Federal Register Vol. 80, No.172,

Federal Register Volume 80, Issue 172 (September 4, 2015)

Page Range53457-53689
FR Document

80_FR_172
Current View
Page and SubjectPDF
80 FR 53514 - Farm Credit Administration Board; Sunshine Act; Regular MeetingPDF
80 FR 53569 - Government in the Sunshine Act Meeting NoticePDF
80 FR 53487 - Privacy Act of 1974; Amendments to Existing System of RecordsPDF
80 FR 53565 - Outer Continental Shelf, Region-Wide Gulf of Mexico, Oil and Gas Lease Sales for Years 2017-2022PDF
80 FR 53564 - Outer Continental Shelf, Gulf of Mexico, Oil and Gas Western Planning Area Lease Sale 248PDF
80 FR 53515 - Sunshine Act Amended; Notice of Meeting; September 10, 2015; 8:30 a.m.; In-Person MeetingPDF
80 FR 53497 - Prestressed Concrete Steel Wire Strand From the People's Republic of China: Final Results of Expedited First Sunset Review of Countervailing Duty OrderPDF
80 FR 53496 - Large Power Transformers From the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review; 2013-2014PDF
80 FR 53490 - Certain Steel Nails From the People's Republic of China: Preliminary Results of the Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2013-2014PDF
80 FR 53513 - Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of HawaiiPDF
80 FR 53505 - National Commission on the Future of the Army; Notice of Federal Advisory Committee MeetingPDF
80 FR 53559 - Endangered and Threatened Wildlife and Plants; Proposed Low-Effect Habitat Conservation Plan for the Desert Tortoise, Nye County, NevadaPDF
80 FR 53519 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment RequestPDF
80 FR 53563 - Outer Continental Shelf, Gulf of Mexico, Oil and Gas Central Planning Area Lease Sales 241 and 247 and Eastern Planning Area Lease Sale 226PDF
80 FR 53478 - Cyber Security at Fuel Cycle FacilitiesPDF
80 FR 53585 - Reassessment of NRC's Dollar Per Person-Rem Conversion Factor PolicyPDF
80 FR 53580 - Entergy Nuclear Operations, Inc.; James A. FitzPatrick Nuclear Power Plant, Pilgrim Nuclear Power Station, and Vermont Yankee Nuclear Power StationPDF
80 FR 53591 - North Anna Power Station, Units 1 and 2; Virginia Electric and Power CompanyPDF
80 FR 53473 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Resources of the South Atlantic; Trip Limit ReductionPDF
80 FR 53614 - Motor Carrier Safety Advisory Committee and Medical Review Board Public MeetingsPDF
80 FR 53614 - Commercial Driver's License Standards: Application for Exemption; Daimler Trucks North America (Daimler)PDF
80 FR 53558 - Sport Fishing and Boating Partnership CouncilPDF
80 FR 53520 - Final Effect of Designation of a Class of Employees for Addition to the Special Exposure CohortPDF
80 FR 53557 - Receipt of an Incidental Take Permit Application for Participation in the Oil and Gas Industry Conservation Plan for the American Burying Beetle in OklahomaPDF
80 FR 53483 - Amendment to “Participation by Religious Organizations in USAID Programs” To Implement Executive Order 13559PDF
80 FR 53612 - Meeting of the Regional Resource Stewardship CouncilPDF
80 FR 53484 - Approval and Promulgation of Implementation Plans; Texas; Infrastructure Requirements for the 1997 Ozone and the 1997 and 2006 PM2.5PDF
80 FR 53467 - Approval and Promulgation of Implementation Plans; Texas; Infrastructure Requirements for the 1997 Ozone and the 1997 and 2006 PM2.5PDF
80 FR 53574 - Notice of Exemption Involving Deutsche Bank AG (Deutsche Bank or the Applicant) Located in Frankfurt, GermanyPDF
80 FR 53516 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
80 FR 53611 - 60-Day Notice of Proposed Information Collection: INTERNational ConnectionsPDF
80 FR 53512 - Proposed Prospective Purchaser Agreement for the Delco Chassis Industrial Land I & II Site in Livonia, MichiganPDF
80 FR 53464 - Drawbridge Operation Regulation; Sacramento River, Sacramento, CAPDF
80 FR 53463 - Drawbridge Operation Regulation; Petaluma River, Petaluma, CAPDF
80 FR 53463 - Olympia Harbor Days Tug Boat Races, Budd Inlet, WAPDF
80 FR 53555 - Notice of Intent To Prepare Draft Environmental Impact Statement (EIS) for the Rebuild by Design Hudson River Project: Resist, Delay, Store, Discharge in the City of Hoboken, Township of Weehawken and City of Jersey City, New JerseyPDF
80 FR 53515 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
80 FR 53513 - Environmental Impact Statements; Notice of AvailabilityPDF
80 FR 53569 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Proposed Collection: Revision of Currently Approved Collection Survey: Annual Survey of Jails; Death in Custody Reporting Program-Local Jails; Survey of Jails in Indian CountryPDF
80 FR 53572 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Proposed Collection: Revision of Currently Approved Collection Survey: Death in Custody Reporting Program-PrisonsPDF
80 FR 53569 - Agency Information Collection Activities; Proposed eCollection; eComments Requested; Application for Suspension of Deportation (Form EOIR-40)PDF
80 FR 53517 - Submission for OMB Review; Comment RequestPDF
80 FR 53503 - Proposed Collection; Comment RequestPDF
80 FR 53612 - Public Notice for Waiver of Aeronautical Land-Use AssurancePDF
80 FR 53613 - Notice of Intent To Rule on a Request by Clinton County for FAA Approval of a Land Release From Federal Obligations of the Site Formerly Known as Clinton County Airport, Plattsburgh, NYPDF
80 FR 53546 - Submission for OMB Review; 30-Day Comment Request National Children's Study (NCS) Data and Sample Archive and Access SystemPDF
80 FR 53502 - Procurement List; Additions and DeletionsPDF
80 FR 53501 - Procurement List; Proposed Additions and DeletionsPDF
80 FR 53503 - Agency Information Collection Activities: Comment RequestPDF
80 FR 53621 - Geriatrics and Gerontology Advisory Committee; Notice of MeetingPDF
80 FR 53504 - Submission for OMB Review; Comment RequestPDF
80 FR 53553 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; National Flood Insurance Program Call Center and Agent Referral Enrollment FormPDF
80 FR 53486 - Ravalli Resource Advisory CommitteePDF
80 FR 53457 - Gypsy Moth Generally Infested Areas; Additions in Minnesota, Virginia, West Virginia, and WisconsinPDF
80 FR 53475 - VSTA Records and Reports Specific to International Standards for PharmacovigilancePDF
80 FR 53577 - Comment Request for Information Collection for Placement Verification and Follow-Up of Job Corps Participants, (OMB Control Number 1205-0426), Routine Extension Without RevisionsPDF
80 FR 53486 - Availability of an Environmental Assessment for Field Testing a Swine Influenza Vaccine, H1N1 & H3N2, Modified Live VirusPDF
80 FR 53485 - Highly Pathogenic Avian Influenza; Availability of an Environmental Assessment and Finding of No Significant ImpactPDF
80 FR 53500 - Mid-Atlantic Fishery Management Council (MAFMC); Public MeetingsPDF
80 FR 53501 - New England Fishery Management Council; Public MeetingPDF
80 FR 53499 - Mid-Atlantic Fishery Management Council (MAFMC); Public MeetingPDF
80 FR 53500 - North Pacific Fishery Management Council; Public MeetingPDF
80 FR 53507 - Delaware Public Service Commission, Maryland Public Service Commission v. PJM Interconnection, LLC, Certain Transmission Owners Designated Under Attachment A to the Consolidated Transmission Owners Agreement, Rate Schedule FERC No. 42: Notice of ComplaintPDF
80 FR 53508 - Rockies Express Pipeline LLC; Notice of Availability of the Environmental Assessment for the Proposed Zone 3 Capacity Enhancement ProjectPDF
80 FR 53511 - Blue River Hydro Power, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing ApplicationsPDF
80 FR 53510 - Peterson Machinery Sales; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing ApplicationsPDF
80 FR 53509 - Cat Creek Energy, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing ApplicationsPDF
80 FR 53510 - Owyhee Hydro, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing ApplicationsPDF
80 FR 53512 - Backyard Farms Energy LLC, Devonshire Energy LLC: Notice of Petition for Declaratory OrderPDF
80 FR 53507 - Combined Notice of Filings #2PDF
80 FR 53506 - Combined Notice of Filings #1PDF
80 FR 53482 - Children's Online Privacy Protection Rule Proposed Parental Consent Method; Jest8 Limited Trading as Riyo's Application for Approval of Parental Consent Method; Extension of Comment PeriodPDF
80 FR 53489 - Order Relating to Air Bashkortostan, LTD.PDF
80 FR 53489 - Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment AssistancePDF
80 FR 53498 - U.S. Integrated Ocean Observing System (IOOS®PDF
80 FR 53621 - Commission on Care; Notice of MeetingPDF
80 FR 53514 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
80 FR 53515 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
80 FR 53573 - Conference Call Meeting of the Department of Justice's (DOJ's) National Motor Vehicle Title Information System (NMVTIS) Federal Advisory CommitteePDF
80 FR 53549 - Prospective Grant of an Exclusive Patent Commercialization License: Cerclage Annuloplasty Devices for Treating Mitral Valve RegurgitationPDF
80 FR 53552 - Prospective Grant of an Exclusive Patent Commercialization License: Caval-Aortic Devices for Aortic Valve ReplacementPDF
80 FR 53608 - Agency Information Collection Activities: Proposed Request and Comment Request the Social Security Administration (SSA) Publishes a List of Information Collection Packages Requiring Clearance by the Office of Management and Budget (OMB) in Compliance With Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This Notice Includes Revisions and Extensions of OMB-Approved Information Collections.PDF
80 FR 53488 - Notice of Public Meeting of the Illinois Advisory Committee To Introduce Recently Appointed Committee Members and Discuss Civil Rights Concerns in the StatePDF
80 FR 53552 - Merchant Marine Personnel Advisory Committee; VacanciesPDF
80 FR 53464 - Drawbridge Operation Regulation; Illinois Waterway, Beardstown, ILPDF
80 FR 53567 - Issuance of a General Exclusion Order and Cease and Desist Orders; Termination of Investigation; Certain Toner Cartridges and Components ThereofPDF
80 FR 53499 - Marine Mammals; File No. 18208PDF
80 FR 53615 - Railroad Safety Grants for the Safe Transportation of Energy Products by Rail ProgramPDF
80 FR 53554 - Technical Resource for Incident Prevention (TRIPwire) User RegistrationPDF
80 FR 53601 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Adopting a Principles-Based Approach To Prohibit the Misuse of Material, Non-Public Information by Market Makers by Deleting Rule 810PDF
80 FR 53600 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Its Price List To Raise the NYSE Crossing Session II Fee CapPDF
80 FR 53606 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Regarding FLEX No Minimum Value PilotPDF
80 FR 53592 - Notice of Applications for Deregistration Under Section 8(f) of the Investment Company Act of 1940PDF
80 FR 53593 - The Glenmede Portfolios and Glenmede Investment Management LP; Notice of ApplicationPDF
80 FR 53465 - Safety Zone, Labor Day Long Neck Style Fireworks, Indian River Bay; Long Neck, DEPDF
80 FR 53562 - National Historic Landmarks Committee of the National Park System Advisory Board MeetingPDF
80 FR 53608 - Surrender of License of Small Business Investment CompanyPDF
80 FR 53552 - National Institute on Aging; Notice of Closed MeetingPDF
80 FR 53551 - National Institute on Aging; Notice of Closed MeetingPDF
80 FR 53547 - National Cancer Institute; Notice of Closed MeetingsPDF
80 FR 53550 - Center for Scientific Review; Notice of Closed MeetingsPDF
80 FR 53546 - Center for Scientific Review; Notice of Closed MeetingsPDF
80 FR 53548 - Government-Owned Inventions; Availability for LicensingPDF
80 FR 53588 - In the Matter of BWXT Nuclear Operations Group, Inc.PDF
80 FR 53581 - Watts Bar Nuclear Plant, Unit 1; Application and Amendment to Facility Operating License Involving Proposed No Significant Hazards Consideration DeterminationPDF
80 FR 53480 - Airworthiness Directives; Viking Air Limited AirplanesPDF
80 FR 53586 - U.S. Army Installation Command, Davy Crockett Depleted UraniumPDF
80 FR 53579 - Draft Memorandum of Agreement Between the U.S. Nuclear Regulatory Commission, New Jersey Historic Preservation Office, Advisory Council on Historic Preservation, National Park Service, PSEG Power, LLC, and PSEG Nuclear, LLCPDF
80 FR 53469 - Oxathiapiprolin; Pesticide TolerancesPDF
80 FR 53623 - Takes of Marine Mammals Incidental to Specified Activities; Marine Geophysical Survey in the Eastern Mediterranean Sea, November to December, 2015PDF
80 FR 53657 - Takes of Marine Mammals Incidental to Specified Activities; U.S. Navy Civilian Port Defense Activities at the Ports of Los Angeles/Long Beach, CaliforniaPDF
80 FR 53458 - New Animal Drugs; Approval of New Animal Drug ApplicationsPDF
80 FR 53457 - Strategic Economic and Community DevelopmentPDF
80 FR 53555 - Federal Property Suitable as Facilities To Assist the HomelessPDF
80 FR 53520 - Secretarial Review and Publication of the Annual Report to Congress and the Secretary Submitted by the Consensus-Based Entity Regarding Performance MeasurementPDF
80 FR 53518 - Notice of Meeting: Advisory Committee on the Maternal, Infant and Early Childhood Home Visiting Program EvaluationPDF

Issue

80 172 Friday, September 4, 2015 Contents Agency Agency for International Development PROPOSED RULES Participation by Religious Organizations in USAID Programs, 53483-53484 2015-22039 Agriculture Agriculture Department See

Animal and Plant Health Inspection Service

See

Farm Service Agency

See

Forest Service

See

Rural Business-Cooperative Service

See

Rural Housing Service

See

Rural Utilities Service

Animal Animal and Plant Health Inspection Service RULES Gypsy Moth Generally Infested Areas Additions in Minnesota, Virginia, West Virginia, and Wisconsin, 53457 2015-21998 PROPOSED RULES VSTA Records and Reports Specific to International Standards for Pharmacovigilance, 53475-53478 2015-21997 NOTICES Environmental Assessments; Availability, etc.: Field Testing a Swine Influenza Vaccine, H1N1 & H3N2, Modified Live Virus, 53486 2015-21995 Highly Pathogenic Avian Influenza, 53485 2015-21994 Broadcasting Broadcasting Board of Governors NOTICES Privacy Act; Systems of Records, 53487-53488 2015-22086 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53503 2015-22003 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53515-53517 2015-22020 2015-22033 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53517-53518 2015-22014 Meetings: Advisory Committee on the Maternal, Infant and Early Childhood Home Visiting Program Evaluation, 53518-53519 2015-21332 Civil Rights Civil Rights Commission NOTICES Meetings: Illinois Advisory Committee, 53488-53489 2015-21966 Coast Guard Coast Guard RULES Drawbridge Operations: Illinois Waterway, Beardstown, IL, 53464 2015-21964 Petaluma River, Petaluma, CA, 53463-53464 2015-22025 Sacramento River, Sacramento, CA, 53464-53465 2015-22026 Safety Zones: Labor Day Long Neck Style Fireworks, Indian River Bay, Long Neck, DE, 53465-53467 2015-21953 Special Local Regulations: Olympia Harbor Days Tug Boat Races, Budd Inlet, WA, 53463 2015-22024 NOTICES Requests for Nominations: Merchant Marine Personnel Advisory Committee, 53552-53553 2015-21965 Commerce Commerce Department See

Economic Development Administration

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 53501-53503 2015-22004 2015-22005 Defense Department Defense Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53503-53505 2015-22001 2015-22013 Meetings: National Commission on the Future of the Army, 53505-53506 2015-22062 Economic Development Economic Development Administration NOTICES Trade Adjustment Assistance Eligibility; Petitions, 53489 2015-21977 Employee Benefits Employee Benefits Security Administration NOTICES Exemptions: Deutsche Bank AG, 53574-53577 2015-22034 Employment and Training Employment and Training Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Placement Verification and Follow-up of Job Corps Participants, 53577-53579 2015-21996 Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Texas; Infrastructure Requirements for the Ozone and PM2.5 NAAQS, 53467-53469 2015-22035 Pesticide Tolerances: Oxathiapiprolin, 53469-53473 2015-21917 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Texas; Infrastructure Requirements for the Ozone and the PM2.5 NAAQS, 53484 2015-22036 NOTICES Cross-Media Electronic Reporting: Authorized Program Revision Approval, Hawaii, 53513-53514 2015-22064 Environmental Impact Statements; Weekly Receipts, 53513 2015-22019 Proposed Purchaser Agreement: Delco Chassis Industrial Land I and II Site in Livonia, MI, 53512-53513 2015-22029 Farm Credit Farm Credit Administration NOTICES Meetings; Sunshine Act, 53514 2015-22548 Farm Service Farm Service Agency RULES Strategic Economic and Community Development, 53457-53458 2015-21898 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives: Viking Air Limited Airplanes, 53480-53482 2015-21934 NOTICES Aeronautical Land-Use Assurance Waivers: Akron Fulton International Airport, Akron, OH, 53612-53613 2015-22008 Property Releases: Clinton County Airport, Plattsburgh, NY, 53613-53614 2015-22007 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Flood Insurance Program Call Center and Agent Referral Enrollment Form, 53553-53554 2015-22000 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 53506-53508 2015-21981 2015-21982 Complaints: Delaware Public Service Commission, Maryland Public Service Commission v. PJM Interconnection, LLC, et al., 53507 2015-21989 Environmental Assessments; Availability, etc.: Rockies Express Pipeline LLC; Zone 3 Capacity Enhancement Project, 53508-53509 2015-21988 Permit Applications: Blue River Hydro Power, LLC, 53511-53512 2015-21987 Cat Creek Energy, LLC, 53509-53510 2015-21985 Owyhee Hydro, LLC, 53510-53511 2015-21984 Peterson Machinery Sales, 53510 2015-21986 Petitions for Declaratory Orders: Backyard Farms Energy LLC, Devonshire Energy LLC, 53512 2015-21983 Federal Motor Federal Motor Carrier Safety Administration NOTICES Commercial Driver's License Standards; Applications for Exemption: Daimler Trucks North America (Daimler), 53614-53615 2015-22045 Meetings: Motor Carrier Safety Advisory Committee and Medical Review Board, 53614 2015-22046 Federal Railroad Federal Railroad Administration NOTICES Funding Availability: Railroad Safety Grants for the Safe Transportation of Energy Products by Rail Program, 53615-53621 2015-21960 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 53514-53515 2015-21972 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 53515 2015-21971 Federal Retirement Federal Retirement Thrift Investment Board NOTICES Meetings; Sunshine Act, 53515 2015-22070 Federal Trade Federal Trade Commission PROPOSED RULES Children's Online Privacy Protection Parental Consent Method: Application from Jest8 Limited Trading as Riyo, 53482-53483 2015-21979 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Wildlife and Plants: Low-Effect Habitat Conservation Plan for the Desert Tortoise, Nye County, NV, 53559-53562 2015-22059 Incidental Take Permit Applications: Participation in the Oil and Gas Industry Conservation Plan for the American Burying Beetle in Oklahoma, 53557-53558 2015-22040 Meetings: Sport Fishing and Boating Partnership Council, 53558-53559 2015-22044 Food and Drug Food and Drug Administration RULES New Animal Drugs: Approval of New Animal Drug Applications, 53458-53462 2015-21905 Forest Forest Service NOTICES Meetings: Ravalli Resource Advisory Committee, 53486-53487 2015-21999 Health and Human Health and Human Services Department See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

NOTICES Designation of a Class of Employees for Addition to the Special Exposure Cohort, 53520 2015-22042 Guidance: Annual Report by the Consensus-Based Entity Regarding Performance Measurement; Secretarial Review, 53520-53545 2015-21549
Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53519-53520 2015-22058 Meetings: Advisory Committee on the Maternal, Infant and Early Childhood Home Visiting Program Evaluation, 53518-53519 2015-21332 Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Technical Resource for Incident Prevention User Registration, 53554-53555 2015-21959
Housing Housing and Urban Development Department NOTICES Environmental Impact Statements; Availability, etc.: Rebuild By Design Hudson River Project -- Resist, Delay, Store, Discharge in Hoboken,Weehawken and Jersey City, NJ, 53555-53557 2015-22021 Federal Property Suitable as Facilities to Assist the Homeless, 53555 2015-21637 Industry Industry and Security Bureau NOTICES Orders: Air Bashkortostan, LTD, 53489-53490 2015-21978 Interior Interior Department See

Fish and Wildlife Service

See

National Park Service

See

Ocean Energy Management Bureau

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Steel Nails from the People's Republic of China, 53490-53495 2015-22065 Large Power Transformers from the Republic of Korea, 53496-53497 2015-22066 Prestressed Concrete Steel Wire Strand from the People's Republic of China, 53497-53498 2015-22067 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Toner Cartridges and Components Thereof, 53567-53568 2015-21962 Meetings; Sunshine Act, 53569 2015-22542 Justice Department Justice Department See

Justice Programs Office

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Annual Survey of Jails—Death in Custody Reporting Program—Local Jails; Survey of Jails in Indian Country, 53569-53572 2015-22017 Application for Suspension of Deportation, 53569 2015-22015 Survey—Death in Custody Reporting Program—Prisons, 53572-53573 2015-22016
Justice Programs Justice Programs Office NOTICES Meetings: National Motor Vehicle Title Information System Federal Advisory Committee, 53573 2015-21970 Labor Department Labor Department See

Employee Benefits Security Administration

See

Employment and Training Administration

National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Children's Study (NCS) Data and Sample Archive and Access System, 53546 2015-22006 Exclusive Patent Commercialization Licenses: Cerclage Annuloplasty Devices for Treating Mitral Valve Regurgitation, 53549-53550 2015-21969 Government-Owned Inventions; Availability for Licensing, 53548-53549 2015-21940 Meetings: Center for Scientific Review, 53546-53547, 53550-53551 2015-21941 2015-21942 National Cancer Institute, 53547 2015-21943 National Institute on Aging, 53551-53552 2015-21944 2015-21945 Prospective Grants of Exclusive Patent Commercialization Licenses: Caval-Aortic Devices for Aortic Valve Replacement, 53552 2015-21968 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Snapper-Grouper Resources of the South Atlantic; Trip Limit Reduction, 53473-53474 2015-22047 NOTICES Meetings: Mid-Atlantic Fishery Management Council, 53499-53500 2015-21991 2015-21993 New England Fishery Management Council, 53501 2015-21992 North Pacific Fishery Management Council, 53500 2015-21990 U.S. Integrated Ocean Observing System Advisory Committee, 53498-53499 2015-21976 Permits: Marine Mammals; File No. 18208, 53499 2015-21961 Takes of Marine Mammals Incidental to Specified Activities: Marine Geophysical Survey in the Eastern Mediterranean Sea, November to December, 2015, 53624-53656 2015-21912 Takes of Marine Mammals Incidental to Specified Activities; U.S. Navy Civilian Port Defense Activities at the Ports of Los Angeles/Long Beach, CA, 53658-53689 2015-21911 National Park National Park Service NOTICES Meetings: National Historic Landmarks Committee of the National Park System Advisory Board, 53562-53563 2015-21952 Nuclear Regulatory Nuclear Regulatory Commission PROPOSED RULES Cyber Security at Fuel Cycle Facilities, 53478-53480 2015-22051 NOTICES Draft Memorandum of Agreement: U.S. Nuclear Regulatory Commission, New Jersey Historic Preservation Office, Advisory Council on Historic Preservation, National Park Service, PSEG Power, LLC, and PSEG Nuclear, LLC, 53579-53580 2015-21932 Facility Operating Licenses: Watts Bar Nuclear Plant, Unit 1, 53581-53584 2015-21935 Final Director's Decision: Entergy Nuclear Operations, Inc. -- James A. FitzPatrick Nuclear Power Plant, Pilgrim Nuclear Power Station, and Vermont Yankee Nuclear Power Station, 53580-53581 2015-22049 North Anna Power Station, Units 1 and 2 Virginia Electric and Power Co., 53591-53592 2015-22048 Guidance: Reassessment of NRC's Dollar Per Person-Rem Conversion Factor Policy, 53585-53586 2015-22050 License Amendment Applications: U.S. Army Installation Command, Davy Crockett Depleted Uranium, 53586-53588 2015-21933 License Modification Confirmatory Orders: BWXT Nuclear Operations Group, Inc., 53588-53591 2015-21937 Ocean Energy Management Ocean Energy Management Bureau NOTICES Environmental Impact Statements; Availability, etc.: Outer Continental Shelf, Gulf of Mexico, Oil and Gas Central Planning Area Lease Sales 241 and 247 and Eastern Planning Area Lease Sale 226, 53563-53564 2015-22055 Oil and Gas Leases: Outer Continental Shelf, Gulf of Mexico, Western Planning Area Lease Sale 248, 53564 2015-22071 Requests for Nominations: Outer Continental Shelf, Region-wide Gulf of Mexico, Oil and Gas Lease Sales for Years 2017-2022, 53565-53567 2015-22073 Rural Business Rural Business-Cooperative Service RULES Strategic Economic and Community Development, 53457-53458 2015-21898 Rural Housing Service Rural Housing Service RULES Strategic Economic and Community Development, 53457-53458 2015-21898 Rural Utilities Rural Utilities Service RULES Strategic Economic and Community Development, 53457-53458 2015-21898 Securities Securities and Exchange Commission NOTICES Applications for Deregistration under the Investment Company Act, 53592-53593 2015-21955 Applications: The Glenmede Portfolios and Glenmede Investment Management LP, 53593-53600 2015-21954 Self-Regulatory Organizations; Proposed Rule Changes: International Securities Exchange, LLC, 53601-53606 2015-21958 NASDAQ OMX PHLX LLC, 53606-53608 2015-21956 New York Stock Exchange, LLC, 53600-53601 2015-21957 Small Business Small Business Administration NOTICES Surrender of License of Small Business Investment Company, 53608 2015-21948 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53608-53611 2015-21967 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: INTERNational Connections, 53611-53612 2015-22032 Tennessee Tennessee Valley Authority NOTICES Meetings: Regional Resource Stewardship Council, 53612 2015-22038 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

See

Federal Railroad Administration

Veteran Affairs Veterans Affairs Department NOTICES Meetings: Commission on Care, 53621 2015-21974 Geriatrics and Gerontology Advisory Committee, 53621 2015-22002 Separate Parts In This Issue Part II Commerce Department, National Oceanic and Atmospheric Administration, 53624-53656 2015-21912 Part III Commerce Department, National Oceanic and Atmospheric Administration, 53658-53689 2015-21911 Reader Aids

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

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

80 172 Friday, September 4, 2015 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 301 [Docket No. APHIS-2014-0023] Gypsy Moth Generally Infested Areas; Additions in Minnesota, Virginia, West Virginia, and Wisconsin AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Affirmation of interim rule as final rule.

SUMMARY:

We are adopting as a final rule, without change, an interim rule that amended the gypsy moth regulations by adding areas in Minnesota, Virginia, West Virginia, and Wisconsin to the list of generally infested areas based on the detection of infestations of gypsy moth in those areas. As a result of the interim rule, the interstate movement of regulated articles from those areas was restricted. The interim rule was necessary to prevent the artificial spread of the gypsy moth to noninfested areas of the United States.

DATES:

Effective on September 4, 2015, we are adopting as a final rule the interim rule published at 80 FR 12916-12917 on March 12, 2015.

FOR FURTHER INFORMATION CONTACT:

Mr. Paul Chaloux, National Policy Manager, Emerald Ash Borer Program and Gypsy Moth Program, Plant Protection and Quarantine, APHIS, 4700 River Road Unit 137, Riverdale, MD 20737; (301) 851-2064.

SUPPLEMENTARY INFORMATION:

The gypsy moth, Lymantria dispar (Linnaeus), is a destructive pest of forest, shade, and commercial trees such as nursery stock and Christmas trees. The gypsy moth regulations (contained in 7 CFR 301.45 through 301.45-12 and referred to below as the regulations) restrict the interstate movement of regulated articles from generally infested areas to prevent the artificial spread of the gypsy moth.

In an interim rule 1 effective and published in the Federal Register on March 12, 2015 (80 FR 12916-12917, Docket No. APHIS-2014-0023), we amended the regulations in § 301.45-3(a) by adding the following areas to the list of generally infested areas: Cook and Lake Counties in Minnesota; Tazewell County in Virginia; McDowell, Mercer, Raleigh, Summers, and Wyoming Counties in West Virginia; and Iowa County in Wisconsin. As a result of the interim rule, the interstate movement of regulated articles from these areas was restricted.

1 To view the interim rule and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0023.

Comments on the interim rule were required to be received on or before May 11, 2015. We received two comments by that date. The comments were from the National Plant Board and an individual. Both commenters supported the interim rule. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule without change.

This action also affirms the information contained in the interim rule concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork Reduction Act.

Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.

List of Subjects in 7 CFR Part 301

Agricultural commodities, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Transportation.

PART 301—DOMESTIC QUARANTINE NOTICES Accordingly, we are adopting as a final rule, without change, the interim rule that amended 7 CFR part 301 and that was published at 80 FR 12916-12917 on March 12, 2015. Done in Washington, DC, this 31st day of August 2015. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-21998 Filed 9-3-15; 8:45 am] BILLING CODE 3410-34-P
DEPARTMENT OF AGRICULTURE Rural Business-Cooperative Service Rural Housing Service Rural Utilities Service Farm Service Agency 7 CFR Part 1980 RIN 0570-AA94 Strategic Economic and Community Development AGENCY:

Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, Farm Service Agency, U.S. Department of Agriculture (USDA).

ACTION:

Interim rule with public comment; reopening of public comment period.

SUMMARY:

Through this action, the Rural Housing Service, the Rural Business-Cooperative Service, the Rural Utilities Service, and the Farm Service Agency are reopening the comment period for the interim rule, published on May 20, 2015 “Strategic Economic and Community Development”.

DATES:

Comments on the interim rule that was published on May 20, 2015 (80 FR 28807) and effective June 19, 2015, must be received by September 18, 2015.

ADDRESSES:

Submit your comments on this rule by any of the following methods:

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

Mail: Submit written comments via the U.S. Postal Service to the Branch Chief, Regulations and Paperwork Management Branch, U.S. Department of Agriculture, STOP 0742, 1400 Independence Avenue SW., Washington, DC 20250-0742.

Hand Delivery/Courier: Submit written comments via Federal Express Mail, or other courier service requiring a street address, to the Branch Chief, Regulations and Paperwork Management Branch, U.S. Department of Agriculture, 300 7th Street SW., 7th Floor, Washington, DC 20024.

All written comments will be available for public inspection during regular work hours at the 300 7th Street, SW., 7th Floor address listed above.

FOR FURTHER INFORMATION CONTACT:

Farah Ahmad, Rural Business-Cooperative Service, U.S. Department of Agriculture, Stop 3254, 1400 Independence Avenue SW., Washington, DC 20250-0783, Telephone: 202-245-1169. Email: [email protected]

SUPPLEMENTARY INFORMATION:

On July 20, 2015, the Rural Housing Service, the Rural Business-Cooperative Service, the Rural Utilities Service, and the Farm Service Agency published an interim rule with comment in the Federal Register (80 FR 28807), “Strategic Economic and Community Development.” The interim rule identified that public comments were to be submitted by August 18, 2015. Unfortunately, the Web site Regulations.gov inadvertently closed the comment period on July 20, 2015, which was the closing date for comments on the information collection request. To compensate for closing the comment period early via the Regulations.gov Web site, this action provides commenters additional time to submit comments on the interim rule.

Dated: August 26, 2015. Lisa Mensah, Under Secretary, Rural Development. Dated: August 27, 2015. Michael Scuse, Under Secretary, Farm and Foreign Agricultural Services.
[FR Doc. 2015-21898 Filed 9-3-15; 8:45 am] BILLING CODE 3410-XY-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 524, and 558 [Docket No. FDA-2015-N-0002] New Animal Drugs; Approval of New Animal Drug Applications AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendments.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May and June 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a nonsubstantive change. This technical amendment is being made to improve the accuracy of the regulations.

DATES:

This rule is effective September 4, 2015.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]

SUPPLEMENTARY INFORMATION:

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during May and June 2015, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

Table 1—Original and Supplemental NADAs and ANADAs Approved During May and June 2015 NADA/ANADA Sponsor New animal drug
  • product name
  • Action 21 CFR
  • sections
  • FOIA summary NEPA review
    141-417 Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201 CORAXIS (moxidectin) Topical Solution for Dogs Original approval for the prevention of heartworm disease, and for the treatment and control of intestinal hookworm, roundworm and whipworm infections in dogs 524.1450 yes CE.12 141-188 Merial Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640 MARQUIS (ponazuril) Oral Paste Supplemental approval of a revised dosage that includes a loading dose on the first day of treatment 520.1855 yes CE.12 141-262 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 CERENIA (maropitant citrate) Tablets Supplemental approval extending duration of daily administration until resolution of acute vomiting 520.1315 yes CE.12 141-291 Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom VETORYL (trilostane) Capsules Supplemental approval of a 5-milligram capsule size 520.2598 no CE.12 141-278 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 ZILMAX (zilpaterol hydrochloride) plus RUMENSIN (monensin).
  • Type A medicated articles
  • Supplemental approval to provide for component feeding of combination drug Type C medicated feeds to cattle fed in confinement for slaughter 558.665 yes CE.13
    141-282 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 ZILMAX (zilpaterol hydrochloride) plus RUMENSIN (monensin) plus MGA (melengestrol acetate).
  • Type A medicated articles
  • Supplemental approval to provide for component feeding of combination drug Type C medicated feeds to heifers fed in confinement for slaughter 558.665 yes CE.13
    141-284 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 ZILMAX (zilpaterol hydrochloride) plus MGA (melengestrol acetate).
  • Type A medicated articles
  • Supplemental approval to provide for component feeding of combination drug Type C medicated feeds to heifers fed in confinement for slaughter 558.665 yes CE.13
    200-497 Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland LOXICOM (meloxicam) 1.5 mg/mL Oral Suspension Original approval as a generic copy of NADA 141-213 520.1367 yes CE.13 200-580 Huvepharma AD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria TYLOVET (tylosin phosphate) plus SACOX (salinomycin sodium)
  • Type C medicated feeds
  • Original approval as a generic copy of NADA 141-198 4 558.550 yes CE.13
    1 The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not have a significant effect on the human environment. 2 CE granted under 21 CFR 25.33(d)(1). 3 CE granted under 21 CFR 25.33(a)(1). 4 The regulation does not require amendment.

    Also, the animal drug regulations are being amended to reflect approved labeling for hand feeding bambermycins medicated cattle feed. This technical amendment is being made to improve the accuracy of the regulations.

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

    List of Subjects 21 CFR Parts 520 and 524

    Animal drugs.

    21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 520, 524, and 558 are amended as follows:

    PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: Authority:

    21 U.S.C. 360b.

    2. In § 520.1315, revise paragraph (c)(1) to read as follows:
    § 520.1315 Maropitant.

    (c) * * *

    (1) Indications for use and amount. (i) For prevention of acute vomiting in dogs 2 to 7 months of age, administer a minimum dose of 2.0 mg per kilogram (/kg) body weight once daily for up to 5 consecutive days.

    (ii) For prevention of acute vomiting in dogs 7 months of age and older, administer a minimum dose of 2.0 mg/kg body weight once daily until resolution of acute vomiting.

    (iii) For prevention of vomiting due to motion sickness in dogs 4 months of age and older, administer a minimum of 8.0 mg/kg body weight once daily for up to 2 consecutive days.

    § 520.1367 [Amended]
    3. In § 520.1367, in paragraph (b)(2), remove “No. 013744” and in its place add “Nos. 013744 and 055529”.
    4. In § 520.1855, revise paragraph (c)(1) to read as follows:
    § 520.1855 Ponazuril.

    (c) * * *

    (1) Amount. Administer orally 15 mg per kilogram (kg) (6.81 mg per pound (lb)) body weight as the first dose, followed by 5 mg/kg (2.27 mg/lb) body weight once daily for a period of 27 additional days.

    § 520.2598 [Amended]
    5. In § 520.2598, in paragraph (a), remove “10, 30, or 60 milligrams” and in its place add “5, 10, 30, 60, or 120 milligrams”.
    PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 6. The authority citation for 21 CFR part 524 continues to read as follows: Authority:

    21 U.S.C. 360b.

    7. In § 524.1450, and revise paragraphs (a), (b), and (d), and remove paragraph (e).

    The revisions read as follows:

    § 524.1450 Moxidectin.

    (a) Specifications. Each milliliter of solution contains:

    (1) 5 milligrams (mg) moxidectin (0.5 percent solution).

    (2) 25 mg moxidectin (2.5 percent solution).

    (b) Sponsors. See sponsor numbers in § 510.600 of this chapter:

    (1) No. 000010 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section;

    (2) No. 000859 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.

    (d) Conditions of use—(1) Cattle—(i) Amount. Administer topically 0.5 mg per kilogram (kg) of body weight.

    (ii) Indications for use. Beef and dairy cattle: For treatment and control of internal and external parasites: gastrointestinal roundworms (Ostertagia ostertagi (adult and L4, including inhibited larvae), Haemonchus placei (adult and L4), Trichostrongylus axei (adult and L4), T. colubriformis (adult and L4), Cooperia oncophora (adult and L4), C. pectinata (adult), C. punctata (adult and L4), C. spatulata (adult), C. surnabada (adult and L4), Bunostomum phlebotomum (adult), Oesophagostomum radiatum (adult and L4), Nematodirus helvetianus (adult and L4)); lungworms (Dictyocaulus viviparus (adult and L4)); cattle grubs (Hypoderma bovis, H. lineatum); mites (Chorioptes bovis, Psoroptes ovis (P. communis var. bovis)); lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus, Bovicola (Damalinia) bovis); and horn flies (Haematobia irritans). To control infections and to protect from reinfection with H. placei for 14 days after treatment, O. radiatum and O. ostertagi for 28 days after treatment, and D. viviparus for 42 days after treatment.

    (iii) Limitations. A withdrawal period has not been established for this product on preruminating calves. Do not use on calves to be processed for veal. See § 500.25 of this chapter.

    (2) Dogs—(i) Amount. Administer topically a minimum of 1.1 mg per pound (lb) (2.5 mg/kg) of body weight, once monthly using the appropriate preloaded applicator tube.

    (ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis, as well as the treatment and control of intestinal hookworm (Ancylostoma caninum (adult, immature adult, and L4 larvae) and Uncinaria stenocephala (adult, immature adult, and L4 larvae)), roundworm (Toxocara canis (adult and L4 larvae) and Toxascaris leonina (adult)), and whipworm (Trichuris vulpis (adult)) infections in dogs and puppies that are at least 7 weeks of age and that weigh at least 3 lbs.

    (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 8. The authority citation for 21 CFR part 558 continues to read as follows: Authority:

    21 U.S.C. 360b, 371.

    § 558.95 [Amended]
    9. In § 558.95, in the table in paragraph (d)(4)(ii), in the “Bambermycins in grams/ton” column, remove “2 to 40” and in its place add “2 to 80”; and in the “Limitations” column, remove the first sentence and in its place add “Feed continuously on a hand-fed basis at a rate of 10 to 40 milligrams per head per day in 1 to 10 pounds of supplemental Type C medicated feed.”. 10. In § 558.665, revise paragraphs (d)(2) and (e) to read as follows:
    § 558.665 Zilpaterol.

    (d) * * *

    (2) Labeling of Type A medicated articles and Type B medicated feeds used to manufacture complete Type C medicated feeds shall bear the caution statement in paragraph (d)(3) of this section.

    (e) Conditions of use in cattle. It is administered in feed as follows:

    Zilpaterol
  • hydrochloride
  • in grams/ton
  • Combination in grams/ton Indications for use Limitations Sponsor
    (1) 6.8 Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section 000061 (2) 6.8 Monensin 10 to 40 Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.355(d) of this chapter Monensin as provided by No. 000986 in § 510.600(c) of this chapter 000061
  • 000986
  • (3) 6.8 Melengestrol acetate to provide 0.25 to 0.5 mg/head/day Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; and for suppression of estrus (heat) Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section
  • Melengestrol acetate as provided by Nos. 000986 or 054771 in § 510.600(c) of this chapter
  • 000061
  • 000986
  • (4) 6.8 Monensin 10 to 40 plus melengestrol acetate to provide 0.25 to 0.5 mg/head/day Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for suppression of estrus (heat) Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.342(d) and 558.355(d) of this chapter
  • Monensin as provided by No. 000986; melengestrol acetate as provided by Nos. 000986 or 054771 in § 510.600(c) of this chapter
  • 000061
  • 000986
  • (5) 6.8 Monensin 10 to 40, plus tylosin 8 to 10 For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.355(d) and 558.625(c) of this chapter
  • Monensin as provided by No. 000986; tylosin as provided by Nos. 000986 or 016592 in § 510.600(c) of this chapter
  • 000061
  • 016592
  • (6) 6.8 Monensin 10 to 40, plus tylosin 8 to 10, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/day Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for suppression of estrus (heat) Feed continuously as the sole ration during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.342(d), 558.355(d), and 558.625(c) of this chapter
  • Monensin as provided by No. 000986; tylosin as provided by Nos. 000986 or 016592; and melengestrol acetate as provided by Nos. 000986 or 054771 in § 510.600(c) of this chapter
  • 000061
  • 000986
  • 016592
  • (7) 6.8 to 24 Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section 000061 (8) 6.8 to 24 Monensin 10 to 40 Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.355(d) of this chapter
  • Monensin as provided by No. 000986 in § 510.600(c) of this chapter
  • 000061
    (9) 6.8 to 24 Melengestrol acetate to provide 0.25 to 0.5 mg/head/day Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; and for suppression of estrus (heat) Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.342(d) of this part
  • Melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter
  • 000061
    (10) 6.8 to 24 Monensin 10 to 40, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/day Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for suppression of estrus (heat) Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.342(d) and 558.355(d) of this chapter
  • Monensin as provided by No. 000986; melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter
  • 000061
    (11) 6.8 to 24 Monensin 10 to 40, plus tylosin 8 to 10 Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.355(d) and 558.625(c) of this chapter
  • Monensin and tylosin as provided by No. 000986 in § 510.600(c) of this chapter
  • 000061
    (12) 6.8 to 24 Monensin 10 to 40, plus tylosin 8 to 10, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/day Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for suppression of estrus (heat) Feed continuously during the last 20 to 40 days on feed to provide 60 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.342(d), 558.355(d), and 558.625(c) of this chapter
  • Monensin and tylosin as provided by No. 000986; melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter
  • 000061
    Dated: August 31, 2015. Bernadette Dunham, Director, Center for Veterinary Medicine.
    [FR Doc. 2015-21905 Filed 9-3-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2010-1024] Olympia Harbor Days Tug Boat Races, Budd Inlet, WA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of enforcement of regulation.

    SUMMARY:

    The Coast Guard will enforce the Special Local Regulation, Olympia Harbor Days Tug Boat Races, Budd Inlet, WA from 11:00 a.m. through 8:00 p.m. on September 6, 2015. This action is necessary to restrict vessel movement within the specified race area immediately prior to, during, and immediately after racing activity in order to ensure the safety of participants, spectators and the maritime public. Entry into, transit through, mooring or anchoring within the specified race area is prohibited unless authorized by the Captain of the Port, Puget Sound or Designated Representatives.

    DATES:

    The regulations in 33 CFR 100.1309 will be enforced from 11:00 a.m. through 8:00 p.m. on September 6, 2015.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this document, call or email Petty Officer Ryan Griffin, Sector Puget Sound Waterways Management Division, Coast Guard; telephone 206-510-7888, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Coast Guard is providing notice of enforcement of the Special Local Regulation for Olympia Harbor Days Tug Boat Races, Budd Inlet, WA in 33 CFR 100.1309 on September 6, 2015, from 11:00 a.m. to 8:00 p.m.

    The following area is specified as a race area: All waters of Budd Inlet, WA the width of the navigation channel south of a line connecting the following points: 47°05.530′ N. 122°55.844′ W. and 47°05.528′ N. 122°55.680′ W. until reaching the northernmost end of the navigation channel at a line connecting the following points: 47°05.108′ N. 122°55.799′ ″ W. and 47°05.131′ N. 122°55.659′ W. then southeasterly until reaching the southernmost entrance of the navigation channel at a line connecting the following points: 47°03.946′ N. 122°54.577′ W., 47°04.004′ N. 122°54.471′ W.

    Under the provisions of 33 CFR 100.1309, the regulated area shall be closed immediately prior to, during and immediately after the event to all persons and vessels not participating in the event and authorized by the event sponsor.

    This document is issued under authority of 33 CFR 100.1309 and 5 U.S.C. 552(a). In addition to this document 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. If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this document, he may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area.

    Dated: August 25, 2015. M.W. Raymond, Captain, U.S. Coast Guard, Captain of the Port, Puget Sound.
    [FR Doc. 2015-22024 Filed 9-3-15; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2015-0708] Drawbridge Operation Regulation; Petaluma River, Petaluma, CA 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 Haystack Landing Drawbridge across the Petaluma River, mile 12.4, at Petaluma, CA. The deviation is necessary to allow the bridge owner to replace the bridge. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.

    DATES:

    This deviation is effective without actual notice from September 4, 2015 to 6 p.m. on October 19, 2015. For the purposes of enforcement, actual notice will be used from 6 a.m. on August 31, 2015, until September 4, 2015.

    ADDRESSES:

    The docket for this deviation, [USCG-2015-0708], 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, call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516, email [email protected] If you have questions on viewing the docket, call Cheryl Collins, Program Manager, Docket Operations, telephone 202-366-9826.

    SUPPLEMENTARY INFORMATION:

    Sonoma Marin Area Rail Transit has requested a temporary change to the operation of the Haystack Landing Drawbridge across the Petaluma River, mile 12.4, at Petaluma, CA. The drawbridge navigation span provides approximately 3 feet vertical clearance above Mean High Water in the closed-to-navigation position. In accordance with 33 CFR 117.187(a), the draw is maintained in the fully open position, except for the crossing of trains or for maintenance. Navigation on the waterway is commercial and recreational.

    The drawspan will be periodically secured in the closed-to-navigation position, during daylight hours from 6 a.m. on August 31, 2015 to 6 p.m. on October 19, 2015, due to bridge replacement construction. During daylight hours, the bridge will be secured in the closed to navigation position for construction, and will require four hours advance notice for bridge openings for commercial vessels moving on the tide.

    Scheduled 30-minute bridge openings will be provided at midday for the passage of accumulated, small vessels. The bridge will be secured in the open-to-navigation position nights and weekends, when no work is in progress. This temporary deviation has been coordinated with the waterway users.

    Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies upon two hours advance notice. There is no alternative route available for vessel traffic. The Coast Guard will inform waterway users of this temporary deviation via our Local and Broadcast Notices to Mariners to minimize resulting navigational impacts.

    In accordance with 33 CFR 117.35(e), the drawbridge 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: August 21, 2015. D.H. Sulouff, District Bridge Chief, Eleventh Coast Guard District.
    [FR Doc. 2015-22025 Filed 9-3-15; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket Number USCG-2015-0837] Drawbridge Operation Regulation; Illinois Waterway, Beardstown, IL 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 Burlington Northern Santa Fe Railroad Bridge across the Illinois Waterway, mile 88.8, at Beardstown, Illinois. The deviation is necessary to allow signal upgrades to be installed which can only be done when the bridge is in the closed-to-navigation position. The deviation allows the bridge to be in the closed-to-navigation position for 4 hours.

    DATES:

    This deviation is effective from noon to 4 p.m., September 24, 2015.

    ADDRESSES:

    The docket for this deviation, [USCG-2015-0837] 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, call or email Eric A. Washburn, Bridge Administrator, Western Rivers, Coast Guard; telephone (314) 269-2378, email [email protected] If you have questions on viewing the docket, call Cheryl F. Collins, Program Manager, Docket Operations, telephone (202) 366-9826.

    SUPPLEMENTARY INFORMATION:

    The Burlington Northern Santa Fe Railway Company requested a temporary deviation for the Burlington Northern Santa Fe (BNSF) Railroad Bridge, mile 88.8, at Beardstown, Illinois across the Illinois Waterway. It has a vertical clearance of 19.6 feet above normal pool in the closed position. The BNSF Railroad Bridge currently operates in accordance with 33 CFR 117.393(a) which requires that the bridge be maintained in the open-to-navigation position; closing only when a train needs to transit the bridge.

    The deviation period is from noon to 4 p.m., September 24, 2015, when the draw span will remain in the closed-to-navigation position. During this time signal upgrades will be installed. The draw span will not be returned to its fully open position until the upgrades are completed. Vessels will not be allowed to pass while the signal upgrade is in progress. The bridge can open in case of emergency.

    Navigation at the site of the bridge consists mainly of commercial vessels. Based on known waterway users, as well as coordination with those waterway users, it has been determined that this closure will not have a significant effect on these vessels. No alternate routes are available.

    The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge 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 drawbridge 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: August 31, 2015. David M. Frank, Bridge Administrator, Eighth Coast Guard District.
    [FR Doc. 2015-21964 Filed 9-3-15; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2015-0819] Drawbridge Operation Regulation; Sacramento River, Sacramento, CA 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 Tower Drawbridge across the Sacramento River, mile 59.0 at Sacramento, CA. The deviation is necessary to allow the community to participate in the Farm to Fork dinner event. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.

    DATES:

    This deviation is effective from 1 p.m. to 10 p.m. on September 27, 2015.

    ADDRESSES:

    The docket for this deviation, [USCG-2015-0819], 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, call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516, email [email protected] If you have questions on viewing the docket, call Cheryl Collins, Program Manager, Docket Operations, telephone 202-366-9826.

    SUPPLEMENTARY INFORMATION:

    California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, over Sacramento River, at Sacramento, CA. The drawbridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw opens on signal from May 1 through October 31 from 6 a.m. to 10 p.m. and from November 1 through April 30 from 9 a.m. to 5 p.m. At all other times the draw shall open on signal if at least four hours notice is given, as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.

    The drawspan will be secured in the closed-to-navigation position 1 p.m. to 10 p.m. on September 27, 2015, to allow the community to participate in the Farm to Fork dinner event. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

    Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge 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 drawbridge 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: August 19, 2015. D.H. Sulouff, District Bridge Chief, Eleventh Coast Guard District.
    [FR Doc. 2015-22026 Filed 9-3-15; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2015-0823] RIN 1625-AA00 Safety Zone, Labor Day Long Neck Style Fireworks, Indian River Bay; Long Neck, DE AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone on the waters of Indian River Bay in Long Neck, DE. The safety zone will restrict vessel traffic on a portion of Indian River Bay from operating while a fireworks event is taking place. This temporary safety zone is necessary to protect the surrounding public and vessels from the hazards associated with a fireworks display.

    DATES:

    This rule is effective from 8:00 p.m. to 10:00 p.m. on September 6, 2015.

    ADDRESSES:

    Documents mentioned in this preamble are part of docket [USCG-2015-0823]. To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rulemaking. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email If you have questions on this temporary rule, call or email Lieutenant Brennan Dougherty, U.S. Coast Guard, Sector Delaware Bay, Chief Waterways Management Division, Coast Guard; telephone (215)271-4851, 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 DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking COTP Captain of the Port A. Regulatory History and Information

    The Coast Guard is issuing this 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 as publishing an NPRM is impracticable given that the final details for this event were not received by the Coast Guard until August 18, 2015, and this event is scheduled for September 6, 2015.

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

    B. Basis and Purpose

    The legal basis for the rule is the Coast Guard's authority to establish regulated navigation areas and other limited access areas: 33 U.S.C. 1231; 33 CFR 1.05-1, 160.5; Department of Homeland Security Delegation No. 0170.1.

    The purpose of this safety zone is to protect mariners and spectators from the hazards associated with the fireworks display, such as accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris.

    C. Discussion of the Final Rule

    To mitigate the risks associated with the Labor Day Long Neck Style Fireworks Display, the Captain of the Port, Delaware Bay is establishing a temporary safety zone in the vicinity of the launch site. The safety zone will encompass all waters of Indian River Bay within a 230 Yard radius of the fireworks launch platform in approximate position 38°36′35.8″ N., 075°09′04.4″ W. in Long Neck, DE. The safety zone will be effective and enforced from 8:00 p.m. until 10:00 p.m. on September 6, 2015. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port, Delaware Bay, or his on-scene representative. The Captain of the Port, Delaware Bay, or his on-scene representative may be contacted via VHF channel 16.

    D. Regulatory Analyses

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

    1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. Although this regulation will restrict access to the regulated area, the effect of this rule will not be significant because: the Coast Guard will make extensive notification of the Safety Zone to the maritime public via maritime advisories so mariners can alter their plans accordingly, vessels may still be permitted to transit through the safety zone with the permission of the Captain of the Port on a case-by-case basis, and this rule will be enforced for only the duration of the fireworks display.

    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 rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to anchor or transit along a portion of Indian River Bay in Long Neck, DE from 8:00 p.m. until 10:00 p.m. on September 6, 2015, unless cancelled earlier by the Captain of the Port once all operations are completed.

    This safety zone will not have a significant economic impact on a substantial number of small entities for the reasons stated under paragraph D.1., Regulatory Planning and Review.

    3. Assistance for Small Entities

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

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

    4. Collection of Information

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

    5. Federalism

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

    6. Protest Activities

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

    7. Unfunded Mandates Reform Act

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

    8. Taking of Private Property

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

    9. Civil Justice Reform

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

    10. Protection of Children

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

    11. Indian Tribal Governments

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

    12. Energy Effects

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

    13. Technical Standards

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

    14. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves implementation of regulations within 33 CFR part 165, applicable to safety zones on the navigable waterways. This zone will temporarily restrict vessel traffic from transiting the Indian River Bay along the shoreline of Long Neck, Delaware, in order to protect the safety of life and property on the waters for the duration of the fireworks display. This rule is categorically excluded from further review under paragraph 34(g) 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 rule.

    List of Subjects in 33 CFR Part 165

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

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

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

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

    2. Add § 165.T05-0823 to read as follows:
    § 165.T05-0823 Safety Zone, Labor Day Long Neck Style Fireworks, Indian River Bay; Long Neck, DE.

    (a) Regulated area. The following area is a safety zone: all waters of Indian River Bay within a 230 yard radius of the fireworks launch platform in approximate position 38°36′35.8″ N., 075°09′04.4″ W. in Long Neck, DE.

    (b) Regulations. The general safety zone regulations found in subpart C of this part apply to the safety zone created by this section.

    (1) All persons or vessels wishing to transit through the Safety Zone must request authorization to do so from the Captain of the Port or his designated representative one hour prior to the intended time of transit.

    (2) Vessels granted permission to transit must do so in accordance with the directions provided by the Captain of the Port or his designated representative to the vessel.

    (3) To seek permission to transit the Safety Zone, the Captain of the Port's representative can be contacted via marine radio VHF Channel 16.

    (4) This section applies to all vessels wishing to transit through the safety zone except vessels that are engaged in the following operations:

    (i) Enforcing laws;

    (ii) Servicing aids to navigation; and

    (iii) Emergency response vessels.

    (5) No person or vessel may enter or remain in a safety zone without the permission of the Captain of the Port;

    (6) Each person and vessel in a safety zone shall obey any direction or order of the Captain of the Port.

    (c) Definitions. (1) Captain of the Port means the Commander, Coast Guard Sector Delaware Bay, or any Coast Guard commissioned, warrant or petty officer who has been authorized by the Captain of the Port to act on his behalf.

    (2) Designated representative means any Coast Guard commissioned, warrant or petty officer who has been authorized by the Captain of the Port, Delaware Bay, to assist in enforcing the safety zone described in paragraph (a) of this section.

    (d) Enforcement officials. The U.S. Coast Guard may be assisted by Federal, State, and local agencies in the patrol and enforcement of the zone.

    (e) Enforcement period. This safety zone will be effective from 8:00 p.m. until 10:00 p.m. on September 6, 2015, unless cancelled earlier by the Captain of the Port.

    B.A. Cooper, Captain, U.S. Coast Guard, Captain of the Port Delaware Bay.
    [FR Doc. 2015-21953 Filed 9-3-15; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2013-0808; FRL-9932-50-Region 6] Approval and Promulgation of Implementation Plans; Texas; Infrastructure Requirements for the 1997 Ozone and the 1997 and 2006 PM2.5 NAAQS AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Direct final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is finalizing a change to the Code of Federal Regulations (CFR) to reflect a 2014 EPA approval to a State Implementation Plan (SIP) revision to regulate greenhouse gases (GHGs) in Texas Prevention of Significant Deterioration (PSD) permitting program and to show that the SIP deficiency identified in a prior partial disapproval for the 1997 Ozone and the 1997 and 2006 PM2.5 National Ambient Air Quality Standards (NAAQS) has been addressed.

    DATES:

    This rule is effective on November 3, 2015 without further notice, unless EPA receives relevant adverse comment by October 5, 2015. If EPA receives such comment, EPA will publish a timely withdrawal in the Federal Register informing the public that this rule will not take effect.

    ADDRESSES:

    Submit your comments, identified by Docket No. EPA-R06-OAR-2013-0808, by one of the following methods:

    www.regulations.gov: Follow the on-line instructions.

    Email: Carl Young at [email protected]

    Mail or delivery: Mr. Guy Donaldson, Chief, Air Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-2733.

    Instructions: Direct your comments to Docket ID No. EPA-R06-OAR-2013-0808. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information the disclosure of which is restricted by statute. Do not submit electronically any information that you consider to be CBI or other information whose disclosure is restricted by statute. The http://www.regulations.gov Web site is an “anonymous access” system, which means that the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through http://www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment along with any disk or CD-ROM submitted. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should avoid the use of special characters and any form of encryption and should be free of any defects or viruses. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional information on submitting comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    Docket: The index to the docket for this action is available electronically at www.regulations.gov and in hard copy at EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available at either location (e.g., CBI).

    FOR FURTHER INFORMATION CONTACT:

    Carl Young, 214-665-6645, [email protected] To inspect the hard copy materials, please schedule an appointment with Mr. Young.

    SUPPLEMENTARY INFORMATION:

    Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA.

    I. Background

    In an action on April 4, 2008, we partially approved and partially disapproved the portions of a Texas SIP submittal for the 1997 ozone and 1997 PM2.5 NAAQS pertaining to prevention of significant deterioration (PSD) permitting (76 FR 81371, December 28, 2011). Our partial disapproval was based on the fact that at the time the Texas SIP did not regulate greenhouse gases (GHGs) in the PSD permitting program. Afterwards Texas revised the SIP to regulate GHGs in their PSD permitting program. We approved this revision in 2014 (79 FR 66626, November 10, 2014). Now that Texas has a fully approved SIP for PSD permitting, the deficiency that led to our December 28, 2011 partial disapproval has been addressed. However, in our approval of the GHG program, we did not revise the CFR to reflect that the deficiency had been addressed. We are correcting that oversight in today's action.

    II. Final Action

    Using our authority under 110(k)(6) of the Act, we are finalizing a change to 40 CFR 52.2270(c) to reflect a 2014 EPA approval to a SIP revision to regulate GHGs in Texas' PSD permitting program and to show that the SIP deficiency identified in our prior partial disapproval for the 1997 Ozone and the 1997 and 2006 PM2.5 NAAQS has been addressed.

    EPA is publishing this rule without prior proposal because we view this as a non-controversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the SIP revision if relevant adverse comments are received. This rule will be effective on November 3, 2015 without further notice unless we receive relevant adverse comment by October 5, 2015. If we receive relevant adverse comments, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so now. Please note that if we receive relevant adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

    III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. This action merely revises the CFR to reflect a 2014 EPA approval to a SIP revision to regulate GHGs in Texas PSD permitting program and to show that the SIP deficiency identified in a prior partial disapproval for the 1997 Ozone and the 1997 and 2006 PM2.5 National Ambient Air Quality Standards (NAAQS) has been addressed. For that reason, this action:

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

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

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

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

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

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

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

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

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

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

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

    Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 3, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposed of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Ozone, Particulate matter, Reporting and recordkeeping requirements.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: August 26, 2015. Ron Curry, Regional Administrator, Region 6.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart SS—Texas 2. The second table in § 52.2270(e) titled “EPA Approved Nonregulatory Provisions and Quasi-Regulatory Measures in the Texas SIP” is amended by revising the entry for “Infrastructure and Interstate Transport for the 1997 Ozone and the 1997 and 2006 PM2.5 NAAQS”.

    The revision reads as follows:

    § 52.2270 Identification of plan.

    (e) * * *

    EPA Approved Nonregulatory Provisions and Quasi-Regulatory Measures in the Texas SIP Name of SIP provision Applicable geographic or
  • non-attainment area
  • State approval/submittal date EPA approval date Comments
    *         *         *         *         *         *         * Infrastructure and Interstate Transport for the 1997 Ozone and the 1997 and 2006 PM2.5 NAAQS Statewide 12/12/2007, 3/11/2008, 4/4/2008, 11/23/2009 12/28/2011, 76 FR 81371 Approval for CAA elements 110(a)(2)(A), (B), (E), (F), (G), (H), (K), (L), and (M). Full approval for CAA elements 110(a)(2)(C), (D)(i)(II), (D)(ii) and (J) with approval of the GHG PSD revision (11/10/2014, 79 FR 66626). *         *         *         *         *         *         *
    [FR Doc. 2015-22035 Filed 9-3-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0114; FRL-9931-18] Oxathiapiprolin; Pesticide Tolerances AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes tolerances for residues of oxathiapiprolin in or on multiple commodities that are identified and discussed later in this document. E.I. du Pont de Nemours and Company (“Dupont”) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

    DATES:

    This regulation is effective September 4, 2015. Objections and requests for hearings must be received on or before November 3, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0114, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

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

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

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0114 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 3, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0114, by one of the following methods:

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

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

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

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Summary of Petitioned-for Tolerance

    In the Federal Register of May 23, 2014 (79 FR 29729) (FRL-9910-29), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3F8220) by Dupont, 1007 Market Street, Wilmington, DE 19898. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide oxathiapiprolin, 1-(4-{4-[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2-yl}-1-piperidyl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl] ethanone, in or on the following commodities: Brassica (cole) leafy vegetables, head and stem brassica crop subgroup 5A at 1.5 ppm; bulb vegetables, onion, bulb, crop subgroup 3-07A at 0.04 ppm; bulb vegetables, onion, green crop subgroup 3-07B at 2 ppm; cucurbit vegetables, crop group 9 at 0.2 ppm; fruiting vegetables crop group 8-10 at 0.2 ppm; grape (import tolerance) at 0.9 ppm; ginseng root at 0.4 ppm; leafy greens crop subgroup 4A at 15 ppm; peas, edible podded at 1 ppm; peas, succulent, shelled at 0.05 ppm; and vegetable, root and tuber vegetables, tuberous corm vegetable crop subgroup 1C at 0.01 ppm. One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C.

    Additionally, in the Federal Register of July 17, 2015 (80 FR 42462) (FRL-9923-13), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing a correction to the filing of a pesticide petition (PP 3F8220) by Dupont. This document corrects the petition announced in the May 23, 2014 Federal Register by adding the omitted entry for dried fruit vegetable at 0.9 ppm. No FFDCA-related comments were received on this notice of filing.

    Based upon review of the data supporting the petition, EPA has revised the tolerance levels of some commodities and corrected several commodity definitions. The reasons for these changes are explained in Unit IV.D.

    III. Aggregate Risk Assessment and Determination of Safety

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

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

    A. Toxicological Profile

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

    In the toxicity studies for oxathiapiprolin, no treatment-related effects were seen at doses up to the limit dose. No treatment-related effects were seen in subchronic or chronic oral toxicity (rats, mice, or dogs), dermal toxicity, neurotoxicity, or immunotoxicity studies. Additionally, there was no evidence of carcinogenicity in cancer studies with rats or mice. No treatment-related effects were seen in maternal or fetal animals in rat or rabbit developmental toxicity studies. Treatment-related effects were observed in offspring animals in rat reproduction studies (decreased body weight and delayed preputial separation); however, the effects were only observed at doses above the limit dose (1,227 milligram/kilogram/day (mg/kg/day)). Such high doses are not relevant for human health risk. No other treatment-related effects were observed in oral or dermal studies with oxathiapiprolin. The lack of observed toxicity is consistent with the low to moderate oral absorption and lack of bioaccumulation reported in the rat metabolism studies. In acute lethality studies, exposure to oxathiapiprolin resulted in low toxicity via the oral, dermal, and inhalation routes of exposure. Oxathiapiprolin was not a dermal or eye irritant, or a skin sensitizer.

    Specific information on the studies received and the nature of the adverse effects caused by oxathiapiprolin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, “Oxathiapiprolin—New Active Ingredient Human Health Risk Assessment of Uses on Turf, Ornamentals, and a Number of Crops” in docket ID number EPA-HQ-OPP-2014-0114.

    B. Toxicological Points of Departure/Levels of Concern

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

    The majority of the toxicity studies for oxathiapiprolin did not demonstrate treatment-related effects, with the exception of the reproduction study. The effects in the reproduction study were minimal and seen at doses (above the limit dose) not relevant for human exposure. There were no adverse acute or chronic effects identified for any population groups (including infants and children). Therefore, due to the limited toxicity in the oxathiapiprolin toxicological database, toxicity endpoints and points of departure were not selected for oxathiapiprolin exposure scenarios and a quantitative risk assessment was not conducted.

    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to oxathiapiprolin, EPA considered exposure under the petitioned-for tolerances. There is likely to be dietary exposure to oxathiapiprolin from its use as a pesticide on food. Should exposure occur, however, minimal to no risk is expected for the general population, including infants and children, due to the low toxicity of oxathiapiprolin.

    2. Dietary exposure from drinking water. Exposure to oxathiapiprolin via drinking water from the proposed uses is expected to be minimal due to rapid foliar uptake and limited quantities available in spray drift. No adverse effects were observed in the submitted toxicological studies for oxathiapiprolin regardless of the route of exposure.

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

    Oxathiapiprolin is not proposed or registered for any specific use pattern that would result in residential handler exposure. However, some of the uses could involve commercial application in areas where residential post-application activities could occur (i.e., individuals playing on treated golf courses, commercial landscapes or treated ornamentals purchased at a retail location). Since no adverse effects were observed for oxathiapiprolin in the submitted toxicological studies (regardless of the route of exposure), quantitative residential handler or post-application exposure assessments are not needed.

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

    D. Safety Factor for Infants and Children

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

    2. Prenatal and postnatal sensitivity. No evidence of increased quantitative or qualitative susceptibility was seen in developmental toxicity studies in rats and rabbits. No treatment related effects were seen in maternal or fetal animals in the studies. However, there was evidence of increased quantitative susceptibility in reproduction studies in rats at doses above the limit dose. Decreased pup weight and delayed sexual maturation (preputial separation) were seen in the studies in the absence of maternal toxicity.

    3. Conclusion. As part of its qualitative assessment, EPA evaluated the available toxicity and exposure data on oxathiapiprolin and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA considers the toxicity database to be complete and has identified no residual uncertainty with regard to prenatal and postnatal toxicity or exposure. No hazard was identified based on the available studies; therefore, EPA concludes that there are no threshold effects of concern to infants, children, or adults from oxathiapiprolin. As a result, EPA concludes that no additional margin of exposure (safety) is necessary.

    E. Aggregate Risks and Determination of Safety

    Taking into account the available data for oxathiapiprolin, EPA has concluded that given the lack of toxicity of this substance, no risks of concern are expected. Therefore, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to oxathiapiprolin.

    IV. Other Considerations A. Analytical Enforcement Methodology

    Method 30422 (Supplement No. 1) was developed for plant commodities, and Method 31138 was developed for livestock commodities. Residues of oxathiapiprolin and associated metabolites are extracted from crop or livestock commodity samples using a solution of formic acid, water and acetonitrile, and diluted with acetonitrile and water. Both methods use liquid chromotography with tandem mass spectrometry (LC/MS/MS), specifically reverse-phase liquid chromatography (LC), and detection by electrospray tandem mass spectrometry (MS/MS).

    The FDA multi-residue methods are not suitable for detection and enforcement of oxathiapiprolin residues or associated metabolites. However, the European Multiresidue Method (DFG Method S19) and the QuEChERS Multiresidue Method have shown success in some matrices.

    Adequate enforcement methodology (LC/MS/MS) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]

    B. International Residue Limits

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

    The Codex has not established a MRL for oxathiapiprolin.

    C. Response to Comments

    One comment was received in response to the notice of filing of Dupont's application. The commenter objected to the increase of chemical residues generally and expressed concerns about the carcinogenic effects of chemicals on humans, particularly children. The Agency understands the commenter's concerns regarding toxic chemicals, their potential effects on humans, and population subgroups such as children. Pursuant to its authority under the FFDCA, and as discussed further in this preamble, EPA conducted a comprehensive assessment of oxathiapiprolin, including its potential for carcinogenicity. Based on its assessment of the available data, the Agency has concluded that there is a reasonable certainty that no harm will result from aggregate exposure to residues of oxathiapiprolin.

    D. Revisions to Petitioned-for Tolerances

    For grape, green onion, cucurbit vegetables, and edible podded pea, EPA has added an additional significant figure (such as 1.0 ppm rather than 1 ppm) to conform to EPA's convention for establishing enforceable tolerances. Thus, the tolerance for grape was revised to 0.70, for green onion to 2.0, for cucurbit vegetables to 0.20, and for edible-podded pea to 1.0. This is in order to avoid the situation where rounding of a residue result to the level of precision of the tolerance expression would be considered non-violative (such as 1.4 ppm being rounded to 1 ppm).

    In the case of crop group 8-10, Fruiting Vegetables, the petitioned-for-tolerance was based on the exclusion of a tomato field trial from the tolerance calculation. If this trial is excluded, all representative commodities (bell pepper, non-bell pepper, and tomato) support a crop group tolerance of 0.20 ppm. However, EPA has concluded that this trial cannot be excluded from the tolerance derivation because there were insufficient data to support this trial as an outlier. Including those data in the tolerance calculation for crop group 8-10, EPA is establishing a tolerance for crop group 8-10 at 0.50 ppm and a tolerance for dried tomatoes at 3.0 ppm. EPA is not issuing a crop group 8-10 tolerance for dried versions of all commodities in that crop group, as EPA's current regulations do not permit the Agency to establish crop group processed commodity tolerances. Moreover, the available data do not support establishing separate individual tolerances for dried versions of the other commodities in crop group 8-10.

    In the case of ginseng, Dupont submitted four field trials at the good agricultural practice (GAP) proposed use rate and two field trials at approximately two times the GAP. Based on a review of the data and consultation with the global partners, EPA has concluded that using the 1× data is more appropriate for setting the tolerance, and is establishing a tolerance at 0.15 ppm based on that data.

    The Agency also corrected the commodity definitions for the following commodities: Bulb vegetables, onion, bulb, crop subgroup 3-07A, to onion, bulb, subgroup 3-07A; bulb vegetables, onion, green crop subgroup 3-07B to onion, green, subgroup 3-07B; brassica (cole) leafy vegetables, head and stem brassica crop subgroup 5A to brassica, head and stem, subgroup 5A; cucurbit vegetables, crop group 9 to vegetable, cucurbit, group 9; fruiting vegetables crop group 8-10 to vegetable, fruiting, group 8-10; ginseng root to ginseng; leafy vegetables (except brassica vegetables), leafy greens crop subgroup 4A to leafy greens, subgroup 4A; peas, edible podded to pea, edible-podded; peas, succulent, shelled to pea, succulent shelled; and vegetable, root and tuber vegetables, tuberous corm vegetable crop subgroup 1C, to vegetable, tuberous and corm, subgroup 1C.

    The registrant did not petition for rotational crop tolerances. However, EPA has concluded that for future MRL harmonization purposes, it is appropriate to set a value of 0.10 ppm for inadvertent residues in all other food commodities/feed commodities (other than those covered by a tolerance as a result of use on growing crops).

    V. Conclusion

    Therefore, tolerances are established for residues of oxathiapiprolin, 1-(4-{4-[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2-yl}-1-piperidyl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl] ethanone, in or on the following commodities: Brassica, head and stem, subgroup 5A at 1.5 ppm; ginseng at 0.15 ppm; grape at 0.70 ppm; leafy greens subgroup 4A at 15 ppm; onion, bulb, crop subgroup 3-07A at 0.04 ppm; onion, green, crop subgroup 3-07B at 2.0 ppm; peas, edible podded at 1.0 ppm; peas, succulent, shelled at 0.05 ppm; tomato, dried at 3.0 ppm; vegetable, cucurbit, crop group 9 at 0.20 ppm; vegetables, fruiting, crop group 8-10 at 0.50 ppm; and vegetable, tuberous and corm, crop subgroup 1C at 0.01 ppm.

    In addition, inadvertent tolerances are established residues of oxathiapiprolin on all other food commodities/feed commodities (other than those covered by a tolerance as a result of use on growing crops) at 0.10 ppm.

    VI. Statutory and Executive Order Reviews

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

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

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

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

    VII. Congressional Review Act

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

    List of Subjects in 40 CFR Part 180

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

    Dated: August 27, 2015. Jack E. Housenger, Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

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

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

    2. Add § 180.685 to subpart C to read as follows:
    §  180.685 Oxathiapiprolin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the fungicide oxathiapiprolin, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on the commodity.

    Commodity Parts per million Brassica, head and stem, subgroup 5A 1.5 Ginseng 0.15 Grape 1 0.70 Leafy greens subgroup 4A 15 Onion, bulb, subgroup 3-07A 0.04 Onion, green, subgroup 3-07B 2.0 Pea, edible-podded 1.0 Pea, succulent shelled 0.05 Tomato, dried 3.0 Vegetable, cucurbit, group 9 0.20 Vegetable, fruiting, group 8-10 0.50 Vegetable, tuberous and corm, subgroup 1C 0.01 1 There is no associated U.S. registration as of September 4, 2015.

    (b) Section 18 emergency exemptions. [Reserved]

    (c) Tolerances with regional registrations. [Reserved]

    (d) Indirect or inadvertent residues. Tolerances are established for residues of the fungicide oxathiapiprolin, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only oxathiapiprolin, 1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone, in or on the commodity.

    Commodity Parts per million All other food commodities/feed commodities (other than those covered by a tolerance as a result of use on growing crops) 0.10
    [FR Doc. 2015-21917 Filed 9-3-15; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 130312235-3658-02] RIN 0648-XE126 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Resources of the South Atlantic; Trip Limit Reduction AGENCY:

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

    ACTION:

    Temporary rule; trip limit reduction.

    SUMMARY:

    NMFS reduces the commercial trip limit for vermilion snapper in or from the exclusive economic zone (EEZ) of the South Atlantic to 500 lb (227 kg), gutted weight. This trip limit reduction is necessary to protect the South Atlantic vermilion snapper resource.

    DATES:

    This rule is effective 12:01 a.m., local time, September 10, 2015, until 12:01 a.m., local time, January 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Catherine Hayslip, NMFS Southeast Regional Office, telephone: 727-824-5305, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The snapper-grouper fishery in the South Atlantic includes vermilion snapper and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

    The commercial ACL (commercial quota) for vermilion snapper in the South Atlantic is divided into two, 6-month periods. The commercial quota is 394,829 lb (179,091 kg), gutted weight, 438,260 lb (198,791 kg), round weight, for January 1 through June 30, 2015, and 394,829 lb (179,091 kg), gutted weight, 438,260 lb (198,791 kg), round weight, for July 1 through December 31, 2015, as specified in 50 CFR 622.190(a)(4)(i)(C) and (ii)(C), respectively. Any unused portion of the January 1 through June 30, 2015, fishing season commercial quota is added to the July 1 through December 31, 2015, fishing season commercial quota, as specified in 50 CFR 622.190(a)(4)(iii). In 2015, there was no unused commercial quota for the January through June period as the commercial sector reached its quota during the first 6-month period. The sector was closed on April 15, 2015, through June 30, 2015 (80 FR 19243, April 10, 2015).

    Under 50 CFR 622.191(a)(6)(ii), NMFS is required to reduce the commercial trip limit for vermilion snapper from 1,000 lb (454 kg), gutted weight, 1,110 lb (503 kg), round weight, to 500 lb (227 kg), gutted weight, 555 lb (252 kg), round weight, when 75 percent of the fishing season quota is reached or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register, as implemented by the final rule for Regulatory Amendment 18 to the FMP (78 FR 47574, August 6, 2013). Based on current data, NMFS has determined that 75 percent of the available vermilion snapper commercial quota for the July 1 through December 31, 2015, fishing season will be reached on or before September 10, 2015. Accordingly, NMFS is reducing the commercial trip limit for vermilion snapper to 500 lb (227 kg), gutted weight, 555 lb (252 kg), round weight, in or from the South Atlantic EEZ at 12:01 a.m., local time, on September 10, 2015. This 500-lb (227-kg), gutted weight, 555-lb (252-kg), round weight, trip limit will remain in effect until the commercial sector reaches its quota and the sector closes, or through December 31, 2015, whichever occurs first.

    Classification

    The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of South Atlantic vermilion snapper and is consistent with the Magnuson-Stevens Act and other applicable laws.

    This action is taken under 50 CFR 622.191(a)(6) and is exempt from review under Executive Order 12866.

    These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

    This action responds to the best scientific information available. The Assistant Administrator for Fisheries, NOAA (AA), finds that the need to immediately implement this commercial trip limit reduction constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), because prior notice and opportunity for public comment on this temporary rule is unnecessary and contrary to the public interest. Such procedures are unnecessary, because the rule establishing the trip limit reduction has already been subject to notice and comment, and all that remains is to notify the public of the trip limit. They are contrary to the public interest, because there is a need to immediately implement this action to protect the vermilion snapper resource since the capacity of the fishing fleet allows for rapid harvest of the quota. Prior notice and opportunity for public comment on this action would require time and would increase the probability that the commercial sector could exceed the quota.

    For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: September 1, 2015. Jennifer M. Wallace, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-22047 Filed 9-1-15; 4:15 pm] BILLING CODE 3510-22-P
    80 172 Friday, September 4, 2015 Proposed Rules DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Parts 101 and 116 [Docket No. APHIS-2014-0063] RIN 0579-AE11 VSTA Records and Reports Specific to International Standards for Pharmacovigilance AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Proposed rule; withdrawal and reproposal.

    SUMMARY:

    We are proposing to amend the Virus-Serum-Toxin Act regulations concerning records and reports. This change would require veterinary biologics licensees and permittees to record and submit reports concerning adverse events associated with the use of biological products they produce or distribute. The information that must be included in the adverse event reports submitted to the Animal and Plant Health Inspection Service would be provided in separate guidance documents. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document.

    DATES:

    We will consider all comments that we receive on or before November 3, 2015.

    ADDRESSES:

    You may submit comments by either of the following methods:

    • Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0063.

    • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2014-0063, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

    Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0063 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:

    Dr. Donna L. Malloy, Section Leader, Operational Support, Center for Veterinary Biologics Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-1231; (301) 851-3426.

    SUPPLEMENTARY INFORMATION: Background

    The Virus-Serum-Toxin Act regulations in 9 CFR part 116 (referred to below as the regulations) contain requirements for maintaining detailed records of information necessary to give a complete accounting of all the activities within a veterinary biologics establishment. These records include records and reports for unfavorable or unintended events that occur in animals after the use of a biological product.

    Specifically, the regulations in § 116.1, paragraph (a) state that such reports must include, but are not limited to, the items enumerated in the regulations, including inventory and disposition records, (§ 116.2), information concerning product development and preparation and market suspension and recalls (§ 116.5), animal records (§ 116.6), and test records (§ 116.7).

    In § 116.5, paragraph (b) states that if at any time there are indications that raise questions regarding the purity, safety, potency, or efficacy of a product, or if it appears that there may be a problem regarding the preparation, testing, or distribution of a product, the licensee, permittee, or foreign manufacturer must immediately notify the Animal and Plant Health Inspection Service (APHIS) concerning the circumstances and the action taken, if any.

    However, the regulations in § 116.1 do not explicitly require licensees and permittees to maintain records of adverse events associated with the use of veterinary biologics, nor do the regulations in § 116.5 provide specific guidance in determining whether an adverse event should be considered an indication that raises questions regarding the purity, safety, potency, efficacy, preparation, testing, or distribution (PSPEPTD) of such product. Consequently, each veterinary biologics manufacturer makes an independent determination concerning (1) whether an adverse event report raises PSPEPTD questions and (2) when and in what manner such report of the adverse event will be provided to APHIS.

    To limit the harm to animals posed by unsatisfactory veterinary biologics, APHIS must rely on adverse event reports provided by veterinary biologics licensees and permittees. However, without any explicit guidance as to the form those reports should take, licensees and permittees are using nonstandardized methods to record and submit reports regarding adverse events to APHIS. Similarly, without explicit reporting requirements concerning adverse events, reports that may signal problems concerning the use of veterinary biological products are not all being submitted to APHIS in a timely manner.

    The changes we are proposing are also consistent with guidelines set out by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). VICH is a unique project conducted under the World Organization for Animal Health, that brings together the regulatory authorities of the European Union, Japan, and the United States and representatives from the animal health industry in the three regions. Regulatory authorities and industry experts from Australia, Canada, and New Zealand participate as observers.

    The purpose of VICH is to harmonize technical requirements for veterinary medicinal products (both pharmaceuticals and biologics). As a VICH member, APHIS provides expertise on veterinary biological products and participates in efforts to enhance harmonization. Both APHIS and the animal health industry are committed to seek scientifically based harmonized technical requirements for the development and use of veterinary biological products. VICH Guideline GL42 specifically addresses data elements for submission of adverse event reports.1

    1 The VICH pharmacovigilance guidelines can be accessed at http://www.vichsec.org/guidelines/pharmacovigilance.html.

    By amending our regulations based on VICH pharmacovigilance guidelines we would be integrating into our regulations internationally accepted practices that would enhance the safety and efficacy of veterinary biologics in the United States. Furthermore, our consistency with these international guidelines would enhance the ability of the U.S. biologics industry to export their products.

    We have previously undertaken rulemaking to address the problems described above and to bring our reporting and recordkeeping requirements into closer alignment with the VICH guidelines. Specifically, on August 17, 2005, we published in the Federal Register (70 FR 48325-48329, Docket No. 00-071-2) a proposed rule 2 to amend the regulations concerning records and reports to require veterinary biologics licensees and permittees to record and submit reports to APHIS concerning adverse events associated with the use of veterinary biological products that they produce or distribute. The proposed rule would have required veterinary biologics licensees and permittees to report to APHIS the number of doses of each licensed product that they distribute. The proposed rule also would have amended the regulations in 9 CFR part 101 to provide definitions for the terms adverse event and adverse event report.

    2 To view the proposed rule and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2005-0071.

    We solicited comments on our proposal for 60 days ending on October 17, 2005. We received seven comments by that date. The comments were from industry associations, manufacturers of veterinary biologics, and a software company that specializes in pharmacovigilance. Four of these commenters expressed conceptual support for the proposed rule, but were concerned that parts of the proposed regulations were overly broad or ambiguous and would increase the regulatory burden on the industry and possibly compromise confidential business information. One commenter was skeptical of the need for the rule. The remaining commenters neither supported nor opposed the rule but instead either asked for clarification or suggested wording that they believed would provide greater clarity.

    In response to these comments, we believe it is necessary to clarify those provisions that could be subject to multiple interpretations and to provide more specifics concerning the information that should be included in adverse event reports associated with the use of veterinary biologics that are submitted to the Agency. Therefore, we are withdrawing the August 17, 2005, proposed rule and are replacing it with the proposed changes described in this document. The proposed recordkeeping and reporting requirements regarding adverse events that would apply to each licensee, permittee, and foreign establishment that prepares and distributes biological products are described below.

    Definitions

    The regulations in 9 CFR part 101 contain definitions of terms used in the regulations concerning veterinary biologics. The proposed changes to part 116 of the regulations would make it necessary for us to add definitions for two terms used in the proposed regulations to § 101.2. We would define adverse event as “any observation in animals, whether or not the cause of the event is known, that is unfavorable and unintended, and that occurs after any use (as indicated on the label or any off-label use) of a biological product, including events related to a suspected lack of expected efficacy. For products intended to diagnose disease, adverse events refer to a failure in product performance that hinders an expected discovery of the correct diagnosis.” We would define adverse event report as “any communication concerning the occurrence of an adverse event from an identifiable first-hand reporter which includes at least the following information: An identifiable reporter; an identifiable animal; an identifiable biologic product; and one or more adverse events.”

    Adverse Event Records

    We are proposing to add a new § 116.9 to provide requirements for adverse event records and reports. First, we would require that licensees and permittees maintain a detailed record for every adverse event report the licensee or permittee receives that is associated with the use of biological products they produce or distribute. APHIS will provide guidance on the information to be included in the reports on our Web site, based on the recommendations in the VICH Guideline GL42, which addresses data elements for submission of adverse event reports. We will release guidance documents as a final rule is being implemented, and we will make the documents available on our Web site in draft form for public comment.

    Second, we would require that licensees and permittees compile a report of all adverse events reports they receive and submit that report to the APHIS at regular intervals. Specifically, we would require that these reports be submitted immediately if at any time there are indications that raise questions regarding the purity, safety, potency, or efficacy of a product, or if it appears that there may be a problem regarding the preparation, testing, or distribution of a product. If the licensee or permittee determines the adverse event report to be product-related, serious, and unexpected, the report would have to be submitted to APHIS within 15 business days of the date the report was first received. All other adverse event reports would have to be submitted within 90 calendar days of the date the report was first received.

    Completion of Records

    The regulations in §§ 116.1(a)(3) and 116.8 provide that all records (other than disposition records) required under part 116 shall be completed by the licensee, permittee, or foreign manufacturer before any portion of a serial of any product may be marketed in the United States or exported. We are proposing to amend those provisions to also allow adverse event records to be excluded from the list of records that must be completed before a product may be marketed or exported. Like disposition records, adverse event records could not be expected to have been completed prior to the marketing or exportation of a product.

    If this proposed rule is adopted as a final rule, there would be an 18-month implementation period to allow licensees and permittees sufficient time to bring their recordkeeping and reporting into compliance with the new reporting and recordkeeping requirements.

    Miscellaneous

    We would also make several minor, nonsubstantive changes to the regulations to improve their clarity.

    Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

    In accordance with 5 U.S.C. 603, we have performed an initial regulatory flexibility analysis, which is summarized below, regarding the economic effects of this rule on small entities. The full analysis may be viewed on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov) or obtained from the person listed under FOR FURTHER INFORMATION CONTACT.

    The proposed rule would affect all of the approximately 314 U.S. veterinary biologics manufacturers, including permittees. All the affected entities would have to take at least some additional action—even if that additional action involved sending a negative affirmation report to APHIS annually.

    The Small Business Administration (SBA) standard for establishments primarily engaged in manufacturing vaccines, toxoids, blood fractions, and culture media of plant or animal origin (NAICS 325414) is 500 employees or fewer. It is reasonable to assume that most are small in size, under the SBA standards. This assumption is based on composite data for providers of the same and similar services in the United States. In 2012, there were 314 U.S. establishments in NAICS 325414 3 with a total employment of 40,411. The average number of employees per firm in 2012 was 128. Similarly, in 2012, there were 235 U.S. establishments in NAICS 325413, a classification comprised of establishments primarily engaged in manufacturing in-vitro diagnostic substances, including biological substances. The average number of employees per firm in 2012 was 108.4

    3http://thedataweb.rm.census.gov/TheDataWeb_HotReport2/econsnapshot/2012/snapshot.hrml?NAICS=325414.

    4http://thedataweb.rm.census.gov/TheDataWeb_HotReport2/econsnapshot/2012/snapshot.hrml?NAICS=325413.

    The proposed rule has the potential to benefit animals and their owners, to the extent that it allows APHIS to act quickly to limit the harm to animals posed by unsatisfactory veterinary biologics. For animal owners, the monetary benefits are difficult to estimate, because they would depend on several factors that are currently unknown—the significance, or gravity, of the harm that would be avoided with the rule in effect, and the number, and value, of animals that would avoid harm with the rule in effect. For some animal owners, especially those with large numbers of high value animals, the potential monetary benefits could be significant. This proposed rule clarifies reporting requirements. Manufacturer costs to comply with the proposed rule are expected be minimal in most cases. By revising our regulations based on VICH pharmacovigilance guidelines we will be applying an international standard to the industry which will enhance the safety and efficacy of veterinary biologics in the United States. Furthermore, our compliance with this international standard will enhance the ability of the biologics industry to export their products.

    Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)

    Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. This rule would not preempt any State or local laws, regulations, or policies where they are necessary to address local disease conditions or eradication programs. However, where safety, efficacy, purity, and potency of biological products are concerned, it is the Agency's intent to occupy the field. This includes, but is not limited to, the regulation of labeling. Under the Act, Congress clearly intended that there be national uniformity in the regulation of these products. There are no administrative proceedings which must be exhausted prior to a judicial challenge to the regulations under this rule.

    Executive Order 13175

    This rule does not significantly or uniquely affect the communities of Indian tribal governments. The rule does not impose any mandate on tribal governments or impose any duties on these entities. Thus, no further action is required under Executive Order 13175.

    Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS-2014-0063. Please send a copy of your comments to: (1) APHIS, using one of the methods described under ADDRESSES at the beginning of this document, and (2) Clearance Officer, OCIO, USDA, Room 404-W, 14th Street and Independence Avenue SW., Washington, DC 20250.

    This proposed rule would require veterinary biologics licensees and permittees to record and submit reports to APHIS concerning adverse events associated with the use of biological products they produce or distribute. APHIS would provide guidance as to the information to be included in these reports. The reports would also be required to be maintained for a specified amount of time.

    We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:

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

    (2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, 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 information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses).

    Estimate of burden: Public reporting burden for this collection of information is estimated to average 0.33 hours per response.

    Respondents: U.S. importers and exporters of veterinary biological products, shippers of veterinary biological products, State veterinary authorities, and operators of establishments that produce or test veterinary biological products or that engage in product research and development.

    Estimated annual number of respondents: 9,999.

    Estimated annual number of responses per respondent: 1.59.

    Estimated annual number of responses: 15,996.

    Estimated total annual burden on respondents: 5,280 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.)

    Copies of this information collection can be obtained from Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

    E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

    Lists of Subjects 9 CFR Part 101

    Animal biologics.

    9 CFR Part 116

    Animal biologics, Reporting and recordkeeping requirements.

    Accordingly, we propose to amend 9 CFR parts 101 and 116 as follows:

    PART 101—DEFINITIONS 1. The authority citation for part 101 continues to read as follows: Authority:

    21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    2. Section 101.2 is amended by adding definitions for adverse event and adverse event report in alphabetical order to read as follows:
    § 101.2 Administrative terminology.

    Adverse event. Any observation in animals, whether or not the cause of the event is known, that is unfavorable and unintended, and that occurs after any use (as indicated on the label or any off-label use) of a biological product, including events related to a suspected lack of expected efficacy. For products intended to diagnose disease, adverse events refer to a failure in product performance that hinders an expected discovery of the correct diagnosis.

    Adverse event report. Any communication concerning the occurrence of an adverse event from an identifiable first-hand reporter which includes the following information:

    (1) An identifiable reporter;

    (2) An identifiable animal;

    (3) An identifiable biologic product; and

    (4) One or more adverse events.

    PART 116—RECORDS AND REPORTS 3. The authority citation for part 116 continues to read as follows: Authority:

    21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    4. In § 116.1, paragraph (a)(3) is revised to read as follows:
    § 116.1 Applicability and general considerations.

    (a) * * *

    (3) Records (other than disposition records and adverse event records) required by this part must be completed by the licensee, permittee, or foreign manufacturer, as the case may be, before any portion of a serial of any product may be marketed in the United States or exported.

    5. Section 116.8 is revised to read as follows:
    § 116.8 Completion and retention of records.

    All records (other than disposition records and adverse event records) required by this part must be completed by the licensee, permittee, or foreign manufacturer before any portion of a serial of any product may be marketed in the United States or exported. All records must be retained at the licensed or foreign establishment or permittee's place of business for a period of 2 years after the expiration date of a product or longer as may be required by the Administrator.

    6. Section 116.9 is added to read as follows:
    § 116.9 Recording and reporting adverse events.

    (a) Licensees and permittees must maintain a detailed record for every adverse event report the licensee or permittee receives for any biological product it produces or distributes. These records shall be maintained for a period of 3 years after the date the adverse event report is received. The adverse event report form and guidance on how to complete it, including guidance specific to the various information blocks on the form, is available on the APHIS Web site at [ADDRESS TO BE ADDED IN FINAL RULE] or by writing to APHIS at [POSTAL ADDRESS TO BE ADDED IN FINAL RULE].

    (b) A report of all adverse events reports received by a licensee or permittee must be compiled and submitted to the Animal and Plant Health Inspection Service. The frequency of report submission is as follows:

    (1) Immediate notification is required if at any time there are indications that raise questions regarding the purity, safety, potency, or efficacy of a product, or if it appears that there may be a problem regarding the preparation, testing, or distribution of a product.

    (2) Adverse event reports determined by the licensee or permittee to be product-related, serious, and unexpected must be reported within 15 business days of the date the report was first received.

    (3) All other adverse event reports must be reported within 90 calendar days of the date the report was first received.

    Done in Washington, DC, this 31st day of August 2015. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2015-21997 Filed 9-3-15; 8:45 am] BILLING CODE 3410-34-P
    NUCLEAR REGULATORY COMMISSION 10 CFR Part 73 [NRC-2015-0179] RIN 3150-AJ64 Cyber Security at Fuel Cycle Facilities AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Draft regulatory basis; request for comment.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is requesting comments on a draft regulatory basis to support a rulemaking that would amend its regulations by adopting new cyber security requirements for certain nuclear fuel cycle facility (FCF) licensees in order to address safety and security consequences of concern. Potentially affected licensees include certain FCFs authorized to possess Category I, II, or III quantities of special nuclear material and uranium hexafluoride conversion and deconversion facilities.

    DATES:

    Submit comments by October 5, 2015. Comments received after this date will be considered if it is practical to do so, but the NRC is only able to ensure consideration of comments received on or before this date.

    ADDRESSES:

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

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0179. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

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

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

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

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

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

    FOR FURTHER INFORMATION CONTACT:

    Matthew Bartlett, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7154, email: [email protected]

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

    Please refer to Docket ID NRC-2015-0179 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0179.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The draft regulatory basis document is available in ADAMS under Accession No. ML15198A021.

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

    B. Submitting Comments

    Please include Docket ID NRC-2015-0179 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.

    If your comment contains proprietary or sensitive information, please contact the individual listed in the FOR INFORMATION CONTACT section of this document to determine the most appropriate method for submitting your comment.

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

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

    II. Discussion

    The NRC is requesting comments on a draft regulatory basis to support a rulemaking that would amend part 73 of Title 10 of the Code of Federal Regulations (10 CFR), “Physical Protection of Plants and Materials,” by adopting new cyber security regulations for FCF licensees. The specific objectives of this rulemaking effort are to establish new requirements for FCF licensees that: (1) Require licensees authorized to possess a Category I quantity of special nuclear material (SNM) to establish and maintain a cyber security program that provides high assurance that digital computer systems, communication systems, and networks associated with safety, security, emergency preparedness, and material control and accounting (SSEPMCA) functions are protected from cyber attacks up to and including the design basis threats defined in 10 CFR 73.1; (2) require certain licensees authorized to possess source material or a Category II or III quantity of SNM to establish and maintain a cyber security program that provides reasonable assurance that digital computer systems, communication systems, and networks associated with SSEPMCA functions are protected from cyber attacks; (3) codify existing cyber security requirements imposed on FCF licensees by security orders issued following the terrorist attacks of September 11, 2001, and applicable subsequent voluntary actions instituted by FCF licensees; (4) implement a graded, performance-based regulatory framework to prevent cyber attacks that could result in certain consequences of concern; and (5) implement cyber security reporting criteria.

    The scope of the draft regulatory basis includes cyber security for FCFs licensed under 10 CFR part 70 and uranium hexafluoride conversion and deconversion facilities licensed under 10 CFR part 40. These licensees have varying safety and security consequences of concern based on their functions and the type and quantity of material possessed. To account for these differences, the NRC plans to develop a graded, consequence-based approach for the identification and protection of digital assets associated with SSEPMCA functions. The draft regulatory basis, in part, explains why the NRC believes the existing regulations should be updated, revised, and enhanced; presents alternatives to rulemaking; and discusses costs and other impacts of the potential changes.

    III. Specific Requests for Comments

    The NRC requests that stakeholders consider answering the following questions when commenting on the draft regulatory basis:

    • Is the NRC considering an appropriate approach for each objective described in the draft regulatory basis?

    • Chapter 3 of the draft regulatory basis discusses the regulatory concerns the NRC expects to address through rulemaking. Chapter 4 presents the intended regulatory changes to address those regulatory concerns, and Chapter 5 discusses alternatives to rulemaking considered by the NRC staff. Are there other regulatory concerns within or related to the scope of the rulemaking efforts (see Chapter 1 of the draft regulatory basis) that the NRC should consider? Are there other approaches or alternatives the NRC should consider to resolve those regulatory concerns?

    • Chapter 8 of the draft regulatory basis presents the NRC staff's initial consideration of costs and other impacts for a number of key aspects of the potential regulatory changes (i.e., cyber security programs, cyber incident reporting). This initial assessment is based on limited available data. The staff is seeking additional data and input relative to expected and/or unintentional impacts from the desired regulatory changes. What would be the potential impacts to stakeholders/licensees from implementing any of the desired regulatory changes described in this draft regulatory basis (e.g., what would be a reasonable cost estimate for implementation of the cyber security programs, including startup and annual costs)?

    • The NRC staff is aware of licensee voluntary efforts to address cyber security. Is there additional information related to these efforts that would inform the NRC staff's assessment or analysis?

    IV. Cumulative Effects of Regulation

    The Cumulative Effects of Regulation (CER) describes the challenges that licensees or other impacted entities (such as State agency partners) may face while implementing new regulatory positions, programs, and requirements (e.g., rules, generic letters, backfits, inspections). The CER is an organizational effectiveness challenge that results from a licensee or impacted entity implementing a number of complex positions, programs, or requirements within a limited implementation period and with available resources (which may include limited available expertise to address a specific issue). The NRC has implemented CER enhancements to the rulemaking process to facilitate public involvement throughout the rulemaking process. Therefore, the NRC is specifically requesting comment on the cumulative effects that may result from this proposed rulemaking. In developing comments on the draft regulatory basis, consider the following questions:

    (1) In light of any current or projected CER challenges, what should be a reasonable effective date, compliance date, or submittal date(s) from the time the final rule is published to the actual implementation of any new proposed requirements, including changes to programs, procedures, or the facility?

    (2) If current or projected CER challenges exist, what should be done to address this situation (e.g., if more time is required to implement the new requirements, what period of time would be sufficient, and why such a time frame is necessary)?

    (3) Do other regulatory actions (e.g., orders, generic communications, license amendment requests, and inspection findings of a generic nature) by NRC or other agencies influence the implementation of the potential proposed requirements?

    (4) Are there unintended consequences? Does the potential proposed action create conditions that would be contrary to the potential proposed action's purpose and objectives? If so, what are the consequences and how should they be addressed?

    Please provide information on the costs and benefits of the potential proposed action. This information will be used to support any regulatory analysis by the NRC.

    V. Availability of Documents

    The NRC may post additional materials related to this rulemaking activity to the Federal rulemaking Web site at www.regulations.gov under Docket ID NRC-2015-0179. By making these documents publicly available, the NRC seeks to inform stakeholders of the current status of the NRC's rulemaking development activities and to provide preparatory material for future public meetings.

    The Federal rulemaking Web site allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC-2015-0179); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

    VI. Plain Writing

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

    Dated at Rockville, Maryland, this 27th day of August, 2015.

    For the Nuclear Regulatory Commission.

    Marissa G. Bailey, Director, Division of Fuel Cycle Safety, Safeguards, and Environmental Review, Office of Nuclear Materials Safety and Safeguards.
    [FR Doc. 2015-22051 Filed 9-3-15; 8:45 am] BILLING CODE 7590-01-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-3073; Directorate Identifier 2015-CE-017-AD] RIN 2120-AA64 Airworthiness Directives; Viking Air Limited Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Proposed rule; correction.

    SUMMARY:

    The FAA is correcting a notice of proposed rulemaking (NPRM) that published in the Federal Register. That NPRM applies to Viking Air Limited Model DHC-3 airplanes. The repetitive inspection column in “Table 1 of Paragraph (f)(3) of This AD—Inspection Schedule” contains data that is intended to apply to all conditions. However, the way the table is displayed makes it look as if it only applies to the first condition. This document corrects it to assure that it applies to all conditions. In all other respects, the original document remains the same.

    DATES:

    The last date for submitting comments to the NPRM (80 FR 44892, July 28, 2015) remains September 11, 2015.

    ADDRESSES:

    You may send comments by any of the following methods:

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

    Fax: (202) 493-2251.

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

    Hand Delivery: U.S. Department of Transportation, Docket Operations, M-30, 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 service information identified in this proposed AD, contact Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; Fax: 250-656-0673; telephone: (North America) 1-800-663-8444; email: [email protected]; Internet: http://www.vikingair.com/support/service-bulletins. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-3073.You may view this referenced service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-3073; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Aziz Ahmed, Aerospace Safety Engineer, FAA, New York Aircraft Certification Office (ACO), 1600 Steward Avenue, Suite 410, Westbury, New York 11590; telephone: (516) 228-7329; fax: (516) 794-5531; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    On July 28, 2015, a notice of proposed rulemaking (NPRM) (80 FR 44892) was published in the Federal Register to apply to Viking Air Limited Model DHC-3 airplanes. That NPRM proposed to require installing additional wing inspection access panels and inspecting the wings using borescope and visual methods with corrective action as necessary.

    As published, the repetitive inspection column in “Table 1 of Paragraph (f)(3) of This AD—Inspection Schedule” contains data that when displayed makes it look as if the repetitive inspections only apply to the first condition, whereas when printed shows that it applies to all conditions. To correct this, we are including the data in each condition.

    Although no other part of the preamble or regulatory information has been corrected, we are publishing the entire NPRM (80 FR 44892, July 28, 2015) in the Federal Register.

    The last date for submitting comments to the NPRM (80 FR 44892, July 28, 2015) remains September 11, 2015.

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new AD: Viking Air Limited: Docket No. FAA-2015-3073; Directorate Identifier 2015-CE-017-AD. (a) Comments Due Date

    We must receive comments by September 11, 2015. The date as originally published in the NPRM (80 FR 44892, July 28, 2015).

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Viking Air Limited DHC-3 airplanes, all serial numbers, certificated in any category.

    (d) Subject

    Air Transport Association of America (ATA) Code 57: Wings.

    (e) Reason

    This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as reports of corrugation cracking found at various wing stations and on the main spar lower cap. We are issuing this proposed AD to detect cracking and correct as necessary to address the unsafe condition on these products.

    (f) Actions and Compliance

    Unless already done, do the following actions in paragraphs (f)(1) through (f)(5) of this AD:

    (1) Within 30 days after the effective date of this AD, determine the accumulated air time for each wing by contacting Technical Support at Viking Air Limited. You can find contact information for Viking Air Limited in paragraph (h) of this AD.

    (2) Within 30 days after the effective date of this AD, determine all installed supplemental type certificates (STC) or modifications affecting the wings. Based on the accumulated air time determined from paragraph (f)(1) of this AD and before the initial inspection required in paragraph (f)(3) of this AD, install access panels as follows:

    (i) If the airplane is free of STCs or any other modifications affecting the wings, install additional inspection access panels following the Accomplishment Instructions Part A of Viking DHC-3 Otter Service Bulletin No. V3/0002, Revision “C”, dated April 30, 2014.

    (ii) If the airplane is fitted with STC SA2009NY (which can be found on the Internet at: http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/F7309B7D9B008C588625734F00730144?OpenDocument&Highlight=sa02009ny), incorporate additional inspection access panels following the Accomplishment Instructions of Viking Air Limited SB 3-STC (03-50)-001, Revision “NC”, dated April 30, 2014.

    Note 1 to paragraph (f)(2)(ii) of this AD: STC SA03-50 would be the Canadian equivalent of the United States STC 2A2009NY.

    (iii) If there are other STCs or modifications affecting the wings the operator must contact the FAA to request an FAA-approved alternative method of compliance using the procedures in paragraph (g)(1) of this AD and 14 CFR 39.19. To develop these procedures, we recommend you contact the STC holder for guidance in developing substantiating data.

    (3) Based on the accumulated air time on the wings determined in paragraph (f)(1) of this AD, perform initial and repetitive borescope and visual inspections of both the left-hand and right-hand wing box following Part B of the Accomplishment Instructions of Viking DHC-3 Otter Service Bulletin V3/0002, Revision “C”, dated April 30, 2014, using the inspection schedules specified in Table 1 of paragraph (f)(3) of this AD:

    Table 1 of Paragraph (f)(3) of This AD—Inspection Schedule Effectivity Initial inspection Repetitive inspection If Viking Air Limited SB V3/0002, Revision “A”, dated February 22, 2013; or Viking Air Limited SB V3/0002, Revision “B”, dated July 3, 2013; were complied with prior to the effective date of this AD The initial inspection is not required since the inspection was accomplished while complying with Revision “A” or “B” of Viking Air Limited SB V3/0002 Repetitively inspect not to exceed every 1,600 wing air time hours accumulated after the last inspection or 2,100 flight cycles after the last inspection, whichever occurs first. If, as of the effective date of this AD, the airplane has less than 31,200 wing air time hours Inspect within 800 wing air time hours after the effective date of this AD, or within 6 months after the effective date of this AD, whichever occurs first Repetitively inspect not to exceed every 1,600 wing air time hours accumulated after the last inspection or 2,100 flight cycles after the last inspection, whichever occurs first. If, as of the effective date of this AD, the airplane has 31,200 hours wing air time or more but less than 31,600 hours wing air time hours Inspect upon or before accumulating 32,000 wing air time hours or within 6 months after the effective date of this AD, whichever occurs first Repetitively inspect not to exceed every 1,600 wing air time hours accumulated after the last inspection or 2,100 flight cycles after the last inspection, whichever occurs first. If, as of the effective date of this AD, the airplane has 31,600 wing air time hours or more Inspect within 400 wing air time hours accumulated after the effective date of this AD or 3 months after the effective date of this AD, whichever occurs first Repetitively inspect not to exceed every 1,600 wing air time hours accumulated after the last inspection or 2,100 flight cycles after the last inspection, whichever occurs first.

    (4) If the total flight cycles have not been kept, multiply the total number of airplane hours time-in-service (TIS) by 2 to calculate the cycles. For the purpose of this AD, some examples are below:

    (i) .5 hour TIS × 2 = 1 cycle; and

    (ii) 200 hours TIS × 2 = 400 cycles.

    (5) If any cracks are found, contact Technical Support at Viking Air Limited for an FAA-approved repair and incorporate the repair before further flight. You can find contact information for Viking Air Limited in paragraph (i) of this AD. The FAA-approved repair must specifically reference this AD.

    (g) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Aziz Ahmed, Aerospace Safety Engineer, FAA, New York Aircraft Certification Office (ACO), 1600 Steward Avenue, Suite 410, Westbury, New York 11590; telephone: (516) 228-7329; fax: (516) 794-5531; email: [email protected] Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.

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

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

    (h) Related Information

    Refer to MCAI Transport Canada AD No. CF-2015-05, dated March 18, 2015. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-3073. For service information related to this AD, contact Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; Fax: 250-656-0673; telephone: (North America) 1-800-663-8444; email: [email protected]; Internet: http://www.vikingair.com/support/service-bulletins. You may review this referenced service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

    Issued in Kansas City, Missouri, on August 28, 2015. Earl Lawrence, Manager, Small Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2015-21934 Filed 9-3-15; 8:45 am] BILLING CODE 4910-13-P
    FEDERAL TRADE COMMISSION 16 CFR Part 312 RIN 3084-AB20 Children's Online Privacy Protection Rule Proposed Parental Consent Method; Jest8 Limited Trading as Riyo's Application for Approval of Parental Consent Method; Extension of Comment Period AGENCY:

    Federal Trade Commission (FTC or Commission).

    ACTION:

    Extension of comment period.

    SUMMARY:

    The Federal Trade Commission is extending the comment period concerning the proposed parental consent method submitted by Jest8 Limited, trading as Riyo (“Riyo”), under the Voluntary Commission Approval Processes provision of the Children's Online Privacy Protection Rule.

    DATES:

    Written comments on the request for public comment published August 7, 2015 (80 FR 47429) must be received on or before September 14, 2015.

    ADDRESSES:

    Interested parties may file a comment at http://ftcpublic.commentworks.com/ftc/riyocoppaconsent online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write “Jest8 Limited Trading as Riyo's Application for Parental Consent Method, Project No. P-155405” on your comment, and file your comment online at http://ftcpublic.commentworks.com/ftc/riyocoppaconsent by following the instructions on the Web-based form. If you prefer to file your comment on paper, write “Jest8 Limited Trading as Riyo's Application for Parental Consent Method, Project No. P-155405” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex E), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex E), Washington, DC 20024.

    FOR FURTHER INFORMATION CONTACT:

    Miry Kim, Attorney, (202) 326-3622, Division of Privacy and Identity Protection, Federal Trade Commission, Washington, DC 20580.

    SUPPLEMENTARY INFORMATION: Section A. Background

    On October 20, 1999, the Commission issued its final Rule 1 pursuant to the Children's Online Privacy Protection Act, 15 U.S.C. 6501 et seq., which became effective on April 21, 2000.2 On December 19, 2012, the Commission amended the Rule, and these amendments became effective on July 1, 2013.3 The Rule requires certain Web site operators to post privacy policies and provide notice, and to obtain verifiable parental consent, prior to collecting, using, or disclosing personal information from children under the age of 13. The Rule enumerates methods for obtaining verifiable parental consent, while also allowing an interested party to file a written request for Commission approval of parental consent methods not currently enumerated.4 To be considered, the party must submit a detailed description of the proposed parental consent method, together with an analysis of how the method meets the requirements for parental consent described in 16 CFR 312.5(b)(1).

    1 64 FR 59888 (November 3, 1999).

    2 16 CFR part 312.

    3 78 FR 3972 (January 17, 2013).

    4 16 CFR 312.12(a); 78 FR 3991 (January 17, 2013).

    Pursuant to Section 312.12(a) of the Rule, Riyo has submitted a proposed parental consent method to the Commission for approval. The full text of its application is available on the Commission's Web site at www.ftc.gov.

    On July 31, 2015, the Commission issued a Federal Register document seeking comments on Riyo's proposed parental consent method. The comment period was scheduled to end on September 3, 2015. One group that frequently comments on issues relating to the Rule, the Center for Digital Democracy, requested a short extension for the filing of comments. Such an extension would not affect the deadline applicable to the Commission's determination whether to grant or deny the application. The Commission agrees that extending the comment period to allow interested parties adequate time to address issues raised by the proposed consent method will facilitate a more complete record. Accordingly, the Commission has decided to extend the public comment period eleven days, until September 14, 2015.

    Section B. Invitation To Comment

    You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before September 14, 2015. Write “Jest8 Limited Trading as Riyo's Application for Parental Consent Method, Project No. P-155405” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

    Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, likes anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, including medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is . . . privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

    If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).5 Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest.

    5 In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c), 16 CFR 4.9(c).

    Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at http://ftcpublic.commentworks.com/ftc/riyocoppaconsent, by following the instructions on the Web-based form. If this document appears at http://www.regulations.gov/#!home, you also may file a comment through that Web site.

    If you file your comment on paper, write “Jest8 Limited Trading as Riyo's Application for Parental Consent Method, Project No. P-155405” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex E), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street, SW., 5th Floor, Suite 5610 (Annex E), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

    Visit the Commission Web site at http://www.ftc.gov to read this document and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before September 14, 2015. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see http://www.ftc.gov/ftc/privacy.htm.

    By direction of the Commission.

    Donald S. Clark, Secretary.
    [FR Doc. 2015-21979 Filed 9-3-15; 8:45 am] BILLING CODE 6750-01-P
    AGENCY FOR INTERNATIONAL DEVELOPMENT 22 CFR Part 205 RIN 0412-AA75 Amendment to “Participation by Religious Organizations in USAID Programs” To Implement Executive Order 13559 AGENCY:

    U.S Agency for International Development.

    ACTION:

    Notice of proposed rulemaking; extension of comment period.

    SUMMARY:

    The U.S. Agency for International Development (USAID) is extending the public comment period on the Notice of proposed rulemaking entitled “Amendment to `Participation by Religious Organizations in USAID Programs' to Implement Executive Order 13559,” which was published in the Federal Register on August 6, 2015. The original public comment period would have ended on September 8, 2015. USAID intended to give a 60-day public comment period. Therefore, a comment period extension, to October 5, 2015, is appropriate.

    DATES:

    The comment period for the notice of proposed rulemaking published in the Federal Register on August 6, 2015 (80 FR 47237), is extended. Written comments must be received by the extended due date of October 5, 2015. USAID may not fully consider comments received after this date.

    ADDRESSES:

    Address all comments concerning this notice to C. Eduardo Vargas, Center for Faith-Based & Community Initiatives (A/AID/CFBCI), U.S Agency for International Development, Room 6.07-100 RRB, 1300 Pennsylvania Avenue NW., Washington, DC 20523. Submit comments, identified by title of the action and Regulatory Information Number (RIN) by any of the following methods:

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

    Email: Submit electronic comments to [email protected] See SUPPLEMENTARY INFORMATION for file formats and other information about electronic filing.

    Mail: USAID, Center for Faith-Based & Community Initiatives (A/AID/CFBCI), Room 6.07-100, 1300 Pennsylvania Avenue NW., Washington, DC 20523.

    A copy of each communication submitted will be available for inspection and copying between 8:30 a.m. and 5:30 p.m. at the above address.

    FOR FURTHER INFORMATION CONTACT:

    Mark Brinkmoeller, Director, Center for Faith-Based and Community Initiatives, USAID, Room 6.07-023, 1300 Pennsylvania Avenue NW., Washington, DC 20523; telephone: (202) 712-4080 (this is not a toll-free number).

    SUPPLEMENTARY INFORMATION:

    USAID published a notice of proposed rulemaking entitled “Amendment to `Participation by Religious Organizations in USAID Programs' to Implement Executive Order 13559,” which was published in the Federal Register on August 6, 2015 (80 FR 47237). This proposed rule is intended to amend 22 CFR part 205, Participation by Religious Organizations in USAID Programs, to make it consistent with Executive Order 13559. This proposed rule would amend USAID's regulations to replace the term “inherently religious activities” with the term “explicitly religious activities” and define the latter term as “including activities that involve overt religious content such as worship, religious instruction, or proselytization.” This proposed rule would also clarify that organizations who receive USAID financial assistance through subawards must comply with the requirements relating to protections for beneficiaries and the restrictions on prohibited uses of federal financial assistance. This proposed rule would also add language to the sections of the rule covering protections for beneficiaries to conform more directly to the Executive Order language. This proposed would also provide that decisions about awards of Federal financial assistance must be free from political interference or even the appearance of such interference.

    USAID intended to give a 60-day public comment period, which would mirror the comment period given in the related proposed rules of eight other federal agencies. Therefore, a comment period extension, to October 5, 2015, is appropriate without unduly delaying a final rulemaking decision. Accordingly, written comments must be submitted by the extended due date of October 5, 2015. USAID may not fully consider comments received after this date.

    Dated: August 25, 2015. C. Eduardo Vargas, Deputy Director, Center for Faith-Based and Community Initiatives (Acting Director).
    [FR Doc. 2015-22039 Filed 9-3-15; 8:45 am] BILLING CODE 6116-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2013-0808; FRL-9932-49-Region 6] Approval and Promulgation of Implementation Plans; Texas; Infrastructure Requirements for the 1997 Ozone and the 1997 and 2006 PM2.5 NAAQS AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to finalize a change to the Code of Federal Regulations (CFR) to reflect a 2014 EPA approval to a State Implementation Plan (SIP) revision to regulate greenhouse gases (GHGs) in Texas' Prevention of Significant Deterioration (PSD) permitting program and to show that the SIP deficiency identified in a prior partial disapproval for the 1997 Ozone and the 1997 and 2006 PM2.5 National Ambient Air Quality Standards (NAAQS) has been addressed.

    DATES:

    Written comments should be received on or before October 5, 2015.

    ADDRESSES:

    Comments may be mailed to Mr. Guy Donaldson, Chief, Air Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-2733. Comments may also be submitted electronically or through hand delivery/courier by following the detailed instructions in the ADDRESSES section of the direct final rule located in the rules section of this Federal Register.

    FOR FURTHER INFORMATION CONTACT:

    Carl Young, 214-665-6645, [email protected]

    SUPPLEMENTARY INFORMATION:

    In the final rules section of this Federal Register, the EPA is finalizing a change to the CFR without prior proposal because the Agency views this as noncontroversial submittal and anticipates no adverse comments. The change is to reflect a 2014 EPA approval to a SIP revision to regulate GHGs in the Texas PSD permitting program and to show that the SIP deficiency identified in a prior partial disapproval has been addressed. A detailed rationale for the approval is set forth in the direct final rule. If no relevant adverse comments are received in response to this action no further activity is contemplated. If the EPA receives relevant adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. The EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.

    For additional information, see the direct final rule which is located in the rules section of this Federal Register.

    Dated: August 26, 2015. Ron Curry, Regional Administrator, Region 6.
    [FR Doc. 2015-22036 Filed 9-3-15; 8:45 am] BILLING CODE 6560-50-P
    80 172 Friday, September 4, 2015 Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2015-0058] Highly Pathogenic Avian Influenza; Availability of an Environmental Assessment and Finding of No Significant Impact AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Notice of availability and request for comments.

    SUMMARY:

    We are advising the public that an environmental assessment has been prepared by the Animal and Plant Health Inspection Service relative to a national approach for the control of highly pathogenic avian influenza outbreaks within the United States. Based on our environmental assessment, we have concluded that such an approach will not have a significant impact on the quality of the human environment. We are making this environmental assessment and finding of no significant impact available to the public for review and comment.

    DATES:

    We will consider all comments that we receive on or before October 5, 2015.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0058.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2015-0058, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

    The environmental assessment, finding of no significant impact, and any comments we receive may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0058 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:

    Ms. Lori Miller, PE, Senior Staff Officer and Environmental Engineer, APHIS Veterinary Services, 4700 River Road Unit 41, Riverdale, MD 20737; (301) 851-3512.

    SUPPLEMENTARY INFORMATION:

    Highly pathogenic avian influenza (HPAI) is a significant and often fatal zoonotic disease of poultry. In December 2014, two H5 viruses of HPAI were discovered in the United States. These viruses were subsequently detected in both migratory waterfowl and domestic poultry, and significantly affected domestic poultry production within the United States. Two poultry production sectors, commercial meat turkeys and laying chickens, were heavily impacted by the disease, resulting in the loss or destruction of over 48 million birds between December 2014 and June 2015.

    While disease eradication efforts, northern migration of wild waterfowl, and the natural disinfecting effect of summer heat have currently halted the spread of the disease within the United States, the migration southward of potentially infected wild waterfowl during the autumn could precipitate a new round of outbreaks.

    To address this potential new round of outbreaks, the Animal and Plant Health Inspection Service (APHIS) has prepared an environmental assessment, titled “High Pathogenicity Avian Influenza Control in Commercial Poultry Operations—A National Approach,” relative to a national approach to controlling outbreaks of HPAI within the United States. The environmental assessment suggests an approach in which APHIS uses its centralized management of carcass disposal activities to ensure consistency throughout the United States with regard to control efforts in response to HPAI outbreaks. Under this approach, APHIS would provide information and other support to State and local authorities to help them determine which depopulation, disposal, and cleaning and disinfection methods are most appropriate for the situation. Based on the environmental assessment, APHIS has decided to implement this approach, and has concluded that the approach will not have a significant impact on the quality of the human environment.

    We are making both this environmental assessment and finding of no significant impact available to the public for review and comment. We will consider all comments that we receive on or before the date listed under the heading DATES at the beginning of this notice. If comments suggest issues that were not previously considered, APHIS may issue a supplement to the environmental assessment and finding of no significant impact.

    The environmental assessment and finding of no significant impact may be viewed on the Regulations.gov Web site or in our reading room (see ADDRESSES above for a link to Regulations.gov and information on the location and hours of the reading room). You may request paper copies of the environmental assessment or finding of no significant impact by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT. Please refer to the title of the documents when requesting copies.

    The environmental assessment and finding of no significant impact have been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

    Done in Washington, DC, this 31st day of August 2015. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2015-21994 Filed 9-3-15; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2015-0054] Availability of an Environmental Assessment for Field Testing a Swine Influenza Vaccine, H1N1 & H3N2, Modified Live Virus AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Notice of availability.

    SUMMARY:

    We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment concerning authorization to ship for the purpose of field testing, and then to field test, an unlicensed Swine Influenza Vaccine, H1N1 & H3N2, Modified Live Virus. The environmental assessment, which is based on a risk analysis prepared to assess the risks associated with the field testing of this vaccine, examines the potential effects that field testing this veterinary vaccine could have on the quality of the human environment. Based on the risk analysis and other relevant data, we have reached a preliminary determination that field testing this veterinary vaccine will not have a significant impact on the quality of the human environment, and that an environmental impact statement need not be prepared. We intend to authorize shipment of this vaccine for field testing following the close of the comment period for this notice unless new substantial issues bearing on the effects of this action are brought to our attention. We also intend to issue a U.S. Veterinary Biological Product license for this vaccine, provided the field test data support the conclusions of the environmental assessment and the issuance of a finding of no significant impact and the product meets all other requirements for licensing.

    DATES:

    We will consider all comments that we receive on or before October 5, 2015.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0054.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2015-0054, 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-2015-0054 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:

    Dr. Donna Malloy, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-1231; phone (301) 851-3426, fax (301) 734-4314.

    For information regarding the environmental assessment or the risk analysis, or to request a copy of the environmental assessment (as well as the risk analysis with confidential business information removed), contact Dr. Patricia L. Foley, Risk Manager, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010; phone (515) 337-6100, fax (515) 337-6120.

    SUPPLEMENTARY INFORMATION:

    Under the Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.), a veterinary biological product must be shown to be pure, safe, potent, and efficacious before a veterinary biological product license may be issued. A field test is generally necessary to satisfy prelicensing requirements for veterinary biological products. Prior to conducting a field test on an unlicensed product, an applicant must obtain approval from the Animal and Plant Health Inspection Service (APHIS), as well as obtain APHIS' authorization to ship the product for field testing.

    To determine whether to authorize shipment and grant approval for the field testing of the unlicensed product referenced in this notice, APHIS considers the potential effects of this product on the safety of animals, public health, and the environment. Using the risk analysis and other relevant data, APHIS has prepared an environmental assessment (EA) concerning the field testing of the following unlicensed veterinary biological product:

    Requester: Boehringer Ingelheim Vetmedica, Inc.

    Product: Swine Influenza Vaccine, H1N1 & H3N2, Modified Live Virus.

    Possible Field Test Locations: Iowa, Missouri, North Carolina, and Utah.

    The above-mentioned product consists of two live attenuated swine influenza vaccine viruses, subtypes H1N1 and H3N2, each containing a truncated NS1 gene. The attenuated vaccine is intended for vaccination of healthy, susceptible pigs one day of age or older, as an aid in the prevention of clinical disease associated with swine influenza infection.

    The EA has been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.); (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508); (3) USDA regulations implementing NEPA (7 CFR part 1b); and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

    Unless substantial issues with adverse environmental impacts are raised in response to this notice, APHIS intends to issue a finding of no significant impact (FONSI) based on the EA and authorize shipment of the above product for the initiation of field tests following the close of the comment period for this notice.

    Because the issues raised by field testing and by issuance of a license are identical, APHIS has concluded that the EA that is generated for field testing would also be applicable to the proposed licensing action. Provided that the field test data support the conclusions of the original EA and the issuance of a FONSI, APHIS does not intend to issue a separate EA and FONSI to support the issuance of the product license, and would determine that an environmental impact statement need not be prepared. APHIS intends to issue a veterinary biological product license for this vaccine following completion of the field test provided no adverse impacts on the human environment are identified and provided the product meets all other requirements for licensing.

    Authority:

    21 U.S.C. 151-159.

    Done in Washington, DC, this 31st day of August 2015. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2015-21995 Filed 9-3-15; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Forest Service Ravalli Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Ravalli Resource Advisory Committee (RAC) will meet in Hamilton, Montana. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with title II of the Act. Additional RAC information, including the meeting agenda and the meeting summary/minutes can be found at the following Web site: http://www.fs.usda.gov/main/bitterroot/workingtogether/advisorycommittees.

    DATES:

    The meeting will be held September 22, 2015, at 6:30 p.m.

    All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Bitteroot National Forest (NF) Supervisor's Office, 1801 North 1st Street, Hamilton, Montana.

    Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at the Bitteroot NF Supervisor's Office. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Ryan Domsalla, Designated Federal Officer, by phone at 406-821-3269 or via email at [email protected]; or Joni Lubke, RAC Coordinator, by phone at 406-363-7182 or via email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is:

    1. Project presentations; and

    2. To review monitoring reports.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by September 18, 2015, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Joni Lubke, RAC Coordinator, 1801 N. 1st Street, Hamilton, Montana 59840; by email to [email protected], or via facsimile to 406-363-7159.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: August 24, 2015. Julie K. King, Forest Supervisor.
    [FR Doc. 2015-21999 Filed 9-3-15; 8:45 am] BILLING CODE 3411-15-P
    THE BROADCASTING BOARD OF GOVERNORS Privacy Act of 1974; Amendments to Existing System of Records AGENCY:

    The Broadcasting Board of Governors.

    ACTION:

    Notice of Amendments to an Existing System of Records.

    SUMMARY:

    In accordance with the Privacy Act of 1974 (5 U.S.C. 552a), as amended, the Broadcasting Board of Governors (BBG) proposes to amend the system of records currently listed under “BBG-13 M/PT—Office of Personnel (Training and Development Division).” The amended system of records notice includes updates to reflect organizational changes within the BBG, includes records on contractor training registration, and includes other administrative changes.

    DATES:

    This action will be effective without further notice on October 14, 2015, unless comments are received that would result in a contrary determination.

    ADDRESSES:

    Send written comments to the Broadcasting Board of Governors, ATTN: Paul Kollmer, Chief Privacy Officer, 330 Independence Avenue, Room 3349, Washington, DC 20237.

    FOR FURTHER INFORMATION CONTACT:

    David Milligan, Director of the Office of Workforce Support and Development, (202) 203-4500

    Dated: September 1, 2015. André Mendes, Interim CEO and Director, BBG. BBG 13—Office of Workforce Support and Development System name:

    OWSDS—Office of Workforce Support and Development System

    Security classification:

    None.

    System location:

    Office of Workforce Support and Development, Broadcasting Board of Governors, International Broadcasting Bureau, 330 C St. SW., Washington, DC 20237.

    Categories of individuals covered by the system:

    BBG employees and contractor personnel receiving Agency-provided training.

    Categories of records in the system:

    Employee and contractor personnel training registration data, applications, biographic data, educational backgrounds, training records, training program outlines, evaluations of training courses.

    Authority for maintenance of the system:

    The United States Information and Educational Exchange Act of 1948, as amended (22 U.S.C. 1431, et seq.); the U.S. International Broadcasting Act of 1994, as amended (22 U.S.C. 6201, et seq.); and the Foreign Affairs Consolidation Act of 1998 (Pub. L. 105-277).

    Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

    Background material used to determine eligibility for training; justification for training reports and record-keeping; evaluation and selection of lecturers and contractors to provide training; preparation of reports to Congress and other Government agencies on training provided and training costs, as well as projected training needs and costs.

    Information is made available on a need-to-know basis to personnel of the BBG as may be required in the performance of their official duties. The principal users of this information outside the BBG are personnel officers in other Government agencies as a result of transfer, detail, or reassignment of the individual to whom the record pertains, other agencies considering employees for detail or transfer, and investigators performing their job functions.

    The information may also be released to other Government agencies that have statutory or other lawful authority to maintain such information. Also see Statement of General Routine Uses.

    Policies and practices for storing retrieving, accessing, retaining, and disposing of records in the system:

    Storage: Paper records stored in file folders and file cabinets. Computer records stored on computer drives.

    Retrievability: Manually retrieved by name, by computer generated lists of training statistics, or by training course title or description.

    Safeguards: Access to files is limited only to authorized BBG employees having an official use or need for the information. All files are maintained in locked file cabinets during non-duty hours and are protected by office personnel when being used during duty hours. All files are contained within a secure building with access only to individuals with appropriate identification. All users of personal information in connection with the performance of their jobs protect information from public view and from unauthorized personnel entering an unsupervised office or workspace.

    Retention and disposal: Training records maintained until employee is separated, until records are no longer needed, or otherwise as directed by the General Records Schedule. Budget records and cost statistics are kept for three to five years or otherwise as directed by the General Records Schedule.

    System manager(s) and address:

    Director, Office of Workforce Support and Development, Broadcasting Board of Governors, International Broadcasting Bureau, 330 C St. SW. Washington, DC 20237.

    Notification procedures:

    Individuals who want to know whether this system of records contains information about them, or who want access to their records, or who want to contest the contents of a record, should make a written request to: FOIA/Privacy Act Officer, BBG, Suite 3349, 330 Independence Ave. SW. Washington, DC 20237. Individuals' requests should contain the name and address of the system manager (listed above) and the following information to enable their records to be located and identified:

    A. Full legal name;

    B. Date of Birth;

    C. Social Security Number;

    D. Last employing organization (include duty station location) and the approximate dates of employment or contact; and

    E. Signature.

    Record access procedures:

    Individuals wishing to request access to their records should follow the Notification Procedures (listed above). Individuals requesting access will also be required to provide adequate identification, such as driver's license, employee identification card, and/or other identifying document. Additional identification procedures may be required in some instances. A notarized signature is required if the request is made by written correspondence. To request a file other than your own, you must have a notarized, signed statement giving you express permission to access the file from the individual to whom the file pertains.

    Contesting record procedures:

    The BBG's rules for access and for contesting record contents and appealing determinations appear in 22 CFR part 505. The right to contest records is limited to information that is incomplete, irrelevant, erroneous or untimely.

    Record source categories:

    The employee; training applications and records; training officers and other individuals involved in personnel management; supervisors; contracting officer representatives; trainee evaluations.

    Exemptions claimed for the system:

    Certain records contained within this system of records may be exempted by 5 U.S.C. 552a(k)(2); (k)(4); (k)(5); and (k)(6).

    [FR Doc. 2015-22086 Filed 9-3-15; 8:45 am] BILLING CODE 8610-01-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Illinois Advisory Committee To Introduce Recently Appointed Committee Members and Discuss Civil Rights Concerns 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 that the Illinois Advisory Committee (Committee) will hold a meeting on Wednesday, September 30, 2015, at 12:00 p.m. CDT for the purpose of introducing Committee members appointed August 14, 2015, and beginning a discussion regarding civil rights concerns in the State for the Committee's consideration.

    Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-510-1765, conference ID: 9957072. Any interested member of the public may call this number and listen to the meeting. 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.

    Member of the public are also invited and welcomed to make statements at the end of the conference call. In addition, members of the public may submit written comments; the comments must be received in the regional office by October 30, 2015. Written comments may be mailed to the Regional Programs Unit, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Administrative Assistant, Carolyn Allen at [email protected] Persons who desire additional information may contact the Regional Programs Unit at (312) 353-8311.

    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=246 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, 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 Regional Programs Unit at the above email or street address.

    Agenda
    Welcome and Introductions Committee Roles and Responsibilities Ethics Jurisdiction and Scope of Duties Project Process and Examples Discussion Current Civil Rights Issues in Illinois Future Plans and Actions Open Comment Adjournment DATES:

    The meeting will be held on Wednesday, September 30, 2015, at 12:00 p.m. CDT.

    Public Call Information:

    Dial: 888-510-1765 Conference ID: 9957072 FOR FURTHER INFORMATION CONTACT:

    Melissa Wojnaroski, DFO, at 312-353-8311 or [email protected]

    Dated: September 1, 2015. David Mussatt, Chief, Regional Programs Unit.
    [FR Doc. 2015-21966 Filed 9-3-15; 8:45 am] BILLING CODE 6335-01-P
    DEPARTMENT OF COMMERCE Economic Development Administration Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance AGENCY:

    Economic Development Administration, Department of Commerce.

    ACTION:

    Notice and opportunity for public comment.

    Pursuant to section 251 of the Trade Act 1974, as amended (19 U.S.C. 2341 et seq.), the Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of these firms contributed importantly to the total or partial separation of the firm's workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.

    List of Petitions Received by EDA for Certification Eligibility To Apply for Trade Adjustment Assistance [8/26/2015 through 8/31/2015] Firm name Firm address Date
  • accepted for
  • investigation
  • Product(s)
    NU-CO Tool, Inc 7310 North Liberty, Edinburg, TX 78541 8/26/2015 The firm manufactures precision machined tools. Bamar Plastics, Inc 1702 South Robinson Street, South Bend, IN 46613 8/26/2015 The firm manufactures precision injection molded thermoplastic parts for the automotive industry.

    Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance for Firms Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice.

    Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.

    Dated: August 31, 2015. Michael S. DeVillo, Eligibility Examiner.
    [FR Doc. 2015-21977 Filed 9-3-15; 8:45 am] BILLING CODE 3510-WH-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security [15-BIS-001] Order Relating to Air Bashkortostan, LTD.

    In the Matter of:

    Air Bashkortostan, LTD. with a last known address of: 142001, Moscow Region, City of Domodedovo, Centralny District, Promyshlennaya Street, 11B, Russian Federation, Respondent.

    The Bureau of Industry and Security, U.S. Department of Commerce (“BIS”), has notified Air Bashkortostan, LTD., of Bashkortostan, Russia (“Air Bashkortostan”), that it has initiated an administrative proceeding against Air Bashkortostan pursuant to Section 766.3 of the Export Administration Regulations (the “Regulations”),1 and Section 13(c) of the Export Administration Act of 1979, as amended (the “Act”),2 through the issuance of a Charging Letter to Air Bashkortostan that alleges that Air Bashkortostan committed four violations of the Regulations. Specifically, the charges are:

    1 The Regulations are currently codified in the Code of Federal Regulations at 15 CFR parts 730-774 (2015). The charged violations occurred in 2009. The Regulations governing the violations at issue are found in the 2009 version of the Code of Federal Regulations (15 CFR parts 730-774 (2009)). The 2015 Regulations set forth the procedures that apply to this matter.

    2 50 U.S.C. app. §§ 2401-2420 (2000). Since August 21, 2001, the Act has been in lapse and the President, through Executive Order 13,222 of August 17, 2001 (3 CFR, 2001 Comp. 783 (2002)), which has been extended by successive Presidential Notices, the most recent being that of August 7, 2015 (80 FR 48,233 (Aug. 11, 2015)), has continued the Regulations in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701, et seq. (2006 & Supp. IV 2010).

    Charges 1-4: 15 CFR 764.2(a)—Engaging in Prohibited Conduct

    On four occasions between on or about January 7, 2009, and on or about March 19, 2009, Air Bashkortostan engaged in conduct prohibited by the Regulations when on each occasion it reexported a Boeing 757 aircraft from Russia to Iran without the required U.S. Government authorization. These four U.S.-origin aircraft were subject to the Regulations, classified under Export Control Classification Number (“ECCN”) 9A991.b, and controlled for anti-terrorism reasons pursuant to Sections 742.8 and 746.7 of the Regulations. The transactions were valued at a total of $4.5 million.

    The aircraft were reexported pursuant to lease agreements between Air Bashkortostan and Eram Air, an airline based in Iran, and were operated on flights into and out of Iran, a Country Group E:1 destination under the Regulations.3 During the period of the leases, the maintenance of the aircraft was performed in Iran.

    3See Supplement No. 1 to 15 CFR part 740 (2009).

    At all times pertinent hereto, Sections 742.8 and 746.7 of the Regulations imposed a BIS license requirement for the reexport of these aircraft from any foreign country, including Russia, to Iran. In order to avoid duplication, reexporters were not required under the Regulations to seek authorization from both BIS and the Treasury Department's Office of Foreign Assets Control (“OFAC”) for exports and reexports subject to both the Regulations and the Iranian Transactions Regulations (“ITR”) administered by OFAC.4 Accordingly, an authorization granted by OFAC would have been considered authorization for purposes of the EAR as well. However, Air Bashkortostan did not seek or obtain authorization from BIS, or from OFAC, in connection with any of the transactions at issue.

    4 31 CFR part 560 (2009). By Federal Register notice dated October 22, 2012, the Department of the Treasury's Office of Foreign Assets Control renamed the ITR as the Iranian Transactions and Sanctions Regulations and reissued the set of regulations in its entirety. 77 FR 64,664 (Oct. 22, 2012).

    In engaging in the activity alleged above, Air Bashkortostan committed four violations of Section 764.2(a) of the Regulations.

    Whereas, BIS and Air Bashkortostan have entered into a Settlement Agreement pursuant to Section 766.18(b) of the Regulations, whereby they agreed to settle this matter in accordance with the terms and conditions set forth therein; and

    Whereas, I have approved of the terms of such Settlement Agreement;

    It is therefore ordered:

    First, Air Bashkortostan shall be assessed a civil penalty in the amount of $350,000, all of which shall be suspended for a period of one year from the date of this Order, and thereafter shall be waived, provided that during this one-year probationary period, Air Bashkortostan has committed no violation of the Act, or any regulation, order, license, or authorization issued thereunder. If Air Bashkortostan commits a violation of the Act or any regulation, order, license, or authorization issued thereunder, during the probationary period under this Order, the suspension of the civil penalty may be modified or revoked by BIS and the $350,000 made due and owing immediately.

    Second, that for a period of one (1) year from the date of this Order, Air Bashkortostan LTD., with a last known address of 142001, Moscow Region, City of Domodedovo, Centralny District, Promyshlennaya Street, 11B, Russian Federation, and when acting for or on its behalf, its successors, assigns, directors, officers, employees, representatives, or agents, (hereinafter collectively referred to as “Denied Person”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations, including, but not limited to:

    A. Applying for, obtaining, or using any license, License Exception, or export control document;

    B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations; or

    C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations.

    Third, that no person may, directly or indirectly, do any of the following:

    A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;

    B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;

    C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;

    D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or

    E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.

    Fourth, that, after notice and opportunity for comment as provided in Section 766.23 of the Regulations, any person, firm, corporation, or business organization related to the Denied Person by affiliation, ownership, control, or position of responsibility in the conduct of trade or related services may also be made subject to the provisions of the Order.

    Fifth, Air Bashkortostan shall not take any action or make or permit to be made any public statement, directly or indirectly, denying the allegations in the Charging Letter or the Order. The foregoing does not affect Air Bashkortostan's testimonial obligations in any proceeding, nor does it affect its right to take legal or factual positions in civil litigation or other civil proceedings in which the U.S. Department of Commerce is not a party.

    Sixth, that the Charging Letter, the Settlement Agreement, and this Order shall be made available to the public.

    Seventh, that this Order shall be served on Air Bashkortostan, and shall be published in the Federal Register.

    This Order, which constitutes the final agency action in this matter, is effective immediately.5

    5 Review and consideration of this matter have been delegated to the Deputy Assistant Secretary of Commerce for Export Enforcement.

    Issued this 28th day of August, 2015. Richard R. Majauskas, Deputy Assistant Secretary of Commerce for Export Enforcement.
    [FR Doc. 2015-21978 Filed 9-3-15; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-909] Certain Steel Nails From the People's Republic of China: Preliminary Results of the Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2013-2014 AGENCY:

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

    SUMMARY:

    The Department of Commerce (“Department”) is conducting the sixth administrative review of the antidumping duty order on certain steel nails (“nails”) from the People's Republic of China (“PRC”).1 The Department selected two respondents for individual review.2 The Department preliminarily determines that Stanley sold subject merchandise in the United States at prices below normal value (“NV”) during the period of review (“POR”), August 1, 2013, through July 31, 2014. The Department also preliminarily determines that Shandong Oriental Cherry failed to cooperate to the best of its ability in participating in the review, warranting the application of facts otherwise available with adverse inferences, and that it is part of the PRC-wide entity. If these preliminary results are adopted in the final results, the Department will instruct U.S. Customs and Border Protection (“CBP”) to assess antidumping duties on all appropriate entries of subject merchandise during the POR. Interested parties are invited to comment on these preliminary results.

    1See Notice of Antidumping Duty Order: Certain Steel Nails from the People's Republic of China, 73 FR 44961 (August 1, 2008) (“Order”).

    2 Stanley Works (Langfang) Fastening Systems Co., Ltd. and Stanley Black & Decker, Inc. (collectively “Stanley”), and Shandong Oriental Cherry Hardware Group., Ltd. (“Shandong Oriental Cherry”).

    DATES:

    Effective Date: September 4, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Matthew Renkey or Julia Hancock, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: 202-482-2312 or 202-482-1394, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On September 30, 2014, the Department initiated the sixth administrative review of the antidumping duty order on nails from the PRC for the period August 1, 2013, through July 31, 2014.3 On April 14, 2015, the Department partially extended the deadline for issuing the preliminary results by 100 days.4 On July 10, 2015, the Department fully extended the deadline for issuing the preliminary results by 20 days,5 to August 31, 2015.

    3See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 79 FR 58729 (September 30, 2014) (“Initiation Notice”).

    4See Memorandum to Gary Taverman, Senior Advisor for Antidumping and Countervailing Duty Operations, through James C. Doyle, Director, Office V, Antidumping and Countervailing Duty Operations regarding “Certain Steel Nails from the People's Republic of China: Extension of Deadline for Preliminary Results of 2013-2014 Antidumping Duty Administrative Review,” dated April 14, 2015.

    5See Memorandum to Gary Taverman, Senior Advisor for Antidumping and Countervailing Duty Operations, through James C. Doyle, Director, Office V, Antidumping and Countervailing Duty Operations regarding “Certain Steel Nails from the People's Republic of China: Extension of Deadline for Preliminary Results of 2013-2014 Antidumping Duty Administrative Review,” dated July 10, 2015. We note that second extension of the preliminary results listed the extended deadline as September 1, 2015; however, the correct extended deadline is August 31, 2015.

    Scope of the Order

    The merchandise covered by the order includes certain steel nails having a shaft length up to 12 inches. Certain steel nails subject to the order are currently classified under the Harmonized Tariff Schedule of the United States (“HTSUS”) subheadings 7317.00.55, 7317.00.65, 7317.00.75, and 7907.00.6000.6 While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the order is dispositive.7

    6 The Department recently added the Harmonized Tariff Schedule category 7907.00.6000, “Other articles of zinc: Other,” to the language of the Order. See Memorandum to Gary Taverman, Senior Advisor for Antidumping and Countervailing Duty Operations, through James C. Doyle, Director, Office 9, Antidumping and Countervailing Duty Operations, regarding “Certain Steel Nails from the People's Republic of China: Cobra Anchors Co. Ltd. Final Scope Ruling,” dated September 19, 2013.

    7See “Certain Steel Nails from the People's Republic of China: Decision Memorandum for the Preliminary Results of the 2013-2014 Antidumping Duty Administrative Review,” (“Preliminary Decision Memorandum”), dated concurrently with these results and hereby adopted by this notice, for a complete description of the Scope of the Order.

    Preliminary Determination of No Shipments

    Based on the no-shipments letters filed by 11 different companies subject to this review, the Department preliminarily determines that these companies did not have any reviewable transactions during the POR. For additional information regarding this determination, including a list of these companies, see the Preliminary Decision Memorandum. Consistent with our assessment practice in non-market economy (“NME”) cases, the Department is not rescinding this review for these companies, but intends to complete the review and issue appropriate instructions to CBP based on the final results of the review.8

    8See Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694, 65694-95 (October 24, 2011) and the “Assessment Rates” section, below.

    Preliminary Affiliation and Single Entity Determination

    Based on the record evidence for these preliminary results, we find that Shandong Oriental Cherry Hardware Group., Ltd., Shandong Oriental Cherry Hardware Import & Export Co., Ltd., Shandong Oriental Cherry Hardware Group Heze Products Co., Ltd., Jining Huarong Hardware Products Co., Ltd., Jining Dragon Fasteners Co., Ltd., and Jining Yonggu Metal Products Co., Ltd. are affiliated, pursuant to sections 771(33)(A), (E), (F), and (G) of the Tariff Act of 1930, as amended (“the Act”). Additionally, under 19 CFR 351.401(f)(1)-(2) and as facts available, we preliminarily find that these companies should be considered a single entity, (collectively known as the “Shandong Oriental Cherry Entity”), for purposes of these preliminary results.9

    9 For further information, please see the Preliminary Decision Memorandum.

    Application of Facts Available and Use of Adverse Inference

    As discussed below and in further detail in the Preliminary Decision Memorandum, pursuant to sections 776(a)(2)(A), (B), and (C) of the Act, the Department determines that the use of facts otherwise available is warranted with respect to Shandong Oriental Cherry. Specifically, Shandong Oriental Cherry failed to provide in the form and manner requested by the Department: (1) An accurate, reliable sales reconciliation regarding its reported sales of subject merchandise to the United States during the POR; (2) an accurate, reliable factors of production (“FOP”) database that is reported on a CONNUM-specific basis; and (3) sales data, FOP data, and full product specifications from Shandong Oriental Cherry's affiliate, Jining Dragon Fasteners Co., Ltd., for the shooting nails it sold to the United States during the POR. Additionally, Shandong Oriental Cherry along with its affiliate, Jining Dragon Fasteners Co., Ltd., significantly impeded the proceeding by not providing accurate or complete responses to the Department's questions about its U.S. sales data and FOP data regarding its sales of subject merchandise to the United States during the POR.

    The Department finds that, taken together, and as explained in more detail in the Preliminary Decision Memorandum, these deficiencies indicate that the Department cannot rely on Shandong Oriental Cherry's submitted information. In selecting from among the facts otherwise available, pursuant to section 776(b) of the Act, an adverse inference is warranted when the Department has determined that a respondent has failed to cooperate by not acting to the best of its ability to comply with a request for information. Within the meaning of section 776(b) of the Act, the Department preliminarily finds that Shandong Oriental Cherry failed to cooperate by not acting to the best of its ability to comply with the Department's requests for information and that the application of AFA is warranted. As AFA, and as explained in the Preliminary Decision Memorandum, we have found that the Shandong Oriental Cherry Entity has failed to establish its independence from the PRC-wide entity and, as a result, is subject to the PRC-wide entity's rate.

    Separate Rates

    The Department preliminarily determines that information placed on the record by the mandatory respondent Stanley, as well as by the 20 other separate rate applicants, demonstrates that these companies are entitled to separate rate status. For additional information, see the Preliminary Decision Memorandum.

    PRC-Wide Entity

    The Department's change in policy regarding conditional review of the PRC-wide entity applies to this administrative review.10 Under this policy, the PRC-wide entity will not be under review unless a party specifically requests, or the Department self-initiates, a review of the entity. Because no party requested a review of the PRC-wide entity in this review, the entity is not under review and the entity's rate is not subject to change (i.e., 118.04 percent).11 Aside from the no shipments and separate rate companies discussed above, the Department considers all other companies for which a review was requested,12 as well as the Shandong Oriental Cherry Entity, to be part of the PRC-wide entity. For additional information, see the Preliminary Decision Memorandum; see also Appendix 2 for a list of companies considered as part of the PRC-wide entity.

    10See Antidumping Proceedings: Announcement of Change in Department Practice for Respondent Selection in Antidumping Duty Proceedings and Conditional Review of the Nonmarket Economy Entity in NME Antidumping Duty Proceedings, 78 FR 65963 (November 4, 2013).

    11See, e.g., id.; Certain Steel Nails from the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2012-2013, 80 FR 18816, 18817 and accompanying Issues and Decision Memorandum (“AR5 Final Results”).

    12See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 79 FR 51548, 51549 (August 29, 2014) (“All firms listed below that wish to qualify for separate rate status in the administrative reviews involving NME countries must complete, as appropriate, either a separate rate application or certification * * *”).

    Rate for Separate-Rate Companies Not Individually Examined

    The statute and the Department's regulations do not address the establishment of a rate to be applied to respondents not selected for individual examination when the Department limits its examination of companies subject to the administrative review pursuant to section 777A(c)(2)(B) of the Act. Generally, the Department looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when calculating the rate for respondents not individually examined in an administrative review. Section 735(c)(5)(A) of the Act articulates a preference for not calculating an all-others rate using rates which are zero, de minimis or based entirely on facts available. Accordingly, the Department's usual practice has been to determine the dumping margin for companies not individually examined by averaging the weighted-average dumping margins for the individually examined respondents, excluding rates that are zero, de minimis, or based entirely on facts available.13 Consistent with this practice, in this review, we calculated a weighted-average dumping margin for Stanley that is above de minimis and not based entirely on FA; therefore, the Department assigned to the companies not individually examined, but which demonstrated their eligibility for a separate rate, the weighted-average dumping margin calculated for Stanley.

    13See Ball Bearings and Parts Thereof From France, Germany, Italy, Japan, and the United Kingdom: Final Results of Antidumping Duty Administrative Reviews and Rescission of Reviews in Part, 73 FR 52823, 52824 (September 11, 2008), and accompanying Issues and Decision Memorandum at Comment 16.

    Methodology

    The Department conducted this review in accordance with sections 751(a)(1)(B) and 751(a)(2)(A) of the Act. Constructed export prices and export prices have been calculated in accordance with section 772 of the Act. Because the PRC is a non-market economy country within the meaning of section 771(18) of the Act, NV has been calculated in accordance with section 773(c) of the Act.

    For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    Preliminary Results of Review

    The Department preliminarily determines that the following weighted-average dumping margins exist for the period August 1, 2013, through July 31, 2014:

    Exporter Weighted-
  • average
  • margin
  • (percent)
  • Stanley 12.51 Chiieh Yung Metal Ind. Corp 12.51 Dezhou Hualude Hardware Products Co., Ltd 12.51 Hebei Cangzhou New Century Foreign Trade Co., Ltd 12.51 Nanjing Caiqing Hardware Co., Ltd 12.51 Qingdao D&L Group Ltd 12.51 SDC International Aust. PTY. Ltd 12.51 Shandong Dinglong Import & Export Co., Ltd 12.51 Shanghai Curvet Hardware Products Co., Ltd 12.51 Shanghai Yueda Nails Industry Co., Ltd 12.51 Shanxi Hairui Trade Co., Ltd 12.51 Shanxi Pioneer Hardware Industrial Co., Ltd 12.51 Shanxi Tianli Industries Co., Ltd 12.51 S-Mart (Tianjin) Technology Development Co., Ltd 12.51 Suntec Industries Co., Ltd 12.51 Tianjin Jinchi Metal Products Co., Ltd 12.51 Tianjin Jinghai County Hongli Industry & Business Co., Ltd 12.51 Tianjin Lianda Group Co., Ltd 12.51 Tianjin Universal Machinery Imp. & Exp. Corporation 12.51 Tianjin Zhonglian Metals Ware Co., Ltd 12.51 Xi'an Metals & Minerals Import & Export Co., Ltd 12.51
    Disclosure, Public Comment and Opportunity To Request a Hearing

    The Department intends to disclose the calculations used in our analysis to parties in this review within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

    Interested parties may submit case briefs within 30 days after the date of publication of these preliminary results of review in the Federal Register.14 Rebuttals to case briefs, which must be limited to issues raised in the case briefs, must be filed within five days after the time limit for filing case briefs.15 Parties who submit arguments are requested to submit with the argument (a) a statement of the issue, (b) a brief summary of the argument, and (c) a table of authorities.16 Parties submitting briefs should do so pursuant to the Department's electronic filing system, ACCESS.17

    14See 19 CFR 351.309(c)(1)(ii).

    15See 19 CFR 351.309(d)(1) and (2).

    16See 19 CFR 351.309(c)(2), (d)(2).

    17See 19 CFR 351.303 (for general filing requirements).

    Any interested party may request a hearing within 30 days of publication of this notice.18 Hearing requests should contain the following information: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Oral presentations will be limited to issues raised in the briefs. If a request for a hearing is made, parties will be notified of the time and date for the hearing to be held at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.19

    18See 19 CFR 351.310(c).

    19See 19 CFR 351.310(d).

    The Department intends to issue the final results of this administrative review, which will include the results of our analysis of all issues raised in the case briefs, within 120 days of publication of these preliminary results in the Federal Register, pursuant to section 751(a)(3)(A) of the Act.

    Assessment Rates

    Upon issuance of the final results, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.20 The Department intends to issue assessment instructions to CBP 15 days after the publication date of the final results of this review.

    20See 19 CFR 351.212(b).

    For assessment purposes, the Department applied the assessment rate calculation method adopted in Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification. 21 For any individually examined respondent whose weighted average dumping margin is above de minimis (i.e., 0.50 percent) in the final results of this review, the Department will calculate importer-specific assessment rates on the basis of the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of sales, in accordance with 19 CFR 351.212(b)(1). Where an importer- (or customer-) specific ad valorem rate is greater than de minimis, the Department will instruct CBP to collect the appropriate duties at the time of liquidation.22 Where either a respondent's weighted average dumping margin is zero or de minimis, or an importer- (or customer-) specific ad valorem rate is zero or de minimis, the Department will instruct CBP to liquidate appropriate entries without regard to antidumping duties.23 For the respondents that were not selected for individual examination in this administrative review and that qualified for a separate rate, the assessment rate will be based on the average of the mandatory respondents.24 We intend to instruct CBP to liquidate entries containing subject merchandise exported by the PRC-wide entity at the PRC-wide rate.

    21See Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification, 77 FR 8101 (February 14, 2012) in the manner described in more detail in the Preliminary Decision Memorandum.

    22See 19 CFR 351.212(b)(1).

    23See 19 CFR 351.106(c)(2).

    24See Preliminary Decision Memorandum.

    Pursuant to the Department's practice, for entries that were not reported in the U.S. sales databases submitted by companies individually examined during the administrative review, the Department will instruct CBP to liquidate such entries at the PRC-wide rate. Additionally, if the Department determines that an exporter had no shipments of the subject merchandise, any suspended entries that entered under that exporter's case number (i.e., at that exporter's rate) will be liquidated at the PRC-wide rate.25

    25 For a full discussion of this practice, see Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 24, 2011).

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this review for shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by sections 751(a)(2)(C) of the Act: (1) For the companies listed above that have a separate rate, the cash deposit rate will be that established in the final results of this review (except, if the rate is zero or de minimis, then zero cash deposit will be required); (2) for previously investigated or reviewed PRC and non-PRC exporters not listed above that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate; (3) for all PRC exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be that for the PRC-wide entity; and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporter that supplied that non-PRC exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Importers

    This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during the POR. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    This preliminary determination is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).

    Dated: August 28, 2015. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix 1—List of Topics Discussed in the Preliminary Decision Memorandum 1. Summary 2. Background 3. Scope of the Order 4. Preliminary Determination of No Shipments 5. Non-Market Economy Country Status 6. PRC-Wide Entity 7. Separate Rates 8. Affiliation 9. Application of Facts Available and Use of Adverse Inference 10. Surrogate Country 11. Date of Sale 12. Comparisons to Normal Value 13. Determination of Comparison Method 14. Results of Differential Pricing Analysis 15. U.S. Price 16. Normal Value 17. Factor Valuations 18. Currency Conversion Appendix 2—Companies Subject to This Administrative Review That Are Considered To Be Part of the PRC-Wide Entity ABF Freight System, Inc. Agritech Products Ltd. Aihua Holding Group Co., Ltd. Aironware (Shanghai) Co. Ltd. Anping County Anning Wire Mesh Co. Anping Fuhua Wire Mesh Making Co. APM Global Logistics O/B Hasbro Toy Beijing Daruixing Global Trading Co., Ltd. Beijing Daruixing Nail Products Co., Ltd. Beijing Hong Sheng Metal Products Co., Ltd. Beijing Hongsheng Metal Products Co., Ltd. Beijing Jinheuang Co., Ltd. Beijing Kang Jie Kong Cargo Agent Beijing KJK Intl Cargo Agent Co., Ltd. Beijing Long Time Rich Tech Develop Beijing Tri-Metal Co., Ltd. Beijing Yonghongsheng Metal Products Co., Ltd. Brighten International, Inc. Cana (Tianjin) Hardware Ind., Co., Ltd. Cana (Tianjin) Hardware Industrial Co., Ltd. Century Shenzhen Xiamen Branch Changzhou MC I/E Co., Ltd. Changzhou Quyuan Machinery Co., Ltd. Changzhou Refine Flag & Crafts Co., Ltd. Chao Jinqiao Welding Material Co., Ltd. Chaohu Bridge Nail Industry Co., Ltd. Chaohu Jinqiao Welding Material Co. Chewink Corp. Chiieh Yung Metal Industrial Corp. Chiieh Yung Metal Industrial Corporation China Container Line (Shanghai) Ltd. China Silk Trading & Logistics Co., Ltd. China Staple Enterprise (Tianjin) Co., Ltd. Chongqing Hybest Nailery Co., Ltd. Chongqing Hybest Tools Group Co., Ltd. Cintee Steel Products Co., Ltd. Cyber Express Corporation CYM (Nanjing) Nail Manufacture Co., Ltd. CYM (Nanjing) Ningquan Nail Manufacture Co., Ltd. Dagang Zhitong Metal Products Co., Ltd. Damco Shenzhen Daxing Niantan Industrial Delix International Co., Ltd. Dingzhou Derunda Material and Trade Co., Ltd. Dingzhou Ruili Nail Production Co., Ltd. Dong'e Fugiang Metal Products Co., Ltd. Dongguan Five Stone Machinery Products Trading Co., Ltd. ECO System Co., Ltd. ECO System Corporation Elite International Logistics Co. Elite Master International Ltd. England Rich Group (China) Ltd. Entech Manufacturing (Shenzhen) Ltd. Expeditors China Tianjin Branch Faithful Engineering Products Co. Ltd. Fedex International Freight Forward Agency Services (Shanghai) Co., Ltd. Feiyin Co., Ltd. Fension International Trade Co., Ltd. Foreign Economic Relations & Trade Fujiansmartness Imp. & Exp. Co., Ltd. Fuzhou Builddirect Ltd. Goal Well Stone Co., Ltd. Gold Union Group Ltd. Goldever International Logistics Co. Goldmax United Ltd. Grace News Inc. Guangdong Foreign Trade Import & Export Corporation Guangzhou Qiwei Imports and Exports Co., Ltd. Guoxin Group Wang Shun I/E Co., Ltd. GWP Industries (Tianjin) Co., Ltd. Haierc Industry Co., Ltd. Haixing Hongda Hardware Production Co., Ltd. Haixing Linhai Hardware Products Factory Haiyan Fefine Import and Export Co. Handuk Industrial Co., Ltd. Hangzhou Kelong Electrical Appliance & Tools Co. Ltd. Hangzhou New Line Co., Ltd. Hangzhou Zhongding Imp. & Exp. Co., Ltd. Hebei Development Metals Co., Ltd. Hebei Jinsidun (JSD) Co., Ltd. Hebei Machinery Import and Export Co., Ltd. Hebei Minmetals Co., Ltd. Hebei My Foreign Trade Co., Ltd. Hebei Super Star Pneumatic Nails Co., Ltd. Henan Pengu Hardware Manufacturing Co., Ltd. Hengshui Mingyao Hardware & Mesh Products Co., Ltd. Heretops (Hong Kong) International Ltd. Heretops Import & Export Co., Ltd. Hilti (China) Limited HK Villatao Sourcing Co., Ltd. Hong Kong Hailiang Metal Trading Ltd. Hong Kong Yu Xi Co., Ltd. Huadu Jin Chuan Manufactory Co Ltd. Huanghua Honly Industry Corp. Huanghua Huarong Hardware Products Co., Ltd. Huanghua Jinhai Metal Products Co., Ltd. Huanghua Shenghua Hardware Manufactory Factory Huanghua Xinda Nail Production Co., Ltd. Huanghua Xiong Hua Hardware Product Co., Ltd. Huanghua Yufutai Hardware Products Co., Ltd. Hubei Boshilong Technology Co., Ltd. Huiyuan Int'l Commerce Exhibition Co., Ltd. Jiashan Superpower Tools Co., Ltd. Jiaxing Yaoliang Import & Export Co., Ltd. Jinhua Kaixin Imp & Exp Ltd. Jining Huarong Hardware Products Joto Enterprise Co., Ltd. Karuis Custom Metal Parts Mfg. Ltd. Kasy Logistics (Tianjin) Co., Ltd. K.E. Kingstone Koram Panagene Co., Ltd. Kuehne & Nagel Ltd. Kum Kang Trading Co., Ltd. Kyung Dong Corp. Le Group Industries Corp. Ltd. Leang Wey Int. Business Co., Ltd. Liang's Industrial Corp. Lijiang Liantai Trading Co., Ltd. Linhai Chicheng Arts & Crafts Co., Ltd. Lins Corp. Linyi Flying Arrow Imp & Exp. Co., Ltd. Maanshan Cintee Steel Products Co., Ltd. Maanshan Leader Metal Products Co. Ltd. Maanshan Longer Nail Product Co., Ltd. Manufacutersinchina (HK) Company Ltd. Marsh Trading Ltd. Master International Co., Ltd. Mingguang Abundant Hardware Products Co., Ltd. Nanjing Dayu Pneumatic Gun Nails Co., Ltd. Nanjing Yuechang Hardware Co. Ltd. Nantong Corporation for Internation Ningbo Bolun Electric Co., Ltd. Ningbo Dollar King Industrial Co., Ltd. Ningbo Endless Energy Electronic Co., Ltd. Ningbo Fension International Trade Center Ningbo Fortune Garden Tools and Equipment Inc. Ningbo Haixin Railroad Material Co. Ningbo Huamao Imp & Exp. Co., Ltd. Ningbo Hyderon Hardware Co., Ltd. Ningbo JF Tools Industrial Co., Ltd. Ningbo KCN Electric Co., Ltd. Ningbo Meizhi Tools Co., Ltd. Ningbo Ordam Import & Export Co., Ltd. OEC Logistics (Qingdao) Co. Ltd. Omega Products International OOCL Logistics O B of Winston Marketing Group Orisun Electronics HK Co., LTd. Pacole International Ltd. Panagene Inc. Pavilion Investmen Ltd. Perfect Seller Co., Ltd. Prominence Cargo Service, Inc. Qianshan Huafeng Trading Co., Ltd. Qidong Liang Chyuan Metal Industry Co., Ltd. Qingdao Bestworld Industry Trading Qingdao D&L Group, Ltd. Qingdao D&L Group Co., Ltd. Qingdao Denarius Manufacture Co. Limited Qingdao Golden Sunshine ELE-EAQ Co., Ltd. Qingdao International Fastening Systems Inc. Qingdao Koram Steel Co., Ltd. Qingdao Lutai Industrial Products Manufacturing Co., Ltd. Qingdao Meijia Metal Products Co. Qingdao Rohuida International Trading Co., Qingdao Sino-Sun International Trading Company Limited Qingdao Super United Metals & Wood Prods. Co. Ltd. Qingdao Tiger Hardware Co., Ltd. Qingfu Metal Craft Manufacturing Ltd. Qinghai Wutong (Group) Industry Co. Qingyuan County Hongyi Hardware Products Factory Qingyun Hongyi Hardware Factory Qinhuangdao Kaizheng Industry and Trade Co. Q-Yield Outdoor Great Ltd. Region International Co., Ltd. Richard Hung Ent. Co. Ltd. River Display Ltd. Rizhao Changxing Nail-Making Co., Ltd. Rizhao Handuk Fasteners Co., Ltd. Rizhao Qingdong Electronic Appliance Co., Romp (Tianjin) Hardware Co., Ltd. Saikelong Electric Appliances (Suzhou) Co., Se Jung (China) Shipping Co., Ltd. SDC International Australia Pty., Ltd. SDC International Australia (Pty) Ltd. Senco Products, Inc. Senco-Xingya Metal Products (Taicang) Co., Ltd. Shandex Co., Ltd. Shandex Industrial Inc. Shandong Liaocheng Minghua Metal Products Co. Ltd. Shandong Minmetals Co., Ltd. Shandong Oriental Cherry Entity comprised of Shandong Oriental Cherry Hardware Group., Ltd., Shandong Oriental Cherry Hardware Import & Export Co., Ltd., Shandong Oriental Cherry Hardware Group Heze Products Co., Ltd., Jining Huarong Hardware Products Co., Ltd., Jining Dragon Fasteners Co., Ltd., and Jining Yonggu Metal Products Co., Ltd. Shanghai Chengkai Hardware Product. Co., Ltd. Shanghai Colour Nail Co., Ltd. Shanghai Ding Ying Printing & Dyeing CLO Shanghai GBR Group International Co. Shanghai Holiday Import & Export Co., Ltd. Shanghai Jian Jie International TRA Shanghai March Import & Export Company Ltd. Shanghai Mizhu Imp & Exp Corporation Shanghai Nanhui Jinjun Hardware Factory Shanghai Pioneer Speakers Co., Ltd. Shanghai Pudong Int'l Transportation Booking Dep't Shanghai Seti Enterprise International Co., Ltd. Shanghai Shengxiang Hardware Co. Shanghai Suyu Railway Fastener Co. Shanghai Tengyu Hardware Products Co., Ltd. Shanghai Tymex International Trade Co., Ltd. Shanghai Yueda Fasteners Co., Ltd. Shanxi Tianli Enterprise Co., Ltd. Shanxi Yuci Wire Material Factory Shaoguang International Trade Co. Shaoxing Chengye Metal Producting Co., Ltd. Shenyang Yulin International Shenzhen Changxinghongye Imp. Shenzhen Erisson Technology Co., Ltd. Shenzhen Meiyuda Trade Co., Ltd. Shenzhen Pacific-Net Logistics Inc. Shenzhen Shangqi Imports-Exports TR Shijiazhuang Anao Imp & Export Co. Ltd. Shijiazhuang Fangyu Import & Export Corp. Shijiazhuang Glory Way Trading Co. Shijiazhuang Fitex Trading Co., Ltd. Shijiazhuang Shuangjian Tools Co., Ltd. Shitong Int'l Holding Limited Shouguang Meiqing Nail Industry Co., Ltd. Sinochem Tianjin Imp & Exp Shenzhen Corp. Sirius Global Logistics Co., Ltd. SMart (Tianjin) Technology Development Co., Ltd. Sunfield Enterprise Corporation Sunlife Enterprises (Yangjiang) Ltd. Sunworld International Logistics Superior International Australia Pty Ltd. Suzhou Guoxin Group Wangshun I/E Co. Imp. Exp. Co., Ltd. Suzhou Xingya Nail Co., Ltd. Suzhou Yaotian Metal Products Co., Ltd. Stanley Fastening Systems LP Shandex Industrial Telex Hong Kong Industry Co., Ltd. The Everest Corp. Thermwell Products Tian Jin Sundy Co., Ltd. (a/k/a/Tianjin Sunny Co., Ltd.) Tianjin Baisheng Metal Product Co., Ltd. Tianjin Bosai Hardware Tools Co., Ltd. Tianjin Chengyi International Trading Co., Ltd. Tianjin Chentai International Trading Co., Ltd. Tianjin City Dagang Area Jinding Metal Products Factory Tianjin City Daman Port Area Jinding Metal Products Factory Tianjin City Jinchi Metal Products Co., Ltd. Tianjin Dagang Dongfu Metallic Products Co., Ltd. Tianjin Dagang Hewang Nail Factory Tianjin Dagang Hewang Nails Manufacture Plant Tianjin Dagang Huasheng Nailery Co., Ltd. Tianjin Dagang Jingang Nail Factory Tianjin Dagang Jingang Nails Manufacture Plant Tianjin Dagang Linda Metallic Products Co., Ltd. Tianjin Dagang Longhua Metal Products Plant Tianjin Dagang Shenda Metal Products Co., Ltd. Tianjin Dagang Yate Nail Co., Ltd. Tianjin Dery Import and Export Co., Ltd. Tianjin Everwin Metal Products Co., Ltd. Tianjin Foreign Trade (Group) Textile & Garment Co., Ltd. Tianjin Hewang Nail Making Factory Tianjin Huachang Metal Products Co., Ltd. Tianjin Huapeng Metal Company Tianjin Huasheng Nails Production Co., Ltd. Tianjin Jetcom Manufacturing Co., Ltd. Tianjin Jieli Hengyuan Metallic Products Co., Ltd. Tianjin Jietong Hardware Products Co., Ltd. Tianjin Jietong Metal Products Co., Ltd. Tianjin Jin Gang Metal Products Co., Ltd. Tianjin Jinjin Pharmaceutical Factory Co., Ltd. Tianjin Jishili Hardware Co., Ltd. Tianjin JLHY Metal Products Co., Ltd. Tianjin Jurun Metal Products Co., Ltd. Tianjin Kunxin Hardware Co., Ltd. Tianjin Kunxin Metal Products Co., Ltd. Tianjin Lianda Group Ltd. Tianjin Linda Metal Company Tianjin Longxing (Group) Huanyu Imp. & Exp. Co., Ltd. Tianjin Master Fastener Co., Ltd. (a/k/a Master Fastener Co., Ltd.) Tianjin Mei Jia Hua Trade Co., Ltd. Tianjin Metals and Minerals Tianjin Port Free Trade Zone Xiangtong Intl. Industry & Trade Corp. Tianjin Products & Energy Resources Dev. Co., Ltd. Tianjin Qichuan Metal Products Co. Ltd. Tianjin Ruiji Metal Products Co., Ltd. Tianjin Senbohengtong International Tianjin Senmiao Import and Export Co., Ltd. Tianjin Shenyuan Steel Producting Group Co., Ltd. Tianjin Shishun Metal Product Co., Ltd. Tianjin Shishun Metallic Products Co., Ltd. Tianjin Tailai Import Export Tianjin Universal Machinery Imp & Exp Corporation Tianjin Universal Machinery Imp. & Exp. Corp. Ltd. Tianjin Universal Machinery Import & Export Corp. Tianjin Xiantong Fucheng Gun Nail Manufacture Co., Ltd. Tianjin Xiantong Juxiang Metal MFG Co., Ltd. Tianjin Xiantong Material & Trade Co., Ltd. Tianjin Xinyuansheng Metal Products Co., Ltd. Tianjin Yihao Metallic Products Co., Ltd. Tianjin Yongchang Metal Product Co., Ltd. Tianjin Yongxu Metal Products Co., Ltd. Tianjin Yongye Furniture Tianjin Yongyi Standard Parts Production Co., Ltd. Tianjin Zhong Jian Wanli Stone Co., Ltd. Tianjin Zhongsheng Garment Co., Ltd. Tianwoo Logistics Developing Co. Ltd. Topocean Consolidation Service (CHA) Ltd. Traser Mexicana, S.A. De C.V. Treasure Way International Dev. Ltd. True Value Company (HK) Ltd. Unicatch Industrial Co. Ltd. Unigain Trading Co., Ltd. Union Enterprise (Kunshan) Co., Ltd. a.k.a. Union Enterprise Co., Ltd. Wintime Import & Export Corporation Limited of Zhongshan Weifang Xiaotian Machine Co., Ltd. Wenzhou KLF Medical Plastics Co., Lt. Wenzhou Ouxin Foreign Trade Co., Ltd. Wenzhou Yuwei Foreign Trade Co., Ltd. Winsmart International Shipping Ltd. O/B Zhaoqing Harvest Nails Co., Ltd. Wintime Import & Export Corporation Limited of Zhongshan Worldwide Logistics Co., Ltd. (Tianjin Branch) Wuhan Xinxin Native Produce & Animal By-Products Mfg. Co. Ltd. Wuhu Sheng Zhi Industrial Co., Ltd. Wuhu Shijie Hardware Co., Ltd. Wuhu Xin Lan De Industrial Co., Ltd. Wuqiao County Huifeng Hardware Products Factory Wuqiao County Xinchuang Hardware Products Factory Wuqiao Huifeng Hardware Production Co., Ltd. Wuxi Baolin Nail Enterprises Wuxi Baolin Nail-Making Machinery Co., Ltd. Wuxi Chengye Metal Products Co., Ltd. Wuxi Colour Nail Co., Ltd. Wuxi Qiangye Metalwork Production Co., Ltd. Wuxi Jinde Assets Management Co., Ltd. Wuxi Moresky Developing Co., Ltd. Xiamen New Kunlun Trade Co., Ltd. Xi'an Metals & Minerals Import and Export Co., Ltd. Xi'an Steel XL Metal Works Co., Ltd. XM International, Inc. Xuzhou CIP International Group Co., Ltd. Yeswin Corporation Yitian Nanjing Hardware Co., Ltd. Yiwu Dongshun Toys Manufacture Yiwu Excellent Import & Export Co., Ltd. Yiwu Jiehang Import & Export Co., Ltd. Yiwu Qiaoli Import & Export Co., Ltd. Yiwu Richway Imp & Exp Co., Ltd. Yiwu Zhongai Toys Co., Ltd. Yongcheng Foreign Trade Corp. Yu Chi Hardware Co., Ltd. Yue Sang Plastic Factory Yuhuan Yazheng Importing Zhangjiagang Lianfeng Metals Products Co., Ltd. Zhangjiagang Longxiang Packing Materials Co. Zhaoqing Harvest Nails Co., Ltd. Zhejiang Hungyan Xingzhou Industria Zhejiang Jinhua Nail Factory Zhejiang Minmetals Sanhe Imp & Exp Co. Zhejiang Qifeng Hardware Make Co., Ltd. Zhejiang Taizhou Eagle Machinery Co. Zhejiang Yiwu Huishun Import/Export Co., Ltd. Zhongshan Junlong Nail Manufactures Co., Ltd. ZJG Lianfeng Metals Product Ltd.
    [FR Doc. 2015-22065 Filed 9-3-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-580-867] Large Power Transformers From the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review; 2013-2014 AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on large power transformers (LPTs) from the Republic of Korea (Korea).1 The period of review (POR) is August 1, 2013, through July 31, 2014. The review covers five producers/exporters of the subject merchandise, Hyosung Corporation (Hyosung), Hyundai Heavy Industries Co., Ltd. (Hyundai), ILJIN, ILJIN Electric Co., Ltd. (ILJIN Electric), and LSIS Co., Ltd. (LSIS). We preliminarily determine that sales of subject merchandise by Hyosung and Hyundai, the two companies selected for individual examination, were made at less than normal value during the POR. Interested parties are invited to comment on these preliminary results.

    1See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 79 FR 58729 (September 30, 2014).

    DATES:

    Effective Date: September 4, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Brian Davis or Edythe Artman, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-7924 or (202) 482-3931, respectively.

    SUPPLEMENTARY INFORMATION:

    Scope of the Order

    The scope of this order covers large liquid dielectric power transformers (LPTs) having a top power handling capacity greater than or equal to 60,000 kilovolt amperes (60 megavolt amperes), whether assembled or unassembled, complete or incomplete. The merchandise subject to the order is currently classified in the Harmonized Tariff Schedule of the United States at subheadings 8504.23.0040, 8504.23.0080 and 8504.90.9540. This tariff classification is provided for convenience and Customs purposes; however, the written description of the scope of the order is dispositive. A full description of the scope of the order is contained in the memorandum from Gary Taverman, Associate Deputy Assistant Secretary for AD/CVD Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance, titled “Decision Memorandum for Preliminary Results of Antidumping Duty Administrative Review: Large Power Transformers from the Republic of Korea; 2013-2014” (Preliminary Decision Memorandum), which is issued concurrent with and hereby adopted by this notice.

    The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). Access to ACCESS is available to registered users at http://access.trade.gov and is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the Internet at http://enforcement.trade.gov/frn/index.html. A list of topics discussed in the Preliminary Decision Memorandum is attached as an Appendix to this notice. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    Methodology

    The Department has conducted this review in accordance with section 751(a)(2) of the Tariff Act of 1930, as amended (the Act). Constructed export price (CEP) is calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum.

    Preliminary Results of Review

    We preliminarily determine that, for the period August 1, 2013, through July 31, 2014, the following dumping margins exist: 2

    2 As we did not have publicly-ranged U.S. sales volumes for Hyosung for the period August 1, 2013, through July 31, 2014, to calculate a weighted-average percentage margin for the non-selected companies (i.e., ILJIN, ILJIN Electric, and LSIS) in this review, the rate applied to the non-selected companies is a simple average percentage margin calculated based on the margins calculated for Hyosung and Hyundai.

    Manufacturer/exporter Weighted-average margin
  • (percent)
  • Hyosung Corporation 11.01 Hyundai Heavy Industries Co., Ltd 3.96 ILJIN Electric Co., Ltd 7.49 ILJIN 7.49 LSIS Co., Ltd 7.49
    Disclosure and Public Comment

    The Department will disclose to parties to the proceeding any calculations performed in connection with these preliminary results of review within five days after the date of publication of this notice.3 The Department will announce the briefing schedule to interested parties at a later date. Interested parties may submit case briefs on the deadline that the Department will announce and rebuttal briefs within five days after the time limit for filing case briefs.4 Rebuttal briefs, the content of which is limited to the issues raised in the case briefs, must be filed within five days from the deadline date for the submission of case briefs.5

    3See 19 CFR 351.224.(b).

    4See 19 CFR 351.309(c)(1)(ii) and (d)(1).

    5See 19 CFR 351.309(d)(1) and (2).

    Parties who submit arguments in this proceeding are requested to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.6 Case and rebuttal briefs should be filed using ACCESS.7 Case and rebuttal briefs must be served on interested parties.8 Executive summaries should be limited to five pages total, including footnotes.

    6See 19 CFR 351.309(c)(2).

    7See generally 19 CFR 351.303.

    8See 19 CFR 351.303(f).

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance within 30 days of the date of publication of this notice. Requests should contain: (1) The party's name, address and telephone number; (2) The number of participants; and (3) A list of issues parties intend to discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, at a date and time to be determined.9 Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    9See 19 CFR 351.310(d).

    The Department intends to publish the final results of this administrative review, including the results of its analysis of issues addressed in any case or rebuttal brief, no later than 120 days after publication of these preliminary results, unless extended.10

    10See section 751(a)(3)(A) of the Act; 19 CFR 351.213(h).

    Assessment Rates

    Upon completion of this administrative review, the Department shall determine, and Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries.11 If respondents' weighted-average dumping margin is not zero or de minimis in the final results of this review, we will calculate importer-specific assessment rates on the basis of the ratio of the total amount of antidumping duties calculated for an importer's examined sales and the total entered value of such sales in accordance with 19 CFR 351.212(b)(1). If respondents' weighted-average dumping margin is zero or de minimis in the final results of review, we will instruct CBP not to assess duties on any of its entries in accordance with the Final Modification for Reviews, i.e., “{w}here the weighted-average margin of dumping for the exporter is determined to be zero or de minimis, no antidumping duties will be assessed.” 12

    11See 19 CFR 351.212(b)(1).

    12See Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification, 77 FR 8101, 8102 (February 14, 2012) (Final Modification for Reviews).

    We intend to issue liquidation instructions to CBP 15 days after publication of the final results of this review.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Hyosung and Hyundai will be that established in the final results of this administrative review; (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or in the investigation but the manufacturer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be the all-others rate of 22.00 percent, which is the all-others rate established in the investigation.13 These cash deposit requirements, when imposed, shall remain in effect until further notice.

    13See Large Power Transformers From the Republic of Korea: Antidumping Duty Order, 77 FR 53177 (August 31, 2012).

    Notification to Importers

    This notice also serves as a reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

    Dated: August 31, 2015. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I—List of Topics Discussed in the Preliminary Decision Memorandum 1. Background 2. Companies Not Selected for Individual Examination 3. Deadline for Submission of Updated Sales and Cost Information 4. Verification 5. Scope of the Order 6. Comparisons to Normal Value A. Determination of Comparison Method B. Results of the Differential Pricing Analysis 7. Product Comparisons 8. Date of Sale 9. Constructed Export Price 10. Normal Value A. Home Market Viability as Comparison Market B. Level of Trade C. Cost of Production 1. Calculation of Cost of Production 2. Test of Comparison Market Sales Prices 3. Results of the Cost of Production Test D. Calculation of Normal Value Based on Comparison Market Prices E. Price-to-Constructed Value Comparison F. Constructed Value 11. Currency Conversion 12. Recommendation
    [FR Doc. 2015-22066 Filed 9-3-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-570-946] Prestressed Concrete Steel Wire Strand From the People's Republic of China: Final Results of Expedited First Sunset Review of Countervailing Duty Order AGENCY:

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

    SUMMARY:

    As a result of this sunset review, the Department of Commerce (the “Department”) finds that revocation of the countervailing duty (“CVD”) order on prestressed concrete steel wire strand (“PC Strand”) from the People's Republic of China (“PRC”) would likely to lead to continuation or recurrence of countervailable subsidies at the level indicated in the “Final Results of Review” section of this notice.

    DATES:

    Effective Date: September 4, 2015.

    FOR FURTHER INFORMATION CONTACT:

    James Terpstra, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3965.

    SUPPLEMENTARY INFORMATION: Background

    On May 1, 2015, the Department initiated a sunset review of the Order  1 pursuant to section 751(c)(2) of the Tariff Act of 1930, as amended (the “Act”) and 19 CFR 351.218(c).2 On May 15, 2015, the Department received a timely notification of intent to participate from Insteel Wire Products Company and Sumiden Wire Products Corporation (collectively, “Domestic Parties” or “Petitioners”), filed in accordance with 19 CFR 351.218(d)(1)(i). On June 1, 2015, the Department received a substantive response from Petitioners, timely filed in accordance with 19 CFR 351.218(d)(3)(i).3 The Department did not receive a substantive response from the Government of China (“GOC”) or company respondent interested parties.

    1See Pre-Stressed Concrete Steel Wire Strand from the People's Republic of China: Notice of Amended Final Affirmative Countervailing Duty Determination and Notice of Countervailing Duty Order, 75 FR 38977 (July 7, 2010) (“Order”).

    2See Initiation of Five-Year “Sunset” Review, 80 FR 24900 (May 1, 2015).

    3See Letter to the Department, entitled “Prestressed Concrete Steel Wire Strand from the PRC: Five-Year (“Sunset”) Review of Countervailing Duty Order,” dated June 13, 2015 (“Domestic Producers' Response”).

    Pursuant to 19 CFR 351.218(e)(1)(ii)(C)(2) and section 751(c)(3)(B) of the Act, when there are inadequate responses from respondent interested parties, the Department will conduct an expedited sunset review and, not later than 120 days after the date of publication in the Federal Registerof the notice of initiation, issue final results of review based on the facts available. The Department did not receive a substantive response from the GOC or any PRC producers or exporters. Accordingly, we conducted an expedited (120-day) sunset review of the Order.

    Scope of the Order

    The scope of the Order is PC strand. Imports of merchandise included within the scope of this Order are currently classifiable under subheadings 7312.10.3010 and 7312.10.3012 of the Harmonized Tariff Schedule of the United States (HTSUS). The Issues and Decision Memorandum (“IDM”), which is hereby adopted by this notice, provides a full description of the scope of the Order. 4

    4See Memorandum from Gary Taverman, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance, entitled “Issues and Decision Memorandum for the Final Results of the Expedited First Sunset Review of the Countervailing Duty Order on Prestressed Concrete Steel Wire Strand from the People's Republic of China,” dated concurrently with this notice.

    Analysis of Comments Received

    All issues raised in this review are addressed in the accompanying IDM. The issues discussed in the IDM include the likelihood of continuation or recurrence of a countervailable subsidy and the net countervailable subsidy likely to prevail if the Order were revoked. Parties can find a complete discussion of all issues raised in this expedited sunset review and the corresponding recommendations in this public memorandum which is on file electronically via the Enforcement and Compliance Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”). ACCESS is available to registered users at http://access.trade.gov and to all users in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the IDM can be accessed directly on the Internet at http://enforcement.trade.gov/frn/index.html. The signed IDM and the electronic versions of the IDM are identical in content.

    Final Results of Sunset Review

    Pursuant to sections 752(b)(1) and (3) of the Act, the Department finds that revocation of the Order would be likely to lead to continuation or recurrence of countervailable subsidies, as indicated in the following chart:

    Producer/exporter Net subsidy rate Fasten Group Corporation (Fasten Corp.), Fasten Group Import & Export Co., Ltd. (Fasten I&E), Jiangyin Hongsheng Co. Ltd. (Hongsheng), Jiangyin Fasten Steel Products Co., Ltd. (Fasten Steel), Jiangyin Hongyu Metal Products Co., Ltd. (Hongyu Metal), and Jiangyin Walsin Steel Cable Co., Ltd. (Walsin) (Collectively, the Fasten Companies) 9.42 percent ad valorem. Xinhua Metal Products Company Ltd. (Xinhua), Xinyu Iron and Steel Joint Stock Limited Company (Xinyu), and Xingang Iron and Steel Joint Stock Limited Liability Company (Xingang) (Collectively the Xinhua Companies) 45.85 percent ad valorem. All Others 27.64 percent ad valorem. Notification Regarding Administrative Protective Order

    This notice serves as the only reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

    We are issuing and publishing the results and notice in accordance with sections 751(c), 752, and 777(i)(1) of the Act.

    Dated: August 31, 2015. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix—List of Topics Discussed in the Issues and Decision Memorandum I. Summary II. History of the Order III. Background IV. Scope of the Order V. Discussion of the Issues 1. Likelihood of Continuation or Recurrence of a Countervailable Subsidy 2. Net Countervailable Subsidy Likely to Prevail 3. Nature of the Subsidy Export Subsidies Other Subsidies VI. Final Results of Review VII. Recommendation
    [FR Doc. 2015-22067 Filed 9-3-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration U.S. Integrated Ocean Observing System (IOOS®) Advisory Committee AGENCY:

    National Ocean Service, National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.

    ACTION:

    Notice of Open Meeting (via webinar and teleconference).

    SUMMARY:

    Notice is hereby given of a virtual meeting of the U. S. Integrated Ocean Observing System (IOOS®) Advisory Committee (Committee).

    Dates and Times: The public meeting will be held on Tuesday September 22, 2015, from 12:00 p.m. to 3:00 p.m. EDT. These times and the agenda topics described below are subject to change. Refer to the Web page listed below for the most up-to-date meeting agenda.

    FOR FURTHER INFORMATION CONTACT:

    Jessica Snowden, Designated Federal Official, U.S. IOOS Advisory Committee, U.S. IOOS Program, 1315 East-West Highway, 2nd Floor, Silver Spring, MD 20910, Silver Spring, MD 20910; Phone 301-713-3070 x 141; Fax 301-713-3281; Email [email protected] or visit the U.S. IOOS Advisory Committee Web site at http://www.ioos.noaa.gov/advisorycommittee.

    SUPPLEMENTARY INFORMATION:

    The IOOS Advisory Committee meeting will be held via webinar and teleconference. Members of the public who wish to participate in the meeting must register in advance by September 18, 2015. Please register by contacting Jessica Snowden, Designated Federal Official at email: [email protected] or tel (301) 713-3070 x 141. Webinar and teleconference information will be provided to registrants prior to the meeting. While the meeting will be open to the public, webinar and teleconference capacity may be limited.

    The Committee was established by the NOAA Administrator as directed by Section 12304 of the Integrated Coastal and Ocean Observation System Act, part of the Omnibus Public Land Management Act of 2009 (Pub. L. 111-11). The Committee advises the NOAA Administrator and the Interagency Ocean Observation Committee (IOOC) on matters related to the responsibilities and authorities set forth in section 12302 of the Integrated Coastal and Ocean Observation System Act of 2009 and other appropriate matters as the Under Secretary refers to the Committee for review and advice.

    The Committee will provide advice on:

    (a) Administration, operation, management, and maintenance of the System;

    (b) expansion and periodic modernization and upgrade of technology components of the System;

    (c) identification of end-user communities, their needs for information provided by the System, and the System's effectiveness in dissemination information to end-user communities and to the general public; and

    (d) any other purpose identified by the Under Secretary of Commerce for Oceans and Atmosphere or the Interagency Ocean Observation Committee.

    The meeting will be open to public participation with a 15-minute public comment period on September 22, 2015, from 2:45 p.m. to 3:00 p.m. (check agenda on Web site to confirm time.) The Committee expects that public statements presented at its meetings will not be repetitive of previously submitted verbal or written statements. In general, each individual or group making a verbal presentation will be limited to a total time of three (3) minutes. Written comments should be received by the Designated Federal Official by September 15, 2015 to provide sufficient time for Committee review. Written comments received after September 15, 2015, will be distributed to the Committee, but may not be reviewed prior to the meeting date.

    Matters To Be Considered: The meeting will focus on review of draft recommendations including ICOOS Act reauthorization, regional IOOS certification, and addressing the need for resilient communities. The agenda is subject to change. The latest version will be posted at http://www.ioos.noaa.gov/advisorycommittee.

    Dated: August 28, 2015. Zdenka Willis, Director, U.S. Integrated Ocean Observing System Office.
    [FR Doc. 2015-21976 Filed 9-3-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XD560 Marine Mammals; File No. 18208 AGENCY:

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

    ACTION:

    Notice; issuance of permit.

    SUMMARY:

    Notice is hereby given that a permit has been issued to Randy Sacco, Ph.D., Ruminant Diseases and Immunology Research Unit, National Animal Disease Center, 1920 Dayton Road, P.O. Box 70, Ames, IA 50010, to receive cell line specimens of Atlantic spotted (Stenella frontalis), Atlantic bottlenose (Tursiops truncatus), and common (Delphinus delphis) dolphin for scientific research purposes.

    ADDRESSES:

    The permit and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    FOR FURTHER INFORMATION CONTACT:

    Amy Sloan or Jennifer Skidmore, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    On October 28, 2014, notice was published in the Federal Register (70 FR 64174) that a request for a permit to receive cell line specimens from the species identified above for scientific research purposes had been submitted by the above-named applicant. The requested permit has been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.), and the regulations governing the taking and importing of marine mammals (50 CFR part 216).

    The permit authorizes the applicant to receive cell lines from up to two Atlantic spotted, three Atlantic bottlenose, and three common dolphins to study mechanisms whereby respiratory pathogens alter dolphin anti-viral or cytokine/chemokine responses using a parainfluenza virus isolated from a bottlenose dolphin. The objective is to provide information on how influenza viruses affect dolphins and potentially induce disease. Cell lines will be obtained from the American Type Culture Collection or other permitted researchers authorized to maintain cell lines, and would be analyzed at the National Animal Disease Center in Ames, IA. The permit is valid for 5 years from the date of issuance.

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), a final determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

    Dated: August 24, 2015. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2015-21961 Filed 9-3-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE159 Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting AGENCY:

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

    ACTION:

    Notice; public meeting.

    SUMMARY:

    The Mid-Atlantic Fishery Management Council's (MAFMC's) Summer Flounder, Scup, and Black Sea Bass Monitoring Committee will hold a public meeting.

    DATES:

    The meeting will be held on Wednesday, Sept. 23, 2015, from 9 a.m. to 12 p.m. For agenda details, see SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    The meeting will be held via webinar with a telephone-only connection option. Webinar and telephone-only connection details are available at: http://www.mafmc.org.

    Council address: Mid-Atlantic Fishery Management Council, 800 N. State Street, Suite 201, Dover, DE 19901; telephone: (302) 674-2331 or on their Web site at www.mafmc.org.

    FOR FURTHER INFORMATION CONTACT:

    Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.

    SUPPLEMENTARY INFORMATION:

    The MAFMC's Summer Flounder, Scup, and Black Sea Bass Monitoring Committee (Committee) has initiated an evaluation of several current management measures for the summer flounder, scup, and black sea bass commercial fisheries (e.g., minimum commercial fish sizes, minimum mesh sizes, seasonal possession limits triggering the minimum mesh sizes, other gear restrictions, and exemption programs). The Committee will meet via webinar to review initial analyses evaluating the effectiveness of the current regulations, identify additional work to be completed, and potentially begin development of recommendations to the MAFMC.

    Special Accommodations

    The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.

    Dated: September 1, 2015. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-21991 Filed 9-3-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE157 North Pacific Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of public meeting.

    SUMMARY:

    The North Pacific Fishery Management Council (Council) Groundfish Plan Team will meet September 21, 2015 to September 24, 2015.

    DATES:

    The meeting will be held on Monday, September 21, 2015 through Thursday, September 24, 2015, from 8 a.m. to 5 p.m., each day.

    ADDRESSES:

    The meeting will be held at the Alaska Fishery Science Center Traynor Room 2076 and NMML Room 2039, 7600 Sand Point Way NE., Building 4, Seattle, WA 98115.

    Council address: North Pacific Fishery Management Council, 605 W. 4th Ave., Suite 306, Anchorage, AK 99501-2252; telephone: (907) 271-2809.

    FOR FURTHER INFORMATION CONTACT:

    Diana Stram, Council staff; telephone: (907) 271-2809.

    SUPPLEMENTARY INFORMATION: Agenda Monday, September 21 to Thursday September 24, 2015

    The agenda includes review of halibut discard mortality rates, upcoming assessment changes for Sablefish, EBS, AI and GOA Pacific cod, BSAI and GOA rockfish assessments, GOA Northern and southern rock sole, CIE review of BSAI Atka Mackerel, GOA pollock, review of a size structured octopus model and updates on the observer program, EBS bottom trawl survey, ecosystem considerations chapter, NMML report and Economic SAFE report. The Agenda is subject to change, and the latest version will be posted at http://www.npfmc.org/.

    Special Accommodations

    These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.

    Dated: September 1, 2015. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-21990 Filed 9-3-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE161 Mid-Atlantic Fishery Management Council (MAFMC); Public Meetings AGENCY:

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

    ACTION:

    Notice; public meetings.

    SUMMARY:

    The Mid-Atlantic Fishery Management Council's (Council) Spiny Dogfish Monitoring Committee will hold a public meeting to develop spiny dogfish management recommendations. The Council will also host a public information meeting to gather public perspectives on spiny dogfish management.

    DATES:

    The meetings will be held on Tuesday, Sept. 22, 2015, from 9:30 a.m. to 12 p.m. for the Monitoring Committee and from 6 p.m. to 8 p.m. (on the same day) for the public information meeting. For agenda details, see SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    The meeting will be held via webinar. Webinar connection details will be available at: http://www.mafmc.org.

    Council address: Mid-Atlantic Fishery Management Council, 800 N. State Street, Suite 201, Dover, DE 19901; telephone: (302) 674-2331 or on their Web site at www.mafmc.org.

    FOR FURTHER INFORMATION CONTACT:

    Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.

    SUPPLEMENTARY INFORMATION:

    The Council's Spiny Dogfish Monitoring Committee will meet Tuesday, September 22, 2015 at 9:30 a.m. to develop 2016-18 spiny dogfish management measure recommendations based on the Acceptable Biological Catch (ABC) recommendations of the Council's Scientific and Statistical Committee (SSC). A summary of current management is available at: http://www.greateratlantic.fisheries.noaa.gov/regs/infodocs/spinydogfactsheet.pdf. At 6 p.m. on the same day, Council staff will hold a public information meeting to gather public perspectives on spiny dogfish management. The results of both meetings will be summarized for the Council when it meets in October 2015 to set spiny dogfish specifications and associated management measures. Contact Jason Didden at 302-526-5254 if you have questions about using a webinar to participate in a meeting.

    Special Accommodations

    These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.

    Dated: September 1, 2015. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-21993 Filed 9-3-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE160 New England Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice; public meeting.

    SUMMARY:

    The New England Fishery Management Council (Council) is scheduling a public meeting of its Habitat Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

    DATES:

    This meeting will be held on Wednesday, September 23, 2015 at 9 a.m.

    ADDRESSES:

    The meeting will be held at the DoubleTree by Hilton, 50 Ferncroft Road, Danvers, MA 01923; phone: (978) 777-2500; fax: (978) 750-7959.

    Council address: New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950.

    FOR FURTHER INFORMATION CONTACT:

    Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.

    SUPPLEMENTARY INFORMATION: Agenda

    The Habitat Committee will discuss future habitat-related management actions. These will include a possible clam exemption area framework, continuation of the Omnibus Deep-Sea Coral Amendment, and a general discussion of 2016 Council priorities related to habitat issues. The Committee may discuss other business as needed.

    Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: September 1, 2015. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-21992 Filed 9-3-15; 8:45 am] BILLING CODE 3510-22-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Proposed Additions and Deletions AGENCY:

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

    ACTION:

    Proposed Additions to and Deletions from the Procurement List.

    SUMMARY:

    The Committee is proposing to add products to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and a service previously furnished by such agencies.

    DATES:

    Comments must be received on or before: 10/5/2015.

    ADDRESSES:

    Committee for Purchase from People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    For Further Information or to Submit Comments Contact:

    Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION:

    This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

    Additions

    If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.

    The following products are proposed for addition to the Procurement List for production by the nonprofit agencies listed:

    Products NSN(s)—Product Name(s): 4510-00-NIB-0045—Purell-Skilcraft ADX 1200 ml Dispenser Manual Pump 4510-00-NIB-0131—Purell Skilcraft LTX 1200 ml Dispenser Hands Free 8520-00-NIB-0134—Purell Instant Hand Sanitizer, Green-Certified, 8 oz. Bottle—Purell Instant 8520-00-NIB-0135—Hand Sanitizer, Green-Certified, 12 oz. Bottle 8520-00-NIB-0141—Instant Hand Sanitizer, Alcohol-Free, 535 ml Pump Bottle 8520-00-NIB-0142—Instant Hand Sanitizer, Alcohol-Free, 45 ml Pump Bottle 8520-00-NIB-0143—Instant Hand Sanitizer, Alcohol-Free, 1200 ml LTX Cartridge Refill 8520-00-NIB-0144—Instant Hand Sanitizer, Alcohol-Free, 1200 ml ADX Cartridge Refill Mandatory Source of Supply: Austin Lighthouse, Austin, TX Mandatory Purchase For: 100% of the requirement of the Department of Homeland Security Contracting Activity: Department of Homeland Security, Office of Procurement Operations Distribution: C-List NSN(s)—Product Name(s): 8415-01-644-9620—Gaiter, Fire Resistant Environmental Ensemble (FREE), Army, Army Tan Mandatory Source of Supply: NYSARC, Inc., Seneca-Cayuga Counties Chapter, Waterloo, NY Mandatory Purchase For: 100% of the requirement of the U.S. Army Contracting Activity: Dept of the Army, W6QK ACC-APG Natick Distribution: C-List Deletions

    The following products and service are proposed for deletion from the Procurement List:

    Products USMC Sun Hats: 8415-01-485-6637—Woodland with Logo 8415-01-485-6713—Woodland with Logo 8415-01-485-6750—Woodland with Logo 8415-01-485-6755—Woodland with Logo 8415-01-485-6757—Woodland with Logo 8415-01-485-6760—Woodland with Logo 8415-01-485-6771—Woodland with Logo 8415-01-485-6777—Woodland with Logo 8415-01-485-8131—Desert with Logo 8415-01-485-8134—Desert with Logo 8415-01-485-8137—Desert with Logo 8415-01-485-8138—Desert with Logo 8415-01-485-8140—Desert with Logo 8415-01-485-8143—Desert with Logo 8415-01-485-8144—Desert with Logo 8415-01-485-8145—Desert with Logo 8415-00-NSH-1100—Desert without Logo 8415-00-NSH-1101—Desert without Logo 8415-00-NSH-1102—Desert without Logo 8415-00-NSH-1103—Desert without Logo 8415-00-NSH-1104—Desert without Logo 8415-00-NSH-1105—Desert without Logo 8415-00-NSH-1106—Desert without Logo 8415-00-NSH-1107—Desert without Logo 8415-00-NSH-1108—Desert without Logo 8415-00-NSH-1109—Desert without Logo 8415-00-NSH-1110—Desert without Logo 8415-00-NSH-1112—Desert without Logo 8415-00-NSH-1113—Desert without Logo 8415-00-NSH-1114—Desert without Logo 8415-00-NSH-1115—Woodland without Logo 8415-00-NSH-1116—Woodland without Logo 8415-00-NSH-1117—Woodland without Logo 8415-00-NSH-1118—Woodland without Logo 8415-00-NSH-1119—Woodland without Logo 8415-00-NSH-1120—Woodland without Logo 8415-00-NSH-1121—Woodland without Logo 8415-00-NSH-1122—Woodland without Logo 8415-00-NSH-1123—Woodland without Logo 8415-00-NSH-1124—Woodland without Logo 8415-00-NSH-1125—Woodland without Logo 8415-00-NSH-1126—Woodland without Logo 8415-00-NSH-1127—Woodland without Logo 8415-00-NSH-1128—Woodland without Logo Mandatory Source of Supply: Southeastern Kentucky Rehabilitation Industries, Inc., Corbin, KY Contracting Activity: W6QK ACC-APG Natick Service Service Type: Warehousing Service Mandatory For: Barbers Point Naval Air Station Barbers Point, HI Mandatory Source of Supply: Trace, Inc., Boise, ID Contracting Activity: Defense Commissary Agency Barry S. Lineback, Director, Business Operations.
    [FR Doc. 2015-22004 Filed 9-3-15; 8:45 am] BILLING CODE 6353-01-P
    COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Additions and Deletions AGENCY:

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

    ACTION:

    Additions to and Deletions from the Procurement List.

    SUMMARY:

    This action adds products to the Procurement List that will be furnished by the nonprofit agency employing persons who are blind or have other severe disabilities, and deletes products from the Procurement List previously furnished by such agency.

    DATES:

    Effective on 10/5/2015.

    ADDRESSES:

    Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.

    FOR FURTHER INFORMATION CONTACT:

    Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email [email protected]

    SUPPLEMENTARY INFORMATION: Additions

    On 8/4/2015 (80 FR 46250), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed additions to the Procurement List.

    After consideration of the material presented to it concerning capability of qualified nonprofit agency to provide the products and impact of the additions on the current or most recent contractors, the Committee has determined that the products listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

    Regulatory Flexibility Act Certification

    I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

    1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organization that will furnish the products to the Government.

    2. The action will result in authorizing a small entity to furnish the products to the Government.

    3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products proposed for addition to the Procurement List.

    End of Certification

    Accordingly, the following products are added to the Procurement List:

    Products NSN(s)—Product Name(s): MR 10681—Bib, Baby, Halloween MR 10683—Socks, Halloween MR 10684—Gloves, Halloween MR 10685—Party Favors, Halloween, Spiders and Webs MR 10686—Party Favors, Halloween, Witch's Fingers MR 10687—Party Favors, Halloween, Nose and Glasses MR 10688—Party Favors, Halloween, Fangs MR 10689—Party Favors, Halloween, Mini Spiral Note Book MR 10690—Party Favors, Halloween, Sticky Eyes Mandatory Source of Supply: Winston-Salem Industries for the Blind, Inc., Winston-Salem, NC Mandatory Purchase For: Military commissaries and exchanges in accordance with the Code of Federal Regulations, Chapter 51, 51-6.4. Contracting Activity: Defense Commissary Agency Distribution: C-List Deletions

    On 8/4/2015 (80 FR 46250), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.

    After consideration of the relevant matter presented, the Committee has determined that the products listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

    Regulatory Flexibility Act Certification

    I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

    1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

    2. The action may result in authorizing a small entity to furnish the products to the Government.

    3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products deleted from the Procurement List.

    End of Certification

    Accordingly, the following products are deleted from the Procurement List:

    Products NSN(s)—Product Name(s): 8440-00-205-2509—Belt, General Officers, Leather, Army, Black, 44 8440-00-205-2510—Belt, General Officers, Leather, Army, Black, 28 8440-00-205-2511—Belt, General Officers, Leather, Army, Black, 29 8440-00-205-2512—Belt, General Officers, Leather, Army, Black, 30 8440-00-205-2513—Belt, General Officers, Leather, Army, Black, 31 8440-00-205-2514—Belt, General Officers, Leather, Army, Black, 32 8440-00-205-2515—Belt, General Officers, Leather, Army, Black, 33 8440-00-205-2516—Belt, General Officers, Leather, Army, Black, 34 8440-00-205-2517—Belt, General Officers, Leather, Army, Black, 35 8440-00-205-2518—Belt, General Officers, Leather, Army, Black, 36 8440-00-205-2519—Belt, General Officers, Leather, Army, Black, 37 8440-00-205-2520—Belt, General Officers, Leather, Army, Black, 38 8440-00-205-2521—Belt, General Officers, Leather, Army, Black, 39 8440-00-205-2522—Belt, General Officers, Leather, Army, Black, 40 8440-00-205-2523—Belt, General Officers, Leather, Army, Black, 41 8440-00-205-2524—Belt, General Officers, Leather, Army, Black, 42 8440-00-205-2525—Belt, General Officers, Leather, Army, Black, 43 Mandatory Source of Supply: Stone Belt ARC, Inc., Bloomington, IN Contracting Activity: Defense Logistics Agency Troop Support Barry S. Lineback, Director, Business Operations.
    [FR Doc. 2015-22005 Filed 9-3-15; 8:45 am] BILLING CODE 6353-01-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION [Docket No: CFPB-2015-0037] Agency Information Collection Activities: Comment Request AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice and request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (CFPB) is requesting a new information collection titled, “Web-Based Quantitative Testing of Point of Sale/ATM (POS/ATM) Overdraft Disclosure Forms.”

    DATES:

    Written comments are encouraged and must be received on or before November 3, 2015 to be assured of consideration.

    ADDRESSES:

    You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:

    Electronic: http://www.regulations.gov. Follow the instructions for submitting comments.

    Mail: Consumer Financial Protection Bureau (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552.

    Hand Delivery/Courier: Consumer Financial Protection Bureau (Attention: PRA Office), 1275 First Street NE., Washington, DC 20002.

    Please note that comments submitted after the comment period will not be accepted. In general, all comments received will become public records, including any personal information provided. Sensitive personal information, such as account numbers or social security numbers, should not be included.

    FOR FURTHER INFORMATION CONTACT:

    Documentation prepared in support of this information collection request is available at www.regulations.gov. Requests for additional information should be directed to the Consumer Financial Protection Bureau, (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552, (202) 435-9575, or email: [email protected] Please do not submit comments to this mailbox.

    SUPPLEMENTARY INFORMATION:

    Title of Collection: Web-Based Quantitative Testing of Point of Sale/ATM (POS/ATM) Overdraft Disclosure Forms.

    OMB Control Number: 3170-XXXX.

    Type of Review: New Collection (Request for a new OMB control number).

    Affected Public: Individuals or Households.

    Estimated Number of Respondents: 41,351.

    Estimated Total Annual Burden Hours: 2,827.

    Abstract: The CFPB seeks approval from the Office of Management and Budget (“OMB”) to conduct a national web survey of 8,000 individuals as part of its study of ATM/debit card overdraft disclosure forms, which is being undertaken under the CFPB's regulatory authority for the Electronic Fund Transfer Act.

    The survey will explore consumer comprehension and decision-making in response to revised overdraft disclosure forms. It will also explore financial product usage, behavioral traits, and other consumer characteristics that may interact with a consumer's experiences with overdraft programs and related disclosure forms. The survey will include a representative sample of the U.S. adult checking account-holding population, with oversampling of respondents who are more likely to have experience with overdraft fees.

    Request for Comments: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the CFPB, including whether the information will have practical utility; (b) The accuracy of the CFPB's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record.

    Dated: August 25, 2015. Linda F. Powell, Chief Data Officer, Bureau of Consumer Financial Protection.
    [FR Doc. 2015-22003 Filed 9-3-15; 8:45 am] BILLING CODE 4810-AM-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DoD-2015-OS-0089] Proposed Collection; Comment Request AGENCY:

    Pentagon Force Protection Agency, DoD.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the Pentagon Force Protection Agency announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

    DATES:

    Consideration will be given to all comments received by November 3, 2015.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

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

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

    Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at http://www.regulations.gov for submitting comments. Please submit comments on any given form identified by docket number, form number, and title.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Pentagon Force Protection Agency Project Integration Directorate (PFPA\PID), 9000 Defense Pentagon, Washington, DC 20301-9000, ATTN: PID, or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Privilege Management Program (PMP); DD Form 2249A and Pentagon Tours Web site; OMB Control Number 0704-TBD.

    Needs and Uses: The information collection requirement is necessary to facilitate background investigations and properly assign privileges to the customer utilized within the Pentagon Reservation and National Capital Region (NCR). The collection is also required to facilitate verification of background investigations for individuals applying for access to the Pentagon in connection with Pentagon Visitor Tours.

    The Visitor & Parking Management feature of the Privilege Management Program (PMP—Access Control System) utilizes DD Form 2249A as evidence that the customer has been properly vetted and provides justification for access to the locations needed to perform their occupational duties. The information collection requirement is necessary to facilitate background investigations and properly assign physical access and parking privileges to the customer utilized within the Pentagon Reservation.

    The Electronic Security System of the PMP is related to the Pentagon Tours feature of the PMP whereby the information is provided by the individual requesting the tour and is entered directly into the PFPA Web site.

    PMP Visitor and Parking Management—Access Control System (DD Form 2249a)

    Affected Public: Individuals or Households.

    Annual Burden Hours: 2,208.

    Number of respondents: 26,500.

    Responses per Respondent: 1.

    Annual Responses: 26,500.

    Average Burden per Response: 5 minutes.

    Frequency: On occasion.

    PMP Electronic Security System: Pentagon Tours Web site

    Affected Public: Individuals or Households.

    Annual Burden Hours: 12,917.

    Number of Respondents: 155,000.

    Responses per Respondent: 1.

    Annual Responses: 155,000.

    Average Burden per Response: 5 minutes.

    Frequency: On occasion.

    PMP Combined Burden Estimates

    Annual Burden Hours: 15,125.

    Number of Respondents: 181,500.

    Responses per Respondent: 1.

    Annual Responses: 181,500.

    Average Burden per Response: 5 minutes.

    Frequency: On occasion.

    Respondents are tenants and visitors who are provided identification badges, submit biometric attributes for collection, and/or have access privileges assigned. The PMP Access Control System is the authoritative system which integrates into American Magnetics System, AMAG, for the Pentagon, and SoftwareHouse C-Cure-9000 for the Mark Center and the Defense Health Headquarters.

    The PMP Visitor Management & Parking Management Systems utilize the DD Form 2249A and records customer information to facilitate verification of background investigations for individuals applying for access and parking to DOD buildings in connection with their official duties. If DD Form 2249A is not completed by the customer at time of enrollment, the enrollment agent cannot issue credential(s). Having qualified agents provide credentialing and enrollment services is essential to maintaining daily operations and access rights to various installations throughout the NCR. The data are collected and stored in the PMP database at the time of enrollment.

    Regarding the Pentagon tours Web site, respondents are visitors who wish to be conducted on a tour of the Pentagon. The Pentagon Visitor Tour Online Web site records customer information to facilitate verification of background investigations for individuals applying for access to Pentagon in connection with Pentagon Visitor Tours. If the online information is not presented by customers they will not be scheduled or allowed access into the Pentagon. The data are collected and stored in the PMP Electronic Security System Database at the time of tour scheduling.

    Dated: September 1, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-22013 Filed 9-3-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DoD-2015-OS-0021] 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 October 5, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Fred Licari, 571-372-0493.

    SUPPLEMENTARY INFORMATION:

    Title, Associated Form and OMB Number: DISAM Information Technology Mission System (DISM); DISAM Form GSI-001 and Student Registration Form; OMB Control Number 0704-XXXX.

    Type of Request: Existing Collection in use without an OMB Control Number.

    Number of Respondents: 5024.

    Responses per Respondent: 1.5.

    Annual Responses: 7536.

    Average Burden per Response: 15 Minutes (.25 Hours).

    Annual Burden Hours: 1884 Hours.

    Needs and Uses: The DISAM Information Technology Mission System (DISM) was established to hold several web applications for the purpose of better management of students through centralized maintenance of data including the support of the security cooperation community. DISM also allows for more effective management of personnel within DISAM. The types of information collected in DISM include Guest Speaker, Personnel, Student, and Travel data.

    Affected Public: Individuals or households.

    Frequency: On occasion.

    Respondent's Obligation: Voluntary.

    OMB Desk Officer: Ms. Jasmeet Seehra.

    Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at [email protected] Please identify the proposed information collection by DoD Desk Officer and the Docket ID number and title of the information collection.

    You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

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

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

    DOD Clearance Officer: Mr. Frederick Licari.

    Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.

    Dated: September 1, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-22001 Filed 9-3-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary National Commission on the Future of the Army; Notice of Federal Advisory Committee Meeting AGENCY:

    Deputy Chief Management Officer, Department of Defense (DoD).

    ACTION:

    Notice of Federal Advisory Committee Meeting.

    SUMMARY:

    The DoD is publishing this notice to announce two days of meetings of the National Commission on the Future of the Army (“the Commission”). The meetings will be partially closed to the public.

    DATES:

    Date of the Closed Meeting: Wednesday, September 16, 2015, from 1:00 p.m. to 4:30 p.m.

    Date of the Open Meeting: Thursday, September 17, 2015, from 9:30 a.m. to 12:00 p.m.

    ADDRESSES:

    Address of Closed Meeting, September 16, 2015: Rm. 12110, 5th Floor, Zachary Taylor Building, 2530 Crystal Dr., Arlington, VA 22202.

    Address of Open Meeting, September 17, 2015: Polk Conference Room, Room 12158, James Polk Building, 2521 S. Clark St., Arlington, VA 22202.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Don Tison, Designated Federal Officer, National Commission on the Future of the Army, 700 Army Pentagon, Room 3E406, Washington, DC 20310-0700, Email: [email protected] Desk (703) 692-9099. Facsimile (703) 697-8242.

    SUPPLEMENTARY INFORMATION:

    Due to circumstances beyond the control of the Designated Federal Officer and the Department of Defense, the National Commission on the Future of the Army was unable to provide public notification of its meeting of September 16-17, as required by 41 CFR 102-3.150(a). Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement. This meeting will be held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.

    Purpose of Meetings

    During the closed meeting on Wednesday, September 16, 2015, the Commission will receive a classified interim report from the Aviation Subcommittee National Commission on the Future of the Army and engage in discussion on the preparation for the classified table top war game in October.

    During the open meeting on Thursday, September 17, 2015, the Commission will hear subcommittee interim reports, engage in discussions on DoD's Role in State and National Crisis, the Public will have the opportunity to provide verbal comments, and immediately afterwards the Commission will discuss topics raised during the subcommittee, presentations and public comment session.

    Agendas

    September 16, 2015—Closed Hearing: The Commission will hear a classified subcommittee interim report from members of the aviation subcommittee discussing cost and sufficiency analysis of aviation restructuring initiative alternatives, the Commission Staff will provide a classified overview of preparation for the upcoming war game seminar where a scenario of the current war plans will be selected and applied to the war game's analytical framework. The warplan selected will undergo a classified force structure analysis. All presentations and resulting discussion are classified.

    September 17, 2015—Open Hearing: The Commission will hear subcommittee interim reports, testimony from the National Governor's Association on the relationship between Governors and Defense during state crisis, testimony from the Federal Emergency Management Agency on DoD's support to civil authorities, and comments from members of the public. Immediately afterwards, the Commission will discuss topics raised during the subcommittee, presentations and public comment session.

    Meeting Accessibility

    In accordance with applicable law, 5 U.S.C. 552b(c), and 41 CFR 102-3.155, the DoD has determined that the portion of the meeting scheduled for Wednesday, September 16, 2015, from 1:00 p.m. to 4:30 p.m. will be closed to the public. Specifically, the Assistant Deputy Chief Management Officer, with the coordination of the DoD FACA Attorney, has determined in writing that this portion of the meeting will be closed to the public because it will discuss matters covered by 5 U.S.C. 552b(c)(1).

    Pursuant to 41 CFR 102-3.140 through 102-3.165 and the availability of space, the meeting scheduled for September 17, 2015 from 9:30 a.m. to 12:00 p.m. at the James Polk Building is open to the public. Seating is limited and pre-registration is strongly encouraged. Media representatives are also encouraged to register. Members of the media must comply with the rules of photography and video filming in the James Polk Building. The closest public parking facility is located in the basement and along the streets. Visitors will be required to present one form of photograph identification. Visitors to the James Polk Office Building will be screened by a magnetometer, and all items that are permitted inside the building will be screened by an x-ray device. Visitors should keep their belongings with them at all times. The following items are strictly prohibited in the James Polk Office Building: Any pointed object, e.g., knitting needles and letter openers (pens and pencils are permitted); any bag larger than 18″ wide x 14″ high x 8.5″ deep; electric stun guns, martial arts weapons or devices; guns, replica guns, ammunition and fireworks; knives of any size; mace and pepper spray; razors and box cutters.

    Written Comments

    Pursuant to section 10(a)(3) of the FACA and 41 CFR 102-3.105(j) and 102-3.140, the public or interested organizations may submit written comments to the Commission in response to the stated agenda of the open and/or closed meeting or the Commission's mission. The Designated Federal Officer (DFO) will review all submitted written statements. Written comments should be submitted to Mr. Donald Tison, DFO, via facsimile or electronic mail, the preferred modes of submission. Each page of the comment must include the author's name, title or affiliation, address, and daytime phone number. All comments received before Tuesday, September 15, 2015, will be provided to the Commission before the September 17, 2015, meeting. Comments received after Tuesday, September 15, 2015, will be provided to the Commission before its next meeting. All contact information may be found in the FOR FURTHER INFORMATION CONTACT section.

    Oral Comments

    In addition to written statements, fifteen minutes will be reserved for individuals or interest groups to address the Commission on September 17, 2015. Those interested in presenting oral comments to the Commission must summarize their oral statement in writing and submit with their registration. The Commission's staff will assign time to oral commenters at the meeting; no more than five minutes each for individuals. While requests to make an oral presentation to the Commission will be honored on a first come, first served basis, other opportunities for oral comments will be provided at future meetings.

    Registration

    Individuals and entities who wish to attend the public hearing and meeting on Thursday, September 17, 2015 are encouraged to register for the event with the DFO using the electronic mail and facsimile contact information found in the FOR FURTHER INFORMATION CONTACT section. The communication should include the registrant's full name, title, affiliation or employer, email address, day time phone number. This information will assist the Commission in contacting individuals should it decide to do so at a later date. If applicable, include written comments and a request to speak during the oral comment session. (Oral comment requests must be accompanied by a summary of your presentation.) Registrations and written comments should be typed.

    Additional Information

    The DoD sponsor for the Commission is the Deputy Chief Management Officer. The Commission is tasked to submit a report, containing a comprehensive study and recommendations, by February 1, 2016 to the President of the United States and the Congressional defense committees. The report will contain a detailed statement of the findings and conclusions of the Commission, together with its recommendations for such legislation and administrative actions it may consider appropriate in light of the results of the study. The comprehensive study of the structure of the Army will determine whether, and how, the structure should be modified to best fulfill current and anticipated mission requirements for the Army in a manner consistent with available resources.

    Dated: September 1, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-22062 Filed 9-3-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC15-195-000,

    Applicants: RET Modesto Solar LLC,

    Description: Application of RET Modesto Solar, LLC for Authorization Under Section 203 and Request for Expedited Consideration and Confidential Treatment.

    Filed Date: 8/27/15,

    Accession Number: 20150827-5337,

    Comments Due: 5 p.m. ET 9/17/15,

    Docket Numbers: EC15-196-000.

    Applicants: Breckinridge Wind Project, LLC.

    Description: Application for Authorization Under Section 203 of the Federal Power Act and Request for Expedited Action of Breckinridge Wind Project, LLC.

    Filed Date: 8/27/15.

    Accession Number: 20150827-5353.

    Comments Due: 5 p.m. ET 9/17/15.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER15-2547-000.

    Applicants: Florida Power & Light Company.

    Description: Section 205(d) Rate Filing: FPL Revisions to FKEC Rate Schedule FERC No. 322 to be effective 1/1/2014.

    Filed Date: 8/27/15.

    Accession Number: 20150827-5281.

    Comments Due: 5 p.m. ET 9/17/15.

    Docket Numbers: ER15-2548-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Cancellation: Notice of Cancellation of WMPA No. 3677, Queue No. V4-025 to be effective 8/12/2015.

    Filed Date: 8/27/15.

    Accession Number: 20150827-5300.

    Comments Due: 5 p.m. ET 9/17/15.

    Docket Numbers: ER15-2549-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Cancellation: Notice of Cancellation of Original Service Agreement No. 3676, Queue No. V4-025 to be effective 8/12/2015.

    Filed Date: 8/27/15.

    Accession Number: 20150827-5302.

    Comments Due: 5 p.m. ET 9/17/15.

    Docket Numbers: ER15-2550-000.

    Applicants: Rancho Cucamonga Municipal Utility.

    Description: Petition of Rancho Cucamonga Municipal Utility for Limited Waiver of the California Independent System Operator Corporation's Tariff Provisions.

    Filed Date: 8/27/15.

    Accession Number: 20150827-5317.

    Comments Due: 5 p.m. ET 9/17/15.

    Docket Numbers: ER15-2551-000.

    Applicants: Avista Corporation.

    Description: Avista Corporation submits Average System Cost Filing for Sales of Electric Power to the Bonneville Power Administration, FY 2016-2017.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5069.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2552-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Section 205(d) Rate Filing: 2015-08-28_SA 2794 ATC-City of Gladstone CFA to be effective 10/27/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5103.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2553-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Section 205(d) Rate Filing: 2015-08-28_SA 2797 ATC-Lake Mills Light and Water CFA to be effective 10/27/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5105.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2554-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Section 205(d) Rate Filing: 2015-08-28_SA 2798 ATC-City of Menasha CFA to be effective 10/27/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5106.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2555-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Section 205(d) Rate Filing: 2015-08-28_SA 2799 ATC-City of New London CFA to be effective 10/27/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5107.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2556-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Section 205(d) Rate Filing: 2015-08-28_SA 2801 ATC-City of Sturgeon Bay CFA to be effective 10/27/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5108.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2557-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Section 205(d) Rate Filing: 2015-08-28_SA 2804 ATC-City of Richland Center CFA to be effective 10/27/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5110.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2558-000.

    Applicants: Florida Power & Light Company.

    Description: Section 205(d) Rate Filing: FPL Revisions to LCEC Rate Schedule FERC No. 317 to be effective 1/1/2014.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5142.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2559-000.

    Applicants: Arizona Public Service Company.

    Description: Section 205(d) Rate Filing: Rate Schedule No. 217 Exhibit B Revisions to be effective 10/28/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5153.

    Comments Due: 5 p.m. ET 9/18/15.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: August 28, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-21981 Filed 9-3-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL15-95-000] Delaware Public Service Commission, Maryland Public Service Commission v. PJM Interconnection, LLC, Certain Transmission Owners Designated Under Attachment A to the Consolidated Transmission Owners Agreement, Rate Schedule FERC No. 42: Notice of Complaint

    Take notice that on August 28, 2015, pursuant to sections 206 of the Federal Power Act (FPA), 16 U.S.C. 824(e), and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206, Delaware Public Service Commission and Maryland Public Service Commission (Complainant) filed a formal complaint against PJM Interconnection, LLC (PJM) and Certain Transmission Owners Designated under Attachment A to the Consolidated Transmission Owners Agreement, Rate Schedule FERC No. 42 (Respondent) alleging that PJM tariff provisions requiring the use of a solution-based DFAX methodology to allocate the costs of the Artificial Island Project are unjust, unreasonable, and unduly discriminatory, in violation of the Federal Power Act, as more fully explained in the Complaint.

    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. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.

    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 electronic review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern Time on September 17, 2015.

    Dated: August 28, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-21989 Filed 9-3-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #2

    Take notice that the Commission received the following exempt wholesale generator filings:

    Docket Numbers: EG15-118-000.

    Applicants: South Plains Wind Energy, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of South Plains Wind Energy, LLC.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5212.

    Comments Due: 5 p.m. ET 9/18/15.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER15-36-001.

    Applicants: The Dayton Power and Light Company.

    Description: Compliance filing: FERC Rate Schedule No. 304, Village of Mendon to be effective 1/1/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5184.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-37-001.

    Applicants: The Dayton Power and Light Company.

    Description: Compliance filing: FERC Rate Schedule No. 305, Village of Waynesfield to be effective 1/1/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5186.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-38-001.

    Applicants: The Dayton Power and Light Company.

    Description: Compliance filing: FERC Rate Schedule No. 306, Village of Yellow Springs to be effective 1/1/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5187.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-40-001.

    Applicants: The Dayton Power and Light Company.

    Description: Compliance filing: FERC Rate Schedule No. 301, Village of Arcanum to be effective 1/1/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5189.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-41-001.

    Applicants: The Dayton Power and Light Company.

    Description: Compliance filing: FERC Rate Schedule No. 302, Village of Eldorado to be effective 1/1/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5193.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2560-000.

    Applicants: Southwest Power Pool, Inc.

    Description: Section 205(d) Rate Filing: 2198R19 Kansas Power Pool NITSA NOA to be effective 8/1/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5181.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2561-000.

    Applicants: DB Energy Trading LLC.

    Description: Tariff Cancellation: Notice of Cancellation of Market-Based Rate Tariff to be effective 10/27/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5211.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2562-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Section 205(d) Rate Filing: Revisions to OATT Schedule 12-Appdx A- RTEP approved by PJM Board in July 2015 to be effective 11/26/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5221.

    Comments Due: 5 p.m. ET 9/18/15.

    Docket Numbers: ER15-2563-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Section 205(d) Rate Filing: Revisions to OATT Schedule 12- Appdx A-RTEP Artificial Island Projects July 2015 to be effective 11/26/2015.

    Filed Date: 8/28/15.

    Accession Number: 20150828-5243.

    Comments Due: 5 p.m. ET 9/18/15.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: August 28, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-21982 Filed 9-3-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP15-137-000] Rockies Express Pipeline LLC; Notice of Availability of the Environmental Assessment for the Proposed Zone 3 Capacity Enhancement Project

    The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared an environmental assessment (EA) for the Zone 3 Capacity Enhancement Project, proposed by Rockies Express Pipeline LLC (REX) in the above-referenced docket. REX requests authorization to construct and operate natural gas compression facilities in Fayette, Pickaway, Muskingum, and Warren Counties, Ohio and Decatur County, Indiana. The REX Zone 3 Capacity Enhancement Project would provide an additional 800 million cubic feet per day of east-to-west transportation service.

    The EA assesses the potential environmental effects of the construction and operation of the Zone 3 Capacity Enhancement Project in accordance with the requirements of the National Environmental Policy Act. The FERC staff concludes that approval of the proposed project, with appropriate mitigating measures, would not constitute a major federal action significantly affecting the quality of the human environment.

    The proposed REX Zone 3 Capacity Enhancement Project includes the following facilities:

    • One new 49,428 horsepower (hp) compressor station in Pickaway County, Ohio (Columbus Compressor Station);

    • one new 31,791 hp compressor station in Fayette County, Ohio (Washington Court House Compressor Station);

    • one new 37,038 hp compressor station in Decatur County, Indiana (St. Paul Compressor Station);

    • an additional 38,400 hp of compression, gas cooling facilities, and a new power and control building at the existing Chandlersville Compressor Station in Muskingum County, Ohio; and

    • gas cooling facilities and a new power and control building at the existing Hamilton Compressor Station in Warren County, Ohio.

    The FERC staff mailed copies of the EA to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; potentially affected landowners and other interested individuals and groups; newspapers and libraries in the project area; and parties to this proceeding. In addition, the EA is available for public viewing on the FERC's Web site (www.ferc.gov) using the eLibrary link. A limited number of copies of the EA are available for distribution and public inspection at: Federal Energy Regulatory Commission, Public Reference Room, 888 First Street NE., Room 2A, Washington, DC 20426, (202) 502-8371.

    Any person wishing to comment on the EA may do so. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. The more specific your comments, the more useful they will be. To ensure that the Commission has the opportunity to consider your comments prior to making its decision on this project, it is important that we receive your comments in Washington, DC on or before September 30, 2015.

    For your convenience, there are three methods you can use to file your comments to the Commission. In all instances, please reference the project docket number (CP15-137-000) with your submission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or [email protected]

    (1) You can file your comments electronically using the eComment feature on the Commission's Web site (www.ferc.gov) under the link to Documents and Filings. This is an easy method for submitting brief, text-only comments on a project;

    (2) You can also file your comments electronically using the eFiling feature on the Commission's Web site (www.ferc.gov) under the link to Documents and Filings. With eFiling, you can provide comments in a variety of formats by attaching them as a file with your submission. New eFiling users must first create an account by clicking on “eRegister.” You must select the type of filing you are making. If you are filing a comment on a particular project, please select “Comment on a Filing”; or

    (3) You can file a paper copy of your comments by mailing them to the following address: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.

    Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214).1 Only intervenors have the right to seek rehearing of the Commission's decision. The Commission grants affected landowners and others with environmental concerns intervenor status upon showing good cause by stating that they have a clear and direct interest in this proceeding which no other party can adequately represent. Simply filing environmental comments will not give you intervenor status, but you do not need intervenor status to have your comments considered.

    1 See the previous discussion on the methods for filing comments.

    Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site (www.ferc.gov) using the eLibrary link. Click on the eLibrary link, click on “General Search,” and enter the docket number excluding the last three digits in the Docket Number field (i.e., CP15-137). Be sure you have selected an appropriate date range. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or for TTY, contact (202) 502-8659. The eLibrary link also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rulemakings.

    In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: August 31, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-21988 Filed 9-3-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14655-000] Cat Creek Energy, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications

    On December 12, 2014, Cat Creek Energy, LLC (Cat Creek) filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act, proposing to study the feasibility of the Cat Creek Energy Generation Facility Pumped Storage Hydroelectric Project (Cat Creek project). The project would be located at the US Bureau of Reclamation's (Reclamation) Anderson Ranch reservoir 1 on the South Fork of the Boise River near Mountain Home in Elmore County, Idaho.

    1 On November 24, 2014, Owyhee Hydro, LLC also filed a preliminary permit to use the Anderson Ranch reservoir as a lower reservoir for the Anderson Ranch Pumped Storage Hydroelectric Project (P-14648), and thus may be competing for the same water resource.

    The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.

    On December 19, 2014, the Commission asked Reclamation to confirm that non-federal development is authorized at the Anderson Ranch site. On January 30, 2015, Reclamation responded stating that it retains jurisdiction over hydropower development at the Anderson Ranch dam, reservoir, and powerhouse, which are part of Reclamation's Boise Project. On June 8, 2015, the Commission responded and agreed with Reclamation's jurisdictional decision over hydropower development at the Boise Project's Anderson Ranch dam, powerhouse, and reservoir. However, the Commission would retain jurisdiction for hydropower facilities that would be located outside of Reclamation's development. Thus, an entity seeking to build a hydropower project that would use Reclamation's Boise Project facilities would need to obtain a lease of power privilege from Reclamation, but it also would need to obtain a license from the Commission for those facilities of the hydropower project that are not under Reclamation's jurisdiction.

    On August 21, 2015, Cat Creek filed minor revisions to the original Cat Creek project permit application. The revised Cat Creek project would use the existing Anderson Ranch reservoir, and would consist of the following new facilities: (1) A 3.4-mile-long, 80-foot-high earthen dam; (2) a 38,000-acre-foot impoundment as an upper reservoir; (3) two, 5,600-foot-long, 22-foot-diameter steel penstocks; (4) two, 100-foot-diameter concrete silos; (5) two, 200-megawatt vertical Francis turbines/generators; (6) an 8.0-mile-long, 230- kilovolt transmission line interconnecting with the existing Bonneville Power Administration Dixie Substation; (7) an approximately 3.6-mile-long access road; and (8) appurtenant facilities. The estimated annual generation of the Cat Creek project would be 1,401.6 gigawatt-hours.

    Applicant Contact for the Cat Creek project: Nicholas Josten, Cat Creek Energy, LLC, 1989 South 1875 East, Gooding, ID 83330; phone: (208) 954-5090.

    FERC Contact: Karen Sughrue; phone: (202) 502-8556.

    Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.

    The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-14655-000.

    More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-14655) in the docket number field to access the document. For assistance, contact FERC Online Support.

    Dated: August 28, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-21985 Filed 9-3-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14681-000] Peterson Machinery Sales; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications

    On June 3, 2015, Peterson Machinery Sales filed an application for a preliminary permit under section 4(f) of the Federal Power Act proposing to study the feasibility of the proposed Boardman River Hydro-Electric Project No. 14681-000, to be located on the Boardman River near Traverse City, Grand Traverse County, Michigan. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.

    The proposed project consists of the Boardman Dam Development located at River Mile 6.1 and the Sabin Dam Development located at River Mile 5.3. The Boardman Dam Development would consist of: (1) A 103-acre Boardman Pond; (2) a 650-foot-long west earth-filled abutment, a 20-foot-wide emergency spillway, a 40-foot-long intake structure containing twin 10-foot-diameter by 73-foot-long steel penstocks leading to the powerhouse, and an approximately 150-foot-long earth-filled east abutment; (3) a 70-foot-long, 20-foot-wide reinforced concrete powerhouse containing a 1,000 kilowatt turbine-generator; and (4) appurtenant facilities.

    The Sabin Dam Development would consist of: (1) A 40-acre Sabin Pond; (2) a 60-foot-long earth west embankment, a 70-foot-long by 20-foot-wide reinforced concrete powerhouse integral with the dam containing a 500 kilowatt turbine-generator, a 52-foot-long intermediate earth embankment, a 32-foot-long stop wide spillway section, an 18-foot wide tainter gate spillway section, and a 330-foot-long earth east embankment; and (3) appurtenant facilities. The project would generate an estimated 7,600 megawatt hours annually.

    Applicant Contact: Charles R. Peterson, 9627 Seth Road, Northport, MI 49670; phone: 231-649-8706.

    FERC Contact: Sergiu Serban, (202) 502-6211.

    Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36. The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-14681-000.

    More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-14681) in the docket number field to access the document. For assistance, contact FERC Online Support.

    Dated: August 28, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-21986 Filed 9-3-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14648-000] Owyhee Hydro, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications

    On November 24, 2014, Owyhee Hydro, LLC (Owyhee Hydro) filed an application for preliminary permit, pursuant to section 4(f) of the Federal Power Act, proposing to study the feasibility of the Anderson Ranch Pumped Storage Hydroelectric Project (Anderson Ranch project). The project would be located at the U.S. Bureau of Reclamation's (Reclamation) Anderson Ranch dam and reservoir 1 on the South Fork of the Boise River near Mountain Home in Elmore County, Idaho.

    1 On December 12, 2014, Cat Creek Energy, LLC also filed for a preliminary permit to use the Anderson Ranch reservoir as a lower reservoir for the Cat Creek Energy Generation Facility Pumped Storage Hydroelectric Project (P-14655), and thus may be competing for the same water resource.

    The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.

    On December 4, 2014, the Commission asked Reclamation to confirm that non-federal development is authorized at the Anderson Ranch site. On January 30, 2015, Reclamation responded stating that it retains jurisdiction over hydropower development at the Anderson Ranch dam, reservoir, and powerhouse, which are part of Reclamation's Boise Project. On June 8, 2015, the Commission responded and agreed with Reclamation's jurisdictional decision over hydropower development at the Boise Project's Anderson Ranch dam, powerhouse, and reservoir. However, the Commission would retain jurisdiction for hydropower facilities that would be located outside of Reclamation's development. Thus, an entity seeking to build a hydropower project that would use Reclamation's Boise Project facilities would need to obtain a lease of power privilege from Reclamation, but it also would need to obtain a license from the Commission for those facilities of the hydropower project that are not under Reclamation's jurisdiction.

    On July 27, 2015, Owyhee Hydro filed a revised application providing an additional alternative to the proposed Anderson Ranch project. The revised Anderson Ranch project has three alternatives: Alternatives A, B, and C. Alternatives A and B would use the existing Anderson Ranch dam, reservoir, powerhouse, tailrace, and transmission lines, and would consist of the following new facilities: (1) A 1,060-foot-long, 65-foot-high zoned earth or concrete faced rockfill dam; (2) a 900-acre-foot impoundment as an upper reservoir; (3) a 4,180-foot-long, 9.1-foot-diameter single steel penstock (6.5-foot-diameter if twin conduit); (4) a single 80-megawatt (MW) reversible pump turbine/generator to be located within the third bay of the existing powerhouse; and (5) appurtenant facilities. Alternative C would use the existing Anderson Ranch dam, reservoir, and powerhouse, and would consist of the same new facilities as in Alternatives A and B except it would have: (1) A 4,180-foot-long, 9.1-foot-diameter single steel penstock (6.5-foot-diameter if twin conduit) and a 3,440-foot-long, 9.1-foot-diameter single steel penstock (6.5-foot-diameter if twin conduit); (2) a 250-foot-long, 90-foot-wide concrete powerhouse located adjacent to the existing Anderson Ranch reservoir; (3) a single 80-MW Pelton turbine/generator; and (4) a 3,400-foot-long, 69 or 115-kilovolt transmission line interconnecting with the existing Bonneville Power Administration Dixie Substation. The estimated annual generation for the Anderson Ranch project would be 175.2 gigawatt-hours.

    Applicant Contact for the Anderson Ranch project: Mr. Matthew Shapiro, Owyhee Hydro, LLC, 1210 W. Franklin St., Ste. 2, Boise, ID 83702; phone: (208) 246-9925.

    FERC Contact: Karen Sughrue; phone: (202) 502-8556.

    Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.

    The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-14648-000.

    More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-14648) in the docket number field to access the document. For assistance, contact FERC Online Support.

    Dated: August 28, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-21984 Filed 9-3-15; 8:45 am] BILLING CODE 6717-0-1P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14690-000] Blue River Hydro Power, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications

    On July 1, 2015, Blue River Hydro Power, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Blue River Hydroelectric Project (Blue River Project or project) to be located at Blue River Dam near the Town of Blue River in Lane County, Oregon. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.

    The proposed project would utilize flows at the existing Blue River Dam, and would consist of the following new features: (1) A 12-foot-diameter, 500-foot-long steel liner pipe installed in the downstream portion of the existing dam outlet tunnel, (2) a gatehouse containing two 7-foot-wide, 8-foot-high steel slidegates to regulate pipe pressure and release excess water, (3) a 9-foot- to 12-foot-diameter, 600-foot-long steel penstock, (4) a 70-foot-wide, 55-foot-long reinforced concrete powerhouse, (5) two 10 megawatt vertical-shaft Francis turbine/generators, (6) an approximately 40-foot-wide, 40-foot-long concrete tailrace returning flows to the Blue River, (7) a switchyard and a 2.5-mile-long, 12.5-kilovolt buried transmission line interconnecting with Lane Electric Cooperative's existing Blue River substation, and (8) appurtenant facilities. The estimated annual generation of the Blue River Project would be 50 gigawatt-hours.

    Applicant Contact: Mr. Rett Hubbard, Blue River Hydro Power, LLC, 285 East Oregon Avenue, Suite 7, Creswell, Oregon 97426; phone: (541) 632-4706.

    FERC Contact: Sean O'Neill; phone: (202) 502-6462.

    Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.

    The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-14690-000.

    More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-14690) in the docket number field to access the document. For assistance, contact FERC Online Support.

    Dated: August 28, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-21987 Filed 9-3-15; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL15-96-000] Backyard Farms Energy LLC, Devonshire Energy LLC: Notice of Petition for Declaratory Order

    Take notice that on August 27, 2015, in accordance with section 35.42(a)(2) of the regulations of the Federal Energy Regulatory Commission (Commission), 18 CFR 35.42(a)(2), Order No. 652,1 and Order No. 697,2 Backyard Farms Energy LLC and Devonshire Energy LLC (MBR Entities), filed a petition for declaratory order requesting that the Commission find that the MBR Entities are not affiliates of or under “common control” with the Fidelity Accounts or FIL Limited (FIL), or, in the alternative, that even if such an affiliation is deemed to exist, investments by the Fidelity Accounts or FIL would not affect the conditions relied upon by the Commission when granting market-based rate authorization to the extent such investments are passive investments, as more fully described in the petition.

    1Reporting Requirement for Changes in Status for Public Utilities With Market-Based Rate Authority, Order No. 652, 70 FR 8253 (Feb. 18, 2005), reh'g, 111 FERC ¶ 61,413 (2005).

    2Market-Based Rates for Wholesale Sales of Electric Energy, Capacity and Ancillary Services by Public Utilities, Order No. 697, 72 FR 39904 (July 20, 2007), clarified, 72 FR 72239 (Dec. 20, 2007), reh'g, Order No. 697-A, 73 FR 25832 (May 7, 2008) (“Order No. 697-A”), reh'g, 124 FERC ¶ 61,055 (2008), reh'g, Order No. 697-B, 73 FR 79610 (Dec. 30, 2008), reh'g, Order No. 697-C, 74 FR 30924 (June 29, 2009), reh'g, Order No. 697-D, 57 FR 14342 (March 25, 2010), clarified 131 FERC ¶ 61,021 (2010), reh'g denied, 134 FERC ¶ 61,046 (2011), reh'g denied, 143 FERC ¶ 61,126 (2013).

    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 September 28, 2015.

    Dated: August 28, 2015. Kimberly D. Bose, Secretary.
    [FR Doc. 2015-21983 Filed 9-3-15; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9933-59-Region 5] Proposed Prospective Purchaser Agreement for the Delco Chassis Industrial Land I & II Site in Livonia, Michigan AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice; request for public comment.

    SUMMARY:

    In accordance with the Prospective Purchaser Agreement, notice is hereby given of a proposed administrative settlement concerning a portion of the Delco Chassis Industrial Land I & II Site in Livonia, Michigan with the following settling party: Livonia West Commerce Center, LLC. The settlement requires the Settling Party to provide access to the Property, exercise due care with respect to existing contamination, and, if necessary, execute and record a Declaration of Restrictive Covenant. The settlement includes a covenant not to sue the Settling Party pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act or the Resource Conservation and Recovery Act with respect to the Existing Contamination. Existing Contamination is defined as any hazardous substances, pollutants, or contaminants or Waste Material present or existing on or under the Property as of the Effective Date of the Settlement Agreement; any hazardous substances, pollutants, or contaminants or Waste Material that migrated from the Property prior to the Effective Date of the Settlement Agreement; and any hazardous substances, pollutants, or contaminants or Waste Material presently at the Site that migrates onto, on, under, or from the Property after the Effective Date of the Settlement Agreement.

    For thirty (30) days following the date of publication of this notice, the Agency will receive written comments relating to the settlement. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at the EPA, Region 5, Records Center, 77 W. Jackson Blvd., 7th Fl., Chicago, Illinois 60604.

    DATES:

    Comments must be submitted on or before October 5, 2015.

    ADDRESSES:

    The proposed settlement is available for public inspection at the EPA, Region 5, Records Center, 77 W. Jackson Blvd., 7th Fl., Chicago, Illinois 60604. A copy of the proposed settlement may be obtained from Peter Felitti, Assoc. Regional Counsel, EPA, Office of Regional Counsel, Region 5, 77 W. Jackson Blvd., Mail Code: C-14J, Chicago, Illinois 60604. Comments should reference the Delco Chassis Industrial Land I & II Site, Livonia, Michigan and EPA Docket No. V-W-15-C-024 and should be addressed to Peter Felitti, Assoc. Regional Counsel, EPA, Office of Regional Counsel, Region 5, 77 W. Jackson Blvd., Mail Code: C-14J, Chicago, Illinois 60604.

    FOR FURTHER INFORMATION CONTACT:

    Peter Felitti, Assoc. Regional Counsel, EPA, Office of Regional Counsel, Region 5, 77 W. Jackson Blvd., Mail Code: C-14J, Chicago, Illinois 60604.

    SUPPLEMENTARY INFORMATION:

    The Settling Party proposes to acquire ownership of a portion of the former General Motors Corporation North American operation, at 12950 and 13000 Eckles Road, Livonia, Michigan. The EPA identification number for the RCRA corrective action responsibilities at the Delco Chassis Industrial Land I & II Site is # MID005356621. The Site is one of the 89 sites that were placed into an Environmental Response Trust (the “Trust”) as a result of the resolution of the 2009 GM bankruptcy. The Trust is administrated by Revitalizing Auto Communities Environmental Response.

    Dated: August 17, 2015. Samuel Borries, Acting Director, Superfund Division.
    [FR Doc. 2015-22029 Filed 9-3-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-9022-7] Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General Information (202) 564-7146 or http://www2.epa.gov/nepa.

    Weekly receipt of Environmental Impact Statements (EISs). Filed 08/24/2015 Through 08/28/2015. Pursuant to 40 CFR 1506.9. Notice

    Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

    EIS No. 20150245, Third Draft Supplemental, BOEM, TX, Gulf of Mexico OCS Oil and Gas Lease Sale 248, Comment Period Ends: 10/19/2015, Contact: Michelle Nannen 504-731-6682. EIS No. 20150246, Final, FHWA, IA, Eastern Hills Drive and Connecting Roadways, Review Period Ends: 10/05/2015, Contact: Michael La Pietra 515-233-7302. EIS No. 20150247, Final, USN, CA, LEGISLATIVE—Renewal of Naval Air Weapons Station China Lake Public Land Withdrawal, Review Period Ends: 10/05/2015, Contact: Teresa Bresler 619-532-4452. EIS No. 20150248, Draft, USAF, AK, United States Air Force F-35A Operational Beddown—Pacific, Comment Period Ends: 10/19/2015, Contact: Toni Ristau 907-377-2116. EIS No. 20150249, Final Supplement, BOEM, LA, Gulf of Mexico OCS Oil and Gas Lease Sales: 2016 and 2017, Central Planning Area Lease Sales 241 and 247, Eastern Planning Area Lease Sale 226, Review Period Ends: 10/05/2015, Contact: Gary D. Goeke 504-736-3233. EIS No. 20150250, Draft, USFS, WV, 2016-2020 Fernow Experimental Forest, Comment Period Ends: 10/19/2015, Contact: Thomas M. Schuler 304-478-2000. EIS No. 20150251, Draft, NOAA, USFWS, MI, PROGRAMMATIC—Restoration Resulting from the Kalamazoo River Natural Resource Damage Assessment, Comment Period Ends: 10/19/2015, Contact: Julie Sims 734-741-2385. The U.S. Department of the Interior's Fish and Wildlife Service and the U.S. Department of Commerce's National Oceanic and Atmospheric Administration are joint lead agencies for the above project. EIS No. 20150252, Final, USFWS, CO, Rocky Mountain Arsenal National Wildlife Refuge, Review Period Ends: 10/05/2015, Contact: Bernardo Garza 303-236-4377. Amended Notices EIS No. 20150177, Draft, NHTSA, REG, Phase 2 Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles, Comment Period Ends: 10/01/2015, Contact: James MacIsaac 202-366-9108 Revision to the FR Notice Published 06/26/2015; Extending the Comment Period from 08/31/2015 to 10/01/2015. Dated: September 1, 2015. Karin Leff, Acting Director, NEPA Compliance Division, Office of Federal Activities.
    [FR Doc. 2015-22019 Filed 9-3-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9927-86-OEI] Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Hawaii AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    This notice announces EPA's approval of the State of Hawaii's request to revise/modify certain of its EPA-authorized programs to allow electronic reporting.

    DATES:

    EPA's approval is effective September 4, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Karen Seeh, U.S. Environmental Protection Agency, Office of Environmental Information, Mail Stop 2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-1175, [email protected]

    SUPPLEMENTARY INFORMATION:

    On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the Federal Register (70 FR 59848) and codified as part 3 of title 40 of the CFR. CROMERR establishes electronic reporting as an acceptable regulatory alternative to paper reporting and establishes requirements to assure that electronic documents are as legally dependable as their paper counterparts. Subpart D of CROMERR requires that state, tribal or local government agencies that receive, or wish to begin receiving, electronic reports under their EPA-authorized programs must apply to EPA for a revision or modification of those programs and obtain EPA approval. Subpart D provides standards for such approvals based on consideration of the electronic document receiving systems that the state, tribe, or local government will use to implement the electronic reporting. Additionally, § 3.1000(b) through (e) of 40 CFR part 3, subpart D provides special procedures for program revisions and modifications to allow electronic reporting, to be used at the option of the state, tribe or local government in place of procedures available under existing program-specific authorization regulations. An application submitted under the subpart D procedures must show that the state, tribe or local government has sufficient legal authority to implement the electronic reporting components of the programs covered by the application and will use electronic document receiving systems that meet the applicable subpart D requirements.

    On July 23, 2015, the Hawaii Department of Health (HI DOH) submitted an application titled “State & Local Emissions Inventory” for revisions/modifications to its EPA-approved programs under title 40 CFR to allow new electronic reporting. EPA reviewed HI DOH's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the application met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Hawaii's request to revise/modify its following EPA-authorized programs to allow electronic reporting under 40 CFR parts 51, and 70 is being published in the Federal Register:

    Part 52—Approval and Promulgation of Implementation Plans; and

    Part 70—State Operating Permit Programs.

    HI DOH was notified of EPA's determination to approve its application with respect to the authorized programs listed above.

    Matthew Leopard, Director, Office of Information Collection.
    [FR Doc. 2015-22064 Filed 9-3-15; 8:45 am] BILLING CODE 6560-50-P
    FARM CREDIT ADMINISTRATION Farm Credit Administration Board; Sunshine Act; Regular Meeting AGENCY:

    Farm Credit Administration.

    SUMMARY:

    Notice is hereby given, pursuant to the Government in the Sunshine Act, of the regular meeting of the Farm Credit Administration Board (Board).

    Dates and Time: The regular meeting of the Board will be held at the offices of the Farm Credit Administration in McLean, Virginia, on September 10, 2015, from 9:00 a.m. until such time as the Board concludes its business.

    FOR FURTHER INFORMATION CONTACT:

    Dale L. Aultman, Secretary to the Farm Credit Administration Board, (703) 883-4009, TTY (703) 883-4056.

    ADDRESSES:

    Farm Credit Administration, 1501 Farm Credit Drive, McLean, Virginia 22102-5090. Submit attendance requests via email to [email protected] See SUPPLEMENTARY INFORMATION for further information about attendance requests.

    SUPPLEMENTARY INFORMATION:

    Parts of this meeting of the Board will be open to the public (limited space available), and parts will be closed to the public. Please send an email to [email protected] at least 24 hours before the meeting. In your email include: name, postal address, entity you are representing (if applicable), and telephone number. You will receive an email confirmation from us. Please be prepared to show a photo identification when you arrive. If you need assistance for accessibility reasons, or if you have any questions, contact Dale L. Aultman, Secretary to the Farm Credit Administration Board, at (703) 883-4009. The matters to be considered at the meeting are:

    Open Session A. Approval of Minutes • August 13, 2015 B. New Business • Fall 2015 Abstract of the Unified Agenda of Federal Regulatory and Deregulatory Actions and Fall 2015 Regulatory Projects Plan • Quarterly Report on Economic Conditions and FCS Conditions Closed Session* • Office of Examination Quarterly Report Dated: September 1, 2015. Dale L. Aultman, Secretary, Farm Credit Administration Board.

    * Session Closed—Exempt pursuant to 5 U.S.C. Section 552b(c)(8) and (9).

    [FR Doc. 2015-22548 Filed 9-2-15; 4:15 pm] BILLING CODE 6705-01-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 September 22, 2015.

    A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:

    1. Rodney L. Duroe, Jesup, Iowa, individually, and acting in concert with the Duroe Family Control Group consisting of Albert C. Duroe, Suzanne C. Duroe, Danielle M. Trumbauer, Jason P. Trumbauer, and other minor grandchildren, all of Jesup, Iowa; the William B. Dohrmann Revocable Trust and the Susan J. Dohrmann Revocable Trust, with William B. Dohrmann and Susan J. Dohrmann as co-trustees of both trusts, all of Fayette, Iowa; Linda Ellis and William Ellis, both of Newport Beach, California; to retain voting shares of FSB Financial Services Inc., and thereby indirectly acquire voting shares of Farmers State Bank, Waterloo, Iowa.

    B. Federal Reserve Bank of St. Louis (Yvonne Sparks, Community Development Officer) P.O. Box 442, St. Louis, Missouri 63166-2034:

    1. The Carl R. Landrum Trust A (Douglas B. Moore acting for Landmark Bank, National Association, Yulia Guseva, and Brenda L. Bingham, trustees); the Carl R. Landrum Trust B (Douglas B. Moore acting for Landmark Bank, National Association, Yulia Guseva, and Brenda L. Bingham, trustees); the Carl R. Landrum Trust, f/b/o John Bennett Landrum (Douglas B. Moore acting for Landmark Bank, National Association, John B. Landrum, and Brenda L. Bingham, trustees); the Carl R. Landrum Trust, f/b/o Jennifer Ruth Landrum (Douglas B. Moore acting for Landmark Bank, National Association, Jennifer R. Landrum, and Brenda L. Bingham, trustees); the Carl R. Landrum Trust, f/b/o Lara Jean Landrum (Douglas B. Moore acting for Landmark Bank, National Association, Lara J. Landrum, and Brenda L. Bingham, trustees); the Marquis C. Landrum Marital Trust (Douglas B. Moore acting for Landmark Bank, National Association, Yulia Guseva, and Brenda L. Bingham, trustees); the Marquis C. Landrum GSST Exempt Marital Trust (Douglas B. Moore acting for Landmark Bank, National Association, Yulia Guseva, and Brenda L. Bingham, trustees); the Marquis C. Landrum Residual Trust (Douglas B. Moore acting for Landmark Bank, National Association, Yulia Guseva, and Brenda L. Bingham, trustees); The Landrum Company ESOP (Douglas B. Moore acting for Landmark Bank, National Association, trustee); and The Landrum Company Combined Benefits Plan (Douglas B. Moore acting for Landmark Bank, National Association, trustee); all as members of The Landrum Control Group, all of Columbia, Missouri; to acquire voting shares of Landrum Company, and thereby indirectly acquire voting shares of Landmark Bank, N.A., both in Columbia, Missouri.

    C. Federal Reserve Bank of Minneapolis (Jacquelyn K. Brunmeier, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:

    1. Ann Groff, Victor, Montana, and Kay Clevidence Stevensville, Montana, individually, and Ryan Clevidence, and Sara Clevidence, both of Lolo, Montana, to retroactively join the Groff-Clevidence Family Control Group; to retain voting shares of Farmers State Financial Corporation, and thereby indirectly retain voting shares of Farmers State Bank, both in Victor, Montana.

    D. Federal Reserve Bank of San Francisco (Gerald C. Tsai, Director, Applications and Enforcement) 101 Market Street, San Francisco, California 94105-1579:

    1. Douglas Wayne Schmitt and Amber Marie Schmitt, both of Round Rock, Texas; DeAne Marie Blakley, Vancouver, Washington; Cheryl Ann Cornett, Hillsboro, Oregon; and Gary Gaye Schmitt, Vancouver, Washington; to acquire additional voting shares of Washington Bancorp, Inc., and thereby indirectly acquire additional voting shares of Bank of Washington, both in Lynnwood, Washington.

    Board of Governors of the Federal Reserve System, September 1, 2015. Michael J. Lewandowski, Associate Secretary of the Board.
    [FR Doc. 2015-21972 Filed 9-3-15; 8:45 am] BILLING CODE 6210-01-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 October 2, 2015.

    A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:

    1. Farmers Exchange Bancorporation, Inc., Cherokee, Oklahoma; to acquire 100 percent of the voting shares of The First National Bank of Nash, Nash, Oklahoma.

    Board of Governors of the Federal Reserve System, September 1, 2015. Michael J. Lewandowski, Associate Secretary of the Board.
    [FR Doc. 2015-21971 Filed 9-3-15; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Sunshine Act Amended; Notice of Meeting; September 10, 2015; 8:30 a.m.; In-Person Meeting PLACE:

    10th Floor Board Meeting Room, 77 K Street NE., Washington, DC 20002.

    STATUS:

    Open to the Public.

    MATTERS TO BE CONSIDERED:

    Closed Session 8:30 a.m.—10:00 a.m. 1. Procurement 2. Security Open Session 10:00 a.m.—11:30 a.m. 3. Approval of the Minutes for the August 24, 2015 Board Member Meeting 4. Monthly Reports (a) Monthly Participant Activity Report (b) Monthly Investment Report (c) Legislative Report 5. Auto Escalation 6. OCE Communication 7. FY 16 Budget Review and Approval 8. Audit Report 9. OERM Report Closed Session 11:30 a.m.—12:00 p.m. 1. Procurement Adjourn Contact Person For More Information:

    Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.

    Dated: August 27, 2015. James Petrick, General Counsel, Federal Retirement Thrift Investment Board.
    [FR Doc. 2015-22070 Filed 9-2-15; 11:15 am] BILLING CODE 6760-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-643 and CMS-10575] Agency Information Collection Activities: Submission for OMB Review; Comment Request ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments on the collection(s) of information must be received by the OMB desk officer by October 5, 2015.

    ADDRESSES:

    When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 or Email: [email protected]

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    Reports Clearance Office at (410) 786-1326.

    SUPPLEMENTARY INFORMATION:

    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. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

    1. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Hospice Survey and Deficiencies Report Form and Supporting Regulations; Use: We use the information collected as the basis for certification decisions for hospices that wish to obtain or retain participation in the Medicare and Medicaid programs. The information is used by CMS regional offices, which have the delegated authority to certify Medicare facilities for participation, and by State Medicaid agencies, which have comparable authority under Medicaid. The information on the Hospice Survey and Deficiencies Report Form is coded for entry into the OSCAR system. The data is analyzed by the CMS regional offices and by the CMS central office components for program evaluation and monitoring purposes. The information is also available to the public upon request. Form Number: CMS-643 (OMB control number: 0938-0379); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 3,976; Total Annual Responses: 1,325; Total Annual Hours: 1,325. (For policy questions regarding this collection contact Annette Snyder at 410-786-0807.)

    2. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Generic Clearance for the Heath Care Payment Learning and Action Network; Use: The Center for Medicare and Medicaid Services (CMS), through the Center for Medicare and Medicaid Innovation, develops and tests innovative new payment and service delivery models in accordance with the requirements of section 1115A and in consideration of the opportunities and factors set forth in section 1115A(b)(2) of the Act. To date, CMS has built a portfolio of 26 models (in operation or already announced) that have attracted participation from a broad array of health care providers, states, payers, and other stakeholders. During the development of models, CMS builds on ideas received from stakeholders—consulting with clinical and analytical experts, as well as with representatives of relevant federal and state agencies.

    On January 26, 2015, Secretary Burwell announced the ambitious goal to have 30% of Medicare Fee-For-Service payments tied to alternative payment models (such as Pioneer ACOs or bundled payment arrangements) by the end of 2016, and 50% of payments by the end of 2018. To reach this goal, CMS will continue to partner with stakeholders across the health care system to catalyze transformation through the use of alternative payment models. To this end, CMS launched the Health Care Payment Learning and Action Network, an effort to accelerate the transition to alternative payment models, identify best practices in their implementation, collaborate with payers, providers, consumers, purchasers, and other stakeholders, and monitor the adoption of value-based alternative payment models across the health care system. A system wide transition to alternative payment models will strengthen the ability of CMS to implement existing models and design new models that improve quality and decrease costs for CMS beneficiaries.

    The information collected from LAN participants will be used by the CMS Innovation Center to potentially inform the design, selection, testing, modification, and expansion of innovative payment and service delivery models in accordance with the requirements of section 1115A, while monitoring progress towards the Secretary's goal to increase the percentage of payments tied to alternative payment models across the U.S. health care system. In addition, the requested information will be made publically available so that LAN participants (payers, providers, consumers, employers, state agencies, and patients) can use the information to inform decision making and better understand market dynamics in relation to alternative payment models. Form Number: CMS-10575 (OMB control number: 0938-NEW); Frequency: Occasionally; Affected Public: Individuals; Private Sector (Business or other For-profit and Not-for-profit institutions), State, Local and Tribal Governments; Number of Respondents: 9,570; Total Annual Responses: 20,280; Total Annual Hours: 49,432. (For policy questions regarding this collection contact Dustin Allison at 410-786-8830.)

    Dated: September 1, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2015-22020 Filed 9-3-15; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-1728-94 and CMS-2567] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments must be received by November 3, 2015.

    ADDRESSES:

    When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

    1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

    2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number ____, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    Reports Clearance Office at (410) 786-1326.

    SUPPLEMENTARY INFORMATION:

    Contents

    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

    CMS-10387 Skilled Nursing Facility (SNF) Prospective Payment System and Consolidated Billing CMS-2567 Statement of Deficiencies and Plan of Correction and Supporting Regulations

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

    Information Collection

    1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Home Health Agency Cost Report; Use: Providers of Services participating in the Medicare program are required under sections 1815(a), 1833(e) and 1861(v)(1)(A) of the Social Security Act (42 U.S.C. 1395g) to submit annual information to achieve settlement of costs for health care services rendered to Medicare beneficiaries. In addition, regulations at 42 CFR 413.20 and 413.24 require adequate cost data and cost reports from providers on an annual basis. The Form CMS-1728-94 cost report is needed to determine a provider's reasonable cost incurred in furnishing medical services to Medicare beneficiaries and reimbursement due to or from a provider. Form Number: CMS-1728-94 (OMB control number: 0938-0022); Frequency: Annually; Affected Public: Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 11,352; Total Annual Responses: 11,352; Total Annual Hours: 2,576,904. (For policy questions regarding this collection contact Angela DiGorgio at 410-786-4516.)

    2. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Statement of Deficiencies and Plan of Correction Supporting Regulations; Use: Section 1864(a) of the Social Security Act requires that the Secretary use state survey agencies to conduct surveys to determine whether health care facilities meet Medicare and Clinical Laboratory Improvement Amendments participation requirements. The Form CMS-2567 is the means by which the survey findings are documented. This section of the law further requires that compliance findings resulting from these surveys be made available to the public within 90 days of such surveys. The Form CMS-2567 is the vehicle for this disclosure. The form is also used by health care facilities to document their plan of correction and by CMS, the states, facilities, purchasers, consumers, advocacy groups, and the public as a source of information about quality of care and facility compliance. The regulations at 42 CFR 488.18 require that state survey agencies document all deficiency findings on a statement of deficiencies and plan of correction, which is the CMS-2567. Sections 488.26 and 488.28 further delineate how compliance findings must be recorded and that CMS prescribed forms must be used. Form Number: CMS-2567 (OMB Control Number: 0938-0391); Frequency: Yearly and occasionally; Affected Public: Private Sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 64,500; Total Annual Responses: 64,500; Total Annual Hours: 128,083. (For policy questions regarding this collection contact Sharon Lash at 410-786-9457.)

    Dated: September 1, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2015-22033 Filed 9-3-15; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request

    Title: Assets for Independence (AFI) Program Evaluation.

    OMB No.: 0970-0414.

    Description: The U.S. Department of Health and Human Services, Administration for Children and Families (ACF) is proposing a data collection activity as part of an experimental evaluation of the Assets for Independence (AFI) Program. The purpose of this study is to assess the impact of participation in AFI-funded individual development account (IDA) projects on the savings, asset purchases, and economic well-being of low-income individuals and families. While some evaluations suggest that IDAs help low-income families save, rigorous experimental research is limited. Few studies have focused on AFI-funded IDAs, and few have tested alternative design features. The Assets for Independence Evaluation is the first experimental evaluation of IDA projects operating under the Assets for Independence Act, and will contribute importantly to understanding the effects of IDA project participation on project participants. The evaluation was launched in fall 2011 in two sites, with the random assignment of AFI-eligible cases to program and control groups. OMB approved three data collection efforts related to this project in October 2012, including approval of a baseline survey, 12-month follow-up survey, and implementation study protocols.

    This Federal Register Notice provides the opportunity to comment on a proposed new information collection activity: The AFI Evaluation second follow-up survey (at 36 months post-random assignment) of both treatment and control group members. The content of this survey is the same as the content approved for the 12-month follow-up. The purpose of the AFI Evaluation 36-month follow-up survey is to follow-up with study participants to document their intermediate savings and savings patterns, asset purchases, and other economic outcomes. The evaluation consists of both an impact study and an implementation study. Data collection activities will span a three-year period. Data collection activities to submit in a future information collection request include a third follow-up survey for AFI Evaluation study participants approximately 60 months after study enrollment.

    Respondents: Individuals enrolled in AFI programs, individuals who have left AFI programs, and control group members.

    Annual Burden Estimates Instrument Total number of respondents Annual
  • number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • Annual burden hours
    Follow-Up Survey: AFI-eligible participants 814 271 1 1 271

    Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]

    OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected], Attn: Desk Officer for the Administration for Children and Families.

    Robert Sargis, ACF Reports Clearance Officer.
    [FR Doc. 2015-22014 Filed 9-3-15; 8:45 am] BILLING CODE 4184-26-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Health Resources and Services Administration Notice of Meeting: Advisory Committee on the Maternal, Infant and Early Childhood Home Visiting Program Evaluation ACTION:

    Notice of meeting: Advisory Committee on the Maternal, Infant and Early Childhood Home Visiting Program Evaluation (MIECHVPE).

    Authority: Section 511(g)(1) of the Social Security Act (42 U.S.C. 711(g)) and Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463).

    Name: Advisory Committee on the Maternal, Infant, and Early Childhood Home Visiting Program Evaluation.

    Date and Time: Monday, September 21, 2015, 11 a.m.-6 p.m. EST.

    Place: Webinar.

    The Advisory Committee on the Maternal, Infant and Early Childhood Home Visiting Program Evaluation (Committee) will meet for its fifth session on Monday, September 21, 2015, 11 a.m.-6 p.m. ET. The purpose of the meeting is to allow the Committee to comment on the analysis plan of the MIHOPE project. The general public (“attendees”) can join the meeting via webinar by logging onto https://attendee.gotowebinar.com/register/8910471186935462146, and then follow the instructions for registering. Attendees should launch the webinar no later than 10:45 a.m. ET in order for the logistics to be established for participation in the call. If there are technical problems gaining access to the call or webinar, please call 888-569-3848 or press *0, and for GoToWebinar technical support call 800-263-6317.

    Meeting Registration: Attendees are asked to register for the conference by going to the registration Web site at https://attendee.gotowebinar.com/register/8910471186935462146.

    Special Accommodations: Attendees with special needs requiring accommodations such as large print materials or other accommodations may make requests when registering at the online Web site by answering the “Special accommodations” question on the registration page: https://attendee.gotowebinar.com/register/8910471186935462146.

    Agenda: The meeting will include updates on the progress of the evaluation and will present the evaluation's impact, implementation, impact variation, and cost data analysis plans. Agenda items are subject to change as priorities dictate.

    Public Comments: Members of the public may submit written comments that will be distributed to Committee members prior to the meeting. Written comments must be received by Monday, September 14, 2015 for consideration. Comments can be submitted to Nancy Margie at [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Any person interested in obtaining other information relevant to joining the webinar can contact Carolyn Swaney at [email protected]

    SUPPLEMENTARY INFORMATION:

    The Advisory Committee on the Maternal, Infant and Early Childhood Home Visiting (MIECHV) Program Evaluation is authorized by subsection 511(g)(1) of Title V of the Social Security Act (42 U.S.C. 711(g)(1)) as added by section 2951 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) (Affordable Care Act) and amended by Public Law 114-10 (Medicare Access and CHIP Reauthorization Act of 2015), Section 218.

    The purpose of the Committee is to review, and make recommendations on, the design and plan for the evaluation required under paragraph 511(g)(2); maintain and advise the Secretary regarding the progress of the evaluation; and comment, if the Committee so desires, on the report submitted to Congress under subsection 511(g)(3).

    The Department of Health and Human Services has contracted with MDRC (formerly known as Manpower Demonstration Research Corporation), a nonprofit, nonpartisan education and social policy research organization, to conduct the evaluation of the MIECHV program.

    As specified in the legislation, the evaluation provided a state-by-state analysis of the needs assessments and the States' actions in response to the assessments. Additionally, as specified in the legislation, the evaluation will provide an assessment of: (a) T he effect of early childhood home visiting programs on outcomes for parents, children, and communities with respect to domains specified in the authorizing legislation (such as maternal and child health status, school readiness, and domestic violence, among others); (b) the effectiveness of such programs on different populations, including the extent to which the ability to improve participant outcomes varies across programs and populations; and (c) the potential for the activities conducted under such programs, if scaled broadly, to enhance health care practices, eliminate health disparities, improve health care system quality, and reduce costs.

    Naomi Goldstein, Director, Office of Planning, Research, and Evaluation, ACF. Michael Lu, Associate Administrator, Maternal and Child Health Bureau, HRSA.
    [FR Doc. 2015-21332 Filed 9-3-15; 8:45 am] BILLING CODE 4184-74-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request AGENCY:

    Health Resources and Services Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

    DATES:

    Comments on this ICR should be received no later than October 5, 2015.

    ADDRESSES:

    Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to [email protected] or by fax to 202-395-5806.

    FOR FURTHER INFORMATION CONTACT:

    To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443-1984.

    SUPPLEMENTARY INFORMATION: Information Collection Request Title: Providing Primary Care and Preventive Medical Services in Ryan White-Funded Medical Care Settings, OMB No. 0915-xxxx—New

    Abstract: Since 1990, the Ryan White HIV/AIDS Program (Ryan White Program) has funded the provision of HIV care to eligible persons living with HIV (PLWH). With the advent of effective antiretroviral treatment, PLWH are living longer and normal lives. With this shift, PLWH are beginning to experience typical health issues that come with aging. Ryan White Program-funded clinics are seeing their patients develop other common preventable chronic diseases such as diabetes, heart disease, and hypertension. In addition, clinicians need to address non-primary care issues such mental health and substance abuse issues that are prevalent to PLWH and interferes with managing and treating HIV and other conditions. By shifting HIV care into a broader system of primary care, including preventative care, clinics can offer a more holistic approach to further improving the lives of PLWH.

    However, with limited resources, these Ryan White-funded clinics may struggle to provide primary and preventative care services in-house or have insufficient referral systems. This study will examine how Ryan White-funded clinics are integrating the provision of primary and preventative care services to the overall HIV care model. Specifically, it will look at the protocols and strategies used by clinics to manage care for PLWH, specifically care coordination, referral systems, and patient-centered strategies to keep PLWH in care.

    Need and Proposed Use of the Information: The proposed study will provide the HRSA HIV/AIDS Bureau and policymakers with a better understanding of how the Ryan White Program currently provides primary and preventative care to PLWH. The first online survey will be targeted to clinic directors from a sample of about 160 Ryan White-funded clinics and will collect data on care models used; primary care services, including preventive services; and coordination of care. Data collected from this survey will provide the HIV/AIDS Bureau with a general overview of the various HIV care models used as well as insight to possible facilitators and barriers to providing primary and preventative care services. More in-depth data collection will be conducted with a smaller number of 30 clinics representing clinic type (publicly funded community health organization, other community-based organization, health department, and hospital or university-based) and size. There will be three data collection instruments used: (1) an online survey completed by three clinicians at each of the clinics, (2) a data extraction of select primary and preventative care services, and (3) a telephone interview with the medical director. The clinician survey will provide a more in-depth look at the clinic protocols and strategies and how they are being used and implemented by the clinicians. The data extraction will provide quantitative information on the provision of select primary and preventative care services within a certain time period. With these data, the study team can assess the accuracy of information provided in the online surveys on the provision of care. Lastly, the interviews with the medical director will allow the study team to follow-up on the results of the survey and data extraction and collect qualitative data and more in-depth details on the provision of primary and preventative care services, specifically any facilitators and barriers. These data will provide the HIV/AIDS Bureau with the background to make informed policies and changes to the Ryan White Program in this new era when the well-being of PLWH demands a more complex and long-term HIV care model.

    Likely Respondents: Clinics funded by the Ryan White HIV/AIDS Program.

    Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. 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. The total annual burden hours estimated for this ICR are summarized in the table below.

    Total Estimated Annualized Burden—Hours

    Form name Number of
  • responses
  • Number of
  • responses per
  • respondents
  • Total
  • responses
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden hours for all responses
    Clinic Director Online Survey 130 1 130 0.5 65 Clinician Online Survey 90 1 90 0.5 45 Data Extraction 30 1 30 4.0 120 Medical Director Interview Guide 30 1 30 0.5 15 Total 280 280 245
    Jackie Painter, Director, Division of the Executive Secretariat.
    [FR Doc. 2015-22058 Filed 9-3-15; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY:

    National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    SUMMARY:

    HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Westinghouse Electric Corp. in Bloomfield, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

    FOR FURTHER INFORMATION CONTACT:

    Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, NIOSH, 1090 Tusculum Avenue, MS C-46, Cincinnati, OH 45226-1938, Telephone 877-222-7570. Information requests can also be submitted by email to [email protected]

    SUPPLEMENTARY INFORMATION:

    Authority: 42 U.S.C. 7384q(b). 42 U.S.C. 7384l(14)(C).

    On July 28, 2015, as provided for under 42 U.S.C. 7384l(14)(C), the Secretary of HHS designated the following class of employees as an addition to the SEC:

    All Atomic Weapons Employees who worked at the facility owned by Westinghouse Electric Corp., in Bloomfield, New Jersey, during the period from February 1, 1958, through May 31, 1958, or during the period from June 1, 1959, through June 30, 1959, for a number of work days aggregating at least 250 work days, occurring either solely under this employment, or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort.

    This designation became effective on August 27, 2015. Therefore, beginning on August 27, 2015, members of this class of employees, defined as reported in this notice, became members of the SEC.

    John Howard, Director, National Institute for Occupational Safety and Health.
    [FR Doc. 2015-22042 Filed 9-3-15; 8:45 am] BILLING CODE 4163-19P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Secretarial Review and Publication of the Annual Report to Congress and the Secretary Submitted by the Consensus-Based Entity Regarding Performance Measurement AGENCY:

    Office of the Secretary of Health and Human Services, HHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice acknowledges the Secretary of the Department of Health and Human Services' (HHS) receipt and review of the 2015 Annual Report to Congress and the Secretary submitted by the consensus-based entity (CBE) in contract with the Secretary as mandated by section 1890(b)(5) of the Social Security Act, which was created by section 183 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) and amended by section 3014 of the Patient Protection and Affordable Care Act of 2010. The statute requires the Secretary to review and publish the report in the Federal Register together with any comments of the Secretary on the report not later than six months after receiving the report. This notice fulfills those requirements.

    FOR FURTHER INFORMATION CONTACT:

    Corette Byrd, (410) 786-1158.

    The order in which information is presented in this notice is as follows:

    I. Background II. The 2015 Annual Report to Congress and the Secretary: “National Quality Forum Report of 2014 Activities to Congress and the Secretary of the Department of Health and Human Services” III. Secretarial Comments on the 2015 Annual Report to Congress and the Secretary IV. Future Steps V. Collection of Information Requirements I. Background

    In recent years we have seen significant improvements in many important dimensions of the quality of the nation's health care. The 2014 National Quality and Disparities Report, published in April 2015 by the Agency for Healthcare Research and Quality and available at http://www.ahrq.gov/research/findings/nhqrdr/nhqdr14/index.html, shows, for example, significant improvement in the quality of hospital care in 2013, with an estimated 1.3 million fewer harmful conditions acquired by patients while in the hospital and 50,000 fewer deaths occurred during hospital stays as compared to 2010. However, the Report also indicates that there are many challenges to improving quality in health care across the nation. The Report shows that many patients are still potentially harmed by the care they receive, and only 70 percent of recommended care is received by patients as assessed by a broad array of quality measurements. It also shows that people of low income and racial and ethnicity minorities often receive lesser quality health care.

    To address these problems, the Department of Health and Human Services is working to improve the nation's health care delivery system so that the care provided when people are ill is consistently high quality, and that healthy people are helped to stay healthy. Similarly, many States are leveraging their purchasing power to achieve these same ends; and in the private sector, provider organizations, accrediting bodies, foundations, and other non-profit organizations are working to target and align efforts to quicken the pace of improvement.

    An essential factor for the success of all these efforts is the accurate, valid, and reliable measurement of the quality (and efficiency) of health care. Recognizing the need for good quality measures, the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) created section 1890 of the Social Security Act (the Act), which requires the Secretary of HHS to contract with a consensus-based entity (CBE) to perform multiple duties pertaining to healthcare performance measurement. Section 3011 of the Patient Protection and Affordable Care Act of 2010 (ACA) expanded the activities of the CBE in improving health care quality.

    In January of 2009, a competitive contract was awarded by HHS to the National Quality Forum (NQF) to fulfill requirements of section 1890 of the Act. A second, multi-year contract was awarded to NQF again after an open competition in 2012. This contract includes the following duties as mandated by section 1890(b) of the Act:

    Priority Setting Process: Formulation of a National Strategy and Priorities for Health Care Performance Measurement. The CBE is to synthesize evidence and convene key stakeholders to make recommendations on an integrated national strategy and priorities for health care performance measurement in all applicable settings. In doing so, the CBE is to give priority to measures that: (a) Address the health care provided to patients with prevalent, high-cost chronic diseases; (b) have the greatest potential for improving quality, efficiency and patient-centered health care; and (c) may be implemented rapidly due to existing evidence, standards of care or other reasons. Additionally, the CBE must take into account measures that: (a) May assist consumers and patients in making informed health care decisions; (b) address health disparities across groups and areas; and (c) address the continuum of care across multiple providers, practitioners and settings.

    Endorsement of Measures: The CBE is to provide for the endorsement of standardized health care performance measures. This process must consider whether measures are evidence-based, reliable, valid, verifiable, relevant to enhanced health outcomes, actionable at the caregiver level, feasible to collect and report, responsive to variations in patient characteristics such as health status, language capabilities, race or ethnicity, and income level and are consistent across types of health care providers including hospitals and physicians.

    Maintenance of CBE Endorsed Measures. The CBE is required to establish and implement a process to ensure that endorsed measures are updated (or retired if obsolete) as new evidence is developed.

    Review and Endorsement of an Episode Grouper Under the Physician Feedback Program. “Episode-based” performance measurement is an approach to better understanding the utilization and costs associated with a certain condition by grouping together all the care related to that condition. “Episode groupers” are software tools that combine data to assess such condition-specific utilization and costs over a defined period of time. The CBE is required to provide for the review, and as appropriate, endorsement of an episode grouper as developed by the Secretary.

    Convening Multi-Stakeholder Groups. The CBE must convene multi-stakeholder groups to provide input on: (1) The selection of certain categories of quality and efficiency measures, from among such measures that have been endorsed by the entity; and such measures that have not been considered for endorsement by such entity but are used or proposed to be used by the Secretary for the collection or reporting of quality and efficiency measures; and (2) national priorities for improvement in population health and in the delivery of health care services for consideration under the national strategy. The CBE provides input on measures for use in certain specific Medicare programs, for use in programs that report performance information to the public, and for use in health care programs that are not included under the Social Security Act. The multi-stakeholder groups provide input on measures to be implemented through the federal rulemaking process for various federal health care quality reporting and quality improvement programs including those that address certain Medicare services provided through hospices, hospital inpatient and outpatient facilities, physician offices, cancer hospitals, end stage renal disease (ESRD) facilities, inpatient rehabilitation facilities, long-term care hospitals, psychiatric hospitals, and home health care programs.

    Transmission of Multi-Stakeholder Input. Not later than February 1 of each year, the CBE is to transmit to the Secretary the input of multi-stakeholder groups.

    Annual Report to Congress and the Secretary. Not later than March 1 of each year the CBE is required to submit to Congress and the Secretary of HHS an annual report. The report is to describe:

    (i) The implementation of quality and efficiency measurement initiatives and the coordination of such initiatives with quality and efficiency initiatives implemented by other payers;

    (ii) recommendations on an integrated national strategy and priorities for health care performance measurement;

    (iii) performance of the CBE's duties required under its contract with HHS;

    (iv) gaps in endorsed quality and efficiency measures, including measures that are within priority areas identified by the Secretary under the national strategy established under section 399HH of the Public Health Service Act (National Quality Strategy), and where quality and efficiency measures are unavailable or inadequate to identify or address such gaps;

    (v) areas in which evidence is insufficient to support endorsement of quality and efficiency measures in priority areas identified by the Secretary under the National Quality Strategy, and where targeted research may address such gaps; and

    (vi) the convening of multi-stakeholder groups to provide input on: (1) The selection of quality and efficiency measures from among such measures that have been endorsed by the CBE and such measures that have not been considered for endorsement by the CBE but are used or proposed to be used by the Secretary for the collection or reporting of quality and efficiency measures; and (2) national priorities for improvement in population health and the delivery of health care services for consideration under the National Quality Strategy.

    The statutory requirements for the CBE to annually report to Congress and the Secretary of HHS also specify that the Secretary of HHS must review and publish the CBE's annual report in the Federal Register, together with any comments of the Secretary on the report, not later than six months after receiving it.

    This Federal Register notice complies with the statutory requirement for Secretarial review and publication of the CBE's annual report. NQF submitted a report on its 2014 activities to the Secretary on February 25, 2015. This 2015 annual report to Congress and the Secretary of the Department of Health and Human Services (dated March 1, 2015) is presented below in Section II. Comments of the Secretary on this report are presented below in section III.

    II. The 2015 Annual Report to Congress and the Secretary: “NQF Report of 2014 Activities to Congress and the Secretary of the Department of Health and Human Services” NQF Report on 2014 Activities to Congress and the Secretary of the Department of Health and Human Services I. Executive Summary

    Over the last seven years, Congress has passed two statutes with several extensions that call upon the Department of Health and Human Services (HHS) to work with a consensus-based entity (the “Entity”) to facilitate multistakeholder input into (1) setting national priorities for improvement in population health and quality, and (2) recommending use of quality and efficiency measures. The first of these statutes is the 2008 Medicare Improvements for Patients and Providers Act (MIPPA) (PL 110-275), which established the responsibilities of the consensus-based entity by creating section 1890 of the Social Security Act. The second statute is the 2010 Patient Protection and Affordable Care Act (ACA) (PL 111-148), which modified and added to the consensus-based entity's responsibilities. The American Taxpayer Relief Act of 2012 (PL 112-240) extended funding under the MIPPA statute to the consensus-based entity through fiscal year 2013. The Protecting Access to Medicare Act of 2014 (PL113-93) extended funding under the MIPPA and ACA statutes to the consensus-based entity through March 31, 2015. HHS has awarded contracts to the consensus-based entity identified in the statute which is currently the National Quality Forum (NQF).

    These laws specifically charge the Entity to report annually on its work:

    As amended by the above laws, the Social Security Act (the Act)—specifically section 1890(b)(5)(A)—also mandates that the entity report to Congress and the Secretary of HHS no later than March 1st of each year. The report must include descriptions of: (1) How NQF has implemented quality and efficiency measurement initiatives under the Act and coordinated these initiatives with those implemented by other payers; (2) NQF's recommendations with respect to activities conducted under the Act; (3) NQF's performance of the duties required under its contract with HHS; (4) gaps in endorsed quality and efficiency measures, including measures that are within priority areas identified by the Secretary under HHS' National Quality Strategy; (5) areas in which evidence is insufficient to support endorsement of quality and efficiency measures in priority areas identified by the National Quality Strategy, and where targeted research may address such gaps; and (6) the matters described in clauses (i) and (ii) of paragraph (7)(A) of section 1890(b).1

    This sixth Annual Report highlights NQF's work conducted between January 1, 2014 and December 31, 2014 related to these statutes and conducted under contract with HHS. The deliverables produced under contract in 2014 are referenced throughout this report, and a full list is included in Appendix A.

    In addition to NQF's statutorily mandated work, NQF worked with federal partners such as the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) in 2014 on a lean improvement project in order to streamline its endorsement processes. Also in 2014, NQF began to work with CMS and private insurers to further the uniform use of measures (commonly referred to as alignment) between the public and private sectors. Both of these initiatives were funded by NQF without the support of federal funds.

    Recommendations on the National Quality Strategy and Priorities

    Section 1890(b)(1) of the Social Security Act (the Act), mandates that the consensus-based entity (CBE) also required under section 1890 of the Act shall “synthesize evidence and convene key stakeholders to make recommendations . . . on an integrated national strategy and priorities for healthcare performance measurement in all applicable settings.” In making such recommendations, the entity shall ensure that priority is given to measures that address the healthcare provided to patients with prevalent, high-cost chronic diseases, that focus on the greatest potential for improving the quality, efficiency, and patient-centeredness of healthcare, and that may be implemented rapidly due to existing evidence and standards of care, or other reasons. In addition, the entity will take into account measures that may assist consumers and patients in making informed healthcare decisions, address health disparities across groups and areas, and address the continuum of care a patient receives, including services furnished by multiple healthcare providers or practitioners and across multiple settings.

    In 2010, at the request of the Department of Health and Human Services (HHS), the NQF-convened National Priorities Partnership (NPP) provided input that helped shape the initial version of the National Quality Strategy (NQS). 2 The NQS was released in March 2011, setting forth a cohesive roadmap for achieving better, more affordable care, and better health. Upon the release of the NQS, HHS accentuated the word `national' in its title, emphasizing that healthcare stakeholders across the country, both public and private, all play a role in making the NQS a success.

    NQF has continued to further the NQS by convening diverse stakeholder groups to reach consensus on key strategies for improvement. In 2014, NQF completed work in several emerging areas of importance that address the National Quality Strategy, such as how to improve population health within communities; how to organize measures and other meaningful information to help consumers make informed healthcare decisions in the federal exchange marketplace; and how to dramatically improve patient safety in high-priority areas such as maternity care, avoidable readmissions, and patient- and family-centered engagement. NQF also continued its work in support of the Common Formats, which helps standardize electronic reporting of patient safety event data.

    Quality and Efficiency Measurement Initiatives (Performance Measures)

    Under section 1890(b)(2) and (3) of the Act, the entity must provide for the endorsement of standardized healthcare performance measures. The endorsement process shall consider whether measures are evidence-based, reliable, valid, verifiable, relevant to enhanced health outcomes, actionable at the caregiver level, feasible for collecting and reporting data, responsive to variations in patient characteristics, and consistent across healthcare providers. In addition, the entity must maintain endorsed measures, including updating endorsed measures or retiring obsolete measures as new evidence is developed.

    Since its inception in 1999, NQF has developed a portfolio that covers many aspects of measurement and currently contains approximately 600 measures which are in widespread use across an array of settings. About 300 NQF-endorsed measures are used in more than 20 federal public reporting and pay-for-performance programs; these and other measures are also used in private sector and state programs.

    Over the past several years, NQF in partnership with HHS and private-sector stakeholders has worked to evolve the science of performance measurement. This effort has included placing greater emphasis on both evidence behind a measure and ensuring a clear link to outcomes; a focus on addressing key measurement gaps, including measures related to care coordination and patient experience; and implementation of a requirement that testing of measures demonstrate their reliability and validity. In addition, NQF has moved from convening experts for the duration of a project to using standing committees to be able to respond in real time to newly published research to ensure its endorsed measures are accurate, evidence-based, and meaningful.

    NQF also has laid the foundation for the next generation of measures by providing guidance on criteria to evaluate episode groupers, as well as how and when to incorporate socioeconomic (SES) and sociodemographic factors in measurement. Beginning in January 2015, NQF will undertake a two year trial period during which measure developers will be invited to submit measures that take into account socioeconomic and sociodemographic factors where appropriate. These measures would be eligible for NQF endorsement and are required to include the non-risk-adjusted, stratified, and socioeconomically adjusted measures. This trial period will enable the field to compare measures which are adjusted and not adjusted for SES and to consider the implications of adjustment. When the trial period is over, NQF will determine if its endorsement criteria should be permanently changed to include SES adjustment where appropriate.

    Across six HHS-funded projects in 2014, NQF added 98 measures to its portfolio. Forty-eight of these measures were new measure submissions, and 50 were measures that retained their NQF endorsement. Twenty-seven of the 98 endorsed measures are outcome measures, 59 are process measures, 7 are composite measures, 2 are structural measures, and 3 are cost and resource use measures.

    In 2014, NQF endorsed measures in order to:

    Drive the system to be more responsive to patient/family needs—In 2014, this effort included Person- and Family-Centered Care and Care Coordination endorsement projects, including patient-reported outcomes and patient experience surveys. These measures are used in programs such as the Hospital Inpatient Quality Reporting (IQR) Program and Physician Quality Reporting System (PQRS) and are also reported on the Hospital Compare Web site.

    Improve care for highly prevalent conditions—NQF's work included Cardiovascular, Endocrine, and Musculoskeletal endorsement projects in 2014. NQF-endorsed measures in these areas are used in the Hospital IQR Program and PQRS.

    Emphasize cross-cutting areas to foster better care and coordination—In 2014, this effort included Behavioral Health and Patient Safety endorsement projects. NQF-endorsed measures in these areas are used in the Home Health Quality Reporting Program, Hospital IQR Program, the Inpatient Psychiatric Facility Quality Reporting Program, and PQRS.

    Support new accountability efforts coming online—NQF's work included Cost/Resource Use and Readmission endorsement projects. For example, the NQF-endorsed readmissions measures are used in CMS' Hospital Readmissions Reduction Program and Physician Value-Based Payment Modifier Program.

    During 2014, NQF also removed 93 measures from its portfolio for a variety of reasons: Measures no longer met endorsement criteria; measures were harmonized with other similar, competing measures; measure developers chose to retire measures they no longer wished to maintain; a better, substitute measure was submitted; or measures “topped out,” with providers consistently performing at the highest level. Consistently culling the portfolio through these means and through the measure maintenance process ensures that the NQF portfolio is relevant to the most current practices in the field.

    In September 2014, HHS awarded NQF additional measure endorsement projects, addressing topics such as eye, ear, nose, and throat conditions; renal, surgery, and cardiovascular conditions; and patient safety. NQF has begun work on these projects by issuing calls for measures to be reviewed and considered for endorsement.

    Stakeholder Recommendations on Quality and Efficiency Measures and National Priorities

    Under section 1890A of the Act, HHS is required to establish a pre-rulemaking process under which a consensus-based entity (currently NQF) would convene multistakeholder groups to provide input to the Secretary on the selection of quality and efficiency measures for use in certain federal programs. The list of quality and efficiency measures HHS is considering for selection is to be publicly published no later than December 1 of each year. No later than February 1 of each year, the consensus-based entity (NQF) is to report to HHS the input of the multistakeholder groups, which will be considered by HHS in the selection of quality and efficiency measures.

    The Measure Applications Partnership (MAP) is a public-private partnership convened by NQF to provide input to HHS on the selection of performance measures for more than 20 federal public reporting and performance-based payment programs. MAP brings together approximately 150 healthcare leaders and experts representing nearly 90 private-sector organizations as well as federal liaisons from 7 different agencies for an intensive annual review of measures being considered by HHS. HHS then takes these recommendations under consideration as it develops and updates the regulations that govern these programs.

    In 2014, HHS requested that MAP review measures for 20 federal public reporting and payment programs. MAP's work fosters use of a more uniform set of measures across federal programs and across the public and private sectors. This uniformity—commonly referred to as alignment—helps providers better identify key areas in which to improve quality; reduces wasteful data collection for hospitals, physicians, and nurses; and helps to curb the proliferation of redundant measures which could confuse patients and payers.

    MAP also developed “families of measures” (groups of measures selected to work together across settings of care in pursuit of specific healthcare improvement goals) for the high-priority areas of affordability, population health, and person- and family-centered care; and provided input on measures for vulnerable populations, including Medicare-Medicaid enrollees and adults and children enrolled in Medicaid.

    Gaps in Endorsed Quality and Efficiency Measures and Evidence and Targeted Research Needs

    Under section 1890(b)(5)(iv) of the Act, the entity is required to describe gaps in endorsed quality and efficiency measures, including measures within priority areas identified by HHS under the agency's National Quality Strategy, and where quality and efficiency measures are unavailable or inadequate to identify or address such gaps. Under section 1890(b)(5)(v) of the Act, the entity is also required to describe areas in which evidence is insufficient to support endorsement of quality and efficiency measures in priority areas identified by the Secretary under the National Quality Strategy and where targeted research may address such gaps.

    NQF continued in 2014 its efforts to fill measurement gaps—areas where there is a need for performance measures—by building on and supplementing the analytic work that informed previous Measure Gap Analysis Reports.3 Through both the MAP and performance measurement projects, NQF took initial steps to encourage gap-filling by identifying areas in which no adequate measures exist, offering more detailed suggestions for measure development, and involving measure developers in discussions about gaps.

    In an effort to provide more detailed recommendations in key measurement gap areas, HHS requested in 2013 that NQF convene multistakeholder committees to recommend priorities for performance measurement development across five topics areas that corresponded to important aspects of the National Quality Strategy, including:

    • Adult Immunization—identifying critical areas for performance measurement to optimize vaccination rates and outcomes across adult populations;

    • Alzheimer's Disease and Related Dementias—targeting a high-impact condition with complex medical and social implications that impact patients, their families, and their caregivers;

    • Care Coordination—focusing on team-based care and coordination between providers of primary care and community-based services in the context of the “health neighborhood”;

    • Health Workforce—emphasizing the role of the workforce in prevention and care coordination, linkages between healthcare and community-based services, and workforce deployment; and

    • Person-Centered Care and Outcomes—considering measures that are most important to patients—particularly patient-reported outcomes—and how to advance them through health information technology.

    Several important conclusions have been drawn from NQF's 2014 work in the gaps space. MAP reported in its 2014 pre-rulemaking review 4 of proposed measures that the topic areas that need measures were largely the same as from the previous year. Those gaps are in safety, patient and family engagement, healthy living, care coordination, affordability, and prevention and treatment of leading causes of mortality. Measure development in these areas should be a priority. NQF's efforts to define in more detail measures needed in these and other areas may help fill these gaps in the future. NQF is also exploring efforts in partnering with other organizations to address persistent measure gaps.

    II. Recommendations on the National Quality Strategy and Priorities

    Section 1890(b)(1) of the Social Security Act (the Act), mandates that the consensus-based entity (CBE) also required under section 1890 of the Act shall “synthesize evidence and convene key stakeholders to make recommendations . . . on an integrated national strategy and priorities for healthcare performance measurement in all applicable settings.” In making such recommendations, the entity shall ensure that priority is given to measures: 1) That address the health care provided to patients with prevalent, high-cost chronic diseases; 2) with the greatest potential for improving the quality, efficiency, and patient-centeredness of healthcare; and 3) that may be implemented rapidly due to existing evidence, standards of care, or other reasons. In addition, the entity will take into account measures that: 1) May assist consumers and patients in making informed healthcare decisions; 2) address health disparities across groups and areas; and 3) address the continuum of care a patient receives, including services furnished by multiple healthcare providers or practitioners and across multiple settings.

    In 2010, at the request of HHS, the NQF-convened National Priorities Partnership (NPP) provided input that helped shape the initial version of the National Quality Strategy (NQS). The NQS was released in March 2011, setting forth a cohesive roadmap for achieving better, more affordable care, and better health. Upon the release of the NQS, HHS accentuated the word `national' in its title, emphasizing that healthcare stakeholders across the country, both public and private, all play a role in making the NQS a success.

    NQF has continued to further the NQS by convening diverse stakeholder groups to reach consensus on key strategies for improvement. In 2014, NQF began or completed work in several emerging areas of importance that address the National Quality Strategy, such as how to improve population health within communities; providing advice to CMS on what information on healthcare quality is available to make informed healthcare coverage decisions through the Federal Health Insurance Marketplace; how to dramatically improve patient safety in high-priority areas through the use of Action Teams focusing on maternity care, avoidable readmissions, and patient and family engagement; and working with AHRQ to develop Common Formats for patient safety data reporting. Accomplishments in these areas in 2014 are described below.

    Improving Population Health Within Communities

    The National Quality Strategy's population health aim focuses on:

    “Improv[ing] the health of the U.S. population by supporting proven interventions to address behavioral, social, and environmental determinants of health in addition to delivering higher-quality care.”

    One of the NQS' six priorities specifically emphasizes:

    “Working with communities to promote wide use of best practices to enable healthy living.”

    With the expansion of coverage due to the ACA, the federal government has an opportunity to meaningfully coordinate its improvement efforts with those of local communities in order to better integrate and align medical care and population health. Such efforts can help improve the nation's health and lower costs.

    To support these efforts, NQF is conducting a multiphase project focused on helping communities implement population health initiatives. In August 2014, NQF produced “The Guide for Community Action” handbook. With funding from HHS, NQF brought together a multistakeholder committee to develop this Guide through an open and iterative process. The Committee included population and community health experts, public health practitioners, healthcare providers, coordinators of home and community based services, consumer advocates, employers, and others who influence population health.

    To inform creation of the Guide, an Advisory Group consisting of a smaller subset of the full Committee was convened to do an environmental scan at the start of the project. Additional input was provided by the full Committee, federal partners engaged in the work, and from the Government Task Lead (GTL) overseeing this project.

    The Guide 5 was created to be used by anyone who wants to improve health across a population, whether locally, in a broader region or state, or even nationally. The Guide's purpose is to support individuals and groups working together at all levels to successfully promote and improve population health over time. It contains brief summaries of 10 elements important to consider during community-based efforts, along with actions to take and examples of practical resources, to build a coalition that can improve population health. The 10 elements are summarized below:

    Element Examples of questions to ask Self-assessment about readiness to engage in this work What types of assessments have already been done in efforts to improve the health of this population? Leadership across the region and within organizations Which individuals or organizations in the region are recognized or potential leaders in population health improvement? Organizational planning and priority-setting process Which organizations in the region engage in collaborative planning and priority setting to guide activities to improve health in the region? Community health needs assessment and asset mapping process Which organizations in the region already conduct community health needs assessments or asset mapping regarding population health? An agreed-upon, prioritized set of health improvement activities What are the focus areas of existing population health improvement projects or programs, if any? Selection and use of measures and performance targets Which measures, metrics, or indicators are already being used to assess population health in the region, if any? Audience-specific strategic communication What is the level of skill or capability to engage in effective communication with each of the key audiences in the region? Joint reporting on progress toward achieving intended results Which organizations in the region publicly or privately report on progress in improving population health Indications of scalability For current or new population health work in the region, what is the potential for expansion into additional groups or other regions? Plan for sustainability What new policy directions, structural changes, or specific resources in the region may be useful for sustaining population health improvement efforts over time?

    Upon release of the Guide, NQF launched phase 2 of the project. During this phase, NQF began enlisting 10 communities to field test the Action Guide developed in phase 1 of the project. These 10 communities, selected in November 2014, represent a diverse set of groups, each with different levels of experience, varied geographic and demographic focus, and demonstrated involvement in or plans to establish population health-focused programs. The groups selected for the 18-month field test will be participating in a variety of activities, such as applying the content of the Guide to new or existing population health improvement projects, determining what works and what needs enhancement, and offering examples and ideas for revised or new content based on their own experiences. The selected groups also will have the opportunity to interact with one another and with members of the committee through in-person meetings and monthly conference calls.

    The 10 field testing groups include:

    1. Colorado Department of Health Care Policy and Financing (HCPF), Denver, CO 2. Community Service Council of Tulsa, Tulsa, OK 3. Designing a Strong and Healthy NY (DASH-NY), New York, NY 4. Empire Health Foundation, Spokane, WA 5. Kanawha Coalition for Community Health Improvement, Charleston, WV 6. Mercy Medical Center and Abbe Center for Community Mental Health—A Community Partnership with Geneva Tower, Cedar Rapids, IA 7. Michigan Health Improvement Alliance, Central Michigan 8. Oberlin Community Services and The Institute for eHealth Equity, Oberlin, OH 9. Trenton Health Team, Inc., Trenton, NJ 10. The University of Chicago Medicine Population Health Management Transformation, Chicago, IL Health Insurance Marketplaces Quality Rating System

    Under the statutory provision that the consensus-based entity will “take into account measures that may assist consumers and patients in making informed healthcare decisions,” HHS directed NQF to convene multistakeholder groups to provide input and comment on the proposed quality and efficiency measures that will form a core measure set, the hierarchical structure, and organization of a Quality Rating System (QRS). The measures will help consumers select health plans through the new Health Insurance Marketplaces established by the Affordable Care Act.

    NQF's Measure Applications Partnership (MAP) carried out this project. MAP is made up of stakeholders from a wide array of healthcare sectors and 7 federal agencies, as well as 150 subject matter experts representing nearly 90 private-sector organizations, tasked with recommending measures for federal public reporting, payment, and other programs to enhance healthcare value.

    In the final deliverable for this project, the report titled Input on the Quality Rating System for Qualified Health Plans in the Health Insurance Marketplaces, 6 MAP recognized that the initial implementation of the QRS will be limited to existing, developed measures at the health plan level and identified four primary steps to moving forward over the next five years:

    • First, HHS should immediately begin to address areas that are important to consumers but are not represented across the existing measures in the QRS, specifically, out-of-pocket costs and shared decisionmaking.

    • Second, HHS should thoroughly test all aspects of the QRS with diverse marketplace populations without delaying implementation and monitor on an ongoing basis.

    • Third, HHS should include provider-level quality information within three years after initial implementation for comprehensive support of consumer decisionmaking.

    • Fourth, HHS should add functionality to the QRS within five years of initial implementation that allows consumers to customize and prioritize information to assist in their unique decisionmaking processes.

    MAP considered HHS' proposed measures and structure for the marketplace that will be implemented in 2016 within the context of the broader vision bulleted above. MAP supported 28 out of 42 measures proposed for the family core set and 19 out of 25 measures proposed for the child core set. Additionally, MAP conditionally supported eight measures for the family core set and four for the child core set, and did not support six measures for the family core set and two for the child core set. The recommended measures span a wide range of areas including CAHPS surveys for various topics, preventative care measures, resource use measures, readmissions measures, prenatal care, diabetes measures and other measures that address prevalent conditions. Recognizing that the proposed measures are limited to those currently available, MAP identified three measures to address gap areas, and prioritized gap areas for measure development. The specific measures proposed by HHS and MAP's recommendations are listed in Appendix G of the report.

    Improving Patient Safety in High-Priority Areas

    NQF is leveraging its membership of over 400 organizations from every part of the healthcare system and its relationships with key stakeholders across the healthcare field to further mobilize private sector action in support of HHS' Partnership for Patients,7 an initiative started in spring 2011 to improve patient safety across the country. Specifically, in 2013 NQF formed three Action Teams—multistakeholder teams tasked with developing and acting on specific goals aligned with the NQS safety priority—to address high-priority areas for improvement, including maternity care, patient and family engagement, and readmissions. This work concluded in 2014.

    The Action Teams comprised diverse national organizations that have members or chapters in communities across the country. Through coordination at the national level, Action Teams spur changes to the delivery system at the local level. These Teams were committed to specific goals, including:

    • Reducing early elective deliveries (EEDs);

    • Reducing readmissions for complex and vulnerable populations; and

    • Engaging patients and families in health system improvement.

    The Action Teams developed Action Pathway Reports and other tools as resources for those who wish to learn from the challenges and successes of the Action Teams.

    Additionally in 2014, NQF held four quarterly meetings and developed four impact reports that called out innovative ideas and best practices that have the potential to accelerate change in the area of patient safety. These meetings focused on specific drivers for safety, including strengthening the workforce, accreditation and certification, purchasing and payment, and patient and family engagement. Quarterly impact reports provided a synopsis of Action Team and stakeholder activities as well as the quarterly meetings. The accomplishments of each of the three Action Teams are described below.

    Maternity Action Team

    The Maternity Action Team was reconvened in early 2014 to continue its work on addressing inappropriate maternity care. Although significant progress has been made in reducing EEDs, there are many areas of the country that are still finding it difficult to achieve results. As described in the Action Team's report, Maternity Action Team Action Pathway: Promoting Healthy Mothers and Babies,8 the overarching goal of the Action Team was to reduce EEDs prior to 39 weeks gestation to 5 percent or less in every state. To support this goal, three specific strategies were identified: Measurement, partnership, and consumer and provider engagement.

    The Action Team developed and disseminated a Playbook for the Successful Elimination of Early Elective Deliveries9 in August 2014 to provide guidance and strategies to help those still struggling to reduce their rates of EEDs.

    Readmissions Action Team

    The Readmissions Action Team was formed to support the Partnership for Patients goal of reducing hospital readmissions within 30 days by 20 percent on a national level. As described in the Readmissions Action Team Action Pathway: Reducing Avoidable Admissions and Readmissions10 report, the focus of this team was to achieve the Partnership for Patients goals by identifying high-risk patients with psychosocial needs, and leveraging patient, provider, and community partnership to address those needs so as to prevent unwarranted readmissions. Strategies identified by the Action Team include working together across stakeholder groups to enhance systems improvement, collaboration among providers, and patient and family engagement. The Action Team shared best practices and approaches to improving the quality of care for high-risk populations to foster both individual and collective efforts to further progress.

    Patient and Family Engagement Action Team

    The Patient and Family Engagement Action Team supports the Partnership for Patients goals around patient safety by utilizing the support of patients and families to be patient safety advocates, and by partnering with healthcare organizations to encourage person-centered care as an organizational core value. As described in the Team's Patient and Family Engagement Action Pathway: Fostering Authentic Partnerships between Patients, Families, and Care Teams11 report, three strategies were used to support the goal of fostering authentic partnerships: Identifying tools, resources, and practices that reflect patient-preferred practices, and encourage meaningful dialogue among providers; leveraging existing networks and relationships to spread these tools and practices; and activating patients and families to participate in organizational redesign and governance to drive system-level change.

    In support of the strategy to identify tools that can foster dialogue between patients and caregivers, the Action Team created and promoted the use of a Patient Passport, a tool to assist patients in having meaningful and effective communication with providers, particularly in the hospital setting. The tool allows patients to initiate and guide conversations with their providers, with the added benefit of making frontline staff's work simpler by presenting to them information about the patient that is concise and meaningful.

    Common Formats for Patient Safety Data

    For more than 10 years, both NQF and the Agency for Healthcare Research and Quality (AHRQ) have developed and promulgated standardized approaches for reporting and reducing adverse safety events to enable shared learning across the country. NQF's list of Serious Reportable Events (SREs), first published in 2002, has helped raise awareness and stimulate action around preventable adverse events that should be publicly reported. The Patient Safety and Quality Improvement Act of 2005 advanced reporting further by authorizing the development of common and consistent definitions and standardized formats to collect, collate, and analyze patient safety events occurring within and across healthcare providers. AHRQ developed the Common Formats—a standardized method for collection and compilation of information about patient safety events occurring in the United States, including Serious Reportable Events—to help operationalize the Act.

    To ensure the Common Formats are feasible for use in the field, AHRQ has contracted with NQF to implement a process that ensures broad stakeholder input on new Common Formats modules developed by AHRQ for both hospitals and nursing homes.

    NQF has established a process and tools for receiving comments on the Common Formats beginning with the release of each set and version and continuing for a specified period thereafter. This project is guided by an NQF-convened Expert Panel that considers and makes recommendations regarding comments from healthcare stakeholders. Previously, based upon the Expert Panel's recommendations, NQF supported AHRQ in its iterative revisions and refinements of Common Formats for hospitals and nursing homes. AHRQ has now developed Common Formats for surveillance in hospitals.

    In 2014, NQF continued to collect comments on all versions of Common Formats for Event Reporting—Hospital, Common Formats for Event Reporting—Nursing Home V.0.1 Beta, and for individual modules that have been integrated into these sets. NQF continues to collect comments on Hospital V.1.1 and V.1.2 and Nursing Home V.0.1 Beta. All comments received in 2014 have been acted upon by the Expert Panel and recommendations have been provided to AHRQ. Future expansions of the Common Formats will include patient events in ambulatory settings.

    III. Quality and Efficiency Measurement Initiatives (Performance Measures)

    Under section 1890(b)(2) and (3) of the Act, the entity must provide for the endorsement of standardized health care performance measures. The endorsement process shall consider whether measures are evidence-based, reliable, valid, verifiable, relevant to enhanced health outcomes, actionable at the caregiver level, feasible for collecting and reporting data, responsive to variations in patient characteristics, and consistent across types of healthcare providers. In addition, the entity must maintain endorsed measures by ensuring that such measures are updated, or retired, as new evidence is developed.

    Standardized healthcare performance measures are used by a range of healthcare stakeholders for a variety of purposes. Measures help clinicians, hospitals, and other providers understand whether the care they provide their patients is optimal and appropriate, and if not, where to focus their efforts to improve. In addition, performance measures are increasingly used in federal accountability pay for reporting and payment programs, to inform patient choice, and to assess the effects of care delivery changes.

    Working with multistakeholder committees to build consensus, NQF reviews and endorses healthcare performance measures. Since its inception in 1999, NQF has developed a portfolio of approximately 600 NQF-endorsed measures which are in widespread use across an array of settings. The federal government, states, and private sector organizations use NQF's endorsed measures to evaluate performance and share information with patients and their families. Together, NQF measures serve to enhance healthcare value by ensuring that consistent, high-quality performance information and data are available, which allows for comparisons across providers and the ability to benchmark performance.

    Over the past several years, NQF, in partnership with HHS and others, has worked to evolve the science of performance measurement. This effort has included placing greater emphasis on evidence and requiring a clear link to outcomes; a greater focus on addressing key gaps in care, including care coordination and patient experience; and a requirement that testing of measures demonstrates their reliability and validity. In addition, in 2014 NQF moved to using standing committees to be able to respond in real time to newly published research to ensure its endorsed measures are accurate, evidence-based, and meaningful.

    In 2014, NQF also laid the foundation for the next generation of measures by providing guidance on how to address socioeconomic and sociodemographic factors related to measurement; 12 criteria to use in evaluating episode groupers; 13 and beginning a project on how to use measures to evaluate performance for rural and low-volume providers.

    Current State of NQF Measures Portfolio: Responding to Evolving Needs

    Across 6 HHS-funded projects in 2014, NQF added 98 measures to its portfolio. This contrasts with 27 measures endorsed in 2013 across 6 HHS-funded projects. The difference in endorsed measures between 2013 and 2014 can be attributed to the fact that the 2013 work was primarily conducted within a contract that was nearing completion due to a delay in funding. New measure endorsement projects for 2014 were awarded under a new contracting vehicle implemented in September 2013.

    NQF ensures that the measure portfolio contains “best-in-class” measures across a variety of clinical and cross-cutting topic areas. Expert committees review both previously endorsed and new measures in a particular topic area to determine which measures deserve to be endorsed or re-endorsed because they are best-in-class. Working with expert multistakeholder committees,14 NQF undertakes actions to keep its endorsed measure portfolio relevant.

    During 2014, NQF also removed 93 measures from its portfolio. NQF removed about 90 measures from its portfolio in 2013. NQF removes measures for a variety of reasons including: measures no longer met more rigorous endorsement criteria; measures are harmonized with other similar, competing measures; measure developers chose to retire measures they no longer wish to maintain; or measures are “topped-out.”

    These “topped-out” measures are put into reserve because they show consistently high levels of performance and are therefore no longer meaningful in differentiating performance across providers This culling of measures ensures that time is spent measuring aspects of care in need of improvement rather than retaining measures related to areas where widespread success has already been achieved.

    While NQF pursues strategies to make its measure portfolio appropriately lean and responsive to real-time changes in clinical evidence, it also aggressively seeks measures from the field that will help to fill known measure gaps and to align with the NQS goals. Several important factors motivate NQF to expand its portfolio, including the need for eMeasures; measures that are applicable to multiple clinical specialties and settings of care; measures which assist in the evaluation of new payment models (e.g., bundled payment, Accountable Care Organizations, etc.); and the need for more advanced measures that help close cross-cutting gaps in areas such as care coordination and patient-reported outcomes.

    Finally, NQF also works with stewards and developers who create measures, in order to harmonize related or near-identical measures and eliminate nuanced differences. Harmonization is critical to reducing measurement burden for providers, who may be inundated with requests to report near-identical measures. Successful harmonization results in fewer endorsed measures for providers to report and for payers and consumers to interpret. Where appropriate, NQF works with measure developers to replace existing process measures with more meaningful outcome measures.

    Measure Endorsement Accomplishments

    As mentioned previously, NQF added 98 measures to its portfolio in 2014. Forty-eight of these measures were new measure submissions and 50 were measures that retained their NQF endorsement. Twenty-seven of the 98 endorsed measures are outcome measures, 59 are process measures, 7 are composite measures, 2 are structural measures, and 3 are cost and resource use measures.

    In 2014, NQF endorsed measures in order to:

    Drive the system to be more responsive to patient/family needs—In 2014, NQF conducted work on Person- and Family-Centered Care and Care Coordination endorsement projects, including patient-reported outcomes and patient experience surveys. These measures are used in programs such as Hospital Inpatient Quality Reporting (IQR) Program, and the Physician Quality Reporting System (PQRS) as well as reported on the Hospital Compare Web site.

    Improve care for highly prevalent conditions—In 2014, NQF conducted work on Cardiovascular, Endocrine, and Musculoskeletal endorsement projects. NQF-endorsed measures in these areas are used in the Hospital IQR Program and PQRS.

    Foster better care and coordination by focusing on crosscutting areas—NQF also conducted work on Behavioral Health and Patient Safety endorsement projects in 2014. NQF-endorsed measures in these areas are used in the Home Health Quality Reporting Program, Hospital IQR Program, the Inpatient Psychiatric Facility Quality Reporting Program, and PQRS.

    Support new accountability efforts coming online— In 2014, NQF conducted work on Cost/Resource Use and Readmission endorsement projects. For example, the NQF-endorsed readmissions measures are used in CMS' Hospital Readmissions Reduction Program and Physician Value-Based Payment Modifier Program.

    Other project work also began in 2014 on topics such as health and well-being, patient safety, musculoskeletal, person- and family-centered care, and surgery.

    Measure highlights in 2014 include the following:

    Behavioral health measures. In the United States, it is estimated that approximately 26.4 percent of the population suffers from a diagnosable mental disorder. These disorders—which can include serious mental illnesses, substance use disorders, and depression—are associated with poor health outcomes, increased costs, and premature death. Although general behavioral health disorders are widespread, the burden of serious mental illness is concentrated in about six percent of the population. In 2005, an estimated $113 billion was spent on mental health treatment in the United States. Of that amount, $22 billion was spent on substance abuse treatment alone, making substance abuse one of the most costly (and treatable) illnesses in the nation. In 2014, phase 2 of this project was completed and phase 3 is in progress. During phase 2 of the project, the Behavioral Health Steering Committee evaluated 13 new measures and 11 measures undergoing maintenance review of which 20 measures were ratified for endorsement.

    In phase 3 of this project, which is currently ongoing, the Behavioral Health Standing Committee reviewed 13 new measures and 6 measures undergoing maintenance review. The Committee recommended 13 measures for endorsement (9 process measures, 3 outcome measures, and 1 composite measure were approved); 1 measure was not recommended; and 1 measure was deferred.

    Cost and resource use measures. To expand NQF's portfolio of measures that could be used to assess efficiency and contribute to an assessment of value, NQF has undertaken foundational work on cost and resource use definitions. Phases 2 and 3 of this project were conducted in 2014.

    Phase 2 focused on cardiovascular condition-specific measures; phase 3 focused on pulmonary condition-specific measures, and condition-specific episode based measures. The Cost and Resource Use Standing Committee reviewed three measures, and three were recommended for endorsement. In phase 2, three measures were ratified for endorsement; 2 out of the 3 measures received endorsement only with conditions. The conditions include a one-year look-back assessment of unintended consequences by reviewing the related data, as well as consideration for the SES trial period.

    In phase 3, all three recommended measures were ratified in December 2014 with the same conditions as the phase 2 measures: one-year look-back assessment of unintended consequences, consideration for the SES trial period and attribution.

    Cardiovascular measures. Cardiovascular disease is the leading cause of death for men and women in the United States. It accounts for approximately $312.6 billion in healthcare expenditures annually. Coronary heart disease (CHD), the most common type, accounts for 1 of every 6 deaths in the United States. Hypertension—a major risk factor for heart disease, stroke, and kidney disease—affects 1 in 3 Americans, with an estimated annual cost of $156 billion in medical costs, lost productivity, and premature deaths.

    In Phase 1 of the Cardiovascular project, the Standing Committee evaluated 8 new measures and 9 measures undergoing maintenance review against NQF's standard measure evaluation criteria. 14 (6 process measures, 5 outcome measures and 3 composite measures) of the 17 measures submitted were recommended by the Committee, while 3 were not recommended.

    The second phase began in September 2014. Within this phase, the Standing Committee will provide recommendations for endorsement on 16 measures (10 new measures and 6 measures undergoing maintenance review) against NQF's measure evaluation criteria. The final technical report for this phase will be posted on the NQF Cardiovascular phase 2 Web page and submitted to HHS in July 2015.

    As part of NQF's ongoing work with performance measurement for cardiovascular conditions, an open call for measures is now underway for the third phase of this project. Within this project, NQF is soliciting new measures and concepts on any cardiovascular condition, including hypertension, coronary artery disease, acute myocardial infarction, PCI, heart failure, atrial fibrillation, or any other heart disease, and any treatments, diagnostic studies, interventions, procedures (excluding surgical procedures), or outcomes associated with these conditions.

    Endocrine measures. Endocrine conditions most often result from the endocrine system producing either too much or too little of a particular hormone. In the United States, two of the most common endocrine disorders are diabetes and osteoporosis. Diabetes, a group of diseases characterized by high blood glucose levels, affects as many as 25.8 million Americans and ranks as the seventh leading cause of death in the United States. Osteoporosis, a bone disease characterized by low bone mass and density, affects an estimated 9 percent of U.S. adults age 50 and over. Many of the diabetes measures in the portfolio are among NQF's longest-standing measures.

    NQF selected the Endocrine measure evaluation project to pilot test a process improvement to allow frequent submission and evaluation of measures in order to help speed up the time from measure development to use in the field. This 22-month project will include three full endorsement cycles, allowing for the submission and review of both new and previously-endorsed measures every six months, instead of every three years which had been the norm. In addition, this project is one of the first to transition to the use of Standing Committees, meaning that the measure endorsement committee is able to review measures on a frequent basis instead of once at the start of a project as done previously.

    In cycle 1, the Standing Committee recommended 14 out of 15 measures submitted for endorsement; the measures were ratified by the Board in 2014. In cycle 2, all six measures (all maintenance, no new measures were submitted) were recommended for endorsement. The measures were all process measures and related to diabetes and osteoporosis. All recommended measures were ratified in December 2014. The submission deadline for cycle 3 closed in December 2014; one composite measure and one outcome measure related to diabetes were submitted for maintenance review. The measures will be reviewed by the Committee in January 2015.

    Care coordination measures. Care coordination is increasingly recognized as fundamental to the effectiveness of healthcare systems in improving patient outcomes. Poorly coordinated care regularly leads to unnecessary suffering for patients, as well as avoidable readmissions and emergency department visits, increased medical errors, and higher costs.

    People with chronic conditions and multiple co-morbidities—and their families and caregivers—often find it difficult to navigate our already complex healthcare system. As this ever-growing population transitions from one care setting to another, they are more likely to suffer the adverse effects of poorly coordinated care. Incomplete or inaccurate transfer of information, poor communication, and a lack of follow-up can lead to poor outcomes, such as medication errors. Effective communication within and across the continuum of care will improve both quality and affordability.

    In the third phase of the Care Coordination project, the Standing Committee evaluated 1 new measure and 11 measures undergoing maintenance review. Eleven of the measures were recommended for endorsement by the Committee, and one was not recommended. Following review of the measures, the Committee recommended that a suite of seven measures regarding Emergency Transfer Communication be combined into one measure. The Board of Directors ratified the recommendations of the Committee in September 2014 and approved five measures (two process measures and three outcome measures) for endorsement.

    All-cause admissions and readmissions measures. Unnecessary admissions and avoidable readmissions to acute care facilities are an important focus for quality improvement by the healthcare system. Previous studies have shown that nearly 1 in 5 Medicare patients is readmitted to the hospital within 30 days of discharge, costing upwards of $426 billion annually.

    In 2014, the All-Cause Admissions and Readmissions Standing Committee evaluated 15 new measures and 3 measures undergoing maintenance review against NQF's standard evaluation criteria. Fifteen of the 18 measures were recommended for endorsement by the Committee. Seventeen of the 18 measures were recommended for endorsement and approved by the CSAC. All 17 measures were ratified for endorsement by the NQF Board but only with the following conditions: A one-year look-back assessment of unintended consequences and consideration for the SES trial period.

    Health and well-being measures. Social, environmental, and behavioral factors can have significant negative impact on health outcomes and economic stability; yet only 3 percent of national health expenditures are spent on prevention, while 97 percent is spent on healthcare services. Population health includes a focus on health and well-being, along with disease and illness prevention and health promotion. Using the right measures can determine how successful initiatives are in reducing mortality and excess morbidity through prevention and wellness and help focus future work to improve population health in appropriate areas.

    In phase 1, the Health and Well-Being Standing Committee evaluated seven newly submitted measures and eight measures undergoing endorsement review. One measure was withdrawn from consideration at the request of the Committee and the developer and will be evaluated in Health and Well-Being phase 2. Most new measures were related to dental care and a breast cancer screening measure was updated to reflect current guidelines. The Standing Committee recommended 13 measures for endorsement while one measure was not recommended. The 13 measures (7 process measures and 6 outcome measures) were ratified for endorsement in October 2014 and the final technical report was posted to the NQF Health and Well-Being phase 1 project Web page and submitted to HHS in December 2014.

    Phase 2 of the Health and Well-Being project launched in October 2014. The call for measures is open until January 16, 2015. In this phase, seven measures are undergoing maintenance review against NQF's measure evaluation criteria.

    Patient safety measures. NQF has a 10-year history of focusing on patient safety. Through various projects, NQF has previously endorsed over 100 consensus standards related to patient safety. The Safe Practices, Serious Reportable Events (SREs), and NQF-endorsed patient safety measures are important tools for tracking and improving patient safety performance in American healthcare. However, gaps still remain in the measurement of patient safety. There is also a recognized need to expand available patient safety measures beyond the hospital setting and harmonize safety measures across sites and settings of care. In order to develop a more robust set of safety measures, NQF will be soliciting patient safety measures to address environment-specific issues with the highest potential leverage for improvement.

    In phase 1, the Patient Safety Standing Committee evaluated 4 new measures and 12 measures undergoing maintenance review. Eight of the measures (five process measures and three outcome measures) were recommended for endorsement by the Committee, and eight were not recommended. In addition, the Patient Safety Standing Committee conducted an ad hoc review of measure 0500, Severe Sepsis and Septic Shock: Management Bundle, due to change in the underlying evidence per a randomized control trial. The Committee recommended continued endorsement of this measure.

    NQF opened the phase 2 call for measures for Patient Safety measures in 2014. The Steering Committee's evaluation will take place in 2015.

    Musculoskeletal measures. This project focuses on both individual and composite measures inclusive of all aspects of musculoskeletal health for all populations, with an emphasis on disparate and vulnerable populations. Improvement efforts for musculoskeletal conditions include imaging for low back pain; screening, assessment, and therapies for rheumatoid arthritis; assessment, monitoring, and therapies in the treatment of gout; and timely pain management for long bone fracture which are consistent with the NQS triple aim and align with several of the NQS priorities. NQF selected the Musculoskeletal project as the first to pilot test the optional path of eMeasure trial approval, which is intended for eMeasures that are ready for implementation but cannot yet be adequately tested to meet NQF endorsement criteria. These measures are not recommended at this stage for use in accountability applications such as public reporting or payment, but they have been judged to be ready for implementation in real-world settings in order to generate the data required to assess reliability and validity. They may be considered for endorsement after sufficient data to assess reliability and validity testing have been submitted to NQF, within three years of trial approval.

    In 2014, the Musculoskeletal Standing Committee evaluated eight new measures and four measures undergoing maintenance review. Three measures were recommended for endorsement, and four measures were recommended for eMeasure trial approval. All recommended measures were process measures and related to gout and rheumatoid arthritis.

    Person- and family-centered care measures. Ensuring person- and family-centered care is a core concept embedded in the National Quality Strategy priority of ensuring that each person and family is engaged as partners in their care. Person- and family-centered care encompasses the outcomes of interest to patients receiving healthcare services, including health-related quality of life, functional status, symptoms and symptom burden, and experience with care as well as patient and family engagement in care, including shared decisionmaking and preparation and activation for self-care management. This project is focusing on patient-reported outcomes (PROs), but also may include some clinician-assessed functional status measures. NQF's 2012 project on PROs15 in performance measurement provides a basis for reviewing PRO-based performance measures, referred to as PRO-PMs.

    NQF has identified 40 endorsed measures that are due for endorsement maintenance. Given the number and complexity of endorsed measures to review as well as an expectation of additional new measure submissions, NQF will undertake this project in two phases. Phase 1 examined experience with care measures, and phase 2 will review measures of functional status (clinician and patient-assessed).

    In phase 1, the Standing Committee evaluated one new measure and 11 measures undergoing maintenance review. The Committee recommended 10 measures for endorsement; one measure was not recommended and one measure was withdrawn by the developer. The 10 recommended measures (all outcome measures) were ratified for endorsement in December 2014.

    The second phase began in September 2014, and a total of 28 measures (14 new measures and 14 measures undergoing maintenance review) will be reviewed and evaluated. The majority of phase 2 measures are outcome measures with the exception of four process measures.

    Surgery measures. The rate of surgical procedures is increasing annually. In 2010, 51.4 million inpatient surgeries were performed in the United States; 53.3 million procedures were performed in ambulatory surgery centers. Ambulatory surgery centers have been the fastest growing provider type participating in Medicare. As part of NQF's ongoing work with performance measurement for patients undergoing surgery, this project seeks to identify and endorse performance measures that address a number of surgical areas, including cardiac, thoracic, vascular, orthopedic, neurosurgery, urologic, and general surgery. This project will seek new performance measures in addition to conducting maintenance reviews of surgical measures endorsed prior to 2012 using the most recent NQF measure evaluation criteria.

    In 2014, the Surgery Standing Committee evaluated 9 new measures and 20 measures undergoing maintenance review in phase 1. Twenty-one of these measures (10 outcome measures, 6 outcome measures, 2 composite measures, and 3 structural measures) were recommended (9 recommended for reserve status) for endorsement by the Committee, 7 were not recommended, and 1 was withdrawn by the developer.

    Phase 2 of this project builds on the work of the previous Surgery Endorsement project, launched in 2013. Phase 2 will seek to identify and endorse new measures that can be used to assess surgical conditions at any level of analysis or setting of care, and review endorsed measures scheduled for maintenance. The call for measures under phase 2 was initiated in 2014 and closed on January 14, 2015. A total of 26 measures will undergo maintenance review in this phase.

    Eye care and ear, nose, and throat conditions measures. This project seeks to identify and endorse performance measures for accountability that address eye care and ear, nose, and throat health. Nineteen measures will undergo maintenance review using NQF's measure evaluation criteria in the areas of glaucoma, macular degeneration, hearing screening and evaluation, and ear infections. NQF initiated the call for measures in 2014.

    Renal measures. Renal disease is a leading cause of morbidity and mortality in the United States. This project will identify and endorse performance measures for accountability and quality improvement for renal conditions. Specifically, the work will examine measures that address conditions, treatments, interventions, or procedures relating to end-stage renal disease (ESRD), chronic kidney disease (CKD) and other renal conditions. Measures that address outcomes, treatments, diagnostic studies, interventions, and procedures associated with these conditions will be considered. In addition, 21 measures will undergo maintenance review using NQF's measure evaluation criteria. NQF opened a call for measures in 2014; it will remain open until February 27, 2015.

    Advancing Measurement Science

    In 2014, NQF was again asked to provide guidance on emerging areas of importance by bringing together experts and diverse stakeholders to achieve consensus on next steps in deciding whether or not it is appropriate to risk adjust measures for socioeconomic and sociodemographic factors and how to best define and construct episode groupers. The reports—Risk Adjustment for Socioeconomic Status or Other Sociodemographic Factors16 and Evaluating Episode Groupers: A Report from the National Quality Forum,17 were completed to help advance the science of performance measurement.

    Risk Adjustment for Socioeconomic Status or other Sociodemographic Factors. With funding from HHS, NQF convened an Expert Panel tasked with considering whether to adjust performance measures for socioeconomic status (SES) and other demographic factors, including income, education, primary language, health literacy, race, and other factors. The Panel's report, released in August, has several major implications for NQF policy and the field of measurement.

    Whether to adjust measures for SES and sociodemographic factors is of high interest to stakeholders who have passionate views and concerns on all sides of the issue. As a testament to these concerns, NQF received more public comments on this topic than any other project to date. All stakeholders expressed a need for performance measures to provide fair comparisons across those being measured, and also agreed that disparities in healthcare and health faced by disadvantaged patients should not be hidden. In addition there are major challenges for the providers and health plans that care for these disadvantaged populations that should not be ignored.

    The Expert Panel recommended that measures should be adjusted for socioeconomic status if certain conditions are met. The panel further recommended that if a measure is adjusted for SES factors, the performance data must be stratified so that any disparities are made visible. The panel also made specific recommendations for operationalizing potential SES and sociodemographic adjustment, including guidelines for selecting risk factors and the kind of information to submit for measure review. Finally, the Panel recommended that NQF appoint a standing Disparities Committee which will ensure consistency in applying standards for SES adjusted measures and study whether or not there were unintended consequences when using such measures in the field.

    Moving forward, NQF has accepted the recommendations of the Panel and will begin a two-year trial period in 2015 during which the previous NQF restriction against SES risk adjustment will be lifted.

    Committees evaluating measures will be able to recommend that a measure be risk adjusted for socioeconomic or sociodemographic factors only if certain conditions are met. After the trial period concludes, NQF will determine if its criteria should be permanently changed to include SES adjustment under certain circumstances. In addition, work has begun to seat the new standing Disparities Committee. Additional details describing the trial period will be posted on the NQF Web site as they become available.

    Episode Grouper Criteria. Episode-based performance measurement is one approach to better understanding the utilization and costs associated with certain conditions by grouping care into condition-specific or procedure-specific episodes. Episode grouper software tools are an accepted method for aggregating claims data into episodes to assess condition-specific utilization and costs. Using an episode grouper, healthcare services provided over a defined period of time can be analyzed and grouped by specific clinical conditions to generate an overall picture of the services used to manage that condition.

    Section 3003 of the Patient Protection and Affordable Care Act (Affordable Care Act) Pub. L. 111-148, requires the Secretary of HHS to develop an episode grouper. With funding from HHS, NQF convened an Expert Panel to define the characteristics and challenges of constructing episode groupers; determine an initial set of criteria by which episode groupers could be evaluated; and identify implications and considerations for NQF endorsement of episode groupers. The panel did not focus on a particular grouper or product, but instead recommended criteria that can be applied to any episode grouper that may be submitted for evaluation.

    The panel recommended the following submission items for evaluation: descriptive information on the intent and planned use of the grouper; the clinical logic and data required for grouping claims; and reliability and validity testing. In particular, the panel emphasized the importance of understanding the intent and planned use for evaluating potential threats to validity and possible unintended consequences of using the grouper.

    Further input from NQF's Consensus Standards Approval Committee (CSAC) confirmed the complexity of issues regarding the evaluation of episode groupers. CSAC suggested that endorsement for episode groupers is premature, however, and acknowledged there is a need for: (1) A qualitative peer review process to initially evaluate episode groupers, and (2) a process to facilitate transparency for stakeholders about what is contained within episode groups. The framework outlined in the NQF report 18 addresses these needs and moves the field forward to eventual evaluation and endorsement of episode groupers.

    The Panel also generally agreed that evaluation of the CMS public episode grouper would be a suitable starting point to learn and understand the feasibility of applying the approaches and criteria outlined in this report. In order to fully implement this process, additional work would be needed to refine the criteria and submission elements and build out a process for evaluation. Taking into account NQF's expertise, further efforts to explore groupers should focus on how the measures developed from an episode grouper can be evaluated and endorsed.

    New Work Ahead

    Since September 2014, HHS has awarded to NQF several additional endorsement projects as well as new conceptual work related to the use of HIT to further performance measurement, and work to develop measurement frameworks for both rural areas and home- and community-based services. The new endorsement work focuses on eye, ear, nose, and throat conditions, and renal care. NQF has begun these projects, as well as issuing calls for measures to be reviewed by expert panels and considered for endorsement.

    Work Related to Facilitating eMeasurement

    Implementation and adoption of health information technology (HIT) is widely viewed as essential to the transformation of healthcare. While the use of HIT presents many new opportunities to improve patient care and safety, it can also create new hazards, and will fulfill its potential only if the risks associated with its use are identified and a coordinated effort is developed to mitigate those risks.

    An HIT-related safety event—sometimes called “e-iatrogenesis”—has been defined as “patient harm caused at least in part by the application of health information technology.” 19 Detecting and preventing HIT-related safety events is challenging, because these are often multifaceted events, involving not only potentially unsafe technological features of electronic health records, for example, but also user behaviors, organizational characteristics, and rules and regulations that guide most technology-focused activities.

    This project will be guided by a multistakeholder NQF Committee which includes experts in health information technology data systems and electronic health records, providers across different settings, front-line clinicians, public and private payers, and experts in patient safety issues related to the use of HIT. The Committee will work to explore the intersection of HIT and patient safety in order to create a report that will provide a comprehensive framework for assessment of HIT safety measurement efforts, a measure gap analysis and recommendations for gap-filling, and best practices and challenges in measurement of HIT safety issues to-date. In 2014, NQF released a call for nominations and finalized the standing committee for this project.

    In addition, NQF was awarded a project on value sets in late 2014 that will begin in 2015.

    IV. Stakeholder Recommendations on Quality and Efficiency Measures and National Priorities Measure Applications Partnership

    Under section 1890A of the Act, HHS is required to establish a pre-rulemaking process under which a consensus-based entity (currently NQF) would convene multistakeholder groups to provide input to the Secretary on the selection of quality and efficiency measures for use in certain federal programs. The list of quality and efficiency measures HHS is considering for selection is to be publicly published no later than December 1 of each year. No later than February 1 of each year, the consensus-based entity is to report the input of the multistakeholder groups, which will be considered by HHS in the selection of quality and efficiency measures.

    The Measure Applications Partnership (MAP) is a public-private partnership convened by NQF, as mandated by the ACA (Pub. L. 111-148, section 3014). MAP was created to provide input to HHS on the selection of performance measures for more than 20 federal public reporting and performance-based payment programs. Launched in the spring of 2011, MAP is composed of representatives from more than 90 major private-sector stakeholder organizations, 7 federal agencies, and approximately 150 individual technical experts. For detailed information regarding the MAP representatives, criteria for selection to MAP and length of service, please see Appendix D.

    MAP provides a forum to get the private and public sectors on the same page with respect to use of measures to enhance healthcare value. In addition, MAP serves as an interactive and inclusive vehicle by which the federal government can solicit critical feedback from stakeholders regarding measures used in federal public reporting and payment programs. This approach augments CMS' traditional rulemaking, allowing the opportunity for substantive input to HHS in advance of rules being issued. Additionally, MAP provides a unique opportunity for public- and private-sector leaders to develop and then broadly review and comment on a future-focused performance measurement strategy, as well as provide shorter-term recommendations for that strategy on an annual basis. MAP strives to offer recommendations that apply to and are coordinated across settings of care; federal, state, and private programs; levels of attribution and measurement analysis; payer type; and points in time.

    In 2014, the MAP took on several diverse tasks focused on recommending measures for federal public reporting and payment programs; developing “families of measures” (groups of measures selected to work together across settings of care in pursuit of specific healthcare improvement goals); and providing input on measures for vulnerable populations, including Medicare-Medicaid enrollees and adults and children enrolled in Medicaid.

    2014 Pre-Rulemaking Input

    On December 1, 2013, MAP received and began reviewing a list of 234 measures under consideration by HHS for use in more than 20 Medicare programs covering clinician, hospital, and post-acute care/long-term care settings. The MAP Pre-Rulemaking Report: 2014 Recommendations on Measures Under Consideration by HHS20 represents the MAP's third annual round of input regarding performance measures under consideration for use in federal programs.

    In this pre-rulemaking report issued in 2014, MAP recommended that HHS include 216 measures in different Medicare programs. As MAP supported some measures for use in multiple programs, this equaled 115 unique measures. Further, MAP recommended that HHS remove 48 measures from the programs. To sharpen its feedback, MAP provided new descriptions for its recommendations. Starting this year, it initiated the term “conditional support” in order to define explicit conditions that must be resolved before a measure receives MAP's full support for implementation. This designation, which replaces the previous option of “supporting the direction” of a measure, provides a clearer pathway for getting the measure into use.

    MAP enhanced its 2014 pre-rulemaking process by utilizing the following approach (also contained in Appendix C of the pre-rulemaking report):

    • MAP's deliberations were informed by its prior work, including its 2012 and 2013 pre-rulemaking reports, families of measures, and measure gaps previously identified across all MAP reports.

    • MAP used its Measure Selection Criteria to evaluate existing measures in use by programs before receiving the new measures under consideration to help make meetings more efficient.

    • Building upon its program measure set evaluations, MAP determined whether the measures on HHS' list of measures under consideration would enhance the program measure sets and provided rationales for its recommendations.

    • Finally, after reviewing the measures under consideration, MAP reassessed the program measure sets for remaining high-priority gaps.

    In its 2014 pre-rulemaking report, MAP noted some progress towards both measurement alignment—uniform use of measures across federal programs—and filling of measure gaps. In terms of measure alignment, MAP found that a majority of measures are being used in more than one HHS program. While this is promising, MAP noted the need to make further progress in using similar measures across a variety of public- and private-sector initiatives. In terms of measure gaps, MAP found similarly mixed results. Although there are now measures deployed to address areas in which there had previously been no meaningful way to measure performance, multiple gaps remain. These gaps include critical hospital safety measure gaps in the Inpatient Hospital Quality Reporting, Hospital Value-Based Purchasing, and Hospital Acquired Conditions Reduction Programs and clinician outcome measures for the Value-Based Payment Modifier and Physician Compare. MAP members have noted that they would like to see a more systematic assessment of ongoing progress towards gap-filling going forward.

    2015 Pre-Rulemaking Input

    In 2014, the MAP also began work on the 2015 Pre-Rulemaking Report. The four MAP workgroups—Clinician, Dual Eligible Beneficiaries, Hospital, and Post-Acute Care/Long-Term Care—met individually in December to review and provide input to the MAP Coordinating Committee on measure sets for use in federal programs addressing their respective populations. A report detailing recommended measures will be released on February 1, 2015. In addition, two topical pre-rulemaking reports will be issued in 2015, one on hospital and PAC/LTC programs (February 15, 2015) and another on clinician programs and cross-cutting measures (March 15, 2015).

    Families of Measures: Affordability, Person- and Family-Centered Care, and Population Health

    In 2014, HHS again tasked the MAP to identify new families of measures—groups of measures selected to work together across settings of care in pursuit of specific healthcare improvement goals—in three high-priority areas that relate to NQS priorities: Affordability, person- and family-centered care, and population health. In July 2014, the MAP Task Forces for the Affordability, Person- and Family-Centered Care, and Population Health topics released a final report, Finding Common Ground for Healthcare Priorities: Families of Measures for Assessing Affordability, Population Health, and Person-and Family-Centered Care. 21

    There were several cross-cutting issues that emerged across these three families of measures. First, measures need to be aligned with important concept areas, such as the aims of the NQS. Second, families of measures provide a tool that stakeholders can use to identify the most relevant available measures for particular measurement needs, promoting alignment by highlighting important measurement categories that can be applied to other measurement initiatives. And finally, while families include important current measures, there are not sufficient measures for assessing several priority areas within each family. This finding highlights the need for further development of measures in affordability, population health, and person- and family-centered care.

    Affordability Family of Measures

    Measurement plays a critical role in improving affordability. Rising healthcare costs are affecting all stakeholders, and all stakeholders have a shared responsibility for making care affordable. In order to help address this issue, MAP and NQF staff went through a multistage process to identify the most promising affordability measures to constitute a family of related measures. These measures were identified and selected based on evidence of impact, such as the leading causes of preventable death or the conditions associated with highest healthcare spending. Measures were then separated into two overarching categories, measures of current spending, and measures of cost drivers. A chart detailing the framework and measures identified for the Affordability Family are included in Appendix C of the report,22 Finding Common Ground for Healthcare Priorities: Families of Measures for Assessing Affordability, Population Health, and Person- and Family-Centered Care.

    On a broader level, MAP pointed out that the current United States health system is opaque in terms of price and cost. This lack of transparency is a challenge for patients who cannot find out in advance what any given healthcare service will cost. In addition, to fully understand efficiency and value, cost measures must be considered in conjunction with measures of quality. This would allow consumers to understand trade-offs between cost and quality and would allow the user to identify when cost can be reduced while maintaining or improving quality.

    MAP also noted that current measures are limited in their ability to describe the full cost picture. In addition, MAP highlighted that there are direct and indirect costs from disease and treatment, and that current measures focus on direct costs while excluding indirect costs that may be significant for patients and families, e.g., transportation to providers, lost income from missing work. An additional challenge is the limited number of composite measures that provide high-level information to consumers, payers, and purchasers and give them a big picture idea of affordability. Further work is needed to produce measures that comprehensively capture cost at multiple levels.

    Population Health Family of Measures

    Measuring the upstream determinants of health, both in healthcare and community settings, is critical for improving population health. Although it is important to focus on the health of the entire population, attention should also be given to health disparities and the unique needs of subpopulations. Focusing on interventions that both improve the health of people in geographic or geopolitical areas as well as population-based outcomes will help achieve the goals of the NQS. For the Population Health Family of Measures, MAP selected measures of clinical preventive services, such as screenings and immunizations, as well as a number of measures that address topics outside of the traditional healthcare system. In addition, MAP considered how measures could be used in applications such as a community health needs assessment and public health activities. This approach coincides with efforts to redirect focus from individual sick care to the health and well-being of populations.

    MAP selected a family of population health measures based on an overarching framework and broad measurement domains which included consideration for measures of total population health, determinants of health, and health improvement activities. MAP refined this conceptual framework to identify topic areas that address key aspects of population health, with the final groupings largely aligning with the Healthy People 2020 Leading Health Indicator topic areas. A chart detailing the framework and measures identified for the Affordability Family are included in Appendix D of the report,23 Finding Common Ground for Healthcare Priorities: Assessing Affordability, Population Health, and Person- and Family-Centered Care.

    Person- and Family-Centered Care Family of Measures

    Collaborative partnerships between persons, families, and their care providers are critical to enabling person- and family-centered care across the healthcare continuum. Family involvement has been correlated with improved patient and family outcomes and decreased healthcare costs. Given the positive impact that person- and family-centered care can have, measurement should strive to not only capture patients' experience of care but also include patient-reported measures that evaluate meaningful outcomes for those receiving care.

    Working with a set of guiding principles for person- and family-centered care, MAP focused on creating a family of measures that covered five high priority topic areas: interpersonal relationships, patient and family engagement, care planning and delivery, access to support, and quality of life. A chart detailing the high-priority topic areas and measures identified for the Person- and Family-Centered Care Family of measures is included in Appendix E of the report,24 Finding Common Ground for Healthcare Priorities: Assessing Affordability, Population Health, and Person- and Family-Centered Care. Also included under Appendix E is a crosswalk of all the pertinent CAHPS survey tools at the measure level to the topic areas within the family of measures.

    2014 Input on Quality Measures for Dual Eligible Beneficiaries

    In support of the NQS aims to provide better, more patient-centered care as well as improve the health of the U.S. population through behavioral and social interventions, HHS asked NQF to again convene a multistakeholder group via MAP to address measurement issues related to people enrolled in both the Medicare and Medicaid programs—a population often referred to as the “dual eligibles” or Medicare-Medicaid enrollees. In August 2014, MAP released its fifth report focused on this population: 2014 Input on Quality Measures for Dual Eligible Beneficiaries. 25

    In this report, MAP provided its latest guidance to HHS on the use of performance measures to evaluate and improve care provided to Medicare-Medicaid enrollees. Building on prior work in this area, MAP:

    • Updated the Family of Measures for Dual Eligible Beneficiaries and described persistent gaps in measures;

    • Explored strategies to improve health-related quality of life by fostering shared accountability across providers on a given team; and

    • Described an approach to gathering feedback from stakeholders across the field using measures focused on Medicare-Medicaid enrollees to inform MAP's future decisionmaking.

    The Family of Measures for Dual Eligible Beneficiaries is a group of 59 total measures determined to be the best available to address the needs of this unique population. It was updated in 2014 with the removal of two measures and the addition of one measure. The measures MAP removed related to e-prescribing and HIV screening, and were no longer NQF-endorsed or being maintained by their measure stewards. Three newly endorsed measures were considered for inclusion into the Family and one measure (NQF #2158 Payment-Standardized Medicare Spending Per Beneficiary) was added to address the important topic of cost. The Family still lacks an equivalent measure of costs incurred by Medicaid in caring for Medicare-Medicaid enrollees.

    MAP also continued to monitor the pipeline of measures in development that are relevant to Medicare-Medicaid enrollees, including six measures NCQA is designing for use in managed long-term services and supports programs. Critical measure gap areas remain, including shared decisionmaking and psychosocial needs.

    Since the start of MAP's work, quality of life has been identified as a high-leverage opportunity for improvement through measurement. MAP discussed methods for measuring and improving quality of life outcomes tied to long-lasting health conditions. Specifically, MAP's report describes how the medical model needs to be coupled with a social orientation to providing care and supports. Four tactics are explored: person- and family-centered care, team-based approaches to care, shared accountability, and shared decisionmaking. MAP looked to current examples of how quality of life has been quantified, including indicators and surveys such as the CMS CARE Tool that measures functional status, and the National Core Indicators survey that evaluates quality of life aspects as reported by consumers with developmental disabilities.

    2014 Report on the Core Set of Health Care Quality Measures for Adults Enrolled in Medicaid

    MAP reviewed the Core Set of Health Care Quality Measures for Adults Enrolled in Medicaid (Medicaid Adult Core Set) to carefully evaluate and identify opportunities to improve the measures in use. In doing so, MAP considered states' feedback from the first year of implementation and applied its standard Measure Selection Criteria. MAP supported the continued use of most measures in the Core Set to maintain stability for participating states. The committee recommended the removal of one measure (NQF #0063 Comprehensive Diabetes Care: LDL-C Screening) because clinical guidelines underpinning it are in flux. Additionally, MAP requested the phased addition of up to three measures to the Core Set, addressing the topics of diabetes care, medication management for asthma, and care transitions.

    MAP recommended that HHS continue to support states' efforts to gather, report, and analyze data that inform quality improvement activities. The Medicaid core set program is still new, and uses of quality data are expected to gradually mature from an internal focus on accuracy and year-over-year improvement to a more sophisticated approach involving benchmarking and public reporting. At the same time, HHS and MAP remain conscious that states are voluntarily participating in submitting data on the Medicaid Adult Core Set and need to be mindful of that reality. The program measure set will continue to evolve in response to changing federal, state, and stakeholder needs and its maintenance should be considered a long-term strategic goal.

    Strengthening the Core Set of Health Care Quality Measures for Children Enrolled in Medicaid and CHIP, 2014

    HHS awarded NQF additional work in 2014 to assess and strengthen the Core Set of Health Care Quality Measures for Children Enrolled in Medicaid and CHIP (Child Core Set). Using a similar approach to its review of the Adult Core Set, MAP performed an expedited review over a period of ten weeks to provide input to HHS within the 2014 federal fiscal year. MAP considered states' feedback from their ongoing participation in the voluntary reporting program and applied its standard measure selection criteria to identify opportunities to improve the Child Core Set.

    MAP supported the continued use of all but one measure in the Child Core Set—Percentage of Eligibles That Received Dental Treatment Services—because it is not actionable for quality improvement purposes. Additionally, MAP requested the phased addition of up to six measures to the Child Core Set, two of which are oral health measures that would serve as appropriate replacements for the measure suggested for removal. Other measures MAP recommended for addition address family experience of hospital care, suicide risk assessment for children and adolescents with major depression, and birth outcomes.

    MAP members discussed numerous cross-cutting and strategic issues related to this reporting program, including limitations in the data infrastructure to support measurement, feasibility concerns for measures not specified for state-level analysis, and increasing alignment of Child Core Set measures with the Medicaid Adult Core Set and other quality reporting programs. A major strategic consideration for the future direction of the Child Core Set is the large volume of pediatric measures in development under the auspices of the AHRQ-CMS Pediatric Quality Measures Program (PQMP); these measures will become available for MAP's consideration over the course of the next year.

    V. Gaps in Endorsed Quality and Efficiency Measures and Evidence and Targeted Research Needs

    Under section 1890(b)(5)(iv) of the Act, the entity is required to describe gaps in endorsed quality and efficiency measures, including measures within priority areas identified by HHS under the agency's National Quality Strategy, and where quality and efficiency measures are unavailable or inadequate to identify or address such gaps. Under section 1890(b)(5)(v) of the Act, the entity is also required to describe areas in which evidence is insufficient to support endorsement of quality and efficiency measures in priority areas identified by the Secretary under the National Quality Strategy and where targeted research may address such gaps.

    MAP Pre-Rulemaking Input Related to Gap Filling

    NQF continued in 2014 to address the need to fill measurement gaps to build on and supplement the analytic work that has informed previous Measure Gap Analysis Reports as well as other MAP reports. However, much work remains to be done by measure developers, NQF, and many other entities to accelerate the closing of gaps.

    With each MAP pre-rulemaking cycle, MAP examines progress on both alignment and measure gap-filling, and assesses how best to achieve these objectives. MAP's 2014 pre-rulemaking review of proposed measures submitted by HHS yielded a list of topic areas that needed measures that was largely the same as the one developed the previous year. Public commenters generally agreed with the gap areas identified on the NQF list, which include gaps in:

    • Safety: Healthcare-associated infections, medication and infusion safety, perioperative/procedural safety, pain management, venous thromboembolism, falls and mobility, and obstetric adverse events;

    • Patient and family engagement: Person-centered communication, shared decisionmaking and care planning, advanced illness care, and patient-reported measures;

    • Healthy living: Well-being, healthy lifestyle behaviors, social and environmental determinants of health, social connectedness for people with long-term services and supports needs, sense of control/autonomy/self-determination, and safety risk assessment;

    • Care coordination: Communication, care transitions, system and infrastructure support, and avoidable admissions and readmissions;

    • Affordability: Ability to obtain follow-up care, total cost of care, consideration of patient out of pocket cost, and use of radiographic imaging in the pediatric population;

    • Prevention and treatment of leading causes of mortality: Primary and secondary prevention, cancer, cardiovascular conditions, depression, diabetes, and musculoskeletal conditions.

    MAP has observed mixed results in filling measure gaps. An example of a success story is the CAHPS In-Center Hemodialysis Survey measure (NQF #0258) for the ESRD Quality Incentive Program that MAP supported in its 2014 review because it fills a previously identified measure gap in consumers' experience of care. HHS now plans to implement this measure.

    NQF is working with measure developers and other stakeholders to more rapidly expand the pipeline of new measures that may ultimately become endorsed. Such efforts include more frequent measure submission and endorsement review opportunities, consideration of new approaches to endorsement dependent on application, implementation of trial use endorsement designation for e-measures, and exploring the development of a measure incubator.

    In the meantime, the drive to expeditiously fill measure gaps played a role in MAP's decision to support a limited number of measures—less than 20—that are currently not NQF-endorsed with expectations that they would be later reviewed for endorsement by NQF. MAP also noted critical measure gap areas during the creation of measure families. If maintained and applied broadly, measure families can help achieve increased alignment and keep attention focused on high-priority measure gaps. Public commenters expressed strong support for the use and continued development of MAP measure families.

    Priority Setting for Health Care Performance Measurement: Addressing Performance Gaps in Priority Areas

    In an effort to get more specific and detailed guidance to developers with respect to key measurement gap areas, HHS requested in 2013 that NQF recommend priorities for performance measurement development across five topics areas specified by HHS, including:

    • Adult immunization—identifying critical areas for performance measurement to optimize vaccination rates and outcomes across adult populations;

    • Alzheimer's disease and related dementias—targeting a high-impact condition with complex medical and social implications that impact patients, their families, and their caregivers;

    • Care coordination—focusing on team-based care and coordination between providers of primary care and community-based services in the context of the “health neighborhood”;

    • Health workforce—emphasizing the role of the workforce in prevention and care coordination, linkages between healthcare and community-based services, and workforce deployment; and

    • Person-centered care and outcomes—considering measures that are most important to patients—particularly patient-reported outcomes—and how to advance them through health information technology.

    In 2014, NQF has completed these analyses through the use of topic-specific committees that were tasked with reviewing the evidence base and existing measures to identify opportunities for using performance measurement to improve health and healthcare, as well as to reduce disparities, costs, and measurement burden. After these environmental scans, the committees then developed measurement frameworks for each topic which helped identify measure gap areas. In 2014, NQF submitted five final reports to HHS (Adult Immunization, Care Coordination, Health Workforce, Person-Centered Care and Outcomes, and Alzheimer's Disease and Related Dementias). These five reports are described in more detail below.

    Adult Immunization

    The Adult Immunization Committee—with the help of an advisory group—submitted a report titled, Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps for Adult Immunizations, 26 in August 2014 that builds on concepts identified by the Quality and Performance Measures Workgroup of the HHS Interagency Adult Immunization Task Force, and seeks to illustrate measure gaps in specific age bands and special populations including young adults, pregnant women, the elderly, and adults overall.

    A total of 225 unique measures or concepts were identified as relevant to adult immunization. An analysis of the identified measures showed that there is a plethora of measures that address influenza immunization (79 measures, 35 percent of identified measures) and pneumococcal immunization (60 measures, 27 percent of identified measures). The majority of measures identified in the environmental scan are process measures (69 percent) and only 4 of the 46 outcome measures are at the provider level; the majority are population and surveillance measures.

    The Committee then developed and used a conceptual measurement framework to prioritize measurement needs and identify more than 30 potential measure gaps. The gaps were grouped into several measure categories requested by HHS: Adult vaccines for which there are no NQF-endorsed measures; vaccines for specific age groups consistent with the adult immunization schedule issued by Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (ACIP/CDC); vaccines for specific populations such as persons with diabetes or other chronic conditions; vaccines for healthcare personnel; composite measures including both immunizations alone and composite measures that include other clinical preventive services; outcome measures; and measures for Immunization Information Systems.

    The Committee then discussed the results at an in-person meeting and agreed upon the 10 measure gap priorities listed below.

    Age-Specific Priorities • HPV vaccination catch-up for females ages 19-26 years and for males-ages 19-21 years • Tdap/pertussis-containing vaccine for ages 19+ years • Zoster vaccination for ages 60-64 years • Zoster vaccination for ages 65+ years (with caveats) Composite Measure Priorities • Composite including immunization with other preventative care services as recommended by age and gender • Composite of Tdap and influenza vaccination for all pregnant women (including adolescents) • Composite including influenza, pneumococcal, and hepatitis B vaccination measures with diabetes care processes or outcomes for individuals with diabetes • Composite including influenza, pneumococcal, and hepatitis B vaccinations measures with renal care measures for individuals with kidney failure/end-stage renal disease (ESRD) • Composite including Hepatitis A and B vaccinations for individuals with chronic liver disease • Composite of all ACIP/CDC recommended vaccinations for healthcare personnel

    To provide further guidance, the Committee also identified two short-term and long-term priorities from the list of 10 measure gap priorities above:

    Short-Term Priorities:

    • HPV vaccination catch-up for females ages 19-26 years and for males ages 19-21 years • Composite of Tdap and influenza vaccination for all pregnant women (including adolescents)

    Long-Term Priorities:

    • Composite measures that include immunization with other preventive care services • Composite measures for healthcare personnel of all ACIP/CDC recommended vaccines Alzheimer's Disease and Related Dementias

    The Alzheimer's Disease and Related Dementias Committee was charged with developing a conceptual measurement framework and recommending priorities for future performance measurement development in this area. NQF submitted a draft conceptual framework and environmental scan in February 2014 which was used by the committee to create their final report, Priority Setting for Healthcare Performance Measurement: Alzheimer's. 27

    The project's environmental scan yielded 125 dementia-specific performance measures. To identify measure gaps, NQF staff mapped these measures to the National Quality Strategy priority areas. This analysis showed that there is a need for performance measures focused on the well-being of caregivers, person- and family-centered measures, and outcome measures focused on quality of life and experience of care, and measures of affordability.

    Using the information from the environmental scan, the Committee developed a conceptual measure framework and recommended priorities for future performance measurement development. Five measurement themes emerged as the committee deliberated: Importance of connection to community-based services, need for accountability at the community level, a focus on person- and family-centered approaches, diagnostic accuracy, and safety. The committee also recommended the following three areas as the highest priority for measure development: Composite measure of comprehensive diagnostic evaluation and needs assessment, composite measure of caregiver support, and measures to reflect a dementia-capable healthcare and community care system.

    Finally, the Committee identified broad recommendations for performance measurement related to dementia as well as overarching policy recommendations. These recommendations included stratifying existing performance measures to assess quality of care for those with dementia, modifying the CAHPS surveys to allow proxy response for those with dementia so that their experience of care can be recorded, and using existing data sources to aid research that could identify those who should be assessed for cognitive impairment.

    Care Coordination

    The multistakeholder Expert Committee guiding this work focused on examining opportunities to measure care coordination, particularly between providers of primary care and health-related services provided in the community. The conceptual framework adopted by the Committee describes a three-way set of relationships between care recipients, clinics/clinicians, and community resources. The framework notes that the most powerful measures that could be developed would capture the interaction of all three elements. The Committee also provided additional recommendations to enhance the practice of care coordination itself.

    The Care Coordination Committee framework builds on work from the Agency for Healthcare Research and Quality's Care Coordination Measures Atlas and their Clinical-Community Relationship Measurement concept. The project's environmental scan identified a total of 363 measures related to care coordination, most of which were general, and uncovered very few measures related to ongoing interactions between primary care and community-based service providers to support improved health and quality of life. In general, currently available measures are either too narrowly or too broadly designed to be actionable by providers of primary care. Further, no available measures directly apply to providers of community services.

    The Committee recommended quick and deliberate action in their report, Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps in Care Coordination, 28 particularly in filling performance measure gaps in four high-impact areas:

    1. Linkages and synchronization of care and services to promote the purposeful collaboration of all members of a care team, achieved through continuous monitoring of individuals' care plans, multidirectional communication, and problem-solving.

    2. Individuals' progression toward goals for their health and quality of life, with measurement centered on whether care recipients have a person-centered care plan and the support required to make reasonable progress toward their goals.

    3. A comprehensive assessment process that incorporates the perspective of a care recipient and anyone who plays a role in addressing that person's needs; both medical and psychosocial risk factors should inform the determination of how to coordinate delivery of care and supports.

    4. Shared accountability within a care team that hinges upon all team members understanding their responsibilities for contributing to progress toward the care recipient's goals.

    Successful care coordination relies upon the execution of a care plan that includes a structured arrangement of standardized data elements. However, such standardization is not yet widespread and this has been a barrier to systematic measurement of care coordination activities.

    Health Workforce

    Achieving the National Quality Strategy's aims of better care, affordable care, and healthy people/healthy communities requires an adequate supply and distribution of a well-trained workforce. Therefore, in consultation with HHS and with input from advisory members, NQF developed a draft conceptual framework for measurement that captures elements necessary for successful and measureable workforce deployment. This framework provided the basis for the report, Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps for the Health Workforce. 29

    A total of 252 measures were identified in the environmental scan as potential health workforce measures. Large sets of measures were found related to training and development, mostly related to professional educational programs and the number of graduates in specific health professions. Although many measures of patient and family experience of care related to workforce performance were identified, few measures capturing workforce experience were found. Workforce capacity and productivity measures proved to have a substantial presence, especially those related to geographical distribution and skill mix.

    Eight domains within the framework were identified as key areas for measurement:

    1. Training, retraining, and development 2. Infrastructure to support the health workforce and to improve access 3. Retention and recruitment 4. Assessment of community and volunteer workforce 5. Experience (health workforce and person and family experience) 6. Clinical, community, and cross disciplinary relationships 7. Workforce capacity and productivity 8. Workforce diversity

    Within the eight domains above, the Committee identified the five highest priority domains for measurement in the near term, and recommended concepts for measurement.

    Public comments echoed the Committee's acknowledgement of new and future initiatives in this area, which will impact and improve workforce measurement, particularly those that capture person- and family-centered perspectives, and address vulnerable populations and under-resourced geographic areas. Future measure development could focus on measures of health workforce deployment and use resulting in the greatest impact on health outcomes.

    Person-Centered Care and Outcomes

    HHS charged NQF with convening a multistakeholder committee to prioritize the person- and family-centered care performance measurement gaps that need to be addressed. The Committee provided its recommendations in the report, Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps in Person-Centered Care and Outcomes. 30

    The Committee highlighted three key principles that should inform the identification of measure concepts for person- and family-centered care. The concepts are:

    • Selected and/or developed in partnership with individuals to ensure measures are meaningful to those receiving care;

    • focused on the person's entire care experience, rather than a single setting, program, or point in time; and

    • measured from the person's perspective and experience.

    The Committee identified specific measure concepts for potential measure development, and recommended priorities for measuring performance on person- and family-centered care. Overarching recommendations included integrating individual and family input into performance measure development decisions, focusing measurement on person-reported experiences, going beyond silos of accountability and measurement by challenging the norms of the current healthcare environment, and considering how those being measured would act on the information.

    In the short term, the Committee had several recommendations that could be implemented almost immediately by providers and healthcare systems when caring for patients. These recommendations include focusing on patients with higher levels of need such as those with comorbidities, advanced dementia and other serious illnesses; considering the use of Consumer Assessment of Healthcare Providers and Systems (CAHPS) performance measures; and convening CAHPS and Patient Reported Outcomes Measurement Information System (PROMIs) experts for mutual learning in applying new methods of measurement.

    Identifying Other Measure Gaps

    NQF identified additional high-priority measure gaps as a natural byproduct of NQF's endorsement and maintenance work. Those gaps are listed by topic area in Appendix E of this report.

    In addition to identifying gaps through measure endorsement work and through the topical gaps reports, the Dual Eligible Beneficiaries Workgroup identified the following gaps in their report, 2014 Input on Quality Measures for Dual Eligible Beneficiaries:31

    • Goal-directed, person-centered care planning and implementation • Shared decisionmaking • Systems to coordinate healthcare with nonmedical community resources and service providers • Beneficiary sense of control/autonomy/self-determination • Psychosocial needs assessment and care planning • Community integration/inclusion and participation • Optimal functioning (e.g., improving when possible, maintaining, managing decline)

    Importantly, this list reflects the MAP's vision specifically for high-quality care for Medicare-Medicaid enrollees but also applies more broadly to the general population as MAP has articulated in previous reports. Identification of these gaps supports a philosophy about health that broadly accounts for individuals' health outcomes, personal wellness, social determinants (e.g., housing, transportation, access to community resources), and desire for a more cohesive system of care delivery. Many gaps are long-standing, which underscores both the importance of nonmedical supports and services in contributing to improved healthcare quality and the difficulty of quantifying and measuring these factors as indicators of performance.

    Specifically, MAP recommends for future measure development continuing a focus on topics that address the social issues that affect health outcomes in vulnerable populations, including individuals with a history of incarceration and veterans of military service. MAP will continue to communicate with measure developers and other stakeholders positioned to help fill measurement gaps.

    Although MAP's work to-date on measure gaps—including the pre-rulemaking efforts and input from specific workgroups—is starting to bear fruit, persistent gaps across sectors, such as care coordination and patient experience of care, continue to frustrate measurement efforts. Current measures fail to capture the complex and dynamic array of conditions that are at play in an acutely or chronically ill person's life over time. Resources outside of MAP's control need to be allocated to research that can explore new methodologies for measurement of complex topics such as nonclinical processes and person-centered outcomes. However, MAP, in coordination with NQF's larger initiatives, will continue to try to influence ongoing progress in filling measure gaps through its specific recommendations and by enhanced collaboration with other stakeholders.

    VI. Conclusion and Looking Ahead

    NQF has evolved in the 15 years it has been in existence and since it endorsed its first performance measures more than a decade ago. While its focus on improving quality, enhancing safety, and reducing costs by endorsing performance measures has remained a constant, its role has expanded through both public and private support, including from foundations and member dues.

    More specifically, NQF has convened multiple private sector stakeholders to help inform the development and implementation of the first-ever National Quality Strategy and to advise CMS on selection of measures for 20 plus federal programs. Other examples of recent work beyond endorsement include an NQF-funded Kaizen, or lean, process improvement undertaken to streamline MAP and performance measurement processes in conjunction with CMS and ONC. In 2014, NQF also worked with CMS and America's Health Insurance Plans (AHIP) to identify a common, discrete set of aligned measures that both the public and private payers agree to request from physicians and other providers.

    With respect to NQF's recent work through MAP to identify measure gaps in order to catalyze the field to fill them, several important conclusions have been drawn. MAP reported in its 2014 pre-rulemaking review of proposed measures that the topic areas that need measures were largely the same as from the previous year. Those gaps are in safety, patient and family engagement, healthy living, care coordination, affordability, and prevention and treatment of leading causes of mortality. Measure development in these areas should be a priority. NQF's initial efforts to define in detail measures needed in these and other high-priority areas may help fill these gaps. NQF is also exploring efforts to partner with other organizations to address persistent measure gaps, including potential development of a measure incubator.

    In 2015, with funding from HHS, NQF is tackling several critical issues affecting healthcare quality and safety that will help advance the aims and priorities of the National Quality Strategy, as well as building on landmark work done in 2014 such as readmissions and issues regarding risk adjustment for socioeconomic and sociodemographic factors. The work in the year ahead will include NQF simultaneously culling and building out a measurement portfolio that drives the healthcare system to delivering higher value healthcare at lower cost. NQF will also serve as a forum for all stakeholders across the public and private sectors to contribute to furthering the future of measurement and quality improvement for the nation.

    Appendix A: 2014 Activities Performed Under Contract With HHS Description Output Status
  • (as of 12/31/2014)
  • Notes/scheduled or actual completion date
    1. Recommendations on the National Quality Strategy and Priorities Multistakeholder input on a National Priority: Improving Population Health by Working with Communities A common framework that offers guidance on strategies for improving population health within communities Phase 1 completed Phase 1 completed August 2014. Phase 2 in progress. Phase 2 in progress. Multistakeholder input into the Quality Rating System Review and input into core measures and organization of information for the Health Insurance Marketplaces Quality Rating System Completed Completed January 2014. Multistakeholder Action Pathway Model in support of the Partnership for Patients (PfP) Initiative Quarterly reports and meetings detailing progress of three action teams addressing maternity care, readmissions, and patient and family engagement Completed Quarterly meetings held on:
  • • January 29, 2014
  • • April 24, 2014
  • • July 14, 2014
  • • October 3, 2014.
  • Quarterly reports released on:
  • • January 31, 2014
  • • April 30, 2014
  • • July 31, 2014
  • • October 15, 2014.
  • Common Formats for patient safety data A set of comments and advice for further refining additional modules for the Common Formats, an AHRQ-based initiative that helps standardize electronic reporting of patient safety event data In progress Completed-comments received in 2014 reviewed by Expert Panel and given to AHRQ. 2. Quality and Efficiency Measurement Initiatives Behavioral health Set of endorsed measures for behavioral health Phase 2 Completed Phase 2 endorsed 20 measures in May 2014. Phase 3 in progress Phase 3 will be completed in May 2015. Readmissions and all-cause admissions and readmissions measures and maintenance review Set of endorsed measures for admissions and readmissions In progress Will be completed in March 2015. Cost and resource use measures Set of endorsed measures for cost and resource use Phase 2 in progress Phase 2 will be completed in March 2015. Phase 3 in progress Phase 3 will be completed in March 2015. Cardiovascular measures and maintenance review Set of endorsed measures for cardiovascular conditions Phase 1 Completed Phase 1 completed November 2014. Phase 2 in progress Phase 2 will be completed in July 2015. Phase 3 in progress Phase 3 will be completed in April 2016. Endocrine measures and maintenance review Set of endorsed measures for endocrine conditions Phase 1 Completed Phase 1 was completed in November 2014. Phase 2 in progress Phase 2 will be completed in February 2015. Phase 3 in progress Phase 3 will be completed in September 2015. Health and well-being measures and maintenance review Set of endorsed measures for health and well-being Phase 1 Completed Phase 1 was completed in December 2014. Phase 2 in progress Phase 2 will be completed in December 2015. Patient safety measures and maintenance review Set of endorsed measures for patient safety Phase 1 in progress Phase 1 will be completed in January 2015. Phase 2 in progress Phase 2 will be completed in February 2016. Care coordination measures and maintenance review Set of endorsed measures for care coordination Completed Was completed in November 2014. Musculoskeletal measures and maintenance review Set of endorsed measures for musculoskeletal conditions In progress Will be completed in January 2015. Person- and family-centered care measures and maintenance review Set of endorsed measures for person- and family-centered care Phase 1 in progress Phase 1 will be completed in March 2015. Phase 2 in progress Phase 2 will be completed in August 2015. Surgery measures and maintenance review Set of endorsed measures for surgery Phase 1 in progress Phase 1 will be completed in February 2015. Phase 2 in progress Phase 2 will be completed in October 2015. Eye care, ear, nose, and throat conditions measures and maintenance review Set of endorsed measures for eye care, ear, nose, and throat conditions In progress Final report will be completed in January 2016. Renal measures and maintenance review Set of endorsed measures for renal care In progress Final report will be completed in December 2015. Episode grouper criteria Report examining necessary submission elements for evaluation, as well as best practices for episode grouper construction Completed Final report completed September 2014. Prioritization and identification of health IT patient safety measures Report will provide a comprehensive framework for assessment of HIT safety measurement efforts In progress Final report will be completed in February 2016. Quality measurement for home and community-based services Report will provide a conceptual framework and environmental scan to address performance measure gaps in home and community-based services to enhance the quality of community living In progress Final report will be completed in September 2016. Risk Adjustment for socioeconomic status or other sociodemographic factors Report providing a set of recommendations on the inclusion of socioeconomic status and other sociodemographic factors in risk adjustment for outcome and resource use performance measures Completed Final report completed August 15, 2014. Rural health This project will provide recommendations to HHS on performance measurement issues for rural and low-volume providers In progress Final report will be completed in September 2015. 3. Stakeholder Recommendations on Quality and Efficiency Measures and National Priorities Recommendations for measures to be implemented through the 2014 federal rulemaking process for public reporting and payment Measure Applications Partnership Pre-Rulemaking Report: Input on Measures Under Consideration by HHS for 2014 Rulemaking Completed Completed January 31, 2014. Recommendations for measures to be implemented through the 2015 federal rulemaking process for public reporting and payment Measure Applications Partnership Pre-Rulemaking Report: Input on Measures Under Consideration by HHS for 2015 Rulemaking In progress Measure specific recommendations will be completed on February 1, 2015.
  • Hospital, PAC/LTC Programmatic Report will be completed on February 15, 2015.
  • Clinician and Cross Cutting Report will be completed on March 15, 2015.
  • Synthesizing evidence and convening key stakeholders to make recommendations on families of measures and risk adjustment New families of measures covering affordability, population health, and person- and family-centered care. Also a final set of recommendations focused on risk adjustment for resource use performance measures Completed Completed July 1, 2014. Identification of quality measures for dual-eligible Medicare-Medicaid enrollees and adults enrolled in Medicaid Annual input on the Initial Core Set of Health Care Quality Measures for Adults Enrolled in Medicaid, and additional refinements to previously published Families of Measures Completed Completed August 29, 2014. Next annual recommendations due by September 1, 2015. Identification of quality measures for children in Medicaid Annual input on the Initial Core Set of Health Care Quality Measures for Children enrolled in Medicaid In Progress Completed November 14th, 2014. Next annual recommendations due by September 1, 2015. 4. Gaps in Evidence and Targeted Research Needs Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps for the Health Workforce Recommended sets of priorities for performance improvement for the health workforce Completed Completed August 15, 2014. Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps for Adult Immunizations Recommended sets of priorities for performance improvement for adult immunizations Completed Completed August 15, 2014. Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps in Care Coordination Recommended sets of priorities for performance improvement for care coordination Completed Completed August 15, 2014. Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps in Person-Centered Care and Outcomes Recommended sets of priorities for performance improvement for person-centered care and outcomes Completed Completed August 15, 2014. Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps for Alzheimer's Disease Recommended sets of priorities for performance improvement for person-centered care and outcomes Completed Completed October 15, 2014.
    Appendix B: Measure Evaluation Criteria

    Measures are evaluated for their suitability based on standardized criteria in the following order:

    1. Importance to Measure and Report: http://www.qualityforum.org/docs/measure_evaluation_criteria.aspx#importance 2. Scientific Acceptability of Measure Properties: http://www.qualityforum.org/docs/measure_evaluation_criteria.aspx#scientific 3. Feasibility: http://www.qualityforum.org/docs/measure_evaluation_criteria.aspx#feasibility 4. Usability and Use: http://www.qualityforum.org/docs/measure_evaluation_criteria.aspx#usability 5. Related and Competing Measures: http://www.qualityforum.org/docs/measure_evaluation_criteria.aspx#comparison

    More information is available on the NQF Web site at: http://www.qualityforum.org/docs/measure_evaluation_criteria.aspx#1_2.

    Appendix C: Federal Public Reporting and Performance-Based Payment Programs Considered by MAP End-Stage Renal Disease Quality Incentive Program Home Health Quality Reporting Program Hospice Quality Reporting Program Inpatient Rehabilitation Facility Quality Reporting Program Long-Term Care Hospital Quality Reporting Program Ambulatory Surgical Center Quality Reporting Program Hospital-Acquired Condition Reduction Program Hospital Inpatient Quality Reporting Program Hospital Outpatient Quality Reporting Program Hospital Readmission Reduction Program Hospital Value-Based Purchasing Program Inpatient Psychiatric Facility Quality Reporting Program Prospective Payment System (PPS) Exempt Cancer Hospital Quality Reporting Program Medicare and Medicaid Electronic Health Records (EHR) Incentive Programs Medicare and Medicaid Electronic Health Records (EHR) Incentive Programs for Eligible Professionals Medicare Shared Savings Program Physician Quality Reporting System Physician Feedback/Value-Based Payment Modifier Program Physician Compare Appendix D: MAP Structure, Members, and Criteria for Service

    MAP operates through a two-tiered structure. Guided by the priorities and goals of HHS's National Quality Strategy, the MAP Coordinating Committee provides direction and direct input to HHS. MAP's workgroups advise the Coordinating Committee on measures needed for specific care settings, care providers, and patient populations. Time-limited task forces consider more focused topics, such as developing “families of measures”—related measures that cross settings and populations—and provide further information to the MAP Coordinating Committee and workgroups. Each multistakeholder group includes individuals with content expertise and organizations particularly affected by the work.

    MAP's members are selected based on NQF Board-adopted selection criteria, through an annual nominations process and an open public commenting period. Balance among stakeholder groups is paramount. Due to the complexity of MAP's tasks, individual subject matter experts are included in the groups. Federal government ex officio members are nonvoting because federal officials cannot advise themselves. MAP members serve staggered three-year terms.

    MAP members Coordinating Committee Committee Co-Chairs (Voting) George J. Isham, MD, MS Elizabeth A. McGlynn, Ph.D., MPP Organizational Members (Voting) AARP Joyce Dubow, MUP Academy of Managed Care Pharmacy Marissa Schlaifer, RPh, MS AdvaMed Steven Brotman, MD, JD AFL-CIO Shaun O'Brien American Board of Medical Specialties Lois Margaret Nora, MD, JD, MBA American College of Physicians Amir Qaseem, MD, Ph.D., MHA American College of Surgeons Frank G. Opelka, MD, FACS American Hospital Association Rhonda Anderson, RN, DNSc, FAAN American Medical Association Carl A. Sirio, MD American Medical Group Association Sam Lin, MD, Ph.D., MBA American Nurses Association Marla J. Weston, Ph.D., RN America's Health Insurance Plans Aparna Higgins, MA Blue Cross and Blue Shield Association Trent T. Haywood, MD, JD Catalyst for Payment Reform Shaudi Bazzaz, MPP, MPH Consumers Union Lisa McGiffert Federation of American Hospitals Chip N. Kahn, III Healthcare Financial Management Association Richard Gundling, FHFMA, CMA Healthcare Information and Management Systems Society To be determined The Joint Commission Mark R. Chassin, MD, FACP, MPP, MPH LeadingAge Cheryl Phillips. MD, AGSF Maine Health Management Coalition Elizabeth Mitchell National Alliance for Caregiving Gail Hunt National Association of Medicaid Directors Foster Gesten, MD, FACP National Business Group on Health Steve Wojcik National Committee for Quality Assurance Margaret E. O'Kane, MHS National Partnership for Women and Families Alison Shippy Pacific Business Group on Health William E. Kramer, MBA Pharmaceutical Research and Manufacturers of America (PhRMA) Christopher M. Dezii, RN, MBA, CPHQ Individual Subject Matter Experts (Voting) Bobbie Berkowitz, Ph.D., RN, CNAA, FAAN Marshall Chin, MD, MPH, FACP Harold A. Pincus, MD Carol Raphael, MPA Federal Government Liaisons (Non-Voting) Agency for Healthcare Research and Quality (AHRQ) Richard Kronich, Ph.D./Nancy J. Wilson, MD, MPH Centers for Disease Control and Prevention (CDC) Chesley Richards, MD, MH, FACP Centers for Medicare & Medicaid Services (CMS) Patrick Conway, MD, MSc Office of the National Coordinator for Health Information Technology (ONC) Kevin Larsen, MD, FACP Clinician Workgroup Committee Chair (Voting) Mark McClellan, MD, Ph.D. The Brookings Institution, Engelberg Center for Health Care Reform Organizational Members (Voting) The Alliance Amy Moyer, MS, PMP American Academy of Family Physicians Amy Mullins, MD, CPE, FAAFP American Academy of Nurse Practitioners Diane Padden, Ph.D., CRNP, FAANP American Academy of Pediatrics Terry Adirim, MD, MPH, FAAP American College of Cardiology * Representative to be determined American College of Emergency Physicians Jeremiah Schuur, MD, MHS American College of Radiology David Seidenwurm, MD Association of American Medical Colleges Janis Orlowski, MD Center for Patient Partnerships Rachel Grob, Ph.D. Consumers' CHECKBOOK Robert Krughoff, JD Kaiser Permanente Amy Compton-Phillips, MD March of Dimes Cynthia Pellegrini Minnesota Community Measurement Beth Averbeck, MD National Business Coalition on Health Bruce Sherman, MD, FCCP, FACOEM National Center for Interprofessional Practice and Education James Pacala, MD, MS Pacific Business Group on Health David Hopkins, MS, Ph.D. Patient-Centered Primary Care Collaborative Marci Nielsen, Ph.D., MPH Physician Consortium for Performance Improvement Mark L. Metersky, MD Wellpoint * Representative to be determined Individual Subject Matter Experts (Voting) Luther Clark, MD Subject Matter Expert: Disparities Merck & Co., Inc Constance Dahlin, MSN, ANP-BC, ACHPN, FPCN, FAAN Subject Matter Expert: Palliative Care Hospice and Palliative Nurses Association Eric Whitacre, MD, FACS; Surgical Care Subject Matter Expert: Surgical Care Breast Center of Southern Arizona Federal Government Liaisons (Non-Voting) Centers for Disease Control and Prevention (CDC) Peter Briss, MD, MPH Centers for Medicare & Medicaid Services (CMS) Kate Goodrich, MD Health Resources and Services Administration (HRSA) Girma Alemu, MD, MPH Dual Eligible Beneficiaries Workgroup Liaison (Non-Voting) Humana, Inc. George Andrews, MD, MBA, CPE, FACP, FACC, FCCP Dual Eligible Beneficiaries Workgroup Committee Chairs (Voting) Alice R. Lind, RN, MPH (Chair) Jennie Chin Hansen, RN, MS, FAAN (Vice-Chair) Organizational Members (Voting) AARP Public Policy Institute Susan Reinhard, RN, Ph.D., FAAN American Federation of State, County and Municipal Employees Sally Tyler, MPA American Geriatrics Society Gregg Warshaw, MD American Medical Directors Association Gwendolen Buhr, MD, MHS, Med, CMD America's Essential Hospitals Steven R. Counsell, MD Center for Medicare Advocacy Kata Kertesz, JD Consortium for Citizens with Disabilities E. Clarke Ross, DPA Humana, Inc. George Andrews, MD, MBA, CPE iCare Thomas H. Lutzow, Ph.D., MBA National Association of Social Workers Joan Levy Zlotnik, Ph.D., ACSW National PACE Association Adam Burrows, MD SNP Alliance Richard Bringewatt Matter Experts (Voting) Mady Chalk, MSW, Ph.D. Anne Cohen, MPH James Dunford, MD Nancy Hanrahan, Ph.D., RN, FAAN K. Charlie Lakin, Ph.D. Ruth Perry, MD Gail Stuart, Ph.D., RN Federal Government Liaisons (Non-Voting) Administration for Community Living (ACL) Jamie Kendall, MPP Centers for Medicare & Medicaid Services (CMS) Venesa J. Day Office of the Assistant Secretary for Planning and Evaluation D.E.B. Potter, MS Hospital Workgroup Committee Chairs (Voting) Frank G. Opelka, MD, FACS (Chair) Ronald S. Walters, MD, MBA, MHA, MS (Vice-Chair) Organization Members (Voting) Alliance of Dedicated Cancer Centers Karen Fields, MD American Federation of Teachers Healthcare Kelly Trautner American Hospital Association Nancy Foster American Organization of Nurse Executives Amanda Stefancyk Oberlies, RN, MSN, MBA, CNML, Ph.D.(c) America's Essential Hospitals David Engler, Ph.D. ASC Quality Collaboration Donna Slosburg, BSN, LHRM, CASC Blue Cross Blue Shield of Massachusetts Wei Ying, MD, MS, MBA Children's Hospital Association Andrea Benin, MD Memphis Business Group on Health Cristie Upshaw Travis, MHA Mothers against Medical Error Helen Haskell, MA National Coalition for Cancer Survivorship Shelley Fuld Nasso National Rural Health Association Brock Slabach, MPH, FACHE Pharmacy Quality Alliance Shekhar Mehta, PharmD, MS Premier, Inc. Richard Bankowitz, MD, MBA, FACP Project Patient Care Martin Hatlie, JD Service Employees International Union Jamie Brooks Robertson, JD St. Louis Area Business Health Coalition Louise Y. Probst, MBA, RN Individual Subject Matter Experts (Voting) Dana Alexander, RN, MSN, MBA Jack Fowler, Jr., Ph.D. Mitchell Levy, MD, FCCM, FCCP Dolores L. Mitchell R. Sean Morrison, MD Michael P. Phelan, MD, FACEP Ann Marie Sullivan, MD Federal Government Liaisons (Non-Voting) Agency for Healthcare Research and Quality (AHRQ) Pamela Owens, Ph.D. Centers for Disease Control and Prevention (CDC) Daniel Pollock, MD Centers for Medicare & Medicaid Services (CMS) Pierre Yong, MD, MPH Post-Acute Care/Long-Term Care Workgroup: Committee Chair (Voting) Carol Raphael, MPA Organizational Members (Voting) Aetna Joseph Agostini, MD American Medical Rehabilitation Providers Association Suzanne Snyder Kauserud, PT American Occupational Therapy Association Pamela Roberts, Ph.D., OTR/L, SCFES, CPHQ, FAOTA American Physical Therapy Association Roger Herr, PT, MPA, COS-C American Society of Consultant Pharmacists Jennifer Thomas, PharmD Caregiver Action Network Lisa Winstel Johns Hopkins University School of Medicine Bruce Leff, MD Kidney Care Partners Allen Nissenson, MD, FACP, FASN, FNKF Kindred Healthcare Sean Muldoon, MD National Consumer Voice for Quality Long-Term Care Robyn Grant, MSW National Hospice and Palliative Care Organization Carol Spence, Ph.D. National Pressure Ulcer Advisory Panel Arthur Stone, MD National Transitions of Care Coalition James Lett, II, MD, CMD Providence Health & Services Dianna Reely Visiting Nurses Association of America Margaret Terry, Ph.D., RN Individual Subject Matter Experts (Voting) Louis Diamond, MBChB, FCP(SA), FACP, FHIMSS Gerri Lamb, Ph.D. Marc Leib, MD, JD Debra Saliba, MD, MPH Thomas von Sternberg, MD Federal Government Liaisons (Non-Voting) Centers for Medicare & Medicaid Services (CMS) Alan Levitt, MD Office of the National Coordinator for Health Information Technology (ONC) Elizabeth Palena Hall, MIS, MBA, RN Substance Abuse and Mental Health Services Administration (SAMHSA) Lisa C. Patton, Ph.D.
    Appendix E: Specific Measure Gaps Identified Through 2014 Measure Endorsement Work Cost and Resource Use • Total cost of care • Consumer out-of-pocket expenses • Actual prices paid by patients and health plans • Trends in cost performance over time at the health plan level • Systematic cost drivers • Costs rolled up from all levels of analysis which can be deconstructed to understand costs at lower levels of analysis Behavioral Health • Measures specific to child and adolescent behavioral health needs • Outcome measures for substance abuse/dependence that can be used by substance use specialty providers • Quality measures assessing care for persons with intellectual disabilities • Quality measures that align indicators of clinical need and treatment selection and ideally, patient preferences • Measures that assess aspects of recovery-oriented care for individuals with serious mental illness • Measures related to coordination of care across sectors involved in the support of persons with chronic mental health problems • Adapt measure concepts for inpatient care to other outpatient care settings • Measures that assess whether evidence based psychosocial interventions are being applied consistent with their evidence base • Expand the number of conditions for which quality of care can be assessed in the context of measurement-based care (e.g. suite of endorsed measures now available for depression) • Measurement strategies for assessing the adequacy of screening and prevention interventions for general medical conditions • Screening for alcohol and drugs • Screening for post-traumatic stress disorder and bipolar disorder in patients diagnosed with depression Cardiovascular • Patient-reported outcome measures for heart failure symptoms and activity assessment • Composite measures for heart failure • Measures of cardiometabolic risk factors • “Episode of care” composite measure for AMI that includes outcome as well as process measures • Consideration of socioeconomic determinants of health and disparities • Global measures of cardiovascular care Care Coordination • Measures focused on health information technology (IT), transitions of care, and structural measures • Cross-cutting measures that span various types of providers and episodes of care. Such measures have the potential to be applied more broadly and be more useful for those with multiple chronic conditions • Measures of patient-caregiver engagement • Measures that evaluate “system-ness” rather than measures that address care within silos • Outcome and composite measures, which are prioritized by both the Committee and MAP over individual process and structural measures, but with the recognition that some of these latter measures are valuable Surgery • Various specialty areas that are still in their infancy in terms of quality measurement, including orthopedic surgery, bariatric surgery, neurosurgery, and others • Measures of adverse outcomes that are structured as “days since last event” or “days between events”; this could help address some of the concerns about measuring low-volume events • Measures around functional status or return to function after surgery, as well as other patient-centered and patient-reported outcomes like patient experience Health and Well-Being • Measures that assess social, economic, and environmental determinants of health • Measures that assess physical environment (e.g., built environments) • Measures that assess policy (e.g., smoke-free zones) • Measures that assess health and well-being for specific sub-populations (e.g., people with disabilities, elderly) • Patient and population outcomes linked to improvement in functional status • Counseling for physical activity and nutrition in younger and middle-aged adults (18 to 65 years) • Composites that assess population experience Endocrine • Measures of other endocrine-related conditions, particularly thyroid disease, both for adults and for the pediatric population • Incidence of heart attacks and strokes among persons with diabetes, measured at the health plan level • Measures of overuse, particularly for thyroid conditions (e.g., ultrasound for thyroid nodules, overdiagnosis/overtreatment of thyroid cancer) • Measures for pre-diabetes/metabolic syndrome • “Delta” measures for intermediate clinical outcomes (e.g., LDL levels, HbA1c levels) • Education measures (e.g., for diabetes) that go beyond asking if education was provided and instead assesses whether the patient was able to understand and apply the education (needed at diagnosis, not just when complications arise) • Measures that utilize other types of patient information (e.g., time-in-range measures for patients with continuous glucose monitors) • More complex measures, including composite measures for diabetes screening and for neuropathy care • Measures of hypoglycemia among the elderly, including medication safety measures • Measures focusing on the use of testosterone • Measures of Body Mass Index (BMI) or in adult patients with diabetes mellitus • Patient-centered measures of lifestyle management and health-related quality of life • Access to care and medications • Treatment preferences, psychosocial needs, shared decisionmaking, family engagement, cultural diversity, and health literacy • Communication, coordination, and transitions of care • General prevention and treatment of diabetes, as well as measures of the sequelae of diabetes • Glycemic control for complex patients (e.g., geriatric population, multiple chronic conditions) and for the pediatric population at the clinician, facility, and system levels of analysis • Evaluation of bone density, and prevention and treatment of osteoporosis in ambulatory settings Patient Safety • Safety outcome measures, particularly mediation safety measures • Radiation safety measures Musculoskeletal • Management of chronic pain • Use of MRI for management of chronic knee pain • Tendinopathy: evaluation, treatment, and management • Outcomes: spinal fusion, knee and hip replacement • Overutilization of procedures • Secondary fracture prevention National Quality Forum, 1030 15th St. NW., Suite 800, Washington, DC 20005, http://www.qualityforum.org ISBN 978-1-933875-86-6 ©2015 National Quality Forum III. Secretarial Comments on the 2015 Annual Report to Congress and the Secretary

    The 2015 Annual Report to Congress and the Secretary by the National Quality Forum (NQF) shows the range and complexity of issues that face all people and organizations working to improve the effectiveness and efficiency of health care quality measurement. Approximately 16 percent of 600 quality measures in NQF's portfolio of endorsed measures were removed and an almost equal percentage of new measures were added in 2014, indicating the dynamic and continuously evolving nature of the field of quality measurement. The substantial progress in strengthening the set of endorsed measures was facilitated by collaborations between NQF, the Centers for Medicare & Medicaid Services (CMS), the Office of the National Coordinator for Health Information Technology, and many other stakeholders that aimed to reduce the complexity of the measure endorsement process. The streamlined process that resulted enables more measures to be reviewed, considered for endorsement, and endorsed as appropriate.

    Having a greater portfolio of endorsed measures is key to HHS' efforts to find better ways to deliver health care, pay providers, and keep people healthy and safe. HHS uses performance measures across many programs to achieve this. For example, the INR Monitoring for Individuals on Warfarin measure (NQF # 0555) is endorsed by the CBE and adds to the existing set of measures in the Centers for Medicare and Medicaid Services (CMS)'s medication management and clinical effectiveness portfolios. This measure is especially valuable, because it addresses an important issue that can be used to improve patient safety and is useful for many CMS initiatives (e.g., CMS's Physician Quality Reporting System and the National Action Plan for Adverse Drug Event Prevention). The Cardiovascular Health Screening for people with Schizophrenia or Bipolar Disorder Who Are Prescribed Antipsychotic Medications measure (NQF # 1927) also is “cross-cutting,” applicable to measurement of such areas as care coordination and clinical effectiveness. Further, this measure can be applied to potentially reduce health disparities for individuals with mental illness and improve population health by incentivizing providers to better manage complex chronic conditions. In addition to HHS' use of NQF-endorsed measures in current programs, having a strong slate of endorsed measures overall will help HHS in its plans to move the Medicare program, and the health care system at large, toward paying providers based on the quality, rather than the quantity, of care they give patients.

    However, this report also presents some weaknesses in the current portfolio of endorsed measures available to evaluate health care. With respect to healthcare quality, NQF identified that some gaps remain in certain measure categories: (1) patient safety (especially for settings other than hospitals), (2) patient and family engagement, (3) healthy living, (4) care coordination, (5) affordability, and (6) prevention and treatment of leading causes of mortality. The report also highlights the need for measures of population health, person- and family-centered care, and for measures of the intersection of health information technology (HIT) and health care safety. With respect to measures of the efficiency of healthcare, NQF's report also calls attention to the need for better measures of the price and cost of health care, noting that current measures focus on direct costs while excluding indirect costs that may be significant for persons and families, e.g., transportation to and from providers and lost income from missing work. NQF reports that much work remains to close the gaps in the set of endorsed measures currently available.

    This report also calls attention to the need to increase our knowledge about how best to use measures of health care quality and efficiency. For example, as healthcare providers increasingly grapple with the need to accommodate patient differences including patient preferences, social, cultural, economic, and demographic factors in order to help people be healthy and safe, public reporting and value based payment programs also need to understand the extent to which (and if so, how) sociodemographic factors should be incorporated into their quality measurements. Similarly, NQF's committee studying the use of episode groupers affirmed their value to performance measurements, but also concluded that endorsement of any particular episode grouper is not yet possible and set forth an agenda for additional work.

    These complexities in the science of measurement are mirrored by the complexities faced by consumers when using quality and efficiency measures to select health plans and providers. The NQF project undertaken to provide input on the measures and the hierarchy for HHS' proposed Quality Rating System to help consumers select qualified health plans through Health Insurance Marketplaces documented the need for such rating systems to pay attention not just to what measures should be presented to consumers, but also how the measures should be displayed to consumers. It documented the need for such efforts to test all aspects of information displays with diverse populations, to incorporate provider-level quality information within health plan quality information, to provide functionality that allows consumers to customize and prioritize information to assist in their unique decision-making processes; and for such rating systems to continue to evolve as new measures are developed. Accomplishing this will help HHS provide better information to consumers for informing their choices about qualified health plans in the Marketplaces.

    Increasing the number and comprehensiveness of endorsed measures, producing new knowledge to inform how best to deploy such measures, and making measures of quality and efficiency readily available and understandable to all stakeholders are critical components of HHS' work in strengthening the health care delivery system and helping people stay healthy and safe. HHS recognizes the success of the National Quality Forum in bringing together diverse stakeholders and fostering consensus to advise HHS' efforts in these areas. In addition, we appreciate the many people who participate in NQF's consensus projects by contributing their time and expertise in quality measurement. In this report, NQF notes that just one of its projects—the public-private Measure Applications Partnership (MAP), which provides input on the selection of performance measures for more than 20 Medicare public reporting and performance-based payment programs—now involves approximately 150 healthcare leaders and experts from nearly 90 private-sector organizations as well as liaisons from seven different federal agencies.

    Stakeholders convened by NQF include entire communities as well. Participants in the population health initiative undertaken by NQF on behalf of HHS include the Colorado Department of Health Care Policy and Financing; the Community Service Council of Tulsa, Oklahoma; the Designing a Strong and Healthy NY (DASH-NY) coalition of New York, NY; the Empire Health Foundation of Spokane, Washington; the Kanawha Coalition for Community Health Improvement of Charleston, West Virginia; Mercy Medical Center and Abbe Center for Community Mental Health—A Community Partnership with Geneva Tower, Cedar Rapids, Iowa; the Michigan Health Improvement Alliance of Central Michigan; Oberlin Community Services and The Institute for eHealth Equity, in Oberlin, Ohio; Trenton Health Team, Inc., in Trenton, New Jersey; and The University of Chicago Medicine Population Health Management Transformation initiative.

    Such coalitions remind us that it takes all stakeholders working together to achieve better health care and health.

    HHS thanks the NQF for this past year's work and for bringing together diverse stakeholders to achieve consensus in key performance measurement areas. We look forward to continuing to work together to advance the science and achieve the benefits of performance measurement.

    IV. Future Steps

    NQF annually undertakes several activities which constitute a recurring agenda. These include, for example, the endorsement and maintenance of standardized health care performance measures and making recommendations on measures under consideration by HHS for use in its many Medicare quality reporting and payment programs. In the coming year, in addition to the work on these ongoing annual projects, HHS will closely follow the progress of several special projects underway by NQF. In particular, NQF's two-year trial period which will test specific recommendations for attending to potential socioeconomic and sociodemographic factors in quality measurement is of interest. This project, added to analyses already underway by HHS in response to the Improving Medicare Post-Acute Care Transformation Act of 2014 will provide a better understanding of how to address these factors in quality measurement, reporting and payment policy.

    A second NQF special project focusing on population health, including community action to promote healthy living, will also contribute to the knowledge base of how to address social determinants of health as we seek to create a health care system that promotes prevention and wellness and keeps people healthy. This project also responds to one of the CBE duties (specified at Section 1890(b)(7)(a)(ii) of the Act) which requires the CBE to convene multi-stakeholder groups to provide input on national priorities for improvement in population health as identified in the national strategy. Specifically, one of the national strategy's three aims is to: “Improve the health of the U.S. population by supporting proven interventions to address behavioral, social, and environmental determinants of health in addition to delivering higher-quality care.” And one of the NQS' six priorities calls for “Working with communities to promote wide use of best practices to enable healthy living.” To successfully address this aim and priority, multi-stakeholder input is needed on how federal, state and local governments and private sector community stakeholders can most effectively engage in:

    1. “Supporting proven interventions to address behavioral, social, and environmental determinants of health;” and

    2. “Working with communities to promote wide use of best practices to enable healthy living.”

    Other special projects to address gaps in measures for people dually eligible for Medicaid and Medicare services, and people who use long term care services and supports are also of great interest. HHS also will be following the progress of a special project to achieve greater consistency in the definitions of some of the data elements that comprise measures derived from electronic health records. Having consistent definitions of these data elements will enable these measures to perform more reliably, and promote more efficient assessment, endorsement and maintenance of measures derived from electronic data sources.

    HHS will also seek to address gaps in measures identified in NQF's report, as HHS pursues new measure development and application in its value-based purchasing, public reporting, and other quality measurement and improvement initiatives.

    V. Collection of Information Requirements

    This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35).

    Dated: August 24, 2015. Sylvia M. Burwell, Secretary, Department of Health and Human Services.

    1 Throughout this report, a summary of the relevant statutory language appears in italicized text.

    2 Department of Health and Human Services (HHS). Report to Congress: National Strategy for Quality Improvement in Health Care. Washington, DC: HHS; 2011. Available at http://www.ahrq.gov/workingforquality/nqs/nqs2011annlrpt.pdf. Last accessed February 2015.

    3 National Quality Forum (NQF). Report from the National Quality Forum: 2012 NQF Measure Gap Analysis. Washington, DC: NQF, 2013. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=72981. Last accessed February 2015.

    4 NQF. MAP 2014 Recommendations on Measures for More Than 20 Federal Programs. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=74634. Last accessed February 2015.

    5 NQF. Multistakeholder Input on a National Priority: Improving Population Health by Working with Communities—Action Guide 1.0. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77293. Last accessed February 2015.

    6 NQF. Input on the Quality Rating System for Qualified Health Plans in the Health Insurance Marketplaces. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=74552. Last accessed February 2015.

    7 Centers for Medicare & Medicaid Services (CMS) Web site. Welcome to the Partnership for Patients. Baltimore, MD: 2015. Available at http://partnershipforpatients.cms.gov/. Last accessed February 2015.

    8 NQF. Maternity Action Team Action Pathway: Promoting Healthy Mothers and Babies. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77424. Last accessed February 2015.

    9 NQF. Playbook for the Successful Elimination of Early Elective Deliveries. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=idItemID=77396. Last accessed February 2015.

    10 NQF. Readmissions Action Team Action Pathway: Reducing Avoidable Admissions and Readmissions. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77291. Last accessed February 2015.

    11 NQF. Patient and Family Engagement Action Pathway: Fostering Authentic Partnerships between Patients, Families, and Care Teams. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77357. Last accessed February 2015. Last accessed February 2015.

    12 NQF. Risk Adjustment for Socioeconomic Status or Other Sociodemographic Factors. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77474. Last accessed February 2015.

    13 NQF. Evaluating Episode Groupers: A Report from the National Quality Forum. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77592. Last accessed February 2015.

    14 NQF steering committees are comparable to the expert advisory committees typically convened by federal agencies.

    15 NQF Web site. Patient-Reported Outcomes. Available at http://www.qualityforum.org/Projects/n-r/Patient-Reported_Outcomes/Patient-Reported_Outcomes.aspx. Last accessed February 2015.

    16 NQF. Risk Adjustment for Socioeconomic Status or Other Sociodemographic Factors. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77474. Last accessed February 2015.

    17 NQF. Evaluating Episode Groupers: A Report from the National Quality Forum. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77592. Last accessed February 2015.

    18 NQF. Evaluating Episode Groupers: A Report from the National Quality Forum. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77592. Last accessed February 2015.

    19 Weiner JP, Kfuri T, Fowles JB. “E-iatrogenesis”: The most critical unintended consequence of CPOE and other HIT. J Am Med Inform Assoc. 2007;14(3):387-388.

    20 NQF. MAP 2014 Recommendations on Measures for More Than 20 Federal Programs. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=74634. Last accessed February 2015.

    21 NQF. Finding Common Ground for Healthcare Priorities: Families of Measures for Assessing Affordability, Population Health, and Person- and Family-Centered Care. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77001. Last accessed February 2015.

    22 NQF. Finding Common Ground for Healthcare Priorities: Families of Measures for Assessing Affordability, Population Health, and Person- and Family-Centered Care. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77001. Last accessed February 2015.

    23 NQF. Finding Common Ground for Healthcare Priorities: Families of Measures for Assessing Affordability, Population Health, and Person- and Family-Centered Care. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77001. Last accessed February 2015.

    24 NQF. Finding Common Ground for Healthcare Priorities: Families of Measures for Assessing Affordability, Population Health, and Person- and Family-Centered Care. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77001. Last accessed February 2015.

    25 NQF. 2014 Input on Quality Measures for Dual Eligible Beneficiaries. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77520. Last accessed February 2015.

    26 NQF. Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps for Adult Immunizations. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77416. Last accessed February 2015.

    27 NQF. Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps for Dementia, including Alzheimer's Disease. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=78039. Last accessed February 2015.

    28 NQF. Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps in Care Coordination. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77422. Last accessed February 2015.

    29 NQF. Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps for the Health Workforce. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77414. Last accessed February 2010.

    30 NQF. Priority Setting for Healthcare Performance Measurement: Addressing Performance Measure Gaps in Person-Centered Care and Outcomes. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77423. Last accessed February 2015.

    31 NQF. 2014 Input on Quality Measures for Dual Eligible Beneficiaries. Washington, DC: NQF, 2014. Available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=77520. Last accessed February 2015.

    [FR Doc. 2015-21549 Filed 9-3-15; 8:45 am] BILLING CODE 4150-05-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request National Children's Study (NCS) Data and Sample Archive and Access System SUMMARY:

    Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 22, 2015, Vol. 80, No. 77 and allowed 60 days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

    Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974, Attention: Desk Officer for NIH.

    Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

    FOR FURTHER INFORMATION CONTACT:

    To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Sarah L. Glavin, Deputy Director, Office of Science Policy, Analysis and Communication, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland 20892, or call a non-toll free number (301) 496-7898 or Email your request, including your address to [email protected] Formal requests for additional plans and instruments must be requested in writing.

    Proposed Collection: National Children's Study (NCS) Data and Sample Archive and Access System, 0925-NEW, National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH).

    Need and Use of Information Collection: The primary use of this information collected from potential users of the NCS Data and Sample Archive and Access System is to document, track, and monitor its use. The purpose of the archive is to share data collected in the NCS Vanguard (OMB #0925-0593) with qualified users. Users will provide basic contact information, complete brief data user training, and agree to terms and conditions of data and archive use prior to accessing any data. A Research Plan describing the information and materials requested will also be required for access to certain types of research materials. This information is necessary to fulfill the requirements of the proposed research projects and will help NIH understand and evaluate the use of archived data and samples by the research community. OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 109.

    Estimated Annualized Burden Hours Form Number of
  • respondents
  • Frequency of response Average time per response
  • (in hours)
  • Total annual burden hours
    Vanguard Downloadable Data Access Form (Attachment A.1) 300 1 10/60 50 Vanguard Data Request Form (Attachment A.2) 50 1 20/60 17 Vanguard Specimen and Data Request Form (Attachment A.3) 50 1 30/60 25 Research Materials Distribution Agreement (Attachment A.4) 100 1 10/60 17
    Dated: August 26, 2015. Sarah L. Glavin, Project Clearance Officer, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Deputy Director, Office of Science Policy, Analysis, and Communications, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health.
    [FR Doc. 2015-22006 Filed 9-3-15; 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 PAR 14-260: Interventions for Health Promotion and Disease Prevention in Native American Populations (R01).

    Date: September 30, 2015.

    Time: 9:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817.

    Contact Person: Delia Olufokunbi Sam, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD 20892, 301-435-0684, [email protected]

    Name of Committee: Cell Biology Integrated Review Group, Cellular Signaling and Regulatory Systems Study Section.

    Date: October 1, 2015.

    Time: 8:00 a.m. to 8:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: St. Gregory Hotel, 2033 M Street, NW, Washington, DC 20036.

    Contact Person: Elena Smirnova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5187, MSC 7840, Bethesda, MD 20892, 301-357-9112, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel, PAR-14-228: Science Education Award Program (SEPA) grants.

    Date: October 6, 2015.

    Time: 8:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Admiral Fell Inn, 888 South Broadway, Baltimore, MD 21231.

    Contact Person: Jonathan Arias, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5170, MSC 7840, Bethesda, MD 20892, 301-435-2406, [email protected]

    Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group, Neurogenesis and Cell Fate Study Section.

    Date: October 7, 2015.

    Time: 9:00 a.m. to 7:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Renaissance Arlington Capital View Hotel, 2800 South Potomac Avenue, Arlington, VA 22207.

    Contact Person: Joanne T Fujii, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4184, MSC 7850, Bethesda, MD 20892, (301) 435-1178, [email protected]

    Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group, Skeletal Muscle and Exercise Physiology Study Section.

    Date: October 8-9, 2015.

    Time: 8:00 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Virginian Suites, 1500 Arlington Boulevard, Arlington, VA 22209.

    Contact Person: Richard Ingraham, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4116, MSC 7814, Bethesda, MD 20892, 301-496-8551 [email protected]

    Name of Committee: Cell Biology Integrated Review Group, Membrane Biology and Protein Processing Study Section.

    Date: October 8-9, 2015.

    Time: 8:00 a.m. to 5:30 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: Janet M Larkin, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5142, MSC 7840, Bethesda, MD 20892, 301-806-2765, [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: August 31, 2015. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-21941 Filed 9-3-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c) (4) and 552b(c) (6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Cancer Institute Special Emphasis Panel NCI R03 & R21 Omnibus SEP-6.

    Date: October 8-9, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Doubletree Hilton Hotel Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Dona Love, Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W236, Rockville, MD 20850, 240-276-5264, [email protected]

    Name of Committee: National Cancer Institute Special Emphasis Panel NCI Omnibus SEP-4.

    Date: October 14-15, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Doubletree Hilton Hotel Bethesda, 8120 Wisconsin Avenue, Ballroom A, Bethesda, MD 20814.

    Contact Person: Clifford W. Schweinfest, Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W108, Rockville, MD 20850, 240-276-6343, [email protected]

    Name of Committee: National Cancer Institute Special Emphasis Panel ETCTN Applications Review.

    Date: October 22, 2015.

    Time: 8:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W030, Rockville, MD 20850.

    Contact Person: Shamala K. Srinivas, Ph.D., Scientific Review Officer, Office of Referral, Review, and Program Coordination, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W530, Bethesda, MD 20892, 240-276-6442, [email protected]

    Name of Committee: National Cancer Institute Special Emphasis Panel NCI Training SEP.

    Date: October 22, 2015.

    Time: 11:00 a.m. to 12:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W126, Rockville, MD 20850, (Telephone Conference Call).

    Contact Person: Caron A. Lyman, Ph.D., Chief, Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W126, Bethesda, MD 20892-8328, 240-276-6348, [email protected]

    Name of Committee: National Cancer Institute Special Emphasis Panel NCI R01 Review.

    Date: October 23, 2015.

    Time: 11:00 a.m. to 12:30 p.m.

    Agenda: To review and evaluate grant applications,

    Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W126, Rockville, MD 20850, (Telephone Conference Call),

    Contact Person: Caron A. Lyman, Ph.D., Chief, Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W126, Bethesda, MD 20892-8328 240-276-6348, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS)
    Dated: August 31, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-21943 Filed 9-3-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

    FOR FURTHER INFORMATION CONTACT:

    Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

    SUPPLEMENTARY INFORMATION:

    Technology descriptions follow.

    Live Attenuated Vaccine To Prevent Disease Caused by West Nile Virus

    Description of Technology: West Nile virus (WNV) has recently emerged in the U.S. and is considered a significant emerging disease that has embedded itself over a considerable region of the U.S. WNV infections have been recorded in humans as well as in different animals. From 1999-2014, WNV killed 1,765 people in the U.S. and caused severe disease in more than 41,762 others. This project is part of NIAID's comprehensive emerging infectious disease program.

    The methods and compositions of this invention provide a means for prevention of WNV infection by immunization with attenuated, immunogenic viral vaccines against WNV. The invention involves a chimeric virus form comprising parts of WNV and Dengue virus. Construction of the hybrids and their properties are described in detail in multiple publications. The WNV chimeric vaccine does not target the central nervous system, which would be the case in an infection with wild type WNV. Importantly, two successful Phase I clinical trials were recently carried out with the vaccine. The live attenuated WNV vaccine is safe, well-tolerated, and immunogenic in healthy adult volunteers. Furthermore, the vaccine virus may also be considered for use as a safe reagent handled at bio-safety level 2 facilities for WNV diagnosis and surveillance.

    Potential Commercial Applications • Human West Nile vaccine • Veterinary West Nile vaccine • West Nile Virus diagnostics • West Nile Virus therapeutics Competitive Advantages • Low cost of manufacture • Proven chimeric vaccine technology • Phase I clinical data available Development Stage • In vivo data available (animal) • In vivo data available (human)

    Inventors: Alexander G. Pletnev, Robert M. Chanock, Joseph R. Putnak, Brian R. Murphy, Joseph E. Blaney, Stephen S. Whitehead (all of NIAID)

    Publications 1. Pletnev AG, et al. West Nile virus/dengue type 4 virus chimeras that are reduced in neurovirulence and peripheral virulence without loss of immunogenicity or protective efficacy. Proc Natl Acad Sci USA. 2002 Mar 5;99(5):3036-41. [PMID 11880643] 2. Pletnev AG, et al. Molecularly engineered live-attenuated chimeric West Nile/dengue virus vaccines protect rhesus monkeys from West Nile virus. Virology. 2003 Sep 15;314(1):190-5. [PMID 14517072] 3. Hanley KA, et al. Infectivity of West Nile/dengue chimeric viruses for West Nile and dengue mosquito vectors. Vector Borne Zoonotic Dis. 2005 Spring;5(1):1-10. [PMID 15815144] 4. Pletnev AG, et al. Chimeric West Nile/dengue virus vaccine candidate: preclinical evaluation in mice, geese and monkeys for safety and immunogenicity. Vaccine. 2006 Sep 29;24(40-41):6392-404. [PMID 16831498] 5. Durbin AP, et al. The live attenuated chimeric vaccine rWN/DEN4delta30 is well-tolerated and immunogenic in healthy flavivirus-naïve adult volunteers. Vaccine. 2013 Nov 19;31(48):5772-7. [PMID 23968769] 6. Maximova OA, et al. Assurance of neuroattenuation of a live vaccine against West Nile virus: a comprehensive study of neuropathogenesis after infection with chimeric WN/DEN4delta30 vaccine in comparison to two parental viruses and a surrogate flavivirus reference vaccine. Vaccine. 2014 May 30;32(26):3187-97. [PMID 24736001]

    Intellectual Property: HHS Reference No. E-357-2001/1—

    • US Patent No. 8,778,671 issued 15 Jul 2014 • US Patent Application No. 14/305,572 filed 16 Jun 2014 • Various international patents/applications issued/pending

    Licensing Contact: Peter Soukas; 301-435-4646; [email protected]

    Three-Dimensional Curved Catheter for Right Atrial Appendage Traversal

    Description of Technology: Available for licensing and commercial development is a three-dimensionally configured curved catheter for safe traversal of the right atrial appendage (RAA). The device is configured to optimize one-way access of the pericardial space through the right atrium and into the RAA reducing the risk of coronary lacerations. Specifically the curved catheter is best described in three segments: a proximal segment, a transitional segment and a distal segment; the transition segment having a clockwise spiral shaped curvature. When inserted into a patient, the proximal segment is positioned within the inferior vena cava, the transition segment extends across the caval-atrial junction and curves rightward, forward, and upward such that the catheter abuts a right lateral wall of the right atrium, and the distal segment curves leftward, forward, and upward from the transition segment through the right atrium such that the catheter abuts an anterior wall of the right atrium adjacent to the RAA. The catheter is configured to guide a coaxial puncturing device to through the superior left sulcal wall of the RAA.

    Potential Commercial Applications • Left atrial appendage ligation • Circumferential tricuspid annuloplasty • Epicardial ablation Competitive Advantages: Reduced risk of coronary or myocardial laceration Development Stage • Early-stage • Prototype

    Inventors: Robert Lederman (NHLBI), Toby Rogers (NHLBI), Nasser Rafiee (Mehr Medical), Adam Greenbaum (Henry Ford Hospital), William O'Neill (Henry Ford Hospital).

    Intellectual Property: HHS Reference No. E-078-2015—US Provisional Patent Application 62/162,453 filed May 15, 2015.

    Related Technologies: HHS Reference No. E-027-2013; HHS Reference No. E-115-2013; HHS Reference No. E-018-2014; and HHS Reference Nos. E-068-2014/E-124-2014.

    Licensing Contact: Michael Shmilovich, Esq.; 301-435-5019; [email protected]

    Collaborative Research Opportunity: The National Heart, Lung and Blood Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize devices for pericardial interventional procedures. For collaboration opportunities, please contact Peg Koelble at 301-594-4095 or [email protected]

    Pseudomonas Exotoxin A With Modified Furin Cleavage Site

    Description of Technology: Immunotoxins kill cancer cells while allowing healthy, essential cells to survive. As a result, patients receiving immunotoxins are less likely to experience the deleterious side-effects associated with non-specific therapies such as chemotherapy. In order to make an effective immunotoxin, three components are generally required: A targeting domain, a furin cleavage site (FCS), and a toxic payload molecule (such as Pseudomonas exotoxin A (PE)). The purpose of the FCS is to allow the toxin domain to be processed by the target cell so that it can exert its toxic effect. This technology concerns the engineering of FCS in order to improve the efficacy of specific immunotoxins having distinct targeting domains. Several novel FCS have been generated which can be substituted for the native FCS in PE. By using specific FCS with different targeting moieties, it is possible to engineer an immunotoxin that is better suited to treating specific types of cancer.

    Potential Commercial Applications • Essential for the payload component of immunotoxins • Treatment of any disease associated with increased or preferential expression of a specific cell surface receptor • Specific diseases include hematological cancers, lung cancer (including mesothelioma), ovarian cancer, breast cancer, and head and neck cancers Competitive Advantages • Designing specific furin cleavage sites for particular immunotoxins can improve cleavage and enhance toxin efficacy, resulting in improved therapeutic effectiveness • Targeted therapy decreases non-specific killing of healthy, essential cells, resulting in fewer non-specific side-effects and healthier patients

    Development Stage: In vitro data available.

    Inventors: Ira Pastan et al. (NCI).

    Publications 1. Weldon JE, et al. Designing the furin-cleavable linker in recombinant immunotoxins based on Pseudomonas exotoxin A. Bioconjug Chem. 2015 Jun 17;26(6):1120-8. [PMID 25997032] 2. Weldon JE, et al. A protease-resistant immunotoxin against CD22 with greatly increased activity against CLL and diminished animal toxicity” Blood. 2009 Apr 16;113(16):3792-800. [PMID 18988862]

    Intellectual Property: HHS Reference No. E-197-2015/0-US-01—US Provisional Application No. 62/163,667 filed May 19, 2015.

    Related Technologies • HHS Reference E-262-2005/0 • HHS Reference E-292-2007/0 • HHS Reference E-269-2009/0 • HHS Reference E-174-2011/0 • HHS Reference E-263-2011/0

    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; [email protected]

    Collaborative Research Opportunity: The National Cancer Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Pseudomonas Exotoxin A with Modified Furin Cleavage Site. For collaboration opportunities, please contact John D. Hewes, Ph.D. at [email protected]

    Dated: August 31, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health.
    [FR Doc. 2015-21940 Filed 9-3-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent Commercialization License: Cerclage Annuloplasty Devices for Treating Mitral Valve Regurgitation 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, is contemplating the grant of a worldwide exclusive license to practice the inventions embodied in:

    NIH Ref No. Patent application No. Filing date Title E-048-2009/0-US-01 61/157,267 March 4, 2009 Cerclage Locking Device And Delivery System. E-048-2009/0-PCT-02 PCT/US2010/026245 March 4, 2010 Cerclage Locking Device And Delivery System. E-048-2009/0-US-03 13/254,160 March 4, 2010 Cerclage Locking Device And Delivery System. E-108-2010/0-US-01 61/383,061 September 15, 2010 Methods and Devices For Transcatheter Cerclage Annuloplasty. E-108-2010/0-PCT-02 PCT/US2011/51748 September 15, 2011 Methods and Devices For Transcatheter Cerclage Annuloplasty. E-108-2010/0-EP-03 11760945.3 September 15, 2011 Methods and Devices For Transcatheter Cerclage Annuloplasty. E-108-2010/0-US-04 13/824,198 March 15, 2013 Methods and Devices For Transcatheter Cerclage Annuloplasty. To Transmural Systems, LLC, a limited liability company incorporated under the laws of the State of Massachusetts and having its principle place of business in Andover, Massachusetts.

    The contemplated exclusive license may be limited to cerclage annuloplasty devices for treating mitral valve regurgitation.

    DATES:

    Only written comments and/or applications for a license that are received by the NIH Office of Technology Transfer on or before October 5, 2015 will be considered.

    ADDRESSES:

    Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael Shmilovich, Esq. Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-5019; Facsimile: (301) 402-0220; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    E-048-2009

    The invention relates to a device that can be used to non-invasively secure surgical suture loops when combined with a percutaneous delivery system. It has been shown to be effective in correcting mitral valve regurgitation (MVR) in an animal model. During the procedure, a guidewire is percutaneously conveyed to the atrium of the heart and is used to secure the “cerclage” suture encircling the mitral valve annulus, which is delivered using a delivery catheter. The locking device is advanced over the suture by the delivery catheter and it permanently secures the suture and maintains the tension on the annulus once the delivery system is removed. This locking device, in combination with the percutaneous procedure, allows for more complete coaptation of the valve leaflets and correction of MVR without the need for open heart surgery and its associated risks. The locking device is also adjustable, allowing the user to vary the tension on the suture if further tightening or loosening is required. It is also MRI compatible and all follow-up studies can be performed under MRI. This invention demonstrated its ability to correct MVR in animals where the locking device was observed to maintain the correct position and tension after implantation. This device has the potential to replace the traditional loop and knot method used for surgical correction of MVR, and may also be useful for other conditions that require permanently secured suture loops.

    E-108-2010

    The invention relates to techniques and devices for cardiovascular valve repair, particularly annuloplasty techniques and devices in which tensioning elements are positioned to treat regurgitation of the mitral valve or tricuspid valve. More specifically, the technology pertains to a new device for myocardial septal traversal (“cerclage reentry”) that also serves to capture (ensnare) and externalize the traversing guidewire. The focus of the invention is to avoid a phenomenon in cardiac surgery known as “trabecular entrapment.” The device features an expandable and collapsible mesh deployed in the right ventricle to simplify capture of a reentering guidewire during transcatheter cerclage annuloplasty. The wire mesh exerts pressure against trabecular-papillary elements of the tricuspid valve to displace them against the right ventricular septal wall. By abutting the right ventricular reentry site of the cerclage guidewire, trabecular entrapment is avoided. The device comprises a shaft having a distal loop which provides a target in the interventrical myocardial septum through which a catheter-delivered tensioning system is guided. The loop ensnares the catheter-delivered tensioning system as it reenters the right ventricle or right atrium. The expandable and collapsible mesh is disposed within the right ventricle such that the catheter-delivered tensioning system is directed from the ventricular septum into the right ventricular cavity through only a suitable opening in the mesh and such that the catheter delivered tensioning system is captured or ensnared within the mesh opening.

    The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404. 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 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: September 1, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health.
    [FR Doc. 2015-21969 Filed 9-3-15; 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: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group Surgery, Anesthesiology and Trauma Study Section.

    Date: October 7-8, 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: Weihua Luo, MD, Ph.D., Scientific Review Officer, Center for Scientific Review,National Institutes of Health, 6701 Rockledge Drive, Room 5114, MSC 7854, Bethesda, MD 20892, (301) 435-1170, [email protected]

    Name of Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group Integrative Nutrition and Metabolic Processes Study Section.

    Date: October 8-9, 2015.

    Time: 8:00 a.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Courtyard Long Beach, 500 E 1st Street, Long Beach, CA 90802.

    Contact Person: Gregory S Shelness, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Dr., Room 6156, Bethesda, MD 20892-7892, (301) 435-0492, [email protected].

    Name of Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated, Review Group, Molecular and Cellular Endocrinology Study Section.

    Date: October 8-9, 2015.

    Time: 8:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Courtyard Long Beach, 500 East First Street, Long Beach, CA 90802.

    Contact Person: John Bleasdale, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6170 MSC 7892, Bethesda, MD 20892, (301) 435-4514, [email protected]

    Name of Committee: Genes, Genomes, and Genetics Integrated Review Group Prokaryotic Cell and Molecular Biology Study Section.

    Date: October 12-13, 2015.

    Time: 8:30 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Sheraton Delfina Santa Monica Hotel, 530 West Pico Boulevard, Santa Monica, CA 90405.

    Contact Person: Dominique Lorang-Leins, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Room 5108, MSC 7766, Bethesda, MD 20892, (301) 326-9721, [email protected]

    Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group Arthritis, Connective Tissue and Skin Study Section.

    Date: October 13-14, 2015.

    Time: 830 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Agenda: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852.

    Contact Person: Aftab A Ansari, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4108, MSC 7814, Bethesda, MD 20892, 301-237-9931, [email protected]

    Name of Committee: Bioengineering Sciences & Technologies Integrated Review Group Biomaterials and Biointerfaces Study Section.

    Date: October 14-15, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Agenda: Crowne Plaza Old Town Alexandria, 901 North Fairfax Street, Alexandria, VA 22314.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 Academic Research Enhancement Award.

    Date: October 14, 2015.

    Time: 1:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Inna Gorshkova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301-435-1784, [email protected]

    Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group, Oral, Dental and Craniofacial Sciences Study Section.

    Date: October 15-16, 2015.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Ritz-Carlton Hotel at Pentagon City, 1250 South Hayes Street, Arlington, VA 22202.

    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: Bioengineering Sciences & Technologies Integrated Review Group, Modeling and Analysis of Biological Systems Study Section.

    Date: October 15-16, 2015.

    Time: 8:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854.

    Contact Person: Craig Giroux, Ph.D., Scientific Review Officer, BST IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5150, Bethesda, MD 20892, 301-435-2204, [email protected]

    Name of Committee: Digestive, Kidney and Urological Systems Integrated Review Group, Kidney Molecular Biology and Genitourinary Organ Development.

    Date: October 15, 2015.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Crowne Plaza Washington National Airport, 1489 Jefferson Davis Hwy, Arlington, VA 22202.

    Contact Person: Ryan G Morris, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4205, MSC 7814, Bethesda, MD 20892, 301-435-1501, [email protected]

    Name of Committee: Immunology Integrated Review Group, Vaccines Against Microbial Diseases Study Section.

    Date: October 15-16, 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: 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: Infectious Diseases and Microbiology Integrated Review Group, Pathogenic Eukaryotes Study Section.

    Date: October 15-16, 2015.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Marriott Alexandria, 1456 Duke Street, Alexandria, VA 22314.

    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: Brain Disorders and Clinical Neuroscience Integrated Review Group, Clinical Neuroimmunology and Brain Tumors Study Section.

    Date: October 15-16, 2015.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015.

    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: Center for Scientific Review Special Emphasis Panel, PAR Panel: Academic Industrial Partnership.

    Date: October 15, 2015.

    Time: 9:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Donald Scott Wright, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5108, MSC 7854, Bethesda, MD 20892, (301) 435-8363,[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: August 31, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-21942 Filed 9-3-15; 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 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 on Aging Initial Review Group, Behavior and Social Science of Aging Review Committee.

    Date: October 1-2, 2015.

    Time: 3:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: DoubleTree by Hilton Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Kimberly Firth, Ph.D., National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301-402-7702, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
    Dated: August 31, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-21944 Filed 9-3-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent Commercialization License: Caval-Aortic Devices for Aortic Valve Replacement 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, is contemplating the grant of a worldwide exclusive license to practice the inventions embodied in: HHS Ref. No. E-553-2013/0, U.S. Provisional Patent Application No. 61/863,071, filed August 7, 2013; International Patent Application PCT/US2013/072344 filed November 27, 2013 entitled “Transvascular and Transcameral Device Access And Closure,” to Transmural Systems, LLC, a limited liability company incorporated under the laws of the State of Massachusetts and having its principle place of business in Andover, Massachusetts.

    The contemplated exclusive license may be limited to caval-aortic devices for aortic valve replacement.

    DATES:

    Only written comments and/or applications for a license that are received by the NIH Office of Technology Transfer on or before October 5, 2015 will be considered.

    ADDRESSES:

    Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael Shmilovich, Esq. Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-5019; Facsimile: (301) 402-0220; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The technology pertains to devices and methods for transcatheter correction of cardiovascular abnormalities and more specifically for the delivery of prosthetic valves to the heart. Featured is a device implant for closing a caval-aortic iatrogenic fistula created by the introduction of a transcatheter device from the inferior vena cava into the abdominal aorta. The occlusion device includes an expandable transvascular implant with an elastomeric surface capable of extending between a vein and artery which conforms to the boundaries of an arteriovenous fistula tract between the artery and vein. A guidewire channel is disposed within the occlusion device wherein the channel also has elastomeric wall surfaces that conform or can be expanded to the area so that it occludes the channel when the guidewire is not present. The implant is resiliently deformable into a radially compressed configuration for delivery through the catheter. When the device is not deformed into the radially compressed configuration, the distal end of the device is radially enlarged relative to the intermediate neck whereby the distal end forms an enlarged distal skirt, such as a disk or button shaped member. A polymer coating on the radially enlarged distal end conforms to the endoluminal aortic wall for deployment against an internal wall of the artery.

    The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404. 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 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: September 1, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health.
    [FR Doc. 2015-21968 Filed 9-3-15; 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 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 on Aging Special Emphasis Panel Menopause and Alzheimer's Disease.

    Date: October 27, 2015.

    Time: 12:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute on Aging, Gateway Building, 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone Conference Call).

    Contact Person: Maurizio Grimaldi, Ph.D., MD, Scientific Review Officer, National Institute on Aging, National Institutes of Health, 7201 Wisconsin Avenue, Room 2C218, Bethesda, MD 20892, 301-496-9374, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
    Dated: August 31, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2015-21945 Filed 9-3-15; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-USCG-2015-0676] Merchant Marine Personnel Advisory Committee; Vacancies AGENCY:

    Coast Guard, DHS.

    ACTION:

    Request for applications.

    SUMMARY:

    The Coast Guard seeks applications for membership on the Merchant Marine Personnel Advisory Committee. This Committee advises the Secretary of the Department of Homeland Security on matters related to personnel in the U.S. merchant marine, including but not limited to training, qualifications, certification, documentation, and fitness standards.

    DATES:

    Completed applications should reach the Coast Guard on or before November 3, 2015.

    ADDRESSES:

    Applicants should send a cover letter expressing interest in an appointment to the Merchant Marine Personnel Advisory Committee that identifies which membership category the applicant is applying under, along with a resume detailing the applicant's experience via one of the following methods:

    By Email: [email protected]

    By Fax: (202) 372-8382.

    By Mail: Davis J. Breyer, Marine Transportation Specialist, Commandant (CG-OES-1), US Coast Guard Stop 7509, 2703 Martin Luther King Jr Ave SE, Washington, DC 20593-7509.

    FOR FURTHER INFORMATION CONTACT:

    Davis J. Breyer, Alternate Designated Federal Officer of the Merchant Marine Personnel Advisory Committee; telephone 202-372-1445 or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice of this action is given under the Federal Advisory Committee Act, Title 5 United States Code Appendix. The Merchant Marine Personnel Advisory Committee was established under authority of section 310 of the Howard Coble Coast Guard and Maritime Transportation Act of 2014, Title 46, United States Code, section 8108, and chartered under the provisions of the Federal Advisory Committee Act. The Committee acts solely in an advisory capacity to the Secretary of the Department of Homeland Security through the Commandant of the Coast Guard on matters relating to personnel in the U.S. merchant marine, including but not limited to training, qualifications, certification, documentation, and fitness standards and other matters as assigned by the Commandant; shall review and comment on proposed Coast Guard regulations and policies relating to personnel in the United States merchant marine, including training, qualifications, certification, documentation, and fitness standards; may be given special assignments by the Secretary and may conduct studies, inquiries, workshops, and fact finding in consultation with individuals and groups in the private sector and with State or local governments; shall advise, consult with, and make recommendations reflecting its independent judgment to the Secretary; shall meet not less than twice each year; and may make available to Congress recommendations that the Committee makes to the Secretary. It may also meet for extraordinary purposes. Its subcommittees and working groups may also meet to consider specific tasks as required.

    Each Merchant Marine Personnel Advisory Committee member serves a term of office of up to three years. Members may be considered to serve up to two consecutive terms. All members serve without compensation from the Federal Government; however, upon request, they may receive travel reimbursement and per diem.

    We will consider applications for the following five positions that expire or become vacant on June 1, 2016:

    (1) One position for a licensed engineering officer who is licensed as either a limited chief engineer or a designated duty engineer;

    (2) One position for a licensed deck officer with an unlimited tonnage master's license with experience on tank vessels;

    (3) One position for a member who represents the viewpoint of shipping companies employed in ship operation management;

    (4) One position for an unlicensed seaman who represents the viewpoint of Qualified Members of the Engine Department; and

    (5) One position for a member who will be drawn from the general public.

    If you are selected as a member from the general public, you will be appointed and serve as a Special Government Employee as defined in section 202(a) of Title 18, United States Code. As a candidate for appointment as a Special Government Employee, applicants are required to complete a Confidential Financial Disclosure Report (OGE Form 450). Coast Guard may not release the reports or the information in them to the public except under an order issued by a Federal court or as otherwise provided under the Privacy Act (5 U.S.C. 552a). Only the Designated Coast Guard Ethics Official or his or her designee may release a Confidential Financial Disclosure Report. Applicants can obtain this form by going to the Web site of the Office of Government Ethics (www.oge.gov) or by contacting the individual listed above in the FOR FURTHER INFORMATION CONTACT. Applications for a member drawn from the general public that are not accompanied by a completed OGE-Form 450 will not be considered.

    Registered lobbyists are not eligible to serve on federal advisory committees in an individual capacity. See “Revised Guidance on Appointment of Lobbyists to Federal Advisory Committees, Boards, and Commissions” (79 FR 47482, August 13, 2014). Registered lobbyists are lobbyists required to comply with provisions contained in the Lobbying Disclosure Act of 1995 (2 U.S.C. 1605; Public Law 104-65 as amended by Title II of Public Law 110-81).

    The Department of Homeland Security does not discriminate in selection of Committee members on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability and genetic information, age, membership in an employee organization, or any other non-merit factor. The Department of Homeland Security strives to achieve a widely diverse candidate pool for all of its recruitment actions.

    If you are interested in applying to become a member of the Committee, send your cover letter and resume to Davis J. Breyer, Alternate Designated Federal Officer of the Merchant Marine Personnel Advisory Committee via one of the transmittal methods in the ADDRESSES section by the deadline in the DATES section of this notice.

    To visit our online docket, go to http://www.regulations.gov enter the docket number (USCG-2015-0676) in the Search box, and click “Search”. Please do not post your resume or OGE 450 Form on this site.

    Dated: August 31, 2015. J.G. Lantz, Director of Commercial Regulations and Standards.
    [FR Doc. 2015-21965 Filed 9-3-15; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA-2015-0014; OMB No. 1660-0059] Agency Information Collection Activities: Submission for OMB Review; Comment Request; National Flood Insurance Program Call Center and Agent Referral Enrollment Form AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and the actual data collection instruments FEMA will use.

    DATES:

    Comments must be submitted on or before October 5, 2015.

    ADDRESSES:

    Submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the Desk Officer for the Department of Homeland Security, Federal Emergency Management Agency, and sent via electronic mail to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection should be made to Director, Records Management Division, 500 C Street, SW., Washington, DC 20472-3100, or email address [email protected]

    SUPPLEMENTARY INFORMATION:

    This proposed information collection previously published in the Federal Register on May 28, 2015 at 80 FR 30482 with a 60 day public comment period. No comments were received. The purpose of this notice is to notify the public that FEMA will submit the information collection abstracted below to the Office of Management and Budget for review and clearance.

    Collection of Information

    Title: National Flood Insurance Program Call Center and Agent Referral Enrollment Form.

    Type of information collection: Extension, without change, of a currently approved information collection.

    OMB Number: 1660-0059.

    Form Titles and Numbers: FEMA Form 517-0-1, National Flood Insurance Program Agent Site Registration; FEMA Form 512-0-1, National Flood Insurance Program Agent Referral Questionnaire.

    Abstract: Consumer names, addresses, and telephone numbers collected through the Call Center or FloodSmart Web site will be used exclusively for providing information on flood insurance and/or facilitate the purchase of a flood insurance policy through referrals or direct transfers to insurance agents in the agent referral service. Agent names, addresses, telephone numbers, and business information is retained for dissemination to interested consumers who would like to talk to an agent about purchasing a flood insurance policy as part of the agent referral program.

    Affected Public: Individuals or households; businesses or other for-profit.

    Estimated Number of Respondents: 59,194.

    Estimated Total Annual Burden Hours: 2,819 hours.

    Estimated Cost: The estimated annual cost to respondents for the hour burden is $65,209. There are no annual costs to respondents' operations and maintenance costs for technical services. There are no annual start-up or capital costs. The cost to the Federal Government is $406,941.

    Dated: August 31, 2015. Richard W. Mattison, Records Management Program Chief, Mission Support, Federal Emergency Management Agency, Department of Homeland Security.
    [FR Doc. 2015-22000 Filed 9-3-15; 8:45 am] BILLING CODE 9111-52-P
    DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2015-0036] Technical Resource for Incident Prevention (TRIPwire) User Registration AGENCY:

    National Protection and Programs Directorate, DHS.

    ACTION:

    60-day notice and request for comments; Extension of previously approved Information Collection Request: 1670-0028.

    SUMMARY:

    The Department of Homeland Security (DHS), National Protection and Programs Directorate, (NPPD), Protective Security Coordination Division (PSCD), Office for Bombing Prevention (OBP) will submit the following Information Collection Request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35).

    DATES:

    Comments are encouraged and will be accepted until November 3, 2015. This process is conducted in accordance with 5 CFR 1320.1.

    ADDRESSES:

    Written comments and questions about this Information Collection Request should be forwarded to Department of Homeland Security (Attn: NPPD/PSCD/OBP) 245 Murray Lane SW., Mail Stop 0612, Arlington, VA 20598-0612. Emailed requests should go to [email protected] Written comments should reach the contact person listed no later than November 3, 2015. Comments must be identified by “DHS-2012-0022”and may be submitted by one of the following methods:

    • Federal eRulemaking Portal: http://www.regulations.gov.

    • Email: Include the docket number in the subject line of the message.

    Instructions: All submissions received must include the words “Department of Homeland Security” and the docket number for this action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided.

    OMB is particularly interested in comments that:

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

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

    3. Enhance the quality, utility, and clarity of the information to be collected; or

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

    SUPPLEMENTARY INFORMATION:

    The Technical Resource for Incident Prevention (TRIPwire) is OBP's online, collaborative, information-sharing network for bomb squad, law enforcement, and other emergency services personnel to learn about current terrorist improvised explosive device (IED) tactics, techniques, and procedures, including design and emplacement considerations. TRIPwire was established as an IED information-sharing resource under Homeland Security Presidential Directive 19 (HSPD-19), which calls for a unified national policy for the prevention and detection of, protection against, and response to terrorist use of explosives in the United States. Users from federal, state, local, and tribal government entities, as well as business and for-profit industries can register through the TRIPwire Secure Portal. The TRIPwire portal contains sensitive information related to terrorist use of explosives and, therefore, user information is needed to verify eligibility and access to the system. TRIPwire applicants must provide their full name, assignment, citizenship, job title, employer name, professional address and contact information, as well as an Employment Verification Contact and their contact information. The system does not store sensitive personally identifiable information (PII) such as social security numbers. The collection of PII by TRIPwire to establish user accounts occurs in accordance with the DHS Privacy Impact Assessment PIA-015, “DHS Web Portals,” DHS/ALL-004—General Information Technology Access Account Records System (GITAARS) September 29, 2009, 74 FR 49882, and DHS/ALL-002—Department of Homeland Security Mailing and Other Lists System November 25, 2008, 73 FR 71659. The TRIPwire User Registration is a voluntary registration designed to measure users' suitability to access the secure environment.

    The information collected during the TRIPwire user registration process is reviewed electronically by the project team to vet the user's “need to know,” which determines their eligibility for and access to TRIPwire. Memberships are re-verified annually based on the information users provide upon registration or communication with the TRIPwire help desk analysts. The information collected is for internal TRIPwire and OBP use only.

    Analysis

    Agency: Department of Homeland Security, National Protection and Programs Directorate, Office of Infrastructure Protection, Protective Security Coordination Division, Office for Bombing Prevention.

    Title: Technical Resource for Incident Prevention (TRIPwire) User Registration.

    OMB Number: 1670-0028.

    Frequency: Once.

    Affected Public: Federal, state, local, and tribal government entities, and business or other for-profit.

    Number of Respondents: 3,500 respondents (estimate).

    Estimated Time per Respondent: 10 minutes.

    Total Burden Hours: 595 burden hours.

    Total Burden Cost (capital/startup): $0.

    Total Recordkeeping Burden: $0.

    Total Burden Cost (operating/maintaining): $16,006.

    Dated: August 31, 2015. Scott Libby, Deputy Chief Information Officer, National Protection and Programs Directorate, Department of Homeland Security.
    [FR Doc. 2015-21959 Filed 9-3-15; 8:45 am] BILLING CODE P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5828-N-36] Federal Property Suitable as Facilities To Assist the Homeless AGENCY:

    Office of the Assistant Secretary for Community Planning and Development, HUD.

    ACTION:

    Notice.

    SUMMARY:

    This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.

    FOR FURTHER INFORMATION CONTACT:

    Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7262, Washington, DC 20410; telephone (202) 402-3970; TTY number for the hearing- and speech-impaired (202) 708-2565, (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588.

    SUPPLEMENTARY INFORMATION:

    In accordance with the December 12, 1988 court order in National Coalition for the Homeless v. Veterans Administration, No. 88-2503-OG (D.D.C.), HUD publishes a Notice, on a weekly basis, identifying unutilized, underutilized, excess and surplus Federal buildings and real property that HUD has reviewed for suitability for use to assist the homeless. Today's Notice is for the purpose of announcing that no additional properties have been determined suitable or unsuitable this week.

    Dated: August 27, 2015. Brian P. Fitzmaurice, Director, Division of Community Assistance, Office of Special Needs Assistance Programs.
    [FR Doc. 2015-21637 Filed 9-3-15; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5892-N-01] Notice of Intent To Prepare Draft Environmental Impact Statement (EIS) for the Rebuild by Design Hudson River Project: Resist, Delay, Store, Discharge in the City of Hoboken, Township of Weehawken and City of Jersey City, New Jersey AGENCY:

    Office of the Assistant Secretary for Community Planning and Development, HUD.

    ACTION:

    Notice of intent to prepare an EIS.

    SUMMARY:

    This provides notice that the New Jersey Department of Environmental Protection (NJDEP) intends to prepare an Environmental Impact Statement (EIS) for the Rebuild by Design Hudson River Project: Resist, Delay, Store, Discharge (the Project) in the City of Hoboken, Township of Weehawken, and City of Jersey City, New Jersey. The Proposed Project was developed as a concept through the Hurricane Sandy Rebuilding Task Force's Rebuild by Design (RBD) program, a design competition to promote the development of resiliency in the Sandy-affected region.

    The Proposed Project will consist of a four-part comprehensive strategy, including (1) hard infrastructure and soft landscape for coastal defense (Resist); (2) policy recommendations, guidelines and urban infrastructure to slow storm water runoff (Delay); (3) green and/or grey infrastructure improvements to allow for greater storage of excess rainwater (Store); and (4) water pumps and alternative routes to support drainage (Discharge). The proposed project will occur throughout the City of Hoboken, with linkages to the adjoining communities in the Township of Weehawken and City of Jersey City.

    The Proposed Project was selected by HUD through the RBD competition, and HUD Community Development Block Grant-Disaster Recovery (CDBG-DR) funds have been allocated to it. CDBG-DR funding requires compliance with the National Environmental Policy Act (NEPA) as stated in HUD's regulations as outlined in 24 CFR part 58. The Project is also subject to the Council of Environmental Quality (CEQ) NEPA regulations at 40 CFR parts 1500-1508. HUD has further outlined the project's environmental review requirements in a Federal Register notice published on October 16, 2014 (79 FR 62182).

    The State of New Jersey, acting through the New Jersey Department of Community Affairs, is the responsible entity that has assumed environmental responsibilities for the Sandy CDBG-DR programs in accordance with 24 CFR 58.1(b)(1). The New Jersey Department of Community Affairs has designated NJDEP to assist with the environmental review. NJDEP will prepare the EIS in accordance with HUD's procedures for NEPA found at 24 CFR part 58. This Notice of Intent to prepare an EIS (as defined at 40 CFR 1508.22) is in accordance with CEQ regulations, and represents the beginning of the public scoping process as outlined in 40 CFR 1501.7. As part of the public scoping process, a Draft Scope of Work will be prepared and submitted for public comment. The Draft Scope of Work will outline in detail the proposed Project actions as well as a description of areas of impact to be studied in the Draft EIS. The Draft Scope of Work will be finalized to reflect substantive comments received during the scoping comment period. After this is completed, the Draft EIS will be prepared and ultimately submitted for public comment. The Draft EIS will be circulated to the general public, as well as groups and government agencies that have been identified as having particular interest in the Proposed Project. A Notice of Availability will be published in the Federal Register and local media outlets at that time in accordance with HUD and CEQ regulations.

    FOR FURTHER INFORMATION CONTACT:

    The New Jersey Department of Environmental Protection (NJDEP) by email to [email protected] or mail to David Rosenblatt, Director, Office of Flood Hazard Risk Reduction Measures, 501 East State Street, Mail Code 501-01A, P.O. Box 420, Trenton, NJ 08625-0420.

    SUPPLEMENTARY INFORMATION:

    A. Project Background

    The project area, comprising the entire city of Hoboken, and parts of Weehawken and Jersey City, is vulnerable to flooding from coastal storm surge events. Superstorm Sandy exposed the vulnerabilities within the project area by flooding over two thirds of the City of Hoboken's low-lying areas. The project area is also susceptible to flooding from high-intensity and long-duration rainfall events. Rainfall-induced flooding is more common within the project area and happens more frequently than coastal storm surge flooding. However, the effects of rainfall flooding on property damage are considerably less than from coastal storm surge flooding. The entire project area is serviced by a combined storm-sewer system that collects sewer flow from existing buildings and combines it with storm water runoff during rainfall events. This combined system does not have the capacity to treat the increased volume created during intense storm events, resulting in sewage backups in homes and onto city streets as well as the discharge of raw sewage into the Hudson River. Were Sandy to have been a substantial rainfall event as well as a storm surge event, Hoboken's past history of flooding during heavy rainfall events indicates that the storm could have further increased flooding levels and property damages.

    HUD launched the RBD competition in the summer of 2013 (July 29, 2013, 78 FR 45551) to develop ideas to improve physical, ecological, economic, and social resilience in regions affected by Superstorm Sandy. The competition sought to promote innovation by developing flexible solutions that would increase regional resilience. The Proposed Project was one of the competition's six winning concepts; it was developed with the goal of reducing frequent flooding due to storm surge, high tide, and heavy rainfall. HUD awarded $230 million to the State of New Jersey for the Project in the municipalities of Hoboken, Weehawken, and Jersey City.

    B. Project Description

    The Proposed Project takes a multi-faceted approach intended to address flooding from both major storm surges and high tides as well as from heavy rainfall events. The Proposed Project will occur throughout the City of Hoboken, and will extend into Weehawken and Jersey City, with the following approximate boundaries: The Hudson River to the east; Baldwin Avenue (in Weehawken) to the north; the Palisades to the west; and 18th Street, Washington Boulevard and 14th Street (in Jersey City) to the south.

    The project's comprehensive approach to resilience consists of four integrated components:

    1. Resist: a combination of hard infrastructure (such as bulkheads, floodwalls and seawalls) and soft landscaping features (such as berms and/or levees which could be used as parks) that act as barriers along the coast during exceptionally high tide and/or storm surge events;

    2. Delay: Policy recommendations, guidelines and urban green infrastructure to slow stormwater runoff;

    3. Store: Green and grey infrastructure improvements, such as bioretention basins, swales, and green roofs, that slow down and capture stormwater, and which will complement the efforts of the City of Hoboken's existing Green Infrastructure Strategic Plan; and

    4. Discharge: Enhancements to Hoboken's existing stormwater management system, including the identification and upgrading of existing stormwater/sewer lines, outfalls and pumping stations.

    C. Project Alternatives

    The EIS will examine three build alternatives, as well as a No Action Alternative. Each of the three build alternatives will include elements of all four strategic project components: Resist, Delay, Store and Discharge. The three build alternatives vary primarily by the Resist infrastructure's alignment and termination points. The possible Resist alignments include: Along the waterfront, in the water (in the Hudson River), and upland. The waterfront is defined as along the existing walkway/esplanade that runs along the eastern edge of Jersey City, City of Hoboken and Township of Weehawken. The upland portion represents areas landward of the walkway/esplanade. The Resist structures will consist of a combination of multi-purpose levees, floodwalls and other features that will reduce the flood risk within the project area from future coastal storm surge events. In all three build alternatives, the Delay, Store, and Discharge, components will be located on the landward side of the Resist infrastructure and may consist of a combination of green infrastructure (bioswales, storage basins and others) and grey infrastructure (pumps, pipes and others).

    Alternative 1 will analyze a Resist alignment that is constructed along a combination of in-water, waterfront, and upland locations and terminates at appropriate locations upland or on the waterfront. Alternative 2 will analyze a Resist alignment constructed primarily along the waterfront with termination points at appropriate upland or waterfront locations. Alternative 3 will analyze a Resist alignment primarily constructed upland with termination points located upland. The No Action Alternative, which represents no improvements, will also be evaluated as part of the EIS. The alternatives analysis will consist of a comparison of the four alternatives' impacts on the environment pursuant to 24 CFR part 58, as well as how well each alternative meets the Project's Purpose and Need. This process, which will be described in detail in the EIS, will lead to the designation of a Preferred Alternative.

    D. Scoping

    A public EIS Scoping meeting will be held on September 24, 2015, from 7:00 until 9:00 p.m. at the Hoboken Multi-Service Center, located at 124 Grand Street, Hoboken, NJ 07030. The public meeting facility is handicapped accessible to the mobility-impaired. Interpreter services will be made available for persons who are hearing or visually impaired, upon advance request. Additionally, interpreter services will also be made available for persons with Limited English Proficiency through a language access service. The EIS scoping meeting will provide an opportunity for the public to learn more about the proposed Project, as well as provide input on the EIS and the NEPA process. During the meeting, an overview of the Project will be provided as well as details on the early concept development. The public meeting will also provide an opportunity for the public to provide comment on the Project's proposed scope of work. A Draft Scope of Work document will be made available to the public for review and comment at the scoping meeting. An electronic version of the Draft Scope of Work will be available no later than September 8, 2015 at http://www.rbd-hudsonriver.nj.gov. Comments received during the scoping meeting or via email [email protected] or mail to David Rosenblatt, Director, Office of Flood Hazard Risk Reduction Measures, 501 East State Street, Mail Code 501-01A, P.O. Box 420, Trenton, NJ 08625-0420 by October 9, 2015 (within 15 days of the scoping meeting) will be considered for review.

    E. Probable Environmental Effects

    The following areas have been identified for discussion in the EIS: Natural resources, including floodplain management, wetland protection, and threatened and endangered species; coastal zone management; sole source aquifers; wild and scenic rivers; farmland protection; explosive and flammable operations; airport hazards and runway clear zones; socioeconomics; environmental justice; land use; traffic circulation; air quality; noise; vibration; hazardous waste; cultural resources, including historic architectural and archaeological resources; infrastructure; utilities; and cumulative impacts.

    F. Lead Agency

    In accordance with HUD regulations at 24 CFR part 58, the New Jersey Department of Community Affairs has designated NJDEP to assist with the environmental review and preparation of the EIS. Questions may be directed to the individual named in this notice under the heading FOR FURTHER INFORMATION CONTACT.

    Dated: August 31, 2015. Harriet Tregoning, Principal Deputy Assistant, Secretary for Community Planning and Development.
    [FR Doc. 2015-22021 Filed 9-3-15; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R2-ES-2015-N156; FXES11120200000-156-FF02ENEH00] Receipt of an Incidental Take Permit Application for Participation in the Oil and Gas Industry Conservation Plan for the American Burying Beetle in Oklahoma AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of availability; request for public comments.

    SUMMARY:

    Under the Endangered Species Act, as amended (Act), we, the U.S. Fish and Wildlife Service, invite the public to comment on an incidental take permit application for take of the federally listed American burying beetle resulting from activities associated with the geophysical exploration (seismic) and construction, maintenance, operation, repair, and decommissioning of oil and gas well field infrastructure within Oklahoma. If approved, the permit would be issued under the approved Oil and Gas Industry Conservation Plan Associated with Issuance of Endangered Species Act Section 10(a)(1)(B) Permits for the American Burying Beetle in Oklahoma (ICP).

    DATES:

    To ensure consideration, written comments must be received on or before October 5, 2015.

    ADDRESSES:

    You may obtain copies of all documents and submit comments on the applicant's ITP application by one of the following methods. Please refer to the permit number when requesting documents or submitting comments.

    U.S. Mail: U.S. Fish and Wildlife Service, Division of Endangered Species—HCP Permits, P.O. Box 1306, Room 6034, Albuquerque, NM 87103.

    Electronically: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Marty Tuegel, Branch Chief, by U.S. mail at Environmental Review, P.O. Box 1306, Room 6034, Albuquerque, NM 87103; or by telephone at 505-248-6651.

    SUPPLEMENTARY INFORMATION: Introduction

    Under the Endangered Species Act, as amended (16 U.S.C. 1531 et seq.; Act), we, the U.S. Fish and Wildlife Service, invite the public to comment on an incidental take permit (ITP) application for take of the federally listed American burying beetle (Nicrophorus americanus) resulting from activities associated with geophysical exploration (seismic) and construction, maintenance, operation, repair, and decommissioning of oil and gas well field infrastructure within Oklahoma. If approved, the permit would be issued to the applicant under the Oil and Gas Industry Conservation Plan Associated with Issuance of Endangered Species Act Section 10(a)(1)(B) Permits for the American Burying Beetle in Oklahoma (ICP). The ICP was made available for comment on April 16, 2014 (79 FR 21480), and approved on May 21, 2014 (publication of the FONSI notice was on July 25, 2014; 79 FR 43504). The ICP and the associated environmental assessment/finding of no significant impact are available on the Web site at http://www.fws.gov/southwest/es/oklahoma/ABBICP. However, we are no longer taking comments on these documents.

    Applications Available for Review and Comment

    We invite local, State, Tribal, and Federal agencies, and the public to comment on the following application under the ICP, for incidental take of the federally listed ABB. Please refer to the appropriate permit number (TE-73567B) when requesting application documents and when submitting comments. Documents and other information the applicants have submitted with this application are available for review, subject to the requirements of the Privacy Act (5 U.S.C. 552a) and Freedom of Information Act (5 U.S.C. 552).

    Permit TE-73567B

    Applicant: SandRidge Energy, Inc., Oklahoma City, OK.

    Applicant requests a new permit for gas upstream and midstream production, including geophysical exploration (seismic) and construction, maintenance, operation, repair, and decommissioning of gas well field infrastructure, as well as construction, maintenance, operation, repair, decommissioning, and reclamation of gas gathering, transmission, and distribution pipeline infrastructure within Oklahoma.

    Public Availability of Comments

    Written comments we receive become part of the public record associated with this action. 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 request in your comment that we withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. We will not consider anonymous comments. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.

    Authority

    We provide this notice under section 10(c) of the Act (16 U.S.C. 1531 et seq.) and its implementing regulations (50 CFR 17.22) and the National Environmental Policy Act (42 U.S.C. 4321 et seq.) and its implementing regulations (40 CFR 1506.6).

    Dated: August 27, 2015. Joy E. Nicholopoulos, Acting Regional Director, Southwest Region.
    [FR Doc. 2015-22040 Filed 9-3-15; 8:45 am] BILLING CODE 4310-55-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-HQ-FAC-2015-N153; FF09F42300-FVWF97920900000-XXX] Sport Fishing and Boating Partnership Council AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of meeting.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), announce a public meeting of the Sport Fishing and Boating Partnership Council (Council). A Federal advisory committee, the Council was created in part to foster partnerships to enhance public awareness of the importance of aquatic resources and the social and economic benefits of recreational fishing and boating in the United States. This meeting is open to the public, and interested persons may make oral statements to the Council or may file written statements for consideration.

    DATES:

    The meeting will take place Tuesday, October 6, 2015, from 8:30 a.m. to 4:30 p.m. (Mountain Time) and Wednesday, October 7, 2015, from 8:30 a.m. to 3:30 p.m. For deadlines and directions on registering to attend the meeting, submitting written material, and/or giving an oral presentation, please see “Public Input” under SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    The meeting will be held at the U.S. Fish and Wildlife Service's Bozeman Fish Technology Center, 4050 Bridger Canyon Road, Bozeman, Montana 59715. For directions or other information on the Bozeman Fish Technology Center, please contact Robert Muth, Center Director, at 406-994-9902 or [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Brian Bohnsack, Sport Fishing and Boating Partnership Council Coordinator, 5275 Leesburg Pike, MS-3C016A-FAC, Falls Church, VA 22041; telephone (703) 358-2435; fax (703) 358-2210; or email [email protected]

    SUPPLEMENTARY INFORMATION:

    In accordance with the requirements of the Federal Advisory Committee Act, 5 U.S.C. App., we announce that the Sport Fishing and Boating Partnership Council will hold a meeting.

    Background

    The Council was formed in January 1993 to advise the Secretary of the Interior, through the Director of the Service, on aquatic conservation endeavors that benefit recreational fishery resources and recreational boating and that encourage partnerships among industry, the public, and government. The Council represents the interests of the public and private sectors of the recreational fishing, boating, and conservation communities and is organized to enhance partnerships among industry, constituency groups, and government. The 18-member Council, appointed by the Secretary of the Interior, includes the Service Director and the president of the Association of Fish and Wildlife Agencies, who both serve in ex officio capacities. Other Council members are directors from State agencies responsible for managing recreational fish and wildlife resources and individuals who represent the interests of saltwater and freshwater recreational fishing, recreational boating, the recreational fishing and boating industries, recreational fisheries resource conservation, Native American tribes, aquatic resource outreach and education, and tourism. Background information on the Council is available at http://www.fws.gov/sfbpc.

    Meeting Agenda

    The Council will hold a meeting to consider:

    • An update from the FWS Fish and Aquatic Conservation Program on their new strategic plan, the status of the national fish hatchery program and other related programs;

    • An update and discussion regarding a proposed pilot project with several agencies to improve the transparency and efficiency of federal agencies' permitting review processes associated with boating infrastructure projects (e.g., boat dock replacement and maintenance, boat ramp construction and maintenance);

    • An update of the status of aquatic education and outreach programs funded through the Federal Aid in Sport Fish Restoration Program;

    • An update on federal and state programs associated with aquatic invasive species and efforts to prevent their spread by boaters and anglers;

    • An update on Tribal fish and wildlife conservation programs as they pertain to priorities of the Sport Fishing and Boating Partnership Council;

    • An update on the Council's assessment of the Recreational Boating and Fishing Foundation's implementation of the National Outreach and Communication Program (Catalog of Federal Domestic Assistance number 15.653);

    • Other miscellaneous Council business.

    The final agenda will be posted on the Internet at http://www.fws.gov/sfbpc.

    Public Input If you wish to Then you must contact the Council Coordinator (see FOR FURTHER INFORMATION CONTACT) no later than Attend the meeting Wednesday, September 30, 2015. Submit written information or questions before the meeting for the council to consider during the meeting for the council to consider during the meeting Wednesday, September 30, 2015. Give an oral presentation during the meeting Wednesday, September 30, 2015. Attendance

    The Council meeting will be held at the U.S. Fish and Wildlife Service's Bozeman Fish Technology Center, 4050 Bridger Canyon Road, Bozeman, Montana. Signs will be posted to direct attendees to the specific conference room.

    Submitting Written Information or Questions

    Interested members of the public may submit relevant information or questions for the Council to consider during the meeting. Written statements must be received by the date listed above in “Public Input,” so that the information may be made available to the Council for their consideration prior to the meeting. Written statements must be supplied to the Council Coordinator in one of the following formats: One hard copy with original signature, and one electronic copy via email (acceptable file formats are Adobe Acrobat PDF, MS Word, MS PowerPoint, or rich text file).

    Giving an Oral Presentation

    Individuals or groups requesting to make an oral presentation during the meeting will be limited to 2 minutes per speaker, with no more than a total of 30 minutes for all speakers. Interested parties should contact the Council Coordinator, in writing (preferably via email; see FOR FURTHER INFORMATION CONTACT), to be placed on the public speaker list for this meeting. To ensure an opportunity to speak during the public comment period of the meeting, members of the public must register with the Council Coordinator. Registered speakers who wish to expand upon their oral statements, or those who had wished to speak but could not be accommodated on the agenda, may submit written statements to the Council Coordinator up to 30 days subsequent to the meeting.

    Meeting Minutes

    Summary minutes of the meeting will be maintained by the Council Coordinator (see FOR FURTHER INFORMATION CONTACT) and will be available for public inspection within 90 days of the meeting and will be posted on the Council's Web site at http://www.fws.gov/sfbpc.

    Dated: August 18, 2015. James W. Kurth, Acting Director.
    [FR Doc. 2015-22044 Filed 9-3-15; 8:45 am] BILLING CODE 4310-55-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R8-ES-2015-N170; FXES1113088ENDT0-156-FF08ENVD00] Endangered and Threatened Wildlife and Plants; Proposed Low-Effect Habitat Conservation Plan for the Desert Tortoise, Nye County, Nevada AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Receipt of application; request for comment.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service) announce receipt from Valley Electric Association, Inc. of an application for a 30-year incidental take permit (permit) under the Endangered Species Act of 1973, as amended (Act). The requested permit would authorize take of the Mojave desert tortoise resulting from the construction, operation, and maintenance of a solar photovoltaic facility in the town of Pahrump, Nevada. The permit application includes a proposed low-effect habitat conservation plan (HCP) that incorporates measures the applicant would implement to minimize and mitigate effects of project activities on the desert tortoise. In accordance with the requirements of the National Environmental Policy Act (NEPA), we have prepared a draft low-effect screening form supporting our preliminary determination that the proposed action qualifies as a categorical exclusion under NEPA. We are accepting comments on the permit application, proposed low-effect HCP, and draft NEPA compliance documentation.

    DATES:

    Written comments on the permit application, proposed low-effect HCP, and draft NEPA compliance documentation must be received on or before October 5, 2015.

    ADDRESSES:

    Obtaining Documents: Persons wishing to review the application, the proposed low-effect HCP, the draft NEPA compliance documentation, or other related documents may obtain copies by written or telephone request to Jeri Krueger, by mail at U.S. Fish and Wildlife Service, Reno Fish and Wildlife Office, 1340 Financial Boulevard, Suite 234, Reno, NV 89502, or by phone at 775-861-6300. Copies of these documents may also be obtained on the Internet at http://www.fws.gov/nevada.

    Submitting Comments: Please address written comments to Michael J. Senn, Field Supervisor, U.S. Fish and Wildlife Service, Southern Nevada Fish and Wildlife Office, 4701 North Torrey Pines Drive, Las Vegas, NV 89130. You may also send comments by facsimile to 702-515-5231. Please note that your information request or comment is in reference to the Valley Electric Association Community Solar Project Low-Effect HCP, Nye County, Nevada.

    FOR FURTHER INFORMATION CONTACT:

    Jeri Krueger, Reno Fish and Wildlife Office, at the address or telephone number listed above under ADDRESSES.

    SUPPLEMENTARY INFORMATION:

    Document Availability

    You may obtain copies of the permit application, proposed HCP, draft NEPA compliance documentation, and other related documents from the individual listed under FOR FURTHER INFORMATION CONTACT. Copies of these documents are also available for public inspection, by appointment, during regular business hours (8 a.m. to 4:30 p.m.), at the Southern Nevada Fish and Wildlife Office, 4701 North Torrey Pines Drive, Las Vegas, NV 89130.

    Background Information

    Section 9 of the Act (16 U.S.C. 1531-1544 et seq.) and Federal regulations (50 CFR 17) prohibit the taking of fish and wildlife species listed as endangered or threatened under section 4 of the Act. Take of federally listed fish or wildlife is defined under the Act as to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect listed species, or attempt to engage in such conduct. The term “harass” is defined in the regulations as to carry out actions that create the likelihood of injury to listed species to such an extent as to significantly disrupt normal behavioral patterns, which include, but are not limited to, breeding, feeding, or sheltering (50 CFR 17.3). The term “harm” is defined in the regulations as significant habitat modification or degradation that results in death or injury of listed species by significantly impairing essential behavioral patterns, including breeding, feeding, or sheltering (50 CFR 17.3). However, under specified circumstances, the Service may issue permits that allow the take of federally listed species, provided that the take that occurs is incidental to, but not the purpose of, an otherwise lawful activity.

    Regulations governing permits for endangered and threatened species are at 50 CFR 17.22 and 17.32, respectively. Section 10(a)(1)(B) of the Act contains provisions for issuing such incidental take permits to non-Federal entities for the take of endangered and threatened species, provided the following criteria are met:

    (1) The taking will be incidental;

    (2) The applicants will, to the maximum extent practicable, minimize and mitigate the impact of such taking;

    (3) The applicants will develop a proposed HCP and ensure that adequate funding for the HCP will be provided;

    (4) The taking will not appreciably reduce the likelihood of the survival and recovery of the species in the wild; and

    (5) The applicants will carry out any other measures that the Service may require as being necessary or appropriate for the purposes of the HCP.

    Proposed Project

    Valley Electric Association, Inc. (VEA) proposes to construct, operate, and maintain a photovoltaic solar facility with 54,864 fixed panels within an 80-acre parcel of land located in the northeast part of the town of Pahrump that will provide power to VEA's members within their service area located mainly along the Nevada-California border. The project would provide a source of clean energy to be used by VEA members and would create additional job opportunities in the community. The project proponent is applying for an incidental take permit because the project is located within desert tortoise habitat and take would be unavoidable as a result of constructing and operating the solar facility on the project site.

    The leading edge of the solar panels would be raised to a height of 42 inches above the ground, which is about 18 inches above current industry standards. All panels would be blue-black in color and would be composed of the least reflective glass available. Two solar panel spacing configurations would be used: The northern 40 acres would have an inner row spacing of 14 feet, and the southern 40 acres would have an inner row spacing of 20 feet. These design feature modifications are for the purpose of allowing more light to reach beneath the solar array to maintain vegetation underneath the solar panels and encourage continued use of the project site by desert tortoises, and to determine if wider spacing between the panels would reduce the potential for bird strikes on the panels. The project site would be fenced with security chain-link fencing, incorporating 10 by 7-inch gaps along the bottom of the fence to allow desert tortoises to gain access and occupy the site during operation of the solar facility.

    The project proponent would develop and implement an Avian Protection and Monitoring (APM) Plan to minimize and monitor potential impacts to migratory birds from the solar facility. The solar array is designed to determine if different configurations of solar panels may break up the appearance of a lake-like effect from a bird's perspective. The project proponent would use a qualified third-party contractor to design a monitoring protocol to track any differences in effects to migratory birds and incorporate the protocol into the APM Plan.

    The project is located within the town limits of Pahrump in T 19 S, R 53 E, Section 25. In addition, an associated distribution line and access road would be constructed within a 2,640-foot by 20-foot easement in T 19 S, R 53 E, Sections 24 and 25. The project area is approximately 1.4 miles east of Highway 160 and immediately south of Simkins Road.

    Proposed Covered Activities

    The duration of construction activities is expected to last approximately 8 months and the project is anticipated to be in service for 30 years, which is the requested duration of the permit term. Construction of the solar field would include the following:

    • Installation of 30 degree fixed tilt, ground mounted solar PV panels capable of producing 15 MWAC of power. The panels would be installed in twelve groupings each containing 4,572 315-watt panels (54,864 panels in total). Each panel would measure 39 inches by 79 inches, with the leading edge about 42 inches above the ground. The panels would be blue-black in color and would be composed of the least reflective glass available.

    • Construction of a 40-foot wide by 2,642-foot long gravel access road down the east-west center of the site.

    • Installation of 10 inverter stations (12 feet by 40 feet by 7.1 feet tall) adjacent to the access road.

    • Construction of a 0.4-acre switchyard area in the northeast corner of the site, which would include a parking area, a 500 square foot prefabricated building for housing system monitoring equipment and for use as a visitor center, and a switchgear cabinet containing system project equipment, metering, telecommunications equipment, and switches to be mounted on a concrete pad.

    • Conduit and wire that would be buried approximately 4 feet deep between the panels and inverter station and switchgear.

    • Grading and leveling a 0.5-acre area in the northwest corner of the site to be used as a future well site.

    • Placement of rip-rap and culverts in the large wash located in the southern portion of the site.

    • Containment of staging and temporary work areas within the 80-acre site.

    • Installation of a 6-foot tall chain-link perimeter fence around the 80-acre site along with secured access gates. The fence would have barbed wire on top for security purposes. The fence would also include openings along the bottom that are at least 10 inches high and 7 inches wide and spaced approximately 260 feet apart to allow desert tortoise ingress and egress at the site after construction activities are completed.

    • Construction of a 2,640-foot 24.9kV distribution line and 10-foot wide access road that would connect to an existing power line located east of the project site.

    The project would use between 500,000 and 600,000 gallons of water during construction. The water would be obtained off-site from an existing local area water utility and trucked to the project site. After construction, it is not anticipated that the panels would need to be washed. However, should washing become necessary, water would be trucked in to the project site. Any water used for washing would be contained within the project site (i.e., no run-off). Also, the prefabricated building would ultimately have water supplied by a small well and a sewer system. VEA owns one-half acre-foot per year of water rights to use for the building. All water from the future well would be used for the prefabricated building only and not within the solar array or other facilities.

    VEA would manage and control noxious weeds and invasive plant species consistent with applicable regulations. The introduction of noxious weeds and invasive plants would be addressed through the use of certified weed-free seed and mulching; cleaning of vehicles to avoid introducing invasive weeds; and education of personnel on weed identification, the manner in which weeds spread, and methods for treating infestations. Regarding the cleaning of vehicles, a controlled inspection and cleaning area would be established to visually inspect construction equipment arriving at the project site and to remove and collect seeds that may be adhering to tires and other equipment surfaces. Equipment would also be cleaned any time thereafter if the equipment leaves the project site, is used on another project, and reenters the project site. Further, to prevent the spread of invasive species, project developers would determine whether a pre-activity invasive species survey is warranted and if so, to conduct the survey. Were noxious weeds or invasive plants to be introduced to the project site as a result of the project, VEA would use principles of integrated pest management to prevent the spread of invasive species.

    Rather than using the typical construction technique of grading, tilling, and leveling the entire 80-acre project site, the applicant would leave most of the vegetation intact, and would crush, mow, or trim vegetation to avoid interfering with the solar panels. Solar panels would be elevated to a height of 42 inches at the bottom leading edge to promote vegetation to persist underneath the solar array by allowing more light to reach the vegetation left below the solar panels.

    Two solar panel spacing configurations would be designed within the 80-acre project site:

    (1) Industry Standard: The northern 40 acres of the project site would have an inner row spacing (i.e., distance between the upper trailing edge of a panel and the bottom leading edge of the panel behind it) of 14 feet.

    (2) Modified Configuration: The southern 40 acres of the project site would have an inner row spacing of 20 feet in order to allow for more light to reach the ground and encourage vegetation growth and break up the pattern of the solar panels in an effort to reduce the potential for impacts to migratory birds.

    The project includes operation and maintenance of the solar field, which would be accessed primarily along the center access road mostly using lightweight off-highway vehicles. Operation and maintenance activities include but are not limited to: Visual inspections, cleaning of the front screens and rear louvers, cleaning of the air intake filter, verification of electrical connections, and verification of signal connections. Within the PV array, activities would include visual inspections of the PV modules, racking system, electrical wiring, weather stations, and the perimeter fence. Cleaning or washing of PV modules is not expected, but if needed, would be performed with warm water and an environmentally friendly soap that would not harm wildlife or vegetation. Equipment would be replaced as necessary and would be performed on foot whenever possible. Upon retirement of the facility, all equipment would be removed, including fencing, and disturbance reclaimed (holes filled in and raked to match the surrounding topography). The area would then be allowed to recover naturally.

    The project would result in the long-term loss of approximately 4 acres of desert tortoise habitat (2.4 acres from construction of the on-site gravel access road, 0.4 acre associated with the switchyard, 0.5 acre associated with the well site, and 0.65 acre from construction of the distribution line access road). Vegetation within the remaining acreage on the 80-acre project site would be left intact, subject to crushing, mowing, and trimming as necessary, and the facility would remain available for desert tortoises to access and occupy the site.

    Proposed Conservation Measures

    The applicant would install a temporary desert tortoise exclusion fence and access gates along the perimeter of the 80-acre project site prior to commencement of construction activities and perform desert tortoise clearance surveys to temporarily move resident tortoises out of harm's way during construction of the facility. Based on results from desert tortoise presence/absence surveys conducted on the project site in April of 2015, an estimate of 2 to 4 adult tortoises may occupy the project site. Tortoises found during clearance surveys would be moved to a tortoise-fenced enclosure on property owned by the applicant that is located 2,000 feet east of the project site. The applicant would follow all protocols and approved methodologies for handling and care of desert tortoises. Upon completion of construction activities, tortoises would be individually marked, fitted with tracking devices, returned to the project site and released, and the temporary tortoise exclusion fence would be removed.

    The permanent security fence around the perimeter of the solar project area would have tortoise access points constructed to allow tortoises to access and occupy the project site after construction is completed.

    Vegetation would not be bladed and would be left intact, but mowed, clipped, or crushed within the solar project site to maintain root structure of vegetation and to keep the existing seed bed.

    PV panels would be mounted on driven piers to minimize site disturbance by avoiding the need for excavation and concrete placement.

    PV panels would be elevated to a minimum height of 42 inches, which is about 18 inches above the current industry standard, and spacing increased in a portion of the array to accommodate tortoise movement and vegetation growth beneath arrays.

    Combiner boxes would be relocated to the center roadway to minimize trenching.

    Overall, ground disturbance would be kept to the minimum required.

    Desert tortoise exclusion fencing would be constructed along the perimeter of the switchyard and the well site for the lifetime of the project to prevent tortoises from accessing these two high activity areas.

    The on-site gravel access road would be posted with a 15-MPH speed limit once the facility is put into service, and utility terrain vehicles would mostly be used along the route in order to have maximized ground view to watch for tortoises. When use of larger vehicles is required, ground guides would be utilized to walk in front of vehicles to ensure the road is free of tortoises.

    Desert tortoise surveys would be conducted one week prior to the start of construction of the distribution line and associated access road. Tortoise burrows would be flagged and construction modified to avoid impacts. An authorized desert tortoise biologist would be present during construction. If a tortoise is found within the construction area, activities would cease until the desert tortoise moves out of harm's way or is moved out of harm's way by an authorized desert tortoise biologist. Relocation would be the minimum distance possible (with a maximum of 500 meters) within appropriate habitat to ensure its safety from death, injury, or collection associated with the Project or other activities. Other measures would be implemented to minimize impacts to desert tortoise as listed in Appendix D in the HCP and in accordance with the most current Service-approved protocols (currently the Service's 2009 Desert Tortoise Field Manual).

    All employees and contractors involved with the project would be required to complete a sensitive resources education program approved by the Service. The program would cover the distribution, general behavior, and ecology of listed species; sensitivity to human activities; legal protections; penalties for violation of state and Federal laws; reporting requirements; and minimization measures.

    The project proponent would use qualified third-party contractors to design and implement research and monitoring studies to evaluate the impact of the two solar panel configurations on vegetation and migratory birds. Specific to desert tortoise, the studies would be designed to address questions related to effects of solar panels on vegetation growth, ability to seed underneath solar panels with desert tortoise forage species, and effects of solar panels on soil conditions such as temperature, water balance, microbial community, and biotic crust.

    Proposed Action and Alternatives

    The Proposed Action consists of the issuance of an incidental take permit and implementation of the proposed HCP, which includes measures to avoid, minimize, and mitigate impacts to the Mojave desert tortoise. If we approve the permit, take of the Mojave desert tortoise would be authorized for the applicant's activities associated with the Valley Electric Association's Community Solar Project. An estimated 2 to 4 adult desert tortoises may occupy the project site, and would be temporarily moved to a site close to the project area during construction activities and returned to the project site after construction is completed to ensure resident tortoises are not harmed. In the proposed HCP, the applicant considers alternatives to the taking of the Mojave desert tortoise under the proposed action. The Traditional Solar Project Alternative would involve blading and grading the 80-acre project site prior to installation of the PV array. The project site would be fenced with tortoise-proof fencing and cleared of all tortoises, resulting in long-term displacement of resident tortoises and long-term loss of all habitat in the project site. The applicant also considers a no-action alternative under which the project would not be constructed and incidental take of the Mojave desert tortoise would not be authorized. However, the no-action alternative would not meet the needs of the applicant to provide clean energy to residents within their service area.

    Our Preliminary Determination

    The Service has made a preliminary determination that approval of the proposed HCP qualifies as a categorical exclusion under NEPA, as provided by the Department of the Interior Manual (516 DM 2 Appendix 1, 516 DM 6 Appendix 1, and 516 DM 8.5(c)(2)) and as a “low-effect” plan as defined by the Habitat Conservation Planning Handbook (November 1996).

    We base our determination that a HCP qualifies as a low-effect plan on the following three criteria:

    (1) Implementation of the HCP would result in minor or negligible effects on federally listed, proposed, and candidate species and their habitats, including designated critical habitat;

    (2) Implementation of the HCP would result in minor or negligible effects on other environmental values or resources; and

    (3) Impacts of the HCP, considered together with the impacts of other past, present, and reasonably foreseeable similarly situated projects, would not result, over time, in cumulative effects to environmental values or resources that would be considered significant.

    Based upon this preliminary determination, we do not intend to prepare further NEPA documentation. We will consider public comments in making the final determination on whether to prepare such additional documentation.

    Next Steps

    We will evaluate the permit application, associated documents, and comments we receive to determine whether the permit application meets the requirements of section 10(a) of the Act, NEPA, and implementing regulations. If we determine that all requirements are met, we will issue a permit to the applicant for the incidental take of the Mojave desert tortoise from the implementation of the covered activities described in the Habitat Conservation Plan for Valley Electric Association's Community Solar Project, Pahrump, Nye County, Nevada. We will not make our final decision until after the end of the 30-day public comment period, and we will fully consider all comments we receive during the public comment period.

    Public Availability of Comments

    All comments we receive become part of the public record. Requests for copies of comments will be handled in accordance with the Freedom of Information Act, NEPA, and Service and Department of Interior policies and procedures. 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 to withhold your personal identifying information from public review, we cannot guarantee we will be able to do so.

    Authority

    We provide this notice under section 10(c) of the Act (16 U.S.C. 1531 et seq.) and its implementing regulations (50 CFR 17.22 and 17.32), and the NEPA (42 U.S.C. 4321 et seq.) and its implementing regulations (40 CFR 1500-1508).

    Dated: August 31, 2015. Michael J. Senn, Field Supervisor, Southern Nevada Fish and Wildlife Office, Las Vegas, Nevada.
    [FR Doc. 2015-22059 Filed 9-3-15; 8:45 am] BILLING CODE 4310-55-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NRNHL-19054;PPWOCRADP2, PCU00RP14.R50000] National Historic Landmarks Committee of the National Park System Advisory Board Meeting AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice of meeting.

    SUMMARY:

    Notice is hereby given in furtherance of the Federal Advisory Committee Act, (5 U.S.C. Appendix 1-16), and Part 65 of title 36 of the Code of Federal Regulations, that a meeting of the National Historic Landmarks Committee of the National Park System Advisory Board will be held beginning at 10:00 a.m. on November 16, 2015, at the Charles Sumner School Museum and Archives. The meeting will continue beginning at 9:30 a.m. on November 17, 2015.

    DATES:

    The meeting will be held on Monday, November 16, 2015, from 10:00 a.m. to 4:30 p.m.; and Tuesday, November 17 from 9:30 a.m. to 4:30 p.m. (EASTERN).

    Location: The Charles Sumner School Museum and Archives, 3rd Floor, The Richard L. Hurlbut Memorial Hall, 1201 17th Street NW., Washington, DC 20036.

    Agenda: The National Park System Advisory Board and its National Historic Landmarks Committee may consider the following nominations:

    Connecticut JAMES MERRILL HOUSE, Stonington, CT THE STEWARD'S HOUSE, FOREIGN MISSION SCHOOL, Cornwall, CT Florida NORMAN STUDIOS, Jacksonville, FL Indiana ATHENAEUM (DAS DEUTSCHE HAUS), Indianapolis, IN Michigan GAUKLER POINTE (EDSEL AND ELEANOR FORD HOUSE), Macomb County, MI Mississippi MISSISSIPPI STATE CAPITOL, Jackson, MS New York ST. BARTHOLOMEW'S CHURCH AND COMMUNITY HOUSE, New York, NY Ohio ZOAR HISTORIC DISTRICT, Zoar, OH Wisconsin MAN MOUND, Sauk County, WI Wyoming AMES MONUMENT, Albany County, WY HELL GAP PALEOINDIAN SITE, Goshen County, WY

    Proposed Amendments to Existing Designations:

    Maryland MONOCACY BATTLEFIELD, City of Frederick and Frederick County, MD (updated documentation and boundary revision) Ohio JAMES A. GARFIELD HOME, Mentor, OH (updated documentation) WILLIAM HOWARD TAFT HOME, Cincinnati, OH (updated documentation and name change)

    The committee may also consider the following historic trail:

    LEWIS AND CLARK EASTERN LEGACY NATIONAL HISTORIC TRAIL FOR FURTHER INFORMATION CONTACT:

    Patricia Henry, Historian, National Historic Landmarks Program, National Park Service, 1849 C Street NW., Washington, DC 20240, telephone (202) 354-2216 or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting of the National Historic Landmarks Committee of the National Park System Advisory Board is to evaluate nominations of historic properties in order to advise the National Park System Advisory Board of the qualifications of each property being proposed for National Historic Landmark designation, and to make recommendations regarding the possible designation of those properties as National Historic Landmarks to the National Park System Advisory Board at a subsequent meeting at a place and time to be determined. The Committee also makes recommendations to the National Park System Advisory Board regarding amendments to existing designations and proposals for withdrawal of designation. The members of the National Historic Landmarks Committee are:

    Dr. Stephen Pitti, Chair Dr. James M. Allan Dr. Cary Carson Dr. Yong Chen Mr. Douglas Harris Ms. Mary Hopkins Mr. Luis Hoyos, AIA Dr. Sarah A. Leavitt Dr. Barbara J. Mills Dr. Michael E. Stevens Dr. Amber Wiley Dr. David Young

    The meeting will be open to the public. Pursuant to 36 CFR part 65, any member of the public may file, for consideration by the National Historic Landmarks Committee of the National Park System Advisory Board, written comments concerning the National Historic Landmarks nominations, amendments to existing designations, or proposals for withdrawal of designation.

    Comments should be submitted to J. Paul Loether, Chief, National Register of Historic Places and National Historic Landmarks Program, National Park Service, 1849 C Street NW., Washington, DC 20240, email: [email protected]

    Before including your address, telephone 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 may 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: August 31, 2015. Alma Ripps, Chief, Office of Policy.
    [FR Doc. 2015-21952 Filed 9-3-15; 8:45 am] BILLING CODE 4310-EE-P
    DEPARTMENT OF THE INTERIOR Bureau of Ocean Energy Management [MMAA104000] Outer Continental Shelf, Gulf of Mexico, Oil and Gas Central Planning Area Lease Sales 241 and 247 and Eastern Planning Area Lease Sale 226 AGENCY:

    Bureau of Ocean Energy Management (BOEM), Interior.

    ACTION:

    Notice of Availability of a Final Supplemental Environmental Impact Statement.

    SUMMARY:

    BOEM is announcing the availability of a Final Supplemental Environmental Impact Statement (EIS) for the Gulf of Mexico Outer Continental Shelf Oil and Gas Central Planning Area Lease Sales 241 and 247 and Eastern Planning Area Lease Sale 226. The Final Supplemental EIS provides a discussion of potential significant impacts of the proposed actions, provides an analysis of reasonable alternatives to the proposed actions, and identifies the Bureau's preferred alternatives. This Final Supplemental EIS updates the environmental and socioeconomic analyses for proposed CPA and EPA sales evaluated in the following EISs:

    • Gulf of Mexico OCS Oil and Gas Lease Sales: 2012-2017; Western Planning Area Lease Sales 229, 233, 238, 246, and 248; Central Planning Area Lease Sales 227, 231, 235, 241, and 247, Final Environmental Impact Statement (OCS EIS/EA BOEM 2012-019) (2012-2017 WPA/CPA Multisale EIS);

    • Gulf of Mexico OCS Oil and Gas Lease Sales: 2013-2014; Western Planning Area Lease Sale 233; Central Planning Area Lease Sale 231, Final Supplemental Environmental Impact Statement (OCS EIS/EA BOEM 2013-0118) (WPA 233/CPA 231 Supplemental EIS);

    • Gulf of Mexico OCS Oil and Gas Lease Sale: 2015-2017; the Gulf of Mexico OCS Oil and Gas Lease Sales: 2014 and 2016, Eastern Planning Area Lease Sales 225 and 226, Final Environmental Impact Statement (OCS EIS/EA BOEM 2013-200) (EPA 225/226 EIS); and

    • Central Planning Area Lease Sales 235, 241, and 247; Draft Supplemental Environmental Impact Statement (OCS EIS/EA BOEM 2014-010) (CPA 235, 241 and 247 Supplemental EIS).

    The Final Supplemental EIS is available on the Bureau's Web site at http://www.boem.gov/nepaprocess/. BOEM will distribute primarily digital copies of the Final Supplemental EIS on compact discs. You may request a paper copy, compact disc, or the location of a library with a digital copy of the Final Supplemental EIS from BOEM, Gulf of Mexico OCS Region, Public Information Office (GM 250C), 1201 Elmwood Park Boulevard, Room 250, New Orleans, Louisiana 70123-2394 (1-800-200-GULF).

    FOR FURTHER INFORMATION CONTACT:

    Mr. Gary D. Goeke, BOEM, Gulf of Mexico OCS Region, Office of Environment (GM 623E), 1201 Elmwood Park Boulevard, New Orleans, Louisiana 70123-2394 or by email at [email protected] You may also contact Mr. Goeke by telephone at 504-736-3233.

    Authority:

    This NOA is published pursuant to the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321 et seq.), and the Department of the Interior's NEPA implementing regulations at 43 CFR 46.415.

    Dated: August 3, 2015. Abigail Ross Hopper, Director, Bureau of Ocean Energy Management.
    [FR Doc. 2015-22055 Filed 9-3-15; 8:45 am] BILLING CODE 4310-MR-P
    DEPARTMENT OF THE INTERIOR Bureau of Ocean Energy Management [Docket No. BOEM-2015-0094;MMAA104000] Outer Continental Shelf, Gulf of Mexico, Oil and Gas Western Planning Area Lease Sale 248 AGENCY:

    Bureau of Ocean Energy Management (BOEM), Interior.

    ACTION:

    Notice of Availability and Announcement of Public Meetings and Comment Period for the Draft Supplemental Environmental Impact Statement for Proposed Gulf of Mexico Oil and Gas Western Planning Area Lease Sale 248.

    SUMMARY:

    BOEM is announcing the availability of a Draft Supplemental Environmental Impact Statement (EIS) for the proposed Gulf of Mexico (GOM) Outer Continental Shelf (OCS) oil and gas Western Planning Area (WPA) Lease Sale 248 (WPA Sale 248). WPA Sale 248 is tentatively scheduled for August 2016. The Draft Supplemental EIS provides a discussion of the potential significant impacts of the proposed action and an analysis of reasonable alternatives to the proposed action; it considers new information made available since completion of earlier EISs related to WPA Sale 248. The prior EISs supplemented by the Draft Supplemental EIS are available at: http://www.boem.gov/nepaprocess/. This Notice of Availability (NOA) serves to announce the beginning of the public comment period for the Draft Supplemental EIS.

    Public Availability: In keeping with the Department of the Interior's mission to protect natural resources and to limit costs, while ensuring availability of the document to the public, the Draft Supplemental EIS and associated information are available on BOEM's Web site at http://www.boem.gov/nepaprocess/. BOEM will also distribute digital copies of the Draft Supplemental EIS on compact discs. You may request a paper copy or the location of a library with a digital copy of the Draft Supplemental EIS from the Bureau of Ocean Energy Management, Gulf of Mexico OCS Region, Public Information Office (GM 250C), 1201 Elmwood Park Boulevard, Room 250, New Orleans, Louisiana 70123-2394 (1-800-200-GULF).

    DATES:

    Comments should be submitted no later than October 19, 2015. As described below in the “Comments” section, public comments may also be submitted at public meetings being held on September 22 and 23, 2015.

    FOR FURTHER INFORMATION CONTACT:

    For more information on the WPA 248 Draft Supplemental EIS, you may contact Mr. Gary D. Goeke, Bureau of Ocean Energy Management, Gulf of Mexico OCS Region, Office of Environment (GM 623E), 1201 Elmwood Park Boulevard, New Orleans, Louisiana 70123-2394, or by email at [email protected]. You may also contact Mr. Goeke by telephone at 504-736-3233.

    Comments: Federal, State, Tribal, and local governments and/or agencies and the public (including persons and organizations who may be interested or affected) may submit written comments on the WPA 248 Draft Supplemental EIS through the following methods:

    1. Federal eRulemaking Portal: http://www.regulations.gov. In the field “Enter Keyword or ID” enter “Oil and Gas Lease Sales: Gulf of Mexico, Outer Continental Shelf; Western Planning Area Lease Sale 248” (note: it is important to include the quotation marks in your search terms), and then click “search”. Follow the instructions to submit public comments and view supporting and related materials available for this notice;

    2. U.S. mail, in an envelope labeled “Comments for the Draft WPA 248 Supplemental EIS” and addressed to Mr. Gary D. Goeke, Chief, Environmental Assessment Section, Office of Environment (GM 623E), Bureau of Ocean Energy Management, Gulf of Mexico OCS Region, 1201 Elmwood Park Boulevard, New Orleans, Louisiana 70123-2394. To be considered, comments must be postmarked by the last day of the comment period provided in the “Dates” section above; or

    3. Email to: [email protected].

    BOEM will also hold public meetings to solicit comments regarding the WPA 248 Draft Supplemental EIS. The meetings are scheduled as follows:

    Houston, Texas: Tuesday September 22, 2015, Hilton Garden Inn Houston/Bush Intercontinental Airport, 15400 John F. Kennedy Boulevard, Houston, Texas 77032, one meeting beginning at 1:00 p.m. CDT.

    New Orleans, Louisiana: Wednesday, September 23, 2015, Bureau of Ocean Energy Management, Gulf of Mexico OCS Region, 1201 Elmwood Park Boulevard, New Orleans, Louisiana 70123, one meeting beginning at 1:00 p.m. CDT.

    Public Disclosure of Names and Addresses: 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.

    Authority:

    This NOA is consistent with the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321 et seq.) (NEPA) and the regulations implementing NEPA, and is published pursuant to 43 CFR 46.415 and 46.435.

    Dated: August 17, 2015. Abigail Ross Hopper, Director, Bureau of Ocean Energy Management.
    [FR Doc. 2015-22071 Filed 9-3-15; 8:45 am] BILLING CODE 4310-MR-P
    DEPARTMENT OF THE INTERIOR Bureau of Ocean Energy Management [Docket No. BOEM-2015-0075; MMAA104000] Outer Continental Shelf, Region-Wide Gulf of Mexico, Oil and Gas Lease Sales for Years 2017-2022 AGENCY:

    Bureau of Ocean Energy Management (BOEM), Interior.

    ACTION:

    Call for Information and Nominations.

    SUMMARY:

    This Call for Information and Nominations (Call) is the initial step in a multi-sale process covering all proposed lease sales in the Gulf of Mexico (GOM) comprised of the Western, Central, and Eastern Gulf of Mexico Planning Areas (WPA, CPA, and EPA, respectively), proposed for inclusion in the Draft Proposed Five Year Outer Continental Shelf (OCS) Oil and Gas Leasing Program for 2017-2022 (2017-2022 Five Year Program). Ten proposed lease sales are specifically covered by this Call: Five region-wide GOM sales tentatively scheduled in March of each year and five region-wide GOM sales tentatively scheduled in August of each year. This call for region-wide GOM sales will not prevent Bureau of Ocean Energy Management (BOEM) from deciding during the pre-sale process to hold separate sales in individual planning areas without issuing another call. BOEM announced in a Notice of Intent (NOI, 80 FR 23818, April 29, 2015) that it is preparing a multi-sale Environmental Impact Statement (Multi-sale EIS) covering the same 10 lease sales in the proposed GOM sale area, in compliance with the National Environmental Policy Act (NEPA). For each of the 10 proposed individual lease sales associated with this Call, BOEM will continue to comply with NEPA, the Outer Continental Shelf Lands Act (OCSLA), the Coastal Zone Management Act (CZMA) and other applicable law.

    DATES:

    Nominations and comments must be received at the address specified below no later than October 5, 2015 in the Federal Register.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Jaron Ming, Bureau of Ocean Energy Management, Gulf of Mexico OCS Region, 1201 Elmwood Park Boulevard, New Orleans, Louisiana 70123-2394, telephone (504) 736-2537.

    SUPPLEMENTARY INFORMATION:

    On January 27, 2015, the Department of the Interior released the Draft Proposed 2017-2022 Five Year Program. The Draft Proposed 2017-2022 Five Year Program was made available for public comment through March 30, 2015. BOEM also published an NOI to prepare a Programmatic Environmental Impact Statement (PEIS) for the 2017-2022 Five Year Program on January 29, 2015. Scoping for the PEIS closed on March 30, 2015. Information on the development of the proposed 2017-2022 Five Year Program and PEIS are available on BOEM's Web site at: http://www.boem.gov/Five-Year-Program-2017-2022/.

    Because the first Gulf sale is proposed to occur early in the Program and due to the long lead times needed to prepare for proposed oil and gas lease sales, the development of the 2017-2022 Five Year Program and the administrative and environmental analysis processes for individual Gulf of Mexico lease sales must occur simultaneously and in close coordination. This Call covers only the region-wide lease sales in the GOM that are proposed for inclusion in the Draft Proposed 2017-2022 Five Year Program. The Multi-sale EIS being prepared by BOEM will analyze a large region-wide area in the GOM that will include available blocks in the Western, Central, and Eastern Planning Areas not subject to Congressional moratorium (collectively, the “proposed GOM sale area”). The Multi-sale EIS will also include analysis of potential alternatives to the region-wide lease sale proposal.

    Call for Information and Nominations 1. Authority

    This Call is published pursuant to OCSLA, as amended (43 U.S.C. 1331 et seq.), and its implementing regulations (30 CFR part 556).

    2. Purpose of Call

    The purpose of the Call is to gather information for the following tentatively scheduled OCS region-wide GOM sales. The Draft Proposed 2017-2022 Five Year Program has scheduled the following proposed lease sales, which would be region-wide and include all unleased acreage in the GOM not currently subject to Congressional moratorium.

    Lease sale Sale year Sale 249 August 2017. Sale 250 March 2018. Sale 251 August 2018. Sale 252 March 2019. Sale 253 August 2019. Sale 254 March 2020. Sale 256 August 2020. Sale 257 March 2021. Sale 259 August 2021. Sale 261 March 2022.

    BOEM seeks information and nominations on oil and gas leasing, exploration, development, and production within the proposed GOM sale area from all interested parties. This early planning and consultation step ensures that public interests and concerns are communicated to the Department of the Interior for its future decisions in the leasing process, pursuant to section 19 of OCSLA (43 U.S.C. 1344) and its implementing regulations (30 CFR part 556).

    BOEM requests responses regarding proposed sales in the region-wide GOM sale area. Accordingly, this multi-sale process addresses decisions for all 10 region-wide lease sales in the proposed GOM sale area.

    Pursuant to section 18 of OCSLA (43 U.S.C. 1344), the Secretary of the Interior (Secretary) is separately developing the 2017-2022 Five Year Program; therefore, this Call should not be construed as a prejudgment or decision by the Secretary concerning any area to be made available for leasing under the 2017-2022 Five Year Program.

    This Call does not indicate a preliminary decision to lease in the area described below. Final delineation of the area for possible leasing will be made later, in compliance with applicable laws (e.g., NEPA, OCSLA, and CZMA) and established departmental procedures.

    3. Description of Area

    The proposed GOM sale area of this Call includes the entire CPA, WPA, and EPA, except for those areas currently subject to Congressional moratorium.

    The CPA is bound on the north by the Federal-State boundary offshore Louisiana, Mississippi, and Alabama. The eastern boundary of the CPA begins at the offshore boundary between Alabama and Florida and proceeds southeasterly to 26.19°N. latitude, thence southwesterly to 25.6°N. latitude. The western boundary of the CPA begins at the offshore boundary between Texas and Louisiana and proceeds southeasterly to 28.43° N. latitude, thence south-southwesterly to 27.49° N. latitude, thence south-southeasterly to 25.80° N. latitude. The CPA is bounded on the south by the maritime boundary with Mexico as established by the Treaty between the Government of the United States of America and the Government of the United Mexican States on the Delimitation of the Continental Shelf in the Western Gulf of Mexico beyond 200 Nautical Miles, which took effect in January 2001, and by the limit of the U.S. Exclusive Economic Zone in the area east of the continental shelf boundary with Mexico. The CPA includes a small section subject to Congressional moratorium, which currently runs until June 30, 2022, as established by the Gulf of Mexico Energy Security Act of 2006 (GOMESA, Pub. L. 109-432). [This area of the CPA subject to Congressional moratorium is bounded by the area east of the Military Mission Line (86° 41′ west longitude), and the area within the CPA that is within 100 miles of Florida. A map of the moratoria can be found here: http://www.boem.gov/Oil-and-Gas-Energy-Program/Leasing/Areas-Under-Moratoria.aspx.] The CPA available for nominations and comments at this time consists of approximately 66.45 million acres, of which approximately 45.28 million acres are currently unleased.

    The WPA is bound on the west and north by the Federal-State boundary offshore Texas. The eastern boundary begins at the offshore boundary between Texas and Louisiana and proceeds southeasterly to 28.43° N. latitude, thence south-southwesterly to 27.49° N. latitude, thence south-southeasterly to 25.80° N. latitude. The WPA is bounded on the south by the maritime boundary with Mexico as established by the Treaty between the Government of the United States of America and the Government of the United Mexican States on the Delimitation of the Continental Shelf in the Western Gulf of Mexico beyond 200 Nautical Miles, which took effect in January 2001. The WPA available for nominations and comments at this time consists of approximately 28.58 million acres, of which approximately 21.94 million acres are currently unleased.

    The proposed GOM sale area includes a small section of the EPA not subject to Congressional moratorium, which currently runs until June 30, 2022, as established by GOMESA. The portion of the EPA not subject to Congressional moratorium is bound on the east by the Military Mission Line (86°41′ W. longitude), on the south by the limits of the U.S. Exclusive Economic Zone adjacent to the area known as the northern portion of the Eastern Gap, and on the west by the CPA. The EPA available for nominations and comments at this time consists of approximately 657,905 acres, of which approximately 465,201 acres are currently unleased.

    A standard Call map, depicting the proposed GOM sale area on a block-by-block basis, is available from the Bureau of Ocean Energy Management, Public Information Office (MS 5034), 1201 Elmwood Park Boulevard, New Orleans, Louisiana 70123-2394, or by telephone at (800) 200-GULF. The map also is available on the BOEM Web site at http://boem.gov/2017-2022/Call-for-Information/.

    4. Areas Excluded From Call

    The entire proposed GOM sale area will be considered for possible leasing, except for those areas currently subject to Presidential withdrawal or Congressional moratorium.

    5. Nominations and Public Comment Procedures

    BOEM will accept comments from the public in one of two formats: via the Federal internet commenting system at regulations.gov or via regular mail. BOEM's preference is to receive comments via the internet commenting system at regulations.gov. Indications of interest and comments must be received no later than October 5, 2015. BOEM requests that comments be submitted using one of these formats, and include full names and addresses of the individual submitting the comments or indication of interest.

    In order to ensure security and confidentiality of proprietary information to the maximum extent possible, BOEM requests that indications of interest and other proprietary information be sent by regular mail only.

    Submitting Comments via Internet

    Comments may be submitted via the Federal eRulemaking Portal at: http://www.regulations.gov. BOEM requests that commenters follow these instructions to submit their comments via this Web site:

    (1) In the search tab on the main page, search for BOEM-2015-0075.

    (2) Locate the document, then click the “Submit a Comment” link either on the Search Results page or the Document Details page. This will display the Web comment form.

    (3) Enter the submitter information and type the comment on the Web form. Attach any additional files (up to 10MB). (Please do not provide proprietary or confidential comments or indications of interest via the Internet. Proprietary or confidential comments or indications of interest should be sent via the mail only, as described below.)

    (4) After typing the comment, click the “Preview Comment” link to review. Once satisfied with the comment, click the “Submit” button to send the comment.

    Information on using www.regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link.

    Submitting Comments or Indications of Interest via the Mail

    Comments and indications of interest submitted through the mail should be in envelopes labeled “Nominations for Proposed 2017-2022 Lease Sales in the Gulf of Mexico” or “Comments on the Call for Information and Nominations for Proposed 2017-2022 Lease Sales in the Gulf of Mexico” and mailed to the Bureau of Ocean Energy Management, Gulf of Mexico OCS Region, Office of Leasing and Plans, (Attention: Ms. Ann H. Glazner), 1201 Elmwood Park Boulevard (Mail Stop 5422), New Orleans, Louisiana 70123-2394.

    Public Disclosure of Comments and Indications of Interest

    BOEM will not consider anonymous comments. BOEM's practice is to make comments, including the names and addresses of individuals, available for public review. Before including your address, phone number, email address, or other personal identifying information in your comment, please be advised 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 from public review your personal identifying information, we cannot guarantee that we will be able to do so. BOEM will make available for public inspection, in their entirety, all comments submitted by organizations and businesses, or by individuals identifying themselves as representatives of organizations or businesses.

    Individual indications of interest in areas for mineral leasing are considered to be privileged and proprietary information. The names of persons or entities submitting comments or indicating interest will be treated by BOEM as information that may be released to the public. Comments will likewise be released, except that actual individual indications of interest in areas for mineral leasing, trade secrets, commercial or financial information will be treated as confidential and proprietary information that is privileged and will not be released to the public.

    Additional Information for Submitting Comments and Indications of Interest

    The Call map, provided on BOEM's Web site at http://boem.gov/2017-2022/Call-for-Information/, delineates the proposed GOM sale area, all of which BOEM has identified as having potential for the discovery of oil and gas accumulations. Respondents are requested to indicate interest in, and comment on, any or all of the Federal acreage within the boundaries of the proposed GOM sale area that they wish to have included in each of the proposed lease sales in the proposed GOM sale area.

    Respondents indicating their interest should outline the areas of interest along block lines and rank the areas in which they have expressed interest according to their interest priority (e.g., priority 1 [high], 2 [medium], or 3 [low]), specifically indicating blocks by priority. Areas where interest has been indicated, but on which respondents have not indicated priorities, will be considered priority 3 (low).

    Respondents also may nominate a list of blocks identified by Official Protraction Diagram (OPD) and Leasing Map designations to ensure correct interpretation of those nominations. A CD-ROM containing all the GOM leasing maps and OPDs is available from the BOEM Gulf of Mexico OCS Region Public Information Office. These GOM leasing maps and OPDs also are available for free online at http://www.boem.gov/Official-Protraction-Diagrams/. Also, BOEM seeks comments from all interested parties about particular geological, environmental (including natural disasters), biological, archaeological, and socioeconomic conditions or conflicts, or other information that could affect the potential leasing and development of particular areas. Additionally, BOEM seeks comments about possible conflicts between future OCS oil and gas activities and State Coastal Management Programs (CMPs) that may result from the proposed sales. These comments should identify specific CMP policies of concern, the nature of the conflict foreseen, and the proposed means to avoid or mitigate potential conflicts. Comments may refer to both broad areas or to particular blocks.

    6. Information From Call

    Information submitted in response to this Call will be used for several purposes, including identifying and prioritizing areas with potential for oil and gas development, as well as determining possible environmental effects to be further evaluated and potential conflicts in the Call area. BOEM will analyze the areas nominated in the proposed sales, their respective rankings, and the comments received to make a preliminary determination of the potential advantages and disadvantages of oil and gas exploration and development to the region and the Nation. Comments collected may be used to develop proposed actions and alternatives in the EIS process, to develop lease terms and conditions to ensure safe offshore operations, and to assess potential conflicts between offshore oil and gas activities and a State's CMP.

    7. Existing Information

    BOEM routinely assesses the status of information acquisition efforts and the quality of the information base for potential decisions on tentatively scheduled lease sales. As a result of this ongoing assessment, BOEM has determined that the status of existing and extensive data available for planning, analysis, and decision making is adequate.

    An extensive environmental studies program has been underway in the GOM since 1973. The emphasis, including continuing studies, has been on environmental characterization of biologically sensitive habitats, physical oceanography, ocean-circulation modeling, and ecological effects of oil and gas activities.

    A complete listing of available study reports and information for ordering copies can be obtained from the Public Information Office referenced above. The reports also may be ordered, for a fee, from the U.S. Department of Commerce, National Technical Information Service, 5301 Shawnee Road, Alexandria, Virginia 22312, or by telephone at (703) 605-6000 or (800) 553-6847. In addition, a program status report for continuing studies in this area can be obtained from the Chief, Environmental Sciences Section, Bureau of Ocean Energy Management, Gulf of Mexico OCS Region, 1201 Elmwood Park Boulevard, New Orleans, Louisiana 70123-2394, by telephone at (504) 736-2752, or via the BOEM Web site at http://www.boem.gov/Studies/. Finally, this information can be found on BOEM's Environmental Studies Program Information System (ESPIS) at http://www.boem.gov/Environmental-Studies-EnvData/.

    8. Tentative Schedule Milestones for proposed 2017-2022 region-wide GOM area identification Scheduled for Call for Information and Nominations September 2015. Comments received on Call September-October 2015. Area Identification Decision Fall 2015. Dated: September 1, 2015. Abigail Ross Hopper, Director, Bureau of Ocean Energy Management.
    [FR Doc. 2015-22073 Filed 9-3-15; 8:45 am] BILLING CODE 4310-MR-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-918] Issuance of a General Exclusion Order and Cease and Desist Orders; Termination of Investigation; Certain Toner Cartridges and Components Thereof AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission has determined to issue: (1) a general exclusion order barring entry of certain toner cartridges and components thereof that infringe certain patents asserted in this investigation; and (2) cease and desist orders directed against certain domestic defaulting respondents. The Commission has terminated this investigation.

    FOR FURTHER INFORMATION CONTACT:

    Michael Liberman, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-3115. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at http://www.usitc.gov. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at http://edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.

    SUPPLEMENTARY INFORMATION:

    The Commission instituted this investigation under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“Section 337”), on June 12, 2014, based on a complaint filed by Canon Inc. of Japan; Canon U.S.A., Inc. of Melville, New York; and Canon Virginia, Inc. of Newport News, Virginia (collectively, “Canon”). 79 FR 33777-78 (June 12, 2014). The complaint alleges a violation of section 337 by reason of infringement of certain claims of U.S. Patent Nos. 8,280,278 (“the `278 patent”); 8,630,564 (“the `564 patent”); 8,682,215 (“the `215 patent”); 8,676,090 (“the `090 patent”); 8,369,744 (“the `744 patent”); 8,565,640 (“the `640 patent”); 8,676,085 (“the `085 patent”); 8,135,304 (“the `304 patent”); and 8,688,008 (“the `008 patent”). Id. The notice of investigation named thirty-three companies as respondents. Id. The Commission's Office of Unfair Import Investigations was also named as a party. Subsequently, the investigation was partially terminated based on withdrawal of the complaint as to all asserted claims of the following patents: (1) the `744 patent; (2) the `640 patent; (3) the `085 patent; and (4) the `304 patent.

    During the investigation, the ALJ issued initial determinations (“IDs”) terminating the investigation based on consent orders as to fifteen respondents:, Print-Rite Holdings Ltd.; Print-Rite N.A., Inc.; Union Technology Int'l (M.C.O.) Co. Ltd.; Print-Rite Unicorn Image Products Co. Ltd.; Innotex Precision Ltd.; Ninestar Image Tech Limited; Zhuhai Seine Technology Co., Ltd.; Ninestar Technology Company, Ltd.; Seine Tech (USA) Co., Ltd.; Nano Pacific Corporation; International Laser Group, Inc.; Ink Technologies Printer Supplies, LLC; LD Products, Inc.; Linkyo Corporation; and Katun Corporation. See ALJ Order Nos. 13 (not reviewed Nov. 4, 2014), 16 (not reviewed Nov. 24, 2014), 28 (not reviewed Apr. 3, 2015), 29 (not reviewed Apr. 3, 2015), 30 (not reviewed Apr. 3, 2015), 31 (not reviewed Apr. 3, 2015), and 32 (not reviewed Apr. 3, 2015). The ALJ also issued an ID terminating the investigation based on Canon's withdrawal of allegations as to two respondents, Seine Image Int'l Co., Ltd. and Ninestar Image Tech, Ltd. See ALJ Order No. 4 (not reviewed Aug. 1, 2014). Likewise, the ALJ issued another ID terminating the investigation as to respondent Seine Image (USA) Co., Ltd. due to the corporate dissolution of the respondent. See ALJ Order No. 27 (not reviewed Apr. 1, 2015).

    The ALJ also issued IDs finding the following ten respondents in default: Acecom, Inc. -San Antonio of San Antonio, Texas; ACM Technologies, Inc. of Corona, California; Shenzhen ASTA Official Consumable Co., Ltd. of Longgang District, Shenzhen, China; Do It Wiser LLC of Alpharetta, Georgia; Grand Image Inc. of City of Industry, California; Green Project, Inc. of Hacienda Heights, California; Nectron International, Inc. of Sugar Land, Texas; Online Tech Stores, LLC of Reno, Nevada; Printronic Corporation of Santa Ana, California; and Zinyaw LLC of Houston, Texas. See Order Nos. 6 (not reviewed Aug. 25, 2014), 12 (not reviewed Oct. 1, 2014), 15 (not reviewed Nov. 17, 2014).

    The remaining five named respondents are Aster Graphics, Inc. of Placentia, California; Jiangxi Yibo E-Tech Co., Ltd. of Xinyu City, Jiangxi, China; Aster Graphics Co., Ltd. of Zhongshan, Guangdong, China; The Supplies Guys, LLC of Midland Park, New Jersey; and American Internet Holdings, LLC of Midland Park, New Jersey. Each of them has acknowledged and stipulated that it has failed to act within the meaning of Commission Rule 210.17, at least because it failed to file a prehearing statement and brief in accordance with the Procedural Schedule (Order No. 9), and that it therefore has no standing to contest Canon's evidence and arguments that it has violated section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337. See Stipulation Regarding the Status of the Aster and Supplies Guys Respondents (Feb. 26, 2015).

    On May 12, 2015, the ALJ issued an ID (Order No. 34) granting Canon's motion for summary determination of violation and recommending the issuance of a general exclusion order and several cease and desist orders. No party petitioned for review of the ID.

    The Commission determined to affirm the ALJ's finding of a violation of section 337. The Commission also determined to review, and on review, to strike or modify certain portions of the ID. Furthermore, the Commission requested briefing on the issues of remedy, the public interest and bonding. See 80 FR 37299-301 (June 30, 2015). Canon and the Commission investigative attorney filed timely submissions pursuant to the Commission's Notice. No other parties filed any submissions in response to the Commission's Notice.

    Having reviewed the submissions filed in response to the Commission's Notice and the evidentiary record, the Commission has determined that the appropriate form of relief in this investigation is a general exclusion order barring entry of certain toner cartridges and components thereof covered by one or more of claims 160, 165, and 166 of the `278 patent; claims 171, 176, 179, 181, 189, 192, and 200 of the `564 patent; claims 23, 26, 27, and 29 of the `215 patent; claims 1-4 of the `090 patent; and claims 1, 7-9, 11, 12, and 34 of the `008 patent. The Commission has also determined to issue cease and desist orders directed against Acecom, Inc.-San Antonio; Do It Wiser LLC; Grand Image Inc.; Green Project, Inc.; Nectron International, Inc.; Online Tech Stores, LLC; Printronic Corporation; and Zinyaw LLC. The Commission has further determined that the public interest factors enumerated in subsections (d)(l), (f)(1), and (g)(1) (19 U.S.C. 1337(d)(l), (f)(1), (g)(1)) do not preclude issuance of the general exclusion order and cease and desist orders. Additionally, the Commission has determined that a bond in the amount of one hundred (100) percent of the entered value is required to permit temporary importation of the articles in question during the period of Presidential review (19 U.S.C. 1337(j)). The Commission has also issued an opinion explaining the basis for the remedy. The investigation is terminated.

    The Commission's orders and the record upon which it based its determination were delivered to the President and to the United States Trade Representative on the day of their issuance. The Commission has also notified the Secretary of the Treasury of the orders.

    The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

    By order of the Commission.

    Issued: August 31, 2015.

    Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2015-21962 Filed 9-3-15; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION [USITC SE-15-028] Government in the Sunshine Act Meeting Notice Agency Holding the Meeting:

    United States International Trade Commission

    Time and Date:

    September 10, 2015 at 11:00 a.m.

    Place:

    Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.

    Status:

    Open to the public.

    Matters To Be Considered:

    1. Agendas for future meetings: none.

    2. Minutes.

    3. Ratification List.

    4. Vote in Inv. Nos. 701-TA-540-544 and 731-TA-1283-1290 (Preliminary) (Cold-Rolled Steel Flat Products from Brazil, China, India, Japan, Korea, Netherlands, Russia, and the United Kingdom). The Commission is currently scheduled to complete and file its determinations on September 11, 2015; views of the Commission are currently scheduled to be completed and filed on September 18, 2015.

    5. Outstanding action jackets: none.

    In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.

    By order of the Commission.

    Issued: September 2, 2015. William R. Bishop, Supervisory Hearings and Information Officer.
    [FR Doc. 2015-22542 Filed 9-2-15; 4:15 pm] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE [OMB Number 1125-0009] Agency Information Collection Activities; Proposed eCollection; eComments Requested; Application for Suspension of Deportation (Form EOIR-40) AGENCY:

    Executive Office for Immigration Review, Department of Justice.

    ACTION:

    30-day notice.

    SUMMARY:

    The Department of Justice (DOJ), Executive Office for Immigration Review, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the FR 80 38232, on July 2, 2015, allowing for a 60 day comment period.

    DATES:

    Comments are encouraged and will be accepted for an additional 30 days until October 5, 2015.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Charles Adkins-Blanch, Acting General Counsel, Executive Office for Immigration Review, U.S. Department of Justice, Suite 2600, 5107 Leesburg Pike, Falls Church, Virginia 20530; telephone: (703) 305-0470. Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20530 or sent to [email protected]

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Enhance the quality, utility, and clarity of the information to be collected; and/or —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection

    1. Type of Information Collection: Extension, without change, of a currently approved collection.

    2. The Title of the Form/Collection: Application for Suspension of Deportation.

    3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: The form number is EOIR-40, Executive Office for Immigration Review, United States Department of Justice.

    4. Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individual aliens determined to be deportable from the United States. Other: None. Abstract: This information collection is necessary to determine the statutory eligibility of individual aliens, who have been determined to be deportable from the United States, for suspension of their deportation pursuant to former section 244 of the Immigration and Nationality Act and 8 CFR 1240.55 (2011), as well as to provide information relevant to a favorable exercise of discretion.

    5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 160 respondents will complete the form annually with an average of 5 hours and 45 minutes per response.

    6. An estimate of the total public burden (in hours) associated with the collection: The estimated public burden associated with this collection is 920 hours. It is estimated that respondents will take 5 hours and 45 minutes to complete the form.

    If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.

    Dated: September 1, 2015. Jerri Murray, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2015-22015 Filed 9-3-15; 8:45 am] BILLING CODE 4410-30-P
    DEPARTMENT OF JUSTICE [OMB Number 1121-0094] Agency Information Collection Activities; Proposed eCollection eComments Requested; Proposed Collection: Revision of Currently Approved Collection Survey: Annual Survey of Jails; Death in Custody Reporting Program—Local Jails; Survey of Jails in Indian Country AGENCY:

    Bureau of Justice Statistics, Department of Justice.

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

    DATES:

    Comments are encouraged and will be accepted for 60 days until November 3, 2015.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Margaret Noonan, Statistician, Bureau of Justice Statistics, 810 Seventh Street NW., Washington, DC 20531 (email: [email protected]; telephone: 202-353-2060).

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Bureau of Justice Statistics, including whether the information will have practical utility; —Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection

    (1) Type of Information Collection: Extension of a Currently Approved Collection.

    (2) The Title of the Form/Collection: Annual Jail Collection. The collection includes the Annual Survey of Jails (ASJ), Deaths in Custody Reporting Program (DCRP)—Local Jails, and the Survey of Jails in Indian Country (SJIC).

    (3) The agency form number, if any, and the applicable component of the Department sponsoring the collection:

    This collection includes the following forms:

    • CJ-9A/5: Annual Survey of Jails. This form goes to jail jurisdictions in the ASJ sample that are operated by the county or city.

    • CJ-10A/5: Annual Survey of Jails. Multi-Jurisdiction or Private Facility. This form goes to confinement facilities in the ASJ sample that are administered by two or more governments (regional jails) and privately owned or operated confinement facilities.

    • CJ-9A: Deaths in Custody, Annual Summary on Inmates under Jail Jurisdiction. This form goes to jail jurisdictions that are not included in the ASJ sample.

    • CJ-10A: Deaths in Custody, Annual Summary on Inmates in Private and Multi-Jurisdiction Jails. This form goes to confinement facilities administered by two or more local governments (regional jails) and to privately owned or operated confinement facilities that are not included in the ASJ sample.

    • CJ-9: Deaths in Custody, Death Report on Inmates under Jail Jurisdiction. This form goes to all jail jurisdictions that are operated by the county or city. Jails administers are requested to fill out this form if their facilities had one or more deaths in that calendar year.

    CJ-10: Deaths in Custody, Death Report on Inmates in Private and Multi-Jurisdiction Jail. This form goes to all confinement facilities administered by two or more local governments (regional jails) and privately owned or operated confinement facilities. Jails administrators are requested to fill out this form if their facilities had one or more deaths in that calendar year.

    CJ-5B: Survey of Jails in Indian Country. All jail administrators in Indian Country Indian country jails receive the CJ-5B form. Indian Country jails are owned or operated by tribal authorities or the Bureau of Indian Affairs (BIA).

    The applicable component within the Department of Justice is the Bureau of Justice Statistics (Corrections Unit), in the Office of Justice Programs.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: The affected public that will be asked to respond include approximately 3,080 county, city, and tribal jail authorities.

    The Annual Survey of Jails (ASJ) and Survey of Jails in Indian Country (SJIC) provide the nationally-representative data on local jail populations and jails in Indian country. BJS, other federal agencies, and state, local, and tribal corrections authorities and administrators, as well as legislators, researchers, and jail planners use these data to track annual changes in the demographic characteristics of the jail population as well as changes in the jail population, jail capacity and crowding, the flow of inmates moving into and out of jails, and use of jail space by other correctional institutions. Providers of the data are administrators in approximately 941 county and city jails and 80 tribal jails.

    The ASJ collects the following data at from local jails operated at the city or county level. Reporting units within the jail report data for their jail jurisdiction:

    (a) The number of male and female inmate deaths during the previous calendar year (new to the 2015 surveys).

    (b) The number of inmates confined in jail facilities at midyear (last weekday in the month of June).

    (c) The number of inmates confined in jail facilities and the number of inmates under jail supervision but not confined (e.g., electronic monitoring, day reporting, etc.) at yearend (December 31).

    (d) The numbers of following types of confined inmates—males—adult; females—adult; males—17 and under, females—17 and under; 17 and under held as adults; non-U.S. citizen; convicted; unconvicted; held for a felony; held for a misdemeanor; white, black, Hispanic, American Indian, Asian American, Native Hawaiian, and multiracial; and held for Federal authorities, State prison authorities, tribal government, and other local jail jurisdictions—at yearend.

    (e) Whether the jail facilities have a weekend incarceration program and the number of inmates participating.

    (f) The date and count for the greatest number of confined inmates during December.

    (g) The number of new admissions into and final discharges from jail facilities in collection year by sex.

    (h) The average daily population of jail facilities from January 1 to December 31 of collection year by sex.

    (i) Jail rated capacity.

    (j) The numbers of unconfined persons participating in various programs such as electronic monitoring, home detention, community service, day reporting, etc. at yearend.

    (k) The numbers of correctional and other staff employed by sex at yearend.

    The SJIC collects the following data for jails in Indian country at the jail level:

    (a) The total number of confined inmates in jail facilities at midyear (last weekday in the month of June).

    (b) The numbers of following types of confined inmates in jails—males—adult; females—adult; males—17 and under; females—17 and under, 17 and under held as adults, convicted, unconvicted, held for felony, held for misdemeanor, and held for specific offenses such as domestic violence, assault, burglary, larceny, drug violation, etc.—at midyear.

    (c) The average daily population during the 30-day period in June.

    (d) The date and count for the greatest number of confined inmates during the 30-day period in June.

    (e) The number of new admissions into and final discharges during the month of June.

    (f) The number of inmate deaths while confined; the number of deaths attributed to suicide; and the number of confined inmates that attempted suicide from July 1 of the previous year to June 30 of the current collection year.

    (g) The total rated capacity of jail facilities at midyear.

    (h) The number of correctional staff employed by the facility and their occupation (e.g., administration, jail operations, educational staff, etc.) at midyear.

    Originally authorized by the Death in Custody Reporting Act (DICRA) of 2000, the Death in Custody Reporting Program (DCRP)—Local Jails is the only national database that can inform the issue of mortality in jails in depth. BJS uses this data to track and report on total and cause-specific deaths and mortality rates in jails. The DCRP-Local Jails has two components: Jail-level collection of retrospective yearend inmate counts and individual-level collection of information on deceased inmates during the current calendar year. Specifically, the following items are collected:

    (a) The number of inmates confined in jail facilities on December 31 of the previous year by sex.

    (b) The number of inmates admitted to jail facilities in the previous year by sex.

    (c) The number of inmates confined in local jails on behalf of U.S. Immigration and Customs Enforcement, the U.S. Marshals Service or any other hold for another jurisdiction.

    (d) The average daily population of all jail confinement facilities operated by the jurisdiction in the previous year by sex.

    (e) The number of persons who died while under the supervision of the jurisdiction in the previous year by sex.

    (f) The first, last name and middle initial, date of death, date of birth, sex, and race/ethnic origin for each inmate who died during the reporting year.

    (g) Whether the deceased inmate was being held in the local jail or under the authority of the state department of correction; on the behalf of U.S. Immigration and Customs Enforcement; the U.S. Marshals Service, or other counties, jurisdictions or correctional authorities.

    (h) The admission date and current offense(s) for each inmate who died during the reporting year.

    (i) The legal status for each inmate who died during the reporting year.

    (j) Whether the inmate ever stayed overnight in a mental health observation unit or outside mental health facility.

    (k) The location and cause of death of each inmate death that took place during the reporting year.

    (l) The time of day that the incident causing the inmate's death occurred and where the incident occurred (limited to accidents, suicides, and homicides only).

    (m) Whether the cause of death was a preexisting medical condition or a condition that developed after admission to the facility and whether the inmate received treatment for the medical condition after admission and if so, the kind of treatment received (deaths due to accidental injury, intoxication, suicide, or homicide do not apply).

    (n) Whether an autopsy/postmortem exam/review of medical records to determine the cause of death of the inmate was performed and the availability of those results.

    (o) The survey ends with a box in which respondents can enter notes.

    (p) Confirmation or correction of the agency and agency head's name, phone number, email address, and mailing address.

    (q) Confirmation or correction of the agency's primary point of contact for data collection, title, phone number, email address, and mailing address;

    (r) Confirmation or correction of the names of facilities within the jurisdiction.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond

    The ASJ and DCRP—Local Jails previously had separate survey operations. In an effort to reduce burden on respondents and minimize costs associated with the ASJ and the DCRP, the ASJ will be fielded along with the DCRP beginning in reference year 2015. Another major change in the 2015 DCRP-ASJ is the simplification of questionnaire forms. The current ASJ sample includes approximately 335 jail jurisdictions (370 reporting units, or about one-third of ASJ respondents), which are selected with certainty (probability of 1). From 2010 to 2014, these “certainty jails” received a different questionnaire with additional questions on staffing, physical assaults on staff, and the numbers of rule violations by inmates in various categories, while the non-certainty jails received a shorter questionnaire without those items. The previously estimated time to complete the longer form was 2 hours, while the estimated time to complete the shorter form remains 1.25 hours. The total burden hours previously associated with the ASJ was 1,454 hours. Starting in reference year 2015, all ASJ respondents will receive the shorter questionnaire form, regardless of certainty status. This change will result in a total burden hour estimate of 1,176 hours, or a reduction of about 278 burden hours on respondents. The estimated burden hour for each form in the annual jail collection is listed below:

    (a) ASJ (CJ-9A/5 and CJ-10A/5)—There will be 941 respondents to ASJ for collection year 2015. It takes current ASJ respondents an average of 75 minutes to supply the information, so the burden hours are 1,176.

    (b) DCRP—Local Jails annual summary forms (CJ-9A and CJ-10A)—BJS estimates that 2,059 jail respondents will complete these forms, with an average response time of 15 minutes. The burden hours for these forms are 515.

    (c) SJIC (CJ-5B)—eighty respondents will be asked to respond to SJIC for collection year 2016. BJS estimates that it takes an average of 75 minutes to supply the information for a total burden of 100 hours.

    (d) Local jails/death reports (forms CJ-9 and CJ-10)—Analysis of data from data years 2000 through 2013 shows that annually approximately 80% of jails nationwide have no death in a given calendar year and do not need to complete a death report form. Approximately 600 jails will complete reports for 950 inmate deaths. Each report takes about 30 minutes, for a total of 450 hours. Unlike the CJ-9A/5, CJ-10A/5, CJ9A, and CJ10A forms, the CJ-9 and CJ-10 forms are not retrospectively. As a result, the reference year is the same as the calendar year.

    (e) BJS collection agent also makes verification calls to jail respondents to ensure data quality. With 3000 respondents and 9 minute per call, data verification induces a burden of 450 hours.

    Form Purpose of contact Number of data suppliers Number of
  • responses
  • Average
  • reporting time
  • (min)
  • Burden hours
    CJ-9A/5, CJ-10A/5 ASJ-DCRP 941 941 75 1,176 CJ-9A, CJ-10A DCRP annual summary 2059 2059 15 515 CJ-5B SJIC 80 80 75 100 CJ-9, CJ-10 DCRP death records 600 950 30 450 ASJ-DCRP verification call 3,000 3,000 9 450 Total 2,691

    (6) An estimate of the total public burden (in hours) associated with the collection: The estimated total burden hours associated with this collection for reference years is 2,691.

    If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.

    Dated: September 1, 2015. Jerri Murray, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2015-22017 Filed 9-3-15; 8:45 am] BILLING CODE 4410-18-P
    DEPARTMENT OF JUSTICE [OMB Number 1121-0249] Agency Information Collection Activities; Proposed eCollection eComments Requested; Proposed Collection: Revision of Currently Approved Collection Survey: Death in Custody Reporting Program—Prisons AGENCY:

    Bureau of Justice Statistics, Department of Justice.

    ACTION:

    60-day notice.

    SUMMARY:

    The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

    DATES:

    Comments are encouraged and will be accepted for 60 days until November 3, 2015.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Margaret Noonan, Statistician, Bureau of Justice Statistics, 810 Seventh Street NW., Washington, DC 20531 (email: [email protected]; telephone: 202-353-2060).

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Bureau of Justice Statistics, including whether the information will have practical utility; —Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection

    (1) Type of Information Collection: Extension of a Currently Approved Collection.

    (2) The Title of the Form/Collection: Deaths in Custody Reporting Program—State Prisons. The collection includes the Deaths in Custody Reporting Program (DCRP)—State Prisons.

    (3) The agency form number, if any, and the applicable component of the Department sponsoring the collection:

    This collection includes the following forms:

    • NPS-4: Annual Summary of Inmate Deaths in State Prisons. This is sent to the 50 state departments of correction.

    • NPS-4A: State Prison Inmate Death Report. This is sent to the 50 state departments of correction.

    The applicable component within the Department of Justice is the Bureau of Justice Statistics (Corrections Unit), in the Office of Justice Programs.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: The affected public that will be asked to respond include 50 state department of corrections authorities.

    Originally authorized by the Death in Custody Reporting Act (DICRA) of 2000, the Death in Custody Reporting Program (DCRP) is the only national database that can inform the issue of mortality in local jails and prisons in depth. BJS uses this data to track and report on total and cause-specific deaths and mortality rates in correctional facilities. The local jail portion of the collection is now part of the BJS Annual Jail Collection, and is not addressed in this notice. The arrest-related death collection, which was historically part of the DCRP, has been temporarily suspended and is also not part of this clearance.

    The DCRP-prisons collection has two components: A summary count of the number of deaths occurring in state departments of correction and individual-level death forms that collect information on inmates dying while in the custody of state prisons. Specifically, the following items are collected:

    (a) Number of persons who died while in the custody of state correctional facilities.

    (b) The first, last name and middle initial, date of death, date of birth, sex, and race/ethnic origin for each inmate who died during the reporting year.

    (c) The name and location of the correctional facility involved.

    (d) The admission date and current offense(s) for each inmate who died during the reporting year.

    (e) Whether the inmate ever stayed overnight in a mental health observation unit or outside mental health facility.

    (f) The location and cause of death of each inmate death that took place during the reporting year.

    (g) The time of day that the incident causing the inmate's death occurred and where the incident occurred (limited to accidents, suicides, and homicides only).

    (h) Whether the cause of death was a preexisting medical condition or a condition that developed after admission to the facility and whether the inmate received treatment for the medical condition after admission and if so, the kind of treatment received (deaths due to accidental injury, intoxication, suicide, or homicide do not apply).

    (i) Whether an autopsy/postmortem exam/review of medical records to determine the cause of death of the inmate was performed and the availability of those results.

    (j) The survey ends with a box in which respondents can enter notes.

    (k) Confirmation or correction of the agency and agency head's name, phone number, email address, and mailing address.

    (l) Confirmation or correction of the agency's primary point of contact for data collection, title, phone number, email address, and mailing address;

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: Prior to 2015, DCRP clearance included deaths in the process of arrest, local jails and state prisons. The arrest-related death collection has been temporarily suspended due to data quality and coverage issues. The arrest-related death collection will seek a separate OMB clearance when work on the project begins again. In an effort to reduce burden on respondents and minimize costs associated with the ASJ and the DCRP, the ASJ will be fielded along with the DCRP beginning in early 2016. The major change to the DCRP collection is the downgrade in burden hours to account for the ARD and DCRP-jail collections no longer being a part of the clearance package. Otherwise, there are no proposed substantive changes to the DCRP-prisons collection. DCRP-prisons (NPS-4, NPS-4A)—There will be 50 respondents to DCRP-prisons for collection year 2015. It takes current DCRP respondents an average of 30 minutes to complete the death form and 5 minutes to complete the annual summary form, or 1,704 burden hours.

    (a) BJS collection agent also makes verification calls to prison respondents to ensure data quality. With 50 respondents and 9 minute per call, data verification induces a burden of 8 hours.

    Form Purpose of contact Number of
  • data suppliers
  • Number of
  • responses
  • Average
  • reporting time
  • (min)
  • Burden
  • hours
  • NPS-4 DCRP Annual Summary 50 50 5 4 NPS-4A DCRP death records 50 3,400 30 1,700 ASJ-DCRP verification call 50 50 9 8 Total 2016 1,712

    (6) An estimate of the total public burden (in hours) associated with the collection: The estimated total burden hours associated with this collection for report year 2016 is 1,712.

    If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.

    Dated: September 1, 2015. Jerri Murray, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2015-22016 Filed 9-3-15; 8:45 am] BILLING CODE 4410-18-P
    DEPARTMENT OF JUSTICE Office of Justice Programs [OJP (BJA) Docket No. 1694] Conference Call Meeting of the Department of Justice's (DOJ's) National Motor Vehicle Title Information System (NMVTIS) Federal Advisory Committee AGENCY:

    Office of Justice Programs (OJP), Justice.

    ACTION:

    Notice of conference call meeting.

    SUMMARY:

    This is an announcement of a conference call meeting of DOJ's National Motor Vehicle Title Information System (NMVTIS) Federal Advisory Committee to discuss various issues relating to the operation and implementation of NMVTIS.

    DATES:

    The conference call meeting will take place on Thursday, September 24, 2015, from 1:00 p.m. to 3:00 p.m. ET.

    ADDRESSES:

    The meeting will take place as a conference call hosted by the Bureau of Justice Assistance.

    FOR FURTHER INFORMATION CONTACT:

    Todd Brighton, Designated Federal Employee (DFE), Bureau of Justice Assistance, Office of Justice Programs, 810 7th Street NW., Washington, DC 20531; Phone: (202) 616-3879 [note: this is not a toll-free number]; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    This conference call meeting is open to the public. Members of the public who wish to dial into the call must register with Mr. Brighton at the above email address at least seven (7) days in advance of the meeting. Anyone requiring special accommodations should notify Mr. Brighton at least seven (7) days in advance of the meeting.

    Purpose

    The NMVTIS Federal Advisory Committee will provide input and recommendations to the Office of Justice Programs (OJP) regarding the operations and administration of NMVTIS. The primary duties of the NMVTIS Federal Advisory Committee will be to advise the Bureau of Justice Assistance (BJA) Director on NMVTIS-related issues, including but not limited to: Implementation of a system that is self-sustainable with user fees; options for alternative revenue-generating opportunities; determining ways to enhance the technological capabilities of the system to increase its flexibility; and options for reducing the economic burden on current and future reporting entities and users of the system.

    Todd Brighton, NMVTIS Enforcement Coordinator, Bureau of Justice Assistance, Office of Justice Programs.
    [FR Doc. 2015-21970 Filed 9-3-15; 8:45 am] BILLING CODE 4410-18-P
    DEPARTMENT OF LABOR Employee Benefits Security Administration [Prohibited Transaction Exemption 2015-15; Application No. D-11696] Notice of Exemption Involving Deutsche Bank AG (Deutsche Bank or the Applicant) Located in Frankfurt, Germany AGENCY:

    Employee Benefits Security Administration, U.S. Department of Labor.

    ACTION:

    Notice of temporary exemption.

    SUMMARY:

    This document contains a temporary exemption issued by the Department of Labor (the Department). The exemption permits certain entities with specified relationships to Deutsche Bank to continue to rely upon the relief provided by Prohibited Transaction Class Exemption (PTE) 84-14, for a period of nine months, following the criminal conviction of Deutsche Securities Korea Co. (Deutsche Securities Korea Co. or DSK) for spot/futures-linked market price manipulation.

    DATES:

    Effective Date: This exemption is effective for a period of nine months, beginning on the date (the Conviction Date) that a judgment of conviction against DSK is entered in Seoul Central District Court, South Korea, relating to charges filed against DSK under Articles 176, 443, and 448 of South Korea's Financial Investment Services and Capital Markets Act for spot/futures-linked market price manipulation.

    FOR FURTHER INFORMATION CONTACT:

    Scott Ness, telephone (202) 693-8561, Office of Exemption Determinations, Employee Benefits Security Administration, U.S. Department of Labor (this is not a toll-free number).

    SUPPLEMENTARY INFORMATION:

    On August 24, 2015, the Department of Labor (the Department) published a notice of proposed temporary exemption in the Federal Register at 80 FR 51314, for certain entities with specified relationships to Deutsche Bank to continue to rely on the relief provided by Prohibited Transaction Class Exemption (PTE) 84-14,1 notwithstanding an impending judgment of conviction, in Seoul Central District Court, South Korea, against DSK, which could be entered as early as September 3, 2015, for spot/futures-linked market price manipulation (the Conviction).

    1 49 FR 9494 (March 13, 1984), as corrected at 50 FR 41430 (October 10, 1985), as amended at 70 FR 49305 (August 23, 2005), and as amended at 75 FR 38837 (July 6, 2010).

    This exemption was requested by Deutsche Bank pursuant to section 408(a) of the Employee Retirement Income Security Act of 1974, as amended (ERISA) and section 4975(c)(2) of the Internal Revenue Code of 1986, as amended (the Code), and in accordance with the procedures set forth in 29 CFR part 2570, subpart B (76 FR 66637, 66644, October 27, 2011). Effective December 31, 1978, section 102 of the Reorganization Plan No. 4 of 1978, 5 U.S.C. App. 1 (1996), transferred the authority of the Secretary of the Treasury to issue administrative exemptions under section 4975(c)(2) of the Code to the Secretary of Labor. Accordingly, this notice of temporary exemption is being issued solely by the Department.

    As noted in the proposed exemption, once DSK is convicted, asset managers affiliated with DSK (the DB QPAMs) will be unable to rely on the relief provided by PTE 84-14. In this regard, Section I(g) of PTE 84-14 precludes a person who may otherwise meet the definition of a QPAM from relying on the relief provided by that class exemption if that person or its “affiliate” has, within 10 years immediately preceding the transaction, been either convicted or released from imprisonment, whichever is later, as a result of certain specified criminal activity described therein. This exemption preserves the ability of DB QPAMs to continue to rely on the relief provided by PTE 84-14, following the Conviction, for a period of nine months beginning on the Conviction Date, as long as the conditions herein are met. Absent this temporary relief, plans and IRAs with assets managed by the DB QPAMs may incur substantial costs in being forced to liquidate and reinvest their portfolios, and hire new investment managers on short notice. This exemption insulates these plans and IRAs from such sudden costs and/or losses, in a manner that is protective of the plans and IRAs.

    Following Deutsche Bank's submission of Exemption Application No. D-11696, which is the subject of this exemption (the First Request), Deutsche Bank filed an additional exemption application (Exemption Application No. D-11856, hereinafter, the Second Request) regarding an additional impending criminal conviction. The Second Request seeks exemptive relief for DB QPAMs to continue to rely on PTE 84-14 for a period of ten years, notwithstanding both: The criminal conviction of DSK for market manipulation that is the subject of this exemption; and the criminal conviction of a Deutsche Bank affiliate, DB Group Services UK Limited, for one count of wire fraud in connection with its role in manipulating LIBOR.

    The Department has tentatively denied the Second Request, upon initially determining that the exemption sought is not in the interest of affected plans and IRAs, and not protective of those plans and IRAs. If the Department makes a final decision not to propose the Second Request, the DB QPAMs will be unable to rely on the relief set forth in PTE 84-14 upon the earlier of the day that follows the nine month term of this exemption, or the date any of the conditions herein are not met. The Department notes that Deutsche Bank has requested a conference to afford Deutsche Bank the opportunity to provide additional information in support of its exemption request. Following the conference, the Department will review the entire record, including any additional information provided in connection with the conference, before determining whether to continue processing the Second Request.

    Written Comments

    The Department invited all interested persons to submit written comments and/or requests for a public hearing with respect to the notice of proposed exemption published in the Federal Register on August 24, 2015. The Department did not receive any comments or requests for a hearing.

    This exemption contains several conditions, including an audit to be performed by an independent auditor that is designed to ensure legal compliance by each DB QPAM by requiring rigorous training on fiduciary duties and ethical conduct, as outlined in Subsections I(e) and (f). In addition, each DB QPAM is generally required to permit plans and IRAs to transfer their assets to another asset manager without imposing an additional fee, penalty, or charge on such plan or IRA. Also, the DB QPAMs may not require that plans or IRAs insulate the QPAM from liability for violating ERISA or the Code or engaging in prohibited transactions.

    As a final note, the Department stresses that the act of selecting and retaining an investment manager service provider is a fiduciary act; and that a plan fiduciary is under a continuing duty to monitor the service provider's performance at reasonable intervals. Fiduciaries (including investment managers) should be reviewed by the appointing fiduciaries in such a manner as may be reasonably expected to ensure that their performance has been in compliance with the terms of the plan and statutory standards (e.g., prudence, exclusive benefit, and prohibited transactions rules). Such review may cause the appointing fiduciary to reconsider the prudence of employing the fiduciary as a service provider to its ERISA-covered plan.

    The Department has decided to grant this temporary exemption after giving full consideration to: The types of transactions covered by this exemption; the potential harm to plans and IRAs if temporary relief is not granted; and the protective nature of the conditions imposed herein. The complete application file, with copies of the comments, is available for public inspection in the Public Disclosure Room of the Employee Benefits Security Administration, Room N-1515, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210.

    For a more complete statement of the facts and representations supporting the Department's decision to grant this exemption, refer to the proposed exemption published in the Federal Register on August 24, 2015, at 80 FR 51314.

    General Information

    The attention of interested persons is directed to the following:

    (1) The fact that a transaction is the subject of an exemption under section 408(a) of the Act or section 4975(c)(2) of the Code does not relieve a fiduciary or other party in interest or disqualified person from certain other provisions of the Act and/or the Code, including any prohibited transaction provisions to which the exemption does not apply and the general fiduciary responsibility provisions of section 404 of the Act, which, among other things, require a fiduciary to discharge his duties respecting the plan solely in the interest of the participants and beneficiaries of the plan and in a prudent fashion in accordance with section 404(a)(1)(B) of the Act; nor does it affect the requirement of section 401(a) of the Code that the plan must operate for the exclusive benefit of the employees of the employer maintaining the plan and their beneficiaries;

    (2) In accordance with section 408(a) of ERISA and section 4975(c)(2) of the Code, the Department makes the following determinations: The exemption is administratively feasible, the exemption is in the interests of the plan and of its participants and beneficiaries, and the exemption is protective of the rights of participants and beneficiaries of the plan;

    (3) The exemption is supplemental to, and not in derogation of, any other provisions of ERISA, including statutory or administrative exemptions and transitional rules. Furthermore, the fact that a transaction is subject to an administrative or statutory exemption is not dispositive of whether the transaction is in fact a prohibited transaction; and

    (4) The availability of this exemption is subject to the express condition that the material facts and representations contained in the application accurately describe all material terms of the transaction which is the subject of the exemption.

    Accordingly, the following exemption is granted under the authority of section 408(a) of ERISA and section 4975(c)(2) of the Code and in accordance with the procedures set forth in 29 CFR part 2570, subpart B (76 FR 66637, 66644, October 27, 2011):

    Exemption Section I: Covered Transactions

    The DB QPAMs (as defined in Section II(b)) shall not be precluded from relying on the exemptive relief provided by Prohibited Transaction Exemption (PTE) 84-14,2 notwithstanding the Conviction (as defined in Section II(a)), for a period of nine months beginning on the date of the Conviction (the Conviction Date), provided that the following conditions are satisfied:

    2 49 FR 9494 (March 13, 1984), as corrected at 50 FR 41430 (October 10, 1985), as amended at 70 FR 49305 (August 23, 2005), and as amended at 75 FR 38837 (July 6, 2010).

    (a) The DB QPAMs (including their officers, directors, agents other than Deutsche Bank, and employees of such DB QPAMs) did not know of, have reason to know of, or participate in the criminal conduct of DSK that is the subject of the Conviction;

    (b) Any failure of the DB QPAMs to satisfy Section I(g) of PTE 84-14 arose solely from the Conviction;

    (c) The DB QPAMs did not directly receive compensation in connection with the criminal conduct that is the subject of the Conviction;

    (d) A DB QPAM will not use its authority or influence to direct an “investment fund” (as defined in Section VI(b) of PTE 84-14) that is subject to ERISA and managed by such DB QPAM to enter into any transaction with DSK or engage DSK to provide additional services to such investment fund, for a direct or indirect fee borne by such investment fund regardless of whether such transactions or services may otherwise be within the scope of relief provided by an administrative or statutory exemption;

    (e)(1) Each DB QPAM immediately develops, implements, maintains, and follows written policies (the Policies) requiring and reasonably designed to ensure that: (i) The asset management decisions of the DB QPAM are conducted independently of Deutsche Bank's management and business activities; (ii) the DB QPAM fully complies with ERISA's fiduciary duties and ERISA and the Code's prohibited transaction provisions and does not knowingly participate in any violations of these duties and provisions with respect to ERISA-covered plans and IRAs; (iii) the DB QPAM does not knowingly participate in any other person's violation of ERISA or the Code with respect to ERISA-covered plans and IRAs; (iv) any filings or statements made by the DB QPAM to regulators, including but not limited to, the Department of Labor, the Department of the Treasury, the Department of Justice, and the Pension Benefit Guaranty Corporation, on behalf of ERISA-covered plans or IRAs are materially accurate and complete, to the best of such QPAM's knowledge at that time; (v) the DB QPAM does not make material misrepresentations or omit material information in its communications with such regulators with respect to ERISA-covered plans or IRAs, or make material misrepresentations or omit material information in its communications with ERISA-covered plan and IRA clients; (vi) the DB QPAM complies with the terms of this exemption; and (vii) any violations of or failure to comply with items (ii) through (vi) are corrected promptly upon discovery and any such violations or compliance failures not promptly corrected are reported, upon discovering the failure to promptly correct, in writing, to appropriate corporate officers, the head of Compliance, and the General Counsel of the relevant DB QPAM, the independent auditor responsible for reviewing compliance with the Policies, and a fiduciary of any affected ERISA-covered plan or IRA where such fiduciary is independent of Deutsche Bank; however, with respect to any ERISA-covered plan or IRA sponsored by an “affiliate” (as defined in Section VI(d) of PTE 84-14) of Deutsche Bank or beneficially owned by an employee of Deutsche Bank or its affiliates, such fiduciary does not need to be independent of Deutsche Bank; DB QPAMs will not be treated as having failed to develop, implement, maintain, or follow the Policies, provided that they correct any instances of noncompliance promptly when discovered or when they reasonably should have known of the noncompliance (whichever is earlier), and provided that they adhere to the reporting requirements set forth in this item (vii);

    (2) Each DB QPAM immediately develops and implements a program of training (the Training), conducted at least annually for relevant DB QPAM asset management, legal, compliance, and internal audit personnel; the Training shall be set forth in the Policies and, at a minimum, cover the Policies, ERISA and Code compliance (including applicable fiduciary duties and the prohibited transaction provisions) and ethical conduct, the consequences for not complying with the conditions of this exemption, (including the loss of the exemptive relief provided herein), and prompt reporting of wrongdoing;

    (f)(1) Each DB QPAM submits to an audit conducted by an independent auditor, who has been prudently selected and who has appropriate technical training and proficiency with ERISA to evaluate the adequacy of, and compliance with, the Policies and Training described herein; the audit requirement must be incorporated in the Policies. The audit must cover the time period during which this exemption is effective, and must be completed no later than three (3) months after the period to which the audit applies;

    (2) To the extent necessary for the auditor, in its sole opinion, to complete its audit and comply with the conditions for relief described herein, and as permitted by law, each DB QPAM and, if applicable, Deutsche Bank, will grant the auditor unconditional access to its business, including, but not limited to: Its computer systems, business records, transactional data, workplace locations, training materials, and personnel;

    (3) The auditor's engagement shall specifically require the auditor to determine whether each DB QPAM has developed, implemented, maintained, and followed Policies in accordance with the conditions of this exemption and developed and implemented the Training, as required herein;

    (4) The auditor's engagement shall specifically require the auditor to test each DB QPAM's operational compliance with the Policies and Training;

    (5) For each audit, the auditor shall issue a written report (the Audit Report) to Deutsche Bank and the DB QPAM to which the audit applies that describes the procedures performed by the auditor during the course of its examination. The Audit Report shall include the auditor's specific determinations regarding the adequacy of, and compliance with, the Policies and Training; the auditor's recommendations (if any) with respect to strengthening such Policies and Training; and any instances of the respective DB QPAM's noncompliance with the written Policies and Training described in Section I(e) above. Any determinations made by the auditor regarding the adequacy of the Policies and Training and the auditor's recommendations (if any) with respect to strengthening the Policies and Training of the respective DB QPAM shall be promptly addressed by such DB QPAM, and any actions taken by such DB QPAM to address such recommendations shall be included in an addendum to the Audit Report. Any determinations by the auditor that the respective DB QPAM has implemented, maintained, and followed sufficient Policies and Training shall not be based solely or in substantial part on an absence of evidence indicating noncompliance. In this last regard, any finding that the DB QPAM has complied with the requirements under this subsection must be based on evidence that demonstrates the DB QPAM has actually implemented, maintained, and followed the Policies and Training required by this exemption, and not solely on evidence that demonstrates that the DB QPAM has not violated ERISA;

    (6) The auditor shall notify the respective DB QPAM of any instances of noncompliance identified by the auditor within five (5) business days after such noncompliance is identified by the auditor, regardless of whether the audit has been completed as of that date;

    (7) With respect to each Audit Report, the General Counsel or one of the three most senior executive officers of the DB QPAM to which the Audit Report applies, certifies, in writing, under penalty of perjury, that the officer has reviewed the Audit Report and this exemption; and addressed, corrected, or remedied any inadequacies identified in the Audit Report;

    (8) An executive officer of Deutsche Bank reviews the Audit Report for each DB QPAM and certifies in writing, under penalty of perjury, that such officer has reviewed each Audit Report;

    (9) Each DB QPAM provides its certified Audit Report to the Department's Office of Exemption Determinations (OED), 200 Constitution Avenue NW, Suite 400, Washington DC 20210, no later than 30 days following its completion, and each DB QPAM makes its Audit Report unconditionally available for examination by any duly authorized employee or representative of the Department, other relevant regulators, and any fiduciary of an ERISA-covered plan or IRA, the assets of which are managed by such DB QPAM;

    (10) Each DB QPAM and the auditor will submit to OED (A) any engagement agreement(s) entered into pursuant to the engagement of the auditor under this exemption, and (B) any engagement agreement entered into with any other entities retained in connection with such QPAM's compliance with the Training or Policies conditions of this exemption, no later than three (3) months after the date of the Conviction (and one month after the execution of any agreement thereafter);

    (11) The auditor shall provide OED, upon request, all of the workpapers created and utilized in the course of the audit, including, but not limited to: The audit plan, audit testing, identification of any instances of noncompliance by the relevant DB QPAM, and an explanation of any corrective or remedial actions taken by the applicable DB QPAM; and

    (12) Deutsche Bank must notify the Department at least 30 days prior to any substitution of an auditor, except that no such replacement will meet the requirements of this paragraph unless and until Deutsche Bank demonstrates to the Department's satisfaction that such new auditor is independent of Deutsche Bank, experienced in the matters that are the subject of the exemption, and capable of making the determinations required of this exemption;

    (g) With respect to each ERISA-covered plan or IRA for which a DB QPAM provides asset management or other discretionary fiduciary services, each DB QPAM agrees: (1) To comply with ERISA and the Code, as applicable with respect to such ERISA-covered plan or IRA, and refrain from engaging in prohibited transactions that are not otherwise exempt; (2) not to waive (or cause to be waived), limit, or qualify the liability of the DB QPAM for violating ERISA or the Code or engaging in prohibited transactions; (3) not to require the ERISA-covered plan or IRA (or sponsor of such ERISA-covered plan or beneficial owner of such IRA) to indemnify the DB QPAM for violating ERISA or engaging in prohibited transactions, except for violations or prohibited transactions caused by an error, misrepresentation, or misconduct of a plan fiduciary or other party hired by the plan fiduciary who is independent of Deutsche Bank; (4) not to restrict the ability of such ERISA-covered plan or IRA to terminate or withdraw from its arrangement with the DB QPAM, with the exception of reasonable restrictions, appropriately disclosed in advance, that are specifically designed to ensure equitable treatment of all investors in a pooled fund in the event such withdrawal or termination may have adverse consequences for all other investors, provided that such restrictions are applied consistently and in like manner to all such investors; and (5) not to impose any fees, penalties, or charges for such termination or withdrawal with the exception of reasonable fees, appropriately disclosed in advance, that are specifically designed to prevent generally recognized abusive investment practices or specifically designed to ensure equitable treatment of all investors in a pooled fund in the event such withdrawal or termination may have adverse consequences for all other investors, provided that such fees are applied consistently and in like manner to all such investors. Within two (2) months of the date of publication of this notice of exemption in the Federal Register, each DB QPAM will provide a notice of its obligations under this Section I(g) to each ERISA-covered plan or IRA for which a DB QPAM provides asset management or other discretionary fiduciary services;

    (h) Each DB QPAM will maintain records necessary to demonstrate that the conditions of this exemption have been met, for six (6) years following the date of any transaction for which such DB QPAM relies upon the relief in the exemption; and

    (i) The DB QPAMs comply with each condition of PTE 84-14, as amended, with the sole exception of the violation of Section I(g) that is attributable to the Conviction;

    (j) The DB QPAMs will not employ any of the individuals that engaged in the spot/futures-linked market manipulation activities that led to the Conviction;

    (k) The DB QPAMs will provide a notice of the proposed exemption and this notice of temporary exemption, along with a separate summary describing the facts that led to the Conviction as well as a statement that Deutsche Bank has made a separate exemption request, in Application No. D-11856, in connection with the potential conviction of DB Group Services UK Limited for one count of wire fraud in connection with DB Group Services UK Limited's role in manipulating LIBOR, which has been submitted to the Department, and a prominently displayed statement that the Conviction results in a failure to meet a condition in PTE 84-14 to each sponsor of an ERISA-covered plan and each beneficial owner of an IRA invested in an investment fund managed by a DB QPAM, or the sponsor of an investment fund in any case where a DB QPAM acts only as a sub-advisor to the investment fund;

    (l) Deutsche Bank disgorged all of its profits generated by the spot/futures-linked market manipulation activities of DSK personnel that led to the Conviction;

    (m) Deutsche Bank imposes internal procedures, controls, and protocols on DSK designed to reduce the likelihood of any recurrence of the conduct that is the subject of the Conviction, to the extent permitted by local law;

    (n) DSK has not, and will not, provide fiduciary or QPAM services to ERISA-covered plans or IRAs, and will not otherwise exercise discretionary control over plan assets;

    (o) No DB QPAM is a subsidiary of DSK, and DSK is not a subsidiary of any DB QPAM;

    (p) The criminal conduct of DSK that is the subject of the Conviction did not directly or indirectly involve the assets of any plan subject to Part 4 of Title I of ERISA or section 4975 of the Code; and

    (q) A DB QPAM will not fail to meet the terms of this exemption solely because a different DB QPAM fails to satisfy the conditions for relief under this exemption described in Sections I(d), (e), (f), (g), (h), (i), and (k).

    Section II: Definitions

    (a) The term “Conviction” means the judgment of conviction against DSK to be entered on or about September 3, 2015, in Seoul Central District Court, South Korea, relating to charges filed against DSK under Articles 176, 443, and 448 of South Korea's Financial Investment Services and Capital Markets Act for spot/futures-linked market price manipulation;

    (b) The term “DB QPAM” means a “qualified professional asset manager” (as defined in section VI(a) 3 of PTE 84-14) that relies on the relief provided by PTE 84-14 and with respect to which DSK is a current or future “affiliate” (as defined in section VI(d) of PTE 84-14); and

    3 In general terms, a QPAM is an independent fiduciary that is a bank, savings and loan association, insurance company, or investment adviser that meets certain equity or net worth requirements and other licensure requirements and that has acknowledged in a written management agreement that it is a fiduciary with respect to each plan that has retained the QPAM.

    (c) The term “DSK” means Deutsche Securities Korea Co., a South Korean “affiliate” of Deutsche Bank (as defined in section VI(c) of PTE 84-14).

    Signed at Washington, DC, this 1st day of September 2015. Lyssa Hall, Director of Exemption Determinations, Employee Benefits Security Administration, U.S. Department of Labor.
    [FR Doc. 2015-22034 Filed 9-3-15; 8:45 am] BILLING CODE 4510-29-P
    DEPARTMENT OF LABOR Employment and Training Administration Comment Request for Information Collection for Placement Verification and Follow-Up of Job Corps Participants, (OMB Control Number 1205-0426), Routine Extension Without Revisions AGENCY:

    Employment and Training Administration (ETA), Department of Labor.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Labor (Department), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the public and federal agencies with an opportunity to comment on the proposed and continued collection of information in accordance with the Paperwork Reduction Act of 1995 [44 U.S.C. 3506(c)(2)(A)].

    Authorized by the Workforce Investment Act (WIA) of 1998 and reauthorized by the Workforce Innovation and Opportunity Act (WIOA) of 2014, this preclearance consultation program helps ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed.

    Currently, ETA is soliciting comments concerning the extension of the current data collection regarding the Placement Verification and Follow-up of Job Corps Participants, using post-center surveys of Job Corps graduates and former enrollees (OMB Control Number 1205-0426), which expires December 31, 2015. Please note that once OMB approves this extension request, the Department will then submit to OMB a request for approval of revisions to this data collection as required by WIOA.

    A copy of the proposed Information Collection Request (ICR) can be obtained by contacting the person listed below in the addresses section of this notice.

    DATES:

    Written comments must be submitted to the office listed in the address section below on or before November 3, 2015.

    ADDRESSES:

    Submit written comments to Lawrence Lyford, Office of Job Corps, Room N-4507, Employment and Training Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210. Telephone number: 202-693-3121 (this is not a toll-free number). Individuals with hearing or speech impairments may access the telephone number above via TTY by calling the toll-free Federal Information Relay Service at 877-889-5627 (TTY/TDD). Fax: 202-693-3113. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    Job Corps is the country's largest residential training program for at-risk youth ages 16 through 24. It addresses multiple barriers to employment faced by at-risk youth throughout the United States. Through a network of 124 campuses nationwide, Job Corps offers a comprehensive array of career development services to prepare students for successful careers. Job Corps employs a holistic career development training approach which integrates the teaching of academic, career technical, employability skills and social competencies through a combination of classroom, practical, and work-based learning experiences to prepare students for stable, long-term, and high-paying jobs. In addition, Job Corps commits resources to provide job placement and career transition services to all graduates and students who have stayed with the program for more than 60 days, and to conduct placement follow-ups at 6 month and 12 months after initial placement.

    II. Review Focus

    The Department is particularly interested in comments which:

    • Evaluate whether the proposed collection of information is necessary for an agency to properly performs its functions, including whether the information will have practical utility;

    • evaluate the agency's accuracy in estimating the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • enhance the quality, utility, and clarity of the information to be collected; and

    • minimize the burden of information collection on those who are to respond—including that obtained through appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

    III. Current Actions

    This submission requests comments on three primary and two secondary data collection instruments that collect follow-up data about individuals who are no longer actively participating in Job Corps. These youths either graduated from Job Corps or stayed in the program at least 60 days but left before completing graduation requirements (former enrollees). These data collection activities are conducted with the following groups of recent Job Corps participants:

    • Former enrollees who were placed in a job or school program; this group will be contacted 90 days after separation.

    • graduates who were placed in a job or school program; this group will be contacted 90 days after initial placement;

    • graduates who were placed in a job or school program; this group will be contacted 6 months after initial placement;

    • graduates who were placed in a job or school program; this group will be contacted 12 months after initial placement.

    The data collection instrument for graduates 90 to 120 days after their initial placement is called Interim Checkpoint for Eligibility (ICFE). Administration of the ICFE facilitates the key data collection at 6 and 12 months. In addition, two brief questionnaires (one for employers and one for schools or training institutions) are used to collect re-verification data about initial placement for the subset of placed graduates and former enrollees who cannot be contacted directly.

    To maximize the comparability of the data collected from the different subgroups of students, the ICFE, the 90-day follow-up for former enrollees, and the 6-month and 12-month follow-up sections of the data collection instruments use modules with identical sets of questions on the same topics.

    The questions are designed to obtain:

    • Data to re-verify the initial job or school placements of placed graduates and former enrollees (only in the instruments administered at 90 days and the ICFE)

    • information about employment experiences in the previous week

    • information about educational experiences in the previous week

    • summary information about the work, school, and job search activities of those who were neither working nor in school the previous week

    • information about satisfaction with the services provided by Job Corps

    Type of Review: extension without changes.

    Title: Placement Verification and Follow-up of Job Corps Participants.

    OMB Number: 1205-0426.

    Affected Public: Individuals or households and private sector: Businesses and not-for-profit profit institutions.

    Total Annual Burden Cost for Respondents: $0.

    Data collection activity Number of
  • respondents
  • Frequency Total
  • responses
  • Average
  • time per
  • response
  • (hours)
  • Burden hours
    Placed Former Enrollees at 90 days 800 1 800 0.25 200 Placed graduates at 90-120 days 13,800 1 13,800 0.25 3,450 Placed Graduates at Six Months 15,500 1 15,500 0.20 3,100 Placed Graduates at 12 Months 13,200 13,200 0.20 2,640 Employer/Institution Re-verification 5,000 1 5,045 0.17 850 Total 48,300 48,345 10,240

    Comments submitted in response to this comment request will be summarized and/or included in the request for Office of Management and Budget approval of the ICR; they will also become a matter of public record.

    Portia Wu, Assistant Secretary for Employment and Training, Labor.
    [FR Doc. 2015-21996 Filed 9-3-15; 8:45 am] BILLING CODE 4510-FT-P
    NUCLEAR REGULATORY COMMISSION [Docket No. 52-043; NRC-2010-0215] Draft Memorandum of Agreement Between the U.S. Nuclear Regulatory Commission, New Jersey Historic Preservation Office, Advisory Council on Historic Preservation, National Park Service, PSEG Power, LLC, and PSEG Nuclear, LLC AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Request for comment.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is requesting comment on a draft Memorandum of Agreement (MOA) between the NRC, New Jersey Historic Preservation Office (NJ HPO), Advisory Council on Historic Preservation (ACHP), National Park Service (NPS), and PSEG Power, LLC, and PSEG Nuclear, LLC (PSEG). The purpose of the draft MOA is to resolve adverse effects to historic properties identified during consultation for a proposed early site permit (ESP).

    DATES:

    Submit comments by October 5, 2015. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date.

    ADDRESSES:

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

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2010-0215. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Mail comments to: Cindy Bladey, Office of Administration, Mail Stop: OWFN-12-H08, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

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

    FOR FURTHER INFORMATION CONTACT:

    Allen Fetter, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-8556, email: [email protected]

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

    Please refer to Docket ID NRC-2010-0215 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2010-0215.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The draft MOA is available in ADAMS under Accession ML15239B244.

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

    B. Submitting Comments

    Please include Docket ID NRC-2010-0215 in your comment submission.

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

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

    II. Discussion

    On May 25, 2010, PSEG submitted the ESP application via letter pursuant to Part 52 of Title 10 of the Code of Federal Regulations (10 CFR) (ADAMS Accession No. ML101480484). The location of the proposed ESP site is adjacent to the existing Salem and Hope Creek Nuclear Generating Stations on the east bank of the Delaware River in Lower Alloways Creek Township, Salem County, New Jersey.

    An ESP is a licensing option provided under the NRC's regulations in 10 CFR part 52 that allows an applicant to obtain approval for a reactor site. The approval of the ESP indicates that there are no safety or environmental issues at the proposed site that would preclude the construction of a nuclear power plant with the characteristics identified in the plant parameter envelope. Because an ESP is only a site approval and does not authorize the construction or operation of a nuclear power plant, an applicant may obtain an ESP without specifying the design of the reactor(s) that it may separately apply to build and operate at the site. The ESP application and review process makes it possible to evaluate and resolve safety and environmental issues related to siting before the applicant makes a large commitment of resources. Granting an ESP would result in no effects to historic properties; the ESP review includes an analysis of potential adverse effects from construction and operation of a postulated plant to support a site suitability determination.

    Pursuant to 36 CFR 800.8, the NRC is using its National Environmental Policy Act (NEPA) process for developing the ESP environmental impact statement (EIS) to facilitate consultation pursuant to Section 106 of the NHPA (54 U.S.C. 306108). The U.S. Army Corps of Engineers (USACE) participated in the development of the ESP EIS as a cooperating agency, pursuant to NEPA, but is consulting separately under Section 106 of the NHPA for the activities that it regulates.

    On August 22, 2014, the NRC requested comment (79 FR 49820) on its draft EIS analyzing: (1) The impacts of constructing and operating a postulated nuclear plant at the proposed ESP site that is the subject of NRC review, and (2) impacts associated with a USACE permit action on a Department of the Army permit application to perform certain building activities on and near the ESP site.

    The draft ESP EIS contained a finding of no adverse effect to historic properties for the NRC's Section 106 NHPA review. The NJ HPO concurred with this finding. By letter dated December 4, 2014, the NRC received a revised opinion letter from the NJ HPO finding that the proposed project would result in an adverse effect to historic properties (ADAMS Accession No. ML15005A040). The NJ HPO stated that the visual intrusion of two new natural draft cooling towers, which are included in the plant parameter envelope for the ESP application, would, if selected in a subsequent application to construct and operate a nuclear plant at the ESP site, result in an adverse effect to historic properties. The NRC met with the NJ HPO, PSEG representatives, and interested members of the public on January 9, 2015, in Salem County, New Jersey to discuss the NJ HPO's concerns. Between January and August 2015, the NRC met with the NJ HPO, ACHP, NPS, interested members of the public, and PSEG several times to discuss the effects from the proposed project on historic properties and to develop possible mitigation strategies for any potential effects. Between January and August 2015, the NRC conducted seven publicly noticed consultation meetings and teleconferences, pursuant to Section 106 of the NHPA.

    Based on the information from these meetings and additional research, the NRC issued letters on June 24, 2015, to NJ HPO, ACHP, and NPS stating its determination that natural draft cooling towers, if selected, would result in an indirect visual adverse effect on the Abel and Mary Nicholson House National Historic Landmark (127 Fort Elfsborg-Hancock Bridge Road), the property at 349 Fort Elfsborg-Hancock Bridge Road, and the property at 116 Mason Point Road. These properties are within an area the NJ HPO has determined is an NRHP-eligible historic district. In its letter, the NRC stated its intention to develop a MOA to resolve the adverse effect to these three properties.

    The draft MOA addresses the potential indirect adverse visual effect from construction and operation of natural draft cooling towers as analyzed in the ESP EIS and would conclude NHPA Section 106 consultation for the ESP. The draft MOA provides a framework for consultation at the combined license or construction permit/operating license stage.

    I. Request for Public Comment

    The NRC is requesting public comment on the draft MOA. The NRC does not plan to provide individual responses to comments. However, the NRC will consider any comments received when finalizing the MOA and will publish the final MOA in the Federal Register. The draft MOA is available in ADAMS under Accession No. ML15239B244.

    Dated at Rockville, Maryland this 28th day of August, 2015.

    For the Nuclear Regulatory Commission.

    Francis M. Akstulewicz, Director, Division of New Reactor Licensing, Office of New Reactors.
    [FR Doc. 2015-21932 Filed 9-3-15; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-333, 50-293, and 50-271; NRC-2013-0192] Entergy Nuclear Operations, Inc.; James A. FitzPatrick Nuclear Power Plant, Pilgrim Nuclear Power Station, and Vermont Yankee Nuclear Power Station AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Director's decision under 10 CFR 2.206; issuance.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) has issued a director's decision with regard to a petition dated March, 18, 2013, filed by Mr. Timothy Judson on behalf of the Alliance for a Green Economy, Citizens Awareness Network, Pilgrim Watch, and Vermont Citizens Action Network (hereafter, referred to as “the petitioners”) requesting that the NRC take action with regard to James A. FitzPatrick Nuclear Power Plant (FitzPatrick), Pilgrim Nuclear Power Station (Pilgrim), and Vermont Yankee Nuclear Power Station (Vermont Yankee). The petitioners' requests and the director's decision are included in the SUPPLEMENTARY INFORMATION section of this document.

    DATES:

    September 4, 2015.

    ADDRESSES:

    Please refer to Docket ID NRC-2013-0192 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:

    • Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2013-0192. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Richard Guzman, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1030, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given that the Director, Office of Nuclear Reactor Regulation, has issued a director's decision (ADAMS Accession No. ML15162A763) on a petition filed by the petitioners on March, 18, 2013 (ADAMS Accession No. ML13079A022). The petition was supplemented by letters dated April 23, May 7, June 28, July 22, October 16, November 13, November 27, and December 2, 2013, October 20, 2014, and January 27, 2015 (ADAMS Accession Nos. ML13133A161, ML13135A001, ML13184A109, ML13205A251, ML13294A400, ML13335A002, ML14016A361, ML15027A458, ML15027A462, and ML15039A011, respectively).

    The petitioners requested that the NRC take enforcement action to: (1) Suspend operations at FitzPatrick and Vermont Yankee; (2) investigate whether Entergy Nuclear Operations, Inc, (ENO, the licensee) possesses sufficient funds to cease operations and decommission FitzPatrick and Vermont Yankee, per section 50.75 of Title 10 of the Code of Federal Regulations (10 CFR), “Reporting and recordkeeping for decommissioning planning”; and (3) investigate ENO's current financial qualifications per 10 CFR 50.33(f)(5) to determine whether remains qualified to continue operating Pilgrim.

    As the basis of the request, the petitioners asserted that ENO no longer meets the financial qualifications requirements to possess the licenses and operate FitzPatrick, Pilgrim, and Vermont Yankee in accordance with 10 CFR 50.33(f)(2) and 10 CFR 50.80(b)(1)(i).

    On May 7, 2013, the petitioners met with the NRC's Petition Review Board (PRB). The meeting provided the petitioners and the licensee an opportunity to provide additional information and to clarify issues cited in the petition. The transcript for that meeting is available in ADAMS under Accession No. ML13135A001.

    By letter dated August 7, 2013 (ADAMS Accession No. ML13154A313), the NRC informed the petitioners that their request for immediate actions to suspend operations at FitzPatrick and Vermont Yankee was denied. In the same letter, the NRC also informed the petitioners of the PRB's final recommendation to accept the petition for review, because it met the criteria in Management Directive 8.11, Section III.C, “Criteria for Reviewing Petitions Under 10 CFR 2.206.”

    The NRC sent a copy of the proposed director's decision to the petitioners and the licensee for comment on March 27, 2015 (ADAMS Accession Nos. ML15040A159 and ML15040A140, respectively). The petitioners and the licensee were asked to provide comments within 30 days on any part of the proposed director's decision that was considered to be erroneous or any issues in the petition that were not addressed. Comments were received and are addressed in the attachments to the final director's decision.

    The Director of the Office of Nuclear Reactor Regulation denied the petitioners' request for the following actions:

    (1) Suspend operations at FitzPatrick and Vermont Yankee.

    (2) Investigate whether ENO possesses sufficient funds to cease operations and decommission FitzPatrick and Vermont Yankee, per 10 CFR 50.75.

    (3) Investigate ENO's current financial qualifications per 10 CFR 50.33(f)(5) to determine whether the licensee remains qualified to continue operating Pilgrim, be granted.

    The reasons for these decisions are explained in the director's decision (DD-15-08) pursuant to 10 CFR 2.206 of the Commission's regulations.

    The NRC will file a copy of the director's decision with the Secretary of the Commission for the Commission's review in accordance with 10 CFR 2.206. As provided by this regulation, the director's decision will constitute the final action of the Commission 25 days after the date of the decision unless the Commission, on its own motion, institutes a review of the director's decision in that time.

    Dated at Rockville, Maryland, this 27th day of August, 2015.

    For the Nuclear Regulatory Commission.

    Michele G. Evans, Deputy Director, Office of Nuclear Reactor Regulation.
    [FR Doc. 2015-22049 Filed 9-3-15; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [Docket No. 50-390; NRC-2015-0206] Watts Bar Nuclear Plant, Unit 1; Application and Amendment to Facility Operating License Involving Proposed No Significant Hazards Consideration Determination AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    License amendment request; opportunity to comment, request a hearing and petition for leave to intervene.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) received and is considering approval of a license amend request for the Watts Bar Nuclear Plant (WBN), Unit 1. The proposed amendment would revise a current License Condition (Section 2.F) regarding the Fire Protection Program and propose a new License Condition (Section 2.I) regarding a fire protection requirement for WBN, Unit 1. The NRC proposes to determine that this request involve no significant hazards consideration.

    DATES:

    Comments must be filed by October 5, 2015. A request for a hearing must be filed by November 3, 2015.

    ADDRESSES:

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

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0206. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Mail comments to: Cindy Bladey, Office of Administration, Mail Stop: OWFN-12-H08, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

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

    FOR FURTHER INFORMATION CONTACT:

    Jeanne A. Dion, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1349; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2015-0206 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    Federal rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0206.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The application for amendment, dated August 13, 2015, is available in ADAMS under Accession No. ML15225A344.

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

    B. Submitting Comments

    Please include Docket ID NRC-2015-0206 in your comment submission.

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

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

    II. Introduction

    The NRC is considering issuance of an amendment to Facility Operating License No. NFP-90, issued to Tennessee Valley Authority (the licensee), for operation of the Watts Bar Nuclear Plant (WBN), Unit 1 located in Spring City, Tennessee.

    The proposed amendment would revise a current License Condition (Section 2.F) regarding the Fire Protection Program and propose a new License Condition (Section 2.I) regarding a fire protection requirement for WBN, Unit 1. Section 2.F is the license condition associated with fire protection and defines the basis for the NRC's approval of the Fire Protection Program that is applicable to the operation of WBN, Unit 1. The proposed amendment would update the fire protection license condition, Section 2.F, to reflect dual-unit operation and the Fire Protection Program that would be in effect should WBN, Unit 2 receive an operating license (OL). Section 2.I is a new License Condition associated with fire protection requirements to ensure the fire detection monitoring panel in the main control room (MCR) meets the designated standards or is tested and found suitable for the specified purpose.

    Before issuance of the proposed license amendment, the Commission will have made findings required by the Atomic Energy Act of 1954, as amended (the Act), and the Commission's regulations.

    The Commission has made a proposed determination that the amendment request involves no significant hazards consideration. Under the Commission' regulations in § 50.92 of Title 10 of the Code of Federal Regulations (10 CFR), this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The overall effect of the licensing of WBN Unit 2, on the safe operation of WBN Unit 1, is being assessed by the reviews the Nuclear Regulatory Commission (NRC) documents in Supplemental Safety Evaluation Reports (SSERs). This proposed change is limited in scope and will align the OLs for WBN Unit 1 and WBN Unit 2, so that the Fire Protection Program may be managed by a common document, the WBN Unit 1/Unit 2 Fire Protection Report (FPR). Because this proposed change is administrative in nature, no accident analysis conclusions made in the WBN Unit 1 UFSAR [Updated Final Safety Analysis Report] are affected. The proposed change revised the WBN Fire Hazards Analysis (FHA) but did not result in any adverse effects or any adverse effects on any component required for a fire safe shutdown.

    Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    The proposed change adds a requirement to ensure the fire detection monitoring panel in the MCR meets appropriate design standards or is tested and found suitable while not effecting any plant structures, systems, or components (SSCs). The change does not affect plant operations, any design function or an analysis that verifies the capability of an SSC to perform a design function. Because no plant equipment or method of evaluation are affected by this change, the proposed amendment does not change any of the previously evaluated accidents in the updated final safety analysis report (UFSAR).

    No accident analysis conclusions made in the WBN Unit 1 UFSAR are affected. The proposed change does not revise or affect the Fire Hazards Analysis (FHA) or any component required for a fire safe shutdown.

    Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The overall effect of the licensing of WBN Unit 2, on the safe operation of WBN Unit 1, is being assessed by the reviews the NRC documents in SSERs. This proposed change is limited in scope and does not result in any adverse effects on the FHA or any component required for a fire safe shutdown. In addition, no accident analysis conclusions made in the WBN Unit 1 UFSAR are affected. Based on this, the proposed amendment will not alter the requirements or function for systems required during accident conditions.

    Therefore, the proposed changes do not create the possibility of a new or different kind of accident from any accident previously evaluated.

    The proposed change adds a requirement to ensure the fire detection monitoring panel in the MCR meets appropriate design standards or is tested and found suitable and does not change any design function, operation of an SSC, performance of testing or maintenance of an SSC. This proposed change is limited in scope and does not revise or affect the FHA or any component required for a fire safe shutdown. In addition, no accident analysis conclusions made in the WBN Unit 1 UFSAR are affected. Based on this, the proposed amendment will not alter the requirements or function for systems required during accident conditions.

    Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed change involve a significant reduction in the margin of safety?

    Response: No.

    This proposed change is associated with the implementation of WBN's Fire Protection Program for two-unit operation as approved in NRC SSERs. Because the proposed amendment is administrative in nature (updates a condition of the WBN Unit 1 OL), implementation of the amendment will not affect the manner in which safety limits or limiting safety system settings are determined nor will there be any effect on those plant systems necessary to assure the accomplishment of protection functions.

    Therefore, the proposed changes do not involve a significant reduction in a margin of safety.

    This proposed change adds a requirement to ensure that the fire detection monitoring panel in the MCR either meets the appropriate designated standards or has been tested and found suitable for the specified purpose. Implementation of the amendment (the addition of a license condition to the WBN Unit 1 OL) will not affect the manner in which safety limits or limiting safety system settings are determined nor will there be any effect on those plant systems necessary to assure the accomplishment of protection functions.

    Therefore, the proposed change does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.

    Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example, in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the Federal Register a notice of issuance. Should the Commission make a final No Significant Hazards Consideration Determination, any hearing will take place after issuance. The Commission expects that the need to take this action will occur very infrequently.

    III. Opportunity To Request a Hearing and Petition for Leave to Intervene

    Within 60 days after the date of publication of this Federal Register notice, any person whose interest may be affected by this proceeding and who desires to participate as a party in the proceeding must file a written request for hearing or a petition for leave to intervene specifying the contentions which the person seeks to have litigated in the hearing with respect to the license amendment request. Requests for a hearing and petitions for leave to intervene shall be filed in accordance with the NRC's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the NRC's PDR. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at http://www.nrc.gov/reading-rm/doc-collections/cfr/. If a request for a hearing or petition for leave to intervene is filed by the above date, the Commission or a presiding officer designated by the Commission or by the Chief Administrative Judge of the Atomic Safety and Licensing Board Panel, will rule on the request and/or petition; and the Secretary or the Chief Administrative Judge of the Atomic Safety and License Board will issue a notice of a hearing or an appropriate order.

    As required by 10 CFR 2.309, a request for hearing or petition for leave to intervene must set forth with particularity the interest of the petitioner in the proceeding and how that interest may be affected by the results of the proceeding. The hearing request or petition must specifically explain the reasons why intervention should be permitted, with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The hearing request or petition must also include the specific contentions that the requestor/petitioner seeks to have litigated at the proceeding.

    For each contention, the requestor/petitioner must provide a specific statement of the issue of law or fact to be raised or controverted, as well as a brief explanation of the basis for the contention. Additionally, the requestor/petitioner must demonstrate that the issue raised by each contention is within the scope of the proceeding and is material to the findings that the NRC must make to support the granting of a license amendment in response to the application. The hearing request or petition must also include a concise statement of the alleged facts or expert opinion that support the contention and on which the requestor/petitioner intends to rely at the hearing, together with references to those specific sources and documents. The hearing request or petition must provide sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact, including references to specific portions of the application for amendment that the petitioner disputes and the supporting reasons for each dispute. If the requestor/petitioner believes that the application for amendment fails to contain information on a relevant matter as required by law, the requestor/petitioner must identify each failure and the supporting reasons for the requestor's/petitioner's belief. Each contention must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/petitioner who does not satisfy these requirements for at least one contention will not be permitted to participate as a party.

    Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that person's admitted contentions, including the opportunity to present evidence and to submit a cross-examination plan for cross-examination of witnesses, consistent with NRC regulations, policies, and procedures. The Atomic Safety and Licensing Board will set the time and place for any prehearing conferences and evidentiary hearings, and the appropriate notices will be provided.

    Hearing requests or petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)-(iii).

    If a hearing is requested, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of any amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.

    IV. Electronic Submissions (E-Filing)

    All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.

    To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at [email protected], or by telephone at 301-415-1677, to request (1) a digital identification (ID) certificate, which allows the participant (or its counsel or representative) to digitally sign documents and access the E-Submittal server for any proceeding in which it is participating; and (2) advise the Secretary that the participant will be submitting a request or petition for hearing (even in instances in which the participant, or its counsel or representative, already holds an NRC-issued digital ID certificate). Based upon this information, the Secretary will establish an electronic docket for the hearing in this proceeding if the Secretary has not already established an electronic docket.

    Information about applying for a digital ID certificate is available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals/getting-started.html. System requirements for accessing the E-Submittal server are detailed in the NRC's “Guidance for Electronic Submission,” which is available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html. Participants may attempt to use other software not listed on the Web site, but should note that the NRC's E-Filing system does not support unlisted software, and the NRC Meta System Help Desk will not be able to offer assistance in using unlisted software.

    If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser