drugs, in accordance with FDA's draft guidance for industry #230, “Compounding Animal Drugs from Bulk Drug Substances.” You may nominate specific bulk drug substances for this list. This notice describes the information that should be provided to the Agency in support of each nomination.

    DATES:

    To ensure that FDA considers your nominations for the initial version of the bulk drug substances list, submit either electronic or written nominations for the bulk drug substances list by August 17, 2015.

    After the comment period is closed, nominations to add or remove bulk drug substances from the list may be submitted to FDA by citizen petition under § 10.30 (21 CFR 10.30).

    ADDRESSES:

    You may submit nominations by any of the following methods.

    Electronic Submissions

    Submit electronic nominations in the following way:

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

    Written Submissions

    Submit written nominations in the following ways:

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

    Instructions: All submissions received must include the Docket No. FDA-2013-N-1524. All nominations received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting nominations, see the “Request for Nominations” heading of the SUPPLEMENTARY INFORMATION section of this document.

    Docket: For access to the docket to read background documents or nominations 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:

    Neal Bataller, Center for Veterinary Medicine, Food and Drug Administration (HFV-210), 7519 Standish Pl., Rockville, MD 20855, 240-402-5745, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Sections 503A (21 U.S.C. 353a) and 503B (21 U.S.C. 353b) of the FD&C Act do not apply to the compounding of animal drugs. The FD&C Act does not distinguish between compounding animal drugs from bulk drug substances 1 and any other manufacturing or processing of animal drugs. Except with respect to the limited exemption provided by the FD&C Act described in this document, statutory provisions applicable to manufactured animal drugs under the FD&C Act also apply to compounded animal drugs.

    1 FDA regulations define “bulk drug substance” as “any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.” 21 CFR 207.3(a)(4). “Active ingredient” is defined as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.” 21 CFR 210.3(b)(7). Any component other than an active ingredient is an “inactive ingredient.” See 21 CFR 210.3(b)(8). Inactive ingredients used in compounded drug products commonly include flavorings, dyes, diluents, or other excipients.

    Section 512(a)(4) and (5) of the FD&C Act (21 U.S.C. 360b(a)(4) and (5)) provide a limited exemption from certain requirements for use for compounded animal drugs made from already approved animal or human drugs. Such use is considered an extra-label use and the FD&C Act provides that a compounded drug is exempt from the approval requirements and requirements of section 502(f)(1) (21 U.S.C. 352(f)(1)) of the FD&C Act, if it meets the conditions set out in the statute and the extra-label use regulations at 21 CFR part 530.

    Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry #230 entitled “Compounding Animal Drugs from Bulk Drug Substances” (GFI #230).2 The draft guidance describes conditions under which FDA does not generally intend to initiate enforcement action against State-licensed pharmacies, licensed veterinarians, and facilities registered as outsourcing facilities under section 503B of the FD&C Act (outsourcing facilities) that compound animal drugs from bulk drug substances.

    2 GFI #230 can be found at http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm042450.htm.

    For pharmacies, these conditions include receipt of a valid prescription for a compounded drug from a licensed veterinarian for an individually identified animal patient before the facility compounds the drug (with some limited compounding of an animal drug product in advance of receipt of a prescription in quantities based on a history of receipt of patient-specific prescriptions for that drug product). FDA recognizes that there may be some limited circumstances in which a drug compounded from one or more bulk drug substances should be available to a veterinarian for office use and is developing a list of such animal drug products and the bulk drug substances needed to make them applicable to drugs compounded by facilities registered as outsourcing facilities under section 503B of the FD&C Act. The draft guidance proposes that outsourcing facilities compound animal drugs only from bulk drug substances that will be listed in Appendix A of the final guidance, either pursuant to a veterinarian's order or pursuant to a patient-specific prescription. When a facility registered as an outsourcing facility under section 503B of the FD&C Act uses the listed bulk drug substances to make the specified drug products pursuant to an order from a licensed veterinarian without a prescription for an individually identified animal, FDA does not intend to take action under sections 512(a), 501(a)(5) (21 U.S.C. 351(a)(5)), 502(f), and 501(a)(2)(B) as long as such compounding is done in accordance with any associated conditions described in GFI #230. Although an outsourcing facility may fill a veterinarian's order for compounded animal drugs using bulk drug substances listed on Appendix A without obtaining prescriptions for individually identified animal patients, drugs produced by outsourcing facilities remain subject to the requirements in section 503(f) of the FD&C Act. Therefore, an outsourcing facility cannot dispense a compounded drug to the owner or caretaker of an animal patient without a prescription for that individually identified animal patient.

    This list only applies to outsourcing facilities. This list does not limit what bulk drug substances State-licensed pharmacies or licensed veterinarians can use in compounding drugs in accordance with the conditions set forth in the draft guidance, including the condition pertaining to obtaining a patient-specific prescription.

    FDA intends to include a bulk drug substance on Appendix A only when all of the following criteria are met:

    • There is no marketed approved, conditionally approved, or index-listed animal drug that can be used as labeled to treat the condition;

    • there is no marketed approved animal or human drug that could be used under section 512(a)(4) or (a)(5) of the FD&C Act and part 530 (addressing extra-label use of approved animal and human drugs) to treat the condition;

    • the drug cannot be compounded from an approved animal or human drug;

    • immediate treatment with the compounded drug is necessary to avoid animal suffering or death; and

    • FDA has not identified a significant safety concern specific to the use of the bulk drug substance to compound animal drugs (under the listed conditions and limitations).

    Inactive ingredients need not appear on Appendix A to be used in compounding animal drug products.

    II. Request for Nominations A. Active Ingredients

    You may nominate specific bulk drug substances for inclusion on the list in Appendix A. Nominations will only be evaluated if they are for specific ingredients that meet the definition of a bulk drug substance in § 207.3(a)(4) (21 CFR 207.3(a)(4)). Nominated substances that do not meet this definition will not be included on the list.

    To determine if a bulk drug substance should be included in Appendix A, FDA needs the following information about the bulk drug substance being nominated and the animal drug product(s) that will be compounded using such substance:

    1. Confirmation That the Nominated Substance Is a Bulk Drug Substance

    A statement that the nominated substance is an active ingredient that meets the definition of “bulk drug substance” in § 207.3(a)(4), and an explanation of why the substance is considered an active ingredient when it is used in the identified compounded drug product(s), citing to specific sources that describe the active properties of the substance.

    2. General Background on the Bulk Drug Substance

    • Ingredient name;

    • chemical name;

    • common name(s); and

    • identifying codes, as available, from FDA's Unique Ingredient Identifiers used in the FDA/U.S. Pharmacopeial Convention (USP) Substance Registration System, available at http://fdasis.nlm.nih.gov/srs/. Because substance names can vary, this code, where available, will be used by the Agency to confirm the exact substance nominated and to identify multiple nominations of the same substance so the information can be reviewed together.

    • Chemical grade of the ingredient;

    • description of the strength, quality, stability, and purity of the ingredient;

    • information about how the ingredient is supplied (e.g., powder, liquid); and

    • information about recognition of the substance in foreign pharmacopeias and the status of its registration(s) in other countries, including whether information has been submitted to USP for consideration of monograph development.

    B. Information on the Animal Drug Products That Will Be Compounded With the Bulk Drug Substance

    • Information about the dosage form(s) into which the bulk drug substance will be compounded;

    • information about the strength(s) of the compounded product(s); and

    • information about the anticipated route(s) of administration of the compounded product(s).

    C. Need for the Animal Drug Products That Will Be Compounded With the Bulk Drug Substance

    For FDA to be able to meaningfully evaluate a substance, the information provided must be specific to the particular substance nominated and animal drug product to be compounded. A “boilerplate” or general explanation of need for compounding with bulk drug substances will not enable FDA to conduct an adequate review. Unless adequate supporting data are submitted for a bulk drug substance, FDA will be unable to consider it for inclusion in Appendix A.

    Prescribers of compounded animal drug products may be in the best position to explain why a particular bulk drug substance meets the criteria for including a bulk drug substance on Appendix A and are encouraged to provide data in support of a nomination. The following information about need is necessary to provide adequate support for nominations to the Appendix A list:

    • A statement identifying the species and condition(s) that the drug product to be compounded with the nominated bulk drug substance is intended to treat;

    • a bibliography of safety and efficacy data for the drug compounded using the nominated substance, if available,3 including any relevant peer-reviewed veterinary literature;

    3 FDA recognizes that the available safety and efficacy data supporting consideration of a bulk drug substance for inclusion on the list may not be of the same type, amount, or quality as is required to support a new animal drug application.

    • a list of animal drug products, if any, that are approved, conditionally approved, or index listed for the condition(s) in the species that the drug compounded with the nominated substance is intended to address;

    • if there are FDA-approved or index listed drug products that address the same conditions in the same species, an explanation, supported by relevant veterinary literature, of why a compounded drug product is necessary (i.e., why the approved drug product is not suitable for a particular patient population);

    • a review of the veterinary literature to determine whether there are FDA-approved animal or human drugs that could be prescribed as an extra-label use under section 512(a)(4) and (a)(5) of the FD&C Act and part 530 to treat the condition(s) in the species that the drug compounded with the nominated substance is intended to address;

    • if the bulk drug substance is an active ingredient in an approved animal or human drug, an explanation, supported by appropriate scientific data, of why the animal drug product cannot be compounded from the approved drug under 21 CFR 530.13(b);

    • an explanation, supported by relevant veterinary literature, of why the animal drug product to be compounded with the nominated bulk drug substance must be available to the veterinarian for immediate treatment to avoid animal suffering or death. Nominations should include specific information documenting that animal suffering or death will result if treatment is delayed until a compounded animal drug can be obtained pursuant to a prescription for an individually identified animal; and

    • a discussion of any safety concerns associated with use of the nominated bulk drug substance or finished compounded product for the condition(s) in the species that the compounded drug is intended to address. If there are any safety concerns, an explanation, supported by veterinary literature, of why the concerns should not preclude inclusion of that bulk drug substance on Appendix A.

    D. Nomination Process

    For efficient consolidation and review of nominations, nominators are encouraged to submit their nominations in a format that explicitly addresses each item previously listed in the order that they appear. To consider a bulk drug substance for inclusion in Appendix A, FDA must receive adequate supporting data for the substance. FDA cannot guarantee that all drugs nominated during the nomination period will be considered for inclusion on Appendix A prior to its initial publication. Nominations that are not evaluated during this first phase will receive consideration for later addition to Appendix A.

    Individuals and organization may petition FDA to make additional amendments to Appendix A after it is published, in accordance with § 10.30.

    Interested persons may submit either electronic nominations to http://www.regulations.gov or written nominations to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of nominations. Identify nominations with the docket number found in the brackets in the heading of this document. Received nominations may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: May 12, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-11983 Filed 5-18-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2015-D-1176 and FDA-2003-D-0202] Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Withdrawal of Compliance Policy Guide; Section 608.400 Compounding of Drugs for Use in Animals AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; withdrawal.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #230 entitled “Compounding Animal Drugs from Bulk Drug Substances.” The draft guidance describes FDA's policies with regard to compounding animal drugs from bulk drug substances. When final, the guidance will reflect FDA's current thinking on the issues addressed by the guidance.

    FDA is also announcing the withdrawal of the compliance policy guide (CPG) entitled “Section 608.400 Compounding of Drugs for Use in Animals,” which was issued in July 2003. This 2003 CPG is being withdrawn because it is no longer consistent with FDA's current thinking on the issues it addresses.

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on the draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 17, 2015. Submit written or electronic comments on the proposed collection of information by August 17, 2015.

    ADDRESSES:

    Submit written requests for single copies of the draft guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.

    Submit electronic comments on the draft guidance, including comments regarding the proposed collection of information, to http://www.regulations.gov. Submit written comments on the draft guidance, including comments regarding the proposed collection of information, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    With regard to this draft guidance: Division of Compliance, Center for Veterinary Medicine, Food and Drug Administration (HFV-230), 7519 Standish Pl., Rockville, MD 20855, 240-402-7001, [email protected]

    With regard to the proposed collection of information: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd.; COLE-14526, Silver Spring, MD 20993-0002; [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Draft Guidance

    FDA is announcing the availability of a draft GFI #230 entitled “Compounding Animal Drugs from Bulk Drug Substances.” The draft guidance provides information to compounders of animal drugs and other interested stakeholders on FDA's application of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) with respect to the compounding of animal drugs from bulk drug substances.1

    1 FDA regulations define “bulk drug substance” as “any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.” 21 CFR 207.3(a)(4). “Active ingredient” is defined as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.” 21 CFR 210.3(b)(7). Any component other than an active ingredient is an “inactive ingredient.” See 21 CFR 210.3(b)(8). Inactive ingredients used in compounded drug products commonly include flavorings, dyes, diluents, or other excipients.

    Sections 503A (21 U.S.C. 353a) and 503B (21 U.S.C. 353b) of the FD&C Act do not apply to the compounding of animal drugs. The FD&C Act does not distinguish between compounding animal drugs from bulk drug substances and any other manufacturing or processing of animal drugs. Except with respect to the limited exemption provided by the FD&C Act described in this document, statutory provisions applicable to manufactured animal drugs under the FD&C Act also apply to compounded animal drugs.

    Section 512(a)(4) and (5) of the FD&C Act (21 U.S.C. 360b(a)(4) and (5)), provide a limited exemption from certain requirements for use for compounded animal drugs made from already approved animal or human drugs. Such use is considered an extra-label use and the FD&C Act provides that a compounded drug is exempt from the approval requirements and requirements of section 502(f)(1) (21 U.S.C. 352(f)(1)) of the FD&C Act, if it meets the conditions set out in the statute and the extra-label use regulations at 21 CFR part 530.

    This draft guidance does not address the compounding of animal drugs from approved animal or human drugs pursuant to the extra-label provisions of the law, nor does it address the repackaging of approved animal drugs. FDA is considering whether guidance is needed on those issues, and if so, will publish separate guidances. In section III, FDA is asking for comment on specific questions about several issues including the practice of compounding from approved animal and human drugs and the repackaging of drugs for animal use to help determine whether additional guidance is necessary on these topics.

    This draft guidance describes conditions under which FDA does not generally intend to initiate enforcement action against State-licensed pharmacies, licensed veterinarians, and facilities registered as outsourcing facilities under section 503B of the FD&C Act (outsourcing facilities) that compound animal drugs from bulk drug substances. The draft guidance provides that FDA does not generally intend to take action under sections 512(a), 501(a)(5) (21 U.S.C. 351(a)(5)), 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)), and 502(f)(1) of the FD&C Act if a State-licensed pharmacy or a licensed veterinarian compounds drugs intended for use in animals from bulk drug substances in accordance with all of the applicable conditions set out in the guidance. In addition, the draft guidance provides that FDA does not generally intend to take action under sections 512(a), 501(a)(5), and 502(f)(1) of the FD&C Act if the drug product is compounded from a bulk drug substance by an outsourcing facility and that meets all of the applicable conditions set out in the guidance, and the drug product is compounded from a bulk drug substance that appears on Appendix A of the draft guidance.

    Importantly, the draft guidance provides that FDA generally intends to enforce all other adulteration and misbranding provisions of the FD&C Act against entities compounding animal drugs from bulk drug substances.

    To ensure FDA can timely identify and address safety issues related to animal drugs compounded from bulk drug substances, one of the conditions, if met, under which FDA does not generally intend to take action for violations of the provisions described previously is that State-licensed pharmacies and veterinarians report any product defect or serious adverse event associated with animal drugs they compound from a bulk drug substance to FDA, within 15 days of becoming aware of them, using Form FDA 1932a. FDA intends to use these adverse event reports to identify animal drugs compounded from bulk drug substances that present serious risks to animal health. Unlike for human drugs, there are no State Departments of Health or Federal Agencies, such as the Centers for Disease Control and Prevention (CDC), which are responsible for identifying and tracing the source of injury and/or disease in animals. Adverse event reporting regarding drugs compounded from bulk drug substances by compounding pharmacies and veterinarians will provide a mechanism for FDA to identify and possibly prevent adverse events associated with compounded animal drugs. This is another topic on which we are requesting specific comment in section III.

    Elsewhere in this issue of the Federal Register, FDA is publishing a notice soliciting nominations for bulk drug substances that should be included in Appendix A, “List of Bulk Drug Substances That May Be Used By an Outsourcing Facility to Compound Drugs for Use in Animals.” The notice also describes the information that should be provided to the Agency in support of such nominations.

    II. Withdrawal of 2003 Compliance Policy Guide

    In a notice published in the Federal Register of July 14, 2003 (68 FR 41591), FDA announced the availability of CPG Section 608.400 of the Compliance Program Guidance Manual entitled, “Compounding of Drugs for Use in Animals.” This document is being withdrawn because it is no longer consistent with FDA's current thinking on the issue it addresses. The current CPG does not focus on the three main concerns FDA has about animal drug compounding: compounding copies of approved animal or human drugs from bulk drug substances, compounding for food-producing animals from bulk drug substances, and compounding office stock from bulk drug substances. Because the CPG does not reflect FDA's current thinking, to leave it in effect until this draft guidance is finalized may confuse stakeholders about FDA's current enforcement priorities. Stakeholders should be aware that, until this draft guidance is finalized, FDA intends to look at the totality of the circumstances when determining whether to take enforcement action for unlawful animal drug compounding activities.

    III. Specific Topics for Comment

    In addition to comments on the draft guidance as written, we are specifically requesting comments on the following issues:

    • Should the final guidance address the issue of FDA-approved animal and human drugs that are in shortage or are otherwise unavailable (e.g., disruptions in the manufacture or supply chain; business decisions to stop marketing the drug; drug is subject to Agency action based on safety, effectiveness, or manufacturing concerns)? If so:

    ○ How should these situations be addressed in the final guidance?

    ○ How should the final guidance define the terms “shortage” and “unavailable”?

    ○ What criteria should FDA use to determine if an approved animal or human drug is in shortage or otherwise unavailable?

    • Do United States Pharmacopeia and National Formulary (USP-NF) 2 chapters <795> and <797> provide suitable standards for animal drugs compounded by veterinarians, and if not, what standards of safety, purity, and quality should apply to animal drugs compounded by veterinarians?

    2 Chapters <795> “Pharmaceutical Compounding—Nonsterile Preparations” and <797> “Pharmaceutical Compounding—Sterile Preparations” can be found in the combined United States Pharmacopeia and National Formulary (USP-NF), available at http://www.usp.org/.

    • Should licensed veterinarians be able to sell or transfer an animal drug compounded from bulk drug substances by a State-licensed pharmacy or an outsourcing facility to owners or caretakers of animals under the veterinarian's care?

    • How should FDA apply the condition to identify an individual patient when it is not possible to identify an individual animal (e.g., koi in a koi pond)?

    • Should the final guidance include a condition on the amount or percentage of compounded animal drugs that a pharmacy or outsourcing facility can ship in interstate commerce? If so, what would a reasonable amount be?

    • Should facilities registered as outsourcing facilities under section 503B of the FD&C Act be able to compound animal drugs from bulk drug substances that do not appear on Appendix A for an individually identified animal patient under conditions similar to those applicable to state-licensed pharmacies (i.e., the conditions contained in section III.A. of the draft guidance)?

    • Is additional guidance needed to address the repackaging of drugs for animal use?

    ○ How widespread is the practice of repackaging drugs for animal use?

    ○ What types of drugs are repackaged for animal use, and why are they repackaged?

    ○ Have problems been identified with repackaged drugs for animal use?

    • Is additional guidance needed to address the compounding of animal drugs from approved animal or human drugs under section 512(a)(4) or (a)(5) of the FD&C Act and part 530?

    • Is additional guidance needed to address the compounding of animal drugs from bulk drug substances for food-producing animals?

    • As one condition under which FDA does not generally intend to take action for certain violations of the FD&C Act if this and the other conditions are followed, FDA is proposing that State-licensed pharmacies and veterinarians report any product defect or serious adverse event associated with animal drugs they compound from bulk drug substances to FDA within 15 days of becoming aware of the product defect or serious adverse event. Outsourcing facilities are required to report adverse events associated with the drugs they compound. FDA believes it is important to receive this information from State-licensed pharmacies and veterinarians because there are no other State Departments of Health or Federal Agencies (e.g., the CDC) charged with identifying and tracing animal injuries or disease associated with an animal drug compounded by these entities. FDA has the following specific questions with respect to this proposed condition:

    ○ How many State-licensed pharmacies and veterinarians compound animal drugs from bulk drug substances and would potentially be reporting product defects and serious adverse events to FDA?

    ○ Are State-licensed pharmacies and veterinarians reporting the same or similar information to any State regulatory agency (e.g., State boards of pharmacy, State boards of veterinary medicine)? If so, how many reports on average does each State-licensed pharmacy and veterinarian submit to these State agencies each year?

    ○ For purposes of the guidance, how should FDA define the terms “product defect” and “serious adverse event”?

    ○ Can FDA achieve the same objective of identifying and tracing the source of injuries or disease associated with an animal drug compounded from a bulk drug substance through means other than product defect and serious adverse event reporting, and if so, what other means? For example, would reports of product defects alone achieve the same objective?

    IV. Significance of Guidance

    This Level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on compounding animal drugs from bulk drug substances. 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.

    V. Paperwork Reduction Act of 1995

    This draft guidance contains proposed information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). “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 for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing this notice of the proposed collection of information set forth in this document.

    With respect to the collection of information associated with this draft guidance, 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.

    Title: Compounding Animal Drugs from Bulk Drug Substances (OMB Control Number 0910-NEW)

    Description of Respondents: The proposed collection of information would affect State-licensed pharmacies, licensed veterinarians, and outsourcing facilities that compound animal drugs from bulk drug substances.

    Description: This draft guidance describes FDA's current thinking regarding compounding animal drugs from bulk drug substances and describes the conditions under which FDA does not generally intend to take action for violations of the following sections of the FD&C Act: 512, 501(a)(5), 502(f)(1), and, where specified, 501(a)(2)(B), when a State-licensed pharmacy, licensed veterinarian, or an outsourcing facility compounds animal drugs from bulk drug substances. The draft guidance provides three sets of conditions, one for each entity: State-licensed pharmacies, licensed veterinarians, and outsourcing facilities.

    This draft guidance only addresses the compounding of animal drugs from bulk drug substances. It does not apply to the compounding of animal drugs from approved new animal or new human drugs. Such compounding can be conducted in accordance with the provisions of section 512(a)(4) and (5) of the FD&C Act and part 530. In addition, this guidance does not address the compounding of drugs intended for use in humans, which is addressed in other guidances.

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

    Reporting

    This draft guidance contains no new reporting provisions. This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA. The collections of information regarding voluntary reporting of adverse drug experiences or product/manufacturing defects on Form FDA 1932a, “Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report,” have been approved under OMB control number 0910-0284; the information collection provisions regarding establishment registration under section 510 of the FD&C Act (21 U.S.C. 360) have been approved under OMB control number 0910-0777. This draft guidance also refers to proposed collections of information regarding drugs made by an outsourcing facility during the previous 6-month period as described in FDA's notice of November 24, 2014 (79 FR 69857), announcing the availability of a draft guidance entitled “Electronic Reporting for Human Drug Compounding Outsourcing Facilities.” The proposed collections of information in the draft guidance are subject to review by OMB under the PRA. As required by the PRA, FDA published an analysis of the information collection provisions of the draft guidance (79 FR 69857 at 69858) and intends to submit them for OMB approval.

    Recordkeeping

    Entities compounding animal drugs from bulk drug substances should keep adequate records to demonstrate that they are compounding such drugs in accordance with all of the applicable conditions described in the draft guidance. FDA tentatively concludes that it is usual and customary for State-licensed pharmacies, veterinarians, and outsourcing facilities to keep such records, and that this draft guidance imposes no additional recordkeeping burden beyond those usual and customary for the respondents to this collection, with the exception of that described in section III.A.5. Nonetheless, table 1, row 1 provides a nominal estimate of potential recordkeeping burden that respondents may incur. FDA therefore specifically invites comment regarding whether these provisions impose any effort beyond that which would normally be incurred in absence of this draft guidance.

    A condition set forth in section III.A.5. is that, if there is an FDA-approved animal or human drug with the same active ingredient(s), the pharmacy determines that the compounded drug cannot be made from the FDA-approved drug(s), and documents that determination.

    Table 1—Estimated Annual Recordkeeping Burden 1 Guidance section Number of
  • recordkeepers
  • Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours
    III; general recordkeeping beyond usual & customary 138,551 1 138,551 0.01 (30 seconds) 1,386 III.A.5; documentation of determination that compound drug cannot be made from the FDA-approved drug(s) 75,000 84.67 6,350,000 0.01 (30 seconds) 63,500 Total 64,886 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    For row 1, we base our burden estimates on the American Veterinary Medical Association's Market Research Statistics for 2013 for the total number of veterinarians in practice minus those veterinarians in food animal exclusive practice (63,500), the National Pharmacy Market Summary SK&A of March 2010 for the total number of pharmacy sites (75,000), and the number of registered outsourcing facilities as of March 20, 2015 (51), for a total of 138,551 respondents.3

    3 The AVMA's Market Research Statistics—U.S. Veterinarians—2013 can be found at this URL: (https://www.avma.org/KB/Resources/Statistics/Pages/Market-research-statistics-US-veterinarians.aspx); the National Pharmacy Market Summary SK&A (March 2010) can be found at this URL: http://www.skainfo.com/index.php; and the list of registered outsourcing facilities can be found at this URL: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm.

    For row 2, we estimate that approximately 75,000 pharmacies will receive approximately 6,350,000 prescriptions for compounded animal drugs annually, and we also estimate that it will take approximately 30 seconds (0.01 hours) to document that the compounded drug cannot be made from the FDA-approved drug(s) for a total of 63,500 hours recordkeeping burden.

    A condition set forth in section III.A.2. of the draft guidance is that State-licensed pharmacies can compound a drug in advance of receipt of a prescription in a quantity that does not exceed the amount of drug product that the State-licensed pharmacy compounded pursuant to patient-specific prescriptions based on a history of receipt of such patient-specific prescriptions for that drug product over any consecutive 14-day period within the previous 6 months. The records necessary for a State-licensed pharmacy to review to determine that its compounding practices are within the condition set forth in section III.A.2 of the draft guidance are records that State-licensed pharmacies would already be keeping as part of usual and customary business practice; therefore, no burden has been estimated for the recordkeeping associated with this condition.

    This draft guidance also refers to proposed collections of information currently undergoing the process of OMB review under the PRA. Recordkeeping by outsourcing facilities, described in the draft guidance for industry, “Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act” announced July 2, 2014 (79 FR 37743), will be reviewed by OMB in response to an information collection request associated with that guidance.

    Third-Party Disclosure Prescriptions or Orders for Drugs Compounded From Bulk

    This draft guidance contains new third-party disclosures as reported in table 2. Row 1 reflects a potential burden associated with section III.C.9. regarding the following condition: The veterinarian's prescription or order states, in addition to the species, the condition(s) for which the substance is listed in Appendix A. At this time, however, FDA has no data upon which to base an estimated number of prescriptions or orders to outsourcing facilities until the referenced list of bulk drugs (Draft Guidance; Appendix A) is finalized. For purposes of this analysis, however, we are providing an estimate of 1 as a placeholder.

    In section III.A.4., the draft guidance sets forth the following condition: If the drug contains a bulk drug substance that is a component of any marketed FDA-approved animal or human drug, there is a change between the compounded drug and the comparable FDA-approved animal or human drug made for an identified individual patient that produces a clinical difference for that identified individual patient, as determined by the veterinarian prescribing the compounded drug for his/her patient under his/her care. If the drug contains a bulk drug substance that is a component of a marketed FDA-approved animal or human drug, the prescription or documentation accompanying the prescription contains a statement that the change between the compounded drug and the FDA-approved drug produces a clinical difference for the individual identified patient. For example, the veterinarian could state that, “This compounded drug is needed to treat [specifically identified patient] because the approved drug product(s) cannot be divided or diluted into the small dose required.”

    Table 2—Estimated Annual Third-Party Disclosure Burden 1 Activity Number of
  • respondents
  • Number of
  • disclosures per
  • respondent
  • Total annual
  • disclosures
  • Average burden per disclosure Total hours
    III.C.9; documentation of condition to be treated 1 1 1 0.017 (1 minute) 0.017 Statements on prescription (Section III.A.4 of the draft guidance) 63,500 100 6,350,000 0.017 (1 minute) 107,950 Total 107,950 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    For row 2, we estimate that approximately 63,500 veterinarians will, on average, each produce approximately 100 prescriptions for compounded animal drugs annually for a total of 6,350,000 prescriptions. We also estimate that it will take approximately 1 minute (0.017 hours) to include the statement discussed in section III.A.4 of the draft guidance on each prescription for a total of 107,950 hours third-party disclosure burden, as reported in table 1.

    It is usual and customary for licensed veterinarians to write prescriptions in the normal course of their activities. The conditions set forth in the guidance require veterinarians to include certain information on prescriptions for animals drugs compounded from bulk substances. It is usual and customary for veterinarians to include much of this information (except as noted previously); therefore, the time it would take to provide this information on prescriptions or documents accompanying prescriptions is not included in the burden estimate reported in table 2.

    Sections III.A.3 and III.A.6.b of the draft guidance set forth the conditions that the following statements appear verbatim on or with prescriptions for animal drugs compounded from bulk drug substances:

    • “This patient is not a food-producing animal.” (Section III.A.3).

    • “There are no FDA-approved animal or human drugs that can be used as labeled or in an extra-label manner under section 512(a)(4) and (5) and 21 CFR part 530 to appropriately treat the disease, symptom, or condition for which this drug is being prescribed.” (Section III.A.6.b).

    In addition, section III.C.3 of the draft guidance sets forth the condition that the following statement appears verbatim on or with prescriptions or orders for animal drugs compounded by outsourcing facilities from bulk drug substances listed on Appendix A:

    • “This drug will not be dispensed for or administered to food-producing animals.” (Section III.C.3).

    We tentatively conclude that these statements are “public disclosures 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)) and are therefore not subject to review by OMB under the PRA. Thus, the time it would take to provide this information is not included in the burden estimate reported in table 2.

    Labeling of Drugs Compounded From Bulk Drug Substances

    The draft guidance sets forth conditions for the labeling of animal drugs compounded from bulk drug substances. The draft guidance indicates in sections III.A.11 and III.B.9 that, to meet the conditions of the guidance, State-licensed pharmacies and licensed veterinarians include on the label of any compounded drug: The species of the intended animal patient, the name of the animal patient, and the name of the owner or caretaker of the animal patient. It is usual and customary for State-licensed pharmacies and licensed veterinarians to include such information on the labels of compounded drugs in the normal course of their activities; thus, the time it would take to provide this information is not included in the burden estimate reported in table 2.

    In addition, the draft guidance indicates in section III.C.10. that, to meet the conditions of the guidance, outsourcing facilities include on the label of any compounded animal drug pursuant to a specific prescription or order: The active ingredient; the dosage form, strength, and flavoring, if any; direction for use, as provided by the veterinarian prescribing or ordering the drug; the quantity or volume, whichever is appropriate; the lot or batch number of the drug; special storage and handling instructions; the date the drug was compounded; the beyond use date of the drug; the name of the veterinarian prescribing or ordering the drug; the inactive ingredients; and the address and phone number of the outsourcing facility that compounded the drug. It is usual and customary for outsourcing facilities to include such information on the labels of compounded drugs in the normal course of their activities; thus, the time it would take to provide this information is not included in the burden estimate reported in table 2.

    The draft guidance indicates in section III.C.10 that, to meet the conditions of the guidance, outsourcing facilities compounding animal drug from bulk drug substances for office use in veterinary practices include on the label of any compounded drug these four statements:

    • “Not for resale.”

    • “For use only in [fill in species and any associated condition or limitation listed in Appendix A].”

    • “Compounded by [name of outsourcing facility].”

    • “Adverse events associated with this compounded drug should be reported to FDA on a Form FDA 1932a.”

    We tentatively conclude that these four label statements are “public disclosures 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)) and are therefore not subject to review by OMB under the PRA. Thus, the time it would take to provide this information is not included in the burden estimate reported in table 2.

    This draft guidance also refers to previously approved collections of information. A condition set forth in sections III.A.7., III.B.6, and III.C.5 is that any bulk drug substance used is manufactured by an establishment that is registered under section 510 of the FD&C Act (including a foreign establishment that is registered under section 360(i) of the FD&C Act) and is accompanied by a valid certificate of analysis. The information collection related to the disclosure of the certificate of analysis is approved under OMB control number 0910-0139.

    Before the proposed information collection provisions contained in this draft guidance become effective, we will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the proposed information collection provisions. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    VI. Comments

    Interested persons may submit either electronic comments regarding this draft guidance to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with Docket No. FDA-2015-D-1176. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    VII. Electronic Access

    Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm042450.htm or http://www.regulations.gov.

    Dated: May 12, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-11982 Filed 5-18-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting

    Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting.

    Name: National Committee on Vital and Health Statistics (NCVHS) Review Committee, pursuant to Section 1104(i) of the Patient Protection and Affordable Care Act (ACA).

    Time and Date: June 16, 2015, 9:00 a.m.-5:00 p.m. EST; June 17, 2015, 8:00 a.m.-5:15 p.m. EST.

    Place: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics, 3311 Toledo Road, Auditorium B and C, Hyattsville, Maryland 20782, (301) 458-4524.

    Status: Open.

    Purpose: The purpose of this hearing is to obtain information from the health care industry on the currently adopted standards, operating rules, code sets and identifiers used in administrative simplification transactions.

    The objectives of this hearing are as follows: (1) Review currently adopted standards, operating rules, code sets and identifiers used in each of the HIPAA-named administrative simplification transactions and evaluate the degree to which they meet current industry business needs; and (2) Identify transactions, standards, operating rules, code sets and identifiers used in administrative simplification that require changes, deletions or new versions in order to meet industry needs.

    We invite the public to prepare and submit written testimony on any and all areas covered by this hearing. We also invite testifiers to prepare and submit more extensive written testimony, in addition to the oral testimony they will be providing during the hearing. Written testimonies should be sent to Marietta Squire, Committee Management Specialist, Centers for Disease Control and Prevention, National Center for Health Statistics, email [email protected]

    Background on the Review Committee, including the Review Committee's Charter can be accessed at http://www.ncvhs.hhs.gov/subcommittees-work-groups/subcommittee-on-standards/review-committee/.

    Contact Person for More Information: Debbie M. Jackson, Acting Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Room 2339, Hyattsville, Maryland 20782, telephone (301) 458-4614 or Terri Deutsch, Centers for Medicare and Medicaid Services, Office of E-Health Standards and Services, 7500 Security Boulevard, Baltimore, Maryland 21244, telephone (410) 786-9462. Program information as well as summaries of meetings and a roster of committee members are available on the NCVHS home page of the HHS Web site: http://ncvhs.us/, where further information including an agenda will be posted when available.

    Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (301) 458-4EEO (4336) as soon as possible.

    Dated: May 13, 2015. James Scanlon, Deputy Assistant Secretary for Planning and Evaluation Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation.
    [FR Doc. 2015-12106 Filed 5-18-15; 8:45 am] BILLING CODE 4151-05-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Meetings of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health AGENCY:

    Office of the Surgeon General of the United States Public Health Service, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that two meetings are scheduled for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the “Advisory Group”). The meetings will be open to the public. Information about the Advisory Group and the agendas for these meetings can be obtained by accessing the following Web site: http://www.surgeongeneral.gov/initiatives/prevention/advisorygrp/index.html.

    DATES:

    The first meeting will be held on June 11, 2015, from 11:30 a.m. to 2:30 p.m. EST. The second meeting will be held on August 31 from 9:00 a.m. to 5:00 p.m. EST—September 1, 2015, from 9:00 a.m. to 1:00 p.m. EST.

    ADDRESSES:

    The first meeting on June 11, 2015, will be held via teleconference. The second meeting on August 31—September 1, 2015, will be held in Washington, DC Teleconference and meeting location information will be published closer to the meeting dates at: http://www.surgeongeneral.gov/initiatives/prevention/advisorygrp/index.html.

    FOR FURTHER INFORMATION CONTACT:

    Office of the Surgeon General, 200 Independence Ave. SW.; Washington, DC 20201; 202-205-9517; [email protected]

    SUPPLEMENTARY INFORMATION:

    The Advisory Group is a non-discretionary federal advisory committee that was initially established under Executive Order 13544, dated June 10, 2010, to comply with the statutes under Section 4001 of the Patient Protection and Affordable Care Act, Public Law 111-148. The Advisory Group was established to assist in carrying out the mission of the National Prevention, Health Promotion, and Public Health Council (the Council). The Advisory Group provides recommendations and advice to the Council.

    The Advisory Group was terminated on September 30, 2012, by Executive Order 13591, dated November 23, 2011. Authority for the Advisory Group to be re-established was given under Executive Order 13631, dated December 7, 2012. Authority for the Advisory Group to continue to operate until September 30, 2015, was given under Executive Order 13652, dated September 30, 2013.

    It is authorized for the Advisory Group to consist of no more than 25 non-federal members. The Advisory Group currently has 21 members who were appointed by the President. The membership includes a diverse group of licensed health professionals, including integrative health practitioners who have expertise in (1) worksite health promotion; (2) community services, including community health centers; (3) preventive medicine; (4) health coaching; (5) public health education; (6) geriatrics; and (7) rehabilitation medicine.

    Meeting descriptions and relevant materials will be published closer to the meeting dates at: http://www.surgeongeneral.gov/initiatives/prevention/advisorygrp/index.html.

    Members of the public have the opportunity to participate in each meeting and/or provide comments to the Advisory Group. Public comment will be limited to 3 minutes per speaker. Individuals who wish to participate in the meetings and/or provide comments must register by 12:00 p.m. EST on June 4, 2015, for the meeting on June 11, 2015, and by 12:00 p.m. EST on August 24, 2015, for the meeting on August 31-September 1, 2015. In order to register, individuals must send their full name and affiliation via email to [email protected] Individuals who need special assistance and/or accommodations, i.e., sign language interpretation or other reasonable accommodations, should indicate so when they register. Members of the public who wish to have materials distributed to the Advisory Group members at these scheduled meetings should submit those materials by June 4, 2015, for the June meeting and by August 24, 2015, for the August/September meeting.

    Dated: May 6, 2015. Corinne M. Graffunder, Designated Federal Officer, Advisory Group on Prevention, Health Promotion, and Integrative and Public Health, Office of the Surgeon General.
    [FR Doc. 2015-12104 Filed 5-18-15; 8:45 am] BILLING CODE 4163-18-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: Infectious Diseases and Microbiology Integrated Review Group; Pathogenic Eukaryotes Study Section.

    Date: June 4-5, 2015.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Marriott Wardman Park, Washington DC Hotel, 2660 Woodley Road, NW., Washington, DC 20008.

    Contact Person: Tera Bounds, DVM, 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: Infectious Diseases and Microbiology Integrated Review Group; Host Interactions with Bacterial Pathogens Study Section.

    Date: June 5, 2015.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications

    Place: Warwick Seattle Hotel, 401 Lenora Street, Seattle, WA 98121.

    Contact Person: Fouad A El-Zaatari, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3186, MSC 7808, Bethesda, MD 20892, (301) 435-1149, [email protected]

    Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Vector Biology Study Section.

    Date: June 10, 2015.

    Time: 8:30 a.m. to 6:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: George Washington University Inn, 824 New Hampshire Ave., NW., Washington, DC 20037.

    Contact Person: Liangbiao Zheng, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD 20892, 301-402-5671, [email protected]

    Name of Committee: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Biomedical Imaging Technology A Study Section.

    Date: June 11-12, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852.

    Contact Person: Ruth Grossman, DDS, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5215, Bethesda, MD 20892, (301) 435-2409, [email protected]

    Name of Committee: Interdisciplinary Molecular Sciences and Training Integrated Review Group; Enabling Bioanalytical and Imaging Technologies Study Section.

    Date: June 11-12, 2015.

    Time: 8:00 a.m. to 10:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Washington Marriott Georgetown, 1221 22nd Street NW., Washington, DC 20037.

    Contact Person: Kenneth Ryan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3218, MSC 7717, Bethesda, MD 20892, 301-435-0229, [email protected]

    Name of Committee: Oncology 1-Basic Translational Integrated Review Group, Tumor Microenvironment Study Section.

    Date: June 15-16, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hotel Kabuki, 1625 Post Street, San Francisco, CA 94115.

    Contact Person: Angela Y Ng, Ph.D., MBA, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6200, MSC 7804, Bethesda, MD 20892, 301-435-1715, [email protected]

    Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Cellular and Molecular Biology of Neurodegeneration Study Section.

    Date: June 16-17, 2015.

    Time: 8:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Marriott-Courtyard Downtown, 500 East First Street, Long Beach, CA 90802.

    Contact Person: Laurent Taupenot, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4183, MSC 7850, Bethesda, MD 20892, 301-435-1203, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cancer Therapeutics.

    Date: June 16, 2015.

    Time: 1:00 p.m. to 3:30 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: Careen K Tang-Toth, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6214, MSC 7804, Bethesda, MD 20892, (301) 435-3504, [email protected]

    Name of Committee: Digestive, Kidney and Urological Systems Integrated Review Group; Systemic Injury by Environmental Exposure.

    Date: June 17-18, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Patricia Greenwel, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2178, MSC 7818, Bethesda, MD 20892, 301-435-1169, [email protected]

    Name of Committee: Population Sciences and Epidemiology Integrated Review Group, Societal and Ethical Issues in Research Study Section.

    Date: June 17, 2015.

    Time: 9:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Sheraton Silver Spring, 8777 Georgia Avenue, Silver Spring, MD 20910.

    Contact Person: Karin F Helmers, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3148, MSC 7770, Bethesda, MD 20892, (301) 254-9975, [email protected]

    Name of Committee: Cell Biology Integrated Review Group, Intercellular Interactions Study Section.

    Date: June 18, 2015.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Wallace Ip, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5128, MSC 7840, Bethesda, MD 20892, 301-435-1191, [email protected]

    Name of Committee: Digestive, Kidney and Urological Systems Integrated Review Group; Gastrointestinal Mucosal Pathobiology Study Section.

    Date: June 18-19, 2015.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Warwick Allerton Hotel, 701 N. Michigan Avenue, Chicago, IL 60611.

    Contact Person: Jonathan K. Ivins, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2190, MSC 7850, Bethesda, MD 20892, (301) 594-1245, [email protected]

    Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Neuroendocrinology, Neuroimmunology, Rhythms and Sleep Study Section.

    Date: June 18-19, 2015.

    Time: 8:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Pier 5 Hotel, 711 Eastern Avenue, Baltimore, MD 21202.

    Contact Person: Michael Selmanoff, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5164, MSC 7844, Bethesda, MD 20892, 301-435-1119, [email protected]

    Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Child Psychopathology and Developmental Disabilities Study Section.

    Date: June 18-19, 2015.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Wyndham Grand Chicago Riverfront, 71 East Wacker Drive, Chicago, IL 60601.

    Contact Person: Jane A. Doussard-Roosevelt, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3184, MSC 7848, Bethesda, MD 20892, (301) 435-4445, [email protected]

    Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group; Oral, Dental and Craniofacial Sciences Study Section.

    Date: June 18-19, 2015.

    Time: 8:00 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites Washington DC, Convention Center, 900 10th St. NW., Washington, DC 20001.

    Contact Person: Yi-Hsin Liu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, 301-435-1781, [email protected]

    Name of Committee: Genes, Genomes, and Genetics Integrated Review Group; Genetic Variation and Evolution Study Section.

    Date: June 18-19, 2015.

    Time: 8:30 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Pier 2620 Hotel, 2620 Jones Street, San Francisco, CA.

    Contact Person: Ronald Adkins, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2206, MSC 7890, Bethesda, MD 20892, 301-435-4511, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; SBIB Clinical Pediatric and Fetal Applications.

    Date: June 18, 2015.

    Time: 11:00 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, (Virtual Meeting).

    Contact Person: John Firrell, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5118, MSC 7854, Bethesda, MD 20892, 301-435-2598, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Cell, Computational and Molecular Biology.

    Date: June 19, 2015.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Marriott Wardman Park Washington DC Hotel, 2660 Woodley Road, NW., Washington, DC 20008.

    Contact Person: Allen Richon, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6184, MSC 7892, Bethesda, MD 20892, 301-379-9351, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR 13-293: Gut Microbiota-Derived Factors in the Integrated Physiology and Pathophysiology of Diseases within NIDDK's mission.

    Date: June 19, 2015.

    Time: 9:00 a.m. to 11:00 a.m.

    Agenda: To review and evaluate grant applications.

    Place: The Allerton Hotel, 701 North Michigan Avenue, Chicago, IL 60611.

    Contact Person: Jonathan K. Ivins, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040A, MSC 7806, Bethesda, MD 20892, (301) 594-1245, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR 14-242: Role of the Microflora in the Etiology of Gastrointestinal Cancer.

    Date: June 19, 2015.

    Time: 11:00 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Allerton Hotel, 701 North Michigan Avenue, Chicago, IL 60611.

    Contact Person: Jonathan K. Ivins, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040A, MSC 7806, Bethesda, MD 20892, (301) 594-1245, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Epidemiology and Environment.

    Date: June 19, 2015.

    Time: 11:30 a.m. to 12:30 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: Claire E. Gutkin, Ph.D., MPH, 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; PAR 13-213: Outcome Measures for Use in Treatment Trials for Individuals with Intellectual and Developmental Disabilities (R01).

    Date: June 19, 2015.

    Time: 2:30 p.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Wyndham Grand Chicago Riverfront, 71 East Wacker Drive, Chicago, IL 60601.

    Contact Person: Jane A. Doussard-Roosevelt, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3184, MSC 7848, Bethesda, MD 20892, (301) 435-4445, [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: May 13, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-12010 Filed 5-18-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; 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 a meeting of the Board of Scientific Counselors, National Institute of Mental Health.

    The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Mental Health, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Board of Scientific Counselors, National Institute of Mental Health.

    Date: June 15-16, 2015.

    Time: June 15, 2015, 2:20 p.m. to 5:45 p.m.

    Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators.

    Place: National Institutes of Health, Porter Neuroscience Research Center, Room GE 610 and 640, 35A Convent Drive, Bethesda, MD 20892.

    Time: June 15, 2015, 7:30 p.m. to 9:00 p.m.

    Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Time: June 16, 2015, 9:00 a.m. to 5:05 p.m.

    Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators.

    Place: National Institutes of Health, Porter Neuroscience Research Center, Room GE 620/630 and 640, 35A Convent Drive, Bethesda, MD 20892.

    Contact Person: Jennifer E. Mehren, Ph.D., Executive Secretary, Division of Intramural Research Programs, National Institute of Mental Health, NIH, 35A Convent Drive, Room GE 412, Bethesda, MD 20892-3747, 301-496-3501, [email protected]

    (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS)
    Dated: May 13, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-12008 Filed 5-18-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; 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/contract proposals 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/contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel; NIAAA MOBC PAR—R21 applications.

    Date: June 3, 2015.

    Time: 11:00 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: NIAAA, NIH, 5635 Fishers Lane, Room CR2098, Rockville, MD 20852, (Telephone Conference Call).

    Contact Person: Ranga Srinivas, Ph.D., Chief, Extramural Project Review Branch, National Institute on Alcohol Abuse and Alcoholism, NIH, 5635 Fishers Lane, Room 2085, Rockville, MD 20852, (301) 451-2067, [email protected].

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel; NIAAA MOBC PAR—R01.

    Date: June 8, 2015.

    Time: 1:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: NIAAA, NIH, 5635 Fishers Lane, Room CR2098, Rockville, MD 20852, (Telephone Conference Call).

    Contact Person: Ranga Srinivas, Ph.D., Chief, Extramural Project Review Branch, National Institute on Alcohol Abuse and Alcoholism, NIH, 5635 Fishers Lane, Room 2085, Rockville, MD 20852, (301) 451-2067, [email protected].

    Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel; Review of Contract Proposals on Human Lab Paradigms.

    Date: June 11, 2015.

    Time: 11:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: NIAAA, NIH, 5635 Fishers Lane, Room CR2098, Rockville, MD 20852, (Telephone Conference Call).

    Contact Person: Ranga Srinivas, Ph.D., Chief, Extramural Project Review Branch, National Institute on Alcohol Abuse and Alcoholism, NIH, 5635 Fishers Lane, Room 2085, Rockville, MD 20852, (301) 451-2067, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 92.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Supports Awards, National Institutes of Health, HHS)
    Dated: May 13, 2015. Melanie J. Gray-Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-12012 Filed 5-18-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; 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 Institute on Aging Special Emphasis Panel; Inflammation and AD.

    Date: June 18, 2015.

    Time: 8:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: DoubleTree Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Alexander Parsadanian, Ph.D., Scientific Review Officer, National Institute on Aging, Gateway Building 2C/212, 7201 Wisconsin Avenue, Bethesda, MD 20892, 301-496-9666, [email protected]

    Name of Committee: National Institute on Aging Special Emphasis Panel; Epigenetic RFA.

    Date: June 23, 2015.

    Time: 11:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute on Aging, Gateway Building, Suite 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone Conference Call).

    Contact Person: BITA NAKHAI, Ph.D., SCIENTIFIC REVIEW BRANCH, NATIONAL INSTITUTE ON AGING, GATEWAY BLDG., 2C212, 7201 WISCONSIN AVENUE, Bethesda, MD 20814, 301-402-7701, [email protected]

    Name of Committee: National Institute on Aging Special Emphasis Panel, Vascular Contributions to AD.

    Date: June 29, 2015.

    Time: 8:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Garden Inn Bethesda, 7301 Waverly Street, Bethesda, MD 20814.

    Contact Person: Alexander Parsadanian, Ph.D., Scientific Review Officer, National Institute on Aging, Gateway Building 2C/212, 7201 Wisconsin Avenue, Bethesda, MD 20892, 301-496-9666, [email protected]

    Name of Committee: National Institute on Aging Special Emphasis Panel, Novel Molecular Mechanism of Longevity.

    Date: July 15, 2015.

    Time: 12:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute on Aging, Gateway Building, Suite 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone Conference Call).

    Contact Person: Bita Nakhai, Ph.D., Scientific Review Branch, National Institute on Aging, Gateway Bldg., 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301-402-7701, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
    Dated: May 13, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-12013 Filed 5-18-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; 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 Allergy and Infectious Diseases Special Emphasis Panel; Investigator Initiated Program Project Applications.

    Time: June 11, 2015, 9:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Room 4F100, 5601 Fishers Lane, Rockville, MD 20892.

    Time: June 19, 2015, 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Room 4F100, 5601 Fishers Lane, Rockville, MD 20892.

    Contact Person: Maja Maric, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room #3F21A, National Institutes of Health, NIAID, 5601 Fishers Lane, MSC 9823, Rockville, MD 20852, (240) 669-5025, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS)
    Dated: May 13, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-12006 Filed 5-18-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Biomarkers for Acute Ischemic Stroke AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license, to practice the inventions embodied in the following patent applications:

    1. U.S. Provisional Patent Application No. 61/307,233, filed 23 February 2010 HHS Ref. No.: E-023-2010/0-US-01 Titled: Biomarkers for Acute Ischemic Stroke 2. PCT Patent Application No. PCT/US2011/025748, filed 22 February 2011 HHS Ref. No.: E-023-2010/0-PCT-02 Titled: Biomarkers for Acute Ischemic Stroke 3. U.S. Patent Application No. 13/580,571, filed 22 August 2012 HHS Ref. No.: E-023-2010/0-US-03 Titled: Biomarkers for Acute Ischemic Stroke to VuEssence, Inc., a company incorporated under the laws of the State of Florida having its headquarters in Odessa, Florida. The patent rights in these inventions have been assigned to the United States of America. DATES:

    Only written comments and/or applications for a license received by the NIH Office of Technology Transfer on or before June 18, 2015 will be considered.

    ADDRESSES:

    Requests for a copy of the patent applications, inquiries, comments and other materials relating to the contemplated license should be directed to: Jaime M. Greene, M.S., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-5559; Email: [email protected]; Facsimile: (301) 402-0220. A signed confidentiality nondisclosure agreement will be required to receive copies of any patent applications that have not been published or issued by the United States Patent and Trademark Office or the World Intellectual Property Organization.

    SUPPLEMENTARY INFORMATION:

    This technology is directed to gene biomarkers for the diagnosis and potential treatment of acute ischemic stroke. Stroke is the third leading cause of death in the United States, of which 87% are ischemic stroke and result in death within 30 days in 8-12% of the cases. Currently, recombinant tissue plasminogen activator (rtPA, trade name alteplase), is the only FDA approved ischemic stroke treatment, and it is only effective when administered to patients within three hours from the onset of symptoms. Unfortunately, the median time from stroke symptom onset to presentation to the emergency department is 3-6 hours. Although advances in neuroimaging and clinical management have helped with patient survival rates, these techniques are not infallible and at times result in misdiagnosis. The biomarkers identified in this technology may be used to develop a diagnostic testing device for determining stroke subtype in the field.

    The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

    Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: May 12, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health.
    [FR Doc. 2015-12005 Filed 5-18-15; 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; Special Topics in Gastroenterology.

    Date: June 10, 2015.

    Time: 2:00 p.m. to 6:30 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: Jonathan K. Ivins, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040A, MSC 7806, Bethesda, MD 20892, (301) 594-1245, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; NRCS Palliative Care and Survivorship.

    Date: June 11, 2015.

    Time: 11:00 a.m. to 8:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Renaissance Long Beach Hotel, 111 East Ocean Blvd., Long Beach, CA 90802.

    Contact Person: Martha L. Hare, Ph.D., RN, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3154, Bethesda, MD 20892, (301) 451-8504, [email protected]

    Name of Committee: Bioengineering Sciences & Technologies Integrated Review Group; Biomaterials and Biointerfaces Study Section.

    Date: June 17-18, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Admiral Fell Inn, 888 South Broadway, Baltimore, MD 21231.

    Contact Person: Joseph D. Mosca, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5158, MSC 7808, Bethesda, MD 20892, (301) 408-9465, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; BD2K: Biomedical Data Science Training Coordination Center.

    Date: June 17, 2015.

    Time: 2:00 p.m. to 4:00 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: Luis Espinoza, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4140, MSC 7814, Bethesda, MD 20892, 301-435-0952, [email protected]

    Name of Committee: Cardiovascular and Respiratory Sciences Integrated Review Group; Electrical Signaling, Ion Transport, and Arrhythmias Study Section.

    Date: June 18, 2015.

    Time: 7:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Washington Embassy Row, 2015 Massachusetts Ave. NW., Washington, DC 20036.

    Contact Person: Yuanna Cheng, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4138, MSC 7814, Bethesda, MD 20892, (301) 435-1195, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Electrical Signaling, Ion Transport and Arrhythmias Special Panel.

    Date: June 18, 2015.

    Time: 7:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Pier 5 Hotel, 711 Eastern Avenue, Baltimore, MD 21202.

    Contact Person: Lawrence E. Boerboom, Ph.D., Chief, CVRS IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4130, MSC 7814, Bethesda, MD 20892, (301) 435-8367, [email protected]

    Name of Committee: Bioengineering Sciences & Technologies Integrated Review Group; Gene and Drug Delivery Systems Study Section.

    Date: June 18-19, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Amy L. Rubinstein, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5152, MSC 7844, Bethesda, MD 20892, 301-408-9754, [email protected]

    Name of Committee: Oncology 2—Translational Clinical Integrated Review Group; Chemo/Dietary Prevention Study Section.

    Date: June 18, 2015.

    Time: 8:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Renaissance Mayflower Hotel, 1127 Connecticut Avenue NW., Washington, DC 20036.

    Contact Person: Sally A. Mulhern, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6198, MSC 7804, Bethesda, MD 20892, (301) 408-9724, [email protected]

    Name of Committee: Oncology 2—Translational Clinical Integrated Review Group; Developmental Therapeutics Study Section.

    Date: June 18-19, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Handlery Union Square Hotel, 351 Geary Street, San Francisco, CA 94102.

    Contact Person: Sharon K. Gubanich, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6214, MSC 7804, Bethesda, MD 20892, (301) 408-9512, [email protected]

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Clinical Neuroimmunology and Brain Tumors Study Section.

    Date: June 18-19, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Melrose Hotel, 2430 Pennsylvania Ave. NW., Washington, DC 20037.

    Contact Person: Jay Joshi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5196, MSC 7846, Bethesda, MD 20892, (301) 408-9135, [email protected]

    Name of Committee: Cardiovascular and Respiratory Sciences Integrated Review Group; Myocardial Ischemia and Metabolism Study Section.

    Date: June 18-19, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Fairmont Washington, DC, 2401 M Street NW., Washington, DC 20037.

    Contact Person: Kimm Hamann, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4118A, MSC 7814, Bethesda, MD 20892, 301-435-5575, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Biophysical, Physiological, Pharmacological and Bioengineering Neuroscience.

    Date: June 18-19, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites Alexandria, 1900 Diagonal Road, Alexandria, VA 22314.

    Contact Person: Paula Elyse Schauwecker, Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Room 5211, Bethesda, MD 20892, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Clinical Neurophysiology, Devices, Neuroprosthetics, and Biosensors.

    Date: June 18-19, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Fairmont Washington, DC, , 2401 M Street NW., Washington, DC 20037.

    Contact Person: Cristina Backman, Ph.D., Scientific Review Officer, 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; Fellowships: Behavioral Neuroscience.

    Date: June 18-19, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Doubletree by Hilton Chicago Magnificent Mile, 300 E. Ohio Street, Chicago, IL 60611.

    Contact Person: Kristin Kramer, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5205, MSC 7846, Bethesda, MD 20892, (301) 437-0911, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Medical Imaging.

    Date: June 18-19, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852.

    Contact Person: Leonid V. Tsap, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5128, MSC 7854, Bethesda, MD 20892, (301) 435-2507, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; AREA grant review meeting.

    Date: June 18, 2015.

    Time: 8:00 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: Michael L. Bloom, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6187, MSC 7804, Bethesda, MD 20892, 301-451-0132, [email protected]

    Name of Committee: Immunology Integrated Review Group; Vaccines Against Microbial Diseases Study Section.

    Date: June 18-19, 2015.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites DC Convention Center, 900 10th Street, Washington, DC 20001.

    Contact Person: Jian Wang, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4218, MSC 7812, Bethesda, MD 20892, (301) 435-2778, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Cancer, Cardiovascular and Sleep Epidemiology Panel B Study Section.

    Date: June 18-19, 2015.

    Time: 8:30 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Ellen K. Schwartz, EDD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3144, Bethesda, MD 20892, 301-828-6146, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Medical Imaging Investigations.

    Date: June 18, 2015.

    Time: 11:45 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, (Virtual Meeting).

    Contact Person: Mehrdad Mohseni, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5211, MSC 7854, Bethesda, MD 20892, 301-435-0484, [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: May 13, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-12014 Filed 5-18-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; 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 Institute of Mental Health Special Emphasis Panel; Mechanisms of OCD Treatment.

    Date: June 9, 2015.

    Time: 3:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call).

    Contact Person: David I. Sommers, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, National Institutes of Health, 6001 Executive Blvd., Room 6154, MSC 9606, Bethesda, MD 20892-9606, 301-443-7861, [email protected]

    Name of Committee: National Institute of Mental Health Special Emphasis Panel; NIH Pathway to Independence Awards (K99).

    Date: June 10, 2015.

    Time: 1:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: David W. Miller, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH Neuroscience Center, 6001 Executive Blvd., Room 6140, MSC 9608, Bethesda, MD 20892-9608, 301-443-9734, [email protected]

    Name of Committee: National Institute of Mental Health Special Emphasis Panel; Review of R25 Applications.

    Date: June 10, 2015.

    Time: 12:00 p.m. to 4:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: Rebecca Steiner Garcia, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6149, MSC 9608, Bethesda, MD 20892-9608, 301-443-4525, [email protected]

    Name of Committee: National Institute of Mental Health Special Emphasis Panel; Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions.

    Date: June 10, 2015.

    Time: 12:30 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: St. Gregory Hotel, 2033 M Street, NW, Washington, DC 20036.

    Contact Person: Aileen Schulte, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6140, MSC 9608, Bethesda, MD 20892-9608, 301-443-1225, [email protected]

    Name of Committee: National Institute of Mental Health Special Emphasis Panel; NAPLS—miRNA and Immune System Project.

    Date: June 12, 2015.

    Time: 11:30 a.m. to 1:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: David I. Sommers, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, National Institutes of Health, 6001 Executive Blvd., Room 6154, MSC 9606, Bethesda, MD 20892-9606, 301-443-7861, [email protected]

    (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS)
    Dated: May 13, 2015. Carolyn A. Baum, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-12007 Filed 5-18-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse Amended; Notice of Meeting

    Notice is hereby given of a change in the meeting of the National Institute on Drug Abuse Special Emphasis Panel, June 4, 2015, 10:00 a.m. to June 4, 2015, 12:00 p.m., National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, which was published in the Federal Register on April 29, 2015, 80 83 FR 2015-10003.

    The date of the meeting was changed to June 11, 2015. The meeting is closed to the public.

    Dated: May 13, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-12011 Filed 5-18-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center For Scientific Review; Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the Musculoskeletal Tissue Engineering Study Section, June 01, 2015, 8:00 a.m. to June 02, 2015, 5:30 p.m., Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814 which was published in the Federal Register on May 13, 2015, 80 FR Pg 27333.

    The meeting will be held on June 1, 2015 at 8:00 a.m. and end at 6:00 p.m. The meeting location remains the same. The meeting is closed to the public.

    Dated: May 13, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-12009 Filed 5-18-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection [Docket No. USCBP-2015-0020] The U.S. Customs and Border Protection Airport and Seaport Inspections User Fee Advisory Committee (UFAC); Correction AGENCY:

    U.S. Customs and Border Protection, Department of Homeland Security (DHS).

    ACTION:

    Committee Management; Notice of Federal Advisory Public Committee Meeting; correction.

    SUMMARY:

    U.S. Customs and Border Protection (CBP) published in the Federal Register on May 14, 2015 [80 FR 27694], a document announcing that the U.S. Customs and Border Protection Airport and Seaport Inspections User Fee Advisory Committee (UFAC) will meet on Tuesday, June 2, 2015, in Washington, DC. This document corrects that May 14, 2015, document to reflect the correct time zone for the meeting of Eastern Daylight Savings (EDS) time rather than Eastern Standard Time (EST) to prevent confusion, if any.

    DATES:

    The UFAC will meet on Tuesday, June 2, 2015, from 1:00 p.m. to 2:30 p.m. EDT.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Michele Snavely, Paralegal, Regulations and Rulings, Office of International Trade, (202) 325-0354.

    Correction

    In notice document, FR Doc. 2015-11619, beginning on page 27694 in the issue of Thursday, May 14, 2015, make the following corrections in the first column on page 27695:

    Remove “EST” and replace it with “EDT” the three (3) times that it appears in the DATES: section. Please note that all other information in the May 14, 2015, notice is unchanged.

    Dated: May 14, 2015. Joanne Roman Stump, Acting Director, Regulations and Disclosure Law Division, U.S. Customs and Border Protection.
    [FR Doc. 2015-12079 Filed 5-18-15; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R5-FHC-2015-N092; FF05F24400-FXFR13350500000] Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; Horseshoe Crab Tagging Program AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice; request for comments.

    SUMMARY:

    We (U.S. Fish and Wildlife Service) have sent an Information Collection Request (ICR) to OMB for review and approval. We summarize the ICR below and describe the nature of the collection and the estimated burden and cost. This information collection is scheduled to expire on May 31, 2015. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. However, under OMB regulations, we may continue to conduct or sponsor this information collection while it is pending at OMB.

    DATES:

    You must submit comments on or before June 18, 2015.

    ADDRESSES:

    Send your comments and suggestions on this information collection to the Desk Officer for the Department of the Interior at OMB-OIRA at (202) 395-5806 (fax) or [email protected] (email). Please provide a copy of your comments to the Service Information Collection Clearance Officer, U.S. Fish and Wildlife Service, MS BPHC, 5275 Leesburg Pike, Falls Church, VA 22041-3803 (mail), or [email protected] (email). Please include “1018-0127” in the subject line of your comments.

    FOR FURTHER INFORMATION CONTACT:

    To request additional information about this ICR, contact Hope Grey at [email protected] (email) or 703-358-2482 (telephone). You may review the ICR online at http://www.reginfo.gov. Follow the instructions to review Department of the Interior collections under review by OMB.

    SUPPLEMENTARY INFORMATION: Information Collection Request

    OMB Control Number: 1018-0127.

    Title: Horseshoe Crab Tagging Program.

    Service Form Number(s): 3-2310 and 3-2311.

    Type of Request: Extension of currently approved collection.

    Description of Respondents: Tagging agencies include Federal and State agencies, universities, and biomedical companies. Members of the general public provide recapture information.

    Respondent's Obligation: Voluntary.

    Frequency of Collection: On occasion when horseshoe crabs are tagged and when horseshoe crabs are found or captured.

    Activity Number of
  • annual
  • respondents
  • Number of
  • annual
  • responses
  • Completion time per
  • response
  • Annual burden hours
    FWS Form 3-2310 1,160 2,750 10 minutes 458 FWS Form 3-2311 18 18 95 hours * 1,710 Totals 1,178 2,768 2,168 * Average time required per response is dependent on the number of tags applied by an agency in 1 year. Agencies tag between 25 and 9,000 horseshoe crabs annually, taking between 2 to 5 minutes per crab to tag, record, and report data. Each agency determines the number of tags it will apply.

    Estimated Annual Nonhour Burden Cost: None.

    Abstract: Horseshoe crabs play a vital role commercially, biomedically, and ecologically along the Atlantic coast. Horseshoe crabs are commercially harvested and used as bait in eel and conch fisheries. Biomedical companies along the coast also collect and bleed horseshoe crabs at their facilities. Limulus Amoebocyte Lysate is derived from crab blood, which has no synthetic substitute, and is used by pharmaceutical companies to test sterility of products. Finally, migratory shorebirds also depend on the eggs of horseshoe crabs to refuel on their migrations from South America to the Arctic. One bird in particular, the red knot, feeds primarily on horseshoe crab eggs during its stopover. Effective January 12, 2015, the red knot was listed as threatened under the Endangered Species Act.

    In 1998, the Atlantic States Marine Fisheries Commission (ASMFC), a management organization with representatives from each State on the Atlantic Coast, developed a horseshoe crab management plan. The ASMFC plan and its subsequent addenda established mandatory State-by-State harvest quotas, and created the 1,500-square-mile Carl N. Shuster, Jr., Horseshoe Crab Sanctuary off the mouth of Delaware Bay.

    Restrictive measures have been taken in recent years, but populations are increasing slowly. Because horseshoe crabs do not breed until they are 9 years or older, it may take some time before the population measurably increases. Federal and State agencies, universities, and biomedical companies participate in a Horseshoe Crab Cooperative Tagging Program. The Maryland Fishery Resources Office, U.S. Fish and Wildlife Service, maintains the information that we collect under this program and uses it to evaluate migratory patterns, survival, and abundance of horseshoe crabs.

    Agencies that tag and release the crabs complete FWS Form 3-2311 (Horseshoe Crab Tagging) and provide the Service with:

    • Organization name.

    • Contact person name.

    • Tag number.

    • Sex of crab.

    • Prosomal width.

    • Capture site, latitude, longitude, waterbody, State, and date.

    Members of the public who recover tagged crabs provide the following information using the online submission form (http://www.fws.gov/crabtag/) or via a toll-free telephone number:

    • Tag number.

    • Whether or not tag was removed.

    • Condition of crab.

    • Date captured/found.

    • Crab fate.

    • Finder type.

    • Capture method.

    • Capture location.

    • Reporter information.

    • Comments.

    If the public participant who reports the tagged crab requests information, we send data pertaining to the tagging program and tag and release information on the horseshoe crab that was found or captured. Comments Received and Our Responses

    Comments: On February 10, 2015, we published in the Federal Register (80 FR 7490) a notice of our intent to request that OMB renew approval for this information collection. In that notice, we solicited comments for 60 days, ending on April 13, 2015. We did not receive any comments.

    Request for Public Comments

    We again invite comments concerning this information collection on:

    • Whether or not the collection of information is necessary, including whether or not the information will have practical utility;

    • The accuracy of our estimate of the burden for this collection of information;

    • Ways to enhance the quality, utility, and clarity of the information to be collected; and

    • Ways to minimize the burden of the collection of information on respondents.

    Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask OMB in your comment to withhold your personal identifying information from public review, we cannot guarantee that it will be done.

    Dated: May 13, 2015. Tina A. Campbell, Chief, Division of Policy, Performance, and Management Programs, U.S. Fish and Wildlife Service.
    [FR Doc. 2015-12048 Filed 5-18-15; 8:45 am] BILLING CODE 4310-55-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FW-R5-NCTC-2015-N093; FF09X35000-156-FXGO16610900600] Proposed Information Collection; National Initiative To Understand and Connect Americans and Nature AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice; request for comments.

    SUMMARY:

    We (U.S. Fish and Wildlife Service) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act of 1995 and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    To ensure that we are able to consider your comments on this IC, we must receive them by July 20, 2015.

    ADDRESSES:

    Send your comments on the IC to the Information Collection Clearance Officer, U.S. Fish and Wildlife Service, MS BPHC, 5275 Leesburg Pike, Falls Church, VA 22041-3803 (mail); or [email protected] (email). Please include “1018-New” in the subject line of your comments.

    FOR FURTHER INFORMATION CONTACT:

    To request additional information about this IC, contact Hope Grey at [email protected] (email) or 703-358-2482 (telephone).

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    Nature and the outdoors have always been an important part of the fabric of American life. But, there are major questions about the present and future role of nature and the outdoors in our increasingly diverse, technologically oriented, and rapidly changing society. For our programs to remain relevant to American life today and tomorrow, we must be aware of public sentiment toward the part nature plays in the quality of our lifestyles.

    It is for these reasons that we plan to use a quantitative survey to collect: Information on the attitudes that the public maintains towards the natural environment; the effects of contact with nature on participants' health and quality of life; the extent of contact with nature and obstacles to greater contact with nature; general knowledge of nature and wildlife; concerns toward selected environmental issues; and socio-demographic variables. Results will help improve the design and delivery of new or existing programs aimed at engaging the public in nature-related activities (e.g., outreach and educational programming at national wildlife refuges and national fish hatcheries).

    II. Data

    OMB Control Number: 1018-New.

    Title: National Initiative to Understand and Connect Americans and Nature.

    Service Form Number: None.

    Type of Request: Request for a new OMB control number.

    Description of Respondents: Individuals.

    Respondent's Obligation: Voluntary.

    Frequency of Collection: One time.

    Estimated Number of Respondents: 8,950.

    Estimated Number of Annual Responses: 8,950.

    Completion Time per Response: 20 minutes.

    Estimated Annual Burden Hours: 2,983.

    Estimated Annual Nonhour Burden Cost: None.

    III. Comments

    We invite comments concerning this information collection on:

    • Whether or not the collection of information is necessary, including whether or not the information will have practical utility;

    • The accuracy of our estimate of the burden for this collection of information;

    • Ways to enhance the quality, utility, and clarity of the information to be collected; and

    • Ways to minimize the burden of the collection of information on respondents.

    Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this IC. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Dated: May 13, 2015. Tina A. Campbell, Chief, Division of Policy, Performance, and Management Programs, U.S. Fish and Wildlife Service.
    [FR Doc. 2015-12052 Filed 5-18-15; 8:45 am] BILLING CODE 4310-55-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R8-FHC-2015-N102; FXFR1334088TWG0W4-123-FF08EACT00] Trinity River Adaptive Management Working Group; Public Meeting AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service, announce a public meeting of the Trinity River Adaptive Management Working Group (TAMWG). The TAMWG is a Federal advisory committee that affords stakeholders the opportunity to give policy, management, and technical input concerning Trinity River (California) restoration efforts to the Trinity Management Council (TMC). The TMC interprets and recommends policy, coordinates and reviews management actions, and provides organizational budget oversight.

    DATES:

    Public meeting: TAMWG will meet from 9:30 a.m. to 4:45 p.m. Pacific Time on Tuesday, June 16, 2015, and from 9 a.m. to 2:30 p.m. Pacific Time on Wednesday, June 17, 2015. Deadlines: For deadlines on submitting written material, please see “Public Input” under SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    The in-person meeting will be held at the Weaverville Fire Hall, 125 Bremer Street, Weaverville, CA 96093.

    FOR FURTHER INFORMATION CONTACT:

    Joseph C. Polos, U.S. Fish and Wildlife Service, 1655 Heindon Road, Arcata, CA 95521; telephone: 707-822-7201; email: [email protected] Individuals with a disability may request an accommodation by sending an email to the point of contact.

    SUPPLEMENTARY INFORMATION:

    In accordance with the requirements of the Federal Advisory Committee Act, 5 U.S.C. App., we announce that the Trinity River Adaptive Management Working Group will hold a meeting.

    Background

    The TAMWG affords stakeholders the opportunity to give policy, management, and technical input concerning Trinity River (California) restoration efforts to the TMC. The TMC interprets and recommends policy, coordinates and reviews management actions, and provides organizational budget oversight.

    Meeting Agenda

    • Designated Federal Officer (DFO) updates, election of officers, review of charter and bylaws, and administrative procedures,

    • TMC Chair update,

    • Executive Director's update,

    • TRRP Workgroup/Science Coordinator update, and Decision Support System update,

    • TRRP Implementation update, 2015 sites, 2016 sites, and status of permits,

    • Flow management, Water Year 2015 Central Valley Project water management update, BOR long-term fall flow plan update, and fall flow plan for Water Year 2015,

    • Solicitor's guidance on the TRRP watershed efforts,

    • FY 2016 Budget/work planning,

    • TMC current issues,

    • TRRP background/refresher,

    • Gravel augmentation short-term needs, and long-term gravel plan status,

    • TRRP Communications plan, and status,

    • Status of fish returns and goals of the TRRP,

    • Joint meeting with TMC in August, and

    • Public Comment.

    The final agenda will be posted on the Internet at http://www.fws.gov/arcata.

    Public Input If you wish to You must contact Joseph Polos (FOR FURTHER INFORMATION CONTACT) no later than Submit written information or questions for the TAMWG to consider during the meeting June 8, 2015. Submitting Written Information or Questions

    Interested members of the public may submit relevant information or questions for the TAMWG to consider during the meeting. Written statements must be received by the date listed in “Public Input,” so that the information may be available to the TAMWG for their consideration prior to this meeting. Written statements must be supplied to Elizabeth Hadley in one of the following formats: One hard copy with original signature, one electronic copy with original signature, and one electronic copy via email (acceptable file formats are Adobe Acrobat PDF, MS Word, PowerPoint, or rich text file).

    Registered speakers who wish to expand on their oral statements, or those who wished to speak but could not be accommodated on the agenda, may submit written statements to Elizabeth Hadley up to 7 days after the meeting.

    Meeting Minutes

    Summary minutes of the meeting will be maintained by Elizabeth Hadley (see FOR FURTHER INFORMATION CONTACT). The minutes will be available for public inspection within 14 days after the meeting, and will be posted on the TAMWG Web site at http://www.fws.gov/arcata.

    Dated: May 13, 2015. Joseph C. Polos, Supervisory Fish Biologist, Arcata Fish and Wildlife Office, Arcata, California.
    [FR Doc. 2015-12070 Filed 5-18-15; 8:45 am] BILLING CODE 4310-55-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NRNHL-18228; PPWOCRADI0, PCU00RP14.R50000] National Register of Historic Places; Notification of Pending Nominations and Related Actions

    Nominations for the following properties being considered for listing or related actions in the National Register were received by the National Park Service before April 25, 2015. Pursuant to section 60.13 of 36 CFR part 60, written comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation. Comments may be forwarded by United States Postal Service, to the National Register of Historic Places, National Park Service, 1849 C St. NW., MS 2280, Washington, DC 20240; by all other carriers, National Register of Historic Places, National Park Service, 1201 Eye St. NW., 8th floor, Washington, DC 20005; or by fax, 202-371-6447. Written or faxed comments should be submitted by June 3, 2015. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Dated: April 30, 2015. J. Paul Loether, Chief, National Register of Historic Places/National Historic Landmarks Program. COLORADO Las Animas County Santa Fe Trail Mountain Route Trail Segment—Delhi Vicinity I, (Santa Fe Trail MPS), Address Restricted, Delhi, 15000313 Santa Fe Trail Mountain Route Trail Segment—Delhi Vicinity II, (Santa Fe Trail MPS), Address Restricted, Delhi, 15000314 Santa Fe Trail Mountain Route Trail Segment—Delhi Vicinity III, (Santa Fe Trail MPS), Address Restricted, Delhi, 15000315 ILLINOIS Sangamon County Central Springfield Historic District (Boundary Increase and Additional Documentation), Roughly Jefferson, Jackson, 2nd & 7th Sts., Springfield, 15000316 Strawbridge—Shepherd House, 5255 Shepherd Rd., Springfield, 15000317 KANSAS McPherson County Lindquist, P.J., Building, 116 S. Main St., Lindsborg, 15000318 MISSOURI St. Louis Independent city Shell Building, The, 1221 Locust St., St. Louis (Independent City), 15000319 NEVADA Carson City Independent city Nevada State Prison, 3301 E. 5th St., Carson City (Independent City), 15000320 NEW JERSEY Burlington County Florence Public School No. 1, 203 W. 2nd St., Florence Township, 15000321 OHIO Franklin County Drexel Theater, 2254 E. Main St., Bexley, 15000322 Graham, A.B., House, 159 Clinton Heights Ave., Columbus, 15000323 Theresa Building, 823 E. Long St., Columbus, 15000324 United States Carriage Company, 309-319 S. 4th St., Columbus, 15000325 Hamilton County West Fourth Street Historic District (Boundary Increase), 309 Vine St., Cincinnati, 15000326 OKLAHOMA Kay County Hayes—Kennedy—Rivoli Theater Building, 122-124 S. Main, Blackwell, 15000327 Oklahoma County Czech Hall of Oklahoma City—Lodge Laska, 515 SW. 6th St., Oklahoma City, 15000328 Tulsa County Elizabeth Manor, 1820 S. Boulder Ave., W., Tulsa, 15000329 Washington County Comer, C.A., House, (Bruce Goff Designed Resources in Oklahoma MPS) 1316 North Creek, Dewey, 15000330 OREGON Jefferson County Madras Army Air Field North Hanger, 2028 NW. Berg Dr., Madras, 15000331 TENNESSEE Smith County Moss Mounds, (Mississippian Cultural Resources of the Central Basin (AD 900-1450) MPS), Address Restricted, Elmwood, 15000332 Williamson County Glass Mounds Discontiguous Archeological District, 4000 Golf Club Ln., Franklin, 15000333 TEXAS Bastrop County Hopewell School, (Rosenwald School Building Program in Texas MPS), 690 TX 21 W., Cedar Creek, 15000334 Harris County Stowers Building, 820 Fannin, Houston, 15000335 Nueces County Galvan Ballroom, 1632 Agnes, Corpus Christi, 15000336 Tarrant County Parker—Browne Company Building, 1212 E. Lancaster Ave., Fort Worth, 15000337 Terry County Abilene Courts, 633 S. 11th St., Abilene, 15000338 Wichita County Perkins, Joe and Lois, House, 3301 Harrison St., Wichita Falls, 15000339 WISCONSIN Sauk County Downtown Baraboo Historic District, Roughly bounded by 5th & 2nd Aves., 5th, Ash, 1st, Oak & Birch Sts., Baraboo, 15000340 Walworth County Wandawega Inn, W5453 Lake View Dr., Sugar Creek, 15000341
    [FR Doc. 2015-12026 Filed 5-18-15; 8:45 am] BILLING CODE 4312-51-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 15-11] Karen S. Dunning, N.P.; Decision and Order

    On January 9, 2015, I, the Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Karen S. Dunning, N.P. (hereinafter, Respondent) of Kouts, Indiana. The Order to Show Cause and Immediate Suspension of Registration proposed the revocation of Respondent's DEA Certificate of Registration MD2249161, pursuant to which she was authorized to dispense controlled substances in schedules II through V as a practitioner, and the denial of any application to renew or modify her registration, on the ground that she has committed acts which render her “continued registration inconsistent with the public interest.” Show Cause Order, at 1.

    More specifically, the Order alleged that Respondent, who is an Advanced Practice Nurse licensed by the Indiana State Board of Nursing, is not authorized under state law “to prescribe controlled substances in Schedules III and IV for the purpose of weight reduction or to control obesity.” Show Cause Order, at 1. The Order then alleged that “between August 2007 and March 2014,” Respondent issued prescriptions, “on multiple occasions,” for phendimetrazine, a schedule III controlled substance, and phentermine, a schedule IV controlled substance, for “the purpose of weight loss or to control obesity, in violation of state and federal law.” Id. at 2 (citing Ind. Code §§ 35-48-3-11; 25-22.5-8-2(a); 21 CFR 1306.03 & 1306.04(a)). The order then set forth specific allegations regarding Respondent's prescribing of the aforesaid controlled substances to nine patients. Id. at 2-4.

    The Order also alleged that “beginning in February 2014 and for several months thereafter,” Respondent had violated federal law by issuing controlled substance prescriptions for weight loss medications that had been pre-signed by her collaborating physician, as well as that between February and August 2014, she issued controlled substance prescriptions “without a collaborative agreement” having been filed with the Indiana Board of Nursing. Id. at 4 (citing 21 CFR 1306.05 and 1306.03(a)(1); 848 Ind. Admin. Code § 5-1-1(a)(7)). The Order further alleged that Respondent had dispensed Bontril (phendimetrazine) to a patient at an unregistered location. Id. Finally, the Order alleged that Respondent had failed to keep various records as required by DEA regulations. Id. at 5. Based on the totality of Respondent's misconduct, I concluded that her continued registration during the pendency of the proceeding “would constitute an imminent danger to the public health and safety” and therefore ordered that her registration be immediately suspended. Id. at 6-7.

    Following service of the Order, Respondent timely requested a hearing on the allegations. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Administrative Law Judge (ALJ) Christopher B. McNeil, who proceeded to conduct pre-hearing procedures.

    However, the next day, the Government moved for summary disposition and to stay the proceeding, asserting that the Indiana State Board of Nursing had ordered the emergency suspension of Respondent's nursing license and advanced practice nurse prescriptive authority, and that she was without authority to dispense controlled substances and to possess a DEA registration in the State. Mot. For Summ. Disp., at 1-3. As support for its Motion, the Government attached a printout from a license verification Web page maintained by the State of Indiana. See id. at Attachment A. The printout showed that Respondent's Indiana Advanced Practice Nurse Prescriptive Authority license was the subject of an emergency suspension.1 Id.

    1 Subsequently, the Government also filed a copy of the Summary Suspension Order issued to Respondent by the Indiana State Board of Nursing. See Notice of Filing of Written Suspension Order (Exhibit A).

    I take official notice of the registration records of this Agency, which establish that Respondent's registration will not expire until June 30, 2016. See 21 CFR 1316.59(e). Respondent may refute this fact by filing a properly supported motion for reconsideration no later than ten (10) business days from the date of issuance of this Decision and Order.

    Upon review of the Government's Motions, the ALJ issued an Order for Stay and for Respondent's Response to Allegations Concerning Respondent's Lack of State Authority. R.D. at 2. Thereafter, Respondent timely filed her Response, in which she did not dispute that her license was suspended but asserted that section 824(a)(3) “authorizes suspension or revocation of a DEA registration based on the loss of State privileges” and thus “gives a choice of remedies and clearly contemplates the exercise of administrative discretion.” Respondent's Response, at 1.

    Respondent contends that the Nursing Board has only suspended her license and advanced practice nurse prescriptive authority for ninety (90) days. Id. at 3. She further argues that the prior cases in which the Agency revoked a practitioner's registration based on a state's suspension of prescribing authority involved suspensions that “were of indefinite rather than, as here, for a finite, definite, and limited time” and that “[t]his indefiniteness was the gravamen of the decisions holding revocation to be the appropriate remedy.” Id. (citing Anne Lazar Thorn, 62 FR 12847, 12848 (1997)).

    Respondent also argues that the temporary suspension of her license “does not render her `no longer authorized by State law' to dispense controlled substances. It only temporarily restrains her from dispensing controlled substances.” Id. And she further argues that suspending her registration “mean[s] that she is not holding a DEA Registration and would fully satisfy statutory requirements.” Id. She thus contends that revoking her registration would be “arbitrary, capricious, a clear abuse of discretion and not in accordance with the law.” Id. at 4.

    The ALJ correctly rejected these contentions, explaining that the CSA defines the term “practitioner” to “mean[] a physician, dentist, veterinarian . . . or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which [s]he practices to distribute [or] dispense a controlled substance in the course of professional practice,” 21 U.S. C. 802(21), and that under section 823(f), only a person who is authorized to dispense controlled substances and is therefore a practitioner within the meaning of the Act can be registered. R.D., at 3; see also 21 U.S. C. 823(f) (“The Attorney General shall register practitioners . . . to dispense . . . controlled substances . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the States in which he practices.”).

    Respondent contends, however, that the decision in Anne Lazar Thorn, M.D., 62 FR 12847 (1997), stands for the proposition that the Agency's consistent practice of revoking registrations based on a loss of state authority “rests on the indefinite nature of a State suspension.” Respondent's Resp., at 2-3. Respondent quotes the following passage from Thorn:

    [T]he Acting Deputy Administrator recognizes that he has discretionary authority to either revoke or suspend a DEA registration. However, given the indefinite nature of the suspension of Respondent's state license to practice medicine, the Acting Deputy Administrator agrees with [the ALJ] that revocation is appropriate in this case. Id. at 3 (quoting 62 FR at 12848).

    Notwithstanding the implication of the above passage, no decision of this Agency has held that a suspension (rather than a revocation) is warranted where a State has imposed a suspension of a fixed or certain duration. To the contrary, in the case of practitioners, DEA has long and consistently interpreted the CSA as mandating the possession of authority under state law to handle controlled substances as a fundamental condition for obtaining and maintaining a registration. See, e.g., Leonard F. Faymore, 48 FR 32886, 32887 (1983) (collecting cases). As the Thorn decision further explained:

    DEA has consistently interpreted the Controlled Substances Act to preclude a practitioner from holding a DEA registration if the practitioner is without authority to handle controlled substances in the state in which he/she practices. This prerequisite has been consistently upheld.

    The Acting Deputy Administrator finds that the controlling question is not whether a practitioner's license to practice medicine in the state is suspended or revoked; rather it is whether the Respondent is currently authorized to handle controlled substances in the state. In the instant case, it is undisputed that Respondent is not currently authorized to handle controlled substances in the [state in which she practices medicine]. Therefore . . . Respondent is not currently entitled to a DEA registration.

    62 FR at 128438 (citing and quoting 21 U.S. C. 823(f) and 802(21) and collecting cases). Accordingly, in Thorn, the Agency rejected the Respondent's contention that her registration should be suspended rather than revoked.

    As for Respondent's contention that section 824(a) “gives a choice of remedies and clearly contemplates the exercise of administrative discretion,” it is acknowledged that the opening sentence of section 824(a) provides that a registration “may be suspended or revoked by the Attorney General” upon the Attorney General's finding that one of the five grounds set forth exists. 21 U.S. C. 824(a). However, this general grant of authority in imposing a sanction must be reconciled with the CSA's specific provisions which mandate that a practitioner hold authority under state law in order to obtain and maintain a DEA registration. See Gozlon-Peretz v. United States, 498 U.S. 395, 407 (1991) (“A specific provision controls over one of more general application.”); see also Bloate v. United States, 130 S.Ct. 1345, 1354 (2010) (quoting D. Ginsberg & Sons, Inc., v. Popkin, 285 U.S. 204, 208 (1932) (“General language of a statutory provision, although broad enough to include it, will not be held to apply to a matter specifically dealt with in another part of the same enactment.”)).

    Indeed, Respondent's argument has previously been tried and rejected. See James L. Hooper, 76 FR 71371 (2011), pet. for rev. denied, Hooper v. Holder, 481 F. App'x 826 (4th Cir. 2012) (unpublished). As the Fourth Circuit explained in Hooper:

    Section 824(a) does state that the DA may “suspend or revoke” a registration, but the statute provides for this sanction in five different circumstances, only one of which is loss of a State license. Because § 823(f) and § 802(21) make clear that a practitioner's registration is dependent upon the practitioner having state authority to dispense controlled substances, the DA's decision to construe § 824(a)(3) as mandating revocation upon suspension of a state license is not an unreasonable interpretation of the CSA.

    Id. at 828.

    Moreover, while Respondent points to the fact that the suspension imposed by the Board is “temporary” and only “for ninety (90) days,” Respondent's Resp. at 3, the Board's order was non-final. Thus, while Respondent may prevail before the Board, the Board may also impose an additional period of suspension or revoke her license and prescribing authority.

    Accordingly, consistent with the Agency's longstanding precedent, revocation remains warranted.2 See Gary Alfred Shearer, 78 FR 19009 (2013) (holding that revocation is warranted even where a state order has summarily suspended a practitioner's controlled substances authority and the state agency's order remains subject to challenge in either administrative or judicial proceedings); Winfield Drugs, Inc., 52 FR 27070 (1987) (revoking registration based on state emergency suspension order notwithstanding state order was under appeal, noting that the “[r]espondent is not currently authorized to handle controlled substances in the [s]tate” and that “[a]s a matter of law, the [DEA] does not have statutory authority . . . to issue or maintain a registration for a practitioner if the applicant or registrant lacks [s]tate authority to dispense controlled substances”).

    2 As for Respondent's contention that the temporary suspension of her license “does not render her `no longer authorized by State law' to dispense controlled substances,” under Indiana law, “[a] person who . . . practices nursing during the time the person's license issued under this chapter . . . is suspended or revoked commits a Class B misdemeanor.” Ind. Code § 25-23-1-27(5). Thus, Respondent is not currently authorized to dispense controlled substances.

    Order

    Pursuant to the authority vested in me by 21 U.S. C. 824 as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration MD2249161 issued to Karen S. Dunning, N.P., be, and it hereby is, revoked. This Order is effectively immediately.3

    3 Based on the same findings that led me to conclude that Respondent's continued registration during the pendency of the proceeding constitutes an imminent danger to public health and safety, I conclude that the public interest necessitates that this Order be effective immediately. 21 CFR 1316.67.

    Dated: May 1, 2015. Michele M. Leonhart, Administrator. Michelle F. Gillice, Esq., Paul A. Dean, Esq., for the Government. Lakeisha C. Murdaugh, Esq., Scott L. King, Esq., for the Respondent. ORDER GRANTING THE GOVERNMENT'S MOTION FOR SUMMARY DISPOSITION AND FINDINGS OF FACT, CONCLUSIONS OF LAW, AND RECOMMENDED DECISION OF THE ADMINISTRATIVE LAW JUDGE

    Administrative Law Judge Christopher B. McNeil. On January 9, 2015, the Administrator of the Drug Enforcement Administration issued an Order to Show Cause and Immediate Suspension of Respondent's DEA Certificate of Registration, No. MD2249161. The Order affords Respondent the opportunity to show cause why Respondent's DEA registration should not be revoked pursuant to 21 U.S. C. 824(a), on the grounds that Respondent's continued registration would be inconsistent with the public interest. The Order also seeks to deny any pending applications for registration, renewal or modification pursuant to 21 U.S. C. 823(f). In addition, the Administrator immediately suspended Respondent's registration pursuant to 21 U.S. C. 824(d), upon finding Respondent's continued registration constitutes an imminent danger to the public health and safety.

    According to the Government's Notice of Service, Respondent was personally served with the Order to Show Cause on January 14, 2015. On February 18, 2015, the Office of Administrative Law Judges received Respondent's Request for Hearing, dated February 13, 2015. On February 19, 2015, this Office issued an Order for Prehearing Statements and Order Setting the Matter for Hearing.

    On February 20, 2015, this office received Government's Motion for Summary Disposition and Motion to Stay Proceedings. The Government asserted that the Indiana State Board of Nursing ordered an emergency suspension of Respondent's nursing license and her advanced practice nurse prescriptive authority, effective immediately. Citing this lack of state authority, the Government requested that the matter be forwarded to the Administrator for a Final Order and that in the interest of efficiency, I grant a Motion to Stay the Proceedings and continue the deadlines pending the resolution of the Motion for Summary Disposition. In response to the Government's filing, I issued an Order for Stay and for Respondent's Response to Allegations Concerning Respondent's Lack of State Authority. In the Order, I required Respondent to file a response to the Government's Motion for Summary Disposition no later than February 27, 2015. Additionally, I stayed the matter and held all deadlines in abeyance.

    On February 27, 2015, I received Respondent's Response to the Government's Motion for Summary Disposition. Respondent first cites 21 U.S. C. 824(a)(3) to demonstrate that the Administrator has the choice of authorizing suspension or revocation of Respondent's registration. Respondent then asks that I consider suspending her registration based on the premise that the 90 day suspension of her advanced practice nurse prescriptive authority is not equivalent to the indefinite suspensions in the case law cited by the Government.

    The substantial issue raised by the Government rests on an undisputed fact. The Government asserts that Respondent's DEA Certificate of Registration must be revoked because Respondent does not have a nursing licensed issued by the state in which she practices. Under DEA precedent, a practitioner's DEA Certificate of Registration for controlled substances must be summarily revoked if the applicant is not authorized to handle controlled substances in the state in which she maintains her DEA registration.1 Pursuant to 21 U.S. C. 823(f), only a “practitioner” may receive a DEA registration. Under 21 U.S. C. 802(21), a “practitioner” must be “licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute [or] dispense . . . controlled substance[s.]” Given this statutory language, the DEA Administrator does not have the authority under the Controlled Substances Act to maintain a practitioner's registration if that practitioner is not authorized to dispense controlled substances.2

    1See 21 U.S. C. 801(21), 823(f), 824(a)(3); see also House of Medicine, 79 FR 4959, 4961 (DEA 2014); Deanwood Pharmacy, 68 FR 41662-01 (DEA July 14, 2003); Wayne D. Longmore, M.D., 77 FR 67669-02 (DEA November 13, 2012); Alan H. Olefsky, M.D., 72 FR 42127-01 (DEA August 1, 2007); Layfe Robert Anthony, M.D., 67 FR 15811 (DEA May 20, 2002); George Thomas, PA-C, 64 FR 15811-02 (DEA April 1, 1999); Shahid Musud Siddiqui, M.D., 61 FR 14818-02 (DEA April 4, 1996); Michael D. Lawton, M.D., 59 FR 17792-01 (DEA April 14, 1994); Abraham A. Chaplan, M.D., 57 FR 55280-03 (DEA November 24, 1992). See also Bio Diagnosis Int'l, 78 FR 39327-03, 39331 (DEA July 1, 2013) (distinguishing distributor applicants from other “practitioners” in the context of summary disposition analysis).

    2See Abraham A. Chaplan, M.D., 57 FR 55280-03, 55280 (DEA November 24, 1992), and cases cited therein. In Chaplan, DEA Administrator Robert C. Bonner adopts the ALJ's opinion that “the DEA lacks statutory power to register a practitioner unless the practitioner holds state authority to handle controlled substances.” Id.

    Respondent alternatively asks that I consider suspending her registration instead of revoking her registration. This exact issue was addressed in James L. Hooper, M.D.; Decision and Order. 3 Dr. Hooper was subject to a one-year suspension of his state license to practice medicine after which his license would be automatically reinstated.4 In comparison to Hooper, Respondent in this case has a less persuasive case as there is no guarantee that her advanced practice nurse prescriptive authority will be restored after 90 days. Dr. Hooper sought a suspension of his DEA Registration for the same time period his medical license was suspended. DEA Administrator Michele M. Leonhart agreed with Chief Administrative Law Judge John J. Mulrooney, II who did not find Dr. Hooper's argument persuasive. Administrator Leonhart, like Respondent in the case at hand, cited to Anne Lazar Thorn, M.D. 5 Administrator Leonhart cites the Acting Deputy Administrator's statement in Thorn that “the controlling question is not whether a practitioner's license to practice medicine in the state is suspended or revoked; rather, it is whether the Respondent is currently authorized to handle controlled substances in the state.” 6 In Hooper, Administrator Leonhart concludes that “even where a practitioner's state license has been suspended for a period of certain duration, the practitioner no longer meets the statutory definition of a practitioner.” 7 As detailed above, only a “practitioner” may receive a DEA registration. Therefore, I cannot and will not recommend the suspension of Respondent's DEA registration, but will instead recommend the registration be revoked.

    3James L. Hooper, M.D.; Decision and Order, 76 FR 71371-01, 71371 (DEA Nov. 17, 2011).

    4Id.

    5Anne Lazar Thorn, Revocation of Registration M.D, 62 FR 12847, 12848 (DEA Mar. 18, 1997).

    6Id. at 12848.

    7Hooper, 76 FR at 71372.

    Order Granting the Government's Motion for Summary Disposition and Recommendation

    I find there is no genuine dispute regarding whether Respondent is a “practitioner” as that term is defined by 21 U.S. C. 802(21), and that based on the record the Government has established that Respondent is not a practitioner and is not authorized to dispense controlled substances in the state in which she seeks to practice with a DEA Certificate of Registration. I find no other material facts at issue. Accordingly, I GRANT the Government's Motion for Summary Disposition.

    Upon this finding, I ORDER that this case be forwarded to the Administrator for final disposition and I recommended that Respondent's DEA Certificate of Registration should be REVOKED and any pending application for the renewal or modification of the same should be DENIED.

    Dated: March 9, 2015

    Christopher B. McNeil, Administrative Law Judge
    [FR Doc. 2015-12020 Filed 5-18-15; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration Bobby D. Reynolds, N.P., Tina L. Killebrew, N.P. and David R. Stout, N.P.; Decision and Orders

    On November 25, 2013, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued Orders to Show Cause to Bobby D. Reynolds, N.P. (hereinafter, Reynolds), of Limestone, Tennessee; Tina L. Killebrew, N.P. (hereinafter, Killebrew), of Kingsport, Tennessee; and David R. Stout, N.P. (hereinafter, Stout), of Morristown, Tennessee. GXs A, B, & C.

    With respect to Applicant Reynolds, the Show Cause Order proposed the denial of his application for registration as a practitioner, on the ground that his registration “would be inconsistent with the public interest” as evidenced by his repeated violations of state and federal law in prescribing controlled substances to seven patients while employed as a nurse practitioner at the Appalachian Medical Center (AMC), a clinic located in Johnson City, Tennessee. GX A, at 1-2 (citing 21 U.S.C. 823(f)(2), (4) & (5)). The Show Cause Order alleged that he had made unintelligible entries in the medical records of three patients (N.S., T.H., and A.W.), that he had violated state law by referring N.S. to an unlicensed mental health counselor, that he had violated state law by making false entries in N.S.'s chart, that he had failed to maintain complete records for T.H., and that he failed to properly maintain the patient record of C.S. to accurately reflect nursing problems and interventions. GX A, at ¶¶ 5, 6, 7, 11, 12, and 15.

    With respect to Applicant Killebrew, the Show Cause Order proposed the denial of her application for registration as a practitioner, on the ground that her registration “would be inconsistent with the public interest” as evidenced by her repeated violations of state and federal law in prescribing controlled substances to three patients while employed as a nurse practitioner at the AMC. GX B, at 1-2 (citing 21 U.S.C. 823(f)(2)(4) & (5)).

    With respect to Registrant Stout, the Show Cause Order proposed the revocation of his practitioner's registration and the denial of his pending application to renew his registration on two grounds. GX C, at 1-2. First, the Order alleged that Respondent had materially falsified his renewal application when he failed to disclose that on March 10, 2010, the Tennessee Board of Nursing had summarily suspended his nurse practitioner's license and his Certificate of Fitness to prescribe legend drugs in Tennessee. GX C, at 13-14; see also 21 U.S.C. 824(a)(1). The Show Cause Order further alleged that Registrant Stout had failed to disclose that on September 3, 2010, he had entered into a Consent Order with the State Board, pursuant to which the suspension was terminated, but he was placed on probation for two years, his multistate privilege to practice in other party states was voided for the period of his probation, he was ordered to pay a civil penalty of $8,000, and other probationary terms were imposed. GX C, at 14. Second, the Show Cause Order alleged that Registrant Stout had “committed such acts as would render his registration inconsistent with the public interest,” in that he had violated state and federal law in prescribing controlled substances to five patients while employed as a nurse practitioner at the AMC.1

    1 Each Show Cause Order made extensive and detailed allegations specific to each Applicant's conduct, as well as to Registrant Stout's conduct, in prescribing to the various patients. See GX A, at 2-26 (Reynolds OTSC); GX B, at 2-9 (Killebrew Order); GX C, at 2-14 (Stout Order). In its Request for Final Agency Action, the Government pursued only the allegations of unlawful prescribing by the three practitioners, as well as the allegations (which were raised in its prehearing statements) that Applicant Reynolds had made material false statements to a DEA Investigator.

    Following service of the Show Cause Orders, all three individuals timely requested a hearing on the allegations of the respective Order. The matters were then placed on the docket of the Agency's Office of Administrative Law Judges, and assigned to the Chief Administrative Law Judge, who consolidated the matters and proceeded to conduct prehearing procedures. However, after extensive prehearing litigation, each of the parties filed written notices waiving his/her respective right to a hearing, see GXs LL, MM, and PP, and the ALJ terminated the proceeding.2

    2 On March 27, 2014, NP Stout, through counsel, submitted a written request to the Government's counsel seeking to withdraw his application to renew his registration. GX RR. Government Counsel promptly forwarded the request to the Deputy Assistant Administrator. GX SS. According to Government Counsel, no action had been taken on the request as of September 16, 2014, the date on which the record was forwarded to this Office. Id. Nor has this Office been subsequently notified of any action having been taken on the request.

    I conclude that granting Stout's request to withdraw would be contrary to the public interest and that he has otherwise failed to show good cause. Here, the Government has expended extensive resources in investigating the allegations, preparing for a hearing, and in engaging in pre-hearing litigation; it was also fully prepared to go to hearing on the allegations when Stout waived his right to a hearing. Moreover, Stout's counsel has made no offer as to how long he would wait before reapplying. See GX RR (“This proposal is in the public's interest because it saves time and money for valuable employees and staff. There will be no need to review documents, there will be no need to issue decisions and there will be no delay in Mr. Stout being able to show his good faith in hopes of someday being able to reapply.”). Finally, having reviewed the evidence, I conclude that the public interest would be ill-served by allowing him to withdraw his application and thereby avoid the findings of fact and conclusions of law which are clearly warranted by the evidence.

    Thereafter, the Government filed a Request for Final Agency Action and forwarded the entire record to my Office for review. Having reviewed the entire record, I find that the Government has established that Registrant Stout has committed such acts as would render his registration “inconsistent with the public interest.” 21 U.S.C. 824(a)(4). Accordingly, I will order that the registration issued to Registrant Stout be revoked and that his pending application to renew his registration be denied. I further find that the Government has established that granting a new registration to Applicants Reynolds and Killebrew would be “inconsistent with the public interest.” Id. § 823(f). Therefore, I will also order that their respective applications be denied. I make the following findings of fact.

    Findings Jurisdictional Facts

    In 2002, Applicant Bobby D. Reynolds II, FNP, founded the Appalachian Medical Center, a clinic located in Johnson City, Tennessee; Reynolds owned the clinic until 2010, when it was closed. GX 42, at 2-3. Reynolds employed both Applicant Killebrew and Registrant Stout at AMC. Id.

    Reynolds was previously registered under the Controlled Substances Act as a Mid-Level Practitioner, with authority to dispense controlled substances in schedules II-V at the registered address of the AMC, which was located at 3010 Bristol Highway, Johnson City, Tennessee. GX 1, at 1. However, this registration expired on April 30, 2011. On May 19, 2011, Reynolds filed a renewal application; it is this application which is the subject of the Show Cause Order issued to him. Id.

    Tina L. Killebrew, F.N.P., was employed as a nurse practitioner at AMC from approximately June 2006 through March 11, 2010. GX L, at 13-14 (Brief in Response to Amended Order December 30, 2013). She was also previously registered as a Mid-Level Practitioner with authority to dispense controlled substances in schedules II-V at AMC's address. Id. at 11. However, this registration expired on December 31, 2010. On or about August 30, 2011, Killebrew submitted an application for a new registration; it is this application which is the subject of the Show Cause Order issued to her. Id.

    David R. Stout, N.P., currently holds DEA Certificate of Registration MS0443046, pursuant to which he is authorized to dispense controlled substances in schedules II-V as a Mid-Level Practitioner at the registered address of the AMC. GX 1, at 6. While his registration was due to expire on February 28, 2011, on February 16, 2011, Stout filed a renewal application. Accordingly, his registration remains in effect pending the final order in this matter. Id.

    The Government's Evidence of Misconduct

    In support of the allegations, the Government submitted patient files for seven patients, pharmacy records for four patients, along with various other documents. The Government also provided these materials to Amy Bull, Ph.D., a Board Certified Family Nurse Practitioner, who is licensed in Tennessee as both an Advanced Practice Nurse and Registered Nurse. GX 40, at 2-3. Dr. Bull is an Assistant Professor of Nursing at the Belmont University School of Nursing and previously taught at the Vanderbilt University School of Nursing, where she served as Director of the Family Nurse Practitioner Program, was the coordinator for courses in Advanced Pharmacotherapeutics and Health Assessment & Diagnostic Reasoning, and taught various courses. Id. at 1. Dr. Bull also continues to practice as a Nurse Practitioner at a clinic in Dickinson, Tennessee. Id. at 2.

    Dr. Bull reviewed seven patient files. GX 68, at 6-7. Based on her review, Dr. Bull concluded that Reynolds, Killebrew, and Stout acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing controlled substances to the patients, see 21 CFR 1306.04(a), and also violated Tennessee Board of Nursing Rule 1000-04.08, which sets forth the standards of nursing practice for prescribing controlled substances to treat pain. Id. at 7-8. Dr. Bull specifically found that Reynolds, Killebrew and Stout “repeatedly issued prescriptions . . . in the face of red flags that should have indicated to him [or her] that these individuals were abusing and/or diverting controlled substances and without taking appropriate action to prevent further abuse and/or diversion,” and that in doing so, “their conduct fell far below the standard of care in Tennessee and [was] contrary to generally recognized and accepted practices of a nurse practitioner in Tennessee.” Id. at 8. What follows below is a discussion of the evidence with respect to patients N.S., T.H. and C.S.

    N.S.

    N.S.'s first visit to AMC was on June 8, 2004, when she presented complaining of neck and back pain. See GX 2, at 102. N.S. apparently was seen on this visit by a practitioner other than Mr. Reynolds,3 Mr. Stout, or Ms. Killebrew. See GX 3, at 129-130. This practitioner specifically noted that N.S. had a “tender neck and low back with decreased range of motion, low back tender to light touch” and prescribed a thirty-day supply of thirty tablets of Avinza 60 mg (morphine, a schedule II drug), as well as Zanaflex, which is a non-controlled muscle relaxant. See GX 2, at 102; GX 3, at 129.

    3 According to the Expert, while Mr. Reynolds did not see N.S. at her June 8, 2004 visit, he had clearly reviewed the record of this visit as at the bottom of the visit note, there is a handwritten marking which, based on her review of the patient files, the Expert determined was the signature, or abbreviated signature of Reynolds. See GX 2 (ID) at 102; GX 68, at 10.

    According to the Expert, the documentation contained in N.S.'s file did not support the prescribing of a thirty-day supply of Avinza 60 mg and the prescription was below the standard of care in Tennessee and outside the usual course of professional practice. GX 68, at 8. As the Expert noted, N.S.'s file contains radiologic reports (CT scans and plain radiographs of the neck and lower back) from June 28, 2001 which appear to have been generated in connection with N.S.'s prior visit to the emergency room (“ER”) due to a motor vehicle collision and which described previous surgery to the neck and degenerative changes in the lower back. See id. at 8-9; GX 2, at 116-120.

    However, as the Expert then explained, these records were from examinations that were performed nearly three years before N.S.'s first AMC visit. GX 68, at 9. The Expert then observed that N.S.'s file lacked any documentation indicating what, if any, treatment she had received since the accident, nor contain any records of any prior treating physicians, nor any documentation relating to her substance abuse history. Id. Of further note, the Expert observed that N.S. did not list any medication she was then taking on the “New Patient Information Sheet” which she apparently completed at her first visit, see GX 2, at 9-10; and the record of her first visit does not document the she was taking any medications. Id. at 102; GX 68, at 9.

    According to the Expert, the absence of this information in the file indicates that the AMC practitioner did not know what, if any, controlled substances N.S. was then being prescribed, her complete pain history, whether she was suffering from any coexisting diseases or conditions, who her prior treating physicians were, whether she had ever tried non-controlled substances, or whether she had ever received other treatment modalities to address her reported pain, such as physical rehabilitation. GX 68, at 9. The Expert then concluded that absent this information, N.S. should not have been issued a controlled substance prescription on her first visit, especially a schedule II controlled substance such as Avinza, which is a long-acting formulation of morphine. Id. The Expert further explained that if a controlled substance such as Avinza had been indicated, the starting adult dose would have been only 30mg daily (rather than 60mg which was prescribed).4 Id.

    4 The Expert acknowledged that as of the date of N.S.'s first visit, the Tennessee Board of Nursing had yet to adopt BON Rule 1000-04-.08, and that the Rule did not go into effect until January 1, 2005. GX 68, at 10. However, based on her knowledge and experience, the Expert explained that advanced nurse practitioners (“APNs”) in Tennessee were nevertheless employing the practices set forth in the Rule when they prescribed controlled substances for the treatment of pain. Id. Thus, the practices articulated in the guidelines reflected what, in her opinion, was the standard of care in Tennessee for family nurse practitioners as of June 2004. Id. The Expert explained that because of the lack of information of N.S.'s prior treatment history and substance abuse history, it was below the standard of care for a practitioner to issue N.S. a thirty-day supply of a schedule II controlled substance such as morphine at her first visit. Id.

    On July 7, 2004, N.S. returned to AMC for a follow-up, but now was complaining of a migraine headache. See GX 2, at 101. Again, N.S. was seen by a practitioner other than Reynolds, Stout, or Killebrew. See GX 3, at 130.

    Notably, the record states that N.S. displayed “Slurred speech + Somnolence,” which, according to the Expert was a potential red flag that N.S. was abusing prescription drugs.5 GX 68, at 10. The Expert noted that the record indicated that N.S. had Tachycardia, as her pulse rate was above the normal rate for adults (60-100 beats per minute) and was nearly 20 beats higher than at her previous visit. Id. at 11. According to the Expert, while Tachycardia occurs for a variety of reasons, it can be caused by drug withdrawal. Id.

    5 According to the Expert, these symptoms could represent several serious and even life-threatening medical conditions given N.S.'s complaint of a migraine headache. Also, N.S.'s slurred speech and somnolence could have been an indication that N.S. was having an acute neurologic event, such as a hemorrhagic stroke. GX 68, at 10-11.

    The Expert noted that the attending practitioner properly ordered a Urine Drug Screen (UDS) for N.S. Id. According to the Expert, a UDS is a particularly useful tool when the practitioner is presented with a red flag indicating that the patient may not be in compliance, such as when the patient presents at the office exhibiting the behaviors N.S. did on this visit. Id. As the Expert explained, a UDS can assist the practitioner in determining whether the patient has been taking the drug(s) that the practitioner has prescribed and if the patient was ingesting non-prescribed controlled substances, including illicit substances. Id. Thus, UDS results help practitioners to determine whether a patient is abusing and/or diverting controlled substances. Id.

    While this other practitioner appropriately ordered a UDS, according to the Expert, he then inappropriately issued to N.S. another prescription for thirty tablets of Avinza 60 mg at this visit. Id. at 11-12. As the Expert found, at this visit, N.S.'s file still lacked any information of her prior treatment history and substance abuse history. Id. at 12. According to the Expert, in the absence of this information, and in light of the fact that N.S. presented at this visit demonstrating slurred speech and somnolence, the issuance of the Avinza prescription was below the standard of care in Tennessee and outside the usual course of professional practice and actually medically contraindicated given the mental status changes documented in her record. Id. at 12. The Expert further explained that under the circumstances presented by N.S., the standard of care and usual course of professional practice required that the practitioner refer the patient for a comprehensive evaluation (the emergency room) to determine the underlying cause of the symptoms of her increased heart rate, slurred speech, and somnolence. Id. Moreover, the patient should not have received prescriptions (of any type) at this visit until medical clearance was provided that she was not experiencing drug intoxication or an acute neurologic event. Id. Moreover, because N.S. was not referred or transferred for further evaluation, she should not have received any controlled medications until the urine drug screen results were available to the provider. Id.

    Nearly three months later (on September 29, 2004), N.S. returned to AMC for her next visit and was seen by Mr. Reynolds. See GX 2, at 100; GX 3, at 71. Prior to this visit, AMC had received the report of the results of the UDS that had been administered to N.S. at her July 7, 2004 visit. Id. at 115. According to the Expert, on the date of the UDS, N.S. should have had Avinza left from the prescription issued at her first visit and should have still been taking the drug. See GX 2, at 102; GX 3, at 129; GX 68, at 12-13. However, the UDS was negative for opiates, positive for benzodiazepines, and positive for cocaine. Id.; GX 2, at 115.

    According to the Expert, these results should have been a “huge red flag of abuse and diversion” for Mr. Reynolds because not only did N.S. test positive for cocaine, she also tested positive for three different benzodiazepines, none of which had been prescribed to her at her first visit. GX 68, at 13. The Expert further explained that the presence of the three benzodiazepines, in addition to the presence of cocaine, were consistent with the somnolence, slurred speech, and increased pulse rate that were documented during the July 7, 2004 visit. Id. The Expert also noted that N.S. tested negative for opiates, when she should have tested positive for the Avinza which she should have still been taking. Id.

    The Expert also noted that as of this visit, Reynolds still had not acquired any information concerning N.S.'s prior treatment history or substance abuse history. Id. Also, the file contains no documentation that Reynolds had inquired of N.S. where she had been for the nearly three months since her July 7, 2004 AMC visit. See generally GX 2. According to the Expert, the standard of care required that Reynolds inquire about N.S.'s absence and determine what, if anything, she had been doing during this time to address her reported pain. GX 68, at 13. The Expert further noted that while the note for this visit was for the most part illegible, it appeared that Mr. Reynolds did not address N.S.'s absence. See id; GX 2, at 100.

    Nonetheless, Reynolds issued N.S. another prescription for thirty tablets of Avinza 60 mg. See GX 2, at 100; GX 3, at 71. Based on the UDS results and notation in N.S.'s record that she displayed “slurred speech & somnolence,” the Expert concluded that Reynolds was on notice that she was likely diverting the Avinza she obtained at AMC for the purpose of obtaining the cocaine and the benzodiazepines. GX 68, at 14. The Expert also explained that at the time of these events, it was well known in the Tennessee health care community that prescription drug abuse and diversion was a problem that was plaguing East Tennessee. Id.

    The Expert explained that the standard of care and usual course of practice under these circumstances would not have been to issue N.S. an additional thirty-day supply of morphine, because “family nurse practitioners were not then, and are now not equipped, through their training and experience, to address the complex abuse and diversion issues N.S. was presenting.” Id. According to the Expert, rather than continuing to issue N.S. prescriptions for more of the Avinza, the standard of care and usual course of practice required that Reynolds “cease all controlled substances prescriptions to her, and instead referred [sic] her for a consultation with a pain management specialist who [was] equipped with the knowledge to treat a pain patient who has exhibited such aberrant behavior.” Id. The Expert also explained that in the event that a local pain management practice did not have all of these specialists, Mr. Reynolds should have, in addition to sending her to a pain management specialist, referred her to a mental health specialist to address her possible psychological/drug abuse issues. Id. The Expert thus concluded that Reynolds' issuance of this prescription was below the standard of care in Tennessee, outside the usual course of professional practice, and for other than a legitimate medical purpose. Id.

    N.S.'s file reflects that Reynolds, Stout, and Killebrew each continued to issue N.S. controlled substance prescriptions on multiple occasions subsequent to September 29, 2004. In fact, N.S. remained an AMC patient for over five more years and continued to receive numerous controlled substances prescriptions from AMC. See generally GX 2. Based on the evidence of N.S.'s abuse and/or diversion of controlled substances that was documented in her file, the absence of documentation of any prior treatment for pain, and the absence of any substance abuse history, the Expert opined that each and every controlled substance prescription that these three practitioners issued to N.S. from September 29, 2004 forward was below the standard of care, not for a legitimate medical purpose, and outside the usual course of professional practice. GX 68, at 15. However, “because each of the three practitioners issued additional controlled substance prescriptions notwithstanding the existence of more red flags of N.S.'s abuse and/or diversion of controlled substances,” the Expert addressed the invalidity of those prescriptions. Id.

    On December 29, 2004, N.S. returned to AMC and saw Mr. Reynolds, who issued her a prescription for eight tablets of Avinza 60 mg. See GX 2, at 97; GX 3, at 76 According to the Expert, in addition to the previous evidence of N.S.'s abuse and diversion, Reynolds had received an admission report on December 3, 2004 from Johnson City Medical Center (“JCMC”) which notified him that N.S. was hospitalized for a drug overdose the same day. GX 68, at 15; GX 2, at 126-28. He also received notification from JCMC upon N.S.'s discharge on December 7, 2004. GX 2, at 158-61; GX 68, at 16. Reynolds evidently reviewed the report, as his signature marking appears at the bottom of the report's first page. GX 2, at 158. Notably, not only did the report state that N.S. had been admitted for a drug overdose, it also stated that N.S. had a history of multiple prior drug overdoses, the last one being in May 2004, one month before her first AMC visit, and a history of multiple suicide attempts. Id. at 126-27; 158-59.

    Of further significance, the report listed two different primary care physicians for N.S., one of whom, Dr. Michael Dube, was not an AMC practitioner. Id. at 159. Also, the report stated that she was taking Lortab, a combination drug containing hydrocodone (which was then a schedule III controlled substance); Xanax, a schedule IV controlled substance; and Soma (carisoprodol), which was not federally scheduled at that time. Id. at 158. However, Reynolds had not previously prescribed any of these three drugs to N.S. See generally GX 2.

    The report also stated that a urine toxicology test was performed on N.S. and that she tested positive for opiates and benzodiazepines. Id. at 159. However, as before, AMC had not prescribed any benzodiazepines to N.S. As the Expert explained, the report should have been another enormous red flag to Reynolds that N.S. was continuing to abuse and divert controlled substances and was engaging in doctor-shopping by obtaining controlled substances from multiple sources (AMC and Dr. Dube), another red flag of drug-seeking behavior. GX 68, at 16.

    As of the December 29 visit, Reynolds also was aware that the physician who treated N.S. at JCMC had, three weeks earlier, discharged N.S. to Indian Path Pavilion (“IPP”), a local, in-patient mental health facility. See GX 2, at 160. In addition, on December 23, AMC received a fax showing that on December 21, N.S. had been admitted again to IPP for “polysubstance abuse.” See GX 2, at 153-56. Thus, as of N.S.'s December 29 visit, Reynolds was on notice that she may have suffered two overdoses in an approximately three-week period, that these would have been the latest of several overdoses she had suffered, and that she had been sent for mental health treatment on each of those two occasions. GX 68, at 17.

    However, on reviewing N.S.'s patient file, the Expert found (as do I) that Reynolds did not contact: (1) The JCMC to obtain its records of N.S.'s multiple previous overdoses; (2) Dr. Dube to obtain records of the nature and extent of the treatment he had provided N.S., including the controlled substances he had prescribed her, (3) the IPP to obtain records regarding N.S.'s December 21, 2004 admission to that facility for polysubstance abuse; and/or (4) the pharmacy N.S. was using to fill her prescriptions to determine if she was obtaining controlled substances prescriptions from other practitioners. Id. According to the Expert, the standard of care and usual course of professional practice for a family nurse practitioner required that Reynolds obtain all of this information about N.S.'s history of overdoses, her suicide attempts, and her current hospitalizations, as well as information about other practitioners from whom she may have been obtaining controlled substance prescriptions, in order to determine the proper course to take in her care. Id.

    As the Expert previously explained, a family practice nurse practitioner is not qualified to treat the complex issues presented by this type of patient. Thus, the Expert also explained that in light of the information contained in the December 3, 2004 JCMC and the December 21, 2004 IPP admission reports, the standard of care in Tennessee required that Reynolds cease all further controlled substance prescriptions (which he already should have), send N.S. to an out-patient or in-patient detoxification program and refer her to a pain management specialist. Id. at 18. Thus, the Expert concluded that the issuance of the December 29, 2004 Avinza prescription was outside the usual course of professional practice and lacked a legitimate medical purpose. Id.

    Nevertheless, from January 2005 through June 2005, Reynolds continued to see N.S. at AMC on a monthly basis and continued to issue her monthly prescriptions for Avinza 60 mg. See GX 2, at 86-96; GX 3, at 76-79. According to the Expert, the issuance of each of these prescriptions was below the standard of care and outside the usual course of professional practice as well. GX 68, at 18. As the Expert explained, N.S. should not have been treated and prescribed controlled substances at a family practice in light of the drug abuse and diversion issues she presented, and should have been referred to a specialist. Id.

    According to the Expert, on January 1, 2005, the Board of Nursing's Rule 1000-04-.08 went into effect. Id. As a result, Reynolds was required to comply with the controlled substance prescribing guidelines contained in that Rule. However, as of January 6, 2005, Reynolds still had not obtained any information about her treatment history for the three years immediately preceding her first AMC visit on June 8, 2004. See TN BON Rule 1000-04-.08(4)(C)1; see also generally GX 2; GX 68, at 18. Moreover, Reynolds did not create a written treatment plan for N.S.; nor did he document that he had considered the need for further testing, consultations, referrals, or the use of other treatment modalities. GX 2; GX 68, at 18.

    As the Expert explained, under the new Rule, Reynolds was required to create and maintain a “written treatment plan tailored for the individual needs of the patient” that “include[d] objectives such as pain and/or improved physical and psychological function” and was required to “consider the need for further testing, consultations, referrals, or use of other treatment modalities dependent on patient response[.]” GX 68, at 18 (quoting TN BON Rule 1000-04-.08(4)(c)2). As found above, in December 2004, the JCMC and IPP had forwarded to Reynolds information establishing that N.S. had a substantial history of substance abuse which had resulted in multiple drug overdoses and suicide attempts. Based on the results of the July 2004 UDS, he also had information that N.S. may not have been taking the Avinza and possibly was diverting the drug and that she was taking cocaine and benzodiazepines which had not been prescribed by his clinic. GX 68, at 19. The Expert thus concluded that Reynolds did not comply with the Rule and acted outside of the usual course of professional practice when he issued the Avinza prescription to N.S. Id.

    The evidence further shows that beginning on February 8, 2005, Reynolds added Xanax 1 mg. to N.S.'s controlled substance regimen. See GX 2, at 94; GX 3, at 77-79. Reynolds issued this prescription after diagnosing N.S. with “Major Depressive Disorder” and “GAD,” the latter being an abbreviation for “Generalized Anxiety Disorder.” The Xanax prescription issued on February 8, 2005 was the first of numerous Xanax prescriptions N.S. received from Reynolds, Stout, and Killebrew over the course of the next five years. See GX 2.

    According to the Expert, the decision of the nurse practitioners to address N.S.'s mental health issues by prescribing Xanax, was below the standard of care and outside the usual course of professional practice. GX 68, at 19. As support for her opinion, the Expert cited a treatise which she stated was generally recognized and accepted as authoritative by Tennessee family practitioners. Id. at 19-20 (citing Constance R. Uphold & Mary Virginia Graham, Clinical Guidelines in Family Practice, 4th Ed. (2003) (hereinafter, “Uphold & Graham”)). This treatise was submitted as part of the record. See GX 41.

    The Expert explained that “according to Uphold & Graham, benzodiazepines, such as Xanax, are effective only for the short-course treatment of generalized anxiety disorder, or GAD, and family practitioners were cautioned against the use of this class of drugs for greater than a two week period because they carry `the risk of dependence and withdrawal syndrome.' ” Id. at 20 (quoting GX 41, at 8). The Expert then noted that “Uphold & Graham further instructs that if the patient's `anxiety [is] associated with another psychiatric condition, most often depression,' the patient `should be treated for the primary problem,' and `most patients in this category should be referred to a specialist if possible.' ” GX 68, at 20 (quoting GX 41, at 9). Additionally, “Uphold & Graham instructs that for `patients with anxiety that is substance-induced' whether by licit or illicit drugs, family nurse practitioners are to `provide the patient with counseling/referral to a drug detoxification program.' ” Id. According to the Expert, “Uphold & Graham emphasizes that two of the `categories of patients [who] should be referred to specialists for treatment' are `[t]hose with high suicide risk' and `[p]atients with comorbid conditions (primary anxiety disorder, substance abuse, dementia).' ” Id. (quoting GX 41, at 14).

    Thus, based on Uphold & Graham, the Expert concluded that “even assuming N.S. could have been treated for her purported major depressive order in a primary care setting, which she could not, she should not have been started on a benzodiazepine such as Xanax.” Id. (citing GX 41, at 15). The Expert further noted that AMC asserted that its protocols were based on the Uphold & Graham Guidelines. Id. at 19-20 (citing GX 39).

    According to the Expert, Reynolds, Stout, and Killebrew were required under Tennessee law to evaluate N.S. for a continuation or change of her medications at each periodic interval at which they evaluated her. GX 68, at 21; BON Rule 1000-04-.08(4)(c)4. However, while Xanax is a highly abused and diverted drug in Tennessee, Reynolds, Stout and Killebrew prescribed Xanax to N.S., “at numerous periodic intervals over the course of the next several years and in the face of mounting evidence of her abuse of controlled substances, and without referring her for treatment by a specialist.” GX 68, at 21. The Expert thus concluded that the prescriptions issued by the three nurse practitioners fell well below the standard of care and outside the usual course of their professional practice. Id.

    On July 1, 2005, Reynolds issued N.S. prescriptions for 30 capsules of Avinza 60 mg and 60 tablets of Xanax 1 mg. See GX 2, at 86; GX 3, at 79. Reynolds issued these prescriptions even though he had not obtained the results of the UDS he ordered for N.S. during her June 1, 2005 AMC visit (and apparently never did based on a review of N.S.'s patient file). See GX 2, at 87. In fact, N.S.'s patient file does not contain any record of her even having been administered the UDS. GX 68, at 21; see also GX 2.

    In the Expert's opinion, Reynolds' issuance of these prescriptions was below the standard of care and outside the usual course of professional practice. GX 68, at 21. Based on the evidence of N.S.'s abuse and diversion of controlled substances set forth above, and the fact that Reynolds had not obtained the results for the UDS he ordered at N.S.'s previous visit, the standard of care and usual course of professional practice under these circumstances would not have been to issue N.S. further controlled substances prescriptions. Id. at 22. Instead, it would have been to locate the results, and if she had not taken the UDS, which would be a red flag based on her history, require her to provide one and cease all further controlled substances prescribing until the results could be reviewed. Id. (citing Board Rule 1008-04-08(2) & (4) (c)(2)).

    Likewise, on August 2, 2005, Mr. Reynolds issued N.S. prescriptions for 30 capsules of Avinza 60 mg and 60 tablets of Xanax 1 mg, each of which was for a thirty-day supply. See GX 2, at 85; GX 3, at 79. A note in the record of her August 2, 2005 visit states, “Pt. called to request refill on Xanax. Stated she had taken all she had before due date. Script written for Xanax.” GX 2, at 85 (emphasis added). Yet notwithstanding the extensive evidence that N.S. was abusing and diverting controlled substances, Reynolds issued her the prescription and did not refer her to an outside specialist to address her aberrant behavior. See, e.g., GX 41, at 8-9, 14 (Uphold & Graham). The Expert thus concluded that Reynolds' issuance of the prescription was below the standard of care and outside the usual course of professional practice. GX 68, at 22-23.

    Twenty days later, on August 22, 2005, Mr. Reynolds issued N.S. a prescription for 20 tablets of Xanax 0.5 mg. See GX 2, at 84; GX 3, at 80. According to the Expert, this prescription was an extremely early refill, specifically, ten days early, in light of the fact that he had just issued N.S. a thirty-day supply of 60 tablets of Xanax 1 mg on August 2, 2005, and was further evidence that N.S. was either abusing the Xanax by taking extra pills in contravention of his directions, or was diverting the drugs he was prescribing to her. GX 68, at 23.

    Moreover, on September 2, 2005, Mr. Reynolds issued N.S. prescriptions for 30 capsules of Avinza 60 mg and 60 tablets of Xanax 1 mg. See GX 2, at 82; GX 3, at 81. According to the Expert, Reynolds was then aware that N.S. had apparently not complied with his August 24, 2005 request for her to come into AMC for a pill count. See GX 68, at 24; GX 2, at 83. The Expert then explained that the failure of a patient to comply with a practitioner's request for a pill count, which is another tool utilized to monitor the patient's compliance with a controlled substances regimen, is another red flag of possible abuse and/or diversion. GX 28, at 24.

    On October 3, 2005, Mr. Reynolds issued N.S. a prescription for 75 tablets of Xanax 1mg and 60 capsules of Kadian (a brand name for morphine) 30 mg. See GX 2, at 80; GX 3, at 81. N.S.'s file contains a handwritten note dated September 13, 2005, which was just eleven days after Reynolds had prescribed to her a thirty-day supply of 60 tablets of Xanax 1 mg, stating, “Pt requested Xanax 1 mg TID for anxiety attacks.” GX 68, at 25; GX 2, at 81. As of this date, Reynolds was aware that N.S. should have had 19 days of Xanax tablets remaining from the September 2nd prescription, and thus, she was requesting additional Xanax well before she should have consumed the prior prescriptions and was also requesting an increase from two (i.e., “BID”) to three tablets a day (i.e., “TID”). GX 68, at 25.

    On November 1, 2005, Registrant Stout issued his first controlled substance prescriptions to N.S.; the prescriptions were for 75 tablets of Xanax 1 mg and 60 capsules of Kadian 30 mg. See GX 2, at 79; GX 3, at 82. According to the Expert, because this was N.S.'s. first visit with Stout, it was incumbent on him to review N.S.'s file before he issued her controlled substances prescriptions, so that he could determine the appropriate course of treatment. GX 68, at 26. Noting that under Board Rule 1000-04-.08, Stout was required to “evaluate[ ] the patient for continuation or change of medications” and to include in the patient record “progress toward reaching treatment objectives, any new information about the etiology of the pain, and an update on the treatment plan,” the Expert explained that an Advanced Practice Nurse cannot evaluate a patient for the continuation or change of medications, or determine the progress the patient is making towards reaching treatment objectives, or even know what the patient's treatment objectives are, without knowing the patient's treatment history. Id.

    The Expert thus concluded that when Stout issued N.S. the Xanax and Kadian prescriptions, he should have been aware of N.S.'s prior abuse and diversion of controlled substances which was documented in her patient file. Id. Based on N.S.'s history, the Expert further concluded that the standard of care and usual course of professional practice under these circumstances would not have been for Mr. Stout to issue her further controlled substances prescriptions but to cease further prescribing and refer her to an outside specialist to address her aberrant behavior. Id. at 26-27 (citing GX 41, at 8-9, 14) (Uphold & Graham).

    On July 20, 2006, Applicant Killebrew issued her first controlled substances prescriptions to N.S.; the prescriptions were for 75 tablets of Percocet 7.5/325 mg (oxycodone/acetaminophen, a schedule II controlled substance), and 60 tablets of Xanax 0.5 mg. See GX 2, at 76; GX 3, at 84. For the same reasons she identified in her discussion of the validity of Stout's initial prescriptions to N.S., the Expert found that Killebrew's prescriptions were below the standard of care and outside the usual course of professional practice. GX 68, at 27.

    The Expert further noted that this was N.S.'s first visit to AMC in nearly eight months, (her last visit having been a Dec. 1, 2005 visit with Reynolds), and that Killebrew had noted in the record of this visit that N.S. was “[j]ust released from jail 7/6/06 . . . requesting to be put back on pain meds she was on for back and neck pain.” Id. at 27-28 (citing GX 2, at 76). The Expert noted, however, that Killebrew did not document having asked N.S. about the reason for her incarceration, specifically, whether it was drug-related, whether she was on probation, and, if so, whether her probationary status may have prohibited her from possessing controlled substances. GX 68, at 28. Nor did Killebrew document having asked N.S. about how she had addressed her alleged pain during her incarceration when she had told Killebrew that she was not receiving any pain medications. Id. According to the Expert, given N.S.'s history, the standard of care and usual course of professional practice under these circumstances, would not have been to issue her additional controlled substances prescriptions but to refer her to a pain management practice to address her purported back and neck pain and possible continuing substance abuse. Id. (citing GX 41, at 8-9, 14) (Uphold & Graham).

    On August 17, 2006, Stout prescribed N.S. 75 tablets of Percocet 7.5/325 mg and 60 tablets of Xanax 0.5 mg. See GX 2, at 75; GX 3, at 87. According to the medical record, on July 19, 2006, less than a month before he issued N.S. these prescriptions, Stout had treated N.S. while he was working in the North Side Hospital emergency room (“ER”). See GX 16, at 2-3. According to North Side's records, N.S. presented to the ER on that date complaining of neck pain from a fall. Stout noted in the record for the ER visit that N.S. “[r]efused meds . . . Wants stronger narcotics. Admits to having long history of drug abuse. . . .” In the “Impressions” section of this report, Stout had also noted that N.S. displayed “[d]rug seeking behavior.” Id.

    Moreover, N.S.'s AMC record included the note for her July 20 visit (the day after Stout saw her in the ER). Thus, the Expert found that Stout should also have been aware that N.S.'s previous visit was her first visit to AMC in seven months and that she had just been released from jail and had requested to be put back on pain medications. GX 68, at 29; GX 2, at 76. The Expert further explained that “[a]s was the case with N.S.'s visit with Killebrew, Stout did not question N.S. as why she had been incarcerated . . . whether it was drug-related, whether she was on probation, and, if so, whether her probationary status may have prohibited her from possessing controlled substances. He also did not question N.S. about how she had been addressing her alleged pain during her incarceration when she, based on her own report to Killebrew, had not received pain medications.” GX 68, at 29. Based on these circumstances (including the amply documented history of N.S.'s abuse and/or diversion), the Expert found that Stout's issuance of these prescriptions was below the standard of care and outside the usual course of professional practice. Id.

    On October 11, 2006, Stout again saw N.S. and issued her additional prescriptions for 75 tablets of Percocet 7.5 mg and 60 tablets of Xanax 0.5 mg. See GX 2, at 71, 73; GX 3, at 88. In addition to the previous documented incidents of N.S.'s abuse and/or diversion, N.S.'s file contained a note dated September 13, 2006, stating, “[N.S.] selling perocet's (sic.).” See GX 2, at 74. Moreover, in the record of the visit, Stout wrote, “Confronted PT about ? selling meds. PT denies. States meds were stolen. Will do UDS today. Advised PT if UDS (-) drugs/abuse found would d/c. Has been taking meds for past week per pt.” See GX 2, at 71, 73. Also, Stout had N.S. sign a Pain Management Agreement (“PMA”), which he and another AMC employee witnessed, and then issued her the controlled substance prescriptions. See GX 2, at 11-12.

    According to the Expert, the fact that N.S. denied selling her drugs should not have overcome the evidence in her file, including the recent note of the report that she was selling her drugs and the extensive evidence of her history of abuse and/or diversion of controlled substances. GX 68, at 30. The Expert thus concluded that Stout's issuance of these prescriptions was below the standard of care and outside the usual course of professional practice. Id.at 29-30 (citing GX 41, at 8-9, 14 (Uphold & Graham)).

    The UDS results showed that N.S. tested negative for oxycodone/oxymorphone, despite the fact that she had been receiving oxycodone (Percocet) prescriptions from AMC on a monthly basis since July 20, 2006. See GX 2, at 71-75, 105-107; see also GX 3, at 4-5. The results also showed that N.S. tested positive for hydrocodone/hydromorphone, even though no one at AMC had prescribed those drugs to her since she had returned to the practice. GX 2, at 107.

    On November 10, 2006, Reynolds saw N.S. and issued her additional prescriptions for 75 tablets of Percocet 7.5 mg and 60 tablets of Xanax 0.5 mg. See GX 2, at 70; GX 3, at 91. In addition to the various recent notes in her file, Reynolds should have been aware of the October 18, 2006 results of the UDS administered to N.S. at the October 11, 2006 visit. As the Expert explained, based on the UDS results, Reynolds was aware that N.S. had lied to Stout during her October 11, 2006 visit when she told him that she was taking her pain medications, and that she was likely selling her Percocet because she tested negative for this drug. GX 68, at 31. In addition, Reynolds was aware of Stout's warning to N.S. during her October 11, 2006, visit that she would be discharged (“d/c”) if the results were negative (which they were for oxycodone), or if she was found to be abusing drugs, which was established by her testing positive for hydrocodone, a drug that she had not been prescribed at AMC. Id. at 32.

    The Expert thus found that the UDS results were further evidence of N.S.'s continued abuse and/or diversion of controlled substances. Id. at 31. The Expert further opined that the standard of care and usual course of professional practice under these circumstances would not have been to issue N.S. further controlled substance prescriptions, but to discharge her from the practice and to refer her to a pain management practice to address her purported pain issues or a substance abuse/addiction specialist to address her likely substance abuse issues. Id. at 32. Thus, the Expert concluded that Reynolds' issuance of these prescriptions was below the standard of care and outside the usual course of professional practice. Id. at 31 (citing GX 41, at 8-9, 14) (Uphold & Graham)).

    On December 11, 2006, Stout issued N.S. prescriptions for 75 tablets of Percocet 7.5 mg and 60 tablets of Valium 5 mg. See GX 2, at 69; GX 3, at 91. At the time of the visit, Stout had received the results of the UDS and was aware that N.S. had lied to him during her October 11, 2006 visit, when she told him she was taking her pain medications. N.S.'s patient record shows that Stout attempted to refer N.S. to two different pain management practices at this visit—“Appalachian Pain Rehab” (Dr. Tchou) and “Pain med associates.” See GX 2, at 67. However, N.S. had apparently already been seen at those two practices and neither practice was willing to again accept her as a patient.6 Id.

    6 Notes in the file state that N.S. “has been double dotted” at Appalachian Pain Rehab, which “means won't see,” and that N.S. “already has been to Pain med associates + can't be seen there either!!” GX 2, at 67.

    According to the Expert, this additional information should have been another red flag that N.S. was abusing and or diverting controlled substances. GX 68, at 33. The Expert thus concluded that under the circumstances, the standard of care and usual course of professional practice would not have been to issue N.S. more prescriptions, but to enforce the terms of the Pain Management Agreement and to follow through on the warning Stout had given N.S. during her October 11 visit that she would be discharged from AMC if she failed the UDS. Id. Additionally, the standard of care and usual course of professional practice would have been to attempt to refer N.S. to a mental health or an addiction specialist to address her purported pain issues and her likely substance abuse issues. Id. at 33-34 (citing GX 41, at 8-9, 14 (Uphold & Graham excerpts)). Yet Stout failed to either discharge her or refer her to a specialist.

    On February 27, 2007, Reynolds issued N.S. prescriptions for 75 tablets of Percocet 7.5 mg and 60 tablets of Xanax .5 mg. See GX 2, at 66; GX 3, at 93. At the time of the visit, Reynolds was aware of the December 11, 2006 notes stating that neither Appalachian Pain Rehab nor Pain Med Associates would see N.S. See GX 2, at 67. For the same reasons discussed above, the Expert concluded that Reynolds' issuance of the prescriptions was well below the standard of care and outside of the usual course of professional practice. GX 68, at 32.

    On June 1, 2007, Reynolds issued N.S. additional controlled substances prescriptions for 90 tablets of MS Contin 30 mg and 90 tablets of Xanax 0.5 mg. See GX 3, at 96. Notwithstanding that the quantity of both prescriptions had been increased by fifty percent from N.S.'s previous visit, her patient file does not contain a record of Reynolds having seen her on this date, nor any information as to why N.S. was not seen on this occasion. See GX 2, at 63-64. Based on the other documented evidence of N.S.'s abuse and/or diversion, the Expert concluded that Reynolds' issuance of these prescriptions was below the standard of care and outside the usual course of professional practice. GX 68, at 34-35 (citing Rule 1000-04-.08(4)(c) (requiring periodic re-evaluation for continuing or changing control substance prescriptions)).

    On July 2, 2007, after N.S. called in and said she had run out of prescriptions the day before, Killebrew directed that prescriptions be called in for 40 tablets of Lortab 10 mg (hydrocodone/acetaminophen) and 30 tablets of Xanax 0.5 mg. See GX 2, at 63; GX 3, at 96. While Killebrew should have been aware of N.S.'s extensive history of abuse and diversion, according to N.S.'s patient file, she issued these prescriptions without requiring that N.S. come in for an office visit and after being notified that N.S. had called AMC and requested new prescriptions because she was out of her medications. See GX 2, at 63. The Expert further noted that N.S. evidently had not been seen at AMC since her May 3, 2007 office visit and that this was a further red flag given N.S.'s history. GX 68, at 35. Moreover, once again, there is no information in the file documenting why N.S. could not have been seen. Id. The Expert thus concluded that the issuance of the prescriptions was below the standard of care and outside of the usual course of professional practice. Id.

    On November 16, 2007, Reynolds issued N.S. prescriptions for 30 tablets of Lortab 10 mg and 30 tablets of Xanax 0.5 mg. See GX 2, at 52; GX 3, at 102. The Expert found that N.S. was seeking an early refill of her controlled substances, because fifteen days earlier, Reynolds had prescribed her thirty-day supplies of 90 tablets each of Xanax 0.5 mg, MS Contin 30 mg, and Percocet 7.5/500 mg, each of which had a dosing of “one po tid,” or one tablet three times per day. See GX 68, at 36; GX 2, at 53-54; GX 3, at 102. N.S.'s early refill request presented another red flag of her potential abuse and/or diversion of controlled substances, which Reynolds ignored. GX 68, at 36. Moreover, N.S.'s Pain Management Agreement stated that “medications taken early due to reasons not discussed with your provider [will not] be replaced early.” GX 2, at 5. Yet Reynolds did not enforce the Pain Management Agreement. GX 68, at 36.

    The Expert also concluded that given N.S.'s numerous prior red flags of drug abuse and diversion, Reynolds should have taken steps to determine if she was in fact taking the drugs he had been prescribing, or if she was diverting them. Id. at 37. The Expert explained that Reynolds should have required her to submit to a UDS, and that he also should have checked the Tennessee Controlled Substances Monitoring Database (“CSMD”), which became available on January 1, 2007, in order to determine if she possibly was doctor-shopping. Id. The Expert also noted that Reynolds did not ask why she was seeking an early refill. Id. The Expert thus concluded that Reynolds' issuance of these prescriptions was below the standard of care and outside the usual course of professional practice. Id. at 36-37 (citing Board Rule 1000-04-.08(4)(c) (2) & (4) and GX 41, at 8-9, 14 (Uphold & Graham)).

    On January 3, 2008, Reynolds issued N.S. a prescription for 90 tablets of MS Contin 30 mg, 90 tablets of Xanax 0.5 mg, and 30 tablets of Percocet 7.5 mg. See GX 2, at 47-48; GX 3, at 103. According to her file, on November 30, 2007, N.S. had called and sought an early refill. Moreover, documentation in her file establishes that Reynolds should have known (having received reports on both December 22 and 26), that on December 22, N.S. had been admitted to JCMC and diagnosed with, among other conditions, “polysubstance abuse.” See GX 2, at 139-140. Here again, the Expert found that Reynolds' issuance of these prescriptions was below the standard of care and outside the usual course of professional practice and that she should not have been issued any further controlled substance prescriptions. GX 68, at 37 (citing GX 41, at 8-9, 14 (Uphold & Graham)).

    On December 22, 2008, Killebrew issued N.S. prescriptions for 60 tablets of Lortab 7.5 mg and 30 tablets of Xanax 0.5 mg. See GX 2, at 40-41; GX 3, at 106. Notably, the chart indicates that this was N.S.'s first visit to AMC since February 2008 because she was pregnant, see GX 2, at 42-44, and that during the intervening ten months N.S had reportedly been receiving Suboxone/Subutex treatment from another practitioner and apparently had been able to function during the previous ten months without the need for Lortab and Xanax. Id. at 40.

    According to the Expert, based on N.S.'s representations, Killebrew should have taken steps to determine whether N.S. had a legitimate medical need for these drugs prior to prescribing them. GX 68, at 38-39. The Expert explained that the usual course of professional practice would have been for Killebrew to determine the name of the practitioner who had provided Suboxone treatment to N.S. and contact that practitioner to determine the nature and extent of the treatment and to obtain a copy of the records. Id. at 39. The Expert also opined that given N.S.'s history of red flags, Killebrew should have run a check of the Tennessee CSMD to determine if her representations were accurate and to ensure that N.S. was not doctor-shopping. Id. However, according to N.S.'s file, Killebrew did not do so. GX 2. The Expert also found that Killebrew did not document any new illness or injury to N.S. as of this visit. GX 68, at 39. Also, on review of N.S.'s record, the Expert concluded that Killebrew had performed a cursory physical exam and that the lack of additional diagnostics or further evaluation by Killebrew further demonstrates that she failed to establish N.S.'s need for controlled substances at this visit. Id. Thus, the Expert concluded that Killebrew's issuance of these prescriptions was below the standard of care and outside the usual course of professional practice. Id. at 38-39 (citing TN BON Rule 1000-04-.08(4)(c)1, 2, and 4).

    On June 4, 2009, Reynolds prescribed N.S. 60 tablets of MS Contin 30 mg, 30 tablets of Percocet 7.5 mg, and 90 tablets of Xanax 0.5 mg. See GX 2, at 38-39; GX 3, at 107. Significantly, Reynolds issued the prescriptions notwithstanding that N.S. had not been seen at AMC since her December 22, 2008 visit with Killebrew. See GX 2, at 40-41. Moreover, the record of the June 4, 2009 visit does not contain any documentation of what N.S. had been doing to treat her purported pain over the course of the previous five plus months. Id. at 38-39. The Expert also found that Reynolds should have been aware that N.S.'s December 22, 2008 visit had been her first visit to AMC since February 2008, after she had called AMC and informed staff that she was two months pregnant and had destroyed her medications. GX 68, at 39-40.

    As with the previous visit, the Expert explained that the usual course of practice would have been for Reynolds take steps to determine whether N.S. had a legitimate medical need for the drugs prior to prescribing them. Id. at 40. These steps included asking N.S. what she had been doing over the past six months to address her purported pain and, given her history of abuse and diversion, running a check of the Tennessee CSMD to determine if she had been obtaining controlled substances from any other practitioners over the past six months. Id. However, according to N.S.'s file, Reynolds did not conduct such a check. GX 2. The Expert thus concluded that Reynolds' issuance of these prescriptions was below the standard of care and outside the usual course of professional practice. GX 68, at 39-40 (citing TN BON Rule 1000-04-.08(4)(c)(1, 2, 4)).7

    7 The Expert also explained that Reynolds' decision to issue N.S. controlled substances prescriptions on June 4, 2009 was contrary to the additional guidelines AMC was employing at that time as part of its practice protocols. GX 68, at 40. According to the Expert, she reviewed a February 23, 2010 letter Reynolds had sent to a Tennessee Department of Health Investigator, as well as several documents that were enclosed with the letter, including copies of AMC's practice protocols. Id.; see also GX 39. The Expert noted that Reynolds stated in his letter that one of the attached documents was “a copy of the current treatment recommendations for chronic pain in the primary care setting as outlined by the American Family Physician in their [sic] November 2008 article `Chronic Nonmalignant Pain in Primary Care' ” which was authored by R. Jackman, J.M. Purvis, and B.S. Mallett (hereinafter, “Jackman article”). GX 68, at 40-41. According to Reynolds, AMC “currently [is] referencing this article in our charting notes and intend to add these guidelines as an Addendum to our protocols when they are renewed in July 2010.” GX 39, at 1. In his record of N.S.'s June 4, 2009 visit, Reynolds wrote: “[t]his patient's pain has been approached with specific attention to the American Family Physician's November 2008 analysis that indicates nonmalignant pain should be addressed in the primary care setting.” GX 2, at 38.

    The Expert noted that her review of N.S.'s file found that Reynolds overlooked several recommendations contained within that article. GX 68, at 41. These included the article's statement that “[o]pioids pose challenges with abuse, addiction, diversion, lack of knowledge, concerns about adverse effects, and fears of regulatory scrutiny. These challenges may be overcome by adherence to the Federation of State Medical Board's guidelines, use of random urine drug screening, monitoring for aberrant behaviors, and anticipating adverse effects.” See id. (quoting GX 39, at 5). The Expert further noted that the article also states that “[w]hen psychiatric comorbidities are present, risk of substance abuse is high and pain management may require specialized treatment or consultation. Referral to a pain management specialist can be helpful,” and that the evaluation of the patient must include “[a] thorough social and psychiatric history [that] may alert the physician to issues, such as current and past substance abuse, development history, depression, anxiety, or other factors that may interfere with achieving treatment goals.” Id.

    The Expert also noted the article's statement that “[f]or patients at high risk of diversion and abuse, consider the routine use of random urine drug screens to assess for presence of prescribed medications and the absence of illicit substances.” GX 68, at 42 (quoting GX 39, at 9 of 22) (emphasis added). Finally, the Expert noted the article's statement that “[a]berrant behavior that may suggest medication misuse includes use of pain medications other than for pain treatment, impaired control (of self or of medication use), compulsive use of medication . . . selling or altering medications, calls for early refills, losing prescriptions, drug-seeking behavior (e.g. doctor-shopping), or reluctance to try nonpharmacologic intervention.” Id. (quoting GX 39, at 11) (emphasis added).

    On November 11, 2009, Reynolds issued another prescription to N.S. for 14 tablets of Xanax 0.25 mg. See GX 2, at 25; GX 3, at 108. According to N.S.'s file, N.S. sought a refill claiming that the Xanax Reynolds had prescribed to her on October 29, 2009 had been stolen. GX 2, at 25. According to the Expert, a patient reporting that her controlled substances were stolen is another classic red flag of a patient's potential abuse and/or diversion of controlled substances. GX 68, at 43 (citing GX 39, at 11 (Jackman article's examples of aberrant behavior)).

    According to the Expert, the standard of care and the usual course of professional practice would have been for Reynolds to enforce the terms of N.S.'s Pain Management Agreement, and refuse to provide her additional controlled substances. GX 68, at 43-44 (quoting GX 2, at 5; “Lost or stolen medicines will not be replaced”). Also, according to the Expert, Reynolds should have required N.S. to submit to a UDS, and to run a check of the CSMD to determine if N.S. was engaged in diversion. GX 68, at 44. According to N.S.'s file, Reynolds did not take either action and simply issued her an additional Xanax prescription for 36 tablets of .25 mg. GX 2, at 25; GX 3, at 70. The Expert thus concluded that Reynolds' issuance of the prescription was below the standard of care and outside the usual course of professional practice. GX 68, at 43-44.

    According to N.S.'s file, her visits to AMC ended in February 2010 after a nearly six-year relationship with the practice. GX 2. Summarizing her findings, the Expert noted that while during that time, N.S. presented numerous red flags of abuse and diversion, the monitoring of her controlled substances use by Reynolds, Stout, and Killebrew was woefully inadequate, and far below the standard of care in Tennessee. GX 68, at 44. The Expert also observed that over the course of nearly six years, N.S. was only asked to provide two UDSs, both of which she failed by testing positive for a drug she had not been prescribed at AMC (including cocaine on one of the tests), and testing negative for the drug which she had been prescribed. Id.

    The Expert also noted that N.S. was required to come into AMC for but a single pill count, and there was no documentation showing that she even complied with the request. Id. The Expert then noted that even though the CSMD had been available since January 1, 2007, the only time N.S.'s prescription history had been checked was on the date of her last visit in February 2010. Id.; see also GX 2, at 129-131. The Expert also observed that there was no documentation that prior to the implementation of the CSMD, the practitioners had ever checked with N.S.'s pharmacy to ascertain whether she was engaged in drug-seeking or diversionary behavior. GX 68, at 44.

    The Expert concluded by observing that none of these steps were taken, notwithstanding that: (1) N.S. showed up at her second visit exhibiting somnolence and slurred speech; (2) failed the UDS that was administered at that visit, and (3) several months later, suffered a drug overdose that the practitioners learned was the latest of several prior drug overdoses, in addition to multiple prior suicide attempts. Id. at 44-45. As the Expert found, Reynolds, Stout, and Killebrew ignored numerous warning signs that N.S. was abusing and/or diverting controlled substances that continued throughout her nearly six-year association with AMC, and they continued to provide her with controlled substances when they knew or should have known that she was acquiring the controlled substances for other than legitimate medical purposes. Id. at 45.

    In a letter to a DEA Diversion Investigator, Reynolds addressed AMC's treatment of N.S. He asserted that N.S. was kept on the same medication that she had been prescribed by a neurosurgeon who had referred her to AMC. GX 42, at 7. Yet as the Expert noted, no such documentation exists in N.S.'s file.

    Reynolds did acknowledge that on December 3, 2004, N.S. was admitted to a local hospital by a Dr. James for a drug overdose; he also stated that she was subsequently “transferred to Indian Path Pavilion and continued on her then prescribed medications” and that “Dr. James added Soma and Lortab to the AMC regimen.” GX 42, at 7. However, Reynolds also asserted that after this incident, N.S. “never had another overdose incident while being treated at AMC” and “[s]he never again displayed signs of addiction to include requesting increases in medication without cause, going to numerous providers, aberrant behavior, contacting provider for medication after hours or on weekends, early refills, or refusal to follow plans of care.” Id. Finally, Reynolds further asserted that “[i]n October of 2006, she passed drug screens and observation by AMC providers.” Id.

    T.H.

    T.H.'s initial visit was on October 3, 2005. See GX 17, at 4, 47. According to the record of this visit, T.H. was seen by an AMC practitioner other than Reynolds, Stout, or Killebrew. He reported that he was suffering from back pain, but said that it was not due to trauma or injury. Id. at 47; see also id at 4 (report of “Back Pain”). T.H.'s record does not, however, quantify the extent of the pain he reported, nor document how long he had been suffering from back pain. Id. at 47. T.H. also reported a history of anxiety with panic attacks. Id. According to the intake paperwork that T.H. completed, he reported that he was not currently seeing any other provider, id. at 3, and also reported that he was not taking any drugs other than asthma medications. Id. at 4.

    According to the Expert, the record of T.H.'s first visit is noteworthy for the absence of any information about his history and potential for substance abuse. GX 68, at 45; GX 17, at 47. Also, the record does not contain a written treatment plan that documents objectives for evaluating progress from the use of controlled substances. GX 68, at 45; GX 17, at 47. As the Expert explained, all of these issues were required to be, but were not addressed before T.H. was prescribed controlled substances. GX 68, at 46 (citing TN BON Rule 1000-04-.08(4)(c)1 and 2).

    The Expert further found that the record of T.H.'s first visit revealed the first of several red flags of his potential abuse and/or diversion of controlled substances. Id. These included that on the initial intake form he completed, T.H. reported that he had “frequent or recurring problems” with alcohol. GX 17, at 4. He also reported that either he or a close family member had suffered from “Alcoholism” and “Mental Illness.” Id.

    According to the Expert, T.H.'s disclosure of issues with alcohol abuse and mental illness were red flags of his potential drug abuse; she also noted that the Pain Management Agreements which T.H. was required to sign provided that “[t]he use of alcohol and opioid medications is contraindicated.” GX 68, at 46 (citing GX 17, at 5). According to the Expert, T.H.'s disclosures should have been explored further by the nurse practitioner who saw him, but according to the record were not assessed. Id. The Expert further opined that without a further evaluation of these issues, the practitioner should not have issued T.H. a prescription for controlled substances. Id.

    The Expert also explained that if T.H. was in recovery from alcoholism, he should have been referred to a comprehensive pain specialist program, and should not have been treated by a primary care nurse practitioner. Id. As the Expert explained: “ `[p]atients who are alcohol dependent and who also have a psychiatric disorder should be referred for treatment for the underlying disorder as these patients are usually complex.' ” Id. (quoting GX 41, at 23 (Uphold & Graham)). Thus, according to the Expert, the decision to issue him any controlled substance prescriptions at this initial visit was contrary to the guidelines set forth in TN BON Rule 1000-04-.08(4)(c)1 & 2, and accordingly, below the standard of care in Tennessee and outside the usual course of professional practice. Id. at 46-47. Nonetheless, T.H. was issued prescriptions for 30 Lortab 7.5 mg and 30 Xanax .25 mg. GX 17, at 47.

    During his second visit on October 25, 2005, T.H. reported that he had recently lost his job and was looking for a new one. He also reported increased stress, that he was not sleeping, and that he was having “roller coaster feelings.” Id. at 46. According to the Expert, “the reported loss of income by a patient who is receiving opioids, such as hydrocodone (Lortab), is also a red flag of potential diversion. The practitioner must consider the risk that the patient may try to sell those drugs to generate the income he no longer is obtaining from his job.” GX 68, at 47. The Expert noted, however, that there is no documentation in the visit note that the issue of how he was going to pay for his treatments and medications was discussed, nor is there any evidence that T.H. was asked to submit to a UDS to see if he was taking the drugs he had been prescribed. Id.

    The practitioner also diagnosed T.H. as suffering from anxiety and depression. GX 17, at 46. According to the Expert, diagnosing the potential source of a patient's stress is critical in determining the appropriate course of treatment. GX 68, at 47. Thus, the decision to issue T.H. any controlled substance prescriptions at this visit based on the information he reported was contrary to the guidelines set forth in TN BON Rule 1000-04-.08(4)(c)1,2,4, and accordingly, below the standard of care and outside the usual course of professional practice. Id. (citing GX 41 (Uphold & Graham)). However, here again T.H. was issued prescriptions for 45 Lortab 7.5 mg and 30 Xanax .5 mg. GX 17, at 46.

    At T.H.'s third visit on November 28, 2005, the practitioner noted that he discussed marriage counseling, thus indicating that he was having marital problems. Id. at 45; GX 68, at 47. According to the Expert, this was another potential red flag with respect to the prescribing of opioids given T.H.'s reports of anxiety and depression, as well as his prior report that he had lost his job. GX 68, at 47-48. T.H. was referred to another provider (Dr. Williams), and directed to return for a follow-up visit in “2 months.” GX 17, at 45. He was also issued prescriptions 60 Lortab 7.5 mg and 30 Xanax .5 mg. Id.

    Nearly three months later on February 21, 2006, T.H. returned to AMC and saw Reynolds. See GX 17, at 43. In the interim, on December 5, 2005, T.H. was seen at Dr. T. Williams' pain clinic, Pain Medicine Associates. See GX 17, at 57-58; 45-46. John Powell, a Physician Assistant in Dr. Williams' clinic, identified a possible source of the “mechanical low back pain” that T.H. was reporting. GX 17, at 57. Notably, the pain clinic recommended that “facet blocks should be undertaken as a diagnostic procedure followed by radiofrequency denervation if positive.” GX 17, at 58. Also, the pain clinic recommended that T.H. be prescribed 90 tablets of Lortab 10 mg, one tablet three times a day, “until we can get the above accomplished.” Id. (emphasis added).

    Based on her review of the pain clinic's letter, the Expert concluded that the clinic had issued T.H. a prescription for a thirty-day supply of Lortab 10 mg to hold him over until he received the facet blocks. GX 68, at 48. In addition, and significantly, Mr. Powell documented that T.H. had again disclosed that he “had an alcohol problem in the past” and “still drinks occasionally.” GX 17, at 57. Furthermore, Mr. Powell noted that T.H.'s “chronic low back pain” had been going on for “two years.” Id.

    According to the record of his Feb. 21, 2006 visit, T.H. specifically “Requested Bob.” GX 17, at 43. The Expert found that the record of this visit is largely unintelligible due to Reynolds' incomprehensible handwriting. GX 68, at 48. However, there is no evidence in T.H.'s file that the facet blocks had been performed in the two and one-half months since he had seen Mr. Powell. Id.; see also GX 17. In fact, there is no evidence in the file that the facet blocks were ever done. GX 17. Also, there is no documentation of what, if anything, T.H. had been doing to address his pain for the past month when he would have been out of the drugs prescribed by Mr. Powell.8 See GX 68, at 48-49; GX 17, at 43.

    8 In his letter to the DI, Reynolds asserted that TH “returned to AMC on February 21, 2006 from pain management on long-term medication, Oxy[C]ontin, 40 milligrams, twice daily, and Lortab, 10 milligrams, #30. This medication was continued until the patient's death.” GX 42, at 4. There is, however, no evidence in T.H.'s file (such as a discharge summary form Pain Medicine Associates) which supports this assertion.

    Nonetheless, at the visit, Reynolds issued T.H. prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 10 mg, and 90 Xanax 1 mg. See GX 17, at 43; GX 5, at 13. According to the Expert, Reynolds' issuance of these prescriptions was contrary to the guidelines set forth in TN BON Rule 1000-04-.08 and, accordingly, below the standard of care in Tennessee and outside the usual course of professional practice. GX 68, at 49.

    According to the Expert, Reynolds lacked “an appropriate medical justification for adding a prescription for a schedule II controlled substance such as OxyContin 40 mg to treat [T.H.'s] purported pain,” given that the pain specialist (Mr. Powell) was of the opinion that “T.H. did not require anything more than a short-term prescription for Lortab [then a schedule III controlled substance], and for only as long as it took to get the facet blocks completed.” Id. Also, even though Reynolds was now aware (based on Mr. Powell's report) that T.H. had been having back problems for two years, there was still no documentation or records of any prior treatments he had received before he started at AMC in October 2005. See GX 68, at 49-50 (citing TN BON Rule 1000-04-.08(4)(c)1 (requiring documentation of historical data that includes “pertinent evaluations by another provider”)).

    The Expert also found that up to this point, neither Reynolds nor the AMC practitioner who had treated T.H. at his previous visits had adequately documented and evaluated his prior alcohol problems and the extent of his current consumption of alcohol. Id. at 49 (citing TN BON Rule 1000-04-.08(4)(c)1 (requiring documentation of historical data that includes “history of and potential for substance abuse”)). The Expert also found it significant that neither Reynolds nor his colleague had sufficiently explored T.H.'s psychological problems, specifically, the anxiety and increased stress that T.H. previously had reported despite circling “anxious” and “depressed” in the examination section of the record of this visit. Id. at 49-50 (citing TN BON Rule 1000-04-.08(4)(c)1 (requiring documentation of historical data that includes “pertinent coexisting diseases and conditions” and “psychological functions”)). And the Expert noted that Reynolds did not inquire about T.H.'s current employment status, which, in her view, could be significant if he was still unemployed. Id. at 49.

    The Expert observed that Reynolds' failure to evaluate these issues prior to issuing the Xanax prescription was contrary to AMC's own practice guidelines. Id. at 50. Specifically, the Expert explained that according to Uphold & Graham, “ `[s]ubstance abuse can also produce anxiety. . . . Anxiety can also occur as part of the withdrawal from the following: alcohol, cocaine, sedatives, hypnotics, anxiolytics.' ” Id. (quoting GX 41, at 5). Continuing, the Expert explained that according to Uphold & Graham, “ `[a]nxiety associated with other psychiatric disorders (depression and alcohol dependence) is common. Discriminating between an anxiety disorder and a depressive illness is quite difficult because of the overlap in symptoms.' ” Id. at 50 (quoting GX 41, at 6.) The Expert thus concluded that “without a detailed evaluation of T.H.'s anxiety and psychosocial history and substance abuse history (including a drug toxicology screen, or UDS), it was inappropriate for Mr. Reynolds to prescribe Xanax for the treatment for anxiety. He lacked any understanding of the etiology of that reported condition at that juncture.” Id.

    The Expert also explained that the combination and quantity of prescriptions Reynolds issued at the visit was further evidence that these prescriptions were not issued in the usual course of professional practice or for a legitimate medical purpose. Id. According to the Expert, “the combination of OxyContin and Lortab together would not be the next step for a patient with uncontrolled pain. In this situation, the patient's medication [was] escalated to a long-acting opioid, such as OxyContin 10 mg twice daily, which is done when pain management is expected to be for a prolonged period of time.” Id. at 50-51. The Expert then noted that Reynolds had prescribed a starting dose of 40mg twice daily, which is four times the normal starting dose, and that “when starting a patient on a long-acting opioid, a short-acting opioid may be used for break-through pain, but not typically at the initial prescribing of the long-acting medication.” Id. at 51.

    The Expert also explained that Lortab and OxyContin given in combination “may increase the risk of CNS and respiratory depression, profound sedation and hypotension,” and that Lortab and Xanax in combination “may increase risk of CNS depression and cause psychomotor impairment” due to additive effects. Id. Also, according to the Expert, OxyContin given in combination with Xanax may result in “vasodilation, severe hypotension, CNS and respiratory depression, [and] psychomotor impairment due” to additive effects. Id. Finally, the Expert noted that the dose and the amount of Xanax prescribed was excessive as it was six times the total daily dosage of T.H.'s previous prescriptions and could be lethal, especially if taken in combination with two opioids. Id.

    Citing Reynolds' failure to perform a proper evaluation of T.H., the illogical and potentially dangerous escalation of opioid and benzodiazepine dosages in the prescriptions he issued, and the red flags of potential drug abuse and diversion that T.H. presented, the Expert concluded that the prescriptions he issued to T.H. at this visit were below the standard of care for a primary care provider and outside the usual course of professional practice. Id.

    On March 22, 2006, T.H. returned for a follow-up visit and saw Stout. See GX 17, at 42. The Expert found that the record of this visit was sparse, as “Stout simply noted that T.H. was “[h]ere for a follow-up. Denies recent trauma or illness. No fever, chills, nvd,” and then circled entries on the record indicating that T.H. was anxious, depressed, and had lower back pain and cervical pain. GX 68, at 51.

    Stout issued T.H. additional prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 10 mg, and 60 tablets of Xanax 1 mg. See GX 17, at 42; GX 5, at 13. However, the Expert found that Stout did not document any evidence of the appropriateness of therapy by failing to quantify or evaluate T.H.'s pain and that there was also no information provided about the efficacy of the medications or the functionality of the patient. GX 68, at 52 (citing TN BON Rule 1000-04.08(4)(c)). The Expert also noted that while Stout acknowledged that T.H. was anxious and depressed, the visit notes had no additional information about the psychosocial situation of the patient. Id.

    The Expert also observed that Stout did not generate a written treatment plan for T.H. and, as such, there was still no written treatment plan for T.H. Id. (citing TN BON Rule 1000-04.08(4)(c)2). Nor did Stout evaluate or assess T.H.'s history of, or potential for, substance abuse. Id. (citing TN BON Rule 1000-04.08(4)(c)1). The Expert thus concluded that these prescriptions were issued contrary to the guidelines set forth in TN BON Rule 1000-04-.08(4)(c) and, accordingly, below the standard of care and outside the usual course of professional practice. Id.

    On April 21, 2006, T.H. returned to AMC and saw Reynolds, who issued him more prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 10 mg, and 60 tablets of Xanax 1 mg. See GX 17, at 41; GX 5, at 13. Once again, the Expert found that the record for the visit was largely unintelligible. GX 68, at 52. She also observed that while Reynolds documented that T.H. was complaining of right upper quadrant pain and referred him for possible ventral hernia, there did not appear to be any documentation in the file that the prior deficiencies in complying with the guidelines of TN BON Rule 1000-04-.08 had been corrected. Id. at 51-52. Also, no AMC practitioner, including Mr. Reynolds and Mr. Stout, had created a written treatment plan for T.H, id. at 53 (citing TN BON Rule 1000-04.08(4)(c)2); and Reynolds still had not evaluated or assessed T.H.'s history of, or potential for, substance abuse. Id. (citing TN BON Rule 1000-04.08(4)(c)1).

    According to the Expert, “opioids typically would not be indicated in a case of new onset of abdominal pain, or even contraindicated pending an evaluation of the cause of the pain.” Id. Given that T.H. had reported losing his job, the Expert also found it significant that the visit noted stated that he had a “$310 balance; ins no pay.” Id. (quoting GX 17, at 41). According to the Expert, this was a red flag for potential diversion which should have been explored because “it indicates that T.H. [wa]s likely uninsured with increasing medical bills [and] [a] practitioner would have to be concerned about how T.H. was going to pay for not only the balance he owed to AMC, but also the drugs he was being prescribed in the absence of insurance and possibly (still) a job.” Id.

    The Expert also found that T.H. presented another red flag in that, according to the visit note, he did not complain “of constipation.” Id. According to the Expert, “[i]f T.H. actually was taking the amount of narcotics he had been prescribed, Mr. Reynolds should have expected T.H. to complain of constipation and need a prescription to treat this condition. Absence of a constipation complaint may be a signal [that] T.H. was NOT taking the drugs and instead was diverting them.” Id.

    The Expert then explained that under these circumstances, the standard of care and usual course of professional practice required that T.H. undergo a UDS to determine if he was taking the drugs that were prescribed and not diverting them. Id. However, the Expert found that there was no documentation in the visit note, or anywhere else in T.H.'s file, that he was asked to submit to a UDS at this visit. Id.; see also GX 17. The Expert thus concluded that Reynolds' issuance of the April 21, 2006 prescriptions was contrary to the guidelines set forth in TN BON Rule 1000-04-.08(4)(c) and, accordingly, below the standard of care and outside the usual course of professional practice. GX 68, at 53-54.

    On May 22, 2006, T.H. returned to AMC and was seen by both Reynolds and Stout. See GX 17, at 40.9 According to the Expert, the handwriting of both Stout and Reynolds appears on the record of this visit, even though the visit noted was signed by Mr. Stout. GX 68, at 54.

    9 The Expert based her conclusion on the fact that in course of reviewing the records, she had become familiar with the respective handwriting of Reynolds, Stout, and Killebrew. GX 68, at 54.

    During the visit, Stout noted that T.H. reported that he had been seeing another practitioner at the same time that he was obtaining controlled substances from AMC. GX 17, at 40. Specifically, Stout wrote: “[Patient] has spoken with Bob Reynolds about seeing Dr. Doobie [(sic)]. [Patient] states has not seen since 4/2006.” Id.

    As the Expert explained, this was another red flag for diversion and abuse, “which is commonly referred to as `doctor-shopping.' ” GX 68, at 54. Moreover, “T.H.'s disclosure established that he had violated the Pain Management Agreement,” which included the provision that he would “ `use only one physician to prescribe and monitor all opioid medications and adjunctive analgesics,' ” and that “ `[a]ny evidence of . . . acquisition of any opioid medication or adjunctive analgesia from other physicians . . . may result in termination of the doctor-patient relationship.' ” GX 68, at 54-55 (quoting GX 17, at 5). Indeed, in his letter to a DEA Diversion Investigator, Reynolds acknowledged that T.H. had signed the Pain Management Agreement at his first visit to AMC. GX 42, at 4.

    Notwithstanding T.H.'s clear violation of the Agreement, Reynolds issued him more prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 10 mg, and 60 tablets of Xanax 1 mg. See GX 17, at 40; GX 18, at 30. As the Expert explained, when Reynolds issued these prescriptions, T.H. presented with multiple red flags in addition to that of doctor shopping. These included his financial, mental health, and alcohol issues. GX 68, at 55. However, “T.H.'s file contains no indication that either Reynolds or Stout took the measures that a reasonable and prudent practitioner would have taken, such as to contact the other doctor [Dr. Dube] to confirm that he was no longer seeing T.H. and to ascertain the nature and extent of his treatment of T.H.” Id. Also, neither Reynolds nor Stout took “any other steps to ascertain the scope of T.H.'s abuse and/or diversion of controlled substances,” such as by requiring him to provide a UDS. Id.; see also GX 17, at 5 & 40. Moreover, while in the Pain Management Agreement, T.H. had agreed to use only one pharmacy (the Hillcrest pharmacy), GX 17, at 5; neither Reynolds nor Stout checked with the pharmacy to determine if he was, in fact, presenting all of his AMC prescriptions there and if he was also presenting controlled substances prescriptions from other practitioners. See generally GX 17.

    According to the Expert, “each of these steps was an action that a reasonable and prudent family nurse practitioner would have taken when presented with this information, and was required by the standard of care in Tennessee.” GX 68, at 55-56. The Expert thus explained that under the circumstances, the standard of care and the usual course of professional practice required the enforcement of the terms of the Pain Management Agreement, see GX 17, at 5 (pars. 1, 3, and 9); the cessation of the issuance of more controlled substances prescriptions; the taking of measures to ascertain whether T.H. was diverting the drugs he had been prescribed by requiring a UDS and contacting his pharmacy; and the referral of T.H to either a pain management specialist and/or a psychological/addiction specialist. GX 68, at 56.

    On June 20, 2006, T.H. returned to AMC and was again seen by Reynolds. GX 17, at 39. Once again, Reynolds issued T.H. more prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 10 mg, and 60 tablets of Xanax 1 mg. See id.; GX 18, at 30. Moreover, at this visit, T.H. presented a further red flag—specifically, Reynolds learned that T.H. was being treated with Suboxone, a schedule III controlled substance used to treat narcotic dependency, at the same time he had been receiving narcotics from AMC. GX 17, at 39. As the Expert found, the record of this visit contains an entry apparently made by A.N., a Registered Nurse, stating: “ `observed note regarding Medicine Shoppe in Jonesboro TN & Suboxone 8 mg (Knoxville region) & Oxycodone 40 mg from Appalachian Med Center & will consult proprietor of Appalachian Med Center Bob Reynolds FNP regarding urine screen possibly needed & how to proceed in care of this pt. Contact person at Medicine Shoppe is Jeff Street.' ” GX 68, at 56-57 (quoting GX 17, at 39).

    In reviewing T.H.'s file, the Expert observed that the note referenced by A.N. was not in the file. Id. at 57. The Expert also observed that T.H.'s file did not contain any documentation indicating that Reynolds had investigated the information documented by the RN, such as documentation that Reynolds had contacted the pharmacy about T.H.'s Suboxone treatment or obtained a record of the prescriptions T.H. had presented and filled at the pharmacy. Id. And the Expert further explained that the fact that the Medicine Shoppe had prescription information for T.H. was also a red flag because T.H. had agreed to use only the Hillcrest pharmacy to fill his prescriptions. See id. The Expert thus concluded that Reynolds' issuance of the prescriptions was outside of the usual course of professional practice.10 Id. at 56-57.

    10 The Expert further explained that the usual course of professional practice required that the Pain Agreement be enforced, the cessation of controlled substance prescriptions, that the Medicine Shoppe be contacted to follow-up on the items noted, that T.H. be required to submit a UDS, and that T.H. be referred to either a pain management specialist, and/or a psychological/addiction specialist. GX 68, at 57.

    On July 19, 2006, T.H. returned to AMC. Reynolds again issued him more prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 10 mg, and 60 tablets of Xanax 1 mg. See GX 17, at 38; GX 18, at 29. And once again, Reynolds had received additional information indicating that T.H. was likely engaged in abuse. GX 68, at 58.

    More specifically, T.H.'s file contains four documents that apparently were faxed to AMC from “Northside Admin,” and appear to have been faxed on the same date.11 See GX 17, at 59-62. However, the date on the fax banner at the top of each page is cut-off. See id.

    11 The Expert acknowledged that the fax banner on the copies in T.H.'s file was cut off. However, the Expert explained that she had reviewed copies of the same four documents that were sent to another provider (see GX 22), which were provided by DEA, and that the date appearing on the fax banner was July 5, 2006. It is clear, however that these documents were faxed and received by AMC because the next day, one William Clever, another Advance Nurse Practitioner at AMC, wrote a letter to T.H. on AMC's letterhead that he was “withdrawing from further professional attendance with you,” suggested that T.H. find “another provider without delay,” and that “after receipt of this letter, we will no longer be able to prescribe narcotics to you.” GX 21, at 1.

    Notably, one of the documents was an April 21, 2006, letter from Dr. Michael Dube informing T.H. that he “will no longer be treated as a patient at Medical Care Clinic and/or Watauga Walk-in Clinic.” See GX 17, at 61. A second document showed that as of March 31, 2006, T.H. owed $230 to Medical Care Clinic. Id. at 59. A third document showed that as of June 6, 2006, T.H. owed $2,976 to Pain Medicine Associates (Dr. Williams' clinic), where T.H. was seen on December 5, 2005, having been referred by AMC. Id. at 60. The fourth document showed that on June 12, 2006, T.H. had received a prescription for Zoloft, a non-controlled drug used to treat depression, from a medical doctor in Knoxville, Tennessee. Id. at 62.

    As the Expert explained, the letter from Dr. Dube confirmed the information that Reynolds and Stout received at T.H.'s April 20, 2006 visit, namely, that he was seeing another provider at the same time he was receiving controlled substances from AMC, and thus likely doctor-shopping. GX 68, at 58. The billing statements from Medical Care Clinic (Dr. Dube's practice) and Pain Medicine Associates (Dr. Williams' practice), “provide[d] further evidence that T.H. was having significant financial difficulties.” Id. at 58-59. According to the Expert, the fact that T.H. was approximately $3000 in debt to two medical practices should have been viewed as another red flag of his possible diversion of controlled substances. Id. at 59.

    As for the Zoloft prescription, the Expert observed that this was evidence that T.H. was having his mental health issues addressed by another provider. Id. As such, it was also a red flag that T.H. was possibly obtaining controlled substances from another practitioner after he was discharged by Dr. Dube. Id. The Expert further explained that Reynolds should have been interested in knowing if the Zoloft prescriber was the same Knoxville-based practitioner who reportedly was providing T.H. with Suboxone as mentioned in the RN's note for T.H.'s previous visit. Id.

    Noting that there was no evidence that Reynolds had contacted Dr. Dube, the Zoloft prescriber, the Hillcrest Pharmacy, or the Medicine Shoppe Pharmacy; nor evidence that he had required that T.H. provide a UDS; the Expert concluded that Reynolds' issuance of the prescriptions was below the standard of care and outside of the usual course of professional practice. Id. at 58-59. The Expert further opined that under the circumstances, the standard of care and usual course of professional practice would not be to issue T.H. additional controlled substances prescriptions but to enforce the terms of the Pain Management Agreement and cease further prescribing of controlled substances to T.H. Id. at 59.

    On August 10, 2006, T.H. returned to AMC, even though this was just twenty-two days since his last visit. GX 17, at 37. Reynolds again saw T.H. and issued him prescriptions for 10 tablets of Lortab 10 mg and 15 tablets of Xanax 1 mg, which he authorized T.H. to fill on that date, as well as prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 10 mg, and 60 tablets of Xanax 1 mg, which could not be filled until August 15, 2006. See GX 17, at 37; GX 5, at 13. Reynolds issued these prescriptions notwithstanding the evidence that T.H. was abusing and/or diverting controlled substances discussed above, and even though T.H. was seeking an early refill of his Lortab and Xanax prescriptions on this visit. GX 68, at 60. As the Expert explained, T.H. should have had eight days of Xanax tablets remaining on the prescription Reynolds issued him on July 19, 2006. Id. (citing GX 18, at 29).

    Here again, T.H.'s early refill request was another red flag that T.H. was abusing and/or diverting the controlled substances that Reynolds was prescribing to him. Id. For the same reason as stated above, the Expert concluded that “the standard of care and usual course of professional practice under these circumstances would not be to issue T.H. additional controlled substances prescriptions.” Id. Rather, the standard of care and usual course of professional practice required that Reynolds “enforce the terms of the” Pain Contract, see GX 17, at 5 (par. 9), “cease issuing further controlled substances to T.H., contact Hillcrest Pharmacy and Medicine Shoppe pharmacy to determine the prescriptions T.H. had filled, and order T.H. to take a UDS to determine if he was taking or diverting the controlled substances he had been issued or was taking controlled substances he had not been prescribed at AMC.” GX 68, at 60.

    On September 7, 2006, T.H. returned to AMC and was seen by Stout, who issued him prescriptions for 60 tablets of OxyContin 40 mg, 45 tablets of Lortab 10 mg, and 75 tablets of Xanax 1 mg. See GX 17, at 36; GX 18, at 8. According to the Expert, Stout noted in the record of this visit that “[T.H.] got meds filled early on 08/10/06—Rx dated 08/15/06.” GX 68, at 61. As the Expert explained, Stout was clearly aware of this red flag and should have questioned if T.H. was taking more than the prescribed amount or if he was selling the drugs. Id. Notwithstanding this, as well as the extensive other evidence in T.H.'s record that he was either abusing and/or diverting controlled substances, Stout issued the prescription. GX 18, at 8. For the same reasons set forth with respect to T.H.'s previous visit, the Expert concluded that Stout's issuance of the prescriptions was below the standard of care and outside of the usual course of professional practice. GX 68, at 61.

    On September 29, 2006, T.H. returned to AMC and was seen by Reynolds, who issued him prescriptions for 60 tablets of OxyContin 40 mg, 75 tablets of Xanax 1 mg, and 45 Lortab 10 mg. GX 17, at 35; GX 18, at 8. Once again, T.H. presented a red flag in that he was seeking an early refill of both his OxyContin and Xanax prescriptions. GX 68, at 62. According to the Expert, T.H. should have had eight days left on the previous OxyContin prescription (which was for a thirty-day supply) and at least three days left on the previous Xanax prescription (which provided 75 tablets with a dosing of one tablet every 8-12 hours). See GX 68, at 62; GX 17, at 36; GX 18, at 8.

    The Expert also noted that while T.H. had been receiving narcotics from AMC for nearly one year and had yet to be subjected to a UDS, and T.H.'s file documents that Reynolds sent him for blood work after this visit to check his blood counts, thyroid, and metabolic panel, see GX 16, at 50; Reynolds did not require that T.H. provide a UDS. GX 68, at 62. “Based on this new red flag and the prior information indicating T.H.'s abuse and/or diversion of controlled substances,” the Expert concluded that “it was below the standard of care and outside the usual course of professional practice for Reynolds to issue these prescriptions without taking any steps to monitor his controlled substances use, including conducting a UDS and checking with his pharmacy for controlled substances prescriptions he was filling.”12 Id.

    12 Reynolds also saw T.H. on November 6 and December 4, 2006; at each visit, Reynolds issued him prescriptions for 60 OxyContin 40 mg, 30 Percocet 10/325 mg, and 75 Xanax 1 mg. GX 17, at 33-34; GX 18, at 9-10.

    On January 3, 2007, T.H. went to AMC and saw Killebrew, who issued him prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Percocet 10/325 mg, and 75 tablets of Xanax 1 mg. See GX 17, at 32; GX 18, at 28. Killebrew noted in the record of this visit that T.H. was “[g]etting [d]ivorced,” complaining of increased anxiety due to his divorce, and was crying. See GX 17, at 32. The visit note also documents that T.H. had lost six pounds since his last visit. Id.

    According to the Expert, this may indicate that T.H. had depression given the information T.H. shared about his divorce and Killebrew wrote him a prescription for an antidepressant (Celexa) at this visit. GX 68, at 63 (citing GX 17, at 32). T.H. also reported that his pain was a seven out of ten, which indicates that the drug regimen he had been prescribed previously at AMC was not controlling his pain. Id. Killebrew also had T.H. sign a new Pain Management Agreement, which she witnessed. GX 17, at 2.

    The Expert explained that based on the information T.H. reported at this visit, as well as the information in his file from prior visits, T.H. should have been considered a “high-risk patient for managing chronic pain” and whose “care extend[ed] beyond the scope of” a nurse practitioner engaged in family practice “at this point.” GX 68, at 63. The Expert further noted that a prudent practitioner would have considered T.H. to be “a risk for suicide and diversion” and would have referred him “to a mental health specialist and a comprehensive pain management program.” Id. Yet, the Expert found no evidence in the file that Killebrew did so. Id.

    The Expert also noted that there was no documentation in T.H.'s file indicating that Killebrew had checked with the pharmacy T.H. had identified on his pain contracts as the sole pharmacy he would use to fill his prescriptions to determine if he still was engaging in doctor-shopping. Id. The Expert also found no evidence that Killebrew required him to submit to a UDS. Id. at 63-64. Based on the red flags T.H. presented and Killebrew's failure to take these steps to monitor T.H.'s use of controlled substances, the Expert opined that the issuance of the prescriptions was contrary to the Board's Rule 1000-04-.08(4)(c), and, accordingly, below the standard of care and outside the usual course of professional practice. Id. at 64.

    On March 2, 2007, T.H. visited AMC and saw Stout, who issued him prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 10 mg, and 75 tablets of Xanax 1 mg. See GX 17, at 29; GX 18, at 27. The Expert opined that Stout's notes for this visit were “sparse, at best” as they state only that T.H. was “[h]ere for follow-up. Denies recent trauma or illness. Patient states pain medication is controlling his pain. Describes pain as 4/10 while on pain medication. Denies fever, chills, nvd.” GX 68, at 64 (quoting GX 17, at 29). The Expert also observed that the visit notes contained no discussion of T.H.'s anxiety issues which Killebrew had documented during the January 3, 2007 visit. Id. The Expert also found that there was “no documentation of any evaluation or assessment of the alcohol and financial red flags that were presented at several prior visits,” that Stout “neglected to inquire about whether T.H. was now employed or whether he was currently drinking alcohol” even though the form contained a section for alcohol use (“ETOH”), nor elaborated on his purported finding that T.H. was “anxious.” Id.

    The Expert also found that there was still no evidence that a written treatment plan was created for T.H. identifying objectives of treatment, or an update on the treatment plan as required by TN BON Rule 1000-04-.08(4)(c)2 & 4. Id. Moreover, the Expert found that while on January 1, 2007, the Tennessee prescription monitoring program (CSMD) had become available to practitioners to assist them in determining whether their patients were seeing other providers, there was no evidence in the file that Stout conducted a check on T.H. at this visit, even though T.H.'s record documented multiple instances in which AMC obtained information that T.H. was engaged in doctor-shopping. Id. at 64-65. Nor did the Expert find any evidence in the file that Stout had checked with the pharmacy T.H. identified on his pain contracts as the sole pharmacy he would use to fill his prescriptions to determine if he was doctor shopping. Id. at 65. The Expert thus opined that Stout's issuance of these prescriptions was contrary to the guidelines set forth in Tennessee BON Rule 1000-04-.08(4)(c), and, accordingly, below the standard of care in Tennessee and outside the usual course of professional practice. Id.

    On May 1, 2007, T.H. visited AMC and saw Stout, who again issued him prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 10 mg, and 75 tablets of Xanax 1 mg. See GX 17, at 27; GX 18, at 25-26. Once again, the Expert found that Stout's record of the visit was “very sparse,” as it stated only: “Here for follow-up. PT denies trauma. Patient states back pain is controlled by pain medication. Denies radiation of pain or urinary incontinence. Denies chest pain or sob. Denies fever, chills, nvd.” GX 68, at 65. Once again, the Expert observed that the visit note did not document that Stout had discussed with T.H. his use of alcohol (the ETOH portion of the form being blank), his anxiety,13 and his employment and financial situation. Id.

    13 While the note stated that T.H. was “anxious,” the Expert explained that Stout “failed to elaborate on his finding.” GX 68, at 65.

    The Expert also found that there was still no evidence of a written treatment plan for T.H. identifying treatment objectives, or an update on the treatment plan as required by TN BON Rule 1000-04-.08(4)(c)2, 4; she also found that Stout failed to quantify T.H.'s pain on this visit. Id. at 66. And once again, the Expert found that Stout did not take any steps to monitor whether T.H. was currently doctor-shopping and seeing other practitioners. Id. The Expert thus opined that Stout's issuance of these prescriptions was contrary to the guidelines set forth in Tennessee BON Rule 1000-04-.08(4)(c), and accordingly, below the standard of care in Tennessee and outside the usual course of professional practice. Id.

    On June 26, 2007, T.H. visited AMC and saw Stout, who again issued him prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 10 mg, and 75 tablets of Xanax 1 mg. See GX 17, at 23-24; GX 5, at 14-17. While the Expert noted that AMC had started using electronic medical records and that Stout had noted that T.H. “is satisfied with the current treatment plan,” she still found that there was no documentation in the record of a written treatment plan. GX 68, at 66 (citing TN BON Rule 1000-04-.08(4)(c)2). The Expert further noted that while Stout documented that T.H. reported he was having “some increases [sic] problems situationally lately with their [sic] anxiety and depression,” Stout again neglected to inquire about T.H.'s use of alcohol, which could have been the source of his anxiety and depression problems. Id. (quoting GX 17, at 23); also citing GX 41, at 6 (Uphold & Graham).

    According to the Expert, Stout's failure to address this issue was contrary to the requirements of TN BON Rule 1000-04-.08(4)(c)2 because “[w]ithout knowing about the status of his alcohol issues, Mr. Stout was unable, and in fact did not `consider [the] need for further testing, consultations, referrals, or use of other treatment modalities.' ” Id. at 67. Also, while Stout noted that T.H. was having “work issues” and “financial problems,” he failed to document whether T.H. was in fact now employed and capable of paying for his continued treatment (including medications). Id. Moreover, the Expert found no evidence that Stout took any steps to monitor whether T.H. was currently doctor-shopping and seeing other practitioners. Id. The Expert thus opined that Stout's issuance of these prescriptions was contrary to the guidelines set forth in Tennessee BON Rule 1000-04-.08(4)(c), and accordingly, below the standard of care in Tennessee and outside the usual course of professional practice. Id.

    On July 24, 2007, T.H. returned to AMC and saw Killebrew, who issued him prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 10 mg, and 90 tablets of Valium 10 mg. See GX 17, at 21-22; GX 18, at 24. T.H. reported that his pain was a 4 out of 10, that he was having problems with anxiety (which, according to the Expert indicated that the Xanax was not controlling his anxiety), and that he was trying to quit alcohol. GX 17, at 21. T.H. also reported that he had made an appointment with a local mental health facility. Killebrew noted that T.H. presented with “Hand tremors, anxious today” and that he had an elevated blood pressure. Id. According to the Expert, these findings may have been signs of anxiety or alcohol/drug withdrawal. GX 68, at 68.

    According to the Expert, alcohol abuse was a red flag and Killebrew should have considered that if T.H. was abusing alcohol, he may also have been abusing opioids and/or illicit substances. Id. (citing GX 41, at 20-21 (Uphold & Graham)). Relying on Uphold & Graham, the Expert further noted that “ `[p]atients who are alcohol dependent and who also have a psychiatric disorder should be referred for treatment for the underlying disorders as these patients are usually complex.' ” Id. (quoting GX 41, at 23); see also GX 41, at 15 (stating that “[p]atients with comorbid conditions (primary anxiety disorder, substance abuse, dementia)” should be referred to a specialist). According to the Expert, “Killebrew's findings on this visit are further evidence that T.H. required care that was beyond the scope of family practice nurse practitioners.” GX 68, at 68.

    While the Expert noted that Killebrew had documented in T.H.'s record that she had provided him with information on Alcoholics Anonymous and other recovery groups, id. (citing GX 17, at 21); the Expert then explained that “a patient who is trying to quit alcohol is not an appropriate patient for [a] primary care nurse practitioner to attempt to manage his chronic pain” Id. The Expert thus found that “Killebrew should have ceased issuing T.H. further controlled substance prescriptions and sent him for evaluation by a mental health specialist,” and further concluded that Killebrew's issuance of the prescriptions was “contrary to the guidelines set forth in Tennessee BON Rule 1000-04-.08(4)(c), and accordingly, not consistent with the standard of care and outside the usual course of professional practice.” Id.

    On August 23, 2007, Killebrew again saw T.H. and issued him prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Lortab 10 mg, and 90 tablets of Valium 10 mg. See GX 17, at 19-20; GX. 18, at 23. Killebrew noted in the visit record that T.H. had recently gone to the JCMC emergency room after injuring his left leg. See GX 17, at 19.

    According to the Expert, this information was also a red flag suggestive of either abuse or an injury caused by over sedation, as the latter could have resulted from T.H.'s combined ingestion of Valium (which she had previously prescribed to him) and alcohol, or Valium alone, given the high dosage (10 mg three times per day) she had prescribed. GX 68, at 69 (citing GX 17, at 21-22; GX 18, at 24).

    The Expert further noted that Killebrew neither asked T.H. if he had obtained any pain medications at his JCMC ER visit, nor obtained any records from the JCMC to determine whether T.H. had been given any prescriptions. Id. at 69. The Expert also found that Killebrew neither contacted T.H.'s pharmacy to obtain a recent dispensing history, nor conducted a check of the CSMD to see if he had been receiving controlled substances from other practitioners. Id.

    While Killebrew again noted in the record that T.H. was “trying to quit [alcohol]” and “[h]as made an appt. with Frontier Health,” she did not document that she discussed with T.H. his efforts to quit alcohol since his previous visit or that she had discussed with T.H. whether he had been seen by the mental health clinic. GX 17, at 19. As the Expert found, Killebrew simply issued T.H. “additional controlled substance prescriptions in the face of all of the red flags of T.H.'s abuse and diversion of controlled substances set forth in the paragraphs above.” GX 68, at 69-70. The Expert thus concluded that Killebrew's issuance of the additional controlled substance prescriptions was contrary to the guidelines set forth in Tennessee BON Rule 1000-04-.08(4)(c), and accordingly, below the standard of care and outside the usual course of professional practice. Id. at 70 (citing Uphold & Graham, GX 41, at 14, 23).

    On September 19, 2007, T.H. returned to AMC and saw Reynolds, who issued him prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Percocet 10/650 mg, and 90 tablets of Valium 10 mg. See GX 17, at 17-18; GX 18, at 23. According to the Expert, Reynolds issued these prescriptions without discussing with T.H. his visit at the mental health facility and did not obtain any records from the facility, even though the two previous visit notes mentioned that T.H. had made such an appointment. GX 68, at 70. Reynolds also did not acquire any information from T.H. about his efforts to quit alcohol, even though this was also mentioned in the two previous visit notes, and Reynolds did not document that he even addressed with T.H. his alcohol issues. Id.; GX 17, at 17-18. Nor is there any documentation that Reynolds discussed with T.H. his recent visit to the Emergency Room and T.H.'s file contains no record of his visit to the ER. GX 17, at 17-18.

    The Expert further noted that Reynolds “failed to take any other steps to monitor T.H.'s controlled substances use, despite the numerous red flags of potential drug abuse and diversion that T.H. had presented on prior visits.” GX 68, at 70. The Expert thus concluded that “Reynolds' issuance of the additional controlled substance prescriptions was contrary to the guidelines set forth in Tennessee BON Rule 1000-04-.08(4)(c), and accordingly, below the standard of care and outside the usual course of professional practice.” Id.

    On October 17, 2007, T.H. returned to AMC and again saw Reynolds, who issued him more prescriptions for 60 tablets of OxyContin 40 mg, 30 tablets of Percocet 10 mg, 90 tablets of Xanax 1 mg, and Celexa 20 mg (a non-controlled anti-depressant). See GX 17, at 13-15; GX 19, at 2-6. In the visit note, Reynolds documented that T.H. “has had increased problems with depression and had ran out of his Prozac, he is going to seek counseling at wmh and we will restart antidepressant today.” GX 17, at 13.

    Notably, T.H. had not previously been prescribed Prozac by anyone at AMC. See generally GX 17, at 17-47. According to the Expert, this information should have placed Reynolds “on notice that T.H. was seeing another practitioner, in particular a mental health specialist.” GX 68, at 71. The Expert further explained that:

    [i]f a mental health specialist had taken over care for T.H. and his depression was worsening, as . . . Reynolds' notes of this visit reflect, then the usual course of practice would have been for the primary care nurse practitioner to contact the specialist and have the specialist manage T.H.'s care. Under these circumstances, Mr. Reynolds, as the primary care nurse practitioner, should not have changed T.H.'s antidepressant from Prozac to Celexa, and he should not have prescribed him Xanax and opioids, especially in the quantities he did, which have lethal potential in someone with increasing depression and history of alcohol use/abuse. Id. at 71-72.

    According to the Expert, Reynolds should also have asked T.H. about his use of Prozac, run a CSMD check, and required T.H. to submit to a UDS before issuing him more prescriptions. Id. at 71. However, according to T.H.'s record, Reynolds did none of these. See GX 17, at 13-15; GX 68, at 71. Moreover, according to the Expert, while T.H. would still have had several days left on his Valium 10 mg prescription, “Reynolds should have, but according to the record did not” instruct T.H. to stop taking the drug even though Reynolds had prescribed Xanax 1 mg along with the opioids (OxyContin and Percocet). GX 68, at 72 (citing GX 17, at 17-18; GX 18, at 23). According to the Expert, “[a]dding 10 mg Valium to a drug regimen of OxyContin 40 mg, Percocet 10 mg, and Xanax 1 mg had the potential to be a lethal combination because of the respiratory depressing effects of these drugs.” Id. The Expert thus concluded that Reynolds' issuance of the controlled substances prescriptions at this visit “was contrary to the guidelines set forth in Tennessee BON Rule 1000-04-.08(4)(c), and accordingly, below the standard of care and outside the usual course of professional practice.” Id.

    T.H. died the following day. GX 24, at 2. According to the Medical Examiner's report, “[p]ostmortem blood toxicology showed oxycodone (and its metabolite) in a supratherapeutic to potentially lethal concentration, alprazolam in a therapeutic to toxic concentration and diazepam (and its metabolite) in a therapeutic concentration.” Id. at 1. The Medical Examiner thus concluded that “[a]lthough the drugs may be present in therapeutic to potentially lethal concentrations, the combined/synergistic effects of the drugs caused death by central nervous system depression.” Id.

    Summarizing her findings, the Expert explained that during the two-year period in which T.H. went to AMC, he presented “numerous red flags of abuse and diversion” and yet he “was never asked to take a UDS, nor was he ever asked to come into AMC for a pill count.” GX 68, at 72. The Expert also explained that while “the CSMD was available for the last ten months of his AMC visits, none of the practitioners ever conducted a CSMD check for him.” Id. The Expert thus opined that “the monitoring of [T.H.'s] controlled substances use by Mr. Reynolds, Mr. Stout, and Ms. Killebrew was woefully inadequate, and far below the standard of care in Tennessee.” Id.

    C.S.

    On December 12, 2008, C.S. made her first visit to AMC and was seen by Reynolds. GX 26, at 45-46. C.S. completed a patient intake form stating that she had shoulder, knee, and back pain; she wrote that she had suffered injuries from a car accident which resulted in a metal rod in her femur and a plate and screw in her ankle. Id. at 10-11. Notably, on this form, C.S. stated that she did not have a current healthcare provider and did not list any medications that she was currently taking. Id. at 10, 11. C.S. also signed a Pain Management Agreement at this visit, which Reynolds also signed. Id. at 9. Reynolds prescribed a thirty-day supply of 90 tablets of Percocet 7.5/500 mg (oxycodone/acetaminophen, a schedule II drug) and 60 tablets of Valium 5 mg. See GX 26, at 45-46; GX 29, at 3.

    The Expert observed that while Reynolds noted in the record that C.S. had “a longstanding [history] of back pain,” “he did not have any information regarding treatment C.S. had been receiving for the fourteen months immediately preceding her first visit to AMC.” GX 68, at 76 (citing GX 26, at 45). The Expert further observed that the only documentation of prior treatments in C.S.'s file were records Reynolds obtained from a physician who treated her between June 2007 and October 25, 2007.14 Id. Significantly, that physician had noted that C.S. “takes extra Rx pain pills in contrast to my recommendations” and that he did “not think she can self-medicate. . . .” GX 26, at 58-61.

    14 The file does include records indicating that from June-October 2007 C.S. was taking Percocet and Ativan, as well as Effexor, a non-controlled drug prescribed to treat major depressive disorder, anxiety and panic disorder. GX 26, at 58-61.

    According to the Expert, this information “should have been a red flag to Reynolds that C.S. misused and abused previous medications she had been prescribed.” GX 68, at 76. Yet the Expert found that “C.S's file indicates that Reynolds did not take any steps to follow-up on this information, such as contacting the previous physician about these entries and the nature, extent and duration of his treatment of C.S.” Id. Nor, according to the Expert, did Reynolds “obtain any other information related to C.S.'s history of[,] and potential for[,] substance abuse, despite being placed on clear notice of such issues.” Id. The Expert also found that Reynolds “failed to conduct a CSMD check, which would have provided him information about previous treatments with controlled substances and her substance use and abuse history.” Id at 76-77.

    The Expert further found that Reynolds “failed to create a patient record that appropriately documented C.S.'s medical history and pertinent historical data, such as pain history, pertinent evaluations by other providers, history of and potential for substance abuse, and pertinent coexisting diseases and conditions. He also did not create a written treatment plan tailored for C.S.'s individual needs, nor did he consider the need for further testing, consultations, or referrals, or the use of other treatment modalities.” Id. at 77 (citing Tenn. BON Rule 1000-.04-.08(4)(c)1 & 2. The Expert thus concluded that Reynolds' decision to immediately start C.S. on a controlled substances regimen contravened the guidelines of TN BON Rule 1000-04-.08. Id.

    The Expert also noted that Reynolds had written in C.S.'s record that her pain was being treated in accordance with the guidelines in the Jackman article, which AMC had purportedly adopted for its treatment protocols.15 Id. at 73. Consistent with her analysis and conclusions regarding N.S. and T.H., the Expert concluded that Reynolds ignored several recommendations contained within that article in his treatment of C.S. Id.

    15See Robert P. Jackman, M.D., et al., “Chronic Nonmalignant Pain in Primary Care,” American Family Physician (Nov. 2008) (GX 39, at 5-12).

    These included that “[w]hen psychiatric comorbidities are present, risk of substance abuse is high and pain management may require specialized treatment or consultation. Referral to a pain management specialist can be helpful.” Id. (quoting GX 39, at 5) As the Expert explained, the article then instructed that the evaluation of the patient must include “[a] thorough social and psychiatric history [that] may alert the physician to issues, such as current and past substance abuse, development history, depression, anxiety, or other factors that may interfere with achieving treatment goals.” Id. at 74.

    According to the article, “[b]y identifying patients at risk of possible opioid misuse (e.g. persons with past or current substance abuse, persons with psychiatric issues), physicians can choose to modify the monitoring plan or to refer the patient to a pain specialist.” GX 39, at 5. The article further stated that “[f]or patients at high risk of diversion and abuse, consider the routine use of random urine drug screens to assess for presence of prescribed medications and the absence of illicit substances.” Id. at 9 (emphasis added). The article also advised that “[a]berrant behavior that may suggest medication misuse includes use of pain medications other than for pain treatment, impaired control (of self or of medication use), compulsive use of medication . . . selling or altering medications, calls for early refills, losing prescriptions, drug-seeking behavior (e.g. doctor-shopping), or reluctance to try nonpharmacologic intervention.” Id. at 11 (emphasis added).16

    16 The Jackman article was supplemented in the same edition of American Family Physician by an Editorial, which provided additional guidance on the “risk of drug misuse, abuse, and addiction” that exists when treating patient with long-term opioids, a topic that was not fully explored in the Jackman article. See GX 49. The Editorial discussed the steps physicians should take to “monitor” these risks, including focusing on the patient's medical history, obtaining information from family members, focusing on physical signs of possible aberrant drug-taking behavior, such as slurred speech, small pupils, and unusual affect, and the use of urine drug screening that “should be positive for prescribed medications, negative for medications that have not been prescribed, and negative for illicit drugs.” Id. at 1-2. The Editorial, moreover, emphasized that “[t]he current standard of care used by pain management specialists to treat patients with chronic pain and aberrant drug-taking behavior is an abstinence-oriented approach.” Id. at 2. According to the Editorial, “[i]n this approach, patients initially discontinue their opioid use for a `drug holiday.' Formal inpatient or outpatient detoxification is sometimes required to stabilize opioid withdrawal syndrome. Following this, patients are given multidisciplinary treatment for opioid dependency and chronic pain, including cognitive behavior therapy (i.e. for chronic pain and a substance abuse disorder) that is concurrent with nonopioid pain management.” Id.

    Based on the guidance contained in the Jackman article, the Editorial, and the requirements set forth in TN BON Rule 1000-04-.08(4)(c), the Expert concluded that “Reynolds['] issuance of the controlled substances prescriptions to C.S. at her first visit was below the standard of care and outside the usual course of professional practice.” GX 68, at 75. Moreover, based on her review “of C.S.'s patient file through her last visit on November 30, 2009,” the Expert concluded that both Reynolds and Stout “failed to comply with the Rule's guidelines on subsequent visits by C.S.” Id. at 77. More specifically, the Expert found that Reynolds and Stout “never acquired the information that was lacking at C.S.'s initial visit and, therefore, the controlled substances prescriptions they issued at subsequent visits were contrary to the Rule's guidelines for the same reasons as the prescriptions issued on the initial visit.” Id.

    The Expert also found that “at each periodic interval, Reynolds and Stout failed to appropriately evaluate C.S. for continuation or change of medication, and include in the patient record her progress towards reaching treatment objectives, any new information about the etiology of the pain, and an update on the treatment plan.” Id. at 77-78 (citing TN BON Rule 1000-04-.08(4)(c)4). The Expert thus concluded that on C.S.'s subsequent visits, such as those of March 12, 2009 and April 10, 2009, when Stout prescribed 90 tablets of Percocet 7.5/500 mg, 60 tablets of Valium 5 mg, and 30 tablets of Fastin 30 mg (phentermine, a schedule IV drug) to her, he acted in contravention of the Rule's guidelines, as well as the standard of care. Id. at 78 (citing GX 26, 28-37, 40; GX 27, at 2, 4, 5; GX 29, at 4).

    The Expert also found that both Reynolds and Stout ignored red flags of abuse and diversion that were presented to them at C.S.'s subsequent visits, and did so even though C.S. had violated the terms of her Pain Management Agreement. Id. For example, on July 9, 2009, Reynolds issued C.S. prescriptions for 45 tablets of Roxicodone 15 mg (oxycodone), 60 tablets of Valium 5 mg and 30 tablets of Fastin 37.5 mg. See GX 26, at 29-30; GX 28, at 2. Reynolds issued these prescriptions even though on June 12, 2009, Reynolds documented that he had received a phone call from a person at “Genesis Healthcare,” which was a “new practice in Boones Creek”; according to the note, Reynolds was informed that C.S. had told Genesis Healthcare that “she did not have a family practice [and] was seeking to establish new [patient] care.” GX 26, at 31. Reynolds was further informed that C.S. also used another name (“goes by [C.M.]).” Id. Reynolds received this call three days after he had seen C.S. at AMC (on June 9, 2009), and had prescribed to her 45 tablets of Roxicodone 15 mg and 60 tablets of Valium 5 mg. See GX 26, at 33-34; GX 28, at 2. Of further note, the call from Genesis occurred two days after C.S. had called AMC seeking a refill of Fastin, which Reynolds refused to issue. GX 26, at 32.

    According to the Expert, the telephone call from Genesis Healthcare was “a huge red flag.” GX 68, at 79. The Expert explained that it “should have been alarming” to Reynolds “that C.S. told another practice that she did not have a family practice when she had been going to AMC monthly for the past seven months” and that she was also using a second name. Id. As the Expert explained, after the phone call, Reynolds was aware that C.S. had misled both AMC and the other practitioner, and likely was doctor-shopping. Id. This was a violation of the terms of her Pain Management Agreement, which included the provision that: “I will not attempt to obtain any controlled medicines, including opioid pain medicines, controlled stimulants, or anti-anxiety medicines from any other doctors.” Id. (quoting GX 26, at 9).

    Yet, at her July 9, 2009 visit, Reynolds did not discuss or otherwise confront C.S. about the information he had received from Genesis. Id. (citing GX 26, at 29-30). Moreover, C.S.'s patient record contains no documentation that Reynolds addressed C.S.'s violation of her PMA, even though its terms provided that if she broke the agreement, “my provider will stop prescribing controlled substances immediately and only provide care for life threatening and chronic medical conditions” and that she would “either be discharged from th[e] practice or [o]ffered only alternative treatments such as non-narcotic medications and treatment center options.” Id. at 79-80 (quoting GX 26, at 9); see also GX 26, at 29-30.

    Moreover, the medical record contains no evidence that Reynolds took steps to monitor C.S.'s controlled substances use, such as by conducting a check of the CSMD before issuing the prescriptions. Id. at 79-80; see also GX 26. He also did not require her to submit to a UDS to determine if she was taking the drugs she had been prescribed at AMC and if there were any non-AMC prescribed drugs in her system. Id. at 80; GX 26.

    “For all of these reasons,” the Expert concluded that “Reynolds' decision to continue issuing [C.S.] controlled substance prescriptions on July 9, 2009 was contrary to [the] guidelines set forth in Tenn. BON Rule 1000-.04-.08, and accordingly, below the standard of care and outside the usual course of professional practice.” GX 68, at 80. Relying on the Jackman article and accompanying Editorial, the Expert further concluded that “the standard of care and usual course of professional practice . . . would have been to enforce the terms of C.S.'s [Pain Mgmt. Contract], cease prescribing her controlled substances, and refer her to a pain management specialist and/or addiction specialist to address her drug-seeking behavior.” Id.

    On August 4, 2009, C.S. returned to AMC and saw Stout, who issued her prescriptions for 45 tablets of Roxicodone 15 mg, 60 tablets of Valium 5 mg, and 30 tablets of Fastin 37.5 mg. See GX 26, at 27-28; GX 27, at 2; GX 28, at 2 & 14. Stout issued these prescriptions even though he had since received further evidence unequivocally showing that C.S. had engaged in doctor-shopping at both Genesis Healthcare and a third practitioner, as well as pharmacy-shopping. GX 68, at 80. Notably, on the date of this visit, AMC ran two CSMD queries to determine what controlled substances had been dispensed to C.S. during the period August 1, 2008, through August 4, 2009; the report was placed in C.S.'s AMC patient file. Id. (citing GX 26, at 54-57). The query was run using both of the names C.S. was known to have used when she sought controlled substances. Id. As the Expert explained, this demonstrates that AMC and Stout were aware of the fact that C.S. used multiple names. Id. at 80-81.

    According to the Expert, the two CSMD reports revealed the following information:

    (a) On June 3, 2009, C.M. received prescriptions for 56 oxycodone 7.5 mg and 15 Alprazolam 1 mg from the above-referenced practitioner in Boones Creek, Tennessee, which was six days before she visited AMC on June 9, 2009 and obtained prescriptions for 45 tablets of Roxicodone 15 mg and 60 tablets of Valium 5 mg from Reynolds.

    (b) On June 15, 2009, C.S. received a prescription for phentermine 37.5 mg, another schedule IV controlled substance for weight loss, from a third different practitioner just six days after her June 9, 2009 visit to AMC, and five days after Reynolds refused her request to refill her prescription for Fastin.

    (c) C.S. had been treated for narcotic dependence during the several months preceding her first visit to AMC. Specifically, the CSMP report shows that C.S. was treated with Suboxone throughout 2008. Significantly, the CSMP report showed that on October 10, 2008, just two months before C.S. began as a patient at AMC, she was issued a Suboxone prescription by Dr. Vance Shaw, AMC's Medical Director.

    (d) C.S. was pharmacy shopping, in addition to doctor-shopping. On May 11, 2009, C.S. presented to Church Hill Drugs prescriptions for a thirty-day supply of oxycodone and alprazolam that she had obtained from AMC (Reynolds). Twenty-four days later, on June 3, 2009, C.S. presented to a different pharmacy, Wilson Pharmacy, the oxycodone and alprazolam prescriptions she obtained from the Boones Creek practitioner. Then, six days later, on June 9, 2009, which would have been the thirty-day expiration date of the May 11, 2009 prescriptions, C.S. returned to Church Hill Drugs to present the oxycodone and diazepam prescriptions she obtained from AMC (Reynolds). Thus, the CSMP report alerted Stout to the fact that C.S. was consciously selecting different pharmacies at which to present prescriptions for the same types of controlled substances so as to avoid being detected for doctor-shopping and to obtain early refills.

    Id. at 81-82 (citing GX 26, at 49-57).

    Thus, the CSMD reports clearly showed that C.S. had violated the terms of her Pain Management Agreement by both doctor shopping and pharmacy shopping (i.e., filling her controlled substance prescriptions at multiple pharmacies).17 Id. at 82. Notwithstanding the “information showing that C.S. was seeing three different practices at the same time, was pharmacy-shopping, was in violation of her PMA, and was being treated for narcotics dependence for the several months leading up to her first AMC visit, which she had not disclosed to AMC, Stout issued her the above-referenced controlled substances prescriptions.” Id.

    17 In her Pain Management Agreement, C.S. had agreed to use only Church Hill Drugs to fill her controlled substance prescriptions. See GX 26, at 9.

    Indeed, according to C.S.'s file, during the visit, Stout did not even discuss the CSMD reports with C.S. GX 26, at 27-28. Nor did he require her to provide a UDS or subject her to a pill count, which, according to the Expert, would have been reasonable responses to the red flag information he possessed. Id. The Expert thus found that Stout's decision to issue her more controlled substance prescriptions on August 4, 2009 was “contrary to guidelines set forth in Tenn. BON Rule 1000-.04-.08, and accordingly, below the standard of care and outside the usual course of professional practice.” GX 68, at 83.

    Reynolds and Stout issued additional controlled substances prescriptions for oxycodone and benzodiazepines (Valium and Xanax) to C.S. on September 3, 2009, September 30, 2009, October 29, 2009, and November 30, 2009. See GX 26, at 19-26. For the reasons previously stated, the Expert found that Reynolds' and Stout's decisions to issuance C.S. more controlled substance prescription on these dates was contrary to AMC's professed protocols and the Board's Rule 1000-04.-.08(4)(c), and was therefore “below the standard of care and outside the usual course of professional practice.” GX 68, at 84.

    Moreover, the Expert found that on September 30, 2009, another CSMD report was obtained on C.S., presumably by Stout who saw her on this date. GX 68, at 84; GX 26, at 49-52. Significantly, the report showed that on August 4-5, 2009, C.S. presented the prescriptions she received from Mr. Stout on August 4, 2005, see id. at 23-24; to two more pharmacies, Cave's Drugs and P&S Pharmacy. See id. at 49, 51. Stout, however, also ignored this additional violation of the Pain Management Agreement and issued C.S. prescriptions for 45 Roxicodone 15 mg and 60 Valium 5 mg. GX 68, at 84.

    On October 29, 2009, Reynolds saw C.S. and actually increased her Roxicodone prescription from 45 to 60 tablets; he also issued her a prescription for 60 tablets of Valium 5 mg. GX 26, at 22. Not only did he ignore the information regarding C.S.'s doctor and pharmacy shopping, he also did so while noting in the visit record: “No recent accidents or injuries and no significant changes in current medical condition. . . . Pt has no interest in further intervention and is satisfied with current treatment plan. . . .” Id. at 21.

    On November 30, 2009, C.S. made her last visit to AMC and saw Reynolds, who again prescribed to her 60 tablets of Roxicodone 15 mg. Id. at 20. Moreover, while the note contains the same statement that there were “no significant changes in current medical condition” and that the C.S. was “satisfied with current treatment plan,” Reynolds changed her prescription from Valium to 90 dosage units of Xanax .5 mg. Id. at 19-20.

    To be sure, the visit note states her psychiatric condition as follows: “Patient states that they [sic] have had some increases [sic] problems situationally lately with anxiety and depression. This seems to be related to social stressors such as family problems, work issues, financial stressors and sometimes for no reason to mention.” Id. at 19. Yet this was the exact same statement that Reynolds provided in his documentation of C.S.'s psychiatric condition at her previous visit. See id. at 21. The record thus contains no explanation as to why Reynolds changed her prescription.

    C.S. died the next day. Her death certificate lists the cause of death as “multiple drug toxicity—oxycocodone, benzodiazepines, carbamates.” 18 Id. at 5.

    18 While not discussed above because it was not a controlled substance during the period in which C.S. was obtaining the prescriptions from AMC's practitioners, the evidence shows that she had also received Soma (carisoprodol) prescriptions at AMC on multiple occasions in the months prior to her death. See GX 26, at 20, 22-23, 26-27, 30. Carisoprodol is a derivative of carbamate. It has since been placed in schedule IV of the Controlled Substance Act because of substantial evidence of its abuse, particularly when taken in conjunction with narcotics and benzodiazepines. See Placement of Carisoprodol Into Schedule IV, 76 FR 77330 (2011).

    Summing up her conclusion with respect to the latter prescriptions, the Expert found that Reynolds and Stout acted below the standard of care and outside the usual course of professional practice. GX 68, at 84. Consistent with her conclusions regarding the previous prescriptions, the Expert concluded that Reynolds and Stout should have “enforced the terms of the [Pain Management Agreement], ceased issuing her further controlled substances prescriptions, and immediately referred her to a pain management specialist and/or addiction specialist for treatment.” 19 Id. at 85.

    19 In reviewing C.S.'s medical record, the Expert also found that on the nine occasions on which Reynolds saw C.S. between December 12, 2008 and November 30, 2009, he created identical, verbatim records for each visit which included the following entries:

    “Pt reports having increased pain with movement and decreased pain with rest”;

    “Pt states their pain is a 4 out of 10 and that they have a better quality of life and are able to `do more'”;

    “Patient states that they have had a headache for the last 1-2 days, radiating from their neck and around their temples. They relate it to increases in stressors such as home, work, financial, or problems with their family. They note some nause (sic), photophobia, and increased intensity with noise”;

    “Anxiety and depression noted in patients (sic) mannerisms and actions during interview.”

    GX 68, at 85 (quoting GX 26, at 19-46). Moreover, Reynolds and Stout documented the exact same physical exam findings at each of her visits. See id.

    Discussion

    As found above, each of the NPs has an application currently pending before the Agency, and by virtue of his having filed a timely renewal application, Mr. Stout also holds a registration. Pursuant to Section 304(a) of the Controlled Substances Act (CSA), a registration to “dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a)(4). Thus, in determining whether the revocation of an existing registration is necessary to protect the public interest, the CSA directs that I consider the same five factors as I do in determining whether the granting of an application would be consistent with the public interest. These factors are:

    (1) The recommendation of the appropriate State licensing board or professional disciplinary authority.

    (2) The applicant's experience in dispensing . . . controlled substances.

    (3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.

    (4) Compliance with applicable State, Federal, or local laws relating to controlled substances.

    (5) Such other conduct which may threaten the public health and safety.

    Id. § 823(f).

    “These factors are . . . considered in the disjunctive.” Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). I “may rely on any one or a combination of factors, and may give each factor the weight [I] deem[ ] appropriate in determining whether a registration should be revoked.” Id.; see also Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009). While I must consider each factor, I am “not required to make findings as to all of the factors.” Volkman, 567 F.3d at 222; see also Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005). However, even where an Applicant or Registrant ultimately waives his right to a hearing on the allegations, the Government has the burden of proving, by substantial evidence, that the requirements are met for both the denial of an application and the revocation or suspension of an existing registration. 21 CFR 1301.44(d)-(e).

    In this matter, I have considered all of the factors. Based on the Government's evidence with respect to factors two and four, I conclude that each practitioner has engaged in misconduct which establishes that granting his or her application, and in the case of Stout, continuing his registration, would be “inconsistent with the public interest.” 20 21 U.S.C. 823(f) & 824(a)(4).

    20 As for factor one, the recommendation of the state licensing authority, while each of the practitioners apparently retains his/her Advanced Practice Nurse license, the Tennessee Board of Nursing has not made a recommendation to the Agency as to whether he/she should be granted a new DEA registration. Moreover, although each practitioner is currently licensed by the State and thus satisfies an essential condition for obtaining (and maintaining) a registration, see 21 U.S.C. 802(21) & 823(f), DEA has held repeatedly that the possession of state licensure “ `is not dispositive of the public interest inquiry.' ” George Mathew, 75 FR 66138, 66145 (2010), pet. for rev. denied Mathew v. DEA, No. 10-73480, 472 Fed Appx. 453 (9th Cir. 2012); see also Patrick W. Stodola, 74 FR 20727, 20730 n.16 (2009); Robert A. Leslie, 68 FR 15227, 15230 (2003). As the Agency has long held, “the Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.” Mortimer Levin, 57 FR 8680, 8681 (1992). Thus, this factor is not dispositive either for, or against, the granting of Respondent's application. Paul Weir Battershell, 76 FR 44359, 44366 (2009) (citing Edmund Chein, 74 FR 6580, 6590 (2007), pet. for rev. denied Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008)).

    Regarding factor three, there is no evidence that Reynolds, Stout, or Killebrew has been convicted of an offense related to the manufacture, distribution or dispensing of controlled substances. 21 U.S.C. 823(f)(3). However, as there are a number of reasons why a person may never be convicted of an offense falling under this factor, let alone be prosecuted for one, “the absence of such a conviction is of considerably less consequence in the public interest inquiry” and thus, it is not dispositive. David A. Ruben, 78 FR 38363, 38379 n.35 (2013) (citing Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011)).

    Factors II and IV—The Applicant's Experience in Dispensing Controlled Substances and Compliance with Applicable Laws Related to Controlled Substances

    To effectuate the dual goals of conquering drug abuse and controlling both the legitimate and illegitimate traffic in controlled substances, “Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA.” Gonzales v. Raich, 545 U.S. 1, 13 (2005). Consistent with the maintenance of the closed regulatory system, a controlled substance may only be dispensed upon a lawful prescription issued by a practitioner. Carlos Gonzalez, M.D., 76 FR 63118, 63141 (2011).

    Fundamental to the CSA's scheme is the Agency's longstanding regulation, which states that “[a] prescription for a controlled substance [is not] effective [unless it is] issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a). This regulation further provides that “an order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of [21 U.S.C. 829] and . . . the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.” Id.

    As the Supreme Court has explained, “the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.” Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)); United States v. Alerre, 430 F.3d 681, 691 (4th Cir. 2005), cert. denied, 574 U.S. 1113 (2006) (stating that the prescription requirement likewise stands as a proscription against doctors acting not “as a healer[,] but as a seller of wares.”).

    Under the CSA, it is fundamental that a practitioner must establish and maintain a legitimate doctor-patient relationship in order to act “in the usual course of . . . professional practice” and to issue a prescription for a “legitimate medical purpose.” Paul H. Volkman, 73 FR 30629, 30642 (2008), pet. for rev. denied, 567 F.3d 215, 223-24 (6th Cir. 2009); see also Moore, 423 U.S. at 142-43 (noting that evidence established that the physician exceeded the bounds of professional practice, when “he gave inadequate physical examinations or none at all,” “ignored the results of the tests he did make,” and “took no precautions against . . . misuse and diversion”). The CSA, however, generally looks to state law and standards of practice to determine whether a doctor and patient have established a legitimate doctor-patient relationship. Volkman, 73 FR at 30642.

    Moreover, while a finding that a practitioner has violated 21 CFR 1306.04(a) establishes that the practitioner knowing and intentionally distributed a controlled substance in violation of 21 U.S.C. 841(a)(1), “the Agency's authority to deny an application [and] to revoke an existing registration . . . is not limited to those instances in which a practitioner intentionally diverts a controlled substance.” Bienvenido Tan, 76 FR 17673, 17689 (2011) (citing Paul J. Caragine, Jr., 63 FR 51592, 51601 (1998)); see also Dewey C. MacKay, 75 FR at 49974. As Caragine explained: “[j]ust because misconduct is unintentional, innocent, or devoid of improper motive, [it] does not preclude revocation or denial. Careless or negligent handling of controlled substances creates the opportunity for diversion and [can] justify” the revocation of an existing registration or the denial of an application for a registration. 63 FR at 51601.

    “Accordingly, under the public interest standard, DEA has authority to consider those prescribing practices of a physician, which, while not rising to the level of intentional or knowing misconduct, nonetheless create a substantial risk of diversion.” MacKay, 75 FR at 49974; see also Patrick K. Chau, 77 FR 36003, 36007 (2012). Likewise, “[a] practitioner who ignores the warning signs that [his] patients are either personally abusing or diverting controlled substances commits `acts inconsistent with the public interest,' 21 U.S.C. 824(a)(4), even if [he] is merely gullible or naïve.” Jayam Krishna-Iyer, 74 FR 459, 460 n.3 (2009); see also Chau, 77 FR at 36007 (holding that even if physician “did not intentionally divert controlled substances,” State Board Order “identified numerous instances in which [physician] recklessly prescribed controlled substances to persons who were likely engaged in either self-abuse or diversion” and that physician's “repeated failure to obtain medical records for his patients, as well as to otherwise verify their treatment histories and other claims, created a substantial risk of diversion and abuse”) (citing MacKay, 75 FR at 49974).

    As explained by the Government's Expert, in 2004, the Tennessee Board of Nursing promulgated Rule 1000-04-.08, setting forth guidelines for determining whether the prescribing practices of Advance Practice Nurses are within “the usual course of professional practice for a legitimate purpose in compliance with applicable state and federal law”; this rule became effective on January 1, 2005.21 Board Rule 1000-04-.08(4); GX 68, at 10. This rule provided that the patient's medical record “shall include a documented medical history and physical examination by the Advance Practice Nurse . . . providing the medication.” Board Rule 1000-04-.08 (4)(c)(1). It further stated that the “[h]istorical data shall include pain history, any pertinent evaluations by another provider, history of and potential for substance abuse, pertinent coexisting diseases and conditions, psychological functions and the presence of a recognized medical indication for the use of a controlled substance.” Id.

    21See also Board Rule 1000-04-.08(1)(d) (defining “[p]rescribing pharmaceuticals or practicing consistent with the public health and welfare” as “[p]rescribing pharmaceuticals and practicing Advanced Practice Nursing for a legitimate purpose in the usual course of professional practice”).

    The Rule also provided that “[a] written treatment plan tailored for individual needs of the patient shall include objectives such as pain relief and/or improved physical and psychosocial function, and shall consider need for further testing, consultations, referrals or use of other treatment modalities dependent on patient response.” Id. at 4(c)(2). Also, the rule provided that “[a]t each periodic interval” at which the patient is evaluated “for continuation or change of medications, the patient record shall include progress toward reaching treatment objectives, any new information about the etiology of the pain, and an update on the treatment plan.” Id. at (4)(c)(4). And the Expert also testified that Advanced Nurse Practitioners were employing the practices set forth in the guidelines in prescribing controlled substance before the Rule became effective on January 1, 2005.

    As found above, the Government's Expert reviewed the medical records maintained by AMC on patients N.S., T.H., and C.S. and concluded that in issuing the prescriptions, Messrs. Reynolds and Stout, as well as Ms. Killebrew, failed to comply with the Board's Rule and the standard of care as set forth in various practice guidelines which the clinic asserted it followed. Most importantly, the Government's Expert concluded that Reynolds, Stout, and Killebrew had issued multiple controlled substance prescriptions without a legitimate medical purpose and outside of the usual course of professional practice and thus also violated 21 CFR 1306.04(a).

    N.S.

    N.S. was initially seen at AMC by providers other than Reynolds, Stout, and Killebrew. However, at the time of her first visit with Reynolds, the latter knew that N.S. has previously been subjected to a UDS and tested positive for several benzodiazepines, even though these drugs had not been prescribed to her by the other NPs at AMC, as well as cocaine. She also tested negative for opiates even though she had been prescribed Avinza (morphine) at AMC, and on the date of the test, she should still have been taking the drug. Reynolds also knew that at N.S's previous visit, she had shown signs of somnolence, slurred speech, and rapid heart rate. Finally, N.S.'s file still lacked information concerning her prior treatment history and substance abuse history, and given that three months had passed since N.S.'s previous visit, Reynolds should have asked N.S. where she had been, but failed to do so. Reynolds failed to refer her to a specialist who could have addressed her aberrant behavior, and instead, issued her another Avinza prescription.

    As found above, throughout the lengthy course of her visits to AMC, N.S. continued to engage in aberrant behavior, which was largely ignored by Reynolds, Stout, and Killebrew, who continued to prescribe controlled substances to her. These episodes included overdoses resulting in multiple hospitalizations including for mental health treatment. Moreover, the discharge summary for the first of these, which occurred while N.S. was obtaining drugs at AMC, referenced her history of multiple overdoses and suicide attempts; listed two physicians as her primacy care providers (one of whom was not affiliated with AMC); stated that N.S. was taking hydrocodone, Xanax, and carisoprodol, none of which had been prescribed to her at AMC; and reported the results of a UDS, which again showed she was positive for benzodiazepines.

    Yet, notwithstanding these multiple red flags, Reynolds continued to prescribe Avinza to N.S. and did so without having obtained information about her treatment before coming to AMC, did not create a written treatment plan, and did not document that he had considered the need to refer her for further testing or consultations.

    Thereafter, Reynolds added Xanax for N.S.'s anxiety, notwithstanding that because of her obvious psychiatric issues, she should have been referred to a specialist. As the Expert explained, this was contrary to the Uphold & Graham Guidelines, which Reynolds claimed were the protocols that AMC followed.

    Following this, N.S. sought multiple early refills for Xanax; Reynolds also had directed her to come in for a pill count, but N.S. failed to comply. Yet Reynolds continued to issue her more Xanax, and even did so on an occasion when she should have had 19 days left on a prescription.

    As for Stout, while he did not prescribe to N.S. until seventeen months into her visits to AMC, the Expert explained that because it was her first visit with him, he was obligated to review her patient file before prescribing controlled substances to determine whether it was appropriate to continue or change her medications. The Expert thus concluded that Stout should have been aware of N.S.'s history of substance abuse and diversion, which was documented in her file, and that Stout breached the standard of care and acted outside of the usual course of professional practice when he issued her Xanax and Kadian prescriptions, rather than cease further prescribing and refer her to a specialist who could address her aberrant behavior.

    While Killebrew did not see N.S. until July 2006, when she had been going to AMC for more than twenty-five months, the Expert found that she too acted outside of the usual course of professional practice because she was obligated to review N.S.'s patient file and should not have prescribed controlled substances to her given her history of drug abuse and diversion. Moreover, this was N.S.'s first visit to AMC in seven months, and Killebrew noted that N.S. had recently been released from jail. However, Killebrew failed to ask why she had been incarcerated and how she had addressed her pain issues during that period. Killebrew nonetheless issued N.S. prescriptions for Percocet and Xanax.

    Thereafter, N.S. continued to see Reynolds and Stout (and occasionally Killebrew) and repeatedly obtained more controlled substance prescriptions while the practitioners ignored additional red flags. For example, in August 2006, Stout prescribed Percocet and Xanax to N.S., even though the day before N.S.'s July 20 visit with Killebrew, he had treated her while working in a local emergency room and documented that N.S. had admitted “to having a long history of drug abuse” and displayed “drug seeking behavior.” Stout also failed to address with N.S. why she had been jailed and how she addressed her pain issues while she was incarcerated.

    Two months later, Stout issued N.S. more Percocet and Xanax prescriptions, even though her file contained a note (dated one month) earlier stating that she had been selling Percocet. N.S. denied this, claiming her medications had been stolen, but then said she had been taking her medications for the past week. While Stout required that N.S. take a UDS, she tested negative for oxycodone (which she claimed she was taking) but positive for hydrocodone/hydromorphone, even though no one at AMC had prescribed those drugs to her. And notwithstanding these results, which showed that she was abusing and/or diverting, and demonstrated that N.S. had lied to him, Stout issued her more Percocet and Xanax prescriptions.

    Several months later, Stout attempted to refer her to two different pain management practices. However, N.S. had already been seen at these practices and neither would accept her as a patient. Once again, Stout issued her more prescriptions for Percocet and Xanax, and several months later, Reynolds issued more of the same prescriptions, ignoring the evidence that N.S. was abusing and diverting, and acted outside of the usual course of professional practice in doing so.

    Several months later, Reynolds increased the quantity of N.S.'s prescriptions (she had been switched from Percocet to morphine), by fifty percent from those issued at the previous visit, and yet there is no evidence that Reynolds saw her on this occasion and no explanation in her record as to why she was not seen. And the following month, N.S. called AMC and stated that she had run out of her prescriptions and Killebrew directed that prescriptions for Lortab and Xanax be called in for her; however, N.S. had not been seen at AMC in two months, which according to the Expert, also raised a red flag.

    Thereafter, N.S's behavior continued to present red flags, such as in November 2007, when she twice sought refills of controlled substances, including refills which were fifteen days early; yet Reynolds issued her more prescriptions. And the following month, N.S. was admitted to a local hospital which sent AMC both admission and discharge summaries; notably, the summaries listed “polysubstance abuse” as one of her diagnoses. Yet, even after receiving this information, Reynolds prescribed more MS Contin, Xanax, and Percocet to her.

    Thereafter, N.S. became pregnant and did not visit AMC between February and late December 2008, and apparently had received Suboxone or Subutex treatment from a physician (who was not affiliated with AMC) during her pregnancy. Yet, on N.S.'s return, Killebrew prescribed to her both 60 Lortab 7.5 mg and 30 Xanax .5 mg. However, Killebrew did not even obtain the name of the physician who had provided the Suboxone/Subutex treatment, let alone contact him/her. She also did not conduct a check of the State's prescription monitoring database, even though in the Expert's view, N.S's history of doctor shopping warranted this. Moreover, Killebrew did not document that N.S. had incurred a new illness or injury, and according to the Expert, performed a cursory physical exam. I thus adopt the Expert's conclusion that Killebrew acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing the prescriptions. 21 CFR 1306.04(a).

    Following this visit, N.S. did not return to AMC for more than five months. Yet on her return, Reynolds issued her prescriptions for even more potent controlled substances and in even greater quantities (60 MS Contin 30 mg, 30 Percocet 7.5 mg, 90 Xanax .5 mg). However, Reynolds did not document how N.S. had managed her purported pain since her last visit, failed to run a check on her with the CSMD, and failed to conduct a UDS on her. Once again, the Expert concluded that these prescription were issued in violation of 21 CFR 1306.04(a).

    As the Expert explained, over the course of the nearly six-year period in which N.S. obtained controlled substances at AMC, she presented numerous red flags (including overdoses) and yet was subjected to only two UDSs, both of which she failed, and but a single pill count. Moreover, the only time her prescription history was obtained from the CSMD was on the date of her last visit. Also, there were several episodes in which N.S. had not appeared at AMC for months on end, and yet was given more prescriptions without the treating practitioner even attempting to verify her explanation for her absence, asking her how she addressed her pain during her absence, contacting her purported treating physicians, or performing an adequate physical examination. I therefore conclude that all three practitioners acted outside of the usual course of professional practice and lacked a legitimate medical purpose when they issued controlled substance prescriptions to N.S. 21 CFR 1306.04(a).

    I also conclude that all three practitioners acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing multiple controlled substance prescriptions to T.H. As explained by the Expert, from T.H.'s initial visit, the practitioners knew that T.H. had problems with alcohol as well as mental health issues, and yet they failed to adequately evaluate his alcohol-related issues and refer him to a specialist who could properly address his mental health issues.

    Moreover, while T.H. was referred to a pain management clinic, which recommended that he undergo facet blocks and that he take only three Lortab 10 mg per day and do so only for as long as it took to have the procedures performed, T.H. returned to AMC where he saw Reynolds, who failed to determine whether T.H. had ever undergone the procedures. Also, while T.H. should have been out of the controlled substance prescribed by the pain management clinic for a month, Reynolds made no inquiry as to how T.H. had managed his pain. Yet Reynolds then proceeded to escalate T.H.'s prescriptions to 60 OxyContin 40 mg, 30 Lortab 10 mg, and 90 Xanax 1 mg. As the Expert explained, there was no medical justification for adding OxyContin 40 mg to T.H.'s medications, which she explained was four times the normal starting dose. The Expert also explained that the amount of Xanax Reynolds prescribed was excessive as it was six times the daily dosage T.H. had previously received and could be lethal when taken with the narcotics that Reynolds prescribed. The Expert further noted that Reynolds did not properly evaluate T.H.'s alcohol-related problems or his anxiety. I agree with the Expert that Reynolds lacked a legitimate medical purpose and acted outside of the usual course of professional practice in issuing the prescriptions. 21 CFR 1306.04(a).

    At the next visit, T.H. saw Stout, who issued him more prescriptions for the same three drugs. Yet as the Expert explained, Stout did not properly evaluate T.H.'s pain and psychosocial situation, the efficacy of the drugs on his ability to function, did not develop a written treatment plan, and did not evaluate T.H.'s history or potential for abuse. I agree with the Expert's conclusion that Stout lacked a legitimate medical purpose and acted outside of the usual course of professional practice in issuing the prescriptions. Id.

    During the course of the two years in which T.H. visited AMC, he presented multiple red flags. These included that: (1) He was receiving high doses of narcotics and yet never complained of opioid-induced constipation; (2) he admitted that he was simultaneously seeing another physician, yet neither Reynolds nor Stout contacted the physician to determine the nature of the treatment T.H. was receiving; (3) a pharmacy reported that T.H. was receiving Suboxone treatment from still another physician (again, neither Reynolds nor Stout contacted the physician); (4) T.H. was clearly using multiple pharmacies notwithstanding that he had agreed to use only a single pharmacy; (5) AMC had received a fax which included various documents establishing that T.H. had been treated at three other clinics; (6) T.H. was being treated for depression by a physician; (7) T.H. owed approximately $3,000 to two medical practices; (8) T.H. sought multiple early refills; (9) and T.H. was trying to stop abusing alcohol.

    However, T.H. was never required to provide a UDS, was never subjected to a pill count, and a CSMD report was never obtained on him. Moreover, according to the Expert, at no point did any of the three practitioners (including Killebrew, who saw T.H. and prescribed to him on several occasions) create a written treatment plan and properly evaluate his use of alcohol. Yet all three practitioners continued to prescribe both OxyContin and either Percocet or Lortab, as well as Xanax, to T.H., up until the day before he overdosed and died. Based on the Expert's extensive findings, I conclude that each of the practitioners acted outside of the usual course of professional practice and lacked a legitimate medical purpose when they issued T.H. the prescriptions for multiple narcotics and benzodiazepines.22 21 CFR 1306.04(a).

    22 It is noted that Ms. Killebrew's involvement with T.H. was limited to only three visits and that the prescriptions she issued were generally the same as those issued by Reynolds and Stout. With respect to T.H.'s first visit with Killebrew, the Expert opined that the information he reported regarding his impending divorce and increased anxiety rendered him a “high-risk patient for managing chronic pain and whose care extended beyond the scope of a nurse practitioner engaged in family practice,” and that a “prudent practitioner would have considered T.H. to be a risk for suicide and diversion and would have referred him to a mental health specialist and a comprehensive pain management program,” which Killebrew failed to do. GX 68, at 63.

    While the Expert's discussion sounds in malpractice, the Expert further noted that as of the date of his first visit with Killebrew, T.H.'s file contained extensive evidence that he was abusing and/or diverting controlled substances yet Killebrew failed to take steps to monitor his use of controlled substances. I thus agree with the Expert's conclusion that Killebrew acted outside of the usual course of professional practice when she prescribed to T.H. 60 OxyContin 40 mg, 30 Percocet 10 mg, and 75 Xanax 1 mg. Id. at 63-64.

    Similarly, at T.H.'s second visit with her, he reported that he was having problems with anxiety, that he trying quit alcohol, that he had made an appointment at a mental health facility and had hand tremors; according to the Expert, the latter was a sign of anxiety or alcohol/drug withdrawal. Killebrew did not, however, refer T.H. for treatment by specialists as was called for in the Uphold & Graham practice guidelines which AMC had previously adopted as its practice protocols. GX 39, at 15. Instead, she issued him more prescriptions, these being for 60 OxyContin 40 mg, 30 Lortab 10 mg, while changing his prescription for Xanax to 90 Valium 10 mg. She also ignored other red flags which were documented in T.H.'s patient file. At T.H.'s next visit, Killebrew issued T. H. these same prescriptions, again ignoring the red flags he presented and AMC's practice protocols. Consistent with the Expert's testimony, I conclude that Killebrew acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing controlled substances to T.H. 21 CFR 1306.04(a).

    I also agree with the Expert's conclusions that both Reynolds and Stout acted outside of the usual course of professional practice and lacked a legitimate medical purpose when they issued various controlled substance prescriptions to C.S. As the Expert noted, C.S. claimed that she had suffered injuries in a car accident and suffered from back pain (at a level of 4 out of 10) as well as neck pain, although the records also state: “Pt has no interest in further intervention and is satisfied with current treatment plan.” The note for her first visit further stated that C.S. reported that she had “increase[d] problems situationally lately with their anxiety and depression.”

    According to the Expert, at C.S.'s first visit, Reynolds failed to create a patient record that appropriately documented her medical history, including her pain history, pertinent evaluations by other practitioners, her history of, and potential for, substance abuse, and pertinent coexisting diseases and treatments. The Expert also found that he did not create a treatment plan which was tailored for her individual needs. While Reynolds made an entry in the medical record that he had performed a physical exam, notably, with the exception of her vital signs, the physical exam notes for each of her visits are repeated verbatim.

    Notwithstanding that C.S. had reported increased problems with anxiety and depression, and according to the clinic's protocols, presented a higher risk of substance abuse, Reynolds did not refer her to a specialist and did not document that he had even considered doing so. Moreover, while C.S. had reported injuries, she also wrote on her intake form that she did not have a current health care provider. As the Expert explained, there is no evidence that Reynolds inquired as to how she had addressed her pain if she had no current provider. Moreover, while Reynolds could have run a CSMD check to verify if C.S. had, in fact, recently seen another provider, as well as obtain information as to her substance abuse history, he did not do so. Of note, that report would have shown that in the period preceding her visit, she had obtained Suboxone from three different physicians. Reynolds started her on Percocet and Valium. I agree with the Expert's conclusion that the prescriptions lacked a legitimate medical purpose and were issued outside of the usual course of professional practice. 21 CFR 1306.04(a).

    At some point, Reynolds did obtain C.S's medical records from a physician who treated her over a five-month period, which had ended more than thirteen months before her first visit to AMC. Most significantly, the physician had documented that C.S. was taking more pain medications than he recommended and explained that he did not think that she could “self-medicate.” Yet both Reynolds and Stout continued to prescribe multiple controlled substances including Percocet, Valium, and phentermine to C.S. Moreover, there is no evidence that either Reynolds or Stout ever contacted that physician.

    The Expert further found that neither Reynolds nor Stout properly evaluated C.S. at her follow-up visits to determine whether her medications should be continued or changed. Moreover, both Reynolds and Stout repeatedly ignored red flags that C.S. was engaged in both doctor and pharmacy shopping and thus violating her pain contract. These incidents included one in which Reynolds received a phone call from another clinic reporting that C.S. had sought to become a patient, claiming that she did not have a family practice, and that she also used two names at various practices. Neither Reynolds nor Stout documented having addressed this incident with her. Instead, they continued to issue her more prescriptions and never ran a UDS on her.

    Moreover, while AMC eventually obtained CSMD reports on her (two months after the above report), they again ignored multiple items of information in those reports which showed that C.S. had been treated for narcotic dependency prior to her first visit at AMC (and had obtained Suboxone from three physicians), that she had recently obtained controlled substances from two other physicians, and that she had also filled prescriptions at multiple pharmacies in violation of her pain agreement. Yet Reynolds and Stout continued to issue her prescriptions for both oxycodone and benzodiazepines up until her death. I therefore agree with the Expert's conclusion that both Reynolds and Stout acted outside of the usual course of professional practice and lacked a legitimate medical purpose when they issued the prescriptions to C.S. 21 CFR 1306.04(a).

    In summary, I find that the Government's evidence with respect to factors two and four establishes that each of the three practitioners issued prescriptions in violation of the CSA's prescription requirement and engaged in the knowing diversion of controlled substances. I further hold that the Government has established by substantial evidence that the misconduct of each practitioner is sufficiently egregious to conclude that he/she has committed acts which render his/her “registration inconsistent with the public interest.” 21 U.S.C. 823(f) & 824(a)(4). With respect to each of the three practitioners, these findings are sufficient to support the denial of their applications, and in the case of Stout, to revoke his registration.

    Factor Five—Such Other Conduct Which May Threaten Public Health and Safety

    The Government also contends that practitioner Reynolds engaged in actionable misconduct under this factor when he wrote a letter to a DEA Diversion Investigator which contained various material false statements regarding AMC's treatment of N.S. I agree with the Government.

    As recognized by the Sixth Circuit, “[c]andor during DEA investigations, regardless of the severity of the violations alleged, is considered by the DEA to be an important factor when assessing whether a [practitioner's] registration is consistent with the public interest.” Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005). To be actionable, the Government is required to show that the statement was false and material to the investigation. See Roy S. Schwartz, 79 FR 34360, 34363 n.6 (2014); Belinda R. Mori, 78 FR 36582, 36589 (2013). As the Supreme Court has explained, a false statement is material if it “ `has a natural tendency to influence, or was capable of influencing the decision of the decisionmaking body to which it was addressed.' ” Kungys v. United States, 485 U.S. 755, 770 (1988) (quoting Weinstock v. United States, 231 F.2d 699, 701 (D.C. Cir. 1956)). The Court has further explained that:

    it has never been the test of materiality that the misrepresentation . . . would more likely than not have produced an erroneous decision, or even that it would more likely than not have triggered an investigation. Rather, the test is whether the misrepresentation . . . was predictably capable of affecting, i.e., had a natural tendency to affect, the official decision. 485 U.S. at 770-71. “It makes no difference that a specific falsification did not exert influence so long as it had the capacity to do so.” United States v. Alemany Rivera, 781 F.2d 229, 234 (1st Cir. 1985).

    The Government first argues that Reynolds made a materially false statement when he wrote that N.S. “was admitted to JCMC on December 3, 2004 by Dr. . . . James with drug overdose. She was transferred to [IPP] . . . and continued on her then prescribed medications.” Req. for Final Agency Action, at 42 (quoting GX 42, at 7). Based on an affidavit it obtained from Dr. James, the Government argues that Reynolds' statement was false because Dr. James “did not continue N.S. on her then prescribed medications” but “ceased prescribing” all controlled substances to her because she had “been admitted [to JCMC] for a drug overdose, had a history of multiple overdoses and suicide attempts, and was [being transferred] to IPP for inpatient psychiatric treatment.” Id. at 43.

    Notwithstanding Dr. James' statement (which may well have reflected her instructions), the discharge summary for N.S.'s hospitalization (which was part of her patient file), lists Soma, Xanax, MSCN (morphine), and Lortab as “medications to continue” and is blank in the space for listing “medications to discontinue.” GX 2, at 160. While the form was apparently completed by a nurse and not Dr. James, absent proof that Reynolds had otherwise obtained knowledge that Dr. James had instructed that N.S.'s medications were to be discontinued, it was not unreasonable for him to conclude that the nurse had accurately reflected Dr. James' instructions on the discharge summary. I thus reject the contention that Reynolds knowingly made a material false statement when he wrote that N.S. had been continued on her then-prescribed medications.23

    23 Even were I to hold that a negligently made false statement is actionable under factor five, no argument has been made as to why Reynolds was negligent when he relied on the discharge summary.

    Reynolds, however, also claimed that N.S. “never had another overdose incident while being treated at AMC” after a December 3, 2004 hospitalization at Johnson City Medical Center. GX 42, at 7. The Government, however, produced a copy of a report created upon N.S.'s admission to the Johnson City Medical Center on August 19, 2005, which clearly stated that “[t]he patient was transferred from Northside Hospital because of unresponsiveness secondary to drug overdose.” GX 14, at 29.

    The report further stated that N.S. had told her mother that she had taken five Soma tablets, that her mother found her unresponsive on the floor, that she was taken to Northside Hospital where “she was found unresponsive to painful stimuli . . . with pinpoint pupils,” and that Narcan, a drug used to counter the effects of opioids, “was not helpful.” Id. The report also listed “[d]rug overdose” under the attending physician's impressions, and noted that she was to be admitted to the ICU. Id. at 30. Finally, the attending physician listed Reynolds as N.S.'s primary care provider and listed him as a recipient of a copy of the report. Id.

    Based on the above, I conclude that Reynolds knew that N.S. had been hospitalized for a second overdose incident after the December 3, 2004 hospitalization and that his statement was false. I further conclude that the statement was material because it was clearly made by Reynolds to the DI in an attempt to excuse the misconduct he and his fellow practitioners engaged in when they continued to prescribe controlled substances to N.S. even when faced with knowledge that she was drug abuser. See GX 42, at 2 (Reynolds' letter to DI; “I am including in this letter the documents that I have developed to explain my actions and the rationale behind the decisions that have been called into question by the Office of General Counsel of Tennessee and I assume the DEA.”) As explained above, that misconduct is clearly within the Agency's jurisdiction and his statement was clearly capable of influencing the decision of the Agency to pursue this matter.

    In his letter, Reynolds also stated that Dr. James (the physician who admitted N.S. to the JCMC for her December 2004) “took the medical and social history from [N.S.'s] family [and] not the patient.” GX 42, at 7. The Government notes that in the Admission Report, Dr. James documented that N.S. “has had multiple episode of over dose in the past, the last one was in May 2004, when she was admitted to the Intensive Care Unit with drug overdose” and that N.S.'s “[h]istory [wa]s obtained mainly from the emergency room records and the patient's parents.” Req. for Final Agency Action, at 45.

    The Government argues that taken within the context of the letter, Reynolds' statement was materially false and was made “for the purpose of demonstrating that the history noted by Dr. James . . . of `multiple over dose in the past' was somehow inaccurate because” it had not been obtained “directly from N.S.” Id. Notably, in his letter, Reynolds further asserted that when, after the overdose incident, N.S returned to AMC, “[s]he argued with [him] that her overdose was a one-time mistake she had made” which was caused by “domestic issues at home” and that he “gave her the benefit of the doubt” and prescribed more controlled substances to her. GX 42, at 7.

    Here again, I agree with the Government that the statement was made to justify Reynolds' decision to ignore the clear evidence that N.S. was a substance abuser and to excuse his misconduct (as well as that of his fellow practitioners) in continuing to prescribing controlled substances to her. I further conclude that the statement was false and was capable of influencing the Agency's investigation and was therefore material.

    Next, the Government argues that Reynolds made a material false statement when he wrote that after the December 3, 2004 hospitalization, N.S. “ `never again displayed signs of addiction to include . . . aberrant behavior . . . [and] early refills.' ” Req. for Final Agency Action, at 44 (quoting GX 42, at 7). As found above, the record contains substantial evidence that N.S. displayed numerous signs of addiction and aberrant behavior. These included: (1) Her nearly eight-month absence from the practice (between Dec. 1, 2005 and July 20, 2006) and her reappearance at AMC during which she told Killebrew that she had been in jail; (2) Stout's having treated her the day before her reappearance at AMC at a local hospital's ER and noting that she wanted “stronger narcotics” and had “displayed drug seeking behavior”; (3) a Sept. 13, 2006 report that N.S. was selling Percocet; (4) an Oct. 11, 2006 UDS which was positive for narcotics she had not been prescribed but negative for narcotics which she had been prescribed; (5) her false statement at that visit that she was taking the prescribed medications; (6) the December 2006 refusal of two different pain management practices, both of which had previously seen her, to accept her as a patient; (7) her having sought (in November 2007) a refill fifteen days early; (8) her admission to a local hospital in late December 2007, which diagnosed her with various conditions including poly-substance abuse; (9) the more than five-month gap between her December 22, 2008 and June 4, 2009 visit; and (10) her November 2009 claim that her drugs had been stolen and she needed a refill.

    Here again, Reynolds clearly knew of these various incidents and his statement was clearly made to excuse the misconduct he and his fellow practitioners engaged in by continuing to prescribe controlled substances to N.S. in the face of her aberrant behavior. I therefore find that the statement was materially false.

    Reynolds further stated that “[i]n October of 2006, [N.S.] passed drug screens and observations by MC providers.” GX 42, at 7. As found above, this statement was clearly false as N.S. tested positive for hydrocodone/hydromorphone, even though no one at AMC had prescribed these drugs to her, and tested negative for oxycodone/oxymorphone, even though she had received a Percocet prescription at her previous visit to AMC. Here again, Reynolds' statement was false and clearly made to excuse the misconduct that he and his fellow practitioners engaged in by continuing to prescribe controlled substances to N.S.

    Based on the multiple materially false statements Reynolds made in his letter to a DEA Investigator, I further find that Reynolds has engaged in additional conduct which may threaten public health or safety. This finding provides a further reason to deny Reynolds' application.

    Sanction

    Under agency precedent, “where a registrant [or applicant] has committed acts inconsistent with the public interest, [he or] she must accept responsibility for his [or her] . . . actions and demonstrate that he [or she] . . . will not engage in future misconduct.” Jayam Krishna-Iyer, 74 FR 459, 463 (2009); see also Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008). Here, each practitioner has waived his/her right to a hearing and therefore the opportunity to present evidence to refute the Government's showing that he/she has committed acts which render his/her registration “inconsistent with the public interest,” 21 U.S.C. 823(f), and the only evidence in the record relevant to these issues is Reynolds' letter to the DI.

    Therein, Reynolds stated that he has closed his practice and would not re-open it; that he has taken 55 hours of continuing education in ethics, boundaries, pharmacology and pain; and offered to take “other training” to ensure the public safety and his “compliance with DEA standards.” GX 42, at 2. Even were I to give weight to Reynolds's unsworn statement regarding the remedial measures he has undertaken, I would still deny his application because he has presented no evidence that he acknowledges his misconduct. To the