Federal Register Vol. 80, No.37,

Federal Register Volume 80, Issue 37 (February 25, 2015)

Page Range9985-10321
FR Document

80_FR_37
Current View
Page and SubjectPDF
80 FR 10321 - Determination and Waiver Pursuant to Section 1209 of the Carl Levin and Howard P. ``Buck'' McKeon National Defense Authorization Act for Fiscal Year 2015 Regarding the Provision of Assistance to Appropriately Vetted Elements of the Syrian OppositionPDF
80 FR 10313 - Establishment of the Pullman National MonumentPDF
80 FR 10283 - Employment Authorization for Certain H-4 Dependent SpousesPDF
80 FR 10162 - Government in the Sunshine Act Meeting NoticePDF
80 FR 10209 - Call for Nominations for Treasury Secretary Appointments to Tribal Advisory CommitteePDF
80 FR 10171 - Sunshine Act MeetingPDF
80 FR 10003 - Clothianidin; Pesticide Tolerances for Emergency ExemptionsPDF
80 FR 10203 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Airport Noise Compatibility PlanningPDF
80 FR 10091 - Notice of Receipt of Requests for Amendments To Terminate Uses in Certain Pesticide RegistrationsPDF
80 FR 10146 - Guidelines for State Courts and Agencies in Indian Child Custody ProceedingsPDF
80 FR 10087 - Proposed Information Collection Request; Comment Request; Participation by Disadvantaged Business Enterprises in Procurements Under EPA Financial Assistance Agreements (Renewal)PDF
80 FR 10090 - Notification of a Public Teleconference of the Great Lakes Advisory BoardPDF
80 FR 10165 - Concentration Averaging and Encapsulation Branch Technical PositionPDF
80 FR 10045 - Submission for OMB Review; Comment RequestPDF
80 FR 10046 - Submission for OMB Review; Comment RequestPDF
80 FR 10074 - Submission for OMB Review; Comment RequestPDF
80 FR 10007 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Coastal Migratory Pelagic Resources in the Gulf of Mexico and Atlantic Region; Amendment 20B; CorrectionPDF
80 FR 10075 - Judicial Proceedings Since Fiscal Year 2012 Amendments Panel (Judicial Proceedings Panel); Notice of Federal Advisory Committee MeetingPDF
80 FR 10165 - Entergy Nuclear Vermont Yankee, LLC and Entergy Nuclear Operations, Inc.; Establishment of Atomic Safety and Licensing BoardPDF
80 FR 10088 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Iron and Steel Foundry Area Sources (Renewal)PDF
80 FR 10089 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Primary Lead Smelters (Renewal)PDF
80 FR 10123 - Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of MeetingPDF
80 FR 10165 - James Chaisson; Notice of Atomic Safety and Licensing Board ReconstitutionPDF
80 FR 10053 - Trade Mission to South Africa, Kenya and MozambiquePDF
80 FR 10051 - Polyethylene Terephthalate Film, Sheet, and Strip From Taiwan: Final Results of Antidumping Duty Administrative Review; 2012-2013PDF
80 FR 10249 - Fisheries of the Exclusive Economic Zone Off Alaska; Gulf of Alaska; Final 2015 and 2016 Harvest Specifications for GroundfishPDF
80 FR 10051 - Foreign-Trade Zone 45-Portland, Oregon; Revision to Production Authority; Epson Portland, Inc., Subzone 45F; (Inkjet Cartridges and Bulk Ink); Hillsboro, OregonPDF
80 FR 10058 - Atlantic Highly Migratory Species; Meeting of the Atlantic Highly Migratory Species Advisory PanelPDF
80 FR 10094 - Notice of Agreement FiledPDF
80 FR 10059 - Caribbean Fishery Management Council: Scoping MeetingsPDF
80 FR 10083 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Shipbuilding and Ship Repair Facilities-Surface Coating (Renewal)PDF
80 FR 10085 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Reporting and Recordkeeping Requirements for Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles (Renewal)PDF
80 FR 10001 - Automobile or Other Conveyance and Adaptive Equipment Certificate of Eligibility for Veterans or Members of the Armed Forces With Amyotrophic Lateral SclerosisPDF
80 FR 10114 - Proposed Priority-National Institute on Disability, Independent Living, and Rehabilitation Research-Disability and Rehabilitation Research Projects ProgramPDF
80 FR 10161 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
80 FR 10125 - National Medical Device Postmarket Surveillance System Planning Board Report; Availability, Web Site Location and Request for CommentsPDF
80 FR 10103 - Proposed Priority-National Institute on Disability, Independent Living, and Rehabilitation Research-Rehabilitation Research and Training CentersPDF
80 FR 10026 - Over-the-Counter Sunscreen Drug Products-Regulatory Status of EnzacamenePDF
80 FR 10035 - Over-the-Counter Sunscreen Drug Products-Regulatory Status of EcamsulePDF
80 FR 10111 - Proposed priority-National Institute on Disability, Independent Living, and Rehabilitation Research-Rehabilitation Research and Training CentersPDF
80 FR 10117 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Finished PharmaceuticalsPDF
80 FR 10106 - Proposed Priority-National Institute on Disability, Independent Living, and Rehabilitation Research-Rehabilitation Research and Training CentersPDF
80 FR 10099 - Proposed Priority-National Institute on Disability, Independent Living, and Rehabilitation Research-Rehabilitation Research and Training CentersPDF
80 FR 10169 - Joint Industry Plan; Order Approving the Eighth Amendment to the National Market System Plan To Address Extraordinary Market Volatility by BATS Exchange, Inc., BATS Y-Exchange, Inc., Chicago Board Options Exchange, Incorporated, Chicago Stock Exchange, Inc., EDGA Exchange, Inc., EDGX Exchange, Inc., Financial Industry Regulatory Authority, Inc., NASDAQ OMX BX, Inc., NASDAQ OMX PHLX LLC, The Nasdaq Stock Market LLC, National Stock Exchange, Inc., New York Stock Exchange LLC, NYSE MKT LLC, and NYSE Arca, Inc.PDF
80 FR 10201 - In the Matter of Akesis Pharmaceuticals, Inc., Stellar Resources, Ltd., and Thwapr, Inc.; Order of Suspension of TradingPDF
80 FR 10201 - In the Matter of Revonergy Inc., Siberian Energy Group Inc., Tao Minerals Ltd., (n/k/a Canam Gold Corp.), and Todays Alternative Energy Corp.; Order of Suspension of TradingPDF
80 FR 10201 - In the Matter of Innovative Software Technologies, Inc., National Health Partners, Inc., The Laguna Group, Inc. (a/k/a Eco Energy Pumps, Inc.), and TYIN Group Holdings Limited; Order of Suspension of TradingPDF
80 FR 10200 - In the Matter of Calypte Biomedical Corporation, EC Development, Inc., and Information Architects Corporation (n/k/a Dakota Creative Group Corporation); Order of Suspension of TradingPDF
80 FR 10050 - Submission for OMB Review; Comment RequestPDF
80 FR 10164 - Advisory Committee for Cyberinfrastructure; Notice of MeetingPDF
80 FR 10085 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Petroleum Refineries (Renewal)PDF
80 FR 10084 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Municipal Solid Waste Landfills (Renewal)PDF
80 FR 10082 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Calciners and Dryers in Mineral Industries (Renewal)PDF
80 FR 10086 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Metal Coil Surface Coating (Renewal)PDF
80 FR 10089 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Certification of Pesticide Applicators (Renewal)PDF
80 FR 10162 - Tetrahydrofurfuryl Alcohol From China; Scheduling of an Expedited Five-Year ReviewPDF
80 FR 10077 - Advisory Committee on Arlington National Cemetery Honor Subcommittee Meeting NoticePDF
80 FR 10076 - Advisory Committee on Arlington National Cemetery Remember Subcommittee Meeting NoticePDF
80 FR 10137 - Port Access Route Study: In the Chukchi Sea, Bering Strait and Bering SeaPDF
80 FR 10131 - Policy Letters: Guidance for the Use of Liquefied Natural Gas as a Marine FuelPDF
80 FR 10060 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to San Francisco Bay Area Water Emergency Transportation Authority Central Bay Operations and Maintenance Facility Project in Alameda, CaliforniaPDF
80 FR 10066 - Takes of Marine Mammals Incidental to Specified Activities; Seabird Research Activities in Central California, 2015-2016PDF
80 FR 10047 - Request for Information: Software Vendors of State and Local Management Information Systems (MIS) and Other Technology Solutions for the National School Lunch and School Breakfast ProgramsPDF
80 FR 10159 - Draft Environmental Impact Statement for Alcatraz Ferry Embarkation Plan, San Francisco County, California.PDF
80 FR 10126 - Request for Information on Specific Areas of Public Health Concern Related to Racial/Ethnic Demographic Subgroups for Additional Research by the Office of Minority HealthPDF
80 FR 10093 - Information Collection Being Submitted for Review and Approval to the Office of Management and BudgetPDF
80 FR 10092 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
80 FR 10122 - Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
80 FR 10144 - Notice of Public Meetings on the Proposed Revised Guidelines for Implementing Executive Order 11988, Floodplain Management, as Revised Through the Federal Flood Risk Management StandardPDF
80 FR 9987 - Authorization To Seize Property Involved in Drug Offenses for Administrative Forfeiture (2012R-9P)PDF
80 FR 10138 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; National Fire Incident Reporting System (NFIRS) v5.0PDF
80 FR 10140 - Final Flood Hazard DeterminationsPDF
80 FR 10138 - Final Flood Hazard DeterminationsPDF
80 FR 10163 - Petitions for Modification of Application of Existing Mandatory Safety StandardsPDF
80 FR 10022 - Position Limits for Derivatives and Aggregation of PositionsPDF
80 FR 10121 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary IngredientPDF
80 FR 10098 - Proposed Information Collection Activity; Comment RequestPDF
80 FR 10168 - New Postal ProductPDF
80 FR 10203 - Reporting and Recordkeeping Requirements Under OMB ReviewPDF
80 FR 10096 - Proposed Data Collections Submitted for Public Comment and RecommendationsPDF
80 FR 10095 - Proposed Data Collections Submitted for Public Comment and RecommendationsPDF
80 FR 10051 - Submission for OMB Review; Comment RequestPDF
80 FR 10202 - Data Collection Available for Public CommentsPDF
80 FR 10175 - Self-Regulatory Organizations; ISE Gemini, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Extend the Limit Up-Limit Down Obvious Error PilotPDF
80 FR 10192 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Exchange Rule 6.25PDF
80 FR 10179 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify and Reorganize Chapter VI (Trading Systems), Section 8 (BX Opening and Halt Cross) of the Exchange's Options RulesPDF
80 FR 10198 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Extending the Pilot Period Applicable to Rule 953.1NY(c), Obvious and Catastrophic Errors, Until October 23, 2015PDF
80 FR 10187 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Extending the Pilot Period Applicable to Rule 6.65A(c), Obvious and Catastrophic Errors, Until October 23, 2015PDF
80 FR 10196 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Pilot Period Applicable to Rule 530 Relating To Limit Up/Limit DownPDF
80 FR 10177 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Pilot Program That Suspends Certain Obvious Error Provisions During Limit Up-Limit Down States in Securities That Underlie Options Traded on the ExchangePDF
80 FR 10194 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Order Disapproving Proposed Rule Changes To List and Trade Options on Shares of the iShares ETFs and Market Vectors ETFsPDF
80 FR 10189 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change Relating to the Listing and Trading of the Shares of the Tuttle Tactical Management U.S. Core ETF of ETFis Series Trust IPDF
80 FR 10171 - Self-Regulatory Organizations; the Options Clearing Corporation; Order Approving Proposed Rule Change To Clarify That OCC Would not Treat a Futures Transaction That Is an Exchange-for-Physical or Block Trade as a Non-Competitively Executed Trade if the Exchange on Which Such Trade Is Executed Has Provided OCC With Representations That it Has Policies or Procedures Requiring That Such Trades Be Executed at Reasonable Prices and That Such Price Is Validated by the ExchangePDF
80 FR 10173 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange Rule 404PDF
80 FR 10203 - Regulatory Fairness Hearing; Region VIII-Salida, ColoradoPDF
80 FR 10202 - Reporting and Recordkeeping Requirements Under OMB ReviewPDF
80 FR 10044 - Notice of Renewal of Charter of the Global Development CouncilPDF
80 FR 10094 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
80 FR 10169 - Product Change-Priority Mail Negotiated Service AgreementPDF
80 FR 10049 - Codex Alimentarius Commission: Meeting of the Codex Committee on General PrinciplesPDF
80 FR 10210 - Public Meeting: Citizens Coinage Advisory CommitteePDF
80 FR 10145 - Enforcement Actions SummaryPDF
80 FR 10080 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 21st Century Community Learning Centers Annual Performance ReportPDF
80 FR 10077 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Annual Report on Appeals Process RSA-722PDF
80 FR 10078 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Charter Schools Program (CSP) Grant Award DatabasePDF
80 FR 10079 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Quarterly Cumulative Caseload ReportPDF
80 FR 10079 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; HBCU All Star Student ProgramPDF
80 FR 10072 - Compliance Bulletin-Treatment of Confidential Supervisory InformationPDF
80 FR 10127 - Submission for OMB Review; 30-Day Comment Request Division of Cancer Epidemiology and Genetics (DCEG) Fellowship Program and Summer Student Applications (NCI)PDF
80 FR 10128 - Submission for OMB Review; 30-Day Comment Request; Assessment of Oncology Nursing Education and Training in Low and Middle Income Countries (NCI)PDF
80 FR 10206 - Petition for Waiver of CompliancePDF
80 FR 10204 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal SystemPDF
80 FR 10073 - Proposed Collection; Comment RequestPDF
80 FR 10053 - Export Trade Certificate of ReviewPDF
80 FR 10205 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal SystemPDF
80 FR 10207 - Petition for Waiver of CompliancePDF
80 FR 10146 - Rental Assistance Demonstration (RAD)-Alternative Requirements or Waivers: Waiving and Specifying Alternative Requirements for the 20 Percent Portfolio Cap on Project-Basing and Certain Tenant Protection and Participation Provisions for the San Francisco Housing Authority's RAD ProjectsPDF
80 FR 10129 - Government-Owned Inventions; Availability for LicensingPDF
80 FR 10130 - Center for Scientific Review; Notice of Closed MeetingsPDF
80 FR 10124 - Robotically-Assisted Surgical Devices: Challenges and Opportunities; Public Workshop; Request for CommentsPDF
80 FR 10208 - Petition for Waiver of CompliancePDF
80 FR 10081 - Combined Notice of Filings #1PDF
80 FR 10050 - Notice of Proposed New Fee Site; Federal Lands Recreation Enhancement ActPDF
80 FR 9985 - Airworthiness Directives; Sikorsky Aircraft Corporation (Sikorsky) HelicoptersPDF
80 FR 10080 - National Advisory Committee on Institutional Quality and Integrity MeetingPDF
80 FR 10008 - Part 400-General Administrative Regulation-Subpart V-Submission of Policies, Provisions of Policies and Rates of PremiumPDF
80 FR 10211 - Energy Conservation Program: Test Procedures for Portable Air ConditionersPDF
80 FR 9989 - Definition of Spouse Under the Family and Medical Leave ActPDF
80 FR 10162 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Family and Medical Leave Act of 1993, as AmendedPDF

Issue

80 37 Wednesday, February 25, 2015 Contents Editorial Note:

Administrative Order, Libya; Continuation of National Emergency (Notice of February 23, 2015) at 80 FR 9983 was published in the printed version of the Federal Register for Tuesday, February 24, 2015, but was inadvertently omitted from the Table of Contents of the Federal Register.

Agency Agency for International Development NOTICES Charter Renewals: Global Development Council, 10044-10045 2015-03807 Agriculture Agriculture Department See

Federal Crop Insurance Corporation

See

Food and Nutrition Service

See

Food Safety and Inspection Service

See

Forest Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10045-10047 2015-03907 2015-03911 2015-03912
Army Army Department NOTICES Meetings: Advisory Committee on Arlington National Cemetery Honor Subcommittee, 10077 2015-03861 Advisory Committee on Arlington National Cemetery Remember Subcommittee, 10076-10077 2015-03860 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Compliance Bulletin: Treatment of Confidential Supervisory Information, 10072-10073 2015-03791 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10094-10098 2015-03826 2015-03805 2015-03825 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Affordable Care Act Tribal Maternal, Infant, and Early Childhood Home Visiting Program: Guidance for Submitting an Annual Report to the Secretary, 10098-10099 2015-03830 Coast Guard Coast Guard NOTICES Guidance: Use of Liquefied Natural Gas as a Marine Fuel, 10131-10137 2015-03852 Meetings: Port Access Route Study—Chukchi Sea, Bering Strait and Bering Sea, 10137-10138 2015-03859 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2015-03824 10050-10051 2015-03870
Commodity Futures Commodity Futures Trading Commission PROPOSED RULES Position Limits for Derivatives and Aggregation of Positions, 10022-10026 2015-03834 Community Living Administration NOTICES Proposed Priorities: National Institute on Disability, Independent Living, and Rehabilitation Research, 10103-10117 2015-03880 2015-03882 2015-03885 2015-03888 National Institute on Disability, Independent Living, and Rehabilitation Research; Rehabilitation Research and Training Centers, 10099-10102 2015-03877 Defense Department Defense Department See

Army Department

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10073-10075 2015-03785 2015-03906 Meetings: Judicial Proceedings Since Fiscal Year 2012 Amendments Panel, 10075-10076 2015-03904
Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: 21st Century Community Learning Centers Annual Performance Report, 10080 2015-03797 Annual Report on Appeals Process, 10077-10078 2015-03796 Charter Schools Program Grant Award Database, 10078-10079 2015-03795 HBCU All Star Student Program, 10079 2015-03793 Quarterly Cumulative Caseload Report, 10079-10080 2015-03794 Meetings: National Advisory Committee on Institutional Quality and Integrity, 10080-10081 2015-03612 Employment Standards Employment Standards Administration See

Wage and Hour Division

Energy Department Energy Department See

Federal Energy Regulatory Commission

PROPOSED RULES Energy Conservation Program: Test Procedures for Portable Air Conditioners, 10212-10248 2015-03589
Environmental Protection Environmental Protection Agency RULES Pesticide Tolerances for Emergency Exemptions: Clothianidin, 10003-10007 2015-03928 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Certification of Pesticide Applicators, 10089-10090 2015-03864 NESHAP for Iron and Steel Foundry Area Sources, 10088-10089 2015-03902 NESHAP for Primary Lead Smelters, 10089 2015-03901 NESHAP for Shipbuilding and Ship Repair Facilities - Surface Coating, 10083-10084 2015-03891 NSPS for Calciners and Dryers in Mineral Industries, 10082-10083 2015-03866 NSPS for Metal Coil Surface Coating, 10086-10087 2015-03865 NSPS for Municipal Solid Waste Landfills, 10084-10085 2015-03867 NSPS for Petroleum Refineries, 10085 2015-03868 Participation by Disadvantaged Business Enterprises in Procurements Under EPA Financial Assistance Agreements, 10087-10088 2015-03918 Reporting and Recordkeeping Requirements for Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles, 10085-10086 2015-03890 Meetings: Great Lakes Advisory Board; Public Teleconference, 10090-10091 2015-03916 Requests for Amendments To Terminate Uses in Certain Pesticide Registrations, 10091-10092 2015-03926 Executive Office of the President See

Presidential Documents

Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Sikorsky Aircraft Corporation (Sikorsky) Helicopters, 9985-9987 2015-03703 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Airport Noise Compatibility Planning, 10203-10204 2015-03927 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10092-10094 2015-03844 2015-03845 Federal Crop Federal Crop Insurance Corporation PROPOSED RULES Submission of Policies, Provisions of Policies and Rates of Premium, 10008-10022 2015-03604 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Fire Incident Reporting System, 10138 2015-03838 Final Flood Hazard Determinations, 10138-10144 2015-03836 2015-03837 Meetings: Proposed Revised Guidelines for Floodplain Management, As Revised Through the Federal Flood Risk Management Standard, 10144 2015-03840 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 10081-10082 2015-03759 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 10094 2015-03893 Federal Railroad Federal Railroad Administration NOTICES Applications: Railroad Signal Systems; Discontinuances or Modifications, 10204-10206 2015-03767 2015-03783 2015-03786 Petitions for Waivers of Compliance, 10206-10209 2015-03762 2015-03763 2015-03768 2015-03782 2015-03787 Food and Drug Food and Drug Administration PROPOSED RULES Over-the-Counter Sunscreen Drug Products: Status of Ecamsule, 10035-10043 2015-03883 Status of Enzacamene, 10026-10035 2015-03884 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals, 10117-10121 2015-03881 Premarket Notification for a New Dietary Ingredient, 10121-10122 2015-03833 Guidance: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices, 10122-10123 2015-03843 Meetings: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee, 10123-10124 2015-03900 Robotically-Assisted Surgical Devices—Challenges and Opportunities; Workshops, 10124-10125 2015-03769 National Medical Device Postmarket Surveillance System Planning Board Report, 10125-10126 2015-03886 Requests for Information: Public Health Concern Related to Racial/Ethnic Demographic Subgroups for Office of Minority Health Research, 10126-10127 2015-03846 Food and Nutrition Food and Nutrition Service NOTICES Requests for Information: Software Vendors of State and Local Management Information Systems and Other Technology Solutions, National School Lunch and Breakfast Programs, 10047-10049 2015-03848 Food Safety Food Safety and Inspection Service NOTICES Meetings: Codex Alimentarius Commission: Codex Committee on General Principles, 10049-10050 2015-03800 Foreign Trade Foreign-Trade Zones Board NOTICES Authorization of Production Activity: Epson Portland, Inc., Subzone 45F, Hillsboro, OR, 10051 2015-03895 Forest Forest Service NOTICES Proposed New Fee Sites, 10050 2015-03725 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Children and Families Administration

See

Community Living Administration

See

Food and Drug Administration

See

National Institutes of Health

Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

See

Transportation Security Administration

RULES Employment Authorization for Certain H-4 Dependent Spouses, 10284-10312 2015-04042
Housing Housing and Urban Development Department NOTICES Rental Assistance Demonstration; Alternative Requirements or Waivers: San Francisco Housing Authority, 10146 2015-03780 Indian Affairs Indian Affairs Bureau NOTICES Guidelines for State Courts and Agencies in Indian Child Custody Proceedings, 10146-10159 2015-03925 Interior Interior Department See

Indian Affairs Bureau

See

National Park Service

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Polyethylene Terephthalate Film, Sheet, and Strip From Taiwan, 10051-10053 2015-03897 Export Trade Certificates of Review, 10053 2015-03784 Trade Missions: South Africa, Kenya and Mozambique, 10053-10058 2015-03898 International Trade Com International Trade Commission NOTICES Complaints: Certain Lithium Metal Oxide Cathode Materials, Lithium-Ion Batteries Containing Same, and Products With Lithium-Ion Batteries Containing Same, 10161 2015-03887 Investigations; Determinations, Modifications, and Rulings, etc.: Tetrahydrofurfuryl Alcohol From China; Expedited Five-Year Review, 10162 2015-03863 Meetings; Sunshine Act, 10162 2015-04039 Justice Department Justice Department RULES Authorization To Seize Property Involved in Drug Offenses for Administrative Forfeiture, 9987-9989 2015-03839 Labor Department Labor Department See

Mine Safety and Health Administration

See

Wage and Hour Division

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals Family and Medical Leave Act, 10162-10163 2015-03568
Mine Mine Safety and Health Administration NOTICES Petitions for Modifications: Existing Mandatory Safety Standards, 10163-10164 2015-03835 National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Assessment of Oncology Nursing Education and Training in Low and Middle Income Countries, 10128-10129 2015-03788 Division of Cancer Epidemiology and Genetics Fellowship Program and Summer Student Applications, 10127-10128 2015-03789 Government-Owned Inventions; Availability for Licensing, 10129-10130 2015-03779 Meetings: Center for Scientific Review, 10130-10131 2015-03778 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Coastal Migratory Pelagic Resources in the Gulf of Mexico and Atlantic Region; Corrections, 10007 2015-03905 Fisheries of the Exclusive Economic Zone Off Alaska: Gulf of Alaska; Final 2015 and 2016 Harvest Specifications for Groundfish, 10250-10282 2015-03896 NOTICES Meetings: Atlantic Highly Migratory Species Advisory Panel, 10058-10059 2015-03894 Caribbean Fishery Management Council, 10059-10060 2015-03892 Takes of Marine Mammals Incidental to Specified Activities: San Francisco Bay Area Water Emergency Transportation Authority Central Bay Operations and Maintenance Facility Project, Alameda, CA, 10060-10066 2015-03850 Seabird Research Activities in Central California, 2015-2016, 10066-10071 2015-03849 National Park National Park Service NOTICES Environmental Impact Statements; Availability, etc.: Alcatraz Ferry Embarkation Plan, San Francisco County, CA, 10159-10161 2015-03847 National Science National Science Foundation NOTICES Meetings: Advisory Committee for Cyberinfrastructure, 10164-10165 2015-03869 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Atomic Safety and Licensing Boards: Entergy Nuclear Vermont Yankee, LLC and Entergy Nuclear Operations, Inc., Vernon, VT, 10165 2015-03903 James Chaisson; Reconstitutions, 10165 2015-03899 Concentration Averaging and Encapsulation Branch Technical Position, 10165-10168 2015-03913 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 2015-03828 10168-10169 2015-03829 Postal Service Postal Service NOTICES Product Changes: Priority Mail Negotiated Service Agreement, 2015-03802 10169 2015-03804 Presidential Documents Presidential Documents PROCLAMATIONS Pullman National Monument; Establishment (Proc. 9233), 10313-10319 2015-04090 ADMINISTRATIVE ORDERS Syrian Opposition Asistance; Determination and Waiver to Section 1209 of the National Defense Authorization Act for FY 2015 (Presidential Determination) No. 2015-04 of February 20, 2015, 10321 2015-04091 Securities Securities and Exchange Commission NOTICES Joint Industry Plans: BATS Exchange, Inc., BATS Y-Exchange, Inc., Chicago Board Options Exchange, Inc., et al., 10169-10171 2015-03875 Meetings; Sunshine Act, 10171 2015-03947 Self-Regulatory Organizations; Proposed Rule Changes: BOX Options Exchange LLC, 10177-10179 2015-03814 Chicago Board Options Exchange, Inc., 10192-10194 2015-03820 ISE Gemini, LLC, 10175-10177 2015-03822 Miami International Securities Exchange LLC, 10173-10175, 10194-10198 2015-03810 2015-03813 2015-03815 NASDAQ OMX BX, Inc., 10179-10187 2015-03819 NASDAQ Stock Market LLC, 10189-10192 2015-03812 NYSE Arca, Inc., 10187-10189 2015-03816 NYSE MKT LLC, 10198-10200 2015-03817 Options Clearing Corp., 10171-10173 2015-03811 Trading Suspension Orders: Akesis Pharmaceuticals, Inc., et al., 10201 2015-03874 Calypte Biomedical Corp., EC Development, Inc., et al., 10200-10201 2015-03871 Innovative Software Technologies, Inc., et al., 10201 2015-03872 Revonergy Inc., Siberian Energy Group Inc., et al., 10201 2015-03873 Small Business Small Business Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2015-03808 2015-03818 10202-10203 2015-03823 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Settlement Sheet, 10203 2015-03827 Meetings: Regulatory Fairness; Region VIII; Salida, CO; Hearings, 10203 2015-03809 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Railroad Administration

See

Transportation Security Administration

Security Transportation Security Administration NOTICES Enforcement Actions Summary, 10145-10146 2015-03798 Treasury Treasury Department See

United States Mint

NOTICES Requests for Nominations: Tribal Advisory Committee, 10209-10210 2015-03986
U.S. Mint United States Mint NOTICES Meetings: Citizens Coinage Advisory Committee, 10210 2015-03799 Veteran Affairs Veterans Affairs Department RULES Automobile or Other Conveyance and Adaptive Equipment Certificate of Eligibility: Veterans or Members of the Armed Forces With Amyotrophic Lateral Sclerosis, 10001-10003 2015-03889 Wage Wage and Hour Division RULES Definition of Spouse Under the Family and Medical Leave Act, 9989-10001 2015-03569 Separate Parts In This Issue Part II Energy Department, 10212-10248 2015-03589 Part III Commerce Department, National Oceanic and Atmospheric Administration, 10250-10282 2015-03896 Part IV Homeland Security Department, 10284-10312 2015-04042 Part V Presidential Documents, 10313-10319, 10321 2015-04090 2015-04091 Reader Aids

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80 37 Wednesday, February 25, 2015 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-0397; Directorate Identifier 2014-SW-048-AD; Amendment 39-18107; AD 2015-04-05] RIN 2120-AA64 Airworthiness Directives; Sikorsky Aircraft Corporation (Sikorsky) Helicopters AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule; request for comments.

SUMMARY:

We are adopting a new airworthiness directive (AD) for certain Sikorsky Model S-76A, B, C, and D helicopters. This AD requires inspecting the tail rotor drive shaft (TDS) flange-to-shaft attachment hardware for correct assembly and correct torque of the fasteners. If there is a discrepancy, this AD requires, before further flight, applying an index mark to the flange and TDS, inspecting the flange and shaft for a crack, fracture, wear, and certain measurements, and replacing any part that does not meet the approved criteria before further flight. This AD is prompted by a partial loss of tail rotor drive resulting in a forced landing. The actions specified by this AD are intended to prevent failure at the flange-to-shaft attachment, loss of a tail rotor drive, and subsequent loss of control of the helicopter.

DATES:

This AD becomes effective March 12, 2015.

The Director of the Federal Register approved the incorporation by reference of a certain document as of March 12, 2015.

We must receive comments on this AD by April 27, 2015.

ADDRESSES:

You may send comments by any of the following methods:

Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your comments electronically.

Fax: 202-493-2251.

Mail: Send comments to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.

Hand Delivery: Deliver to the “Mail” address between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, any incorporated by reference service information, the economic evaluation, any comments received, and other information. The street address for the Docket Operations Office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

For service information identified in this AD, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email [email protected]. You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-0397.

FOR FURTHER INFORMATION CONTACT:

Michael Schwetz, Aviation Safety Engineer, Boston Aircraft Certification Office, Engine & Propeller Directorate, FAA, 12 New England Executive Park, Burlington, Massachusetts 01803; telephone (781) 238-7761; email [email protected].

SUPPLEMENTARY INFORMATION: Comments Invited

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, we invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit them only one time. We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.

Discussion

We are adopting a new AD for certain Sikorsky Model S-76A, B, C, and D helicopters. This AD requires inspecting the TDS flange-to-shaft attachment hardware at four locations for correct installation and correct torque of the fasteners. If there is movement, misalignment of the torque stripe, a misassembled part, or torque of less than 105 inch-pounds on any nut, this AD requires applying an index mark to the flange and shaft to make sure the flange is reinstalled in the same position to maintain shaft balance, and, before further flight, inspecting the flange and shaft for a crack, fracture, wear on the mounting hole, and diameter measurements, and replacing the TDS if the flange or stub does not meet the inspection criteria. This AD is prompted by a partial loss of tail rotor drive resulting in a forced landing, and instances where TDS flange-to-shaft attachment hardware was found to be loose or fractured. The actions specified by this AD are intended to detect loose or fractured hardware and prevent failure of the TDS at the flange-to-shaft attachment, loss of a tail rotor drive, and subsequent loss of control of the helicopter.

FAA's Determination

We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of these same type designs.

Related Service Information Under 1 CFR Part 51

Sikorsky issued Alert Service Bulletin ASB 76-66-52, Basic Issue, on April 1, 2014, which specifies a one-time inspection of the TDS flange-to-shaft attachment hardware for proper installation and torque. If there is movement, torque stripe misalignment, or misassembled hardware, the ASB specifies removing and returning the hardware to Sikorsky with certain forms and replacing hardware with airworthy TDS hardware before returning the helicopter to service. The ASB also specifies either replacing the TDS or inspecting the flange and shaft for a crack, fracture, wear of the mounting hole, and diameter and replacing any part that does not meet the approved criteria. The ASB states there were instances where the TDS flange-to-shaft attachment hardware was found loose or fractured. This service information is reasonably available; see ADDRESSES for ways to access this service information.

AD Requirements

This AD requires, within 30 days:

• Inspecting each TDS flange attachment hardware at all four locations for looseness and torque stripe misalignment, inspecting each nut to determine whether it can be rotated by hand, determining whether the hardware is assembled correctly, and determining the torque of each nut.

• If there is no looseness, torque stripe misalignment, incorrect hardware assembly, and if no nut can be rotated by hand and the torque of any nut is not less than 105 inch-pounds, no further action is required by this AD.

• If there is looseness, torque stripe misalignment, incorrect hardware assembly, a nut rotated by hand, or the torque of any nut is less than 105 inch-pounds:

○ Applying an index mark to the flange and shaft, unbolting and removing the flange from the shaft, visually inspecting each radius washer for wear or fretting, and replacing any washer with wear or fretting.

○ Inspecting the flange and shaft for a crack, fracture, wear on the mounting hole, and diameter, and replacing the TDS with an airworthy TDS if the flange and shaft fail any of the inspection criteria.

○ Aligning index marks, installing the flange on the shaft, and coating the grip length of each bolt and the contact surfaces on each radius washer and washer with epoxy polyamide primer.

○ Torquing each nut.

Differences Between This AD and the Service Information

The AD does not require returning the unairworthy parts with certain forms to the manufacturer as does the service information.

Costs of Compliance

We estimate that this AD affects 260 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. We estimate $85 per work-hour for labor. We estimate 2.2 work-hours to inspect the hardware assembly and torque at a cost of $187 per helicopter and $48,620 for the fleet. We estimate 2.2 work-hours if the hardware is replaced and $1,200 for the required parts, for a total cost of $1,387 per helicopter.

FAA's Justification and Determination of the Effective Date

Providing an opportunity for public comments before adopting these AD requirements would delay implementing the safety actions needed to correct this known unsafe condition. Therefore, we find that the risk to the flying public justifies waiving notice and comment before adopting this rule because the required corrective actions must be done within 30 days, a very short time period based on the average flight-hour utilization rate of these helicopters used for commuter, air ambulance, and offshore operations.

Since an unsafe condition exists that requires the immediate adoption of this AD, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in less than 30 days.

Authority for This Rulemaking

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

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

Regulatory Findings

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

For the reasons discussed, I certify that this AD:

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

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

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

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

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2015-04-05 Sikorsky Aircraft Corporation: Amendment 39-18107; Docket No. FAA-2015-0397; Directorate Identifier 2014-SW-048-AD. (a) Applicability

This AD applies to Model S-76A, S-76B, S-76C, and S-76D helicopters, serial numbers (S/N) up to and including 761050, certificated in any category, with a tail drive shaft (TDS) part number (P/N) and S/N as follows:

(a) P/N 76361-04004 (all dash numbers) with an S/N up to and including A127-01092; or

(b) P/N 76361-04604 (all dash numbers) with an S/N with a prefix A240 or B240, or with an S/N C240-00001 through C240-00880.

(b) Unsafe Condition

This AD defines the unsafe condition as loose or fractured TDS flange-to-shaft attachment hardware. This condition could result in loss of a tail rotor drive and subsequent loss of control of the helicopter.

(c) Effective Date

This AD becomes effective March 12, 2015.

(d) Compliance

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

(e) Required Actions

Within 30 hours time-in-service:

(1) Inspect each TDS flange attachment hardware at all four locations for looseness and torque stripe misalignment as depicted in Figure 1 and shown in Figure 2 of Sikorsky Aircraft Corporation Alert Service Bulletin ASB 76-66-52, Basic Issue, dated April 1, 2014 (ASB). Inspect each nut to determine whether it can be rotated by hand. Determine whether the hardware is assembled correctly by following the Accomplishment Instructions, paragraph B.(3)(a) through B.(3)(b) of the ASB. Determine the torque of each nut.

(2) If there is no looseness, torque stripe misalignment, incorrect hardware assembly, and if no nut can be rotated by hand and the torque of any nut is not less than 105 inch-pounds, no further action is required by this AD.

(3) If there is looseness, torque stripe misalignment, incorrect hardware assembly, a nut rotated by hand, or the torque of any nut is less than 105 inch-pounds, do the following:

(i) Apply an index mark to the flange and shaft to make sure the flange is reinstalled in the same position and to maintain shaft balance, unbolt and remove the flange from the shaft, and visually inspect each radius washer for wear or fretting. Replace any washer with wear or fretting.

(ii) Inspect the flange and shaft for a crack, fracture, wear on the mounting hole, and diameter by following the Accomplishment Instructions, paragraph 3.D.(5)(a) through 3.D.(5)(e), of the ASB. If the flange and shaft fail any of the inspection criteria, before further flight, replace the TDS with an airworthy TDS.

(iii) Align index marks, install the flange on the shaft, and coat the grip length of each bolt and the contact surfaces on each radius washer and washer with epoxy polyamide primer.

(iv) Torque each nut by following either paragraph D.(9) or D.(10) of the Accomplishment Instructions of the ASB.

(f) Alternative Methods of Compliance (AMOCs)

(1) The Manager, Boston Aircraft Certification Office, FAA, may approve AMOCs for this AD. Send your proposal to: Michael Schwetz, Aviation Safety Engineer, Engine & Propeller Directorate, FAA, 12 New England Executive Park, Burlington, Massachusetts 01803; telephone (781) 238-7761; email [email protected]

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

(g) Subject

Joint Aircraft Service Component (JASC) Code: 6510 Tail Rotor Drive Shaft.

(h) Material Incorporated by Reference

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

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

(i) Sikorsky Aircraft Corporation Alert Service Bulletin ASB 76-66-52, Basic issue, dated April 1, 2014.

(ii) Reserved.

(3) For Sikorsky Aircraft Corporation service information identified in this AD, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email [email protected].

(4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137. For information on the availability of this material at the FAA, call (817) 222-5110.

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

Issued in Fort Worth, Texas, on February 9, 2015. Bruce E. Cain, Acting Directorate Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2015-03703 Filed 2-24-15; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF JUSTICE 28 CFR Part 0 [AG Order No. 3495-2015] Authorization To Seize Property Involved in Drug Offenses for Administrative Forfeiture (2012R-9P) AGENCY:

Department of Justice.

ACTION:

Final rule.

SUMMARY:

The Department of Justice is amending its regulations to delegate to the Director of the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) authority to seize and administratively forfeit property involved in controlled substance offenses.

DATES:

This rule is effective February 25, 2015.

FOR FURTHER INFORMATION CONTACT:

Denise Brown, Enforcement Programs and Services, Bureau of Alcohol, Tobacco, Firearms, and Explosives, U.S. Department of Justice, 99 New York Avenue NE., Washington, DC 20226, telephone: (202) 648-7070.

SUPPLEMENTARY INFORMATION: Background

After the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) became part of the Department of Justice (DOJ) in January 2003, pursuant to the Homeland Security Act of 2002 (Pub. L. 107-296), the Attorney General delegated to ATF the authority to investigate, seize, and forfeit property involved in a violation or attempted violation within its investigative jurisdiction. See 28 CFR 0.130(b)(1). ATF investigations focusing on violent crime frequently involve complex criminal organizations with multiple criminal enterprises and uncover drug-related offenses in addition to offenses within ATF's primary jurisdiction, such as violations of the Gun Control Act, 18 U.S.C. Chapter 44, the National Firearms Act, 26 U.S.C. Chapter 53, or the Contraband Cigarette Trafficking Act, 18 U.S.C. Chapter 114. In such investigations, ATF historically did not have authority under 21 U.S.C. Chapter 13 to seize for administrative forfeiture property involved in controlled substance offenses. Instead, ATF generally referred such property to the Drug Enforcement Administration (DEA), which is primarily responsible for investigating violations of drug laws contained in title 21 of the United States Code. DEA would then initiate, process, and conclude all necessary administrative forfeiture actions for the controlled substance-related property. In other situations, ATF had to request that the local U.S. Attorney's office pursue a judicial forfeiture of such drug-related property.

The Department believes that forfeiting the assets of criminals is an essential tool in combating criminal activity that provides law enforcement with the ability to dismantle criminal organizations, deprive wrongdoers of the proceeds of their crimes, and deter crime. The Department further believes that administrative forfeiture permits the expedient and effective use of this valuable law enforcement tool.

An uncontested administrative forfeiture can be perfected in 60-90 days for minimal cost, including the personal notice to interested parties and the notice by publication required by statute. Conversely, the costs associated with judicial forfeiture can amount to hundreds or thousands of dollars and the judicial process generally can take anywhere from 6 months to years. In the meantime, the government incurs additional costs if the property requires storage or maintenance until a final order of forfeiture can be obtained.

One of the primary missions of ATF is to combat firearm-related violent crime. The nexus between drug trafficking and firearm violence is well established. Upon review of the current role and mission of ATF within DOJ, the Attorney General decided to authorize a temporary delegation of title 21 seizure and forfeiture authority to determine whether such authority can enhance the effectiveness of ATF in the investigation of violent crimes involving firearms. On August 21, 2012, the Attorney General signed a final rule delegating seizure and forfeiture authority under 21 U.S.C. 881 to the ATF for a trial period of one year, effective February 25, 2013. 77 FR 51698 (Aug. 27, 2012). By subsequent action, the Attorney General extended the same authority to ATF for an additional one-year period to give ATF more time to refine its process, fully hire and train all necessary staff, and further demonstrate the effectiveness of the delegation in the investigation of violent crimes involving firearms. 79 FR 12060 (Mar. 4, 2014).

ATF has refined its title 21 asset forfeiture process, and strengthened the overall asset forfeiture program, by changing organizational structure, adding experienced personnel and resources to review and more efficiently process all of ATF's administrative forfeitures, and providing additional asset forfeiture training to all agency personnel involved in the forfeiture process, together with a renewed focus on the proper execution of all phases of ATF's asset forfeiture mission to ensure that all interested parties are afforded due process under the law, that all seized assets are accounted for and properly maintained, and that all forfeited property is disposed of according to law in a timely and cost-efficient manner.

This authority has given ATF the ability to process drug-related property seized in criminal investigations in which firearms and explosives also are seized. From February 25, 2013, to September 30, 2014, ATF used its authority under title 21 to seize more than 1,700 assets with a total value in excess of $19,300,000.

The delegation of authority has afforded cost savings to the United States government by streamlining the forfeiture process to prevent unnecessary burden on the judicial system and the public and by permitting the government to process forfeitures within a single agency. The grant of title 21 seizure and forfeiture authority will permit ATF to continue its use of asset forfeiture as a valuable tool in support of its law enforcement mission and enable the Department to further increase the speed and efficiency of uncontested forfeiture actions.

Final Rule

This rule amends the regulations in 28 CFR part 0 to delegate to the Director of ATF the authority to seize, forfeit, and remit or mitigate the forfeiture of property in accordance with 21 U.S.C. 881.

Forfeiting the assets of criminals is an essential tool in combating criminal activity and provides law enforcement with the capacity to dismantle criminal organizations, deprive wrongdoers of the proceeds of their illegal activities, and deter crime. Therefore, the Attorney General has decided to delegate to the Director of ATF without a time limit administrative seizure and forfeiture authority under title 21 to permit expedient and effective use of this valuable law enforcement tool in the investigation of violent crime involving firearms.

How This Document Complies With the Federal Administrative Requirements for Rulemaking Administrative Procedure Act (APA)

Notice and comment rulemaking is not required for this final rule. Under the APA, “rules of agency organization, procedure or practice,” 5 U.S.C. 553(b)(A), that do not “affect[] individual rights and obligations,” Morton v. Ruiz, 415 U.S. 199, 232 (1974), are exempt from the general notice and comment requirements of section 553 of title 5 of the United States Code. See JEM Broad. Co. v. FCC, 22 F.3d 320, 326 (D.C. Cir. 1994) (section 553(b)(A) applies to “agency actions that do not themselves alter the rights or interests of parties, although [they] may alter the manner in which the parties present themselves or their viewpoints to the agency”) (quoting Batterton v. Marshall, 648 F.2d 694, 707 (D.C. Cir. 1980) (internal quotation marks omitted)). The revisions to the regulations in 28 CFR part 0 are purely a matter of agency organization, procedure, and practice that will not affect individual rights and obligations. This rule does not expand the government's ability as a matter of law to effectuate forfeitures; it simply authorizes the Director of ATF to effectuate such forfeitures. Internal delegations of authority such as in this final rule are “rules of agency organization, procedure, or practice” under the APA. In addition, this rule is exempt from the usual requirements of prior notice and comment and a 30-day delay in effective date because, as an internal delegation of authority, it relates to a matter of agency management or personnel. See 5 U.S.C. 553(a)(2).

Regulatory Flexibility Act

The Attorney General, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), has reviewed this rule and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities because it pertains to personnel and administrative matters affecting the Department. Further, a Regulatory Flexibility Analysis is not required for this final rule because the Department was not required to publish a general notice of proposed rulemaking for this matter.

Executive Order 12866 and Executive Order 13563

This rule has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review,” section 1(b), Principles of Regulation, and with Executive Order 13563, “Improving Regulation and Regulatory Review.” This rule is limited to agency organization, management, or personnel matters as described by Executive Order 12866, section 3(d)(3) and, therefore, is not a “regulation” or “rule” as defined by that Executive Order.

This rule will not have an annual effect on the economy of $100 million or more, nor will it adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal government or communities. Accordingly, this rule is not a “significant regulatory action” as defined in Executive Order 12866.

Executive Order 12988

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, “Civil Justice Reform.”

Executive Order 13132

This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, “Federalism,” the Department has determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

Unfunded Mandates Reform Act of 1995

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501 et seq.

Small Business Regulatory Enforcement Fairness Act of 1996

This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.

Congressional Review Act

This action pertains to agency management, personnel, and organization and does not substantially affect the rights or obligations of non-agency parties. Accordingly, it is not a rule for purposes of the reporting requirement of 5 U.S.C. 801.

List of Subjects in 28 CFR Part 0

Authority delegations (Government agencies), Government employees, Organization and functions (Government agencies), Privacy, Reporting and recordkeeping requirements, Whistleblowing.

Authority and Issuance

Accordingly, by virtue of the authority vested in me as Attorney General, including 5 U.S.C. 301 and 28 U.S.C. 509, 510, and for the reasons set forth in the preamble, part 0 of title 28 of the Code of Federal Regulations is amended as follows:

PART 0—ORGANIZATION OF THE DEPARTMENT OF JUSTICE 1. The authority citation for 28 CFR part 0 continues to read as follows: Authority:

5 U.S.C. 301; 28 U.S.C. 509, 510, 515-519.

§ 0.130 [Amended]
2. In § 0.130, amend paragraph (b)(2) by removing the second sentence.
Dated: February 20, 2015. Eric H. Holder, Jr., Attorney General.
[FR Doc. 2015-03839 Filed 2-24-15; 8:45 am] BILLING CODE 4410-19-P
DEPARTMENT OF LABOR Wage and Hour Division 29 CFR Part 825 RIN 1235-AA09 Definition of Spouse Under the Family and Medical Leave Act AGENCY:

Wage and Hour Division, Department of Labor.

ACTION:

Final rule.

SUMMARY:

The Department of Labor's (Department) Wage and Hour Division (WHD) revises the regulation defining “spouse” under the Family and Medical Leave Act of 1993 (FMLA or the Act) in light of the United States Supreme Court's decision in United States v. Windsor, which found section 3 of the Defense of Marriage Act (DOMA) to be unconstitutional.

DATES:

This Final Rule is effective March 27, 2015.

FOR FURTHER INFORMATION CONTACT:

Mary Ziegler, Director of the Division of Regulations, Legislation, and Interpretation, U.S. Department of Labor, Wage and Hour Division, 200 Constitution Avenue NW., Room S-3502, Frances Perkins Building, Washington, DC 20210; telephone: (202) 693-0406 (this is not a toll-free number). Copies of this Final Rule may be obtained in alternative formats (large print, braille, audio tape or disc), upon request, by calling (202) 693-0675 (this is not a toll-free number). TTY/TDD callers may dial toll-free 1-877-889-5627 to obtain information or request materials in alternative formats.

Questions of interpretation and/or enforcement of the agency's current regulations may be directed to the nearest WHD district office. Locate the nearest office by calling WHD's toll-free help line at (866) 4US-WAGE ((866) 487-9243) between 8 a.m. and 5 p.m. in your local time zone, or log onto WHD's Web site for a nationwide listing of WHD district and area offices at http://www.dol.gov/whd/america2.htm. Please visit http://www.dol.gov/whd for more information and resources about the laws administered and enforced by WHD. Information and compliance assistance materials specific to this Final Rule can be found at: http://www.dol.gov/whd/fmla/spouse/.

SUPPLEMENTARY INFORMATION: I. Background A. What the FMLA Provides

The Family and Medical Leave Act of 1993, 29 U.S.C. 2601 et seq., entitles eligible employees of covered employers to take job-protected, unpaid leave, or to substitute appropriate accrued paid leave, for up to a total of 12 workweeks in a 12-month period for the birth of the employee's son or daughter and to care for the newborn child; for the placement of a son or daughter with the employee for adoption or foster care; to care for the employee's spouse, parent, son, or daughter with a serious health condition; when the employee is unable to work due to the employee's own serious health condition; or for any qualifying exigency arising out of the fact that the employee's spouse, son, daughter, or parent is a military member on covered active duty. 29 U.S.C. 2612. An eligible employee may also take up to 26 workweeks of FMLA leave during a “single 12-month period” to care for a covered servicemember with a serious injury or illness, when the employee is the spouse, son, daughter, parent, or next of kin of the servicemember. Id.

FMLA leave may be taken in a block, or under certain circumstances, intermittently or on a reduced leave schedule. Id. In addition to providing job-protected family and medical leave, employers must also maintain any preexisting group health plan coverage for an employee on FMLA-protected leave under the same conditions that would apply if the employee had not taken leave. 29 U.S.C. 2614. Once the leave period is concluded, the employer is required to restore the employee to the same or an equivalent position with equivalent employment benefits, pay, and other terms and conditions of employment. Id. If an employee believes that his or her FMLA rights have been violated, the employee may file a complaint with the Department of Labor or file a private lawsuit in federal or state court. If the employer has violated the employee's FMLA rights, the employee is entitled to reimbursement for any monetary loss incurred, equitable relief as appropriate, interest, attorneys' fees, expert witness fees, and court costs. Liquidated damages also may be awarded. 29 U.S.C. 2617.

Title I of the FMLA is administered by the U.S. Department of Labor and applies to private sector employers of 50 or more employees, private and public elementary and secondary schools, public agencies, and certain federal employers and entities, such as the U.S. Postal Service and Postal Regulatory Commission. Title II is administered by the U.S. Office of Personnel Management and applies to civil service employees covered by the annual and sick leave system established under 5 U.S.C. Chapter 63 and certain employees covered by other federal leave systems.

B. Who the Law Protects

The FMLA generally covers employers with 50 or more employees. To be eligible to take FMLA leave, an employee must meet specified criteria, including employment with a covered employer for at least 12 months, performance of a specified number of hours of service in the 12 months prior to the start of leave, and work at a location where there are at least 50 employees within 75 miles.

C. Regulatory History

The FMLA required the Department to issue initial regulations to implement Title I and Title IV of the FMLA within 120 days of enactment (by June 5, 1993) with an effective date of August 5, 1993. The Department published a Notice of Proposed Rulemaking (NPRM) in the Federal Register on March 10, 1993. 58 FR 13394. The Department received comments from a wide variety of stakeholders, and after considering these comments the Department issued an Interim Final Rule on June 4, 1993, effective August 5, 1993. 58 FR 31794.

After publication, the Department invited further public comment on the interim regulations. 58 FR 45433. During this comment period, the Department received a significant number of substantive and editorial comments on the interim regulations from a wide variety of stakeholders. Based on this second round of public comments, the Department published final regulations to implement the FMLA on January 6, 1995. 60 FR 2180. The regulations were amended February 3, 1995 (60 FR 6658) and March 30, 1995 (60 FR 16382) to make minor technical corrections. The final regulations went into effect on April 6, 1995.

The Department published a Request for Information (RFI) in the Federal Register on December 1, 2006 requesting public comments on experiences with the FMLA (71 FR 69504) and issued a report on the RFI responses on June 28, 2007 (72 FR 35550). The Department published an NPRM in the Federal Register on February 11, 2008 proposing changes to the FMLA's regulations based on the Department's experience administering the law, two Department of Labor studies and reports on the FMLA issued in 1996 and 2001, several U.S. Supreme Court and lower court rulings on the FMLA, and a review of the comments received in response to the 2006 RFI. 73 FR 7876. The Department also sought comments on the military family leave statutory provisions enacted by the National Defense Authorization Act for Fiscal Year 2008. In response to the NPRM, the Department received thousands of comments from a wide variety of stakeholders. The Department issued a Final Rule on November 17, 2008, which became effective on January 16, 2009. 73 FR 67934.

The Department published an NPRM in the Federal Register on February 15, 2012 primarily focused on changes to the FMLA's regulations to implement amendments to the military leave provisions made by the National Defense Authorization Act for Fiscal Year 2010 and to the employee eligibility requirements for airline flight crew employees made by the Airline Flight Crew Technical Corrections Act. 77 FR 8960. The Department issued a Final Rule on February 6, 2013, which became effective on March 8, 2013. 78 FR 8834.

The Department commenced the current rulemaking by publishing an NPRM in the Federal Register on June 27, 2014 (79 FR 36445), inviting public comment for 45 days. The comment period closed on August 11, 2014. The Department received 77 comment submissions on the NPRM, representing over 18,000 individuals. Specific comments are discussed in detail below.

II. FMLA Spousal Leave

The FMLA provides eligible employees with leave to care for a spouse in the following situations: (1) When needed to care for a spouse due to the spouse's serious health condition; (2) when needed to care for a spouse who is a covered servicemember with a serious illness or injury; and (3) for a qualifying exigency related to the covered military service of a spouse. The FMLA defines “spouse” as “a husband or wife, as the case may be.” 29 U.S.C. 2611(13). In the 1993 Interim Final Rule, the Department defined spouse as “a husband or wife as defined or recognized under state law for purposes of marriage, including common law marriage in states where it is recognized.” 58 FR 31817, 31835 (June 4, 1993). In commenting on the Interim Final Rule, both the Society for Human Resource Management and William M. Mercer, Inc., questioned which state law would apply when an employee resided in one State but worked in another State. 60 FR 2190. In response to these comments, the 1995 Final Rule clarified that the law of the State of the employee's residence would control for determining eligibility for FMLA spousal leave. Id. at 2191. Accordingly, since 1995 the FMLA regulations have defined spouse as a husband or wife as defined or recognized under state law and the regulation has looked to the law of the State where the employee resides. §§ 825.102, 825.122(a) (prior to the 2013 Final Rule the same definition appeared at §§ 825.113(a) and 825.800). The definition has also included common law marriage in States where it is recognized. Id.

The Defense of Marriage Act (DOMA) was enacted in 1996. Public Law 104-199, 110 Stat. 2419. Section 3 of DOMA restricted the definitions of “marriage” and “spouse” for purposes of federal law, regulations, and administrative interpretations: “the word `marriage' means only a legal union between one man and one woman as husband and wife, and the word `spouse' refers only to a person of the opposite sex who is a husband or a wife.” 1 U.S.C. 7. For purposes of employee leave under the FMLA, the effect of DOMA was to limit the availability of FMLA leave based on a spousal relationship to opposite-sex marriages. While the Department did not revise the FMLA regulatory definition of “spouse” to incorporate DOMA's restrictions, in 1998 WHD issued an opinion letter that addressed, in part, the limitation section 3 of DOMA imposed on the availability of FMLA spousal leave.

Under the FMLA (29 U.S.C. 2611(13)), the term “spouse” is defined as a husband or wife, which the regulations (29 CFR 825.113(a)) clarified to mean a husband or wife as defined or recognized under State law for purposes of marriage in the State where the employee resides, including common law marriage in States where it is recognized. The legislative history confirms that this definition was adapted to ensure that employers were not required to grant FMLA leave to an employee to care for an unmarried domestic partner. (See Congressional Record, S 1347, February 4, 1993). Moreover, the subsequently enacted Defense of Marriage Act of 1996 (DOMA) (Pub. L. 104-199) establishes a Federal definition of “marriage” as only a legal union between one man and one woman as husband and wife, and a “spouse” as only a person of the opposite sex who is a husband or wife. Because FMLA is a Federal law, it is our interpretation that only the Federal definition of marriage and spouse as established under DOMA may be recognized for FMLA leave purposes.

Opinion Letter FMLA-98 (Nov. 18, 1998). WHD also referenced DOMA's limitations on spousal FMLA leave in a number of sub-regulatory guidance documents posted on its Web site.

On June 26, 2013, the Supreme Court held in United States v. Windsor, 133 S. Ct. 2675 (2013), that section 3 of DOMA was unconstitutional under the Fifth Amendment. It concluded that this section “undermines both the public and private significance of state-sanctioned same-sex marriages” and found that “no legitimate purpose overcomes” section 3's “purpose and effect to disparage and to injure those whom the State, by its marriage laws, sought to protect[.]” Id. at 2694-96.

Because of the Supreme Court's holding in Windsor that section 3 of DOMA is unconstitutional, the Department is no longer prohibited from recognizing same-sex marriages as a basis for FMLA spousal leave. Accordingly, as of June 26, 2013, under the current FMLA regulatory definition of spouse, an eligible employee in a legal same-sex marriage who resides in a State that recognizes the employee's marriage may take FMLA spousal leave. On August 9, 2013, the Department updated its FMLA sub-regulatory guidance to remove any references to the restrictions imposed by section 3 of DOMA and to expressly note that the regulatory definition of spouse covers same-sex spouses residing in States that recognize such marriages. Similarly, as a result of the Windsor decision, the interpretation expressed in Opinion Letter FMLA-98 of the definition of spouse as a person of the opposite sex as defined in DOMA is no longer valid.

III. Summary of Comments

The Department commenced this rulemaking by publishing an NPRM on June 27, 2014. 79 FR 36445. In the NPRM the Department proposed to change the definition of spouse to look to the law of the jurisdiction in which the marriage was entered into (including for common law marriages), as opposed to the law of the State in which the employee resides, and to expressly reference the inclusion of same-sex marriages in addition to common law marriages. The Department proposed to change the definition of spouse to ensure that all legally married couples, whether opposite-sex or same-sex, will have consistent federal family leave rights regardless of where they live. The Department received 77 comment submissions on the NPRM, representing over 18,000 individuals, which are available for review at the Federal eRulemaking Portal, www.regulations.gov, Docket ID WHD-2014-0002. The vast majority of those individuals submitted identical letters, which expressed strong support for the proposed rule, that were part of a comment campaign by the Human Rights Campaign (HRC). In addition, hundreds of commenters submitted nearly identical but individualized letters, which also strongly supported the proposed rule, as part of the HRC comment campaign. Beyond these campaign comments, the majority of the comments were supportive of the proposed rule. Comments were received from advocacy organizations, labor organizations, employer associations, a state agency, United States Senators, and private individuals. The Department received one comment after the close of the comment period; the comment was not considered by the Department. A number of the comments received addressed issues that are statutory and therefore beyond the scope or authority of the proposed regulations, such as expanding the coverage of the Act to include domestic partners and parents in law. Because addressing these issues would require statutory changes, these comments are not addressed in this Final Rule. Moreover, the Department has previously issued guidance on some of these issues. See, e.g., Opinion Letter FMLA-98 (Nov. 18, 1998) (the FMLA does not cover absences to care for a domestic partner with a serious health condition) 1 ; Opinion Letter FMLA-96 (June 4, 1998) (“parent” as referenced in the Act does not include a parent-in-law).

1 As noted above, the portion of Opinion Letter FMLA-98 that relied on DOMA's definition of spouse and marriage is now invalid in light of Windsor. The remaining portion of Opinion Letter FMLA-98, however, continues to be valid. Specifically, the opinion letter noted that the FMLA's legislative history indicated that the definition of spouse was meant to ensure that employers would not be required to provide leave to care for an employee's domestic partner.

The Department has carefully considered all of the relevant and timely comments. The major comments received on the proposed regulatory changes are summarized below, together with a discussion of the Department's responses. The Final Rule adopts the changes to the regulations as proposed in the NPRM.

IV. Analysis of the Proposed Changes to the FMLA Regulations

In the NPRM the Department proposed to change the regulatory definition of spouse in §§ 825.102 and 825.122(b) to mean the other person with whom an individual entered into marriage. The Department proposed to look to the law of the jurisdiction in which the marriage was entered into (including for common law marriages), as opposed to the law of the State in which the employee resides, and to expressly reference the inclusion of same-sex marriages in addition to common law marriages. The Department also proposed to include in the definition same-sex marriages entered into abroad by including marriages entered into outside of any State as long as the marriage was legally valid in the place where it was entered into and could have been entered into legally in at least one State.

The proposed definition included the statutory language defining spouse as a husband or wife but made clear that these terms included all individuals in lawfully recognized marriages. As noted in the NPRM, the Department is aware that the language surrounding marriage is evolving and that not all married individuals choose to use the traditional terms of husband or wife when referring to their spouse. 79 FR 36448. The Department intended the proposed definition to cover all spouses in legally valid marriages as defined in the regulation regardless of whether they use the terms husband or wife. The Department adopts the definition of spouse as proposed.

The Department is moving from a state of residence rule to a rule based on the jurisdiction where the marriage was entered into (place of celebration) to ensure that all legally married couples, whether opposite-sex or same-sex, will have consistent federal family leave rights regardless of where they live. 79 FR 36448. The Department noted in the proposed rule that while many States and foreign countries currently legally recognize same-sex marriage, not all do. As of February 13, 2015, thirty-two States and the District of Columbia extend the right to marry to both same-sex and opposite-sex couples (Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Hawaii, Idaho, Illinois, Indiana, Iowa, Maine, Maryland, Massachusetts, Minnesota, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, Rhode Island, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming).2 Additionally, as of February 13, 2015, eighteen countries extend the right to marry to both same-sex and opposite-sex couples (Argentina, Belgium, Brazil, Canada, Denmark, England/Wales/Scotland, Finland, France, Iceland, Luxembourg, The Netherlands, New Zealand, Norway, Portugal, Spain, South Africa, Sweden, and Uruguay). The Department notes that this list of States and countries currently recognizing same-sex marriage does not limit the revised definition of spouse in any way. Legal recognition of same-sex marriage has expanded rapidly and the Department anticipates that the number of States and countries recognizing same-sex marriage will continue to grow.

2 On January 16, 2015, the Supreme Court granted review of the Sixth Circuit's decision upholding state law bans on same-sex marriage in Kentucky, Michigan, Ohio, and Tennessee. See DeBoer v. Snyder, No. 14-571, 2015 WL 213650 (S. Ct. Jan. 16, 2015). The case is currently pending before the Supreme Court.

The vast majority of commenters, including the HRC letter-writing campaign commenters, applauded the Department's proposed use of a place of celebration rule. As the Maine Women's Lobby, A Better Balance, the 9to5 National Association of Working Women, the American Federation of Teachers, the North Carolina Justice Center, the Women's Law Project, the Religious Action Center for Reform Judaism, and many other commenters noted, under a state of residence rule, employees in legally valid same-sex marriages who live in a State that does not recognize their marriage are often forced to risk their jobs and financial wellbeing when they need time off to care for their ill or injured spouse or to address qualifying exigencies relating to their spouse's military service. These commenters stated that a place of celebration rule will provide security to all legally married same-sex spouses in knowing that they will be able to exercise their FMLA rights when the need arises. An individual similarly commented that, as the mother of a daughter in a same-sex marriage, she supported the rule because it would provide comfort to her as a parent who lives far from her daughter in knowing that, should her daughter need care, her daughter's same-sex spouse would be able to care for the daughter without having to worry that she would lose her job. Commenters such as the Family Equality Council (Family Equality), the National Partnership for Women & Families (National Partnership), the National Minority AIDS Council (NMAC), and twenty-three United States Senators who submitted a joint comment, also noted that nationally consistent and uniform access to leave as provided by the proposed rule will further the original purpose of the FMLA.

Many commenters, including the National Center for Transgender Equality, Family Values @Work, the National Employment Lawyers Association, the National Partnership, the Feminist Majority Foundation, the National Council of Jewish Women, and Equal Rights Advocates approved of the proposed place of celebration rule because it would provide certainty to same-sex couples regarding their FMLA leave rights, which would encourage worker mobility. The National Partnership commented that “[g]eographic mobility is a significant part of economic mobility for American workers . . . . By ensuring that [lesbian, gay, bisexual, and transgender (LGBT)] couples receive the same federal family leave protections if they move to a state that does not recognize their marriage, the rule makes it easier for workers to accept promotions or new jobs . . . .” This commenter also observed that the rule would provide important protections for LGBT military families who relocate due to military assignment.

Commenters also noted that a place of celebration rule will benefit employers as well as employees. The National Partnership observed that, by securing federal family leave rights to legally married same-sex spouses regardless of the State in which they reside, employers will be able to fill job positions with the most qualified workers. The National Business Group on Health expressed support for this rule because it will reduce the administrative burden on employers that operate in more than one State or have employees who move between States. The National Consumers League and the National Women's Law Center, among other commenters, echoed this observation that a place of celebration rule will simplify FMLA administration for employers that operate in multiple States.

The Department concurs with these comments. A place of celebration rule provides consistent federal family leave rights for legally married couples regardless of the State in which they reside, thus reducing barriers to the mobility of employees in same-sex marriages in the labor market and ensuring employees in same-sex marriages will be able to exercise their FMLA leave rights. Moreover, such a rule also reduces the administrative burden on employers that operate in more than one State, or that have employees who move between States with different marriage recognition rules; such employers will not have to consider the employee's state of residence and the laws of that State in determining the employee's eligibility for FMLA leave.

Several commenters were appreciative that the proposed place of celebration rule would be consistent with the interpretations adopted by other federal government agencies, such as the Department of Defense and the Internal Revenue Service, as this would create greater uniformity for employees and employers. See, e.g., the Legal Aid Employment Law Center, the American Federation of State, County, and Municipal Employees, AFL-CIO, the Fenway Institute at Fenway Health. The Society for Human Resource Management, the U.S. Chamber of Commerce, and the College and University Professional Association for Human Resources, which submitted a joint comment (collectively SHRM), appreciated the use by multiple federal agencies of a place of celebration rule because “consistent definitions are of tremendous importance and value for those seeking to comply with the FMLA.” The Department agrees with these comments. In addition, as stated in the NPRM, the Department believes that, in relation to Department of Defense policy, it is appropriate whenever possible to align the availability of FMLA military leave with the availability of other marriage-based benefits provided by the Department of Defense. 79 FR 36448.

SHRM, the U.S. Conference of Catholic Bishops (USCCB), and the National Automobile Dealers Association (NADA) expressed concern regarding the potential burden on employers to know the marriage laws of jurisdictions beyond those in which they operate. NADA and SHRM requested that the Department provide guidance on how to determine if a same-sex marriage is legally valid, perhaps with a chart on the Department's Web site with current information on the status of same-sex marriage in the States and foreign jurisdictions.

The Department does not believe that further guidance on state and foreign marriage laws is necessary at this time. Employers do not need to know the marriage laws of all 50 States and all foreign countries. Rather, employers will only need to know the same-sex marriage laws of a specific State or country in situations where an employee has requested leave to care for a spouse, child, or parent and the basis for the family relationship is a same-sex marriage. In such a situation, for purposes of confirming the qualifying basis of the leave, the employer would need to know the marriage laws of only the individual State or country where the marriage at issue was entered into. The Department believes that making this determination will not be burdensome. There are a number of organizations focused on providing up-to-date information on the status of same-sex marriages in the 50 States within the United States and foreign jurisdictions. Some examples of organizations that provide this information include http://www.freedomtomarry.org/states/ and http://gaymarriage.procon.org/. Because such information is readily available, the Department does not believe that it is necessary at this time to provide such information on its own Web site.

A few commenters addressed common law marriages as referenced in the proposed definition of spouse. Family Equality questioned whether the wording of the proposed definition could be interpreted to exclude an individual in a same-sex common law marriage. This commenter requested that the definition be modified to make clear that same-sex common law spouses are included in the definition. SHRM and the Food Marketing Institute (FMI) expressed concern that knowing the common law marriage standards of numerous States will be particularly burdensome for employers.

The Department has retained the proposed language regarding common law marriage in the Final Rule. The Department believes that the language regarding common law marriage in the definition of “spouse” in the Final Rule will not result in a significant change in employers' administration of the FMLA. Common law marriages have been included in the definition of spouse under the FMLA since 1995. § 825.113(a) (1995).3 While the majority of States do not permit the formation of common law marriages within their borders, these States generally will recognize a common law marriage that was validly entered into in another State. Therefore, under the current regulation, looking to the law of the State in which the employee resides to determine the existence of a common law marriage will often require looking, in turn, to the common law marriage standards of another State. For example, under the current regulation, an FMLA-eligible employee of a covered employer who validly entered into an opposite sex common law marriage in Alabama, a State that permits the formation of common law marriages, and later relocated to North Dakota, a State that does not permit the formation of common law marriages, would be considered to have a legal marriage and would be entitled to FMLA spousal leave.

3 This definition was not changed in the 2008 and 2013 rulemakings. See 73 FR 67934; 78 FR 8834.

The only change from the current definition of spouse to the definition in the Final Rule in regards to common law marriage is that in States that permit same-sex common law marriages, employees who have entered into a same-sex common law marriage in those States will now be eligible to take FMLA spousal leave regardless of the State in which they reside. In response to Family Equality's comment above, the Department believes that the language used in the proposed definition and adopted in the Final Rule already encompasses spouses in same-sex common law marriages.

Moreover, under both the current and revised definitions of spouse, an employer would only need to know the common law marriage standards for a particular State for confirmation purposes in the event that an eligible employee requests FMLA leave to care for a spouse, child, or parent and the basis for the family relationship is a common law marriage. The Department does not believe that this will be burdensome and notes that there are organizations that provide information to the public on the status of common law marriages in the 50 States within the United States. Some examples of organizations that provide this information include http://www.nolo.com/legal-encyclopedia/common-law-marriage-faq-29086-2.html and http://usmarriagelaws.com/search/united_states/common_law_marriage/. Finally, the Department notes that in its experience, the inclusion of common law marriages within the definition of spouse has not caused problems in the last 20 years and the Department does not anticipate that the Final Rule's recognition of common law marriages based on the place of celebration will result in any significant problems.

A few commenters addressed the documentation that employers may require from employees to confirm a family relationship. SHRM recommended that the Department clarify the type of proof an employer may require to confirm that an employee has a valid marriage, and permit employers to ask for documentation of proof of marriage on a case-by-case basis. FMI commented that it will be burdensome for employers to determine whether a common law marriage is valid, and requested guidance on how to confirm the existence of a common law marriage. Due to these concerns, this commenter recommended that the definition of spouse be revised to apply only to those who have a valid, government-issued document recognizing the marriage, such as a marriage certificate, court order, or letter from a federal agency such as the Social Security Administration. The National Women's Law Center urged the Department to modify the regulation at § 825.122(k) to require that employers request documentation of a family relationship in a consistent and non-discriminatory manner so that employees in same-sex marriages are not singled out with special burdens when they attempt to exercise their FMLA rights.

The Department declines to modify the regulation at § 825.122(k). That regulation permits employers to require employees who take leave to care for a family member to provide reasonable documentation of the family relationship. Reasonable documentation may take the form of either a simple statement from the employee or documentation such as a birth certificate or court document.

In response to the comments, the Department believes that the current regulation adequately addresses the nature of the documentation that employers may require. An employee may satisfy an employer's requirement to confirm a family relationship by providing either a simple statement asserting that the requisite family relationship exists, or documentation such as a child's birth certificate, a court document, etc. It is the employee's choice whether to provide a simple statement or another type of documentation. Thus, in all cases, a simple statement of family relationship is sufficient under the regulation to satisfy the employer's request. In response to FMI's comment, the Department does not believe that it is necessary or that it would be appropriate to require government-issued documentation to confirm common law marriages when an employee can document all other marriages with a simple statement. In response to SHRM's and the National Women's Law Center's comments, the Department notes that the change to a place of celebration rule in the definition of spouse does not alter the instances in which an employer can require an employee to confirm a family relationship, nor does it alter how an employee can do so. Employers have the option to request documentation of a family relationship but are not required to do so in all instances. Employers may not, however, use a request for confirmation of a family relationship in a manner that interferes with an employee's exercise or attempt to exercise the employee's FMLA rights. See 29 U.S.C. 2615(a). The Department also notes that if an employee has already submitted proof of marriage to the employer for some other purpose, such as obtaining health care benefits for the employee's spouse, such proof is sufficient to confirm the family relationship for purposes of FMLA leave. Lastly, the Department notes that where an employee chooses to satisfy a request for documentation of family relationship with a simple statement, the employer may require that such statement be written.

Two commenters raised concerns about a tension between the proposed definition and state laws prohibiting the recognition of same-sex marriages. USCCB commented that it believed the proposed definition of spouse is “at odds” with the Supreme Court's decision in Windsor because the definition does not defer to the laws of the States that define marriage as the union of one man and one woman. The South Dakota Department of Labor and Regulation commented that same-sex marriages are not recognized or valid under the South Dakota Constitution.

The Department believes that using a place of celebration rule in the definition of spouse under the FMLA is consistent with the Court's decision in Windsor. The FMLA is a federal law that entitles eligible employees to take unpaid, job-protected leave for qualifying reasons, and the Final Rule's definition of spouse simply defines a familial relationship that may be the basis of an employee's qualifying reason to take leave. The Final Rule does not require States to recognize or give effect to same-sex marriages or to provide any state benefit based on a same-sex marriage. The Final Rule impacts States only in their capacity as employers and merely requires them to provide unpaid FMLA leave to eligible employees based on a federal definition of spouse. The Department notes that, after Windsor, the current definition of spouse already requires States in their capacity as employers to provide unpaid FMLA leave to employees in same-sex marriages if the employees reside in a different State that recognizes same-sex marriages. Moreover, the Department believes that defining the term spouse to include all legally married couples best serves the FMLA's goal of promoting “the stability and economic security of families,” and the “national interests in preserving family integrity,” 29 U.S.C. 2601, because the need to care for a spouse does not differ based on the gender of the spouses.

The Department noted in the NPRM that the proposed change to a place of celebration rule for the definition of spouse under the FMLA would also have some impact beyond spousal leave. 79 FR 36448. Specifically, the Department noted that under the Department's proposed rule, an employee in a legal same-sex marriage would be able to take leave to care for a stepchild (i.e., the employee's same-sex spouse's child) to whom the employee does not stand in loco parentis. Id. Similarly, an employee whose parent is in a legal same-sex marriage would be able to take leave to care for the parent's same-sex spouse (i.e., the employee's stepparent) who did not stand in loco parentis to the employee when the employee was a child. Id.

Several commenters addressed the interplay between the proposed rule and the Administrator's Interpretation FMLA 2010-3 (June 22, 2010) that addresses in loco parentis. See, e.g., HRC, the HRC comment campaign, the National Gay and Lesbian Task Force (Task Force), the National Center for Lesbian Rights, the Statewide Parent Advocacy Network and Family Voices. These commenters stated that basing an employee's ability to take leave to care for a child on the employee's same-sex marriage could put the employee at risk of losing the ability to take leave to care for the child should the marriage dissolve. These commenters stated that recognizing an employee as standing in loco parentis, as the Administrator's Interpretation FMLA 2010-3 does, ensures that the employee who stands in loco parentis to a child will retain the ability to take leave to care for the child despite dissolution of the marriage. Therefore, the commenters requested that the Department clarify that this rule will not affect the in loco parentis Administrator's Interpretation both in how parents are determined to stand in loco parentis and in recognizing that more than two adults may stand in loco parentis to a child. The Department recognizes that the existence of an in loco parentis relationship, using the standards set out in Administrator's Interpretation FMLA 2010-3, is an important basis for an employee to take leave to care for a child. The Department notes that it has consistently recognized the eligibility of employees to take leave to care for a child of the employee's same-sex partner (whether the employee and the partner are married or not) provided that the employee meets the in loco parentis requirement of providing day-to-day care or financial support for the child. Id.; see Administrator's Interpretation FMLA 2010-3 (June 22, 2010). For example, where an employee and the employee's same-sex spouse provide day-to-day care for the same-sex spouse's biological child, if the marriage dissolves but the employee continues to have an in loco parentis relationship with the child, the employee would be able to take leave to care for the child notwithstanding the dissolution of the marriage.

The Department did not intend for the proposed rule to have any impact on the standards for in loco parentis set out in the Administrator's Interpretation and this Final Rule has no impact on the standards for determining the existence of an in loco parentis relationship set out in Administrator's Interpretation FMLA 2010-3. Rather, the place of celebration rule means that employees in same-sex marriages, regardless of the State in which they reside, do not need to establish the requirements for in loco parentis for their spouse's child (the employee's stepchild) in order to take leave to care for the child. Only one type of relationship need apply for an employee to satisfy the requisite family relationship under the FMLA. See 825.102, which defines “son or daughter” to include a stepchild; see also 825.122(d), 825.122(h), and 825.122(i). Thus, the place of celebration rule expands the basis for an employee to take leave to care for a child.

A few commenters also expressed concern about the regulatory definition of “parent” in § 825.122(c), which provides that a parent means a biological, adoptive, step or foster father or mother, or any other individual who stood in loco parentis to the employee when the employee was a son or daughter as defined in paragraph (d) of this section.4 These commenters suggested that, as currently worded, the definition could be read to imply either that a particular adult may be recognized as a biological, adoptive, step, or foster parent, or as a person who stood in loco parentis, but not both, or that a biological, adoptive, step, or foster parent must meet the criteria of in loco parentis. See, e.g., NMAC, HRC, Family Equality, Task Force. These commenters requested that the Department modify the definition of parent to avoid such misinterpretation.

4 While the commenters cited only to § 825.122(c), this same definition of parent is contained in § 825.102.

The Department declines to modify the definition of parent as suggested. The Department believes that the definition of parent as currently worded is not causing confusion. Nonetheless, the Department understands that further clarification may be useful. As an initial matter, the Department notes that the definition of parent in § 825.122(c) is relevant only to instances of an employee needing FMLA leave to care for a parent or to attend to a qualifying exigency arising out of the parent's military service. It is not relevant to instances of an employee needing to take leave to care for the employee's child. The regulatory definition of parent lists various types of parents, separated by commas. §§ 825.102, 825.122(c). The term “any other individual who stood in loco parentis to the employee when the employee was a son or daughter as defined in paragraph (d) of this section” is set off by a comma from the list of other types of parents (i.e., “biological, adoptive, step or foster father or mother”). By setting the phrase off by a comma, the Department believes it is clear that in loco parentis applies only to “any other individual”; it does not apply to a “biological, adoptive, step or foster father or mother.” When an employee seeks leave to care for a biological, adoptive, step, or foster parent, there is no need to inquire whether the parent stood in loco parentis to the employee; that parent automatically satisfies the definition of “parent” for FMLA purposes and an analysis of whether the in loco parentis requirements are met is not necessary.

Two commenters addressed the publication and effective date of the Final Rule. FMI requested that the Department delay publication of the Final Rule until the Department provides guidance on how employers can confirm the existence of an employee's common law marriage. The National Business Group on Health requested that the Department delay the effective date of the Final Rule for at least 12 months to allow employers time to modify their policies and procedures. The Department does not believe that any delay is warranted given the limited scope of this Final Rule. Therefore, the Final Rule will become effective 30 days after publication.

Lastly, notwithstanding the Final Rule's definition of spouse as including all legally married couples according to the law of the place of celebration, an employer may, of course, offer an employment benefit program or plan that provides greater family or medical leave rights to employees than the rights established by the FMLA. See § 825.700(a). FMLA regulations state: “[N]othing in the Act is intended to discourage employers from adopting or retaining more generous leave policies.” § 825.700(b).

V. Conforming Changes

Minor editorial changes were proposed to §§ 825.120, 825.121, 825.122, 825.127, 825.201 and 825.202 to make references to husbands and wives, and mothers and fathers gender neutral where appropriate so that they apply equally to opposite-sex and same-sex spouses. The Department proposed using the terms “spouses” and “parents,” as appropriate, in these regulations. As stated in the NPRM, these editorial changes do not change the availability of FMLA leave but simply clarify its availability for all eligible employees who are legally married. 79 FR 36449. The Department received no comments on these changes and adopts them as proposed.

VI. Paperwork Reduction Act

The Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq., and its attendant regulations, 5 CFR part 1320, require that the Department consider an agency's need for its information collections, their practical utility, the impact of paperwork and other information collection burdens imposed on the public, and how to minimize those burdens. Under the PRA, an agency may not collect or sponsor the collection of information, nor may it impose an information collection requirement unless it displays a currently valid Office of Management and Budget (OMB) control number. See 5 CFR 1320.8(b)(3)(vi).

OMB has assigned control number 1235-0003 to the FMLA information collections. As required by the PRA (44 U.S.C. 3507(d)), the Department has submitted these proposed information collection amendments to OMB for its review. The Department will publish a notice in the Federal Register to announce the result of the OMB review.

Summary: The Department seeks to minimize the paperwork burden for individuals, small businesses, educational and nonprofit institutions, federal contractors, state, local, and tribal governments, and other persons resulting from the collection of information by or for the agency. The PRA typically requires an agency to provide notice and seek public comments on any proposed collection of information contained in a proposed rule. See 44 U.S.C. 3506(c)(2)(B); 5 CFR 1320.8.

The Department's Final Rule revises the regulation defining “spouse” under the FMLA, in light of the United States Supreme Court's holding that section 3 of the Defense of Marriage Act is unconstitutional. Amending the definition of spouse to include all legally married spouses as recognized under state law for purposes of marriage in the State where the marriage was entered into or, in the case of a marriage entered into outside of any State, if the marriage is valid in the place where entered into and could have been entered into in at least one State, expands the availability of FMLA leave to legally married same-sex spouses regardless of the State in which they reside. Under the revised definition of spouse, eligible employees are able to take FMLA leave based on a same-sex marital relationship regardless of the state in which they reside.

In light of the June 26, 2013 Windsor decision and under the current regulation, employees in same-sex marriages have the right to take FMLA leave based on their same-sex marriage only if they reside in a State that recognizes same-sex marriage. In contrast, under the Final Rule's place of celebration rule, all eligible employees in same-sex marriages will be able to take FMLA leave based on their marital relationship, regardless of their state of residence. These information collection amendments update the burden estimates to include same-sex couples nationwide—both employees whom Windsor rendered eligible to take FMLA leave under the current regulation and employees who will be able to take such leave due to the changes in this Final Rule.

Covered, eligible employees in same-sex marriages are already eligible to take FMLA leave for certain FMLA qualifying reasons (e.g., the employee's own serious health condition, the employee's parent's or child's serious health condition, etc.). This Final Rule does not increase the number of employees eligible to take FMLA leave; rather, it allows employees in same-sex marriages to take FMLA leave on the basis of their marriage regardless of their state of residence, in addition to the other reasons for which they were already able to take leave. That is, FMLA coverage and eligibility provisions are unchanged by this Final Rule, and employees who were not previously eligible and employed by a covered establishment do not become eligible as a result of this rule.

Accordingly, the Department developed an estimate that focuses on FMLA leave that employees can currently and will be able to take to care for a family member based on a same-sex marital relationship. The final regulations, which do not substantively alter the FMLA but instead allow FMLA leave to be taken on the basis of an employee's same-sex marriage regardless of their state of residence, will create additional burdens on some of the information collections.

Circumstances Necessitating Collection: The FMLA, 29 U.S.C. 2601, et seq., requires private sector employers who employ 50 or more employees, all public and private elementary schools, and all public agencies to provide up to 12 weeks of unpaid, job-protected leave during any 12-month period to eligible employees for certain family and medical reasons (i.e., for birth of a son or daughter and to care for the newborn child; for placement with the employee of a son or daughter for adoption or foster care; to care for the employee's spouse, son, daughter, or parent with a serious health condition; because of a serious health condition that makes the employee unable to perform the functions of the employee's job; to address qualifying exigencies arising out of the deployment of the employee's spouse, son, daughter, or parent to covered active duty in the military), and up to 26 workweeks of unpaid, job-protected leave during a single 12-month period to an eligible employee who is the spouse, son, daughter, parent, or next of kin of a covered servicemember with a serious injury or illness for the employee to provide care for the servicemember. FMLA section 404 requires the Secretary of Labor to prescribe such regulations as necessary to enforce this Act. 29 U.S.C. 2654.

The Department's authority for the collection of information and the required disclosure of information under the FMLA stems from the statute and/or the implementing regulations.

Purpose and Use: No WHD forms or other information collections are changed by this Final Rule, except in when they may apply. While the use of the Department's FMLA forms is optional, the regulations require employers and employees to make the third-party disclosures that the forms cover. The FMLA third-party disclosures ensure that both employers and employees are aware of and can exercise their rights and meet their respective obligations under the FMLA.

Technology: The regulations prescribe no particular order or form of records. See § 825.500(b). Employers may maintain records in any format, including electronic, when adhering to the recordkeeping requirements covered by this information collection. The preservation of records in such forms as microfilm or automated word or data processing memory is acceptable, provided the employer maintains the information and provides adequate facilities to the Department for inspection, copying, and transcription of such records. Photocopies of records are also acceptable under the regulations. Id.

Aside from the general requirement that third-party notifications be in writing, with a possible exception for the employee's FMLA request that depends on the employer's leave policies, there are no restrictions on the method of transmission. Respondents may meet many of their notification obligations by using Department-prepared publications available on the WHD Web site, www.dol.gov/whd. These forms are in PDF, fillable format for downloading and printing.

Duplication: The FMLA information collections do not duplicate other existing information collections. In order to provide all relevant FMLA information in one set of requirements, the recordkeeping requirements restate a portion of the records employers must maintain under the Fair Labor Standards Act (FLSA). Employers do not need to duplicate the records when basic records maintained to meet FLSA requirements also document FMLA compliance. With the exception of records specifically tracking FMLA leave, the additional records required by the FMLA regulations are records that employers ordinarily maintain in the usual and ordinary course of business. The regulations do impose, however, a three-year minimum time limit that employers must maintain such records. The Department minimizes the FMLA information collection burden by accepting records maintained by employers as a matter of usual or customary business practices to the extent those records meet the FMLA requirements. The Department also accepts records kept due to other governmental requirements (e.g., records maintained for tax and payroll purposes). The Department has reviewed the needs of both employers and employees to determine the frequency of the third-party notifications covered by this collection to establish frequencies that provide timely information with the least burden. The Department has further minimized the burden by developing prototype notices for many of the third-party disclosures covered by this information collection.

Minimizing Small Entity Burden: The Department minimizes the FMLA information collection burden by accepting records maintained by employers as a matter of usual or customary business practices. The Department also accepts records kept due to requirements of other governmental requirements (e.g., records maintained for tax and payroll purposes). The Department has reviewed the needs of both employers and employees to determine the frequency of the third-party notifications covered by this collection to establish frequencies that provide timely information with the least burden. The Department has further minimized burden by developing prototype notices for many of the third-party disclosures covered by this information collection and giving the text employers must use, in accordance with FMLA section 109 (29 U.S.C. 2619), in providing a general notice to employees of their FMLA rights and responsibilities, in addition to the prototype optional-use forms.

Agency Need: The Department is assigned a statutory responsibility to ensure employer compliance with the FMLA. The Department uses records covered by this information collection to determine compliance, as required of the agency by FMLA section 107(b)(1). 29 U.S.C. 2617(b)(1). Without the third-party notifications, the Department would have difficulty determining the extent to which employers and employees had met their FMLA obligations.

Special Circumstances: Because of the unforeseeable and often urgent nature of the need for FMLA leave, notice and response times must be of short duration to ensure that employers and employees are sufficiently informed and can exercise their FMLA rights and satisfy their FMLA obligations.

Privacy: Employers must maintain employee medical information they obtain for FMLA purposes as confidential medical records separately from other personnel files. Employers must also maintain such records in conformance with any applicable Americans with Disabilities Act and Genetic Information Nondiscrimination Act confidentiality requirements, except that: Supervisors and managers may be informed regarding necessary restrictions on the work or duties of an employee and necessary accommodations; first aid and safety personnel may be informed (when appropriate) if the employee's physical or medical condition might require emergency treatment; and government officials investigating compliance with FMLA (or other pertinent law) shall be provided relevant information upon request.

Agency: Wage and Hour Division.

Title of Collection: The Family and Medical Leave Act, as Amended.

OMB Control Number: 1235-0003.

Affected Public: Individuals or Households; Private Sector—Businesses or other for profits and not for profit institutions, farms, state, local, and tribal governments.

Total estimated number of respondents: 7,182,916 (no change).

Total estimated number of responses: 82,371,724 (38,106 responses added by this Final Rule).

Total estimated annual burden hours: 9,313,503 (4,918 hours added by this Final Rule).

Burden Cost: $236,283,571 ($124,770 from this final rule).

Other Respondent Cost Burden (capital/start-up): 0.$

Other Respondent Cost Burden (operations/maintenance): $184,932,912 ($108,326 (rounded) from this final rule).

The PRA requires agencies to consider public comments on information collections and to explain in final rules how public engagement resulted in changes from proposed rules. The Department discussed public comments regarding comments on documentation requirements related to establishing a family relationship earlier in this rulemaking.

VII. Executive Orders 12866 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review)

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Although this rule is not economically significant within the meaning of Executive Order 12866, it has been reviewed by OMB.

The Department revised the regulatory definition of “spouse” for the purpose of the FMLA to allow all legally married employees to take leave to care for their spouse regardless of whether their state of residence recognizes their marriage. As a result of this Final Rule, covered and eligible employees will be entitled to take FMLA leave regardless of their state of residence to care for their same-sex spouse with a serious health condition; to care for a stepchild with a serious health condition to whom the employee does not stand in loco parentis; to care for their parent's same-sex spouse with a serious health condition who did not stand in loco parentis to the employee when the employee was a child; for qualifying exigency reasons related to the covered active duty of their same-sex spouse; and to care for their same-sex spouse who is a covered servicemember with a serious injury or illness. This Final Rule will not expand coverage under the FMLA; that is, the coverage and eligibility provisions of the FMLA are unchanged by this rule and employees who were not previously eligible and employed by a covered establishment will not become eligible as a result of this Final Rule.

Estimates of the number of individuals in same-sex marriages vary widely due to issues with state level data tracking, reliance on self-reporting, and changes in survey formatting. The Department bases its estimate of same-sex marriages on the 2013 American Community Survey (ACS), conducted by the U.S. Census Bureau. The 2013 ACS showed 251,695 self-reported same-sex marriages, which represents 503,390 individuals. The Department estimates, based on the 2013 ACS, that in 45.2 percent of same-sex marriages both partners are employed and, for the purposes of this analysis, the Department assumes that one spouse is employed in the remaining 54.8 percent of same-sex marriages.5

5 U.S. Census Bureau, 2013. American Community Survey 1-year data file. Table 1: Household Characteristics of Opposite-Sex and Same-Sex Couple Households; and, Table 2: Household Characteristics of Same-Sex Couple Households by Assignment Status. Available at: http://www.census.gov/hhes/samesex/.

The Department recently surveyed employers and employees nationwide on FMLA leave taking, Family and Medical Leave in 2012.6 Based on these survey findings, 59.2 percent of employees meet the eligibility requirements for FMLA leave and are employed by covered establishments.7 Of those employees, 16.8 percent were married and took FMLA leave 8 and of those who took leave, 17.6 percent took leave to care for a parent, spouse, or child, and 1.4 percent took leave to address issues related to a military family member's covered active duty.9 Applying these findings to the number of individuals in same-sex marriages based on the 2013 ACS results in an estimated 8,202 new instances of FMLA leave annually as a result of the proposed change to the regulatory definition of spouse.10 11 This likely overestimates the number of instances of new leave that would be taken, as covered and eligible employees in same-sex marriages were already entitled in most instances to take FMLA leave to care for a parent or child with a serious health condition.

6 See Wage and Hour Division FMLA Surveys Web page at: http://www.dol.gov/whd/fmla/survey/.

7 Family and Medical Leave in 2012: Technical Report, exhibit 2.2.1, page 20, available at: http://www.dol.gov/asp/evaluation/fmla/FMLA-2012-Technical-Report.pdf.

8 Family and Medical Leave in 2012: Technical Report, exhibit 4.1.5, page 64.

9 Family and Medical Leave in 2012: Technical Report, exhibits 4.4.2, page 70, and 4.4.7, page 74.

10 (251,695 marriages × 45.2 percent × 2) + (251,695 × 54.8 percent) = 227,532 + 137,929 = 365,461 employed same-sex spouses.

365,461 employees × 59.2 percent = 216,353 covered, eligible employees.

216,353 × 16.8 percent = 36,347 covered, eligible employees taking leave.

In past rulemakings the Department has estimated that covered, eligible employees taking leave take 1.5 instances of leave per year for traditional FMLA purposes, 13 instances of leave per year for qualifying exigency purposes, 44 instances of leave per year for military caregiver leave to care for an active-duty servicemember, and 51 instances of leave per year for military caregiver leave to care for a covered veteran. The Department uses those same estimates for this analysis. The Department estimates a weighted average for an employee who takes military caregiver leave at 45.4 instances of leave per year ((29,100 respondents × 44 responses) + (6,966 respondents × 51 responses) → 1,280,400 + 355,266 = 1,635,666 → 1,635,666/(29,100 + 6,966) = 45.4).

To determine total new instances of leave, the Department first totaled the number of respondents per type of leave, then determined the percentage that respondents for each type of leave represent of all total respondents, and lastly, applied these percentages and the averages of instances of leave per type of leave to the Department's estimate of 36,347 same-sex, married employees who are FMLA-covered, FMLA-eligible and actually take FMLA leave per year. These calculations are as follows:

Traditional FMLA leave respondents: 7,000,000 + 5,950 = 7,005,950

Qualifying Exigency leave respondents: 110,000 + 30,900 = 140,900

Military Caregiver (all) leave respondents: 29,100 + 6,966 = 36,066

Total respondents: 7,182,916.

Percentage that each type of leave represents of all total respondents:

Traditional FMLA leave respondents: 7,005,950/7,182,916 = 0.9754 or 97.54 percent.

Qualifying Exigency leave respondents: 140,900/7,182,916 = 0.0196 or 1.96 percent.

Military Caregiver (all) leave respondents: 36,066/7,182, 916 = 0.0050 or 0.50 percent.

36,347 employees × 0.9754 × 1.5 = 53,180 instances of traditional leave

36,347 employees × 0.0196 × 13 = 9,256 instances of qualifying exigency leave

36,347 employees × 0.0050 × 45.4 = 8,263 instances of military caregiver leave

Total instances of leave or responses taken by individuals in same-sex marriages: 70,699.

70,699 × 17.6 percent = 12,443 instances of leave to care for a parent, spouse, or child.

70,699 × 1.4 percent = 990 instances of leave for qualifying exigency reasons.

70,699 × 1.4 percent = 990 instances of leave for military caregiver reasons.

The Department assumes that half (6,222) of the 12,443 instances of leave for the employee's parent, child, or spouse would be taken for the employee's same-sex spouse, stepchild, or stepparent, in recognition of the fact that an employee with a same-sex partner is already able to take leave to care for the employee's parent or child.

6,222 + 990 + 990 = 8,202 new instances of FMLA leave.

11 PRA analysis estimates burdens imposed by the “paperwork” requirements, while E.O. 12866 analysis estimates the effect the proposed regulations will have on the economy. Because E.O. 12866 and the PRA impose differing requirements, and because the corresponding analyses are intended to meet different needs, the estimated number of instances of leave in the PRA analysis differs from the estimated number in the E.O. 12866 analysis.

Because FMLA leave is unpaid leave, the costs to employers resulting from this Final Rule are: regulatory familiarization, maintenance of preexisting employee health benefits during FMLA leave, and administrative costs associated with providing required notices to employees, requesting certifications, reviewing employee requests and medical certifications, and making necessary changes to employer policies. The costs related to requesting and reviewing employee requests for leave and certifications and of providing required notices to employees are discussed in the Paperwork Reduction Act section of this Final Rule. The Department expects the remaining costs to be minimal to employers. The Department has determined that this rule will not result in an annual effect on the economy of $100 million or more. No comments were received on the Department's regulatory impact analysis.

VIII. Final Regulatory Flexibility Analysis

The Regulatory Flexibility Act of 1980 (RFA) as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), hereafter jointly referred to as the RFA, requires agencies to evaluate the potential effects of their proposed and final rules on small businesses, small organizations and small governmental jurisdictions. See 5 U.S.C. 603-604. If the rule is not expected to have a significant economic impact on a substantial number of small entities, the RFA allows an agency to certify such, in lieu of preparing an analysis. See 5 U.S.C. 605.

The Department certifies that this Final Rule does not have a significant economic impact on a substantial number of small entities within the meaning of the RFA. Therefore, a final regulatory flexibility analysis is not required. The factual basis for this certification is set forth below.

This Final Rule amending the FMLA regulations' definition of spouse will not substantively alter current FMLA regulatory requirements, but instead will allow more employees to take leave based on a same-sex marital relationship. The Department estimates that this definitional revision will result in 6,222 new instances of FMLA leave taken to care for an employee's same-sex spouse, stepchild, or stepparent; 990 new instances for qualifying exigency purposes; and 990 new instances for military caregiver purposes. These numbers reflect the Department's estimate that a total of 8,202 new instances of FMLA leave might be taken as a result of this Final Rule, as detailed in the Executive Orders 12866 and 13563 section of this Final Rule preamble. This likely overestimates the number of new instances of leave-taking as covered and eligible employees in same-sex marriages are already entitled in most cases to take FMLA leave to care for a parent or child with a serious health condition.

Because the FMLA does not require the provision of paid leave, the costs of this rule are limited to the cost of hiring replacement workers, maintenance of employer-provided health insurance to the employee while on FMLA leave, compliance with the FMLA's notice requirements, and regulatory familiarization.

The need to hire replacement workers represents a possible cost to employers. In some businesses employers are able to redistribute work among other employees while an employee is absent on FMLA leave, but in other cases the employer may need to hire temporary replacement workers. This process involves costs resulting from recruitment of temporary workers with needed skills, training the temporary workers, and lost or reduced productivity of these workers. The cost to compensate the temporary workers is in most cases offset by the amount of wages not paid to the employee absent on FMLA leave, when the employee's FMLA leave is unpaid (i.e., the employee is not using accrued sick or vacation leave).

In the first FMLA rulemaking, the Department drew upon available research to suggest that the cost per employer to adjust for workers who are on FMLA leave is fairly small. 58 FR 31810. Subsequent rulemakings have not produced evidence to the contrary; therefore, for the purpose of this discussion, the Department will continue to assume that these costs are fairly small. Furthermore, most employers subject to this Final Rule have been subject to the FMLA for some time and have already developed internal systems for work redistribution and recruitment of temporary workers.

Additionally, one cost to employers consists of the health insurance benefits maintained by employers during employees' FMLA leave. Based on the Department's recent survey on FMLA leave, Family and Medical Leave in 2012, the average length of leave taken in one year by a covered, eligible employee is 27.5 days.12 Assuming that most employees worked an eight-hour day, the average length of FMLA leave for an employee totals 220 hours in a given year.

12 2012 FMLA survey data showed that employees' average length of leave in past twelve months was 27.5 days. Family and Medical Leave in 2012: Technical Report, page 68, available at: http://www.dol.gov/asp/evaluation/fmla/FMLA-2012-Technical-Report.pdf.

Further, based on methodology used in the 2008 Final Rule, which first implemented the FMLA's military leave provisions, the Department estimates that a covered, eligible employee will take 200 hours of FMLA leave for qualifying exigency leave under § 825.126 in a given year. Additionally, using the same methodology, the Department estimates that a covered, eligible employee will take 640 hours of FMLA leave for military caregiver leave in a given year under § 825.127. 73 FR 68051.

To calculate the costs of providing health insurance, the Department utilizes data from the BLS Employer Costs for Employee Compensation survey. According to BLS' March, 2014 report, employers spend an average of $2.45 per hour on insurance.13 Cost estimates are derived by multiplying the average leave duration with both the number of new instances of FMLA leave taken in each category and the $2.45 hourly cost to employers for health insurance, as follows:

13http://bls.gov/ro7/ro7ecec.htm.

Estimated annual employer benefits cost for FMLA leave taken for employee's same-sex spouse, stepchild, or stepparent: $3,353,658 (6,222 new instances × 220 hours 14 × $2.45)

14 Note that 220 hours (27.5 days) is likely an overestimate, since some of these hours would be for FMLA leave that the employee was already eligible to take (e.g., leave for employee's parent, spouse, or child).

Estimated annual employer benefit cost for FMLA leave taken for qualifying exigency leave: $485,100 (990 new instances × 200 hours × $2.45)

Estimated annual employer benefit cost for FMLA leave taken for military caregiver leave: $1,552,320 (990 new instances × 640 hours × $2.45).

Assuming that all covered, eligible employees taking FMLA leave receive employer-provided health insurance benefits, the estimated total cost to employers for providing benefits is $5,391,078 ($3,353,658 + $485,100 + $1,552,320).

Further, employers will incur costs related to the increase in the number of required notices and responses to certain information collections due to this Final Rule. As explained in the Paperwork Reduction Act section of this Final Rule preamble, the Department has estimated the paperwork burden cost associated with this regulatory change to be $233,096 per year.

Lastly, in response to this Final Rule, each employer will need to review the definitional change, determine what revisions are necessary to their policies, and update their handbooks or other leave-related materials to incorporate any needed changes. This is a one-time cost to each employer, calculated as 30 minutes at the hourly wage of a Human Resources Specialist. The median hourly wage of a Human Resources Specialist is $27.23 plus 40 percent in fringe benefits, which results in a total hourly rate of $38.12 (($27.23 × 0.40) + $27.23). See BLS Occupational Employment Statistics, Occupational Employment and Wages, May 2013 (http://www.bls.gov/oes/current/oes131071.htm). The Department estimates total annual respondent costs for the value of their time dedicated to regulatory familiarization costs to be $7,261,860 ($38.12 × 0.5 hour × 381,000 covered firms and government agencies with 1.2 million establishments subject to the FMLA).

Therefore, the Department estimates the total cost of this Final Rule to be $12,886,034 ($5,391,078 in employer provided health benefits + $233,096 in paperwork burden cost + $7,261,860 in regulatory familiarization costs).

The Department believes this to be an overestimate. The FMLA applies to public agencies and to private sector employers that employ 50 or more employees for each working day during 20 or more calendar weeks in the current or preceding calendar year. 29 U.S.C. 2611(4). In addition, the FMLA excludes employees from eligibility for FMLA leave if the total number of employees employed by that employer within 75 miles of that employee's worksite is less than 50. 29 U.S.C. 2611(2)(B)(ii). Therefore, changes to the FMLA regulations by definition will not impact small businesses with fewer than 50 employees. The Department acknowledges that some small employers that are within the SBA definition of small business (50-500 employees) will still have to comply with the regulation and incur costs.

In its 2012 proposed rule, the Department estimated there were 381,000 covered firms and government agencies with 1.2 million establishments subject to the FMLA. 77 FR 8989. Applying the SBA size definitions for small entities, the Department estimated that approximately 83 percent, or 314,751 employers, are small entities subject to the FMLA. 77 FR 9004. Dividing the total cost of this Final Rule by the Department's estimate for the number of affected small entities results in an annual cost per small entity of $40.77 ($12,831,808/314,751 small entities). This is not deemed a significant cost. In addition, if the Department assumed that all covered employers were small entities, the annual cost per small entity would only be $33.82 ($12,886,034/381,000 small entities). This also is not deemed a significant cost.

The Department received no comments on its determination that the proposed rule would not have a significant economic impact on a substantial number of small entities within the meaning of the RFA. The Department certifies to the Chief Counsel for Advocacy that this Final Rule will not have a significant economic impact on a substantial number of small entities.

IX. Unfunded Mandates Reform Act

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments as well as on the private sector. Under section 202(a) of UMRA, the Department must generally prepare a written statement, including a cost-benefit analysis, for proposed and final regulations that “includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector” in excess of $100 million in any one year ($141 million in 2012 dollars, using the Gross Domestic Product deflator).

State, local, and tribal government entities are within the scope of the regulated community for this regulation. The Department has determined that this Final Rule contains a federal mandate that is unlikely to result in expenditures of $141 million or more for state, local, and tribal governments, in the aggregate, or the private sector in any one year.

X. Executive Order 13132, Federalism

This Final Rule does not have federalism implications as outlined in E.O. 13132 regarding federalism. Although States are covered employers under the FMLA, this Final Rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

XI. Executive Order 13175, Indian Tribal Governments

This Final Rule was reviewed under the terms of E.O. 13175 and determined not to have “tribal implications.” This Final Rule also does not have “substantial direct effects 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.” As a result, no tribal summary impact statement has been prepared.

XII. Effects on Families

The undersigned hereby certifies that this Final Rule will not adversely affect the well-being of families, as discussed under section 654 of the Treasury and General Government Appropriations Act, 1999.

XIII. Executive Order 13045, Protection of Children

E.O. 13045 applies to any rule that (1) is determined to be “economically significant” as defined in E.O. 12866, and (2) concerns an environmental health or safety risk that the promulgating agency has reason to believe may have a disproportionate effect on children. This Final Rule is not subject to E.O. 13045 because it is not economically significant as defined in Executive Order 12866 and, although the rule addresses family and medical leave provisions of the FMLA, it does not concern environmental health or safety risks that may disproportionately affect children.

XIV. Environmental Impact Assessment

A review of this Final Rule in accordance with the requirements of the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321 et seq.; the regulations of the Council on Environmental Quality, 40 CFR 1500 et seq.; and the Departmental NEPA procedures, 29 CFR part 11, indicates that this Final Rule will not have a significant impact on the quality of the human environment. Thus, no corresponding environmental assessment or environmental impact statement have been prepared.

XV. Executive Order 13211, Energy Supply

This Final Rule is not subject to E.O. 13211. It will not have a significant adverse effect on the supply, distribution, or use of energy.

XVI. Executive Order 12630, Constitutionally Protected Property Rights

This Final Rule is not subject to E.O. 12630, because it does not involve implementation of a policy “that has takings implications” or that could impose limitations on private property use.

XVII. Executive Order 12988, Civil Justice Reform Analysis

This rule was drafted and reviewed in accordance with E.O. 12988 and will not unduly burden the federal court system. This Final Rule was: (1) Reviewed to eliminate drafting errors and ambiguities; (2) written to minimize litigation; and (3) written to provide a clear legal standard for affected conduct and to promote burden reduction.

List of Subjects in 29 CFR Part 825

Employee benefit plans, Health, Health insurance, Labor management relations, Maternal and child health, Teachers.

Signed at Washington, DC, this 18th day of February, 2015. David Weil, Administrator, Wage and Hour Division.

For the reasons set forth in the preamble, the Department amends Title 29, Part 825 of the Code of Federal Regulations as follows:

PART 825—THE FAMILY AND MEDICAL LEAVE ACT OF 1993 1. The authority citation for part 825 continues to read as follows: Authority:

29 U.S.C. 2654.

2. In § 825.102 revise the definition of “spouse” to read as follows:
§ 825.102 Definitions.

Spouse, as defined in the statute, means a husband or wife. For purposes of this definition, husband or wife refers to the other person with whom an individual entered into marriage as defined or recognized under state law for purposes of marriage in the State in which the marriage was entered into or, in the case of a marriage entered into outside of any State, if the marriage is valid in the place where entered into and could have been entered into in at least one State. This definition includes an individual in a same-sex or common law marriage that either:

(1) Was entered into in a State that recognizes such marriages; or

(2) If entered into outside of any State, is valid in the place where entered into and could have been entered into in at least one State.

3. Amend § 825.120 by: a. Revising paragraph (a)(1); b. Revising the first and fifth sentences of paragraph (a)(2); c. Revising the first, second, fifth, and last sentences of paragraph (a)(3); d. Revising the first and fourth sentences of paragraph (a)(4); e. Revising the first sentence of paragraph (a)(5); f. Revising paragraph (a)(6); and g. Revising the sixth sentence of paragraph (b).

The revisions to read as follows:

§ 825.120 Leave for pregnancy or birth.

(a) * * *

(1) Both parents are entitled to FMLA leave for the birth of their child.

(2) Both parents are entitled to FMLA leave to be with the healthy newborn child (i.e., bonding time) during the 12-month period beginning on the date of birth. * * * Under this section, both parents are entitled to FMLA leave even if the newborn does not have a serious health condition.

(3) Spouses who are eligible for FMLA leave and are employed by the same covered employer may be limited to a combined total of 12 weeks of leave during any 12-month period if the leave is taken for birth of the employee's son or daughter or to care for the child after birth, for placement of a son or daughter with the employee for adoption or foster care or to care for the child after placement, or to care for the employee's parent with a serious health condition. This limitation on the total weeks of leave applies to leave taken for the reasons specified as long as the spouses are employed by the same employer. * * * Where spouses both use a portion of the total 12-week FMLA leave entitlement for either the birth of a child, for placement for adoption or foster care, or to care for a parent, the spouses would each be entitled to the difference between the amount he or she has taken individually and 12 weeks for FMLA leave for other purposes. * * * Note, too, that many state pregnancy disability laws specify a period of disability either before or after the birth of a child; such periods would also be considered FMLA leave for a serious health condition of the birth mother, and would not be subject to the combined limit.

(4) The expectant mother is entitled to FMLA leave for incapacity due to pregnancy, for prenatal care, or for her own serious health condition following the birth of the child. * * * The expectant mother is entitled to leave for incapacity due to pregnancy even though she does not receive treatment from a health care provider during the absence, and even if the absence does not last for more than three consecutive calendar days. * * *

(5) A spouse is entitled to FMLA leave if needed to care for a pregnant spouse who is incapacitated or if needed to care for her during her prenatal care, or if needed to care for her following the birth of a child if she has a serious health condition. * * *

(6) Both parents are entitled to FMLA leave if needed to care for a child with a serious health condition if the requirements of §§ 825.113 through 825.115 and 825.122(d) are met. Thus, spouses may each take 12 weeks of FMLA leave if needed to care for their newborn child with a serious health condition, even if both are employed by the same employer, provided they have not exhausted their entitlements during the applicable 12-month FMLA leave period.

(b) * * * The employer's agreement is not required for intermittent leave required by the serious health condition of the expectant mother or newborn child. * * *

4. Amend § 825.121 by: a. Revising the first, second, and fifth sentences of paragraph (a)(3); and b. Revising the second sentence of paragraph (a)(4).

The revisions to read as follows:

§ 825.121 Leave for adoption or foster care.

(a) * * *

(3) Spouses who are eligible for FMLA leave and are employed by the same covered employer may be limited to a combined total of 12 weeks of leave during any 12-month period if the leave is taken for the placement of the employee's son or daughter or to care for the child after placement, for the birth of the employee's son or daughter or to care for the child after birth, or to care for the employee's parent with a serious health condition. This limitation on the total weeks of leave applies to leave taken for the reasons specified as long as the spouses are employed by the same employer. * * * Where spouses both use a portion of the total 12-week FMLA leave entitlement for either the birth of a child, for placement for adoption or foster care, or to care for a parent, the spouses would each be entitled to the difference between the amount he or she has taken individually and 12 weeks for FMLA leave for other purposes. * * *

(4) * * * Thus, spouses may each take 12 weeks of FMLA leave if needed to care for an adopted or foster child with a serious health condition, even if both are employed by the same employer, provided they have not exhausted their entitlements during the applicable 12-month FMLA leave period.

5. Revise § 825.122(b) to read as follows:
§ 825.122 Definitions of covered servicemember, spouse, parent, son or daughter, next of kin of a covered servicemember, adoption, foster care, son or daughter on covered active duty or call to covered active duty status, son or daughter of a covered servicemember, and parent of a covered servicemember.

(b) Spouse, as defined in the statute, means a husband or wife. For purposes of this definition, husband or wife refers to the other person with whom an individual entered into marriage as defined or recognized under state law for purposes of marriage in the State in which the marriage was entered into or, in the case of a marriage entered into outside of any State, if the marriage is valid in the place where entered into and could have been entered into in at least one State. This definition includes an individual in a same-sex or common law marriage that either:

(1) Was entered into in a State that recognizes such marriages; or

(2) If entered into outside of any State, is valid in the place where entered into and could have been entered into in at least one State.

6. Amend § 825.127 by revising the first and second sentences of paragraph (f) to read as follows:
§ 825.127 Leave to care for a covered servicemember with a serious injury or illness (military caregiver leave).

(f) Spouses who are eligible for FMLA leave and are employed by the same covered employer may be limited to a combined total of 26 workweeks of leave during the single 12-month period described in paragraph (e) of this section if the leave is taken for birth of the employee's son or daughter or to care for the child after birth, for placement of a son or daughter with the employee for adoption or foster care, or to care for the child after placement, to care for the employee's parent with a serious health condition, or to care for a covered servicemember with a serious injury or illness. This limitation on the total weeks of leave applies to leave taken for the reasons specified as long as the spouses are employed by the same employer. * * *

7. Amend § 825.201 by revising the first, second, and fifth sentences of paragraph (b) to read as follows:
§ 825.201 Leave to care for a parent.

(b) Same employer limitation. Spouses who are eligible for FMLA leave and are employed by the same covered employer may be limited to a combined total of 12 weeks of leave during any 12-month period if the leave is taken to care for the employee's parent with a serious health condition, for the birth of the employee's son or daughter or to care for the child after the birth, or for placement of a son or daughter with the employee for adoption or foster care or to care for the child after placement. This limitation on the total weeks of leave applies to leave taken for the reasons specified as long as the spouses are employed by the same employer. * * * Where the spouses both use a portion of the total 12-week FMLA leave entitlement for either the birth of a child, for placement for adoption or foster care, or to care for a parent, the spouses would each be entitled to the difference between the amount he or she has taken individually and 12 weeks for FMLA leave for other purposes. * * *

8. Amend § 825.202 by revising the third sentence of paragraph (c) to read as follows:
§ 825.202 Intermittent leave or reduced leave schedule.

(c) * * * The employer's agreement is not required, however, for leave during which the expectant mother has a serious health condition in connection with the birth of her child or if the newborn child has a serious health condition. * * *

[FR Doc. 2015-03569 Filed 2-23-15; 11:15 am] BILLING CODE 4510-27-P
DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 3 RIN 2900-AP26 Automobile or Other Conveyance and Adaptive Equipment Certificate of Eligibility for Veterans or Members of the Armed Forces With Amyotrophic Lateral Sclerosis AGENCY:

Department of Veterans Affairs.

ACTION:

Interim final rule.

SUMMARY:

The Department of Veterans Affairs (VA) is amending its adjudication regulation regarding certificates of eligibility for financial assistance in the purchase of an automobile or other conveyance and adaptive equipment. The amendment authorizes automatic issuance of a certificate of eligibility for financial assistance in the purchase of an automobile or other conveyance and adaptive equipment to all veterans with service-connected amyotrophic lateral sclerosis (ALS) and members of the Armed Forces serving on active duty with ALS.

DATES:

Effective Date: This interim final rule is effective February 25, 2015.

Comment Date: Comments must be received by VA on or before April 27, 2015.

Applicability Date: The provisions of this regulatory amendment apply to all applications for a certificate of eligibility for an automobile or other conveyance and adaptive equipment allowance pending before VA on or received after February 25, 2015.

ADDRESSES:

Written comments may be submitted through www.Regulations.gov; by mail or hand-delivery to Director, Regulation Policy and Management (02REG), Department of Veterans Affairs, 810 Vermont Ave. NW., Room 1068, Washington, DC 20420; or by fax to (202) 273-9026. Comments should indicate that they are submitted in response to “RIN 2900-AP26—Automobile or Other Conveyance and Adaptive Equipment Certificate of Eligibility for Veterans or Members of the Armed Forces With Amyotrophic Lateral Sclerosis Connected to Military Service.” Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1068, between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call (202) 461-4902 for an appointment. (This is not a toll free number.) In addition, during the comment period, comments may be viewed online through the Federal Docket Management System (FDMS) at www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Randy A. McKevitt, Legal Consultant, Regulations Staff (211D), Compensation Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-9700. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION:

In a document published in the Federal Register on December 20, 2011 (76 FR 78823), VA amended its regulations pertaining to the percent disability evaluation assignable for service-connected amyotrophic lateral sclerosis (ALS). As of January 19, 2012, the effective date of that amendment, 38 CFR 4.124a, diagnostic code 8017, provides a 100-percent disability evaluation for veterans with service-connected ALS. VA determined that assigning a 100-percent evaluation in all cases eliminates the need to unnecessarily reevaluate veterans with ALS repeatedly over a short period of time as the condition worsens and inevitably progresses to total disability. The change was necessary to adequately compensate veterans who suffer from this progressive, untreatable, and fatal disease. However, the change did not specifically address entitlement to certificates of eligibility for financial assistance in the purchase of an automobile or other conveyance and adaptive equipment.

Section 3901(1), title 38, United States Code (U.S.C.), provides specific criteria for determining eligibility for an automobile and adaptive equipment allowance. To be eligible for an automobile and adaptive equipment allowance, a veteran must be in receipt of compensation under chapter 11 of title 38 U.S.C. for (or a member of the Armed Forces serving on active duty must have) loss or permanent loss of use of one or both feet; loss or permanent loss of use of one or both hands; permanent impairment of vision of both eyes with central visual acuity of 20/200 or less in the better eye with the use of corrective glasses or central visual acuity of more than 20/200 if there is a field defect in which the peripheral field has contracted to such an extent that the widest diameter of visual field subtends an angular distance no greater than twenty degrees in the better eye; or a severe burn injury. 38 U.S.C. 3901(1). These disabilities must be the result of an injury incurred or disease contracted in or aggravated by active military, naval, or air service. Id.

VA's automobile and adaptive equipment allowance eligibility regulation, 38 CFR 8.808 Automobiles or other conveyances and adaptive equipment; certification, which was promulgated to implement 38 U.S.C. 3901 and 3902, includes the same criteria for entitlement to a certificate of eligibility as 38 U.S.C. 3901. Because ALS is a rapidly progressive, totally debilitating, and irreversible disease, VA has determined that progression of ALS will routinely, and quickly, satisfy these existing certificate of eligibility criteria. This interim final rule permits VA to determine entitlement to a certificate of eligibility for an automobile or other conveyance and adaptive equipment as soon as a veteran establishes service connection for ALS, or a member of the Armed Forces serving on active duty is diagnosed with ALS, eliminating the need for additional development and reducing wait times. By streamlining the eligibility process, this regulatory amendment will allow veterans with service-connected ALS and members of the Armed Forces serving on active duty with ALS to receive and utilize to maximum advantage the automobile or other conveyance and adaptive equipment benefit, without unnecessary delay.

From the standpoint of entitlement to a certificate of eligibility for automobile or other conveyance and adaptive equipment qualification procedures, the effect of this regulatory amendment is to allocate resources more efficiently and ensure a better lifestyle for veterans with service-connected ALS and members of the Armed Forces serving on active duty with ALS who want to purchase and adapt an automobile or other conveyance and adaptive equipment so they can remain mobile as long as possible. In this regard, as the ALS progresses, the need for assistive devices adapting an automobile or other conveyance and adaptive equipment so that the veteran or member of the Armed Forces serving on active duty can continue to be mobile, including attending examinations and treatment by medical personnel, while remaining in their home for as long as possible, will be greatly assisted. Without these benefits, a veteran or member of the Armed Forces serving on active duty may be required to be institutionalized sooner than otherwise necessary to receive medical treatment.

Thus, there exists an immediate need for VA to focus this regulatory change upon the entitlement for a certificate of eligibility for automobile or other conveyance and adaptive equipment process. Because the prognosis of the progression of ALS is typically established after a brief period of observation, in most cases less than 3 months, VA has determined that it is fair and reasonable to provide a certificate of eligibility for automobile or other conveyance and adaptive equipment upon determination of service connection for ALS in a veteran or on diagnosis and receipt of an application from a member of the Armed Forces serving on active duty.

VA, therefore, intends to establish entitlement for a certificate of eligibility for automobile or other conveyance and adaptive equipment eligibility for eligible veterans with service-connected ALS and members of the Armed Forces serving on active duty with ALS. VA is doing so by adding a new provision to 38 CFR 3.808, which governs eligibility for entitlement for a certificate of eligibility for automobile or other conveyance and adaptive equipment under 38 U.S.C. 3901 and 3902. This new provision adds ALS as a qualifying disability for eligibility to this benefit and will allow eligible individuals to access this benefit without further development and delay. VA incorporates this new category of criteria in § 3.808 as new paragraph (b)(5). Current paragraph (b)(5) will be redesignated as paragraph (b)(6).

Administrative Procedure Act

Pursuant to 5 U.S.C. 553(b)(B) and (d)(3), we find that there is good cause to dispense with advance public notice and opportunity to comment on this rule and good cause to publish this rule with an immediate effective date. This interim final rule is necessary to implement immediately the Secretary's decision to establish entitlement for a certificate of eligibility for automobile or other conveyance and adaptive equipment for all veterans with service-connected ALS and members of the Armed Forces serving on active duty with ALS. Delay in the implementation of this rule would be impracticable and contrary to the public interest, particularly to veterans and members of the Armed Forces serving on active duty.

Because the survival period for persons suffering from ALS is generally 18-48 months or less from the onset of symptoms, any delay in establishing entitlement for a certificate of eligibility for automobile or other conveyance and adaptive equipment eligibility is extremely detrimental to veterans and members of the Armed Forces serving on active duty who are currently afflicted with ALS. Any delay in implementation until after a public-comment period could delay modifying the regulated certificate of eligibility process, depriving ALS veterans and members of the Armed Forces serving on active duty with ALS of quick and efficient access to automobile or other conveyance and adaptive equipment benefits.

For the foregoing reasons, the Secretary is issuing this rule as an interim final rule with immediate effect.

Paperwork Reduction Act

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

Regulatory Flexibility Act

The Secretary hereby certifies that this interim final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This interim final rule will not affect any small entities. Only VA beneficiaries will be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this interim final rule is exempt from the final regulatory flexibility analysis requirements of section 604.

Executive Orders 12866 and 13563

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

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

Unfunded Mandates

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any 1 year. This interim final rule will have no such effect on State, local, and tribal governments, or on the private sector.

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.100, Automobiles and Adaptive Equipment for Certain Disabled Veterans and Members of the Armed Forces and 64.109, Veterans Compensation for Service-Connected Disability.

Signing Authority

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Jose D. Riojas, Chief of Staff, approved this document on February 12, 2015, for publication.

List of Subjects in 38 CFR Part 3

Administrative practice and procedure, Claims, Disability benefits, Health care, Pensions, Veterans.

Dated: February 20, 2015. William F. Russo, Acting Director, Office of Regulation Policy & Management, Office of the General Counsel, U.S. Department of Veterans Affairs.

For the reasons set out in the preamble, VA amends 38 CFR part 3 as follows:

PART 3—ADJUDICATION Subpart A—Pension, Compensation, and Dependency and Indemnity Compensation 1. The authority citation for part 3, subpart A continues to read as follows: Authority:

38 U.S.C. 501(a), unless otherwise noted.

2. Amend § 3.808 by redesignating paragraph (b)(5) as paragraph (b)(6) and adding a new paragraph (b)(5) to read as follows:
§ 3.808 Automobiles or other conveyances and adaptive equipment; certification.

(b) * * *

(5) Amyotrophic lateral sclerosis.

[FR Doc. 2015-03889 Filed 2-24-15; 8:45 am] BILLING CODE P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0253; FRL-9919-59] Clothianidin; Pesticide Tolerances for Emergency Exemptions AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes a time-limited tolerance for residues of clothianidin, (E)-N-[(2-chloro-5-thiazolyl)methyl]-N'-methyl-N”-nitroguanidine, in or on fruit, citrus, group 10-10. This action is in response to EPA's granting of an emergency exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on citrus. This regulation establishes a maximum permissible level for residues of clothianidin in or on citrus. The time-limited tolerance expires on December 31, 2017.

DATES:

This regulation is effective February 25, 2015. Objections and requests for hearings must be received on or before April 27, 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-2014-0253, 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 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 section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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-2014-0253 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 April 27, 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-2014-0253, 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 athttp://www.epa.gov/dockets.

II. Background and Statutory Findings

EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a time-limited tolerance for residues of clothianidin, (E)-N-[(2-chloro-5-thiazolyl)methyl]-N'-methyl-N”-nitroguanidine, in or on fruit, citrus, group 10-10 at 0.07 parts per million (ppm). This time-limited tolerance expires on December 31, 2017.

Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement of a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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 . . . . ”

Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Clothianidin in or on Immature Citrus Trees and FFDCA Tolerances

The Florida Department of Agriculture and Consumer Services requested the EPA Administrator to issue a specific exemption for the use of clothianidin as a soil drench application on immature citrus trees to control the transmission of Huanglongbing (HLB) disease vectored by the Asian Citrus Psyllid (ACP). The applicant asserts that clothianidin is needed to control HLB disease due to the lack of effective available alternatives for season long control practices, and that significant economic losses will occur if this urgent, non-routine disease is not controlled.

Further, the Applicant asserts that an emergency condition exists in accordance with the criteria for approval of an emergency exemption, and issued a crisis exemption under FIFRA section 18 to allow the use of clothianidin on immature citrus trees for control of the transmission of HLB disease vectored by the ACP in Florida. After having reviewed the submission, EPA concurred that an emergency condition exists for Florida citrus growers and authorized a specific emergency exemption under FIFRA section 18 for control of clothianidin on immature citrus trees to control the transmission of HLB disease vectored by the ACP.

As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of clothianidin in or on citrus. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although this time-limited tolerance expires on December 31, 2017, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on fruit, citrus, group 10-10 after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by the time-limited tolerance at the time of that application. EPA will take action to revoke this time-limited tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because this time-limited tolerance is being approved under emergency conditions, EPA has not made any decisions about whether clothianidin meets FIFRA's registration requirements for use on fruit, citrus, group 10-10 or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of clothianidin by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State other than Florida to use this pesticide on the applicable crop under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for clothianidin contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. 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. . . .”

As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of clothianidin in or on citrus. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2) and decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18.

Consistent with 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 emergency action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of this emergency exemption and the time-limited tolerance for residues of clothianidin in or on fruit, citrus, group 10-10 at 0.07 ppm.

EPA recently evaluated the currently approved uses of clothianidin when establishing tolerances for residues of clothianidin in three non-citrus commodity groups in the March 29, 2013 Federal Register (78 FR 19130) (FRL-9378-6). A summary of the human risk assessment toxicological endpoints is discussed in Units 111.A. and B. of the March 29, 2013 Final Rule.

EPA has also recently evaluated the dietary exposure that would result from a similar use of clothianidin on citrus that would result in clothianidin residues of 0.60 ppm. This is significantly higher than the 0.07 ppm time-limited tolerance level established in today's final rule. In order to expedite this time-limited tolerance rule, EPA has relied on its previous dietary risk assessment assuming clothianidin residues of 0.60 ppm on citrus. The higher application rates and concentrations assure that exposure and risk resulting from the emergency use are not underestimated. In addition, the estimated drinking water concentrations based on the clothianidin use on citrus resulted in higher acute drinking water estimates than those previously assessed. The chronic analysis drinking water estimate remains the same as it was in the previous dietary assessment. Even with these conservative assumptions, the revised acute dietary risk estimates from exposure to clothianidin through food and water are below the Agency's level of concern for all population subgroups.

In its aggregate assessment of exposures and risk associated with clothianidin, including use on citrus which was assessed at a significantly higher use rate, EPA concluded that the acute dietary exposure from food and water to clothianidin would occupy 28% of the acute population adjusted dose (aPAD) for children 1-2 years old, the population subgroup receiving the greatest exposure; and that chronic exposure to clothianidin from food and water would utilize 28% of the chronic population adjusted dose (cPAD) for children 1-2 years old, the population subgroup receiving the greatest exposure. These population adjusted doses represent the levels below which exposure is not of health concern. Because these levels of dietary exposures for the most exposed subpopulations would be well below the aPAD and cPAD, the expected lower levels of dietary exposures are not of concern.

There are no new residential uses of clothianidin at this time. However, existing uses of clothianidin on turf, ornamental plants, and/or indoor surfaces for bed bug control may result in human exposure in a residential setting. Such exposures may occur during application of products containing clothianidin (handler exposure) as well as following application (post-application exposure) and are expected to be of short-term (1-30 days) duration.

For clothianidin, residential handler and post-application risk estimates are considered to be of potential concern when the dermal margin of exposure (MOE) is less than 100, the inhalation MOE is less than 1,000, and/or the aggregate risk index (ARI), reflecting combined dermal and inhalation exposure, is less than one. The residential handler and post-application risk estimates are not of concern (ARIs range from 1.9 to 990). The aggregate ARIs, which combine residential and dietary exposure, ranged from 1.2 to 6.5, which are not of concern (i.e. when the ARI is greater 1).

Therefore, EPA concluded there is a reasonable certainty that no harm will result to the general population and to infants and children from aggregate exposure to clothianidin residues as a result of existing uses and the proposed section 18 use pattern.

Refer to the March 29, 2013 final rule, available at http://regulations.gov, for a summary of the aggregate risk assessment and determination of safety. Detailed discussion of the aggregate risk assessments and the determinations of safety relied upon in this action may be found in the Agency reviews and human health risk assessments provided as supporting documents in the docket for this action under docket ID number EPA-HQ-OPP-2014-0253.

V. Other Considerations A. Analytical Enforcement Methodology

An adequate enforcement methodology, based on solvent extraction and liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) separation, identification, and quantification, is available for plant (Morse Method#Meth-164-modified, RM-39C-1, or Bayer Method 00552) matrices to enforce the tolerance expression. The limit of quantitation (LOQ) for clothianidin in plant commodities is 0.01 ppm. Clothianidin and its major metabolites are not adequately recovered using any of the United States Food and Drug Administration (FDA) multi-residue methods.

The methods 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 established MRLs for clothianidin in or on citrus fruits at 0.07 ppm, the same level the U.S. is establishing for the time-limited-tolerance.

VI. Conclusion

Therefore, a time-limited tolerance is established for residues of clothianidin, in or on fruit, citrus, group 10-10 at 0.07 ppm. This tolerance expires on December 31, 2017.

VII. Statutory and Executive Order Reviews

This final rule establishes tolerances under FFDCA sections 408(e) and 408(l)(6). 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 final rule has been exempted from review under Executive Order 12866, this final rule 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 final rule 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 in accordance with FFDCA sections 408(e) and 408(l)(6), 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 final rule 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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note).

VIII. 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: February 13, 2015. Susan Lewis, Director, Registration Division, 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. In § 180.586, revise paragraph (b) to read as follows:
§ 180.586 Clothianidin; tolerances for residues.

(b) Section 18 emergency exemptions. A time-limited tolerance specified in the following table is established for residues of clothianidin, (E)-N-[(2-chloro-5-thiazolyl)methyl]-N'-methyl-N”-nitroguanidine, in or on the specified agricultural commodity, resulting from use of the pesticide pursuant to FIFRA section 18 emergency exemptions. This tolerance expires on the date specified in the table.

Commodity Parts per million Expiration date Fruit, citrus, group 10-10 0.07 12/31/17
[FR Doc. 2015-03928 Filed 2-24-15; 8:45 am] BILLING CODE 6560-50-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 131211999-5045-02] RIN 0648-BD86 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Coastal Migratory Pelagic Resources in the Gulf of Mexico and Atlantic Region; Amendment 20B; Correction AGENCY:

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

ACTION:

Final rule; correction.

SUMMARY:

This document contains a correction to the final rule to implement Amendment 20B to the Fishery Management Plan for the Coastal Migratory Pelagic Resources in the exclusive economic zone of the Gulf of Mexico and Atlantic Region (Amendment 20B) that was published in the Federal Register January 27, 2015.

DATES:

This correction is effective March 1, 2015.

FOR FURTHER INFORMATION CONTACT:

Anik Clemens, 727-551-5611; email: [email protected]

SUPPLEMENTARY INFORMATION:

Need for Correction

On January 27, 2015, (80 FR 4216), NMFS published an incorrect annual catch limit (ACL) value for Atlantic migratory group Spanish mackerel in § 622.388(d)(1)(iii). The commercial ACL for Atlantic migratory group Spanish mackerel is equal to the commercial quota. The commercial quota value was published correctly in § 622.384(c)(2), however, the commercial ACL value was published incorrectly in § 622.388(d)(1)(iii). This document corrects the commercial ACL value for Atlantic migratory group Spanish mackerel.

Correction

1. On page 4223, in the first column, § 622.388(d)(1)(iii) is correctly revised to read as follows:

§ 622.388 Annual catch limits (ACLs), annual catch targets (ACTs), and accountability measures (AMs).

(d) * * *

(1) * * *

(iii) The commercial ACL for the Atlantic migratory group Spanish mackerel is 3.33 million lb (1.51 million kg).

Dated: February 19, 2015. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.
[FR Doc. 2015-03905 Filed 2-24-15; 8:45 am] BILLING CODE 3510-22-P
80 37 Wednesday, February 25, 2015 Proposed Rules DEPARTMENT OF AGRICULTURE Federal Crop Insurance Corporation 7 CFR Part 400 [Docket No. FCIC-13-0006] RIN 0563-AC46 Part 400—General Administrative Regulation—Subpart V—Submission of Policies, Provisions of Policies and Rates of Premium AGENCY:

Federal Crop Insurance Corporation, USDA.

ACTION:

Proposed rule.

SUMMARY:

The Federal Crop Insurance Corporation (FCIC) proposes to replace the General Administrative Regulation—Subpart V—Submission of Policies, Provisions of Policies and Rates of Premium. The intended effect of this action is to incorporate legislative changes to the Federal Crop Insurance Act (Act) stemming from the Agricultural Act of 2014, clarify existing regulations, lessen the burden of submitters of crop insurance policies, provisions of policies, or rates of premium under section 508(h) of the Act, provide guidance on the submission and payment for concept proposals under section 522 of the Act, and to incorporate changes that are consistent with those made in the Common Crop Insurance Policy Basic Provisions (Basic Provisions).

DATES:

Written comments and opinions on this proposed rule will be accepted until close of business April 27, 2015 and will be considered when the rule is to be made final.

ADDRESSES:

FCIC prefers that comments be submitted electronically through the Federal eRulemaking Portal. You may submit comments, identified by Docket ID No. FCIC-13-0006 by any of the following methods:

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

Mail: Director, Product Administration and Standards Division, Risk Management Agency, United States Department of Agriculture, P.O. Box 419205, Kansas City, MO 64133-6205. All comments received, including those received by mail, will be posted without change to http://www.regulations.gov, including any personal information provided, and can be accessed by the public.

All comments must include the agency name and docket number or Regulatory Information Number (RIN) for this rule. For detailed instructions on submitting comments and additional information, see http://www.regulations.gov. If you are submitting comments electronically through the Federal eRulemaking Portal and want to attach a document, we ask that it be in a text-based format. If you want to attach a document that is a scanned Adobe PDF file, it must be scanned as text and not as an image, thus allowing FCIC to search and copy certain portions of your submissions. For questions regarding attaching a document that is a scanned Adobe PDF file, please contact the RMA Web Content Team at (816) 823-4694 or by email at [email protected]

Privacy Act: Anyone is able to search the electronic form of all comments received for any dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the complete User Notice and Privacy Notice for Regulations.gov at http://www.regulations.gov/#!privacyNotice.

FOR FURTHER INFORMATION CONTACT:

Tim Hoffmann, Product Administration and Standards Division, Risk Management Agency, United States Department of Agriculture, Beacon Facility, Stop 0812, Room 421, P.O. Box 419205, Kansas City, MO 64141-6205, telephone (816) 926-7730.

SUPPLEMENTARY INFORMATION: Executive Order 12866

This rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, it has not been reviewed by the OMB.

Paperwork Reduction Act of 1995

Pursuant to the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the collections of information in this rule have been approved by the Office of Management and Budget (OMB) under control number 0563-0064.

E-Government Act Compliance

FCIC is committed to complying with the E-Government Act of 2002, 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.

Unfunded Mandates Reform Act of 1995

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This rule contains no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.

Executive Order 13132

It has been determined under section 1(a) of Executive Order 13132, Federalism, that this rule does not have sufficient implications to warrant consultation with the States. The provisions contained in this rule will not have a substantial direct effect on States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

Executive Order 13175

This rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.

Regulatory Flexibility Act

FCIC certifies that this regulation will not have a significant economic impact on a substantial number of small entities. The regulation does not require any more action on the part of the small entities than is required on the part of large entities. No matter the size of the submitter, all submitters are required to perform the same tasks and those tasks are necessary to ensure that the concept proposal can be made into a viable and marketable submission and any submission can be made into viable and marketable, actuarially sound insurance product. A Regulatory Flexibility Analysis has not been prepared since this regulation does not have an impact on small entities, and, therefore, this regulation is exempt from the provisions of the Regulatory Flexibility Act (5 U.S.C. 605).

Federal Assistance Program

This program is listed in the Catalog of Federal Domestic Assistance under No. 10.450.

Executive Order 12372

This program is not subject to the provisions of Executive Order 12372, which require intergovernmental consultation with State and local officials. See the Notice related to 7 CFR part 3015, subpart V, published at 48 FR 29115, June 24, 1983.

Executive Order 12988

This proposed rule has been reviewed in accordance with Executive Order 12988 on civil justice reform. The provisions of this rule will not have a retroactive effect. The provisions of this rule will preempt State and local laws to the extent such State and local laws are inconsistent herewith. With respect to any direct action taken by FCIC or to require the insurance provider to take specific action under the terms of the crop insurance policy, the administrative appeal provisions published at 7 CFR part 11 must be exhausted before any action against FCIC for judicial review may be brought.

Environmental Evaluation

This action is not expected to have a significant economic impact on the quality of the human environment, health, or safety. Therefore, neither an Environmental Assessment nor an Environmental Impact Statement is needed.

Background

FCIC makes available standard policies for producers to insure certain agricultural commodities against various agricultural production risks and perils. Under the provisions of section 508(h) of the Act, any person may submit or propose other crop insurance policies, plans of insurance, provisions of policies, or rates of premium to the FCIC Board of Directors (Board) for approval for reinsurance and subsidy. These policies may be submitted without regard to certain limitations contained in the Act. Section 508(h) of the Act also requires that FCIC issue regulations to establish guidelines for the submission and Board review of policies or other material submitted to the Board under the Act. These regulations were published at 7 CFR part 400, subpart V (Subpart V) and provided the process for making submissions, its contents, the approval process, and the procedures for requests for reimbursement of research and development costs and maintenance. Section 522 of the Act authorizes the advance payment of research and development costs for concept proposals and this proposed rule includes the procedures for requesting such advanced payment.

The Agricultural Act of 2014 amended parts of section 508(h) as well as other sections of the Act. One such change requires FCIC to develop procedures for submitting index-based weather plans of insurance. Another change mandated by the Agricultural Act of 2014 requires submitters of products for specialty crops to follow certain consultation requirements with grower groups in the major producing areas. The Agricultural Act of 2014 also contains amendments that require changes to review criteria and establish approval priorities and considerations of submissions under section 508(h) of the Federal Crop Insurance Act.

In addition to the changes required by the Agricultural Act of 2014, other changes are being proposed to provide clarity or lessen the burden on submitters or FCIC. This rule contains proposed revisions to definitions to clarify the meaning of terms used in Subpart V as well as new definitions for terms that were either not defined or not previously used. This rule also contains proposed changes to clarify FCIC and submitter responsibilities with respect to timing, content, approval, reimbursement for research and development costs and maintenance costs, and potential user fees for such submissions. To lessen the burden on submitters, this rule proposes to reduce the number of printed copies of the submission that must be provided to FCIC. This rule proposes to provide additional guidance for submitting concept proposals, including confidentially standards and advance payment provisions. This rule also proposes changes to guidelines for non-reinsured supplemental policies to be submitted to FCIC including a proposed provision to decrease the burden on FCIC by increasing the time FCIC has to review such policies from 120 to 150 days.

List of Subjects in 7 CFR Part 400

Administrative practice and procedure, Crop insurance.

Proposed Rule

Accordingly, as set forth in the preamble, FCIC proposes to amend 7 CFR part 400 by replacing subpart V in its entirety as set forth below:

PART 400—GENERAL ADMINISTRATIVE REGULATIONS

Revise subpart V to read as follows:

Subpart V—Submission of Policies, Provisions of Policies, Rates of Premium, and Non-Reinsured Supplemental Policies Sec. 400.700 Basis, purpose, and applicability. 400.701 Definitions. 400.702 Confidentiality and duration of confidentiality. 400.703 Timing and format. 400.704 Covered by this subpart. 400.705 Contents for new and changed submissions, concept proposals, and index-based weather plans of insurance. 400.706 Review. 400.707 Presentation to the Board for approval or disapproval. 400.708 Post approval. 400.709 Roles and responsibilities. 400.710 Preemption and premium taxation. 400.711 Right of review, modification, and the withdrawal of approval. 400.712 Research and development reimbursement, maintenance reimbursement, advance payments for concept proposals, and user fees. 400.713 Non-reinsured supplemental (NRS) policy. Subpart V—Submission of Policies, Provisions of Policies, Rates of Premium, and Non-Reinsured Supplemental Policies. Authority:

7 U.S.C. 1506(l), 1506(o), 1508(h), 1522(b), 1523(i).

§ 400.700 Basis, purpose, and applicability.

This subpart establishes guidelines, the approval process, and responsibilities of FCIC and the applicant for policies, provisions of policies, and rates of premium submitted to the Board as authorized under section 508(h) of the Act. It also provides procedures for reimbursement of research and development costs and maintenance costs for concept proposals and approved submissions. Guidelines for submitting concept proposals and the standards for approval and advance payments are provided in this subpart. This subpart also provides guidelines and reference to procedures for submitting index-based weather plans of insurance as authorized under section 523(i) of the Act. The procedures for submitting non-reinsured supplemental policies in accordance with the Standard Reinsurance Agreement (SRA) are also contained within.

§ 400.701 Definitions.

Act. Subtitle A of the Federal Crop Insurance Act, as amended (7 U.S.C. 1501-1524).

Actuarial documents. The information for the crop or insurance year that is available for public inspection in your agent's office and published on RMA's Web site, and that shows available insurance policies, coverage levels, information needed to determine amounts of insurance and guarantees, prices, premium rates, premium adjustment percentages, practices, particular types or varieties of the insurable crop or agricultural commodity, insurable acreage, and other related information regarding insurance in the county or state.

Actuarially appropriate. Premium rates expected to cover anticipated losses and establish a reasonable reserve based on valid reasoning, an examination of available risk data, or knowledge or experience of the expected value of future costs associated with the risk to be covered. This will be expressed by a combination of data including, but not limited to liability, premium, indemnity, and loss ratios based on actual data or simulations reflecting the risks covered by the policy.

Administrative and operating (A&O) subsidy. The subsidy for the administrative and operating expenses authorized by the Act and paid by FCIC on behalf of the producer to the approved insurance provider. Loss adjustment expense reimbursement paid by FCIC for catastrophic risk protection (CAT) eligible crop insurance contracts is not considered as A&O subsidy.

Advance payment. A portion, up to 50 percent, of the estimated research and development costs, that may be approved by the Board under section 522(b) of the Act for an approved concept proposal, and after the applicant has begun research and development activities, the Board may at its sole discretion provide up to an additional 25 percent advance payment of the estimated research and development costs.

Agent. An individual licensed by the State in which an eligible crop insurance contract is sold and serviced for the reinsurance year, and who is employed by, or under contract with, the approved insurance provider, or its designee, to sell and service such eligible crop insurance contracts.

Applicant. Any person or entity that submits to the Board for approval a submission under section 508(h) of the Act, a concept proposal under section 522 of the Act, or an index-based weather plan of insurance under section 523(i) of the Act.

Approved insurance provider. A legal entity that has entered into a reinsurance agreement with FCIC for the applicable reinsurance year.

Approved procedures. The applicable handbooks, manuals, memoranda, bulletins or other directives issued by RMA or the Board.

Board. The Board of Directors of FCIC.

Commodity. Has the same meaning as section 518 of the Act.

Complete. A submission, concept proposal, or index-based weather plan of insurance determined by RMA and the Board to contain all required documentation in accordance with § 400.705 and is of sufficient quality, as determined by the Board and RMA, to conduct a meaningful review.

Complexity. Consideration of factors such as originality of policy materials, underwriting methods, actuarial rating methodology, and the pricing methodology used in design, construction and processes for the full development of a policy or plan of insurance.

Concept proposal. A written proposal for a prospective submission, submitted under section 522 of the Act for advance payment of research and development, and containing enough information that the Board is able to determine that, if approved, will be developed into a viable and marketable policy consistent with Board approved procedures, these regulations, and section 508(h) of the Act.

Delivery system. The components or parties that make the policy or plan of insurance available to the public for sale. The delivery system includes, but is not limited to RMA, approved insurance providers, and agents.

Development. The process of composing documentation and procedures, pricing and rating methodologies, administrative and operating procedures, systems and software, supporting materials, and documentation necessary to create and implement a submission.

Disinterested third party. A person who:

(1) Does not have any familial relationship (parents, brothers, sisters, children, spouse, grandchildren, aunts, uncles, nieces, nephews, first cousins, or grandparents, related by blood, adoption or marriage, are considered to have a familial relationship) with the submitter;

(2) Who will not benefit financially from the submission, concept proposal, or index-based weather plan of insurance if approved, or from the administration of any approved policy or plan of insurance; or

(3) Must not be employed by or work under contract or be associated in any similar manner to the applicant on a regular basis.

Endorsement. A document that amends or revises an insurance policy reinsured under the Act in a manner that changes existing, or provides additional, coverage provided by such policy.

Expert reviewer. Independent persons contracted by the Board who meets the criteria for underwriters or actuaries that are selected by the Board to review a concept proposal, submission, or index-based weather plan of insurance and provide advice to the Board regarding the results of their review,

FCIC. The Federal Crop Insurance Corporation, a wholly owned government corporation within USDA, whose programs are administered by RMA.

Index-based weather plan of insurance. A risk management product in which indemnities are based on a defined weather parameter exceeding or failing to meet a given threshold during a specified time period. The weather index is a proxy to measure expected loss of production when the defined weather parameter does not meet the threshold.

Limited resource producer. Has the same meaning as the term defined by USDA at: www.lrftool.sc.egov.usda.gov/LRP_Definition.aspx or a successor Web site.

Livestock commodity. Has the same meaning as the term in section 523(i) of the Act.

Maintenance. For the purposes of this subpart only, the process of continual support, revision or improvement, as needed, for an approved submission, including the periodic review of premium rates and prices, updating or modifying the rating or pricing methodologies, updating or modifying policy terms and conditions, adding a new commodity under similar policy terms and conditions with similar rating and pricing methodology, or expanding a plan or policy to additional states and counties, and any other actions necessary to provide adequate, reasonable and meaningful protection for producers, ensure actuarial soundness, or to respond to statutory or regulatory changes. A concept proposal that is similar to a previously approved submission will be considered maintenance for the similar approved submission if submitted by the same person.

Maintenance costs. Specific expenses associated with the maintenance of an approved submission as authorized by § 400.712.

Maintenance period. A period of time that begins on the date the Board approves the submission and ends on the date that is not more than four reinsurance years after such approval.

Manager. The Manager of FCIC.

Marketing plan. A plan that identifies, at a minimum, the expected number of potential buyers, premium, liability, and the data upon which such information is based. Such data must include, but is not limited to, focus group results, market research studies, qualitative market estimates, effects upon the delivery system or participants, an assessment of factors that could negatively or adversely affect the market, responses from a reasonable representative cross-section of producers or significant market segment to be affected by the policy or plan of insurance, and if applicable, results from the consultation with the major producer groups of specialty crops demonstrating their interest in purchasing the product.

Multiple peril crop insurance (MPCI). Policies reinsured by FCIC that provide protection against multiple causes of loss that adversely affect production or revenue, such as to natural disasters, such as hail, drought, and floods.

National Agricultural Statistics Service (NASS). An agency within USDA, or its successor agency that collects and analyzes data collected from producers and other sources.

Non-reinsured supplemental policy (NRS). A policy, endorsement, or other risk management tool not reinsured by FCIC under the Act, that offers additional coverage, other than for loss related to hail.

Non-significant changes. Minor changes to the policy or plan of insurance, such as technical corrections, that do not affect the rating or pricing methodologies, the amount of subsidy owed, the amount or type of coverage, FCIC's reinsurance risk, or any other condition that does not affect liability or the amount of loss to be paid under the policy. Revisions to approved plans required by statutory or regulatory changes are included in this category. Changes to the policy that involve concepts that have been previously sent for expert review are also included in this category.

Plan of insurance. A class of policies, such as yield, revenue, or area based that offers a specific type of coverage to one or more agricultural commodities.

Policy. Has the same meaning as the term in section 1 of the Basic Provisions (7 CFR 457.8).

Rate of premium. The dollar amount per insured unit, or percentage rate per dollar of liability, that is needed to pay anticipated losses and provide a reasonable reserve.

Reinsurance year. The term beginning July 1 and ending on June 30 of the following year and, for reference purposes, identified by reference to the year containing June.

Related material. The actuarial documents for the insured commodity and any underwriting or loss adjustment manuals, handbooks, forms, instructions or other information needed to administer the policy.

Research. For the purposes of development, the gathering of information related to: producer needs and interests for risk management; the marketability of the policy or plan of insurance; appropriate policy terms, premium rates, price elections, administrative and operating procedures, supporting materials, documentation, and the systems and software necessary to implement a policy or plan of insurance. The gathering of information to determine whether it is feasible to expand a policy or plan of insurance to a new area or to cover a new commodity under the same policy terms and conditions, price, and premium rates is not considered research.

Research and development costs. Specific expenses incurred and directly related to the research and development activities of a submission as authorized in § 400.712.

Risk Management Agency (RMA). An agency within USDA that is authorized to administer the crop insurance program on behalf of FCIC.

Risk subsidy. The portion of the premium paid by FCIC on behalf of the insured.

Sales closing date. A date contained in the Special Provisions by which an application must be filed and the last date by which the insured may change the crop insurance coverage for a crop year.

Secretary. The Secretary of the United States Department of Agriculture.

Significant change. Any change to the policy or plan of insurance that may affect the rating and pricing methodologies, the amount of subsidy owed, the amount of coverage, the interests of producers, FCIC's reinsurance risk, or any condition that may affect liability or the amount of loss to be paid under the policy.

Special Provisions. Has the same meaning as the term in section 1 of the Basic Provisions (7 CFR 457.8).

Specialty crops. Fruits and vegetables, tree nuts, dried fruits, and horticulture and nursery crops (including floriculture).

Socially disadvantaged producer. Has the same meaning as section 2501(E) of the Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C. 2279(e)).

Standard Reinsurance Agreement (SRA). The reinsurance agreement between FCIC and the approved insurance provider, under which the approved insurance provider is authorized to sell and service the eligible crop insurance contracts for which the premium discount is proposed. For the purposes of this subpart, all references to the SRA will also include any other reinsurance agreements entered into with FCIC, including the Livestock Price Reinsurance Agreement.

Submission. A policy, plan of insurance, provision of a policy or plan of insurance, or rates of premium provided by an applicant to FCIC in accordance with the requirements of § 400.705. Submissions as referenced in this subpart do not include concept proposals, index-based weather plans of insurance, or non-reinsured supplemental policies.

Submitter. Same meaning as applicant.

Sufficient quality. The material presented is complete, understandable and unambiguous, so that a disinterested third party can understand, comprehend and make calculations, draw substantiated conclusions or results to determine whether the submission, concept proposal, or index-based weather plan of insurance is, or can result in, a viable and marketable insurance product with actuarially appropriate rates, reasonable expected market prices, provides meaningful coverage, and that protects the interests of producers and program integrity. The material must be presented in Microsoft Office format and must also contain adequate information that is presented clearly enough for the determination to be made whether RMA has the resources to implement, administer, and deliver the submission effectively and efficiently. Liability (guarantee), premium, and indemnity are clearly defined and consistent in calculation throughout the policy materials and appropriate for the commodity and the risks covered. As applicable, the policy, loss adjustment methods, underwriting procedures, and actuarial rating and pricing methodologies must be clearly identified and correspond to the risks covered.

Targeted producer. Producers who are considered small, socially disadvantaged, beginning and limited resource or other specific aspects designated by FCIC for review.

USDA. The United States Department of Agriculture.

User fees. Fees, approved by the Board, that can be charged to approved insurance provider for use of a policy or plan of insurance once the period for maintenance has expired that covers the expected maintenance costs to be incurred by the submitter.

Viable and marketable. A determination by the Board based on a detailed, written marketing plan demonstrating that a sufficient number of producers will purchase the product to justify the resources and expenses required to offer the product for sale and maintain the product for subsequent years.

§ 400.702 Confidentiality and duration of confidentiality.

(a) Pursuant to section 508(h)(4)(A) of the Act, prior to approval by the Board, any submission submitted to the Board under section 508(h) of the Act, concept proposal submitted under section 522 of the Act, or index-based weather plan of insurance submitted under section 523(i) of the Act, including any information generated from the submission, concept proposal, or index-based weather plan of insurance, will be considered confidential commercial or financial information for purposes of 5 U.S.C. 552(b)(4) and will not be released by FCIC to the public, unless the applicant authorizes such release in writing.

(b) Once the Board approves a submission or an index-based weather plan of insurance, information provided with the submission (including information from the concept proposal) or the index-based weather plan of insurance, or generated in the approval process, may be released to the public, as applicable, including any mathematical modeling and data, unless it remains confidential business information under 5 U.S.C. 552(b)(4). While the expert reviews are releasable once the submission or an index-based weather plan of insurance has been approved, the names of the expert reviewers may be redacted to prevent any harassment or undue pressure on the expert reviewers.

(c) Any submission, concept proposal, or index-based weather plan of insurance disapproved by the Board will remain confidential commercial or financial information in accordance with 5 U.S.C. 552(b)(4) and no information related to such submission, concept proposal, or index-based weather plan of insurance will be released by FCIC unless authorized in writing by the applicant.

(d) All submissions, concept proposals, and index-based weather plans of insurance, will be kept confidential until approved by the Board and will be given an identification number for tracking purposes, unless the applicant advises otherwise.

§ 400.703 Timing and format.

(a) A submission, concept proposal, or index-based weather plan of insurance may only be provided to FCIC during the first five business days in January, April, July, and October.

(b) A submission, concept proposal, or index-based weather plan of insurance must be provided to FCIC in the following format:

(1) Electronic format, sent to the address in paragraph (d)(1) of this section by the due date in paragraph (a) of this section. The electronic copy must be provided as a single document so that when printed the order and content exactly match the hard copy; and

(2) Two hard copies, mailed to the addresses in paragraph (d)(2) of this section and postmarked by the due date in paragraph (a) of this section. The hard copies must exactly match the electronic copy.

(c) Any submission, concept proposal, or index-based weather plan of insurance not provided within the first 5 business days of a month stated in paragraph (a) of this section will be considered to have been provided in the next month stated in paragraph (a). For example, if an applicant provides a submission on January 10, it will be considered to have been received on April 1.

(d) Any submission, concept proposal, or index-based weather plan of insurance must be provided:

(1) In electronic format to the Deputy Administrator for Product Management (or successor) at [email protected] and the Administrator at [email protected]; and

(2) In hard copy format, with one hard copy provided to the Deputy Administrator for Product Management (or any successor position), USDA/Risk Management Agency, Beacon Facility Mail Stop 0812, 9240 Troost Ave., Kansas City, MO 64131-3055, and one identical hard copy must be provided to the Administrator, Risk Management Agency, 1400 Independence Ave., Stop 0801, Room 3053 South Building, Washington, DC 20250-0801.

(e) In addition to the requirements in paragraph (a) of this section, a submission must be received not later than 240 days prior to the earliest proposed sales closing date to be considered for sale in the requested crop year.

(f) To be offered for sale in a crop year, there must be at least sixty days between the date the policy has been approved by the Board and ready to be made available for sale and the earliest sales closing date, unless this requirement is waived by the Board.

(g) Notwithstanding, paragraph (f) of this section, the Board, or RMA if authorized by the Board, shall determine when sales can begin for a submission approved by the Board.

§ 400.704 Covered by this subpart.

(a) An applicant may submit to the Board, in accordance with § 400.705, a submission that is:

(1) A policy or plan of insurance not currently reinsured by FCIC;

(2) One or more proposed revisions to a policy or plan of insurance authorized under the Act; or

(3) Rates of premium for any policy or plan of insurance authorized under the Act.

(b) An applicant must submit to the Board, any significant change to a previously approved submission, including requests for expansion, prior to making the change in accordance with § 400.705.

(c) An applicant may submit a concept proposal to the Board prior to developing a full submission, in accordance with this subpart and the Procedures Handbook 17030—Approved Procedures for Submission of Concept Proposals Seeking Advance Payment of Research and Development Expenses, which can be found on the RMA Web site at www.rma.usda.gov.

(d) An applicant who is an approved insurance provider may submit an index-based weather plan of insurance for consideration as a pilot program in accordance with this subpart and the Procedures Handbook 17050—Approved Procedures for Submission of Index-based Weather Plans of Insurance, which can be found on the RMA Web site at www.rma.usda.gov.

(e) An applicant must submit a non-reinsured supplemental policy or endorsement to RMA in accordance with § 400.713.

§ 400.705 Contents for new and changed submissions, concept proposals, and indexed-based weather plans of insurance.

(a) A complete submission must contain the following material, as applicable, in the order given, in a 3-ring binder for hard copies and in a single Microsoft Word document file for electronic copies, with a table of contents, page numbers, and section dividers clearly labeling each section, as applicable. All relevant materials should be provided in the designated section and not appended to the end of the submission.

(b) The first section will contain general information numbered as follows (1, 2, 3, etc.), including, as applicable:

(1) The applicant's name(s), address or primary business location, phone number, and email address;

(2) The type of submission (see § 400.704) and a notation of whether or not the submission was approved by the Board as a concept proposal;

(3) A statement of whether the applicant is requesting:

(i) Reinsurance;

(ii) Risk subsidy;

(iii) A&O subsidy;

(iv) Reimbursement for research and development costs, as applicable and, if the submission was previously submitted as a concept proposal, the amount of the advance payment for expected research and development costs; or

(v) Reimbursement for expected maintenance costs, if applicable;

(4) The proposed agricultural commodities to be covered, including types, varieties, and practices covered by the submission;

(5) The crop or insurance year and reinsurance year in which the submission is proposed to be available for purchase by producers;

(6) The proposed sales closing date, if applicable, or if not applicable, the earliest date the applicant expects to release the product to the public;

(7) The proposed area for the plan of insurance and if applicable, the reasons why the submission is not being proposed for other areas producing the commodity;

(8) Any known or anticipated future expansion plans;

(9) Identification, including names, addresses, telephone numbers, and email addresses, of the person(s) responsible for:

(i) Addressing questions regarding the policy, underwriting rules, loss adjustment procedures, rate and price methodologies, data processing and record-keeping requirements, and any other questions that may arise in implementing or administering the program if it is approved; and

(ii) Annual reviews to ensure compliance with all requirements of the Act, this subpart, and any agreements executed between the applicant and FCIC; and

(10) A statement of whether the submission will be filed with the applicable office responsible for regulating insurance in each state proposed for insurance coverage, and if not, reasons why the submission will not be filed for review.

(c) The second section must contain the benefits of the plan, including, as applicable, a summary that includes:

(1) How the submission offers coverage or other benefits not currently available from existing public or private programs;

(2) The projected demand for the submission, including support for and against development from market research, producers or producer groups, agents, lending institutions, and other interested parties that provide verifiable evidence of demand;

(3) Potential impacts the submission may have on producers both where the new plan will and will not be available (include both positive and negative impacts);

(4) How the submission meets public policy goals and objectives consistent with the Act and other laws, as well as policy goals supported by USDA and the Federal Government; and

(5) A detailed description of the coverage provided by the submission and its applicability to all producers, including targeted producers.

(d) Except as provided in this section, the third section must contain the policy, that is clearly written in plain language in accordance with the Plain Writing Act of 2010 (5 U.S.C. 301) such that producers will be able to understand the coverage being offered. The policy language permits actuaries to form a clear understanding of the payment contingencies for which they will set rates. The policy language does not encourage an excessive number of disputes or legal actions because of misinterpretations.

(1) If the submission involves a new insurance policy or plan of insurance:

(i) All applicable policy provisions; and

(ii) A list of any additional coverage that may be elected by the insured in conjunction with the submission such as applicable endorsements (include a description of the coverage and how such coverage may be obtained).

(2) If the submission involves a change to a previously approved policy, plan of insurance, or rates of premium, the proposed revisions, rationale for each change, data and analysis supporting each change, the impact of each change, and the impact of all changes in aggregate.

(e) The fourth section must contain a marketing plan, including, as applicable:

(1) A list of counties and states where the submission is proposed to be offered;

(2) The amount of commodity (acres, head, board feet, etc.), the amount of production, and the value of each agricultural commodity proposed to be covered in each proposed county and state;

(3) A reasonable estimate of expected liability and premium, for each proposed county and state and total expected liability and premium by crop year based on the marketing plan and an estimate of the market penetration of other similar products;

(4) If available, any insurance experience for each year and in each proposed county and state in which the policy has been previously offered for sale including an evaluation of the policy's performance and, if data are available, a comparison with other similar insurance policies reinsured under the Act;

(5) Focus group results, both positive and negative reactions;

(6) Market research studies that include:

(i) Evidence the proposed submission will be positively received by producers; and

(ii) Market estimates that show demand and level of coverage for which producers are willing to pay;

(7) For submissions proposing products for specialty crops a consultation report must be provided that includes a summary and analysis of discussions with groups representing producers of those agricultural commodities in all major producing areas for commodities to be served or potentially impacted, either directly or indirectly, and the expected impact of the proposed submission on the general marketing and production of the crop from both a regional and national perspective including evidence that the submission will not create adverse market distortions;

(8) Effects upon the delivery system or participants including:

(i) Estimated computer system impacts and costs;

(ii) Estimated administrative and training costs; and

(iii) What, if any, efficiency will be gained;

(9) Correspondence from producers expressing the need for such policy or plan of insurance; and

(10) A commitment in writing from at least one approved insurance provider to sell and support the policy or plan of insurance.

(f) The fifth section must contain the information related to the underwriting and loss adjustment of the submission, including as applicable:

(1) Detailed rules for determining insurance eligibility, including all producer reporting requirements;

(2) Relevant dates;

(3) Step by step examples of the data and calculations needed to establish the insurance guarantee (liability) and premium per acre or other unit of measure, including worksheets that provide the calculations in sufficient detail and in the same order as presented in the policy to allow verification that the premiums charged for the coverage are consistent with policy provisions;

(4) Step-by-step examples of calculations used to determine indemnity payments for all probable situations where a partial or total loss may occur;

(5) A detailed description of the causes of loss covered by the policy or plan of insurance and any causes of loss excluded;

(6) Any statements to be included in the actuarial documents including any intended Special Provisions statements that may change any underlying policy terms or conditions; and

(7) The loss adjustment standards handbook for the policy or plan of insurance that includes:

(i) A table of contents and introduction;

(ii) A section containing abbreviations, acronyms, and definitions;

(iii) A section containing insurance contract information (insurability requirements; Crop Provisions not applicable to catastrophic risk protection; specific unit division guidelines, if applicable; notice of damage or loss provisions; quality adjustment provisions; etc.);

(iv) A section that thoroughly explains appraisal methods, if applicable;

(v) Illustrative samples of all the applicable forms needed for insuring and adjusting losses in regards to the submission, plus detailed instructions for their use and completion;

(vi) Instructions, examples of calculations, and loss adjustment procedures that are necessary to establish the amounts of coverage and loss;

(vii) A section containing any special coverage information (i.e., replanting, tree replacement or rehabilitation, prevented planting, etc.), as applicable; and

(viii) A section containing all applicable reference material (i.e., minimum sample requirements, row width factors, etc.).

(g) The sixth section must contain information related to prices and rates of premium, including, as applicable:

(1) A detailed description of the specific premium rating methodology proposed to be used and the basis for selection of the rating methodology;

(2) A list of all assumptions made in the premium rating and commodity pricing methodologies, and the basis for these assumptions;

(3) A detailed description of the pricing and rating methodologies, including:

(i) Supporting documentation;

(ii) All mathematical formulas and equations;

(iii) Data and data sources used in determining rates and prices and a detailed assessment of the data and how it supports the proposed rates and prices;

(iv) A detailed explanation of how the rates account for each of the risks covered by the policy; and

(v) A detailed explanation of how the prices are applicable to the policy;

(4) An example of both a rate calculation and a price calculation;

(5) A discussion of the applicant's objective evaluation of the accuracy of the data, the short and long term availability of the data, and how the data will be obtained (if the data source is confidential or proprietary explain the cost of obtaining the data); and

(6) An analysis of the results of simulations or modeling showing the performance of proposed rates and commodity prices, as applicable, based on one or more of the following (Such simulations must use all years of experience available to the applicant and must reflect both partial losses and total losses):

(i) A recalculation of total premium and losses compared to a similar or comparable insurance plan offered under the authority of the Act with modifications, as needed, to represent the components of the submission;

(ii) A simulation that shows liability, premium, indemnity, and loss ratios for the proposed insurance product based on the probability distributions used to develop the rates and commodity prices, as applicable, including sensitivity tests that demonstrate price or yield extremes, and the impact of inappropriate assumptions; or

(iii) Any other comparable simulation that provides results indicating both aggregate and individual performance of the submission including expected liability, premium, indemnity, and loss ratios for the proposed insurance product, under various scenarios depicting good and poor actuarial experience.

(h) The seventh section must contain forms, instructions for completing forms, and statements for all forms applicable to the submission in a format compatible with the Document and Supplemental Standards Handbook (FCIC 24040) found at http://www.rma.usda.gov/handbooks/24000/index.html.

(i) The eighth section must contain the following:

(1) A statement certifying that the submitter and any approved insurance provider or its affiliates will not solicit or market the submission until at least 60 days after all policy materials are released to the public by RMA, unless otherwise specified by the Board;

(2) An explanation of any provision of the policy not authorized under the Act and identification of the portion of the rate of premium due to these provisions; and

(3) If applicable, agent and loss adjuster training plans.

(j) The ninth section must contain a statement from the submitter that, if the submission is approved, the submitter will work with RMA and its computer programmers as needed to assure an effective and efficient implementation process. The applicant must consult with RMA to determine whether or not the submission can be effectively and efficiently implemented and administered through the current information technology standards and systems.

(1) If FCIC approves the submission and determines that its information technology systems have the capacity to implement and administer the submission, the applicant must provide a document detailing acceptable computer processing requirements consistent with those used by RMA as shown on the RMA Web site in the Appendix III/M-13 Handbook. This information details the acceptable computer processing requirements in a manner consistent with that used by RMA to facilitate the acceptance of producer applications and related data.

(2) Any computer systems, requirements, code and software must be consistent with that used by RMA and comply with the standards established in Appendix III/M-13 Handbook, or any successor document, of the SRA or other reinsurance agreement as specified by FCIC.

(3) These requirements are available from the USDA/Risk Management Agency, Beacon Facility Mail Stop 0812, 9240 Troost Ave., Kansas City, MO 64131-3055, or on RMA's Web site at http://www.rma.usda.gov/data/#m13, or a successor Web site.

(k) The tenth section submitted on separate pages and in accordance with §§ 400.712 must specify:

(1) On one page, the amount received for an advance payment, an estimate of the total amount of reimbursement for research and development costs (new products only) or an estimate for maintenance costs for the year that the submission will be effective (for products that are within the maintenance period); and

(2) On another page, a detailed estimate of maintenance costs for future years of the maintenance period and the basis that such maintenance costs will be incurred, including, but not limited to:

(i) Any anticipated expansion;

(ii) Anticipated changes or updates to policy materials;

(iii) The generation of premium rates;

(iv) The determination of prices; and

(v) Any other costs that the applicant anticipates will be requested for reimbursement of maintenance costs or expenses;

(l) The eleventh section must contain executed (signed) certification statements in accordance with the following:

(1) “{Applicant's Name} hereby claim that the basis and amounts set forth in this section and § 400.712 are correct and due and owing to {Applicant's Name} by FCIC under the Federal Crop Insurance Act”; and

(2) “{Applicant Name} understands that, in addition to criminal fines and imprisonment, the submission of false or fraudulent statements or claims may result in civil and administrative sanctions.”

(m) The contents required for concept proposals are found in the Procedures Handbook 17030—Approved Procedures for Submission of Concept Proposals Seeking Advance Payment of Research and Development Expenses. In addition, the proposal must provide a detailed description of why the concept provides insurance:

(1) In a significantly improved form;

(2) To a crop or region not traditionally served by the Federal crop insurance program; or

(3) In a form that addresses a recognized flaw or problem in the program;

(n) The contents required for index-based weather plans of insurance are found in the Procedures Handbook 17050—Approved Procedures for Submission of Index-based Weather Plans of Insurance. In accordance with the Board approved procedures, the approved insurance provider that submits the index-based weather plan of insurance must provide evidence they have:

(1) Adequate experience underwriting and administering policies or plans of insurance that are comparable to the proposed policy of plan of insurance;

(2) Sufficient assets or reinsurance to satisfy the underwriting obligations of the approved insurance provider, and possess a sufficient insurance credit rating from an appropriate credit rating bureau; and

(3) Applicable authority and approval from each State in which the approved insurance provider intends to sell the insurance product.

§ 400.706 Review.

(a) Prior to providing a submission, concept proposal, or index-based weather plan of insurance to the Board, RMA will:

(1) Review the submission, concept proposal, or index-based weather plan of insurance to determine if all required documentation is included in accordance with § 400.705;

(2) Review the submission, concept proposal, or index-based weather plan of insurance to determine whether it is of sufficient quality to conduct a meaningful review such that the Board will be able to make an informed decision regarding approval or disapproval;

(3) In accordance with section 508(h)(1)(B) of the Act, at its sole discretion, determine if the policy or plan of insurance:

(i) Will likely result in a viable and marketable policy;

(ii) Will provide crop insurance coverage in a significantly improved form; and

(iii) Adequately protect the interests of producers.

(4) Except for submissions developed from a concept proposal funded for advanced payment by the Board, reject and return any submission, concept proposal, or indexed based weather plan of insurance that:

(i) Does not contain all the required information or is not of sufficient quality to conduct a meaningful review;

(ii) Is unlikely result in a viable and marketable policy;

(iii) Will not provide crop insurance coverage in a significantly improved form; and

(iv) Will not adequately protect the interests of producers.

(5) Except as provided in paragraph (a)(4) of this section or if the submission was developed from an approved concept proposal, forward the submission, concept proposal, or index-based weather plan of insurance, and the results of RMA's initial review, to the Board for its determination of completeness.

(b) Upon the Board's receipt of a submission, the Board will:

(1) Determine if the submission is complete (The date the Board votes to contract with the expert reviewers is the date the submission is deemed to be complete for the start of the 120 day time-period for approval);

(2) Unless the submission makes non-significant changes to a policy or plan of insurance, or involves policy provisions that have already undergone expert review, forward the complete submission to at least five expert reviewers to review the submission:

(i) Of the five expert reviewers, no more than one will be employed by the Federal Government, and none may be employed by any approved insurance provider or their representative; and

(ii) The expert reviewers will each provide their individual assessment of whether the submission:

(A) Protects the interests of agricultural producers and taxpayers;

(B) Is actuarially appropriate;

(C) Follows appropriate insurance principles;

(D) Meets the requirements of the Act;

(E) Does not contain excessive risks;

(F) Follows sound, reasonable, and appropriate underwriting principles;

(G) Will provide a new kind of coverage that is likely to be viable and marketable;

(H) Will provide crop insurance coverage in a manner that addresses a clear and identifiable flaw or problem in an existing policy;

(I) Will provide a new kind of coverage for a commodity that previously had no available crop insurance, or has demonstrated a low level of participation or coverage level under existing coverage;

(J) May have a significant adverse impact on the crop insurance delivery system;

(K) Contains a marketing plan that reasonably demonstrates the product would be viable and marketable;

(L) If applicable, contains a consultation report that provides evidence the submission will not create adverse market distortions; and

(M) Meets any other criteria the Board may deem necessary;

(3) Return to the applicant any submission the Board determines is not complete, along with an explanation of the reason for the determination and:

(i) With respect to submissions developed from approved concept proposals, the provisions in § 400.712(c)(1) shall apply; and

(ii) Except for submissions developed from concept proposals, if the submission is resubmitted at a later date, it will be considered a new submission solely for the purpose of determining the amount of time that the Board must take action;

(4) For complete submissions:

(i) Request review by RMA to provide its assessment of whether the submission:

(A) Meets the criteria listed in subsections (b)(2)(ii)(A) through (M);

(B) Is consistent with USDA's public policy goals;

(C) Does not increase or shift risk to any other FCIC reinsured policy;

(D) Can be implemented, administered, and delivered effectively and efficiently using RMA's information technology and delivery systems; and

(E) Contains requested amounts of government reinsurance, risk subsidy, and administrative and operating subsidies that are reasonable and appropriate for the type of coverage provided by the policy submission; and

(ii) Seek review from the Office of the General Counsel (OGC) to determine if the submission conforms to the requirements of the Act and all applicable Federal statutes and regulations.

(5) Unless all the requirements for approval for submissions in this subsection are met or reasons for notice of disapproval exist as specified in subsection (k), provide a notice of intent to disapprove, including the reasons for the intent to disapprove.

(c) Upon the Board's receipt of a concept proposal, the Board will:

(1) Determine whether the concept proposal is complete (The date the Board votes to contract with expert reviewers is the date the concept proposal is deemed to be a complete concept proposal for the start of the 120 day time-period for approval);

(2) If complete, forward the complete concept proposal to at least two expert reviewers with underwriting or actuarial experience to review the concept in accordance with section 522(b)(2) of the Act, this subpart, and Procedures Handbook 17030—Approved Procedures for Submission of Concept Proposals Seeking Advance Payment of Research and Development Expenses;

(3) Return to the applicant any concept proposal the Board determines is not complete, along with an explanation of the reason for the determination (If the concept proposal is resubmitted at a later date, it will be considered a new concept proposal solely for the purposes of determining the amount of time that the Board must take action);

(4) Determine whether the concept proposal, if developed into a policy or plan of insurance would, in good faith, would meet the requirement of being likely to result in a viable and marketable policy consistent with section 508(h);

(5) At its sole discretion, determine whether the concept proposal, if developed into a policy or plan of insurance would meet the requirement of providing coverage:

(i) In a significantly improved form;

(ii) To a crop or region not traditionally served by the Federal crop insurance program; or

(iii) In a form that addresses a recognized flaw or problem in the program;

(6) Determine whether the proposed budget and timetable are reasonable;

(7) Determine whether the concept proposal meets all other requirements imposed by the Board or as otherwise specified in Procedures Handbook 17030—Approved Procedures for Submission of Concept Proposals Seeking Advance Payment of Research and Development Expenses;

(8) Provide a date by which the submission must be provided in consultation with the applicant; and

(9) Unless all the requirements for approval of concept proposals in this subsection are met or reasons for disapproval exist as specified in subsection (l), provide a notice of disapproval, including the reasons for disapproval.

(d) Upon the Board's receipt of an index-based weather plan of insurance, the Board will:

(1) Determine whether the index-based weather plan of insurance is complete (The date the Board votes to contract with expert reviewers is the date the index-based weather plan of insurance is deemed to be a complete for the start of the 120 day time-period for approval);

(2) If determined to be complete, contract with five expert reviewers and review the index-based weather plan of insurance in accordance with section 523(i) of the Act, this subpart, and Procedures Handbook 17050—Approved Procedures for Submission of Index-based Weather Plans of Insurance;

(3) Return to the applicant any index-based weather plan of insurance the Board determines is not complete, along with an explanation of the reason for the determination (If the index-based weather plan of insurance is resubmitted at a later date, it will be considered a new index-based weather plan of insurance solely for the purposes of determining the amount of time that the Board must take action);

(4) Give the highest priority for approval of index-based weather plans of insurance that provide a new kind of coverage for specialty crops and livestock commodities that previously had no available crop insurance, or has demonstrated a low level of participation under existing coverage; and

(5) Unless all the requirements for approval of index-based weather plans of insurance in this subsection are met or reasons for notice of disapproval exist as specified in paragraph (m) of this section, provide a notice of intent to disapprove including the reasons for the intent to disapprove.

(e) All comments and evaluations will be provided to the Board by a date determined by the Board to allow the Board adequate time for review.

(f) The Board will consider all comments, evaluations, and recommendations in its review process. Prior to making a decision, the Board may request additional information from RMA, OGC, the expert reviewers, or the applicant.

(g) In considering whether to approve a submission and when such submission will be offered for sale, the Board will:

(1) First, consider policies or plans of insurance that address underserved commodities, including commodities for which there is no insurance;

(2) Second, consider existing policies or plans of insurance for which there is inadequate coverage or there exists low levels of participation; and

(3) Last, consider all policies or plans of insurance submitted to the Board that do not meet the criteria described in paragraph (g)(1) or (2) of this section.

(h) At any time an applicant may request a time delay after the submission, concept proposal, or index-based weather plan of insurance has been placed on the Board meeting agenda. The Board is not required to agree to such an extension.

(1) With respect to submissions from concept proposals approved by the Board for advanced payment, the applicant must provide good cause why consideration should be delayed.

(2) Any requested time delay is not limited in the length of time unless a date is set by the Board by which all revisions to the submission, concept proposal or indexed-based weather plan of insurance must be made. However, delays may make implementation of the submission for the targeted crop year impractical or impossible as determined by the Board.

(3) The time period during which the Board will make a decision to approve or disapprove the submission, concept proposal or indexed-based weather plan of insurance shall be extended commensurately with any time delay requested by the applicant.

(i) The applicant may withdraw a submission, concept proposal, index-based weather plan of insurance, or a portion of a submission or concept proposal, at any time by presenting a request to the Board. A withdrawn submission, concept proposal or index-based weather plan of insurance that is resubmitted will be deemed a new submission, concept proposal, or index-based weather plan of insurance solely for the purposes of determining the amount of time that the Board must take action.

(j) The Board will render a decision on a submission, concept proposal, or indexed-based weather plan of insurance, with or without revision within 90 days after the date the submission, concept proposal, or indexed-based weather plan of insurance is considered complete by the Board, unless the Board agrees to a time delay in accordance with paragraph (h) of this section. Failure to approve a submission, concept proposal, or indexed-based weather plan of insurance constitutes intent to give of intent to disapprove a submission or index-based weather plan of insurance or disapproval of a concept proposal.

(k) The Board may provide a notice of intent to disapprove a submission if it determines:

(1) The interests of producers and taxpayers are not protected, including but not limited to:

(i) The submission does not provide adequate coverage or treats producers disparately;

(ii) The applicant has not presented sufficient documentation that the submission will provide a new kind of coverage that is likely to be viable and marketable;

(iii) Coverage would be similar to another policy or plan of insurance that has not demonstrated a low level of participation or does not contain a clear and identifiable flaw, and the producer would not significantly benefit from the submission;

(iv) The submission may create adverse market distortions or adversely impact other crops or agricultural commodities if marketed;

(v) The submission will have a significant adverse impact on the private delivery system; or

(vi) The submission cannot be implemented, administered, and delivered effectively and efficiently using RMA's information technology and delivery systems;

(2) The premium rates are not actuarially appropriate;

(3) The submission does not conform to sound insurance and underwriting principles;

(4) The risks associated with the submission are excessive or it increases or shifts risk to another reinsured policy;

(5) The submission does not meet the requirements of the Act; or

(6) The 90 day deadline under subsection (i) will expire before the Board has time to make an informed decision to approve or disapprove the submission.

(l) The Board may disapprove a concept proposal if it determines:

(1) The concept, in good faith, will not likely result in a viable and marketable policy consistent with section 508(h);

(2) At the sole discretion of the Board, the concept, if developed into a policy and approved by the Board, would not provide crop insurance coverage:

(i) In a significantly improved form;

(ii) To a crop or region not traditionally served by the Federal crop insurance program; or

(iii) In a form that addresses a recognized flaw or problem in the program;

(3) The proposed budget and timetable are not reasonable, as determined by the Board; or

(4) The concept proposal fails to meet one or more requirements established by the Board.

(m) The Board may provide a notice of intent to disapprove an index-based weather plan of insurance if it determines there is not:

(1) Adequate experience underwriting and administering policies or plans of insurance that are comparable to the proposed policy or plan of insurance;

(2) Sufficient assets or reinsurance to satisfy the underwriting obligations of the approved insurance provider, and possess a sufficient insurance credit rating from an appropriate credit rating bureau, in accordance with Board procedures; and

(3) Applicable authority and approval from each State in which the approved insurance provider intends to sell the insurance product.

(n) Unless otherwise provided for in this section:

(1) If the Board intends to disapprove a submission or index-based weather plan of insurance or disapproves a concept proposal, the Board will provide the applicant with a written explanation outlining the basis for the intent to disapprove or disapproval; and

(2) Any approval or disapproval of a submission, concept proposal, or index-based weather plan of insurance must be made by the Board in writing not later than 120 days after the Board has determined it to be complete.

(o) If a notice of intent to disapprove all or part of a submission or index-based weather plan of insurance has been provided by the Board, the applicant must provide written notice to the Board not later than 30 days after the Board provides such notice if the submission or index-based weather plan of insurance will be modified. If the applicant does not respond within the 30-day period, the Board will send the applicant a letter stating the submission or index-based weather plan of insurance is disapproved.

(p) If the applicant elects to modify the submission or index-based weather plan of insurance:

(1) The applicant must advise the Board of a date by which the modified submission or index-based weather plan of insurance will be presented to the Board; and

(2) The remainder of the time left between the Board's notice of intent to disapprove and the expiration of the 120 day deadline is tolled until the modified submission or index-based weather plan of insurance is received by the Board.

(3) The Board will disapprove a modified submission or index-based weather plan of insurance if the:

(i) Causes for disapproval stated by the Board in its notification of intent to disapprove the submission or index-based weather plan of insurance are not satisfactorily addressed;

(ii) Board determines there is insufficient time for the Board to finish its review before the expiration of the 120-day deadline for disapproval of a submission or index-based weather plan of insurance, unless the applicant grants the Board an extension of time to adequately consider the modified submission or index-based weather plan of insurance (If an extension of time is agreed upon, the time period during which the Board must act on the modified submission or index-based weather plan of insurance will tolled during the extension); or

(iii) Applicant does not present a modification of the submission or index-based weather plan of insurance to the Board on the date the applicant specified and the applicant does not request an additional time delay.

(q) If the Board fails to render a decision on a new submission or index-based weather plan of insurance within the time periods specified in paragraph (j) or (n) of this section, such submission or index-based weather plan of insurance will be deemed approved by the Board for the initial reinsurance year designated for the submission or index-based weather plan of insurance. The Board must approve the submission or index-based weather plan of insurance for it to be available for any subsequent reinsurance year.

§ 400.707 Presentation to the Board for approval or disapproval.

(a) The Board will inform the applicant of the date, time, and place of the Board meeting.

(b) The applicant will be given the opportunity and is encouraged to present the submission, concept proposal, or index-based weather plan of insurance to the Board in person. The applicant must confirm in writing, email or fax whether the applicant will present in person to the Board.

(c) If the applicant elects not to present the submission, concept proposal, or index-based weather plan of insurance to the Board, the Board will make its decision based on the information provided in accordance with § 400.705 and § 400.706.

§ 400.708 Post approval.

(a) After a submission is approved by the Board, and prior to it being made available for sale to producers:

(1) The following must be executed, as applicable:

(i) If required by FCIC, an agreement between the applicant and FCIC that specifies:

(A) In addition to the requirements in § 400.709, responsibilities of each with respect to the implementation, delivery and maintenance of the submission; and

(B) The required timeframes for submission of any information and documentation needed to administer the approved submission;

(ii) A reinsurance agreement if terms and conditions differ from the available existing reinsurance agreements; and

(iii) A training package to facilitate implementation of the approved submission;

(2) The Board may limit the availability of coverage, for any policy or plan of insurance developed under the authority of the Act and this regulation, on any farm or in any county or area;

(3) A submission approved by the Board under this subpart will be made available to all approved insurance providers under the same reinsurance, subsidy, and terms and conditions as received by the applicant;

(4) Any solicitation, sales, marketing, or advertising of the approved submission by the applicant before FCIC has made the policy materials available to all interested parties through its official issuance system will result in the denial of reinsurance, risk subsidy, and A&O subsidy for those policies affected; and

(5) The property rights to the submission will automatically transfer to FCIC if the applicant elects not to maintain the submission under § 400.712(a)(3) or fails to notify FCIC of its decision to elect or not elect maintenance of the program under § 400.712(l).

(b) Requirements and procedures for approved index-based weather plans of insurance are contained in Procedures Handbook 17050—Approved Procedures for Submission of Index-based Weather Plans of Insurance. In accordance with the Board approved procedures, index-based weather plans of insurance are not eligible for federal reinsurance, but may be approved for risk subsidy and A&O subsidy.

§ 400.709 Roles and responsibilities.

(a) With respect to the applicant:

(1) The applicant is responsible for:

(i) Preparing and ensuring that all policy documents, rates of premium, prices, and supporting materials, including actuarial documents, are submitted by the deadline specified by FCIC, in the form approved by the Board, and are in compliance with Section 508 of the Rehabilitation Act;

(ii) Annually updating and providing maintenance changes no later than 180 days prior to the earliest contract change date for the commodity in all counties or states in which the policy or plan of insurance is sold;

(iii) Timely addressing responses to procedural issues, questions, problems or clarifications in regard to a policy or plan of insurance (all such resolutions for approved submissions will be communicated to all approved insurance providers through FCIC's official issuance system); and

(iv) If requested by the Board, providing an annual review of the policy's performance, in writing to the Board, 180 days prior to the contract change date for the plan of insurance (The first annual report will be submitted one full year after implementation of an approved policy or plan of insurance, as agreed to by the submitter and RMA);

(2) Only the applicant may make changes to the policy, plan of insurance, or rates of premium approved by the Board:

(i) Any changes to approved submissions, both non-significant and significant, must be submitted to FCIC in the form of a submission for review in accordance with this subpart no later than 180 days prior to the earliest contract change date for the commodity in all counties or states in which the policy or plan of insurance is sold; and

(ii) Significant changes will be considered a new submission;

(3) Except as provided in paragraph (a)(4) of this section, the applicant is solely liable for any mistakes, errors, or flaws in the submitted policy, plan of insurance, their related materials, or the rates of premium that have been approved by the Board unless the policy or plan of insurance is transferred to FCIC in accordance with § 400.712(l) (The applicant remains liable for any mistakes, errors, or flaws that occurred prior to transfer of the policy or plan of insurance to FCIC);

(4) If the mistake, error, or flaw in the policy, plan of insurance, their related materials, or the rates of premium is discovered more than 45 days prior to the cancellation or termination date for the policy or plan of insurance, the applicant may request in writing that FCIC withdraw the approved policy, plan of insurance, or rates of premium:

(i) Such request must state the discovered mistake, error, or flaw in the policy, plan of insurance, or rates of premium, and the expected impact on the program; and

(ii) For all timely received requests for withdrawal, no liability will attach to such policies, plans of insurance, or rates of premium that have been withdrawn and no producer, approved insurance provider, or any other person will have a right of action against the applicant;

(5) Notwithstanding the policy provisions regarding cancellation, any policy, plan of insurance, or rates of premium that have been withdrawn by the applicant, in accordance with paragraph (a)(4) of this section is deemed canceled and applications are deemed not accepted as of the date that FCIC publishes the notice of withdrawal on its Web site at www.rma.usda.gov.

(i) Approved insurance providers will be notified in writing by FCIC that the policy, plan of insurance, or premium rates have been withdrawn; and

(ii) Producers will have the option of selecting any other policy or plan of insurance authorized under the Act that is available in the area by the sales closing date for such policy or plan of insurance; and

(6) Failure of the applicant to perform all of the applicant's responsibilities may result in the withdrawal of approval for the policy or plan of insurance.

(b) With respect to FCIC:

(1) FCIC is responsible for:

(i) Conducting a review of the submission in accordance with § 400.706 and providing its recommendations to the Board;

(ii) With respect to submissions:

(A) Ensuring that all approved insurance providers receive the approved policy or plan of insurance, and related material, for sale to producers in a timely manner (All such information shall be communicated to all approved insurance providers through FCIC's official issuance system);

(B) As applicable, ensuring that approved insurance providers receive reinsurance under the same terms and conditions as the applicant (Approved insurance providers should contact FCIC to obtain and execute a copy of the reinsurance agreement) if required; and

(C) Reviewing the activities of approved insurance providers, agents, loss adjusters, and producers to ensure that they are in accordance with the terms of the policy or plan of insurance, the reinsurance agreement, and all applicable procedures;

(2) FCIC will not be liable for any mistakes, errors, or flaws in the policy, plan of insurance, their related materials, or the rates of premium and no cause of action may be taken against FCIC as a result of such mistake, error, or flaw in a submission or index-based weather plan of insurance submitted under this subpart;

(3) If at any time prior to the cancellation date, FCIC discovers there is a mistake, error, or flaw in the policy, plan of insurance, their related materials, or the rates of premium, or any other reason for withdrawal of approval contained in § 400.706(k) exists, FCIC will deny reinsurance for such policy or plan of insurance (If reinsurance is denied, a written notice will be provided to on RMA's Web site at www.rma.usda.gov);

(4) If maintenance of the policy or plan of insurance is transferred to FCIC in accordance with § 400.712(l), FCIC will assume liability for the policy or plan of insurance for any mistake, error, or flaw that occur after the date the policy is transferred.

(c) If approval by the Board is withdrawn or reinsurance is denied for any submission, the approved insurance provider must cancel the policy or plan of insurance in accordance with its terms.

§ 400.710 Preemption and premium taxation.

A policy or plan of insurance that is approved by the Board for FCIC reinsurance is preempted from state and local taxation. This preemption does not apply to index-based weather plans of insurance approved for premium subsidy or A&O subsidy under this part.

§ 400.711 Right of review, modification, and the withdrawal of approval.

(a) At any time after approval, the Board may review any policy, plan of insurance, related material, or rates of premium approved under this subpart, including index-based weather plans of insurance and request additional information to determine whether the policy, plan of insurance, related material, or rates of premium comply with the requirements of this subpart.

(b) The Board will notify the applicant of any problem or issue that may arise and allow the applicant an opportunity to make any needed change. If the contract change date has passed, the applicant will be liable for such problems or issues for the crop year in accordance with § 400.709 until the policy may be changed.

(c) The Board may withdraw approval for the applicable policy, plan of insurance or rate of premium, including index-based weather plans of insurance, as applicable, if:

(1) The applicant fails to perform the responsibilities stated under § 400.709(a);

(2) The applicant does not timely and satisfactorily provide materials or resolve any issue to the Board's satisfaction so that necessary changes can be made prior to the earliest contract change date;

(3) The Board determines the applicable policy, plan of insurance or rate of premium, including index-based weather plans of insurance is not in conformance with the Act, these regulations or the applicable procedures;

(4) The policy, plan of insurance, or rates of premium are not sufficiently marketable according to the applicant's estimate in the submission or fails to perform sufficiently as determined by the Board; or

(5) The interest of producers or tax payers is not protected or the continuation of the program raises questions or issues of program integrity.

§ 400.712 Research and development reimbursement, maintenance reimbursement, advance payments for concept proposals, and user fees.

(a) For submissions approved by the Board for reinsurance under section 508(h) of the Act:

(1) The submission may be eligible for a one-time payment of research and development costs and reimbursement of maintenance costs for up to four reinsurance years, as determined by the Board;

(2) Reimbursement of research and development costs or maintenance costs will be considered as payment in full by FCIC for the submission, and no additional amounts will be owed to the applicant if the submission is transferred to FCIC in accordance with paragraph (l) of this section; and

(3) If the applicant elects at any time not to continue to maintain the submission, it will automatically become the property of FCIC and the applicant will no longer have any property rights to the submission and will not receive any user fees for the plan of insurance;

(b) The Board approved procedures and time-frames must be followed, or research and development costs and maintenance costs may not be reimbursed, unless otherwise determined by the Board.

(1) After a submission has been approved by the Board for reinsurance, to be considered for reimbursement of:

(i) Research and development costs, the applicant must submit the total amount requested and all supporting documentation to FCIC by electronic method or by hard copy and such information must be received by FCIC on or before August 1 immediately following the date the submission was released to approved insurance providers through FCIC's issuance system; or

(ii) Maintenance costs, the applicant must submit the total amount requested and all supporting documentation to FCIC by electronic method or by hard copy and such information must be received by FCIC on or before August 1 of each year of the maintenance period.

(2) Given the limitation on funds, regardless of when the request is received, no payment will be made prior to September 15 of the applicable fiscal year.

(c) Applicants submitting a concept proposal may request an advance payment of up to 50 percent of the projected total research and development costs, and after the applicant has begun research and development activities, the Board may at its sole discretion provide up to an additional 25 percent advance payment of the estimated research and development costs, if requested in accordance with Procedures Handbook 17030—Approved Procedures for Submission of Concept Proposals Seeking Advance Payment of Research and Development Expenses.

(1) If a concept proposal is approved by the Board for advance payment, the applicant is responsible for independently developing a submission that is complete and of sufficient quality as specified in this subpart by the deadline set by the Board.

(i) If an applicant fails to fulfill the obligation to provide a submission that is complete and of sufficient quality by the deadline set by the Board, the Board shall provide a notice of non-compliance to the applicant and allow not less than 30 days for the applicant to respond;

(ii) If the applicant fails to respond, to the satisfaction of the Board, with just cause as to why a submission that is complete and of sufficient quality was not provided by the deadline set by the Board, the applicant shall return the amount of the advance payment plus interest at the rate of 1.25 percent simple interest per calendar month;

(iii) If the applicant responds, to the satisfaction of the Board, with just cause as to why a submission that is complete and of sufficient quality was not provided by the deadline set by the Board, the applicant will be given a new deadline by which to provide a submission that is complete and of sufficient quality; and

(iv) If the applicant fails to provide a submission that is complete and of sufficient quality by the deadline, no additional extensions will be approved by the Board and the applicant shall return the amount of the advance payment plus interest at the rate of 1.25 percent simple interest per calendar month.

(2) If an applicant receives an advance payment for a portion of the expected research and development costs for a concept proposal that is developed into a submission and determined by the Board to be complete and of sufficient quality, but the submission is not approved by the Board following expert review, the Board will not:

(i) Seek a refund of any advance payments for research and development costs; and

(ii) Make any further research and development cost reimbursements associated with the submission.

(d) Under section 522 of the Act, there are limited funds available on an annual fiscal year basis to pay for reimbursements of research and development costs (including advance payments for concept proposals) and maintenance costs. Consistent with paragraphs (e) through (j) of this section if all applicants' requests for reimbursement of research and development costs (including advance payments for concept proposals) and maintenance costs in any fiscal year:

(1) Do not exceed the maximum amount authorized by law, the applicants may receive the full amount of reimbursement determined reasonable by the Board; or

(2) Exceed the amount authorized by law, each applicant's reimbursement determined reasonable by the Board will be determined by dividing the total amount of each individual applicant's reimbursable costs authorized in paragraphs (e) through (j) of this section by the total amount of the aggregate of all applicants' reimbursable costs authorized in paragraphs (e) through (j) for the year and multiplying the result by the amount of reimbursement authorized under the Act.

(e) The amount of reimbursement for research and development costs requested by the applicant may be reduced based on:

(1) The complexity of the policy, plan of insurance, or rates of premium, so requests for reimbursements for submissions:

(i) Adding commodities to existing plans of insurance (i.e., Yield Protection and Revenue Protection under the Common Crop insurance Policy Basic Provisions, Area Risk Protection, Actual Revenue History, Whole Farm, Rainfall Index, Vegetative Index, etc.) may be reduced by as much as 20 percent;

(ii) Using existing rating methodologies or commodity prices or a price methodology may be reduced by as much as 10 percent;

(iii) Using existing policy provisions, procedures, etc., may be reduced by as much as 10 percent; and

(2) The scope as measured by the agricultural commodities proposed to be covered or geographic area the proposed submission will cover, as determined by FCIC so requests for reimbursements for submissions:

(i) That cover a single commodity may be reduced by 10 percent; and

(ii) That cover a small geographic area compared to the total growing area for the commodity may be reduced by 10 percent.

(f) Research and development and maintenance costs must be supported by itemized statements and supporting documentation (copies of contracts, billing statements, time sheets, travel vouchers, accounting ledgers, etc.).

(1) Actual costs submitted will be examined for reasonableness and may be adjusted at the sole discretion of the Board.

(2) Allowable research and development costs and maintenance costs (directly related to research and development or maintenance of the submission only) may include the following:

(i) Wages and benefits, exclusive of bonuses, overtime pay, or shift differentials;

(A) One line per employee or contractor, include job title, total hours, and total dollars;

(B) The rates charged must be commensurate with the tasks performed (For example, a person performing the task of data entry should not be paid at the rate for performing data analysis);

(C) The wage rate and benefits shall not exceed two times the hourly wage rate plus benefits provided by the Bureau of Labor Statistics; and

(D) The applicant must report any familial or business relationship that exists between the applicant and the contractor or employee (Reimbursement may be limited or denied if the contractor or employee is associated to the applicant and they may be considered as one and the same. This includes a separate entity being created by the applicant to conduct research and development. Reimbursement may be limited or denied if the contractor is paid a salary or other compensation);

(ii) Travel and transportation (One line per event, include the job title, destination, purpose of travel, lodging cost, mileage, air or other identified transportation costs, food and miscellaneous expenses, other costs, and the total cost);

(iii) Software and computer programming developed specifically to determine appropriate rates, prices, or coverage amounts (Identify the item, include the purpose, and provide receipts or contract or straight-time hourly wage, hours, and total cost. Software developed to send or receive data between the producer, agent, approved insurance provider or RMA or such other similar software may not be included as an allowable cost);

(iv) Miscellaneous expenses such as postage, telephone, express mail, and printing (Identify the item, cost per unit, number of items, and total dollars); and

(v) Training costs expended to facilitate implementation of a new approved submission (Include instructor(s) hourly rate, hours, and cost of materials and travel) conducted at a national level, directed to all approved insurance providers interested in selling the submission, and approved prior to the training by RMA).

(3) The following expenses are specifically not eligible for research and development and maintenance cost reimbursement:

(i) Copyright fees, patent fees, or any other charges, costs or expenses related to the use of intellectual property;

(ii) Training costs, excluding training costs to facilitate implementation of the approved submission in accordance with subsection (f)(2)(v);

(iii) State filing fees and expenses;

(iv) Normal ongoing administrative expenses or indirect overhead costs (for example, costs associated with the management or general functions of an organization, such as costs for internet service, telephone, utilities, and office supplies);

(v) Paid or incurred losses;

(vi) Loss adjustment expenses;

(vii) Sales commission;

(viii) Marketing costs;

(ix) Lobbying costs;

(x) Product or applicant liability resulting from the research, development, preparation or marketing of the policy;

(xi) Copyright infringement claims resulting from the research, development, preparation or marketing of the policy;

(xii) Costs of making program changes as a result of any mistakes, errors or flaws in the policy or plan of insurance;

(xiii) Costs associated with building rents or space allocation;

(xiv) Costs in paragraphs (i) and (j) of this section determined by the Board to be ineligible for reimbursement; and

(xv) Local, State, or Federal taxes.

(g) Requests for reimbursement of maintenance costs must be supported by itemized statements and supporting documentary evidence for each reinsurance year in the maintenance period.

(1) Actual costs submitted will be examined for reasonableness and may be adjusted at the sole discretion of the Board.

(2) Maintenance costs for the following activities may be reimbursed:

(i) Expansion of the original submission into additional crops, counties or states;

(ii) Non-significant changes to the policy and any related material;

(iii) Non-significant or significant changes to the policy as necessary to protect program integrity or as required by Congress; and

(iv) Any other activity that qualifies as maintenance.

(h) Projected costs for research and development for concept proposals shall be based on a reasonable estimate of the costs allowed in paragraph (f) of this section.

(i) If a submission is determined to be of insufficient quality to refer to expert review, or is considered incomplete and is subsequently resubmitted and approved, the costs to perfect the submission may not be considered reimbursable costs depending on the level of insufficiency or incompleteness of the submission, as determined at the sole discretion of the Board.

(j) Reimbursement of costs associated with addressing issues raised by the Board, expert reviewers and RMA will be evaluated based on the substance of the issue and the amount of time reasonably necessary to address the specific issue raised. Delays and additional costs caused by the inability or refusal to adequately address issues may not be considered reimbursable, as determined at the sole discretion of the Board.

(k) If the Board withdraws its approval for reinsurance at any time during the period that reimbursement for maintenance is being made or user fees are being collected, no maintenance reimbursement shall be made nor any user fee be owed after the date of such withdrawal.

(l) Not later than 180 days prior to the end of the last reinsurance year in which a maintenance reimbursement will be paid for the approved submission, the applicant must notify FCIC in writing regarding its decision on future ownership and maintenance of the policy or plan of insurance.

(1) The applicant must notify FCIC in writing whether it intends to:

(i) Continue to maintain the policy or plan of insurance and charge approved insurance providers a user fee to cover maintenance expenses for all policies earning premium; or

(ii) Transfer responsibility for maintenance to FCIC.

(2) If the applicant fails to notify FCIC in writing by the deadline, the policy or plan of insurance will automatically transfer to FCIC beginning with the next reinsurance year.

(3) If the applicant elects to:

(i) Continue to maintain the policy or plan of insurance, the applicant must submit a request for approval of the user fee by the Board at the time of the election; or

(ii) Transfer the policy or plan of insurance to FCIC, FCIC may at its sole discretion, continue to maintain the policy or plan of insurance or elect to withdraw the availability of the policy or plan of insurance.

(4) Requests for approval of the user fee must be accompanied by written documentation to support the amount requested will only cover direct costs to maintain the plan of insurance. Costs that are not eligible for research and development and maintenance reimbursements under this section are not eligible to be considered for determining the user fee.

(5) The Board will approve the amount of user fee, including the maximum amount of total maintenance that may be collected per year, that is payable to the applicant by approved insurance providers unless the Board determines that the user fee charged:

(i) Is unreasonable in relation to the maintenance costs associated with the policy or plan of insurance; or

(ii) Unnecessarily inhibits the use of the policy or plan of insurance by approved insurance providers.

(6) If the total user fee exceeds the maximum amount determined by the Board, the maximum amount determined by the Board will be divided by the number of policies earning premium to determine the amount to be paid by each approved insurance provider.

(7) Reasonableness of the initial request to charge a user fee will be determined by the Board based on a comparison of the amount of reimbursement for maintenance previously received, the number of policies, the number of approved insurance providers, and the expected total amount of user fees to be received in any reinsurance year.

(8) A user fee unnecessarily inhibits the use of a policy or plan of insurance if it is so high that approved insurance providers will not sell the policy.

(9) The user fee charged to each approved insurance provider will be considered payment in full for the use of such policy, plan of insurance or rate of premium for the reinsurance year in which payment is made.

(10) It is the sole responsibility of the applicant to collect such fees from an approved insurance provider and any indebtedness for such fees must be resolved by the applicant and approved insurance provider.

(i) Applicants may request that FCIC provide the number of policies sold by each approved insurance provider.

(ii) Such information will be provided not later than 90 days after such request is made or not later than 90 days after the requisite information has been provided to FCIC by the approved insurance provider, whichever is later.

(11) Every two years after approval of a user fee, or if the applicant has made a significant change to the approved submission, applicants must submit documentation to the Board for review in determining if the user fee should be revised.

(12) The Board may review the amount of the user fee at any time at its sole discretion.

(m) The Board may consider information from the Equal Access to Justice Act, 5 U.S.C. 504, the Bureau of Labor Statistic's Occupational Employment Statistics Survey, the Bureau of Labor Statistic's Employment Cost Index, and any other information determined applicable by the Board, in making a determination whether to approve a submission for reimbursement of research and development costs, maintenance costs, or user fees.

(n) For purposes of this section, rights to, or obligations of, research and development cost reimbursement, maintenance cost reimbursement, or user fees cannot be transferred from any individual or entity unless specifically approved in writing by the Board.

(o) Applicants requesting reimbursement for research and development costs, maintenance costs, or user fees, may present their request in person to the Board prior to consideration for approval.

(p) Index-based weather plans of insurance are not eligible for reimbursement from FCIC for maintenance costs or research and development costs. Submitters of approved index-based weather plans of insurance may collect user fees from other approved insurance providers in accordance with Procedures Handbook 17050—Approved Procedures for Submission of Index-based Weather Plans of Insurance.

§ 400.713 Non-reinsured supplemental (NRS) policy.

(a) Unless otherwise specified by FCIC, any NRS policy that covers the same agricultural commodity as any policy reinsured by FCIC under the Act must be provided to RMA to ensure it does not shift any loss under the FCIC reinsured policy. Failure to provide such NRS policy or endorsement to RMA prior to its issuance shall result in the denial of reinsurance, A&O subsidy and risk subsidy on the underlying FCIC reinsured policy for which such NRS policy was sold.

(b) Three hard copies, and an electronic copy in a format approved by RMA, of the new or revised NRS policy and related materials must be submitted at least 150 days prior to the first sales closing date applicable to the NRS policy. At a minimum, examples that demonstrate how liability and indemnities are determined under differing scenarios must be included.

(1) Hard copies of the NRS must be sent to the Deputy Administrator for Product Management (or successor), USDA/Risk Management Agency, Beacon Facility Mail Stop 0812, 9240 Troost Ave., Kansas City, MO 64131-3055.

(2) Electronic copies of the NRS must be sent to the Deputy Administrator for Product Management (or successor) at [email protected]

(c) RMA will review the NRS policy. If any of the conditions found in paragraphs (c)(1) through (5) of this section are found to occur, FCIC will deny reinsurance, A&O subsidy and risk subsidy on the underlying FCIC reinsured policy for which such NRS policy was sold.

(1) If the NRS policy materially increases or shifts risk to the underlying policy or plan of insurance reinsured by FCIC.

(i) An NRS policy will be considered to materially increase or shift risk to the underlying policy or plan of insurance reinsured by FCIC if it creates an incentive for moral hazard such as a financial incentive to increase the number or size of losses or, allows for aggregate indemnities in excess of the expected value of the insured commodity.

(ii) The NRS must include language that clearly states no indemnity will be paid in excess of the initial value of the insured commodity.

(2) The NRS reduces or limits the rights of the insured with respect to the underlying policy or plan of insurance reinsured by FCIC. An NRS policy will be considered to reduce or limit the rights of the insured with respect to the underlying policy or plan of insurance if it alters the terms or conditions of the underlying policy or otherwise preempts procedures issued by FCIC.

(3) The NRS disrupts the marketplace. An NRS policy will be considered to disrupt the marketplace if it encourages planting more acres of the insured commodity in excess of normal market demand, adversely affects the sales or administration of reinsured policies, undermines producers' confidence in the Federal crop insurance program, or harms public perception of the Federal crop insurance program.

(4) The NRS is an impermissible rebate. An NRS may be considered to be an impermissible rebate if FCIC determines that the premium rates charged are insufficient to cover the expected losses and a reasonable reserve or it offers other benefits that are generally provided at a cost.

(5) The NRS policy is conditioned upon or provides incentive for the purchase of the underlying policy or plan of insurance reinsured by FCIC with a specific agent or approved insurance provider.

(d) RMA will respond not less than 60 days before the first sales closing date or provide notice why RMA is unable to respond within the time frame allotted.

(e) NRS policies reviewed by RMA will not need to be submitted for a five year period unless a change is made to the NRS or the underlying policy or the loss ratio for the NRS policy exceeds 2.0. Once any changes are made to either policy or the five year period has concluded, the NRS must be resubmitted for review.

Signed in Washington, DC, on February 13, 2015. Brandon Willis, Manager, Federal Crop Insurance Corporation.
[FR Doc. 2015-03604 Filed 2-23-15; 8:45 am] BILLING CODE 3410-08-P
COMMODITY FUTURES TRADING COMMISSION 17 CFR Parts 1, 15, 17, 19, 32, 37, 38, 140, and 150 RIN 3038-AD99; 3038-AD82 Position Limits for Derivatives and Aggregation of Positions AGENCY:

Commodity Futures Trading Commission.

ACTION:

Notice of proposed rulemaking; provision of Table 11a; and reopening of comment periods.

SUMMARY:

On December 12, 2013, the Commodity Futures Trading Commission (“Commission”) published in the Federal Register a notice of proposed rulemaking (the “Position Limits Proposal”) to establish speculative position limits for 28 exempt and agricultural commodity futures and options contracts and the physical commodity swaps that are economically equivalent to such contracts. On November 15, 2013, the Commission published in the Federal Register a notice of proposed rulemaking (the “Aggregation Proposal”) to amend existing regulations setting out the Commission's policy for aggregation under its position limits regime. The Commission's Energy and Environmental Markets Advisory Committee has scheduled a public meeting to be held on February 26, 2015, which will consider, among other matters, exemptions for bona fide hedging positions. In conjunction with the meeting of the Commission's Energy and Environmental Markets Advisory Committee, the Commission will post an agenda and associated materials, if any, on the Commission's Web site; additionally, access to a video webcast of the meeting will be added to the Web site. In addition, and in connection with the meeting, the Commission is providing counts of the unique persons over percentages of the 28 proposed position limit levels (currently provided in Table 11 of the Position Limits Proposal based on counts from the period of January 1, 2011, to December 31, 2012 period) in a new table, Table 11a, based on counts from the period of January 1, 2013, to December 31, 2014. To provide commenters with a sufficient period of time to respond to questions raised and points made at the Energy and Environmental Markets Committee meeting, as well as to provide an opportunity to comment on Table 11a, the Commission will reopen the comment periods for an additional 30 days. The Commission is providing notice that comments may be made on the issues addressed at the meeting or in the associated materials posted to the Commission's Web site, as they pertain to energy commodities. Furthermore, comments may be made on Table 11a, showing counts of the unique persons over percentages of the 28 proposed position limit levels based on counts from the period of January 1, 2013, to December 31, 2014.

DATES:

The comment periods for the Aggregation Proposal published November 15, 2013, at 78 FR 68946, and for the Position Limits Proposal published December 12, 2013, at 78 FR 75680, will reopen on February 26, 2015, and will close on March 28, 2015.

ADDRESSES:

You may submit comments, identified by RIN 3038-AD99 for the Position Limits Proposal or RIN 3038-AD82 for the Aggregation Proposal, by any of the following methods:

Agency Web site: http://comments.cftc.gov;

Mail: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581;

Hand Delivery/Courier: Same as Mail, above; or

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

Please submit your comments using only one method. All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to http://www.cftc.gov. You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that may be exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted under § 145.9 of the Commission's regulations (17 CFR 145.9).

The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from http://www.cftc.gov that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the rulemaking will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the Freedom of Information Act.

FOR FURTHER INFORMATION CONTACT:

Stephen Sherrod, Senior Economist, Division of Market Oversight, (202) 418-5452, [email protected]; or Riva Spear Adriance, Senior Special Counsel, Division of Market Oversight, (202) 418-5494, [email protected]; Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581.

SUPPLEMENTARY INFORMATION:

I. Background

The Commission has long established and enforced speculative position limits for futures and options contracts on various agricultural commodities as authorized by the Commodity Exchange Act (“CEA”).1 The part 150 position limits regime 2 generally includes three components: (1) the level of the limits, which set a threshold that restricts the number of speculative positions that a person may hold in the spot-month, individual month, and all months combined,3 (2) exemptions for positions that constitute bona fide hedging transactions and certain other types of transactions,4 and (3) rules to determine which accounts and positions a person must aggregate for the purpose of determining compliance with the position limit levels.5 The Position Limits Proposal generally sets out proposed changes to the first and second components of the position limits regime and would establish speculative position limits for 28 exempt and agricultural commodity futures and option contracts, and physical commodity swaps that are “economically equivalent” to such contracts (as such term is used in CEA section 4a(a)(5)).6 The Aggregation Proposal generally sets out proposed changes to the third component of the position limits regime.7

1 7 U.S.C. 1 et seq.

2See 17 CFR part 150. Part 150 of the Commission's regulations establishes federal position limits on futures and option contracts in nine enumerated agricultural commodities.

3See 17 CFR 150.2.

4See 17 CFR 150.3.

5See 17 CFR 150.4.

6See Position Limits for Derivatives, 78 FR 75680 (Dec. 12, 2013).

7See Aggregation of Positions, 78 FR 68946 (Nov. 15, 2013).

The Commission published the Position Limits Proposal and the Aggregation Proposal separately because it believes that the proposed amendments regarding aggregation of positions could be appropriate regardless of whether the Position Limits Proposal is finalized.8 If the Aggregation Proposal is finalized first, the modifications would apply to the current position limits regime for futures and option contracts on nine enumerated agricultural commodities. If the Position Limits Proposal is subsequently finalized, the modifications in the Aggregation Proposal would apply to the position limits regime for 28 exempt and agricultural commodity futures and options contracts and the physical commodity swaps that are economically equivalent to such contracts.

8See id. at 68947.

In order to provide interested parties with an opportunity to comment on the Aggregation Proposal during the comment period on the Position Limits Proposal, the Commission extended the comment period for the Aggregation Proposal to February 10, 2014, the same end date as the comment period for the Position Limits Proposal.9

9See 79 FR 2394 (Jan. 14, 2014).

Subsequent to publication of the Position Limits Proposal and the Aggregation Proposal, the Commission directed staff to schedule a June 19, 2014, public roundtable to consider certain issues regarding position limits for physical commodity derivatives. The roundtable focused on hedges of a physical commodity by a commercial enterprise, including gross hedging, cross-commodity hedging, anticipatory hedging, and the process for obtaining a non-enumerated exemption. Discussion included the setting of spot month limits in physical-delivery and cash-settled contracts and a conditional spot-month limit exemption. Further, the roundtable included discussion of: The aggregation exemption for certain ownership interests of greater than 50 percent in an owned entity; and aggregation based on substantially identical trading strategies. As well, the Commission invited comment on whether to provide parity for wheat contracts in non-spot month limits. In conjunction with the roundtable, staff questions regarding these topics were posted on the Commission's Web site.

To provide commenters with a sufficient period of time to respond to questions raised and points made at the roundtable, the Commission published a document in the Federal Register on May 29, 2014 (79 FR 30762), reopening the comment periods for the Position Limit Proposal and the Aggregation Proposal for three weeks, from June 12, 2014 to July 3, 2014. The Commission published a document in the Federal Register on July 3, 2014 (79 FR 37973), further extending the comment periods to August 4, 2014.

The Commission's Agricultural Advisory Committee met on December 9, 2014. The agenda adopted for the meeting included consideration, among other matters, of two issues associated with the Position Limits rulemaking: Deliverable supply and exemptions for bona fide hedging positions. In conjunction with the meeting of the Commission's Agricultural Advisory Committee, the Commission posted questions and presentation materials on the Commission's Web site; additionally, access to a video webcast of the meeting was added to the Web site.10 To provide interested persons with a sufficient period of time to respond to questions raised and points made at the Agricultural Advisory Committee meeting, the Commission reopened both the Position Limit Proposal and the Aggregation Proposal for an additional 45-day comment period.11

10 Questions, presentation materials, and a video webcast have been made available at http://www.cftc.gov/PressRoom/Events/opaevent_aac120914.

11See 79 FR 71973 (Dec. 4, 2014). The Commission also provided notice and clarification that, in addition to commenting on the agenda issues noted in the December 4, 2014, Federal Register release providing notice of the reopened comment period, comments could be made on the issues addressed at the meeting or in associated materials posted to the Commission's Web site, as they pertained to agricultural commodities, including hedges of a physical commodity by a commercial enterprise; and the process for estimating deliverable supplies used in the setting of spot month limits, as each pertained to agricultural commodities. See also 80 FR 200 (Jan. 5, 2015).

Comment letters received on the Position Limits Proposal are available at http://comments.cftc.gov/PublicComments/CommentList.aspx?id=1436. Comment letters received on the Aggregation Proposal are available at http://comments.cftc.gov/PublicComments/CommentList.aspx?id=1427.

II. Reopening of Comment Period

The Commission's Energy and Environmental Markets Advisory Committee has scheduled a meeting on February 26, 2015. The agenda adopted for the meeting includes consideration of exemptions for bona fide hedging positions. In conjunction with the meeting of the Commission's Energy and Environmental Markets Advisory Committee, the Commission will post associated materials on the Commission's Web site; additionally, access to a video webcast of the meeting will be added to the Web site. To provide interested persons with a sufficient period of time to respond to questions raised and points made at the Energy and Environmental Markets Advisory Committee meeting, the Commission is reopening both the Position Limit Proposal and the Aggregation Proposal for an additional 30-day comment period. The Commission is providing notice that, in addition to commenting on the agenda issues, comments may be made on the issues addressed at the meeting or in associated materials posted to the Commission's Web site, as they pertain to energy commodities, including hedges of a physical commodity by a commercial enterprise, as pertains to energy commodities.

In addition, and in connection with the Energy and Environmental Markets Advisory Committee meeting, the Commission is providing counts of the unique persons exceeding the 28 proposed position limit levels (currently provided in Table 11 of the Positions Limits Proposal based on counts from the period of January 1, 2011, to December 31, 2012 period 12 ) by certain specified percentages in a new table, Table 11a, based on counts from the period of January 1, 2013, to December 31, 2014. As was the case with Table 11, to provide the public with additional information regarding the number of large position holders in the past two calendar years, Table 11a provides counts of unique persons over 60, 80, 100, and 500 percent of the levels of the position limits proposed for 28 core referenced futures products.13 Note that the 500 percent line is omitted from Table 11a for contracts where no person held a position over that level. The Commission notes that in addition to commenting on the agenda issues and on the issues addressed at the meeting or in associated materials posted to the Commission's Web site, as they pertain to energy commodities, comments may be made on Table 11a.

12See 78 FR 75680 at 75731 (Dec. 12, 2013).

13 As is the case for Table 11, the Commission notes that Table 11a is presented using the proposed initial limit levels, without regard to alternatives presented in the proposed rule. See 78 FR at 75839 for the proposed initial limit levels for the spot month. The Commission also proposed alternatives methods for setting initial levels for the spot month. See FR at 75727-8. The proposed initial limit levels for the non-spot months are found at 78 FR 76787 (Dec. 19, 2013). The Commission also proposed an alternative method to establish higher initial limit levels in the non-spot months. See FR 78 at 75734.

Table 11a—Unique Persons Over Percentages of Proposed Position Limit Levels, January 1, 2013, to December 31, 2014 Commodity type/core referenced futures contract Percent of level Unique persons over level Spot month (physical-
  • delivery)
  • Spot month (cash-settled) Single month All months
    Legacy Agricultural CBOT Corn (C) 60 206 12 25 80 147 4 7 100 49 (*) 5 500 4 CBOT Oats (O) 60 (*) 11 12 80 (*) 6 8 100 (*) 5 CBOT Soybeans (S) 60 127 14 18 80 90 9 11 100 31 6 9 500 9 CBOT Soybean Meal (SM) 60 53 42 54 80 31 12 19 100 16 6 11 500 (*) CBOT Soybean Oil (SO) 60 82 31 38 80 51 10 18 100 18 5 11 500 (*) CBOT Wheat (W) 60 39 35 33 80 30 12 17 100 10 8 11 500 (*) ICE Cotton No. 2 (CT) 60 16 15 22 80 10 10 14 100 7 8 10 500 4 KCBT Hard Winter Wheat (KW) 60 17 32 39 80 7 16 27 100 (*) 12 12 MGEX Hard Red Spring Wheat (MWE) 60 7 33 36 80 4 20 29 100 (*) 15 21 Other Agricultural CBOT Rough Rice (RR) 60 9 6 5 80 7 4 4 100 (*) (*) (*) CME Milk Class III (DA) 60 NA 5 (*) 26 80 NA 4 15 100 NA (*) 10 CME Feeder Cattle (FC) 60 NA 113 8 14 80 NA 70 (*) 8 100 NA 28 5 CME Lean Hog (LH) 60 NA 98 19 34 80 NA 74 8 24 100 NA 45 (*) 14 CME Live Cattle (LC) 60 51 14 29 80 7 7 16 100 5 (*) 8 ICUS Cocoa (CC) 60 4 47 42 80 4 38 30 100 (*) 21 21 ICE Coffee C (KC) 60 14 30 32 80 10 13 16 100 6 8 11 500 (*) ICE FCOJ-A (OJ) 60 5 7 7 80 5 4 4 100 5 4 4 ICE Sugar No. 11 (SB) 60 55 41 39 80 42 31 29 100 16 21 22 500 (*) ICE Sugar No. 16 (SF) 60 5 6 13 80 5 6 11 100 4 5 11 Energy NYMEX Henry Hub Natural Gas (NG) 60 187 236 (*) 7 80 142 205 (*) (*) 100 83 187 (*) 500 (*) 46 NYMEX Light Sweet Crude Oil (CL) 60 135 100 (*) 12 80 95 87 (*) 7 100 44 65 (*) 500 NYMEX NY Harbor ULSD (HO) 60 76 68 13 16 80 49 63 7 9 100 31 44 (*) 6 500 5 NYMEX RBOB Gasoline (RB) 60 97 57 26 30 80 67 52 15 17 100 36 37 11 12 500 (*) Metals COMEX Copper (HG) 60 12 61 62 80 9 37 40 100 4 29 30 COMEX Gold (GC) 60 13 22 24 80 9 14 14 100 5 10 11 COMEX Silver (SI) 60 9 34 32 80 4 20 21 100 (*) 16 16 NYMEX Palladium (PA) 60 9 12 13 80 5 9 5 100 (*) 4 4 NYMEX Platinum (PL) 60 11 29 29 80 7 18 18 100 (*) 9 9 Legend: * means fewer than 4 unique owners exceeded the level. — means no unique owner exceeded the level. NA means not applicable.14

    Both comment periods will reopen on February 26, 2015, and will close on March 28, 2015.

    14 Table notes: (1) Aggregation exemptions were not used in computing the counts of unique persons; (2) the position data was for futures, futures options and swaps that are significant price discovery contracts (SPDCs).

    Issued in Washington, DC, on February 19, 2015, by the Commission. Christopher J. Kirkpatrick, Secretary of the Commission. Note:

    The following appendix will not appear in the Code of Federal Regulations.

    Appendix to Position Limits for Derivatives and Aggregation of Positions Reopening of Comment Periods—Commission Voting Summary

    On this matter, Chairman Massad and Commissioners Wetjen, Bowen, and Giancarlo voted in the affirmative. No Commissioner voted in the negative.

    [FR Doc. 2015-03834 Filed 2-24-15; 8:45 am] BILLING CODE 6351-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 310 [Docket Nos. FDA-2003-N-0196 (Formerly 2003N-0233), FDA-1978-N-0018 (Formerly 1978N-0038 and 78N-0038), and FDA-1996-N-0006 (Formerly 96N-0277)] Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed order; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is issuing a proposed sunscreen order (proposed order) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA). The proposed order announces FDA's tentative determination that enzacamene is not generally recognized as safe and effective (GRASE) and is misbranded when used in over-the-counter (OTC) sunscreen products because the currently available data are insufficient to classify it as GRASE and not misbranded, and additional information is needed to allow us to determine otherwise.

    DATES:

    Submit either electronic or written comments on this proposed order by April 13, 2015. Sponsors may submit written requests for a meeting with FDA to discuss this proposed order by March 27, 2015. See section VI for the proposed effective date of a final order based on this proposed order.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Electronic Submissions

    Submit electronic comments in the following way:

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

    Written Submissions

    Submit written submissions in the following ways:

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

    Instructions: All submissions received must clearly identify the specific active ingredient (enzacamene) and the Docket Nos. FDA-2003-N-0196, FDA-1978-N-0018, and FDA-1996-N-0006 for this rulemaking. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document.

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

    Submit requests for a meeting with FDA to discuss this proposed order to Kristen Hardin (see FOR FURTHER INFORMATION CONTACT).

    FOR FURTHER INFORMATION CONTACT:

    Kristen Hardin, Division of Nonprescription Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5491, Silver Spring, MD 20993-0002, 240-402-4246.

    SUPPLEMENTARY INFORMATION: I. Regulatory Background A. Regulatory and Statutory Framework

    The data and information addressed in this proposed order were originally submitted for review under FDA's Time and Extent Application (TEA) regulation, § 330.14 (21 CFR 330.14), a process that has since been supplemented with new statutory procedures established in the SIA (Pub. L. 113-195), enacted November 26, 2014. The discussion that follows briefly describes and compares the pre- and post-SIA processes as they apply to the regulatory status of enzacamene.

    The TEA regulation established a process through which a sponsor could request that an active ingredient or other OTC condition,1 particularly one not previously marketed in the United States, be added to an OTC drug monograph to enable compliant OTC drug products containing the condition to be marketed in the United States without an approved new drug application (NDA) or abbreviated new drug application (ANDA). Because this proposed order specifically addresses an OTC sunscreen active ingredient (enzacamene), the remainder of this discussion will refer only to “active ingredients.”

    1 For purposes of OTC drug regulation, a “condition” is defined as an active ingredient or botanical drug substance (or a combination of active ingredients or botanical drug substances), dosage form, dosage strength, or route of administration marketed for a specific OTC use, with specific exclusions (see § 330.14(a)(2)). This document will refer simply to new “active ingredients,” since that is the condition under consideration.

    Critical steps in a proceeding under the TEA regulation include the following: (1) FDA's determination that an active ingredient had been marketed for the proposed OTC use for a material time and to a material extent (eligibility determination), and public call for submission of safety and efficacy data, followed by; (2) review of safety and efficacy data submitted by the sponsor or other interested parties; and (3) FDA's initial determination that the data show the active ingredient to be either GRASE or not GRASE for OTC use under the applicable monograph conditions (including any new conditions rising from FDA's review) (GRASE determination). Under the TEA regulation, FDA's GRASE determinations are effectuated through notice and comment rulemaking to amend or establish the appropriate monograph.

    The TEA process in FDA regulations was supplemented by Congress's enactment of the SIA. Among other amendments it makes to the FD&C Act, the SIA creates new procedures specifically for reviewing the safety and effectiveness of nonprescription sunscreen active ingredients, including those, such as enzacamene, that were the subject of pending TEA proceedings at the time the SIA was enacted. Like the TEA regulation, the SIA calls for an initial eligibility determination phase for nonprescription sunscreen active ingredients, followed by submissions of safety and efficacy data and a GRASE determination phase. However, the SIA requires FDA to make proposed and final GRASE determinations for nonprescription sunscreen active ingredients in the form of administrative orders rather than the multistep public rulemaking required by the TEA regulation, and establishes strict timelines for the necessary administrative actions.

    Among other requirements, no later than 90 days after the SIA was enacted (i.e., no later than February 24, 2015), FDA must publish a proposed sunscreen order in the Federal Register for any nonprescription sunscreen active ingredient, including enzacamene, for which, on the date of enactment, an eligibility determination had been issued under the TEA regulation and submissions of safety and efficacy data received, and for which a TEA feedback letter had not yet been issued (section 586C(b)(4) of the FD&C Act (21 U.S.C. 360fff-3(b)(4)), as amended by the SIA). Other provisions of the SIA that are not discussed in this proposed order address procedures applicable to other pending and future sunscreen active ingredient GRASE determinations, pending and future GRASE determinations for OTC products other than sunscreens, issuance of specified guidances and reports, and completion of pending sunscreen rulemakings, among others.

    A proposed sunscreen order under the SIA is an order containing FDA's tentative determination proposing that a nonprescription sunscreen active ingredient or combination of ingredients: (1) Is GRASE and is not misbranded when marketed in accordance with the proposed order; (2) is not GRASE and is misbranded; or (3) is not GRASE and is misbranded because the data are insufficient to classify the active ingredient or combination of ingredients as GRASE and not misbranded, and additional information is necessary to allow FDA to determine otherwise (section 586(7) of the FD&C Act, as amended by the SIA). Publication of a proposed sunscreen order triggers several timelines under the SIA, including a 45-day public comment period, and a 30-day period in which a sponsor may request a meeting with FDA to discuss the proposed order.

    B. FDA's Review of Enzacamene

    Buchanan Ingersoll submitted a TEA in 2002 on behalf of Merck KGaA under § 330.14(c) seeking OTC monograph status for the sunscreen active ingredient enzacamene (also known as 4-Methylbenzylidene Camphor (4-MBC) or Eusolex 6300) at concentrations up to 4 percent for use in OTC sunscreen products (enzacamene TEA) (Note 1). FDA issued a TEA notice of eligibility for enzacamene on July 11, 2003 (68 FR 41386), stating that enzacamene at concentrations of up to 4 percent is eligible to be considered for inclusion in the OTC sunscreen monograph (21 CFR part 352, currently stayed) and calling for submission of safety and effectiveness data for enzacamene. In response, a submission of data dated October 9, 2003, was made to the docket on behalf of Merck KGaA (enzacamene data submission) (Note 2), which referred to materials previously submitted to other dockets.2 At the time the SIA was enacted, FDA had not issued a TEA feedback letter or otherwise responded to that submission.

    2 These include FDA-1978-N-0018-0744-0756 (Sup 24, 25, 26, 27 and 28), Request to Reopen Rulemaking Record Respect Sunscreen Drug Products for OTC, submitted on April 12, 1999 (1999 enzacamene submission); FDA-1978-N-0018-0766, Citizen Petition (CP1), submitted on December 17, 1980; and Tracking number: 805596eb Legacy Doc. ID, SUP 5, “Supplement from Rona Pearle” SUP5, submitted on August 15, 1985.

    In accordance with new section 586C(b)(4) of the FD&C Act as amended by the SIA, we are issuing this notice as a proposed order for enzacamene. Based on our review of the available safety and efficacy data, we have made a tentative determination that enzacamene is not GRASE and is misbranded because the data are insufficient to classify it as GRASE and not misbranded for use in OTC sunscreens, and additional information is necessary to allow us to determine otherwise. The remainder of this proposed sunscreen order describes our review of the available safety and efficacy data, identifies additional data needed to demonstrate that enzacamene is GRASE for the requested use, and explains our rationale for specific conclusions and data requirements.

    This proposed order will be open for public comment (see DATES). The sponsor may request a meeting with FDA to discuss this proposed order (see DATES). We also invite the sponsor to submit additional safety and/or efficacy data to inform our further consideration, as publication of a final sunscreen order under the SIA for enzacamene will be contingent on receipt of such information. (See section 586C(b)(9)(ii) of the FD&C Act.) We specifically encourage the sponsor to discuss any proposed study protocols with us before performing the studies.

    II. Safety Data Considerations for OTC Sunscreen Products Containing Enzacamene

    In evaluating the safety of a proposed monograph active ingredient, FDA applies the following regulatory standard: Safety means a low incidence of adverse reactions or significant side effects under adequate directions for use and warnings against unsafe use as well as low potential for harm which may result from abuse under conditions of widespread availability. Proof of safety shall consist of adequate tests by methods reasonably applicable to show the drug is safe under the prescribed, recommended, or suggested conditions of use. This proof shall include results of significant human experience during marketing. General recognition of safety shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data (§ 330.10(a)(4)(i) (21 CFR 330.10(a)(4)(i))).

    FDA's OTC drug regulations generally identify the types of information that may be submitted as evidence that an active ingredient or other OTC drug condition is safe, as part of the consideration of whether an active ingredient or other condition is GRASE (§ 330.10(a)(2)). For convenience, this order uses the term “generally recognized as safe (GRAS)” to refer to that aspect of the GRASE determination. To apply the general OTC safety standard to each potential new condition, FDA uses its scientific expertise to determine what constitutes “adequate tests by methods reasonably applicable to show the drug is safe under the prescribed, recommended, or suggested conditions of use.” In assessing what specific testing or other data are needed to adequately demonstrate the safety of enzacamene for use in sunscreen, FDA considers the circumstances under which OTC sunscreen products that could contain enzacamene would be used by consumers.

    When used as directed with other sun protection measures, broad spectrum OTC sunscreen products with a sun protection factor (SPF) value of 15 or higher strongly benefit the public health by decreasing the risk of skin cancer and premature skin aging associated with solar ultraviolet (UV) radiation, as well as by helping to prevent sunburn. (Sunscreens with lower SPF values, or without broad spectrum protection, also help prevent sunburn.) When used as directed by the required labeling, all OTC sunscreen products are applied liberally to the skin and reapplied frequently throughout the day (§ 201.327(e) (21 CFR 201.327(e))). Because the effects of UV exposure are cumulative, to obtain the maximum benefit, users of broad spectrum sunscreens with an SPF value of 15 or higher are directed to use such products regularly—on a routine basis (id.). Given these conditions of use, our safety evaluation of an OTC sunscreen active ingredient such as enzacamene must consider both short-term safety concerns (such as skin sensitization/irritation and photosafety) and potential concerns related to long-term sunscreen use, including potential systemic exposure via dermal absorption.

    The purpose of the safety testing described in this section II is to establish whether an OTC sunscreen product containing enzacamene and otherwise marketed under the conditions described in a final sunscreen order and in accordance with all requirements applicable to nonprescription drugs would be GRAS for use as labeled. To demonstrate that these requirements are met for enzacamene, initial safety testing should be performed using enzacamene as the sole active ingredient up to the highest concentration for which marketing status is sought and eligibility has been established: 4 percent. If initial testing suggests a particular safety concern associated with enzacamene (e.g., a hormonal activity), FDA may request additional studies to address that concern.

    A. Human Safety Data 1. Human Irritation, Sensitization, and Photosafety Studies

    Studies of skin irritation, sensitization, and photosafety are standard elements in the safety evaluation of topical drug products that, like enzacamene-containing sunscreens, are applied to the skin repeatedly over long periods of time. FDA recommends separate studies for skin irritation and sensitization. Skin irritation studies should generally include at least 30 evaluable subjects and should evaluate the test formulation (i.e., enzacamene in an appropriate test vehicle), the vehicle alone, and both negative and positive controls. Skin sensitization studies generally should include at least 200 subjects and should evaluate the test formulation containing enzacamene, the vehicle, and a negative control. For both irritation and sensitization studies, test site applications should be randomized and the test observer blinded to the identities of the test formulations.

    FDA recommends that photosafety evaluation generally involve studies of skin photoirritation (phototoxicity) and skin photosensitization (photoallergenicity). General principles for designing and conducting photosafety studies are described in FDA guidance (Ref. 1). Photosafety studies, like sensitization and irritation studies, should be conducted using enzacamene 4 percent in an appropriate test vehicle, the vehicle alone, and a negative control. In addition, phototoxicity studies should include at least 30 evaluable subjects and photoallerginicity studies should include at least 45 evaluable subjects.

    Data Available for Enzacamene: Human Irritation, Sensitization, and Photosafety Studies

    We reviewed the submitted study reports for human safety studies, including a skin irritation and sensitization study of enzacamene 5 percent in 30 subjects (Note 3); skin irritation and sensitization study of enzacamene 5 percent in 10 subjects (Note 4); a photoirritation study of 4 percent enzacamene in 5 subjects (Note 5); and two photosensitization studies, one using 4 percent enzacamene in 5 subjects and the other using an unknown concentration in 25 subjects (Notes 6 and 7). Although these studies suggest that enzacamene may not be a primary irritant, sensitizer, photosensitizer, or photoirritant, each of the submitted studies has limitations, such as inadequate sample size, lack of blinding, and lack of positive and negative controls, that prevent us from making definitive conclusions. In addition, protocol information, such as the inclusion and exclusion criteria used in subject selection, was not consistently provided.

    FDA concludes that the data submitted are not sufficient to assess the dermal safety of enzacamene and specifically its potential to cause irritation, sensitization, photoirritation, or photoallergenicity. We recommend submission of additional data from human irritation, sensitization, and photosafety studies to demonstrate that an OTC sunscreen containing up to 4 percent enzacamene is not an irritant, sensitizer, photosensitizer, or photoirritant.

    2. Human Dermal Pharmacokinetic (Bioavailability) Studies

    Because sunscreens are topically applied, another important safety consideration for enzacamene for use in sunscreens is whether dermal application may result in skin penetration and systemic exposure to enzacamene, and if so, to what extent. A well-designed and -conducted human dermal pharmacokinetic study can be expected to detect and quantify the presence of enzacamene and/or any metabolites in blood or other bodily fluids that may have a bearing on safety, using recognized parameters such as bioavailability percentage, maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), total area under the plasma concentration versus time curve (AUC), half-life, clearance, and volume of distribution. This information can help identify potential safety concerns and help determine whether an adequate safety margin for sunscreens containing enzacamene exists. FDA recommends that the pharmacokinetic studies performed on enzacamene also collect additional safety-related data from regularly scheduled physical examinations, collection of vital signs, and other measures, which may help capture adverse skin events or other potential safety signals. To ensure that maximum penetration of enzacamene has taken place and chances of it being detected are optimal, studies should continue until steady state is reached.

    General information and recommendations on the design and conduct of human pharmacokinetic studies can be found in FDA guidance (Ref. 2). To support a GRAS determination for enzacamene (up to 4 percent), such a study should be conducted under maximal use conditions using enzacamene 4 percent in various vehicles, including vehicles that would be expected to enhance absorption. We encourage study sponsors to consult with us before conducting pharmacokinetic studies, because the properties of enzacamene bear on the optimal design.

    Data Available for Enzacamene: Human Dermal Pharmacokinetic (Bioavailability) and Clinical Pharmacology Studies

    We reviewed three submitted reports of dermal absorption studies in humans in which percutaneous absorption was estimated using radiolabeled (14C) formulations of enzacamene. In one study (Note 8) a 14C-labeled 5 percent formulation of enzacamene was applied to the lower arms of six volunteers for 6 hours, followed by a 3-day collection of urine and feces. Investigators reported that approximately 54.6 percent of the 14C-activity applied to the skin was recovered. An average of 0.76 percent enzacamene was recovered in urine and 0.14 percent in the feces. In a second study (Note 9), investigators reported a total recovery of 98.2 percent and 90.7 percent overall recovery of the 14C-activity applied to the skin from two volunteers, respectively. The third study report (Note 10) was similar to the previous two studies in terms of the general design. Following the analysis of the data from the planned six volunteers, two more volunteers were enrolled to evaluate the low observed recovery (54 to 69 percent) of the radiolabeled enzacamene. A different recovery schema was applied to these last two patients with satisfactory results in line with the previous studies. As to the utility of the aggregate data, we cannot draw definitive conclusions regarding the dermal absorption of enzacamene based on these studies. The overall number of subjects was low, the studies were single-dose studies, a limited surface area was exposed to the formulation, the recovery of radioactivity was variable, and finally no blood or other body fluids were sampled to provide direct information about systemic exposure. We also note that these studies were conducted in the 1980s and the limit of analytical detection for enzacamene was much higher than it is today.

    A review of the published literature identified more recent studies related to the extent of absorption of enzacamene in humans after dermal application. A 2004 article from Janjua et al. (Ref. 3) reports on the absorption from a formulation containing 10 percent enzacamene and 2 other active sunscreen ingredients after whole body application for 4 days in 15 healthy males and 17 postmenopausal females. The article provides only summary bioavailability information but claims that the maximum plasma concentrations were 20 milligrams (mg)/milliliter (mL) in both men and women and that increasing plasma levels of enzacamene and metabolites were seen, suggesting the presence of accumulation. It is noted that thyroid function was also assessed during this study, but results are confounded by the simultaneous application of three active sunscreen ingredients. A 2006 article from Shauer et al. (Ref. 4) includes in vivo pharmacokinetic data from six healthy volunteers exposed to 4 percent enzacamene applied over 90 percent body surface area for a 12-hour period. The data are limited by the small number of subjects included; however, there was gender-related difference observed in those males who had blood levels that were approximately twice that of females. A 2008 article by Janjua et al. contains a more complete analysis of in vivo absorption for enzacamene in a 10 percent enzacamene formulation (Ref. 5). The levels of absorption were generally low but accumulation was observed. However, the age of the females enrolled in the study was 2 to 3 times that of the males, confounding the interpretation of age or gender effects.

    Overall, the data available are incomplete for the assessment of human bioavailability (dermal absorption) of enzacamene. Accordingly, we request data from human pharmacokinetic studies to assess potential for and extent of systemic absorption. These studies should be performed under expected maximal-use conditions with the proposed maximum concentration as discussed previously.

    In addition to the bioavailability data described previously, three reports of clinical pharmacology studies were submitted that evaluate the potential effect of enzacamene on thyroid function. The first was a pilot study in which a 5 percent enzacamene formulation was applied twice, at 3-hour intervals, to the abdomen and back of four adult subjects (two males and two females) (Note 11). Subsequent increases in the thyroid analytes thyroid-stimulating hormone (TSH), T3, and T4 were observed in some subjects. Blood and urine levels of enzacamene were reported to have been measured but no data were reported. We consider the number of subjects in this study too small to draw conclusions about the safety of enzacamene. In addition, there were missing data and the report lacked information about whether subjects' thyroid analyte levels exceeded normal levels.

    A second study evaluated the effect on thyroid function of topical application of 5 percent enzacamene (6 grams (g) applied twice, at 3-hour intervals) in nine healthy volunteers (Note 12). This was a double-blind, placebo-controlled, crossover design study, and investigators reported that there was a statistically significant lowering of mean T3 and T4 values in the active treatment group at 24 hours after application. Although larger than the pilot study, this is a small single-dose study and the changes reported were small relative to placebo and were of questionable clinical significance. Interpretation of the results is also hampered by the fact that some analytes (TSH and free T4) were below normal levels at baseline.

    A third study was a parallel-group, placebo-controlled design in which 48 subjects received treatment with either enzacamene (5 g of a 6 percent enzacamene formulation per dose) or placebo twice daily for 14 days (Note 13). According to the investigators, the results of the study did not reveal any significant differences in thyroid function tests between enzacamene and placebo, although there was a small between-group difference in thyroid volume gland decrease (a 1.7 percent reduction in the enzacamene arm and an increase of 3.1 percent in the placebo group). The quality of the study report submitted is inadequate to be used to verify the analyses, but no adverse events of hypothyroidism or hyperthyroidism or abnormal thyroid function tests were reported.

    The three clinical pharmacology studies submitted are insufficient either to substantiate or dismiss clinical concerns related to potential thyroid effects from enzacamene. We request submission of any additional clinical thyroid function data or analyses that have not yet been submitted to us, including any provided to the European Scientific Committee on Cosmetic Products and Nonfood Products (SCCNFP) to support its 2008 conclusion that enzacamene at a concentration up to 4 percent is safe for use in finished cosmetic products for whole body application (Ref. 6). If, after full review of nonclinical toxicology data (discussed in section I.B of this proposed order) and any additional clinical data, concerns exist regarding enzacamene's thyroid safety, we will recommend that additional clinical study be carried out. It is recommended that we be consulted regarding the study protocols prior to commencement of such investigations.

    3. Human Safety Data To Establish Adverse Event Profile

    An evaluation of safety information from adverse event reports and other safety-related information derived from commercial marketing experience of sunscreen products containing enzacamene, as well as from other sources, is a critical aspect of FDA's safety review for enzacamene. The TEA regulation under which the original request for enzacamene was submitted specifically calls for submission of information on all serious adverse drug experiences, as defined in 21 CFR 310.305(a) and 314.80(a), from each country where the active ingredient or other condition has been or is currently marketed as either a prescription or OTC drug; in addition, it calls for submission of all data generally specified in § 330.10(a)(2), which includes documented case reports and identification of expected or frequently reported side effects (§ 330.14(f)(1) and (f)(2)). To evaluate enzacamene, FDA continues to seek individual adverse drug experience reports, a summary of all serious adverse drug experiences, and expected or frequently reported side effects of the condition (id.). To assist in the Agency's safety evaluation of enzacamene, FDA emphasizes our need for the following data:

    • A summary of all available reported adverse events potentially associated with enzacamene;

    • All available documented case reports of serious side effects

    • Any available safety information from studies of the safety and effectiveness of enzacamene in humans; and

    • Relevant medical literature describing adverse events associated with enzacamene. Submissions of adverse event data should also include a description of how each country's system identifies and collects adverse events, unless this information has been previously submitted as part of enzacamene's TEA package.

    Although we recognize that adverse event data from foreign marketing experience may reflect patterns of use and regulatory reporting requirements that differ from those in the United States, we nonetheless consider such information to be strongly relevant both to our overall GRASE assessment of enzacamene for use in sunscreens and to our consideration of potential product labeling. FDA recognizes that such information may not be available from all countries; where that is the case, please provide a written explanation for the lack of data. Overall, we seek sufficient data to characterize enzacamene's adverse event profile.3

    3 See 67 FR 3060 at 3069 (January 23, 2002) (agreeing that the absence of an adverse experience reporting system in a foreign country for drugs or cosmetics does not necessarily mean that a condition cannot be GRAS/E. The GRAS/E determination will be based on the overall quality of the data and information presented to substantiate safety and effectiveness).

    Data Available for Enzacamene: Human Safety Data To Establish Adverse Event Profile

    The 1999 enzacamene submission states that no complaints from customers concerning tolerance or adverse reactions had been reported for enzacamene by the cosmetic industry during the prior 10 years (Note 14). This information was referred to in the 2002 TEA submission and the 2003 enzacamene data submission. The 1999 enzacamene submission also included a literature search for adverse reactions to enzacamene from the following databases: Medline (1966-1998), Derwent Drug File (1983-1998), and CCSearch (week 3 1998-week 48 1998) (Note 15). There were 17 articles reviewed which had been published or translated into English. Of these, 10 articles describe contact dermatitis and resultant positive photopatch testing in one or two patients. The 7 other articles are literature or case series reviews of up to 400 patients, describing dermatologic adverse reactions to sunscreen use and subsequent photopatch testing. On the whole, these reports suggest that enzacamene has the potential to cause contact allergy and photocontact allergy. However, data from this literature have limitations. In some cases, the testing methodology used to determine that enzacamene is an allergen is not described. Also, some of the test formulations used are not described. It is conceivable that the observed reactions may have been specific to particular test formulations, including formulations containing other active ingredients.

    The submitted information and literature do not fulfill the criteria described previously. To support the evaluation of safety of enzacamene for use in OTC sunscreens, we request that the sponsor either supplement the data already submitted, including more recent adverse drug experience data, or explain why such data cannot be provided.

    B. Nonclinical (Animal) Studies

    Another important element of FDA's GRAS review of enzacamene for use in sunscreens is an assessment of data from nonclinical (animal) studies that characterize the potential long-term dermal and systemic effects of exposure to enzacamene. Even if the bioavailability data discussed in section II.A.2 suggest that dermal application is unlikely to result in skin penetration and systemic exposure to enzacamene, FDA still considers data on the effects of systemic exposure to be an important aspect of our safety evaluation of enzacamene. A determination that enzacamene up to 4 percent is GRASE for use in sunscreens would permit its use in as-yet-unknown product formulations, which might in turn alter the skin penetration of the active ingredient. Therefore, an understanding of the effects of enzacamene, were systemic exposure to occur, is critical to determine whether and how regulatory parameters can be defined to assure that all conforming enzacamene-containing sunscreens would be GRASE as labeled.

    FDA recommends animal testing of the potential long-term dermal and systemic effects of exposure to enzacamene because these effects cannot be easily assessed from previous human use. Taken together, the carcinogenicity studies, developmental and reproductive toxicity studies, and toxicokinetic studies described in sections II.B.1 through II.B.3 should provide the information needed to characterize both the potential dermal and systemic toxic effects and the levels of exposure at which they occur. These data, when viewed in the context of human exposure data, can be used to determine a margin of safety for use of enzacamene in OTC sunscreens.

    Data Available for Enzacamene: Nonclinical (Animal) Studies Generally

    The enzacamene submissions included data from the following types of nonclinical safety studies:

    • Acute-dose toxicity studies ○ Oral toxicity (rats, dogs) (Note 16) ○ Dermal toxicity (rats) (Note 17) ○ Intraperitoneal toxicity (rats) (Note 18) ○ Mucosal irritation (rabbits) (Note 19) ○ Skin irritation and sensitization (guinea pigs) (Note 20) ○ Phototoxicity potential (mice) (Note 21) ○ Photosensitization (guinea pig) (Note 22) • Repeat-dose toxicity studies ○ 17 days oral (rat) (Note 23) ○ 4 weeks oral (rat) (Note 24) ○ 13 weeks oral (rat) (Note 25) ○ Liver enzyme induction study (rat) (Note 26) • Genotoxicity and mutagenicity assays ○ Chromosome aberration assay (Chinese hamster V79 cells) (Note 27) ○ Mutagenicity (Salmonella typhimurium) (Note 28) ○ Photomutagenicity (S. typhimurium, Escherichia coli) (Note 29) • Reproductive and developmental toxicity studies ○ Orienting tests for embryotoxicity (rabbit) (Note 30) ○ Toxicological investigation (incubated hen's egg) (Note 31) ○ Teratogenicity (rat) (Note 32)

    Based on the submitted studies, acute toxicity was low. However, the standard battery of tests detected findings that we will consider further as additional data become available to inform our GRAS assessment. Studies submitted by the sponsor showed an increase in thyroid weight and changes in thyroid function that included an increase in T3 and TSH, along with a decrease in T4. Other thyroid findings included follicular epithelium hypertrophy and hyperplasia. A decrease in adrenal and prostate weights, and alterations in ovarian weights (an increase was seen in some studies while decreased weight was noted in others), was documented with a no observed adverse effect level (NOAEL) of 25-30 mg/kilograms (kg)/day (Note 33).

    To followup on these findings, we identified published literature that describes related enzacamene activity. A number of these articles indicate that exposure to enzacamene at high doses has been associated with hormonal changes. Among the in vitro findings (Refs. 7 through 16), a number of articles described the in vitro binding activity of enzacamene to estrogen (ER) and androgen (AR) receptors where it was able to bind to ERß but showed inconsistent binding activity at ERα receptors. No androgenic activity and mixed results for antiandrogenic activity were also documented.

    Other effects of enzacamene included in vivo alterations of reproductive tissues and behavior in rats (Refs. 17 through 25). Findings include decreased testis weight; increased prostate volume and altered duct development; delayed preputial separation; decreased prostate weight in males; and increased uterine weight, decreased ovarian weight, and altered sexual behavior in females. Overall, we cannot arrive at a final determination about the findings described in the literature until we receive a complete nonclinical assessment as described in sections II.B.1 through II.B.3.

    We did not receive data from toxicokinetic or dermal or systemic carcinogenicity studies. Upon assessment of all available information for enzacamene and based on the nonclinical studies currently recommended to support sunscreen development, the following nonclinical studies are recommended to support the safety of enzacamene:

    • Dermal and systemic carcinogenicity

    • Fertility

    • Prenatal/postnatal toxicity

    • Toxicokinetics

    Additional discussion of study findings and data gaps are provided in the following subsections.

    1. Carcinogenicity Studies: Dermal and Systemic

    FDA guidance recommends that carcinogenicity studies be performed for any pharmaceutical that is expected to be clinically used continuously for at least 6 months or “repeatedly in an intermittent manner” (Refs. 26, 27, and 28). Because the proposed use of enzacamene in OTC sunscreens falls within this category, these studies should be conducted to help establish that enzacamene is GRAS for its proposed use. Carcinogenicity studies assist in characterizing potential dermal and systemic risks by identifying the type of toxicity observed, the level of exposure at which toxicity occurs, and the highest level of exposure at which no adverse effects occur (i.e., NOAEL). The NOAEL would then be used in determining the safety margin for human exposure to sunscreens containing enzacamene.

    Systemic carcinogenicity studies can also help to identify other systemic or organ toxicities that may be associated with enzacamene, such as hormonal effects. For example, the effect of persistent disruption of particular endocrine gland systems (e.g., hypothalamic-pituitary-adrenal axis), if any, can be captured by these assays.

    Data Available for Enzacamene: Genotoxicity Studies

    Enzacamene showed no evidence of DNA mutations in one standard Ames test. A chromosomal aberration assay using a Chinese hamster V79 cell line and a photomutagenicity assay were negative. Although these studies somewhat ease concerns about potential genotoxicity and mutagenicity, they were not definitive evaluations of potential toxic effects from long-term systemic or dermal exposure.

    Data Available for Enzacamene: Carcinogenicity Studies

    We did not receive dermal or systemic carcinogenicity studies. Assessments of both dermal and systemic carcinogenicity are recommended because sunscreen products containing enzacamene are expected to be applied over large portions of the body with multiple daily applications. In addition, as discussed previously, marketing of this product according to a final sunscreen order might permit its formulation in a variety of as-yet-unknown vehicles that might have an impact on systemic absorption. Consequently, FDA seeks information on dermal and system carcinogenicity, in case of the possibility that systemic absorption could occur.

    2. Developmental and Reproductive Toxicity (DART) Studies (Ref. 29)

    FDA recommends conducting DART studies to evaluate the potential effects that exposure to enzacamene may have on developing offspring throughout gestation and postnatally until sexual maturation, as well as on the reproductive competence of sexually mature male and female animals. Gestational and neonatal stages of development may also be particularly sensitive to active ingredients with hormonal activity. For this reason, we recommend that these studies include assessments of endpoints such as vaginal patency, preputial separation, anogenital distance, and nipple retention, which can be incorporated into traditional DART study designs to assess potential hormonal effects of enzacamene on the developing offspring. We also recommend conducting behavioral assessments (e.g., mating behavior) of offspring, which may also detect neuroendocrine effects.

    Data Available for Enzacamene: DART Studies

    Potential reproductive and developmental effects from enzacamene were evaluated in two embryotoxicity studies and one teratogenicity study. Enzacamene did not show evidence of embryotoxicity in a pilot rabbit test and hen's egg assay. In a teratogenicity study in rats with oral administration of single daily doses of 10, 30, and 100 mg/kg of enzacamene administered on days 6 to 15 after conception, enzacamene was not found to be teratogenic in any of the treated groups. Additional DART testing is recommended to assess fertility and prenatal and postnatal development in a rodent model.

    3. Toxicokinetics (Ref. 30)

    We recommend conducting animal toxicokinetic studies because they provide an important bridge between toxic levels seen in animal studies and potential human exposure. Data from these studies can be correlated to potential human exposure via clinical dermal pharmacokinetic study findings. Toxicokinetic data could be collected as part of animal studies being conducted to assess one or more of the safety parameters described previously.

    Data Available for Enzacamene: Toxicokinetics

    No toxicokinetic data were submitted as part of any of the nonclinical studies, thus it is difficult to bridge from animal findings to potential human exposure. Toxicokinetic data should be collected as part of the animal studies to allow exposure comparisons between animals and humans.

    Toxicokinetic data are particularly important to the evaluation of enzacamene's safety for use in sunscreens because enzacamene appears to have the potential to affect some endocrine-responsive endpoints. We need toxicokinetic data to develop more information about exposure parameters, in order to understand whether a margin of safety exists between the exposures that cause the effects in animals and estimated human exposures. Should we find, after review of a more complete nonclinical program, that additional clinical studies are warranted, we will provide additional recommendations regarding the design of the studies.

    III. Effectiveness Data Considerations for OTC Sunscreen Products Containing Enzacamene

    FDA's evaluation of the effectiveness of active ingredients under consideration for inclusion in an OTC drug monograph is governed by the following regulatory standard: Effectiveness means a reasonable expectation that, in a significant proportion of the target population, the pharmacological effect of the drug, when used under adequate directions for use and warnings against unsafe use, will provide clinically significant relief of the type claimed. Proof of efficacy shall consist of controlled clinical investigations as defined in 21 CFR 314.126(b). Investigations may be corroborated by partially controlled or uncontrolled studies, documented clinical studies by qualified experts, and reports of significant human experience during marketing. Isolated case reports, random experience, and reports lacking the details that permit scientific evaluation will not be considered. General recognition of effectiveness shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data (§ 330.10(a)(4)(ii)). For convenience, this order uses the term “generally recognized as effective” (GRAE) when referring to this aspect of the GRASE determination.

    To evaluate the efficacy of enzacamene for use in OTC sunscreen products, FDA requests evidence from at least two adequate and well-controlled SPF studies showing that enzacamene effectively prevents sunburn. To determine that enzacamene is GRAE for use in OTC sunscreens at concentrations in a range with the proposed maximum strength of 4 percent as requested, two adequate and well-controlled SPF studies of enzacamene at a lower concentration should be conducted according to established standards.4 These SPF studies should demonstrate that the selected concentration (below 4 percent) provides an SPF of 2 or more.

    4 The upper bound of any concentration of enzacamene ultimately established in the OTC sunscreen monograph will be governed by the safety data, as well as by efficacy.

    The current standard procedure for SPF testing is described in FDA's regulations in § 201.327(i).5 Further SPF tests for enzacamene should be performed as described in these regulations, using a test formulation containing enzacamene as the only active ingredient to identify its contribution to the overall SPF test results. (See the following subsection Data Available for Enzacamene: Effectiveness for further discussion of submitted SPF tests.) The study should also include a vehicle control arm in order to rule out any contribution the vehicle may have on the SPF test results. Finally, as described in § 201.327(i), an SPF standard formulation comparator arm should be another component of the study design.

    5 Although the SPF testing procedure is used primarily for final formulation testing of finished products marketed without approved NDAs, under the sunscreen monograph, it is equally applicable for determining whether or not a sunscreen active ingredient is GRAE.

    Although current sunscreen testing and labeling regulations also specify a “broad spectrum” testing procedure to support related labeling claims for certain OTC sunscreen products marketed without approved new drug applications that contain specified active ingredients included in the stayed sunscreen monograph, those additional claims are permitted, but not required (§ 201.327(c)(2) and (j)). Under current regulations, sunscreen active ingredients need only be effective for the labeled indication of sunburn prevention, for which the SPF test can provide sufficient evidence. Consistent with this approach, we here do not request broad spectrum testing data for enzacamene. Broad spectrum protection is often, although not always, the result of the combined contribution of multiple active ingredients in a final sunscreen formulation. Thus, under the current regulations applicable to other sunscreens, the determination of whether an individual sunscreen product may be labeled as broad spectrum and bear the related additional claims is made on a product-specific basis, applying standard testing methods set forth in those regulations. If enzacamene is established to be GRASE for use in nonprescription sunscreens (based in part on the efficacy data requested here), the final order can likewise address broad-spectrum testing and related labeling conditions for final sunscreen formulations containing enzacamene.

    Data Available for Enzacamene: Effectiveness

    A total of 11 efficacy studies were submitted. Two studies, an in vitro assessment and a field study, both dated from the 1970s, did not use study designs that we consider valid for SPF assessment for a GRASE determination (Docket No. 78N-0038, OTC Volume 060083, submitted December 18, 1973; Docket No. 78N-0038, OTC Volume 060130, submitted November 1974). The other nine studies all tested enzacamene as the only active ingredient. These included two studies of 1.25 percent enzacamene and three studies of 2.5 percent enzacamene, concentrations within the range found eligible for consideration of GRASE status in the Agency's 2003 eligibility determination, and three studies of 5 percent enzacamene and one study of 10 percent enzacamene, concentrations above the maximum established to be eligible for consideration, which studies we do not further address in this proposed order. (FDA-1978-N-0018-0766, Citizen Petition (CP1), submitted December 17, 1980.) In each of the five studies addressing enzacamene at concentrations of 1.25 percent and 2.5 percent, enzacamene achieved a mean SPF of 2, but there is substantial variability in the data and it cannot be confirmed that that efficacy was established at any of the concentrations tested. In addition, none of these study reports specified the use of appropriate standard controls to validate the test results. Currently, there are insufficient data to support a finding that enzacamene is GRAE at concentrations up to 4 percent.

    To support a finding that enzacamene is GRAE at concentrations up to 4 percent, we request data from two adequate and well-controlled SPF studies conducted according to established standards to demonstrate that the lowest selected concentration provides an SPF of 2 or more. Because no study has been identified that establishes that enzacamene is effective at a concentration of 4 percent, we also recommend that such a study be conducted and submitted.

    IV. Summary of Current Data Gaps for Enzacamene

    Based on our review of the available safety and efficacy data as discussed previously, we request the types of data listed in this section of the proposed order, at minimum, for us to reverse our tentative determination that enzacamene is not GRASE and is misbranded because the data are insufficient to classify enzacamene as GRASE and not misbranded, and additional data are necessary to allow us to determine otherwise. For additional information about the purpose and design of studies recommended to address these data gaps, please refer to the earlier sections of this proposed order referenced in parentheses. We welcome discussions on design of any of the studies prior to their commencement. We request the following types of data:

    Safety Data (see section II) A. Human Clinical Studies 1. Skin irritation/sensitization and photosafety (see section II.A.1) 2. Human dermal pharmacokinetic (bioavailability) studies (see section II.A.2)

    The need for additional human safety studies (e.g., for evaluation of hormonal disruption) will be based on review of the completed nonclinical studies, as recommended in section IV.C.

    B. Human Safety Data To Establish Adverse Event Profile (II.A.3) 1. A summary of all available reported adverse events potentially associated with enzacamene 2. All available documented case reports of serious side effects 3. Any available safety information from studies of the safety and effectiveness of sunscreen products containing enzacamene in humans 4. Relevant medical literature describing adverse events associated with enzacamene

    Alternatively, the results of a literature search that found no reports of adverse events may be provided. In that case, detailed information on how the search was conducted should be provided.

    C. Nonclinical (Animal) Studies 1. Dermal and systemic carcinogenicity (see section II.B.1) 2. Fertility (see section II.B.2) 3. Prenatal/postnatal development (see section II.B.2) 4. Toxicokinetics (see section II.B.3) Effectiveness Data (see section III)

    In order for concentrations of enzacamene up to 4 percent to be found to be GRASE for use in nonprescription sunscreen products as requested, at least two SPF studies showing effectiveness of a selected concentration lower than 4 percent should be conducted. An efficacy study of enzacamene at 4 percent is also recommended.

    V. Administrative Procedures

    A copy of this proposed order will be filed in the Division of Dockets Management in Docket Numbers FDA-2003-N-0196, FDA-1978-N-0018, and FDA-1996-N-0006. To inform FDA's evaluation of whether this ingredient is GRASE and not misbranded for use in sunscreen products, we encourage the sponsor and other interested parties to submit additional data regarding the safety and effectiveness of this ingredient for use as an OTC sunscreen product. We also encourage the sponsor and other interested parties to notify us in writing of their intent to submit additional data. However, as noted previously, because the data submitted to date are not sufficient to support a determination that enzacamene is GRASE for use as an active ingredient in OTC sunscreen drug products, at present, OTC sunscreen products containing enzacamene may not be marketed without approval of an NDA (see section 586C(e)(1)(A) of the FD&C Act, as amended by the SIA). Data submissions relating to this proposed order should be submitted to Docket Numbers FDA-2003-N-0196, FDA-1978-N-0018, and FDA-1996-N-0006 at the Division of Dockets Management (see ADDRESSES). In addition, you can submit the data through the Federal eRulemaking Portal at: http://www.regulations.gov. Follow the instructions for submitting comments.

    Section 586C(b)(7) of the FD&C Act, as amended by the SIA, provides that the sponsor may, within 30 days of publication of a proposed order (see DATES), submit a request to FDA for a meeting to discuss the proposed order. Submit meeting requests electronically to http://www.regulations.gov or in writing to the Division of Dockets Management (see ADDRESSES), identified with the active ingredient name enzacamene, the docket numbers found in brackets in the heading of this proposed order, and the heading “Sponsor Meeting Request.” To facilitate your request, please also send a copy to Kristen Hardin (see FOR FURTHER INFORMATION CONTACT).

    VI. Proposed Effective Date

    FDA proposes that any final administrative order based on this proposal become effective on the date of publication of the final order in the Federal Register.

    VII. Comments

    Similarly, section 586C(b)(6) of the FD&C Act, as amended by the SIA, establishes that a proposed sunscreen order shall provide 45 days for public comment. Interested persons wishing to comment on this proposed order may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the active ingredient name (enzacamene) and the docket numbers found in brackets in the heading of this proposed order. Received comments on this proposed order may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    VIII. Notes

    1. FDA-2003-N-0196-0056, Time and Extent Application (TEA) Request to Reopen the Rulemaking Record; submitted August 21, 2002.

    2. FDA-2003-N-0196-0028, C1, dated October 9, 2003.

    3. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 10, dated November 27, 1972.

    4. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 20, dated September 8, 1982.

    5. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 11, dated February 20, 1980.

    6. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 12, dated February 20, 1980.

    7. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 21, dated June 5, 1985.

    8. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 14, dated November 29, 1982.

    9. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 15, dated July 17, 1984.

    10. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 16, dated July 8, 1984.

    11. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 19, dated August 1, 1981.

    12. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 18, dated July 2, 1982.

    13. FDA-1978-N-0018-0762 (Sup 28), Volume 5, Report 29, Study no. 43/20792, dated October 18, 1995.

    14. FDA-1978-N-0018-0754 (Sup 24), dated April 12, 1999.

    15. FDA-1978-N-0018-0755 (Sup 24), Attachment 1, dated April 12, 1999.

    16. FDA-1978-N-0018-0758 (Sup 24), Volume 1, Reports 1, 2, 3 and 4, Study no. 4/83/71, 4/130/73, 4/131/73, 4/52/80.

    17. FDA-1978-N-0018-0758 (Sup 24), Volume 1, Reports 2 and 3, Study no. 4/130/73 and 4/131/73.

    18. Id.

    19. Id.

    20. Id.

    21. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 8, dated October 16, 1978.

    22. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 9, dated October 16, 1978.

    23. FDA-1978-N-0018-0758 (Sup 24), Volume 1, Report 5, dated May 5, 1983.

    24. Id.

    25. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 7, dated April 26, 1984.

    26. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 17, dated May 1, 1984.

    27. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 22, Study no. LMP166, dated April 25, 1986.

    28. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 13, Study no. 4/56/80, dated June 2, 1980.

    29. FDA-1978-N-0018-0761 (Sup 27), Volume 4, Report 28, Study no. 40/13/93, dated April 14, 1993.

    30. FDA-1978-N-0018-0760 (Sup 26), Volume 3, Report 23, Study no. 4/20/84, Experiment No. T9207.

    31. FDA-1978-N-0018-0761 (Sup 27), Volume 4, Report 24 and 25, dated October 23, 1987, and October 26, 1987.

    32. FDA-1978-N-0018-0761 (Sup 27), Volume 4, Report 26, Study no. 4/43/88, Experiment No. T9305, dated September 14, 1983.

    33. FDA-1978-N-0018-0759 (Sup 25), Volume 2, Report 7, dated April 26, 1984.

    IX. References

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

    1. FDA, Guidance for industry, “Photosafety Testing,” May 2003 (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079252.pdf). 2. FDA, Guidance for Industry, “Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application,” February 1987 (available at http://www.fda.gov/downloads/drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072112.pdf). 3. Janjua, N.R., et al., “Systemic Absorption of the Sunscreens Benzophenone-3, Octyl-Methoxycinnamate, and 3-(4-Methyl-Benzylidene) Camphor After Whole Body Topical Application and Reproductive Hormone Levels in Humans.” Journal of Investigative Dermatology, vol. 123, pp. 57-61, 2004. 4. Schauer, U.M., et al., “Kinetics of 3-(methylbenzlidene) Camphor in Rats and Humans After Dermal Application.” Toxicology and Applied Pharmacology, vol. 216(2), pp. 339-346, 2006. 5. Janjua, N.R., et al., “Sunscreens in Human Plasma and Urine After Repeated Whole-Body Topical Application.” Journal of the European Academy of Dermatology and Venereology, vol. 22, pp. 456-461, 2008. 6. Scientific Committee on Consumer Products (SCCP)/1184/08—SCCNFP opinion on 4-Methylbenzylidene camphor (4-MBC) Colipa n° S60 adopted during the 16th plenary meeting of June 24, 2008 (available at http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_141.pdf). 7. Jiménez-Díaz, I., et al., “Simultaneous Determination of the UV-Filters Benzyl Salicylate, Phenyl Salicylate, Octyl Salicylate, Homosalate, 3-(4-Methylbenzylidene) Camphor and 3-Benzylidene Camphor in Human Placental Tissue by LC-MS/MS. Assessment of Their In Vitro Endocrine Activity.” Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 936, pp. 80-87, 2013. 8. Gomez, E., et al., “Estrogenic Activity of Cosmetic Components in Reporter Cell Lines: Parabens, UV Screens and Musks.” Journal of Toxicology and Environmental Health, Part A, vol. 68, pp. 239-251, 2005. 9. Ma, R., et al., “UV Filters With Antagonistic Action at Androgen Receptors in the MDA-kb2 Cell Transcriptional-Activation Assay.” Toxicological Sciences, vol. 74(1), pp. 43-50, 2003. 10. Mueller, S.O., et al., “Activation of Estrogen Receptor Alpha and ERbeta by 4-Methylbenzylidene-Camphor in Human and Rat Cells: Comparison With Phyto- and Xenoestrogens.” Toxicology Letters, vol. 142(1-2), pp. 89-101, 2003. 11. Schlumpf, M., et al., “Estrogenic Activity and Estrogen Receptor Beta Binding of the UV Filter 3-Benzylidene Camphor. Comparison With 4-Methylbenzylidene Camphor.” Toxicology, vol. 199(2-3), pp. 109-120, 2004. 12. Schmutzler, C., et al., “Endocrine Disruptors and the Thyroid Gland—A Combined In Vitro and In Vivo Analysis of Potential New Biomarkers.” Environmental Health Perspectives, vol. 115 (Supplement 1), pp. 77-83, 2007. 13. Schreurs, R., et al., “Estrogenic Activity of UV Filters Determined by an In Vitro Reporter Gene Assay and an In Vivo Transgenic Zebrafish Assay.” Archives of Toxicology, vol. 76, pp. 257-261, 2002. 14. Seidlová-Wuttke, D., et al., “Comparison of Effects of Estradiol With Those of Octylmethoxycinnamate and 4-Methylbenzylidene Camphor on Fat Tissue, Lipids and Pituitary Hormones.” Toxicology and Applied Pharmacology, vol. 214(1), pp. 1-7, 2006. 15. Søeborg, T., et al., “Risk Assessment of Topically Applied Products.” Toxicology, vol. 236(1-2), pp. 140-148, 2007. 16. Tinwell, H., et al., “Confirmation of Uterotrophic Activity of 3-(4-Methylbenzylidine) Camphor in the Immature Rat.” Environmental Health Perspectives, vol. 110(5), pp. 533-536, 2002. 17. Durrer, S., et al., “Estrogen Sensitivity of Target Genes and Expression of Nuclear Receptor Co-Regulators in Rat Prostate After Pre- and Postnatal Exposure to the Ultraviolet Filter 4-Methylbenzylidene Camphor.” Environmental Health Perspectives, vol. 115 (Supplement 1), pp. 42-50, 2007. 18. Durrer, S., et al., “Estrogen Target Gene Regulation and Coactivator Expression in Rat Uterus After Developmental Exposure to the Ultraviolet Filter 4-Methylbenzylidene Camphor.” Endocrinology, vol. 146(5), pp. 2130-2139, 2005. 19. Faass, O., et al., “Female Sexual Behavior, Estrous Cycle and Gene Expression in Sexually Dimorphic Brain Regions After Pre- and Postnatal Exposure to Endocrine Active UV Filters.” Neurotoxicology, vol. 30(2), pp. 249-260, 2009. 20. Hofkamp, L., et al., “Region-Specific Growth Effects in the Developing Rat Prostate Following Fetal Exposure to Estrogenic Ultraviolet Filters.” Environmental Health Perspectives, vol. 116(7), pp. 867-872, 2008. 21. Maerkel, K., et al., “Sexually Dimorphic Gene Regulation in Brain as a Target for Endocrine Disrupters: Developmental Exposure of Rats to 4-Methylbenzylidene Camphor.” Toxicology and Applied Pharmacology, vol. 218(2), pp. 152-165, 2007. 22. Maerkel, K., et al., “Sex- and Region-Specific Alterations of Progesterone Receptor mRNA Levels and Estrogen Sensitivity in Rat Brain Following Developmental Exposure to the Estrogenic UV Filter 4-Methylbenzylidene Camphor.” Environmental Toxicology and Pharmacology, vol. 19(3), pp. 761-765, 2005. 23. Schlumpf, M., et al., “In Vitro and In Vivo Estrogenicity of UV Screens.” Environmental Health Perspectives, vol. 109(3), pp. 239-244, 2001. Erratum in: Environmental Health Perspectives, vol. 109(11), p. A517, 2001. 24. Schlumpf, M., et al., “Estrogenic Activity and Estrogen Receptor Beta Binding of the UV Filter 3-Benzylidene Camphor. Comparison With 4-Methylbenzylidene Camphor.” Toxicology, vol. 199(2-3), pp. 109-120, 2004. 25. Schlumpf, M., et al. “Endocrine Activity and Developmental Toxicity of Cosmetic UV Filters—An Update.” Toxicology, vol. 205(1-2), pp. 113-122, 2004. 26. International Conference on Harmonization (ICH), Guidance for Industry, “The Need for Long Term Rodent Carcinogenicity Studies of Pharmaceuticals S1A,” March 1996 (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidance/UCM074911.pdf). 27. ICH, Guidance for Industry, “S1B Testing for Carcinogenicity of Pharmaceuticals,” July 1997 (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM074916.pdf). 28. ICH, “S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals SIC(R2)” (Revision 1), September 2008 (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM074919.pdf). 29. ICH Harmonized Tripartite Guideline for Industry, “Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2),” 2005 (available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S5_R2/Step4/S5_R2__Guideline.pdf). 30. ICH, Guideline for Industry, “Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3A,” March 1995 (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM074937.pdf). Dated: February 20, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-03884 Filed 2-24-15; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 310 [Docket No. FDA-2008-N-0474] Over-the-Counter Sunscreen Drug Products—Regulatory Status of Ecamsule AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed order; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is issuing a proposed sunscreen order (proposed order) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA). The proposed order announces FDA's tentative determination that ecamsule (also known as terephthalylidene dicamphor sulfonic acid) at concentrations up to 10 percent is not generally recognized as safe and effective (GRASE) and is misbranded when used in over-the-counter (OTC) sunscreen products because the currently available data are insufficient to classify it as GRASE and not misbranded, and additional information is needed to allow us to determine otherwise.

    DATES:

    Submit either electronic or written comments on this proposed order by April 13, 2015. Sponsors may submit written requests for a meeting with FDA to discuss this proposed order by March 27, 2015. See section VI for the proposed effective date of a final order based on this proposed order.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Electronic Submissions

    Submit electronic comments in the following way:

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

    Written Submissions

    Submit written submissions in the following ways:

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

    Instructions: All submissions received must clearly identify the specific active ingredient (ecamsule) and the Docket No. FDA-2008-N-1474 for this rulemaking. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document.

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

    Submit requests for a meeting with FDA to discuss this proposed order to Kristen Hardin (see FOR FURTHER INFORMATION CONTACT).

    FOR FURTHER INFORMATION CONTACT:

    Kristen Hardin, Division of Nonprescription Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5491, Silver Spring, MD 20993-0002, 240-402-4246.

    SUPPLEMENTARY INFORMATION:

    I. Regulatory Background A. Regulatory and Statutory Framework

    The data and information addressed in this proposed order were originally submitted for review under FDA's Time and Extent Application (TEA) regulation, § 330.14 (21 CFR 330.14), a process that has since been supplemented with new statutory procedures established in the SIA (Pub. L. 113-195), enacted November 26, 2014. The discussion that follows briefly describes and compares the TEA and SIA processes as they apply to the regulatory status of ecamsule.

    The TEA regulation established a process through which a sponsor could request that an active ingredient or other OTC condition,1 particularly one not previously marketed in the United States, be added to an OTC drug monograph to enable compliant OTC drug products containing the condition to be marketed in the United States without an approved new drug application (NDA) or abbreviated new drug application (ANDA). Because this proposed order specifically addresses an OTC sunscreen active ingredient (ecamsule), the remainder of this discussion will refer only to “active ingredients.”

    1 For purposes of OTC drug regulation, a “condition” is defined as an active ingredient or botanical drug substance (or a combination of active ingredients or botanical drug substances), dosage form, dosage strength, or route of administration marketed for a specific OTC use, with specific exclusions (see § 330.14(a)(2)). This document will refer simply to new “active ingredients,” since that is the condition under consideration.

    Critical steps in a proceeding under the TEA regulation include the following: (1) FDA's determination that an active ingredient had been marketed for the proposed OTC use for a material time and to a material extent (eligibility determination), and public call for submission of safety and efficacy data, followed by; (2) review of safety and efficacy data submitted by the sponsor or other interested parties; and (3) FDA's initial determination that the data show the active ingredient to be either GRASE or not GRASE for OTC use under the applicable monograph conditions (including any new conditions rising from FDA's review) (GRASE determination). Under the TEA regulation, FDA's GRASE determinations are effectuated through notice and comment rulemaking to amend or establish the appropriate monograph.

    The TEA process in FDA regulations was supplemented by Congress's enactment of the SIA. Among other amendments it makes to the FD&C Act, the SIA creates new procedures specifically for reviewing the safety and effectiveness of nonprescription sunscreen active ingredients, including those, such as ecamsule, that were the subject of pending TEA proceedings at the time the SIA was enacted. Like the TEA regulation, the SIA calls for an initial eligibility determination phase for nonprescription sunscreen active ingredients, followed by submissions of safety and efficacy data and a GRASE determination phase. However, the SIA requires FDA to make proposed and final GRASE determinations for nonprescription sunscreen active ingredients in the form of administrative orders rather than the multistep public rulemaking required by the TEA regulation, and establishes strict timelines for the necessary administrative actions.

    Among other requirements, no later than 90 days after the SIA was enacted (i.e., no later than February 24, 2015), FDA must publish a proposed sunscreen order in the Federal Register for any nonprescription sunscreen active ingredient, including ecamsule, for which, on the date of enactment, an eligibility determination had been issued under the TEA regulation and submissions of safety and efficacy data received, and for which a TEA feedback letter had not yet been issued (section 586C(b)(4) of the FD&C Act (21 U.S.C. 360fff-3(b)(4)), as amended by the SIA). Other provisions of the SIA that are not discussed in this proposed order address procedures applicable to other pending and future sunscreen active ingredient GRASE determinations, pending and future GRASE determinations for OTC products other than sunscreens, issuance of specified guidances and reports, and completion of pending sunscreen rulemakings, among others.

    A proposed sunscreen order under the SIA is an order containing FDA's tentative determination proposing that a nonprescription sunscreen active ingredient or combination of ingredients: (1) Is GRASE and is not misbranded when marketed in accordance with the proposed order; (2) is not GRASE and is misbranded; or (3) is not GRASE and is misbranded because the data are insufficient to classify the active ingredient or combination of ingredients as GRASE and not misbranded, and additional information is necessary to allow FDA to determine otherwise (section 586(7) of the FD&C Act, as amended by the SIA). Publication of a proposed sunscreen order triggers several timelines under the SIA, including a 45-day public comment period, and a 30-day period in which a sponsor may request a meeting with FDA to discuss the proposed order.

    B. FDA's Review of Ecamsule

    L'Oreal asked FDA to include ecamsule in concentrations up to 10 percent as an active ingredient in the OTC sunscreen monograph in a TEA submitted September 19, 2007. FDA announced on September 12, 2008, that ecamsule had been found eligible in concentrations up to 10 percent to be considered for inclusion in the OTC sunscreen monograph (21 CFR part 352, currently stayed), and requested submissions of safety and effectiveness data to support a GRASE determination for the requested OTC use (73 FR 53029). L'Oreal submitted safety and efficacy data on ecamsule to the designated docket (FDA-2008-N-0474) on November 14, 2008 (ecamsule data submission). At the time the SIA was enacted, FDA had not issued a TEA feedback letter or otherwise responded to that submission.

    In accordance with new section 586C(b)(4) of the FD&C Act as amended by the SIA, we are issuing this notice as a proposed order for ecamsule. Based on our review of the ecamsule data submission, we have made a tentative determination that ecamsule is not GRASE for OTC sunscreen use and is misbranded because the data are insufficient to classify it as GRASE and not misbranded, and additional information is necessary to allow us to determine otherwise. The remainder of this proposed sunscreen order describes our review of safety and efficacy data, identifies additional data needed to demonstrate that ecamsule is GRASE for the requested use, and explains our rationale for specific conclusions and data requirements.

    This proposed order will be open for public comment (see DATES). The sponsor may request a meeting with FDA to discuss this proposed order (see DATES). We also invite the sponsor to submit additional safety and/or efficacy data to inform our further consideration, as publication of a final sunscreen order for ecamsule under the SIA will be contingent on receipt of such information. (See section 586C(b)(9)(ii) of the FD&C Act.) We specifically encourage the sponsor to discuss any proposed study protocols with us before performing the studies.

    II. Safety Data Considerations for OTC Sunscreen Products Containing Ecamsule

    In evaluating the safety of a proposed monograph active ingredient, FDA applies the following regulatory standard: Safety means a low incidence of adverse reactions or significant side effects under adequate directions for use and warnings against unsafe use as well as low potential for harm which may result from abuse under conditions of widespread availability. Proof of safety shall consist of adequate tests by methods reasonably applicable to show the drug is safe under the prescribed, recommended, or suggested conditions of use. This proof shall include results of significant human experience during marketing. General recognition of safety shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data (§ 330.10(a)(4)(i) (21 CFR 330.10(a)(4)(i))).

    FDA's OTC drug regulations generally identify the types of information that may be submitted as evidence that an active ingredient or other OTC drug condition is safe, as part of the consideration of whether an active ingredient or other condition is GRASE (§ 330.10(a)(2)). For convenience, this order uses the term “generally recognized as safe (GRAS)” to refer to that aspect of the GRASE determination. To apply the general OTC safety standard to each potential new condition, FDA uses its scientific expertise to determine what constitutes “adequate tests by methods reasonably applicable to show the drug is safe under the prescribed, recommended, or suggested conditions of use.” In assessing what specific testing or other data are needed to adequately demonstrate the safety of ecamsule for use in sunscreen, FDA considers the circumstances under which OTC sunscreen products that could contain ecamsule would be used by consumers.

    When used as directed with other sun protection measures, broad spectrum OTC sunscreen products with a sun protection factor (SPF) value of 15 or higher strongly benefit the public health by decreasing the risk of skin cancer and premature skin aging associated with solar ultraviolet (UV) radiation, as well as by helping to prevent sunburn. (Sunscreens with lower SPF values, or without broad spectrum protection, also help prevent sunburn.) When used as directed by the required labeling, all OTC sunscreen products are applied liberally to the skin and reapplied frequently throughout the day (§ 201.327(e) (21 CFR 201.327(e))). Because the effects of UV exposure are cumulative, to obtain the maximum benefit, users of broad spectrum sunscreens with an SPF value of 15 or higher are directed to use such products regularly—on a routine basis (id.). Given these conditions of use, our safety evaluation of an OTC sunscreen active ingredient such as ecamsule must consider both short-term safety concerns (such as skin sensitization/irritation and photosafety) and potential concerns related to long-term sunscreen use, including potential systemic exposure via dermal absorption.

    The purpose of the safety testing described in this section II is to establish whether an OTC sunscreen product containing ecamsule and otherwise marketed under the conditions described in a final sunscreen order and in accordance with all requirements applicable to nonprescription drugs would be GRAS for use as labeled. To demonstrate that these requirements are met for ecamsule, initial safety testing should be performed using ecamsule as the sole active ingredient up to the highest concentration for which marketing status is sought and eligibility has been established: 10 percent. If initial testing suggests a particular safety concern associated with ecamsule (e.g., a hormonal activity), FDA may request additional studies to address that concern.

    A. Human Safety Data 1. Human Irritation, Sensitization, and Photosafety Studies

    Studies of skin irritation, sensitization, and photosafety are standard elements in the safety evaluation of topical drug products that, like ecamsule-containing sunscreens, are applied to the skin repeatedly over long periods of time. FDA recommends separate studies for skin irritation and sensitization. Skin irritation studies should generally include at least 30 evaluable subjects and should evaluate the test formulation (i.e., ecamsule in an appropriate test vehicle), the vehicle alone, and both negative and positive controls. Skin sensitization studies generally should include at least 200 subjects and should evaluate the test formulation containing ecamsule, the vehicle, and a negative control. For both irritation and sensitization studies, test site applications should be randomized and the test observer blinded to the identities of the test formulations.

    FDA recommends that photosafety evaluation generally involve studies of skin photoirritation (phototoxicity) and skin photosensitization (photoallergenicity). General principles for designing and conducting photosafety studies are described in FDA guidance (Ref. 1). Photosafety studies, like sensitization and irritation studies, should be conducted using ecamsule 10 percent in an appropriate test vehicle, the vehicle alone, and a negative control. In addition, phototoxicity studies should include at least 30 evaluable subjects and photoallerginicity studies should include at least 45 evaluable subjects.

    Data Available for Ecamsule: Human Irritation, Sensitization, and Photosafety Studies

    We received information regarding 26 non-U.S. human dermal safety studies evaluating formulations containing up to approximately 4 percent ecamsule with one or more other additional active ingredients (Note 1). These studies exposed a total of approximately 1,500 adults to formulations containing ecamsule. Reports of 21 of these studies were complete: 2 of these studies assessed primary cutaneous irritation, 7 assessed cumulative irritation and sensitization potential, 9 assessed phototoxicity potential, and 3 assessed photosensitizing potential. However, the information provided in the 21 complete study reports does not meet FDA's current standards to support the human dermal safety of ecamsule at any concentration. All of these studies assessed formulations containing more than one active ingredient and therefore provide only limited insight into the safety of ecamsule. Furthermore, the formulations used in these studies included ecamsule only in concentrations of between 0.33 percent and 3.96 percent, and therefore would not support a determination that ecamsule is GRAS at concentrations between 3.96 percent and 10.0 percent as found eligible for review and requested for GRASE evaluation by L'Oreal. Other deficiencies noted included:

    • Failure to provide individual skin reaction scores to negative controls in all studies.

    • Failure to enroll a sufficient number of subjects in the sensitization, phototoxicity, and photoallergenicity studies.

    • Although the cumulative irritation studies enrolled an adequate number of evaluable subjects, there was a failure to indicate whether positive controls were used, and only three study reports indicated a negative control was used.

    • Failure to indicate whether or not investigators in the primary cutaneous irritation, phototoxicity, and photoallergenicity studies were blinded to patch applications.

    • Failure to indicate whether the phototoxicity and photoallergenicity studies included vehicle controls.

    The ecamsule data submission also included reports for 14 studies exposing a total of over 500 children primarily between 3 and 12 years of age to sunscreen formulations containing ecamsule in concentrations of 1.5 percent to 9 percent, with 1 or more other additional active ingredients (Note 2). Numerous dermatologic reactions were reported; however, none were considered serious.

    Three human safety-related literature citations listed in the submission were limited to studies describing photoallergic reactions to combination sunscreen products formulated both with and without ecamsule (Note 3). One publication described a single case of photoallergy to an ecamsule-containing sunscreen product (Ref. 2). A second publication was a review that summarized published and unpublished data from a single center's experience with patch and photopatch testing in a consecutive series of 402 patients who presented to a photobiology unit from 1981 to 1996 with suspected clinical photosensitivity (Ref. 3). The authors did not observe allergy or photoallergy to 1 percent ecamsule, but experience with ecamsule was limited in this study because it was included in the sunscreen series beginning in 1995, towards the end of the 15-year study period. The third publication was a case report describing no photoallergy to an ecamsule-containing combination sunscreen drug product in a 71-year-old male patient with persistent photocontact allergy to other UV filters (Ref. 4). A literature search conducted by FDA did not identify additional publications regarding the human dermal safety of ecamsule in concentrations up to 10 percent for use as an OTC sunscreen.

    FDA concludes that the data submitted are not sufficient to assess the dermal safety of ecamsule in concentrations up to 10 percent and specifically its potential to cause irritation, sensitization, photoirritation, or photoallergenicity. Submission of data from human irritation, sensitization, and photosafety studies that meet FDA standards (see section II.A.1) is recommended to demonstrate that an OTC sunscreen product containing up to 10 percent ecamsule is not an irritant, sensitizer, photosensitizer, or photoirritant.

    2. Human Dermal Pharmacokinetic (Bioavailability) Studies

    Because sunscreens are topically applied, another important safety consideration for ecamsule for use in sunscreens is whether dermal application may result in skin penetration and systemic exposure to ecamsule, and if so, to what extent. A well-designed and -conducted human dermal pharmacokinetic study can be expected to detect and quantify the presence of ecamsule and/or any metabolites in blood or other bodily fluids that may have a bearing on safety, using recognized parameters such as bioavailability percentage, maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), total area under the plasma concentration versus time curve (AUC), half-life, clearance, and volume of distribution. This information can help identify potential safety concerns and help determine whether an adequate safety margin for sunscreens containing ecamsule exists. FDA recommends that the pharmacokinetic studies performed on ecamsule also collect additional safety-related data from regularly scheduled physical examinations, collection of vital signs, and other measures, which may help capture adverse skin events or other potential safety signals. To ensure that maximum penetration of ecamsule has taken place and chances of it being detected are optimal, studies should continue until steady state is reached.

    General information and recommendations on the design and conduct of human pharmacokinetic studies can be found in FDA guidance (Ref. 5). To support a GRAS determination for ecamsule (up to 10 percent), such a study should be conducted under maximal use conditions using ecamsule up to 10 percent in various vehicles, including vehicles that would be expected to enhance absorption. We encourage study sponsors to consult with us before conducting pharmacokinetic studies, because the properties of ecamsule bear on the optimal design.

    Data Available for Ecamsule: Human Dermal Pharmacokinetic (Bioavailability) Studies

    Human dermal pharmacokinetic studies for ecamsule were submitted in response to our call for data. We reviewed one in vitro study that evaluated the potential for dermal penetration of topically applied ecamsule from human skin samples (Note 4). Because this study was not designed to detect or quantify ecamsule in the blood or other body fluids, it provides no useful information about systemic exposure. One urinary excretion study conducted with a 4.95 percent ecamsule test formulation suggested minimal systemic absorption in seven male volunteers dosed over an extensive body surface area for a total of 5 days (Note 5). A study in which radiolabeled 2 percent ecamsule was topically applied to the forearms of five male volunteers and retained for 4 hours detected a minimal level of radiation above background in urine after dosing but radiation levels above background were not detected in blood (Note 6). Although this study suggests that ecamsule is minimally absorbed following dermal application, the study formulation contained ecamsule at a concentration much lower than the requested 10 percent maximum and only a small number of subjects were dosed over a limited surface area. The last human dermal pharmacokinetic study assessed the absorption of 3 percent ecamsule from a formulation containing a total of four active ingredients (Note 7). The formulation was applied to an extensive body surface area of six male subjects twice daily for 8 days. Results showed that there were quantifiable plasma concentrations of ecamsule at several time points, suggesting that ecamsule is absorbed via dermal application. None of the submitted human dermal pharmacokinetic studies assessed an adequate number of subjects, or tested ecamsule at the maximum requested concentration of 10 percent.

    Our literature search found no additional publications regarding human pharmacokinetics of ecamsule. Accordingly, we request data from human pharmacokinetic studies to assess the potential for and the extent of systemic absorption. These studies should be performed under expected maximal use conditions with the proposed maximum concentration, as discussed previously in this section, in a sufficiently large study population to control for both gender and age.

    3. Human Safety Data To Establish Adverse Event Profile

    An evaluation of safety information from adverse event reports and other safety-related information derived from commercial marketing experience of sunscreen products containing ecamsule, as well as from other sources, is a critical aspect of FDA's safety review for ecamsule. The TEA regulation under which the original request for ecamsule was submitted specifically calls for submission of information on all serious adverse drug experiences, as defined in 21 CFR 310.305(a) and 314.80(a), from each country where the active ingredient or other condition has been or is currently marketed as either a prescription or an OTC drug; in addition, it calls for submission of all data generally specified in § 330.10(a)(2), which includes documented case reports and identification of expected or frequently reported side effects (§ 330.14(f)(1) and (f)(2)). To evaluate ecamsule, FDA continues to seek individual adverse drug experience reports, a summary of all serious adverse drug experiences, and expected or frequently reported side effects of the condition (id.). To assist in the Agency's safety evaluation of ecamsule, FDA emphasizes its need for the following data:

    • A summary of all available reported adverse events potentially associated with ecamsule;

    • All available documented case reports of serious side effects;

    • Any available safety information from studies of the safety and effectiveness of ecamsule in humans; and

    • Relevant medical literature describing adverse events associated with ecamsule. Submissions of adverse event data should also include a description of how each country's system identifies and collects adverse events, unless this information has been previously submitted as part of ecamsule's TEA package.

    Although we recognize that adverse event data from foreign marketing experience may reflect patterns of use and regulatory reporting requirements that differ from those in the United States, we nonetheless consider such information to be strongly relevant both to our overall GRASE assessment of ecamsule for use in sunscreens and to our consideration of potential product labeling. FDA recognizes that such information may not be available from all countries; where that is the case, please provide a written explanation for the lack of data. Overall, we seek sufficient data to characterize ecamsule's adverse event profile.2

    2 See 67 FR 3060 at 3069 (January 23, 2002) (agreeing that the absence of an adverse experience reporting system in a foreign country for drugs or cosmetics does not necessarily mean that a condition cannot be GRAS/E. The GRAS/E determination will be based on the overall quality of the data and information presented to substantiate safety and effectiveness).

    Ecamsule: Human Safety Data To Establish Adverse Event Profile

    The submission describes the marketing history of ecamsule and provides eight case report forms (Form FDA 3500A) that have been submitted to FDA's MedWatch program in association with marketed sunscreen products containing ecamsule in combination with other active ingredients (Note 8). Our review of the FDA Adverse Event Reporting System (FAERS) identified one additional case report associated with such a sunscreen product. These case reports describe serious allergic reactions such as redness, swelling and urticaria, breathing difficulties, and anaphylaxis. The role, if any, of ecamsule in these cases cannot be fully assessed due in part to the presence of multiple active ingredients in the associated sunscreen products. To support the evaluation of the safety of ecamsule for use in OTC sunscreens, we request that the sponsor either supplement the information already submitted with adverse event or other safety-related data derived from commercial marketing experience, or explain why such information cannot be provided.

    B. Nonclinical (Animal) Studies

    Another important element of FDA's GRAS review of ecamsule for use in sunscreens is an assessment of data from nonclinical (animal) studies that characterize the potential long-term dermal and systemic effects of exposure to ecamsule. Even if the bioavailability data discussed in section II.A.2 suggest that dermal application is unlikely to result in skin penetration and systemic exposure to ecamsule, FDA still considers data on the effects of systemic exposure to be an important aspect of our safety evaluation of ecamsule. A determination that ecamsule up to 10 percent is GRASE for use in sunscreens would permit its use in as-yet-unknown product formulations, which might in turn alter the skin penetration of the active ingredient. Therefore, an understanding of the effects of ecamsule, were systemic exposure to occur, is critical to determine whether and how regulatory parameters can be defined to assure that all conforming ecamsule-containing sunscreens would be GRASE as labeled.

    FDA recommends animal testing of the potential long-term dermal and systemic effects of exposure to ecamsule because these effects cannot be easily assessed from previous human use. Taken together, the carcinogenicity studies, developmental and reproductive toxicity studies, and toxicokinetic studies described in sections II.B.1 through II.B.3 should provide the information needed to characterize both the potential dermal and systemic toxic effects and the levels of exposure at which they occur. These data, when viewed in the context of human exposure data, can be used to determine a margin of safety for use of ecamsule in OTC sunscreens.

    Data Available for Ecamsule: Nonclinical (Animal) Studies Generally

    The ecamsule submission included reports of the following types of nonclinical safety studies:

    • Single-dose toxicity studies ○ Oral toxicity (rat, mouse) (Note 9) ○ Dermal toxicity (rat, mouse) (Note 10) ○ Intravenous toxicity (rat, mouse) (Note 11) ○ Mucosal and skin irritation (rabbit) (Note 12) ○ Skin irritation and sensitization (guinea pig) (Note 13) ○ Photoirritation and photosensitization (guinea pig) (Note 14) • Repeat-dose toxicity studies ○ 4-week bridging dermal (mouse) (Note 15) ○ 13-week dermal (mouse) (Note 16) ○ 9-month dermal (minipig) (Note 17) • Genotoxicity and mutagenicity assays ○ Ames test (Salmonella typhimurium, Escherichia coli) (Note 18) ○ Chromosomal aberration assay (Chinese hamster ovary (CHO cells)) (Note 19) ○ Micronucleus test (rat) (Note 20) ○ Photomutagenicity (E. coli) (Note 21) ○ HPRT test (CHO cells) (Note 22) ○ Photochromosomal aberration assay (CHO cells) (Note 23) • Reproductive and developmental toxicity studies ○ Fertility and early embryonic development, oral (rat) (Note 24) ○ Pre/postnatal development, oral (rat) (Note 25) ○ Embryotoxicity/teratogenicity, dermal (rabbit) (Note 26) ○ Embryofetal development/teratogenicity, oral (rat) (Note 27) ○ Embryofetal development/teratogenicity, oral (rabbit) (Note 28) • Carcinogenicity and photocarcinogenicity ○ 104 weeks dermal carcinogenicity (mouse) (Note 29) ○ 12 months photocarcinogenicity (mouse) (Note 30) • Pharmacokinetics ○ Pharmacokinetic study, oral (rat) (Note 31) ○ Pharmacokinetic study, dermal (mouse, rat) (Note 32) ○ Microsome metabolism (interspecies, in vitro) (Note 33) ○ Excretion, oral and dermal (rat) (Note 34)

    The submission includes summary reports of nonclinical studies that are of the types FDA requests as a basis for evaluating whether ecamsule is GRAS for use in sunscreen (chronic toxicity, carcinogenicity, reproductive and developmental toxicity, and toxicokinetics). However, the submission did not provide the full reports and full comprehensive data sets that would be needed for an adequate review of the data for these studies. Because the summary data provided can support only tentative conclusions about these studies, full final study reports and data sets need to be made available to support a final GRASE determination.

    Additional discussion of study findings and data gaps are provided in the following subsections.

    1. Carcinogenicity Studies: Dermal and Systemic

    FDA guidance recommends that carcinogenicity studies be performed for any pharmaceutical that is expected to be clinically used continuously or “repeatedly in an intermittent manner” for a total of 6 months of exposure (Refs. 6, 7, and 8). Because the proposed use of ecamsule in OTC sunscreens falls within this category, these studies should be conducted to help establish that ecamsule is GRAS for its proposed use. Carcinogenicity studies assist in characterizing potential dermal and systemic risks by identifying the type of toxicity observed, the level of exposure at which toxicity occurs, and the highest level of exposure at which no adverse effects occur (i.e., NOAEL). The NOAEL would then be used in determining the safety margin for human exposure to sunscreens containing ecamsule.

    Systemic carcinogenicity studies can also help to identify other systemic or organ toxicities that may be associated with ecamsule, such as hormonal effects. For example, the effect of persistent disruption of particular endocrine gland systems (e.g., hypothalamic-pituitary-adrenal axis), if any, can be captured by these assays.

    Data Available for Ecamsule: Genotoxicity Studies

    The ecamsule submission included some information regarding genotoxicity studies. Based on the reviewable genotoxicity data included in the ecamsule data submission, ecamsule appears to be negative for causing genotoxic activity under the conditions studied (Notes 35 through 43). As we believe that data from the recommended systemic carcinogenicity and developmental and reproductive toxicology (DART) studies will provide an adequate and appropriate measure of potential long-term effects of systemic or dermal exposure to ecamsule, we do not request further genotoxicity studies.

    Data Available for Ecamsule: Carcinogenicity Studies

    We have reviewed study summaries for four dermal carcinogenicity and photocarcinogenicity studies, which appear to be negative (Notes 44 through 47). However, full final study reports need to be made available to support a final GRASE determination. In addition, we did not receive any systemic carcinogenicity data, which are recommended to support the safety of long-term use of ecamsule. We request that the sponsor provide a systemic carcinogenicity study, as well as make available full final study reports for the previously conducted carcinogenicity studies that were submitted in a summarized form.

    2. DART Studies (Ref. 9)

    FDA recommends conducting DART studies to evaluate the potential effects that exposure to ecamsule may have on developing offspring throughout gestation and postnatally until sexual maturation, as well as on the reproductive competence of sexually mature male and female animals. Gestational and neonatal stages of development may also be particularly sensitive to active ingredients with hormonal activity. For this reason, we recommend that these studies include assessments of endpoints such as vaginal patency, preputial separation, anogenital distance, and nipple retention, which can be incorporated into traditional DART study designs to assess potential hormonal effects of ecamsule on the developing offspring. We also recommend conducting behavioral assessments (e.g., mating behavior) of offspring, which may also detect neuroendocrine effects.

    Data Available for Ecamsule: DART Studies

    We received study summaries for five developmental and reproductive toxicity assays (Notes 48 through 52), which appear to be negative for the potential to cause adverse developmental or reproductive effects. However, comprehensive data sets were not provided.

    We request that the sponsor make available full final study reports, including full comprehensive datasets, to support a final GRASE determination.

    3. Toxicokinetics (Ref. 10)

    We recommend conducting animal toxicokinetic studies because they provide an important bridge between toxic levels seen in animal studies and potential human exposure. Data from these studies can be correlated to potential human exposure via clinical dermal pharmacokinetic study findings. Toxicokinetic data could be collected as part of animal studies being conducted to assess one or more of the safety parameters described previously.

    Data Available for Ecamsule: Toxicokinetics

    We reviewed single-dose pharmacokinetic studies conducted in animal models which showed that systemic exposure was achieved under the conditions of the conducted studies (Notes 53 and 54). However, we did not receive any pharmacokinetic data reflecting drug levels following long-term exposure, which are usually collected from repeat toxicity studies such as chronic (systemic or dermal) studies. We recommend that a time course toxicokinetic study be conducted following repeat-dose exposure (via the oral and dermal routes) to evaluate the steady-state exposure level of ecamsule. Data obtained from this study could be used to compare drug levels in animals to those in humans under maximal exposure conditions to establish a margin of safety for human exposure.

    III. Effectiveness Data Considerations for OTC Sunscreen Products Containing Ecamsule

    FDA's evaluation of the effectiveness of active ingredients under consideration for inclusion in an OTC drug monograph is governed by the following regulatory standard: Effectiveness means a reasonable expectation that, in a significant proportion of the target population, the pharmacological effect of the drug, when used under adequate directions for use and warnings against unsafe use, will provide clinically significant relief of the type claimed. Proof of efficacy shall consist of controlled clinical investigations as defined in 21 CFR 314.126(b). Investigations may be corroborated by partially controlled or uncontrolled studies, documented clinical studies by qualified experts, and reports of significant human experience during marketing. Isolated case reports, random experience, and reports lacking the details that permit scientific evaluation will not be considered. General recognition of effectiveness shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data (§ 330.10(a)(4)(ii)). For convenience, this order uses the term “generally recognized as effective” (GRAE) when referring to this aspect of the GRASE determination.

    To evaluate the efficacy of ecamsule for use in OTC sunscreen products, FDA requests evidence from at least two adequate and well-controlled SPF studies showing that ecamsule effectively prevents sunburn. To determine that ecamsule is GRAE for use in OTC sunscreens at concentrations in a range with the proposed maximum strength of 10 percent as requested, two adequate and well-controlled SPF studies of ecamsule at a lower concentration should be conducted according to established standards.3 These SPF studies should demonstrate that the selected concentration (below 10 percent) provides an SPF of 2 or more.

    3 The upper bound of any concentration of ecamsule ultimately established in the OTC sunscreen monograph will be governed by the safety data, as well as by efficacy.

    The current standard procedure for SPF testing is described in FDA's regulations in § 201.327(i).4 Further SPF tests for ecamsule should be performed as described in these regulations, using a test formulation containing ecamsule as the only active ingredient to identify its contribution to the overall SPF test results. (See the following subsection Data Available for Ecamsule: Effectiveness for further discussion of submitted SPF tests.) The study should also include a vehicle control arm to rule out any contribution the vehicle may have on the SPF test results. Finally, as described in § 201.327(i), an SPF standard formulation comparator arm should be another component of the study design.

    4 Although the SPF testing procedure is used primarily for final formulation testing of finished products marketed without approved NDAs, under the sunscreen monograph, it is equally applicable for determining whether or not a sunscreen active ingredient is GRAE.

    Although current sunscreen testing and labeling regulations also specify a “broad spectrum” testing procedure to support related labeling claims for certain OTC sunscreen products marketed without approved new drug applications that contain specific ingredients included in the OTC sunscreen monograph, those additional claims are permitted, but not required, for these products (§ 201.327(c)(2) and (j)). Under current regulations, sunscreen active ingredients need only be effective for the labeled indication of sunburn prevention, for which the SPF test can provide sufficient evidence. Consistent with this approach, we here do not request broad spectrum testing for ecamsule. Broad spectrum protection is often, although not always, the result of the combined contribution of multiple active ingredients in a final sunscreen formulation. Thus, under the current regulations applicable to other sunscreens, the determination of whether an individual sunscreen product may be labeled as broad spectrum and bear the related additional claims is made on a product-specific basis, applying standard testing methods set forth in those regulations. If ecamsule is established to be GRASE for use in nonprescription sunscreens (based in part on the efficacy data requested here), the final sunscreen order can likewise address broad-spectrum testing and related labeling conditions for final sunscreen formulations containing ecamsule.

    Data Available for Ecamsule: Effectiveness

    Study reports were submitted for two studies that assessed SPF of formulations containing ecamsule, at a concentration of either 2 percent or 3 percent (Notes 55 and 56, respectively), in combination with other active ingredients. Neither of these studies provides a direct evaluation of the efficacy of ecamsule alone. These studies were not adequately designed to provide evidence of efficacy on which to base a GRAE determination for ecamsule. No adequately designed studies of ecamsule efficacy were identified in our search of the published literature. To support the finding that ecamsule is GRAE when used at concentrations up to 10 percent, we request submission of data from two adequate and well-controlled SPF studies conducted according to established standards to demonstrate that the lowest selected concentration provides an SPF of 2 or more. Because no study has been identified that assesses the effectiveness of ecamsule at a concentration of 10 percent, it is recommended that such a study be conducted and submitted.

    IV. Summary of Current Data Gaps for Ecamsule

    Based on our review of the available safety and efficacy data as discussed previously, we request the types of data listed in this section of the proposed order, at minimum, for us to reverse our tentative determination that ecamsule is not GRASE and is misbranded because the data are insufficient to classify ecamsule as GRASE and not misbranded, and additional data are necessary to allow us to determine otherwise. Note that, in some cases, as discussed in section II of this proposed order, the ecamsule data submission provided some information from nonclinical studies of the type FDA requests as part of the basis for a GRAS determination, but only in summary form. Were complete study data generally available from these previously conducted studies, they might address several aspects of our GRASE consideration. If data from these previously conducted studies are not made available, further studies of those types would be needed to support a finding that ecamsule is GRASE for use in sunscreens. Further, as summarized in the following subsections, some additional studies of other types are needed. For additional information about the purpose and design of studies recommended to address present data gaps, please refer to the earlier sections of this proposed order referenced in parentheses. We welcome discussions on the design of any of the studies prior to their commencement. We request the following types of data:

    Safety Data (see section II) A. Human Clinical Studies

    1. Skin irritation/sensitization, and photosafety (see section II.A.1)

    2. Human dermal pharmacokinetic (bioavailability) studies (see section II.A.2)

    B. Human Safety Data To Establish Adverse Event Profile (see Section II.A.3)

    1. A summary and analysis of all available reported adverse events potentially associated with ecamsule

    2. A summary and analysis of all available documented case reports of serious side effects

    3. A summary and analysis of any available safety information from studies of the safety and effectiveness of sunscreen products containing ecamsule in humans

    4. A summary and analysis of relevant medical literature describing adverse events associated with ecamsule

    Alternatively, the results of a literature search that found no reports of adverse events may be provided. In that case, detailed information on how the search was conducted should be provided.

    C. Nonclinical (Animal) Studies

    Full study reports will be needed for the following studies:

    1. Systemic and dermal carcinogenicity (see section II.B.1)

    2. Reproductive and developmental toxicity studies (see section II.B.2)

    3. Toxicokinetics (see section II.B.3)

    Effectiveness Data (see section III)

    For concentrations of ecamsule up to 10 percent to be found to be GRASE for use in nonprescription sunscreen products as requested, at least two SPF studies showing effectiveness of a selected concentration lower than 10 percent should be conducted. An efficacy study of ecamsule at 10 percent is also recommended.

    V. Administrative Procedures

    A copy of this proposed order will be filed in the Division of Dockets Management in Docket No. FDA-2008-N-0474. To inform FDA's evaluation of whether this ingredient is GRASE and not misbranded for use in sunscreen products, we encourage the sponsor and other interested parties to submit additional data regarding the safety and effectiveness of this ingredient for use as an OTC sunscreen product. We also encourage the sponsor and other interested parties to notify us in writing of their intent to submit additional data. However, as noted previously, because the data submitted to date are not sufficient to support a determination that ecamsule is GRASE for use as an active ingredient in OTC sunscreen drug products, at present, OTC sunscreen products containing ecamsule may not be marketed without approval of an NDA or ANDA (see section 586C(e)(1)(A) of the FD&C Act, as amended by the SIA). Data submissions relating to this proposed order should be submitted to Docket No. FDA-2008-N-0474 at the Division of Dockets Management (see ADDRESSES). In addition, you can submit the data through the Federal eRulemaking Portal at http://www.regulations.gov. Follow the instructions for submitting comments.

    Section 586C(b)(7) of the FD&C Act, as amended by the SIA, provides that the sponsor may, within 30 days of publication of a proposed order (see DATES), submit a request to FDA for a meeting to discuss the proposed order. Submit meeting requests electronically to http://www.regulations.gov or in writing to the Division of Dockets Management (see ADDRESSES), identified with the active ingredient name ecamsule, Docket No. FDA-2008-N-0474, and the heading “Sponsor Meeting Request.” To facilitate your request, please also send a copy to Kristen Hardin (see FOR FURTHER INFORMATION CONTACT).

    VI. Proposed Effective Date

    FDA proposes that any final administrative order based on this proposal become effective on the date of publication of the final order in the Federal Register.

    VII. Comments

    Similarly, section 586C(b)(6) of the FD&C Act, as amended by the SIA, establishes that a proposed sunscreen order shall provide 45 days for public comment. Interested persons wishing to comment on this proposed order may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the active ingredient name (ecamsule) and the docket number found in brackets in the heading of this proposed order. Received comments on this proposed order may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    VIII. Notes

    1. FDA-2008-N-0474-0012 and FDA-2008-N-0474-0013, Volumes 6 and 7, dated November 14, 2008.

    2. FDA-2008-N-0474-0015 and FDA-2008-N-0474-0016, Volumes 9 and 10, dated November 14, 2008.

    3. FDA-2008-N-0474-0007, Volume 1, dated November 14, 2008, FDA-2008-N-0474-0006, TEA submission.

    4. FDA-2008-N-0474-0008, Volume 2, Study no. 16039/G2347.

    5. FDA-2008-N-0474-0014, Volume 8, Study no. V3156.

    6. FDA-2008-N-0474-0014, Volume 8, Study no. V99.1203.

    7. FDA-2008-N-0474-0014, Volume 8, Study no. CG.03.SRE.2607.

    8. FDA-2008-N-0474-0007, Volume 1, dated November 14, 2008.

    9. FDA-2008-N-0474-0009, Volume 3, Study no. 3667-109/309, Study no. 1.CG.03.SRE.12160.

    10. FDA-2008-N-0474-0009, Volume 3, Study no. 4222-109/310, Study no. 1.CG.03.SRE.12156.

    11. FDA-2008-N-0474-0009, Volume 3, Study no. 1.CG.03.SRE.12158, Study no. 1.CG.03.SRE.12157.

    12. FDA-2008-N-0474-0009, Volume 3, Study no. 712332, Volume 4, Study no. 712320.

    13. FDA-2008-N-0474-0010, Volume 4, Study no. 802410, Study no. 3697-109/313.

    14. FDA-2008-N-0474-0010, Volume 4, Study no. 1.CG.03.SRE.12163, Study no. 1.CG.03.SRE.12164.

    15. FDA-2008-N-0474-0010, Volume 4, Study no. RDA.03.SRE.12268.

    16. FDA-2008-N-0474-0009, Volume 3, Study no. 93/LOL/007/0971.

    17. FDA-2008-N-0474-0009, Volume 3, Study no. 1.CG.03.SRE.12183.

    18. FDA-2008-N-0474-0011, Volume 5, Study no. G185-109/314.

    19. FDA-2008-N-0474-0011, Volume 5, Study no. G220-109/381, Study no. G220-109/381A, Study no. 12174MIC, Study no. 413/52-D6172.

    20. FDA-2008-N-0474-0011, Volume 5, Study no. 12639MAR.

    21. FDA-2008-N-0474-0011, Volume 5, Study no. EU1REBRP.031.

    22. FDA-2008-N-0474-0011, Volume 5, Study no. LRL 170/921503.

    23. FDA-2008-N-0474-0011, Volume 5, Study no. ICHUREBRP.031.

    24. FDA-2008-N-0474-0010, Volume 4, Study no. 1.CG.03.SRE.12181.

    25. FDA-2008-N-0474-0011, Volume 5, Study no. 1.CG.03.SRE.12182.

    26. FDA-2008-N-0474-0011, Volume 5, Study no. 10297 RSL.

    27. FDA-2008-N-0474-0010, Volume 4, Study no. 1412 RMR/064.89.

    28. FDA-2008-N-0474-0011, Volume 5, RCC Project 682874.

    29. FDA-2008-N-0474-0010, Volume 4, Study no. 95/LOL/008/1217, Study no. LOL/011/980150.

    30. FDA-2008-N-0474-0010, Volume 4, Study no. C-1012-001, Study no. RDS.03.SRE.12215.

    31. FDA-2008-N-0474-0009, Volume 3, Study no. 10225PAR, Study no. 1.CG.03.SRE.12269/RDS.03.SRE.12269.

    32. FDA-2008-N-0474-0009, Volume 3, Study no. 10507 PAS, Study no. RDS.03.SRE 12268, Study no. RDS.03.SRE.12269/1.CG.03.SRE.12269.

    33. FDA-2008-N-0474-0009, Volume 3, Study no. 2.CG.03.SRE.11029.

    34. FDA-2008-N-0474-0009, Volume 3, Study no. 1.CG.03.SRE.12270.

    35. FDA-2008-N-0474-0011, Volume 5, Study no. G185-109/314.

    36. FDA-2008-N-0474-0011, Volume 5, Study no. G220-109/381.

    37. FDA-2008-N-0474-0011, Volume 5, Study no. G220-109/381A.

    38. FDA-2008-N-0474-0011, Volume 5, Study no. 12174MIC.

    39. FDA-2008-N-0474-0011, Volume 5, Study no. 413/52-D6172.

    40. FDA-2008-N-0474-0011, Volume 5, Study no. 12639MAR.

    41. FDA-2008-N-0474-0011, Volume 5, Study no. EU1REBRP.031.

    42. FDA-2008-N-0474-0011, Volume 5, Study no. LRL 170/921503.

    43. FDA-2008-N-0474-0011, Volume 5, Study no. ICHUREBRP.031.

    44. FDA-2008-N-0474-0010, Volume 4, Study no. 95/LOL/008/1217.

    45. FDA-2008-N-0474-0010, Volume 4, Study no. LOL/011/980150.

    46. FDA-2008-N-0474-0010, Volume 4, Study no. C-1012-001.

    47. FDA-2008-N-0474-0010, Volume 4, Study no. RDS.03.SRE.12215.

    48. FDA-2008-N-0474-1000, Volume 4, Study no. 1.CG.03.SRE.12181.

    49. FDA-2008-N-0474-0011, Volume 5, Study no. 1.CG.03.SRE.12182, Study no. 1412 RMR/064.89.

    50. FDA-2008-N-0474-0011, Volume 5, RCC Project 682874.

    51. FDA-2008-N-0474-0011, Volume 5, RCC Project 682874.

    52. FDA-2008-N-0474-0011, Volume 5, Study no. 1.CG.03.SRE.12182.

    53. FDA-2008-N-0474-0009, Volume 3, Study no. 10225PAR.

    54. FDA-2008-N-0474-0009, Volume 3, Study no. 1.CG.03.SRE.12269/RDS.03.SRE.12269.

    55. FDA-2008-N-0474-0017, Volume 11, Study no. PEN.810.02.

    56. FDA-2008-N-0474-0017, Volume 11, Study no. PEN.810.06.

    IX. References

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

    1. FDA, Guidance for Industry, “Photosafety Testing,” May 2003 (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079252.pdf).

    2. Leonard, F., B. Kalis, H. Adamski, et al., “The New Standard Battery of Photopatch Test in France.” Nouvelles Dermatologiques, vol. 15, pp. 343-348, 1996.

    3. Schauder, S., and H. Ippen, “Contact and Photocontact Sensitivity to Sunscreens. Review of a 15-Year Experience and of the Literature.” Contact Dermatitis, vol. 37(5), pp. 221-232, 1997.

    4. Schmidt, T., J. Ring, and D. Abeck, “Photoallergic Contact Dermatitis Due to Combined UVB (4-Methylbenzylidene Camphor/Octyl Methoxycinnamate) and UVA (Benzophenone-3/Butyl Methoxydibenzoylmethane) Absorber Sensitization.” Dermatology, vol. 196(3), pp. 354-357, 1998.

    5. FDA, Guidance for Industry, “Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application,” February 1987 (available at http://www.fda.gov/downloads/drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072112.pdf).

    6. International Conference on Harmonization (ICH), Guidance for Industry, “The Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals S1A,” March 1996 (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidance/UCM074911.pdf).

    7. ICH, Guidance for Industry, “S1B Testing for Carcinogenicity of Pharmaceuticals,” July 1997 (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM074916.pdf).

    8. ICH, “S1C(R2) Dose Selection for Carcinogenicity Studies” (Revision 1), September 2008 (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM074919.pdf).

    9. ICH Harmonized Tripartite Guideline for Industry, “Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2),” 2005 (available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S5_R2/Step4/S5_R2__Guideline.pdf).

    10. ICH, Guideline for Industry, “Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3A,” March 1995 (available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM074937.pdf).

    Dated: February 20, 2015. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2015-03883 Filed 2-24-15; 8:45 am] BILLING CODE 4164-01-P
    80 37 Wednesday, February 25, 2015 Notices AGENCY FOR INTERNATIONAL DEVELOPMENT Notice of Renewal of Charter of the Global Development Council AGENCY:

    United States Agency for International Development.

    ACTION:

    Notice of Charter Renewal.

    SUMMARY:

    Pursuant to the Federal Advisory Committee Act, notice is hereby given of the renewal of the Charter of the President's Global Development Council.

    Purpose of the Committee

    The President's Global Development Council brings together representatives of a variety of sectors, including, among others, institutions of higher education, non-profit and philanthropic organizations, civil society, and private industry to inform U.S. global development policy and programs and to support new and existing public-private partnerships to advance the global development policy agenda.

    The Charter is being renewed for two years effective from the date of filing on February 20, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Jayne Thomisee, 202-712-5506

    Dated: February 19, 2015. Christa White, Committee Management Officer. Charter of the President's Global Development Council 1. Committee's Official Designation

    President's Global Development Council (Council).

    2. Authority

    Executive Order 13600 of February 9, 2012 provided the authority to establish the President's Global Development Council. The Council is established in accordance with the provisions of the Federal Advisory Committee Act (FACA) as amended, 5.U.S.C. App.

    Executive Order 13652, Continuation of Certain Federal Advisory Committees, dated September 30, 2013, authorized the continuation of the Global Development Council until September 30, 2015.

    3. Objectives and Scope of Activities

    To advise and support the President, through the National Security Staff/National Economic Council staff, in furtherance of the policy set forth in the Executive Order establishing the Global Development Council and the President's Policy Directive on Global Development.

    4. Description of Duties

    To inform the policy and practice of U.S. global development policy and programs by providing advice to the President and other senior officials on issues including:

    (i) Innovative, scalable approaches to development with proven demonstrable impact, particularly on sustainable economic growth and good governance;

    (ii) Areas for enhanced collaboration between the Federal Government and public and private sectors to advance development policy;

    (iii) Best practices for and effectiveness of research and development in low and middle income economies; and

    (iv) Long-term solutions to issues central to strategic planning for U.S. development efforts.

    To support new and existing public-private partnerships by:

    (i) Identifying key areas for enhanced collaboration and any barriers to collaboration; and

    (ii) Recommending concrete efforts that the private and public sectors together can take to promote economic development priorities and initiatives; and

    (iii) Increase awareness and action in support of development by soliciting public input on current and emerging issues in the field of global development as well as bringing to the President's attention concerns and ideas that would inform policy options.

    5. Agency or Official to Whom the Committee Reports

    The Council reports to the President through the National Security Staff and the National Economic Council.

    6. Support

    Support to the Council is provided by staff of the Office of the Administrator at USAID.

    7. Estimated Annual Operating Costs and Staff Years

    The annual operating costs in dollars and person-years for the Council and subcommittees thereof are estimated to be approximately $250,000 and one staff year respectively.

    8. Designated Federal Officer

    The Designated Federal Officer (DFO) for the Council is the Executive Director of the President's Global Development Council. The Chair, in coordination with the National Security Staff/National Economic Staff, shall convene and preside at meetings, determine the agendas, and direct the Council's work. The DFO will assist the Chair and the National Security Staff/National Economic Staff in calling all of the advisory committee meetings, preparing all meeting agendas, attending Council meetings, and adjourning meetings.

    9. Estimated Number and Frequency of Meetings

    It is expected that the Council will hold approximately two public meetings annually. It's subcommittees and/or working groups, as and if requested by the Council, will meet as determined necessary.

    10. Duration

    The need for this advisory committee is continuing; however, this charter is subject to renewal every two years.

    11. Termination

    The Council shall terminate on September 30, 2015, two years after the date of Executive Order 136562 unless renewed by the President.

    12. Membership and Designation

    The membership of the Council shall be as follows:

    (a) The Council shall be composed of the officials described in paragraph (b) of this section and not more than 12 individuals from outside the Federal Government appointed by the President. Appointed members of the Council may serve as representatives of a variety of sectors, including, among others, institutions of higher education, non-profit and philanthropic organizations, civil society, and private industry.

    (b) The Secretary of State, the Secretary of the Treasury, the Secretary of Defense, the USAID Administrator, the Chief Executive Officer of the Millennium Challenge Corporation, the United States Trade Representative, and the Chief Executive Officer of the Overseas Private Investment Corporation shall serve as non-voting members of the Council and may designate, to perform the Council functions of the member, a senior-level official who is part of the member's department, agency, or office, and who is a full-time officer or employee of the Federal Government.

    13. Subcommittees

    The Council, in coordination with USAID, may create subcommittees and/or working groups as necessary. These subcommittees/working groups shall report back to the Council and not directly to a federal officer or agency.

    14. Recordkeeping

    The records of this Committee, all formally and informally established subcommittees/working groups shall be handled in accordance with General Records Schedule 26, Item 2, or other approved agency records disposition schedule. These records shall be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552 and will be posted on the Council's Web site.

    15. Filing Date

    February 20, 2015.

    [FR Doc. 2015-03807 Filed 2-20-15; 11:15 am] BILLING CODE 6116-02-P
    DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request February 19, 2015.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by March 27, 2015 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street, NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Agricultural Research Service

    Title: Use of the Grounds and Facilities as well as Commercial Photography and Cinematography at the U.S. Arboretum.

    OMB Control Number: 0518-0024.

    Summary of Collection: The mission of the U.S. National Arboretum (USNA) is to conduct research, provide education, and conserve and display trees, shrubs, flowers, and other plans to enhance the environment. The USNA is a 446-acre public facility. The grounds of the USNA are available to the general public for purposes of education and passive recreation. The USNA has many spectacular feature and garden displays which are very popular to visitors and photographers. Section 890(b) of the Federal Agriculture Improvement and Reform Act of 1996, Public Law 104-107 (“FAIR ACT”) provided statutory authorities regarding the USNA. These authorities include the ability to charge fees for temporary use by individuals or groups of USNA facilities and grounds for any purpose consistent with the mission of USNA. Also, the authority was provided to charge fees for the use of the USNA for commercial photography and cinematography.

    Need and Use of the Information: USNA officials will collect the information using applications in the form of questionnaires. The collected information is used by USNA management to determine if a requestor's needs can be met and the request is consistent with the mission and goals of the USNA uses of the information. If the basic information is not collected, USNA officials will not be able to determine if a requestor's needs are met.

    Description of Respondents: Business or other for profit; Not-for-profit institutions; Individuals or households; State, Local or Tribal Government.

    Number of Respondents: 284.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 142.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2015-03911 Filed 2-24-15; 8:45 am] BILLING CODE 3410-03-P
    DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request February 19, 2015

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by March 27, 2015 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street, NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Animal & Plant Health Inspection Service

    Title: Importation of Poultry Meat and Other Poultry Products from Sinaloa and Sonora, Mexico

    OMB Control Number: 0579-0144.

    Summary of Collection: The Animal Health Protection Act of 2002 (Title X, Subtitle E, Sec. 10401-18 of Pub. L. 107-171) is the primary Federal law governing the protection of animal health. Disease prevention is the most effective method for maintaining a healthy animal population and for enhancing the U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS), Veterinary Services' ability to allow United States animal producers to compete in the world market of animal and animal product trade APHIS currently has regulations in place that restrict the importation of poultry meat and other poultry products from Mexico due to the presence of Newcastle Disease (ND) in that country. However, APHIS allows the importation of poultry meat and poultry products from the Mexican States of Sinaloa and Sonora because APHIS has determined that poultry meat and products from these two Mexican States pose a negligible risk of introducing ND into the United States. To ensure that these items are safe for importation, APHIS requires that certain data appear on the foreign meat inspection certificate that accompanies the poultry meat and other poultry products from Sinaloa and Sonora to the United States. APHIS also requires that serial numbered seals be applied to containers carrying the poultry meat and other poultry products.

    Need and Use of the Information: APHIS will collect information to certify that the poultry meat or other poultry products were (1) derived from poultry born and raised in commercial breeding establishments in Sinaloa and Sonora; (2) derived from poultry that were slaughtered in Sinaloa or Sonora in a Federally-inspected slaughter plant approved to export these commodities to the United States in accordance with Food Safety & Inspection regulations; (3) processed at a Federally inspected processing plant in Sinaloa or Sonora; and (4) kept out of contact with poultry from any other State within Mexico. APHIS will also collect information to ensure that the poultry meat or poultry products from Sinaloa and Sonora pose the most negligible risk possible for introducing ND into the United States.

    Description of Respondents: Business or other for-profit; Federal Government.

    Number of Respondents: 386.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 386.

    Animal and Plant Health Inspection Service

    Title: Importation of Fresh Pitaya Fruit from Central America into the Continental United States.

    OMB Control Number: 0579-0378.

    Summary of Collection: Under the Plant Protection Act (7 U.S.C. 7701-7772), the Secretary of Agriculture is authorized to carry out operations or measures to detect, eradicate, suppress, control, prevent, or retard the spread of plant pests new to the United States or not known to be widely distributed throughout the United States. The regulations “Subpart-Fruit and Vegetables” (7 CFR 319.56-1 through 319 56-71), prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests that are not widely distributed within the United States. The Animal and Plant Health Inspection Service (APHIS) allows the importation of fresh pitaya fruit from Central America into the continental United States.

    Need and Use of the Information: The Animal and Plant Health Inspection Service uses the following activities to collect information: Production Site Certification, Review and Maintain Documents, Registration of Packinghouses, Bilateral Workplan, Records of Fruit Fly Detections and Update Records, Shipping Documents Identifying the Places of Production, Phytosanitary Certificate with Additional Declaration, Production Site Registration, and Box Markings. If the information is not collected, APHIS' ability to protect the United States from exotic insect pest would be severely compromised.

    Description of Respondents: Business or other for-profit; Federal Government.

    Number of Respondents: 97.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 287.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2015-03912 Filed 2-24-15; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request February 19, 2015.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by March 27, 2015 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street, NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Animal & Plant Health Inspection Service

    Title: National Poultry Improvement Plan (NPIP).

    OMB Control Number: 0579-0007.

    Summary of Collection: Under the Animal Health Protection Act (7 U.S.C. 8301 et.seq.), the Animal and Plant Health Inspection Service (APHIS) is authorized to among other things, administer the National Poultry Improvement Plan (NPIP or the Plan), the primary purpose of which is to protect the health of the U.S. poultry population. NPIP is a voluntary Federal-State-industry cooperative program for the improvement of poultry flocks and products through disease control techniques. The NPIP regulations are contained in 9 CFR parts 56, 145, 146 and 147.

    Need and Use of the Information: APHIS will collect information using several forms to continually improve the health of the U.S. poultry population and the quality of U.S. poultry products. If the information were collected less frequently or not collected, APHIS could not affectively monitor the health of the nation's poultry population.

    Description of Respondents: Business or other for-profit; State, Local or Tribal Government.

    Number of Respondents: 18,097.

    Frequency of Responses: Recordkeeping; Reporting: On occasion.

    Total Burden Hours: 104,311.

    Animal and Plant Health Inspection Service

    Title: Control of Chronic Wasting Disease.

    OMB Control Number: 0579-0189.

    Summary of Collection: The Animal Health Protection Act (AHPA) of 2002 is the primary Federal law governing the protection of animal health. The law gives the Secretary of Agriculture broad authority to detect, control, and eradicate pests or diseases of livestock or poultry, and to pay claims arising from destruction of animals. Disease prevention is the most effective method for maintaining a healthy animal population and enhancing the Animal and Plant Health Inspection Service (APHIS) ability to complete in exporting animals and animal products. Chronic wasting disease (CWD) is a transmissible spongiform encephalopathy (TSE) of elk, deer and moose typified by chronic weight loss leading to death. The presence of CWD disease in cervids causes significant economic and market losses to U.S. producers. In an effort to accelerate the control and limit the spread of this disease in the United States, APHIS created a cooperative, voluntary Federal-State-private sector CWD Herd Certification Program designed to identify farmed or captive herds infected with CWD and provided for the management of these herds in a way that reduces the risk of spreading CWD. APHIS is combining 0579-0237 into this information collection (0579-0189) and will retire 0579-0237 upon the approval of this renewal of 0579-0189.

    Need and Use of the Information: APHIS will collect information from owners of elk, deer, and moose herds who choose to participate in the CWD Herd Certification program. They would need to follow program requirements for animal identification, testing, herd management, and movement of animals into and from herds. APHIS also established requirements for the interstate movement of cervids to prevent movement of elk, deer, and moose that pose a risk of spreading CWD. Carrying out this program will entail the use of several information collection activities: Memoranda of understandings; participation requests/applications; sample collections and lab submissions; herd records; cervid identification; reports of cervid disappearances, escapes, and deaths; herd plans; annual reports; consistent State reviews; epidemiological investigations; appraisal, destruction, and payment of indemnity; letter to appeal suspension; Interstate Certificates of Veterinary Inspection (ICVI); and wild cervid ICVI, and surveillance data. Failure to collect this information would cripple APHIS' ability to effectively sustain its CWD control program.

    Description of Respondents: Business or other for-profit; State, Local or Tribal Government.

    Number of Respondents: 5,735.

    Frequency of Responses: Reporting and Recordkeeping: On occasion.

    Total Burden Hours: 383,383.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2015-03907 Filed 2-24-15; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Food and Nutrition Service Request for Information: Software Vendors of State and Local Management Information Systems (MIS) and Other Technology Solutions for the National School Lunch and School Breakfast Programs AGENCY:

    Food and Nutrition Service (FNS), USDA.

    ACTION:

    Notice; request for information.

    SUMMARY:

    This is a request for information from Management Information Systems (MIS) software and hardware vendors and developers (“vendors”) to learn about the functionality of State and School Food Authority National School Lunch and School Breakfast Program (NSLP/SBP) data management information systems. It is not a request for proposal and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the Government and will not be returned. All responses will become part of the public record and will not be held confidential.

    The United States Department of Agriculture (USDA) is seeking information that will inform future data reporting requirements for the Department's oversight and management of NSLP/SBP. The Department is aware that all States and many school districts have installed and implemented MIS or other technology solutions to improve State and local program management. To better understand the availability and implementation of these solutions, USDA is requesting information from vendors about NSLP/SBP data systems they offer and have deployed at the State and local levels.

    The objectives of this request for information (RFI) are to:

    1. Obtain background data to inform later research on State and School Food Authority (SFA) NSLP/SBP data management information systems.

    2. Describe the functionality and capabilities of systems currently in use by State agencies and SFAs, or available to States and SFA for purchase.

    3. Describe the typical costs of system development, installation, maintenance, and upgrades.

    4. Identify which States and SFAs are using particular systems.

    DATES:

    To be assured of consideration, written comments must be submitted or postmarked on or before April 27, 2015.

    ADDRESSES:

    The Food and Nutrition Service, USDA, invites the submission of the requested information through one of the following methods:

    Preferred Method: Submit information through the Federal eRulemaking Portal at http://www.regulations.gov. Follow the online instructions for submissions.

    Mail: Submissions should be addressed to Dennis Ranalli, Social Science Policy Analyst, Office of Policy Support, FNS, U.S. Department of Agriculture, 3101 Park Center Drive, Room 1014, Alexandria, VA 22302.

    • Comments may also be emailed to [email protected]

    All information properly and timely submitted, using one of the three methods described above, in response to this request for information will be included in the record and will be made available to the public on the Internet at http://www.regulations.gov. Please be advised that the substance of the information provided and the identity of the individuals or entities submitting it will be subject to public disclosure.

    All written comments will be open for public inspection at the FNS office located at 3101 Park Center Drive, Alexandria, Virginia, 22302, Room 1014, during regular business hours (8:30 a.m. to 5:00 p.m., Monday through Friday). All responses to this notice will be summarized and included in the request for Office of Management and Budget (OMB) approval. All comments will be a matter of public record.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of this request for information should be directed to Dennis Ranalli at [email protected]

    SUPPLEMENTARY INFORMATION:

    The current Food and Nutrition Service (FNS) routine data collection requirements for the National School Lunch Program and School Breakfast Program (NSLP/SBP) have their roots in the paper and early computer eras and reflect concerns with paperwork and reporting burden. Thus, data collected to administer and monitor these programs is typically reported at the State level, with detailed data collected at the service delivery point (e.g., individual meal transactions, school) often aggregated at one or more levels (e.g., school to SFA to State-level) before being submitted to FNS. Data aggregation results in a significant loss of potentially valuable information that could support administration, monitoring, and policy development.

    FNS recognizes that, in fact, managing a school food service program is a complex and data intensive operation, and that SFAs collect, generate, and maintain far more data than they report to their State child nutrition agencies. This includes data on costs, revenues, inventories, vendor management, and other business, administrative and regulatory activity. The same is true of State agencies that are responsible for monitoring the work of many SFAs. Some States and SFAs have developed more sophisticated data management systems to manage program data, however there is no comprehensive inventory of NSLP/SBP management information systems (MIS) in use, the number of States and SFAs that use MIS, or the data elements collected to support FNS reporting and general program management.

    The Review of Child Nutrition Data and Analysis for Program Management project will fill this knowledge gap by fully documenting SFA and State NSLP/SBP management information systems. This baseline “as is” review will document overall NSLP/SBP information system design, capabilities, functions, development/replacement and maintenance costs, and typical lifespan. The “as is” review is focusing particular attention on NSLP/SBP program management data that are collected or generated at the SFA or State agency levels, but are not required to be reported to FNS on any FNS program report forms. Findings from the RFI and additional review activities will provide a baseline for potential improvements to data collection practices and help support future MIS modernization and paperwork reduction efforts. They will also help identify promising and emerging practices and define models for MIS at both the state and local SFA levels.

    FNS requests that vendors respond in detail to the items below. Vendors are encouraged to provide any material that addresses the information requested or any other information that may be pertinent. Additional references or links to materials are welcome.

    I. Vendor Information

    a. Name of Company

    b. Address and Telephone Number

    c. Vendor Representative, contact number and email address

    II. Vendor Overview & Experience

    Briefly describe your company, your products and services, history, and ownership; for example:

    a. Web site address

    b. Main product/services

    c. Main market/customers

    d. Company location(s)

    e. Product deployment sites/school systems

    1. Number of School District/schools currently deployed

    2. Average/typical size of the school system

    3. Year of first deployment

    4. Years serving schools

    III. Product Information

    a. List and describe the core modules provided by your product. For example:

    1. Point of Sale/Service (POS)

    2. Prepayment system(s) for parents

    3. Nutrient Analysis and Menu Planning

    4. Inventory Management

    5. Purchasing/Vendor Management

    6. Production Records

    7. Financial Management

    8. Free and Reduced-Price Meals Applications

    • Scanning paper applications

    • Processing On-line applications

    • Making eligibility determinations

    • Creating benefit issuance documents

    • Conducting verification

    9. Direct Certification

    • SNAP recipients

    • Extended SNAP household members

    • Other direct certification—homeless, migrant, foster

    10. Meal counting and claiming

    11. Administrative Review

    12. Reporting

    13. Any other not listed above

    b. Describe the capabilities and reporting functionalities of your product.

    c. Describe your platform—site-based, central office w/satellite, cloud-based, etc.

    d. For SFAs, are POS terminals proprietary or third-party?

    e. Is your system a commercial off the shelf (COTS) product with application in multiple industry segments or school nutrition specific?

    f. Does your firm rely on any `third party software products/systems' for implementation and/or operation?

    g. Are any additional licenses required from `third party sources' to utilize your product?

    h. What is your product's ability to interface with other vendor systems? What level of customization is available?

    i. List the minimum and recommended hardware requirements to implement and utilize your product at each level of installation.

    j. Describe the interface capabilities between your product and various within-district student data base systems.

    k. Describe the interface capabilities between your product and State agency systems.

    l. Does your system adhere to Schools Interoperability Framework (SIF) standards?

    m. Please provide a list of data elements captured/stored by your product. For example:

    1. Name of the data element

    2. Description of the data element

    3. Possible values

    n. Describe the processes/procedures/steps associated with planning, installation, setup, data import and conversion, data migration, quality assurance, deployment, and roll-out for your product.

    IV. Customer Support, Maintenance and Security

    a. Describe your model for providing customer support, including charge/cost structure (e.g., hours of support, levels of support).

    b. Describe your incident reporting and tracking systems, and the ability for customer staff to access those systems directly.

    c. List the types of support access that are available (web, email, chat, telephone etc.).

    d. Describe the communication and escalation processes/protocols in the event of failure, network outages, degraded service, and/or exceeded planned utilization.

    e. Describe your replication, archival and retrieval processes, including your disaster recovery model.

    f. Describe the warranty and maintenance plan(s) for your product. Have there been recent upgrades or updates to your product? How often do you typically develop and release upgrades?

    g. Is your support agreement integrated into the license agreement?

    h. Describe your understanding and system approach to privacy rules, specifically those related to children and students (Children's Online Privacy Protection Act, Family Educational Rights and Privacy Act, etc.).

    i. Describe your process for upgrading your product to meet federal and state regulations.

    j. Does your product support access through smartphones, tablets, laptops etc.?

    V. Pricing

    a. Describe your pricing models relevant to each component of your product.

    b. Is your pricing model based on purchasing the entire product or individual module(s), or is it based on usage/users?

    c. Describe the upgrade process and cost to upgrade.

    d. List any additional pricing/cost information that would be useful to evaluate the affordability of the product.

    VI. Training

    a. What type of technical training do you provide?

    b. Describe your product's documentation and in-program help?

    Dated: February 11, 2015. Audrey Rowe, Administrator, Food and Nutrition Service.
    [FR Doc. 2015-03848 Filed 2-24-15; 8:45 am] BILLING CODE 3410-30-P
    DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2015-0007] Codex Alimentarius Commission: Meeting of the Codex Committee on General Principles AGENCY:

    Office of the Under Secretary for Food Safety, USDA.

    ACTION:

    Notice of public meeting and request for comments.

    SUMMARY:

    The Office of the Under Secretary for Food Safety, U.S. Department of Agriculture (USDA) is sponsoring a public meeting on February 25, 2015. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 29th Session of the Codex Committee on General Principles (CCGP) of the Codex Alimentarius Commission (Codex), which will take place in Paris, France, March 9-13,2015. The Deputy Under Secretary for Food Safety recognizes the importance of providing interested parties the opportunity to obtain background information on the 29th Session of CCGP and to address items on the agenda.

    DATES:

    The public meeting is scheduled for Wednesday, February 25, 2014 from 1-4 p.m.

    ADDRESSES:

    The public meeting will take place at the South Building, United States Department of Agriculture (USDA), 1400 Independence Ave SW., Room 1160, Washington, DC 20250. Documents related to the 29th Session of CCGP will be accessible on-line at the following address: http://www.codexalimentarius.org/meetings-reports/en/.

    Mary Frances Lowe, U.S. Delegate to the 29th Session of CCGP, invites interested U.S. parties to submit their comments electronically to the following email address: [email protected]

    Call-In Number

    If you wish to participate in the public meeting for the 29th Session of CCGP by conference call on February 25, 2015, please use the call-in number and participant code listed below:

    Call-in Number: 1 (888) 844-9904

    Participant code: 5126092

    Registration

    Attendees may register by emailing [email protected] by February 24, 2015. Early registration is encouraged because it will expedite entry into the building. The meeting will be held in a Federal building. Attendees should also bring photo identification and plan for adequate time to pass through security screening systems. Those who are not able to attend the meeting in-person, but wish to participate may do so by phone.

    FOR FURTHER INFORMATION CONTACT:

    For Further Information About the 29th Session of CCGP Contact: Mary Frances Lowe, U.S. Codex Office, 1400 Independence Avenue, Room 4861, Washington, DC 20250, Phone: (202) 205-7760, Fax: (202) 720-3157, Email: [email protected]

    For Further Information About the Public Meeting Contact: Barbara McNiff, U.S. Codex Office, 1400 Independence Avenue, Room 4861, Washington, DC 20250. Phone: (202) 205-7760, Fax: (202) 720-3157, Email: [email protected] .

    SUPPLEMENTARY INFORMATION: Background

    Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.

    The CCGP is responsible for dealing with procedural and general matters referred to it by Codex, for proposing amendments to the Codex Procedural Manual, and for reviewing and endorsing procedural provisions and texts forwarded by Codex Committees for inclusion in the Procedural Manual.

    The Committee is hosted by France.

    Issues To Be Discussed at the Public Meeting

    The following items on the agenda for the 29th Session of CCGP will be discussed during the public meeting:

    • Matters Referred to the Committee

    • Proposed amendments to the Terms of Reference of CCGP

    • Proposed amendments to the Procedures for the Elaboration of Codex Standards and Related Texts

    • Consistency of the Risk Analysis Texts across the Relevant Committees

    • Codex Work Management and Functioning of the Executive Committee

    • Other Business

    Each issue listed will be fully described in documents distributed, or to be distributed, by the Secretariat prior to the Committee meeting. Members of the public may access or request copies of these documents (see ADDRESSES).

    Public Meeting

    At the February 25, 2015, public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to Mary Frances Lowe, U.S. Delegate for the 29th Session of CCGP (see ADDRESSES). Written comments should state that they relate to activities of the 29th Session of CCGP.

    Additional Public Notification

    Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS Web page located at: http://www.fsis.usda.gov/federal-register.

    FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Update is available on the FSIS Web page. Through the Web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

    USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.

    How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which is available accessed on-line at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized representative. Send your completed complaint form or letter to USDA by mail, fax, or email:

    Mail

    U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.

    Fax

    (202) 690-7442.

    Email

    [email protected]

    Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

    Dated: February 19, 2015. Marie Maratos, Acting U.S. Manager for Codex Alimentarius.
    [FR Doc. 2015-03800 Filed 2-24-15; 8:45 am] BILLING CODE 3410-DM-P
    DEPARTMENT OF AGRICULTURE Forest Service Notice of Proposed New Fee Site; Federal Lands Recreation Enhancement Act AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of proposed fee increase on Christmas tree permits.

    SUMMARY:

    The Sawtooth National Forest is proposing to increase the fee for Christmas tree permits from $5.00 to $10.00 per tag. The fee is proposed and will be determined upon further analysis and public comment. Funds from fees would be used for the continued operation, visitor services, maps, and law enforcement while issuing and enforcing Christmas tree permits.

    DATES:

    Comments will be accepted through May 30, 2015. Increased fees would begin November 2015 for Christmas tree permits.

    ADDRESSES:

    Kit Mullen, Forest Supervisor, Sawtooth National Forest, 2647 Kimberly Road East, Twin Falls, Idaho 83301.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Blake, Recreation Fee Coordinator, by phone at 208-737-3216 or via email at [email protected] Information about proposed fee changes can also be found on the Sawtooth National Forest Web site: http://www.fs.usda.gov/sawtooth.

    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 Federal Recreation Lands Enhancement Act (Title VII, Pub. L. 108-447) directed the Secretary of Agriculture to publish a six month advance notice in the Federal Register whenever new recreation fee areas are established.

    Once public involvement is complete, the fee increases will be reviewed by a Recreation Resource Advisory Committee prior to a final decision and implementation.

    Dated: February 18, 2015. Jennifer Blake, Acting Forest Supervisor.
    [FR Doc. 2015-03725 Filed 2-24-15; 8:45 am] BILLING CODE 3410-11-P
    DEPARTMENT OF COMMERCE Submission for OMB Review; Comment Request

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

    Agency: National Institute of Standards and Technology, Commerce.

    Title: Summer High School Intern Program (SHIP).

    OMB Control Number: 0693-XXXX.

    Form Number(s): None.

    Type of Request: Regular Submission (new collection).

    Number of Respondents: 350.

    Average Hours per Response: 8.

    Burden Hours: 2,800.

    Needs and Uses: The Summer High School Intern Program (SHIP) is a NIST-wide 8-week summer intern program for students who will have finished their junior or senior year of high school by the start of the program, are U.S. citizens, and are interested in scientific research. Students selected for this competitive volunteer program will participate in cutting-edge research at NIST, and will work closely with NIST staff scientists and engineers on a specific research problem.

    The first round of the application process is completed via an on-line application through the Student Information System which collects basic biographical information about the student. This information is reviewed and finalists are invited to submit secondary materials via email to [email protected] These secondary materials include a resume, transcript, letters of recommendation, personal statement, and parental consent and commitment form.

    Affected Public: Individuals or households; local government (public schools).

    Frequency: Once a year.

    Respondent's Obligation: Voluntary.

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

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

    Dated: February 20, 2015. Glenna Mickelson, Management Analyst, Office of the Chief Information Officer.
    [FR Doc. 2015-03870 Filed 2-24-15; 8:45 am] BILLING CODE 3510-DT-P
    DEPARTMENT OF COMMERCE Submission for OMB Review; Comment Request

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

    Agency: National Institute of Standards and Technology (NIST).

    Title: NIST Three-Year Generic Request for Customer Service—Related Data Collections.

    OMB Control Number: 0693-0031.

    Form Number(s): None.

    Type of Request: Regular submission.

    Number of Respondents: 90,000.

    Average Hours Per Response: Less than 2 minutes for a response card; 2 hours for focus group participation. The estimated response time is expected to be less than 30 minutes.

    Burden Hours: 15,000.

    Needs and Uses: NIST conducts surveys, focus groups, and other customer satisfaction/service data collections. The collected information is needed and will be used to determine the kind and the quality of products, services, and information our key customers want and expect, as well as their satisfaction with and awareness or existing products, services, and information.

    Affected Public: Business or other for-profit organizations, individuals or households, not-for-profit institutions.

    Frequency: On occasion.

    Respondent's Obligation: Voluntary, providing the requested information is necessary to obtain accurate information regarding customer satisfaction with NIST products, services and information.

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

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

    Dated: February 19, 2015. Glenna Mickelson, Management Analyst, Office of the Chief Information Officer.
    [FR Doc. 2015-03824 Filed 2-24-15; 8:45 am] BILLING CODE 3510-13-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-76-2014] Foreign-Trade Zone 45—Portland, Oregon; Revision to Production Authority; Epson Portland, Inc., Subzone 45F; (Inkjet Cartridges and Bulk Ink); Hillsboro, Oregon

    On October 20, 2014, Epson Portland, Inc. (EPI) submitted a notification of proposed revision to existing production authority to the Foreign-Trade Zones (FTZ) Board for EPI's facility in Hillsboro, Oregon, within Subzone 45F.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (79 FR 64168-64169, 10-28-2014). The FTZ Board has determined that no further review of the proposed revision to the scope of production authority is warranted at this time. The proposed revision described in the notification is authorized, subject to the FTZ Act and the Board's regulations, including Section 400.14.

    Dated: February 19, 2015. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2015-03895 Filed 2-24-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-583-837] Polyethylene Terephthalate Film, Sheet, and Strip From Taiwan: Final Results of Antidumping Duty Administrative Review; 2012-2013 AGENCY:

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

    SUMMARY:

    On August 21, 2014, the Department of Commerce (“the Department”) published its preliminary results of the administrative review of the antidumping duty order on polyethylene terephthalate film, sheet, and strip (PET film) from Taiwan.1 Based upon our analysis of the comments received, we have made no changes to the margin calculations for these final results and continue to determine that Nan Ya Plastics Corporation (“Nan Ya”) made sales of subject merchandise to the United States at below normal value. The final dumping margin is listed below in the “Final Results of Review” section of this notice.

    1See Polyethylene Terephthalate Film, Sheet, and Strip From Taiwan: Preliminary Results of Antidumping Duty Administrative Review; 2012-2013, 79 FR 49496 (August 21, 2014) (“Preliminary Results”).

    DATED:

    Effective Date: February 25, 2015.2

    2 Due to the closure of the Federal Government in Washington, DC on February 17, 2015, the Department reached this determination on the next business day (i.e., February 18, 2015). See Notice of Clarification: Application of “Next Business Day” Rule for Administrative Determination Deadlines Pursuant to the Tariff Act of 1930, As Amended, 70 FR 24533 (May 10, 2005).

    FOR FURTHER INFORMATION CONTACT:

    Milton Koch or Toni Page at (202) 482-2584, or (202) 482-1398, respectively; AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.

    SUPPLEMENTARY INFORMATION:

    Background

    On August 21, 2014, the Department published the Preliminary Results of this administrative review. The administrative review covers one producer and exporter of the subject merchandise to the United States, Nan Ya. On January 8, 2014, the Department published a notice rescinding the review with respect to Shinkong Materials Technology Corporation.3 The period of review (POR) is July 1, 2012, through June 30, 2013. We invited parties to comment on the Preliminary Results. Nan Ya timely filed a case brief on September 29, 2014; however, the Department rejected the case brief for containing new factual information. Nan Ya resubmitted its case brief on October 14, 2014. Petitioners timely filed a rebuttal brief on October 21, 2014.

    3See Polyethylene Terephthalate Film From Taiwan: Partial Rescission of Antidumping Duty Administrative Review; 2012-2013, 79 FR 1362 (January 8, 2014).

    Scope of the Order

    The products covered by the antidumping duty order are all gauges of raw, pretreated, or primed polyethylene terephthalate film, sheet, and strip, whether extruded or coextruded. Excluded are metalized films and other finished films that have had at least one of their surfaces modified by the application of a performance-enhancing resinous or inorganic layer of more than 0.00001 inches thick. Imports of polyethylene terephthalate film, sheet, and strip are currently classifiable in the Harmonized Tariff Schedule of the United States (“HTSUS”) under item number 3920.62.00.90. HTSUS subheadings are provided for convenience and customs purposes. The written description of the scope of the antidumping duty order is dispositive.

    Analysis of Comments Received

    The sole issue raised in the case and rebuttal briefs by parties regarding differential pricing methodology is addressed in the Issues and Decision Memorandum, which is dated concurrently with these final results and incorporated herein by reference.4 The Issues and Decision Memorandum is a public document and is on file in the Central Records Unit (“CRU”), Room 7046 of the main Department of Commerce building, as well as 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 in the CRU. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the internet at http://www.trade.gov/enforcement. The signed Issues and Decision Memorandum and the electronic versions of the Issues and Decision Memorandum are identical in content.

    4See Memorandum to Paul Piquado, Assistant Secretary for Enforcement and Compliance, “Decision Memorandum for Final Results of Antidumping Duty Administrative Review: Polyethylene Terephthalate Film, Sheet, and Strip from Taiwan; 2012-2013,” dated February 18, 2015 (Issues and Decision Memorandum).

    Changes Since the Preliminary Results

    Based on our analysis of the comments received, we have made no adjustments to the margin calculations for Nan Ya.

    Final Results of Review

    We determine that Nan Ya's weighted-average dumping margin is 1.56 percent for entries of subject merchandise that were produced and/or exported by Nan Ya and that entered, or were withdrawn from warehouse, for consumption during the period July 1, 2012, through June 30, 2013.

    Assessment Rates

    The Department shall determine, and U.S. Customs and Border Protection (“CBP”) shall assess, antidumping duties on all appropriate entries. The Department intends to issue assessment instructions to CBP 15 days after the date of publication of the final results of this review. For any individually examined respondents whose weighted-average dumping margin is above de minimis (i.e., 0.5 percent) in the final results, we will calculate importer-specific ad valorem duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those sales in accordance with 19 CFR 351.212(b)(1). We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review when the importer-specific assessment rate calculated in the final results of this review is above de minimis. Where either the respondent's weighted average dumping margin is zero or below de minimis or an importer-specific assessment rate is zero or below de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. The Department clarified its “automatic assessment” regulation on May 6, 2003.5 This clarification will apply to entries of subject merchandise during the POR produced by each respondent for which they did not know that their merchandise was destined for the United States. In such instances, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.6

    5See Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003) (“Assessment Policy Notice”).

    6 For a full discussion of this clarification, see Assessment Policy Notice.

    Cash Deposit Requirements

    The following deposit requirements will be effective for all shipments of PET film from Taiwan entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review, as provided for by section 751(a)(2)(C) of the Tariff Act of 1930, as amended (“the Act”): (1) The cash deposit rate for Nan Ya will be the rate established in the final results of this 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 the less-than-fair-value 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) if neither the exporter nor the manufacturer is a firm covered in this or any previous review, the cash deposit rate will be the all others rate for this proceeding, 2.40 percent, as established in the less-than-fair-value investigation.7 These deposit requirements, when imposed, shall remain in effect until further notice.

    7See Notice of Amended Final Antidumping Duty Determination of Sales at Less Than Fair Value and Antidumping Duty Order: Polyethylene Terephthalate Film, Sheet, and Strip (PET Film) From Taiwan, 67 FR 44174 (July 1, 2002), as corrected in Notice of Amended Final Determination of Sales at Less Than Fair Value and Antidumping Duty Order: Polyethylene Terephthalate Film, Sheet, and Strip (PET Film) from Taiwan, 67 FR 46566 (July 15, 2002).

    Disclosure

    We will disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).

    Notification Regarding Administrative Protective Orders

    This notice is the only reminder to parties subject to the administrative protective order (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under the APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

    Notification to Importers

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

    These final results of administrative review and notice are published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h).

    Dated: February 18, 2015. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2015-03897 Filed 2-24-15; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [Application No. 99-8A005] Export Trade Certificate of Review ACTION:

    Notice of Application to Amend the Export Trade Certificate of Review Issued to California Almond Export Association, LLC (“CAEA”), Application No. (99-8A005).

    SUMMARY:

    The Office of Trade and Economic Analysis (“OTEA”) of the International Trade Administration, Department of Commerce, has received an application to amend an Export Trade Certificate of Review (“Certificate”). This notice summarizes the proposed amendment and requests comments relevant to whether the amended Certificate should be issued.

    FOR FURTHER INFORMATION CONTACT:

    Joseph Flynn, Director, Office of Trade and Economic Analysis, International Trade Administration, (202) 482-5131 (this is not a toll-free number) or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Title III of the Export Trading Company Act of 1982 (15 U.S.C. Sections 4001-21) (“the Act”) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. The regulations implementing Title III are found at 15 CFR part 325 (2014). Section 302(b)(1) of the Export Trade Company Act of 1982 and 15 CFR 325.6(a) require the Secretary to publish a notice in the Federal Register identifying the applicant and summarizing its application. Under 15 CFR 325.6(a), interested parties may, within twenty days after the date of this notice, submit written comments to the Secretary on the application.

    Request for Public Comments

    Interested parties may submit written comments relevant to the determination whether an amended Certificate should be issued. If the comments include any privileged or confidential business information, it must be clearly marked and a nonconfidential version of the comments (identified as such) should be included. Any comments not marked as privileged or confidential business information will be deemed to be nonconfidential.

    An original and five (5) copies, plus two (2) copies of the nonconfidential version, should be submitted no later than 20 days after the date of this notice to: Export Trading Company Affairs, International Trade Administration, U.S. Department of Commerce, Room 21028, Washington, DC 20230.

    Information submitted by any person is exempt from disclosure under the Freedom of Information Act (5 U.S.C. 552). However, nonconfidential versions of the comments will be made available to the applicant if necessary for determining whether or not to issue the amended Certificate. Comments should refer to this application as “Export Trade Certificate of Review, application number 99-8A005.”

    Summary of the Application

    Applicant: California Almond Export Association, LLC (“CAEA”), 4800 Sisk Road Modesto, CA 95356.

    Contact: Bill Morecraft, Chairman, Telephone: (916) 446-8537.

    Application No.: 99-8A005.

    Date Deemed Submitted: February 6, 2014.

    Proposed Amendment: CAEA seeks to amend its Certificate to delete the following company as a Member of CAEA's Certificate: Minturn Nut Company, Inc., Le Grand, CA.

    CAEA's proposed amendment of its Export Trade Certificate of Review would result in the following companies as Members under the Certificate: Almonds California Pride, Inc., Caruthers, CA, Baldwin-Minkler Farms, Orland, CA, Blue Diamond Growers, Sacramento, CA, Campos Brothers, Caruthers, CA, Chico Nut Company, Chico, CA, Del Rio Nut Company, Inc., Livingston, CA, Fair Trade Corner, Inc., Chico, CA, Fisher Nut Company, Modesto, CA, Hilltop Ranch, Inc., Ballico, CA, Hughson Nut, Inc., Hughson, CA, Mariani Nut Company, Winters, CA, Nutco, LLC d.b.a. Spycher Brothers, Turlock, CA, Paramount Farms, Inc., Los Angeles, CA, P-R Farms, Inc., Clovis, CA, Roche Brothers International Family Nut Co., Escalon, CA, South Valley Almond Company, LLC, Wasco, CA, Sunny Gem, LLC, Wasco, CA, Western Nut Company, Chico, CA.

    Dated: February 19, 2015. Joseph Flynn, Director, Office of Trade and Economic Analysis, International Trade Administration.
    [FR Doc. 2015-03784 Filed 2-24-15; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE International Trade Administration Trade Mission to South Africa, Kenya and Mozambique AGENCY:

    International Trade Administration, Department of Commerce.

    ACTION:

    Replacement of Trade Mission Statement.

    SUMMARY:

    The United States Department of Commerce, International Trade Administration is replacing a notice published June 14, 2014, at 79 FR 36290, for the Trade Mission to South Africa and Mozambique, With an Optional Stop in Kenya; February 23-27, 2015.

    SUPPLEMENTARY INFORMATION:

    Replacement of Trade Mission Statement.

    Background

    The United States Department of Commerce, International Trade Administration is replacing its Trade Mission to South Africa and Mozambique, With an Optional Stop in Kenya; February 23-27, 2015 with a new trade mission as notified herein. Replacement.

    Trade Mission to Mozambique, Kenya and South Africa June 18-26, 2015 Mission Description

    The U. S. Department of Commerce, International Trade Administration, is organizing a Trade Mission to Mozambique, Kenya and South Africa, June 18-26, 2015, which will be led by a senior executive of the U.S. Department of Transportation. The mission is designed to help U.S. firms find business partners and sell equipment and services. Target sectors holding high potential for U.S exporters include:

    Transportation Infrastructure and Equipment, such as: road, bridge and dam construction and reconstruction; automatic fare collection systems, new and refurbished railroad locomotives, new bulk car and other dedicated rolling freight fleets, smart signaling and rail operation automation, rolling stock depot design, strategic route design and network planning, port mobile, weighbridges and quayside systems and upgrading of existing port equipment and oil and gas development infrastructure.

    Energy Equipment and Services, such as: power generation (including renewable energy); transmission and distribution (including smart grid), energy efficiency, oil and gas exploration and production and project development.

    Agricultural Equipment, such as: crop production equipment and machinery, irrigation equipment and technology, crop storage and handling, precision farming technologies and fertilizers.

    Although focused on the sectors above, the mission also will consider participation from companies in other appropriate sectors as space permits.

    This trade mission will include one-on-one business appointments with pre-screened potential buyers, agents, distributors and joint venture partners; meetings with national and regional government officials, chambers of commerce, and business groups; and networking receptions. The mission will help participating firms and trade associations gain market insights, make industry contacts, solidify business strategies, and advance specific projects, with the goal of increasing U.S. exports to Mozambique, Kenya and South Africa.

    Commercial Setting

    Mozambique, with a population of 23 million, grew its economy from 1994 to 2009 at an average rate of eight percent per year—one of the fastest rates of growth of any sub-Saharan African economy over this period. In 2013, GDP reached $15 billion. While the country was devastated after the civil war ended in 1992, it has since benefited from macroeconomic reforms and large foreign investment projects.

    Though infrastructure remains weak and the population is still largely rural, the government is committed to building a strong commercial environment. The United States has traditionally been a relatively minor trading partner, but U.S. investment in the energy sector, particularly off-shore natural gas, is expected to grow tremendously in the next several years. External competition, local labor quotas, periodic flooding, and an often-contentious political situation present some challenges to doing business in Mozambique.

    Kenya, with a population of 43 million, is the dominant economy in the East African Community. Given its position as the economic, commercial, and logistical hub of East Africa, more U.S. companies are investing in Kenya and setting up local and regional operations there. Kenya's first election under a new constitution with a devolved government structure was held in April 2013, and should position it for further growth. Investor confidence is high, as demonstrated by Kenya's record-breaking $2 billion debut sovereign bond offering in 2014.

    Kenya also boasts a large number of well-educated English-speaking and multi-lingual professionals, and a strong entrepreneurial tradition. Doing business in Kenya includes a number of challenges, such as crime, unemployment, limited infrastructure, and corruption.

    South Africa, a country of 52 million people, has the most advanced, broad-based industrial economy in Africa, enjoys relative macroeconomic stability and boasts sound financial, legal and accounting institutions; not to mention an English-speaking workforce. It remains the primary choice for U.S. companies wishing to develop the promising markets of sub-Saharan Africa, although it suffers from large disparities in income distribution and over 25 percent unemployment. In 2014 South Africa's GDP grew by less than two percent to $357 billion. Doing business in South Africa includes a number of challenges including corruption and power shortages, as well as a series of protectionist policies that has precipitated a series of downgrades by the major credit agencies.

    Best Prospects in Targeted Sectors Transportation Infrastructure and Equipment Mozambique

    Transport networks and infrastructure will be instrumental to developing Mozambique's growth potential in the near and long term. The recently concluded $500 million Millennium Challenge Corporation compact funded extensive rehabilitation of key roads, a dam, and a water supply project in two northern provinces. The Government of Mozambique is investing heavily in expanding rail and port capacity to manage the rising production of mineral resources. A rail line to the deepest natural port on the East Coast of Africa should significantly lower coal transport costs, and two foreign companies have recently been contracted to begin work on a new rail line ending at Macuze port. As total coal exports are projected to reach 40 million tons per year by 2015 and long term estimates are in the range of 100 million tons per year, infrastructure around this sector remains a priority. In addition, rapid investment in infrastructure to support planned liquefied natural gas (LNG) projects in northern Mozambique, one of its least developed regions, could bring vast opportunities to U.S. firms.

    Kenya

    Kenya enjoys an extensive, but uneven, infrastructure that is still superior in many cases to that of its neighbors. Nairobi is the undisputed transportation hub of Eastern and Central Africa and the largest city between Cairo and Johannesburg. The Port of Mombasa is the most important deep-water port in the region, supplying the shipping needs of more than a dozen countries despite persistent deficiencies in equipment, inefficiency and corruption. As a result of these deficiencies, the Port of Mombasa has been earmarked for major expansion and re-habilitation.

    Kenya's “Vision 2030” infrastructure development plans call for significant improvements to the provision of water, renewable energy, ICT, housing, roads, bridges, railways, seaports and airports over the next 20 years. The construction industry in Kenya is driven primarily by two key infrastructure sectors: Transportation and housing, given the large housing deficit that exists in Kenya. Construction and infrastructure development will also present new opportunities, especially with the passage of the new public-private partnership (PPP) law which will make government procurements more transparent and less risky.

    South Africa

    South Africa's Transnet, the largest State Owned Enterprise (SOE) within the Department of Public Enterprises (DPE) has announced and allocated funding for significant transportation infrastructure capital investments. In 2012, the government announced the allocation of funding for investments estimated at over $90 billion over 15 years. Though there have been complaints of slow implementation, leading some contractors to re-focus business elsewhere in the continent, in late 2013 and early 2014 commitments were made to procure passenger rolling stock, locomotives, signaling and track upgrades. Also, the development of the significant Durban phase 2 port extension (in the old Durban International Airport precinct) has been initiated.

    The Passenger Rail Agency of South Africa (Prasa) of the SA Department of Transport (SADOT) in March 2012 announced a 20-year rail improvement program estimated at more than $13.6 billion. Of this, $1.3 billion will be invested in signaling, new depots, modern stations and integrated ticketing, while $1.1 billion is being spent on new locomotives.

    SOE Transnet Freight Rail (TFR) and others are expanding logistics projects such as upgrading the Sishen-Saldanha Bay ore line, the Richard Bay coal line and other new coal line networks in the northwest. Transnet's rail and port projects are reportedly set to cost around $30 billion over seven years and include augmenting the tractive and bulk car fleet, signaling, maintenance, advanced train management systems and network expansion/concession models. For the second large diesel locomotive program of 465 units, one U.S. and one Chinese manufacturer were selected as preferred bidders in February 2014.

    Transnet Port Terminals (TPT), the port operating SOE is set to invest $3.3 billion over the next seven years for the expansion and improvement of its bulk and container terminals. Significant capacity-creating projects included the expansion of the Durban Container Terminal's (DCT's) Pier 1 that would increase its capacity from 700,000 twenty-foot equivalent units (TEUs) to 820,000 TEUs by 2013 and 1.2 million TEUs by 2016/17. Other expansion projects include the Ngqura Container Terminal, Durban Ro-Ro and Maydon Wharf terminal, the iron-ore bulk terminal at the Port of Saldanha and the ageing Richards Bay Terminal where $370 million is set aside for mobile and quayside equipment, as well as weighbridges.

    Energy Mozambique

    Mozambique is set to become one of the world's largest new suppliers of natural gas. The country's massive offshore discoveries have launched a scramble among exploration and production companies to develop these new-found resources. In early 2014, the Oil and Gas Journal raised Mozambique's proven reserves to 100 trillion cubic feet (Tcf), making it the third-largest proved natural gas holder in Africa. Although much of the Mozambique's offshore acreage still remains underexplored, one U.S. company already has announced recoverable finds totaling some 45-65 Tcf. The country's rich resources could support up to ten LNG trains in one province alone, and a floating LNG facility is under consideration. Developers focusing on Mozambique's LNG infrastructure expect to begin exporting as early as 2018. Additionally, although the United States exported only $25 million of oil and gas field equipment to Mozambique in 2013, this is up from $1 million only five years prior and comprises about 19 percent of the country's relatively small total of $132 million for that year. More than 80 percent of U.S. exports to Mozambique are in pipe products, indicating the early stages of the industry.

    Mozambique is a net exporter of energy. But in order to support its growing economy the country requires significant investment to upgrade old infrastructure and conclude new generation projects. The majority of power produced in the country comes from the Cahora Bassa hydro-power scheme in central Mozambique, where the government plans a multi-million dollar “North Bank” expansion. It will add an additional 1,250 MW with transmission lines to South Africa, the South African Power Pool, Maputo, and Northern Mozambique. Planning for a second multi-billion dollar, 1,500-plus MW hydropower dam 35 miles downstream at Mphanda Nkuwa is well underway, and the operators are expected to finalize financing this year, with commercial operations due to start as early as 2017. The government of Mozambique recently approved new renewable feed-in tariffs as part of an ongoing strategy to promote private investment in renewable energy sources.

    Kenya

    In response to strong economic growth and increasing demand for electricity, Kenya is focused on developing its power generation and transmission and distribution infrastructure. Today, Kenya is faced with brownouts, blackouts, and power surges that damage equipment and necessitate emergency power, driving up the cost of electricity. The supply deficit and costly short-term solutions impede economic growth, and reduce the competitiveness of Kenya's private sector in the region. With only 25 percent of the population connected to the grid, the Kenyan government is currently implementing a plan to connect an additional 5,000MW to the grid to meet growing demand and help reduce electricity tariffs by 40 percent by 2017, with a goal of achieving universal access by 2030.

    In ITA's Renewable Energy Top Markets for U.S.-Exports 2014-2015, Kenya was ranked 13th most promising export market for U.S. renewable energy companies, and first in the geothermal sector, which makes up about 22 percent of Kenya's energy mix (about 583 MW). More than 40 wells per year currently are being drilled, with a target of developing over 5,000 MW, approximately half of its capacity, in the next two decades. Kenya has extensive plans to increase other renewables as well. The country is gradually diversifying its energy mix and is keen to wean off expensive thermal diesel power, whose supply is impacted by recurring droughts; and thermal power, which is sensitive to global fuel prices.

    Kenya is also an increasingly promising player in the booming East Africa oil and gas market. The multiple onshore discoveries announced since 2012, largely in Turkana County, have led exploration and production companies to sound optimistic notes about the country's potential. The greatest enthusiasm surrounds offshore resources, where drillers hope to replicate Mozambique and Tanzania's vast natural gas discoveries. To date, Kenya's oil resources are estimated to be 600 million barrels, with at least one firm projecting that Kenya's resource base could amount to as much as 10 billion barrels, though exploration is still in the early stages. While movement on key planned infrastructure projects, such as the $25 billion Lamu Port, South Sudan Ethiopia, Transport (LAPSSET) Corridor, has been slow, if all goes smoothly, a Uganda-Kenya pipeline could be completed by as early as 2019.

    South Africa

    Electricity supply constraints are significant and are expected to remain a feature of South Africa's social and economic landscape for several years to come. ESKOM, the government owned power utility, with a virtual monopoly on generation, transmission and distribution (responsible for around 95 percent of local generation) is experiencing budgetary and infrastructure challenges. As a result of these challenges, the government has put a renewed focus on the increased generation of power, increased energy efficiency and decreased consumption. ESKOM's reserve of power has recently become so low that it has been forced to utilize its contractual rights with large industrial users to require them to reduce consumption at critical times, and it has implemented scheduled brownouts or “load-shedding” outages for all users. It has also been forced to use expensive diesel to power generators at peak load periods. Though there is current and planned infrastructure investment to ensure future supply, there have been significant delays in bringing these planned power generation facilities on line.

    ESKOM is currently investigating smart grid as an option to manage peak load demand. Renewable energy programs have also been introduced in order to facilitate clean renewable independent energy production. The government's Renewable Energy Independent Power Producer Procurement program (REIPPP) has been relatively successful and marks the first time independent power producers have been allowed to sell power back to the grid. In ITA's Renewable Energy Top Markets for U.S.-Exports 2014-2015, South Africa was ranked 12th; however, local content requirements, which have increased in recent months, may limit potential U.S. exports.

    Further capital expenditure is ongoing with the two large scale coal-fired plants under construction—Medupi Power Station (4,800 MW) and Kusile Power Station (4800 MW)—as well as a pumped storage project (1,332 MW) and a wind energy facility (1,00MW). With on-going power outages, the government of South Africa has also recently opened bids to independent power producers for the provision of 2,500 MW of base-load (coal) power.

    South Africa boasts the world's eighth largest supply of technically recoverable shale gas resources, according to the U.S. Department of Energy's Energy Information Administration. In 2012, the government lifted a moratorium on exploring the country's estimated 390 trillion cubic feet (tcf) of unconventional deposits. While licenses have yet to be issued, President Zuma announced in June 2014 that the government would proceed with shale gas development plans, indicating the government's willingness to move forward with development in the sector.

    South Africa has announced plans to add 9,600 MW of nuclear power over the next twenty years and the government is in talks with multiple countries about resources to develop South Africa's civil nuclear energy program. The country currently has two nuclear reactors that generate 5 percent of its electricity.

    Agricultural Equipment Mozambique

    Mozambique has vast needs and vast opportunities in the agriculture sector. Boasting a landmass about the size of Texas and Louisiana combined, a coastline longer than the eastern seaboard of the United States, and a geographic location well-positioned to export to burgeoning Asian markets, agriculture is still small-scale and subsistence. Growth in agriculture has lagged in relation to GDP growth, largely due to the lack of mechanization and irrigation. Opportunities for U.S. companies vary from cold storage, irrigation and food processing equipment.

    Mozambique recognizes agriculture as the key to poverty reduction and employment and is focused on policy reforms to attract more private sector investment. The Government of Mozambique is committed to promoting the use of technology, irrigation, and improved methods to raise yields. This commitment has resulted in plans by U.S. and other foreign agribusiness companies to establish commercial farms.

    Kenya

    Agriculture remains the backbone of Kenya's economy. It accounts for about 24 percent of GDP directly and 75 percent of the labor force indirectly. Cash crop (tea, coffee, and horticulture), food crops (maize, wheat and rice), and livestock dominate the agricultural sector. Kenyan agriculture faces many challenges. It is predominately rainfall dependent and thus subject to wide production variances. It is undercapitalized, implying low technological absorption resulting in low productivity. Small-scale farmers contribute about 75 percent to the country's total value of agricultural output and account for nearly 85 percent of total employment in the agricultural sector. These attributes, coupled with challenges arising from limited institutional capacity, poor infrastructure, and risks associated with liberalized markets, explain the relative stagnation of agricultural productivity and incomes.

    Kenya's horticulture industry is a major export success in Africa. It is almost entirely dominated by the private sector and provides many opportunities for increased importation of fertilizers, pesticides and equipment. Similar opportunities lie in the floriculture industry in Kenya, which is the leading exporter of fresh cut flowers to the flower auction in Holland. Other important commodities include maize, tea, coffee, sugarcane and wheat, which will require additional use of fertilizers as production grows. The government has embarked on a mechanization program to increase use of more modern means of farming to increase output. In addition, the government has set aside 1.2 million acres of land for irrigation that for growing maize and wheat, and livestock farming. Agricultural equipment is tax exempt under the VAT Act 2013 to provide support to the sector.

    Kenya imports virtually all of its agricultural chemicals because local production is insignificant. Kenya's fertilizer use has almost doubled since the liberalization of the market in the 1990s and the removal of government price controls and import licensing quotas. The growth in use has been noted especially among the smallholder farmers in growth of both food crops (maize, domestic horticulture) and export crops (tea, coffee). Growth in the industry is largely due to huge private investment in both importation and retailing of fertilizers. Fertilizer is also tax exempted under the new VAT Act.

    South Africa

    South Africa has by far the most modern, productive and diverse agricultural economy in Sub Saharan Africa. Agriculture in South Africa remains an important sector despite its relatively small contribution to the GDP. The sector plays an important role in terms of job creation, especially in rural areas, but is also a foremost earner of foreign exchange.

    South Africa has a market-oriented agricultural economy that is highly diversified, including production of all the major grains (except rice), oilseeds, deciduous and subtropical fruits, sugar, citrus, wine and most vegetables. Livestock production includes cattle, dairy, pigs, sheep, and a well-developed broiler and egg industry. Value-added sector activities include slaughtering, processing and preserving of meat; processing and preserving of fruit and vegetables; dairy products; grain mill products; crushing of oilseeds; prepared animal feeds; and sugar refining amongst other food products. South Africa also exports wine, corn, mohair, groundnuts, karakul pelts, sugar, and wool.

    South Africa offers U.S. exporters in the agricultural equipment and technology sector a wide range of opportunities. Five percent of all new agriculture equipment is being produced locally; 95 percent of all agriculture equipment and parts are being sourced from international markets, and at least 20 percent of new equipment and technologies are currently being sourced from the U.S.

    Mission Goals

    The goal of this trade mission is to provide U.S. participants with first-hand market information, and one-on-one meetings with business contacts, including potential agents, distributors and partners so they can position themselves to enter or expand their presence in these markets.

    Mission Scenario

    This mission will visit Maputo, Mozambique, Nairobi, Kenya and Johannesburg, South Africa allowing participants to access the largest markets and business centers in these countries.

    Proposed Mission Timetable Day of Week Location Activity Wednesday, June 17 Maputo Companies arrive Maputo. Welcome Breakfast. Thursday, June 18 Maputo Briefing by U.S. Embassy. One-on-one business appointments. Evening business reception. Friday, June 19 Maputo One-on-one business appointments continue. Saturday, June 20 Maputo/Nairobi Site visit or travel to Nairobi. Sunday, June 21 Maputo/Nairobi Remain in or travel to Nairobi. Welcome Breakfast. Monday, June 22 Nairobi Briefing by U.S. Embassy. One-on-one business appointments. Evening business reception. Tuesday, June 23 Nairobi One-on-one business appointments continue. Wednesday, June 24 Nairobi/Johannesburg Travel to Johannesburg. Welcome Breakfast. Thursday, June 25 Johannesburg Briefing by U.S. Embassy. One-on-one business appointments. Evening business reception. Friday, June 26 Johannesburg One-on-one business appointments continue.
  • Mission Ends.
  • *Note: The final schedule and potential site visits will depend on the availability of local government and business officials, specific goals of mission participants, and air travel schedules.
    Participation Requirements

    All parties interested in participating in the trade mission must complete and submit an application package for consideration by the U.S. Department of Commerce. All applicants will be evaluated on their ability to meet certain conditions and best satisfy the selection criteria as outlined below. A minimum of 15 and maximum of 20 firms and/or trade associations or organizations will be selected from the applicant pool to participate in the mission.

    Fees and Expenses

    After a company or trade association/organization has been selected to participate on the mission, a payment to the U.S. Department of Commerce in the form of a participation fee is required. The participation fee for the mission is $4,600 for small or medium-sized enterprises (SME),1 and $6,200 for large firms and trade associations/organizations. The fee for each additional representative (large firm, SME or trade association/organization) is $750.

    1 An SME is defined as a firm with 500 or fewer employees or that otherwise qualifies as a small business under SBA regulations (see http://www.sba.gov/services/contractingopportunities/sizestandardstopics/index.html). Parent companies, affiliates, and subsidiaries will be considered when determining business size. The dual pricing reflects the Commercial Service's user fee schedule that became effective May 1, 2008 (see http://www.export.gov/newsletter/march2008/initiatives.html for additional information).

    Exclusions

    The mission fee does not include any personal travel expenses such as lodging, most meals, local ground transportation and air transportation. Delegate members will however, be able to take advantage of U.S. Government rates for hotel rooms. Government fees and processing expenses to obtain such visas are also not included in the mission costs. However, the U.S. Department of Commerce will provide instructions to each participant on the procedures required to obtain necessary business visas.

    Conditions for Participation

    Applicants must submit a completed and signed mission application and supplemental application materials, including adequate information on the company's or association/organization's products and/or services, primary market objectives, and goals for participation by April 17, 2015. If the Department of Commerce receives an incomplete application, the Department may either: reject the application, request additional information/clarification, or take the lack of information into account when evaluating the applications.

    Each applicant must also certify that the products and services it seeks to export through the mission are either produced in the U.S., or, if not, are marketed under the name of a U.S. firm and have at least fifty-one percent U.S. content. In the case of a trade association or organization, the applicant must certify that for each company to be represented by the association/organization, the products and/or services the represented company seeks to export are either produced in the U.S. or, if not, marketed under the name of a U.S. firm and have at least fifty-one percent U.S. content.

    In addition, each applicant must:

    Certify that the products and services that it wishes to market through the mission would be in compliance with U.S. export controls and regulations;

    Certify that it has identified to the Department of Commerce for its evaluation any business pending before the Department that may present the appearance of a conflict of interest;

    Certify that it has identified any pending litigation (including any administrative proceedings) to which it is a party that involves the Department of Commerce; and

    Sign and submit an agreement that it and its affiliates (1) have not and will not engage in the bribery of foreign officials in connection with a company's/participant's involvement in this mission, and (2) maintain and enforce a policy that prohibits the bribery of foreign officials.

    Selection Criteria for Participation

    Targeted mission participants are U.S. companies and trade associations/organizations providing or promoting products and services that have interest in entering or expanding their business in markets of Mozambique, Kenya and South Africa. The following criteria will be used in selecting participants:

    Suitability of a company's (or in the case of a trade association/organization, represented companies') products or services to these markets.

    Company's (or in the case of a trade association/organization, represented companies') potential for business in the markets, including likelihood of exports resulting from the mission.

    Consistency of the applicant company's (or in the case of a trade association/organization, represented companies') goals and objectives with the stated scope of the mission.

    Referrals from political organizations and any documents, including the application, containing references to partisan political activities (including political contributions) will be removed from an applicant's submission and not considered during the selection process.

    Timeframe for Recruitment and Application

    Mission recruitment will be conducted in an open and public manner, including publication in the Federal Register, posting on the Commerce Department trade mission calendar (http://www.export.gov/trademissions/) and other Internet Web sites, press releases to general and trade media, notices by industry trade associations and other multiplier groups, and publicity at industry meetings, symposia, conferences, and trade shows.

    Recruitment for this mission will begin immediately and conclude April 17, 2015. We will inform applicants of selection decisions as soon as possible after April 17, 2015. Applications received after April 17, 2015 will be considered only if space and scheduling constraints permit.

    FOR FURTHER INFORMATION CONTACT: U.S. Commercial Service, Johannesburg, South Africa, Brent Omdahl, Deputy Senior Commercial Officer, Phone: 27-11-290-3227, Email: [email protected] Trade Missions Office, Washington, DC, Anne Novak, Phone: (202) 482-8178, Email: [email protected] Frank Spector, International Trade Specialist.
    [FR Doc. 2015-03898 Filed 2-24-15; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XD770 Atlantic Highly Migratory Species; Meeting of the Atlantic Highly Migratory Species Advisory Panel AGENCY:

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

    ACTION:

    Notice of public meeting and webinar/conference call.

    SUMMARY:

    NMFS will hold a 3-day Atlantic Highly Migratory Species (HMS) Advisory Panel (AP) meeting in March 2015. The intent of the meeting is to consider options for the conservation and management of Atlantic HMS. The meeting is open to the public.

    DATES:

    The AP meeting and webinar will be held from 10:30 a.m. to 5 p.m. on Tuesday, March 10, 2015; from 8:30 a.m. to 5 p.m. on Wednesday, March 11, 2015; and from 8:30 a.m. to 12 p.m. on Thursday, March 12, 2015. There will be an introduction for new AP members at 9 a.m. on Tuesday, March 10, 2015.

    ADDRESSES:

    The meeting will be held at the DoubleTree by Hilton Hotel, 8120 Wisconsin Avenue, Bethesda, MD 20814. The meeting presentations will also be available via WebEx webinar/conference call.

    On Tuesday, March 10, 2015, the conference call information is phone number 1-800-857-6552; Participant Code: 8099565; and the webinar event address is: https://noaaevents2.webex.com/noaaevents2/onstage/g.php?d=393951018&t=a; event password: NOAA.

    On Wednesday, March 11, 2015, the conference call information is phone number 1-800-857-6552; Participant Code: 8099565; and the webinar event address is: https://noaaevents2.webex.com/noaaevents2/onstage/g.php?d=395887510&t=a ; event password: NOAA.

    On Thursday, March 12, 2015, the conference call information is phone number 1-800-857-6552; Participant Code: 8099565; and the webinar event address is: https://noaaevents2.webex.com/noaaevents2/onstage/g.php?d=394954698&t=a ; event password: NOAA.

    Participants are strongly encouraged to log/dial in fifteen minutes prior to the meeting. NMFS will show the presentations via webinar and allow public comment during identified times on the agenda.

    FOR FURTHER INFORMATION CONTACT:

    Peter Cooper or Margo Schulze-Haugen at (301) 427-8503.

    SUPPLEMENTARY INFORMATION:

    The Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1801 et seq., as amended by the Sustainable Fisheries Act, Public Law 104-297, provided for the establishment of an AP to assist in the collection and evaluation of information relevant to the development of any Fishery Management Plan (FMP) or FMP amendment for Atlantic HMS. NMFS consults with and considers the comments and views of AP members when preparing and implementing FMPs or FMP amendments for Atlantic tunas, swordfish, billfish, and sharks.

    The AP has previously consulted with NMFS on: Amendment 1 to the Billfish FMP (April 1999); the HMS FMP (April 1999); Amendment 1 to the HMS FMP (December 2003); the Consolidated HMS FMP (October 2006); and Amendments 1, 2, 3, 4, 5a, 5b, 6, 7, 8, and 9 to the 2006 Consolidated HMS FMP (April and October 2008, February and September 2009, May and September 2010, April and September 2011, March and September 2012, January and September 2013, April and September 2014), among other things.

    The intent of this meeting is to consider alternatives for the conservation and management of all Atlantic tunas, swordfish, billfish, and shark fisheries. We anticipate discussing the following Amendments to the 2006 Consolidated HMS FMP: Draft Amendment 6 on the future of shark fishery, providing updates on Amendment 5b on dusky shark management and Amendment 9 on smoothhound shark management and ongoing stock assessment, reviewing Final Amendment 7 on bluefin tuna management measures, as well as discussing the HMS Essential Fish Habitat 5-Year Review. The meeting will also include discussion of the Electronic Technologies Implementation Plan for Atlantic HMS, implementation of 2014 ICCAT recommendations, and updates on the Atlantic HMS Management-Based Research Priorities document and other research activities, among other updates.

    Additional information on the meeting and a copy of the draft agenda will be posted prior to the meeting at: http://www.nmfs.noaa.gov/sfa/hms/advisory_panels/hms_ap/meetings/ap_meetings.html.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Peter Cooper at (301) 427-8503 at least 7 days prior to the meeting.

    Dated: February 20, 2015. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-03894 Filed 2-24-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XD791 Caribbean Fishery Management Council: Scoping Meetings AGENCY:

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

    ACTION:

    Notice of scoping meetings on Caribbean Federal permits.

    SUMMARY:

    The harvest activities of all fishing sectors must be understood to the greatest degree possible to assure that societal goals encompassed in the Magnuson-Stevens Fishery Conservation and Management Act are met. Thus, the need for timely, effective, and efficient means to monitor harvest from all sectors is fundamental. The goal of this Scoping Hearing is to allow the public to comment on the scoping document and to provide alternative options and ideas not yet considered by the Council and NMFS.

    Dates and Addresses:

    Written comments can be sent to the Council not later than April 10th, 2015, by regular mail to the address below, or via email to [email protected] or [email protected]

    In Puerto Rico March 11, 2015—7 p.m.-10 p.m.—Verdanza Hotel, Tartak St. Isla Verde Puerto Rico March 25, 2015—7 p.m.-10 p.m.—Mayaguez Holiday Inn, 2701 Hostos Avenue, Mayagüez, Puerto Rico In the U.S. Virgin Islands March 16, 2015—7 p.m.-10 p.m.—The Buccaneer Hotel, Estate Shoys, Christiansted, St. Croix, U.S. Virgin Islands March 18, 2015—7 p.m.-10 p.m.—Windward Passage Hotel, Charlotte Amalie, St. Thomas, U.S. Virgin Islands. FOR FURTHER INFORMATION CONTACT:

    Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico 00918-1903, telephone: (787) 766-5926.

    SUPPLEMENTARY INFORMATION:

    The Caribbean Fishery Management Council is considering establishing federal permits for fishing in the U.S. Caribbean exclusive economic zone (EEZ), and is conducting scoping meetings to obtain public comments regarding this matter.

    Background

    A permitting system provides a comprehensive method to achieve this goal. Permitting supports professionalization of individual fisheries, identifying and acknowledging those fishers dedicated to and reliant upon a specific component of the commercial fishery. Permits also allow for direct communication with fishing entities, enabling focused outreach and education opportunities.

    A permitting system allows fishery scientists and managers to gather more accurate data, decreasing both scientific and management uncertainty. Scientific uncertainty can be mitigated to some degree by increasing knowledge of the fishery and the health of the fish populations that support that fishery. A permit system that identifies the universe of fishers operating within a fishing sector and allows tracking of the disposition and characteristics of harvested resources would substantially enhance knowledge of the fishery. Data derived from a comprehensive permit system would also contribute to reducing management uncertainty by providing better estimates of harvesting effort and the timing of harvest, thereby improving management design and responsiveness. More accurate and reliable catch data allows for more informed management.

    The absence of a federal permit system, or mandatory federal reporting requirements, has been identified as a major contributor to the lack of fishing effort information in the U.S. Caribbean EEZ. A permitting system would allow better estimates for measuring fishing effort for the Council-managed fisheries while shedding light on the effectiveness of regulations implemented to manage that effort.

    Some of the needs and Issues that a permitting system could address in the EEZ:

    1. Provide accurate and timely data on landings.

    2. Allow estimation of catch per unit of fishing effort.

    3. Identify spatial and temporal trends in effort, including the relative importance of fishing to individual communities.

    4. Manage competing interests for the resource.

    5. Identify trends in the health of targeted fish stocks.

    6. Quantify the socioeconomic importance of permitted fishing sectors and mitigate negative impacts of management to fishing communities.

    7. Provide permitted fishers with a better understanding of their fishery and the opportunities and implications of management to that fishery.

    There are many aspects to implementing fishing permits in the U.S. Caribbean exclusive economic zone (EEZ) and many options regarding the design of a permit system. Options for developing and designing a permit system include, but are not limited to:

    1. Require commercial fishers to obtain a federal permit to fish in the U.S. Caribbean EEZ;

    2. Require commercial fishers to obtain a commercial fishing license from either Puerto Rico or the U.S. Virgin Islands (USVI) to fish in the U.S. Caribbean EEZ;

    3. Require commercial fishers to obtain a federal permit or a commercial fishing license from either Puerto Rico or the USVI to fish in the U.S. Caribbean EEZ

    4. Require a species/species group/fishery-specific permit in the U.S. Caribbean EEZ;

    5. Require a gear-specific permit in the U.S. Caribbean EEZ;

    6. Require a dealer permit to purchase fish harvested from the U.S. Caribbean EEZ;

    7. Conduct a pilot study with some or all fishers from some or all island groups to evaluate the practicality of permits in the U.S. Caribbean EEZ.

    The goal of these scoping meetings is to allow the public to comment on the options listed above and to provide alternative options not yet considered by the Council and NMFS.

    Copy of the Scoping Document to address the Development of Federal Permits in the U.S. Caribbean Exclusive Economic Zone can be found at http://sero.nmfs.noaa.gov/sustainable_fisheries/caribbean/index.html under Current Rule Making or and the Caribbean Council Web site at caribbeanfmc.com.

    Special Accommodations

    These meetings are physically accessible to people with disabilities. For more information or request for sign language interpretation and other auxiliary aids, please contact Mr. Miguel A. Rolón, Executive Director, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico, 00918-1903, telephone (787) 766-5926, at least 5 days prior to the meeting date.

    Dated: February 20, 2015. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2015-03892 Filed 2-24-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XD444 Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to San Francisco Bay Area Water Emergency Transportation Authority Central Bay Operations and Maintenance Facility Project in Alameda, California AGENCY:

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

    ACTION:

    Notice; issuance of an incidental take authorization.

    SUMMARY:

    In accordance with the Marine Mammal Protection Act (MMPA) regulations, notification is hereby given that NMFS has issued an Incidental Harassment Authorization (IHA) to the San Francisco Bay Area Water Emergency Transportation Authority (WETA) to take, by harassment, small numbers of two species of marine mammals incidental to pile driving and removal associated with the Central Bay Operations and Maintenance Facility Project in the City of Alameda, California, between December 1, 2015, through November 30, 2016.

    DATES:

    Effective December 1, 2015, through November 30, 2016.

    ADDRESSES:

    A copy of the application containing a list of the references used in this document, NMFS's Environmental Assessment (EA), Finding of No Significant Impact (FONSI), and the IHA may be obtained visiting the Internet at: http://www.nmfs.noaa.gov/pr/permits/incidental.htm#applications.

    Documents cited in this notice may be viewed, by appointment, during regular business hours, at 1315 East West Highway, Silver Spring, MD 20910.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION: Background

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

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

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

    Summary of Request

    On April 9, 2014, NMFS received an application from WETA for the taking of marine mammals incidental to the construction of a Central Bay Operations and Maintenance Facility (Project). The purpose of the Project is to serve as the central San Francisco Bay (Bay) base for WETA's ferry fleet. After NMFS provided comments on the draft IHA application, WETA submitted a revised IHA application on May 15, 2014. NMFS determined that the application was adequate and complete on July 31, 2014. No changes was made for the proposed WETA's construction Project as described in the proposed IHA except the Project duration was changed to December 1, 2015, through November 30, 2016, from the original June 15 through October 15, 2014, due to funding and other constraints. Please refer to Federal Register notice for the proposed IHA for a detailed description of the project activities.

    Comments and Responses

    A notice of NMFS' proposal to issue an IHA to WETA was published in the Federal Register on September 17, 2014 (79 FR 55479). That notice described, in detail, WETA's activity, the marine mammal species that may be affected by the activity, and the anticipated effects on marine mammals. During the 30-day public comment period, NMFS received comments from the Marine Mammal Commission (Commission), the Sierra Club, the San Francisco Bay Conservation and Development Commission (BCDC), and 40 private citizens.

    All comments specific to WETA's application that address the statutory and regulatory requirements or findings NMFS must make to issue an IHA are addressed in this section of the Federal Register notice.

    Comment 1: The Commission recommends NMFS issue the IHA to WETA, subject to inclusion of the proposed mitigation and monitoring measures described in the proposed IHA. In addition, the Commission recommends that NMFS only authorize in-season adjustments in the sizes of the exclusion and/or disturbance zones (zones of influence) if the size(s) of the estimated zones are determined to be too small.

    Response: NMFS agrees with the Commission's recommendation and has issued the IHA with mitigation and monitoring measures described below in this document, with the requirement that the exclusion and/or zones of influence be adjusted only of the size(s) of the estimated zones are determined to be too small.

    Comment 2: Citing WETA's permit application to BCDC to construct the Central Bay Operations and Maintenance Facility Project, BCDC points out that an abandoned small craft floating dock located at the proposed project site that harbor seals use as a haul-out site, would be removed for the construction. BCDC states that there are relatively few haul-out locations in the Bay for harbor seals, and BCDC is concerned that removal of a haul-out location may result in harmful impacts to wildlife. The Sierra Club and 40 private citizens also have concerns about the loss of a harbor seal haul-out due to the removal of the floating dock.

    BSDC recommends that NMFS review the potential habitat impacts associated with removal of these harbor seal haul-out locations, including suggestions for mitigation and monitoring, where appropriate, as part of the IHA application for the project.

    Response: NMFS was not aware this issue during its initial analysis of potential impacts to the loss of one harbor seal haul-out site as a result of the proposed WETA construction project in the Bay. Therefore, the potential impact of marine mammal habitat did not address this in the Federal Register (79 FR 55479; September 17, 2014) for the proposed IHA. Subsequently, NMFS conducted further investigation and worked with NMFS West Coast Regional Office to assess the potential impacts to harbor seal haul-out and habitat in general in the Bay.

    The harbor seal haul-out site that would be affected is a small craft dock located at the project site and was abandoned by the Navy when it vacated the Naval Air Station-Alameda in 1997. The unmaintained dock has been deteriorating slowly over the last 17 years and the deterioration has appeared to be accelerating in the last five years. In 2010, the portion connecting the floating dock to land broke off and sank, leaving remnant parts of the floating dock isolated from land. Since 2010, additional remnant parts of the marina have also been lost. During this period of time harbor seals have been opportunistically using the dock for haul-out purposes. At present, seals have been observed by local residents hauling out on the portion of the dock that is furthest from shore.

    It is observed that on an average, about 10 to 20 harbor seals use the floating dock as haul-out periodically. Although during the spring of 2014, one pup was observed reared at the floating dock, the site is not a known breeding area for harbor seal. Because the dock has been in a gradual state of decay since the closure of the naval base and will likely continue to fall apart, the haul-out area on the dock provided for harbor seals is expected to decrease and eventually disappear.

    Finally, several nearby haul-out sites are available in the Bay that are available to resident harbor seals in the area. These areas include the tip of Breakwater Island (1 mile from the WETA project site) and the haul-out at Yerba Buena Island (4 to 5 miles from the WETA project site) which is identified as one of the five major haul-out sites for harbor seals in the San Francisco Bay (Gibble 2011).

    Therefore, the removal of the remnant abandoned dock would have negligible impact to harbor seal habitat in the proposed WETA construction site.

    NMFS has thoroughly reviewed WETA's IHA application, including the proposed mitigation and monitoring measures to reduce potential impacts from the construction activities. These mitigation and monitoring measures include using noise attenuation devices for impact pile driving, power down/shutdown of pile driving hammer if a marine mammal is observed approaching the exclusion zone, and monitoring the exclusion zones and zones of influence. Detailed description of these monitoring and mitigation measures and NMFS analysis is provided in the Federal Register (79 FR 55479; September 17, 2014) for the proposed IHA, therefore, it is not repeated here.

    Comment 3: The Sierra Club and several private citizens recommend that NMFS requires WETA to construct a new haul-out dock nearby to compensate and mitigate the loss of harbor seal haul-out, if the current old floating dock is to be removed.

    Response: NMFS does not consider building an artificial harbor seal haul-out is a good conservation measure to compensate for the loss of the old floating dock that is being used as a haul-out by 10-20 harbor seals. As the Sierra Club also stated in its comment, “[i]n the case of the WETA ferry facility project, it is not a traditional natural shoreline that will be disturbed or destroyed.” The floating dock proposed to be removed is a manmade structure that is bound to disappear as it deteriorates and falls apart. To build another new structure without maintenance will likely have the same issue in the near future. Therefore, NMFS considers it better conservation practice not to construct a new structure just to replace the current deteriorating artificial one.

    Description of Marine Mammals in the Area of the Specified Activity

    The marine mammal species under NMFS jurisdiction most likely to occur in the proposed construction area include Pacific harbor seal (Phoca vitulina richardsi) and California sea lion (Zalophus californianus). Although harbor porpoise (Phocoena phocoena), killer whale (Orcinus orca), and gray whale (Eschrichtius robustus) have been sighted near the vicinity of the proposed construction area, their presence at the activity area is considered unlikely, because the proposed construction area is not typical habitat for these species. The southern sea otter (Enhydra lutris) also may occur in the proposed construction area, but that species is managed by the U.S. Fish and Wildlife Service and is not considered further in this proposed IHA notice. A list of the marine mammal species under NMFS jurisdiction and their abundance and Endangered Species Act (ESA) status is provided in Table 1.

    Additional information on the marine mammal species found in California waters can be found in Caretta et al. (2013), which is available at the following URL: http://www.nmfs.noaa.gov/pr/sars/pdf/po2012.pdf, and in the Federal Register notice (79 FR 55479) for the proposed IHA.

    Table 1—List of Marine Mammal Species Under NMFS Jurisdiction That Occur in the Vicinity of the WETA Central Bay Operations and Maintenance Facility Project Area Common name Scientific name Stock ESA Status Abundance California sea lion Zalophus californianus U.S. Not listed 296,750 Harbor seal Phoca vitulina richardsi California Not listed 30,196 Potential Effects of the Specified Activity on Marine Mammals and Marine Mammal Habitat

    The primary potential impacts to marine mammals and marine mammal habitat are associated with elevated sound levels, but the project may also result in additional effects to marine mammal prey species and short-term, local water turbidity caused by in-water construction due to pile removal and pile driving. These potential effects are discussed in detail in the Federal Register notice for the proposed IHA and are not repeated here. The potential affected habitat on harbor seal haul-out was not discussed in the proposed IHA because NMFS was not aware of that issue at the time. An analysis of the potential effect on the removal of a harbor seal haul-out is provided below.

    The harbor seal haul-out site that would be affected is a small craft dock located at the project site and was abandoned by the Navy when it vacated the Naval Air Station-Alameda in 1997. The unmaintained dock has been deteriorating slowly over the last 17 years and the deterioration has appeared to be accelerating in the last five years. Later in 2010, the portion connecting the floating dock to land broke off and sank, leaving remnant parts of the floating dock isolated from land. Since 2010, additional remnant parts of the marina have also been lost. During this period of time harbor seals have been opportunistically using the dock for haul-out purposes. At present, seals have been observed by local residents hauling out on the portion of the dock that is furthest from shore.

    It is observed that on an average, about 10 to 20 harbor seals use the floating dock as haul-out periodically. Although during the spring of 2014, one pup was observed reared at the floating dock, the site is not a known breeding area for harbor seal. Because the dock has been in a gradual state of decay since the closure of the naval base and will likely continue to fall apart, the haul-out area on the dock provided for harbor seals is expected to decrease and eventually disappear.

    Finally, several nearby haul-out sites are available in the Bay that are available to resident harbor seals in the area. These areas include the tip of Breakwater Island (1 mile from the WETA project site) and the haul-out at Yerba Buena Island (4 to 5 miles from the WETA project site) which is identified as one of the five major haul-out sites for harbor seals in the San Francisco Bay (Gibble 2011).

    Therefore, the removal of the remnant abandoned dock would have negligible impact to harbor seal habitat in the proposed WETA construction site.

    Mitigation

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

    For WETA's proposed Central Bay Operations and Maintenance Facility Project, NMFS required the following mitigation measures to minimize the potential impacts to marine mammals in the Project vicinity. The primary purposes of these mitigation measures are to minimize sound levels from the activities, to monitor marine mammals within designated zones of influence corresponding to NMFS' current Level B harassment thresholds and, if marine mammals with the ZOI appear disturbed by the work activity, to initiate immediate shutdown or power down of the piling hammer, making it very unlikely potential injury or hearing impairment to marine mammals would occur and ensuring that Level B behavioral harassment of marine mammals would be reduced to the lowest level practicable.

    Use of Noise Attenuation Devices

    Noise attenuation systems (i.e., bubble curtains) will be used during all impact pile driving of steel piles to dampen the acoustic pressure and reduce the impact on marine mammals. By reducing underwater sound pressure levels at the source, bubble curtains would reduce the area over which Level B harassment would occur, thereby potentially reducing the numbers of marine mammals affected. In addition, the bubble curtain system would reduce sound levels below the threshold for injury (Level A harassment), and thus eliminate the need for an exclusion zone for Level A harassment.

    Time Restrictions

    Work would occur only during daylight hours, when visual monitoring of marine mammals can be conducted.

    In addition, all in-water construction will be limited to the period between August 1 and November 30, 2016.

    Establishment of Harassment Zones of Influence

    Before the commencement of in-water pile driving activities, WETA shall establish Level B behavioral harassment zones of influence (ZOIs) where received underwater sound pressure levels (SPLs) are higher than 160 dB (rms) and 120 dB (rms) re 1 μPa for impulse noise sources (impact pile driving) and non-impulses noise sources (vibratory pile driving and mechanic dismantling), respectively. The ZOIs delineate where Level B harassment would occur. Because of the relatively low source levels from vibratory pile driving and from impact pile driving with air bubble curtains, there will be no area where the noise level would exceed the threshold for Level A harassment for pinnipeds, which is 190 dB (rms) re 1 μPa. The modeled maximum isopleths for ZOIs are listed in Table 2.

    Table 2—Modeled Level B Harassment Zones of Influence for Various Pile Driving Activities Pile driving methods Pile material and size Distance to 120 dB re 1
  • μPa (rms) (m)
  • Distance to 160 dB re 1
  • μPa (rms) (m)
  • Impact pile driving with air bubble curtain 30″ epoxy coated steel piles
  • 24″ epoxy coated steel piles
  • 18″ epoxy coated steel piles
  • NA
  • NA
  • NA
  • 250
  • 185
  • 93
  • Vibratory pile driving 18″ plastic fender piles 2,154 NA

    In addition, although Level A harassment and injury by noise are not expected to occur due to implementation of noise attenuation devices and vibratory pile driving, a minimum shutdown zone of 10 m will be established during all pile driving and removal activities, regardless of the estimated zone. These precautionary measures are intended to prevent the already unlikely possibility of physical interaction with construction equipment and to establish a precautionary minimum zone with regard to acoustic effects.

    Once the underwater acoustic measurements are conducted during initial test pile driving, WETA shall adjust the sizes of the exclusion zones and ZOIs only if the measured exclusion zones and ZOIs are larger than modeled zones. These zones will be monitored as described under the Proposed Monitoring section below.

    Soft Start

    A “soft-start” technique is intended to allow marine mammals to vacate the area before the pile driver reaches full power. Whenever there has been downtime of 30 minutes or more without pile driving, the contractor will initiate the driving with ramp-up procedures described below.

    For vibratory hammers, the contractor will initiate the driving for 15 seconds at reduced energy, followed by a 1-minute waiting period. This procedure shall be repeated two additional times before continuous driving is started. This procedure would also apply to vibratory pile extraction.

    For impact driving, an initial set of three strikes would be made by the hammer at 40 percent energy, followed by a 1-minute waiting period, then two subsequent three-strike sets at 40 percent energy, with 1-minute waiting periods, before initiating continuous driving.

    Shutdown Measures

    WETA shall implement shutdown measures for pile driving or pile removal activities if a marine mammal is sighted within or is about to enter the 10 m exclusion zone.

    In addition, WETA shall discontinue pile driving or pile removal activities if a marine mammal within a ZOI appears disturbed by the work activity. Work may not resume until the animal is seen to leave the ZOI or 30 minutes have passed since the disturbed animal was last sighted.

    Furthermore, for in-water heavy machinery work with the potential to affect marine mammals (other than pile driving), if a marine mammal comes within 10 m, operations shall cease until the animal has left the shutdown zone or 15 minutes has passed. Heavy machinery work could include setting the pile and removal of the pile from the water column/substrate via a crane (i.e., dead pull).

    Finally, if any marine mammal species not authorized for take are encountered during pile driving or removal and are likely to be exposed to sound pressure levels (SPLs) greater than or equal to 160 dB re 1 μPa (rms) for impact pile driving or greater than or equal to 120 dB re 1 μPa (rms) for vibratory driving or removal, then the Holder of this IHA must cease those activities prior to the animal entering the applicable Level B zone to avoid take. Activities cannot commence until the animal has left the Level B zone.

    Mitigation Conclusions

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

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

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

    • The practicability of the measure for applicant implementation.

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

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

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

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

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

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

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

    Based on our evaluation of the applicant's proposed measures, as well as other measures considered by NMFS, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammals species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

    Monitoring and Reporting

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

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

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

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

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

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

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

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

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

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

    Monitoring Measures

    WETA shall employee NMFS-approved protected species observers (PSOs) to conduct marine mammal monitoring for its Central Bay Operations and Maintenance Facility Project. The PSOs will observe and collect data on marine mammals in and around the project area for 30 minutes before, during, and for 30 minutes after all pile removal and pile installation work. If a PSO observes a marine mammal within a ZOI that appears to be disturbed by the work activity, the PSO will notify the work crew to initiate shutdown measures.

    Monitoring of marine mammals around the construction site shall be conducted using high-quality binoculars (e.g., Zeiss, 10 × 42 power). Marine mammal visual monitoring shall be conducted from the best vantage point available, including the pier, breakwater, and adjacent docks within the harbor, to maintain an excellent view of the ZOIs and adjacent areas during the survey period. Monitors would be equipped with radios or cell phones for maintaining contact with work crews.

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

    Reporting Measures

    WETA would be required to submit weekly monitoring reports to NMFS that summarize the monitoring results, construction activities, and environmental conditions.

    A final monitoring report would be submitted to NMFS within 90 days after completion of the construction work. This report would detail the monitoring protocol, summarize the data recorded during monitoring, and estimate the number of marine mammals that may have been harassed. NMFS would have an opportunity to provide comments on the report, and if NMFS has comments, WETA would address the comments and submit a final report to NMFS within 30 days.

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

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

    Estimated Take by Incidental Harassment

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

    As discussed above, in-water pile removal and pile driving (vibratory and impact) generate loud noises that could potentially harass marine mammals in the vicinity of WETA's proposed Central Bay Operations and Maintenance Facility Project.

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

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

    As explained above, ZOIs will be established that encompass the areas where received underwater SPLs exceed the applicable thresholds for Level B harassment. There will not be a zone for Level A harassment in this case, because the bubble curtain system will keep all underwater noise below the threshold for Level A harassment.

    Incidental take is estimated for each species by estimating the likelihood of a marine mammal being present within a ZOI during active pile removal or driving. Expected marine mammal presence is determined by past observations and general abundance near the project area during the construction window. Typically, potential take is estimated by multiplying the area of the ZOI by the local animal density. This provides an estimate of the number of animals that might occupy the ZOI at any given moment. However, this type of calculation is not applicable in this case, because the ZOI will be relatively small and there is no specific local animal density for harbor seals or California sea lions. Based on observational data, the maximum number of harbor seals observed along the closest breakwater near the project vicinity ranges from 10 to 20 individuals. Observational data on California sea lions are not available, but they are generally less abundant than harbor seals; therefore, the number of harbor seals will be used to estimate impacts for both species.

    While it is unlikely that 10 to 20 individuals would be present inside the ZOI at any one time, given the distance from the nearest haul-out site, as a worst-case, this analysis assumes that up to 20 individuals might be present.

    For the Project, the total number of pile removal hours is estimated to not exceed 18 hours over 3 days, and the total number of pile driving hours is estimated to not exceed 60 hours over 10 days. Therefore, the estimated total number of days of activities that might impact marine mammals is 13 days. For the exposure estimate, it is assumed that the highest count of harbor seals observed, and the same number of California sea lions, will be foraging within the ZOI and be exposed multiple times during the Project.

    The calculation for marine mammal exposures for this Project is estimated by:

    Exposure estimate = N * (10 days of pile driving activity + 3 days of pile removal activity), where:

    N = # of animals potentially present = 20.

    This formula results in the following exposure estimate:

    Exposure estimate = 20 animals * 13 days = 260 animals.

    Therefore, WETA is requesting authorization for Level B acoustical harassment of up to 260 harbor seals and up to 260 California sea lions due to pile removal and driving. A summary of the take estimates and the proportions of the stocks potentially affected is provided in Table 4.

    Table 4—Summary of Potential Marine Mammal Takes and Percentages of Stocks Affected Estimated density Estimated take by level B harassment Abundance of stock Percentage of stock potentially affected Population trend California sea lion NA 260 396,750 0.06% Stable. Harbor seal NA 260 30,196 0.86% Stable. Analysis and Determinations Negligible Impact

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

    WETA's proposed Central Bay Operations and Maintenance Facility Project would involve pile removal and pile driving activities. Elevated underwater noises are expected to be generated as a result of these activities; however, these noises are expected to result in no mortality or Level A harassment and limited, if any, Level B harassment of marine mammals. WETA would use noise attenuation devices (i.e., bubble curtains) during the impact pile driving, thus eliminating the potential for injury (including PTS) and TTS from impact driving. For vibratory pile removal and pile driving, noise levels are not expected to reach the level that may cause TTS, injury (including PTS), or mortality to marine mammals. Therefore, NMFS does not expect that any animals would experience Level A harassment (including injury or PTS) or Level B harassment in the form of TTS from being exposed to in-water pile removal and pile driving associated with WETA's construction project.

    In addition, WETA's proposed activities are localized and of short duration. The entire project area is limited to WETA's Central Bay Operations and Maintenance Facility near Pier 3 in the City of Alameda. The entire Project would involve the removal of 35 existing concrete piles and installation of a total of 61 steel piles ranging from 18 inches to 30 inches in diameter and 24 plastic piles of 18-inch diameter. The duration for pile removal is expected to be fewer than three days and the duration for pile driving is expected to be fewer than 10 days, for a total of 13 days of activity. The duration for removing each pile would be about 30 minutes, and the duration for driving each pile would be about 10 to 30 minutes for impact steel pile driving and about 10 to 20 minutes for plastic vibratory pile driving. These low-intensity, localized, and short-term noise exposures may cause brief startle reactions or short-term behavioral modification by the animals. These reactions and behavioral changes are expected to subside quickly when the exposures cease. Moreover, the proposed mitigation and monitoring measures are expected to reduce potential exposures and behavioral modifications even further. Additionally, no important feeding and/or reproductive areas for marine mammals are known to be near the proposed action area. Therefore, the take resulting from the proposed Central Bay Operations and Maintenance Project is not reasonably expected to, and is not reasonably likely to, adversely affect the marine mammal species or stocks through effects on annual rates of recruitment or survival.

    The Project also is not expected to have significant adverse effects on affected marine mammals' habitat, as analyzed in detail in the “Anticipated Effects on Marine Mammal Habitat” section in the Federal Register notice (79 FR 55479; September 17, 2014). The project activities would not modify existing marine mammal habitat. The activities may cause some fish to leave the area of disturbance, thus temporarily impacting marine mammals' foraging opportunities in a limited portion of the foraging range, but because of the short duration of the activities and the relatively small area of the habitat that may be affected, the impacts to marine mammal habitat are not expected to cause significant or long-term negative consequences.

    Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS finds that the total marine mammal take from WETA's Central Bay Operations and Maintenance Facility Project will have a negligible impact on the affected marine mammal species or stocks.

    Small Number

    Based on analyses provided above, it is estimated that approximately 260 California sea lions and 260 Pacific harbor seals could be exposed to received noise levels that could cause Level B behavioral harassment from the proposed construction work at the WETA Central Bay Operations and Maintenance Facility in Alameda, CA. These numbers represent approximately 0.06% and 0.86% of the stocks and populations of these species that could be affected by Level B behavioral harassment, respectively (see Table 4 above), which are small percentages relative to the total populations of the affected species or stocks.

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

    Impact on Availability of Affected Species for Taking for Subsistence Uses

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

    Endangered Species Act (ESA)

    No species listed under the ESA are expected to be affected by these activities. Therefore, NMFS has determined that a section 7 consultation under the ESA is not required.

    National Environmental Policy Act (NEPA)

    NMFS prepared an Environmental Assessment (EA) and analyzed the potential impacts to marine mammals that would result from WETA's Central Bay Operations and Maintenance Facility project in Alameda, California. Therefore, A Finding of No Significant Impact (FONSI) was issued for this action. A copy of the EA and FONSI is available upon request.

    Authorization

    NMFS has issued an IHA to USCG for the potential harassment of small numbers of marine mammal species incidental to its waterfront repair project at Station Monterey in California, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.

    Dated: February 19, 2015. Donna S. Wieting, Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2015-03850 Filed 2-24-15; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XD660 Takes of Marine Mammals Incidental to Specified Activities; Seabird Research Activities in Central California, 2015-2016 AGENCY:

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

    ACTION:

    Notice; issuance of an incidental harassment authorization.

    SUMMARY:

    In accordance with the Marine Mammal Protection Act (MMPA) regulations, we hereby give notification that the National Marine Fisheries Service has issued an Incidental Harassment Authorization (IHA) to Point Blue Conservation Science (Point Blue), to take marine mammals, by Level B harassment, incidental to conducting seabird and pinniped research activities in central California, January 2015 through January 2016.

    DATES:

    Effective January 31, 2015, through January 30, 2016.

    ADDRESSES:

    The public may obtain an electronic copy of the Point Blue's application, supporting documentation, the authorization, and a list of the references cited in this document by visiting: http://www.nmfs.noaa.gov/pr/permits/incidental/research.htm. In the case of problems accessing these documents, please call the contact listed here (see FOR FURTHER INFORMATION CONTACT).

    The Environmental Assessment and associated Finding of No Significant Impact, prepared pursuant to the National Environmental Policy Act of 1969, are also available at the same site.

    FOR FURTHER INFORMATION CONTACT:

    Jeannine Cody, Office of Protected Resources, NMFS (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    Section 101(a)(5)(D) of the Marine Mammal Protection Act (MMPA; 16 U.S.C. 1361 et seq.) directs the Secretary of Commerce to authorize, upon request, the incidental, but not intentional, taking of small numbers of marine mammals of a species or population stock, by United States citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if: (1) We make certain findings; (2) the taking is limited to harassment; and (3) we provide a notice of a proposed authorization to the public for review.

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

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

    Summary of Request

    We received an application on July 30, 2014, from Point Blue requesting the taking by harassment of small numbers of marine mammals incidental to conducting seabird and pinniped research activities on Southeast Farallon Island, Año Nuevo Island, Point Reyes National Seashore, San Francisco Bay, and the Russian River in central California. We determined the application complete and adequate on December 7, 2014.

    Point Blue, along with partners Oikonos Ecosystem Knowledge, Point Reyes National Seashore with the National Park Service, and the Gulf of the Farallones National Marine Sanctuary would conduct this research under cooperative agreements with the U.S. Fish and Wildlife Service in consultation with the Gulf of the Farallones National Marine Sanctuary.

    The proposed research activities would occur for one year, January 31, 2015, through January 30, 2016, and would involve annual monitoring and censusing of seabird colonies; seabird nesting habitat observations; nesting burrows restoration; breeding elephant seals observations; and the periodic resupply of a field station.

    These proposed activities would occur in the vicinity of pinniped haul out sites and could likely result in the incidental take of marine mammals. We anticipate take, by Level B Harassment only, of individuals of either California sea lions (Zalophus californianus), Pacific harbor seals (Phoca vitulina), northern elephant seals (Mirounga angustirostris), or Steller sea lions (Eumetopias jubatus) to result from the specified activity.

    This is the organization's sixth request for an Authorization. To date, we have issued an Incidental Harassment Authorization (Authorization) to Point Blue (formerly known as PRBO Conservation Science) for the conduct of similar activities from 2007 to 2013 (72 FR 71121, December 14, 2007; 73 FR 77011, December 18, 2008; 75 FR 8677, February 19, 2010; 77 FR 73989, December 7, 2012, 78 FR 66686, November 6, 2013).

    Description of the Specified Activity Overview

    Point Blue proposes to monitor and census seabird colonies; observe seabird nesting habitat; restore nesting burrows; observe breeding elephant and harbor seals; and resupply a field station annually in central California (i.e., Southeast Farallon Island, West End Island, Año Nuevo Island, Point Reyes National Seashore, San Francisco Bay, and the Russian River in Sonoma County).

    The purpose of the seabird research is to continue a 30-year monitoring program of the region's seabird populations. Point Blue's long-term pinniped research program monitors pinniped colonies to understand elephant and harbor seal population dynamics and to contribute to the conservation of both species.

    Dates and Duration

    The Authorization would be effective from January 31, 2015 through January 30, 2016. Following is a brief summary of the dates and duration of the activities.

    Seabird Research on Southeast Farallon Island: Daily observations of seabird colonies would occur at a maximum frequency of three 15-minute visits. Daily observations of breeding common murre (Uria aalge) colonies would occur at a maximum frequency of a single five-hour visit. These activities usually involve one or two observers conducting daily censuses of seabirds or conducting mark/recapture studies of breeding seabirds on the island.

    Field Station Resupply on Southeast Farallon Island: Resupply of the field station would occur once every two weeks at a maximum frequency of 26 visits annually. Resupply activities involve personnel approaching either the North Landing or East Landing by motorboat to offload supplies.

    Pinniped Research in Central California: Surveys of breeding northern elephant seals on Southeast Farallon and Año Nuevo Islands, the coastline of Point Reyes Peninsula, San Francisco Bay, and the Russian River, would occur in early December and late February, annually. At least three researchers would visit the sites at a maximum frequency of five times per year.

    Seabird Research and Field Supply on Año Nuevo Island: Researchers would monitor seabird burrow nesting habitat quality, conduct habitat restoration, and resupply the field station from April through August at a maximum frequency of 20 visits annually. Occasionally, researchers would also conduct intermittent visits to the island throughout the year. These activities involve two to three researchers accessing the island by motorboat.

    Seabird Research on Point Reyes National Seashore: The National Park Service in collaboration with Point Blue monitors seabird breeding and roosting colonies; conducts habitat restoration; removes non-native plants; monitors intertidal areas; and maintains coastal dune habitat. Seabird monitoring usually involves one or two observers conducting the survey by small boats along the shoreline. Researchers would visit the site at a maximum frequency of 20 times per year.

    Specified Geographic Region

    Point Blue will conduct their research activities within the vicinity of pinniped haul out sites in the following locations:

    South Farallones Islands: The South Farallon Islands consist of Southeast Farallon Island located at 37°41′54.32″ N; 123° 0′8.33″ W and West End Island. The South Farallon Islands have a land area of approximately 120 acres (0.49 square kilometers (km)) and are part of the Farallon National Wildlife Refuge. The islands are located near the edge of the continental shelf 28 miles (mi) (45.1 km) west of San Francisco, CA, and lie within the waters of the Gulf of the Farallones National Marine Sanctuary.

    Año Nuevo Island: Año Nuevo Island located at 37° 6′29.25″ N; 122°20′12.20″ W is one-quarter mile (402 meters (m)) offshore of Año Nuevo Point in San Mateo County, CA. The island lies within the Monterey Bay National Marine Sanctuary and the Año Nuevo State Marine Conservation Area.

    Point Reyes National Seashore: Point Reyes National Seashore is approximately 40 miles (64.3 km) north of San Francisco Bay and also lies within the Gulf of the Farallones National Marine Sanctuary.

    San Francisco Bay: The main part of San Francisco Bay measures approximately 3 to 12 miles (5 to 20 km) wide east-to-west and between 48 miles (77 km) and 60 miles (97 km) north-to-south.

    Russian River: The Russian River coastline stretches for approximately 55 miles just south of San Francisco. Starting at Lake Mendocino, the Russian River flows south through valleys in Mendocino and Sonoma County, and empties into the Pacific Ocean at Jenner, California.

    Detailed Description of Activities

    We outlined the purpose of Point Blue's activities in a previous notice for the proposed authorization (79 FR 76975, December 23, 2014). The proposed activities have not changed between the proposed authorization notice and this final notice announcing the issuance of the Authorization. For a more detailed description of the authorized action, we refer the reader to the notice for the proposed authorization (79 FR 76975, December 23, 2014).

    Comments and Responses

    We published a notice of receipt of Point Blue's application and proposed Authorization in the Federal Register on December 23, 2014 (79 FR 76975). During the 30-day comment period, we received one comment from the Marine Mammal Commission (Commission) which recommended that we issue the requested Authorization, provided that Point Blue carries out the required monitoring and mitigation measures as described in the notice of the proposed authorization (79 FR 76975, December 23, 2014) and the application. We have included all measures proposed in the notice of the proposed authorization (79 FR 76975, December 23, 2014) in the Authorization.

    Description of the Marine Mammals in the Area of the Proposed Specified Activity

    The marine mammals most likely to be harassed incidental to conducting seabird and pinniped research at the proposed research areas are primarily California sea lions, northern elephant seals, Pacific harbor seals, and to a lesser extent the eastern distinct population segment (DPS) of the Steller sea lion, which NMFS has removed from the list of threatened species under the U.S. Endangered Species Act of 1973 (ESA; 16 U.S.C. 1531 et seq.), effective November 2013. The ESA does not categorize California sea lions, northern elephant seals, Pacific harbor seals as threatened or endangered and the MMPA categorizes these species as not depleted. On the other hand, despite the delisting of Steller sea lions as endangered under the ESA, NMFS still categorizes the species as a strategic stock and depleted species under the MMPA. The agency will consider designating the eastern stock of Steller sea lions as non-strategic and not depleted under the MMPA following review by the Alaska Scientific Review Group in 2014.

    We refer the public to Carretta et al., (2014) for general information on these species which we presented in the notice of the proposed authorization (79 FR 76975, December 23, 2014). The publication is available at: http://www.nmfs.noaa.gov/pr/sars/pdf/po2012.pdf.

    Other Marine Mammals in the Proposed Action Area

    California (southern) sea otters (Enhydra lutris nereis), listed as threatened under the ESA and categorized as depleted under the MMPA, usually range in coastal waters within 1.24 miles (2 km) of the shoreline. Point Blue has not encountered California sea otters during the course of their seabird or pinniped research activities over the past five years. This species is managed by the U.S. Fish and Wildlife Service and we do not consider it further in this notice of issuance of an Authorization.

    Potential Effects on Marine Mammals

    Acoustic and visual stimuli generated by: (1) Noise generated by motorboat approaches and departures; (2) noise generated during restoration activities and loading operations while resupplying the field station; and (3) human presence during seabird and pinniped research activities, have the potential to cause California sea lions, Pacific harbor seals, northern elephant seals, and Steller sea lions hauled out in areas within Southeast Farallon Island, West End Island, Año Nuevo Island, Point Reyes National Seashore, San Francisco Bay, and the Russian River to flush into the surrounding water or to cause a short-term behavioral disturbance for marine mammals.

    We expect that acoustic and visual stimuli resulting from the proposed motorboat operations and human presence has the potential to harass marine mammals. We also expect that these disturbances would be temporary and result, at worst, in a temporary modification in behavior and/or low-level physiological effects (Level B harassment) of certain species of marine mammals.

    We included a summary and discussion of the ways that the types of stressors associated with Point Blue's specified activities (i.e., visual and acoustic disturbance) have the potential to impact marine mammals in a previous notice for the proposed authorization (79 FR 76975, December 23, 2014).

    Vessel Strike: The potential for striking marine mammals is a concern with vessel traffic. However, it is highly unlikely that the use of small, slow-moving boats to access the research areas would result in injury, serious injury, or mortality to any marine mammal. Typically, the reasons for vessel strikes are fast transit speeds, lack of maneuverability, or not seeing the animal because the boat is so large. Point Blue's researchers will access areas at slow transit speeds in easily maneuverable boats negating any chance of an accidental strike.

    Rookeries: No research activities would occur on pinniped rookeries and breeding animals are concentrated in areas where researchers would not visit. Therefore, we do not expect mother and pup separation or crushing of pups during flushing.

    The potential effects to marine mammals described in the notice for the proposed authorization (79 FR 76975, December 23, 2014) did not take into consideration the proposed monitoring and mitigation measures described later in this document (see the “Proposed Mitigation” and “Proposed Monitoring and Reporting” sections).

    Anticipated Effects on Habitat

    We considered these impacts in detail in the notice for the proposed authorization (79 FR 76975, December 23, 2014). Briefly, we do not anticipate that the proposed research activities would result in any significant or long-term effects on the habitats used by the marine mammals in the proposed area, including the food sources they use (i.e., fish and invertebrates). While we anticipate that the specified activity could potentially result in marine mammals avoiding certain areas due to temporary ensonification and human presence, this impact to habitat is temporary and reversible. We do not consider behavioral modification to cause significant or long-term consequences for individual marine mammals or their populations.

    Mitigation

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

    Point Blue has based the mitigation measures which they will implement during the proposed research, on the following: (1) Protocols used during previous Point Blue seabird research activities as required by our previous authorizations for these activities; and (2) recommended best practices in Richardson et al. (1995).

    To reduce the potential for disturbance from acoustic and visual stimuli associated with the activities Point Blue and/or its designees has proposed to implement the following mitigation measures for marine mammals:

    (1) Postpone beach landings on Año Nuevo Island until pinnipeds that may be present on the beach have slowly entered the water.

    (2) Select a pathway of approach to research sites that minimizes the number of marine mammals harassed.

    (3) Avoid visits to sites used by pinnipeds for pupping.

    (4) Monitor for offshore predators and do not approach hauled out pinnipeds if great white sharks (Carcharodon carcharias) or killer whales (Orcinas orca) are present. If Point Blue and/or its designees see predators in the area, they must not disturb the animals until the area is free of predators.

    (5) Keep voices hushed and bodies low to the ground in the visual presence of pinnipeds.

    (6) Conduct seabird observations at North Landing on Southeast Farallon Island in an observation blind, shielded from the view of hauled out pinnipeds.

    (7) Crawl slowly to access seabird nest boxes on Año Nuevo Island if pinnipeds are within view.

    (8) Coordinate research visits to intertidal areas of Southeast Farallon Island (to reduce potential take) and coordinate research goals for Año Nuevo Island to minimize the number of trips to the island.

    (9) Coordinate monitoring schedules on Año Nuevo Island, so that areas near any pinnipeds would be accessed only once per visit.

    (10) Have the lead biologist serve as an observer to evaluate incidental take.

    Mitigation Conclusions

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

    (1) The manner in which, and the degree to which, we expect that the successful implementation of the measure would minimize adverse impacts to marine mammals;

    (2) The proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and

    (3) The practicability of the measure for applicant implementation.

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

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

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

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

    4. A reduction in the intensity of exposures (either total number or number at biologically important time or location) to activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing the severity of harassment takes only).

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

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

    Based on our evaluation of Point Blue's proposed measures, we have determined that the mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

    Proposed Monitoring

    In order to issue an incidental take authorization for an activity, section 101(a)(5)(D) of the Marine Mammal Protection Act states that we must set forth “requirements pertaining to the monitoring and reporting of such taking.” The Act's implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for an incidental take authorization must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and our expectations of the level of taking or impacts on populations of marine mammals present in the action area.

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

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

    2. An increase in our understanding of how many marine mammals are likely to be exposed to levels of potential stressor(s) associated with the action (e.g., sound or visual stimuli) that we associate with specific adverse effects, such as behavioral harassment, TTS, or PTS;

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

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

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

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

    4. An increased knowledge of the affected species; and

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

    As part of its 2015-2016 application, Point Blue proposes to sponsor marine mammal monitoring during the present project, in order to implement the mitigation measures that require real-time monitoring, and to satisfy the monitoring requirements of the incidental harassment authorization. The Point Blue researchers will monitor the area for pinnipeds during all research activities. Monitoring activities will consist of conducting and recording observations on pinnipeds within the vicinity of the proposed research areas. The monitoring notes would provide dates, location, species, the researcher's activity, behavioral state, numbers of animals that were alert or moved greater than one meter, and numbers of pinnipeds that flushed into the water.

    Point Blue has complied with the monitoring requirements under the previous authorizations for the 2007 through 2014 seasons. The results from previous Point Blue's monitoring reports support our findings that the proposed mitigation measures, which we also required under the 2007-2014 Authorizations provide the means of effecting the least practicable adverse impact on the species or stock.

    Point Blue will submit a monitoring report on the January 31, 2014 through January 30, 2015 research period by April 2015. Upon receipt and review, we will post this annual report on our Web site at http://www.nmfs.noaa.gov/pr/permits/incidental/research.htm.

    Proposed Reporting

    Point Blue must submit a draft final report to NMFS' Office of Protected Resources within 60 days after the conclusion of the 2016 field season. The report will include a summary of the information gathered pursuant to the monitoring requirements set forth in the Authorization.

    Point Blue will submit a final report to the Chief, Permits and Conservation Division, Office of Protected Resources, within 30 days after receiving comments from NMFS on the draft final report. If Point Blue does not receive any comments from NMFS on the draft report, NMFS and Point Blue will consider the draft final report to be the final report.

    Estimated Take by Incidental Harassment

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

    NMFS proposes to authorize take by Level B harassment only for the proposed seabird research activities on Southeast Farallon Island, Año Nuevo Island, and Point Reyes National Seashore. Acoustic (i.e., increased sound) and visual stimuli generated during these proposed activities may have the potential to cause marine mammals in the harbor area to experience temporary, short-term changes in behavior.

    Based on Point Blue's previous research experiences, with the same activities conducted in the proposed research area, and on marine mammal research activities in these areas, we estimate that approximately 9,871 California sea lions, 343 harbor seals, 196 northern elephant seals, and 106 Steller sea lions could be affected by Level B behavioral harassment over the course of the effective period of the proposed Authorization.

    The authorized take differs from Point Blue's original request for California sea lions (10,092), northern elephant seals (261), harbor seals (526) and Steller sea lions (185). NMFS bases these new estimates on historical data from previous monitoring reports and anecdotal data for the same activities conducted in the proposed research area. In brief, for each species, we created a statistical model to derive an estimate of the average annual increase of reported take based on a best fit regression analysis (i.e., linear or polynomial regression) of reported take from 2007 to 2013. Next, we added the predicted annual increase in take to a baseline of take reported for 2013-2014 season to project the estimated take for each species for the 2015-2016 Authorization. We carried through the same predicted annual increase in take for future Authorizations (2014-2017) to obtain a mean projected take for each species. Last, we analyzed the reported take for each activity by calculating the upper bound of the 99 percent confidence interval of the mean reported take (2007-2013) and mean projected take (2014-2017) for each species. Our use of the upper confidence interval represents the best available information that supports our precautionary deliberation of how much take could occur annually.

    There is no evidence that Point Blue's planned activities could result in injury, serious injury or mortality within the action area. Moreover, the required mitigation and monitoring measures will minimize further any potential risk for injury, serious injury, or mortality. Thus, we do not authorize any injury, serious injury or mortality. We expect all potential takes to fall under the category of Level B harassment only.

    Encouraging and Coordinating Research

    Point Blue will continue to coordinate monitoring of pinnipeds during the research activities occurring on Southeast Farallon Island, Año Nuevo Island, and Point Reyes National Seashore. Point Blue conducts bone fide research on marine mammals, the results of which may contribute to the basic knowledge of marine mammal biology or ecology, or are likely to identify, evaluate, or resolve conservation problems.

    Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.” The lack of likely adverse effects on annual rates of recruitment or survival (i.e., population level effects) forms the basis of a negligible impact finding.

    In addition to considering estimates of the number of marine mammals that might be “taken” through behavioral harassment, NMFS must consider other factors, such as the likely nature of any responses (their intensity, duration, etc.), the context of any responses (critical reproductive time or location, feeding, migration, etc.), as well as the number and nature of estimated Level A harassment takes, the number of estimated mortalities, effects on habitat, and the status of the species.

    In making a negligible impact determination, we consider:

    (1) The number of anticipated injuries, serious injuries, or mortalities;

    (2) The number, nature, and intensity, and duration of Level B harassment;

    (3) The context in which the takes occur (e.g., impacts to areas of significance, impacts to local populations, and cumulative impacts when taking into account successive/contemporaneous actions when added to baseline data);

    (4) The status of stock or species of marine mammals (i.e., depleted, not depleted, decreasing, increasing, stable, impact relative to the size of the population);

    (5) Impacts on habitat affecting rates of recruitment/survival; and

    (6) The effectiveness of monitoring and mitigation measures.

    For reasons stated previously in this document and based on the following factors, NMFS does not expect Point Blue's specified activities to cause long-term behavioral disturbance, abandonment of the haulout area, injury, serious injury, or mortality:

    (1) The effects of the pinniped and seabird research activities would be limited to short-term startle responses and localized behavioral changes due to the short and sporadic duration of the research activities. Minor and brief responses, such as short-duration startle or alert reactions, are not likely to constitute disruption of behavioral patterns, such as migration, nursing, breeding, feeding, or sheltering.

    (2) The availability of alternate areas for pinnipeds to avoid the resultant acoustic and visual disturbances from the research operations. Results from previous monitoring reports also show that the pinnipeds returned to the various sites and did not permanently abandon haul-out sites after Point Blue conducted their pinniped and research activities.

    (3) There is no potential for large-scale movements leading to injury, serious injury, or mortality because the researchers must delay ingress into the landing areas until after the pinnipeds present have slowly entered the water.

    (4) The limited access of Point Blue's researchers to Southeast Farallon Island, Año Nuevo Island, and Point Reyes National Seashore during the pupping season.

    We do not anticipate that any injuries, serious injuries, or mortalities would occur as a result of Point Blue's proposed activities, and we do not authorize injury, serious injury or mortality. These species may exhibit behavioral modifications, including temporarily vacating the area during the proposed seabird and pinniped research activities to avoid the resultant acoustic and visual disturbances. Further, these proposed activities would not take place in areas of significance for marine mammal feeding, resting, breeding, or calving and would not adversely impact marine mammal habitat. Due to the nature, degree, and context of the behavioral harassment anticipated, the activities are not expected to impact annual rates of recruitment or survival.

    NMFS does not expect pinnipeds to permanently abandon any area that is surveyed by researchers, as is evidenced by continued presence of pinnipeds at the sites during annual monitoring counts. Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed mitigation and monitoring measures, NMFS finds that the total marine mammal take from Point Blue's seabird research activities will not adversely affect annual rates of recruitment or survival and therefore will have a negligible impact on the affected species or stocks.

    Small Numbers

    As mentioned previously, NMFS estimates that four species of marine mammals could be potentially affected by Level B harassment over the course of the proposed Authorization. Because these are maximum estimates, actual take numbers are likely to be lower, as some animals may select other haulout sites the day the researchers are present. For each species, these numbers are small numbers (each, less than or equal to two percent) relative to the population size. These incidental harassment numbers represent approximately 3.33 percent of the U.S. stock of California sea lion, 1.74 percent of the California stock of Pacific harbor seal, 0.16 percent of the California breeding stock of northern elephant seal, and 0.17 percent of the eastern distinct population segment of Steller sea lion.

    Impact on Availability of Affected Species or Stock for Taking for Subsistence Uses

    Section 101(a)(5)(D) of the MMPA also requires us to determine that the taking will not have an unmitigable adverse effect on the availability of marine mammal species or stocks for subsistence use. There are no relevant subsistence uses of marine mammals implicated by this action. Thus, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

    Endangered Species Act

    On October 23, 2013 NMFS announced the removal of the eastern distinct population segment of Steller sea lions from the list of threatened species under the ESA. No marine mammal species listed under the ESA are anticipated to occur in the action area. Therefore, NMFS has determined that a section 7 consultation under the ESA is not required.

    National Environmental Policy Act (NEPA)

    In 2014, we prepared an Environmental Assessment (EA) analyzing the potential effects to the human environment from NMFS' issuance of a proposed Authorization to Point Blue for their seabird research activities. In January 2014, NMFS issued a Finding of No Significant Impact (FONSI) on the issuance of an Authorization for Point Blue's research activities in accordance with section 6.01 of the NOAA Administrative Order 216-6 (Environmental Review Procedures for Implementing the National Environmental Policy Act, May 20, 1999). Point Blue's proposed activities and impacts for 2015-2016 are within the scope of the 2014 EA and FONSI. NMFS has reviewed the 2014 EA and determined that there are no new direct, indirect, or cumulative impacts to the human and natural environment associated with the Authorization requiring evaluation in a supplemental EA and NMFS, therefore, reaffirms the 2014 FONSI.

    Authorization

    As a result of these determinations, we have issued an Authorization to Point Blue for the take of marine mammals incidental to proposed seabird and pinniped research activities, provided they incorporate the previously mentioned mitigation, monitoring, and reporting requirements.

    Dated: February 3, 2015. Donna S. Wieting, Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2015-03849 Filed 2-24-15; 8:45 am] BILLING CODE 3510-22-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION Compliance Bulletin—Treatment of Confidential Supervisory Information AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Compliance Bulletin.

    SUMMARY:

    The Bureau of Consumer Financial Protection (CFPB) is issuing a compliance bulletin entitled “Treatment of Confidential of Supervisory Information” as a reminder that, with limited exceptions, persons in possession of confidential information, including confidential supervisory information (CSI), may not disclose such information to third parties.

    DATES:

    This bulletin is effective February 25, 2015 and applicable beginning January 27, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Christopher Young, Managing Senior Counsel and Chief of Staff, (202) 435-7408, Office of Supervision Policy.

    SUPPLEMENTARY INFORMATION:

    I. Introduction

    The CFPB issues this compliance bulletin as a reminder that, with limited exceptions, persons in possession of confidential information, including CSI, may not disclose such information to third parties.1 More particularly, this bulletin:

    1 “Confidential information” means “confidential consumer complaint information, confidential investigative information, and confidential supervisory information, as well as any other CFPB information that may be exempt from disclosure under the Freedom of Information Act pursuant to 5 U.S.C. 552(b). Confidential information does not include information contained in records that have been made publicly available by the CFPB or information that has otherwise been publicly disclosed by an employee with the authority to do so.” 12 CFR 1070.2(f). CSI, the focus of this bulletin, is but one type of confidential information. See 12 CFR 1070.2(i) (defining “confidential supervisory information”).

    1. Sets forth the definition of CSI;

    2. Provides examples of CSI;

    3. Highlights certain legal restrictions on the disclosure of CSI; and

    4. Explains that private confidentiality and non-disclosure agreements (NDAs) neither alter the legal restrictions on the disclosure of CSI nor impact the CFPB's authority to obtain information from covered persons 2 and service providers 3 in the exercise of its supervisory authority.

    2 “Covered person[s]” include “(A) any person that engages in offering or providing a consumer financial product or service; and (B) any affiliate of a person described [in (A)] if such affiliate acts as a service provider to such person.” 12 U.S.C. 5481(6).

    3 “Service provider” means “any person that provides a material service to a covered person in connection with the offering or provision by such covered person of a consumer financial product or service, including a person that—(i) participates in designing, operating, or maintaining the consumer financial product or service; or (ii) processes transactions relating to the consumer financial product or service (other than unknowingly or incidentally transmitting or processing financial data in a manner that such data is undifferentiated from other types of data of the same form as the person transmits or processes) . . . . The term `service provider' does not include a person solely by virtue of such person offering or providing to a covered person—(i) a support service of a type provided to businesses generally or a similar ministerial service; or (ii) time or space for an advertisement for a consumer financial product or service through print, newspaper, or electronic media.” 12 U.S.C. 5481(26).

    II. Compliance Bulletin

    The CFPB has supervisory authority over certain covered persons, including very large depository institutions, credit unions and their affiliates; 4 certain nonbanks; 5 and service providers 6 (collectively, supervised financial institutions).7 Many supervised financial institutions became subject to federal supervision for the first time under the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act).8

    4 12 U.S.C. 5515(a).

    5 Under 12 U.S.C. 5514, the CFPB has supervisory authority over all nonbank covered persons offering or providing three enumerated types of consumer financial products or services: (1) Origination, brokerage, or servicing of consumer loans secured by real estate, and related mortgage loan modification or foreclosure relief services; (2) private education loans; and (3) payday loans. 12 U.S.C. 5514(a)(1)(A), (D), (E). The CFPB also has supervisory authority over “larger participant[s] of a market for other consumer financial products or services,” as the CFPB defines by rule. 12 U.S.C. 5514(a)(1)(B), (a)(2). Additionally, the CFPB has the authority to supervise any nonbank covered person that it “has reasonable cause to determine, by order, after notice to the covered person and a reasonable opportunity . . . to respond[,] . . . is engaging, or has engaged, in conduct that poses risks to consumers with regard to the offering or provision of consumer financial products or services.” 12 U.S.C. 5514(a)(1)(C).

    6 12 U.S.C. 5514(e), 5515(d).

    7 “Financial institution” means “any person involved in the offering or provision of a `financial product or service,' including a `covered person' or `service provider,' as those terms are defined by 12 U.S.C. 5481.” 12 CFR 1070.2(l). “Supervised financial institution” means “a financial institution that is or that may become subject to the CFPB's supervisory authority.” 12 CFR 1070.2(q).

    8 Public Law 111-203 (codified at 12 U.S.C. 5301 et seq.).

    Pursuant to authority granted under the Dodd-Frank Act,9 the CFPB has issued regulations that govern the use and disclosure of CSI.10 The CFPB expects all supervised financial institutions to know and comply with the regulations governing CSI, and provides the following guidance to assist with such compliance.

    9 12 U.S.C. 5512(c)(6)(A).

    10See 12 CFR part 1070. In addition to the confidentiality protections afforded by the CFPB's regulation, CSI may also be subject to other laws regarding disclosure, including the bank examination or other privileges, privacy laws, and other restrictions.

    A. Definition of CSI

    Under the CFPB's regulations, “confidential supervisory information” means:

    • Reports of examination, inspection and visitation, non-public operating, condition, and compliance reports, and any information contained in, derived from, or related to such reports;

    • Any documents, including reports of examination, prepared by, or on behalf of, or for the use of the CFPB or any other Federal, State, or foreign government agency in the exercise of supervisory authority over a financial institution, and any supervision information derived from such documents;

    • Any communications between the CFPB and a supervised financial institution or a Federal, State, or foreign government agency related to the CFPB's supervision of the institution;

    • Any information provided to the CFPB by a financial institution to enable the CFPB to monitor for risks to consumers in the offering or provision of consumer financial products or services, or to assess whether an institution should be considered a covered person, as that term is defined by 12 U.S.C. 5481, or is subject to the CFPB's supervisory authority; and/or

    • Information that is exempt from disclosure pursuant to 5 U.S.C. 552(b)(8).11

    11 12 CFR 1070.2(i).

    CSI does not include documents prepared by a financial institution for its own business purposes and that the CFPB does not possess.12

    12 12 CFR 1070.2(i)(2).

    B. Examples of CSI

    Supervised financial institutions and other persons that may come into possession of CSI should understand what constitutes CSI in order to comply with the applicable rules.13 Examples of CSI include, but are not limited to:

    13See generally 12 CFR 1070.

    • CFPB examination reports and supervisory letters;

    • All information contained in, derived from, or related to those documents, including an institution's supervisory Compliance rating;

    • Communications between the CFPB and the supervised financial institution related to the CFPB's examination of the institution or other supervisory activities; and

    • Other information created by the CFPB in the exercise of its supervisory authority.

    Thus, CSI includes any workpapers or other documentation that CFPB examiners have prepared in the course of an examination. CSI also includes supervisory information requests from the CFPB to a supervised financial institution, along with the institution's responses. In addition, any CFPB supervisory actions, such as memoranda of understanding between the CFPB and an institution, and related submissions and correspondence, are CSI.

    C. Disclosure of Confidential Information Generally Prohibited

    Subject to limited exceptions, supervised financial institutions and other persons in possession of CSI of the CFPB may not disclose such information.14

    14See 12 CFR 1070.41(a) (providing that “[e]xcept as required by law or as provided in this part, no . . . person in possession of confidential information[] shall disclose such confidential information by any means (including written or oral communications) or in any format (including paper and electronic formats), to: (1) [a]ny person who is not an employee, contractor, or consultant of the CFPB; or (2) [a]ny CFPB employee, contractor, or consultant when the disclosure of such confidential information . . . is not relevant to the performance of the employee's, contractor's, or consultant's assigned duties”); see also 12 CFR 1070.42(b) (setting forth exceptions relating to the disclosure of “confidential supervisory information of the CFPB” which is “lawfully in [the] possession” of any “supervised financial institution”).

    D. Exceptions to General Prohibition on Disclosure of CSI

    There are certain exceptions to the general prohibition against disclosing CSI to third parties. A supervised financial institution may disclose CSI of the CFPB lawfully in its possession to:

    • Its affiliates;

    • Its directors, officers, trustees, members, general partners, or employees, to the extent that the disclosure of such CSI is relevant to the performance of such individuals' assigned duties;

    • The directors, officers, trustees, members, general partners, or employees of its affiliates, to the extent that the disclosure of such CSI is relevant to the performance of such individuals' assigned duties;

    • Its certified public accountant, legal counsel, contractor, consultant, or service provider.15

    15 12 CFR 1070.42(b).

    Supervised financial institutions may also in certain instances disclose CSI to others with the prior written approval of the Associate Director for Supervision, Enforcement, and Fair Lending, or his or her delegee (Associate Director).16 The recipient of CSI shall not, without the prior written approval of the Associate Director, utilize, make, or retain copies of, or disclose CSI for any purpose, except as is necessary to provide advice or services to the supervised financial institution or its affiliate.17 Moreover, any supervised financial institution or affiliate disclosing CSI shall take reasonable steps as specified in the regulations to ensure that the recipient complies with the rules governing CSI.18

    16 12 CFR 1070.42(b)(2)(ii).

    17 12 CFR 1070.42(b)(3)(i).

    18 12 CFR 1070.42(b)(3)(ii).

    Confidential information made available by the CFPB pursuant to 12 CFR part 1070 remains the property of the CFPB. There are other important requirements relating to the disclosure of confidential information, including disclosure pursuant to third-party legally enforceable demands, such as subpoenas or Freedom of Information Act requests. Among a number of other requirements, a recipient of a demand for confidential information must inform the CFPB's General Counsel of the demand.19

    19 12 CFR 1070.47.

    E. NDAs Do Not Supersede Federal Legal Requirements

    The CFPB recognizes that some supervised financial institutions may have entered into third-party NDAs that, in part, purport to: (1) Restrict the supervised financial institution from sharing certain information with a supervisory agency; and/or (2) require the supervised financial institution to advise the third party when the institution shares with a supervisory agency information subject to the NDA. However, such provisions in NDAs between supervised financial institutions and third parties do not alter or limit the CFPB's supervisory authority or the supervised financial institution's obligations relating to CSI.

    A supervised financial institution should not attempt to use an NDA as the basis for failing to provide information sought pursuant to supervisory authority. The CFPB has the authority to require supervised financial institutions and certain other persons to provide it with reports and other information to conduct supervisory activities, pursuant to the Dodd-Frank Act.20 Failure to provide information required by the CFPB is a violation of law for which the CFPB will pursue all available remedies.21

    20 12 U.S.C. 5514, 5515.

    21See 12 U.S.C. 5536(a)(2) (making it unlawful for a supervised financial institution “to fail or refuse, as required by Federal consumer financial law, or any rule or order issued by the CFPB thereunder—(A) to permit access to or copying of records; . . . or (C) to make reports or provide information to the Bureau.”).

    In addition, a supervised financial institution may risk violating the law if it relies upon provisions of an NDA to justify disclosing CSI in a manner not otherwise permitted. As noted above, any disclosure of CSI outside of the applicable exceptions would require the prior written approval of the Associate Director for Supervision, Enforcement, and Fair Lending (or his or her delegee).22

    22See 12 CFR 1070.42(b)(2)(ii).

    Supervised financial institutions should contact appropriate CFPB supervisory personnel with any questions regarding this Bulletin.

    III. Regulatory Requirements

    This compliance bulletin provides nonbinding guidance on matters including limitations on disclosure of CSI under applicable law. It is therefore exempt from the notice and comment rulemaking requirements under the Administrative Procedure Act pursuant to 5 U.S.C. 553(b). Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis.23 In addition, the CFPB has determined that this bulletin summarizes existing requirements and does not establish any new nor revise any existing recordkeeping, reporting, or disclosure requirements on covered entities or members of the public that would be collections of information requiring OMB approval under the Paperwork Reduction Act.24

    23 5 U.S.C. 603(a), 604(a).

    24 44 U.S.C. 3501 et seq.

    Dated: February 2015. Richard Cordray, Director, Bureau of Consumer Financial Protection.
    [FR Doc. 2015-03791 Filed 2-24-15; 8:45 am] BILLING CODE 4810-AM-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID DoD-2015-OS-0021] Proposed Collection; Comment Request AGENCY:

    Defense Security Cooperation Agency, DoD.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the Defense Security Cooperation 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 April 27, 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: Federal Docket Management System Office, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.

    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 the same electronic docket and downloaded for reviewing/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 Defense Security Cooperation Agency (DSCA) (ATTN: David Frasher, 220 12th Street South, Suite 203, Arlington VA, 22202-5408 or call (703) 601-4459 or Defense Institute of Security Assistance Management (DISAM), ATTN: Donald McCormick, 2475 K Street, Wright-Patterson AFB, OH 45433-7803, or call Director of Academic Support, at 937-713-3340.

    SUPPLEMENTARY INFORMATION:

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

    Needs and Uses: The DISAM Information Technology Mission System (DISM): Is a web based portal designed to hold several web applications for the purposes of efficient administration of U.S. and international students, and the effective management of DISAM personnel and guest lecturers. The portal provides DISAM personnel the ability to submit travel request and travel arrangements. Finally, the web based portal uses a relational database to record, manage and report information about students, personnel, travel. Reports of annual training of Foreign nationals to Congress as required by 22 U.S. Code 2394 (Foreign Assistance Act (FAA)) and 22 U.S. Code 2770A (Arms Export Control Act (AECA)).

    Affected Public: Individuals and Households.

    Disam Student Registration Form:

    Annual Burden Hours: 2388 hours.

    Number of Respondents: 4775.

    Responses per Respondent: 2.

    Annual Responses: 9551.

    Average Burden per Response: 15 minutes.

    Frequency: On occasion.

    Disam Guest Speaker Form: (Still in development).

    Annual Burden Hours: 62.

    Number of Respondents: 249.

    Responses per Respondent: 1.

    Annual Responses: 249.

    Average Burden per Response: 15 min.

    Frequency: On occasion.

    Average Totals:

    Annual Burden Hours: 1884 hours.

    Number of Respondents: 5024.

    Responses per Respondent: 1.5.

    Annual Responses: 7536.

    Average Burden per Response: 15 min.

    Respondents are contractor personnel, non-DOD U.S. Federal Government, Foreign Service nationals and industry students, guest speakers and lecturers involved in the Security Cooperation initiatives as prescribed by the President of the United States, Congress and Departments of State and Defense. Security Cooperation and Assistance programs as authorized by the Foreign Assistance Act (FAA), and the Arms Export Control Act (AECA) are required to be administered by qualified personnel receiving formal education through the Defense Institute of Security Assistance Management (DISAM) or other authorized Security Cooperation agencies. If the information collected on the student registration form is not collected, personnel looking to verify the qualifications of individuals in the Security Cooperation workforce database on the SAN, DISAM Student Database or the DISAM Personnel Database would be unable to match personnel to training and ensure compliance with DepSecDef directive and federal law requiring the reporting of training of foreign nationals (ref. AECA). The DISAM Personnel Database in conjunction with the Travel Forms maintains records of the personnel TDY travel and reimbursement as required by federal law and DoD regulations.

    Dated: February 19, 2015. Aaron Siegel, Alternate OSD Federal Register, Liaison Officer, Department of Defense.
    [FR Doc. 2015-03785 Filed 2-24-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID DoD-2014-HA-0146] 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 March 27, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Fred Licari, 571-372-0493.

    SUPPLEMENTARY INFORMATION:

    Title, Associated Form and OMB Number: Screening and Monitoring of DoD Personnel Deployed to Ebola Outbreak Areas; DD Form 2990, DD Form 2991; OMB Control Number 0720-0056.

    Type of Request: Extension.

    Number of Respondents: 1,200.

    Responses per Respondent: 2.

    Annual Responses: 2,400.

    Average Burden per Response: 12 minutes.

    Annual Burden Hours: 480.

    Needs And Uses: The information collection requirement is necessary to ensure DoD personnel deployed in support of Operation UNITED ASSISTANCE are promptly evaluated for possible exposure(s) to the Ebola virus during deployment to, and within 12 hours prior to departing from, an Ebola outbreak country or region (West Africa). Ebola is a Quarantinable Communicable Disease as named in Executive Order 13295 and supported by several DoD regulations and Federal laws. This information will be used by DoD medical and public health officials to (1) ensure Ebola exposure risk is evaluated, (2) proper prevention and quarantine efforts are implemented, (3) appropriate medical care is provided, (4) medical surveillance programs are robust and (5) the spread of Ebola beyond West Africa is minimized. The DoD has consulted with the Centers for Disease Control and Prevention, the Department of State, the Agency for International Development, and several Defense Agencies regarding disease control efforts and health surveillance in response to the public health emergency in West Africa. DoD has also specifically discussed these new information collections with representatives of the various Military Services, representing deploying military members who have participated in the development of the content of these forms.

    Affected Public: Individuals or households.

    Frequency: On occasion.

    Respondent's Obligation: Voluntary.

    OMB Desk Officer: Ms. Jasmeet Seehra.

    Written comments and recommendations on the proposed information collection should be sent to Ms. Jasmeet Seehra at the Office of Management and Budget, Desk Officer for DoD, Room 10236, New Executive Office Building, Washington, DC 20503.

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

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

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

    DOD Clearance Officer: Mr. Frederick Licari.

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

    Dated: February 20, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-03906 Filed 2-24-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Judicial Proceedings Since Fiscal Year 2012 Amendments Panel (Judicial Proceedings Panel); Notice of Federal Advisory Committee Meeting AGENCY:

    Department of Defense.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Department of Defense is publishing this notice to announce the following Federal Advisory Committee meeting of the Judicial Proceedings since Fiscal Year 2012 Amendments Panel (“the Judicial Proceedings Panel” or “the Panel”). The meeting is open to the public.

    DATES:

    A meeting of the Judicial Proceedings Panel will be held on Friday, March 13, 2015. The Public Session will begin at 9:00 a.m. and end at 5:00 p.m.

    ADDRESSES:

    U.S. District Court for the District of Columbia, 333 Constitution Avenue NW, Courtroom #20, 6th floor, Washington, DC 20001.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Julie Carson, Judicial Proceedings Panel, One Liberty Center, 875 N. Randolph Street, Suite 150, Arlington, VA 22203. Email: [email protected] Phone: (703) 693-3849. Web site: http://jpp.whs.mil.

    SUPPLEMENTARY INFORMATION:

    This public meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.

    Purpose of the Meeting: In Section 576(a)(2) of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 112-239), as amended, Congress tasked the Judicial Proceedings Panel to conduct an independent review and assessment of judicial proceedings conducted under the Uniform Code of Military Justice involving adult sexual assault and related offenses since the amendments made to the Uniform Code of Military Justice by section 541 of the National Defense Authorization Act for Fiscal Year 2012 (Pub. L. 112—81; 125 Stat. 1404), for the purpose of developing recommendations for improvements to such proceedings. At this meeting, the Panel will consider the adequacy of the provision of compensation and restitution for victims of offenses under the UCMJ, and develop recommendations on expanding such compensation and restitution. Specifically, the Panel will consider options for providing the forfeited wages of incarcerated members of the Armed Forces to victims of offenses as compensation; including bodily harm among the injuries meriting compensation for redress under section 939 of title 10, United States Code (article 139 of the UCMJ); and requiring restitution by members of the Armed Forces to victims of their offenses upon the direction of a court-martial. The Panel is interested in written and oral comments from the public, including non-governmental organizations, relevant to these issues or any of the Panel's tasks.

    Agenda: • 8:30 a.m.-9:00 a.m. Administrative Session (41 CFR 102-3.160, not subject to notice & open meeting requirements) • 9:00 a.m.-10:00 a.m. DoD Overview of Compensation and Restitution (public meeting begins) Speakers: Department of Defense subject matter experts • 10:00 a.m.-11:00 a.m. Economic Needs of Sexual Assault Victims and Barriers to Compensation Speakers: Law school professors with recent scholarship on restitution and compensation for victims of sexual assault crimes • 11:00 a.m.-12:15 p.m. State Compensation Programs: History, Purposes, and Use by Military/Dependent Victims Speakers: Representatives from national and state crime victim compensation associations • 12:15 p.m.-1:00 p.m. Lunch • 1:00 p.m.-2:15 p.m. How Victims Can Obtain Restitution or Compensation for Crimes Under the Uniform Code of Military Justice Speakers: Military Services' subject matter experts • 2:15 p.m.-4:45 p.m. Perspectives on Compensation and Restitution for Sexual Assault Victims Speakers: Civilian and military practitioners, representatives from victim advocacy organizations • 4:45 p.m.-5:00 p.m. Public Comment

    Availability of Materials for the Meeting: A copy of the March 13, 2015 meeting agenda or any updates to the agenda, to include individual speakers not identified at the time of this notice, as well as other materials presented related to the meeting, may be obtained at the meeting or from the Panel's Web site at http://jpp.whs.mil.

    Public's Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is limited and is on a first-come basis.

    Special Accommodations: Individuals requiring special accommodations to access the public meeting should contact Ms. Julie Carson at [email protected] at least five (5) business days prior to the meeting so that appropriate arrangements can be made.

    Procedures for Providing Public Comments: Pursuant to 41 CFR 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written comments to the Panel about its mission and topics pertaining to this public session. Written comments must be received by Ms. Julie Carson at least five (5) business days prior to the meeting date so that they may be made available to the Judicial Proceedings Panel for their consideration prior to the meeting. Written comments should be submitted via email to Ms. Carson at [email protected] in the following formats: Adobe Acrobat or Microsoft Word. Please note that since the Judicial Proceedings Panel operates under the provisions of the Federal Advisory Committee Act, as amended, all written comments will be treated as public documents and will be made available for public inspection. If members of the public are interested in making an oral statement, a written statement must be submitted along with a request to provide an oral statement. Oral presentations by members of the public will be permitted between 4:45 p.m. and 5:00 p.m. on March 13, 2015 in front of the Panel. The number of oral presentations to be made will depend on the number of requests received from members of the public on a first-come basis. After reviewing the requests for oral presentation, the Chairperson and the Designated Federal Officer will, having determined the statement to be relevant to the Panel's mission, allot five minutes to persons desiring to make an oral presentation.

    Committee's Designated Federal Officer: The Panel's Designated Federal Officer is Ms. Maria Fried, Judicial Proceedings Panel, 1600 Defense Pentagon, Room 3B747, Washington, DC 20301-1600.

    Dated: February 20, 2015. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2015-03904 Filed 2-24-15; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Army Advisory Committee on Arlington National Cemetery Remember Subcommittee Meeting Notice AGENCY:

    Department of the Army, DoD.

    ACTION:

    Notice of open subcommittee meeting.

    SUMMARY:

    The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the Remember Subcommittee of the Advisory Committee on Arlington National Cemetery (ACANC). The meeting is open to the public. For more information about the Committee and the Remember Subcommittee, please visit http://www.arlingtoncemetery.mil/About/Advisory-Committee-on-Arlington-National-Cemetery/Charter.

    DATES:

    The Remember Subcommittee will meet from 0900 a.m.-1000 a.m. on Thursday, March 12, 2015.

    ADDRESSES:

    Women in Service to America Memorial, Arlington National Cemetery, Arlington, VA 22211.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Renea C. Yates; Designated Federal Officer for the committee and the Remember Subcommittee, in writing at Arlington National Cemetery, Arlington VA 22211, or by email at [email protected], or by phone at 703-614-1248.

    SUPPLEMENTARY INFORMATION:

    This subcommittee meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (U.S.C. 552b, as amended) and 41 Code of the Federal Regulations (CFR 102-3.150).

    Purpose of the Meeting: The Advisory Committee on Arlington National Cemetery is an independent Federal advisory committee chartered to provide the Secretary of the Army independent advice and recommendations on Arlington National Cemetery, including, but not limited to, cemetery administration, the erection of memorials at the cemetery, and master planning for the cemetery. The Secretary of the Army may act on the committee's advice and recommendations. The primary purpose of the Remember Subcommittee is to review and provide recommendations on preservation and care for the marble components of the Tomb of the Unknown Soldier, including addressing the cracks in the large marble sarcophagus, the adjacent marble slabs, and the disposition of the dye block already gifted to the Army.

    Proposed Agenda: The subcommittee will review the current status of monument preservation as well as request for a Commemorative Monument to be placed at Arlington National Cemetery from the Vietnam Helicopter Association. Public's Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is on a first-come basis. The Women in Military Service to America Memorial is fully handicapped accessible. For additional information about public access procedures, contact Ms. Renea Yates, the subcommittee's Designated Federal Officer, at the email address or telephone number listed in the FOR FURTHER INFORMATION CONTACT section.

    Written Comments and Statements: Pursuant to 41 CFR 102-3.105(j) and 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act, the public or interested organizations may submit written comments or statements to the subcommittee, in response to the stated agenda of the open meeting or in regard to the subcommittee's mission in general. Written comments or statements should be submitted to Ms. Renea Yates, the subcommittee's Designated Federal Officer, via electronic mail, the preferred mode of submission, at the address listed in the FOR FURTHER INFORMATION CONTACT section. Each page of the comment or statement must include the author's name, title or affiliation, address, and daytime phone number. Written comments or statements being submitted in response to the agenda set forth in this notice must be received by the Designated Federal Officer at least seven business days prior to the meeting to be considered by the subcommittee. The Designated Federal Officer will review all timely submitted written comments or statements with the subcommittee Chairperson, and ensure the comments are provided to all members of the subcommittee before the meeting. Written comments or statements received after this date may not be provided to the subcommittee until its next meeting. Pursuant to 41 CFR 102-3.140d, the subcommittee is not obligated to allow the public to speak; however, interested persons may submit a written statement or a request to speak for consideration by the subcommittee. After reviewing any written statements or requests submitted, the subcommittee Chairperson and the Designated Federal Officer may choose to invite certain submitters to present their comments verbally during the open portion of this meeting or at a future meeting. The Designated Federal Officer, in consultation with the subcommittee Chairperson, may allot a specific amount of time for submitters to present their comments verbally.

    Brenda S. Bowen, Army Federal Register Liaison Officer.
    [FR Doc. 2015-03860 Filed 2-24-15; 8:45 am] BILLING CODE 3710-08-P
    DEPARTMENT OF DEFENSE Department of the Army Advisory Committee on Arlington National Cemetery Honor Subcommittee Meeting Notice AGENCY:

    Department of the Army, DoD.

    ACTION:

    Notice of open subcommittee meeting.

    SUMMARY:

    The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the Honor Subcommittee of the Advisory Committee on Arlington National Cemetery (ACANC). The meeting is open to the public. For more information about the Committee and the Honor Subcommittee, please visit http://www.arlingtoncemetery.mil/About/Advisory-Committee-on-Arlington-National-Cemetery/Charter.

    DATES:

    The Honor Subcommittee will meet from 10:00 a.m.-11:30 a.m. on Thursday, March 12, 2015.

    ADDRESSES:

    Women in Service to America Memorial, Arlington National Cemetery, Arlington, VA 22211.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Renea C. Yates; Designated Federal Officer for the committee and the Honor Subcommittee, in writing at Arlington National Cemetery, Arlington VA 22211, or by email at [email protected], or by phone at 703-614-1248.

    SUPPLEMENTARY INFORMATION:

    This subcommittee meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (U.S.C. 552b, as amended) and 41 Code of the Federal Regulations (CFR 102-3.150).

    Purpose of the Meeting: The Advisory Committee on Arlington National Cemetery is an independent Federal advisory committee chartered to provide the Secretary of the Army independent advice and recommendations on Arlington National Cemetery, including, but not limited to, cemetery administration, the erection of memorials at the cemetery, and master planning for the cemetery. The Secretary of the Army may act on the committee's advice and recommendations. The primary purpose of the Honor Subcommittee is to review and provide recommendations to the parent committee on extending the future locations and availability of active burial gravesites at Arlington National Cemetery, veteran eligibility criteria, and master planning.

    Proposed Agenda: The subcommittee will receive an update on the status of all major infrastructure and expansion projects. Public's Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is on a first-come basis. The Women in Military Service to America Memorial is fully handicapped accessible. For additional information about public access procedures, contact Ms. Renea Yates, the subcommittee's Designated Federal Officer, at the email address or telephone number listed in the FOR FURTHER INFORMATION CONTACT section.

    Written Comments and Statements: Pursuant to 41 CFR 102-3.105(j) and 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act, the public or interested organizations may submit written comments or statements to the subcommittee, in response to the stated agenda of the open meeting or in regard to the subcommittee's mission in general. Written comments or statements should be submitted to Ms. Renea Yates, the subcommittee's Designated Federal Officer, via electronic mail, the preferred mode of submission, at the address listed in the FOR FURTHER INFORMATION CONTACT section. Each page of the comment or statement must include the author's name, title or affiliation, address, and daytime phone number. Written comments or statements being submitted in response to the agenda set forth in this notice must be received by the Designated Federal Officer at least seven business days prior to the meeting to be considered by the subcommittee. The Designated Federal Officer will review all timely submitted written comments or statements with the subcommittee Chairperson, and ensure the comments are provided to all members of the subcommittee before the meeting. Written comments or statements received after this date may not be provided to the subcommittee until its next meeting. Pursuant to 41 CFR 102-3.140d, the subcommittee is not obligated to allow the public to speak; however, interested persons may submit a written statement or a request to speak for consideration by the subcommittee. After reviewing any written statements or requests submitted, the subcommittee Chairperson and the Designated Federal Officer may choose to invite certain submitters to present their comments verbally during the open portion of this meeting or at a future meeting. The Designated Federal Officer, in consultation with the subcommittee Chairperson, may allot a specific amount of time for submitters to present their comments verbally.

    Brenda S. Bowen, Army Federal Register Liaison Officer.
    [FR Doc. 2015-03861 Filed 2-24-15; 8:45 am] BILLING CODE 3710-08-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2014-ICCD-0165] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Annual Report on Appeals Process RSA-722 AGENCY:

    Office of Special Education and Rehabilitative Services (OSERS), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 27, 2015.

    ADDRESSES:

    Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting Docket ID number ED-2014-ICCD-0165 or via postal mail, commercial delivery, or hand delivery. If the regulations.gov site is not available to the public for any reason, ED will temporarily accept comments at [email protected] Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted; ED will ONLY accept comments during the comment period in this mailbox when the regulations.gov site is not available. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Mailstop L-OM-2-2E319, Room 2E105, Washington, DC 20202.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Edward West, 202-245-6145.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Annual Report on Appeals Process RSA-722.

    OMB Control Number: 1820-0563.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: State, Local and Tribal Governments.

    Total Estimated Number of Annual Responses: 80.

    Total Estimated Number of Annual Burden Hours: 160.

    Abstract: Pursuant to subsection 102(c)(8)(A) and (B) of the Rehabilitation Act of 1973 as amended by the Workforce Innovation and Opportunity Act the RSA-722 is needed to meet specific data collection requirements on the number of requests for mediations, hearings, administrative reviews and other methods of dispute resolution requested and the manner in which they were resolved. The information collected is used to evaluate the types of complaints made by applicants and eligible individuals of the vocational rehabilitation program and the final resolution of appeals filed. Respondents are State agencies that administer the Federal/State Program for Vocational Rehabilitation.

    Dated: February 19, 2015. Stephanie Valentine, Acting Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management.
    [FR Doc. 2015-03796 Filed 2-24-15; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2014-ICCD-0164] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Charter Schools Program (CSP) Grant Award Database AGENCY:

    Office of Innovation and Improvement (OII), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 27, 2015.

    ADDRESSES:

    Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting Docket ID number ED-2014-ICCD-0164 or via postal mail, commercial delivery, or hand delivery. If the regulations.gov site is not available to the public for any reason, ED will temporarily accept comments at [email protected] Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted; ED will ONLY accept comments during the comment period in this mailbox when the regulations.gov site is not available. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Mailstop L-OM-2-2E319, Room 2E105, Washington, DC 20202.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Patricia Kilby-Robb, 202-260-2225.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Charter Schools Program (CSP) Grant Award Database.

    OMB Control Number: 1855-0016.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: State, Local and Tribal Governments.

    Total Estimated Number of Annual Responses: 81.

    Total Estimated Number of Annual Burden Hours: 139.

    Abstract: This request is for an extension of OMB approval to collect data for the Charter Schools Program (CSP) Grant Awards Database. This current data collection is being coordinated with the EDFacts Initiative to reduce respondent burden and fully utilize data submitted by States and available to the U.S. Department of Education (ED). Specifically, under the current data collection, ED collects CSP grant award information from grantees (State agencies, charter management organizations, and some schools) to create a new database of current CSP-funded charter schools. Together, these data allow ED to monitor CSP grant performance and analyze data related to accountability for academic purposes, financial integrity, and program effectiveness.

    Dated: February 19, 2015. Stephanie Valentine, Acting Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management.
    [FR Doc. 2015-03795 Filed 2-24-15; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2014-ICCD-0162] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; HBCU All Star Student Program AGENCY:

    Office of the Secretary/Office of the Deputy Secretary (OS), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a new information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 27, 2015.

    ADDRESSES:

    Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting Docket ID number ED-2014-ICCD-0162 or via postal mail, commercial delivery, or hand delivery. If the regulations.gov site is not available to the public for any reason, ED will temporarily accept comments at [email protected] Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted; ED will ONLY accept comments during the comment period in this mailbox when the regulations.gov site is not available. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Mailstop L-OM-2-2E319, Room 2E105, Washington, DC 20202.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Sedika Franklin, (202) 453-5630.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: HBCU All Star Student Program.

    OMB Control Number: 1894-New.

    Type of Review: A new information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 105.

    Total Estimated Number of Annual Burden Hours: 367.

    Abstract: This program was designed to recognize current HBCU students for their dedication to academics, leadership and civic engagement. Nominees were asked to submit a nomination package containing a signed nomination form, unofficial transcripts, short essay, resume, and endorsement letter. Items in this package provide the tools necessary to select current HBCU students who are excelling academically and making differences in their community.

    Dated: February 19, 2015. Stephanie Valentine, Acting Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management.
    [FR Doc. 2015-03793 Filed 2-24-15; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2014-ICCD-0163] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Quarterly Cumulative Caseload Report AGENCY:

    Office of Special Education and Rehabilitative Services (OSERS), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 27, 2015.

    ADDRESSES:

    Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting Docket ID number ED-2014-ICCD-0163 or via postal mail, commercial delivery, or hand delivery. If the regulations.gov site is not available to the public for any reason, ED will temporarily accept comments at [email protected] Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted; ED will ONLY accept comments during the comment period in this mailbox when the regulations.gov site is not available. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Mailstop L-OM-2-2E319, Room 2E105, Washington, DC 20202.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Joan Ward, 202-245-7565.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Quarterly Cumulative Caseload Report.

    OMB Control Number: 1820-0013.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: State, Local and Tribal Governments.

    Total Estimated Number of Annual Responses: 320.

    Total Estimated Number of Annual Burden Hours: 320.

    Abstract: State agencies that administer vocational rehabilitation programs provide key caseload data on this form, including numbers of persons who are applicants, determined eligible/ineligible, waiting for services, and their program outcomes. The Rehabilitation Services Administration collects this information quarterly from states and reports it in the Annual Report to Congress on the Rehabilitation Act.

    Dated: February 19, 2015. Stephanie Valentine, Acting Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management.
    [FR Doc. 2015-03794 Filed 2-24-15; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2014-ICCD-0166] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 21st Century Community Learning Centers Annual Performance Report AGENCY:

    Office of Elementary and Secondary Education (OESE), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 27, 2015.

    ADDRESSES:

    Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting Docket ID number ED-2014-ICCD-0166 or via postal mail, commercial delivery, or hand delivery. If the regulations.gov site is not available to the public for any reason, ED will temporarily accept comments at [email protected] Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted; ED will ONLY accept comments during the comment period in this mailbox when the regulations.gov site is not available. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Mailstop L-OM-2-2E319, Room 2E105, Washington, DC 20202.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Daryn Hedlund, 202-401-3008.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: 21st Century Community Learning Centers Annual Performance Report.

    OMB Control Number: 1810-0668.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: Private Sector.

    Total Estimated Number of Annual Responses: 54.

    Total Estimated Number of Annual Burden Hours: 2,433.

    Abstract: The purpose of the 21st Century Community Learning Centers (21st CCLC) program, as authorized under title IV, part B, of the Elementary and Secondary Education Act, sections 4201 et seq., (20 U.S.C. 7171 et seq., attached to submission package), is to provide expanded academic enrichment opportunities for children attending low-performing schools. Tutorial services and academic enrichment activities are designed to help students meet local and state academic standards in subjects such as reading and math. In addition, 21st CCLC programs provide youth development activities, drug and violence prevention programs, technology education programs, art, music and recreation programs, counseling, and character education to enhance the academic component of the program. In support of this program, Congress appropriated nearly $1.1 billion for 21st CCLC programs for fiscal year 2013. Consisting of public and nonprofit agencies, community- and faith-based organizations, local businesses, postsecondary institutions, scientific/cultural and other community entities, 4,077 subgrantees—operating 9,989 centers—provided academic and enrichment services and activities to over 1.7 million children.

    Dated: February 19, 2015. Stephanie Valentine, Acting Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management.
    [FR Doc. 2015-03797 Filed 2-24-15; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION National Advisory Committee on Institutional Quality and Integrity Meeting AGENCY:

    National Advisory Committee on Institutional Quality and Integrity (NACIQI), Office of Postsecondary Education, Department of Education.

    ADDRESSES:

    U.S. Department of Education, Office of Postsecondary Education, 1990 K Street NW., Room 8072, Washington, DC 20006.

    ACTION:

    Notice of an open (virtual) meeting and the opportunity to make third party comments.

    Naciqi's Statutory Authority And Function: The NACIQI is established under Section 114 (d)(2)(B) of the HEA of 1965, as amended, 20 U.S.C. 1011c. The NACIQI advises the Secretary of Education about:

    • The establishment and enforcement of the criteria for recognition of accrediting agencies or associations under Subpart 2, Part H, Title IV, of the HEA, as amended.

    • The recognition of specific accrediting agencies or associations or a specific State approval agency.

    • The preparation and publication of the list of nationally recognized accrediting agencies and associations.

    • The eligibility and certification process for institutions of higher education under Title IV, of the HEA, together with recommendations for improvement in such process.

    • The relationship between (1) accreditation of institutions of higher education and the certification and eligibility of such institutions, and (2) State licensing responsibilities with respect to such institutions.

    • Any other advisory function relating to accreditation and institutional eligibility that the Secretary may prescribe.

    SUMMARY:

    This notice sets forth the schedule for the March 23, 2015, virtual meeting of NACIQI, and provides information to members of the public on registering for the meeting, and for submitting written comments and requests to make oral comments. The notice of this virtual meeting is required under Section 10(a)(2) of the Federal Advisory Committee Act (FACA) and Section 114(d)(2)(B) of the Higher Education Act (HEA) of 1965, as amended, 20 U.S.C. 1011c.

    DATES:

    The NACIQI virtual meeting will be held on Monday, March 23, 2015, beginning at 1:00 p.m. and ending at 4:00 p.m., Eastern Time. The proposed agenda for this virtual meeting consists of discussion and final action on the draft NACIQI Policy Recommendations Report. The report may be accessed at:http://www2.ed.gov/about/bdscomm/list/naciqi-dir/2014-fall/naciqi-draft-recomendations-report-01012015.pdf.

    Meeting Registration: The deadline for registering to attend the virtual meeting is Monday, March 9, 2015. Registration space for the virtual meeting is limited. To register to attend the virtual meeting, email your registration to [email protected] mailbox and enter “Registration for NACIQI” in the subject line of the message. In the body of the email message, please include your name, title, affiliation, mailing address, email address, and telephone number. All registrants will receive an email with the call-in number.

    Submission of Written/Oral Comments Regarding the Committee's Policy Recommendations: Written comments must be received by March 9, 2015, in [email protected] mailbox and include the subject line “Written Comments: Policy Recommendations 2014”. The email must include the name(s), title, organization/affiliation, mailing address, email address, and telephone number, of the person(s) making the comment. Comments should be submitted as a Microsoft Word document or in a medium compatible with Microsoft Word (not a PDF file) that is attached to an electronic mail message (email) or provided in the body of an email message. Please do not send material directly to the NACIQI members.

    To request to make oral comments during the meeting, email your request to [email protected] mailbox and enter “Registration for NACIQI and Request to Make Oral Comments” in the subject line of the email message. In the body of the email message, please provide your name, title, affiliation, mailing address, email address, and telephone number as well as a brief explanation of no more than five sentences that summarize your anticipated comments.

    A total of 30 minutes will be allotted for public comment. Six commenters will be selected on a first-come, first-served basis. Each commenter will be allotted no more than five minutes. The Department will inform all requesters of their selection status in advance of the meeting. Individuals who need accommodations for a disability in order to attend the virtual meeting should contact Patricia Howes at [email protected], or email [email protected] mailbox no later than March 9, 2015. The virtual meeting site is accessible to individuals with disabilities.

    FOR FURTHER INFORMATION CONTACT:

    Carol Griffiths, Executive Director, NACIQI, U.S. Department of Education, 1990 K Street NW., Room 8073, Washington, DC 20006-8129, telephone: (202) 219-7035, fax: (202) 502-7874, or email [email protected]

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Authority:

    Section 114 (d)(2)(B) of the HEA of 1965, as amended, 20 U.S.C. 1011c.

    Lynn B. Mahaffie, Deputy Assistant Secretary for Policy, Planning, and Innovation, Delegated the Authority to Perform the Functions and Duties of the Assistant Secretary for Postsecondary Education.
    [FR Doc. 2015-03612 Filed 2-24-15; 8:45 am] BILLING CODE 4000-01-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: EC11-119-001.

    Applicants: Gabelli, Mario J., GGCP, Inc., GGCP Holdings, LLC, GAMCO Investors, Inc.

    Description: Request for Reauthorization and Extension of Blanket Authorizations Under Section 203 of the Federal Power Act and Request for Expedited Consideration of Mario J. Gabelli, et al.

    Filed Date: 2/12/15.

    Accession Number: 20150212-5210.

    Comments Due: 5 p.m. ET 3/5/15.

    Docket Numbers: EC15-74-000.

    Applicants: Quantum Choctaw Power, LLC.

    Description: Application for Authorization of Disposition of Jurisdictional Facilities under FPA Section 203 of Quantum Choctaw Power, LLC.

    Filed Date: 2/12/15.

    Accession Number: 20150212-5217.

    Comments Due: 5 p.m. ET 3/5/15.

    Docket Numbers: EC15-75-000.

    Applicants: Bluco Energy, LLC.

    Description: Application Under Section 203 of Bluco Energy, LLC.

    Filed Date: 2/12/15.

    Accession Number: 20150212-5219.

    Comments Due: 5 p.m. ET 3/5/15.

    Take notice that the Commission received the following exempt wholesale generator filings:

    Docket Numbers: EG15-47-000.

    Applicants: Shafter Solar, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of Shafter Solar, LLC.

    Filed Date: 2/13/15.

    Accession Number: 20150213-5145.

    Comments Due: 5 p.m. ET 3/6/15.

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

    Docket Numbers: ER13-80-005.

    Applicants: Tampa Electric Company.

    Description: Compliance filing per 35: OATT Order No. 1000 Amendment of Compliance Filing to be effective 1/1/2015.

    Filed Date: 2/13/15.

    Accession Number: 20150213-5065.

    Comments Due: 5 p.m. ET 3/6/15.

    Docket Numbers: ER13-86-005.

    Applicants: Duke Energy Florida, Inc., Duke Energy Carolinas, LLC.

    Description: Compliance filing per 35: Additional Enrollees Filing to be effective 1/1/2015.

    Filed Date: 2/13/15.

    Accession Number: 20150213-5073.

    Comments Due: 5 p.m. ET 3/6/15.

    Docket Numbers: ER13-104-006.

    Applicants: Florida Power & Light Company.

    Description: Compliance filing per 35: FPL Order No. 1000 Further Regional Compliance Filings to be effective 1/1/2015.

    Filed Date: 2/13/15.

    Accession Number: 20150213-5146.

    Comments Due: 5 p.m. ET 3/6/15.

    Docket Numbers: ER14-2518-002.

    Applicants: New York Independent System Operator, Inc.

    Description: Tariff Amendment per 35.17(b): Deficiency Response, request to change effective date—Outage States to be effective 5/1/2015.

    Filed Date: 2/12/15.

    Accession Number: 20150212-5198.

    Comments Due: 5 p.m. ET 3/5/15.

    Docket Numbers: ER15-838-001.

    Applicants: AEP Texas Central Company.

    Description: Tariff Amendment per 35.17(b): TCC-San Roman Wind I Interconnection Agreement Amendment to be effective 1/29/2015.

    Filed Date: 2/13/15.

    Accession Number: 20150213-5088.

    Comments Due: 5 p.m. ET 3/6/15.

    Docket Numbers: ER15-1033-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) rate filing per 35.13(a)(2)(iii): Original Service Agreement No. 4093; Queue Y2-055 (WMPA) to be effective 1/14/2015.

    Filed Date: 2/12/15.

    Accession Number: 20150212-5171.

    Comments Due: 5 p.m. ET 3/5/15.

    Docket Numbers: ER15-1034-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) rate filing per 35.13(a)(2)(iii): Service Agreement No. 3754; Queue No. Y3-036 to be effective 1/13/2015.

    Filed Date: 2/12/15.

    Accession Number: 20150212-5177.

    Comments Due: 5 p.m. ET 3/5/15.

    Docket Numbers: ER15-1035-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) rate filing per 35.13(a)(2)(iii): Three GIAs with Boomer Solar 8 LLC, Boomer Solar 22 LLC, Boomer Solar 14 LLC to be effective 2/14/2015.

    Filed Date: 2/13/15.

    Accession Number: 20150213-5001.

    Comments Due: 5 p.m. ET 3/6/15.

    Docket Numbers: ER15-1036-000.

    Applicants: ISO New England Inc.

    Description: ISO New England Inc. submits 4th Quarter 2014 Capital Budget Report.

    Filed Date: 2/12/15.

    Accession Number: 20150212-5211.

    Comments Due: 5 p.m. ET 3/5/15.

    Docket Numbers: ER15-1037-000.

    Applicants: Wabash Valley Power Association, Inc.

    Description: § 205(d) rate filing per 35.13(a)(2)(iii): Amendment to Section 3.002.001.001—Amended T&LF Agreement to be effective 1/1/2015.

    Filed Date: 2/13/15.

    Accession Number: 20150213-5074.

    Comments Due: 5 p.m. ET 3/6/15.

    Docket Numbers: ER15-1038-000.

    Applicants: Duke Energy Indiana, Inc.

    Description: § 205(d) rate filing per 35.13(a)(2)(iii): Amended TL&F Agreement to be effective 1/1/2015.

    Filed Date: 2/13/15.

    Accession Number: 20150213-5075.

    Comments Due: 5 p.m. ET 3/6/15.

    Docket Numbers: ER15-1039-000.

    Applicants: Homer City Generation, L.P.

    Description: § 205(d) rate filing per 35.13(a)(2)(iii): Homer City Offer of Settlement to be effective 2/12/2015.

    Filed Date: 2/13/15.

    Accession Number: 20150213-5090.

    Comments Due: 5 p.m. ET 3/6/15.

    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: February 13, 2015. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2015-03759 Filed 2-24-15; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OECA-2014-0028; FRL-9922-33-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Calciners and Dryers in Mineral Industries (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency has submitted an information collection request (ICR), “NSPS for Calciners and Dryers in Mineral Industries (40 CFR part 60, subpart UUU) (Renewal)” (EPA ICR No. 0746.09, OMB Control No. 2060-0251), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq). This is a proposed extension of the ICR, which is currently approved through February 28, 2015. Public comments were previously requested via the Federal Register (79 FR 30117) on May 27, 2014, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may neither conduct nor sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before March 27, 2015.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0028, to: (1) EPA online using www.regulations.gov (our preferred method), or by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460; and (2) OMB via email to [email protected] Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

    Abstract: Respondents are owners or operators of calciners and dryers at mineral processing plants that either process or produce any of the following minerals and their concentrates or any mixture of which the majority is any of the following minerals or a combination of these minerals: Alumina, ball clay, bentonite, diatomite, feldspar, fire clay, fuller's earth, gypsum, industrial sand, kaolin, lightweight aggregate, magnesium compounds, perlite, roofing granules, talc, titanium dioxide, and vermiculite. Particulate matter is the pollutant regulated under this subpart. Feed and product conveyors are not considered part of the affected facility. Facilities subject to NSPS Subpart LL, Metallic Mineral Processing Plants, are not subject to these standards. There are additional processes and process units at mineral processing plants listed at section 60.730(b) which are not subject to the provisions of this subpart.

    In general, all NSPS standards require initial notification reports, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS. Any owner/operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least two years following the date of such measurements, maintenance reports, and records.

    Form Numbers: None.

    Respondents/affected entities: Owners or operators of calciners and dryers at mineral processing plants.

    Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart UUU).

    Estimated number of respondents: 167 (total).

    Frequency of response: Initially, occasionally and semiannually.

    Total estimated burden: 6,436 hours (per year). Burden is defined at 5 CFR 1320.3(b).

    Total estimated cost: $738,649 (per year), which includes $108,550 in either annualized capital or operation & maintenance costs or both.

    Changes in the Estimates: There is an increase of two hours in the total estimated burden as currently identified in the OMB Inventory of Approved ICR Burdens. This increase is not due to any program changes. In the previous ICR, the burden associated with writing the “notification of physical or operation change” was incorrectly calculated with zero respondents. In this ICR, it was corrected to one respondent.

    Courtney Kerwin, Acting-Director, Collection Strategies Division.
    [FR Doc. 2015-03866 Filed 2-24-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OECA-2014-0056; FRL-9923-08-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Shipbuilding and Ship Repair Facilities—Surface Coating (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency has submitted an information collection request (ICR), “NESHAP for Shipbuilding and Ship Repair Facilities—Surface Coating (40 CFR part 63, subpart II) (Renewal)” (EPA ICR No. 1712.09, OMB Control No. 2060-0330) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through February 28, 2015. Public comments were previously requested via the Federal Register (79 FR 30117) on May 27, 2014, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before March 27, 2015.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0056, to (1) EPA online using www.regulations.gov (our preferred method), by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to [email protected] Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Abstract: The respondents are owners or operators of shipbuilding and ship repair facilities. Operations covered include: primer and top coat application in manufacturing processes and in ship repair processes. Owners or operators of shipbuilding and ship repair facilities are required to report startup, initial performance test, and retest information. Facilities will also periodically report emission exceedances, changes to equipment, and comply with other requirements of the NESHAP.

    Form Numbers: None.

    Respondents/affected entities: Owners or operators of shipbuilding and ship repair facilities.

    Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart II).

    Estimated number of respondents: 56 (total).

    Frequency of response: Initially, occasionally, and semiannually.

    Total estimated burden: 28,594 hours (per year). Burden is defined at 5 CFR 1320.3(b).

    Total estimated cost: $2,799,388 (per year), includes $0 annualized capital or operation & maintenance costs.

    Changes in the Estimates:

    There is no change of hours in the total estimated respondent burden compared with the ICR currently approved by OMB.

    Courtney Kerwin, Acting Director, Collection Strategies Division.
    [FR Doc. 2015-03891 Filed 2-24-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OECA-2014-0047; FRL-9923-61-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Municipal Solid Waste Landfills (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency has submitted an information collection request (ICR), “NSPS for Municipal Solid Waste Landfills (40 CFR part 60, subpart WWW) (Renewal)” (EPA ICR No. 1557.09, OMB Control No. 2060-0220) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through February 28, 2015. Public comments were previously requested via the Federal Register (79 FR 30117) on May 27, 2014 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before March 27, 2015.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0047, to (1) EPA online using www.regulations.gov (our preferred method), by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to [email protected] Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Abstract: These regulations apply to MSW landfills for which construction, modification, or reconstruction commences on or after May 30, 1991. A MSW landfill is an entire disposal facility in a contiguous geographical space where household waste is placed in or on. An MSW landfill may also receive other types of RCRA Subtitle D wastes (§ 257.2 of this title) such as commercial solid waste, nonhazardous sludge, conditionally exempt small quantity generator waste, and industrial solid waste. Portions of an MSW landfill may be separated by access roads. An MSW landfill may be publicly or privately owned, and may be a new landfill, an existing landfill, or a lateral expansion. This information is being collected to assure compliance with 40 CFR part 60, subpart WWW.

    In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS. Any owner/operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least five years following the date of such measurements, maintenance reports, and records.

    Form Numbers: None.

    Respondents/affected entities: Owners or operators of municipal solid waste landfills for which construction, modification, or reconstruction commences on or after May 30, 1991.

    Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart WWW).

    Estimated number of respondents: 195 (total).

    Frequency of response: Initially, occasionally, quarterly and annually.

    Total estimated burden: 111,471 hours (per year). Burden is defined at 5 CFR 1320.3(b).

    Total estimated cost: $11,677,667 (per year), includes $764,400 annualized capital or operation & maintenance costs.

    Changes in the Estimates: There is an adjustment increase in the total estimated burden as currently identified in the OMB Inventory of Approved ICR Burdens. The change resulted from incorporating comments received, addressing respondent activities that were not included in the previous ICR and increased the burden estimate for activities that were already included.

    There is also an increase in the total estimated Capital/Startup and O&M costs. This increase occurred as a result of incorporating comments received, which stated that the previous ICR did not include the purchase price and O&M costs of three additional devices that respondents are required to use.

    Courtney Kerwin, Acting Director, Collection Strategies Division.
    [FR Doc. 2015-03867 Filed 2-24-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OECA-2014-0033; FRL-9923-60-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Petroleum Refineries (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency has submitted an information collection request (ICR), “NSPS for Petroleum Refineries (40 CFR part 60, subpart J) (Renewal)” (EPA ICR No. 1054.12, OMB Control No. 2060-0022) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through February 28, 2015. Public comments were previously requested via the Federal Register (79 FR 30117) on May 27, 2014 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before March 27, 2015.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0033, to (1) EPA online using www.regulations.gov (our preferred method), by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to [email protected]. Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address: [email protected].

    SUPPLEMENTARY INFORMATION:

    Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Abstract: The affected sources are (1) fluid catalytic cracking unit (FCCU) catalyst regenerator or fuel gas combustion device (FGCD) other than a flare that commenced construction, reconstruction or modification after June 11, 1973 and on or before May 14, 2007; (2) FGCD fuel gas combustion device that is also a flare that commenced construction, reconstruction or modification after June 11, 1973 and on or before June 24, 2008; or (3) any Claus sulfur recovery plant which commenced construction, reconstruction or modification after October 4, 1976 and on or before May 14, 2007. Units that are constructed, reconstructed or modified after the end date of Subpart J applicability are subject to the requirements under regulations at 40 CFR part 60, subpart Ja. At the time of this ICR renewal, all refinery flares are complying with the NSPS Subpart Ja requirements.

    Form Numbers: None.

    Respondents/affected entities: Petroleum refineries.

    Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart J).

    Estimated number of respondents: 150 (total).

    Frequency of response: Initially, occasionally, and semiannually.

    Total estimated burden: 15,784 hours (per year). Burden is defined at 5 CFR 1320.3(b).

    Total estimated cost: $2,264,370 (per year), includes $719,100 annualized capital or operation & maintenance costs.

    Changes in the Estimates: There is no change in the respondent labor hours in this ICR compared to the previous ICR because the 2012 rule amendments did not require additional monitoring, recordkeeping and reporting requirements under NSPS J. Modified or reconstructed sources under NSPS Subpart J would trigger NSPS Subpart Ja applicability.

    Courtney Kerwin, Acting Director, Collection Strategies Division.
    [FR Doc. 2015-03868 Filed 2-24-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2010-0162; FRL-9922-19-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Reporting and Recordkeeping Requirements for Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency has submitted an information collection request (ICR), “Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles” (EPA ICR No. 2394.03, OMB Control No. 2060-0678), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through February 28, 2015. Public comments were previously requested via the Federal Register (79 FR 53190) on September 8, 2014 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before March 27, 2015.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number No. EPA-HQ-OAR-2010-0162, to (1) EPA online using www.regulations.gov (our preferred method), by email to a-and[email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to [email protected] Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Fakhri Hamady, Office of Transportation and Air Quality, Mail Code 6406J, Environmental Protection Agency, 2000 Traverwood Dr., Ann Arbor, MI 48105; telephone number: 734-214-4330; fax number: 734-214-4869; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Abstract: Under Title II of the Clean Air Act (CAA) (42 U.S.C. 7521 et seq.), EPA issues certificates of conformity for motor vehicle designs and engines that comply with applicable emission standards set under section 202(a)(1) of the CAA, such as those for CO2, N2O, and CH4 in the final regulation. Under 49 U.S.C. 32902, NHTSA is mandated to require manufacturers comply with fuel economy and consumption standards. Manufacturers will submit applications to certify their products and respond to the information collection activities detailed in the HD National Program. They will also submit reports, conduct compliance testing, label certified vehicles, provide final year-end-reports and retain records of information.

    Manufacturer test results will be used by EPA to perform confirmatory testing on a sufficient number of engines and vehicles to confirm manufacturer-reported results. EPA's emission certification programs and NHTSA's fuel efficiency programs are statutorily mandated. EPA does not have discretion to cease these functions under Section 206(a) of the CAA (42 U.S.C. 7521).

    Form Numbers: None.

    Respondents/affected entities: Manufacturers of Medium- and Heavy-Duty Engines and Vehicles; owners of heavy-duty truck fleets.

    Respondent's obligation to respond: Mandatory (42 U.S.C. 7521) (40 CFR 1036.730 and 1037.730).

    Estimated number of respondents: 34 (total).

    Frequency of response: Quarterly, Annually, On Occasion.

    Total estimated burden: 41,305 hours (per year). Burden is defined at 5 CFR 1320.03(b)

    Total estimated cost: $4,565,145 (per year), includes $1,458,333 annualized capital and operation & maintenance costs.

    Changes in Estimates: There is no change of hours in the total estimated burden compared with the ICR currently approved by OMB.

    Courtney Kerwin, Acting Director, Collection Strategies Division.
    [FR Doc. 2015-03890 Filed 2-24-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OECA-2014-0026; FRL-9922-96-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Metal Coil Surface Coating (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency has submitted an information collection request (ICR), “NSPS for Metal Coil Surface Coating (40 CFR part 60, subpart TT) (Renewal)” (EPA ICR No. 0660.12, OMB Control No. 2060-0107) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through February 28, 2015. Public comments were previously requested via the Federal Register (79 FR 30117) on May 27, 2014, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before March 27, 2015.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0026, to (1) EPA online using www.regulations.gov (our preferred method), by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to [email protected] Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, EPA William Jefferson Clinton West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Abstract: The New Source Performance Standards (NSPS) for Metal Coil Surface Coating (40 CFR part 60, subpart TT) were: Proposed on January 5, 1981; promulgated on November 1, 1982; and amended on June 24, 1986 and October 17, 2000. These regulations apply to the following surface coating lines in the metal coil surface coating industry: Each prime coat operation; each finish coat operation; and each prime and finish coat operation cured simultaneously, where the finish coat is applied wet-on-wet over the prime coat. These regulations apply to facilities commencing construction, modification, or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR part 60, subpart TT.

    In general, all NSPS standards require initial notification reports, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.

    Any owner/operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least two years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated state or local authority. In the event that there is no such delegated authority, the reports are sent directly to the U.S. Environmental Protection Agency (EPA) regional office.

    Form Numbers: None.

    Respondents/affected entities: Owners and operators of primary copper smelter.

    Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart TT).

    Estimated number of respondents: 158 (total).

    Frequency of response: Initially, occasionally, quarterly, and semiannually.

    Total estimated burden: 15,643 hours (per year). Burden is defined at 5 CFR 1320.3(b).

    Total estimated cost: $1,863,362 (per year), includes $331,800 annualized capital or operation & maintenance costs.

    Changes in the Estimates: There is no change in the total estimated respondent burden compared with the ICR currently approved by OMB.

    Courtney Kerwin, Acting Director, Collection Strategies Division.
    [FR Doc. 2015-03865 Filed 2-24-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OA-2006-0278; FRL-9923-50-OA] Proposed Information Collection Request; Comment Request; Participation by Disadvantaged Business Enterprises in Procurements Under EPA Financial Assistance Agreements (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “Participation by Disadvantaged Business Enterprises in Procurement under EPA Financial Assistance Agreements (Renewal)” (EPA ICR No. 2047.05, OMB Control No. 2090-0030) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through August 31, 2015. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Comments may be submitted on or before April 27, 2015.

    ADDRESSES:

    Submit your comments, referencing Docket ID No. EPA-HQ-OA-2006-0278 online using www.regulations.gov (our preferred method), by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Teree Henderson, Office of Small Business Programs, (mail code: 1230T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-566-2222; fax number: 202-566-0548; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

    Abstract: EPA currently requires an entity to be certified in order to be considered a Minority Business Enterprise (MBE) or Women's Business Enterprise (WBE) under EPA's Disadvantaged Business Enterprise (DBE) Program. To qualify as an MBE or WBE under EPA's programs an entity must establish that it is owned and/or controlled by socially and economically disadvantaged individuals who are of good character and are citizens of the United States. The EPA DBE Program also includes contract administration requirements designed to prevent unfair practices that adversely affect DBEs.

    Form Numbers: 6100-1a, 6100-1b, 6100-1c, 6100-1d, 6100-1e, 6100-1f, 6100-1g, 6100-1h, 6100-1i, 6100-2, 6100-3, and 6100-4.

    Respondents/Affected Entities: Private Sector.

    Respondent's Obligation to Respond: Required to obtain or retain a benefit per 40 CFR 33, Subpart B and 40 CFR 33, Subpart E.

    Estimated Number of Respondents: 1,865 (total).

    Frequency of Response: Certification: On occasion.

    Total Estimated Burden: 11,614 hours (per year). Burden is defined at 5 CFR 1320.03(b)

    Total Estimated Cost: $372,817.43 (per year), includes $0 annualized capital or operation & maintenance costs.

    Changes in the Estimates: There is an increase of $10,104 in the total estimated cost which reflects updated wage rates as determined by the Department of Labor. There are no changes to the total estimated respondent burden. EPA is currently performing a comprehensive review of the DBE Rule which is scheduled to be completed by September 30, 2015. The ICR will be revised in accordance with lessons learned from this review with a focus on maximizing practical utility and minimizing public burden associated with collection.

    Dated: February 5, 2015. Kimberly Patrick, Director, Office of Small Business Programs.
    [FR Doc. 2015-03918 Filed 2-24-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OECA-2014-0096; FRL-9923-49-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Iron and Steel Foundry Area Sources (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency has submitted an information collection request (ICR), “NESHAP for Iron and Steel Foundry Area Sources (40 CFR part 63, subpart ZZZZZ) (Renewal)” (EPA ICR No. 2267.04, OMB Control No. 2060-0605), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq). This is a proposed extension of the ICR, which is currently approved through February 28, 2015. Public comments were previously requested via the Federal Register (79 FR 30117) on May 27, 2014, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before March 27, 2015.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0096, to: (1) EPA online using www.regulations.gov (our preferred method), by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460; and (2) OMB via email to [email protected] Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

    Abstract: The NESHAP for Iron and Steel Foundry Area Sources applies to either owners or operators of any existing or new iron or steel foundry that is an area source of hazardous air pollutant (HAP) emissions. Research and development facilities are not covered by the rule. Foundries covered by the rule would not be required to obtain a Title V operating permit. Small iron and steel foundries are required to comply with pollution prevention management practices for scrap materials, the removal of mercury switches, and binder formulations. Large iron and steel foundries are required to comply with the same pollution prevention management practices as small foundries in addition to emissions limitations for melting furnaces and foundry operations. Owners or operators must submit an initial notification report that the facility is subject to the rule, notification of performance test, notification of compliance status (including results of performance tests and other initial compliance demonstrations), and the semiannual compliance report.

    Form Numbers: None.

    Respondents/affected entities: Iron and steel foundries.

    Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart ZZZZZ).

    Estimated number of respondents: 427 (total).

    Frequency of response: Initially, occasionally and semiannually.

    Total estimated burden: 7,893 hours (per year). Burden is defined at 5 CFR 1320.3(b).

    Total estimated cost: $772,735 (per year), which includes no annualized capital or operation & maintenance costs.

    Changes in the Estimates: The increase in burden from the most-recently approved ICR is due to several changes. This ICR adds burden requirements to repeat certain performance tests (PM tests for large foundries and opacity tests for all foundries), and corrects the average number of respondents per year.

    Courtney Kerwin, Acting Director, Collection Strategies Division.
    [FR Doc. 2015-03902 Filed 2-24-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OECA-2014-0068; FRL-9923-46-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Primary Lead Smelters (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency has submitted an information collection request (ICR), “NESHAP for Primary Lead Smelters (40 CFR part 63, subpart TTT) (Renewal)” (EPA ICR No. 1856.10, OMB Control No. 2060-0414) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through February 28, 2015. Public comments were previously requested via the Federal Register (79 FR 30117) on May 27, 2014 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before March 27, 2015.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0068, to (1) EPA online using www.regulations.gov (our preferred method), by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB via email to [email protected] Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Abstract: The NESHAP is applicable to primary lead processing facilities that are engaged in the production of lead metal from lead sulfide ore concentrate. The final amendment establishes new emission limits, revises testing, reporting, and recordkeeping requirements. Sources subject to the NESHAP are required to comply with the stack testing, monitoring, reporting, and recordkeeping requirements of the standard.

    Form Numbers: None.

    Respondents/affected entities: Owners and operators of primary lead smelting facilities.

    Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart TTT).

    Estimated number of respondents: 1 (total).

    Frequency of response: Initially, quarterly and semiannually.

    Total estimated burden: 6,265 hours (per year). Burden is defined at 5 CFR 1320.3(b).

    Total estimated cost: $782,379 (per year), includes $169,000 annualized capital or operation & maintenance costs.

    Changes in the Estimates: There is an overall decrease in the respondent and Agency burden and cost from the OMB Inventory of Approved Burdens. The currently approved burden is the cumulative burden and cost from EPA ICR Number 1856.06 (existing rule) and EPA ICR Number 1856.08 (2011 amendment). In this ICR renewal, we have combined the two ICRs to reflect current rule requirements and removed duplicate items. In addition, this ICR renewal reflects a decrease in the number of respondents from two to one since EPA ICR Number 1856.06. We have assumed that there are an estimated one respondent subject to NSPS Subpart TTT since rule is still in effect. These changes result in an apparent decrease in labor hours and costs.

    Courtney Kerwin, Acting Director, Collection Strategies Division.
    [FR Doc. 2015-03901 Filed 2-24-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2014-0446; FRL-9922-66-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Certification of Pesticide Applicators (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency has submitted an information collection request (ICR), “Certification of Pesticide Applicators (Renewal)” (EPA ICR No. 0155.12, OMB Control No. 2070-0029) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed revision of the ICR, which is currently approved through February 28, 2015. Public comments were previously requested via the Federal Register (79 FR 43039) on July 24, 2014 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before March 27, 2015.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OPP-2014-0446, to (1) EPA online using www.regulations.gov (our preferred method), by email to [email protected], or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to [email protected]. Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Lily G. Negash, Office of Pesticide Programs, Field & External Affairs Division, 7605P, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 703-347-8515; fax number: 703-305-5884; email address: [email protected].

    SUPPLEMENTARY INFORMATION:

    Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Abstract: The Environmental Protection Agency (EPA) administers certification programs for pesticide applicators under section 11 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). FIFRA allows EPA to classify a pesticide as “restricted use” if the pesticide meets certain toxicity or risk criteria. Due to the potential of improperly applied restricted use pesticides (RUPs) to harm human health or the environment, pesticides under this classification may be purchased and applied only by “certified applicators” or by persons under the direct supervision of certified applicators. The completion of a certification program or test is required in order to become a certified applicator.

    Personally identifying information (PII) is collected in the process of certifying individuals to apply RUPs as private or commercial applicators. This information is collected to differentiate between individuals sharing the same names and is subject to Agency-wide security requirements governing all Privacy Act database systems at EPA.

    Form Numbers: EPA Form 8500-17 and EPA Form 8500-17-N.

    Respondents/affected entities: Registrants, commercial and private applicators, and dealers of restricted use pesticides; Indian tribes and State regulators.

    Respondent's obligation to respond: Mandatory (FIFRA Sections 3 & 11).

    Estimated number of respondents: 421,000 (total).

    Frequency of response: On occasion.

    Total estimated burden: 1,320,254 hours (per year). Burden is defined at 5 CFR 1320.03(b).

    Total estimated cost: $42,637,865 (per year), includes $0 annualized capital or operation & maintenance costs.

    Changes in the Estimates: There is a decrease of 415 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This net decrease is due to EPA's updates to burden estimates, addition of a recently-implemented optional, voluntary offering, and a change in the number of entities whose certification programs are directly overseen by EPA. This change is both an adjustment and the result of a program change.

    Courtney Kerwin, Acting Director, Collection Strategies Division.
    [FR Doc. 2015-03864 Filed 2-24-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9923-51-OA] Notification of a Public Teleconference of the Great Lakes Advisory Board AGENCY:

    Environmental Protection Agency, (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency (EPA) announces a teleconference of the Great Lakes Advisory Board (Board). The purpose of this teleconference is to discuss the Great Lakes Restoration Initiative covering (GLRI) FY15-19 and other relevant matters.

    DATES:

    The teleconference will be held Thursday, March 19, 2015 from 9 a.m. to 11 a.m. Central Time, 10 a.m. to 12 p.m. Eastern Time. An opportunity will be provided to the public to comment.

    ADDRESSES:

    The public teleconference will be held by teleconference only. The teleconference number is: (877) 744-6030; Participant code: 83810127.

    FOR FURTHER INFORMATION CONTACT:

    Any member of the public wishing further information regarding this meeting may contact Rita Cestaric, Designated Federal Officer (DFO), by email at [email protected] General information on the GLRI and the Board can be found at http://www.glri.us under the “Public Engagement” tab.

    SUPPLEMENTARY INFORMATION:

    Background: The Board is a federal advisory committee chartered under the Federal Advisory Committee Act (FACA), Public Law 92-463. EPA established the Board in 2013 to provide independent advice to the EPA Administrator in her capacity as Chair of the federal Great Lakes Interagency Task Force (IATF). The Board conducts business in accordance with FACA and related regulations.

    The Board consists of 16 members appointed by EPA's Administrator in her capacity as IATF Chair. Members serve as representatives of state, local and tribal government, environmental groups, agriculture, business, transportation, foundations, educational institutions, and as technical experts.

    Availability of Meeting Materials: The agenda and other materials in support of the teleconference will be available on the GLRI Web site at http://www.glri.us under the “Public Engagement” tab in advance of the teleconference.

    Procedures for Providing Public Input: Federal advisory committees provide independent advice to federal agencies. Members of the public can submit relevant comments for consideration by the Board. Input from the public to the Board will have the most impact if it provides specific information for the Board to consider. Members of the public wishing to provide comments should contact the DFO directly.

    Oral Statements: In general, individuals or groups requesting an oral presentation at this public meeting will be limited to three minutes per speaker, subject to the number of people wanting to comment. Interested parties should contact the DFO in writing (preferably via email) at the contact information noted above by March 17, 2015 to be placed on the list of public speakers for the meeting.

    Written Statements: Written statements must be received by March 17, 2015 so that the information may be made available to the Board for consideration. Written statements should be supplied to the DFO in the following formats: One hard copy with original signature and one electronic copy via email. Commenters are requested to provide two versions of each document submitted: one each with and without signatures because only documents without signatures may be published on the GLRI Web page.

    Accessibility: For information on access or services for individuals with disabilities, please contact the DFO at the phone number or email address noted above, preferably at least seven days prior to the meeting, to give EPA as much time as possible to process your request.

    Dated: February 12, 2015. Cameron Davis, Senior Advisor to the Administrator.
    [FR Doc. 2015-03916 Filed 2-24-15; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2014-0888; FRL-9921-65] Notice of Receipt of Requests for Amendments To Terminate Uses in Certain Pesticide Registrations AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of request for amendments by registrants to terminate uses in certain pesticide registrations. FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any request in the Federal Register.

    DATES:

    Unless a request is withdrawn by March 27, 2015 for registrations for which the registrant requested a waiver of the 180-day comment period, EPA expects to issue orders terminating these uses. The Agency will consider withdrawal requests postmarked no later than March 27, 2015. Comments must be received on or before March 27, 2015, for those registrations where the 180-day comment period has been waived.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2014-0888, 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 Confidential Business Information (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. Written Withdrawal Request, ATTN: Christopher Green, Information Technology and Resources Management Division (7502P).

    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.
    FOR FURTHER INFORMATION CONTACT:

    Mark Hartman, Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-5440; email address: [email protected]

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

    This action is directed to the public in general. Although this action may be of particular interest to persons who produce or use pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action.

    B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

    II. What action is the agency taking?

    This notice announces receipt by the Agency of applications from registrants to terminate uses in certain pesticide products registered under FIFRA section 3 (7 U.S.C. 136a) or 24(c) (7 U.S.C. 136v(c)). These registrations are listed in Table 1 of this unit by registration number, product name, active ingredient, and specific uses terminated.

    Table 1—Requests for Amendments To Terminate Uses in Certain Pesticide Registrations EPA registration no. Product name Active ingredient Use to be terminated 352-690 DuPont Mankocide Fungicide/Bactericide Mancozeb & Copper hydroxide Turf, Ornamental plants & Non-bearing citrus. 464-660 Bioban CS-1135 Antimicrobial Agent 4,4-Dimethyloxazolidine Paints, Inks, Emulsions, Adhesives (Non-Food Contact), Metalworking Fluids, Die-Cast Lubricants, Mold-Release Agents, Consumer, Household & Institutional Products, Mineral Slurries & Surfactants. 1624-120 Borogard ZB Zinc borate Paints and coatings. 39967-118 Veriguard OD Dazomet & o-Phenylphenol (No Inert use) Arts, Crafts Latex, Finger Paints, Paints, Coating, Inks & Dyes. 71368-61 Imidacloprid Technical Imidacloprid Terrestrial Nonfood Crop, Domestic Indoor & Outdoor: Companion Animals. 81598-9 Rotam Methomyl Technical Methomyl Barley, Oats & Rye. 83100-27 Rotam Methomyl 29LV Insecticide Methomyl Barley, Oats & Rye. 83100-28 Rotam Methomyl 90SP Insecticide Methomyl Barley, Oats & Rye.

    Unless a request is withdrawn by the registrant within 30 days of publication of this notice, EPA expects to issue orders terminating all of these uses. Users of these pesticides or anyone else desiring the retention of a use should contact the applicable registrant directly during this 30-day period.

    Table 2 of this unit includes the names and addresses of record for all registrants of the products in Table 1 of this unit, in sequence by EPA company number:

    Table 2—Registrants Requesting Amendments to Terminate Uses in Certain Pesticide Registrations EPA Company No. Company name and address 352 E. I. Du Pont De Nemours and Company, 1007 Market Street, Wilmington, DE 19898-0001. 464 The Dow Chemical Co., 1500 E. Lake Cook Road, Buffalo Grove, IL 60089. 1624 U.S. Borax, Inc., Agent Name: Delta Analytical Corporation, 12510 Prosperity Drive, Suite 160, Silver Spring, MD 20904. 39967 Lanxess Corporation, 111 RIDC West Park Drive, Pittsburgh, PA 15275-1112. 71368 Nufarm, Inc., 4020 Aerial Center Parkway, Suite 101, Morrisville, NC 27560. 81598 Rotam Limited, Agent Name: Wagner Regulatory Associates, Inc., P.O. Box 640, Hockessin, DE 19707. 83100 Rotam Agrochemical Company, Ltd., Agent Name: Wagner Regulatory Associates, Inc., P.O. Box 640, Hockessin, DE 19707. III. What is the agency's authority for taking this action?

    Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register. Thereafter, the EPA Administrator may approve such a request.

    IV. Procedures for Withdrawal of Request

    Registrants who choose to withdraw a request for use termination must submit such withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT, postmarked before March 27, 2015, for the requests that the registrants requested to waive the 180-day comment period. This written withdrawal of the request for use termination will apply only to the applicable FIFRA section 6(f)(1) request listed in this notice. If the products have been subject to a previous use termination action, the effective date of termination and all other provisions of any earlier termination action are controlling.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: February 10, 2015. Mark A. Hartman, Director, Information Technology and Resources Management Division, Office of Pesticide Programs.
    [FR Doc. 2015-03926 Filed 2-24-15; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1154] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written PRA comments should be submitted on or before April 27, 2015. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-1154.

    Title: Commercial Advertisement Loudness Mitigation (“CALM”) Act; General Waiver Requests.

    Form Number: Not applicable.

    Type of Review: Revision of a currently approved collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents and Responses: 20 respondents and 20 responses.

    Frequency of Response: On occasion reporting requirement.

    Estimated Time per Response: 20 hours.

    Total Annual Burden: 400 hours.

    Total Annual Cost to Respondents: $12,000.

    Obligation to Respond: Required to obtain benefits. The statutory authority for this collection of information is contained in 47 U.S.C. 151, 152, 154(i), 303(r) and 621.

    Nature and Extent of Confidentiality: There is no assurance of confidentiality provided to respondents, but, in accordance with the Commission's rules, 47 CFR 0.459, a station/MVPD may request confidential treatment for financial information supplied with its waiver request.

    Privacy Impact Assessment: No impact(s).

    Needs and Uses: TV stations and MVPDs may file general waiver requests to request waiver of the rules implementing the CALM Act for good cause. The information obtained by general waiver requests will be used by Commission staff to evaluate whether grant of a waiver would be in the public interest.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary, Office of the Managing Director.
    [FR Doc. 2015-03844 Filed 2-24-15; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [3060-0806] Information Collection Being Submitted for Review and Approval to the Office of Management and Budget AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written comments should be submitted on or before March 27, 2015. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicholas A. Fraser, OMB, via email [email protected]; and to Nicole Ongele, FCC, via email [email protected] and to [email protected] Include in the comments the OMB control number as shown in the SUPPLEMENTARY INFORMATION section below.

    FOR FURTHER INFORMATION CONTACT:

    For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page <http://www.reginfo.gov/public/do/PRAMain>, (2) look for the section of the Web page called “Currently Under Review,” (3) click on the downward-pointing arrow in the “Select Agency” box below the “Currently Under Review” heading, (4) select “Federal Communications Commission” from the list of agencies presented in the “Select Agency” box, (5) click the “Submit” button to the right of the “Select Agency” box, (6) when the list of FCC ICRs currently under review appears, look for the OMB control number of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0806.

    Title: Universal Service—Schools and Libraries Universal Service Program, FCC Forms 470 and 471.

    Form Numbers: FCC Forms 470 and 471.

    Type of Review: Extension of a currently approved collection.

    Respondents: Not-for-profit institutions, and state, local or tribal government public institutions.

    Number of Respondents and Responses: 82,000 respondents, 82,000 responses.

    Estimated Time per Response: 3 hours to fill out FCC Form 470 and 4 hours to fill out the FCC Form 471 plus 0.5 hours for each form for the ten-year recordkeeping requirement.

    Frequency of Response: On occasion, annual reporting, and recordkeeping requirements.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C.s 151—154, 201—205, 218—220, 254, 303(r), 403, and 405.

    Total Annual Burden: 334,000 hours.

    Total Annual Cost: No cost.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no assurance of confidentiality provided to respondents concerning this information collection. If the Commission requests applicants to submit information that the respondents believe is confidential, respondents may request confidential treatment of their information under 47 CFR 0.459 of the Commission's rules.

    Needs and Uses: FCC Forms 470 and 471 collect the information the Commission and the Universal Service Administrative Company (USAC) need to administer the schools and libraries universal service mechanism (informally known as the E-rate program), determine if entities are eligible for funding pursuant to the schools and libraries support mechanism, determine the amount of support entities seeking funding are eligible to receive, determine if entities are complying with the Commission's rules, and prevent waste, fraud, and abuse. The forms collect specific information to establish that economically disadvantaged schools and rural schools receive a greater share of E-rate program funding based on the percentage of students eligible in that school district for the national school lunch program (NSLP) (or other acceptable indicators of economic disadvantage determined by the Commission). The student poverty level needed to determine discounts for libraries are based on the NSLP information for the school district nearby. In the E-rate Modernization Order, among other things, the Commission took steps to streamline the application process, provide exemptions from competitive bidding, implement a “district-wide” discount calculation mechanism, establish budgets for internal broadband connectivity, and extend the document retention period to ten years. FCC Forms 470 and 471 execute these changes for the E-rate application process and enable the Commission to collect data to facilitate measurement of progress towards the adopted performance goals established in the E-rate Modernization Order.

    In addition, this collection is necessary to allow the Commission to evaluate the extent to which the E-rate program is meeting the statutory objectives specified in section 254(h) of the 1996 Act.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary, Office of the Managing Director.
    [FR Doc. 2015-03845 Filed 2-24-15; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL MARITIME COMMISSION Notice of Agreement Filed

    The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the Federal Register. A copy of the agreement is available through the Commission's Web site (www.fmc.gov) or by contacting the Office of Agreements at (202) 523-5793 or [email protected]

    Agreement No.: 012288-001.

    Title: Hoegh/NYK Atlantic/Pacific Space Charter Agreement.

    Parties: Hoegh Autoliners AS and Nippon Yusen Kaisha.

    Filing Party: Joshua Stein, Esq.; Cozen O'Connor; 1627 I Street NW., Suite 1100; Washington, DC 20006.

    Synopsis: The amendment adds the trade between the U.S. West Coast, on the one hand, and China, South Korea, and Japan, on the other hand, to the geographic scope of the agreement, revises the duration of the agreement, changes the name of the agreement to reflect the new geographic scope, and restates the agreement.

    By Order of the Federal Maritime Commission.

    Dated: February 20, 2015. Karen V. Gregory, Secretary.
    [FR Doc. 2015-03893 Filed 2-24-15; 8:45 am] BILLING CODE 6730-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-15-15FY] Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 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. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) 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; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) 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; and (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

    Proposed Project

    State Health Department Access to Electronic Health Record Data from Healthcare Facilities during a Healthcare-Associated Infection Outbreak: A Retrospective Assessment—New—National Center for Emerging and Zoonotic Infections Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Two years ago, contaminated steroid injections caused the largest fungal meningitis outbreak in the United States, affecting 20 states and resulting in 751 infections and 64 deaths. The subsequent healthcare-associated infection (HAI) outbreak response required significant collaboration between healthcare providers and facilities and public health departments (HDs). Following the outbreak response, HDs reported that various challenges with access to patient health information in electronic health records (EHRs) hindered the efficient and rapid identification of potential fungal meningitis cases in healthcare facilities. The fungal meningitis outbreak experience highlights the need to better understand the landscape of granting and using access to EHRs for outbreak investigations.

    The Division of Healthcare Quality Promotion (a component of NCEZID), the Office for State, Tribal, Local and Territorial Support, and the Office of Public Health Scientific Services at the Centers for Disease Control and Prevention (CDC) are partnering with Association of State and Territorial Health Officials and The Keystone Center to evaluate the challenges surrounding HDs access to EHRs in healthcare facilities' during an HAI outbreak investigation. The evaluation seeks to compile information across states from experts in the public and private sector to assess experiences, identify issues, and seek recommendations for improving HDs access to EHRs during future outbreaks.

    In addition to a study report, the insights from healthcare facility staff will be used to build a toolkit to help state HDs understand the perspectives and needs of the healthcare facilities related to EHR access. The toolkit will provide perceived barriers, recommendations to overcome those barriers, best practices that support EHR access, and practical tools such as templates, memorandums of understanding (MOUs), and policies. The toolkit will be distributed to HDs, healthcare facilities, and other stakeholders to support awareness and strengthen relationships between public health and clinical care.

    These activities will facilitate the quick and efficient identification of cases in future outbreaks and protect the health and safety of patients. This request corresponds with an initial ongoing data collection (Phase I), State Health Department Access to Electronic Health Record Data during an Outbreak: A Retrospective Assessment, which involves interviews with four types of Health Department staff: Healthcare-associated infection coordinator, epidemiologist, legal counsel, and informatics director (OMB Number 0920-0879, approved on 04/24/2014). Phase I data analysis is ongoing.

    For Phase II of this study, we will be requesting participation from hospital and clinic staff in their official capacities across the same 15 states included in the Phase I request. The states chosen for Phase I and Phase II data collections are: Florida, Indiana, Kansas, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Tennessee, Texas, and Virginia. Data will be collected from 150 hospital and clinic staff in their official capacities using one 30-minute telephone interview per person and limiting interviews to two hospitals and two clinics per state. Hospital participants include: Infection preventionists, informatics directors, and others as referred. Clinic participants include: Clinic directors and others as referred.

    The focus of this OMB request is to conduct interviews with 150 healthcare facilities' staff, hospitals and clinics, in their official capacity who has been asked by HDs to provide access to their EHRs during an HAI outbreak investigation. In hospitals, the evaluation team will be conducting interviews with staff members serving in one of three roles: Infection preventionist, informatics director, and other as referred (e.g. privacy officer, risk management, etc.). In clinics, the evaluation team will be conducting interviews with the clinic director, and other as referred (e.g. patient records manager, etc.)

    The maximum estimates for burden hours are derived from interview guide pilot testing and data collection with HDs during Phase I data collection, in which interviews took 27 minutes. The total annual burden is 90 hours.

    The data to be collected do not involve questions of a personal or sensitive nature and should have no impact on the individual's privacy. There are no costs to the respondents other than their time.

    Estimated Annualized Burden Hours Type of respondent Form name Number of respondents Number of
  • responses per respondent
  • Average
  • burden per
  • response
  • (in hours)
  • HD Epidemiologist Interview Guide 15 1 60/60 Infection Preventionist Interview Guide 30 1 30/60 Informatics Director Interview Guide 30 1 Other as referred by Infection Preventionist or Informatics Director (for example, privacy officer or risk management specialist) Interview Guide 30 1 Clinic Director Interview Guide 30 1 Other as referred by Clinic Director (for example, patient records manager) Interview Guide 30 1
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2015-03805 Filed 2-24-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day-15-15PI] Proposed Data Collections Submitted for Public Comment and Recommendations

    The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. To request more information on the below proposed project or to obtain a copy of the information collection plan and instruments, call 404-639-7570 or send comments to Leroy A. Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to [email protected]

    Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Written comments should be received within 60 days of this notice.

    Proposed Project

    Extended Evaluation of the National Tobacco Prevention and Control Public Education Campaign—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    In 2012, Centers for Disease Control and Prevention (CDC) launched the first federally funded, national mass media campaign to educate consumers about the adverse health consequences of tobacco use (the National Tobacco Prevention and Control Public Education Campaign, or “The Campaign”). The Campaign continued in 2013 and 2014 with advertisements known as “Tips from Former Smokers.” Activities for Phase 3 of the campaign are ongoing. To assess the impact of The Campaign in Phases 1-3, CDC obtained OMB approval to conduct a series of longitudinal surveys of smokers and nonsmokers (OMB Control Number 0920-0923, exp. 3/31/2017).

    New media activities for Phases 4 and 5 of The Campaign are scheduled to launch in March 2015. To support evaluation of The Campaign through Phase 5, CDC plans to field four new waves of information collection. The surveys will be fielded in English and Spanish and will occur during late 2015, 2016, and early 2017. Once enrolled in the first wave of data collection, all participants will be re-contacted for follow-up at subsequent survey waves.

    The sample for the data collection will originate from two sources: (1) An online longitudinal cohort of smokers and nonsmokers, sampled randomly from postal mailing addresses in the United States (address-based sample, or ABS); and (2) the existing GfK KnowledgePanel, an established long-term online panel of U.S. adults. The ABS-sourced longitudinal cohort will consist of smokers and nonsmokers who have not previously participated in any established online panels to reduce potential panel conditioning bias from previous participation. The new cohort will be recruited by GfK, utilizing similar recruitment methods that are used in the recruitment of KnowledgePanel. The GfK KnowledgePanel will be used in combination with the new ABS-sourced cohort to support larger sample sizes that will allow for more in-depth subgroup analysis, which is a key objective for CDC. All online surveys, regardless of sample source, will be conducted via the GfK KnowledgePanel Web portal for self-administered surveys.

    Information will be collected through Web surveys to be self-administered on computers in the respondents' homes or in another convenient location. Information will be collected about smokers' and nonsmokers' awareness of and exposure to specific campaign advertisements; knowledge, attitudes, beliefs related to smoking and secondhand smoke; and other marketing exposure. The surveys will also measure behaviors related to smoking cessation (among the smokers in the sample) and behaviors related to nonsmokers' encouragement of smokers to quit smoking, recommendations of cessation services, and attitudes about other tobacco and nicotine products.

    It is important to evaluate The Campaign in a context that assesses the dynamic nature of tobacco product marketing and uptake of various tobacco products, particularly since these may affect successful cessation rates. Survey instruments may be updated to include new or revised items on relevant topics, including cigars, noncombustible tobacco products, and other emerging trends in tobacco use.

    OMB approval is requested for two years. Participation is voluntary and there are no costs to respondents other than their time.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden
  • (in hours)
  • General Population Screening and Consent Questionnaire 25,000 1 5/60 2,083 Adults Smokers and Nonsmokers, ages 18-54, in the United States Smoker Survey (Wave A)
  • Smoker Survey (Wave B)
  • Smoker Survey (Wave C)
  • 6,500
  • 4,000
  • 4,000
  • 1
  • 1
  • 1
  • 30/60
  • 30/60
  • 30/60
  • 3,250
  • 2,000
  • 2,000
  • Smoker Survey (Wave D) 4,000 1 30/60 2,000 Nonsmoker Survey (Wave A) 2,500 1 30/60 1,250 Nonsmoker Survey (Wave B) 2,000 1 30/60 1,000 Nonsmoker Survey (Wave C) 2,000 1 30/60 1,000 Nonsmoker Survey (Wave D) 2,000 1 30/60 1,000 Total 15,583
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2015-03825 Filed 2-24-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-15-0824] Proposed Data Collections Submitted for Public Comment and Recommendations

    The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. To request more information on the below proposed project or to obtain a copy of the information collection plan and instruments, call 404-639-7570 or send comments to Leroy A. Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to [email protected]

    Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Written comments should be received within 60 days of this notice.

    Proposed Project

    National Syndromic Surveillance Program (BioSense, OMB Control No. 0920-0824, Expiration Date 10/31/2015)—Revision—Center for Surveillance, Epidemiology and Laboratory Services (CSELS), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    The BioSense Program was created by congressional mandate as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and was launched by the Centers for Disease Control and Prevention (CDC) in 2003. The BioSense Program has since been expanded into the National Syndromic Surveillance Program (NSSP) to promote the use of high-quality syndromic surveillance data for improved nationwide all-hazard situational awareness for public health decision making and enhanced responses to hazardous events and outbreaks.

    NSSP is a collaboration among individuals and organizations from the local, state, and federal levels of public health; other federal agencies, including the Department of Defense (DoD) and the Department of Veterans Affairs (VA); and associations of public health officials, including the Association of State and Territorial Health Officials. NSSP includes a community of practice, a stakeholder governance process, and a cloud-based syndromic surveillance platform (the NSSP platform) that hosts the BioSense application and other analytic tools and services.

    Syndromic surveillance is a process that regularly and systematically uses health and health-related data in near real-time to make information on the health of a community available to public health officials. Patient encounter, laboratory, and pharmacy data from healthcare settings including emergency departments, urgent care, ambulatory care and inpatient settings provide critical information for syndromic surveillance and are used by public health agencies under authorities granted to them by applicable local and state laws.

    CDC requests a three-year approval for a Revision for NSSP (BioSense, OMB Control No. 0920-0824, Expiration Date 10/31/2015). With this revision, CDC also requests the following collection title: National Syndromic Surveillance Program (NSSP). The NSSP will continue to receive and processes four different types of information: (1) Contact information for state and local public health officials who wish to have data from their jurisdictions submitted to NSSP (recruitment data); (2) contact information for public health officials and other new users needed to provide them with access to the NSSP Platform (registration data); (3) NSSP user information needed to determine for development of the NSSP platform and to assess the usability of the platform (user data) (since the number of respondents will not exceed nine non-federal users to assess usability, the associated burden is not applicable to this request); and (4) existing healthcare encounter, pharmacy, and laboratory data (healthcare data) without personally identifiable information (PII).

    As in the past, healthcare data will continue to be submitted to NSSP by state and local health departments or hospitals in those jurisdictions, federal agencies including the VA, DoD, a national level private sector clinical laboratory, and a private sector health information exchange company.

    In addition, healthcare data will be submitted from urgent care, ambulatory care and inpatient settings. The inclusion of these additional data in NNSP is consistent with the Department of Health and Human Services' criteria for the “meaningful use” by public health of electronic health records for syndromic surveillance.

    There are no costs to respondents other than their time. Respondents in this data submission include state and local public health jurisdictions, federal agencies, and the private sector providers of healthcare, laboratory and pharmacy data.

    Though a large number of electronic health records are transmitted to NSSP, once the automated interfaces are set up for transmission (developing the data sharing agreements), there is no burden for record transmission. The estimated annual burden is 51 hours.

    Estimated Annualized Burden Hours Type of respondents Number
  • of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average burden per response
  • (in hours)
  • Total
  • burden
  • (in hours)
  • Recruitment Information Collection State and Local Public Health Jurisdictions 20 1 1 20 Federal Government 2 1 1 2 Private Sector 3 1 1 3 Registration Information Collection State and Local Public Health Jurisdictions 200 1 5/60 17 Federal Government 30 1 5/60 3 Private Sector 50 1 5/60 4 Healthcare Information Collection: Administrator Data Sharing Agreements/Permissions State and Local Public Health Jurisdictions 20 1 5/60 2 Federal Government 2 0 5/60 0 Private Sector 3 0 0 0 Total 51
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2015-03826 Filed 2-24-15; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request

    Title: Affordable Care Act Tribal Maternal, Infant, and Early Childhood Home Visiting Program: Guidance for Submitting an Annual Report to the Secretary.

    OMB No.: 0970-0409.

    Description: Section 511(e)(8)(A) of the Social Security Act, as added by Section 2951 of the Affordable Care Act, requires that grantees under the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program for states and jurisdictions submit an annual report to the Secretary of Health and Human Services regarding the program and activities carried out under the program, including such data and information as the Secretary shall require. Section 511 (h)(2)(A) further states that the requirements for the MIECHV grants to tribes, tribal organizations, and urban Indian organizations are to be consistent, to the greatest extent practicable, with the requirements for grantees under the MIECHV program for states and jurisdictions.

    The Administration for Children and Families, Office of Child Care, in collaboration with the Health Resources and Services Administration, Maternal and Child Health Bureau, has awarded grants for the Tribal Maternal, Infant, and Early Childhood Home Visiting Program (Tribal Home Visiting). The Tribal Home Visiting discretionary grants support cooperative agreements to conduct community needs assessments; plan for and implement high-quality, culturally-relevant, evidence-based home visiting programs in at-risk tribal communities; establish, measure, and report on progress toward meeting performance measures in six legislatively-mandated benchmark areas; and participate in rigorous evaluation activities to build the knowledge base on home visiting among Native populations.

    Tribal Home Visiting grantees have been notified that in every year of their grant, after the first year, they must comply with the requirement for submitting an Annual Report to the Secretary that should feature activities carried out under the program during the past reporting period. In order to assist grantees with meeting the requirements of the Annual Report to the Secretary, ACF created guidance for grantees to use when writing their annual reports. The existing guidance (OMB Control No. 0970-0409, Expiration Date 9/30/15) provides sections where grantees must address the following:

    • Update on Home Visiting Program Goals and Objectives

    • Update on the Implementation of Home Visiting Program in Targeted Community(ies)

    • Progress toward Meeting Legislatively Mandated Benchmark Requirements

    • Update on Rigorous Evaluation Activities

    • Home Visiting Program Continuous Quality Improvement (CQI) Efforts

    • Administration of Home Visiting Program

    • Technical Assistance Needs

    The proposed data collection form is as follows:

    ACF is requesting approval to renew and update the existing Tribal Home Visiting Guidance for Submitting an Annual Report to the Secretary (OMB Control No. 0970-0409) that will include instructions for grantees to submit either an annual or final report (in the final year of the grant) on the progress of their program to the Secretary, depending on the reporting period.

    Respondents: Tribal Maternal, Infant, and Early Childhood Home Visiting Program Managers (The information collection does not include direct interaction with individuals or families that receive the services).

    Annual Burden Estimates Instrument Annual number of respondents Number of responses per
  • respondent
  • Total
  • responses
  • Average burden hours per response Total annual burden hours
    Annual/Final Report to the Secretary (depending on reporting period) 25 1 1 50 1250 Estimated Total Annual Burden Hours: 1,250.

    In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above.

    Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address: [email protected] All requests should be identified by the title of the information collection.

    The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

    Robert Sargis, Reports Clearance Officer.
    [FR Doc. 2015-03830 Filed 2-24-15; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living [CFDA Number: 84.133B-1] Proposed Priority—National Institute on Disability, Independent Living, and Rehabilitation Research—Rehabilitation Research and Training Centers AGENCY:

    Administration for Community Living, HHS.

    ACTION:

    Notice of proposed priority.

    SUMMARY:

    The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for an RRTC on Employer Practices Leading to Successful Employment Outcomes for Individuals with Disabilities. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment practices and successful employment outcomes for individuals with disabilities.

    DATES:

    We must receive your comments on or before March 27, 2015.

    ADDRESSES:

    Submit your comments through the Federal eRulemaking Portal or via postal mail or commercial delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.

    Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on using Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under “Are you new to the site?”

    Postal Mail or Commercial Delivery: If you mail or deliver your comments about these proposed regulations, address them to Patricia Barrett, U.S. Department of Health and Human Services, 400 Maryland Avenue SW., Room 5142, Potomac Center Plaza (PCP), Washington, DC 20202-2700.

    Privacy Note: The Department's policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available.

    FOR FURTHER INFORMATION CONTACT:

    Patricia Barrett. Telephone: (202) 245-6211 or by email: [email protected]

    If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION:

    This notice of proposed priority is in concert with NIDILRR's currently approved Long-Range Plan (Plan). The Plan, which was published in the Federal Register on April 4, 2013 (78 FR 20299), can be accessed on the Internet at the following site: www.ed.gov/about/offices/list/osers/nidrr/policy.html.

    The Plan identifies a need for research and training regarding employment of individuals with disabilities. To address this need, NIDILRR seeks to: (1) Improve the quality and utility of disability and rehabilitation research; (2) foster an exchange of research findings, expertise, and other information to advance knowledge and understanding of the needs of individuals with disabilities and their family members, including those from among traditionally underserved populations; (3) determine effective practices, programs, and policies to improve community living and participation, employment, and health and function outcomes for individuals with disabilities of all ages; (4) identify research gaps and areas for promising research investments; (5) identify and promote effective mechanisms for integrating research and practice; and (6) disseminate research findings to all major stakeholder groups, including individuals with disabilities and their family members in formats that are appropriate and meaningful to them.

    This notice proposes one priority that NIDILRR intends to use for one or more competitions in fiscal year (FY) 2015 and possibly later years. NIDILRR is under no obligation to make an award under this priority. The decision to make an award will be based on the quality of applications received and available funding. NIDILRR may publish additional priorities, as needed.

    Invitation to Comment: We invite you to submit comments regarding this proposed priority. To ensure that your comments have maximum effect in developing the final priority, we urge you to identify clearly the specific topic within the priority that each comment addresses.

    We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from this proposed priority. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.

    During and after the comment period, you may inspect all public comments by following the instructions found under the “Are you new to the site?” portion of the Federal eRulemaking Portal at wwww.regulations.gov. Any comments sent to NIDILRR via postal mail or commercial delivery can be viewed in Room 5142, 550 12th Street SW., PCP, Washington, DC, between the hours of 8:30 a.m. and 4 p.m., Washington, DC time, Monday through Friday of each week except Federal holidays.

    Assistance to Individuals with Disabilities in Reviewing the Rulemaking Record: On request we will provide an appropriate accommodation or auxiliary aid to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for this notice. If you want to schedule an appointment for this type of accommodation or auxiliary aid, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Purpose of Program: The purpose of the Disability and Rehabilitation Research Projects and Centers Program is to plan and conduct research, demonstration projects, training, and related activities, including international activities, to develop methods, procedures, and rehabilitation technology that maximize the full inclusion and integration into society, employment, independent living, family support, and economic and social self-sufficiency of individuals with disabilities, especially individuals with the most severe disabilities, and to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended (Rehabilitation Act).

    Rehabilitation Research and Training Centers

    The purpose of the RRTCs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to achieve the goals of, and improve the effectiveness of, services authorized under the Rehabilitation Act through well-designed research, training, technical assistance, and dissemination activities in important topical areas as specified by NIDILRR. These activities are designed to benefit rehabilitation service providers, individuals with disabilities, family members, policymakers and other research stakeholders. Additional information on the RRTC program can be found at: http://www2.ed.gov/programs/rrtc/index.html#types.

    Program Authority: 29 U.S.C. 762(g) and 764(b)(2).

    Applicable Program Regulations: 34 CFR part 350.

    Proposed Priority: This notice contains one proposed priority.

    RRTC on Employer Practices Leading to Successful Employment Outcomes for Individuals With Disabilities

    Background: Individuals with disabilities experience lower rates and quality of employment than those without disabilities. The percentage of the population that is employed is lower for individuals with disabilities (17.6%) than for individuals without disabilities (64.0%), and this difference has been relatively stable since 2012 (U.S. Department of Labor, 2014a, 2014b). Of those individuals who are employed, individuals with disabilities are more likely to work part time (34%) than are individuals without disabilities (19%) (U.S. Department of Labor, 2014a), and individuals with disabilities earn less than do individuals without disabilities (Brault, 2012; Schur et al., 2009; U.S. Department of Commerce, 2013). In addition, employees with disabilities have more limited opportunities for experiences related to retention and advancement, such as training and participation in decision-making, and less job security (Schur et al., 2009).

    Although the employment of individuals with disabilities is the result of a complex interaction among many variables, employer practices comprise an important factor in the employment of individuals with disabilities. In recent years, researchers (Bruyère & Barrington, 2012; Chan et al., 2010a) have recognized the importance of considering demand-side, i.e., employer, variables to understand and decrease the difference in employment outcomes between individuals with and without disabilities. In addition, a number of Federal initiatives have highlighted the need for employers to change their practices to improve employment outcomes for individuals with disabilities (e.g., new regulations for Section 503 of the Rehabilitation Act, establishing nationwide 7% employment goals for qualified individuals with disabilities for companies doing business with the Federal government; Executive Order 13548 (2010), “Increasing Federal Employment of Individuals with Disabilities”).

    A number of employer practices are associated with better employment outcomes (i.e., hiring, retention, or advancement) for individuals with disabilities. These include, but are not limited to: Employer knowledge of the Americans with Disabilities Act, the inclusion of disability in employer diversity plans, diversity training for management, targeted recruitment, and employer-provided accommodations (Bruyère & Barrington, 2012; Chan et al., 2010b; Hirsh & Kmec, 2009; Schur et al., 2009). Factors associated with employment of individuals with disabilities vary by employer size, industry type, and sector of the economy (U.S. Department of Labor, 2008; Bruyère & Barrington, 2012; Fraser et al., 2010).

    However, knowledge of employer practices that are associated with better employment outcomes for individuals with disabilities does not tell us whether those practices actually caused those outcomes (Bruyère & Barrington, 2012; Fraser et al., 2011). In addition to the need for a stronger evidence base for the effectiveness of promising employer practices, there is a need for the development of measures that employers can use to track employment outcomes for individuals with disabilities (Erickson et al., 2013; Von Schrader et al., 2013). Both of these types of knowledge are critical to the development of effective workplace programs and practices to improve employment outcomes for individuals with disabilities.

    References Brault, M. W. (2012). Americans with disabilities: 2010. U.S. Department of Commerce, Economics and Statistics Administration, US Census Bureau. Bruyère, S. M., & Barrington, L. (2012). Current issues, controversies, and solutions. In S.M. Bruyère and L. Barrington, (Eds.), Employment and work. Sage Publications. Chan, F., Strauser, D., Gervey, R., & Lee, E-J. (2010a). Introduction to demand-side factors related to employment of people with disabilities. Journal of Occupational Rehabilitation, 20, 407-411. Chan, F., Straser, D., Maher, P., Lee, E-J., Jones, R., & Johnson, E. T. (2010b). Demand-side factors related to employment of people with disabilities: A survey of employers in the Midwest region of the United Sates. Journal of Occupational Rehabilitation, 20, 412-419. Erickson, W. A., von Schrader, S., Bruyère, S. M., & VanLooy, S. A. (2013). The employment environment: Employer perspectives, policies, and practices regarding the employment of persons with disabilities. Rehabilitation Counseling Bulletin, 0034355213509841. Exec. Order No. 13548, 3 C. F. R. 168 (2010). Fraser, R. T., Johnson, K., Hebert, J., Ajzen, I., Copeland, J., Brown, P., & Chan, F. (2010). Understanding employers' hiring intentions in relation to qualified workers with disabilities: Preliminary findings. Journal of Occupational Rehabilitation, 20(4), 420-426. Fraser, R., Ajzen, I., Johnson, K., Hebert, J., & Chan, F. (2011). Understanding employers' hiring intention in relation to qualified workers with disabilities. Journal of Vocational Rehabilitation, 35(1), 1-11. Hirsh, E., & Kmec, J. A. (2009). Human resource structures: Reducing discrimination or raising rights awareness?. Industrial Relations: A Journal of Economy and Society, 48(3), 512-532. Schur, L., Kruse, D., Blasi, J., & Blanck, P. (2009). Is disability disabling in all workplaces? Workplace disparities and corporate culture. Industrial Relations: A Journal of Economy and Society, 48(3), 381-410. Von Schrader, S., Malzer, V., & Bruyère, S. (2013). Perspectives on disability disclosure: The importance of employer practices and workplace climate. Employee Responsibilities and Rights Journal, 26(4), 237-255. U.S. Department of Commerce, U.S. Census Bureau. (2013). Selected economic characteristics for the civilian noninstitutionalized population by disability status. 2013 American Community Survey 1-year estimates. http://factfinder2.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ACS_13_1YR_S1811&prodType=table Retrieved November 19, 2014. U.S. Department of Labor, Bureau of Labor Statistics (2014a). Persons with A Disability: Labor Force Characteristics—2013. Available at http://www.bls.gov/news.release/pdf/disabl.pdf Retrieved November 14, 2014. U.S. Department of Labor, Bureau of Labor Statistics (2014b). Table A6. Employment status of the civilian population by sex, age, and disability status, not seasonally adjusted. Available at http://www.bls.gov/news.release/empsit.t06.htm Retrieved November 19, 2014. U.S. Department of Labor, Office on Disability Employment Policy (2008). Survey of Employer Perspectives on the Employment of People with Disabilities. Technical report. Available at http://www.dol.gov/odep/documents/survey_report_jan_09.doc. Retrieved February 2, 2015.

    Definitions: The research that is proposed under this priority must be focused on one or more stages of research. If the RRTC is to conduct research that can be categorized under more than one research stage, or research that progresses from one stage to another, those research stages must be clearly specified. For purposes of this priority, the stages of research are from the notice of final priorities and definitions published in the Federal Register on June 7, 2013 (78 FR 34261).

    (a) Exploration and Discovery means the stage of research that generates hypotheses or theories by conducting new and refined analyses of data, producing observational findings, and creating other sources of research-based information. This research stage may include identifying or describing the barriers to and facilitators of improved outcomes of individuals with disabilities, as well as identifying or describing existing practices, programs, or policies that are associated with important aspects of the lives of individuals with disabilities. Results achieved under this stage of research may inform the development of interventions or lead to evaluations of interventions or policies. The results of the exploration and discovery stage of research may also be used to inform decisions or priorities.

    (b) Intervention Development means the stage of research that focuses on generating and testing interventions that have the potential to improve outcomes for individuals with disabilities. Intervention development involves determining the active components of possible interventions, developing measures that would be required to illustrate outcomes, specifying target populations, conducting field tests, and assessing the feasibility of conducting a well-designed interventions study. Results from this stage of research may be used to inform the design of a study to test the efficacy of an intervention.

    (c) Intervention Efficacy means the stage of research during which a project evaluates and tests whether an intervention is feasible, practical, and has the potential to yield positive outcomes for individuals with disabilities. Efficacy research may assess the strength of the relationships between an intervention and outcomes, and may identify factors or individual characteristics that affect the relationship between the intervention and outcomes. Efficacy research can inform decisions about whether there is sufficient evidence to support “scaling-up” an intervention to other sites and contexts. This stage of research can include assessing the training needed for wide-scale implementation of the intervention, and approaches to evaluation of the intervention in real world applications.

    (d) Scale-Up Evaluation means the stage of research during which a project analyzes whether an intervention is effective in producing improved outcomes for individuals with disabilities when implemented in a real-world setting. During this stage of research, a project tests the outcomes of an evidence-based intervention in different settings. It examines the challenges to successful replication of the intervention, and the circumstances and activities that contribute to successful adoption of the intervention in real-world settings. This stage of research may also include well-designed studies of an intervention that has been widely adopted in practice, but that lacks a sufficient evidence-base to demonstrate its effectiveness.

    Proposed Priority: The Administrator for Community Living proposes a priority for an RRTC on Employer Practices Leading to Successful Employment Outcomes for Individuals with Disabilities. The purpose of the RRTC is to generate new knowledge about effective employer practices that support successful employment outcomes for individuals with disabilities. The RRTC must contribute to improving the employment outcomes of individuals with disabilities by:

    (a) Identifying promising employer practices most strongly associated with desired employment outcomes for individuals with disabilities as well as the prevalence of these practices. Practices should include those related to the hiring, retention, and advancement of individuals with disabilities.

    (b) Developing measures of employment outcomes that include hiring, retention, and advancement of individuals with disabilities. These measures must be developed for use by employers and other stakeholders. These measures may also include employment quality, such as, but not limited to, earnings, full- or part-time employment, or opportunities for on-the-job training. In developing these measures, the RRTC must collaborate with the NIDILRR-funded RRTC on Employment Policy and Measurement.

    (c) Generating new knowledge of the effectiveness of promising employer practices by identifying or developing, and then implementing and evaluating pilot workplace program(s) based on practices identified in (a). This work should be conducted in employment settings in collaboration with employers, and should include:

    (1) Implementation of practices that are particularly likely to be effective in improving employment outcomes for individuals with disabilities;

    (2) Implementation of practices among different types of employers (e.g., small v. large employers, private v. public sector employers);

    (3) Collection of data using, but not limited to, outcome measures from (b) above.

    (d) Focusing its research on one or more specific stages of research. If the RRTC is to conduct research that can be categorized under more than one of the research stages, or research that progresses from one stage to another, those stages should be clearly justified.

    (e) Serving as a national resource center related to employment for individuals with disabilities, their families, and other stakeholders by conducting knowledge translation activities that include, but are not limited to:

    (1) Providing information and technical assistance to employers, employment service providers, employer groups, individuals with disabilities and their representatives, and other key stakeholders;

    (2) Providing training, including graduate, pre-service, and in-service training, to employers and employer groups, to facilitate more effective employer practices for individuals with disabilities. This training may be provided through conferences, workshops, public education programs, in-service training programs, and similar activities;

    (3) Disseminating research-based information and materials related to increasing employment levels for individuals with disabilities; and

    (4) Involving key stakeholder groups in the activities conducted under paragraphs (a) and (b) of this priority to promote the new knowledge generated by the RRTC.

    Final Priority: We will announce the final priority in a notice in the Federal Register. We will determine the final priority after considering responses to this notice and other information available to the Department. This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

    Note:

    This notice does not solicit applications. In any year in which we choose to use this priority, we invite applications through a notice in the Federal Register or in a Funding Opportunity Announcement posted at www.grants.gov.

    Executive Orders 12866 and 13563 Regulatory Impact Analysis

    Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive Order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

    (1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);

    (2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

    (3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

    (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive Order.

    This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

    We have also reviewed this regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

    (1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

    (2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

    (3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

    (4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

    (5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

    Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

    We are issuing this proposed priority only upon a reasoned determination that its benefits would justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that this proposed priority is consistent with the principles in Executive Order 13563.

    We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

    In accordance with both Executive Orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

    The benefits of the Disability and Rehabilitation Research Projects and Centers Program have been well established over the years. Projects similar to one envisioned by the proposed priority have been completed successfully, and the proposed priority would generate new knowledge through research. The new RRTC would generate, disseminate, and promote the use of new information that would improve outcomes for individuals with disabilities in the area of employment.

    Intergovernmental Review: This program is not subject to Executive Order 12372.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Dated: February 19, 2015. Kathy Greenlee, Administrator.
    [FR Doc. 2015-03877 Filed 2-24-15; 8:45 am] BILLING CODE 4154-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living [CFDA Number: 84.133B-5] Proposed Priority—National Institute on Disability, Independent Living, and Rehabilitation Research—Rehabilitation Research and Training Centers AGENCY:

    Administration for Community Living, HHS.

    ACTION:

    Notice of proposed priority.

    SUMMARY:

    The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for an RRTC on Employment for Individuals with Blindness or other Visual Impairments. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment for individuals with blindness or other visual impairments.

    DATES:

    We must receive your comments on or before March 27, 2015.

    ADDRESSES:

    Submit your comments through the Federal eRulemaking Portal or via postal mail or commercial delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.

    Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on using Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under “Are you new to the site?”

    Postal Mail or Commercial Delivery: If you mail or deliver your comments about these proposed regulations, address them to Patricia Barrett, U.S. Department of Health and Human Services, 400 Maryland Avenue SW., Room 5142, Potomac Center Plaza (PCP), Washington, DC 20202-2700.

    Privacy Note: The Department's policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available.

    FOR FURTHER INFORMATION CONTACT:

    Patricia Barrett. Telephone: (202) 245-6211 or by email: [email protected]

    If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION:

    This notice of proposed priority is in concert with NIDRR's currently approved Long-Range Plan (Plan). The Plan, which was published in the Federal Register on April 4, 2013 (78 FR 20299), can be accessed on the Internet at the following site: www.ed.gov/about/offices/list/osers/nidrr/policy.html.

    The Plan identifies a need for research and training regarding employment of individuals with disabilities. To address this need, NIDILRR seeks to: (1) Improve the quality and utility of disability and rehabilitation research; (2) foster an exchange of research findings, expertise, and other information to advance knowledge and understanding of the needs of individuals with disabilities and their family members, including those from among traditionally underserved populations; (3) determine effective practices, programs, and policies to improve community living and participation, employment, and health and function outcomes for individuals with disabilities of all ages; (4) identify research gaps and areas for promising research investments; (5) identify and promote effective mechanisms for integrating research and practice; and (6) disseminate research findings to all major stakeholder groups, including individuals with disabilities and their family members in formats that are appropriate and meaningful to them.

    This notice proposes one priority that NIDILRR intends to use for one or more competitions in fiscal year (FY) 2015 and possibly later years. NIDILRR is under no obligation to make an award under this priority. The decision to make an award will be based on the quality of applications received and available funding. NIDILRR may publish additional priorities, as needed.

    Invitation to Comment: We invite you to submit comments regarding this proposed priority. To ensure that your comments have maximum effect in developing the final priority, we urge you to identify clearly the specific topic within the priority that each comment addresses.

    We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from this proposed priority. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.

    During and after the comment period, you may inspect all public comments by following the instructions found under the “Are you new to the site?” portion of the Federal eRulemaking Portal at wwww.regulations.gov. Any comments sent to NIDILRR via postal mail or commercial deliver can be viewed in room 5142, 550 12th Street SW., PCP, Washington, DC, between the hours of 8:30 a.m. and 4:00 p.m., Washington, DC time, Monday through Friday of each week except Federal holidays.

    Assistance to Individuals With Disabilities in Reviewing the Rulemaking Record: On request we will provide an appropriate accommodation or auxiliary aid to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for this notice. If you want to schedule an appointment for this type of accommodation or auxiliary aid, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Purpose of Program: The purpose of the Disability and Rehabilitation Research Projects and Centers Program is to plan and conduct research, demonstration projects, training, and related activities, including international activities, to develop methods, procedures, and rehabilitation technology that maximize the full inclusion and integration into society, employment, independent living, family support, and economic and social self-sufficiency of individuals with disabilities, especially individuals with the most severe disabilities, and to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended (Rehabilitation Act).

    Rehabilitation Research and Training Centers

    The purpose of the RRTCs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to achieve the goals of, and improve the effectiveness of, services authorized under the Rehabilitation Act through well-designed research, training, technical assistance, and dissemination activities in important topical areas as specified by NIDILRR. These activities are designed to benefit rehabilitation service providers, individuals with disabilities, family members, policymakers and other research stakeholders. Additional information on the RRTC program can be found at: http://www2.ed.gov/programs/rrtc/index.html#types.

    Program Authority: 29 U.S.C. 762(g) and 764(b)(2).

    Applicable Program Regulations: 34 CFR part 350.

    Proposed Priority: This notice contains one proposed priority.

    RRTC on Employment for Individuals With Blindness or Other Visual Impairments

    Background: Employment rates for individuals with blindness or other visual impairments are low compared to other persons with disabilities and the nondisabled population. Of 3.5 million working age adults who report vision loss, only 1.3 million or 37 percent are employed (U.S. Census Bureau, 2012). Key groups within the population of persons with blindness and visual impairments would benefit from research and development to promote better employment outcomes. These groups include:

    (a) Deaf blindness—Rough estimates suggest there are approximately 45 to 50 thousand individuals with deaf-blindness in the United States (Gallaudet University, 2010). Among students who received services under the Individuals with Disabilities Education Act (IDEA), 36.1 percent of students with multiple disabilities/deaf-blindness were employed after leaving high school as compared to 62.4 percent among students with visual impairments only (American Federation of the Blind, 2014). For the 2,020 persons with deaf-blindness who received services through the Federal/State Vocational Rehabilitation program from 2008 through 2013, 64.5 percent achieved employment outcomes (Rehabilitation Services Administration, 2014). Prevalence and employment data thus vary considerably and strategies for improving communication, social development, self-determination, and employment for this subpopulation have not kept pace with emerging technologies accessible to most citizens (Hartman, 2010). Development and testing of new technologies focused on improving the employment and quality of life outcomes of people with deaf-blindness is needed along with effective knowledge translation and dissemination.

    (b) Blindness or low vision related to traumatic brain injury (TBI)—In 2010, approximately 2.5 million people received a traumatic brain injury (Center for Disease Control (2010). TBI is also a signature cause of disability among veterans of the wars in Iraq and Afghanistan (U.S. Department of Defense, 2012). Closed head injuries often result in focal axonal swelling and disconnection, damage to optic nerves, impaired visual processing, and eye movement difficulties due to cranial nerve disruption. Research has estimated that among individuals with TBI in the United States, 42 percent were unemployed (Doctor, Castro, Temkin, Fraser, Machamer & Dikmen, 2005). For Vocational Rehabilitation consumers with TBI, 49.4 percent or 6,040 achieved employment in 2013 (Rehabilitation Services Administration, 2014). There are little data on the employment outcomes of individuals with TBI who experience low-vision and blindness, however. Research is needed to document the employment outcomes of individuals who experience low vision and blindness due to or in addition to TBI and to develop effective neuropsychological rehabilitation, psychotherapy, vocational rehabilitation, and other interventions for improving employment outcomes for these individuals.

    (c) Transition-age students—High school students with blindness or visual impairments demonstrate higher academic achievement and are more likely to continue with postsecondary education when compared to other students receiving special education services under the IDEA. However, these students are less likely to achieve employment outcomes despite demonstrated academic success (Wagner, Newman, Cameto, Levine & Garza 2006; McDonnall, 2010). Qualitative research suggests that early intervention and planning, family involvement, interagency coordination and early work-based experiences may improve employment outcomes for transition-age students with blindness or visual impairments (Crudden, 2012). Rigorous research evaluating the potential of these and other employment-focused strategies, including vocational rehabilitation, may thus yield results that inform effective policies and practice.

    References:

    American Federation of the Blind (2014). NLTS2 Tables: Transition of Youth with Visual Impairments, Multiple Impairments, or Deaf-Blindness. Retrieved January 9, 2015, from: http://www.afb.org/info/programs-and-services/public-policy-center/employment-and-rehabilitation/nlts2-tables/1235#table5. Census Bureau (2012). American Community Survey, American FactFinder, Table B18120. Retrieved September 23, 2013, from: http://factfinder2.census.gov. Center for Disease Control (2010). National Hospital Discharge Survey (NHDS). Retrieved January 9, 2015, from: http://www.cdc.gov/traumaticbraininjury/data/index.html. Crudden, A. (2012). Transition to Employment for Students with Visual Impairments: Components for Success. Journal of Visual Impairment & Blindness. January 9, 2015, from: http://www.afb.org/afbpress/pubjvib.asp?DocID=jvib060702. Doctor J.N., Castro J., Temkin N.R., Fraser R.T., Machamer J.E., Dikmen S.S. (2005). Workers' risk of unemployment after traumatic brain injury: a normed comparison. Journal of International Neuropsychological Society 11(6):747-52. Gallaudet University Library (2010). American Deaf-Blind Population. Retrieved January 9, 2015, from: http://libguides.gallaudet.edu/content.php?pid=119476&sid=1029203. Hartman, E. (2011). National Consortium on Deafblindness: Universal Design for Learning. Retrieved January 9, 2015, from: http://files.eric.ed.gov/fulltext/ED531767.pdf. McDonnall, M. (2010). Factors affecting employment outcomes for young adults with visual impairments. Rehabilitation Counseling Bulletin (54), 36-45. Rehabilitation Services Administration (2014). RSA-911 Case Service Report. Retrieved January 9, 2015, from: www2.ed.gov/policy/speced/guid/rsa/pd-04-04.doc. U.S. Department of Defense (2012). Traumatic Brain Injury Special Report. Retrieved January 9, 2015, from: http://www.defense.gov/home/features/2012/0312_tbi/. Wagner, M., Newman, L., Cameto, R., Levine, P., and Garza, N. (2006). An Overview of Findings From Wave 2 of the National Longitudinal Transition Study-2 (NLTS2). Retrieved January 9, 2015, from: http://ies.ed.gov/ncser/pdf/20063004.pdf.

    Definitions: The research that is proposed under this priority must be focused on one or more stages of research. If the RRTC is to conduct research that can be categorized under more than one research stage, or research that progresses from one stage to another, those research stages must be clearly specified. For purposes of this priority, the stages of research are from the notice of final priorities and definitions published in the Federal Register on June 7, 2013 (78 FR 34261).

    (a) Exploration and Discovery means the stage of research that generates hypotheses or theories by conducting new and refined analyses of data, producing observational findings, and creating other sources of research-based information. This research stage may include identifying or describing the barriers to and facilitators of improved outcomes of individuals with disabilities, as well as identifying or describing existing practices, programs, or policies that are associated with important aspects of the lives of individuals with disabilities. Results achieved under this stage of research may inform the development of interventions or lead to evaluations of interventions or policies. The results of the exploration and discovery stage of research may also be used to inform decisions or priorities.

    (b) Intervention Development means the stage of research that focuses on generating and testing interventions that have the potential to improve outcomes for individuals with disabilities. Intervention development involves determining the active components of possible interventions, developing measures that would be required to illustrate outcomes, specifying target populations, conducting field tests, and assessing the feasibility of conducting a well-designed interventions study. Results from this stage of research may be used to inform the design of a study to test the efficacy of an intervention.

    (c) Intervention Efficacy means the stage of research during which a project evaluates and tests whether an intervention is feasible, practical, and has the potential to yield positive outcomes for individuals with disabilities. Efficacy research may assess the strength of the relationships between an intervention and outcomes, and may identify factors or individual characteristics that affect the relationship between the intervention and outcomes. Efficacy research can inform decisions about whether there is sufficient evidence to support “scaling-up” an intervention to other sites and contexts. This stage of research can include assessing the training needed for wide-scale implementation of the intervention, and approaches to evaluation of the intervention in real world applications.

    (d) Scale-Up Evaluation means the stage of research during which a project analyzes whether an intervention is effective in producing improved outcomes for individuals with disabilities when implemented in a real-world setting. During this stage of research, a project tests the outcomes of an evidence-based intervention in different settings. It examines the challenges to successful replication of the intervention, and the circumstances and activities that contribute to successful adoption of the intervention in real-world settings. This stage of research may also include well-designed studies of an intervention that has been widely adopted in practice, but that lacks a sufficient evidence-base to demonstrate its effectiveness.

    Proposed Priority: The Administrator of the Administration for Community Living proposes a priority for an RRTC on Employment for Individuals with Blindness or other Visual Impairments. The purpose of the proposed RRTC is to conduct research that generates new knowledge about the efficacy of rehabilitative services and technology used to support improved employment outcomes of individuals with blindness or other visual impairments, including subpopulations that are the focus of this priority.

    The RRTC must contribute to improving the employment outcomes of individuals with blindness or other visual impairments by:

    (a) Conducting research on the efficacy of rehabilitation services and technology used to enhance employment outcomes of individuals with blindness or other visual impairments. Outcomes must include but are not limited to obtaining employment, retention, promotion, and quality of salary and benefits. The RRTC must focus its research on the target population of individuals with blindness or other visual impairments, including at least one of the following subpopulations of particular concern: (1) Individuals who are deaf-blind, (2) individuals with blindness or low vision related to traumatic brain injury, and (3) transition-age young people with blindness or other visual impairments;

    (b) Generating new knowledge about how the outcomes of the services and technologies investigated in paragraph (a) vary with relevant variables such as service type, consumer characteristics, and provider characteristics;

    (c) Focusing its research on one or more specific stages of research. If the RRTC is to conduct research that can be categorized under more than one of the research stages, or research that progresses from one stage to another, those stages should be clearly justified;

    (d) Serving as a national resource center related to employment for individuals with blindness or other visual impairments, their families, and other stakeholders by conducting knowledge translation, technical assistance, and training activities;

    (e) Disseminating research-based information and materials related to improving the quality of services to individuals with blindness or other visual impairments; and

    (f) Involving key stakeholder groups in the activities conducted under paragraphs (a) and (b) of this priority to promote the new knowledge generated by the RRTC.

    Final Priority: We will announce the final priority in a notice in the Federal Register. We will determine the final priority after considering responses to this notice and other information available to the Department. This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

    Note:

    This notice does not solicit applications. In any year in which we choose to use this priority, we invite applications through a notice in the Federal Register, Executive Orders 12866 and 13563 or in a Funding Opportunity Announcement posted at www.grants.gov.

    Executive Orders 12866 and 13563 Regulatory Impact Analysis

    Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive Order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

    (1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);

    (2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

    (3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

    (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive Order.

    This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

    We have also reviewed this regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

    (1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

    (2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

    (3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

    (4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

    (5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

    Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

    We are issuing this proposed priority only upon a reasoned determination that its benefits would justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that this proposed priority is consistent with the principles in Executive Order 13563.

    We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

    In accordance with both Executive Orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

    The benefits of the Disability and Rehabilitation Research Projects and Centers Program have been well established over the years. Projects similar to one envisioned by the proposed priority have been completed successfully, and the proposed priority would generate new knowledge through research. The new RRTC would generate, disseminate, and promote the use of new information that would improve employment outcomes for individuals with blindness or other visual impairments.

    Intergovernmental Review: This program is not subject to Executive Order 12372.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Dated: February 19, 2015. Kathy Greenlee, Administrator.
    [FR Doc. 2015-03885 Filed 2-24-15; 8:45 am] BILLING CODE 4154-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living [CFDA Number: 84.133B-4] Proposed Priority—National Institute on Disability, Independent Living, and Rehabilitation Research—Rehabilitation Research and Training Centers AGENCY:

    Administration for Community Living.

    ACTION:

    Notice of proposed priority.

    SUMMARY:

    The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for an RRTC on Self-Directed Care to Promote Recovery, Health, and Wellness for Individuals with Serious Mental Illness. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment for individuals with serious mental illness (SMI) and co-occurring conditions.

    DATES:

    We must receive your comments on or before March 27, 2015.

    ADDRESSES:

    Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.

    Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on using Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under “Are you new to the site?”

    Postal Mail, Commercial Delivery, or Hand Delivery: If you mail or deliver your comments about these proposed regulations, address them to Patricia Barrett, U.S. Department of Health and Human Services, 400 Maryland Avenue SW., Room 5142, Potomac Center Plaza (PCP), Washington, DC 20202-2700.

    Privacy Note:

    The Department's policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available.

    FOR FURTHER INFORMATION CONTACT:

    Patricia Barrett. Telephone: (202) 245-6211 or by email: [email protected]

    If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION:

    This notice of proposed priority is in concert with NIDRR's currently approved Long-Range Plan (Plan). The Plan, which was published in the Federal Register on April 4, 2013 (78 FR 20299), can be accessed on the Internet at the following site: www.ed.gov/about/offices/list/osers/nidrr/policy.html.

    The Plan identifies a need for research and training regarding employment of individuals with disabilities. To address this need, NIDILRR seeks to: (1) Improve the quality and utility of disability and rehabilitation research; (2) foster an exchange of research findings, expertise, and other information to advance knowledge and understanding of the needs of individuals with disabilities and their family members, including those from among traditionally underserved populations; (3) determine effective practices, programs, and policies to improve community living and participation, employment, and health and function outcomes for individuals with disabilities of all ages; (4) identify research gaps and areas for promising research investments; (5) identify and promote effective mechanisms for integrating research and practice; and (6) disseminate research findings to all major stakeholder groups, including individuals with disabilities and their family members in formats that are appropriate and meaningful to them.

    This notice proposes one priority that NIDILRR intends to use for one or more competitions in fiscal year (FY) 2015 and possibly later years. NIDILRR is under no obligation to make an award under this priority. The decision to make an award will be based on the quality of applications received and available funding. NIDILRR may publish additional priorities, as needed.

    Invitation to Comment: We invite you to submit comments regarding this proposed priority. To ensure that your comments have maximum effect in developing the final priority, we urge you to identify clearly the specific topic within the priority that each comment addresses.

    We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from this proposed priority. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.

    During and after the comment period, you may inspect all public comments by following the instructions found under the “Are you new to the site?” portion of the Federal eRulemaking Portal at wwww.regulations.gov. Any comments sent to NIDILRR via postal mail, commercial deliver, or hand delivery can be viewed in room 5142, 550 12th Street SW., PCP, Washington, DC, between the hours of 8:30 a.m. and 4:00 p.m., Washington, DC time, Monday through Friday of each week except Federal holidays.

    Assistance to Individuals With Disabilities in Reviewing the Rulemaking Record: On request we will provide an appropriate accommodation or auxiliary aid to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for this notice. If you want to schedule an appointment for this type of accommodation or auxiliary aid, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Purpose of Program: The purpose of the Disability and Rehabilitation Research Projects and Centers Program is to plan and conduct research, demonstration projects, training, and related activities, including international activities, to develop methods, procedures, and rehabilitation technology that maximize the full inclusion and integration into society, employment, independent living, family support, and economic and social self-sufficiency of individuals with disabilities, especially individuals with the most severe disabilities, and to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended (Rehabilitation Act).

    Rehabilitation Research and Training Centers

    The purpose of the RRTCs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to achieve the goals of, and improve the effectiveness of, services authorized under the Rehabilitation Act through well-designed research, training, technical assistance, and dissemination activities in important topical areas as specified by NIDILRR. These activities are designed to benefit rehabilitation service providers, individuals with disabilities, family members, policymakers and other research stakeholders. Additional information on the RRTC program can be found at: http://www2.ed.gov/programs/rrtc/index.html#types.

    Program Authority: 29 U.S.C. 762(g) and 764(b)(2).

    Applicable Program Regulations: 34 CFR part 350.

    Proposed Priority: This notice contains one proposed priority.

    RRTC on Self-Directed Care To Promote Recovery, Health, and Wellness for Individuals With Serious Mental Illness Background

    Mental health disorders are one of the leading causes of disability in the United States. In 2012, there were an estimated 9.6 million adults aged 18 or older in the U.S. with serious mental illness, representing 4.1 percent of all U.S. adults (U.S. Department of Health and Human Services, 2012a). Most individuals with mental illness today live in community settings—a result of the deinstitutionalization movement of the 1960s to 1980s, the Americans with Disabilities Act of 1990, and the 1999 U.S. Supreme Court Olmstead decision (National Council on Disability, 2008; Olmstead v. L.C., 527 U.S. 581 (1999); Salzer, Kaplan, & Atay, 2006). Individuals with mental illness are less likely to achieve successful employment outcomes than individuals without mental illness (Cook, 2006). For those who are employed, mental illness is associated with decreased productivity and lower levels of job retention (Cook, 2006; Lerner et al., 2012). In addition, individuals with mental illness experience higher mortality rates and poorer physical health than individuals without mental illness (Banham & Gilbody, 2010). This disparity in general health is exacerbated by barriers to healthcare delivery services for individuals with mental illness, at both the system and the individual levels (Kelly et al., 2014). Furthermore, employment outcomes and health are related in this population. At the individual level, mental illness symptoms and comorbid medical conditions are associated with poorer employment outcomes (Cook et al., 2007; Frey et al., 2008). At the system level, the relations among health care systems, and those between employment service systems and health care systems, are complex (Frey et al., 2008; Kelly et al., 2014).

    Over the last few decades, the concept of self-determination has become more widespread in the design and conceptualization of services for individuals with mental illness. In this context, self-determination refers to individuals' rights to direct their own services, to be involved in decisions that impact their wellbeing, to be meaningfully involved in the design, delivery and evaluation of services and supports, and to develop and use their own personal goals to guide their lives and actions (Cook & Jonikas, 2002). Self-determination is a central component of the Substance Abuse and Mental Health Services Administration's definition of recovery (U.S. Department of Health and Human Services, 2012b) and has become an important component of recovery-oriented mental health treatment and services. It is closely related to the guiding principle of informed choice in vocational rehabilitation and supported employment (Drake, Bond & Becker, 2012; Workforce Innovation and Opportunity Act of 2014). In the field of general health care, self-determination principles are reflected in the concept of self-direction (e.g., Centers for Medicare and Medicaid Services, no date). Principles of self-determination can be incorporated into many types of services and supports for individuals with mental illness and into efforts to address system and individual-level barriers to health and employment services.

    At the system level, the self-determination approach in health care has informed systems in which individuals with disabilities control the services they receive. These systems are known by a variety of names, (e.g., person-centered funding, person-directed services, participant-directed services, cash and counseling) (Barczyk & Lincove, 2010; O'Brien et al., 2005; Powers & Sowers, 2006; Robert Wood Johnson Foundation, 2006). When the system is designed for individuals with serious mental illness, this type of service is frequently referred to as self-directed care. It uses public funds to provide individuals with the cash value of services and allows individuals to choose, organize, and purchase services (Alakeson, 2008), thereby providing both self-direction and a mechanism to purchase services and goods traditionally covered by different funding sources. Individuals may choose services and supports that are not traditionally provided in the mental health system, such as wellness services, transportation, medical or dental services, and tangible items that support community participation (Cook et al., 2008). Individuals are provided with assistance to help them develop their own individual service plans and budgets. The mechanism involved can vary, (e.g., direct payments, individual budgets, flexible funds). Early data on the effectiveness of this approach for individuals with mental illness suggest that self-directed care can yield positive results for a variety of outcomes, including employment, quality of life, and service use (Alakeson, 2008; Cook et al., 2008; O'Brien et al., 2005; Webber et al., 2014). However, self-directed care has been implemented in few States, and very little is known about the effectiveness of this approach for many recovery-oriented outcomes, such as employment.

    Other system-level approaches to improving both access to health care and the health of individuals with mental illness have incorporated principles of care coordination to integrate mental health services with general medical services (Barry & Huskamp, 2014; Croft & Parish, 2012; Druss et al., 2010; Kelly et al., 2014; Mechanic, 2014). Services provided through care coordination models can bridge the gap between mental health and general health services and improve outcomes both in mental and in general medical health (Woltmann et al., 2012). Although care coordination organizations do not necessarily incorporate self-determination features, they can do so. For example, care coordination models may include illness self management programs, which train individuals on how to manage their symptoms and improve their functioning and quality of life. In fact, the Improving Chronic Illness Care Initiative includes illness self-management as a core feature (Kelly et al., 2014; McDonald et al., 2007; Woltmann et al., 2012). Illness self-management interventions can be effective for people with mental illness dealing with general medical problems (Kelly et al., 2014) or mental illness (Roe et al., 2009). In addition, there is preliminary evidence that mental illness self-management may have positive effects on employment outcomes (Michon, 2011).

    However, coordinated care systems can be complex for consumers to negotiate. Therefore, many systems provide staff who serve as navigators to help guide clients through the barriers of complex health care systems and provide support for consumers in such self-directed activities as developing plans and making choices. Early research indicates that provision of navigator services can improve health outcomes and use of medical services for individuals with mental illness (Griswold et al., 2010; Kelly et al., 2013). In addition, having peers serve either as navigators or to deliver mental or general healthcare interventions can be effective for individuals with mental illness (Brekke et al., 2013; Chinman et al., 2014; Kelly et al, 2014; Pitt et al., 2013).

    Research on the use of self-directed services and supports, and self-directed care, for individuals with mental illness is in preliminary stages. There is a need for better understanding of the optimal use of self-directed strategies in the integration of general health care and mental health care, as well as the optimal involvement of peer supports for people with serious mental illness.

    References:

    Alakeson, V., (2008). Let patients control the purse strings. British Medical Journal, 336, 807-809. Banham, L., & Gilbody, S. (2010). Smoking cessation in severe mental illness: What works? Addiction, 105(7), 1176-1189. Barczyk, A.N., & Lincove, J.A. (2010). Cash and counseling: A model for self-directed care programs to empower individuals with serious mental illnesses. Social Work in Mental Health, 8(3), 209-224. Barry, C.L., & Huskamp, H.A. (2011). Moving beyond parity—mental health and addiction care under the ACA. New England Journal of Medicine, 365(11), 973-975. Brekke, J.S., Siantz, E., Pahwa, R., Kelly, E., Tallen, L., & Fulginiti, A. (2013). Reducing Health Disparities for People with Serious Mental Illness. Best Practices in Mental Health, 9(1), 62-82. Centers for Medicaid and Medicare Services. (no date). Self directed services. Retrieved from: http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Delivery-Systems/Self-Directed-Services.html. Chinman, M., George, P., Dougherty, R.H., Daniels, A.S., Ghose, S.S., Swift, A., & Delphin-Rittmon, M.E. (2014). Peer support services for individuals with serious mental illnesses: assessing the evidence. Psychiatric Services, 65(4), 429-441. Cook, J. (2006). Employment barriers for persons with psychiatric disabilities: Update of a report for the President's Commission. Psychiatric Services, 57(10), 1391-1405. Cook, J.A., & Jonikas, J.A. (2002). Self-Determination Among Mental Health Consumers/Survivors Using Lessons From the Past to Guide the Future. Journal of Disability Policy Studies, 13(2), 88-96. Cook, J.A., Razzano, L.A., Burke-Miller, J.K., Blyler, C.R., Leff, H.S., Mueser, K.T.,Gold, P.B., Goldberg, R.W., Shafer, M.S., Onken, S.J., McFarlane, W.R., Donegan, K., Carey, M.A., Kauffmann, C., & Grey, D.D. (2007). Effects of co-occurring disorders on employment outcomes in a multisite randomized study of supported employment for people with severe mental illness. Journal of Rehabilitation Research and Development, 44(6), 837. Cook, J., Russell, C., Grey, D., & Jonikas, J. (2008). Economic grand rounds: A self-directed care model for mental health recovery. Psychiatric Services, 59(6), 600-602. Croft, B., & Parish, S.L. (2013). Care integration in the patient protection and affordable care act: Implications for behavioral health. Administration and Policy in Mental Health and Mental Health Services Research, 40(4), 258-263. Drake, R.E., Bond, G. R., & Becker, D. R. (2012). Individual placement and support: An evidence-based approach to supported employment. Oxford University Press. Druss, B.G., Zhao, L., von Esenwein, S.A., Bona, J.R., Fricks, L., Jenkins-Tucker, S., Sterling, E., DiClemente, R., & Lorig, K. (2010). The Health and Recovery Peer (HARP) Program: a peer-led intervention to improve medical self-management for persons with serious mental illness. Schizophrenia Research, 118(1), 264-270. Frey, W.D., Azrin, S.T., Goldman, H.H., Kalasunas, S., Salkever, D.S., Miller, A.L., Bond, G.R., & Drake, R.E. (2008). The mental health treatment study. Psychiatric Rehabilitation Journal, 31(4), 306. Griswold, K.S., Homish, G.G., Pastore, P.A., & Leonard, K.E. (2010). A randomized trial: Are care navigators effective in connecting patients to primary care after psychiatric crisis? Community Mental Health Journal, 46(4), 398-402. Kelly, E.L., Fenwick, K.M., Barr, N., Cohen, H., & Brekke, J.S. (2014). A Systematic Review of Self-Management Health Care Models for Individuals With Serious Mental Illnesses. Psychiatric Services, 65(11), 1300-1310. Kelly, E., Fulginiti, A., Pahwa, R., Tallen, L., Duan, L., & Brekke, J.S. (2013). A pilot test of a peer navigator intervention for improving the health of individuals with serious mental illness. Community Mental Health Journal, 50(4), 435-446. Lerner, D., Adler, D., Hermann, R.C., Chang, H., Ludman, E.J., Greenhill, A., Perch, K., McPeck, W.C., & Rogers, W.H. (2012). Impact of a work-focused intervention on the productivity and symptoms of employees with depression. Journal of Occupational and Environmental Medicine, 54(2), 128. Mechanic, D. (2014). Seizing opportunities under the Affordable Care Act for transforming the mental and behavioral health system. Health Affairs, 31(2), 376-382. Michon, H.W., Van Weeghel, J., Kroon, H., & Schene, A.H. (2011). Illness self-management assessment in psychiatric vocational rehabilitation. Psychiatric Rehabilitation Journal, 35(1), 21. National Council on Disability (2008). Inclusive livable communities for people with psychiatric disabilities. Washington, DC: National Council on Disability. Retrieved from www.ncd.gov/publications/2008/03172008. O'Brien, D., Ford, L., & Malloy, J. M. (2005). Person centered funding: Using vouchers and personal budgets to support recovery and employment for people with psychiatric disabilities. Journal of Vocational Rehabilitation, 23, 71-79. Pitt, V., Lowe, D., Hill, S., Prictor, M., Hetrick, S.E., Ryan, R., & Berends, L. (2013). Consumer-providers of care for adult clients of statutory mental health services. Cochrane Database Systematic Reviews, 3. Powers L.E., & Sowers, J. (2006). A cross-disability analysis of person-directed, long-term services. Journal of Disability Policy Studies, 17, 66-76. Robert Wood Johnson Foundation (2006). Choosing independence: An overview of the cash and counseling model of self-directed personal assistance services. Princeton NJ: Robert Wood Johnson Foundation. Roe, D., Hasson-Ohayon, I., Salyers, M.P., & Kravetz, S. (2009). A one year follow-up of illness management and recovery: Participants' accounts of its impact and uniqueness. Psychiatric Rehabilitation Journal, 32(4), 285-291. Salzer, M., Kaplan, K., & Atay, J. (2006). State psychiatric hospital census after the 1999 Olmstead decision: Evidence of decelerating deinstitutionalization. Psychiatric Services, 57(10), 1501-1504. U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (2012a). Results from the 2012 National Survey on Drug Use and Health: Mental Health Findings. Retrieved from: http://www.samhsa.gov/data/sites/default/files/2k12MH_Findings/2k12MH_Findings/NSDUHmhfr2012.htm#sec2-2. U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (2012b). SAMHSA's Working Definition of Recovery. Retrieved from: http://store.samhsa.gov/shin/content//PEP12-RECDEF/PEP12-RECDEF.pdf. Webber, M., Treacy, S., Carr, S., Clark, M., & Parker, G. (2014). The effectiveness of personal budgets for people with mental health problems: A systematic review. Journal of Mental Health, 23(3), 146-155. Woltmann, E., Grogan-Kaylor, A., Perron, B., Georges, H., Kilbourne, A.M., & Bauer, M.S. (2012). Comparative effectiveness of collaborative chronic care models for mental health conditions across primary, specialty, and behavioral health care settings: Systematic review and meta-analysis. American Journal of Psychiatry, 169(8), 790-804. Workforce Innovation and Opportunity Act of 2014. Public Law 113-128. Definitions

    The research that is proposed under this priority must be focused on one or more stages of research. If the RRTC is to conduct research that can be categorized under more than one research stage, or research that progresses from one stage to another, those research stages must be clearly specified. For purposes of this priority, the stages of research are from the notice of final priorities and definitions published in the Federal Register on June 7, 2013 (78 FR 34261).

    (a) Exploration and Discovery means the stage of research that generates hypotheses or theories by conducting new and refined analyses of data, producing observational findings, and creating other sources of research-based information. This research stage may include identifying or describing the barriers to and facilitators of improved outcomes of individuals with disabilities, as well as identifying or describing existing practices, programs, or policies that are associated with important aspects of the lives of individuals with disabilities. Results achieved under this stage of research may inform the development of interventions or lead to evaluations of interventions or policies. The results of the exploration and discovery stage of research may also be used to inform decisions or priorities.

    (b) Intervention Development means the stage of research that focuses on generating and testing interventions that have the potential to improve outcomes for individuals with disabilities. Intervention development involves determining the active components of possible interventions, developing measures that would be required to illustrate outcomes, specifying target populations, conducting field tests, and assessing the feasibility of conducting a well-designed interventions study. Results from this stage of research may be used to inform the design of a study to test the efficacy of an intervention.

    (c) Intervention Efficacy means the stage of research during which a project evaluates and tests whether an intervention is feasible, practical, and has the potential to yield positive outcomes for individuals with disabilities. Efficacy research may assess the strength of the relationships between an intervention and outcomes, and may identify factors or individual characteristics that affect the relationship between the intervention and outcomes. Efficacy research can inform decisions about whether there is sufficient evidence to support “scaling-up” an intervention to other sites and contexts. This stage of research can include assessing the training needed for wide-scale implementation of the intervention, and approaches to evaluation of the intervention in real world applications.

    (d) Scale-Up Evaluation means the stage of research during which a project analyzes whether an intervention is effective in producing improved outcomes for individuals with disabilities when implemented in a real-world setting. During this stage of research, a project tests the outcomes of an evidence-based intervention in different settings. It examines the challenges to successful replication of the intervention, and the circumstances and activities that contribute to successful adoption of the intervention in real-world settings. This stage of research may also include well-designed studies of an intervention that has been widely adopted in practice, but that lacks a sufficient evidence-base to demonstrate its effectiveness.

    Proposed Priority

    The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority on Self-Directed Care to Promote Recovery, Health, and Wellness for Individuals with Serious Mental Illness. This RRTC will be jointly funded by NIDILRR and the Substance Abuse and Mental Health Services Administration. The RRTC will conduct research to develop, adapt, and enhance self-directed models of general medical, mental health, and nonmedical services that are designed to improve health, recovery, and employment outcomes for individuals with serious mental illness. The RRTC must conduct research, knowledge translation, training, dissemination, and technical assistance within a framework of consumer-directed services and self-management. Under this priority, the RRTC must contribute to the following outcomes:

    (1) Increased knowledge that can be used to enhance the health and well-being of individuals with serious mental illness and co-occurring conditions. The RRTC must contribute to this outcome by:

    (a) Conducting research to develop a better understanding of the barriers to and facilitators of implementing models that integrate general medical and mental health care for individuals with SMI. These models must incorporate self-management and self-direction strategies. This research must specifically examine models that incorporate peer-provided services and supports along with research-based service integration strategies such as health navigation and care coordination.

    (b) Conducting research to identify or develop and then test interventions that use individual budgets or flexible funds to increase consumer choice. The RRTC must design this research to determine the extent to which the consumer-choice intervention improves health outcomes and promotes recovery among individuals living with SMI. In carrying out this activity, the grantee must investigate the applicability of strategies that have proven successful with the general population or other subpopulations to determine if they are effective with individuals with SMI and co-occurring conditions.

    (2) Improved employment outcomes among individuals with SMI. The RRTC must contribute to this outcome by:

    (a) Conducting research to develop a better understanding of the barriers to and facilitators of implementing vocational service and support models that incorporate self management and self-direction features. These features must include self-directed financing and flexible funding of services that support mental health treatment and recovery, general health, and employment. These services may include services and supports not traditionally supplied by mental health or general medical systems.

    (3) Increased incorporation of research findings related to SMI, self-directed care, health management, and employment into practice or policy.

    (a) Developing, evaluating, or implementing strategies to increase utilization of research findings related to SMI, co-occurring conditions, health management, and employment.

    (b) Conducting training, technical assistance, and dissemination activities to increase utilization of research findings related to self-directed care of individuals living with SMI to promote and co-occurring conditions, health management, and employment.

    Final Priority

    We will announce the final priority in a notice in the Federal Register. We will determine the final priority after considering responses to this notice and other information available to the Department. This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

    Note:

    This notice does not solicit applications. In any year in which we choose to use this priority, we invite applications through a notice in the Federal Register or in a Funding Opportunity Announcement posted at www.grants.gov.

    Executive Orders 12866 and 13563 Regulatory Impact Analysis

    Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive Order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

    (1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);

    (2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

    (3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

    (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive Order.

    This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

    We have also reviewed this regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

    (1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

    (2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

    (3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

    (4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

    (5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

    Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

    We are issuing this proposed priority only upon a reasoned determination that its benefits would justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that this proposed priority is consistent with the principles in Executive Order 13563.

    We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

    In accordance with both Executive Orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

    The benefits of the Disability and Rehabilitation Research Projects and Centers Program have been well established over the years. Projects similar to one envisioned by the proposed priority have been completed successfully, and the proposed priority would generate new knowledge through research. The new RRTC would generate, disseminate, and promote the use of new information that would improve recovery, health, and wellness outcomes for individuals with serious mental illness (SMI) and co-occurring conditions.

    Intergovernmental Review: This program is not subject to Executive Order 12372.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Dated: February 19, 2015. Kathy Greenlee, Administrator.
    [FR Doc. 2015-03880 Filed 2-24-15; 8:45 am] BILLING CODE 4151-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living [CFDA Number: 84.133B-3] Proposed priority—National Institute on Disability, Independent Living, and Rehabilitation Research—Rehabilitation Research and Training Centers AGENCY:

    Administration for Community Living, Department of Health and Human Services.

    ACTION:

    Notice of proposed priority.

    SUMMARY:

    The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for an RRTC on Employment Policy and Measurement. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved employment outcomes for individuals with disabilities.

    DATES:

    We must receive your comments on or before March 27, 2015.

    ADDRESSES:

    Submit your comments through the Federal eRulemaking Portal or via postal mail or commercial delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.

    Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on using Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under “Are you new to the site?”

    Postal Mail or Commercial Delivery: If you mail or deliver your comments about these proposed regulations, address them to Patricia Barrett, U.S. Department of Health and Human Services, 400 Maryland Avenue SW., Room 5142, Potomac Center Plaza (PCP), Washington, DC 20202-2700.

    Privacy Note: The Department's policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available.

    FOR FURTHER INFORMATION CONTACT:

    Patricia Barrett. Telephone: (202) 245-6211 or by email: [email protected]

    If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION:

    This notice of proposed priority is in concert with NIDRR's currently approved Long-Range Plan (Plan). The Plan, which was published in the Federal Register on April 4, 2013 (78 FR 20299), can be accessed on the Internet at the following site: www.ed.gov/about/offices/list/osers/nidrr/policy.html.

    The Plan identifies a need for research and training regarding employment of individuals with disabilities. To address this need, NIDILRR seeks to: (1) Improve the quality and utility of disability and rehabilitation research; (2) foster an exchange of research findings, expertise, and other information to advance knowledge and understanding of the needs of individuals with disabilities and their family members, including those from among traditionally underserved populations; (3) determine effective practices, programs, and policies to improve community living and participation, employment, and health and function outcomes for individuals with disabilities; (4) identify research gaps and areas for promising research investments; (5) identify and promote effective mechanisms for integrating research and practice; and (6) disseminate research findings to all major stakeholder groups, including individuals with disabilities and their family members in formats that are appropriate and meaningful to them.

    This notice proposes one priority that NIDILRR intends to use for one or more competitions in fiscal year (FY) 2015 and possibly later years. NIDILRR is under no obligation to make an award under this priority. The decision to make an award will be based on the quality of applications received and available funding. NIDILRR may publish additional priorities, as needed.

    Invitation to Comment: We invite you to submit comments regarding this proposed priority. To ensure that your comments have maximum effect in developing the final priority, we urge you to identify clearly the specific topic within the priority that each comment addresses.

    We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from this proposed priority. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.

    During and after the comment period, you may inspect all public comments by following the instructions found under the “Are you new to the site?” portion of the Federal eRulemaking Portal at wwww.regulations.gov. Any comments sent to NIDILRR via postal mail or commercial delivery can be viewed in Room 5142, 550 12th Street SW., PCP, Washington, DC, between the hours of 8:30 a.m. and 4:00 p.m., Washington, DC time, Monday through Friday of each week except Federal holidays.

    Assistance to Individuals With Disabilities in Reviewing the Rulemaking Record: On request we will provide an appropriate accommodation or auxiliary aid to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for this notice. If you want to schedule an appointment for this type of accommodation or auxiliary aid, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Purpose of Program: The purpose of the Disability and Rehabilitation Research Projects and Centers Program is to plan and conduct research, demonstration projects, training, and related activities, including international activities, to develop methods, procedures, and rehabilitation technology that maximize the full inclusion and integration into society, employment, independent living, family support, and economic and social self-sufficiency of individuals with disabilities, especially individuals with the most severe disabilities, and to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended (Rehabilitation Act).

    Rehabilitation Research and Training Centers

    The purpose of the RRTCs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to achieve the goals of, and improve the effectiveness of, services authorized under the Rehabilitation Act through well-designed research, training, technical assistance, and dissemination activities in important topical areas as specified by NIDILRR. These activities are designed to benefit rehabilitation service providers, individuals with disabilities, family members, policymakers and other research stakeholders. Additional information on the RRTC program can be found at: http://www2.ed.gov/programs/rrtc/index.html#types.

    Program Authority:

    29 U.S.C. 762(g) and 764(b)(2).

    Applicable Program Regulations: 34 CFR part 350.

    Proposed Priority

    This notice contains one proposed priority.

    RRTC on Employment Policy and Measurement Background

    Since the 2007 recession, Social Security Disability Insurance (SSDI) applications and awards have increased rapidly. There are nearly 9 million beneficiaries currently receiving SSDI payments, and this figure is expected to grow as workers age and increase their likelihood of experiencing disability. With this growth in program participation, actuaries estimate that the SSDI trust fund will be depleted in late 2016 unless substantial changes occur (Social Security Administration, 2014). Given this scenario, developing informed employment policy options is essential. These options require sound research to inform policymakers regarding the projected impacts of policies that encourage employment among individuals with disabilities while ensuring an adequate safety net. Research is also needed to evaluate the long-term impacts of policies and programs that aim to facilitate employment and improve the quality of life among people with disabilities.

    The interactions between Social Security disability programs and public health insurance programs have long been considered a substantial barrier to employment for people with disabilities (Loprest & Maag, 2001; National Council on Disability, 2007). The 2010 enactment of the Patient Protection and Affordable Care Act (ACA) provided improved access to public and private insurance for all Americans including those with disabilities. For example, the ACA prevents health care coverage denials due to pre-existing conditions, increases coverage requirements, and provides mental health parity for persons with psychiatric disabilities. The impact of the ACA on employment outcomes for people with disabilities is an important research area.

    Prior RRTC-EPM work focused on examining and improving extant methods of measuring disability status, as well as measuring employment outcomes among people with disabilities. For example, the RRTC illustrated how self-reported disability status changes over time through an analysis of longitudinal data focusing on youth (Mann and Honeycutt, 2014). These analyses indicated that the proportion of respondents with a disability doubled from 12 percent to nearly 25 percent over the course of 13 years. Multivariate analyses showed that women were more likely than men to report changes in health condition or disability status, and those with mild disabilities were relatively less likely than those without or with severe disabilities to experience changes in disability status. The RRTC also studied extant surveys and found that commonly used measures overestimated employment and underestimated receipt of disability income assistance such as SSDI (Burkhauser, Houtenville and Tenant, 2014). Other researchers have recently explored similar issues related to the reliability and stability of disability measures (Brault, 2013; Davies & Fisher, 2013; Sears & Rupp, 2003). Knowledge gained through this work has highlighted a need to develop improved methods of measuring both disability and employment in ways that generate more reliable and valid research findings. Continued innovation is thus needed to develop measures and metrics that accurately reflect the changing nature of disability across the life span as well as changes in the workforce over time. By doing so, research results may be