Federal Register Vol. 81, No.74,

Federal Register Volume 81, Issue 74 (April 18, 2016)

Page Range22511-22909
FR Document

81_FR_74
Current View
Page and SubjectPDF
81 FR 22650 - Sunshine Act MeetingPDF
81 FR 22594 - Sunshine Act MeetingPDF
81 FR 22628 - Notice of Availability of the Final Environmental Impact Statement for the Continental Divide-Creston Natural Gas Development Project, WyomingPDF
81 FR 22595 - Sunshine Act Meeting; Board Member MeetingPDF
81 FR 22567 - Announcement of Grant Application Deadlines and Funding LevelsPDF
81 FR 22623 - Accreditation of Dixie Services Inc., as a Commercial LaboratoryPDF
81 FR 22583 - Announcement of an Open Public MeetingPDF
81 FR 22624 - Accreditation and Approval of Oiltest, Inc., as a Commercial Gauger and LaboratoryPDF
81 FR 22639 - National Commission on Forensic Science Solicitation of Applications for Additional Commission Membership To Support Digital EvidencePDF
81 FR 22575 - Order Denying Export PrivilegesPDF
81 FR 22576 - Order Denying Export PrivilegesPDF
81 FR 22700 - Marine Highway Projects Open SeasonPDF
81 FR 22580 - National Wetland Plant ListPDF
81 FR 22625 - Agency Information Collection Activities: Prior DisclosurePDF
81 FR 22575 - Foreign-Trade Zone (FTZ) 183-Austin, Texas; Authorization of Proposed Production Activity, Samsung Austin Semiconductor, L.L.C., Subzone 183B, (Semiconductors), Austin, TexasPDF
81 FR 22575 - Foreign-Trade Zone (FTZ) 20-Newport News, Virginia; Authorization of Proposed Production Activity, Canon Virginia, Inc., Subzone 20D, (Toner Cartridges and Bottles); Newport News, VirginiaPDF
81 FR 22577 - Calcium Hypochlorite From the People's Republic of China: Rescission of Countervailing Duty Administrative Review; 2014-2015PDF
81 FR 22595 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
81 FR 22580 - Endangered and Threatened Species; Take of Anadromous FishPDF
81 FR 22578 - Narrow Woven Ribbons With Woven Selvedge From Taiwan; Final Results of Antidumping Duty Administrative Review; 2013-2014PDF
81 FR 22520 - Orders: Reporting by Regulated Entities of Stress Testing Results as of December 31, 2015; Summary Instructions and GuidancePDF
81 FR 22700 - Notice of Request To Release Airport PropertyPDF
81 FR 22620 - Tobacco Farm Site Tours ProgramPDF
81 FR 22615 - Radiation Biodosimetry Medical Countermeasure Devices; Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
81 FR 22525 - Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System AnalyzersPDF
81 FR 22626 - Agency Information Collection Activities: Application for Travel Document (Carrier Documentation), Form I-131A; New CollectionPDF
81 FR 22546 - Drawbridge Operation Regulation; Isle of Wight (Sinepatuxent) Bay, Ocean City, MDPDF
81 FR 22627 - Notice of Realty Action: Recreation and Public Purposes Act Classification, Clark County, NV (N-80613)PDF
81 FR 22608 - AbbVie Inc.; Withdrawal of Approval of New Drug Applications for ADVICOR and SIMCORPDF
81 FR 22619 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons ProgramPDF
81 FR 22702 - Proposed Agency Information Collection Activities; Comment RequestPDF
81 FR 22514 - Energy Conservation Program for Consumer Products and Certain Commercial and Industrial Equipment: Determination of Portable Air Conditioners as a Covered Consumer ProductPDF
81 FR 22592 - Information Collection Being Submitted for Review and Approval to the Office of Management and BudgetPDF
81 FR 22593 - Information Collections Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
81 FR 22549 - Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph Proposed Rule; Reopening of the Comment PeriodPDF
81 FR 22612 - AbbVie Inc. et al; Withdrawal of Approval of Indications Related to the Coadministration With Statins in Applications for Niacin Extended-Release Tablets and Fenofibric Acid Delayed-Release CapsulesPDF
81 FR 22548 - Appliance Standards and Rulemaking Federal Advisory Committee: Notice of Open Meetings for the Dedicated Purpose Pool Pumps (DPPP) Working Group To Negotiate a Notice of Proposed Rulemaking (NOPR) for Energy Conservation StandardsPDF
81 FR 22585 - SeaOne Gulfport, LLC; Application for Long-Term, Multi-Contract Authorization To Export Natural Gas Contained in Compressed Gas Liquid to Non-Free Trade Agreement CountriesPDF
81 FR 22549 - Country-by-Country Reporting; HearingPDF
81 FR 22606 - Public Meeting on Patient-Focused Drug Development for Neuropathic Pain Associated With Peripheral NeuropathyPDF
81 FR 22614 - Public Meeting on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human UsePDF
81 FR 22610 - Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; AvailabilityPDF
81 FR 22611 - Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act; AvailabilityPDF
81 FR 22617 - Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; AvailabilityPDF
81 FR 22649 - Agency Information Collection Activities; Proposed Collections; Comment RequestPDF
81 FR 22544 - Special Local Regulation, Daytona Beach Grand Prix of the Seas; Atlantic Ocean, Daytona Beach, FLPDF
81 FR 22648 - Agency Information Collection Activities: Account Based Disclosures in Connection With Truth in Savings; Comment RequestPDF
81 FR 22602 - Submission for OMB Review; Use of Project Labor Agreements for Federal Construction ProjectsPDF
81 FR 22604 - Submission for OMB Review; Central Contractor RegistrationPDF
81 FR 22601 - Submission for OMB Review; Taxpayer Identification Number InformationPDF
81 FR 22603 - Submission for OMB Review; Accident Prevention Plans and RecordkeepingPDF
81 FR 22698 - Agency Information Collection Activities: Proposed Request and Comment RequestPDF
81 FR 22707 - Special Medical Advisory Group, Notice of MeetingPDF
81 FR 22651 - Business and Operations Advisory Committee MeetingPDF
81 FR 22627 - Housing Counseling Federal Advisory Committee; Charter ReestablishmentPDF
81 FR 22622 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 22586 - Notice of Public Availability of FY 2015 Service Contract Inventories and Supplemental DataPDF
81 FR 22590 - Northern Natural Gas Company; Notice of Intent To Prepare an Environmental Assessment for the Planned Northern Lights 2017 Expansion Project, Request for Comments on Environmental IssuesPDF
81 FR 22589 - Wisconsin Public Service Corporation; Notice of Application Tendered for Filing With the Commission and Establishing Procedural Schedule for Licensing and Deadline for Submission of Final AmendmentsPDF
81 FR 22588 - Energy Resources USA Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing ApplicationsPDF
81 FR 22589 - Deschutes Valley Water District; Notice of Availability of Environmental AssessmentPDF
81 FR 22587 - Hawks Nest Hydro, LLC; Notice of Application Accepted for Filing, Soliciting Motions To Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Preliminary Terms and Conditions, and Preliminary Fishway PrescriptionsPDF
81 FR 22589 - Yuba County Water Agency; Notice Soliciting Comments on Final Technical MemorandaPDF
81 FR 22605 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 22707 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board; Notice of MeetingsPDF
81 FR 22707 - Veterans Rural Health Advisory Committee MeetingPDF
81 FR 22702 - Denial of Motor Vehicle Defect PetitionPDF
81 FR 22648 - Notice of Information CollectionPDF
81 FR 22584 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Application Package for Strengthening Historically Black Graduate Institutions (HBGI)PDF
81 FR 22638 - Importer of Controlled Substances Registration: Johnson Matthey, Inc.PDF
81 FR 22632 - Certain Laser Abraded Denim Garments; Commission Determination To Review Order No. 43, and on Review Vacating That Order as Moot; Termination of the InvestigationPDF
81 FR 22638 - Importer of Controlled Substances Registration: Meridian Medical TechnologiesPDF
81 FR 22634 - Manufacturer of Controlled Substances Registration: Cody Laboratories, Inc.PDF
81 FR 22634 - Importer of Controlled Substances Registration: Research Triangle InstitutePDF
81 FR 22631 - Record of Decision for the Channel Islands National Park General Management Plan/Wilderness Study, Santa Barbara County, CaliforniaPDF
81 FR 22574 - Agenda and Notice of Public Meeting of the New Mexico Advisory CommitteePDF
81 FR 22573 - Public Meeting of the Hawai`i State Advisory CommitteePDF
81 FR 22572 - Notice of Public Meeting of the California State Advisory CommitteePDF
81 FR 22630 - Record of Decision for Development Concept Plans for Cottonwood Cove and Katherine Landing, Lake Mead National Recreation Area, Nevada and ArizonaPDF
81 FR 22639 - Privacy Act of 1974; System of RecordsPDF
81 FR 22625 - Extension of Agency Information Collection Activity Under OMB Review: Generic Clearance for the Collection of Qualitative Feedback on Agency Service DeliveryPDF
81 FR 22511 - Tart Cherries Grown in the States of Michigan, et al.; Revision of Exemption RequirementsPDF
81 FR 22513 - Specialty Crop Block Grant Program Regulation; Removal of a Final RulePDF
81 FR 22520 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of SponsorshipPDF
81 FR 22659 - Nuveen Fund Advisors, LLC, et al.; Notice of ApplicationPDF
81 FR 22681 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing of Proposed Rule Change To List and Trade Under BZX Rule 14.11(c)(4) Shares of the Following Series of Market Vectors ETF Trust: Market Vectors 6-8 Year Municipal Index ETF; Market Vectors 8-12 Year Municipal Index ETF; and Market Vectors 12-17 Year Municipal Index ETFPDF
81 FR 22673 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Schedule of FeesPDF
81 FR 22674 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Amend Rules 4702 and 4703PDF
81 FR 22656 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Its Price List To Adopt a Rebate Program for the NYSE BondsSMPDF
81 FR 22678 - Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Fees Under Rule 7018(a)PDF
81 FR 22691 - Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Adopt Rule 8.17 To Provide a Process for an Expedited Suspension Proceeding and Rule 12.15 To Prohibit Layering and SpoofingPDF
81 FR 22676 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending the NYSE Arca Equities Schedule of Fees and Charges for Exchange ServicesPDF
81 FR 22651 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Amendment No. 1 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 1, To List and Trade Shares of RiverFront Dynamic US Dividend Advantage ETF and RiverFront Dynamic US Flex-Cap ETF under NYSE Arca Equities Rule 8.600PDF
81 FR 22675 - Options Price Reporting Authority; Notice of Filing and Immediate Effectiveness of Proposed Amendment to the Plan for Reporting of Consolidated Options Last Sale Reports and Quotation Information To Amend the Redistribution Fee Set Forth in OPRA's Fee SchedulePDF
81 FR 22668 - Options Price Reporting Authority; Notice of Filing and Immediate Effectiveness of Proposed Amendment to the Plan for Reporting of Consolidated Options Last Sale Reports and Quotation Information To Amend the Professional Subscriber Device-Based Fees Set Forth in OPRA's Fee SchedulePDF
81 FR 22670 - Options Price Reporting Authority; Notice of Filing and Immediate Effectiveness of Proposed Amendment to the Plan for Reporting of Consolidated Options Last Sale Reports and Quotation Information To Amend Certain Provisions of the OPRA's Fee SchedulePDF
81 FR 22596 - Enforcement Policy Statement on Deceptively Formatted AdvertisementsPDF
81 FR 22594 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
81 FR 22567 - Forest Resource Coordinating CommitteePDF
81 FR 22633 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Advanced Media Workflow Association, Inc.PDF
81 FR 22633 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-IMS Global Learning Consortium, Inc.PDF
81 FR 22621 - Agency Information Collection Activities: Proposed Collection: Public Comment RequestPDF
81 FR 22621 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
81 FR 22622 - Center for Scientific Review; Notice of Closed MeetingPDF
81 FR 22632 - Certain Tissue Paper Products From China; Cancellation of Hearing for Full Five-Year ReviewPDF
81 FR 22573 - Notice of Public Meeting of the Alaska State Advisory CommitteePDF
81 FR 22650 - Meetings of Humanities PanelPDF
81 FR 22640 - Program Year (PY) 2016 Workforce Innovation and Opportunity Act (WIOA) Allotments; PY 2016 Wagner-Peyser Act Final Allotments and PY 2016 Workforce Information GrantsPDF
81 FR 22550 - Proposed Priorities-Enhanced Assessment InstrumentsPDF
81 FR 22530 - Procedures for Handling Retaliation Complaints Under Section 402 of the FDA Food Safety Modernization ActPDF
81 FR 22709 - Endangered and Threatened Wildlife and Plants; Withdrawal of the Proposed Rule To List the West Coast Distinct Population Segment of FisherPDF
81 FR 22809 - Protection of Stratospheric Ozone: Proposed New Listings of Substitutes; Changes of Listing Status; and Reinterpretation of Unacceptability for Closed Cell Foam Products Under the Significant New Alternatives Policy Program; and Revision of Clean Air Act Section 608 Venting Prohibition for PropanePDF
81 FR 22697 - Requiring Electronic Access to the Electronic Folder by Certain Claimant RepresentativesPDF
81 FR 22555 - Aquatic Life Criteria for Copper and Cadmium in OregonPDF

Issue

81 74 Monday, April 18, 2016 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22605-22606 2016-08856 Agricultural Marketing Agricultural Marketing Service RULES Exemption Requirements: Tart Cherries Grown in Michigan, etc., 22511-22513 2016-08834 Specialty Crop Block Grant Program: Removal, 22513-22514 2016-08832 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Forest Service

See

Rural Utilities Service

Antitrust Division Antitrust Division NOTICES Membership Changes under the National Cooperative Research and Production Act: Advanced Media Workflow Association, Inc., 22633-22634 2016-08804 IMS Global Learning Consortium, Inc., 22633 2016-08803 Civil Rights Civil Rights Commission NOTICES Meetings: Alaska State Advisory Committee, 22573-22574 2016-08793 California State Advisory Committee, 22572-22573 2016-08838 Hawai'i State Advisory Committee, 22573 2016-08839 New Mexico Advisory Committee, 22574 2016-08840 Coast Guard Coast Guard RULES Drawbridge Operations: Isle of Wight (Sinepatuxent) Bay, Ocean City, MD, 22546-22547 2016-08896 Special Local Regulations: Daytona Beach Grand Prix of the Seas; Atlantic Ocean, Daytona Beach, FL, 22544-22546 2016-08875 Commerce Commerce Department See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22702-22707 2016-08892 Defense Department Defense Department See

Engineers Corps

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Accident Prevention Plans and Recordkeeping, 22603-22604 2016-08870 Central Contractor Registration, 22604-22605 2016-08872 Taxpayer Identification Number Information, 22601-22602 2016-08871 Use of Project Labor Agreements for Federal Construction Projects, 22602-22603 2016-08873
Drug Drug Enforcement Administration NOTICES Importers of Controlled Substances; Registrations: Johnson Matthey, Inc., 22638 2016-08847 Meridian Medical Technologies, 22638 2016-08844 Research Triangle Institute, 22634-22638 2016-08842 Manufacturers of Controlled Substances; Registrations: Cody Laboratories, Inc., 22634 2016-08843 Education Department Education Department PROPOSED RULES Proposed Priorities: Enhanced Assessment Instruments, 22550-22555 2016-08726 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application Package for Strengthening Historically Black Graduate Institutions, 22584-22585 2016-08849 Meetings: National Advisory Council on Indian Education, 22583-22584 2016-08929 Employment and Training Employment and Training Administration NOTICES Funding Availability: Workforce Innovation and Opportunity Act Allotments; Wagner-Peyser Act Final Allotments and Workforce Information Grants, 22640-22648 2016-08747 Energy Department Energy Department See

Federal Energy Regulatory Commission

RULES Energy Conservation Program for Consumer Products and Certain Commercial and Industrial Equipment: Determination of Portable Air Conditioners as a Covered Consumer Product, 22514-22520 2016-08891 PROPOSED RULES Energy Conservation Standards: Meeting of Appliance Standards and Rulemaking Federal Advisory Committee Dedicated Purpose Pool Pumps Working Group, 22548 2016-08886 NOTICES Authorizations to Export Liquefied Natural Gas: SeaOne Gulfport, LLC, 22585-22586 2016-08884
Engineers Engineers Corps NOTICES National Wetland Plant List, 22580-22583 2016-08917 Environmental Protection Environmental Protection Agency PROPOSED RULES Aquatic Life Criteria for Copper and Cadmium in Oregon, 22555-22566 2016-08038 Protection of Stratospheric Ozone: Proposed New Listings of Substitutes; Changes of Listing Status; and Reinterpretation of Unacceptability for Closed Cell Foam Products, etc., 22810-22909 2016-08163 Federal Aviation Federal Aviation Administration NOTICES Requests to Release Airport Properties: Hebron Municipal Airport, Hebron, NE, 22700 2016-08902 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22592-22594 2016-08889 2016-08890 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22702-22707 2016-08892 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 22594 2016-09035 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Wisconsin Public Service Corp., 22589-22590 2016-08861 Availability of FY 2015 Service Contract Inventories and Supplemental Data, 22586-22587 2016-08863 Environmental Assessments; Availability, etc.: Deschutes Valley Water District, 22589 2016-08859 Northern Natural Gas Co.; Northern Lights 2017 Expansion Project, 22590-22592 2016-08862 Hydroelectric Applications: Hawks Nest Hydro, LLC, 22587-22588 2016-08858 Preliminary Permit Applications: Energy Resources USA Inc., 22588-22589 2016-08860 Technical Memoranda: Yuba County Water Agency, 22589 2016-08857 Federal Housing Finance Agency Federal Housing Finance Agency RULES Orders: Reporting by Regulated Entities of Stress Testing Results as of December 31, 2015; Summary Instructions and Guidance, 22520 2016-08903 Federal Maritime Federal Maritime Commission NOTICES Meetings; Sunshine Act, 22594 2016-09002 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22702-22707 2016-08892 Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 22594-22595 2016-08809 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 22595 2016-08808 2016-08906 Federal Retirement Federal Retirement Thrift Investment Board NOTICES Meetings; Sunshine Act, 22595 2016-08999 Federal Trade Federal Trade Commission NOTICES Enforcement Policy Statement on Deceptively Formatted Advertisements, 22596-22601 2016-08813 Fish Fish and Wildlife Service PROPOSED RULES Endangered and Threatened Wildlife and Plants: Listing of the West Coast Distinct Population Segment of Fisher; Withdrawal, 22710-22808 2016-08288 Food and Drug Food and Drug Administration RULES Cardiovascular Devices: External Pacemaker Pulse Generator Devices; Pacing System Analyzers; Reclassifications, 22525-22530 2016-08898 New Animal Drugs: Approval of New Animal Drug Applications; Changes of Sponsorship, 22520-22525 2016-08827 PROPOSED RULES Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients under Consideration for Inclusion in an Over-the-Counter Monograph, 22549 2016-08888 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Inspection by Accredited Persons Program, 22619-22620 2016-08893 Draft Guidance for Industry: Facility Definition under the Federal Food, Drug, and Cosmetic Act, 22611-22612 2016-08878 Hospital and Health System Compounding under the Federal Food, Drug, and Cosmetic Act, 22610-22611 2016-08879 Prescription Requirement the Federal Food, Drug, and Cosmetic Act, 22617-22619 2016-08877 Guidance: Radiation Biodosimetry Medical Countermeasure Devices, 22615-22617 2016-08899 Meetings: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, 22614-22615 2016-08880 Patient-Focused Drug Development for Neuropathic Pain Associated with Peripheral Neuropathy, 22606-22608 2016-08881 New Drug Applications: AbbVie Inc., et al., Coadministration with Statins; Niacin Extended-Release Tablets and Fenofibric Acid Delayed-Release Capsules; Withdrawal, 22612-22613 2016-08887 AbbVie Inc.; ADVICOR and SIMCOR; Withdrawal, 22608-22609 2016-08894 Tobacco Farm Site Tours Program, 22620-22621 2016-08900 Foreign Trade Foreign-Trade Zones Board NOTICES Authorization of Proposed Production Activities: Canon Virginia, Inc. Subzone 20D, Newport News, VA, 22575 2016-08908 Samsung Austin Semiconductor, LLC Subzone 183B, Austin, TX, 22575 2016-08909 Forest Forest Service NOTICES Meetings: Forest Resource Coordinating Committee, 22567 2016-08805 General Services General Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Accident Prevention Plans and Recordkeeping, 22603-22604 2016-08870 Central Contractor Registration, 22604-22605 2016-08872 Taxpayer Identification Number Information, 22601-22602 2016-08871 Use of Project Labor Agreements for Federal Construction Projects, 22602-22603 2016-08873 Health and Human Health and Human Services Department See

Agency for Healthcare Research and Quality

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22621 2016-08802 Homeland Homeland Security Department See

Coast Guard

See

Transportation Security Administration

See

U.S. Citizenship and Immigration Services

See

U.S. Customs and Border Protection

Housing Housing and Urban Development Department NOTICES Charter Renewals: Housing Counseling Federal Advisory Committee, 22627 2016-08866 Industry Industry and Security Bureau NOTICES Denials of Export Privileges: Alexandre Astakhov, 22576-22577 2016-08919 Paweena Pechner a.k.a. Paweena Montasood, 22575-22576 2016-08920 Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

See

National Park Service

Internal Revenue Internal Revenue Service PROPOSED RULES Country-by-Country Reporting; Hearing, 22549-22550 2016-08882 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Calcium Hypochlorite from the People's Republic of China, 22577-22578 2016-08907 Narrow Woven Ribbons with Woven Selvedge from Taiwan, 22578-22579 2016-08904 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Laser Abraded Denim Garments, 22632-22633 2016-08845 Tissue Paper Products from China, 22632 2016-08797 Justice Department Justice Department See

Antitrust Division

See

Drug Enforcement Administration

NOTICES Privacy Act; Systems of Records, 22639 2016-08836 Requests for Nominations: National Commission on Forensic Science, 22639-22640 2016-08926
Labor Department Labor Department See

Employment and Training Administration

See

Occupational Safety and Health Administration

Land Land Management Bureau NOTICES Environmental Impact Statements; Availability, etc.: Continental Divide-Creston Natural Gas Development Project, Wyoming, 22628-22630 2016-09010 Realty Actions: Recreation and Public Purposes Act Classification, Clark County, NV, 22627-22628 2016-08895 Maritime Maritime Administration NOTICES Marine Highway Projects Open Season, 22700-22702 2016-08918 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22648 2016-08851 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Accident Prevention Plans and Recordkeeping, 22603-22604 2016-08870 Central Contractor Registration, 22604-22605 2016-08872 Taxpayer Identification Number Information, 22601-22602 2016-08871 Use of Project Labor Agreements for Federal Construction Projects, 22602-22603 2016-08873 National Credit National Credit Union Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22649-22650 2016-08876 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Account Based Disclosures, 22648-22649 2016-08874 Meetings; Sunshine Act, 22650 2016-09039 National Endowment for the Humanities National Endowment for the Humanities NOTICES Meetings: Humanities Panel, 22650-22651 2016-08790 National Foundation National Foundation on the Arts and the Humanities See

National Endowment for the Humanities

National Highway National Highway Traffic Safety Administration NOTICES Motor Vehicle Defect Petitions; Denials, 22702 2016-08852 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 22622 2016-08800 National Heart, Lung, and Blood Institute, 22621-22622 2016-08801 National Oceanic National Oceanic and Atmospheric Administration NOTICES Endangered and Threatened Species: Takes of Anadromous Fish, 22580 2016-08905 National Park National Park Service NOTICES Environmental Impact Statements; Availability, etc.: Channel Islands National Park General Management Plan/Wilderness Study, Santa Barbara County, CA, 22631-22632 2016-08841 Cottonwood Cove and Katherine Landing, Lake Mead National Recreation Area, NV and AZ, 22630-22631 2016-08837 National Science National Science Foundation NOTICES Meetings: Business and Operations Advisory Committee, 22651 2016-08867 Occupational Safety Health Adm Occupational Safety and Health Administration RULES Procedures for Handling Retaliation Complaints under the FDA Food Safety Modernization Act, 22530-22544 2016-08724 Rural Utilities Rural Utilities Service NOTICES Announcement of Grant Application Deadlines and Funding Levels, 22567-22572 2016-08931 Securities Securities and Exchange Commission NOTICES Applications: Nuveen Fund Advisors, LLC, et al., 22659-22668 2016-08826 Self-Regulatory Organizations; Proposed Rule Changes: Bats BZX Exchange, Inc., 22681-22691 2016-08825 Bats EDGX Exchange, Inc., 22691-22696 2016-08820 International Securities Exchange, LLC, 22673-22674 2016-08824 NASDAQ BX, Inc., 22678-22681 2016-08821 NASDAQ Stock Market, LLC, 22674-22675 2016-08823 New York Stock Exchange, LLC, 22656-22659 2016-08822 NYSE Arca, Inc., 22651-22656, 22676-22678 2016-08818 2016-08819 Options Price Reporting Authority, 22668-22673, 22675-22676 2016-08815 2016-08816 2016-08817 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22698-22700 2016-08869 Requiring Electronic Access to the Electronic Folder by Certain Claimant Representatives, 22697-22698 2016-08162 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 22622-22623 2016-08864 Transportation Department Transportation Department See

Federal Aviation Administration

See

Maritime Administration

See

National Highway Traffic Safety Administration

Security Transportation Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 22625-22626 2016-08835 Treasury Treasury Department See

Comptroller of the Currency

See

Internal Revenue Service

U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Travel Document (Carrier Documentation), 22626-22627 2016-08897 Customs U.S. Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Prior Disclosure, 22625 2016-08910 Commercial Gaugers and Laboratories; Accreditations and Approvals: Dixie Services, Inc., Galena Park, TX, 22623-22624 2016-08930 Oiltest, Inc., Roselle, NJ, 22624-22625 2016-08928 Veteran Affairs Veterans Affairs Department NOTICES Meetings: Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board, 22707-22708 2016-08855 Special Medical Advisory Group, 22707 2016-08868 Veterans Rural Health Advisory Committee, 22707 2016-08854 Separate Parts In This Issue Part II Interior Department, Fish and Wildlife Service, 22710-22808 2016-08288 Part III Environmental Protection Agency, 22810-22909 2016-08163 Reader Aids

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

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

81 74 Monday, April 18, 2016 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 930 [Doc. No. AMS-FV-15-0046; FV15-930-1 FIR] Tart Cherries Grown in the States of Michigan, et al.; Revision of Exemption Requirements AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Affirmation of interim rule as final rule.

SUMMARY:

The Department of Agriculture (USDA) is adopting, as a final rule, without change, an interim rule implementing a recommendation from the Cherry Industry Administrative Board (Board) that revised the exemption provisions under the marketing order for tart cherries grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin (order). The Board locally administers the order and is comprised of growers and handlers operating within the production area. The interim rule changed the number of years that new market development and market expansion projects are eligible for handler diversion credit from one year to three years. The interim rule also revised the composition of the subcommittee which reviews exemption requests. These changes are intended to encourage handlers to participate in new market and market expansion activities to facilitate sales and help ensure impartiality during the review process.

DATES:

Effective April 19, 2016.

FOR FURTHER INFORMATION CONTACT:

Jennie M. Varela, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email: [email protected] or [email protected].

Small businesses may obtain information on complying with this and other marketing order regulations by viewing a guide at the following Web site: http://www.ams.usda.gov/rules-regulations/moa/small-businesses; or by contacting Antoinette Carter, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected].

SUPPLEMENTARY INFORMATION:

This final rule is issued under Marketing Order No. 930, as amended (7 CFR part 930), regulating the handling of tart cherries grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175.

This final rule continues in effect the provisions of the interim rule that revised the exemption provisions prescribed under the order. The interim rule changed the number of years that new market development and market expansion projects are eligible for handler diversion credit from one year to three years. The interim rule also revised the composition of the subcommittee which reviews exemption requests. These changes are intended to encourage the use of new market development and market expansion activities to facilitate sales and to help ensure impartiality during the review process. These changes were unanimously recommended by the Board at its meeting on June 25, 2015.

Section 930.59 of the order authorizes handler diversion. When volume regulation is in effect, handlers may fulfill any restricted percentage requirement in full or in part by acquiring diversion certificates or by voluntarily diverting cherries or cherry products in a program approved by the Board, rather than placing cherries in an inventory reserve.

Section 930.159 of the order's administrative rules specifies methods of handler diversion, including using cherries or cherry products for exempt purposes prescribed under § 930.162. Section 930.162 establishes the terms and conditions of exemption that must be satisfied for handlers to receive diversion certificates for exempt uses. Section 930.162(b) defines the activities which qualify for exemptions under new market development and market expansion and the period for which they are eligible for diversion credit. New market development and market expansion activities include, but are not limited to, sales of cherries into markets that are not yet commercially established, product line extensions, or segmentation of markets along geographic or other definable characteristics.

Section 930.162(d) establishes a Board-appointed subcommittee to review the applications for exemption or renewal of exemption and to either approve or deny the exemption. Prior to this change, this section specified that the subcommittee consist of three members, including the Board manager, or a Board member acting in the manager's stead, the public member, and one industry person who is not on the Board.

The order provides for the use of volume regulation to stabilize prices and improve grower returns during periods of oversupply. At the beginning of each season, the Board examines production and sales data to determine whether a volume regulation is necessary and, if so, announces free and restricted percentages to limit the volume of tart cherries on the market. Free percentage cherries can be used to supply any available market, including domestic markets for pie filling, water packed, and frozen tart cherries. Restricted percentage cherries can be placed in reserve or be used to earn diversion credits as prescribed in §§ 930.159 and 930.162 of the order's administrative rules. These activities include, in part, the development of new products, new market development and market expansion, the development of export markets, and charitable contributions.

In 2012, the Board made a series of changes to the volume control provisions to facilitate the marketing of tart cherries and to help lower restrictions during seasons when volume control is implemented. One of these changes was to decrease the number of years that new market development and market expansion projects are eligible for handler diversion credit from three years to one year. The Board thought this decrease would continue to encourage new market development and market expansion projects while reducing the impact these credits had on volume restriction calculations. At that time, new market and market expansion sales were not included in the average sales figure used to determine optimum supply for volume regulation. The Board anticipated the change would shift more volume to sales, helping to reduce the calculated surplus and lower the restricted percentage.

In revisiting this change, the Board recognized that the underlying rationale for having reduced the duration of diversion credit for new market development and market expansion was no longer an issue. Since that change, the method for calculating average sales for the purpose of volume regulation has been adjusted so that only export sales are excluded from the average sales calculation. Consequently, all sales from market development and market expansion activities are now included as sales when calculating a restriction. Therefore, increasing the number of years new market development and market expansion projects are eligible to receive diversion credit from one year to three years will not significantly impact the calculations for free and restricted percentages.

Further, since limiting these activities to one year, participation in new market development and market expansion activities has dropped dramatically. In years prior to changing from three years to one year, applications for new market activities numbered around 20 to 25 a season. During the 2014-15 season, the first season with volume regulation under the one-year limitation, applications dropped to eight. Handlers stated that it was not worth the time and effort to develop one of these projects if the benefit was only for a single year. It was reported that the shortened time frame did not allow handlers to recoup the resources needed to establish one of these projects.

The Board affirmed its support for new market development and market expansion diversion credit programs. Accordingly, the Board voted unanimously to change the exemption provisions applicable to handler diversion activities by increasing the number of years that new market development and market expansion activities are eligible for diversion credit back to three years. The Board also noted that projects approved for the 2014-15 season would be allowed to continue and be subject to the new three-year cycle.

This action also continues in effect a revision to the composition of the subcommittee appointed to review exemption applications. The subcommittee was formed to assist Board staff members in reviewing and granting exemptions. The subcommittee reviews applications to use restricted cherries for activities related to new product development, new market development and market expansion, the development of export markets, and for experimental purposes. Prior to this change, the previous provisions (§ 930.162(d)) stated that the subcommittee consists of the manager of the Board or a Board member acting in their stead, the public member, and one industry member who is not on the Board. The Board recommended changing the composition of the subcommittee to help ensure impartiality so that no one affiliated with a handler was part of the review process.

Consequently, the Board recommended revising the subcommittee to consist of three members, all of whom are not affiliated with a handler but have industry knowledge. One of these members shall be the public member or the alternate public member, if available to serve. The subcommittee will also include a similarly qualified alternate should one of the other members be unable to serve.

The Board made several other recommendations for changes to the regulations under the order at its June 25, 2015, meeting. These changes are being considered under a separate action.

Final Regulatory Flexibility Analysis

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 600 producers of tart cherries in the regulated area and approximately 40 handlers of tart cherries who are subject to regulation under the order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000 and small agricultural service firms have been defined as those having annual receipts of less than $7,500,000 (13 CFR 121.201).

According to the National Agricultural Statistics Service and Board data, the average annual grower price for tart cherries during the 2014-15 season was $0.35 per pound, and total utilization was around 300 million pounds. Therefore, average receipts for tart cherry producers were around $175,800, well below the SBA threshold for small producers. In 2014, The Food Institute estimated an f.o.b. price of $0.96 per pound for frozen tart cherries, which make up the majority of processed tart cherries. Using this data, average annual handler receipts were about $6.9 million, which is also below the SBA threshold for small agricultural service firms. Assuming a normal distribution, the majority of producers and handlers of tart cherries may be classified as small entities.

This final rule continues in effect the action that revised § 930.162 of the regulations regarding exemptions by changing the number of years that new market development and market expansion projects are eligible for handler diversion credit from one year to three years. This rule also continues in effect the revision to the composition of the subcommittee which reviews exemption requests. These changes are intended to encourage the use of new market development and market expansion activities to facilitate sales and to help ensure impartiality during the review process. The authority for these actions is provided in § 930.59 of the order.

It is not anticipated that this action will impose additional costs on handlers or growers, regardless of size. Rather, this should help handlers receive better returns on their new market development and market expansion projects by providing additional time for the handlers to receive diversion credit for those activities. This should provide more opportunity for them to recoup the time and resources required to establish these projects.

In addition, changing the number of years that these projects are eligible for diversion credits may provide additional incentive for handlers to develop these programs and may facilitate additional sales, which could improve returns for growers and handlers. Further, the Board does not believe that this change significantly impacts the calculations for free and restricted percentages.

The change in composition of the subcommittee is administrative in nature and is not expected to result in any additional costs.

This rule is expected to benefit the industry. The effects of this rule are not expected to be disproportionately greater or less for small handlers or producers than for larger entities.

The Board discussed alternatives to these changes, including not changing the number of years that new market development and market expansion projects were eligible for diversion credit. The Board agreed that increasing the number of years that new market development and market expansion projects are eligible for diversion credit from one year to three years provides handlers with more incentive to utilize these programs while not impacting the calculations for free and restricted percentages.

Another alternative considered was maintaining the previous composition of the subcommittee responsible for reviewing exemption requests. However, the Board wanted to specify that the subcommittee be composed of members who are not affiliated with any handler. Therefore, for the reasons mentioned above, these alternatives were rejected.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0177, (Tart Cherries Grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin). No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.

This rule will not impose any additional reporting or recordkeeping requirements on either small or large tart cherry handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule. Further, the public comment received concerning the proposal did not address the initial regulatory flexibility analysis.

In addition, the Board's meeting was widely publicized throughout the tart cherry industry, and all interested persons were invited to attend and participate in Board deliberations on all issues. Like all Board meetings, the June 25, 2015, meeting was a public meeting, and all entities, both large and small, were able to express views on this issue.

An interim rule concerning this action was published in the Federal Register on November 5, 2015, (80 FR 68424) and was effective November 6, 2015. Copies of the rule were sent via email to all Board members and tart cherry handlers. Finally, the rule was made available through the internet by USDA and the Office of the Federal Register. A 60-day comment period ending January 4, 2016, was provided to allow interested persons to respond to the proposal.

One comment was received during the comment period in response to the interim rule. The commenter, a producer, supported part of the action but offered an alternative to the membership of the subcommittee.

The commenter supported the expansion of handler diversion credits for new market development and market expansion projects from one year to three years. The commenter agreed with the Board's finding that it will encourage growth in the industry.

Regarding the change to the membership of the approval subcommittee, the commenter suggested that membership should be further modified to include cherry growers that are not also handlers. However, the Board's intent in making the revision to the subcommittee requirements was, in part, to ensure impartiality. Consequently, the Board recommended that the subcommittee be composed of members who are not affiliated with any handler. Even growers who are not handlers themselves have a business relationship with the handlers to which they sell.

The additional points in the comment were not relevant to the interim rule. Accordingly, no changes will be made to the interim rule, based on the comment received. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule, without change.

To view the interim rule and the comment that was received, go to: http://www.regulations.gov/#!docketDetail;D=AMS-FV-15-0046.

This action also affirms information contained in the interim rule concerning Executive Orders 12866, 12988, 13175, and 13563; the Paperwork Reduction Act (44 U.S.C. Chapter 35); and the E-Gov Act (44 U.S.C. 101).

After consideration of all relevant material presented, it is found that finalizing the interim rule, without change, as published in the Federal Register (80 FR 68424, November 5, 2015) will tend to effectuate the declared policy of the Act.

List of Subjects in 7 CFR Part 930

Marketing agreements, Reporting and recordkeeping requirements, Tart cherries.

Accordingly, the interim rule that amended 7 CFR part 930 and that was published at 80 FR 68424 on November 5, 2015, is adopted as a final rule, without change. Dated: April 12, 2016. Elanor Starmer, Administrator, Agricultural Marketing Service.
[FR Doc. 2016-08834 Filed 4-15-16; 8:45 am] BILLING CODE 3410-02-P
DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 1290 [Document No. AMS-TM-16-0004] RIN 0581-AC59 Specialty Crop Block Grant Program Regulation; Removal of a Final Rule AGENCY:

Agricultural Marketing Service.

ACTION:

Final rule; removal.

SUMMARY:

The Agricultural Marketing Service (AMS) is rescinding and removing from the Code of Federal Regulations 7 CFR part 1290 entitled “Specialty Crop Block Grant Program” (SCBGP) in its entirety. This regulation implemented the SCBGP for the fiscal years 2006 to 2008 and is now obsolete.

DATES:

Effective April 19, 2016.

FOR FURTHER INFORMATION CONTACT:

Trista Etzig, Grants Division Director; Telephone: (202) 720-8356; email: [email protected]

SUPPLEMENTARY INFORMATION:

SCBGP is authorized under the Specialty Crop Competitiveness Act of 2004 (7 U.S.C. 1621 note).

AMS published 7 CFR part 1290, as a Final rule, in the Federal Register on September 11, 2006 (71 FR 53307), to establish regulations for SCBGP. SCBGP is a noncompetitive grant program that makes funds available to eligible entities for projects to solely enhance the competitiveness of specialty crops. The rule established SCBGP eligibility and application requirements, review and approval processes, and grant administration procedures for SCBGP for the fiscal years 2006 to 2008.

The grant agreements that 7 CFR part 1290 affected have expired and the regulations are now obsolete. Therefore, the AMS is rescinding and removing the regulation implementing the SCBGP from 2006 to 2008 in its entirety.

List of Subjects in 7 CFR Part 1290

Agriculture, Reporting and recordkeeping requirements, Specialty crop block grants.

PART 1290—[REMOVED AND RESERVED]

For the reasons set forth in the preamble, under the authority of 7 U.S.C. 1621 note, 7 CFR part 1290 is removed.

Dated: April 12, 2016. Elanor Starmer, Administrator, Agricultural Marketing Service.
[FR Doc. 2016-08832 Filed 4-15-16; 8:45 am] BILLING CODE 3410-02-P
DEPARTMENT OF ENERGY 10 CFR Part 430 [Docket No. EERE-2013-BT-STD-0033] RIN 1904-AD02 Energy Conservation Program for Consumer Products and Certain Commercial and Industrial Equipment: Determination of Portable Air Conditioners as a Covered Consumer Product AGENCY:

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

ACTION:

Final determination.

SUMMARY:

The U.S. Department of Energy (DOE) is classifying portable air conditioners (ACs) as a covered product under the Energy Policy and Conservation Act (EPCA), as amended. This classification is based on DOE's determination that portable ACs are a type of consumer product that meets the requisite criteria specified in EPCA. Specifically, DOE has determined that classifying portable ACs as a covered product is necessary or appropriate to carry out the purposes of EPCA, and that average U.S. household energy use by portable ACs is likely to exceed 100 kilowatt-hours (kWh) per year.

DATES:

This rule is effective May 18, 2016.

ADDRESSES:

This rulemaking can be identified by docket number EERE-2013-BT-STD-0033 and/or Regulatory Information Number (RIN) 1904-AD02.

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

A link to the docket Web page can be found at: https://www1.eere.energy.gov/buildings/appliance_standards/rulemaking.aspx/ruleid/76. This Web page will contain a link to the docket for this notice on the www.regulations.gov site. The www.regulations.gov Web page contains simple instructions on how to access all documents, including public comments, in the docket.

For further information on how to review the docket, contact Ms. Brenda Edwards at (202) 586-2945 or by email: [email protected]

FOR FURTHER INFORMATION CONTACT:

Mr. Bryan Berringer, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-0371. Email: [email protected]

Ms. Sarah Butler, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-1777. Email: [email protected]

SUPPLEMENTARY INFORMATION:

Table of Contents I. Statutory Authority II. Current Rulemaking Process III. Proposed Definition IV. Evaluation of Portable ACs as a Covered Product Subject to Energy Conservation Standards A. Coverage Necessary or Appropriate To Carry Out Purposes of EPCA B. Average Household Energy Use V. Procedural Issues and Regulatory Review A. Review Under Executive Order 12866 B. Review Under the Regulatory Flexibility Act C. Review Under the Paperwork Reduction Act of 1995 D. Review Under the National Environmental Policy Act of 1969 E. Review Under Executive Order 13132 F. Review Under Executive Order 12988 G. Review Under the Unfunded Mandates Reform Act of 1995 H. Review Under the Treasury and General Government Appropriations Act of 1999 I. Review Under Executive Order 12630 J. Review Under the Treasury and General Government Appropriations Act of 2001 K. Review Under Executive Order 13211 L. Review Under the Information Quality Bulletin for Peer Review I. Statutory Authority

Title III of the Energy Policy and Conservation Act (EPCA), as amended (42 U.S.C. 6291 et seq.), sets forth various provisions designed to improve energy efficiency. Part A of Title III of EPCA (42 U.S.C. 6291-6309) established the “Energy Conservation Program for Consumer Products Other Than Automobiles.” 1 EPCA authorizes the Secretary of Energy to classify additional types of consumer products not otherwise specified in Part A as covered products. For a type of consumer product to be classified as a covered product, the Secretary must determine that:

1 For editorial reasons, upon codification in the U.S. Code, Part B was re-designated Part A.

(1) Classifying the product as a covered product is necessary for the purposes of EPCA; and

(2) The average annual per-household energy use by products of such type is likely to exceed 100 kilowatt-hours (kWh) per year. (42 U.S.C. 6292(b)(1))

For the Secretary to prescribe an energy conservation standard pursuant to 42 U.S.C. 6295(o) and (p) for covered products added pursuant to 42 U.S.C. 6292(b)(1), he must also determine that:

(1) The average household energy use of the products has exceeded 150 kWh per household for a 12-month period;

(2) The aggregate 12-month energy use of the products has exceeded 4.2 terawatt-hours (TWh);

(3) Substantial improvement in energy efficiency is technologically feasible; and

(4) Application of a labeling rule under 42 U.S.C. 6294 is unlikely to be sufficient to induce manufacturers to produce, and consumers and other persons to purchase, covered products of such type (or class) that achieve the maximum energy efficiency that is technologically feasible and economically justified. (42 U.S.C. 6295(l)(1))

Portable ACs are movable units typically designed to provide 8,000-14,000 British thermal units (Btu) per hour (hr) of cooling capacity 2 for a single room. In contrast to room ACs, a covered product that provides consumers with a similar function, portable ACs are not permanently installed on the wall or in a window. DOE has determined that portable ACs meet the statutory requirements under 42 U.S.C. 6292(b)(1), and therefore classifies portable ACs as a covered product. Separately, DOE is conducting rulemakings to consider test procedures and energy conservation standards for portable ACs. DOE will determine if portable ACs satisfy the provisions of 42 U.S.C. 6295(l)(1) during the course of the energy conservation standards rulemaking.

2 As rated according to current industry test methods.

II. Current Rulemaking Process

DOE has not previously conducted an energy conservation standards rulemaking for portable ACs. On July 5, 2013, DOE published in the Federal Register a notice of proposed determination of coverage (NOPD) in which it tentatively determined that portable ACs satisfy the provisions of 42 U.S.C. 6292(b)(1). 78 FR 40403. After considering public comments on the NOPD (see sections III and IV of this notice), DOE is issuing this final determination of coverage for portable ACs and is evaluating in separate rulemakings both test procedures and energy conservation standards for portable ACs.

With respect to the test procedure rulemaking, DOE initially published a notice of data availability (NODA) on May 9, 2014, in which it discussed various industry test procedures and presented results from its investigative testing. 79 FR 26639. In the NODA, DOE evaluated existing methodologies and alternate approaches adapted from these methodologies that could be incorporated in a future DOE test procedure for portable ACs.

After reviewing comments and information received on the NODA, DOE published a test procedure notice of proposed rulemaking (NOPR) on February 25, 2015, in which it proposed to establish test procedures for portable ACs that would measure the energy efficiency, energy use, and estimated annual operating cost of portable ACs during a representative average use period and that would not be unduly burdensome to conduct, as required under 42 U.S.C. 6293(b)(3)). 80 FR 10211. The proposed test procedures were based upon industry methods to determine energy consumption in active modes, standby modes, and off mode, with certain modifications to ensure the test procedures would be repeatable and representative. Based on comments from interested parties on the NOPR, DOE subsequently published a supplemental notice of proposed rulemaking (SNOPR) on November 27, 2015, in which it proposed revisions to the test procedure proposed in the NOPR to improve repeatability, reduce test burden, and ensure that the test procedure is representative of typical consumer usage. 80 FR 74020.

With respect to the energy conservation standards rulemaking, DOE published a notice of public meeting and notice of availability of a preliminary technical support document (TSD) for portable ACs on February 27, 2015. 80 FR 10628. The TSD describes the details of DOE's preliminary analysis. DOE held a public meeting to discuss and receive comments on the preliminary analysis it conducted. The meeting covered the analytical framework, models, and tools that DOE used to evaluate potential standards; the results of preliminary analyses performed by DOE for this product; the potential energy conservation standard levels derived from these analyses that DOE could consider for this product; and other issues relevant to the development of energy conservation standards for portable ACs.

After considering comments and information submitted on the preliminary analysis, DOE expects to complete a full analysis of both the burdens and benefits of potential energy conservation standards in a NOPR, pursuant to 42 U.S.C. 6295(o). Because DOE is classifying portable ACs as a covered product under 42 U.S.C. 6292(b)(1), DOE will also consider as part of any energy conservation standard NOPR whether portable ACs satisfy the requirements of 42 U.S.C. 6295(l)(1). After the publication of the standards NOPR, DOE will afford interested parties an opportunity during a period of not less than 60 days to provide oral and written comment. After receiving and considering the comments on the NOPR and not less than 90 days after the publication of the NOPR, DOE will issue the final rule prescribing any new energy conservation standards for portable ACs.

III. Product Definition

In the NOPD, DOE proposed the following definition of “portable air conditioner” to determine the potential scope of which products would potentially be regulated as a covered product. The proposed definition also provided clarity for interested parties with respect to the test procedure and energy conservation standards rulemakings as DOE continued its analyses. DOE initially proposed that a portable AC was:

A consumer product, other than a “packaged terminal air conditioner,” which is powered by a single phase electric current and which is an encased assembly designed as a portable unit that may rest on the floor or other elevated surface for the purpose of providing delivery of conditioned air to an enclosed space. It includes a prime source of refrigeration and may include a means for ventilating and heating.

78 FR 40403, 40404 (July 5, 2013).

DOE noted that this proposed definition would be mutually exclusive to the current definition for a room AC, which is “designed as a unit for mounting in a window or through the wall.” (10 CFR 430.2) Id.

In response to the NOPD, DOE received several comments from interested parties regarding the kinds of products that would be included under the proposed definition of a portable AC. DOE addressed these comments in the test procedure NOPR and proposed a revised definition to further refine the definition and exclude other similar products. Specifically, DOE proposed the definition:

An encased assembly, other than a “packaged terminal air conditioner,” “room air conditioner,” or “dehumidifier,” designed as a portable unit for delivering cooled, conditioned air to an enclosed space, that is powered by single-phase electric current, which may rest on the floor or other elevated surface. It includes a source of refrigeration and may include additional means for air circulation and heating.

80 FR 10212, 10214-15 (Feb. 25, 2015).

DOE received multiple comments from interested parties in response to the proposed definition in the test procedure NOPR, focusing on the distinction between portable ACs intended for consumer versus commercial applications.

DENSO Products and Services Americas, Inc. (DENSO) noted that portable ACs are used in both residential and commercial settings, and that the typical distinction between the two settings is the use of single-phase versus three-phase power. However, DENSO expressed concern about the proposed definition because some portable ACs with single-phase power may be used in commercial or industrial applications. (DENSO, TP Public Meeting Transcript, No. 13 at pp. 21-22) 3

3 A notation in the form “DENSO, TP Public Meeting Transcript, No. 13 at pp. 21-22” identifies an oral comment that DOE received on March 18, 2015 during the Test Procedure NOPR public meeting, was recorded in the public meeting transcript in the docket for the test procedure rulemaking (Docket No. EERE-2014-BT-TP-0014). This particular notation refers to a comment (1) made by DENSO Products and Services Americas, Inc. (DENSO) during the public meeting; (2) recorded in document number 13, which is the public meeting transcript that is filed in the docket of the test procedure rulemaking; and (3) which appears on pages 21 through 22.

Oceanaire and the National Association of Manufacturers (NAM) supported the exclusion of commercial portable ACs from coverage, given the limited size of the industry and small number of units produced. These commenters stated that requiring additional testing would have a significant negative impact on this niche market. According to Oceanaire and DENSO, annual shipments of commercial portable ACs are only 15,000, as compared to the 973,700 annual shipments of consumer portable ACs in the United States that DOE estimated in its preliminary analysis for portable AC energy conservation standards. (Oceanaire, No. 10 at p. 3; NAM, No. 17 at pp. 1, 3; DENSO, TP NOPR No. 14 at p. 4) 4

4 A notation in the form “DENSO, TP NOPR No. 14 at p. 4” identifies a written comment: (1) Made by DENSO Products and Services Americas, Inc. (DENSO); (2) recorded in document number 14 that is filed in the docket of the test procedure notice of proposed rulemaking as a covered consumer product (Docket No. EERE-2014- BT-TP-0014) and available for review at www.regulations.gov; and (3) which appears on page 4 of document number 14.

To identify products that are commonly referred to as portable ACs but that it contends should be excluded from coverage as consumer products, Oceanaire referred to NAM's definition of a commercial portable AC and the following characteristics it believes are common to commercial portable ACs: (1) A minimum evaporator inlet air flow of 265 cubic feet per minute (CFM) and minimum condenser air flow of 500 CFM at standard temperature, pressure, and rated voltage; (2) a minimum refrigerant charge of 14 ounces per unit; (3) an internal condensate tank of a minimum 2-gallon capacity or a condensate pump capable of a minimum 15-foot head pressure; and (4) a minimum weight of 110 pounds. Oceanaire also stated that cooling capacities of commercial portable ACs typically range up to 65,000 Btu/hr. (Oceanaire, TP NOPR No. 10 at p. 1-2; NAM, TP NOPR No. 17 at p. 3)

A number of commenters asserted that the installation locations, operating conditions, use cases, and necessary product construction for commercial portable ACs are substantially different than those for consumer portable ACs. Oceanaire, NAM, and DENSO cited examples of permanent installations for commercial portable ACs, including steel mills, auto repair shops, cosmetics and food product processing facilities, and other environments that are subject to extreme temperature, humidity, and corrosive conditions. Oceanaire further noted that commercial portable ACs are also used to address temporary or emergency short-term conditions, and are purchased by rental companies that provide temporary service to a variety of businesses. Oceanaire described the construction of commercial portable ACs as having 18 gauge and thicker steel cabinetry and support structures to meet the needs of commercial and industrial customers, and according to Oceanaire, such portable ACs have an average lifetime of 10 years. (Oceanaire, TP NOPR No. 10 at p. 2; NAM, TP NOPR No. 17 at pp. 2-3; DENSO, TP NOPR No. 14 at p. 1)

For the aforementioned reasons, Oceanaire and NAM stated that they believe that commercial portable ACs do not qualify under the provisions of EPCA as a covered product. (Oceanaire, TP NOPR No. 10 at p. 2; NAM, TP NOPR No. 17 at p. 3)

In the test procedure NOPR, DOE stated that portable ACs are not currently a covered product, and did not propose to classify commercial portable ACs as a covered product. Rather, consistent with the authority under EPCA to classify additional types of “consumer product” not otherwise specified in Part A as covered products, DOE proposed to classify “portable ACs” as a covered product.

EPCA defines “consumer product” as any article of a type that consumes, or is designed to consume, energy and which, to any significant extent, is distributed in commerce for personal use or consumption by individuals. (42 U.S.C. 6291(1)) EPCA further specifies that the definition of a consumer product applies “without regard to whether the product is in fact distributed in commerce for personal use or consumption by an individual.” (42 U.S.C. 6291(1)(B)) Under the definition of “portable air conditioner” proposed by DOE, portable ACs clearly meet EPCA's definition of “consumer product.”

Although the definition of consumer product does not depend on whether the product is, in fact, distributed in commerce for personal use or consumption by an individual, DOE has proposed a definition of “portable air conditioner” that excludes units that could normally not be used in a residential setting by limiting the definition to include only portable ACs powered by single-phase electric current. As such, a product that requires three-phase power, a characteristic that is not appropriate for consumer products, would not be covered under DOE's definition. Conversely, any product with single-phase power that otherwise meets the definition of a portable AC would be considered by DOE to be a portable AC regardless of the manufacturer-intended application or installation location.

Moreover, air flow rates, refrigerant charge, condensate handling system, and product weight are not attributes that inherently determine suitability for consumer use. For example, DOE identified multiple portable ACs marketed as consumer products with evaporator air flow rates greater than 265 CFM, the threshold suggested by Oceanaire and NAM, and rugged construction with correspondingly higher weight that may be desirable in some residential applications such as garages or temporary attic cooling. Further, a portable AC that meets the single-phase power requirement in the portable AC definition would not meet certain minimum thresholds for some of the product attributes in NAM's definition of a commercial portable AC, such that the power requirement would have the same effect as if the definition were to specifically include those thresholds.

For these reasons, DOE is establishing in 10 CFR 430.2 the definition of “portable air conditioner” proposed in the test procedure NOPR with minor editorial revisions that do not modify the intent or scope of the definition:

A portable encased assembly, other than a “packaged terminal air conditioner,” “room air conditioner,” or “dehumidifier,” that delivers cooled, conditioned air to an enclosed space, and is powered by single-phase electric current. It includes a source of refrigeration and may include additional means for air circulation and heating.

IV. Evaluation of Portable ACs as a Covered Product Subject to Energy Conservation Standards

The following sections describe DOE's determination that portable ACs fulfill the criteria for being added as a covered product pursuant to 42 U.S.C. 6292(b)(1). As stated previously, DOE may classify a type of consumer product as a covered product if (1) classifying products of such type as covered products is necessary and appropriate to carry out the purposes of EPCA; and (2) the average annual per-household energy use by products of such type is likely to exceed 100 kWh (or its Btu equivalent) per year.

A. Coverage Necessary or Appropriate To Carry Out Purposes of EPCA

DOE tentatively concluded in the NOPD that coverage of portable ACs is necessary or appropriate to carry out the purposes of EPCA, which include: (1) To conserve energy supplies through energy conservation programs, and, where necessary, the regulation of certain energy uses; and (2) to provide for improved energy efficiency of motor vehicles, major appliances, and certain other consumer products. (42 U.S.C. 6201) In the NOPD, DOE presented the results of its initial analysis, which suggested that the aggregate energy use of portable ACs has been increasing as these units have become popular in recent years. DOE estimated, based on market studies, that 973.7 thousand units shipped in North America in 2012, with a projected growth to 1743.7 thousand units by 2018, representing nearly 80-percent growth over 6 years.5 DOE notes that the number of entries in the California Energy Commission's product database for “spot air conditioners” 6 increased from 295 in August 2013 to 442 in October 2015, suggesting that DOE's initial estimate of significant growth in this product category is reasonable. DOE stated in the NOPD that coverage of portable ACs would enable the conservation of energy supplies through both labeling programs and the regulation of portable AC efficiency. DOE also asserted that there is significant variation in the annual energy consumption of different models currently available, such that technologies exist to reduce the energy consumption of portable ACs. 78 FR 40403, 40404 (Jul. 5, 2013).

5 Transparency Media Research. Air Conditioning Systems Market—Global Scenario, Trends, Industry Analysis, Size, Share and Forecast, 2012-2018. January 2013.

6 California regulations define “spot air conditioner” as “an air conditioner that discharges cool air into a space and discharges rejected heat back into that space, where there is no physical boundary separating the discharges.” This definition is distinct from the regulations' definition of “room air conditioner” as “a factory-encased air conditioner that is designed: (1) As a unit for mounting in a window, through a wall, or as a console, and (2) for delivery without ducts of conditioned air to an enclosed space.” (California Code of Regulations, Title 20: Division 2; Chapter 4, Article 4, Section 1602(c) and (d)) Entries in the CEC database listed as spot ACs include varying configurations of portable ACs, including those that reject heat outside the conditioned space, as well as products that would not meet DOE's definition of portable AC because they operate on three-phase power.

The Appliance Standards Awareness Project (ASAP), Alliance to Save Energy (ASE), American Council for an Energy-Efficient Economy (ACEEE), Consumers Union (CU), and Northwest Energy Efficiency Alliance (NEEA) (hereinafter the “Joint Commenters”) and AHAM supported DOE's proposed determination that classifying portable ACs as a covered product is necessary or appropriate to carry out the purposes of EPCA. (AHAM, No. 6 at pp. 1-2; Joint Commenters, No. 4 at p. 2) The Joint Commenters further recommended that DOE classify portable ACs as a covered product to enable subsequent development of test procedures and consideration of energy conservations standards for portable ACs because: (1) Shipments are growing; (2) portable ACs have high per-unit energy use; and (3) competing products (such as room ACs) are currently covered. (Joint Commenters, No. 4 at p. 2)

DOE, therefore, reaffirms its tentative conclusion in the NOPD and determines that classifying portable ACs as a covered product is necessary and appropriate to carry out the purposes of EPCA. In consideration of the potential for improved energy efficiency of portable ACs and associated national energy savings, DOE has developed a proposed test procedure in a recent rulemaking that would establish appendix CC, and is currently addressing potential energy conservation standards for portable ACs in a standards rulemaking.

B. Average Household Energy Use

In the NOPD, DOE estimated the average household portable AC energy use of portable ACs. DOE based its calculations on a review of the current market and a comparison to room AC energy use, and determined that the typical rated energy efficiency ratio (EER) of portable ACs is approximately 9.5, with a large available range (approximately 8.2-14.3), and that typical cooling capacities range from 8,000-14,000 Btu/hr. DOE further estimated average per-household annual electricity consumption of a portable AC, based on a typical unit with EER 9.5, to be approximately 650 kWh/yr (750 kWh/yr for EER 8.2, and 400 kWh/yr for EER 14.3). DOE also noted that one set of laboratory tests 7 measured the cooling capacity of units to be half of manufacturers' reported values, suggesting that in-field energy use is much larger than the rated value would imply. Therefore, DOE tentatively determined in the NOPD that the average annual per-household energy use for portable ACs is very likely to exceed 100 kWh/yr, satisfying the criterion of 42 U.S.C. 6292(b)(1)(B) required for classification of portable ACs as a covered product under Part A of Title III of the EPCA, as amended. 78 FR 40403, 40404-40405.

7 Consumer Reports. Buying Advice: Portable Air Conditioners. http://news.consumerreports.org/home/2008/06/air-condition-1.html.

AHAM agreed with the result of DOE's estimate of portable AC annual energy use, although it did not agree with DOE's methodology. Specifically, AHAM suggested that the usage profiles of portable ACs differ from those for room ACs, which were the basis for DOE's analysis. AHAM stated its belief that portable ACs are used for a shorter period of time because some consumers may use them to supplement conditioned air in a particular space or area of a room instead of as the primary means of cooling. Nevertheless, AHAM stated that it does not believe that these differences would change the determination that per-household energy use for portable ACs is likely to exceed 100 kWh/yr. (AHAM, No. 6 at pp. 2-3) The California IOUs stated that DOE's estimate of annual energy use for a typical portable AC unit is significant and comparable to the per-unit energy use of many major household appliances. (California IOUs, No. 5 at p. 3) DOE solicited, but did not receive, portable AC usage data in both the test procedure and energy conservation standards rulemakings. DOE agrees, however, that the potential differences between portable AC and room AC usage would not change DOE's initial determination that portable ACs meet the threshold per-household energy use, particularly because DOE's estimates were at least a factor of four greater than the 100 kWh/yr requirement. Therefore, DOE determines here that average annual per-household energy use by portable ACs is likely to exceed 100 kWh (or its Btu equivalent) per year.

Accordingly, DOE has determined that portable ACs meet the statutory requirements under 42 U.S.C 6292(b)(1), and therefore classifies portable ACs as a covered product. DOE amends the definition of covered product in 10 CFR 430.2 to reflect this determination.

V. Procedural Issues and Regulatory Review

DOE has reviewed this final determination of coverage for portable ACs under the following executive orders and acts.

A. Review Under Executive Order 12866

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

B. Review Under the Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act of 1996) requires preparation of a regulatory flexibility analysis for any rule that, by law, must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. A regulatory flexibility analysis examines the impact of the rule on small entities and considers alternative ways of reducing negative effects. Also, as required by E.O. 13272, “Proper Consideration of Small Entities in Agency Rulemaking” 67 FR 53461 (Aug. 16, 2002), DOE published procedures and policies on February 19, 2003 to ensure that the potential impact of its rules on small entities are properly considered during the DOE rulemaking process. 68 FR 7990 (Feb. 19, 2003). DOE makes its procedures and policies available on the Office of the General Counsel's Web site at http://energy.gov/gc/office-general-counsel.

DOE reviewed this final determination under the provisions of the Regulatory Flexibility Act and the policies and procedures published on February 19, 2003. This final determination sets no standards; it only positively determines that future standards may be warranted and should be explored in an energy conservation standards and test procedure rulemaking. Economic impacts on small entities would be considered in the context of such rulemakings. On the basis of the foregoing, DOE certifies that the determination has no significant economic impact on a substantial number of small entities. Accordingly, DOE has not prepared a regulatory flexibility analysis for this final determination. DOE will transmit this certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the Small Business Administration for review under 5 U.S.C. 605(b).

C. Review Under the Paperwork Reduction Act of 1995

This final determination, which concludes that portable ACs meet the criteria for a covered product for which the Secretary may prescribe an energy conservation standard pursuant to 42 U.S.C. 6295(o) and (p), imposes no new information or record-keeping requirements. Accordingly, the OMB clearance is not required under the Paperwork Reduction Act. (44 U.S.C. 3501 et seq.)

D. Review Under the National Environmental Policy Act of 1969

In this notice, DOE positively determines that portable ACs meet the criteria for classification as covered products and that future standards may be warranted to regulate their energy use. Should DOE pursue that option, the relevant environmental impacts would be explored as part of that rulemaking. As a result, DOE has determined that this action falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and DOE's implementing regulations at 10 CFR part 1021. Specifically, this action establishes a class of products (portable ACs) for which energy conservation standards would be appropriate. However, this action does not establish energy conservation standards, and, therefore, does not result in any environmental impacts. Thus, this action is covered by Categorical Exclusion A6 “Procedural rulemakings” under 10 CFR part 1021, subpart D. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

E. Review Under Executive Order 13132

Executive Order (E.O.) 13132, “Federalism” 64 FR 43255 (Aug. 10, 1999), imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to assess carefully the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in developing regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process that it will follow in developing such regulations. 65 FR 13735 (Mar. 14, 2000). DOE has examined this final determination and concludes that it does not preempt State law or have substantial direct effects on the States, on the relationship between the Federal government and the States, or on the distribution of power and responsibilities among the various levels of government. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the product that is the subject of this final determination. States can petition DOE for exemption from such preemption to the extent permitted, and based on criteria, set forth in EPCA. (42 U.S.C. 6297) No further action is required by E.O. 13132.

F. Review Under Executive Order 12988

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

G. Review Under the Unfunded Mandates Reform Act of 1995

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4, codified at 2 U.S.C. 1501 et seq.) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and tribal governments and the private sector. For regulatory actions likely to result in a rule that may cause expenditures by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any 1 year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a) and (b)) UMRA requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and tribal governments on a proposed “significant intergovernmental mandate.” UMRA also requires an agency plan for giving notice and opportunity for timely input to small governments that may be potentially affected before establishing any requirement that might significantly or uniquely affect them. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820 (Mar. 18, 1997). (This policy also is available at http://energy.gov/gc/office-general-counsel). DOE reviewed this final determination pursuant to these existing authorities and its policy statement and determined that the rule contains neither an intergovernmental mandate nor a mandate that may result in the expenditure of $100 million or more in any year, so the UMRA requirements do not apply.

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

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

I. Review Under Executive Order 12630

Pursuant to E.O. 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights” 53 FR 8859 (Mar. 15, 1988), DOE determined that this final determination does not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.

J. Review Under the Treasury and General Government Appropriations Act of 2001

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

K. Review Under Executive Order 13211

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

DOE has concluded that this regulatory action establishing certain definitions and determining that portable ACs meet the criteria for a covered product for which the Secretary may prescribe an energy conservation standard pursuant to 42 U.S.C. 6295(o) and (p) does not have a significant adverse effect on the supply, distribution, or use of energy. This action is also not a significant regulatory action for purposes of E.O. 12866, and the OIRA Administrator has not designated this final determination as a significant energy action under E.O. 12866 or any successor order. Therefore, this final determination is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.

L. Review Under the Information Quality Bulletin for Peer Review

On December 16, 2004, OMB, in consultation with the Office of Science and Technology Policy (OSTP), issued its Final Information Quality Bulletin for Peer Review (the Bulletin). 70 FR 2664 (Jan. 14, 2005). The Bulletin establishes that certain scientific information shall be peer reviewed by qualified specialists before it is disseminated by the Federal government, including influential scientific information related to agency regulatory actions. The purpose of the Bulletin is to enhance the quality and credibility of the Government's scientific information. DOE has determined that the analyses conducted for the regulatory action discussed in this document do not constitute “influential scientific information,” which the Bulletin defines as “scientific information the agency reasonably can determine will have or does have a clear and substantial impact on important public policies or private sector decisions.” 70 FR 2667 (Jan. 14, 2005). The analyses were subject to pre-dissemination review prior to issuance of this rulemaking.

DOE will determine the appropriate level of review that would apply to any future rulemaking to establish energy conservation standards for portable ACs.

VI. Approval of the Office of the Secretary

The Secretary of Energy has approved publication of this final determination.

List of Subjects in 10 CFR Part 430

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

Issued in Washington, DC, on April 11, 2016. David Friedman, Principal Deputy Assistant Secretary, Energy Efficiency and Renewable Energy.

For the reasons stated in the preamble, DOE amends part 430 of chapter II of title 10, Code of Federal Regulations as set forth below:

PART 430—ENERGY CONSERVATION PROGRAM FOR CONSUMER PRODUCTS 1. The authority citation for part 430 continues to read as follows: Authority:

42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.

2. Section 430.2 is amended by revising the definition of “covered product” and adding the definition of “portable air conditioner” in alphabetical order to read as follows:
§ 430.2 Definitions.

Covered product means a consumer product—

(1) Of a type specified in section 322 of the Act, or

(2) That is a ceiling fan, ceiling fan light kit, medium base compact fluorescent lamp, dehumidifier, battery charger, external power supply, torchiere, or portable air conditioner.

Portable air conditioner means a portable encased assembly, other than a “packaged terminal air conditioner,” “room air conditioner,” or “dehumidifier,” that delivers cooled, conditioned air to an enclosed space, and is powered by single-phase electric current. It includes a source of refrigeration and may include additional means for air circulation and heating.

[FR Doc. 2016-08891 Filed 4-15-16; 8:45 am] BILLING CODE 6450-01-P
FEDERAL HOUSING FINANCE AGENCY 12 CFR Part 1238 [No. 2016-N-05] Orders: Reporting by Regulated Entities of Stress Testing Results as of December 31, 2015; Summary Instructions and Guidance AGENCY:

Federal Housing Finance Agency.

ACTION:

Orders.

SUMMARY:

In this document, the Federal Housing Finance Agency (FHFA) provides notice that it issued Orders, dated March 2, 2016, with respect to stress test reporting as of December 31, 2015, under section 165(i)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act). Summary Instructions and Guidance accompanied the Orders to provide testing scenarios.

DATES:

Effective April 18, 2016. Each Order is applicable March 2, 2016.

FOR FURTHER INFORMATION CONTACT:

Naa Awaa Tagoe, Senior Associate Director, Office of Financial Analysis, Modeling and Simulations, (202) 649-3140, [email protected]; Stefan Szilagyi, Examination Manager, FHLBank Modeling, FHLBank Risk Modeling Branch (202) 649-3515, [email protected]; Karen Heidel, Senior Counsel, Office of General Counsel, (202) 649-3073, [email protected]; or Mark D. Laponsky, Deputy General Counsel, Office of General Counsel, (202) 649-3054, [email protected] The telephone number for the Telecommunications Device for the Hearing Impaired is (800) 877-8339.

SUPPLEMENTARY INFORMATION:

I. Background

FHFA is responsible for ensuring that the regulated entities operate in a safe and sound manner, including the maintenance of adequate capital and internal controls, that their operations and activities foster liquid, efficient, competitive, and resilient national housing finance markets, and that they carry out their public policy missions through authorized activities. See 12 U.S.C. 4513. These Orders are being issued under 12 U.S.C. 4516(a), which authorizes the Director of FHFA to require by Order that the regulated entities submit regular or special reports to FHFA and establishes remedies and procedures for failing to make reports required by Order. The Orders, through the accompanying Summary Instructions and Guidance, prescribe for the regulated entities the scenarios to be used for stress testing. The Summary Instructions and Guidance also provides to the regulated entities advice concerning the content and format of reports required by the Orders and the rule.

II. Orders, Summary Instructions and Guidance

For the convenience of the affected parties and the public, the text of the Orders follows below in its entirety. You may access these Orders and the Summary Instructions and Guidance from FHFA's Web site at http://www.fhfa.gov/SupervisionRegulation/DoddFrankActStressTests. The Orders and Summary Instructions and Guidance also will be available for public inspection and copying at the Federal Housing Finance Agency, Eighth Floor, 400 Seventh St. SW., Washington, DC 20219. To make an appointment call (202) 649-3804.

The text of the Orders is as follows:

Federal Housing Finance Agency Order Nos. 2016-OR-B-1, 2016-OR-FNMA-1, and 2016-OR-FHLMC-1 REPORTING BY REGULATED ENTITIES OF STRESS TESTING RESULTS AS OF DECEMBER 31, 2015

Whereas, section 165(i)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”) requires certain financial companies with total consolidated assets of more than $10 billion, and which are regulated by a primary Federal financial regulatory agency, to conduct annual stress tests to determine whether the companies have the capital necessary to absorb losses as a result of adverse economic conditions;

Whereas, FHFA's rule implementing section 165(i)(2) of the Dodd-Frank Act is codified as 12 CFR 1238 and requires that “[e]ach regulated entity must file a report in the manner and form established by FHFA.” 12 CFR 1238.5(b);

Whereas, The Board of Governors of the Federal Reserve System issued stress testing scenarios on January 28, 2016 and supplemented on February 4, 2016; and

Whereas, section 1314 of the Safety and Soundness Act, 12 U.S.C. 4514(a) authorizes the Director of FHFA to require regulated entities, by general or specific order, to submit such reports on their management, activities, and operation as the Director considers appropriate.

Now Therefore, it is hereby Ordered as follows:

Each regulated entity shall report to FHFA and to the Board of Governors of the Federal Reserve System the results of the stress testing as required by 12 CFR 1238, in the form and with the content described therein and in the Summary Instructions and Guidance, with Appendices 1 through 12 thereto, accompanying this Order and dated March 2, 2016.

It Is So Ordered, this the 2nd day of March, 2016.

This Order is effective immediately.

Signed at Washington, DC, this 2nd day of March, 2016.

Melvin L. Watt, Director, Federal Housing Finance Agency. Dated: April 12, 2016. Melvin L. Watt, Director, Federal Housing Finance Agency.
[FR Doc. 2016-08903 Filed 4-15-16; 8:45 am] BILLING CODE 8070-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 522, 524, 529, 556, and 558 [Docket No. FDA-2016-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in January and February.

DATES:

This rule is effective April 18, 2016.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION: I. Approval Actions

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January and February 2016, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

Table 1—Original and Supplemental NADAs and ANADAs Approved During January and February 2016 File No. Sponsor Product name Action 21 CFR
  • section
  • FOIA
  • summary
  • NEPA
  • review
  • 141-444 Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW United Kingdom ZYCORTAL Suspension (desoxycorticosterone pivalate injectable suspension) Original approval for use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison's disease) 522.535 yes CE.12 141-448 Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601 THYRO-TABS CANINE (levothyroxine sodium tablets) Original approval for replacement therapy for diminished thyroid function in dogs 520.1248 yes CE.12 141-452 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 SIMPARICA (sarolaner) Chewables Original approval for killing adult fleas, and for the treatment and prevention of flea infestations and the treatment and control of tick infestations in dogs 520.2086 yes CE.12 141-263 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 CERENIA (maropitant citrate) Injectable Solution Supplemental approval providing for intravenous administration in dogs and cats 522.1315 yes CE.12 141-449 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 SAFE-GUARD AquaSol (fenbendazole oral suspension) Suspension Concentrate Supplemental approval for the treatment and control of certain nematode worms in swine, except for nursing piglets; and of a revised tolerance in swine liver 520.905a, 556.275 yes EA/FONSI.3 200-600 ECO LLC, 344 Nassau St., Princeton, NJ 08540 WORMX (pyrantel pamoate) Flavored Tablets Original approval as a generic copy of NADA 139-191 520.2041 yes CE.12 1 The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not have a significant effect on the human environment. 2 CE granted under 21 CFR 25.33(d)(1). 3 The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of no significant impact (FONSI).

    Also, FDA is amending the regulations to reflect the approval of several minor supplemental applications that revised classes of food-producing animals in indications and in food safety warnings for decoquinate and robenidine in medicated feeds. A food safety precautionary statement has also been revised for use of monensin in medicated chicken feed.

    II. Changes of Sponsorship

    Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee, Mission, KS 66201 has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:

    File No. Product name 21 CFR section 006-391 S.Q. (sulfaquinoxaline) 40% Medicated Feed 558.586 006-677 S.Q. (sulfaquinoxaline) 20% Solution 520.2325a 007-087 Sulfaquinoxaline Solubilized 520.2325a 033-157 SPECTAM Scour Halt (spectinomycin dihydrochloride pentahydrate) Solution 520.2123c 040-040 SPECTAM (spectinomycin) Injectable Solution 522.2120 048-287 Oxytetracycline-50 (oxytetracycline hydrochloride) Injection 522.1662a 065-110 PEN-G-MAX (penicillin G procaine) Injectable Suspension 522.1696b 065-498 DUAL-CILLIN (benzathine penicillin G and procaine penicillin G) Injectable Suspension 522.1696a 119-142 PVL Iron Dextran (iron hydrogenated dextran) Injectable 522.1182 128-089 ZONOMETH (dexamethasone) Injectable Solution 522.540 140-270 SULFASURE SR (sulfamethazine) Sustained-Release Cattle Bolus 520.2260b 200-068 Oxytetracycline Hydrochloride 100 mg/mL Injection 522.1662a 200-108 Dexamethasone Injectable Solution 522.540 200-118 Neomycin (neomycin sulfate) Oral Solution 520.1484 200-123 MAXIM-200 (oxytetracycline) Injection 522.1660a 200-147 GENTA-JECT (gentamicin sulfate) Injectable Solution 522.1044 200-153 NEO 200 (neomycin sulfate) Oral Solution 520.1484 200-162 Tripelennamine Hydrochloride Injection 522.2615 200-174 Gentamicin Sulfate Pig Pump Oral Solution 520.1044b 200-177 Sulfadimethoxine Injection 40% 522.2220 200-192 Sulfadimethoxine 12.5% Oral Solution 520.2220a 200-219 Ivermectin Pour-On for Cattle 524.1193 200-463 Amprolium-P 9.6% Oral Solution 520.100

    Also, Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666.

    File No. Product name 21 CFR section 038-200 OXY WS (oxytetracycline) Soluble Antibiotic 520.1660d 065-178 FERMYCIN (chlortetracycline) Soluble 520.441 065-496 Tetracycline Soluble Powder 520.2345d

    In addition, Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:

    File No. Product name 21 CFR section 006-891 SUL-Q-NOX (sulfaquinoxaline) Soluble Powder 520.2325a 065-140 TET-SOL 324 (tetracycline hydrochloride) Soluble Powder 520.2345d 100-094 POULTRYSULFA (sulfamerazine, sulfamethazine, and sulfaquinoxaline) Soluble Powder 520.2218 128-686 BIO-COX (salinomycin) Type A Medicated Article 558.550 130-435 OXY-TET (oxytetracycline hydrochloride) Soluble Powder/Solution 520.1660d 134-284 BIO-COX/FLAVOMYCIN (bambermycins) 558.550 200-106 R-PEN (Penicillin G potassium) Soluble Powder 520.1696b 200-130 NEO-SOL 50 (neomycin sulfate) Soluble Powder 520.1484 200-189 Lincomycin Soluble Powder 520.1263c 200-441 AUREOMYCIN (chlortetracycline) Soluble Powder 520.441

    As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship.

    III. Technical Amendments

    FDA has noticed that it failed to amend all necessary regulations to reflect the change of sponsorship of an oxytetracycline soluble powder (80 FR 13226, March 13, 2015). At this time, we are amending 21 CFR 529.1660 to include the drug labeler code for the new sponsor. This action is being taken to improve the accuracy of the regulations.

    FDA has also noticed that in § 558.355 (21 CFR 558.355) use of bacitracin methylenedisalicylate at 100 to 200 grams/ton in combination with monensin in broiler and replacement chicken feeds was codified in error for NADA 141-140 (66 FR 13236, March 5, 2001). At this time, § 558.355 is amended by removing paragraphs (f)(1)(xxx) and (f)(4)(v). In addition, paragraph (f)(4)(iv), a remnant of a previous technical amendment (79 FR 10963, February 27, 2014), is also being removed. We have also noticed that certain paragraphs describing approved conditions of use were removed in error from § 558.355 during codification of a supplemental application to NADA 138-456 that increased the dose range for monensin used in combination with bacitracin methylenedisalicylate in broiler chicken feed (57 FR 6554, February 26, 1992). At this time, § 558.355 is amended by adding paragraphs (f)(1)(xxiv)(a) and (b). These actions are being taken to improve the accuracy of the regulations.

    FDA has noticed that in error we removed the approved conditions of use for gleptoferron, an injectable iron used to prevent anemia in young piglets. At this time, 21 CFR 522.1055 is being added. This action is being taken to improve the accuracy of the regulations.

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

    List of Subjects 21 CFR Parts 520, 522, 524, and 529

    Animal drugs.

    21 CFR Part 556

    Animal drugs, Food.

    21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 520, 522, 524, 529, 556, and 558 are amended as follows:

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

    21 U.S.C. 360b.

    § 520.100 [Amended]
    2. In § 520.100, remove and reserve paragraph (b)(3).
    3. In § 520.441, revise paragraph (b)(1), remove paragraph (b)(2); redesignate paragraphs (b)(3) and (4) as paragraphs (b)(2) and (3); and revise newly redesignated paragraph (b)(2).

    The revisions read as follows:

    § 520.441 Chlortetracycline powder.

    (b) * * *

    (1) Nos. 000010, 016592, 054771, and 069254 for use as in paragraph (d) of this section.

    (2) No. 066104 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) through (d)(4)(iv) of this section.

    4. In § 520.905a, in paragraph (a), remove “paragraph (e)(5)” and in its place add “paragraphs (e)(5) and (6)”; and add paragraph (e)(6) to read as follows:
    § 520.905a Fenbendazole suspension.

    (e) * * *

    (6) Swine, except for nursing piglets—(i) Amount. Administer orally via the drinking water at a daily dose of 2.2 mg/kg of body weight (1.0 mg/lb) for 3 consecutive days.

    (ii) Indications for use. For the treatment and control of lungworms: Adult Metastrongylus apri, adult M. pudendotectus; gastrointestinal worms: Adult and larvae (L3, L4 stages, liver, lung, intestinal forms) large roundworms (Ascaris suum); nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); small stomach worms (Hyostrongylus rubidus): Adult and larvae (L2, L3, L4 stages—intestinal mucosal forms) whipworms (Trichuris suis); and kidney worms: Adult and larvae Stephanurus dentatus.

    (iii) Limitations. Swine intended for human consumption must not be slaughtered within 2 days from the last treatment.

    § 520.1044b [Amended]
    5. In § 520.1044b, in paragraph (b), remove “000859” and in its place add “016592”.
    6. Add § 520.1248 to read as follows:
    § 520.1248 Levothyroxine.

    (a) Specifications. Each tablet contains 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or 1.0 milligrams (mg) levothyroxine sodium.

    (b) Sponsor. See No. 061690 in § 510.600(c) of this chapter.

    (c) Conditions of use—(1) Amount. Administer by mouth 0.1 mg/10 pounds of body weight (0.022 mg/kilogram) as a single dose every 24 hours or as a divided dose every 12 hours.

    (2) Indications for use. For replacement therapy for diminished thyroid function in dogs.

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

    7. In § 520.1263c, revise paragraph (b) to read as follows:
    § 520.1263c Lincomycin powder.

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

    (1) No. 016592 for use as in paragraph (d) of this section.

    (2) Nos. 054925, 061623, and 076475 for use as in paragraphs (d)(1) and (d)(2) of this section.

    § 520.1484 [Amended]
    8. In § 520.1484, in paragraph (b)(2), remove “054771” and in its place add “016592, 054771,”; and in paragraph (b)(3), remove “000859” and in its place add “016592”.
    § 520.1660d [Amended]
    9. In § 520.1660d, in paragraph (b)(2), remove “054771” and in its place add “016592”; and in paragraph (b)(3), remove “054628” and in its place add “066104”.
    § 520.1696b [Amended]
    10. In § 520.1696b, in paragraph (b), in numerical order add “016592”.
    § 520.1705 [Amended]
    11. In § 520.1705, in paragraph (a), remove “pergolide mesylate” and in its place add “pergolide (as pergolide mesylate)”.
    § 520.2041 [Amended]
    12. In § 520.2041, in paragraph (b), remove “Nos. 017135 and 051311” and in its place add “Nos. 017135, 051311, and 066916”.
    13. Add § 520.2086 to read as follows:
    § 520.2086 Sarolaner.

    (a) Specifications. Each chewable tablet contains 5, 10, 20, 40, 80, or 120 milligrams (mg) sarolaner.

    (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

    (c) Conditions of use in dogs—(1) Amount. Administer orally once a month at the recommended minimum dosage of 0.9 mg/lb (2 mg/kg).

    (2) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations (Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)) for 1 month in dogs 6 months of age or older and weighing 2.8 pounds or more.

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

    § 520.2123c [Amended]
    14. In § 520.2123c, in paragraph (b), remove “000859” and in its place add “016592”.
    § 520.2218 [Amended]
    15. In § 520.2218, in paragraph (b), remove “054771” and in its place add “016592”.
    § 520.2220a [Amended]
    16. In § 520.2220a, in paragraph (b)(1), remove “000859” and in its place add “016592”.
    § 520.2260b [Amended]
    17. In § 520.2260b, in paragraph (f)(1), remove “000859” and in its place add “016592”.
    § 520.2325a [Amended]
    18. In § 520.2325a, in paragraph (a)(1), remove “000859” and in its place add “016592”; and in paragraph (a)(3), remove “No. 054771” and in its place add “Nos. 016592 and 054771”.
    19. In § 520.2345d, in paragraph (b)(2), remove “054628” and in its place add “066104”; in paragraph (b)(3), remove “No. 054771” and in its place add “Nos. 016592 and 054771”; and revise the first sentence in paragraph (d)(1)(iii) and paragraph (d)(2)(iii) to read as follows:
    § 520.2345d Tetracycline powder.

    (d) * * *

    (1) * * *

    (iii) Limitations. Administer for 3 to 5 days; do not slaughter animals for food within 4 days of treatment for No. 066104 and within 5 days of treatment for Nos. 016592, 054771, 054925, 057561, 059130, and 061623; prepare a fresh solution daily; use as the sole source of tetracycline.* * *

    (2) * * *

    (iii) Limitations. Administer for 3 to 5 days; do not slaughter animals for food within 7 days of treatment for No. 066104 and within 4 days of treatment for Nos. 016592, 054771, 054925, 057561, 059130, and 061623; prepare a fresh solution daily; use as the sole source of tetracycline.

    PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 20. The authority citation for part 522 continues to read as follows: Authority:

    21 U.S.C. 360b.

    21. Revise § 522.535 to read as follows:
    § 522.535 Desoxycorticosterone.

    (a) Specifications. Each milliliter of suspension contains 25 milligrams (mg) of desoxycorticosterone pivalate.

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

    (1) No. 043264 for use as in paragraphs (c)(1)(i), (c)(2)(i), and (c)(3) of this section.

    (2) No. 058198 for use as in paragraphs (c)(1)(ii), (c)(2)(ii), and (c)(3) of this section.

    (c) Conditions of use—(1) Amount. (i) Administer an initial dose of 2.2 mg/kilogram (1 mg/lb) of body weight by subcutaneous injection. Subsequent dosages should be individualized according to label instructions based on patient response to therapy.

    (ii) Dosage requirements are variable and must be individualized on the basis of the response of the patient to therapy. Initial dose of 1 milligram per pound (0.45 kilogram) of body weight every 25 days, intramuscularly. Usual dose is 0.75 to 1.0 milligram per pound of body weight every 21 to 30 days.

    (2) Indications for use—(i) For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison's Disease).

    (ii) For use as replacement therapy for the mineralocorticoid deficit in dogs with primary adrenocortical insufficiency.

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

    § 522.540 [Amended]
    22. In § 522.540, in paragraphs (a)(2)(i) and (d)(2)(i), remove “000859” and in its place add “016592”.
    § 522.1044 [Amended]
    23. In § 522.1044, in paragraph (b)(4), remove “000859” and in its place add “016592”.
    24. Add § 522.1055 to read as follows:
    § 522.1055 Gleptoferron.

    (a) Specifications. Each milliliter contains the equivalent of 200 milligrams (mg) of elemental iron as gleptoferron (complex of ferric hydroxide and dextran glucoheptonic acid).

    (b) Sponsor. See No. 059120 in § 510.600(c) of this chapter.

    (c) Conditions of use. It is used in young piglets as follows:

    (1) Amounts and indications for use—(i) Administer 200 mg of elemental iron intramuscularly on or before 3 days of age for prevention of iron deficiency anemia.

    (ii) Administer 200 mg of elemental iron intramuscularly for treatment of iron deficiency anemia.

    (2) [Reserved]

    § 522.1182 [Amended]
    25. In § 522.1182, in paragraph (b)(6), remove “000859” and in its place add “016592”; and remove paragraph (b)(8).
    § 522.1315 [Amended]
    26. In § 522.1315, in paragraphs (c)(1)(i) and (c)(2)(i), remove “subcutaneous injection” and in its place add “subcutaneous or intravenous injection”.
    § 522.1660a [Amended]
    27. In § 522.1660a, in paragraph (b), remove “000859” and in its place add “016592”.
    § 522.1662a [Amended]
    28. In § 522.1662a, in paragraphs (h)(2) and (i)(2), remove “000859” and in its place add “016592”.
    § 522.1696a [Amended]
    29. In § 522.1696a, in paragraph (b)(2), remove “000859” and in its place add “016592”.
    § 522.1696b [Amended]
    30. In § 522.1696b, in paragraph (b)(1), remove “000859” and in its place add “016592”.
    § 522.2120 [Amended]
    31. In § 522.2120, in paragraph (b), remove “000859” and in its place add “016592”.
    § 522.2220 [Amended]
    32. In § 522.2220, in paragraph (b)(3), remove “000859” and in its place add “016592”.
    § 522.2615 [Amended]
    33. In § 522.2615, in paragraph (b), remove “000859” and in its place add “016592”.
    PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 34. The authority citation for part 524 continues to read as follows: Authority:

    21 U.S.C. 360b.

    § 524.1193 [Amended]
    35. In paragraph (b)(2) of § 522.1193, remove “000859” and in its place add “016592”.
    § 524.1484k [Amended]
    36. In § 522.1484k, revise the section heading to read: Neomycin and prednisolone suspension.
    PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 37. The authority citation for part 529 continues to read as follows: Authority:

    21 U.S.C. 360b.

    § 529.1660 [Amended]
    38. In § 529.1660, in paragraph (b)(2), remove “048164, 054771, and 061623” and in its place add “054771, 061623, and 069254”.
    PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 39. The authority citation for part 556 continues to read as follows: Authority:

    21 U.S.C. 342, 360b, 371.

    40. In § 556.275, in paragraph (b)(2)(i), remove “6 ppm” and in its place add “3.2 ppm”; redesignate paragraphs (b)(3) and (4) as paragraphs (b)(4) and (5); and add new paragraph (b)(3) and paragraph (c) to read as follows:
    § 556.275 Fenbendazole.

    (b) * * *

    (3) Chickens—(i) Liver (the target tissue). The tolerance for fenbendazole sulfone (the marker residue) is 5.2 ppm.

    (ii) [Reserved]

    (c) Related conditions of use. See §§ 520.905a, 520.905c, 520.905d, 520.905e, and 558.258 of this chapter.

    PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 41. The authority citation for part 558 continues to read as follows: Authority:

    21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

    § 558.195 [Amended]
    42. Amend § 558.195 as follows: a. In the table in paragraph (e)(1)(i), in the “Limitations” column, remove “Do not feed to laying chickens.” and in its place add “Do not feed to laying hens producing eggs for human consumption.”; b. In the table in paragraph (e)(2)(i), in the “Limitations” column, remove “Do not feed to cows producing milk for food.” and in its place add “Do not feed to cows producing milk for human consumption.”; c. In the table in paragraphs (e)(3)(i)1. and (e)(3)(ii)1., in the “Limitations” column, remove “Do not feed to sheep producing milk for food.” and in its place add “Do not feed to sheep producing milk for human consumption.”; and d. In the table in paragraphs (e)(3)(i)2. and (e)(3)(ii)2., in the “Limitations” column, remove “Do not feed to goats producing milk for food.” and in its place add “Do not feed to goats producing milk for human consumption.”
    43. In § 558.340, redesignate paragraphs (c)(1)(i) and (ii) as paragraphs (c)(2) and (3); and revise newly redesignated paragraph (c)(2) to read as follows:
    § 558.340 Maduramicin.

    (c) * * *

    (2) Indications for use. Broiler chickens: For prevention of coccidiosis caused by Eimeria acervulina, E. tenella, E. brunetti, E. maxima, E. necatrix, and E. mivati.

    44. In § 558.355, revise paragraph (f)(1)(xxiv); and revise paragraph (f)(1)(xxv) introductory text and remove and reserve paragraphs (f)(1)(xxx), (f)(4)(iv), and (f)(4)(v).

    The revisions read as follows:

    § 558.355 Monensin.

    (f) * * *

    (1) * * *

    (xxiv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin methylenedisalicylate, 4 to 50 grams.

    (a) Indications for use. For improved feed efficiency; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati.

    (b) Limitations. Do not feed to laying chickens; feed continuously as sole ration; in the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain; as bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter.

    (xxv) Amount per ton. Monensin, 90 to 110 grams, plus bacitracin zinc, 4 to 50 grams.

    § 558.515 [Amended]
    45. In § 558.515, in the table in paragraph (d), in the entry for “30 (0.0033 pct)”, in the first entry under the “Indications for use” column, remove “For broiler and fryer chickens:” and in its place add “Broiler chickens:”; and in the first entry under the “Limitations” column, remove “Do not feed to layers.” and in its place add “Do not feed to chickens producing eggs for food.”
    § 558.550 [Amended]
    46. Amend § 558.550 as follows: a. In paragraph (b)(1), remove “054771” and in its place add “016592”; b. Remove paragraph (b)(2) and redesignate paragraph (b)(3) as paragraph (b)(2); c. In paragraph (d)(1)(xvi)(c), remove “Chlortetracycline as provided by Nos. 054771 and 069254; salinomycin as provided by Nos. 054771 and 016592 in § 510.600(c) of this chapter.” and in its place add “Chlortetracycline as provided by Nos. 054771 and 069254; salinomycin as provided by No. 016592 in § 510.600(c) of this chapter.”; d. In paragraph (d)(1)(xx)(C) and (xxi)(C), remove “Salinomycin as provided by 054771; bacitracin methylene disalicylate as provided by 054771 in § 510.600(c) in this chapter.” and in its place add “Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) in this chapter.”; e. In paragraph (d)(1)(xxii)(B), remove “Salinomycin as provided by Nos. 016592 and 054771; tylosin phosphate as provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter.” and in its place add “Salinomycin as provided by No. 016592; tylosin phosphate as provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter.”; f. In paragraph (d)(1)(xxiii)(b), remove “Salinomycin as provided by Nos. 054771 and 016592; bambermycins by No. 016592 in § 510.600(c) of this chapter.” and in its place add “Salinomycin and bambermycins as provided by No. 016592 in § 510.600(c) of this chapter.”; g. In paragraphs (d)(3)(ii)(B), (iii)(B), and (v)(B), remove “Salinomycin as provided by 054771; bacitracin methylene disalicylate as provided by 054771 in § 510.600(c) of this chapter.” and in its place add “Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter.”; and h. In paragraph (d)(4)(i)(b), remove “Salinomycin as provided by Nos. 054771 and 016592; oxytetracycline as provided by No. 066104 in § 510.600(c) of this chapter.” and in its place add “Salinomycin as provided by No. 016592; oxytetracycline as provided by No. 066104 in § 510.600(c) of this chapter.”
    § 558.586 [Amended]
    47. In § 558.586, in paragraph (b), remove “000859” and in its place add “016592”.
    Dated: April 12, 2016. Tracey Forfa, Acting Director, Center for Veterinary Medicine.
    [FR Doc. 2016-08827 Filed 4-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2011-N-0650] Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA) is issuing a final order to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments class III devices (regulated under product code DTE), into class II (special controls) and to reclassify pacing system analyzers (PSAs) into class II (special controls) based on new information and subject to premarket notification. This final order also creates a separate classification regulation for PSAs and places single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are currently postamendments class III devices, into that new classification regulation.

    DATES:

    This order is effective April 18, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Hina Pinto, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1652, Silver Spring, MD 20993, 301-796-6351, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background—Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

    Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as preamendments devices), are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

    A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification (510(k)) procedures to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a premarket approval application (PMA) until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval or until the device is subsequently reclassified into class I or class II.

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

    A postamendments device that has been initially classified in class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or class II under section 513(f)(3) of the FD&C Act. Section 513(f)(3) of the FD&C Act provides that FDA acting by order can reclassify the device into class I or class II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the proposed new class must have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.

    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA amended section 513(e) of the FD&C Act, changing the mechanism for reclassifying a device under that section from rulemaking to an administrative order.

    Section 513(e) of the FD&C Act provides that FDA may, by administrative order, reclassify a device based upon “new information.” FDA can initiate a reclassification under section 513(e) of the FD&C Act or an interested person may petition FDA to reclassify an eligible device type. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g., Holland-Rantos Co. v. United States Department of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).

    Reevaluation of the data previously before the Agency is an appropriate basis for subsequent action where the reevaluation is made in light of newly available authority (see Bell, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F. Supp. 382, 388-391 (D.D.C. 1991)), or in light of changes in “medical science” (Upjohn, 422 F.2d at 951). Whether data before the Agency are old or new data, the “new information” to support reclassification under section 513(e) must be “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Manufacturers Assoc. v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).) FDA relies upon “valid scientific evidence” in the reclassification process to determine the level of regulation for devices. To be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending PMA (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).

    Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final order to reclassify a device under that section. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the Federal Register; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act and (3) consideration of comments to a public docket. FDA published a proposed order to reclassify EPPG and PSA devices in the Federal Register of September 15, 2014 (79 FR 54927) (the “proposed order”). On September 11, 2013, FDA held a meeting of a device classification panel described in section 513(b) to discuss reclassification of EPPG and PSA devices (the “2013 Panel”). FDA has also received and considered comments on the proposed order as discussed in section III. Therefore, FDA has satisfied the requirements for issuing a final order under section 513(e)(1) of the FD&C Act.

    II. Regulatory History of the Devices

    As noted in the proposed order, on March 9, 1979, the Agency published a proposed rule for the classification of EPPG devices into class III (44 FR 13284). FDA subsequently published a final rule classifying EPPG devices into class III under §  870.3600 (21 CFR 870.3600) after receiving no comments on the March 9, 1979, proposed rule (45 FR 7904, February 5, 1980). In 1987, FDA published a final rule to codify language clarifying that no effective date had been established for the requirement for premarket approval for EPPG devices (52 FR 17732, May 11, 1987). In 2009, FDA published an order (the “515(i) Order”) requiring manufacturers of remaining class III devices for which regulations requiring PMAs had not been issued, including EPPGs, to submit a summary of information concerning those devices by August 7, 2009 (74 FR 16214, April 9, 2009). On October 17, 2011, FDA published a proposed rule proposing the reclassification of EPPG devices from class III to class II (76 FR 64224), which the Agency subsequently withdrew on September 15, 2014 (79 FR 54927). FDA withdrew the proposed rule in response to the new process for reclassifications under section 513(e) of the FD&C Act, as amended by FDASIA, and new information, including new information discussed during the 2013 Panel meeting.

    Single and dual chamber PSAs have historically been classified with EPPG devices. Single and dual chamber PSAs combine the functionality of a single or dual chamber EPPG, which is currently a class III device, and the functionality of a pacemaker electrode function tester, which is regulated as a class II device under § 870.3720 (21 CFR 870.3720). Single and dual chamber PSA devices have been found substantially equivalent to EPPG devices through the 510(k) process. TCPSA devices have not been determined to be substantially equivalent to a predicate device through the 510(k) process and, because TCPSAs were not on the market before May 28, 1976, TCPSAs have been reviewed through the PMA process as postamendments class III devices. This order creates a new classification regulation for single, dual, and triple chamber PSA devices, which combine the functionality of an EPPG and the functionality of a pacemaker electrode function tester.

    As discussed in the proposed order, FDA considered the available information on these devices (EPPG and PSA devices) and concluded that reclassifying these devices to class II, subject to the identified special controls, would provide reasonable assurance of their safety and effectiveness. As required by section 513(e)(1) of the FD&C Act, FDA convened a meeting of a device classification panel described in section 513(b) of the FD&C Act to discuss whether EPPG and PSA devices should be reclassified or remain in class III on September 11, 2013 (78 FR 49272). The reclassification of EPPG and PSA devices was supported by the 2013 Panel. The 2013 Panel recommended that EPPG devices (including single and dual chamber PSAs) be reclassified to class II with special controls when intended for cardiac rate control or prophylactic arrhythmia prevention. In addition, the 2013 Panel agreed that EPPG devices are life-supporting and, per § 860.93 (21 CFR 860.93), explained that its rationale for recommending that EPPG devices be reclassified to class II was based on the proposed special controls FDA presented, which the 2013 Panel believed were adequate (along with general controls) to mitigate the risks of the device.

    The 2013 Panel also recommended that TCPSA devices be reclassified to class II with special controls when intended for use during the pulse generator implant procedure. The 2013 Panel acknowledged that TCPSA devices are life-supporting devices and provided the following rationale per § 860.93 for recommending that TCPSA devices be reclassified to class II: (1) These devices are used only during the implant procedure where backup monitoring is continuous, hazards can be recognized and treated immediately, and where there is a reasonable expectation that users are adequately trained; (2) these devices are not intended to provide the long-term hemodynamic benefit of biventricular pacing or cardiac resynchronization therapy; and (3) the recommended special controls will mitigate the health risks associated with the device. The 2013 Panel transcript and other meeting materials are available on FDA's Web site (Ref. 1). Since the 2013 Panel meeting, FDA has not become aware of new information that would provide a basis for a device classification panel to make a different recommendation or different findings.

    III. Public Comments in Response to the Proposed Order

    In response to the September 15, 2014, proposed order to reclassify EPPG and PSA devices (79 FR 54927), FDA received two comments. FDA previously received three sets of comments on the October 17, 2011, proposed rule to reclassify EPPG devices that was subsequently withdrawn (79 FR 54927). The Agency has considered all of these comments in drafting this final order.

    The comments and FDA's responses to the comments are summarized in this section. Certain comments are grouped together under a single number because the subject matter of the comments is similar. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which it was submitted.

    (Comment 1) Four comments suggested that EPPG devices are life-sustaining and should be subject to premarket approval to provide better assurance of safety and effectiveness; as such, the comments asserted that EPPG devices should remain in class III. Further, one comment indicated that the proposed special controls are not sufficient to mitigate the risks associated with EPPG devices. Three other comments also discussed the risks associated with these devices and the need for adequate mitigation through premarket approval.

    (Response 1) These comments were considered by FDA in drafting this final order. Per 21 CFR 860.3(c)(3), a device is in class III if two conditions are met: (1) Insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls described in 21 CFR 860.3(c)(2) would provide such assurance, and (2) the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury. FDA has concluded that for EPPG devices, special controls will provide reasonable assurance of safety and effectiveness to appropriately mitigate risks to health. Therefore, these life-supporting devices can be reclassified into class II. As discussed in section II, the 2013 Panel agreed with FDA's recommendation of class II for EPPG and TCPSA devices.

    EPPG devices are therapeutic devices designed to be used temporarily and in a controlled clinical setting. The expected presence of clinical support and physician monitoring mitigates many potential complications. Specifically, EPPG devices are used exclusively in hospital environments with the patients supervised by qualified medical personnel. The environment of care for EPPG devices includes resuscitation equipment, hospital level monitoring of heart rhythm, and patient vital status by other devices with alarm functions. The special controls require labeling for EPPG devices to “clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use.” Further, the non-clinical performance testing and labeling special controls appropriately mitigate the risks for EPPG devices by helping to ensure adequate device performance/pacing, as well as proper maintenance of the device.

    (Comment 2) Three comments referenced the number of medical device reports (MDRs) associated with EPPG devices and suggested that MDR data support keeping EPPG devices in class III. Two of those comments also discussed the number of MDR reports for malfunctions associated with EPPG devices and suggested that this shows the performance standards that have been developed and used to support EPPG marketing applications are insufficient to provide reasonable assurance of safety and effectiveness.

    (Response 2) Increased premarket regulatory requirements cannot be assumed to result in fewer MDRs, nor are MDRs necessarily an indicator of poor device performance. FDA performed multiple analyses of MDRs for EPPG devices in the Manufacturer and User Facility Device Experience (MAUDE) database. The Agency's analysis of the available data shows that over 85 percent of reports had either no patient involvement or no known consequences to the patient. These types of malfunction reports were generally discovered during routine servicing, which may be anticipated for reusable electrical devices. FDA's MDR analyses were conducted multiple times during the reclassification process and showed trends of increased reporting, but with an associated sharp decline in the relative number of death and injury reports over the last several years (i.e., the increased reporting was largely for device malfunctions). FDA believes these trends are indicative of tighter adherence to MDR requirements and a related change in reporting practices rather than a change in device performance. FDA's detailed review of MDRs for EPPG devices also did not suggest design or functional issues that would be decreased by requiring premarket approval for EPPG devices.

    FDA also reviewed device recalls for EPPGs over the past 15 years and did not find evidence indicating the need for class III premarket approval regulation of these devices. FDA presented its analysis of MDR and recall data to the 2013 Panel that ultimately recommended reclassification of EPPG devices from class III to class II (special controls). The 2013 Panel identified no new or different risks for EPPG devices based on that information. Therefore, FDA believes that the identified special controls provide adequate mitigation of the health risks posed by the EPPG device.

    (Comment 3) One comment suggested that EPPG devices remain in class III and require PMAs because FDA failed to identify new information on which to base the reclassification recommendation, specifically noting: (1) Performance standards developed in support of PMAs are not publicly available, and (2) FDA used information submitted in response to the 515(i) Order that was not publicly available in the Agency's analysis of risks to health for EPPG devices.

    (Response 3) FDA's presentation to the 2013 Panel included a summary of the available safety and effectiveness information for EPPG devices, including FDA's analysis of adverse event reports from FDA's MAUDE database and available literature. The 2013 Panel agreed with FDA's conclusion that the available scientific evidence is adequate to support reasonable assurance of the safety and effectiveness of EPPG devices and to reclassify EPPG devices to class II. While the 2013 Panel agreed with the identified risks to health presented at the September 11, 2013, meeting, it recommended that FDA consider rewording some of the language for clarity and also to ensure that certain hazards, such as asynchronous pacing and arrhythmia induction, are included in the risks to health. FDA agreed with the 2013 Panel's recommendations and modified the risks to health accordingly as outlined in section V of the 2014 proposed order. The Agency identified in the proposed order special controls, including non-clinical performance testing data and labeling that, together with general controls (including prescription use), would provide reasonable assurance of the safety and effectiveness of EPPG devices. Since the 2013 Panel, FDA has not become aware of new information that would provide a basis for a different recommendation or finding for these devices.

    Information submitted in response to the 2009 515(i) Order that FDA used in its reclassification determination was incorporated in what the Agency presented to the 2013 Panel (see Ref. 1). In addition, that information was listed in the September 15, 2014, proposed order and is publicly available through other sources. The information presented to the 2013 Panel and discussed in the 2014 proposed order also identified and provided information regarding the two recognized consensus standards that address various aspects of design and performance of EPPG devices (IEC 60601-1 and IEC 60601-2-31). The information provided by these consensus standards is particularly important as design control measures and aided in forming part of the basis for FDA's reclassification determination. Therefore, the information that forms the basis for FDA's reclassification determination has been made publicly available.

    (Comment 4) One comment suggested that PSA devices remain in class III because the special controls rely heavily on labeling to mitigate risks, and expressed doubt that labeling would be sufficient to protect the health of patients.

    (Response 4) It should be noted that labeling is not the only mitigation that is proposed to reasonably assure safety and effectiveness of PSAs. Further, neither FDA nor the 2013 Panel believed that clinical performance testing was necessary to provide reasonable assurance of safety or effectiveness. The environment of care for PSAs is limited to the surgical implant suite, which must have backup pacing, defibrillation and resuscitation equipment, and capabilities including intensive care level monitoring of heart rhythm and patient vital signs. Therefore, FDA believes that the non-clinical performance testing and labeling special controls, in addition to general controls, can be established to mitigate the identified risks and provide reasonable assurance of the safety and effectiveness of PSA devices when indicated for use during the implant procedure of pacemakers and defibrillators for the evaluation of the placement and integrity of pacing leads to determine the appropriate pacing parameters for the implanted device. Furthermore, the 2013 Panel agreed that the special controls would mitigate the health risks associated with the PSA devices.

    IV. The Final Order

    Based on the information discussed in the preamble to the proposed order (79 FR 54927, September 15, 2014), the comments received, a review of the MAUDE database and recall data, a review of current scientific literature, and the 2013 Panel deliberations (see the 2013 Panel transcript (Ref. 1)), FDA concludes that special controls, in conjunction with general controls, will provide reasonable assurance of the safety and effectiveness of EPPG and PSA devices. Under sections 513(e) and 513(f) of the FD&C Act, FDA is adopting its findings, as published in the preamble to the proposed order. FDA is issuing this final order to reclassify EPPG devices from class III to class II (special controls), as well as to create a separate classification regulation for PSA devices and reclassify PSA devices into class II (special controls). As noted in the proposed order, FDA is also making a slight modification to the identification for EPPG devices in §  870.3600 to clarify that these are prescription devices.

    Following the effective date of this final order, firms marketing an EPPG or PSA device must comply with the applicable mitigation measures set forth in the codified special controls. Manufacturers of EPPG or PSA devices that have not been legally marketed prior to the effective date of this final order, or models (if any) that have been marketed but are required to submit a new 510(k) under 21 CFR 807.81(a)(3) because the device is about to be significantly changed or modified, must obtain 510(k) clearance and demonstrate compliance with the special controls included in this final order, before marketing the new or changed device.

    Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness of EPPG and PSA devices for their intended uses, and therefore, these device types are not exempt from premarket notification requirements.

    V. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    VI. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; and the collections of information under 21 CFR part 801 have been approved under OMB control number 0910-0485.

    VII. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e) as amended requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously promulgated regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, pursuant to section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this final order, we are revoking the requirements in §  870.3600 related to the classification of EPPG devices as class III devices, and codifying the reclassification of EPPG and PSA devices into class II (special controls).

    VIII. Reference

    The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    1. The panel transcript and other meeting materials for the September 11, 2013, Circulatory System Devices Panel are available on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm342357.htm.

    List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 870 is amended as follows:

    PART 870—CARDIOVASCULAR DEVICES 1. The authority citation for 21 CFR part 870 continues to read as follows: Authority:

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

    2. Section 870.3600 is revised to read as follows:
    § 870.3600 External pacemaker pulse generator.

    (a) Identification. An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.

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

    (1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.

    (2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (i.e., battery power, AC mains connections, or both).

    (3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:

    (i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;

    (ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;

    (iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (e.g. data storage, printing), and indicator(s) functionality under intended use conditions; and

    (iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.

    (4) Appropriate software verification, validation, and hazard analysis must be performed.

    (5) Labeling must include the following:

    (i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;

    (ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals;

    (iii) The labeling must list all pacing modes available in the device;

    (iv) Labeling must include a detailed description of any special capabilities (e.g., overdrive pacing or automatic mode switching); and

    (v) Appropriate electromagnetic compatibility information must be included.

    3. In Subpart D, add § 870.3605 to read as follows:
    § 870.3605 Pacing system analyzer.

    (a) Identification. A pacing system analyzer (PSA) is a prescription device that combines the functionality of a pacemaker electrode function tester (§ 870.3720) and an external pacemaker pulse generator (EPPG) (§ 870.3600). It is connected to a pacemaker lead and uses a power supply and electronic circuits to supply an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential. A PSA may be a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing leads.

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

    (1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.

    (2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (i.e., battery power, AC mains connections, or both).

    (3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:

    (i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;

    (ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;

    (iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (e.g. data storage, printing), and indicator(s) functionality under intended use conditions; and

    (iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.

    (4) Appropriate software verification, validation, and hazard analysis must be performed.

    (5) Labeling must include the following:

    (i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;

    (ii) Connector terminals should be clearly, unambiguously marked on the outside of the PSA. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals. Triple chamber devices should clearly identify atrial, right ventricular, and left ventricular terminals;

    (iii) The labeling must list all pacing modes available in the device;

    (iv) Labeling must include a detailed description of any special capabilities (e.g., overdrive pacing or automatic mode switching);

    (v) Labeling must limit the use of external pacing to the implant procedure; and

    (vi) Appropriate electromagnetic compatibility information must be included.

    Dated: April 12, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08898 Filed 4-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF LABOR Occupational Safety and Health Administration 29 CFR Part 1987 [Docket Number: OSHA-2011-0859] RIN 1218-AC58 Procedures for Handling Retaliation Complaints Under Section 402 of the FDA Food Safety Modernization Act AGENCY:

    Occupational Safety and Health Administration, Labor.

    ACTION:

    Final rule.

    SUMMARY:

    This document provides the final text of regulations governing the employee protection (retaliation or whistleblower) provision found at section 402 of the FDA Food Safety Modernization Act (FSMA), which added section 1012 to the Federal Food, Drug, and Cosmetic Act. An interim final rule governing these provisions and requesting public comment was published in the Federal Register on February 13, 2014. Two comments were received that were responsive to the rule. This rule responds to those comments and establishes the final procedures and time frames for the handling of retaliation complaints under FSMA, including procedures and time frames for employee complaints to the Occupational Safety and Health Administration (OSHA), investigations by OSHA, appeals of OSHA determinations to an administrative law judge (ALJ) for a hearing de novo, hearings by ALJs, review of ALJ decisions by the Administrative Review Board (ARB) (acting on behalf of the Secretary of Labor), and judicial review of the Secretary's final decision.

    DATES:

    This final rule is effective on April 18, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Cleveland Fairchild, Program Analyst, Directorate of Whistleblower Protection Programs, Occupational Safety and Health Administration, U.S. Department of Labor, Room N-4618, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-2199. This is not a toll-free number. Email: [email protected] This Federal Register publication is available in alternative formats. The alternative formats available are: Large print, electronic file on computer disk (Word Perfect, ASCII, Mates with Duxbury Braille System), and audiotape.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The FDA Food Safety Modernization Act (Pub. L. 111-353, 124 Stat. 3885), was signed into law on January 4, 2011. Section 402 of the FDA Food Safety Modernization Act amended the Federal Food, Drug, and Cosmetic Act (FD&C) to add section 1012, 21 U.S.C. 399d, which provides protection to employees against retaliation by an entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food for engaging in certain protected activities. Section 1012 protects employees against retaliation because they provided or are about to provide to their employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of, any provision of the FD&C or any order, rule, regulation, standard, or ban under the FD&C; testified or are about to testify in a proceeding concerning such violation; assisted or participated, or are about to assist or participate, in such a proceeding; or objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee reasonably believed to be in violation of any provision of the FD&C or any order, rule, regulation, standard, or ban under the FD&C.

    Section 1012 became effective upon enactment on January 4, 2011. Although the Food and Drug Administration of the U.S. Department of Health and Human Services (FDA) generally administers the FD&C, the Secretary of Labor is responsible for enforcing the employee protection provision set forth in section 1012 of the FD&C. These rules establish procedures for the handling of whistleblower complaints under section 1012 of the FD&C. Throughout this rule, FSMA refers to section 402 of the FDA Food Safety Modernization Act, codified as section 1012 of the Federal Food, Drug and Cosmetic Act. See 21 U.S.C. 399d.

    II. Summary of Statutory Procedures

    FSMA's whistleblower provisions include procedures that allow a covered employee to file, within 180 days of the alleged retaliation, a complaint with the Secretary of Labor (Secretary). Upon receipt of the complaint, the Secretary must provide written notice to the person or persons named in the complaint alleged to have violated the FSMA (respondent) of the filing of the complaint, the allegations contained in the complaint, the substance of the evidence supporting the complaint, and the rights afforded the respondent throughout the investigation. The Secretary must then, within 60 days of receipt of the complaint, afford the complainant and respondent an opportunity to submit a response and meet with the investigator to present statements from witnesses, and conduct an investigation.

    The statute provides that the Secretary may conduct an investigation only if the complainant has made a prima facie showing that the protected activity was a contributing factor in the adverse action alleged in the complaint and the respondent has not demonstrated, through clear and convincing evidence, that it would have taken the same adverse action in the absence of that activity (see section 1987.104 for a summary of the investigation process). OSHA interprets the prima facie case requirement as allowing the complainant to meet this burden through the complaint as supplemented by interviews of the complainant.

    After investigating a complaint, the Secretary will issue written findings. If, as a result of the investigation, the Secretary finds there is reasonable cause to believe that retaliation has occurred, the Secretary must notify the respondent of those findings, along with a preliminary order that requires the respondent to, where appropriate: Take affirmative action to abate the violation; reinstate the complainant to his or her former position together with the compensation of that position (including back pay) and restore the terms, conditions, and privileges associated with his or her employment; and provide compensatory damages to the complainant, as well as all costs and expenses (including attorney fees and expert witness fees) reasonably incurred by the complainant for, or in connection with, the bringing of the complaint upon which the order was issued.

    The complainant and the respondent then have 30 days after the date of the Secretary's notification in which to file objections to the findings and/or preliminary order and request a hearing before an administrative law judge (ALJ) at the Department of Labor. The filing of objections under FSMA will stay any remedy in the preliminary order except for preliminary reinstatement. If a hearing before an ALJ is not requested within 30 days, the preliminary order becomes final and is not subject to judicial review.

    If a hearing is held, the statute requires the hearing to be conducted “expeditiously.” The Secretary then has 120 days after the conclusion of any hearing in which to issue a final order, which may provide appropriate relief or deny the complaint. Until the Secretary's final order is issued, the Secretary, the complainant, and the respondent may enter into a settlement agreement that terminates the proceeding. Where the Secretary has determined that a violation has occurred, the Secretary, where appropriate, will assess against the respondent a sum equal to the total amount of all costs and expenses, including attorney and expert witness fees, reasonably incurred by the complainant for, or in connection with, the bringing of the complaint upon which the Secretary issued the order. The Secretary also may award a prevailing employer reasonable attorney fees, not exceeding $1,000, if the Secretary finds that the complaint is frivolous or has been brought in bad faith.

    Within 60 days of the issuance of the final order, any person adversely affected or aggrieved by the Secretary's final order may file an appeal with the United States Court of Appeals for the circuit in which the violation allegedly occurred or the circuit where the complainant resided on the date of the violation.

    FSMA permits the employee to seek de novo review of the complaint by a United States district court in the event that the Secretary has not issued a final decision within 210 days after the filing of the complaint, or within 90 days after receiving a written determination. The court will have jurisdiction over the action without regard to the amount in controversy, and the case will be tried before a jury at the request of either party.

    FSMA also provides that nothing therein preempts or diminishes any other safeguards against discrimination, demotion, discharge, suspension, threats, harassment, reprimand, retaliation, or any other manner of discrimination provided by Federal or State law. Finally, FSMA states that nothing therein shall be deemed to diminish the rights, privileges, or remedies of any employee under any Federal or State law or under any collective bargaining agreement, and the rights and remedies in FSMA may not be waived by any agreement, policy, form, or condition of employment.

    III. Summary and Discussion of Regulatory Provisions

    On February 13, 2014, OSHA published in the Federal Register an interim final rule (IFR) establishing rules governing the whistleblower provisions of 402 of the FDA Food Safety Modernization Act. 79 FR 8619. OSHA provided the public an opportunity to comment on the IFR by April 14, 2014.

    In response, OSHA received comments that were responsive to the rule from two organizations. Comments were received from the Roll Law Group (Roll), on behalf of Paramount Farming Company LLC, Paramount Farms International LLC, Pom Wonderful LLC, and Paramount Citrus Holdings LLC, and; Kalijarvi, Chuzi, Newman & Fitch, P.C. (Kalijarvi). OSHA also received one comment that was not responsive to the rule.

    OSHA has reviewed and considered the comments and now adopts this final rule with minor revisions. The following discussion addresses the comments and OSHA's responses. The provisions in the IFR are adopted and continued in this final rule, unless otherwise noted below. The regulatory provisions in this part have been written and organized to be consistent with other whistleblower regulations promulgated by OSHA to the extent possible within the bounds of the statutory language of FSMA. Responsibility for receiving and investigating complaints under FSMA has been delegated to the Assistant Secretary for Occupational Safety and Health (Assistant Secretary). Secretary of Labor's Order No. 1-2012 (Jan. 18, 2012), 77 FR 3912 (Jan. 25, 2012). Hearings on determinations by the Assistant Secretary are conducted by the Office of Administrative Law Judges, and appeals from decisions by ALJs are decided by the ARB. Secretary of Labor's Order No. 2-2012 (Oct. 19, 2012), 77 FR 69378 (Nov. 16, 2012).

    General Comments

    Roll commented that OSHA should “ensure that the rules not only protect employee rights and promote food safety, but uphold equality and fairly address the concerns of both parties involved in these types of matters.” OSHA agrees, and notes that its procedures are designed to ensure a fair process for both parties.

    Kalijarvi commented that “Congress passed the FSMA to protect people from getting sick and dying. When Congress passes a law to accomplish a remedial purpose, that purpose should be central to decisions about interpretation and application of the law.” Kalijarvi elaborated that decisions under FSMA should be made with an eye towards furthering the statute's remedial purpose. In addition, Kalijarvi commented that OSHA's discussion of the reasonable belief doctrine serves as a helpful reminder that “a complainant's whistleblower activity will be protected when it is based on a reasonable belief that any provision of the FD&C, or any order, rule, regulation, standard, or ban under the FD&C, has been violated.” OSHA believes that, generally, support for the remedial nature of the FSMA is found in the statute itself.

    Subpart A—Complaints, Investigations, Findings and Preliminary Orders Section 1987.100 Purpose and Scope

    This section describes the purpose of the regulations implementing FSMA and provides an overview of the procedures covered by these regulations. No comments were received on this section, and no changes were made to it.

    Section 1987.101 Definitions

    This section includes general definitions from the FD&C, which are applicable to the whistleblower provisions of FSMA. The FD&C states that the term “person” includes an individual, partnership, corporation, and association. See 21 U.S.C. 321(e). The FD&C also defines the term “food” as “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.” See 21 U.S.C. 321(f). No comments were received on this section, and no changes were made to it.

    Section 1987.102 Obligations and Prohibited Acts

    This section describes the activities that are protected under FSMA, and the conduct that is prohibited in response to any protected activities. Under FSMA, an entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food may not retaliate against an employee because the employee “provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of any provision of this chapter or any order, rule, regulation, standard, or ban under this chapter.” 21 U.S.C. 399d(a)(1). FSMA also protects employees who testify, assist or participate in proceedings concerning such violations. See 21 U.S.C. 399d(a)(2) and (3). Finally, FSMA prohibits retaliation because an employee “objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee (or other such person) reasonably believed to be in violation of any provision of this chapter, or any order, rule, regulation, standard, or ban under this chapter.” 21 U.S.C. 399d(a)(4). References to “this chapter” refer to the FD&C, which is chapter 9 of title 21. 21 U.S.C. 301 et seq. Although an entity must therefore be engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food in order to be covered by FSMA, a complainant's whistleblower activity will be protected when it is based on a reasonable belief that any provision of the FD&C, or any order, rule, regulation, standard, or ban under the FD&C, has been violated.

    In order to have a “reasonable belief” under FSMA, a complainant must have both a subjective, good faith belief and an objectively reasonable belief that the complained-of conduct violated the FD&C or any order, rule, regulation, standard, or ban under the FD&C. See Sylvester v. Parexel Int'l LLC, ARB No. 07-123, 2011 WL 2165854, at * 11-12 (ARB May 25, 2011) (discussing the reasonable belief standard under analogous language in the Sarbanes-Oxley Act whistleblower provision for employees, 18 U.S.C. 1514A). The requirement that the complainant have a subjective, good faith belief is satisfied so long as the complainant actually believed that the conduct complained of violated the relevant law. See id. The objective “reasonableness” of a complainant's belief is typically determined “based on the knowledge available to a reasonable person in the same factual circumstances with the same training and experience as the aggrieved employee.” Id. at * 12 (internal quotation marks and citation omitted). However, the complainant need not show that the conduct complained of constituted an actual violation of law. Pursuant to this standard, an employee's whistleblower activity is protected where it is based on a reasonable, but mistaken, belief that a violation of the relevant law has occurred. Id. at * 13.

    No comments were received on this section, and no changes were made to it.

    Section 1987.103 Filing of Retaliation Complaint

    This section explains the requirements for filing a retaliation complaint under FSMA. According to section 1012(b)(1) of the FD&C, a complaint must be filed within 180 days of when the alleged violation occurs. Under Delaware State College v. Ricks, 449 U.S. 250, 258 (1980), this is considered to be when the retaliatory decision has been both made and communicated to the complainant. In other words, the limitations period commences once the employee is aware or reasonably should be aware of the employer's decision to take an adverse action. See Equal Emp't Opportunity Comm'n v. United Parcel Serv., Inc., 249 F.3d 557, 561-62 (6th Cir. 2001). The time for filing a complaint may be tolled for reasons warranted by applicable case law. For example, OSHA may consider the time for filing a complaint to be tolled if a complainant mistakenly files a complaint with an agency other than OSHA within 180 days after an alleged adverse action.

    Complaints filed under FSMA need not be in any particular form. They may be either oral or in writing. If the complainant is unable to file the complaint in English, OSHA will accept the complaint in any language. With the consent of the employee, complaints may be filed by any person on the employee's behalf.

    OSHA notes that a complaint of retaliation filed with OSHA under FSMA is not a formal document and need not conform to the pleading standards for complaints filed in federal district court articulated in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) and Ashcroft v. Iqbal, 556 U.S. 662 (2009). See Sylvester, 2011 WL 2165854, at * 9-10 (holding whistleblower complaints filed with OSHA under analogous provisions in the Sarbanes-Oxley Act need not conform to federal court pleading standards). Rather, the complaint filed with OSHA under this section simply alerts OSHA to the existence of the alleged retaliation and the complainant's desire that OSHA investigate the complaint. Upon receipt of the complaint, OSHA is to determine whether the “complaint, supplemented as appropriate by interviews of the complainant” alleges “the existence of facts and evidence to make a prima facie showing.” 29 CFR 1987.104(e). As explained in section 1987.104(e), if the complaint, supplemented as appropriate, contains a prima facie allegation, and the respondent does not show clear and convincing evidence that it would have taken the same action in the absence of the alleged protected activity, OSHA conducts an investigation to determine whether there is reasonable cause to believe that retaliation has occurred. See 21 U.S.C. 399d(b)(2)(A), 29 CFR 1987.104(e).

    No comments were received on this section, and no changes were made to it.

    Section 1987.104 Investigation

    This section describes the procedures that apply to the investigation of complaints under FSMA. Paragraph (a) of this section outlines the procedures for notifying the parties and the FDA of the complaint and notifying the respondent of its rights under these regulations. Paragraph (b) describes the procedures for the respondent to submit its response to the complaint. Paragraph (c) describes OSHA's procedures for sharing a party's submissions during a whistleblower investigation with the other parties to the investigation. Paragraph (d) of this section discusses confidentiality of information provided during investigations.

    Paragraph (e) of this section sets forth the applicable burdens of proof. FSMA requires that a complainant make an initial prima facie showing that protected activity was “a contributing factor” in the adverse action alleged in the complaint, i.e., that the protected activity, alone or in combination with other factors, affected in some way the outcome of the employer's decision. The complainant will be considered to have met the required burden if the complaint on its face, supplemented as appropriate through interviews of the complainant, alleges the existence of facts and either direct or circumstantial evidence to meet the required showing. The complainant's burden may be satisfied, for example, if he or she shows that the adverse action took place within a temporal proximity of the protected activity, or at the first opportunity available to the respondent, giving rise to the inference that it was a contributing factor in the adverse action. See, e.g., Porter v. Cal. Dep't of Corrs., 419 F.3d 885, 895 (9th Cir. 2005) (years between the protected activity and the retaliatory actions did not defeat a finding of a causal connection where the defendant did not have the opportunity to retaliate until he was given responsibility for making personnel decisions).

    If the complainant does not make the required prima facie showing, the investigation must be discontinued and the complaint dismissed. See Trimmer v. U.S. Dep't of Labor, 174 F.3d 1098, 1101 (10th Cir. 1999) (noting that the burden-shifting framework of the Energy Reorganization Act of 1974 (ERA), which is the same framework now applicable to FSMA, serves a “gatekeeping function” that “stem[s] frivolous complaints”). Even in cases where the complainant successfully makes a prima facie showing, the investigation must be discontinued if the employer demonstrates, by clear and convincing evidence, that it would have taken the same adverse action in the absence of the protected activity. Thus, OSHA must dismiss a complaint under FSMA and not investigate further if either: (1) The complainant fails to meet the prima facie showing that protected activity was a contributing factor in the adverse action; or (2) the employer rebuts that showing by clear and convincing evidence that it would have taken the same adverse action absent the protected activity.

    Assuming that an investigation proceeds beyond the gatekeeping phase, the statute requires OSHA to determine whether there is reasonable cause to believe that protected activity was a contributing factor in the alleged adverse action. A contributing factor is “any factor which, alone or in connection with other factors, tends to affect in any way the outcome of the decision.” Marano v. Dep't of Justice, 2 F.3d 1137, 1140 (Fed. Cir. 1993) (internal quotation marks, emphasis and citation omitted) (discussing the Whistleblower Protection Act, 5 U.S.C. 1221(e)(1)); see also Addis v. Dep't of Labor, 575 F.3d 688, 689-91 (7th Cir. 2009) (discussing Marano as applied to analogous whistleblower provision in the ERA); Clarke v. Navajo Express, Inc., ARB No. 09-114, 2011 WL 2614326, at * 3 (ARB June 29, 2011) (discussing burdens of proof under analogous whistleblower provision in the Surface Transportation Assistance Act (STAA)). For protected activity to be a contributing factor in the adverse action, “a complainant need not necessarily prove that the respondent's articulated reason was a pretext in order to prevail,” because a complainant alternatively can prevail by showing that the respondent's “ `reason, while true, is only one of the reasons for its conduct,' ” and that another reason was the complainant's protected activity. See Klopfenstein v. PCC Flow Techs. Holdings, Inc., ARB No. 04-149, 2006 WL 3246904, at * 13 (ARB May 31, 2006) (quoting Rachid v. Jack in the Box, Inc., 376 F.3d 305, 312 (5th Cir. 2004)) (discussing contributing factor test under the Sarbanes-Oxley whistleblower provision), aff'd sub nom. Klopfenstein v. Admin. Review Bd., U.S. Dep't of Labor, 402 F. App'x 936, 2010 WL 4746668 (5th Cir. 2010).

    If OSHA finds reasonable cause to believe that the alleged protected activity was a contributing factor in the adverse action, OSHA may not order relief if the employer demonstrates by clear and convincing evidence that it would have taken the same action in the absence of the protected activity. See 21 U.S.C. 399d(b)(2)(C). The “clear and convincing evidence” standard is a higher burden of proof than a “preponderance of the evidence” standard. Clear and convincing evidence is evidence indicating that the thing to be proved is highly probable or reasonably certain. Clarke, 2011 WL 2614326, at * 3.

    Paragraph (f) describes the procedures OSHA will follow prior to the issuance of findings and a preliminary order when OSHA has reasonable cause to believe that a violation has occurred.

    Roll commented that this section of the IFR did not explicitly state that the respondent has the right to receive copies of the substantive evidence provided by the complainant, and Roll states that it is “essential that both parties receive equal access to all documents throughout the entire matter.” OSHA agrees that the input of both parties in the investigation is important to ensure that OSHA reaches the proper outcome during its investigation. In fact, OSHA's current policy is to request that each party provide the other parties with a copy of all submissions to OSHA that are pertinent to the whistleblower complaint. Where the parties do not provide each other such submissions, OSHA will ensure that each party is provided with such information after redacting the submissions as appropriate. OSHA has revised paragraph (c) to clarify these policies regarding information sharing during the course of an investigation. Further information regarding OSHA's nonpublic disclosure and information sharing policies also may be found in the Whistleblower Investigations Manual, available at, http://www.whistleblowers.gov/regulations_page.html.

    Roll also commented that the IFR did not provide the complainant and the respondent equal opportunity to respond to the each other's submissions to OSHA. OSHA has revised paragraph (c) to clarify that OSHA will ensure that each party is provided with an opportunity to respond to the other party's submissions.

    Apart from the changes to paragraph (c) described above, OSHA has reworded paragraphs (a) and (f) slightly to clarify the paragraphs without changing their meaning.

    Section 1987.105 Issuance of Findings and Preliminary Orders

    This section provides that, on the basis of information obtained in the investigation, the Assistant Secretary will issue, within 60 days of the filing of a complaint, written findings regarding whether or not there is reasonable cause to believe that the complaint has merit. If the findings are that there is reasonable cause to believe that the complaint has merit, the Assistant Secretary will order appropriate relief, including preliminary reinstatement, affirmative action to abate the violation, back pay with interest, and compensatory damages. The findings and, where appropriate, preliminary order, advise the parties of their right to file objections to the findings of the Assistant Secretary and to request a hearing. The findings and, where appropriate, preliminary order, also advise the respondent of the right to request an award of attorney fees not exceeding $1,000 from the ALJ, regardless of whether the respondent has filed objections, if the respondent alleges that the complaint was frivolous or brought in bad faith. If no objections are filed within 30 days of receipt of the findings, the findings and any preliminary order of the Assistant Secretary become the final decision and order of the Secretary. If objections are timely filed, any order of preliminary reinstatement will take effect, but the remaining provisions of the order will not take effect until administrative proceedings are completed.

    As explained in the IFR, in ordering interest on back pay under FSMA, the Secretary has determined that interest due will be computed by compounding daily the Internal Revenue Service interest rate for the underpayment of taxes, which under 26 U.S.C. 6621 is generally the Federal short-term rate plus three percentage points. 79 FR 8623. The Secretary has long applied the interest rate in 26 U.S.C. 6621 to calculate interest on backpay in whistleblower cases. Doyle v. Hydro Nuclear Servs., ARB Nos. 99-041, 99-042, 00-012, 2000 WL 694384, at *14-15, 17 (ARB May 17, 2000); see also Cefalu v. Roadway Express, Inc., ARB No. 09-070, 2011 WL 1247212, at *2 (ARB Mar. 17, 2011); Pollock v. Cont'l Express, ARB Nos. 07-073, 08-051, 2010 WL 1776974, at *8 (ARB Apr. 10, 2010); Murray v. Air Ride, Inc., ARB No. 00-045, slip op. at 9 (ARB Dec. 29, 2000). Section 6621 provides the appropriate measure of compensation under FSMA and other DOL-administered whistleblower statutes because it ensures the complainant will be placed in the same position he or she would have been in if no unlawful retaliation occurred. See Ass't Sec'y v. Double R. Trucking, Inc., ARB No. 99-061, slip op. at 5 (ARB July 16, 1999) (interest awards pursuant to § 6621 are mandatory elements of complainant's make-whole remedy). Section 6621 provides a reasonably accurate prediction of market outcomes (which represents the loss of investment opportunity by the complainant and the employer's benefit from use of the withheld money) and thus provides the complainant with appropriate make-whole relief. See EEOC v. Erie Cnty., 751 F.2d 79, 82 (2d Cir. 1984) (“[s]ince the goal of a suit under the [Fair Labor Standards Act] and the Equal Pay Act is to make whole the victims of the unlawful underpayment of wages, and since [§ 6621] has been adopted as a good indicator of the value of the use of money, it was well within” the district court's discretion to calculate prejudgment interest under § 6621); New Horizons for the Retarded, 283 N.L.R.B. No. 181, 1987 WL 89652, at *2 (NLRB May 28, 1987) (observing that “the short-term Federal rate [used by § 6621] is based on average market yields on marketable Federal obligations and is influenced by private economic market forces”). Similarly, as explained in the IFR, daily compounding of the interest award ensures that complainants are made whole for unlawful retaliation in violation of FSMA. 79 FR 8623.

    As explained in the IFR, in ordering back pay, OSHA will require the respondent to submit the appropriate documentation to the Social Security Administration (SSA) allocating the back pay to the appropriate calendar quarters. Requiring the reporting of back pay allocation to the SSA serves the remedial purposes of FSMA by ensuring that employees subjected to retaliation are truly made whole. See 79 FR 8623; see also Don Chavas, LLC d/b/a Tortillas Don Chavas, 361 NLRB No. 10, 2014 WL 3897178, at *4-5 (NLRB Aug. 8, 2014).

    Finally, as noted in the IFR, in limited circumstances, in lieu of preliminary reinstatement, OSHA may order that the complainant receive the same pay and benefits that he or she received prior to termination, but not actually return to work. See 79 FR 8623. Such “economic reinstatement” is akin to an order for front pay and frequently is employed in cases arising under section 105(c) of the Federal Mine Safety and Health Act of 1977, which protects miners from retaliation. 30 U.S.C. 815(c); see, e.g., Sec'y of Labor ex rel. York v. BR&D Enters., Inc., 23 FMSHRC 697, 2001 WL 1806020, at *1 (ALJ June 26, 2001). Front pay has been recognized as a possible remedy in cases under the whistleblower statutes enforced by OSHA in limited circumstances where reinstatement would not be appropriate. See, e.g., Luder v. Cont'l Airlines, Inc., ARB No. 10-026, 2012 WL 376755, at *11 (ARB Jan. 31, 2012), aff'd, Cont'l Airlines, Inc. v. Admin. Rev. Bd., No. 15-60012, slip op. at 8, 2016 WL 97461, at *4 (5th Cir. Jan. 7, 2016) (unpublished) (under Wendell H. Ford Aviation Investment and Reform Act for the 21st Century, “front-pay is available when reinstatement is not possible”); Moder v. Vill. of Jackson, ARB Nos. 01-095, 02-039, 2003 WL 21499864, at *10 (ARB June 30, 2003) (under environmental whistleblower statutes, “front pay may be an appropriate substitute when the parties prove the impossibility of a productive and amicable working relationship, or the company no longer has a position for which the complainant is qualified”).

    Roll commented on the discussion in the IFR of “economic reinstatement” and front pay and suggested that OSHA should include specific guidelines pertaining to front pay awards. Roll noted that the IFR provided examples of situations where front pay might be appropriate, but the rules themselves do not explicitly state that front pay is an available remedy, which could be “misleading.” Further, Roll questioned whether OSHA has authority to order front pay as a remedy.

    OSHA declines to adopt specific guidelines pertaining to front pay awards in these rules. As explained in the IFR, the appropriateness of “economic reinstatement” or front pay as an alternative to the default statutory remedy of reinstatement has long been recognized. OSHA believes that relevant case law more appropriately addresses the parameters for issuing an award of front pay in lieu of reinstatement. See, e.g., Luder, ARB No. 10-026, slip op. at *11. (holding that front pay must be awarded according to reasonable parameters such as the amount of the proposed award, the length of time the complainant expects to be out of work, and the applicable discount rate) (internal quotation marks and citations omitted), front pay award modified, Luder v. Cont'l Airlines, Inc., ARB No. 13-009, 2014 WL 6850012 (ARB Nov. 2014), aff'd, Cont'l Airlines, Inc. v. Admin. Review Bd., No. 15-60012, slip op. at 8, 2016 WL 97461, at *4 (5th Cir. Jan. 7, 2016) (unpublished).

    Kalijarvi requested that the rule include a reference to Blackburn v. Martin, 982 F.2d 125 (4th Cir. 1992) to inform the public that emotional distress damages may be awarded without the testimony of expert witnesses. A number of ARB decisions have awarded such damages without the testimony of expert witnesses in appropriate circumstances. See e.g., Lockheed Martin Corp. v. Admin. Review Bd., 717 F.3d 1121, 1138 (10th Cir. 2013) (upholding an award of $75,000 for emotional pain and suffering without requiring the testimony of expert witnesses); Menendez v. Halliburton, Inc., ARB Nos 09-002, 09-003 2013 WL 1282255, at *11-12 (ARB Mar. 15, 2013) (upholding award of $30,000 for emotional distress and reputational harm without requiring expert testimony) aff'd sub nom. Halliburton, Inc. v. Admin. Review Bd., 771 F.3d 254 (5th Cir. 2014). OSHA believes that these cases adequately serve to notify the public that emotional distress damages may be awarded without the testimony of expert witnesses.

    For these reasons, OSHA has made no changes to the text of this section.

    Subpart B—Litigation Section 1987.106 Objections to the Findings and the Preliminary Order and Requests for a Hearing

    To be effective, objections to the findings of the Assistant Secretary must be in writing and must be filed with the Chief Administrative Law Judge, U.S. Department of Labor, within 30 days of receipt of the findings. The date of the postmark, facsimile transmittal, or electronic communication transmittal is considered the date of the filing; if the objection is filed in person, by hand-delivery or other means, the objection is filed upon receipt. The filing of objections also is considered a request for a hearing before an ALJ. Although the parties are directed to serve a copy of their objections on the other parties of record, as well as the OSHA official who issued the findings and order, the Assistant Secretary, and the U.S. Department of Labor's Associate Solicitor for Fair Labor Standards, the failure to serve copies of the objections on the other parties of record does not affect the ALJ's jurisdiction to hear and decide the merits of the case. See Shirani v. Calvert Cliffs Nuclear Power Plant, Inc., ARB No. 04-101, 2005 WL 2865915, at *7 (ARB Oct. 31, 2005).

    The timely filing of objections stays all provisions of the preliminary order, except for the portion requiring reinstatement. A respondent may file a motion to stay the Assistant Secretary's preliminary order of reinstatement with the Office of Administrative Law Judges. However, such a motion will be granted only based on exceptional circumstances. The Secretary believes that a stay of the Assistant Secretary's preliminary order of reinstatement under FSMA would be appropriate only where the respondent can establish the necessary criteria for equitable injunctive relief, i.e., irreparable injury, likelihood of success on the merits, a balancing of possible harms to the parties, and the public interest favors a stay. If no timely objection to the Assistant Secretary's findings and/or preliminary order is filed, then the Assistant Secretary's findings and/or preliminary order become the final decision of the Secretary not subject to judicial review.

    No comments were received on this section, and no changes were made to it.

    Section 1987.107 Hearings

    This section adopts the rules of practice and procedure for administrative hearings before the Office of Administrative Law Judges as set forth in 29 CFR part 18 subpart A. This section provides that the hearing is to commence expeditiously, except upon a showing of good cause or unless otherwise agreed to by the parties. Hearings will be conducted de novo, on the record. As noted in this section, formal rules of evidence will not apply, but rules or principles designed to assure production of the most probative evidence will be applied. The ALJ may exclude evidence that is immaterial, irrelevant, or unduly repetitious.

    No comments were received on this section, and no changes were made to it.

    Section 1987.108 Role of Federal Agencies

    The Assistant Secretary, at his or her discretion, may participate as a party or amicus curiae at any time in the administrative proceedings under FSMA. For example, the Assistant Secretary may exercise his or her discretion to prosecute the case in the administrative proceeding before an ALJ; petition for review of a decision of an ALJ, including a decision based on a settlement agreement between the complainant and the respondent, regardless of whether the Assistant Secretary participated before the ALJ; or participate as amicus curiae before the ALJ or in the ARB proceeding. Although OSHA anticipates that ordinarily the Assistant Secretary will not participate, the Assistant Secretary may choose to do so in appropriate cases, such as cases involving important or novel legal issues, multiple employees, alleged violations that appear egregious, or where the interests of justice might require participation by the Assistant Secretary. The FDA, if interested in a proceeding, also may participate as amicus curiae at any time in the proceedings.

    No comments were received on this section, though minor changes were made as needed to clarify the provision without changing its meaning.

    Section 1987.109 Decision and Orders of the Administrative Law Judge

    This section sets forth the requirements for the content of the decision and order of the ALJ, and includes the standard for finding a violation under FSMA. Specifically, the complainant must demonstrate (i.e., prove by a preponderance of the evidence) that the protected activity was a “contributing factor” in the adverse action. See, e.g., Allen v. Admin. Review Bd., 514 F.3d 468, 475 n.1 (5th Cir. 2008) (“The term `demonstrates' [under identical burden-shifting scheme in the Sarbanes-Oxley whistleblower provision] means to prove by a preponderance of the evidence.”). If the employee demonstrates that the alleged protected activity was a contributing factor in the adverse action, the employer, to escape liability, must demonstrate by “clear and convincing evidence” that it would have taken the same action in the absence of the protected activity. See 21 U.S.C. 399d(b)(2)(C).

    Paragraph (c) of this section further provides that OSHA's determination to dismiss the complaint without an investigation or without a complete investigation under section 1987.104 is not subject to review. Thus, section 1987.109(c) clarifies that OSHA's determinations on whether to proceed with an investigation under FSMA and whether to make particular investigative findings are discretionary decisions not subject to review by the ALJ. The ALJ hears cases de novo and, therefore, as a general matter, may not remand cases to OSHA to conduct an investigation or make further factual findings.

    Paragraph (d) notes the remedies that the ALJ may order under FSMA and, as discussed under section 1987.105 above, provides that interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily, and that the respondent will be required to submit appropriate documentation to the SSA allocating any back pay award to the appropriate calendar quarters. Paragraph (e) requires that the ALJ's decision be served on all parties to the proceeding, OSHA, and the U.S. Department of Labor's Associate Solicitor for Fair Labor Standards. Paragraph (e) also provides that any ALJ decision requiring reinstatement or lifting an order of reinstatement by the Assistant Secretary will be effective immediately upon receipt of the decision by the respondent. All other portions of the ALJ's order will be effective 14 days after the date of the decision unless a timely petition for review has been filed with the ARB. If no timely petition for review is filed with the ARB, the decision of the ALJ becomes the final decision of the Secretary and is not subject to judicial review.

    No comments were received on this section, and no changes were made to it.

    Section 1987.110 Decision and Orders of the Administrative Review Board

    Upon the issuance of the ALJ's decision, the parties have 14 days within which to petition the ARB for review of that decision. The date of the postmark, facsimile transmittal, or electronic communication transmittal is considered the date of filing of the petition; if the petition is filed in person, by hand delivery or other means, the petition is considered filed upon receipt.

    The appeal provisions in this part provide that an appeal to the ARB is not a matter of right but is accepted at the discretion of the ARB. The parties should identify in their petitions for review the legal conclusions or orders to which they object, or the objections may be deemed waived. The ARB has 30 days to decide whether to grant the petition for review. If the ARB does not grant the petition, the decision of the ALJ becomes the final decision of the Secretary. If a timely petition for review is filed with the ARB, any relief ordered by the ALJ, except for that portion ordering reinstatement, is inoperative while the matter is pending before the ARB. If the ARB accepts a petition for review, the ALJ's factual determinations will be reviewed under the substantial evidence standard.

    Kalijarvi submitted several comments related to this section of the rule. Kalijarvi requested the removal of the portion of the rule stating that objections not raised in the petition for review to the ARB may be considered waived. Instead, Kalijarvi requested that the provision be altered to instruct parties to identify in their petitions for review the legal conclusions or orders to which they object so that the ARB may determine whether the review presents issues worthy of full briefing. OSHA declines to revise the rule as Kalijarvi has proposed. OSHA notes that the IFR used the phrase “may” be deemed waived, indicating that the parties are not necessarily barred from subsequently raising grounds in addition to those included in the initial petition. Further, OSHA's inclusion of this provision is not intended to limit the circumstances in which parties can add additional grounds for review as a case progresses before the ARB; rather, the rules include this provision to put the public on notice of the possible consequences of failing to specify the basis of an appeal to the ARB. OSHA recognizes that, while the ARB has held in some instances that an exception not specifically urged may be deemed waived, the ARB also has found that the rules provide for exceptions to this general rule.

    Kalijarvi also requested that the deadline for filing a petition for review with the ARB be extended past 14 days, and for this section to allow explicitly for the parties to file a motion to extend the time for submitting a petition for review. Kalijarvi further requested that OSHA explain how the current text of the section furthers FSMA's remedial purpose. OSHA declines to extend the time limit to petition for review because the shorter review period is consistent with the practices and procedures followed in OSHA's other whistleblower programs. Furthermore, as Kalijarvi acknowledges in its comment, parties may file a motion for extension of time to appeal an ALJ's decision, and the ARB has discretion to grant such extensions. OSHA believes that mentioning a motion for an extension of time in these rules, where no other motions are mentioned, could lead the public to mistakenly conclude that the 14 day deadline may be waived as a matter of right, where such is not the case.

    OSHA believes that this section furthers the remedial purpose of FSMA by informing the public of the option of requesting ARB review of ALJ decisions as well as the deadlines associated with such review.

    This section also provides that, based on exceptional circumstances, the ARB may grant a motion to stay an ALJ's preliminary order of reinstatement under FSMA, which otherwise would be effective, while review is conducted by the ARB. The Secretary believes that a stay of an ALJ's preliminary order of reinstatement under FSMA would be appropriate only where the respondent can establish the necessary criteria for equitable injunctive relief, i.e., irreparable injury, likelihood of success on the merits, a balancing of possible harms to the parties, and the public interest favors a stay.

    If the ARB concludes that the respondent has violated the law, it will order the respondent to take appropriate affirmative action to abate the violation, including reinstatement of the complainant to that person's former position, together with the compensation (including back pay and interest), terms, conditions, and privileges of employment, and compensatory damages. At the request of the complainant, the ARB will assess against the respondent all costs and expenses (including attorney and expert witness fees) reasonably incurred. Interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily, and the respondent will be required to submit appropriate documentation to the Social Security Administration (SSA) allocating any back pay award to the appropriate calendar quarters. If the ARB determines that the respondent has not violated the law, an order will be issued denying the complaint. If, upon the request of the respondent, the ARB determines that a complaint was frivolous or was brought in bad faith, the ARB may award to the respondent a reasonable attorney fee, not exceeding $1,000, to be paid by the complainant.

    No changes were made to this section, and other than the comments discussed above, no additional comments were received on this section.

    Subpart C—Miscellaneous Provisions Section 1987.111 Withdrawal of Complaints, Findings, Objections, and Petitions for Review; Settlement

    This section provides the procedures and time periods for withdrawal of complaints, the withdrawal of findings and/or preliminary orders by the Assistant Secretary, and the withdrawal of objections to findings and/or orders. It permits complainants to withdraw their complaints orally and provides that, in such circumstances, OSHA will confirm a complainant's desire to withdraw in writing. It also provides for approval of settlements at the investigative and adjudicative stages of the case.

    Roll commented that this provision should state explicitly that settlements may be conducted in a confidential manner and outside of the administrative proceedings. Because the IFR did not plainly provide such assurances, Roll expressed concern that “the lack of confidentiality will work as a disincentive for both parties . . . [and] will ultimately lead to fewer out-of-court settlements. . . .” Roll further commented that this section should include guidelines regarding when the Secretary will approve or disapprove a settlement agreement, as well as an explanation regarding the settlement options that are available to the parties.

    OSHA is not making any changes to the rule in response to this comment. This section implements FSMA's statutory provision that “[a]t any time before issuance of a final order, a proceeding under this subsection may be terminated on the basis of a settlement agreement entered into by the Secretary, the complainant, and the person alleged to have committed the violation.” 21 U.S.C. 399(b)(3)(A). However, OSHA notes that the Secretary has always recognized that parties may efficiently resolve cases in negotiations between themselves. The Secretary's policy is to approve privately negotiated settlements, provided that each settlement is reviewed by the Secretary to ensure that the terms are fair, adequate, reasonable, and consistent with the purpose and intent of the relevant whistleblower statute and the public interest. See, e.g. , Macktal v. Sec'y of Labor, 923 F.2d 1150, 1154 (5th Cir. 1991) (agreeing that the Secretary may “enter into” a settlement by approving a settlement negotiated and agreed to by the parties); see also OSHA's Whistleblower Investigations Manual, pp. 6-18 to 6-21 (Apr. 21, 2015) available at http://www.whistleblowers.gov/regulations_page.html. OSHA believes that paragraphs (d)(1) and (2) adequately explain that a settlement agreement reached between the parties will settle a pending whistleblower case so long as the agreement is reviewed and approved by OSHA, an ALJ, or the ARB. The resources listed above provide more detailed guidance on when OSHA, an ALJ or the ARB will approve or disprove a settlement agreement, and OSHA thus believes it unnecessary to add such additional details to the regulatory text.

    As to Roll's confidentiality concerns, OSHA, an ALJ or the ARB will not approve an agreement that states or implies that any of these entities, or DOL more generally, is party to a confidentiality agreement. Moreover, as noted in paragraph (e) of this section, any settlement approved by OSHA, the ALJ, or the ARB will constitute the final order of the Secretary, and as such, an approved agreement is an official government record that is subject to applicable public disclosure rules. See, e.g. , Gonzalez v. J.C. Penny Corp., Inc., ARB No. 10-148, 2012 WL 4753923, at *6 (ARB Sept. 28, 2012) (describing the public interest supporting the Secretary's review of settlement agreements); McGuire v. B.P. Prods. N. Am., Inc., 2014-TSC-0001, slip op. at 6-11 (ALJ Jan. 17, 2014) (describing public disclosure interests relating to whistleblower settlements and some of the provisions that the Secretary may not approve in a whistleblower settlement). Thus, for example, while parties may negotiate the terms of a settlement agreement in confidence and may indicate to OSHA, an ALJ or the ARB that they believe a settlement contains information exempt from disclosure under the Freedom of Information Act (FOIA) and that they should receive pre-disclosure notification of a request for disclosure, the Secretary must make his own determination of whether the contents of a settlement may be withheld in response to a request from a member of the public. See, e.g. , Vannoy v. Celanese Corp., ARB No. 09-118, 2013 WL 5872048, at *2 (ARB Sept. 27, 2013) (describing the application of FOIA to a whistleblower settlement).

    Section 1987.112  Judicial Review

    This section describes the statutory provisions for judicial review of decisions of the Secretary and requires, in cases where judicial review is sought, the ALJ or the ARB to submit the record of proceedings to the appropriate court pursuant to the rules of such court. No comments were received on this section, and no changes were made to it.

    Section 1987.113  Judicial Enforcement

    This section describes the Secretary's power under FSMA to obtain judicial enforcement of orders and the terms of settlement agreements. FSMA expressly authorizes district courts to enforce orders, including preliminary orders of reinstatement, issued by the Secretary. See 21 U.S.C. 399d(b)(6) (“Whenever any person has failed to comply with an order issued under paragraph (3), the Secretary may file a civil action in the United States district court for the district in which the violation was found to occur, or in the United States district court for the District of Columbia, to enforce such order.”). Specifically, reinstatement orders issued at the close of OSHA's investigation are immediately enforceable in district court pursuant to 21 U.S.C. 399d(b)(6) and (7). FSMA provides that the Secretary shall order the person who has committed a violation to reinstate the complainant to his or her former position. See 21 U.S.C. 399d(b)(3)(B)(ii). FSMA also provides that the Secretary shall accompany any reasonable cause finding that a violation occurred with a preliminary order containing the relief prescribed by subsection (b)(3)(B), which includes reinstatement where appropriate, and that any preliminary order of reinstatement shall not be stayed upon the filing of objections. See 21 U.S.C. 399d(b)(2)(B) (“The filing of such objections shall not operate to stay any reinstatement remedy contained in the preliminary order.”). Thus, under FSMA, enforceable orders include preliminary orders that contain the relief of reinstatement prescribed by 21 U.S.C. 399d(b)(3)(B). This statutory interpretation is consistent with the Secretary's interpretation of similar language in the whistleblower provisions of the Wendell H. Ford Aviation Investment and Reform Act for the 21st Century, 49 U.S.C. 42121, and Section 806 of the Corporate and Criminal Fraud Accountability Act of 2002, Title VIII of the Sarbanes-Oxley Act of 2002, 18 U.S.C. 1514A. See Brief for the Intervenor/Plaintiff-Appellee Secretary of Labor, Solis v. Tenn. Commerce Bancorp, Inc., No. 10-5602 (6th Cir. 2010); Solis v. Tenn. Commerce Bancorp, Inc., 713 F. Supp. 2d 701 (M.D. Tenn. 2010); but see Bechtel v. Competitive Techs., Inc., 448 F.3d 469 (2d Cir. 2006); Welch v. Cardinal Bankshares Corp., 454 F. Supp. 2d 552 (W.D. Va. 2006) (decision vacated, appeal dismissed, No. 06-2295 (4th Cir. Feb. 20, 2008)). FSMA also permits the person on whose behalf the order was issued to obtain judicial enforcement of the order. See 21 U.S.C. 399d(b)(7).

    No comments were received on this section. OSHA has revised this section slightly to more closely parallel the provisions of the statute regarding the proper venue for an enforcement action.

    Section 1987.114  District Court Jurisdiction of Retaliation Complaints

    This section sets forth provisions that allow a complainant to bring an original de novo action in district court, alleging the same allegations contained in the complaint filed with OSHA, under certain circumstances. FSMA permits a complainant to file an action for de novo review in the appropriate district court if there has been no final decision of the Secretary within 210 days of the filing of the complaint, or within 90 days after receiving a written determination. “Written determination” refers to the Assistant Secretary's written findings issued at the close of OSHA's investigation under section 1987.105(a). See 21 U.S.C. 399d(b)(4). The Secretary's final decision is generally the decision of the ARB issued under section 1987.110. In other words, a complainant may file an action for de novo review in the appropriate district court in either of the following two circumstances: (1) A complainant may file a de novo action in district court within 90 days of receiving the Assistant Secretary's written findings issued under section 1987.105(a), or (2) a complainant may file a de novo action in district court if more than 210 days have passed since the filing of the complaint and the Secretary has not issued a final decision. The plain language of 21 U.S.C. 399d(b)(4), by distinguishing between actions that can be brought if the Secretary has not issued a “final decision” within 210 days and actions that can be brought within 90 days after a “written determination,” supports allowing de novo actions in district court under either of the circumstances described above.

    However, the Secretary believes that FSMA does not permit complainants to initiate an action in federal court after the Secretary issues a final decision, even if the date of the final decision is more than 210 days after the filing of the complaint or within 90 days of the complainant's receipt of the Assistant Secretary's written findings. The purpose of the “kick-out” provision is to aid the complainant in receiving a prompt decision. That goal is not implicated in a situation where the complainant already has received a final decision from the Secretary. In addition, permitting the complainant to file a new case in district court in such circumstances conflicts with the parties' right to seek judicial review of the Secretary's final decision in the court of appeals. See 21 U.S.C. 399d(b)(5)(B) (providing that an order with respect to which review could have been obtained in the court of appeals shall not be subject to judicial review in any criminal or other civil proceeding).

    Under FSMA, the Assistant Secretary's written findings become the final order of the Secretary, not subject to judicial review, if no objection is filed within 30 days. See 21 U.S.C. 399d(b)(2)(B). Thus, a complainant may need to file timely objections to the Assistant Secretary's findings, as provided for in § 1987.106, in order to preserve the right to file an action in district court.

    This section also requires that, within seven days after filing a complaint in district court, a complainant must provide a file-stamped copy of the complaint to OSHA, the ALJ, or the ARB, depending on where the proceeding is pending. In all cases, a copy of the complaint also must be provided to the OSHA official who issued the findings and/or preliminary order, the Assistant Secretary, and the U.S. Department of Labor's Associate Solicitor for Fair Labor Standards. This provision is necessary to notify the agency that the complainant has opted to file a complaint in district court. This provision is not a substitute for the complainant's compliance with the requirements for service of process of the district court complaint contained in the Federal Rules of Civil Procedure and the local rules of the district court where the complaint is filed. This section also incorporates the statutory provisions which allow for a jury trial at the request of either party in a district court action, and which specify the remedies and burdens of proof in a district court action.

    In response to the IFR preamble's statement that the purpose of the “kick-out” provision is to “aid the complainant in receiving a prompt decision,” Kalijarvi commented that the kick-out provision offers additional benefits to complainants, such as an opportunity to receive a jury determination of damages. Indeed, Paragraph (a) of this section provides that an action brought under this section is entitled to trial by jury. OSHA appreciates Kalijarvi's comment, but has left the text of the rule unchanged.

    Section 1987.115  Special Circumstances; Waiver of Rules

    This section provides that in circumstances not contemplated by these rules or for good cause the ALJ or the ARB may, upon application and notice to the parties, waive any rule as justice or the administration of FSMA requires. No comments were received on this section, and no changes were made to it.

    IV. Paperwork Reduction Act

    This rule contains a reporting provision (filing a retaliation complaint, Section 1987.103) which was previously reviewed and approved for use by the Office of Management and Budget (OMB) under the provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The assigned OMB control number is 1218-0236.

    V. Administrative Procedure Act

    The notice and comment rulemaking procedures of section 553 of the Administrative Procedure Act (APA) do not apply “to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice.” 5 U.S.C. 553(b)(A). This is a rule of agency procedure, practice, and interpretation within the meaning of that section, since it provides procedures for the Department's handling of retaliation complaints. Therefore, publication in the Federal Register of a notice of proposed rulemaking and request for comments are not required for these regulations. Although this rule is not subject to the notice and comment procedures of the APA, the Assistant Secretary sought and considered comments to enable the agency to improve the rules by taking into account the concerns of interested persons.

    Furthermore, because this rule is procedural and interpretative rather than substantive, the normal requirement of 5 U.S.C. 553(d) that a rule is effective 30 days after publication in the Federal Register is inapplicable. The Assistant Secretary also finds good cause to provide an immediate effective date for this rule. It is in the public interest that the rule be effective immediately so both parties may know what procedures are applicable to pending cases.

    VI. Executive Orders 12866 and 13563; Unfunded Mandates Reform Act of 1995; Executive Order 13132

    The Department has concluded that this rule is not a “significant regulatory action” within the meaning of section 3(f)(4) of Executive Order 12866, as reaffirmed by Executive Order 13563, because it is not 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 Executive Order 12866. Therefore, no regulatory impact analysis under Section 6(a)(3)(C) of Executive Order 12866 has been prepared.

    For this reason, and because no notice of proposed rulemaking has been published, no statement is required under Section 202 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531 et seq. Finally, this rule does not have “federalism implications.” The 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” and therefore is not subject to Executive Order 13132 (Federalism).

    VII. Regulatory Flexibility Analysis

    The notice and comment rulemaking procedures of Section 553 of the APA do not apply “to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice.” 5 U.S.C. 553(b)(A). Rules that are exempt from APA notice and comment requirements are also exempt from the Regulatory Flexibility Act (RFA). See SBA Office of Advocacy, A Guide for Government Agencies: How to Comply with the Regulatory Flexibility Act 9 (May 2012); also found at: http://www.sba.gov/sites/default/files/rfaguide_0512_0.pdf. This is a rule of agency procedure, practice, and interpretation within the meaning of that section; therefore, the rule is exempt from both the notice and comment rulemaking procedures of the APA and the requirements under the RFA.

    List of Subjects in 29 CFR Part 1987

    Administrative practice and procedure, Employment, Food safety, Investigations, Reporting and recordkeeping requirements, Whistleblower.

    Authority and Signature

    This document was prepared under the direction and control of David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health.

    Signed at Washington, DC, on April 11, 2016. David Michaels, Assistant Secretary of Labor for Occupational Safety and Health.

    Accordingly, for the reasons set out in the preamble, 29 CFR part 1987 is revised to read as follows:

    PART 1987—PROCEDURES FOR HANDLING RETALIATION COMPLAINTS UNDER SECTION 402 OF THE FDA FOOD SAFETY MODERNIZATION ACT Subpart A—Complaints, Investigations, Findings and Preliminary Orders 1987.100 Purpose and scope. 1987.101 Definitions. 1987.102 Obligations and prohibited acts. 1987.103 Filing of retaliation complaint. 1987.104 Investigation. 1987.105 Issuance of findings and preliminary orders. Subpart B—Litigation 1987.106 Objections to the findings and the preliminary order and requests for a hearing. 1987.107 Hearings. 1987.108 Role of Federal agencies. 1987.109 Decision and orders of the administrative law judge. 1987.110 Decision and orders of the Administrative Review Board. Subpart C—Miscellaneous Provisions 1987.111 Withdrawal of complaints, findings, objections, and petitions for review; settlement. 1987.112 Judicial review. 1987.113 Judicial enforcement. 1987.114 District court jurisdiction of retaliation complaints. 1987.115 Special circumstances; waiver of rules. Authority:

    21 U.S.C. 399d; Secretary of Labor's Order No. 1-2012 (Jan. 18, 2012), 77 FR 3912 (Jan. 25, 2012); Secretary of Labor's Order No. 2-2012 (Oct. 19, 2012), 77 FR 69378 (Nov. 16, 2012).

    Subpart A—Complaints, Investigations, Findings and Preliminary Orders
    § 1987.100 Purpose and scope.

    (a) This part sets forth the procedures for, and interpretations of, section 402 of the FDA Food Safety Modernization Act (FSMA), Public Law 111-353, 124 Stat. 3885, which was signed into law on January 4, 2011. Section 402 of the FDA Food Safety Modernization Act amended the Federal Food, Drug, and Cosmetic Act (FD&C), 21 U.S.C. 301 et seq., by adding new section 1012. See 21 U.S.C. 399d. Section 1012 of the FD&C provides protection for an employee from retaliation because the employee has engaged in protected activity pertaining to a violation or alleged violation of the FD&C, or any order, rule, regulation, standard, or ban under the FD&C.

    (b) This part establishes procedures under section 1012 of the FD&C for the expeditious handling of retaliation complaints filed by employees, or by persons acting on their behalf. The rules in this part, together with those codified at 29 CFR part 18, set forth the procedures under section 1012 of the FD&C for submission of complaints, investigations, issuance of findings and preliminary orders, objections to findings and orders, litigation before administrative law judges, post-hearing administrative review, and withdrawals and settlements. In addition, the rules in this part provide the Secretary's interpretations on certain statutory issues.

    § 1987.101 Definitions.

    As used in this part:

    (a) Assistant Secretary means the Assistant Secretary of Labor for Occupational Safety and Health or the person or persons to whom he or she delegates authority under FSMA.

    (b) Business days means days other than Saturdays, Sundays, and Federal holidays.

    (c) Complainant means the employee who filed a complaint under FSMA or on whose behalf a complaint was filed.

    (d) Covered entity means an entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food.

    (e) Employee means an individual presently or formerly working for a covered entity, an individual applying to work for a covered entity, or an individual whose employment could be affected by a covered entity.

    (f) FD&C means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., which is chapter 9 of title 21.

    (g) FDA means the Food and Drug Administration of the United States Department of Health and Human Services.

    (h) Food means articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article.

    (i) FSMA means section 402 of the FDA Food Safety Modernization Act, Public Law 111-353, 124 Stat. 3885 (Jan. 4, 2011) (codified at 21 U.S.C. 399d).

    (j) OSHA means the Occupational Safety and Health Administration of the United States Department of Labor.

    (k) Person includes an individual, partnership, corporation, and association.

    (l) Respondent means the employer named in the complaint who is alleged to have violated the FSMA.

    (m) Secretary means the Secretary of Labor or person to whom authority under the FSMA has been delegated.

    (n) Any future statutory amendments that affect the definition of a term or terms listed in this section will apply in lieu of the definition stated herein.

    § 1987.102 Obligations and prohibited acts.

    (a) No covered entity may discharge or otherwise retaliate against, including, but not limited to, intimidating, threatening, restraining, coercing, blacklisting or disciplining, any employee with respect to the employee's compensation, terms, conditions, or privileges of employment because the employee, whether at the employee's initiative or in the ordinary course of the employee's duties (or any person acting pursuant to a request of the employee), has engaged in any of the activities specified in paragraphs (b)(1) through (4) of this section.

    (b) An employee is protected against retaliation because the employee (or any person acting pursuant to a request of the employee) has:

    (1) Provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of any provision of the FD&C or any order, rule, regulation, standard, or ban under the FD&C;

    (2) Testified or is about to testify in a proceeding concerning such violation;

    (3) Assisted or participated or is about to assist or participate in such a proceeding; or

    (4) Objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee (or other such person) reasonably believed to be in violation of any provision of the FD&C, or any order, rule, regulation, standard, or ban under the FD&C.

    § 1987.103 Filing of retaliation complaint.

    (a) Who may file. An employee who believes that he or she has been retaliated against in violation of FSMA may file, or have filed by any person on the employee's behalf, a complaint alleging such retaliation.

    (b) Nature of filing. No particular form of complaint is required. A complaint may be filed orally or in writing. Oral complaints will be reduced to writing by OSHA. If the complainant is unable to file the complaint in English, OSHA will accept the complaint in any language.

    (c) Place of filing. The complaint should be filed with the OSHA office responsible for enforcement activities in the geographical area where the employee resides or was employed, but may be filed with any OSHA officer or employee. Addresses and telephone numbers for these officials are set forth in local directories and at the following Internet address: http://www.osha.gov.

    (d) Time for filing. Within 180 days after an alleged violation of FSMA occurs, any employee who believes that he or she has been retaliated against in violation of that section may file, or have filed by any person on the employee's behalf, a complaint alleging such retaliation. The date of the postmark, facsimile transmittal, electronic communication transmittal, telephone call, hand-delivery, delivery to a third-party commercial carrier, or in-person filing at an OSHA office will be considered the date of filing. The time for filing a complaint may be tolled for reasons warranted by applicable case law. For example, OSHA may consider the time for filing a complaint to be tolled if a complainant mistakenly files a complaint with an agency other than OSHA within 180 days after an alleged adverse action.

    § 1987.104 Investigation.

    (a) Upon receipt of a complaint in the investigating office, OSHA will notify the respondent of the filing of the complaint, of the allegations contained in the complaint, and of the substance of the evidence supporting the complaint. Such materials will be redacted, if necessary, consistent with the Privacy Act of 1974, 5 U.S.C. 552a, and other applicable confidentiality laws. OSHA will also notify the respondent of its rights under paragraphs (b) and (f) of this section and § 1987.110(e). OSHA will provide an unredacted copy of these same materials to the complainant (or the complainant's legal counsel if complainant is represented by counsel) and to the FDA.

    (b) Within 20 days of receipt of the notice of the filing of the complaint provided under paragraph (a) of this section, the respondent and the complainant each may submit to OSHA a written statement and any affidavits or documents substantiating its position. Within the same 20 days, the respondent and the complainant each may request a meeting with OSHA to present its position.

    (c) During the investigation, OSHA will request that each party provide the other parties to the whistleblower complaint with a copy of submissions to OSHA that are pertinent to the whistleblower complaint. Alternatively, if a party does not provide its submissions to OSHA to the other party, OSHA will provide them to the other party (or the party's legal counsel if the party is represented by counsel) at a time permitting the other party an opportunity to respond. Before providing such materials to the other party, OSHA will redact them, if necessary, consistent with the Privacy Act of 1974, 5 U.S.C. 552a, and other applicable confidentiality laws. OSHA will also provide each party with an opportunity to respond to the other party's submissions.

    (d) Investigations will be conducted in a manner that protects the confidentiality of any person who provides information on a confidential basis, other than the complainant, in accordance with part 70 of this title.

    (e)(1) A complaint will be dismissed unless the complainant has made a prima facie showing (i.e., a non-frivolous allegation) that a protected activity was a contributing factor in the adverse action alleged in the complaint.

    (2) The complaint, supplemented as appropriate by interviews of the complainant, must allege the existence of facts and evidence to make a prima facie showing as follows:

    (i) The employee engaged in a protected activity;

    (ii) The respondent knew or suspected that the employee engaged in the protected activity;

    (iii) The employee suffered an adverse action; and

    (iv) The circumstances were sufficient to raise the inference that the protected activity was a contributing factor in the adverse action.

    (3) For purposes of determining whether to investigate, the complainant will be considered to have met the required burden if the complaint on its face, supplemented as appropriate through interviews of the complainant, alleges the existence of facts and either direct or circumstantial evidence to meet the required showing, i.e., to give rise to an inference that the respondent knew or suspected that the employee engaged in protected activity and that the protected activity was a contributing factor in the adverse action. The burden may be satisfied, for example, if the complaint shows that the adverse action took place within a temporal proximity of the protected activity, or at the first opportunity available to the respondent, giving rise to the inference that it was a contributing factor in the adverse action. If the required showing has not been made, the complainant (or the complainant's legal counsel if complainant is represented by counsel) will be so notified and the investigation will not commence.

    (4) Notwithstanding a finding that a complainant has made a prima facie showing, as required by this section, further investigation of the complaint will not be conducted if the respondent demonstrates by clear and convincing evidence that it would have taken the same adverse action in the absence of the complainant's protected activity.

    (5) If the respondent fails to make a timely response or fails to satisfy the burden set forth in paragraph (e)(4) of this section, OSHA will proceed with the investigation. The investigation will proceed whenever it is necessary or appropriate to confirm or verify the information provided by the respondent.

    (f) Prior to the issuance of findings and a preliminary order as provided for in § 1987.105, if OSHA has reasonable cause, on the basis of information gathered under the procedures of this part, to believe that the respondent has violated FSMA and that preliminary reinstatement is warranted, OSHA will contact the respondent (or the respondent's legal counsel if respondent is represented by counsel) to give notice of the substance of the relevant evidence supporting the complainant's allegations as developed during the course of the investigation. This evidence includes any witness statements, which will be redacted to protect the identity of confidential informants where statements were given in confidence; if the statements cannot be redacted without revealing the identity of confidential informants, summaries of their contents will be provided. The complainant will also receive a copy of the materials that must be provided to the respondent under this paragraph. Before providing such materials, OSHA will redact them, if necessary, consistent with the Privacy Act of 1974, 5 U.S.C. 552a, and other applicable confidentiality laws. The respondent will be given the opportunity to submit a written response, to meet with the investigators, to present statements from witnesses in support of its position, and to present legal and factual arguments. The respondent must present this evidence within 10 business days of OSHA's notification pursuant to this paragraph, or as soon thereafter as OSHA and the respondent can agree, if the interests of justice so require.

    § 1987.105 Issuance of findings and preliminary orders.

    (a) After considering all the relevant information collected during the investigation, the Assistant Secretary will issue, within 60 days of the filing of the complaint, written findings as to whether or not there is reasonable cause to believe that the respondent has retaliated against the complainant in violation of FSMA.

    (1) If the Assistant Secretary concludes that there is reasonable cause to believe that a violation has occurred, the Assistant Secretary will accompany the findings with a preliminary order providing relief to the complainant. The preliminary order will require, where appropriate: Affirmative action to abate the violation; reinstatement of the complainant to his or her former position, together with the compensation (including back pay and interest), terms, conditions and privileges of the complainant's employment; and payment of compensatory damages, including, at the request of the complainant, the aggregate amount of all costs and expenses (including attorney and expert witness fees) reasonably incurred. Interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily. The preliminary order will also require the respondent to submit appropriate documentation to the Social Security Administration allocating any back pay award to the appropriate calendar quarters.

    (2) If the Assistant Secretary concludes that a violation has not occurred, the Assistant Secretary will notify the parties of that finding.

    (b) The findings and, where appropriate, the preliminary order will be sent by certified mail, return receipt requested (or other means that allow OSHA to confirm receipt), to all parties of record (and each party's legal counsel if the party is represented by counsel). The findings and, where appropriate, the preliminary order will inform the parties of the right to object to the findings and/or order and to request a hearing, and of the right of the respondent to request an award of attorney fees not exceeding $1,000 from the administrative law judge (ALJ), regardless of whether the respondent has filed objections, if the respondent alleges that the complaint was frivolous or brought in bad faith. The findings and, where appropriate, the preliminary order also will give the address of the Chief Administrative Law Judge, U.S. Department of Labor. At the same time, the Assistant Secretary will file with the Chief Administrative Law Judge a copy of the original complaint and a copy of the findings and/or order.

    (c) The findings and any preliminary order will be effective 30 days after receipt by the respondent (or the respondent's legal counsel if the respondent is represented by counsel), or on the compliance date set forth in the preliminary order, whichever is later, unless an objection and/or a request for hearing has been timely filed as provided at § 1987.106. However, the portion of any preliminary order requiring reinstatement will be effective immediately upon the respondent's receipt of the findings and the preliminary order, regardless of any objections to the findings and/or the order.

    Subpart B—Litigation
    § 1987.106 Objections to the findings and the preliminary order and requests for a hearing.

    (a) Any party who desires review, including judicial review, of the findings and/or preliminary order, or a respondent alleging that the complaint was frivolous or brought in bad faith who seeks an award of attorney fees under FSMA, must file any objections and/or a request for a hearing on the record within 30 days of receipt of the findings and preliminary order pursuant to § 1987.105. The objections, request for a hearing, and/or request for attorney fees must be in writing and state whether the objections are to the findings, the preliminary order, and/or whether there should be an award of attorney fees. The date of the postmark, facsimile transmittal, or electronic communication transmittal is considered the date of filing; if the objection is filed in person, by hand delivery or other means, the objection is filed upon receipt. Objections must be filed with the Chief Administrative Law Judge, U.S. Department of Labor, and copies of the objections must be mailed at the same time to the other parties of record, the OSHA official who issued the findings and order, the Assistant Secretary, and the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor.

    (b) If a timely objection is filed, all provisions of the preliminary order will be stayed, except for the portion requiring preliminary reinstatement, which will not be automatically stayed. The portion of the preliminary order requiring reinstatement will be effective immediately upon the respondent's receipt of the findings and preliminary order, regardless of any objections to the order. The respondent may file a motion with the Office of Administrative Law Judges for a stay of the Assistant Secretary's preliminary order of reinstatement, which shall be granted only based on exceptional circumstances. If no timely objection is filed with respect to either the findings or the preliminary order, the findings and/or the preliminary order will become the final decision of the Secretary, not subject to judicial review.

    § 1987.107 Hearings.

    (a) Except as provided in this part, proceedings will be conducted in accordance with the rules of practice and procedure for administrative hearings before the Office of Administrative Law Judges, codified at subpart A of part 18 of this title.

    (b) Upon receipt of an objection and request for hearing, the Chief Administrative Law Judge will promptly assign the case to an ALJ who will notify the parties, by certified mail, of the day, time, and place of hearing. The hearing is to commence expeditiously, except upon a showing of good cause or unless otherwise agreed to by the parties. Hearings will be conducted de novo on the record. ALJs have broad discretion to limit discovery in order to expedite the hearing.

    (c) If both the complainant and the respondent object to the findings and/or order, the objections will be consolidated and a single hearing will be conducted.

    (d) Formal rules of evidence will not apply, but rules or principles designed to assure production of the most probative evidence will be applied. The ALJ may exclude evidence that is immaterial, irrelevant, or unduly repetitious.

    § 1987.108 Role of Federal agencies.

    (a)(1) The complainant and the respondent will be parties in every proceeding and must be served with copies of all documents in the case. At the Assistant Secretary's discretion, the Assistant Secretary may participate as a party or as amicus curiae at any time at any stage of the proceeding. This right to participate includes, but is not limited to, the right to petition for review of a decision of an ALJ, including a decision approving or rejecting a settlement agreement between the complainant and the respondent.

    (2) Parties must send copies of documents to OSHA and to the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor, only upon request of OSHA, or when OSHA is participating in the proceeding, or when service on OSHA and the Associate Solicitor is otherwise required by the rules in this part.

    (b) The FDA, if interested in a proceeding, may participate as amicus curiae at any time in the proceeding, at the FDA's discretion. At the request of the FDA, copies of all documents in a case must be sent to the FDA, whether or not the FDA is participating in the proceeding.

    § 1987.109 Decision and orders of the administrative law judge.

    (a) The decision of the ALJ will contain appropriate findings, conclusions, and an order pertaining to the remedies provided in paragraph (d) of this section, as appropriate. A determination that a violation has occurred may be made only if the complainant has demonstrated by a preponderance of the evidence that protected activity was a contributing factor in the adverse action alleged in the complaint.

    (b) If the complainant has satisfied the burden set forth in the prior paragraph, relief may not be ordered if the respondent demonstrates by clear and convincing evidence that it would have taken the same adverse action in the absence of any protected activity.

    (c) Neither OSHA's determination to dismiss a complaint without completing an investigation pursuant to § 1987.104(e) nor OSHA's determination to proceed with an investigation is subject to review by the ALJ, and a complaint may not be remanded for the completion of an investigation or for additional findings on the basis that a determination to dismiss was made in error. Rather, if there otherwise is jurisdiction, the ALJ will hear the case on the merits or dispose of the matter without a hearing if the facts and circumstances warrant.

    (d)(1) If the ALJ concludes that the respondent has violated the law, the ALJ will issue an order that will require, where appropriate: Affirmative action to abate the violation; reinstatement of the complainant to his or her former position, together with the compensation (including back pay and interest), terms, conditions, and privileges of the complainant's employment; and payment of compensatory damages, including, at the request of the complainant, the aggregate amount of all costs and expenses (including attorney and expert witness fees) reasonably incurred. Interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily. The order will also require the respondent to submit appropriate documentation to the Social Security Administration allocating any back pay award to the appropriate calendar quarters.

    (2) If the ALJ determines that the respondent has not violated the law, an order will be issued denying the complaint. If, upon the request of the respondent, the ALJ determines that a complaint was frivolous or was brought in bad faith, the ALJ may award to the respondent a reasonable attorney fee, not exceeding $1,000.

    (e) The decision will be served upon all parties to the proceeding, the Assistant Secretary, and the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor. Any ALJ's decision requiring reinstatement or lifting an order of reinstatement by the Assistant Secretary will be effective immediately upon receipt of the decision by the respondent. All other portions of the ALJ's order will be effective 14 days after the date of the decision unless a timely petition for review has been filed with the Administrative Review Board (ARB), U.S. Department of Labor. The decision of the ALJ will become the final order of the Secretary unless a petition for review is timely filed with the ARB and the ARB accepts the petition for review.

    § 1987.110 Decision and orders of the Administrative Review Board.

    (a) Any party desiring to seek review, including judicial review, of a decision of the ALJ, or a respondent alleging that the complaint was frivolous or brought in bad faith who seeks an award of attorney fees, must file a written petition for review with the ARB, which has been delegated the authority to act for the Secretary and issue final decisions under this part. The parties should identify in their petitions for review the legal conclusions or orders to which they object, or the objections may be deemed waived. A petition must be filed within 14 days of the date of the decision of the ALJ. The date of the postmark, facsimile transmittal, or electronic communication transmittal will be considered to be the date of filing; if the petition is filed in person, by hand delivery or other means, the petition is considered filed upon receipt. The petition must be served on all parties and on the Chief Administrative Law Judge at the time it is filed with the ARB. Copies of the petition for review must be served on the Assistant Secretary and on the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor.

    (b) If a timely petition for review is filed pursuant to paragraph (a) of this section, the decision of the ALJ will become the final order of the Secretary unless the ARB, within 30 days of the filing of the petition, issues an order notifying the parties that the case has been accepted for review. If a case is accepted for review, the decision of the ALJ will be inoperative unless and until the ARB issues an order adopting the decision, except that any order of reinstatement will be effective while review is conducted by the ARB, unless the ARB grants a motion by the respondent to stay that order based on exceptional circumstances. The ARB will specify the terms under which any briefs are to be filed. The ARB will review the factual determinations of the ALJ under the substantial evidence standard. If no timely petition for review is filed, or the ARB denies review, the decision of the ALJ will become the final order of the Secretary. If no timely petition for review is filed, the resulting final order is not subject to judicial review.

    (c) The final decision of the ARB will be issued within 120 days of the conclusion of the hearing, which will be deemed to be 14 days after the date of the decision of the ALJ, unless a motion for reconsideration has been filed with the ALJ in the interim. In such case the conclusion of the hearing is the date the motion for reconsideration is denied or 14 days after a new decision is issued. The ARB's final decision will be served upon all parties and the Chief Administrative Law Judge by mail. The final decision will also be served on the Assistant Secretary and on the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor, even if the Assistant Secretary is not a party.

    (d) If the ARB concludes that the respondent has violated the law, the ARB will issue a final order providing relief to the complainant. The final order will require, where appropriate: Affirmative action to abate the violation; reinstatement of the complainant to his or her former position, together with the compensation (including back pay and interest), terms, conditions, and privileges of the complainant's employment; and payment of compensatory damages, including, at the request of the complainant, the aggregate amount of all costs and expenses (including attorney and expert witness fees) reasonably incurred. Interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily. The order will also require the respondent to submit appropriate documentation to the Social Security Administration allocating any back pay award to the appropriate calendar quarters.

    (e) If the ARB determines that the respondent has not violated the law, an order will be issued denying the complaint. If, upon the request of the respondent, the ARB determines that a complaint was frivolous or was brought in bad faith, the ARB may award to the respondent a reasonable attorney fee, not exceeding $1,000.

    Subpart C—Miscellaneous Provisions
    § 1987.111 Withdrawal of complaints, findings, objections, and petitions for review; settlement.

    (a) At any time prior to the filing of objections to the Assistant Secretary's findings and/or preliminary order, a complainant may withdraw his or her complaint by notifying OSHA, orally or in writing, of his or her withdrawal. OSHA then will confirm in writing the complainant's desire to withdraw and determine whether to approve the withdrawal. OSHA will notify the parties (and each party's legal counsel if the party is represented by counsel) of the approval of any withdrawal. If the complaint is withdrawn because of settlement, the settlement must be submitted for approval in accordance with paragraph (d) of this section. A complainant may not withdraw his or her complaint after the filing of objections to the Assistant Secretary's findings and/or preliminary order.

    (b) The Assistant Secretary may withdraw the findings and/or preliminary order at any time before the expiration of the 30-day objection period described in § 1987.106, provided that no objection has been filed yet, and substitute new findings and/or a new preliminary order. The date of the receipt of the substituted findings or order will begin a new 30-day objection period.

    (c) At any time before the Assistant Secretary's findings and/or order become final, a party may withdraw objections to the Assistant Secretary's findings and/or order by filing a written withdrawal with the ALJ. If the case is on review with the ARB, a party may withdraw a petition for review of an ALJ's decision at any time before that decision becomes final by filing a written withdrawal with the ARB. The ALJ or the ARB, as the case may be, will determine whether to approve the withdrawal of the objections or the petition for review. If the ALJ approves a request to withdraw objections to the Assistant Secretary's findings and/or order, and there are no other pending objections, the Assistant Secretary's findings and/or order will become the final order of the Secretary. If the ARB approves a request to withdraw a petition for review of an ALJ decision, and there are no other pending petitions for review of that decision, the ALJ's decision will become the final order of the Secretary. If objections or a petition for review are withdrawn because of settlement, the settlement must be submitted for approval in accordance with paragraph (d) of this section.

    (d)(1) Investigative settlements. At any time after the filing of a complaint, but before the findings and/or order are objected to or become a final order by operation of law, the case may be settled if OSHA, the complainant, and the respondent agree to a settlement. OSHA's approval of a settlement reached by the respondent and the complainant demonstrates OSHA's consent and achieves the consent of all three parties.

    (2) Adjudicatory settlements. At any time after the filing of objections to the Assistant Secretary's findings and/or order, the case may be settled if the participating parties agree to a settlement and the settlement is approved by the ALJ if the case is before the ALJ, or by the ARB if the ARB has accepted the case for review. A copy of the settlement will be filed with the ALJ or the ARB, as appropriate.

    (e) Any settlement approved by OSHA, the ALJ, or the ARB will constitute the final order of the Secretary and may be enforced in United States district court pursuant to § 1987.113.

    § 1987.112 Judicial review.

    (a) Within 60 days after the issuance of a final order under §§ 1987.109 and 1987.110, any person adversely affected or aggrieved by the order may file a petition for review of the order in the United States Court of Appeals for the circuit in which the violation allegedly occurred or the circuit in which the complainant resided on the date of the violation.

    (b) A final order is not subject to judicial review in any criminal or other civil proceeding.

    (c) If a timely petition for review is filed, the record of a case, including the record of proceedings before the ALJ, will be transmitted by the ARB or the ALJ, as the case may be, to the appropriate court pursuant to the Federal Rules of Appellate Procedure and the local rules of such court.

    § 1987.113 Judicial enforcement.

    Whenever any person has failed to comply with a preliminary order of reinstatement, or a final order, including one approving a settlement agreement, issued under FSMA, the Secretary may file a civil action seeking enforcement of the order in the United States district court for the district in which the violation was found to have occurred or in the United States district court for the District of Columbia. Whenever any person has failed to comply with a preliminary order of reinstatement, or a final order, including one approving a settlement agreement, issued under FSMA, a person on whose behalf the order was issued may file a civil action seeking enforcement of the order in the appropriate United States district court.

    § 1987.114 District court jurisdiction of retaliation complaints.

    (a) The complainant may bring an action at law or equity for de novo review in the appropriate district court of the United States, which will have jurisdiction over such an action without regard to the amount in controversy, either:

    (1) Within 90 days after receiving a written determination under § 1987.105(a) provided that there has been no final decision of the Secretary; or

    (2) If there has been no final decision of the Secretary within 210 days of the filing of the complaint.

    (b) At the request of either party, the action shall be tried by the court with a jury.

    (c) A proceeding under paragraph (a) of this section shall be governed by the same legal burdens of proof specified in § 1987.109. The court shall have jurisdiction to grant all relief necessary to make the employee whole, including injunctive relief and compensatory damages, including:

    (1) Reinstatement with the same seniority status that the employee would have had, but for the discharge or discrimination;

    (2) The amount of back pay, with interest;

    (3) Compensation for any special damages sustained as a result of the discharge or discrimination; and

    (4) Litigation costs, expert witness fees, and reasonable attorney fees.

    (d) Within seven days after filing a complaint in federal court, a complainant must file with OSHA, the ALJ, or the ARB, depending on where the proceeding is pending, a copy of the file-stamped complaint. In all cases, a copy of the complaint also must be served on the OSHA official who issued the findings and/or preliminary order, the Assistant Secretary, and the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor.

    § 1987.115 Special circumstances; waiver of rules.

    In special circumstances not contemplated by the provisions of the rules in this part, or for good cause shown, the ALJ or the ARB on review may, upon application, after three days notice to all parties, waive any rule or issue such orders that justice or the administration of FSMA requires.

    [FR Doc. 2016-08724 Filed 4-15-16; 8:45 am] BILLING CODE 4510-26-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2015-1108] RIN 1625-AA08 Special Local Regulation, Daytona Beach Grand Prix of the Seas; Atlantic Ocean, Daytona Beach, FL AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a special local regulation on the waters of the Atlantic Ocean east of Daytona Beach, Florida during the Daytona Beach Grand Prix of the Seas, a series of high-speed personal watercraft boat races. This action is necessary to provide for the safety of life on the navigable waters surrounding the event. This special local regulation will be enforced daily 8 a.m. to 5 p.m., from April 22 through April 24, 2016. This rulemaking prohibits persons and vessels from being in the regulated area unless authorized by the Captain of the Port (COTP) Jacksonville or a designated representative.

    DATES:

    This rule is effective from April 22, 2016 through April 24, 2016 and will be enforced daily from 8 a.m. to 5 p.m.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2015-1108 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this rulemaking, call or email Lieutenant Allan Storm, Sector Jacksonville, Waterways Management Division, U.S. Coast Guard; telephone 904-714-7616, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking §  Section U.S.C. United States Code II. Background Information and Regulatory History

    On December 7, 2015, Powerboat P1-USA, LLC notified the Coast Guard that it will conduct a series of high speed boat races in the Atlantic Ocean, offshore from Daytona Beach, FL from April 22 through 24, 2016. In response, on February 4, 2016, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Special Local Regulation, Daytona Beach Grand Prix of the Seas; Daytona Beach, FL (81 FR 5967). There we stated why we issued the NPRM and invited comments on our proposed regulatory action related to this boat race. During the comment period that ended March 7, 2016, we received 3 comments.

    Under good cause provisions in 5 U.S.C. 553(d)(3), we are making this rule effective less than 30 days after its publication in the Federal Register. The Coast Guard finds that good cause exists for making this rule effective starting April 22, 2016 because the public was notified of this event well in advance through a proposed rule to regulate waterway activities published on February 4, 2016 [81 FR 5967]. Designated representatives will be on scene to assist the public with compliance during the nine hours per day that the regulation will be enforced.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The COTP Jacksonville determined that potential hazards associated with high speed boat races necessitate the establishment of a special local regulation. The purpose of this rulemaking is to ensure the safety of life on the navigable waters of the United States by prohibiting all vessels and persons not participating in the event from entering the regulated area.

    IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received three comments on the NPRM published February 4, 2016. Two comments received were in support of the rule. The third comment received was opposed to the rule. The comment opposed to the rule disputed the following items: (1) The Coast Guard's position that this high speed boat race poses an extra hazard to the safety of life on the navigable waters surrounding the event, (2) the need to establish a special local regulation to mitigate the hazards associated with this event, (3) the need for Coast Guard presence to enforce the rule (due to monetary cost to taxpayers), and (4) the determination that this rule is not a “significant regulatory action.” In regard to significant regulatory action, the commenter stated that this rule “encroaches on rights of mariners to be in a public area.”

    A marine event is defined as an organized event of limited duration on the navigable waters of the United States conducted according to a prearranged schedule which presents an extra or unusual hazard to the safety of human life that cannot be protected by existing navigation. Prior to taking any regulatory action and to considering the establishment of a special local regulation, the Coast Guard utilizes a risk-informed decision making process to determine if an event meets the definition of a marine event as outlined in 33 CFR 100.05 and is likely to introduce an extra or unusual hazard to the safety of human life. The primary risk factors for determining that this is a marine event included: (1) The expected involvement of an unusually large concentration of traffic on the water that may interfere with routine navigation and (2) the event includes an inherently hazardous competition where craft are expected to travel at high speeds. Once the Coast Guard made the marine event determination, we proposed a safety risk-mitigation tool. In this case, it is the establishment of a special local regulation. Based on an analysis of the factors addressed above, the commenter's position that this race is not a marine event justifying Coast Guard action is not supportable.

    For the enforcement of this rule, the Coast Guard does not need to be on scene. As stated in the regulatory text at the end of this document, the COTP may utilize Federal, state, and local officers (designated representatives) for the enforcement of the regulated area.

    A “significant regulation” under Executive Order 12866, is one that has an impact on the economy of more than $100 million or one that adversely affects in a material way the economy or a sector of the economy; creates a serious inconsistency or interferes with another agency; materially alters the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients; or raises a novel issue of law or policy. For the reasons stated in section V.A below, the Coast Guard determines that this rule is not a significant regulatory action. It is one of a category of regulations considered “routine and frequent” by the Office of Management and Budget.

    This rule establishes a special local regulation for the Daytona Beach Grand Prix of the Seas, a series of high-speed personal watercraft boat races. The regulated area includes the waters of the Atlantic Ocean offshore from Daytona Beach, Florida and will be enforced daily 8 a.m. to 5 p.m., from April 22 through April 24, 2016. Approximately 90 high-speed personal watercraft are anticipated to participate in the races. The regulated area would encompass an approximated offshore area that is 1,350 yards wide extending 600 yards south of the Daytona Beach pier to 1,900 yards north of the pier. No vessel or person will be permitted to enter the regulated area without obtaining permission from the COTP or a designated representative.

    V. Regulatory Analyses

    We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

    A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

    The Coast Guard has determined that this temporary final rule is not a significant regulatory action for the following reasons: (1) The special local regulation would be enforced for a total of only 27 hours over the course of three days; (2) although persons and vessels would not be able to enter, transit through, anchor in, or remain within the regulated area without authorization from the COTP Jacksonville or a designated representative, they would be able to operate in the surrounding area during the enforcement period; (3) persons and vessels would still be able to enter, transit through, anchor in, or remain within the regulated area if authorized by the COTP Jacksonville or a designated representative; and (4) the Coast Guard would provide advance notification of the special local regulation to the local maritime community via Broadcast Notice to Mariners or by on-scene designated representative.

    B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

    While some owners or operators of vessels intending to transit the regulated area may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

    Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a special local regulation that would prohibit persons and vessels from transiting through a 2,500 yard by 1,350 yard regulated area during a three day racing event lasting nine hours daily. It is categorically excluded from further review under paragraphs 34(h) and 35(a) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

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

    33 U.S.C. 1233.

    2. Add § 100.35T07-1108 to read as follows:
    § 100.35T07-1108 Special Local Regulation, Daytona Beach Grand Prix of the Seas; Atlantic Ocean, Daytona Beach, FL.

    (a) Regulated area. The following regulated area is a special local regulation located offshore from Daytona Beach, FL. All waters of the Atlantic Ocean encompassed within the following points: Starting at Point 1 in position 29°14.580′ N., 081°00.820′ W.; thence northeast to Point 2 in position 29°14.783′ N., 081°00.101′ W.; thence southeast to Point 3 in position 29°13.646′ N., 080°59.549′ W.; thence southwest to Point 4 in position 29°13.434′ N., 081°00.224′ W.; thence northwest back to origin. These coordinates are based on North American Datum 1983.

    (b) Definition. The term “designated representative” means Coast Guard Patrol Commanders, including Coast Guard coxswains, petty officers, and other officers operating Coast Guard vessels, and Federal, state, and local officers designated by or assisting the Captain of the Port (COTP) Jacksonville in the enforcement of the regulated area.

    (c) Regulations. (1) All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area unless authorized by the COTP Jacksonville or a designated representative.

    (2) Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the COTP Jacksonville by telephone at 904-714-7557, or a designated representative via VHF-FM radio on channel 16 to request authorization. If authorization is granted, all persons and vessels receiving such authorization must comply with the instructions of the COTP Jacksonville or designated representative.

    (3) The Coast Guard will provide notice of the regulated area through Broadcast Notice to Mariners via VHF—FM channel 16 or by on-scene designated representatives.

    (d) Enforcement period. This section will be enforced daily 8 a.m. to 5 p.m. from April 22 through April 24, 2016.

    Dated: April 12, 2016. J.F. Dixon, Captain, U.S. Coast Guard, Captain of the Port Jacksonville.
    [FR Doc. 2016-08875 Filed 4-15-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0295] Drawbridge Operation Regulation; Isle of Wight (Sinepatuxent) Bay, Ocean City, MD AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the US 50 (Harry W. Kelly Memorial) Bridge across the Isle of Wight (Sinepatuxent) Bay, mile 0.5, at Ocean City, MD. The deviation is necessary to accommodate participants of the 2016 “Island 2 Island” Half Marathon.

    DATES:

    The deviation is effective from 8 a.m. to 10:30 a.m. on Saturday, April 30, 2016.

    ADDRESSES:

    The docket for this deviation, [USCG-2016-0295] is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Mr. Michael Thorogood, Bridge Administration Branch Fifth District, Coast Guard, telephone 757-398-6557, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The OC Tri-Running Sports, on behalf of the Maryland State Highway Administration, who owns the US 50 (Harry W. Kelly Memorial) Bridge has requested a temporary deviation from the current operating regulations set out in 33 CFR 117.559, to facilitate the 2016 “Island 2 Island” Half Marathon.

    Under this temporary deviation, the bridge will be closed to navigation from 8 a.m. to 10:30 a.m. on April 30, 2016. The closure has been requested to ensure the safety of the increased volumes of runners and spectators that will be participating in the “Island 2 Island” Half Marathon on April 30, 2016.

    The bridge is a Double Bascule bridge and has a vertical clearance in the closed position of 13 feet above mean high water. Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternative route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local Notice and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

    Dated: April 12, 2016. Hal R. Pitts, Bridge Program Manager, Fifth Coast Guard District.
    [FR Doc. 2016-08896 Filed 4-15-16; 8:45 am] BILLING CODE 9110-04-P
    81 74 Monday, April 18, 2016 Proposed Rules DEPARTMENT OF ENERGY 10 CFR Part 430 [Docket Number EERE-2015-BT-STD-0008] RIN 1904-AD52 Appliance Standards and Rulemaking Federal Advisory Committee: Notice of Open Meetings for the Dedicated Purpose Pool Pumps (DPPP) Working Group To Negotiate a Notice of Proposed Rulemaking (NOPR) for Energy Conservation Standards AGENCY:

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

    ACTION:

    Notice of public meetings.

    SUMMARY:

    The Department of Energy (DOE) announces public meetings and webinars for the DPPP Working Group. The Federal Advisory Committee Act requires that agencies publish notice of an advisory committee meeting in the Federal Register.

    DATES:

    See SUPPLEMENTARY INFORMATION section for meeting dates.

    ADDRESSES:

    The meetings will be held at U.S. Department of Energy, Forrestal Building, Room 8E-089, 1000 Independence Avenue SW., Washington, DC 20585 unless otherwise stated in the SUPPLEMENTARY INFORMATION section. Individuals will also have the opportunity to participate by webinar. To register for the webinars and receive call-in information, please register at DOE's Web site https://www1.eere.energy.gov/buildings/appliance_standards/rulemaking.aspx/ruleid/14.

    FOR FURTHER INFORMATION CONTACT: Mr. John Cymbalsky, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 287-1692. Email: [email protected] Ms. Johanna Jochum, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-9496. Email: [email protected]
    SUPPLEMENTARY INFORMATION:

    On July 30, 2015, ASRAC met and unanimously passed the recommendation to form a dedicated purpose pool pumps (DPPP) working group to meet and discuss and, if possible, reach consensus on proposed Federal rules that would apply to this equipment. The ASRAC Charter allowed for 3 months of working group meetings to establish the scope, metric, definitions, and test procedure for dedicated purpose pool pumps and decide on a path forward at that time. The working group met this requirement and now more time is required to discuss potential energy conservation standards for this equipment. On January 20, 2016, ASRAC met and recommended that the DPPP Working Group continue its work to develop and recommend potential energy conservation standards for this equipment. This notice announces the next series of meetings for this working group.

    DOE will host public meetings and webinars on the below dates. Meetings will be hosted at DOE's Forrestal Building, unless otherwise stated.

    • May 18, 2016; 9:00 a.m.-5:00 p.m. • May 19, 2016; 9:00 a.m.-3:00 p.m. • June 22, 2016; 9:00 a.m.-5:00 p.m. • June 23, 2016; 9:00 a.m.-3:00 p.m. at DOE's Forrestal Building, Room 4A-104

    Members of the public are welcome to observe the business of the meeting and, if time allows, may make oral statements during the specified period for public comment. To attend the meeting and/or to make oral statements regarding any of the items on the agenda, email [email protected] In the email, please indicate your name, organization (if appropriate), citizenship, and contact information. Please note that foreign nationals participating in the public meeting are subject to advance security screening procedures which require advance notice prior to attendance at the public meeting. If you are a foreign national, and wish to participate in the public meeting, please inform DOE as soon as possible by contacting Ms. Regina Washington at (202) 586-1214 or by email: [email protected] so that the necessary procedures can be completed. Anyone attending the meeting will be required to present a government photo identification, such as a passport, driver's license, or government identification. Due to the required security screening upon entry, individuals attending should arrive early to allow for the extra time needed.

    Due to the REAL ID Act implemented by the Department of Homeland Security (DHS) recent changes have been made regarding ID requirements for individuals wishing to enter Federal buildings from specific states and U.S. territories. Driver's licenses from the following states or territory will not be accepted for building entry and one of the alternate forms of ID listed below will be required.

    DHS has determined that regular driver's licenses (and ID cards) from the following jurisdictions are not acceptable for entry into DOE facilities: Alaska, Louisiana, New York, American Samoa, Maine, Oklahoma, Arizona, Massachusetts, Washington, and Minnesota.

    Acceptable alternate forms of Photo-ID include: U.S. Passport or Passport Card; an Enhanced Driver's License or Enhanced ID-Card issued by the states of Minnesota, New York or Washington (Enhanced licenses issued by these states are clearly marked Enhanced or Enhanced Driver's License); A military ID or other Federal government issued Photo-ID card.

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

    Issued in Washington, DC, on April 8, 2016. Kathleen B. Hogan, Deputy Assistant Secretary for Energy Efficiency, Energy Efficiency and Renewable Energy.
    [FR Doc. 2016-08886 Filed 4-15-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 300, 330, and 610 [Docket No. FDA-2015-N-1260] RIN 0910-AF89 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph Proposed Rule; Reopening of the Comment Period AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule; reopening of the comment period.

    SUMMARY:

    The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule, published in the Federal Register of December 23, 2015 (80 FR 79776), revising its regulations on prescription and nonprescription fixed-combination and co-packaged drugs and on combinations of active ingredients under consideration for inclusion in an over-the-counter monograph. FDA is reopening the comment period to permit time for additional comments.

    DATES:

    Submit either electronic or written comments by May 18, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2015-N-1260 for “Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph Proposed Rule; Reopening of the Comment Period.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Diana J. Pomeranz, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240-402-4654.

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of December 23, 2015 (80 FR 79776), FDA published a proposed rule to revise its regulations on prescription and nonprescription fixed-combination and co-packaged drugs and on combinations of active ingredients under consideration for inclusion in an over-the-counter monograph. Interested persons were originally given until March 22, 2016, to comment on the proposed rule.

    On March 21, 2016, FDA received a request to allow interested persons additional time to comment. The requester asserted that the time period of 90 days was insufficient to respond fully to FDA's specific requests for comments and to thoroughly evaluate and address pertinent issues. Accordingly, we are reopening the comment period.

    Dated: April 13, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08888 Filed 4-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-109822-15] RIN 1545-BM70 Country-by-Country Reporting; Hearing AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Notice of a public hearing on notice of proposed rulemaking.

    SUMMARY:

    This document provides a notice of public hearing on proposed regulations that would require annual country-by-country reporting by certain United States persons that are the ultimate parent entity of a multinational enterprise group.

    DATES:

    The public hearing is being held on Friday, May 13, 2016, at 10 a.m. The IRS must receive outlines of the topics to be discussed at the public hearing by Friday, April 29, 2016.

    ADDRESSES:

    The public hearing is being held in the IRS Auditorium, Internal Revenue Service Building, 1111 Constitution Avenue NW., Washington, DC 20224. Due to building security procedures, visitors must enter at the Constitution Avenue entrance. In addition, all visitors must present photo identification to enter the building.

    Send Submissions to CC:PA:LPD:PR (REG-109822-15), Room 5205, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday to CC:PA:LPD:PR (REG-109822-15), Couriers Desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC 20224 or sent electronically via the Federal eRulemaking Portal at www.regulations.gov (IRS REG-109822-15).

    FOR FURTHER INFORMATION CONTACT:

    Concerning the proposed regulations, Melinda Harvey at (202) 317-6934; concerning submissions of comments, the hearing and/or to be placed on the building access list to attend the hearing Oluwafunmilayo Taylor at (202) 317-6901 (not toll-free numbers).

    SUPPLEMENTARY INFORMATION:

    The subject of the public hearing is the notice of proposed rulemaking (REG-109822-15) that was published in the Federal Register on Wednesday, December 23, 2015 (80 FR 79795).

    The rules of 26 CFR 601.601(a)(3) apply to the hearing. Persons who wish to present oral comments at the hearing that submitted written comments by March 22, 2016, must submit an outline of the topics to be addressed and the amount of time to be denoted to each topic by Friday, April 29, 2016.

    A period of 10 minutes is allotted to each person for presenting oral comments. After the deadline for receiving outlines has passed, the IRS will prepare an agenda containing the schedule of speakers. Copies of the agenda will be made available, free of charge, at the hearing or in the Freedom of Information Reading Room (FOIA RR) (Room 1621) which is located at the 11th and Pennsylvania Avenue NW., entrance, 1111 Constitution Avenue NW., Washington, DC 20224.

    Because of access restrictions, the IRS will not admit visitors beyond the immediate entrance area more than 30 minutes before the hearing starts. For information about having your name placed on the building access list to attend the hearing, see the FOR FURTHER INFORMATION CONTACT section of this document.

    Martin V. Franks, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel, (Procedure and Administration).
    [FR Doc. 2016-08882 Filed 4-15-16; 8:45 am] BILLING CODE 4830-01-P
    DEPARTMENT OF EDUCATION 34 CFR Chapter II [Docket ID ED-2016-OESE-0004; CFDA Number: 84.368A.] Proposed Priorities—Enhanced Assessment Instruments AGENCY:

    Office of Elementary and Secondary Education, Department of Education.

    ACTION:

    Proposed priorities.

    SUMMARY:

    The Assistant Secretary for Elementary and Secondary Education proposes priorities under the Enhanced Assessment Instruments Grant program, also called the Enhanced Assessment Grants (EAG) program. The Assistant Secretary may use one or more of these priorities for competitions using funds from fiscal year (FY) 2016 and later years. Depending on the availability of funds and the use of other priorities under the EAG authority, the Assistant Secretary may also choose not to use one or more of these priorities for competitions using funds from FY 2016 and later years. These proposed priorities are designed to support projects to improve States' assessment systems.

    DATES:

    We must receive your comments on or before May 18, 2016.

    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 and the term “Enhanced Assessment Grants—Comments” 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 the “Help” tab.

    Postal Mail, Commercial Delivery, or Hand Delivery: If you mail or deliver your comments about these proposed priorities, address them to the Office of Elementary and Secondary Education, Attention: Enhanced Assessment Grants—Comments, U.S. Department of Education, 400 Maryland Avenue SW., Room 3e124, Washington, DC 20202-6132.

    Privacy Note:

    The Department of Education's (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:

    Donald Peasley. Telephone: (202) 453-7982 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:

    Invitation to Comment: We invite you to submit comments regarding this notice. To ensure that your comments have maximum effect in developing the notice of final priorities, we urge you to identify clearly the specific proposed 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 these proposed priorities. 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 about these proposed priorities by accessing regulations.gov. You may also inspect the comments in room 3e124, 400 Maryland Avenue SW., 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 EAG program is to enhance the quality of assessment instruments and systems used by States for measuring the academic achievement of elementary and secondary school students.

    Program Authority: Section 6112 of the Elementary and Secondary Education Act of 1965 (ESEA), as amended by the No Child Left Behind Act of 2001 (NCLB), and section 1203(b)(1) of the ESEA, as amended by the Every Student Succeeds Act (Pub. L. 114-95) (ESSA).

    Proposed Priorities:

    This notice contains three proposed priorities.

    Background:

    Section 6112 of the ESEA, as amended by the NCLB, and section 1203(b)(1) of the ESEA, as amended by the ESSA, authorize the Department to make competitive grant awards to State educational agencies (SEAs) and consortia of SEAs to help them enhance the quality of their assessment instruments and assessment systems.1 Under these provisions, State grantees must meet at least one of the program's statutory priorities, including collaborating with organizations to improve the quality, validity, reliability, and efficiency of academic assessments; measuring student academic achievement using multiple measures from multiple sources; measuring student growth on State assessments; and evaluating student academic achievement through the development of comprehensive academic assessment instruments and methods.

    1 The Consolidated Appropriations Act, 2016 (Pub. L. 114-113) appropriated funds for the EAG program under section 6112 of the ESEA, as amended by the NCLB. As such, the upcoming EAG competition will be conducted under that authority. The Department is also establishing these priorities under the authority in section 1203(b)(1) of the ESEA, as amended by the ESSA, which, if funded, would replace the EAG program under section 6112. These priorities may also be used in any competition conducted after FY 2016 under that authority.

    The grants awarded under this competitive grant award program in section 6112 will also lay the groundwork for some new opportunities in the recently reauthorized Elementary and Secondary Education Act of 1965, as amended by the Every Student Succeeds Act. For example, the reauthorization of ESEA, will allow up to seven States or consortia of States to receive an initial demonstration authority to establish an innovative assessment and accountability system for a new approach to assessment for a trial period of up to five years. This can provide SEAs with an opportunity to demonstrate what is possible when assessment systems are redesigned with student learning at the center. The EAG program provides SEAs with support to develop innovative assessment tools and approaches which have the potential to be used by all States, including those approved under the innovative assessment and accountability demonstration authority, and be more widely adopted at scale. In addition, the EAG program provides SEAs with support in developing innovative summative assessment tools and approaches that can be used within the broader context of the multiple measures of student achievement and school accountability of the new ESSA and the President's Testing Action Plan.

    Through this notice, the Department proposes three additional priorities for the EAG program that are designed to support States in continuously improving their assessment systems to measure college- and career-readiness. We believe that an essential part of educating students involves assessing students' progress toward meeting the high standards they need to be ready for college and the workplace. Assessments provide necessary information for States, districts, educators, families, the public, and students themselves to measure progress and improve outcomes for all learners. As such, we recognize the importance of continuously improving and innovating to ensure assessments are fair, of high quality and not duplicative, can be completed in the minimum necessary time while validly and reliably measuring a student's knowledge and skills, and reflect the expectation that students will be prepared for success in college and careers.

    Proposed Priority 1—Developing Innovative Assessment Item Types and Design Approaches.

    Background: The President's Testing Action Plan highlighted the need to reduce the time spent on unnecessary, duplicative, or low-quality testing and improve assessment efficiency and quality to provide educators and parents with more timely and actionable data on students' progress. SEAs and LEAs need to continue developing new methods for collecting evidence about what students know and are able to do as it relates to State learning standards, including by creating innovative item types and design approaches, for example, by developing modular assessments that are given throughout the school year instead of a single summative assessment given at the end of the school year.

    Although traditional assessment items such as multiple-choice questions have advantages, innovative item types such as performance tasks, simulations, and interactive, multi-step, technology-rich items that support competency-based assessments or portfolio assessments which demonstrate applied skills, have the potential to provide a more comprehensive view of a student's knowledge and mastery of standards. Examples include: Items that provide multi-step mathematics problems where students demonstrate their approaches to solving each step; items that permit graphs or other visual response types; and simulated game environments where students interact with stimuli and interaction information is collected.

    As States implement more rigorous standards, it is important that assessment strategies are aligned with the higher-level cognitive skills students are expected to master.2 For example, performance tasks and simulations provide an opportunity for students to apply their understanding and demonstrate their abilities in real-world scenarios. Rather than simply requiring a student to select a response from a list of options, competency-based assessments can allow students to interact with material and concepts to formulate responses. Students' responses to, and performance on, such innovative item types provide insight into their higher-level thinking and problem-solving skills and allow educators to better understand students' mastery of content and concepts.3

    2 Darling-Hammond, Linda, et al. (2013). Criteria for High-Quality Assessment (SCOPE, CRESST, LSRI Policy Brief). https://edpolicy.stanford.edu/sites/default/files/publications/criteria-higher-quality-assessment_1.pdf.

    3 Gorin, Joanna S. (2007). Test Design with Cognition in Mind.

    We believe that good assessments should require the same kind of complex work that students do in an effective classroom or in the real world, including demonstration and application of knowledge and skills. Further, assessments should present information and questions that push students' critical thinking skills so that students gain valuable experience while taking them. The inclusion of new, innovative item types will help to ensure that taking an assessment is a worthwhile experience for students.

    Modular assessment approaches also can help SEAs and LEAs support students and educators in a number of significant ways by breaking down large, summative assessment forms with many items into smaller forms with fewer items (e.g., testing only one mathematics or reading competency). This will allow students to be assessed on specific competencies when they are ready and capable of demonstrating proficiency. This can allow advanced students to move ahead rapidly while providing students who need extra support the flexibility and additional time they need to learn and succeed, as well as the opportunity to demonstrate competence in the areas they have mastered.

    Modules can also provide educators with more individualized, easily-integrated assessments which are used together to provide a summative analysis of each learner.

    Proposed Priority: Under this priority, SEAs must:

    (a) Develop, evaluate, and implement new, innovative item types for use in summative assessments in reading/language arts, mathematics, or science;

    (1) Development of innovative item types under paragraph (a) may include, for example, performance tasks; simulations; or interactive, multi-step, technology-rich items that can support competency-based assessments or portfolio projects;

    (2) Projects under this priority must be designed to develop new methods for collecting evidence about a student's knowledge and abilities and ensure the quality, validity, reliability, and fairness of the assessment and comparability of student data; or

    (b) Develop new approaches to transform traditional, end-of-year summative assessment forms with many items into a series of modular assessment forms, each with fewer items.

    (1) To respond to paragraph (b), applicants must develop modular assessment approaches which can be used to provide timely feedback to educators and parents as well as be combined to provide a valid, reliable, and fair summative assessment of individual learners.

    (c) Applicants proposing projects under either paragraph (a) or (b) must provide a dissemination plan such that their projects can serve as models and resources that can be shared with States across the Nation.

    Proposed Priority 2—Improving Assessment Scoring and Score Reporting.

    Background: By improving assessment scoring and score reporting, SEAs can enhance the testing experience for students and provide more timely and relevant information to parents and educators. While developing high-quality assessments that measure student knowledge and skills against States' standards is an essential part of building strong assessment systems, ensuring that assessment results are available sooner, and provide clear and actionable information is also critically important.

    With continued advancements in technology to support and enhance education in the classroom, it is also becoming possible to improve the testing experience for students by using technology to automatically score non-multiple choice assessment items. Automated scoring can decrease the time needed for scoring and releasing results, lower costs, improve score consistency, and reduce the need for training of, and coordination among, human scorers.4 Recent research has examined existing automated scoring systems for short and extended constructed responses and found these automated scoring systems to be similar to human scorers.5

    4 Williamson, David M., Xiaoming Xi, and F. Jay Breyer. (2012). A Framework for Evaluation and Use of Automated Scoring. Educational Measurement: Issues and Practice. Volume 31, Issue 1, Pages 2-13.

    5 Shermis, Mark D., and Ben Hamner. (2012). Contrasting State-of-the-Art Automated Scoring of Essays: Analysis, National Council on Measurement in Education. www.scoreright.org/NCME_2012_Paper3_29_12.pdf; Shermis, Mark D. (2013). Contrasting State-of-the-Art in the Machine Scoring of Short-Form Constructed Responses. Educational Assessment. www.tandfonline.com/doi/pdf/10.1080/10627197.2015.997617.

    Building on the work done to date and developing better technological tools to score assessments would be advantageous to SEAs, LEAs, educators, and students. Automated scoring would allow SEAs to incorporate more non-multiple choice items, such as essays and constructed responses, in assessments while not adding significantly to the time or cost to score the tests. Assessment results could be returned more quickly to students and educators, who could in turn respond to the results data through timely implementation of additional teaching, supports, or interventions that would help students master content.6 The inclusion of additional non-multiple choice items can also enhance the testing experience for students by requiring more engaging and complex demonstrations of knowledge. To improve scoring, applicants responding to this priority could propose projects to build, test, or enhance automated scoring systems for use with non-multiple choice items in reading/language arts, mathematics, and science. For example, an applicant could propose to build, test, or improve a system for reviewing brief or extended student-constructed responses. Applicants could propose projects that will research, build, or test systems that can score assessments and provide diagnostic information to educators and parents.

    6 For example, the Institute of Education Sciences has recently invested in projects that are promising examples of how technology can be leveraged to improve scoring. The aim of one such project is to develop a computerized oral reading fluency assessment (see https://ies.ed.gov/funding/grantsearch/details.asp?ID=1492). Traditional oral reading fluency assessments require one-on-one administration and hand-scoring, a time-consuming and resource-intensive process that is prone to scoring errors. The assessment under development uses speech recognition software to record and score students' oral reading fluency, making processes more efficient and less prone to scoring errors. Another such project is aimed at developing a new assessment tool to measure the science and math skills of middle school English learners (see https://ies.ed.gov/funding/grantsearch/details.asp?ID=1475). It features auto-scoring to give immediate feedback to teachers and students.

    Score reporting, when done well, provides valuable feedback to educators that can be used to guide instruction and supports for students. This feedback is most relevant when it is available soon after the assessment is administered and when it is actionable for students, parents, and educators. The Department also recognizes a need to improve the design and content of the reports such that they clearly communicate information to stakeholders.

    Efforts to improve the usefulness of score reports could include: Incorporating information about what students' results mean; including multiple levels of information (e.g., overall proficiency, mastery of different standards or skills); 7 providing examples of questions that were likely to be answered correctly or incorrectly (and why); and connecting students and their families to useful resources or aids to address identified areas for improvement. Improving communications related to score reporting could include: Presenting information in easily comprehensible formats (e.g., graphically or numerically); tailoring reporting formats to different audiences or for different modes of dissemination; making results available in a timelier manner (i.e., delivered to teachers and parents as soon as possible after the assessments are administered).

    7 Zapata-Rivera, Diego, and Rebecca Zwick. (2011). Improving Test Score Reporting: Perspectives from the ETS Score Reporting Conference. www.ets.org/Media/Research/pdf/RR-11-45.pdf.

    Proposed Priority: Under this priority, SEAs must:

    (a) Develop innovative tools that leverage technology to score assessments;

    (1) To respond to paragraph (a), applicants must propose projects to reduce the time it takes to provide test results to educators, parents, and students and to make it more cost-effective to include non-multiple choice items on assessments. These innovative tools must improve automated scoring of student assessments, in particular non-multiple choice items in reading/language arts, mathematics, and science; or

    (b) Propose projects, in consultation with organizations representing parents, students, and teachers, to address needs related to score reporting and improve the utility of information about student performance included in reports of assessment results and provide better and more timely information to educators and parents;

    (1) To respond to paragraph (b), applicants must include one or more of the following in their projects:

    (i) Developing enhanced score reporting templates or digital mechanisms for communicating assessment results and their meaning;

    (ii) Improving the assessment literacy of educators and parents to improve the interpretation of test results to support teaching and learning in the classroom; and

    (iii) Developing mechanisms for secure transmission and individual use of assessment results by students and parents.

    (c) Applicants proposing projects under either paragraph (a) or (b) must provide a dissemination plan such that their projects can serve as models and resources that can be shared with States across the Nation.

    Proposed Priority 3—Inventory of State and Local Assessment Systems.

    Background: Recently, there has been significant discussion about the amount of time students spend in formal testing, including classroom, district, and State assessments. While the Department believes that assessments are important tools for measuring progress and improving outcomes for all students, we also recognize that too much testing, or unnecessary testing, takes valuable time away from teaching and learning in the classroom.8

    8 As a part of the President's Testing Action Plan, The Department has recently released a Dear Colleague Letter to State Chief School Officers providing examples of existing Federal funding streams, and best practices, which can be utilized at the State and local levels to improve assessment systems and reduce unnecessary testing: http://www2.ed.gov/admins/lead/account/saa/16-0002signedcsso222016ltr.pdf.

    In response to this issue, some SEAs, local educational agencies (LEAs), and schools are currently in the process of reviewing assessments administered to students in kindergarten through grade 12 to better understand if each assessment is of high quality, maximizes instructional goals, has clear purpose and utility, and is designed to provide information on students' progress toward achieving proficiency on State standards. To support such efforts, the Department made the development of tools to inventory State and local assessment systems an invitational priority in the FY 2015 EAG competition. Through this proposed priority, the Department would fund States that are reviewing and streamlining their statewide assessments and working with some or all of their LEAs to review and streamline local assessments, including eliminating redundant and unnecessary assessments.

    This priority would support the identification of promising practices that could be followed by other SEAs, LEAs, and schools to maximize the utility of their assessments to parents, educators, and students.

    Proposed Priority:

    (a) Under this priority, SEAs must—

    (1) Review statewide and local assessments to ensure that each test is of high quality, maximizes instructional goals, has a clear purpose and utility, and is designed to help students demonstrate mastery of State standards;

    (2) Determine whether assessments are serving their intended purpose to help schools meet their goals and to eliminate redundant and unnecessary testing; and

    (3) Review State and LEA activities related to test preparation to make sure those activities are focused on academic content and not on test-taking skills.

    (b) To meet the requirements in paragraph (a), SEAs must ensure that tests are—

    (1) Worth taking, meaning that assessments are a component of good instruction and require students to perform the same kind of complex work they do in an effective classroom and the real world;

    (2) High quality, resulting in actionable, objective information about students' knowledge and skills, including by assessing the full range of relevant State standards, eliciting complex student demonstrations or applications of knowledge, providing an accurate measure of student achievement, and producing information that can be used to measure student growth accurately over time;

    (3) Time-limited, in order to balance instructional time and the need for assessments, for example, by eliminating duplicative assessments and assessments that incentivize low-quality test preparation strategies that consume valuable classroom time;

    (4) Fair for all students and used to support equity in educational opportunity by ensuring that accessibility features and accommodations level the playing field so tests accurately reflect what all students, including students with disabilities and English learners, know and can do;

    (5) Fully transparent to students and parents, so that States and districts can clearly explain to parents the purpose, the source of the requirement (if appropriate), and the use by teachers and schools, and provide feedback to parents and students on student performance; and

    (6) Tied to improving student learning as tools in the broader work of teaching and learning.

    (c) Approaches to assessment inventories under paragraph (a) must include:

    (1) Review of the schedule for administration of all assessments required at the Federal, State, and local levels;

    (2) Review of the purpose of, and legal authority for, administration of all assessments required at the Federal, State, and local levels; and

    (3) Feedback on the assessment system from stakeholders, which could include information on how teachers, principals, other school leaders, and administrators use assessment data to inform and differentiate instruction, how much time teachers spend on assessment preparation and administration, and the assessments that administrators, teachers, principals, other school leaders, parents, and students do and do not find useful.

    (d) Projects under this priority—

    (1) Must be no longer than 12 months;

    (2) Must include a longer-term project plan, understanding that, beginning with FY 2017, there may be dedicated Federal funds for assessment audit work as authorized under section 1202 of the ESEA, as amended by the ESSA, and understanding that States and LEAs may use other Federal funds, such as the State assessment grant funds, authorized under section 1201 of the ESEA, as amended by the ESSA, consistent with the purposes for those funds, to implement such plans; and

    (3) Are eligible to receive a maximum award of $200,000.

    Types of Priorities:

    When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register. The effect of each type of priority follows:

    Absolute priority: Under an absolute priority, we consider only applications that meet the priority (34 CFR 75.105(c)(3)).

    Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (34 CFR 75.105(c)(2)(ii)).

    Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the priority a preference over other applications (34 CFR 75.105(c)(1)).

    Final Priorities:

    We will announce the final priorities in a notice in the Federal Register. We will determine the final priorities 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 these priorities, we invite applications through a notice in the Federal Register.

    Paperwork Reduction Act of 1995

    As part of its continuing effort to reduce paperwork and respondent burden, the Department provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This helps ensure that: the public understands the Department's collection instructions, respondents can provide the requested data in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the Department can properly assess the impact of collection requirements on respondents.

    These proposed priorities contain information collection requirements that are approved by OMB under the Departmental application control number 1894-0006; this proposed regulation does not affect the currently approved data collection.

    Executive Orders 12866 and 13563 Regulatory Impact Analysis

    Under Executive Order 12866, the Secretary must determine whether this proposed 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 proposed 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 these proposed priorities only on a reasoned determination that their benefits would justify their 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 regulatory action 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 proposed priorities included in this notice would benefit students, parents, educators, administrators, and other stakeholders by improving the quality of State assessment instruments and systems. The proposed priority for an inventory of State and local assessment systems would encourage States to ensure that assessments are of high quality, maximize instructional goals, and have clear purpose and utility. Further, it would encourage States to eliminate unnecessary or redundant tests. The proposed priority for improving assessment scoring and score reporting would allow for States to score non-multiple choice assessment items more quickly and at a lower cost and ensure that assessments provide timely, actionable feedback to students, parents, and educators. The proposed priority for developing innovative assessment item types and design approaches, including the development of modular assessments, would yield new, more authentic methods for collecting evidence about what students know and are able to do and provide educators with more individualized, easily integrated assessments that can support competency-based learning and other forms of personalized instruction.

    Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.

    This document provides early notification of our specific plans and actions for this program.

    Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT.

    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: April 12, 2016. Ann Whalen, Senior Advisor to the Secretary Delegated the Duties of Assistant Secretary for Elementary and Secondary Education.
    [FR Doc. 2016-08726 Filed 4-15-16; 8:45 am] BILLING CODE 4000-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 131 [EPA-HQ-OW-2016-0012; FRL-9944-70-OW] RIN 2040-AF60 Aquatic Life Criteria for Copper and Cadmium in Oregon AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) proposes to establish federal Clean Water Act (CWA) aquatic life criteria for freshwaters under the state of Oregon's jurisdiction, to protect aquatic life from the effects of exposure to harmful levels of copper and cadmium. In 2013, EPA determined that the freshwater acute cadmium criterion and freshwater acute and chronic copper criteria that Oregon adopted in 2004 did not meet CWA requirements to protect aquatic life in the state. Therefore, EPA proposes to establish federal freshwater criteria for cadmium and copper that take into account the best available science, EPA policies, guidance and legal requirements, to protect aquatic life uses in Oregon.

    DATES:

    Comments must be received on or before June 2, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2016-0012, at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    EPA is offering two virtual public hearings so that interested parties may also provide oral comments on this proposed rule. The first hearing will be on Monday, May 16, 2016 from 4:00pm to 6:00pm Pacific Time. The second hearing will be on Tuesday, May 17, 2016 from 9:00am to 11:00am Pacific Time. For more details on the public hearings and a link to register, please visit http://www.epa.gov/wqs-tech/water-quality-standards-regulations-oregon.

    FOR FURTHER INFORMATION CONTACT:

    Erica Fleisig, Office of Water, Standards and Health Protection Division (4305T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: (202) 566-1057; email address: [email protected].

    SUPPLEMENTARY INFORMATION:

    This proposed rule is organized as follows:

    I. General Information Does this action apply to me? II. Background A. Statutory and Regulatory Authority B. EPA's Disapproval of Oregon's Freshwater Copper and Cadmium Criteria C. General Recommended Approach for Deriving Aquatic Life Criteria III. Freshwater Cadmium Aquatic Life Criteria A. EPA's National Recommended Cadmium Criteria B. Proposed Acute Cadmium Criterion for Oregon's Freshwaters C. Implementation of Proposed Freshwater Acute Cadmium Criterion in Oregon IV. Freshwater Copper Aquatic Life Criteria A. EPA's National Recommended Copper Criteria B. Proposed Acute and Chronic Copper Criteria for Oregon's Freshwaters C. Implementation of Proposed Freshwater Acute and Chronic Copper Criteria in Oregon D. Ongoing State Efforts To Develop Copper Criteria for Oregon's Freshwaters E. Incorporation by Reference V. Critical Low-Flows and Mixing Zones VI. Endangered Species Act VII. Under what conditions will federal standards be not promulgated or withdrawn? VIII. Alternative Regulatory Approaches and Implementation Mechanisms A. Designating Uses B. Site-Specific Criteria C. Variances D. Compliance Schedules IX. Economic Analysis A. Identifying Affected Entities B. Method for Estimating Costs C. Results X. Statutory and Executive Order Reviews A. Executive Order 12866 (Regulatory Planning and Review) and Executive Order 13563 (Improving Regulation and Regulatory Review) B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132 (Federalism) F. Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments) G. Executive Order 13045 (Protection of Children From Environmental Health and Safety Risks) H. Executive Order 13211 (Actions That Significantly Affect Energy Supply, Distribution, or Use) I. National Technology Transfer and Advancement Act of 1995 J. Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations) I. General Information Does this action apply to me?

    Copper and cadmium naturally occur at low levels in surface waters but, at higher concentrations, can be toxic to aquatic life. Anthropogenic activities such as coal combustion, mining, electroplating, iron and steel production, and use of pigments, fertilizers and pesticides, can increase levels of cadmium in the environment. Sources of elevated copper in the environment include mining, fabrication of paper, metal products and electronics, and discharges from wastewater treatment plants.

    Entities such as industries, stormwater management districts, or publicly owned treatment works (POTWs) that discharge pollutants to freshwaters of the United States under the state of Oregon's jurisdiction could be indirectly affected by this rulemaking, because federal WQS promulgated by EPA would be applicable to CWA regulatory programs, such as National Pollutant Discharge Elimination System (NPDES) permitting. Citizens concerned with water quality in Oregon could also be interested in this rulemaking. Categories and entities that could potentially be affected include the following:

    Category Examples of potentially affected entities Industry Industries discharging pollutants to freshwaters of the United States in Oregon. Municipalities Publicly owned treatment works or other facilities discharging pollutants to freshwaters of the United States in Oregon. Stormwater Management Districts Entities responsible for managing stormwater runoff in the state of Oregon.

    This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities that could be indirectly affected by this action. Any parties or entities who depend upon or contribute to the water quality of Oregon's waters could be affected by this proposed rule. To determine whether your facility or activities could be affected by this action, you should carefully examine this proposed rule. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

    II. Background A. Statutory and Regulatory Authority

    CWA section 101(a)(2) establishes a national goal wherever attainable of “water quality which provides for the protection and propagation of fish, shellfish, and wildlife and provides for recreation in and on the water . . . ” These are commonly referred to as the “fishable/swimmable” goals of the CWA.

    CWA section 303(c) (33 U.S.C. 1313(c)) directs states to adopt WQS for their waters subject to the CWA. CWA section 303(c)(2)(A) and EPA's implementing regulations at 40 CFR part 131 require, among other things, that a state's WQS specify designated uses of the waters, and water quality criteria that protect those uses. EPA's regulations at 40 CFR 131.11(a)(1) provide that “[s]uch criteria must be based on sound scientific rationale and must contain sufficient parameters or constituents to protect the designated use.” In addition, 40 CFR 131.10(b) provides that “[i]n designating uses of a water body and the appropriate criteria for those uses, the [s]tate shall take into consideration the water quality standards of downstream waters and shall ensure that its water quality standards provide for the attainment and maintenance of the water quality standards of downstream waters.”

    States are required to review applicable WQS at least once every three years and, if appropriate, revise or adopt new standards (CWA section 303(c)(1)). Any new or revised WQS must be submitted to EPA for review and approval or disapproval (CWA section 303(c)(2)(A) and (c)(3)). If EPA determines that a WQS that a state submits to EPA for review does not meet the requirements of the CWA, EPA must notify the state of the changes necessary to meet CWA requirements (CWA section 303(c)(3)). CWA section 303(c)(3) and (c)(4) further specify that if a state does not make those changes within 90 days of notification, EPA must promptly prepare and publish a revised or new WQS for the state. Under CWA section 303(c)(4)(B), the Administrator is authorized to determine, even in the absence of a state submission, that a new or revised standard is needed to meet CWA requirements.

    Under CWA section 304(a), EPA periodically publishes criteria recommendations for states to consider when adopting water quality criteria for particular pollutants to meet the CWA section 101(a)(2) goals. In establishing numeric criteria, states should adopt water quality criteria based on EPA's CWA section 304(a) criteria, section 304(a) criteria modified to reflect site-specific conditions, or other scientifically defensible methods (40 CFR 131.11(b)(1)). Ultimately, whatever methods are used, criteria must protect the designated use and be based on sound scientific rationale (40 CFR 131.11(a)(1)).

    B. EPA's Disapproval of Oregon's Freshwater Copper and Cadmium Criteria

    On July 8, 2004, Oregon submitted 89 revised aquatic life criteria for 25 toxic pollutants to EPA for review under CWA 303(c). Many of Oregon's revised criteria were the same as EPA's nationally recommended 304(a) aquatic life criteria at the time. A subsequent consent decree between EPA and Northwest Environmental Advocates established deadlines for EPA to complete its CWA 303(c) review of Oregon's aquatic life criteria. Prior to taking a final action on the aquatic life criteria, EPA requested formal consultation with the National Marine Fisheries Service (NMFS) and the U.S. Fish and Wildlife Service (USFWS) on its proposed approval of the criteria, consistent with section 7 of the Endangered Species Act (ESA). EPA initiated this consultation on January 14, 2008, by submitting a biological evaluation to the NMFS and USFWS, which contained an analysis of the potential effects of EPA's proposed approval of Oregon's criteria on threatened and endangered species in Oregon.1

    1 EPA initiated consultation on Oregon's aluminum criteria based on its mistaken belief that Oregon's criteria were entirely equivalent to EPA's 1988 304(a) recommended criteria. However, Oregon's criteria specified that they applied “to waters with pH values less than 6.6 and hardness values less than 12 mg/L (as CaCO3)” whereas EPA's 1988 304(a) recommended criteria “apply at pH values of 6.5-9.0.” EPA ultimately disapproved Oregon's criteria because the state had not supplied a scientific rationale for the difference between Oregon's statement of the conditions under which the criteria would be valid and EPA's specified pH range for the criteria. Since EPA was disapproving the aluminum criteria, it sent a letter to the NMFS and USFWS identifying this change. The USFWS had already completed and transmitted its non-jeopardy opinion to EPA by that point, so it was too late for EPA to withdraw the consultation request for aluminum. However, in the letter to the NMFS, EPA withdrew its request for consultation on Oregon's acute and chronic aluminum criteria.

    On July 31, 2012, the USFWS provided its biological opinion to EPA. The biological opinion found that EPA's proposed approval of Oregon's aquatic life criteria would not jeopardize the continued existence of endangered species for which USFWS was responsible. However, on August 14, 2012, the NMFS concluded in its biological opinion that seven of Oregon's revised freshwater criteria would jeopardize the continued existence of endangered species in Oregon for which the NMFS was responsible. These seven criteria were the freshwater criteria Oregon adopted to protect aquatic life from adverse acute and chronic effects from ammonia, copper, and aluminum,2 as well as the criterion to prevent adverse acute effects from cadmium. The NMFS biological opinion contained Reasonable and Prudent Alternatives (RPAs) for each of the four pollutants that would avoid the likelihood of jeopardy to the species. For acute ammonia and cadmium, and acute and chronic aluminum, the RPA specified a process for deriving revised freshwater criteria. For the chronic ammonia criterion, the RPA specified that Oregon's previously applicable chronic ammonia criterion, which was based on EPA's 1985 304(a) recommendation, should remain in place. The NMFS RPA for acute and chronic copper criteria was to establish “a new acute criterion of 2.3 µg/L for freshwater copper using EPA's 2007 [Biotic Ligand Model (BLM)]-based aquatic life criteria” and “a new chronic criterion of 1.45 µg/L for freshwater copper using EPA's 2007 BLM-based aquatic life criteria.” On January 19, 2016 the NMFS sent EPA a letter clarifying that “. . . use of EPA's 2007 copper BLM to derive copper criteria that are specific to individual locations or ecoregions is appropriate under the RPA, provided that the state of Oregon has the appropriate data to input into the BLM and appropriate procedures to use the BLM.”

    2 The NMFS acknowledged EPA's request to withdraw the aluminum criteria from consultation; however, they did not have time to modify the biological opinion to exclude acute and chronic aluminum from the document.

    On January 31, 2013, EPA disapproved several of Oregon's revised aquatic life criteria under CWA 303(c), including the acute cadmium freshwater criterion, and the acute and chronic freshwater ammonia, copper, and aluminum criteria that the NMFS concluded would jeopardize endangered species in Oregon.3 Oregon made changes to its freshwater ammonia criteria in response to EPA's 2013 disapproval and submitted revised freshwater ammonia criteria to EPA on January 23, 2015. EPA evaluated the revised freshwater ammonia criteria's consistency with the RPA for ammonia contained in the 2012 NMFS biological opinion, concluded that the revised criteria would protect endangered species in Oregon, and approved the revised criteria on August 4, 2015. Although Oregon has been working closely with EPA to derive protective freshwater copper criteria that the state would adopt in a future rulemaking, the state has not yet addressed EPA's 2013 disapproval of its freshwater criteria for cadmium, copper, and aluminum. EPA is proposing the freshwater acute cadmium, and acute and chronic copper criteria in this rule in accordance with CWA section 303(c)(3) and (c)(4) requirements. EPA intends to propose freshwater acute and chronic criteria for aluminum in Oregon in a separate rulemaking at a later date following completion of updates to EPA's CWA section 304(a) recommended criteria for aluminum.

    3 The NMFS determined that the criterion Oregon adopted to protect aquatic life from adverse chronic effects from cadmium would not jeopardize the continued existence of endangered species; EPA approved Oregon's chronic cadmium criterion in January 2013.

    C. General Recommended Approach for Deriving Aquatic Life Criteria

    Under the Agency's CWA section 304(a) authority, EPA develops methodologies and specific criteria to protect aquatic life and human health. These methodologies and criteria are subject to public as well as scientific expert review before EPA releases them as formal agency recommendations for states to consider when developing and adopting water quality criteria. To derive criteria for the protection of aquatic life, EPA follows its Guidelines for Deriving Numerical National Water Quality Criteria for the Protection of Aquatic Organisms and Their Uses (referred to as the “1985 Guidelines”).4 These guidelines describe an objective way to estimate the highest concentration of a substance in water that will not present a significant risk to the aquatic organisms in the water.

    4 USEPA. 1985. Guidelines for Deriving Numerical National Water Quality Criteria for the Protection of Aquatic Organisms and Their Uses. U.S. Environmental Protection Agency, Office of Research and Development, Duluth, MN, Narragansett, RI, Corvallis, OR. PB85-227049. http://www.epa.gov/sites/production/files/2015-08/documents/guidelines_for_deriving_nnwqc_for_the_protectin_of_aquatic_organisms_and_their_uses.pdf.

    Numeric criteria derived using EPA's 1985 Guidelines are expressed as short-term (acute) and long-term (chronic) values. The combination of a criteria maximum concentration (CMC), a one-hour average value, and a criteria continuous concentration (CCC), a four-day average value, protects aquatic life from acute and chronic toxicity, respectively.5 Neither value is to be exceeded more than once in three years. EPA selected the CMC's one-hour averaging period because high concentrations of certain pollutants can cause death in one to three hours, and selected the CCC's four-day averaging period to prevent increased adverse effects on sensitive life stages. EPA based its once every three years exceedance frequency recommendation on the ability of aquatic ecosystems to recover from the exceedances (when the average concentration over the duration of the averaging period is above the CCC or the CMC).6

    5 In EPA's 2001 304(a) recommendation for cadmium and the 2007 304(a) recommendation for copper, EPA specified that the acute cadmium and copper criteria (CMCs) had 24-hour (rather than one-hour) durations. Subsequently, in the 2016 304(a) update for cadmium, EPA revised the cadmium CMC duration to one-hour to reflect the acute criteria duration recommended in the 1985 Guidelines. EPA proposes that the duration for both copper and cadmium CMCs in this rule be one-hour, to be consistent with the updated 304(a) recommendation for cadmium and with EPA's 1985 Guidelines. As articulated on page 35 of USEPA's 1991 Technical Support Document for Water Quality-based Toxics Control, March, 1991 (EPA/505/2-90-001), a one-hour averaging period is expected to be fully protective for the fastest-acting toxicants, and even more protective for slower-acting toxicants.

    6See USEPA, 1985. Pages. 5-7.

    Since fresh and salt waters have different chemical compositions and different species assemblages, it is necessary to derive separate acute and chronic criteria for fresh and salt waters. Additionally, criteria may be based on certain water characteristics (e.g., pH, temperature, hardness, dissolved organic carbon (DOC), etc.), since water chemistry can influence a pollutant's bioavailability and toxicity. For metals in particular, EPA recommends expressing the criteria as functions of chemical constituents of the water, since those constituents can form complexes with metals and render the metals biologically unavailable, or compete with metals for binding sites on aquatic organisms. Additionally, in 1995, EPA recommended that criteria for metals be expressed as dissolved (rather than total) metal concentrations, since the concentration of dissolved metal better approximates the toxic fraction.7

    7Water Quality Standards; Establishment of Numeric Criteria for Priority Toxic Pollutants; States' Compliance—Revision of Metals Criteria, May 4, 1995, 60 FR 22229.

    The 1985 Guidelines specify that it is necessary to have toxicity test data from a minimum of eight families of aquatic organisms to derive criteria. These families are intended to be representative of a wide spectrum of aquatic life, and act as surrogates for untested species. Therefore, the specific test organisms do not need to be present in the water(s) where the criteria will apply. However, states may develop site-specific criteria using species residing at the site if they maintain similar broad taxonomic representation. EPA derives acute criteria from 48- to 96-hour tests of lethality or immobilization. EPA derives chronic criteria from longer term (often longer than 28-day) tests that measure survival, growth, or reproduction. If sufficient chronic toxicity data are not available, chronic criteria are set by determining a ratio of acutely toxic to chronically toxic concentrations. Where appropriate, EPA recommends that criteria are lowered to protect commercially or recreationally important species.

    For more detailed information on how EPA derives protective aquatic life criteria, see the 1985 Guidelines.8

    8See USEPA, 1985.

    III. Freshwater Cadmium Aquatic Life Criteria A. EPA's National Recommended Cadmium Criteria

    Water hardness (determined by the presence of calcium and magnesium ions, and expressed as calcium carbonate, CaCO3) affects the toxicity of cadmium, as calcium and magnesium ions compete with cadmium for binding sites on aquatic organisms' gills. Organisms show more sensitivity to cadmium in lower hardness (soft) water than in hard water. EPA therefore expresses the national 304(a) recommended acute and chronic cadmium criteria as functions of water hardness.

    EPA previously published final 304(a) recommended aquatic life criteria for cadmium in 2001.9 In recent years, EPA embarked on an update to the science underlying the 2001 national cadmium criteria recommendations. This work included a literature search of toxicological databases, evaluation of those data, recalculation of the criteria based on those data updates, and revision of supporting documentation. In 2015, EPA completed an external peer review of the draft updated cadmium criteria and revised them accordingly. EPA then published the draft criteria for public comment in the Federal Register, and solicited comments for 60 days (December 1, 2015, 80 FR 75097). EPA revised the criteria to respond to the public comments, and expects the final national updated 304(a) recommended cadmium criteria to be published in the Federal Register in April 2016.10

    9 The 2001 304(a) national recommended freshwater cadmium criteria were the same criteria that Oregon adopted and submitted to EPA in 2004.

    USEPA. 2001. 2001 Update of Ambient Water Quality Criteria for Cadmium. U.S. Environmental Protection Agency, Office of Water, Washington, DC EPA-822-R-01-001. http://water.epa.gov/scitech/swguidance/standards/criteria/current/index.cfm#altable.

    10 See http://www.epa.gov/wqc/aquatic-life-criteria-cadmium.

    B. Proposed Acute Cadmium Criterion for Oregon's Freshwaters

    To protect aquatic life in Oregon's freshwaters from acute toxic effects from cadmium, EPA proposes the one-hour average CMC not exceed e(0.9789 × ln(hardness)−3.866) × CF (µg/L, dissolved) more than once every three years. “CF” refers to the conversion factor and is used to convert the total recoverable concentration to a dissolved concentration, consistent with EPA's policy on criteria for metals. The equation for the acute cadmium CF is CF = 1.136672−[(ln hardness) × (0.041838)]. This is the same freshwater acute cadmium criterion (and associated CF) as in EPA's final 2016 national updated 304(a) recommended cadmium criteria. The (ln hardness) term in both the CMC equation and the CF equation is the natural logarithm of the ambient water hardness in mg/L (CaCO3).

    Where site-specific hardness data are unavailable, EPA proposes to use a default hardness concentration of 25 mg/L (as CaCO3), which equates to a one-hour average dissolved cadmium concentration of 0.49 µg/L.11 As with other metals criteria in Oregon that are expressed as a function of hardness, the acute cadmium criterion equation requires ambient hardness data that represent the entire site to which the criterion will apply to calculate an acute cadmium criterion for a site. EPA strongly recommends that Oregon collect sufficiently representative ambient hardness data to determine the appropriate acute cadmium criterion for a site. However, EPA recognizes that, in certain situations, there will not be sufficiently representative ambient hardness data to adequately characterize the site; thus, EPA is proposing a default hardness concentration to provide clarity to NPDES permit writers and water body assessors on what acute cadmium criterion applies at the site. EPA evaluated the protectiveness of using a default hardness of 25 mg/L by calculating the 10th percentile of existing hardness concentrations in Oregon's waters, using U.S. Geological Survey (USGS) data on calcium and magnesium ion levels in waters within each of the nine Level III ecoregions in Oregon.12 EPA selected the 10th percentile as a statistic that is both protective and can be reliably determined from small sample sizes. The USGS dataset that EPA evaluated indicates that the lowest 10th percentile ecoregional hardness in Oregon is 28 mg/L, suggesting that a default hardness concentration of 25 mg/L would be protective of the majority of Oregon's waters. However, certain water bodies in Oregon, such as relatively un-impacted headwaters, could have hardness concentrations below 25 mg/L, and Oregon should prioritize collecting ambient hardness data in those waters to ensure the resulting acute cadmium criteria are protective of aquatic life.

    11 Oregon currently uses a default hardness concentration of 25 mg/L if no hardness data are available to calculate hardness-dependent metals criteria. See Oregon Department of Environmental Quality. 2014. Methodology for Oregon's 2012 Water Quality Report and List of Water Quality Limited Waters (Pursuant to Clean Water Act Sections 303(d) and 305(b) and OAR 340-041-0046). Pages 76-77.

    12 EPA used 10th percentile calcium and magnesium data from USEPA's Draft Technical Support Document: Recommended Estimates for Missing Water Quality Parameters for Application in EPA's Biotic Ligand Model, February 16, 2016 (EPA 820-R-15-106), along with the following equation to relate calcium and magnesium to hardness: mg/L CaCO3 = 2.5*(calcium concentration in mg/L as Ca2+) + 4.1*(magnesium concentration in mg/L as Mg2+).

    For a map of Level III ecoregions in the continental United States, see http://archive.epa.gov/wed/ecoregions/web/html/level_iii_iv-2.html#LevelIII.

    EPA's proposal to use a default hardness of 25 mg/L in the absence of sufficiently representative ambient hardness data should not be confused with use of a low-end hardness floor even when ambient data are available measuring hardness below 25 mg/L. Consistent with EPA guidance, a site's actual ambient water hardness should be used to calculate the criterion when sufficiently representative hardness data are available, even if the hardness is below 25 mg/L.13

    13 USEPA. 2002. National Recommended Water Quality Criteria: 2002. U.S. Environmental Protection Agency, Office of Water, Washington, DC EPA-822-R-02-047.

    In describing potential remedies to address EPA's January 2013 disapproval, EPA noted that “new scientific data on the toxicity of cadmium [are] now available and would need to be reviewed regarding their quality and relevance prior to being considered in developing an updated recommendation for a specific numeric criterion protective of Oregon aquatic life.” 14 EPA's 2016 section 304(a) recommended cadmium criteria update represents a thorough review and incorporation of the latest scientific data on cadmium toxicity to aquatic life. The updated 304(a) recommended freshwater acute cadmium criterion, which EPA is proposing to apply in Oregon, now incorporates a more robust dataset on cadmium's acutely toxic effects, and was lowered to protect commercially and recreationally important salmonids, consistent with EPA's 1985 Guidelines. Additionally, EPA's proposal of a default hardness value as part of the criterion for Oregon will ensure that protective cadmium criteria can be easily derived for all freshwaters in the state. Therefore, EPA proposes that the 2016 section 304(a) recommended acute cadmium criterion, in combination with a protective hardness default that will apply in the absence of sufficiently representative ambient hardness data, will protect aquatic life in Oregon.

    14 USEPA. 2013. EPA Clean Water Act 303(c) Determinations On Oregon's New and Revised Aquatic Life Toxic Criteria Submitted on July 8, 2004, and as Amended by Oregon's April 23, 2007 and July 21, 2011 Submissions. Page 46.

    C. Implementation of Proposed Freshwater Acute Cadmium Criterion in Oregon

    When calculating a hardness-based criterion value, Oregon should consider the following when defining a site to which the acute cadmium criterion applies: (1) Metals are generally persistent, so calculating the criterion using hardness values from a small site at or near the discharge point could result in a criterion that is not protective of areas that are outside the defined site, and (2) as the size of a site increases, the spatial and temporal variability is likely to increase; thus, more water samples may be required to adequately characterize the entire site.15 Additionally, pursuant to 40 CFR 131.10(b), Oregon must consider downstream WQS when calculating a protective criterion concentration in upstream waters.

    15 USEPA. 1994. Interim Guidance on Determination and Use of Water-Effect Ratios for Metals. U.S. Environmental Protection Agency, Office of Water, Washington, DC EPA-823-B-94-001. February 1994.

    When setting Water Quality-Based Effluent Limitations (WQBELs), Oregon should determine the water body's ambient hardness level under critical conditions (i.e., low hardness) when cadmium toxicity is expected to be higher, such that the resulting cadmium criterion is protective of the entire site at critical and less than critical conditions. EPA's NPDES Permit Writers' Manual describes the importance of determining effluent and receiving water critical conditions, because if a discharge is controlled so that it does not cause water quality criteria to be exceeded in the receiving water under critical conditions, then water quality criteria should be attained under all other conditions.16 Because organisms are more sensitive to cadmium when corresponding hardness concentrations are low, Oregon should ensure that sufficiently representative ambient hardness data are collected to have confidence that critical conditions in the water body are being adequately captured.

    16 USEPA. 2010. NPDES Permit Writers' Manual. U.S. Environmental Protection Agency, Office of Water, Washington, DC EPA-833-K-10-001. September 2010.

    Substantial changes in a site's ambient hardness will likely affect the resulting acute cadmium criterion at that site. Therefore, EPA recommends that Oregon periodically revisit each water body's acute cadmium criterion and re-run the equation when changes in water hardness are evident or suspected at a site, and also as additional monitoring data become available.

    IV. Freshwater Copper Aquatic Life Criteria A. EPA's National Recommended Copper Criteria

    In 2007, EPA issued revised section 304(a) national recommended freshwater aquatic life criteria for copper that represent the best available science and understanding of the interaction between water chemistry and copper toxicity.17 These criteria recommendations incorporate use of a Biotic Ligand Model (BLM), which is a metal bioavailability model that uses receiving water body characteristics to develop water quality criteria on a site-specific basis. The BLM requires ambient data on ten water body-specific characteristics to calculate a freshwater copper criterion (temperature, pH, dissolved organic carbon (DOC), calcium, magnesium, sodium, potassium, sulfate, chloride, and alkalinity).

    17 USEPA. 2007. Aquatic Life Ambient Freshwater Quality Criteria—Copper. U.S. Environmental Protection Agency, Office of Water, Washington, DC EPA-822-R-07-001. http://water.epa.gov/scitech/swguidance/standards/criteria/aqlife/copper/upload/2009_04_27_criteria_copper_2007_criteria-full.pdf.

    Along with the criteria recommendations, EPA released supplementary materials related to using the BLM on a site-specific basis to derive criteria. Training materials that EPA released in 2007 discussed considerations such as collecting sufficiently representative data to account for a site's spatial and temporal variability, properly defining the site to which the BLM-derived criterion applies, reconciling multiple model runs, and estimating input parameters when site-specific data are lacking.18 To address situations where site-specific data are not available for some of the BLM's ten input variables, EPA published for public comment the Draft Technical Support Document: Recommended Estimates for Missing Water Quality Parameters for Application in EPA's Biotic Ligand Model (EPA 820-R-15-106) on February 16, 2016 (81 FR 7784).

    18 USEPA. 2007. Copper Aquatic Life Criteria: Supplementary Training Materials. U.S. Environmental Protection Agency, Office of Water, Washington, DC http://water.epa.gov/scitech/swguidance/standards/criteria/aqlife/copper/faq_index.cfm. See “Data Requirements.”

    B. Proposed Acute and Chronic Copper Criteria for Oregon's Freshwaters

    To protect aquatic life in Oregon's freshwaters, EPA proposes the CMC and CCC based on the 2007 304(a) recommended copper BLM. EPA proposes to express the CMC as a one-hour average dissolved copper concentration (in µg/L) and the CCC as a four-day average dissolved copper concentration (in µg/L), and that the CMC and CCC are not to be exceeded more than once every three years.

    As with hardness data used to determine the acute cadmium criterion discussed earlier, EPA recommends that Oregon collect ambient data to determine protective copper criteria by site. In the absence of sufficiently representative ambient data to run the BLM, EPA proposes default input values for DOC, calcium, magnesium, sodium, potassium, sulfate, chloride, and alkalinity that are based on the 10th percentile of existing concentrations of these variables in waters within each of Oregon's Level III ecoregions.19 If information exists to characterize a water body's stream order (a measure of the relative size of a stream), EPA proposes to instead use the 10th percentile concentrations by stream order within each of Oregon's Level III ecoregions. These defaults (by ecoregion and by stream order within each ecoregion) are set forth in Tables 1 and 2 below and are described further in EPA's Draft Technical Support Document: Recommended Estimates for Missing Water Quality Parameters for Application in EPA's Biotic Ligand Model which can be found in the record for this rulemaking.20 Because EPA is proposing default input parameters, protective copper criteria can be easily derived for assessment and permitting purposes (even in the absence of ambient data). EPA solicits comments on the Agency's proposal to use the 10th percentile of existing concentrations to derive default input parameters. EPA also solicits comments on using default input parameters based on a different percentile, such as the 5th or 25th (or another percentile within that range). Calculations of default input parameters at the 5th and 25th percentiles can also be found in the record for this rulemaking (see Fifth and Twenty-fifth Percentile Estimates for Copper BLM Input Parameters by Oregon Level III Ecoregion).

    19 EPA is not proposing default input values for the other two BLM inputs, pH and temperature, because pH and temperature are highly variable and routinely monitored. EPA anticipates that sufficiently representative site-specific data will be available for these parameters. Even though EPA is proposing default values for DOC, EPA recommends that Oregon collect site-specific measurements of DOC if possible, because copper toxicity and BLM predictions are highly sensitive to DOC concentrations.

    20See USEPA, 2016. EPA's proposed default inputs are from Tables 4, 8, 9, 10 and 20.

    Finally, EPA proposes that in order to calculate final acute and chronic copper criteria, Oregon use a value not to exceed the 10th percentile of individual BLM outputs for the site. While the 10th percentile should be protective in a majority of cases, certain circumstances may warrant use of a more stringent BLM output. When 10 or fewer data points are available for a given site, EPA proposes that Oregon use the lowest individual acute and chronic BLM outputs as the final acute and chronic criteria. EPA solicits comment on this approach, as well as alternative percentiles or approaches to reconciling individual copper BLM outputs into final acute and chronic copper criteria values.

    EPA's proposed acute and chronic copper criteria for Oregon's freshwaters are as follows:

    Acute (CMC) and chronic (CCC) freshwater copper criteria shall be developed using EPA's 2007 Aquatic Life Ambient Freshwater Quality Criteria—Copper (EPA-822-R-07-001), which incorporates use of the copper biotic ligand model (BLM).

    Where sufficiently representative ambient data for DOC, calcium, magnesium, sodium, potassium, sulfate, chloride, or alkalinity are not available, the state shall use the 10th percentile estimated values from Table 1 based on the applicable ecoregion (or Table 2, based on the applicable ecoregion and stream order).

    The final copper criteria shall be calculated as no greater than the 10th percentile of the distribution of individual BLM outputs at a site. If 10 or fewer BLM outputs are available for a given site, the lowest individual acute and chronic BLM output values shall be used as the final acute and chronic copper criteria for that site.

    Table 1—BLM Default Inputs for Each Level III Ecoregion in Oregon Level III Ecoregion Calcium
  • (mg/L)
  • Magnesium
  • (mg/L)
  • Sodium
  • (mg/L)
  • Potassium
  • (mg/L)
  • Alkalinity
  • (mg/L)
  • Chloride
  • (mg/L)
  • Sulfate
  • (mg/L)
  • DOC
    1 Coast Range 8.4 3.2 4.1 0.64 33 3.2 4.8 0.7 3 Willamette Valley 8.2 2.9 4.4 0.90 30 4.7 3.8 0.4 4 Cascades 6.6 2.9 3.5 0.74 35 2.2 3.2 0.3 9 Eastern Cascades Slopes and Foothills 8.2 3.8 6.0 1.0 44 3.2 5.0 0.5 10 Columbia Plateau 15 5.2 9.3 1.8 40 3.3 10 1.0 11 Blue Mountains 11 3.9 7.7 1.4 49 3.3 7.1 0.8 12 Snake River Plain 33 10 13 2.3 109 10 22 1.2 78 Klamath Mountains 8.7 4.6 4.0 0.66 44 2.1 3.5 0.6 80 Northern Basin and Range 26 8.2 20 2.7 89 15 24 1.0
    Table 2—BLM Default Inputs for Each Stream Order Within Each Level III Ecoregion in Oregon Level III Ecoregion Stream order Calcium
  • (mg/L)
  • Magnesium
  • (mg/L)
  • Sodium
  • (mg/L)
  • Potassium
  • (mg/L)
  • Alkalinity
  • (mg/L)
  • Chloride
  • (mg/L)
  • Sulfate
  • (mg/L)
  • DOC
    1 Coast Range SO 1-3 6.0 0.8 1.3 0.1 44 0.6 1.1 0.7 SO 4-6 3.6 1.0 2.0 0.2 15 1.6 2.2 0.7 SO 7-9 12 3.4 4.3 0.8 56 2.3 6.3 0.7 3 Willamette Valley SO 1-3 9.9 3.8 5.6 1.5 2.3 1.5 0.4 SO 4-6 7.1 2.5 4.3 0.8 29 4.6 2.8 0.4 SO 7-9 5.0 1.6 3.4 0.6 20 2.7 2.3 0.4 4 Cascades SO 1-3 1.0 0.2 1.8 0.2 0.5 0.2 0.3 SO 4-6 3.5 1.0 2.8 0.4 16 0.8 0.8 0.3 SO 7-9 13 3.6 3.7 0.9 52 1.7 6.9 0.3 9 Eastern Cascades Slopes and Foothills SO 1-3 4.4 0.9 2.3 0.4 35 0.2 0.2 0.5 SO 4-6 5.5 0.8 2.4 0.5 22 0.9 2.2 0.5 SO 7-9 0.5 10 Columbia Plateau SO 1-3 24.0 9.4 10.2 1.4 127 4.6 11 1.0 SO 4-6 8.6 3.2 4.0 0.9 33 1.4 3.1 1.0 SO 7-9 5.7 1.5 2.0 0.7 16 0.8 4.2 1.0 11 Blue Mountains SO 1-3 8.6 3.2 169 0.8 SO 4-6 3.7 0.8 1.6 0.7 16 0.3 0.7 0.8 SO 7-9 8.5 1.5 3.3 0.7 32 0.8 5.0 0.8 12 Snake River Plain SO 1-3 13 2.0 6.1 0.8 35 1.4 3.7 1.2 SO 4-6 13 2.5 4.9 1.2 40 2.2 3.8 1.2 SO 7-9 37 10 13 2.5 122 11 30 1.2 78 Klamath Mountains SO 1-3 2.1 0.6 SO 4-6 7.9 3.2 4.0 0.6 36 2.1 2.4 0.6 SO 7-9 0.6 80 Northern Basin and Range SO 1-3 6.3 1.1 4.3 2.2 24 0.2 2.5 1.0 SO 4-6 15 5.7 4.1 0.8 54 2.0 9.3 1.0 SO 7-9 8.9 2.4 7.7 2.1 2.1 5.1 1.0

    EPA's 2007 copper BLM represents the latest scientific knowledge on copper speciation and bioavailability. In describing potential remedies to address EPA's January 2013 disapproval, EPA noted that Oregon could use the 2007 copper BLM. The model provides predictable and repeatable outcomes, and EPA is proposing protective default inputs to use in the absence of site-specific data. EPA proposes that the combination of the 2007 copper BLM and default inputs will protect aquatic life in Oregon.

    C. Implementation of Proposed Freshwater Acute and Chronic Copper Criteria in Oregon

    EPA's proposed copper criteria for Oregon will be the first BLM-based criteria in Oregon and, therefore, the state does not have associated implementation methods. EPA strongly recommends that Oregon develop such methods, and give similar consideration to site selection, characterization of critical conditions, and data representativeness, as discussed for cadmium earlier in this proposed rule. Aquatic organisms are more sensitive to copper when corresponding DOC and pH levels in the water are low, so Oregon should ensure that sufficiently representative data are collected for the BLM's input parameters to have confidence that critical conditions are adequately characterized.

    When Oregon derives copper criteria using the BLM, to promote transparency and ensure predictable and repeatable outcomes, EPA recommends that the state make each criterion and the geographic extent of the site to which the criterion applies publicly available on the state's Web site along with information such as:

    1. The number of sampling events used to derive the criterion;

    2. Whether the criterion relied on site-specific data, estimated data, or a combination of both; and

    3. The date when the criterion was developed.

    Finally, as discussed earlier with respect to ambient hardness levels, substantial changes in a site's water chemistry will likely affect any resulting copper criterion at that site. In addition, with regular monitoring and a robust, site-specific dataset, criteria can be developed that more accurately reflect site conditions and copper bioavailability than criteria set using default values or limited data sets. Therefore, EPA recommends that Oregon periodically revisit its copper criteria and re-run the BLM when changes in water chemistry are evident or suspected at a site, and also as additional monitoring data become available.

    D. Ongoing State Efforts To Develop Copper Criteria for Oregon's Freshwaters

    EPA's proposed methodology for deriving protective acute and chronic copper criteria described in the preceding paragraphs is not necessarily the only scientifically defensible and protective approach, and consistent with 40 CFR 131.11(b)(1)(iii), Oregon has the option to establish criteria based on other scientifically defensible methods. In 2015, the Oregon Department of Environmental Quality (DEQ) conducted an analysis of the copper BLM in preparation for adopting revised copper criteria to address EPA's 2013 disapproval. DEQ has spent significant time and resources collecting BLM input parameters at 138 locations across the state, as well as evaluating various methods to develop defaults that can be used in the absence of sufficiently representative ambient data. To date, DEQ has generally modeled its approach after the methodology presented in EPA's Draft Technical Support Document: Recommended Estimates for Missing Water Quality Parameters for Application in EPA's Biotic Ligand Model (EPA 820-R-15-106), but is considering different data sources and alternative geographic groupings of water bodies. EPA is working closely with DEQ, and will continue to provide input on the state's copper criteria development efforts.

    E. Incorporation by Reference

    EPA is proposing that the final EPA rule regulatory text will incorporate one EPA document by reference. In accordance with the requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference EPA's 2007 Aquatic Life Ambient Freshwater Quality Criteria—Copper (EPA-822-R-07-001), discussed in section IV.A. of this preamble. EPA has made, and will continue to make, this document generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

    V. Critical Low-Flows and Mixing Zones

    To ensure that the proposed criteria are applied appropriately to protect Oregon's aquatic life uses, EPA is proposing critical low-flow values for Oregon to use in calculating the available dilution for the purposes of determining the need for and establishing WQBELs in NPDES permits. Dilution is one of the primary mechanisms by which the concentrations of contaminants in effluent discharges are reduced following their introduction into a receiving water. Low flows can exacerbate the effects of effluent discharges because, during a low-flow event, there is less water available for dilution, resulting in higher instream pollutant concentrations. If criteria are implemented using inappropriate critical low-flow values (i.e., values that are too high), the resulting ambient concentrations could exceed criteria when low flows occur.21

    21 USEPA. 2014. Water Quality Standards Handbook-Chapter 5: General Policies. U.S. Environmental Protection Agency, Office of Water. Washington, DC EPA-820-B-14-004. http://www.epa.gov/sites/production/files/2014-09/documents/handbook-chapter5.pdf.

    EPA's March 1991 Technical Support Document for Water Quality-based Toxics Control recommends two methods for calculating acceptable critical low-flow values: The traditional hydrologically based method developed by the USGS and a biologically based method developed by EPA.22 The hydrologically based critical low-flow value is determined statistically using probability and extreme values, while the biologically based critical low-flow is determined empirically using the specific duration and frequency associated with the criterion. For the acute cadmium and acute and chronic copper criteria, EPA proposes the following critical low-flow values:

    22 USEPA. 1991. Technical Support Document For Water Quality-based Toxics Control. U.S. Environmental Protection Agency, Office of Water, Washington, DC EPA/505/2-90-001. http://www3.epa.gov/npdes/pubs/owm0264.pdf.

    Acute Aquatic Life (CMC): 1Q10 or 1B3 Chronic Aquatic Life (CCC): 7Q10 or 4B3 Using the hydrologically based method, the 1Q10 represents the lowest one-day average flow event expected to occur once every ten years, on average, and the 7Q10 represents the lowest seven-consecutive-day average flow event expected to occur once every ten years, on average. Using the biologically based method, 1B3 represents the lowest one-day average flow event expected to occur once every three years, on average, and 4B3 represents the lowest four-consecutive-day average flow event expected to occur once every three years, on average.23

    23See USEPA, 2014.

    The criteria in this proposed rule, once finalized, would apply at the point of discharge unless Oregon authorizes a mixing zone. Where Oregon authorizes a mixing zone, the criteria would apply at the locations allowed by the mixing zone (i.e., the CCC would apply at the defined boundary of the chronic mixing zone and the CMC would apply at the defined boundary of the acute mixing zone).24

    24See USEPA, 1991.

    VI. Endangered Species Act

    As noted earlier in this proposed rule, the NMFS 2012 biological opinion concluded that the acute cadmium and acute and chronic copper criteria that Oregon adopted in 2004 would jeopardize the continued existence of endangered species in Oregon. The opinion also contained RPAs for cadmium and copper that would avoid the likelihood of jeopardy to endangered species in Oregon. EPA will continue to work closely with the NMFS to ensure that the acute cadmium criterion that EPA ultimately finalizes is protective of federally listed species in Oregon. For copper, the NMFS further clarified in January 2016 that adoption of EPA's 2007 copper BLM, which EPA is proposing in this rule, would be consistent with the 2012 RPA.

    VII. Under what conditions will Federal standards be not promulgated or withdrawn?

    Under the CWA, Congress gave states primary responsibility for developing and adopting WQS for their waters (CWA section 303(a)-(c)). Although EPA is proposing cadmium and copper aquatic life criteria for Oregon's freshwaters to remedy EPA's 2013 disapproval, Oregon continues to have the option to adopt and submit to EPA acute cadmium and acute and chronic copper criteria for the state's freshwaters consistent with CWA section 303(c) and EPA's implementing regulations at 40 CFR part 131. EPA encourages Oregon to expeditiously adopt protective aquatic life criteria. Consistent with CWA section 303(c)(4), if Oregon adopts and submits cadmium and/or copper aquatic life criteria, and EPA approves such criteria before finalizing this proposed rule, EPA would not proceed with the promulgation for those waters and/or pollutants for which EPA approves Oregon's criteria.

    If EPA finalizes this proposed rule, and Oregon subsequently adopts and submits cadmium and/or copper aquatic life criteria, EPA proposes that once EPA approves Oregon's WQS, the EPA-approved criteria in Oregon's WQS would become the applicable criteria for CWA purposes and EPA's promulgated criteria would no longer be applicable criteria. EPA would undertake a rulemaking to withdraw the federal criteria for cadmium and/or copper, but that process would not delay Oregon's approved criteria from becoming the sole applicable criteria for CWA purposes.

    VIII. Alternative Regulatory Approaches and Implementation Mechanisms

    Oregon will have considerable discretion to implement these aquatic life criteria, once finalized, through various water quality control programs. Among other things, EPA's regulations: (1) Specify how states and authorized tribes establish, modify or remove designated uses, (2) specify the requirements for establishing criteria to protect designated uses, including criteria modified to reflect site-specific conditions, (3) authorize states and authorized tribes to adopt WQS variances to provide time to achieve the applicable WQS, and (4) allow states and authorized tribes to include compliance schedules in NPDES permits. Each of these approaches are discussed in more detail below.

    A. Designating Uses

    EPA's proposed cadmium and copper criteria apply to freshwaters in Oregon where the protection of fish and aquatic life is a designated use (see Oregon Administrative Rules at 340-041-8033, Table 30). The federal regulations at 40 CFR 131.10 provide information on establishing, modifying, and removing designated uses. If Oregon removes designated uses such that no fish or aquatic life uses apply to any particular water body affected by this rule and adopts the highest attainable use,25 and EPA finds that removal to be consistent with CWA section 303(c) and the implementing regulations at 40 CFR part 131, then the federal cadmium and copper aquatic life criteria would no longer apply to that water body. Instead, any criteria associated with the newly designated highest attainable use would apply to that water body.

    25 Highest attainable use is the modified aquatic life, wildlife, or recreation use that is both closest to the uses specified in section 101(a)(2) of the Act and attainable, based on the evaluation of the factor(s) in § 131.10(g) that preclude(s) attainment of the use and any other information or analyses that were used to evaluate attainability. There is no required highest attainable use where the state demonstrates the relevant use specified in section 101(a)(2) of the Act and sub-categories of such a use are not attainable (see 40 CFR 131.3(m)).

    B. Site-Specific Criteria

    The regulations at 40 CFR 131.11 specify requirements for modifying water quality criteria to reflect site-specific conditions. In the context of this rulemaking, a site-specific criterion (SSC) is an alternative value to the federal freshwater cadmium or copper aquatic life criteria that would be applied on a watershed, area-wide, or water body-specific basis that meets the regulatory test of protecting the designated use, being scientifically defensible, and ensuring the protection and maintenance of downstream WQS. A SSC may be more or less stringent than the otherwise applicable federal criteria. A SSC may be appropriate when further scientific data and analyses can bring added precision to express the concentration of cadmium and/or copper that protects the aquatic life-related designated use in a particular water body.

    C. Variances

    40 CFR part 131 defines WQS variances at § 131.3(o) as time-limited designated uses and supporting criteria for a specific pollutant(s) or water quality parameter(s) that reflect the highest attainable conditions during the term of the WQS variance. WQS variances adopted in accordance with 40 CFR part 131 allow states and authorized tribes to address water quality challenges in a transparent and predictable way. Variances help states and authorized tribes focus on making incremental progress in improving water quality, rather than pursuing a downgrade of the underlying water quality goals through a designated use change, when the current designated use is difficult to attain. Oregon has sufficient authority to use variances when implementing the criteria, as long as such variances are adopted consistent with 40 CFR 131.14. Oregon may use its currently EPA-approved variance procedures with respect to a temporary modification of its uses as it pertains to any federal criteria (see OAR 340-041-0059) when adopting such variances.

    D. Compliance Schedules

    EPA's regulations at 40 CFR 122.47 and 40 CFR 131.15 allow states and authorized tribes to include permit compliance schedules in their NPDES permits if dischargers need additional time to meet their WQBELs based on the applicable WQS. EPA's updated regulations at 40 CFR part 131 also include provisions authorizing the use of permit compliance schedules to ensure that a decision to allow permit compliance schedules includes public engagement and transparency (80 FR 51022, August 21, 2015). Oregon already has an EPA-approved regulation authorizing the use of permit compliance schedules (see OAR 340-041-0061), consistent with 40 CFR 131.15. That state regulation is not affected by this rule, and Oregon is authorized to grant compliance schedules, as appropriate, based on the federal criteria.

    IX. Economic Analysis

    EPA's proposed cadmium and copper criteria may serve as a basis for development of NPDES permit limits. Oregon has NPDES permitting authority, and retains considerable discretion in implementing standards. EPA evaluated the potential costs to NPDES dischargers associated with state implementation of EPA's proposed criteria. This analysis is documented in Economic Analysis for the Proposed Rule: Aquatic Life Criteria for Copper and Cadmium in Oregon, which can be found in the record for this rulemaking.

    Any NPDES-permitted facility that discharges cadmium or copper in Oregon could potentially incur compliance costs. The types of affected facilities could include industrial facilities and POTWs discharging treated wastewater to surface waters (i.e., point sources). EPA expects that dischargers would use similar process and treatment controls to come into compliance with the proposed cadmium and copper criteria as they would to comply with Oregon's existing aquatic life criteria for cadmium and copper (i.e., “baseline criteria”). EPA estimates the incremental impacts of the proposed rule against a baseline of full implementation of currently approved criteria.

    For this analysis, EPA did not estimate the potential for costs to stormwater or nonpoint sources such as agricultural runoff. EPA recognizes that Oregon may require controls for nonpoint sources. However, it is difficult to model and evaluate the potential cost impacts of this rule to those sources because they are intermittent, variable, and occur under hydrologic or climatic conditions associated with precipitation events. Also, baseline total maximum daily loads (TMDLs) for waters with baseline impairment for cadmium or copper have not yet been developed. Therefore, determining which waters would not achieve standards based on the proposed aquatic life criteria after complying with existing (baseline) regulations and policies may not be possible.

    A. Identifying Affected Entities

    For economic analysis purposes, EPA developed hypothetical applications of the proposed cadmium and copper criteria using conservative estimates for hardness and the BLM inputs, respectively. The criteria that EPA derived for the cost analysis would likely be different from and possibly lower (more stringent) than the actual criteria applications that Oregon would derive using ambient data from each water body. As described earlier in this proposed rule, EPA recommends that Oregon collect sufficiently representative ambient data to derive the most accurate and protective cadmium and copper aquatic life criteria.

    Using the criteria derived for the cost analysis, EPA identified 10 point source facilities that could potentially be affected by the rule—all are major dischargers. Major facilities are typically those that discharge more than 1 million gallons per day (mgd). Of these potentially affected facilities, 7 are POTWs and 3 are industrial dischargers. EPA did not include facilities covered by general permits in its analysis because data for such facilities are limited, and flows are usually much lower. EPA did not have cadmium or copper effluent data to evaluate minor facilities for this preliminary analysis.

    B. Method for Estimating Costs

    EPA estimated costs for the 10 potentially affected facilities. EPA evaluated existing baseline permit conditions, reasonable potential to exceed estimates of the aquatic life criteria based on the proposed rule, and potential to exceed projected effluent limitations based on available effluent monitoring data. In instances of exceedances of projected effluent limitations under the proposed criteria, EPA determined the likely compliance scenarios and costs. Only compliance actions and costs that would be needed above the baseline level of controls are attributable to the proposed rule.

    EPA assumed that dischargers would pursue the least cost means of compliance with WQBELs. Incremental compliance actions attributable to the proposed rule may include pollution prevention, end-of-pipe treatment, and alternative compliance mechanisms (e.g., variances). EPA annualized capital costs over an assumed technology lifespan of 20 years, adding recurring Operation & Maintenance costs, and discounted using 3% and 7% discount rates to obtain total annual costs per facility.

    C. Results

    Based on the results for 10 facilities, EPA estimated a total incremental annual cost attributable to the proposed criteria of approximately $0.1 million to $18.2 million at a 3% discount rate.26 The low end of the range reflects the assumption that achieving very low copper limits is infeasible (e.g., available treatment technologies cannot consistently achieve the limits) and dischargers will need to apply for variances. The high end of the range reflects the assumption that dischargers can achieve the projected effluent limits through end-of-pipe treatment. All of the incremental costs are attributable to municipal and industrial dischargers for treatment of copper. There was no reasonable potential to exceed the proposed acute cadmium criterion.

    26 The estimated costs using a 7% discount rate range from $0.1 million to $22.6 million.

    If the revised criteria result in an incremental increase in impaired waters, resulting in the need for TMDL development, there could also be some costs to nonpoint sources of metals. Using available ambient monitoring data, EPA compared cadmium and copper concentrations to the baseline and proposed criteria, identifying waterbodies that may be incrementally impaired (i.e., impaired under the proposed criteria but not under the baseline). Baseline impairment ranged from 8 to 46 stations, depending on whether EPA used impaired water body information from 2010 or 2012. Using available monitoring data, EPA identified copper impairments at 82 monitoring stations based on the proposed criteria. Therefore, water quality data indicate potential for incremental impairment at 36 to 74 stations. This increase suggests that nonpoint sources may bear some compliance costs, although data are not available to estimate the magnitude of these costs. If the net increase in stations (36 to 74) is an indication of the potential increase in the number of TMDLs, then the costs for TMDL development could range from approximately $1.3 million (36 TMDLs × $37,000) to $3.0 million (74 TMDLs × $40,000) 27 . The control of nonpoint sources such as in the context of a TMDL could result in less stringent requirements, and thus lower costs, for point sources.

    27 U.S. EPA (2001) reports that the average cost to develop a TMDL for a single source of impairment ranges from $27,000 to $29,000 (in 2000 dollars), which becomes $37,000 to $40,000 using the Consumer Price Index to escalate to 2015 dollars.

    X. Statutory and Executive Order Reviews A. Executive Order 12866 (Regulatory Planning and Review) and Executive Order 13563 (Improving Regulation and Regulatory Review)

    This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review. The proposed rule does not establish any requirements directly applicable to regulated entities or other sources of toxic pollutants. However, these WQS may serve as a basis for development of NPDES permit limits. Oregon has NPDES permitting authority, and retains considerable discretion in implementing standards. In the spirit of Executive Order 12866, EPA evaluated the potential costs to NPDES dischargers associated with state implementation of EPA's proposed criteria. This analysis, Economic Analysis for the Proposed Rule: Aquatic Life Criteria for Copper and Cadmium in Oregon, is summarized in section IX of the preamble and is available in the docket.

    B. Paperwork Reduction Act

    This action does not impose an information collection burden under the PRA. While actions to implement these WQS could entail additional paperwork burden, this action does not directly contain any information collection, reporting, or record-keeping requirements.

    C. Regulatory Flexibility Act

    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. Small entities, such as small businesses or small governmental jurisdictions, are not directly regulated by this rule.

    D. Unfunded Mandates Reform Act

    This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. As these water quality criteria are not self-implementing, the action imposes no enforceable duty on any state, local or tribal governments or the private sector.

    E. Executive Order 13132 (Federalism)

    This action does not have federalism implications. It 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. This rule does not alter Oregon's considerable discretion in implementing these WQS, nor would it preclude Oregon from adopting WQS that meet the requirements of the CWA, either before or after promulgation of the final rule, which would eliminate the need for federal standards upon EPA approval. Thus, Executive Order 13132 does not apply to this action.

    In the spirit of Executive Order 13132 and consistent with EPA policy to promote communications between EPA and state and local governments, EPA specifically solicits comments on this proposed action from state and local officials.

    F. Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments)

    This action does not have tribal implications as specified in Executive Order 13175. This proposed rule does not impose substantial direct compliance costs on federally recognized tribal governments, nor does it substantially affect the relationship between the federal government and tribes, or the distribution of power and responsibilities between the federal government and tribes. Thus, Executive Order 13175 does not apply to this action.

    Many tribes in the Pacific Northwest hold reserved rights to take fish for subsistence, ceremonial, religious, and commercial purposes. EPA developed the criteria in this proposed rule to protect aquatic life in Oregon from the effects of exposure to harmful levels of cadmium and copper. Protecting the health of fish in Oregon will, therefore, support tribal reserved fishing rights, including treaty-reserved rights, where such rights apply in waters under state jurisdiction.

    Consistent with the EPA Policy on Consultation and Coordination with Indian Tribes, EPA consulted with tribal officials during the development of this action. On November 23, 2015, EPA sent a letter to tribal leaders in Oregon offering to consult on the proposed cadmium and copper criteria in this rule. On December 15, 2015, EPA held a conference call with tribal water quality technical contacts to explain EPA's proposed action and timeline. Formal consultation on the proposed action was not requested by any of the tribes. EPA will continue to communicate with the tribes prior to its final action.

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

    EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

    H. Executive Order 13211 (Actions That Significantly Affect Energy Supply, Distribution, or Use)

    This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

    I. National Technology Transfer and Advancement Act of 1995

    This proposed rulemaking does not involve technical standards.

    J. Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations)

    The human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. The criteria in this proposed rule will support the health and abundance of aquatic life in Oregon, and will therefore benefit all communities that rely on Oregon's ecosystems.

    List of Subjects in 40 CFR Part 131

    Environmental protection, Indians—lands, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Water pollution control.

    Dated: March 31, 2016. Gina McCarthy, Administrator.

    For the reasons set forth in the preamble, EPA proposes to amend 40 CFR part 131 as follows:

    PART 131—WATER QUALITY STANDARDS 1. The authority citation for part 131 continues to read as follows: Authority:

    33 U.S.C. 1251 et seq.

    Subpart D—Federally Promulgated Water Quality Standards 2. Add § 131.46 to read as follows:
    § 131.46 Aquatic Life Criteria for Copper and Cadmium in Oregon.

    (a) Scope. This section promulgates aquatic life criteria for cadmium and copper in freshwaters in Oregon.

    (b) Criteria for cadmium and copper in Oregon. The aquatic life criteria in Table 1 apply to all freshwaters in Oregon where fish and aquatic life are a designated use.

    Table 1—Proposed Cadmium and Copper Aquatic Life Criteria for Oregon Freshwaters Metal CAS No. Criterion Maximum Concentration (CMC) 3
  • (µg/L)
  • Criterion
  • Continuous
  • Concentration (CCC) 4
  • (µg/L)
  • Cadmium 1 2 7440439 [e (0.9789 × ln(hardness) − 3.866)] × CF
  • Where CF = 1.136672 − [(ln hardness) × (0.041838)]
  • Copper 1 7440508 Acute (CMC) and chronic (CCC) freshwater copper criteria shall be developed using EPA's 2007 Aquatic Life Ambient Freshwater Quality Criteria—Copper (EPA-822-R-07-001), which incorporates use of the copper biotic ligand model (BLM). Where sufficiently representative ambient data for DOC, calcium, magnesium, sodium, potassium, sulfate, chloride, or alkalinity are not available, the state shall use the 10th percentile estimated values from Table 2 of paragraph (c) of this section based on the applicable ecoregion (or Table 3 of paragraph (c) of this section, based on the applicable ecoregion and stream order). The final copper criteria shall be calculated as no greater than the 10th percentile of the distribution of individual BLM outputs at a site. If 10 or fewer BLM outputs are available for a given site, the lowest individual acute and chronic BLM output values shall be used as the final acute and chronic copper criteria for that site. 1 The criteria for cadmium and copper are expressed as dissolved metal concentrations. 2 CF is the conversion factor used to convert between the total recoverable and dissolved forms of cadmium. The term (ln hardness) in the CMC and the CF equation is the natural logarithm of the ambient hardness in mg/L (CaCO3). A default hardness concentration of 25 mg/L shall be used to calculate cadmium criteria in the absence of sufficiently representative ambient hardness data. A hardness concentration of 25 mg/L equates to a one-hour average dissolved cadmium concentration of 0.49 µg/L. 3 The CMC is the highest allowable one-hour average instream concentration of cadmium or copper. The CMC is not to be exceeded more than once every three years. The CMC is rounded to two significant figures. 4 The CCC is the highest allowable four-day average instream concentration of copper. The CCC is not to be exceeded more than once every three years. The CCC is rounded to two significant figures.

    (c) Estimated Values to Derive Copper Criteria. The default inputs to calculate copper criteria using the BLM in the absence of sufficiently representative ambient data are shown in Tables 2 and 3.

    Table 2—BLM Default Inputs for Each Level III Ecoregion in Oregon Level III Ecoregion Calcium
  • (mg/L)
  • Magnesium
  • (mg/L)
  • Sodium
  • (mg/L)
  • Potassium
  • (mg/L)
  • Alkalinity
  • (mg/L)
  • Chloride
  • (mg/L)
  • Sulfate
  • (mg/L)
  • DOC
    1 Coast Range 8.4 3.2 4.1 0.64 33 3.2 4.8 0.7 3 Willamette Valley 8.2 2.9 4.4 0.90 30 4.7 3.8 0.4 4 Cascades 6.6 2.9 3.5 0.74 35 2.2 3.2 0.3 9 Eastern Cascades Slopes and Foothills 8.2 3.8 6.0 1.0 44 3.2 5.0 0.5 10 Columbia Plateau 15 5.2 9.3 1.8 40 3.3 10 1.0 11 Blue Mountains 11 3.9 7.7 1.4 49 3.3 7.1 0.8 12 Snake River Plain 33 10 13 2.3 109 10 22 1.2 78 Klamath Mountains 8.7 4.6 4.0 0.66 44 2.1 3.5 0.6 80 Northern Basin and Range 26 8.2 20 2.7 89 15 24 1.0
    Table 3—BLM Default Inputs for Each Stream Order Within Each Level III Ecoregion in Oregon Level III Ecoregion Stream order Calcium
  • (mg/L)
  • Magnesium
  • (mg/L)
  • Sodium
  • (mg/L)
  • Potassium
  • (mg/L)
  • Alkalinity
  • (mg/L)
  • Chloride
  • (mg/L)
  • Sulfate
  • (mg/L)
  • DOC
    1 Coast Range SO 1-3 6.0 0.8 1.3 0.1 44 0.6 1.1 0.7 SO 4-6 3.6 1.0 2.0 0.2 15 1.6 2.2 0.7 SO 7-9 12 3.4 4.3 0.8 56 2.3 6.3 0.7 3 Willamette Valley SO 1-3 9.9 3.8 5.6 1.5 2.3 1.5 0.4 SO 4-6 7.1 2.5 4.3 0.8 29 4.6 2.8 0.4 SO 7-9 5.0 1.6 3.4 0.6 20 2.7 2.3 0.4 4 Cascades SO 1-3 1.0 0.2 1.8 0.2 0.5 0.2 0.3 SO 4-6 3.5 1.0 2.8 0.4 16 0.8 0.8 0.3 SO 7-9 13 3.6 3.7 0.9 52 1.7 6.9 0.3 9 Eastern Cascades Slopes and Foothills SO 1-3 4.4 0.9 2.3 0.4 35 0.2 0.2 0.5 SO 4-6 5.5 0.8 2.4 0.5 22 0.9 2.2 0.5 SO 7-9 0.5 10 Columbia Plateau SO 1-3 24.0 9.4 10.2 1.4 127 4.6 11 1.0 SO 4-6 8.6 3.2 4.0 0.9 33 1.4 3.1 1.0 SO 7-9 5.7 1.5 2.0 0.7 16 0.8 4.2 1.0 11 Blue Mountains SO 1-3 8.6 3.2 169 0.8 SO 4-6 3.7 0.8 1.6 0.7 16 0.3 0.7 0.8 SO 7-9 8.5 1.5 3.3 0.7 32 0.8 5.0 0.8 12 Snake River Plain SO 1-3 13 2.0 6.1 0.8 35 1.4 3.7 1.2 SO 4-6 13 2.5 4.9 1.2 40 2.2 3.8 1.2 SO 7-9 37 10 13 2.5 122 11 30 1.2 78 Klamath Mountains SO 1-3 2.1 0.6 SO 4-6 7.9 3.2 4.0 0.6 36 2.1 2.4 0.6 SO 7-9 0.6 80 Northern Basin and Range SO 1-3 6.3 1.1 4.3 2.2 24 0.2 2.5 1.0 SO 4-6 15 5.7 4.1 0.8 54 2.0 9.3 1.0 SO 7-9 8.9 2.4 7.7 2.1 2.1 5.1 1.0

    (d) Applicability. (1) The criteria in paragraph (b) of this section are the applicable acute cadmium and acute and chronic copper aquatic life criteria in all freshwaters in Oregon where fish and aquatic life are a designated use. After the effective date of this rule, in cases where EPA determines that state cadmium or copper aquatic life criteria meet the requirements of Clean Water Act section 303(c) and 40 CFR part 131, Oregon's cadmium or copper criteria will apply rather than the criteria in paragraph (b) of this section.

    (2) The criteria established in this section are subject to Oregon's general rules of applicability in the same way and to the same extent as are other federally promulgated and state-adopted numeric criteria when applied to freshwaters in Oregon where fish and aquatic life are a designated use.

    (i) For all waters with mixing zone regulations or implementation procedures, the criteria apply at the appropriate locations within or at the boundary of the mixing zones; otherwise the criteria apply throughout the water body including at the end of any discharge pipe, conveyance or other discharge point.

    (ii) The state shall not use a low flow value that is less stringent than the values listed below for waters suitable for the establishment of low flow return frequencies (i.e., streams and rivers) when calculating the available dilution for the purposes of determining the need for and establishing Water Quality-Based Effluent Limitations in National Pollutant Discharge Elimination System permits:

    Acute criteria (CMC) 1Q10 or 1B3. Chronic criteria (CCC) 7Q10 or 4B3. Where: 1. 1Q10 is the lowest one-day average flow event expected to occur once every ten years, on average (determined hydrologically). 2. 1B3 is the lowest one-day average flow event expected to occur once every three years, on average (determined biologically). 3. 7Q10 is the lowest seven-consecutive-day average flow event expected to occur once every ten years, on average (determined hydrologically). 4. 4B3 is the lowest four-consecutive-day average flow event expected to occur once every three years, on average (determined biologically).
    [FR Doc. 2016-08038 Filed 4-15-16; 8:45 am] BILLING CODE 6560-50-P
    81 74 Monday, April 18, 2016 Notices DEPARTMENT OF AGRICULTURE Forest Service Forest Resource Coordinating Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Forest Resource Coordinating Committee (Committee) will meet in Washington, DC. The Committee is authorized under section 8005 of the Food, Conservation, and Energy Act of 2008 (the Act) (Pub. L. 110-246). Additional information concerning the Committee, including the meeting agenda, supporting documents and minutes, can be found by visiting the Committee's Web site at http://www.fs.fed.us/spf/coop/frcc/.

    DATES:

    The meeting will be held on the following dates:

    1. May 25, 2016, from 8:00 a.m. to 5:00 p.m. Eastern Daylight Time (EDT); and

    2. May 25, 2016, from 8:00 a.m. to 5:00 p.m. EDT.

    The meeting is subject to cancellation. For status of the meeting prior to attendance, please contact the person listed under For Further Information Contact.

    ADDRESSES:

    The meeting will be held at the USDA Forest Service, Sidney R. Yates Building, Pinchot Conference Room, 201 14th Street SW., Washington, DC. Members of the public should RSVP to facilitate entry into the Yates Building.

    Written comments may be submitted as described under Supplementary Information. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments placed on the Committee's Web site listed above.

    FOR FURTHER INFORMATION CONTACT:

    Andrea Bedell-Loucks, Designated Federal Officer, by phone at 202-205-1190; or Lori McKean, Committee Coordinator, by phone at 570-296-9672.

    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 Daylight Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to:

    1. Learn how to frame recommendations;

    2. Hear about Office of Sustainability & Climate Changes' State & Private Forestry Climate Change Performance Scorecard; and

    3. Refine outreach strategies to key partners.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should submit a request in writing by May 13, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the Committee may file written statements with the Committee staff before May 1, 2016. Written comments and time requests for oral comments must be sent to Andrea Bedell-Loucks, 1400 Independence Avenue SW., Mailstop 1123, Washington, DC 20250; or by email to [email protected] A summary of the meeting will be posted on the Committee's Web site listed above within 21 days after the meeting.

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

    Dated: April 11, 2016. James E. Hubbard, Deputy Chief, State and Private Forestry.
    [FR Doc. 2016-08805 Filed 4-15-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Rural Utilities Service Announcement of Grant Application Deadlines and Funding Levels AGENCY:

    Rural Utilities Service, USDA.

    ACTION:

    Notice of Funds Availability (NOFA).

    SUMMARY:

    The Rural Utilities Service (RUS), an agency of the United States Department of Agriculture (USDA), herein referred to as RUS or the Agency, announces its Community Connect Grant Program application window for Fiscal Year (FY) 2016. This notice is being issued in order to allow potential applicants time to submit proposals and give the Agency time to process applications within the current fiscal year.

    In addition to announcing the application window, RUS announces the minimum and maximum amounts for Community Connect grants applicable for the fiscal year. The Community Connect Grant Program regulation can be found at 7 CFR part 1739 (Subpart A).

    DATES:

    Submit completed paper or electronic applications for grants according to the following deadlines:

    Paper submissions: Paper submissions must be postmarked and mailed, shipped, or sent overnight no later than June 17, 2016 to be eligible for FY 2016 grant funding. Late or incomplete applications will not be eligible for FY 2016 grant funding.

    Electronic submissions: Electronic submissions must be received no later than June 17, 2016 to be eligible for FY 2016 grant funding. Late or incomplete applications will not be eligible for FY 2016 grant funding.

    • If the submission deadline falls on Saturday, Sunday, or a Federal holiday, the application is due the next business day.

    ADDRESSES:

    Copies of the FY 2016 Application Guide and materials for the Community Connect Grant Program may be obtained through:

    (1) The Community Connect Web site at http://www.rd.usda.gov/programs-services/community-connect-grants or

    (2) The RUS Office of Loan Origination and Approval at 202-720-0800.

    Completed applications may be submitted the following ways:

    (1) Paper: Mail paper applications to the Rural Utilities Service, Telecommunications Program, 1400 Independence Ave. SW., Room 2808, STOP 1597, Washington, DC 20250-1597. Mark address with “Attention: Deputy Assistant Administrator, Office of Loan Origination and Approval, Rural Utilities Service.”

    (2) Electronic: Submit electronic applications through Grants.gov. Information on electronic submission is available on the Grants.gov Web site (http://www.grants.gov) at any time, regardless of registration status. However, applicants must pre-register with Grants.gov to use the electronic applications option.

    FOR FURTHER INFORMATION CONTACT:

    Shawn Arner, Deputy Assistant Administrator, Office of Loan Origination and Approval, Rural Utilities Service, U.S. Department of Agriculture, telephone: (202) 720-0800, fax: 1-884-885-8179.

    SUPPLEMENTARY INFORMATION: Overview

    Federal Agency: Rural Utilities Service (RUS).

    Funding Opportunity Title: Community Connect Grant Program.

    Announcement Type: Initial announcement.

    Funding Opportunity Number: RDRUS-CC-2016.

    Catalog of Federal Domestic Assistance (CFDA) Number: 10.863.

    Dates: Submit completed paper or electronic applications for grants according to the deadlines indicated in Section D(5).

    A. Program Description

    The purpose of the Community Connect Grant Program is to provide financial assistance in the form of grants to eligible applicants that will provide broadband service to currently unserved, lower-income, and extremely rural areas. This broadband service is intended to foster economic growth and deliver enhanced educational, health care, and public safety services on a community-oriented connectivity basis. RUS will give priority to rural areas that have the greatest need for broadband services, based on the criteria contained herein.

    Grant authority will be used for the deployment of broadband service to extremely rural, lower-income communities on a community-oriented connectivity basis. By cultivating the deployment of new broadband services, the community-oriented connectivity concept will stimulate innovative uses and practical applications of the new broadband facilities in order to improve economic development and provide enhanced educational and health care opportunities in rural areas. Such an approach will also give rural communities the opportunity to benefit from the advanced technologies necessary to achieve these goals. The regulation for the Community Connect Program can be found at 7 CFR part 1739 (Subpart A).

    As in years past, the FY 2016 Community Connect Grant Application Guide has been updated based on program experience. All applicants should carefully review and prepare their applications according to instructions in the FY 2016 Application Guide and sample materials. Expenses incurred in developing applications will be at the applicant's own risk.

    B. Federal Award Information

    $11,740,000 is available for grants. Under 7 CFR 1739.2, the Administrator established a minimum grant amount of $100,000 and a maximum grant amount of $3,000,000 for FY 2016.

    The standard grant agreement, which specifies the term of each award, is available at http://www.rd.usda.gov/files/UTP_Comm_ConnectGrantAgreement.pdf. The Agency will make awards, and successful applicants will be required to execute documents appropriate to the project before the Agency will advance funding.

    While prior Community Connect grants cannot be renewed, existing Community Connect awardees may submit applications for new projects, which the Agency will evaluate as new applications. All grant applications must be submitted during the application window.

    C. Eligibility Information 1. Eligible Applicants (See 7 CFR 1739.10)

    a. Only entities legally organized as one of the following are eligible for Community Connect Grant Program financial assistance:

    i. An incorporated organization;

    ii. An Indian tribe or tribal organization, as defined in 25 U.S.C. 450b;

    iii. A state or local unit of government; or

    iv. A cooperative, private corporation, or limited liability company organized on a for-profit or not-for-profit basis.

    b. Applicants must have the legal capacity and authority to enter into contracts, to comply with applicable federal statutes and regulations, and to own and operate the broadband facilities as proposed in their application.

    c. Applicants must have an active registration with current information in the System for Award Management (SAM) (previously the Central Contractor Registry (CCR)) at https://www.sam.gov and have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number. Further information regarding SAM registration and DUNS number acquisition can be found in Sections D(3) and D(4) of this Notice.

    2. Ineligible Applicants

    a. Individuals and partnerships are not eligible for financial assistance.

    b. Corporations that have been convicted of a Federal felony within the past 24 months are not eligible. Any corporation that has been assessed to have any unpaid federal tax liability, for which all judicial and administrative remedies have been exhausted or have lapsed and is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, is not eligible for financial assistance.

    c. In accordance with the Consolidated Appropriations Act, 2016, Sections 743-4, an entity that requires employees or contractors of such entity seeking to report fraud, waste, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or contractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information is not eligible for financial assistance.

    3. Cost Sharing or Matching

    The Community Connect Program requires matching contributions for grants. See 7 CFR 1739.14 and the FY 2016 Application Guide for information on required matching contributions.

    a. Grant applicants must demonstrate matching contributions in cash of at least fifteen percent (15%) of the total amount of financial assistance requested. Matching contributions must be used for eligible purposes of Community Connect grant assistance, as discussed in 7 CFR 1739.12, 7 CFR 1739.13, and Section D(6) of this Notice for more information.

    b. Applications that do not provide sufficient documentation of the required fifteen percent match will be declared ineligible.

    4. Other

    Eligible projects must propose to fulfill the following requirements (see 7 CFR 1739.11 for more information):

    a. Minimum Broadband Service Requirements. Until otherwise revised in the Federal Register, for applications in FY 2016, to qualify as Broadband Service, the minimum rate-of-data transmission is four megabits per second downstream plus one megabit per second upstream for both fixed and mobile broadband service.

    b. Minimum Broadband Grant Speed. The minimum bandwidth that an applicant must propose to deliver to every customer in the proposed funded service area is ten megabits downstream and one megabit upstream for both fixed and mobile service to the customer.

    c. Rural Area. A Rural Area refers to any area, as confirmed by the most recent decennial Census of the United States, which is not located within:

    i. A city, town, or incorporated area that has a population of greater than 20,000 inhabitants; or

    ii. An urbanized area contiguous and adjacent to a city or town that has a population of greater than 50,000 inhabitants. For purposes of the definition of Rural Area, an urbanized area means a densely populated territory as defined in the most recent decennial Census.

    d. Proposed Funded Service Area (PFSA). Applicants must propose a contiguous geographic area within an eligible Rural Area or eligible Rural Areas, in which Broadband Service does not currently exist, and where the applicant proposes to offer service at the Broadband Grant Speed to all residential and business customers. A PFSA must not overlap with the Service Areas of current RUS borrowers and grantees.

    e. Critical Community Facilities. Applicants must propose to offer service, free of charge to users, at the Broadband Grant Speed to all Critical Community Facilities located within the Proposed Funded Service Area for at least two (2) years.

    f. Community Center. Applicants must propose to provide a Community Center with at least two (2) Computer Access Points and wireless access at the Broadband Grant Speed free of charge to users for at least two (2) years.

    D. Application and Submission Information

    The FY 2016 Application Guide provides specific detailed instructions for each item in a complete application. The Agency emphasizes the importance of including every required item and strongly encourages applicants to follow the instructions carefully, using the examples and illustrations in the FY 2016 Application Guide. Applications submitted by the application deadline, but have critical missing items will be returned as ineligible. The Agency will not solicit or consider scoring or eligibility information that is submitted after the application deadline. However, depending on the specific scoring criteria, applications that do not include all items necessary for scoring may still be eligible applications, but may not receive full or any credit if the information cannot be verified. See the FY 2016 Application Guide for a full discussion of each required item. For requirements of completed grant applications, refer to 7 CFR 1739.15.

    1. Address To Request Application Package

    The FY 2016 Application Guide, copies of necessary forms and samples, and the Community Connect Grant Program Regulation are available at:

    a. Electronic copies at http://www.rd.usda.gov/programs-services/community-connect-grants and

    b. Paper copies from the Rural Utilities Service, Office of Loan Origination and Approval, 202-720-0800.

    2. Content and Form of Application Submission

    a. Carefully review the Community Connect Application Guide and the 7 CFR part 1739, which detail all necessary forms and worksheets. A table summarizing the necessary components of a complete application can be found at Section D(2)(d).

    b. Submission of Application Items. Given the high volume of program interest, applicants should submit the required application items in the order indicated in the FY 2016 Application Guide. Applications that are not assembled and tabbed in the specified order prevent timely determination of eligibility. For applications with inconsistencies among submitted copies, the Agency will base its evaluation on the original signed application received.

    c. Additional Information. The Agency may ask for additional or clarifying information for applications submitted by the deadline which appear to meet the eligibility requirements, but require further review.

    d. Table of Required Elements of a Completed Grant Application. This table summarizes the items required for submission and the category into which they fall.

    Application item Regulation Comments A. Application for Federal Assistance Form Form provided in FY 2016 Application Tool Kit. SF-424 Standard Form A-2 SAM Registration Information Form provided in FY 2016 Application Tool Kit. A-3 State Director Notification Form provided in FY 2016 Application Tool Kit. A-4 Equal Opportunity Survey Form provided in FY 2016 Application Tool Kit. B. Executive Summary of the Project Narrative. C. Scoring Criteria Documentation Narrative & Documentation. Special Considerations Documentation. D. System Design Narrative & Documentation. Network Diagram Documentation. Environmental Questionnaire 7 CFR part 1970 Narrative & Documentation. E. Service Area Map Provided in RUS web-based Mapping Tool. Service Area Demographics Documentation. F. Scope of Work Narrative & Documentation. Construction Build-out and Project Milestones Form provided in FY 2016 Application Tool Kit. Project Budget Form provided in FY 2016 Application Tool Kit. G. Community-oriented Connectivity Plan Narrative. H. Financial Information and Sustainability Narrative & Documentation. I. Statement of Experience Narrative J. Evidence of Legal Authority and Existence Documentation K. Additional Funding Narrative & Documentation. L. Compliance with Other Statutes and Regulations Equal Opportunity and Nondiscrimination 7 CFR part 15 (Subpart A) Form provided in FY 2016 Application Tool Kit. Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970 49 CFR part 24 and 7 CFR part 21 Form provided in FY 2016 Application Tool Kit. Debarment, Suspension, and Other Responsibility Matters 7 CFR part 3017 Form provided in FY 2016 Application Tool Kit. Lobbying for Contracts, Grants, Loans, and Cooperative Agreements 7 CFR part 3018 Form provided in FY 2016 Application Tool Kit. Drug-Free Workplace 7 CFR part 3017 Form provided in FY 2016 Application Tool Kit. Architectural Barriers Form provided in FY 2016 Application Tool Kit. Flood Hazard Area Precautions 7 CFR 1970 Form provided in FY 2016 Application Tool Kit. Non-Duplication of Services Form provided in FY 2016 Application Tool Kit. Federal Collection Policies for Commercial Debt Form provided in FY 2016 Application Tool Kit. Assurance Regarding Felony Conviction or Tax Delinquent Status for Corporate Applicants Form provided in FY 2016 Application Tool Kit (corporate applicants—only).

    e. Number of copies of submitted applications.

    i. Applications submitted on paper. Submit the original application and two (2) copies to RUS.

    ii. Applications submitted electronically. Submit the electronic application once. Carefully read the FY 2016 Application Guide for guidance on submitting an electronic application. Applicants should identify and number each page in the same manner as the paper application.

    3. Dun and Bradstreet Universal Numbering System (DUNS) Number

    The applicant for a grant must supply a Dun and Bradstreet Data Universal Numbering System (DUNS) number as part of the application. The Standard Form 424 (SF-424) contains a field for the DUNS number. The applicant can obtain the DUNS number free of charge by calling Dun and Bradstreet. Go to http://fedgov.dnb.com/webform for more information on DUNS number acquisition or confirmation.

    4. System for Award Management (SAM)

    Prior to submitting a paper or an electronic application, the applicant must register in the System for Award Management (SAM) at https://www.sam.gov/portal/public/SAM/. Throughout the RUS application review and the active Federal grant funding period, SAM registration must be active with current data at all times. To maintain active SAM registration, the applicant must review and update the information in the SAM database annually from the date of initial registration or from the date of the last update. The applicant must ensure that the information in the database is current, accurate, and complete.

    5. Submission Dates and Times

    a. Paper applications must be postmarked and mailed, shipped, or sent overnight no later than June 17, 2016 to be eligible for FY 2016 grant funding. Late applications, applications which do not include proof of mailing or shipping, and incomplete applications are not eligible for FY 2016 grant funding. If the submission deadline falls on Saturday, Sunday, or a Federal holiday, the application is due the next business day. In the event of an incomplete application, the Agency will notify the applicant in writing, return the application, and terminate all further action.

    i. Address paper applications to the Telecommunications Program, RUS, U.S. Department of Agriculture, 1400 Independence Ave. SW., Room 2808, STOP 1597, Washington, DC 20250-1597. Applications should be marked, “Attention: Deputy Assistant Administrator, Office of Loan Origination and Approval.”

    ii. Paper applications must show proof of mailing or shipping by the deadline consisting of one of the following:

    A. A legibly dated U.S. Postal Service (USPS) postmark;

    B. A legible mail receipt with the date of mailing stamped by the USPS; or

    C. A dated shipping label, invoice, or receipt from a commercial carrier.

    iii. Due to screening procedures at the U.S. Department of Agriculture, packages arriving via regular mail through the USPS are irradiated, which can damage the contents and delay delivery to the Community Connect Program. RUS encourages applicants to consider the impact of this procedure in selecting their application delivery method.

    b. Electronic grant applications must be received no later than June 17, 2016 to be eligible for FY 2016 funding. Late or incomplete applications will not be eligible for FY 2016 grant funding.

    i. Applications will not be accepted via fax or electronic mail.

    ii. Electronic applications for grants must be submitted through the Federal government's Grants.gov initiative at http://www.grants.gov/. Grants.gov contains full instructions on all required passwords, credentialing, and software.

    iii. Grants.gov requires some credentialing and online authentication procedures. These procedures may take several business days to complete. Therefore, the applicant should complete the registration, credentialing, and authorization procedures at Grants.gov before submitting an application.

    iv. Dun and Bradstreet Data Universal Numbering System. The applicant for a grant must supply a Dun and Bradstreet Data Universal Numbering System (DUNS) number as part of the application. See section D(3) of this Notice for more information.

    v. System for Award Management. Grants.gov requires that the applicant's organization is registered in the System for Award Management (SAM). Be sure to obtain the organization's SAM listing well in advance of the application deadline. See section D(4) of this Notice for more information.

    vi. RUS encourages applicants who wish to apply through Grants.gov to submit their applications in advance of the deadline.

    vii. If system errors or technical difficulties occur, use the customer support resources available at the Grants.gov Web site.

    6. Funding Restrictions

    a. Eligible grant purposes.

    Grant funds may be used to finance:

    i. The construction, acquisition, or leasing of facilities, including spectrum, land or buildings to deploy service at the Broadband Grant Speed to all participating Critical Community Facilities and all required facilities needed to offer such service to all residential and business customers located within the Proposed Funded Service Area;

    ii. The improvement, expansion, construction, or acquisition of a Community Center that furnishes free internet access at the Broadband Grant Speed and provision of Computer Access Points. Grant funds provided for such costs shall not exceed the lesser of ten percent (10%) of the grant amount requested or $150,000; and

    iii. The cost of bandwidth to provide service free of charge at the Broadband Grant Speed to Critical Community Facilities for the first two (2) years of operation.

    b. Ineligible grant purposes.

    Grant funds may not be used to finance:

    i. The duplication of any existing Broadband Service provided by another entity;

    ii. Operating expenses other than the cost of bandwidth for two (2) years to provide service at the Broadband Grant Speed to Critical Community Facilities; or

    iii. Any other operating expenses not specifically permitted in 7 CFR 1739.12.

    c. Other. For more information, see 7 CFR 1739.3 for definitions, 7 CFR 1739.12 for eligible grant purposes, and 7 CFR 1739.13 for ineligible grant purposes.

    E. Application Review Information 1. Criteria

    Grant applications are scored competitively and are subject to the criteria listed below (total possible points: 115. See 7 CFR 1739.17 and the FY 2016 Application Guide for more information on the scoring criteria):

    a. Needs Category. An analysis of the challenges of the following criteria, laid out on a community-wide basis, and how the project proposes to address these issues (up to 50 points):

    i. Economic characteristics;

    ii. Educational challenges;

    iii. Health care needs; and

    iv. Public safety issues.

    b. Stakeholder Involvement Category. The extent of the Project's planning, development, and support from local residents, institutions, and Critical Community Facilities (up to 40 points);

    c. Experience Category. The level of experience and past success of broadband systems operation for the management team (up to 10 points);

    d. Special Consideration Areas Category. In accordance with 7 CFR 1739.1(a), applicants may receive special consideration if they submit documentation demonstrating that they will provide broadband service within the following areas (15 points):

    i. Tribal jurisdiction or trust areas,

    iii. Promise Zone (for further information, see the Promise Zone Web site at http://www.hud.gov/promisezones/, or

    iv. Strike Force area (for further information, see the Strikeforce Web site at http://www.usda.gov/wps/portal/usda/usda?navid=STRIKE_FORCE).

    e. In making a final selection among and between applications with comparable rankings and geographic distribution, the Administrator may take into consideration the characteristics of the Proposed Funded Service Area (PFSA), as identified in 7 CFR 1739.17(d).

    2. Review and Selection Process

    Grant applications are ranked by the final score. RUS selects applications based on those rankings, subject to the availability of funds and consistent with 7 CFR 1739.17. In addition, it should be noted that an application receiving fewer points can be selected over a higher scoring application in the event that there are insufficient funds available to cover the costs of the higher scoring application, as stated in 7 CFR 1739.16(f).

    a. In addition to the scoring criteria that rank applications against each other, the Agency evaluates grant applications on the following items, in accordance with 7 CFR 1739.16:

    i. Financial feasibility. A proposal that does not indicate financial feasibility or that is not sustainable will not be approved for an award.

    ii. Technical considerations. An application that contains flaws that would prevent the successful implementation, operation, or sustainability of the project will not be approved for an award.

    b. Applications conforming with this part will then be evaluated competitively and ranked by a panel of RUS employees that the Administrator of RUS selects, and will be awarded points as described in the scoring criteria in 7 CFR 1739.17. Applications will be ranked and grants awarded in order until all grant funds are expended.

    d. The Agency reserves the right to offer the applicant a lower amount than the amount proposed in the application, as stated in 7 CFR 1739.16(g).

    F. Federal Award Administration Information 1. Federal Award Notices

    a. Successful applications.

    i. Recipient notification. RUS notifies applicants whose projects are selected for awards by mailing or emailing a copy of the award letter. The receipt of an award letter does not authorize the applicant to commence performance under the award. After sending the award letter, the Agency will send an agreement that contains all the terms and conditions, as referenced in 7 CFR 1739.18 and Section B of this Notice. A copy of the standard agreement is posted on the RUS Web site at http://www.rd.usda.gov/programs-services/community-connect-grants. The Rural Utilities Service recognizes that each funded project is unique, and therefore may attach conditions to different projects' award documents. An applicant must execute and return the grant agreement, accompanied by any additional items required by the agreement, within the number of days specified in the selection notice letter.

    2. Administrative and National Policy Requirements

    The items listed in this Notice, the Community Connect Grant Program regulation, the FY2016 Application Guide, and accompanying materials implement the appropriate administrative and national policy requirements, which include, but are not limited to:

    a. Executing a Community Connect Grant Agreement;

    b. Using Form SF 270, “Request for Advance or Reimbursement,” to request reimbursements (along with the submission of receipts for expenditures, timesheets, and any other documentation to support the request for reimbursement);

    c. Providing annual project performance activity reports until the expiration of the award;

    d. Ensuring that records are maintained to document all activities and expenditures utilizing Community Connect grant funds and matching funds (receipts for expenditures are to be included in this documentation);

    e. Providing a final project performance report;

    f. Complying with policies, guidance, and requirements as described in the following applicable Code of Federal Regulations, and any successor regulations;

    i. 2 CFR parts 200 and 400 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards),

    ii. 2 CFR part 417 (Nonprocurement Debarment and Suspension),

    iii. 2 CFR part 180 (Government-wide Debarment and Suspension);

    g. Signing Form AD-3031 (“Assurance Regarding Felony Conviction or Tax Delinquent Status for Corporate Applicants”) (for corporate applicants only); and

    h. Complying with Executive Order 13166, “Improving Access to Services for Persons with Limited English Proficiency.” For information on limited English proficiency and agency-specific guidance, go to http://www.LEP.gov.

    3. Reporting

    a. Performance reporting. All recipients of Community Connect Grant Program financial assistance must provide annual performance activity reports to RUS until the project is complete and the funds are expended. A final performance report is also required; the final report may serve as the last annual report. The final report must include an evaluation of the success of the project in meeting the Community Connect Grant Program objectives. See 7 CFR 1739.19 and 2 CFR 200.328 for additional information on these reporting requirements.

    b. Financial reporting. All recipients of Community Connect Grant Program financial assistance must provide an annual audit, beginning with the first year in which a portion of the financial assistance is expended. Audits are governed by United States Department of Agriculture audit regulations. See 7 CFR 1739.20 and 2 CFR part 200 (Subpart F) for a description of the financial reporting requirements.

    c. Recipient and Sub-recipient Reporting. The applicant must have the necessary processes and systems in place to comply with the reporting requirements for first-tier sub-awards and executive compensation under the Federal Funding Accountability and Transparency Act of 2006 in the event the applicant receives funding unless such applicant is exempt from such reporting requirements pursuant to 2 CFR 170.110(b). The reporting requirements under the Transparency Act pursuant to 2 CFR 170 are as follows:

    i. First Tier Sub-Awards of $25,000 or more (unless they are exempt under 2 CFR part 170) must be reported by the Recipient to https://www.fsrs.gov no later than the end of the month following the month the obligation was made. Please note that currently underway is a consolidation of eight federal procurement systems, including the Federal Sub-award Reporting System (FSRS), into one system, the System for Award Management (SAM). As a result, the FSRS will soon be consolidated into and accessed through https://www.sam.gov/portal/public/SAM/.

    ii. The Total Compensation of the Recipient's Executives (the five most highly compensated executives) must be reported by the Recipient (if the Recipient meets the criteria under 2 CFR part 170) to https://www.sam.gov/portal/public/SAM/ by the end of the month following the month in which the award was made.

    iii. The Total Compensation of the Sub-recipient's Executives (the five most highly compensated executives) must be reported by the Sub-recipient (if the Sub-recipient meets the criteria under 2 CFR part 170) to the Recipient by the end of the month following the month in which the sub-award was made.

    d. Record Keeping and Accounting. The contract will contain provisions related to record keeping and accounting requirements.

    G. Federal Awarding Agency Contacts

    1. Web site: http://www.rd.usda.gov/programs-services/community-connect-grants. This site maintains up-to-date resources and contact information for the Community Connect Grant Program.

    2. Telephone: 202-720-0800.

    3. Fax: 1-844-885-8179.

    4. Email: [email protected]

    5. Main Point of Contact: Shawn Arner, Deputy Assistant Administrator, Office of Loan Origination and Approval, Rural Utilities Service, U.S. Department of Agriculture.

    H. Other Information 1. USDA Non-Discrimination Statement

    USDA prohibits discrimination against its customers, employees, and applicants for employment on the bases of race, color, national origin, age, disability, sex, gender identity, religion, reprisal, and where applicable, political beliefs, marital status, familial or parental status, sexual orientation, or all or part of an individual's income is derived from any public assistance program, or protected genetic information in employment or in any program or activity conducted or funded by USDA. (Not all prohibited bases will apply to all programs and/or employment activities.)

    2. How to File a Complaint

    a. Equal Employment Opportunity Complaint. Individuals who wish to file an employment complaint must contact their Agency's EEO Counselor within 45 days of the date of the alleged discriminatory act, event, or in the case of a personnel action. Additional information can be found online at http://www.ascr.usda.gov/complaint_filing_file.html.

    b. Program Discrimination Complaint. Individuals who wish to file a Program Discrimination Complaint must complete the USDA Program Discrimination Complaint Form (PDF), found online at http://www.ascr.usda.gov/complaint_filing_cust.html or at any USDA office, or call (866) 632-9992 to request the form. A letter may also be written containing all of the information requested in the form. Send the completed complaint form or letter by mail to the U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410, by fax (202) 690-7442, or email at [email protected]

    3. Persons With Disabilities

    Individuals who are deaf, hard of hearing, or have speech disabilities and wish to file either an EEO or program complaint may contact USDA through the Federal Relay Service at (800) 877-8339 (English) or (800) 845-6136 (Spanish).

    Persons with disabilities who wish to file a program complaint, please see information above on how to contact USDA by mail or email. Individuals who require alternative means of communication for program information (e.g., Braille, large print, audiotape, etc.) may contact USDA's TARGET Center at 202-720-2600 (voice and TDD).

    Dated: March 21, 2016. Joshua Cohen Deputy Administrator, Rural Utilities Service.
    [FR Doc. 2016-08931 Filed 4-15-16; 8:45 am] BILLING CODE P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the California State Advisory Committee AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of public meeting.

    DATES:

    Wednesday, June 1, 2016, 12:00 p.m.-1:00 p.m. (Pacific Time).

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the California State Advisory Committee (Committee) to the Commission will be held at 12:00 p.m. (Pacific Time) Wednesday, June 1, 2016, for the purpose of considering the Committee's report on voting integrity in California.

    This meeting is available to the public through the following toll-free call-in number: 888-427-9419; when prompted, please provide conference ID number: 1107449. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number.

    Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number. Hearing-impaired persons who will attend the meeting and require the services of a sign language interpreter should contact the Regional Office at least ten (10) working days before the scheduled date of the meeting.

    Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments. The comments must be received in the Western Regional Office of the Commission by Friday, July 1, 2016. The address is Western Regional Office, U.S. Commission on Civil Rights, 300 N. Los Angeles Street, Suite 2010, Los Angeles, CA 90012. Persons wishing to email their comments may do so by sending them to Angela French-Bell, Regional Director, Western Regional Office, at [email protected]

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at http://facadatabase.gov/committee/meetings.aspx?cid=237. Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Western Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Western Regional Office at the above email or street address.

    Agenda:

    I. Introductory Remarks II. Discussion of the Committee's report on voting integrity in California III. Public Comment IV. Adjournment

    Public Call Information:

    Dial: 888-427-9419.

    Conference ID: 1107449.

    FOR FURTHER INFORMATION CONTACT:

    Angela French-Bell, DFO, at (213) 894-3437 or [email protected]

    Dated April 12, 2016. David Mussatt, Chief, Regional Programs Coordination Unit.
    [FR Doc. 2016-08838 Filed 4-15-16; 8:45 am] BILLING CODE 6335-01-P
    COMMISSION ON CIVIL RIGHTS Public Meeting of the Hawai`i State Advisory Committee AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of Public Meeting.

    DATES:

    Monday, May 23, 2016, 2:00-3:00 p.m. (UTC-10).

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Hawai`i State Advisory Committee (Committee) to the Commission will be held at 2:00 p.m. (Hawaiian Time) Monday, May 23, 2016, for the purpose of considering new topics for the Hawai`i State Advisory Committee's new project for FY 2016.

    This meeting is available to the public through the following toll-free call-in number: 888-428-9473; when prompted, please provide conference ID number: 1594001. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number.

    Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number. Hearing-impaired persons who will attend the meeting and require the services of a sign language interpreter should contact the Regional Office at least ten (10) working days before the scheduled date of the meeting.

    Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments. The comments must be received in the Western Regional Office of the Commission by Thursday, June 23, 2016. The address is Western Regional Office, U.S. Commission on Civil Rights, 300 N. Los Angeles Street, Suite 2010, Los Angeles, CA 90012. Persons wishing to email their comments may do so by sending them to Angela French-Bell, Regional Director, Western Regional Office, at [email protected]

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at http://facadatabase.gov/committee/meetings.aspx?cid=244.Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Western Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Western Regional Office at the above email or street address.

    Agenda
    I. Introductory Remarks II. Discussion of New Projects III. Public Comment IV. Adjournment Public Call Information Dial: 888-428-9473 Conference ID: 1594001 FOR FURTHER INFORMATION CONTACT:

    Angela French-Bell, DFO, at (213) 894-3437 or [email protected]

    Dated: April 12, 2016. David Mussatt, Chief, Regional Programs Coordination Unit.
    [FR Doc. 2016-08839 Filed 4-15-16; 8:45 am] BILLING CODE 6335-01-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Alaska State Advisory Committee AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of public meeting.

    DATES:

    Wednesday, April 27, 2016 & Monday, May 16, 2016.

    Time: 12:00 p.m.-1:00 p.m. (Alaska Time).

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Alaska Advisory Committee (Committee) to the Commission will be held at 12:00 p.m. (Alaska Time) Wednesday, April 27, 2016, and Monday, May 16, 2016 for the purpose of considering and voting upon new topics for the Alaska Advisory Committee's new project for FY 2016.

    These meetings are available to the public through the following toll-free call-in numbers: April 27, 2016: 888-417-8465; when prompted, please provide conference ID number: 7924734. May 16, 2016: 888-556-4997; when prompted, please provide conference ID number: 4783937. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number.

    Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number. Hearing-impaired persons who will attend the meeting and require the services of a sign language interpreter should contact the Regional Office at least ten (10) working days before the scheduled date of the meeting.

    Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments within thirty (30) days of the meeting. The comments must be received in the Western Regional Office of the Commission by Friday, May 27, 2016, and Thursday, June 16, 2016, respectively. The address is Western Regional Office, U.S. Commission on Civil Rights, 300 N. Los Angeles Street, Suite 2010, Los Angeles, CA 90012. Persons wishing to email their comments may do so by sending them to Angela French-Bell, Regional Director, Western Regional Office, at [email protected]

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at http://facadatabase.gov/committee/meetings.aspx?cid=234. Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Western Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Western Regional Office at the above email or street address.

    Agenda For April 27, 2016:

    I. Introductory Remarks II. Discussion of New Projects III. Public Comment IV. Adjournment

    Agenda For May 16, 2016:

    I. Introductory Remarks II. Vote on Proposal III. Public Comment IV. Adjournment FOR FURTHER INFORMATION CONTACT:

    Angela French-Bell, DFO, at (213) 894-3437 or [email protected]

    Dated: April 12, 2016. David Mussatt, Chief, Regional Programs Coordination Unit.
    [FR Doc. 2016-08793 Filed 4-15-16; 8:45 am] BILLING CODE 6335-01-P
    COMMISSION ON CIVIL RIGHTS Agenda and Notice of Public Meeting of the New Mexico Advisory Committee AGENCY:

    Commission on Civil Rights.

    ACTION:

    Announcement of meetings.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the New Mexico Advisory Committee to the Commission will convene at 10:00 a.m. (MDT) on Thursday, May 5, 2016, via teleconference. The purpose of the meeting is to review progress of planning for briefing meeting on the approved project Elder Abuse. The committee will also discuss if there is a need to establish subcommittees.

    Members of the public may listen to the discussion by dialing the following Conference Call Toll-Free Number: 1-888-452-4023; Conference ID: 4078555. Please be advised that before being placed into the conference call, the operator will ask callers to provide their names, their organizational affiliations (if any), and an email address (if available) prior to placing callers into the conference room. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free phone number.

    Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service (FRS) at 1-800-977-8339 and provide the FRS operator with the Conference Call Toll-Free Number: 1-888-452-4023, Conference ID: 4078555. Members of the public are invited to submit written comments; the comments must be received in the regional office by Monday, April 25, 2016. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1050, or emailed to Evelyn Bohor at [email protected] Persons who desire additional information may contact the Rocky Mountain Regional Office at (303) 866-1040.

    Records and documents discussed during the meeting will be available for public viewing as they become available at https://database.faca.gov/committee/meetings.aspx?cid=264 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Rocky Mountain Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's Web site, www.usccr.gov, or to contact the Rocky Mountain Regional Office at the above phone number, email or street address.

    AGENDA:

    • Welcome and Roll-call Sandra Rodriguez, Chair, New Mexico Advisory Committee Malee V. Craft, Regional Director, Rocky Mountain Regional Office (RMRO) • Review planning developments regarding project proposal on Elder Abuse • Discuss the need to establish subcommittees • Next Steps DATES:

    Thursday, May 5, 2016, at 10:00 a.m. (MDT).

    ADDRESSES:

    To be held via teleconference:

    Conference Call Toll-Free Number: 1-888-452-4023, Conference ID: 4078555.

    TDD: Dial Federal Relay Service 1-800-977-8339 and give the operator the above conference call number and conference ID.

    FOR FURTHER INFORMATION CONTACT:

    Malee V. Craft, DFO, [email protected], 303-866-1040.

    Dated: April 12, 2016. David Mussatt, Chief, Regional Programs Unit.
    [FR Doc. 2016-08840 Filed 4-15-16; 8:45 am] BILLING CODE 6335-01-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-85-2015] Foreign-Trade Zone (FTZ) 20—Newport News, Virginia; Authorization of Proposed Production Activity, Canon Virginia, Inc., Subzone 20D, (Toner Cartridges and Bottles); Newport News, Virginia

    On December 14, 2015, Canon Virginia, Inc., operator of Subzone 20D, submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board for its facilities in Newport News, Virginia.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (80 FR 220, January 5, 2016). The FTZ Board has determined that no further review of the activity is warranted at this time. The production activity described in the notification is authorized, subject to the FTZ Act and the Board's regulations, including Section 400.14.

    Dated: April 12, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-08908 Filed 4-15-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-83-2015] Foreign-Trade Zone (FTZ) 183—Austin, Texas; Authorization of Proposed Production Activity, Samsung Austin Semiconductor, L.L.C., Subzone 183B, (Semiconductors), Austin, Texas

    On December 14, 2015, Samsung Austin Semiconductor, L.L.C., operator of Subzone 183B, submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board for its facility in Austin, Texas.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (80 FR 81293, December 29, 2015). The FTZ Board has determined that no further review of the activity is warranted at this time. The production activity described in the notification is authorized, subject to the FTZ Act and the Board's regulations, including Section 400.14.

    Dated: April 12, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-08909 Filed 4-15-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security Order Denying Export Privileges

    In the Matter of: Paweena Pechner, a/k/a Paweena Montasood, 399 Maplewood Avenue, Portsmouth, NH 03801

    Respondent. CheapShop4You LLC, 399 Maplewood Avenue, Portsmouth, NH 03801

    Related Person;

    A. Denial of Export Privileges of Paweena Pechner

    On July 17, 2014, in the U.S. District Court for the District of New Hampshire, Paweena Pechner, a/k/a Paweena Montasood (“Pechner”), was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Pechner knowingly and willfully caused to be exported from the United States to Thailand firearms which were designated as defense articles on the United States Munitions List, without having obtained from the United States Department of State a license or written approval for the export of these defense articles. Pechner was sentenced to probation for two years, assessed a penalty of $600, and fined $3,000.

    Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”) 1 provides, in pertinent part, that “[t]he Director of the Office of Exporter Services, in consultation with the Director of the Office of Export Enforcement, may deny the export privileges of any person who has been convicted of a violation of the EAA, the EAR, of any order, license or authorization issued thereunder; any regulation, license, or order issued under the International Emergency Economic Powers Act (50 U.S.C. 1701-1706); 18 U.S.C. 793, 794 or 798; section 4(b) of the Internal Security Act of 1950 (50 U.S.C. 783(b)), or section 38 of the Arms Export Control Act (22 U.S.C. 2778).” 15 CFR 766.25(a); see also Section 11(h) of the EAA, 50 U.S.C. 4610(h). The denial of export privileges under this provision may be for a period of up to ten (10) years from the date of the conviction. 15 CFR 766.25(d); see also 50 U.S.C. 4610(h). In addition, Section 750.8 of the Regulations states that the Bureau of Industry and Security's Office of Exporter Services may revoke any Bureau of Industry and Security (“BIS”) licenses previously issued in which the person had an interest in at the time of her conviction.

    1 The Regulations are currently codified in the Code of Federal Regulations at 15 CFR parts 730-774 (2015). The Regulations issued pursuant to the Export Administration Act (50 U.S.C. 4601-4623 (Supp. III 2015) (available at http://uscode.house.gov)) (“EAA”). Since August 21, 2001, the EAA has been in lapse and the President, through Executive Order 13222 of August 17, 2001 (3 CFR, 2001 Comp. 783 (2002)), which has been extended by successive Presidential Notices, the most recent being that of August 7, 2015 (80 FR 48233 (August 11, 2015)), has continued the Regulations in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701, et seq. (2006 & Supp. IV 2010)).

    BIS received notice of Pechner's conviction for violating the AECA, and has provided notice and an opportunity for Pechner to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS received a submission from Pechner. Based upon my review and consideration of that submission, and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Pechner's export privileges under the Regulations for a period of ten (10) years from the date of Pechner's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Pechner had an interest at the time of her conviction.

    B. Denial of Export Privileges of Related Person CheapShop4You LLC

    Pursuant to Sections 766.25(h) and 766.23 of the Regulations, the Director of BIS's Office of Exporter Services, in consultation with the Director of BIS's Office of Export Enforcement, may, in order to prevent evasion of a denial order, make a denial order applicable not only to the respondent, but also to other persons related to the respondent by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business.

    As provided in Section 766.23 of the Regulations, BIS gave notice to CheapShop4You LLC (“CheapShop4You”) that its export privileges under the Regulations could be denied for up to ten (10) years due to its relationship with Pechner and that BIS believed that naming CheapShop4You as a person related to Pechner would be necessary to prevent evasion of a denial order imposed against Pechner. In providing such notice, BIS gave CheapShop4You an opportunity to oppose its addition to the Pechner Denial Order as a related party.

    Having received and reviewed a submission from Pechner, I have decided, following consideration of that submission and consultations with BIS's Office of Export Enforcement, including its Director, to name CheapShop4You as a Related Person and make this Denial Order applicable to CheapShop4You, thereby denying its export privileges for ten (10) years from the date of Pechner's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which CheapShop4You had an interest at the time of Pechner's conviction. The 10-year denial period is scheduled to end on July 17, 2024.

    CheapShop4You, a company associated with Pechner, is an online personal shopping business, which Pechner used to accept, process, and export, both lawfully and unlawfully, shipments to customers. CheapShop4You is co-located at Pechner's residence, and Pechner is listed as its registered agent with the New Hampshire Secretary of State. Therefore, CheapShop4You is related to Pechner within the meaning of Section 766.23. BIS also has reason to believe that CheapShop4You should be added as a related person in order to prevent evasion of this Denial Order.

    Accordingly, it is hereby ordered:

    First, from the date of this Order until July 17, 2024, Paweena Pechner a/k/a Paweena Montasood, with a last known address of 399 Maplewood Avenue, Portsmouth, NH 03801, and when acting for or on her behalf, her successors, assigns, employees, agents, or representatives, and CheapShop4You LLC, with a last known address of 399 Maplewood Avenue, Portsmouth, NH 03801, and when acting for or on its behalf, its successors, assigns, directors, officers, employees, agents, or representatives (each as “Denied Person” and collectively the “Denied Persons”) may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations, including but not limited to:

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

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

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

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

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

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

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

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

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

    Third, in addition to the Related Person named above, after notice and opportunity for comment as provided in section 766.23 of the Regulations, any other individual, firm, corporation, or other association or organization or other person related to a Denied Person by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business may also be made subject to the provisions of this Order if necessary to prevent evasion of this Order.

    Fourth, in accordance with Part 756 and Section 766.25(g) of the Regulations, Pechner may file an appeal of the issuance of this Order against her with the Under Secretary of Commerce for Industry and Security. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.

    Fifth, in accordance with Part 756 and Section 766.23(c) of the Regulations, CheapShop4You may file an appeal of its naming as a related person in this Order with the Under Secretary of Commerce for Industry and Security. This appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.

    Sixth, a copy of this Order shall be provided to Pechner and CheapShop4You. This Order shall be published in the Federal Register.

    Seventh, this Order is effectively immediately and shall remain in effect until July 17, 2024.

    Issued this 11th day of April, 2016. Karen H. Nies-Vogel, Director, Office of Exporter Services.
    [FR Doc. 2016-08920 Filed 4-15-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security Order Denying Export Privileges

    In the Matter of: Alexandre Astakhov, Register Number: 68614-066, USP Lewisburg, U.S. Penitentiary, Federal Prison Camp, P.O. Box 2000, Lewisburg, PA 17837.

    On May 7, 2015, in the U.S. District Court for the Eastern District of Pennsylvania, Alexandre Astakhov (“Astakhov”), was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Astakhov knowingly and willfully attempted to export from the United States to Russia, and aided and abetted the attempted export of, defense articles, that is two L-3 CNVD-T thermal clip-on night vision devices, which were designated as a defense article on the United States Munitions List, without having first obtained from the Department of State a license for such export or written authorization for such export. Astakhov was sentenced to 39 months of imprisonment, three years of supervised release, 150 hours of community service, a criminal fine of $2,500 and a $200 assessment.

    Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”) 1 provides, in pertinent part, that “[t]he Director of the Office of Exporter Services, in consultation with the Director of the Office of Export Enforcement, may deny the export privileges of any person who has been convicted of a violation of the Export Administration Act (“EAA”), the EAR, or any order, license or authorization issued thereunder; any regulation, license, or order issued under the International Emergency Economic Powers Act (50 U.S.C. 1701-1706); 18 U.S.C. 793, 794 or 798; section 4(b) of the Internal Security Act of 1950 (50 U.S.C. 783(b)), or section 38 of the Arms Export Control Act (22 U.S.C. 2778).” 15 CFR 766.25(a); see also Section 11(h) of the EAA, 50 U.S.C. 4610(h). The denial of export privileges under this provision may be for a period of up to 10 years from the date of the conviction. 15 CFR 766.25(d); see also 50 U.S.C. 4610(h). In addition, Section 750.8 of the Regulations states that the Bureau of Industry and Security's Office of Exporter Services may revoke any Bureau of Industry and Security (“BIS”) licenses previously issued in which the person had an interest in at the time of her conviction.

    1 The Regulations are currently codified in the Code of Federal Regulations at 15 CFR parts 730-774 (2015). The Regulations issued pursuant to the Export Administration Act (50 U.S.C. 4601-4623 (Supp. III 2015) (available at http://uscode.house.gov)). Since August 21, 2001, the Act has been in lapse and the President, through Executive Order 13222 of August 17, 2001 (3 CFR, 2001 Comp. 783 (2002)), which has been extended by successive Presidential Notices, the most recent being that of August 7, 2015 (80 FR 48,233 (Aug. 11, 2015)), has continued the Regulations in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701, et seq. (2006 & Supp. IV 2010)).

    BIS has received notice of Astakhov's conviction for violating the AECA, and has provided notice and an opportunity for Astakhov to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has received a submission from Astakhov.

    Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Astakhov's export privileges under the Regulations for a period of 10 years from the date of Astakhov's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Astakhov had an interest at the time of her conviction.

    Accordingly, it is hereby ORDERED:

    First, from the date of this Order until May 7, 2025, Alexandre Astakhov, with a last known address of Register Number: 68614-066, USP Lewisburg, U.S. Penitentiary, Federal Prison Camp, P.O. Box 2000, Lewisburg, PA 17837, and when acting for or on his behalf, his successors, assigns, employees, agents or representatives (the “Denied Person”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, including, but not limited to:

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

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

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

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

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

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

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

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

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

    Third, after notice and opportunity for comment as provided in Section 766.23 of the Regulations, any other person, firm, corporation, or business organization related to Astakhov by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business may also be made subject to the provisions of this Order in order to prevent evasion of this Order.

    Fourth, in accordance with Part 756 of the Regulations, Astakhov may file an appeal of this Order with the Under Secretary of Commerce for Industry and Security. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.

    Fifth, a copy of this Order shall be delivered to the Astakhov. This Order shall be published in the Federal Register.

    Sixth, this Order is effective immediately and shall remain in effect until May 7, 2025.

    Issued this 11 day of April 2016. Karen H. Nies-Vogel, Director, Office of Exporter Services.
    [FR Doc. 2016-08919 Filed 4-15-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE International Trade Administration [C-570-009] Calcium Hypochlorite From the People's Republic of China: Rescission of Countervailing Duty Administrative Review; 2014-2015 AGENCY:

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

    SUMMARY:

    The Department of Commerce (“the Department”) is rescinding the administrative review of the countervailing duty order on calcium hypochlorite from the People's Republic of China (“PRC”) for May 27, 2014 through December 31, 2015.

    DATES:

    Effective: April 18, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Katie Marksberry, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-7906.

    SUPPLEMENTARY INFORMATION: Background

    On March 3, 2016, based on a timely request for review on behalf of Haixing Jingmei Chemical Products Sales Co. Ltd. (“Jingmei”) and Haixing Eno Chemical Co., Ltd. (“Eno”),1 the Department published in the Federal Register a notice of initiation of an administrative review of the countervailing duty order on calcium hypochlorite from the PRC covering the period May 27, 2014 through December 31, 2015.2 The review covers Jingmei and Eno.3 On March 25, 2016, Jingmei and Eno withdrew their requests for an administrative review.4 No other party requested a review of these companies or any other exporters of subject merchandise.

    1See Letter to the Department from Jingmei and Eno, Re: “Calcium Hypochlorite from the People's Republic of China: Request for Administrative Review,” dated January 29, 2016.

    2See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 81 FR 11179 (March 3, 2016) (“Initiation Notice”).

    3Id.

    4See Letter to the Department from Jingmei and Eno; Re: “Calcium Hypochlorite from the People's Republic of China: Withdrawal of Request for Annual Administrative Review,” dated March 25, 2016.

    Rescission of Review

    Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if the party that requested the review withdraws its request within 90 days of the publication of the notice of initiation of the requested review. In this case, Jingmei and Eno timely withdrew their request by the 90-day deadline, and no other party requested an administrative review of the countervailing duty order. As a result, pursuant to 19 CFR 351.213(d)(1), we are rescinding the administrative review of calcium hypochlorite from the PRC for the period May 27, 2014 through December 31, 2015, in its entirety.

    Assessment

    Both Jingmei and Eno are subject to an ongoing new shipper review covering the same period of review as this administrative review.5 Accordingly, CBP should continue to suspend liquidation of entries exported by Jingmei and Eno, until the Department instructs otherwise, pursuant to the final results of the new shipper review.

    5See Calcium Hypochlorite from the People's Republic of China: Initiation of Countervailing Duty New Shipper Review; 2014-2015, 81 FR 11516 (March 4, 2016).

    Notifications

    This notice also serves as a final reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).

    Dated: April 11, 2016. Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2016-08907 Filed 4-15-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-583-844] Narrow Woven Ribbons With Woven Selvedge From Taiwan; Final Results of Antidumping Duty Administrative Review; 2013-2014 AGENCY:

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

    SUMMARY:

    On October 7, 2015, the Department of Commerce (the Department) published the Preliminary Results of the fourth administrative review of the antidumping duty (AD) order on narrow woven ribbons with woven selvedge (NWR) from Taiwan.1 The review covers two producers/exporters of the subject merchandise, Roung Shu Industry Corporation (Roung Shu) and A-Madeus Textile Ltd. (A-Madeus). The period of review (POR) is September 1, 2013, through August 31, 2014. We gave interested parties an opportunity to comment on the Preliminary Results and, based upon our analysis of the comments, we continue to find that sales of subject merchandise to the United States have been made at prices below normal value (NV). The final dumping margins for the reviewed companies are listed below in the section entitled “Final Results of the Review.”

    1See Narrow Woven Ribbons With Woven Selvedge from Taiwan; Preliminary Results of Antidumping Duty Administrative Review; 2013-2014, 80 FR 60627 (October 7, 2015) (Preliminary Results).

    DATES:

    Effective Date: April 18, 2016.

    FOR FURTHER INFORMATION CONTACT:

    David Crespo or Alice Maldonado, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3693 and (202) 482-4682, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On October 7, 2015, the Department published the Preliminary Results in the Federal Register. In November 2015, we received a case brief from A-Madeus and a rebuttal brief from the petitioners.2

    2 The petitioners in this case are Berwick Offray LLC and its wholly-owned subsidiary, Lion Ribbon Company, Inc.

    On February 3, 2016, the Department postponed the final results by 60 days.3 4 The Department conducted this administrative review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act).

    3See the February 3, 2016, memorandum to Gary Taverman, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations through Melissa G. Skinner, Director, Office II from David Crespo, Senior International Trade Compliance Analyst, entitled “Narrow Woven Ribbons with Woven Selvedge from Taiwan: Extension of Deadline for Final Results of Antidumping Duty Administrative Review.”

    4 On January 27, 2016, the Department exercised its discretion to toll all administrative deadlines due to the recent closure of the Federal Government. All deadlines in this segment of the proceeding have been extended by four business days. Therefore, the revised deadline for the final results of this review is now April 11, 2016. See Memorandum to the Record from Ron Lorentzen, Acting Assistant Secretary for Enforcement and Compliance, entitled, “Tolling of Administrative Deadlines as a Result of the Government Closure during Snowstorm “Jonas” (January 27, 2016).

    Scope of the Order

    The merchandise subject to this order 5 covers narrow woven ribbons with woven selvedge. The merchandise subject to this order is classifiable under the harmonized tariff schedule of the United States (HTSUS) statistical categories 5806.32.1020; 5806.32.1030; 5806.32.1050 and 5806.32.1060. Subject merchandise also may enter under subheadings 5806.31.00; 5806.32.20; 5806.39.20; 5806.39.30; 5808.90.00; 5810.91.00; 5810.99.90; 5903.90.10; 5903.90.25; 5907.00.60; and 5907.00.80 and under statistical categories 5806.32.1080; 5810.92.9080; 5903.90.3090; and 6307.90.9889. The HTSUS statistical categories and subheadings are provided for convenience and customs purposes; however, the written description of the merchandise covered by this order is dispositive.6

    5See Narrow Woven Ribbons With Woven Selvedge From Taiwan and the People's Republic of China: Amended Antidumping Duty Orders, 75 FR 56982 (Sept. 17, 2010) (Order).

    6 For a complete description of the scope of the order, see the memorandum from Gary Taverman, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance, entitled, “Issues and Decision Memorandum for the Final Results of the Antidumping Duty Administrative Review on Narrow Woven Ribbons with Woven Selvedge from Taiwan (Issues and Decision Memorandum), dated concurrently with and hereby adopted by this notice.

    Analysis of Comments Received

    All issues raised in the case and rebuttal briefs are addressed in the Issues and Decision Memorandum. A list of the issues which parties raised and to which we respond in the Issues and Decision Memorandum is attached to this notice as Appendix I. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's AD and Countervailing Duty (CVD) Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/index.html. The signed Issues and Decision Memorandum and the electronic version of the Issues and Decision Memorandum are identical in content.

    Changes Since the Preliminary Results

    Based on a review of the record and our analysis of the comments received, we made no changes to the margin calculations for Roung Shu or to the rate assigned to A-Madeus in these final results. For further discussion, see the Issues and Decision Memorandum.

    Period of Review

    The POR is September 1, 2013, through August 31, 2014.

    Final Results of the Review

    We are assigning the following weighted-average dumping margins to the firms listed below:

    Producer/exporter Dumping
  • margin
  • (percent)
  • Roung Shu Industry Corporation 0.00 A-Madeus Textile Ltd 30.64
    Assessment Rates

    Pursuant to section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b)(1), the Department has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise and deposits of estimated duties, where applicable, in accordance with the final results of this review. The Department intends to issue appropriate assessment instructions directly to CBP 15 days after publication of the final results of this administrative review.

    Pursuant to the Final Modification for Reviews, 7 because Roung Shu's weighted-average dumping margin is zero, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties,8 pursuant to 19 CFR 351.106(c)(2).

    7See Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Duty Proceedings; Final Modification, 77 FR 8101 (February 14, 2012) (Final Modification for Reviews).

    8Id., 77 FR at 8102.

    For A-Madeus, we will base the assessment rate assigned to the corresponding entries on the margin listed above, using the same methodology stated in the Preliminary Results.

    Cash Deposit Requirements

    The following deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rates for Roung Shu and A-Madeus will be equal to the dumping margins established in the final results of this administrative review (except, if the rate is zero or de minimis, a zero cash deposit rate will be required for that company); (2) for merchandise exported by manufacturers or exporters not covered in this administrative review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently-completed segment; (3) if the exporter is not a firm covered in this review, a prior review, or the original less-than-fair-value (LTFV) investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recently-completed segment of this proceeding for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 4.37 percent, the all-others rate determined in the LTFV investigation.9 These cash deposit requirements, when imposed, shall remain in effect until further notice.

    9See Order, 75 FR 56985.

    Notification to Importers

    This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) 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.

    Notification Regarding Administrative Protective Order

    This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

    This notice is published in accordance with section 751(a)(1) and 777(i)(1) of the Act.

    Dated: April 11, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I—List of Topics Discussed in the Issues and Decision Memorandum 1. Summary 2. Background 3. Margin Calculations 4. Scope of the Order 5. Discussion of the Issues a. The Assigned Rate to A-Madeus 6. Recommendation
    [FR Doc. 2016-08904 Filed 4-15-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE565 Endangered and Threatened Species; Take of Anadromous Fish AGENCY:

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

    ACTION:

    Notice; availability of permit application and request for comment.

    SUMMARY:

    Notice is hereby given that NMFS has received an update to an application for a direct take permit, in the form of a Hatchery and Genetic Management Plan (HGMP), from the Chelan County Public Utility District (PUD) pursuant to the Endangered Species Act (ESA). The HGMP specifies the operation of a portion of a hatchery program rearing salmon in the Methow Basin within the State of Washington. This document serves to notify the public of the availability of the update to the existing permit application for comment prior to a decision by NMFS whether to issue the permit for the proposed hatchery program. NMFS also notifies the public of the intention to issue a separate ESA permit to the Confederated Tribes and Bands of the Yakama Nation for operation of a component of the program described in the application update.

    DATES:

    Comments must be received at the appropriate address or email mailbox (see ADDRESSES) no later than 5 p.m. Pacific time on May 18, 2016.

    ADDRESSES:

    Written comments on the application should be addressed to the NMFS Sustainable Fisheries Division, 1201 NE. Lloyd Boulevard, Suite 1100, Portland, OR 97232, or faxed to 503-872-2737. Comments may be submitted by email. The mailbox address for providing email comments is: [email protected]. Include in the subject line of the email comment the following identifier: Comments on Chelan's 2016 Methow Hatchery Plan. The HGMP is available on the Internet at www.westcoast.fisheries.noaa.gov.

    FOR FURTHER INFORMATION CONTACT:

    Charlene Hurst, at phone number: (503) 230-5409, or via email: [email protected].

    SUPPLEMENTARY INFORMATION: ESA-Listed Species Covered in This Notice

    Chinook salmon (Oncorhynchus tshawytscha): Endangered, naturally produced and artificially propagated Upper Columbia River.

    Steelhead (O. mykiss): Threatened, naturally produced and artificially propagated Upper Columbia River.

    Background

    Section 9 of the ESA and Federal regulations prohibit the “taking” of a species listed as endangered or threatened. The term “take” is defined under the ESA to mean harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct. NMFS may issue permits to take listed species for any act otherwise prohibited by section 9 for scientific purposes or to enhance the propagation or survival of the affected species under section 10(a)(1)(A) of the ESA. NMFS regulations governing permits for threatened and endangered species are promulgated at 50 CFR 222.307.

    The Methow spring Chinook hatchery program is an ongoing hatchery program designed to meet conservation and mitigation responsibilities related to impacts from development in the Methow and Columbia River basins. On November 13, 2012, NMFS received an ESA section 10(a)(1)(A) permit application from the Douglas and Grant County PUDs and the Washington Department of Fish and Wildlife (WDFW) for the Methow spring Chinook hatchery program. The permit application was in the form of an HGMP and was made available for public comment on December 10, 2013 (78 FR 74116).

    On March 29, 2016, the Chelan County PUD submitted an HGMP updating a portion of the original permit application. The HGMP includes a gene flow management plan, a reduction in the number of juveniles released, and a description of an additional remote acclimation/release site. A separate section 10(a)(1)(A) permit would be issued to the Confederated Tribes and Bands of the Yakama Nation for operation of this additional remote acclimation/release site, as described in the Chelan County PUD HGMP.

    Authority

    This notice is provided pursuant to section 10(c) of the ESA. NMFS will evaluate the permit application, associated documents, and comments submitted thereon to determine whether the application meets the requirements of section 10(a)(1)(A) of the ESA. If it is determined that the requirements are met, permits will be issued to WDFW, the PUDs, and the Confederated Tribes and Bands of the Yakama Nation. NMFS will publish a record of its final action in the Federal Register.

    Dated: April 13, 2016. Angela Somma, Chief, Endangered Species Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-08905 Filed 4-15-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF DEFENSE Department of the Army, Corps of Engineers National Wetland Plant List AGENCY:

    Army Corps of Engineers, DoD.

    ACTION:

    Final notice.

    SUMMARY:

    The U.S. Army Corps of Engineers (Corps), as part of an interagency effort with the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS) and the U.S. Department of Agriculture Natural Resources Conservation Service (NRCS), is announcing the availability of the final 2016 National Wetland Plant List (NWPL). The NWPL is used to determine whether the hydrophytic vegetation parameter is met when conducting wetland determinations under the Clean Water Act and the Wetland Conservation Provisions of the Food Security Act. Other applications of the list include wetland restoration, establishment, and enhancement projects. The list will become effective on May 1, 2016 and will be used in any wetland delineation performed after this date. Delineations received prior to this date may still use the 2014 NWPL, or you may choose to use the 2016 list. Always reference the list used on any wetland delineation/determination forms.

    DATES:

    The 2016 NWPL will become effective on May 1, 2016.

    ADDRESSES:

    U.S. Army Corps of Engineers, Attn: CECW-CO-R, 441 G Street NW., Washington, DC 20314-1000.

    FOR FURTHER INFORMATION CONTACT:

    Karen Mulligan, Headquarters, U.S. Army Corps of Engineers, Operations and Regulatory Community of Practice, Washington, DC 20314-1000, by phone at 202-761-4664 or by email at [email protected]

    SUPPLEMENTARY INFORMATION: Background

    The NWPL has undergone several revisions since its inception in 1988. The Corps led interagency efforts to update the list in 2012, 2013, and 2014. The 2012 list contained 7,828 species, the 2013 update contained 7,937 species, and the 2014 update contained 8,061 species. Additions, or deletions, to these lists represent new records, range extensions, nomenclatural and taxonomic changes, and newly proposed species. The latest review process began in 2015 and included the review by Regional Panels (RPs), the National Panel (NP), and the public, whom provided input on changes to the wetland indicator status of 1,689 species. Four groups of species were examined during this update. The first group consisted of rating changes for 25 species (including six new additions) that the public requested on the NWPL Web site (November 10, 2014 to January 31, 2015) and during the Federal Register Comment Period (September 14, 2015 to November 13, 2015). The second group consisted of 166 species with highly variable ratings spanning more than three ratings categories nationally (e.g., rated FACW in the Arid West and UPL in the Caribbean). The third group consisted of five nationally problematic species. Initially, the public requested a rating change for these five species in one region. However, their ratings were re-examined in all regions where they occur, based on a NP request (a total of 21 ratings). Seven species occurred in more than one of these three groups. The fourth group consisted of input received on the wetland ratings of 1,500 species that occur in the South Pacific Islands (SPI) subregion. In group one, based on public requests for rating changes, 88% of the wetland ratings for 25 species were changed on the 2016 NWPL. In group two, species with highly variable ratings, the ratings of all of the species were changed to some degree. In group three, the nationally problematic species, 76% of the 21 ratings were changed for five species. In group four, the SPI species, 12.6% of the ratings were changed.

    The NWPL was first published by the FWS in 1988 and first updated in 2012 to include 7,828 species. The 2014 update contained 8,061 species (Lichvar et al. 2014). Four were rated UPL in all regions where they occur, so there were a total of 8,057 species that occur in wetlands. This update contains 8,092 species, a net change of 35 more species (39 species added in the SPI, six new species in the Continental U.S. (CONUS), and removal of ten UPL species). These 8,092 species have 27,984 unique ratings since each can occur in more than one of the ten regions. The 2016 list includes changes in plant indicator status (OBL, FACW, FAC, FACU and UPL designations) from the 2014 list for 186 species found in the CONUS. Since these 186 species can occur in multiple Corps delineation regions, each having a unique rating, there were a total of 306 rating changes. The indicator status (rating) represents the likelihood that a particular plant occurs in a wetland or upland. The specific breakout of the 306 rating changes was: 49 percent (150 ratings) were assigned wetter indicator ratings and 51 percent (156 ratings) species were assigned drier indicator ratings. Ratings for 41 species were wetter in one region and drier in another region and ratings of three species did not change. In the SPI, there were 189 ratings changes, for a grand total of 495 rating changes in the entire list. A summary of rating changes by region and the response to the technical comments is available at: http://wetland_plants.usace.army.mil/. Policy-level and review process comments are summarized below.

    Discussion of Public Comments 1. Overview

    In response to the September 14, 2015, Federal Register notice, a total of 18 comments were received and reviewed on 50 species from eight Corps wetland delineation regions and one subregion. One additional comment was submitted by mistake. The Corps received seven written comments in response to the September 14, 2015, Federal Register 80 CFR number 177. One agency responded that they had no comments on the proposed ratings and appreciated the opportunity to review the draft NWPL. Three raised technical issues and three commented only on species, offering no objections or comments on the update, and a total of 36 species were commented on in these six letters. Comments on 14 species from 11 individuals were electronically submitted on the NWPL Web site. The final 2016 NWPL was compiled based on the RP and NP reviews and consideration of the 18 comments received.

    General Comments

    Most comments pertained to the rating of specific species in several regions, some supported ratings changes and some did not. The rationale for all ratings changes is provided in the response to technical comments document. One commenter was concerned with the inclusion of invasive/non-native species on the NWPL and how ratings are assigned to these species. Nativity to a particular region of the country is irrelevant for the purpose of assigning wetland indicator ratings. Instead, wetland ratings are based on how often a plant species is found to occur in wetlands vs. uplands (Lichvar et al. 2012, Lichvar and Minkin 2008). For both native and non-native species, wetland indicator ratings are assigned based on the NWPL Review Standard. The Review Standard involves a review of literature citations, herbaria records, and field observations. RPs and NP assign final ratings based on this evidence and professional experience.

    Another commenter expressed concerns that the process for requesting changes to ratings is a burden on the public with regard to time or cost. The time and cost of requesting a rating change is minimal and reasonable; an individual or group simply needs to explain the rationale behind their proposed rating change in order to begin an open dialog on the current wetland rating. The change requests are processed by the RPs and NP, through which the NWPL Review Standard is applied to the species in question.

    One commenter requested the inclusion of non-governmental, private-sector and academic experts on the NWPL panels, stating that government-only membership prevents the public from benefiting from expertise of botanists and other experts who are not federal employees. We do not feel that private sector or academic representatives should serve on the interagency regional or national panels as voting members. We encourage outside entities to provide input into the ratings process by providing scientific information, field data, literature reviews, and the like during the Federal Register notice process and by providing comments on the NWPL Web site. The information obtained can be useful to provide “expertise, knowledge, and clarity” to the NWPL process in this manner and helps inform final NWPL ratings.

    A final concern was the lack of habitat descriptions from the literature for many NWPL species. One commenter suggested removing from the NWPL all species that lack literature. Another criticized the lack of literature from a particular Corps region. The Corps has developed a future plan for collecting habitat citations for all the species that lack them. Ratings of these species will be re-examined in light of any new data according to this timeline: Habitat citations for species that occur in the largest number of U.S. counties will be compiled in 2016, for review during the 2017 NWPL update. Supporting literature for species that occur in fewer counties will be compiled in 2018, for the 2019 NWPL update. Consistent with the current and past updates to the NWPL, we will post the following information to the NWPL Web site: The species' current regional rating, RP rating, NP rating, a summary of the types of data (e.g., literature and herbaria records) used to assign ratings, and the recently acquired literature.

    Supporting documentation will be obtained from trustworthy sources, and the use of state, regional, and national floras or peer-reviewed journal articles is preferred. Online references and herbarium records will expedite data gathering provided the source is reliable. The number of citations/records considered adequate will vary with each species' range. Species with broad ranges that occur in several Corps regions will require more documentation than a species that is endemic to one or two counties. Likewise, few regionally specific references are available for species whose range recently expanded into a new Corps region. For instance, habitat references for species with recent range expansions into the South Pacific Islands, and the Caribbean may be difficult to obtain. Under these circumstances, citations from adjacent states or regions will be considered. During updates these citations from adjacent regions may be used to help guide decisions in regions that lack habitat citations due to recent range expansions. We believe that a minimum of ten citations or herbarium records for each species that currently lacks references is adequate for most species. Fewer records for rare or endemic species may be acceptable. The Corps welcomes public participation in this ongoing effort to improve wetland indicator ratings. Recent habitat citations for wetland plant species that lack literature may be contributed via email ([email protected]).

    The Corps believes we have adequately reviewed the comments and allowed for public and agency input for the proposal. More extensive response to comments can be viewed at http://wetland_plants.usace.army.mil/. Future updates to the NWPL will occur biennially according to the following procedures. A change in indicator status may be requested at any time at http://wetland_plants.usace.army.mil/ by clicking on the “Submit a NWPL Change Request” link and submitting the appropriate data. Data includes ecological data, literature reviews, frequency and abundance data, testing descriptions, and geographic data for the taxon in wetlands and uplands in the Corps wetland region or subregion for which the change is proposed. The regions and subregions are based on Land Resource Regions (LRRs) and Major Land Resource Areas (MLRAs) (http://soils.usda.gov/survey/geography/mlra/) and are shown for each wetland supplement region on the NWPL Web site. If the commenter feels that a wetland supplement region needs a subregion that has not yet been developed, the commenter should identify the MLRAs involved and provide a list of species from within that region that need their own wetland ratings. In addition to these public requests, biennial updates will also include changes in nomenclature and taxonomy, range extensions, and newly proposed species. Proposed rating changes will be compiled in January of odd years (i.e., 2017, 2019) and sent to the RPs for input in February. The NP will assign wetland ratings to non-consensus species and will review all regional lists in April. The proposed changes will be compiled over the summer and published in the Federal Register for public comment in September. In October, public comments will be summarized and the National Panel will review and respond to comments. The final changes will be published in the Federal Register in December of odd years.

    The Corps, in cooperation with the USEPA, USFWS and NRCS, is publishing final wetland indicator statuses for the 2016 NWPL. The final NWPL is available at http://wetland_plants.usace.army.mil/ and state, regional, and national lists can be downloaded from this site. This completes the review of the NWPL. All comments received have been evaluated and final indicator statuses have been set.

    Administrative Requirements Plain Language

    In compliance with the principles in the President's Memorandum of June 1, 1998, (63 FR 31855) regarding plain language, this preamble is written using plain language. The use of “we” in this notice refers to the Corps. We have also used the active voice, short sentences, and common everyday terms except for necessary technical terms.

    Paperwork Reduction Act

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. For the Corps Regulatory Program under Section 10 of the Rivers and Harbors Act of 1899, Section 404 of the Clean Water Act, and Section 103 of the Marine Protection, Research and Sanctuaries Act of 1972, the current OMB approval number for information collection requirements is maintained by the Corps of Engineers (OMB approval number 0710-0003, which expires on August 31, 2015 (extension request currently in review). This update will not have an effect on the paperwork burden because a wetland delineation is not required for a complete application for most permit types. The delineation of special aquatic sites for a complete preconstruction notification only applies to nationwide permits (NWP) and any additional hours will be included in the burden estimate for the 2017 NWP rulemaking.

    The action will not substantially change paperwork burdens on the regulated public because the use of 2016 NWPL will merely be substituted for the 2014 list currently used in the application process in jurisdictional determinations. Further, the NWPL can be viewed on-line or merged into existing documents (e.g., pick lists for delineations/determination forms) and subsequent updates will be made electronically.

    Executive Orders 12866 and 13563

    Under Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821), we must determine whether the regulatory action is “significant” and therefore subject to review by OMB and the requirements of the Executive Orders. The Executive Orders define “significant regulatory action” as one 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 the Executive Order.

    Pursuant to the terms of Executive Orders 12866 and 13563, we determined that this action is not a “significant regulatory action” and therefore, it is not subject to review under requirements of the Executive Orders.

    Executive Order 13132

    Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires the Corps to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” The action does not have federalism implications. We do not believe that the action has substantial direct effects on the States, on the relationship between the Federal government and the States, or on the distribution of power and responsibilities among the various levels of government. The action does not impose any additional substantive obligations on State or local governments. Therefore, Executive Order 13132 does not apply to this action.

    Regulatory Flexibility Act, as Amended by the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 601 et seq.

    The Regulatory Flexibility Act generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice-and-comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

    For purposes of assessing the impacts of the proposed issuance and modification of NWPs on small entities, a small entity is defined as: (1) A small business based on Small Business Administration size standards; (2) a small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; or (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

    After considering the economic impacts of the action on small entities, we certify that the updates to the NWPL will not have a significant impact on a substantial number of small entities since it does not change the Corps' current wetland delineation/identification procedures, or the circumstances under which a wetland delineation is required to make a decision on a Department of the Army permit application. The NWPL is only used to determine if a site has wetland plant community and is not the sole factor for determining whether a site is a wetland under the Clean Water Act. To be considered a wetland under the Clean Water Act, the site must also have wetland hydrology and hydric soils.

    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 and the private sector. Under Section 202 of the UMRA, the agencies generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating a rule for which a written statement is needed, Section 205 of the UMRA generally requires the agencies to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows an agency to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the agency publishes with the final rule an explanation why that alternative was not adopted. Before an agency establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed, under Section 203 of the UMRA, a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of regulatory proposals with significant federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

    We have determined that the NWPL issued today does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or the private sector in any one year. The use of the NWPL is consistent with current agency practice, does not impose new substantive requirements and therefore does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or the private sector in any one year. Therefore, the NWPL issued today is not subject to the requirements of Sections 202 and 205 of the UMRA. For the same reasons, we have determined that the NWPL update contains no regulatory requirements that might significantly or uniquely affect small governments. Therefore, the issuance of the NWPL is not subject to the requirements of Section 203 of UMRA.

    Environmental Documentation

    A decision document has been prepared for this action after all comments received were evaluated. The decision document is available through Headquarters, U.S. Army Corps of Engineers, Operations and Regulatory Community of Practice, 441 G Street NW., Washington, DC 20314-1000.

    Authority

    We utilize the NWPL in conducting wetland determinations under the authority of Section 404 of the Clean Water Act (33 U.S.C. 1344) and Section 10 of the Rivers and Harbors Act of 1899 (33 U.S.C. 401 et seq.).

    Dated: April 5, 2016. Edward E. Belk, Jr., P.E., Chief, Operations and Regulatory Division, Directorate of Civil Works.
    [FR Doc. 2016-08917 Filed 4-15-16; 8:45 am] BILLING CODE 3720-58-P
    DEPARTMENT OF EDUCATION Announcement of an Open Public Meeting AGENCY:

    National Advisory Council on Indian Education, Department of Education.

    ACTION:

    Announcement of an Open Public Meeting.

    SUMMARY:

    This notice sets forth the schedule of an upcoming public meeting conducted by the National Advisory Council on Indian Education (NACIE). Notice of the meeting is required by section 10(a)(2) of the Federal Advisory Committee Act and intended to notify the public of its opportunity to attend. In order to facilitate the Secretary's attendance, this notice is being published less than 15 days prior to the scheduled meeting date.

    DATES:

    The NACIE meeting will be held on April 25-26, 2016; April 25, 2016—8:30 a.m.-4:00 p.m. Eastern Daylight Saving Time, April 26, 2015—9:00 a.m.-1:00 p.m. Eastern Daylight Saving Time.

    The meeting location is 400 Maryland Ave., Room 3C100, SW., Washington, DC 20202.

    FOR FURTHER INFORMATION CONTACT:

    Tina Hunter, Designated Federal Official, Office of Elementary and Secondary Education, U.S. Department of Education, 400 Maryland Avenue SW., Washington, DC 20202. Telephone: 202-205-8527. Fax: 202-205-0310.

    SUPPLEMENTARY INFORMATION:

    NACIE's Statutory Authority and Function: The National Advisory Council on Indian Education is authorized by § 6141 of the Elementary and Secondary Education Act, as amended by Every Student Succeeds Act (ESSA). The Council is established within the Department of Education to advise the Secretary of Education on the funding and administration (including the development of regulations, and administrative policies and practices) of any program over which the Secretary has jurisdiction and includes Indian children or adults as participants or programs that may benefit Indian children or adults, including any program established under Title VI, part A of the Elementary and Secondary Education Act as amended by ESSA. The Council submits to the Congress, not later than June 30 of each year, a report on the activities of the Council that includes recommendations the Council considers appropriate for the improvement of Federal education programs that include Indian children or adults as participants or that may benefit Indian children or adults, and recommendations concerning the funding of any such program.

    One of the Council's responsibilities is to develop and provide recommendations to the Secretary of Education on the funding and administration (including the development of regulations, and administrative policies and practices) of any program over which the Secretary has jurisdiction that can benefit Indian children or adults participating in any program which could benefit Indian children.

    Meeting Agenda

    All attendees must RSVP for the meeting and sign up to provide a public comment no later than April 20, 2016. Speakers will be allowed to provide comments for no more than five (5) minutes. Members of the public interested in submitting written comments may do so via email at [email protected] Comments should pertain to the work of NACIE and/or the Office of Indian Education.

    The purpose of the meeting is to convene the Council to conduct the following business: (1) Final discussion, review and approval of the 2015 recommendations to the Secretary; (2) Present recommendations to the Secretary or Proxy; (3) Overview of ESSA and discuss the impact on Indian Programs with regard to NACIE, and; (4) Conduct discussions and begin work on the development of the annual report to Congress that should be submitted no later than June 30, 2016.

    Access to Records of the Meeting: The Department will post the official report of the meeting on the OESE Web site at: http://www2.ed.gov/about/offices/list/oese/oie/nacie.html#ar 21 days after the meeting. Pursuant to the FACA, the public may also inspect the materials at the Office of Indian Education, United States Department of Education, 400 Maryland Avenue SW., Washington, DC 20202, Monday-Friday, 8:30 a.m. to 5:00 p.m. Eastern Daylight Saving Time or by emailing [email protected] or by calling Terrie Nelson on (202) 401-0424 to schedule an appointment.

    Reasonable Accommodations: The hearing site is accessible to individuals with disabilities. If you will need an auxiliary aid or service to participate in the meeting (e.g., interpreting service, assistive listening device, or materials in an alternate format), notify Vickie Banagan on 205-2189 or at [email protected] no later than April 20, 2016. Although we will attempt to meet a request received after request due date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to make arrangements.

    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:

    The National Advisory Council on Indian Education is authorized by Section 6141 of the Elementary and Secondary Education Act, as amended by ESSA.

    Ann Whalen, Senior Advisor to the Secretary Delegated the Duties of Assistant Secretary for Elementary and Secondary Education.
    [FR Doc. 2016-08929 Filed 4-15-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0042] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Application Package for Strengthening Historically Black Graduate Institutions (HBGI) AGENCY:

    Office of Postsecondary Education (OPE), 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 May 18, 2016.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2016-ICCD-0042. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. 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, Room 2E-103, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Winston Skerrett, 202-453-7605.

    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: Application Package for Strengthening Historically Black Graduate Institutions (HBGI).

    OMB Control Number: 1840-NEW.

    Type of Review: A new information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 24.

    Total Estimated Number of Annual Burden Hours: 576.

    Abstract: The Strengthening Historically Black Graduate Institutions (HBGI) Program provides grants to assist institutions in establishing and strengthening their physical plants, development offices, endowment funds, academic resources and student services so that they may continue to participate in fulfilling the goal of equality of educational opportunity in graduate education.

    Dated: April 13, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-08849 Filed 4-15-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY [FE Docket No. 16-22-CGL] SeaOne Gulfport, LLC; Application for Long-Term, Multi-Contract Authorization To Export Natural Gas Contained in Compressed Gas Liquid to Non-Free Trade Agreement Countries AGENCY:

    Office of Fossil Energy, DOE.

    ACTION:

    Notice of application.

    SUMMARY:

    The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an application (Application), filed on September 18, 2015, by SeaOne Gulfport, LLC (SeaOne), requesting long-term, multi-contract authorization to export up to a total of 1.0 billion cubic feet per day (Bcf/d) of natural gas contained in Compressed Gas Liquid (CGL) by vessel 1 to any country located in or adjoining the Caribbean Basin and the Gulf of Mexico with which the United States does not have a free trade agreement (FTA) requiring national treatment for trade in natural gas, and with which trade is not prohibited by U.S. law or policy (non-FTA countries).2 SeaOne requests the authorization for a 30-year term to commence on the date of first commercial export. The Application was filed under section 3 of the Natural Gas Act (NGA), 15 U.S.C. Section 717b, and Part 590 of the Department of Energy's (“DOE”) regulations, 10 CFR part 590 (2011). SeaOne seeks to export the CGL from its proposed Gulfport CGL production facility, currently being developed within the existing Port of Gulfport, Mississippi. Additional details can be found in SeaOne's Application, posted on the DOE/FE Web site at http://energy.gov/sites/prod/files/2016/04/f30/16-22-cgl.pdf and in SeaOne's response to questions, posted on the DOE/FE Web site at http://energy.gov/sites/prod/files/2016/04/f30/Supplement.pdf. Protests, motions to intervene, notices of intervention, and written comments in response to the Application are invited.

    1 SeaOne does not specify the method of transport in its Application. DOE/FE takes notice of the method indicated in SeaOne's previous authorization. See SeaOne Pascagoula, LLC, Order Granting Long-Term, Multi-Contract Authorization to Export by Vessel Natural Gas Contained In or Mixed With Compressed Gas Liquid From the Proposed Pascagoula Compressed Gas Liquid Export Facility to be Located at the Port of Pascagoula, Mississippi to Free Trade Agreement Nations in the Caribbean Basin and Gulf of Mexico, DOE/FE Docket 14-83-CGL, Order No. 3555 (Dec. 2, 2014); see also SeaOne Gulfport, LLC, Order Granting Request to Amend DOE/FE Order No. 3555 to Reflect Changes in Site Location and Corporate Name, DOE/FE Docket 14-83-CGL, Order No. 3555-A (Sept. 25, 2015) (changing the name of the entity and the site location from Pascagoula, Mississippi to Gulfport, Mississippi).

    2 SeaOne previously received authorization to export natural gas contained in CGL to Free Trade Agreement Nations in DOE/FE Order Nos. 3555 and 3555-A.

    DATES:

    Protests, motions to intervene or notices of intervention, as applicable, requests for additional procedures, and written comments are to be filed using procedures detailed in the Public Comment Procedures section no later than 4:30 p.m., Eastern time, June 17, 2016.

    ADDRESSES:

    Electronic Filing by email: [email protected].

    Regular Mail: U.S. Department of Energy (FE-34), Office of Regulation and International Engagement, Office of Fossil Energy, P.O. Box 44375, Washington, DC 20026-4375.

    Hand Delivery or Private Delivery Services: (e.g., FedEx, UPS, etc.): U.S. Department of Energy (FE-34), Office of Regulation and International Engagement, Office of Fossil Energy, Forrestal Building, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585.

    FOR FURTHER INFORMATION CONTACT: Larine Moore or Benjamin Nussdorf, U.S. Department of Energy (FE-34), Office of Regulation and International Engagement, Office of Fossil Energy, Forrestal Building, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-9478; (202) 586-7893. Edward Myers, U.S. Department of Energy (GC-76), Office of the Assistant General Counsel for Electricity and Fossil Energy, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-9793.
    SUPPLEMENTARY INFORMATION: DOE/FE Evaluation

    The Application will be reviewed pursuant to section 3(a) of the NGA, 15 U.S.C. 717b(a), and DOE will consider any issues required by law or policy. To the extent determined to be relevant, these issues will include the domestic need for the natural gas proposed to be exported, the adequacy of domestic natural gas supply, U.S. energy security, and the cumulative impact of the requested authorization and any other natural gas export application(s) previously approved on domestic natural gas supply and demand fundamentals. DOE may also consider other factors bearing on the public interest, including the impact of the proposed exports on the U.S. economy (including GDP, consumers, and industry), job creation, the U.S. balance of trade, and international considerations; and whether the authorization is consistent with DOE's policy of promoting competition in the marketplace by allowing commercial parties to freely negotiate their own trade arrangements. As part of this analysis, DOE will consider the following two studies examining the cumulative impacts of exporting domestically produced LNG insofar as they may be applicable to this proceeding:

    Effect of Increased Levels of Liquefied Natural Gas Exports on U.S. Energy Markets, conducted by the U.S. Energy Information Administration upon DOE's request (2014 EIA LNG Export Study); 3 and

    3 The 2014 EIA LNG Export Study, published on Oct. 29, 2014, is available at: https://www.eia.gov/analysis/requests/fe/.

    The Macroeconomic Impact of Increasing U.S. LNG Exports, conducted jointly by the Center for Energy Studies at Rice University's Baker Institute for Public Policy and Oxford Economics, on behalf of DOE (2015 LNG Export Study).4

    4 The 2015 LNG Export Study, dated Oct. 29, 2015, is available at: http://energy.gov/sites/prod/files/2015/12/f27/20151113_macro_impact_of_lng_exports_0.pdf.

    Additionally, DOE will consider the following environmental document:

    Addendum to Environmental Review Documents Concerning Exports of Natural as From the United States, 79 FR 48132 (Aug. 15, 2014); 5

    5 The Addendum and related documents are available at: http://energy.gov/fe/draft-addendum-environmental-review-documents-concerning-exports-natural-gas-united-states.

    Parties that may oppose this Application should address the above-listed issues and documents in their comments and/or protests, as well as other issues deemed relevant to the Application.

    The National Environmental Policy Act (NEPA), 42 U.S.C. 4321 et seq., requires DOE to give appropriate consideration to the environmental effects of its proposed decisions. No final decision will be issued in this proceeding until DOE has met its environmental responsibilities.

    Public Comment Procedures

    In response to this Notice, any person may file a protest, comments, or a motion to intervene or notice of intervention, as applicable. Due to the complexity of the issues raised by the Applicant, interested parties will be provided 60 days from the date of publication of this Notice in which to submit their comments, protests, motions to intervene, or notices of intervention.

    Any person wishing to become a party to the proceeding must file a motion to intervene or notice of intervention. The filing of comments or a protest with respect to the Application will not serve to make the commenter or protestant a party to the proceeding, although protests and comments received from persons who are not parties will be considered in determining the appropriate action to be taken on the Application. All protests, comments, motions to intervene, or notices of intervention must meet the requirements specified by the regulations in 10 CFR part 590.

    Filings may be submitted using one of the following methods: (1) Emailing the filing to [email protected], with FE Docket No. 16-22-CGL in the title line; (2) mailing an original and three paper copies of the filing to the Office of Regulation and International Engagement at the address listed in ADDRESSES; or (3) hand delivering an original and three paper copies of the filing to the Office of Regulation and International Engagement at the address listed in ADDRESSES. All filings must include a reference to FE Docket No. 16-22-CGL. PLEASE NOTE: If submitting a filing via email, please include all related documents and attachments (e.g., exhibits) in the original email correspondence. Please do not include any active hyperlinks or password protection in any of the documents or attachments related to the filing. All electronic filings submitted to DOE must follow these guidelines to ensure that all documents are filed in a timely manner. Any hardcopy filing submitted greater in length than 50 pages must also include, at the time of the filing, a digital copy on disk of the entire submission.

    A decisional record on the Application will be developed through responses to this notice by parties, including the parties' written comments and replies thereto. Additional procedures will be used as necessary to achieve a complete understanding of the facts and issues. If an additional procedure is scheduled, notice will be provided to all parties. If no party requests additional procedures, a final Opinion and Order may be issued based on the official record, including the Application and responses filed by parties pursuant to this notice, in accordance with 10 CFR 590.316.

    The Application is available for inspection and copying in the Office of Regulation and International Engagement docket room, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585. The docket room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.

    The Application and any filed protests, motions to intervene or notice of interventions, and comments will also be available electronically by going to the following DOE/FE Web address: http://www.fe.doe.gov/programs/gasregulation/index.html.

    Issued in Washington, DC, on April 12, 2016. John A. Anderson, Director, Office of Regulation and International Engagement, Office of Oil and Natural Gas.
    [FR Doc. 2016-08884 Filed 4-15-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Public Availability of FY 2015 Service Contract Inventories and Supplemental Data April 6, 2016. AGENCY:

    Federal Energy Regulatory Commission, DOE.

    ACTION:

    Notice of Public Availability of FY 2015 Service Contract Inventories and Supplemental Data.

    SUMMARY:

    In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), the Federal Energy Regulatory Commission (FERC) is publishing this notice to advise the public on the availability of the FY 2015 Service Contract Inventory, a report that analyzes the Commission's FY 2015 Service Contract Inventory and an inventory supplement that identifies the amount invoiced and direct labor hours for covered service contract actions.

    The service contract inventory provides information on service contract actions over $25,000 that FERC completed in FY 2015. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010, by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP).

    OFPP's guidance is available at http://www.whitehouse.gov/sites/default/files/omb/procurement/memo/service-contract-inventories-guidance-11052010.pdf.

    On December 19, 2011, OFPP issued additional guidance available at http://www.whitehouse.gov/sites/default/files/omb/procurement/memo/service-contract-inventory-guidance.pdf.

    FERC has posted its FY 2015 inventory and summary at the following link: http://www.ferc.gov/about/offices/oed/oed-fo/oed-acquisition.asp.

    FOR FURTHER INFORMATION CONTACT:

    Katharine Lindner, Acquisition Services Division, Office of the Executive Director, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, (202) 502-6044, [email protected]

    Kimberly D. Bose, Secretary.
    [FR Doc. 2016-08863 Filed 4-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2512-075; Project No. 14439-001] Hawks Nest Hydro, LLC; Notice of Application Accepted for Filing, Soliciting Motions To Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Preliminary Terms and Conditions, and Preliminary Fishway Prescriptions

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.

    a. Type of Application: New Major Licenses.

    b. Project Nos.: 2512-075 and 14439-001.

    c. Date filed: December 29, 2015.

    d. Applicant: Hawks Nest Hydro, LLC (Hawks Nest Hydro).

    e. Name of Project: Hawks Nest and Glen Ferris Hydroelectric Projects.

    f. Location: The existing Hawks Nest and Glen Ferris projects are located on the New and Kanawha rivers, respectively. Both projects are located in Fayette County, West Virginia. The projects do not occupy any federal lands.

    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).

    h. Applicant Contact: Steven Murphy, Manager, Licensing, Brookfield Renewable Energy Group, 33 West 1st Street South, Fulton, New York 13069; Telephone (315) 598-6130.

    i. FERC Contact: Monir Chowdhury, (202) 502-6736, or [email protected].

    j. Deadline for filing motions to intervene and protests, comments, recommendations, preliminary terms and conditions, and preliminary prescriptions: 60 days from the issuance date of this notice; reply comments are due 105 days from the issuance date of this notice.

    The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, recommendations, preliminary terms and conditions, and preliminary fishway prescriptions using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include the applicable project name(s) and docket number(s) (e.g., Hawks Nest P-2512-075).

    The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.

    k. This application has been accepted for filing and is now ready for environmental analysis.

    l. The existing project works consist of the following:

    The existing Hawks Nest Hydroelectric Project consists of: (1) A 948-foot-long concrete-gravity dam with a crest elevation of 795.0 feet National Geodetic Vertical Datum of 1929 (NGVD29); (2) 14 ogee-type spillway bays extending almost the entire length of the dam, each with a 25-foot-high by 50-foot-wide Stoney-type steel lift gate and separated by a 9-foot-wide concrete pier; (3) a 243-acre reservoir with a gross storage capacity of 7,323 acre-feet at a normal pool elevation of 819.9 feet NGVD29; (4) an intake structure located at the right shoreline (looking downstream) of the reservoir just upstream of the dam and consisting of a 110-foot-wide by 50-foot-high trashrack structure and a Stoney-type 42-foot-high by 50-foot-wide bulkhead intake gate that sits back approximately 50 feet from the opening where the trashrack is located; (5) a 16,240-foot-long tunnel that runs along the right side of the river to convey water from the intake to the powerhouse downstream on the New River; (6) a 600-foot-long by 170-foot-wide surge basin located at a point on the tunnel approximately 60 percent of the distance from the intake to the powerhouse; (7) a 116-foot-diameter and 56-foot-high differential surge tank located at the downstream end of the tunnel and before the powerhouse; (8) a 210-foot-long by 74.5-foot-wide powerhouse containing four turbine-generator units, each with a rated capacity of approximately 25.5 megawatts (MW); (9) two parallel approximately 5.5-mile-long, 69-kilovolt (kV) transmission lines; and (10) appurtenant facilities. Hawks Nest Hydro operates the project in a run-of-river mode.

    The existing license for the Hawks Nest Hydroelectric Project requires that the project release a continuous minimum flow of 100 cubic feet per second into the bypassed reach between the dam and the powerhouse (Article 402). Hawks Nest Hydro proposes to continue run-of-river operation and increase the existing minimum flow for the bypassed reach. The project generates an annual average of 544,253 megawatt-hours.

    The existing Glen Ferris Hydroelectric Project consists of: (1) A low concrete dam with a maximum height of 12 feet above the river bed and a crest elevation of 651.0 feet NGVD29, consisting of (from left to right—looking downstream) (i) a 590-foot-long spillway section that generally curves upstream; (ii) a 128-foot-long five-bay stoplog sluice; (iii) a 2,132-foot-long right spillway that runs diagonally in a downstream direction; (iv) a trash sluice section; (v) a 54-foot-long by 38-foot-wide east powerhouse with a 62-foot-wide intake structure; and (vi) a 64.5-foot-long by 63-foot-wide west powerhouse with an 82.3-foot-wide intake structure, with both powerhouses integral to the dam; (2) a 190-acre reservoir with a gross storage capacity of approximately 1,500 acre-feet at the dam crest elevation of 651.0 feet NGVD29; (3) two turbine-generator units in the east powerhouse, each with a rated capacity of approximately 1.9 MW; (4) six turbine-generator units in the west powerhouse, each with a rated capacity of approximately 0.4 MW; (5) a 4-mile-long, 13.8-kV transmission line; and (6) appurtenant facilities.

    The Glen Ferris Hydroelectric Project is currently operated in a run-of-river mode with no usable storage capacity. Hawks Nest Hydro proposes to continue run-of-river operation. The project generates an annual average of 41,482 megawatt-hours.

    m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support. A copy is also available for inspection and reproduction at the address in item h above.

    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.

    All filings must (1) bear in all capital letters the title “PROTEST,” “MOTION TO INTERVENE,” “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” “PRELIMINARY TERMS AND CONDITIONS,” or “PRELIMINARY FISHWAY PRESCRIPTIONS;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    o. Procedural Schedule:

    The application will be processed according to the following revised Hydro Licensing Schedule. Revisions to the schedule may be made as appropriate.

    Milestone Target date Filing of recommendations, preliminary terms and conditions, and preliminary fishway prescriptions June 2016. Commission Issues Draft EA December 2016. Comments on Draft EA January 2017. Modified Terms and Conditions March 2017. Commission Issues Final EA June 2017.

    p. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.

    q. A license applicant must file no later than 60 days following the date of issuance of the notice of acceptance and ready for environmental analysis provided for in 5.22: (1) A copy of the water quality certification; (2) a copy of the request for certification, including proof of the date on which the certifying agency received the request; or (3) evidence of waiver of water quality certification.

    Dated: April 6, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-08858 Filed 4-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14758-000] Energy Resources USA Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications

    On February 19, 2016, Energy Resources USA Inc. filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Bosher Dam Hydroelectric Project (Bosher Project or project) to be located at the existing Bosher Dam on the James River, about 2 miles southwest of Tuckahoe, in Henrico County, Virginia. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.

    The proposed project would consist of the following: (1) An existing 12-foot-high dam; (2) an 1,000-acre-size impoundment with a storage capacity of 2,100-acre-foot and drainage area of 6,753 square miles; (3) a new 700-foot-long, 180-foot-wide intake; (4) a new 300-foot-long, 180-foot-wide tailrace; (5) four new 2-megawatt (MW) turbines; (6) a new 65-foot-long, 197-foot-wide powerhouse; (7) a new 60-foot-long, 50-foot-wide substation; (8) a new 528-foot-long, 69-kilovolt transmission line; and (9) appurtenant facilities. The estimated annual generation of the Bosher Project would be 68,500 megawatt-hours.

    Applicant Contact: Mr. Ander Gonzalez, Energy Resources USA Inc., 350 Lincoln Road, 2nd Floor, Miami Beach, FL 33139; phone: (954) 248-5425.

    FERC Contact: Woohee Choi; phone: (202) 502-6336.

    Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.

    The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-14758-000.

    More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-14758) in the docket number field to access the document. For assistance, contact FERC Online Support.

    Dated: April 6, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-08860 Filed 4-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2246-065] Yuba County Water Agency; Notice Soliciting Comments on Final Technical Memoranda

    On March 31, 2016, Yuba County Water Agency, licensee for the Yuba River Project, filed Technical Memoranda 7-11 and 7-11a, Fish Behavior and Hydraulics near Narrows 2 Powerhouse and Radio Telemetry of Spring- and Fall-Run Chinook Migratory Behavior Downstream of Narrows 2 Powerhouse. 1 The memoranda were required by studies approved by the Commission on September 30, 2011 (modified on December 28, 2011; April 12, 2012; and March 29, 2013) (Study 11) and August 22, 2013 (Study 11a).

    1 These technical memoranda can be viewed at http://elibrary.ferc.gov/idmws/common/OpenNat.asp?fileID=14186240.

    The Commission is soliciting comments on these memoranda. Any comments should be filed within 30 days from the date of this notice. The Commission strongly encourages electronic filing. Please file all documents using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected] In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-2246-065.

    Once the Commission has determined that it has sufficient information to process the license application, it will issue a notice that the application is ready for environmental analysis, requesting comments, recommendations, terms and conditions, or prescriptions.

    For further information, contact Alan Mitchnick at (202) 502-6074.

    Dated: April 6, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-08857 Filed 4-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 5891-009] Deschutes Valley Water District; Notice of Availability of Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office of Energy Projects has reviewed the Deschutes Valley Water District's (licensee) application to amend the license in order to construct and operate fish passage facilities at the Opal Springs Hydroelectric Project No. 5891. The project is located on the Crooked River in Jefferson County, Oregon. The project occupies federal lands administered by the U.S. Bureau of Land Management.

    The application, filed with the Commission on October 8, 2015, contains an Environmental Analysis in its Exhibit E. After independent review of the licensee's Exhibit E, Commission staff has decided to adopt the licensee's Environmental Analysis and issue it as staff's Environmental Assessment (EA). The EA analyzes the potential environmental impacts of construction and operation of fish passage facilities plus the proposed mitigation measures and concludes that granting the proposed amendment would not constitute a major federal action that would significantly affect the quality of the human environment.

    A copy of the EA is on file with the Commission and is available for public inspection. The EA may be viewed on the Commission's Web site at http://www.ferc.gov using the “eLibrary” link. Enter the docket number (P-5891) in the docket number field to access the document. For assistance, contact FERC Online Support at [email protected] or call toll-free at 1-866-208-3676 or (202) 502-8659 (for TTY).

    A copy of the EA may also be accessed using this link: http://elibrary.ferc.gov/idmws/common/OpenNat.asp?fileID=14010704.

    You may also register online at http://www.ferc.gov/docs-filing/esubsription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    All comments must be filed within 30 days of the date of this notice and should reference Project No. 5891-009. The Commission strongly encourages electronic filing. Please file comments using the Commission's efiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support. In lieu of electronic filing, please send a paper copy to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    For further information, contact Jennifer Ambler at (202) 502-8586 or [email protected]

    Dated: April 6, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-08859 Filed 4-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 1940-029] Wisconsin Public Service Corporation; Notice of Application Tendered for Filing With the Commission and Establishing Procedural Schedule for Licensing and Deadline for Submission of Final Amendments

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.

    a. Type of Application: New Major License.

    b. Project No.: P-1940-029.

    c. Date filed: March 28, 2016.

    d. Applicant: Wisconsin Public Service Corporation.

    e. Name of Project: Tomahawk Hydroelectric Project.

    f. Location: The existing project is located on the Wisconsin River in Lincoln County, Wisconsin. The project does not affect federal lands.

    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).

    h. Applicant Contact: Todd P. Jastremski, Asset Manager Hydro Operations, WE Energies, 800 Industrial Park Drive, Iron Mountain, MI 49801; or at (906) 779-4099.

    i. FERC Contact: Lee Emery at (202) 502-8379 or by email at [email protected].

    j. This application is not ready for environmental analysis at this time.

    k. The existing Tomahawk Hydroelectric Project consists of: (1) A 27-foot-high, 3,400-foot-long reinforced concrete and embankment dam that includes a 2,450-foot-long left embankment section, a 300-foot-long right embankment section, 9-foot-long sluice gate section, 267-foot-long radial gate section, 160-foot-long slab and buttress section, and a 60-foot-long abutment section with a crest elevation of 1,441.0 feet National Geodetic Vertical Datum (NGVD); (2) a 2,773-acre reservoir (Lake Mohawksin) at a full-pool elevation of 1,435.5 feet NGVD; (3) a 67-foot-long by 41-foot-wide powerhouse containing two 1.3-megawatt (MW) generators providing a combined installed capacity of 2.6 MW; (4) powerhouse intake trash racks with a 2.7-inch clear bar spacing; (5) two 2.4-kilovolt (kV) generator leads and an associated 3.75-megavolt-ampere, 2.4/24.9-kV three phase transformer; (6) an interconnected substation located adjacent to the powerhouse; and (7) appurtenant facilities.

    The project is operated in a limited peaking mode, with maximum allowed daily reservoir fluctuations of approximately 0.8 feet (1,435.5 feet NGVD to 1,434.7 feet NGVD). During normal peaking operations, the reservoir is drawn down from the maximum pond elevation during the day and refilled at night providing one peaking cycle per day. The amount of fluctuation is determined primarily by the volume of water which can normally be restored to the Tomahawk reservoir during off-peak hours. During low flow periods, the project is required to maintain a minimum flow of 162 cubic feet per second (cfs) or inflow, whichever is less. The operation of the Tomahawk Project is coordinated with the downstream WPS Projects (Grandfather Falls and Alexander Projects) and with the Grandmother Falls Project to make the most effective use of the available water resource.

    The normal tailwater elevation of the project is 1,419.5 feet NGVD. The impoundment provides about 14.5 feet of gross head for power generation purposes. The hydraulic capacity of the project is 2,634 cfs and water flowing through the turbines is discharged via the draft tubes into the tailrace immediately below the dam. Electricity generated from the project is transmitted from the powerhouse via two 2.5-kV generator leads and a 3.75 MVA 2.4/24.9-kV three-phase transformer to the adjacent substation and into Wisconsin Public Service Corporation's distribution system. Wisconsin Public Service Corporation is proposing to continue current operations at the Project for the term of the new license.

    l. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact [email protected], (866) 208-3676 (toll free) or (202) 502-8659 (TTY). A copy is also available for inspection and reproduction at the address in item h above.

    m. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    n. Procedural schedule:

    The application will be processed according to the following preliminary Hydro Licensing Schedule. Revisions to the schedule may be made as appropriate.

    Milestone Target date Notice of Acceptance/Notice of Ready for Environmental Analysis June 2016. Filing of recommendations, preliminary terms and conditions, and fishway prescriptions August 2016. Issue Environmental Assessment (EA) December 2016. Comments due on EA January 2017. Modified terms and conditions March 2017.

    o. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.

    Dated: April 6, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-08861 Filed 4-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PF15-33-000] Northern Natural Gas Company; Notice of Intent To Prepare an Environmental Assessment for the Planned Northern Lights 2017 Expansion Project, Request for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the Northern Lights 2017 Expansion Project involving construction and operation of facilities by Northern Natural Gas Company (Northern) in Dakota County, Minnesota. The Commission will use this EA in its decision-making process to determine whether the project is in the public convenience and necessity.

    This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies on the project. You can make a difference by providing us with your specific comments or concerns about the project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the EA. To ensure that your comments are timely and properly recorded, please send your comments so that the Commission receives them in Washington, DC on or before May 11, 2016.

    If you sent comments on this project to the Commission before the opening of this docket on September 28, 2015, you will need to file those comments in Docket No. PF15-33-000 to ensure they are considered as part of this proceeding.

    This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this planned project and encourage them to comment on their areas of concern.

    If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the planned facilities. The company would seek to negotiate a mutually acceptable agreement. However, if the Commission approves the project, that approval conveys with it the right of eminent domain. Therefore, if easement negotiations fail to produce an agreement, the pipeline company could initiate condemnation proceedings where compensation would be determined in accordance with state law.

    A fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” is available for viewing on the FERC Web site (www.ferc.gov). This fact sheet addresses a number of typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings.

    Public Participation

    For your convenience, there are three methods you can use to submit your comments to the Commission. The Commission will provide equal consideration to all comments received, whether filed in written form or provided verbally. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or [email protected] Please carefully follow these instructions so that your comments are properly recorded.

    (1) You can file your comments electronically using the eComment feature on the Commission's Web site (www.ferc.gov) under the link to Documents and Filings. This is an easy method for submitting brief, text-only comments on a project;

    (2) You can file your comments electronically by using the eFiling feature on the Commission's Web site (www.ferc.gov) under the link to Documents and Filings. With eFiling, you can provide comments in a variety of formats by attaching them as a file with your submission. New eFiling users must first create an account by clicking on “eRegister.” If you are filing a comment on a particular project, please select “Comment on a Filing” as the filing type; or

    (3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket number (PF15-33-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.

    Summary of the Planned Project

    Northern plans to construct and operate approximately 4.8 miles of branch line loop 1 extensions in Sherburne and Isanti counties, Minnesota, and to install an additional 15,900-horsepower compressor unit to an existing compressor station site in Rice County, Minnesota. The Northern Lights 2017 Expansion Project would allow Northern to transport an incremental load of 76 million cubic feet on Northern's existing system. According to Northern, its project would meet the firm transportation service elected during an October 2015 open season by Xcel Energy Inc., CenterPoint Energy, Al-Corn Clean Fuel, and Midwest Natural Gas, Inc.

    1 A pipeline loop is a segment of pipe constructed parallel to an existing pipeline to increase capacity.

    The Northern Lights 2017 Expansion Project would consist of the following facilities:

    • 2.0 miles extending the existing 8-inch-diameter Princeton branch line loop and a new associated valve;

    • 2.8 miles extending the existing 12-inch-diameter St. Cloud branch line loop and a new associated valve;

    • a 15,900-horsepower Solar Mars turbine compressor unit at the Faribault Compressor Station; and

    • cathodic protection test stations.

    The general location of the project facilities is shown in appendix 1.2

    2 The appendices referenced in this notice will not appear in the Federal Register. Copies of the appendices were sent to all those receiving this notice in the mail and are available at www.ferc.gov using the link called “eLibrary” or from the Commission's Public Reference Room, 888 First Street NE., Washington, DC 20426, or call (202) 502-8371. For instructions on connecting to eLibrary, refer to page 7 of this notice.

    Land Requirements for Construction

    Construction of the planned facilities would disturb about 112.4 acres of land for the aboveground facilities and the pipeline. In addition to its existing facilities, Northern would maintain about 2.1 acres for permanent operation of the project's facilities following construction; the remaining acreage would be restored and revert to former uses. Most of the facilities would be located within Northern's existing easements, offset 20 to 25 feet from Northern's existing pipelines, and thus not require any new permanent easements.

    The EA Process

    The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from an action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires us 3 to discover and address concerns the public may have about proposals. This process is referred to as scoping. The main goal of the scoping process is to focus the analysis in the EA on the important environmental issues. By this notice, the Commission requests public comments on the scope of the issues to address in the EA. We will consider all filed comments during the preparation of the EA.

    3 “We,” “us,” and “our” refer to the environmental staff of the Commission's Office of Energy Projects.

    In the EA we will discuss impacts that could occur as a result of the construction and operation of the planned project under these general headings: Geology and soils; land use; water resources, fisheries, and wetlands; cultural resources; vegetation and wildlife; air quality and noise; endangered and threatened species; public safety; and cumulative impacts.

    We will also evaluate possible alternatives to the planned project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.

    Although no formal application has been filed, we have already initiated our NEPA review under the Commission's pre-filing process. The purpose of the pre-filing process is to encourage early involvement of interested stakeholders and to identify and resolve issues before the FERC receives an application. As part of our pre-filing review, we have begun to contact some federal and state agencies to discuss their involvement in the scoping process and the preparation of the EA.

    The EA will present our independent analysis of the issues. The EA will be available in the public record through eLibrary. Depending on the comments received during the scoping process, we may also publish and distribute the EA to the public for an allotted comment period. We will consider all comments on the EA before we make our recommendations to the Commission. To ensure we have the opportunity to consider and address your comments, please carefully follow the instructions in the Public Participation section, beginning on page 2.

    With this notice, we are asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues related to this project to formally cooperate with us in the preparation of the EA.4 Agencies that would like to request cooperating agency status should follow the instructions for filing comments provided under the Public Participation section of this notice.

    4 The Council on Environmental Quality regulations addressing cooperating agency responsibilities are at Title 40, Code of Federal Regulations, Part 1501.6.

    Consultations Under Section 106 of the National Historic Preservation Act

    In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, we are using this notice to initiate consultation with the Minnesota State Historic Preservation Office (SHPO), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.5 We will define the project-specific Area of Potential Effects (APE) in consultation with the SHPO as the project develops. On natural gas facility projects, the APE at a minimum encompasses all areas subject to ground disturbance (examples include construction right-of-way, contractor/pipe storage yards, compressor stations, and access roads). Our EA for this project will document our findings on the impacts on historic properties and summarize the status of consultations under section 106.

    5 The Advisory Council on Historic Preservation regulations are at Title 36, Code of Federal Regulations, Part 800. Those regulations define historic properties as any prehistoric or historic district, site, building, structure, or object included in or eligible for inclusion in the National Register of Historic Places.

    Environmental Mailing List

    The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project. We will update the environmental mailing list as the analysis proceeds to ensure that we send the information related to this environmental review to all individuals, organizations, and government entities interested in and/or potentially affected by the planned project.

    If we publish and distribute the EA, copies will be sent to the environmental mailing list for public review and comment. If you would prefer to receive a paper copy of the document instead of the CD version or would like to remove your name from the mailing list, please return the attached Information Request (appendix 2).

    Becoming an Intervenor

    Once Northern files its application with the Commission, you may want to become an “intervenor” which is an official party to the Commission's proceeding. Intervenors play a more formal role in the process and are able to file briefs, appear at hearings, and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene. Motions to intervene are more fully described at http://www.ferc.gov/resources/guides/how-to/intervene.asp. Instructions for becoming an intervenor are in the “Document-less Intervention Guide” under the “e-filing” link on the Commission's Web site. Please note that the Commission will not accept requests for intervenor status at this time. You must wait until the Commission receives a formal application for the project.

    Additional Information

    Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site (www.ferc.gov) using the eLibrary link. Click on the eLibrary link, click on “General Search” and enter the docket number, excluding the last three digits in the Docket Number field (i.e., PF15-33). Be sure you have selected an appropriate date range. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or for TTY, contact (202) 502-8659. The eLibrary link also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rulemakings.

    In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Finally, public meetings or site visits will be posted on the Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: April 11, 2016.

    Kimberly D. Bose, Secretary.
    [FR Doc. 2016-08862 Filed 4-15-16; 8:45 am] BILLING CODE 6717-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0743] 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 Office of Management and Budget (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 May 18, 2016. 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: 3060-0743.

    Title: Implementation of the Pay Telephone Reclassification and Compensation Provisions of the Telecommunications Act of 1996, CC Docket No. 96-128.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities and state, local and tribal government.

    Number of Respondents and Responses: 4,471 respondents; 10,071 responses.

    Estimated Time per Response: 11.730414 hours.

    Frequency of Response: On occasion, quarterly and monthly reporting requirements, recordkeeping requirement and third party disclosure requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 276 of the Telecommunications Act of 1996, as amended.

    Total Annual Burden: 118,137 hours.

    Total Annual Cost: No cost.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: The Commission is not requesting that respondents submit confidential information to the FCC. If the Commission requests respondents to submit information which respondents believe is confidential, they may request confidential treatment of such information under 47 CFR 0.459 of the Commission's rules.

    Needs and Uses: In CC Docket No. 96-128, the Commission promulgated rules and requirements implementing Section 276 of the Telecommunications Act of 1996. Among other things, the rules (1) establish fair compensation for every completed intrastate and interstate payphone call; (2) discontinue intrastate and interstate access charge payphone service elements and payments, and intrastate and interstate payphone subsidies from basic exchange services; and (3) adopt guidelines for use by the states in establishing public interest payphones to be located where there would otherwise not be a payphone. The information collected under LEC Provision of Emergency Numbers to Carrier-Payers would enable us to ensure that interexchange carriers, payphone service providers (“PSP”), LECs, and the states, comply with their obligations under the 1996 Act.

    Federal Communications Commission. Gloria J. Miles, Register Liaison Officer. Office of the Secretary.
    [FR Doc. 2016-08890 Filed 4-15-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0166, 3060-0076] Information Collections Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written PRA comments should be submitted on or before June 17, 2016. 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 Nicole Ongele, FCC, via email to [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0166.

    Title: Part 42, Sections 42.5, 42.6, and 42.7, Preservation of Records of Communications Common Carriers.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents and Responses: 50 respondents; 50 responses.

    Estimated Time per Response: 2 hours.

    Frequency of Response: Occasional reporting requirement, recordkeeping requirement, and third party disclosure requirement.

    Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in Section 220 of the Communications Act of 1934, as amended, 47 U.S.C. 220.

    Total Annual Burden: 100 hours.

    Total Annual Cost: No cost.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: The respondents are instructed on the appropriate procedures to follow to safeguard information deemed confidential under 47 CFR 0.457 of the Commission's rules, which details the type of records that are not routinely available for public inspection. Section 0.459 of the Commission's rules contains procedures for requesting that material and information submitted to the Commission be withheld from public inspection.

    Needs and Uses. Section 42.6 requires a carrier to retain for eighteen months to assist the Department of Justice in its law enforcement activities telephone toll records that provide the billing information about telephone toll calls: The name, address, and telephone number of the caller, telephone number called, date, time and call length.

    OMB Control Number: 3060-0076.

    Title: Common Carrier Annual Employment Report.

    Form Number: FCC Form 395.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents and Responses: 780 respondents; 780 responses.

    Estimated Time per Response: 1 hour.

    Frequency of Response: Annual reporting requirement and recordkeeping requirement.

    Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in 47 U.S.C. sections 154(i), 303, and 307-310 of the Communications Act of 1934, as amended.

    Total Annual Burden: 780 hours.

    Total Annual Cost: No cost.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: The respondents are instructed on the appropriate procedures to follow to safeguard information deemed confidential under 47 CFR 0.457 of the Commission's rules, which details the type of records that are not routinely available for public inspection. Section 0.459 of the Commission's rules contains procedures for requesting that material and information submitted to the Commission be withheld from public inspection.

    Needs and Uses: FCC Report 395, Common Carrier Annual Employment Report, is a data collection mechanism to implement the FCC's Equal Employment Opportunity (EEO) rules. All common carrier licensees or permittees with sixteen (16) or more full-time employees are required to file the Annual Employment Report. Each common carrier is also obligated to file with this Commission copies of all exhibits, letters, and documents pertaining to all equal employment opportunity statements and annual reports on complaints regarding violations of equal employment provisions of Federal, State, Territorial, or local law. Section 22.321(f), 47 CFR, requires each licensee to maintain these documents for a period of two years. The Annual Employment Report identifies each filer's staff by gender, race, color, and/or national origin in each of ten major job categories. The report and all other EEOC documents are filed with the Commission to detail the applicant's compliance with the Commission's EEO rules. Those documents are available for public inspection at a designated area located in the FCC's Industry Analysis and Technology Division.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer. Office of the Secretary.
    [FR Doc. 2016-08889 Filed 4-15-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meeting AGENCY:

    Federal Election Commission.

    DATE AND TIME:

    Tuesday, March 15, 2016 at 10:00 a.m. and Wednesday, March 16, 2016 at the conclusion of the Open Meeting.

    PLACE:

    999 E Street NW., Washington, DC.

    STATUS:

    This meeting will be closed to the public.

    Federal Register notice of previous announcement—81 FR 12731.

    CHANGE IN THE MEETING:

    This meeting was continued on April 12, 2016.

    PERSON TO CONTACT FOR INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Shelley E. Garr, Deputy Secretary.
    [FR Doc. 2016-09035 Filed 4-14-16; 4:15 pm] BILLING CODE 6715-01-P
    FEDERAL MARITIME COMMISSION Sunshine Act Meeting AGENCY HOLDING THE MEETING:

    Federal Maritime Commission.

    TIME AND DATE:

    April 20, 2016-10 a.m.

    PLACE:

    800 North Capitol Street NW., First Floor Hearing Room, Washington, DC.

    STATUS:

    The meeting will be held in Open Session.

    MATTERS TO BE CONSIDERED:

    Open Session 1. Supply Chain Innovation Team Update 2. Briefing on Upgrade to FMC Online Agreement Library 3. Optional Method of Filing Ocean Common Carrier and Marine Terminal Operator Agreements 4. Presentation of Evidence in Commission Adjudicatory Proceedings CONTACT PERSON FOR MORE INFORMATION:

    Karen V. Gregory, Secretary, (202) 523 5725.

    Karen V. Gregory, Secretary.
    [FR Doc. 2016-09002 Filed 4-14-16; 4:15 pm] BILLING CODE 6731-AA-P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than May 2, 2016.

    A. Federal Reserve Bank of Minneapolis (Jacquelyn K. Brunmeier, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:

    1. Douglas M. Taylor, Bemidji, Minnesota, individually and as trustee of Citizens State Bank Midwest 401(k) Profit Sharing Plan, Cavalier, North Dakota (“Profit Sharing Plan”), and as part of a group acting in concert with the Profit Sharing Plan, Nancy R. Helling, Saint Cloud, Minnesota, and Ramona D. Taylor Vosper, Neche, North Dakota; to acquire voting shares of Pembina County Bankshares, Ltd., and thereby indirectly acquire voting shares of Citizens State Bank—Midwest, both in Cavalier, North Dakota.

    Board of Governors of the Federal Reserve System, April 12, 2016. Michael J. Lewandowski, Associate Secretary of the Board.
    [FR Doc. 2016-08809 Filed 4-15-16; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than May 13, 2016.

    A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:

    1. Blackhawk Bancorporation, Inc., Milan, Illinois; to merge with First Port Byron Bancorp, Inc., and thereby indirectly acquire Port Byron State Bank, both in Port Byron, Illinois.

    Board of Governors of the Federal Reserve System, April 13, 2016. Michael J. Lewandowski, Associate Secretary of the Board.
    [FR Doc. 2016-08906 Filed 4-15-16; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than May 12, 2016.

    A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:

    1. Community Bancshares, Corp., Indianola, Iowa; to acquire 100 percent of the voting shares of IT&S of Iowa, Inc., and thereby indirectly acquire voting shares of TruBank, both in Oskaloosa, Iowa.

    B. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:

    1. Bellwood Community Holding Company, Bellwood, Nebraska; to acquire 100 percent of the voting shares of Hassenstab Management Co., Inc., and thereby indirectly acquire voting shares of Farmers State Bank, both in Humphrey, Nebraska.

    Board of Governors of the Federal Reserve System, April 12, 2016. Michael J. Lewandowski, Associate Secretary of the Board.
    [FR Doc. 2016-08808 Filed 4-15-16; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Sunshine Act Meeting; Board Member Meeting TIME AND DATE:

    April 25, 2016, 8:30 a.m. (In Person).

    PLACE:

    10th Floor Board Meeting Room, 77 K Street NE., Washington, DC 20002.

    Agenda

    Federal Retirement Thrift Investment Board Member Meeting, April 25, 2016, 8:30 a.m. (In-Person).

    Open Session 1. Approval of the Minutes of the March 29, 2016 Board Member Meeting 2. Monthly Reports (a) Participant Activity Report (b) Legislative Report 3. Quarterly Reports (a) Investment Policy (b) Budget Review (c) Audit Status 4. Annual Financial Audit—CLA 5. Planning and Prioritization Closed Session 6. Security Adjourn CONTACT PERSON FOR MORE INFORMATION:

    Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.

    Dated: April 14, 2016. Megan Grumbine, General Counsel, Federal Retirement Thrift Investment Board.
    [FR Doc. 2016-08999 Filed 4-14-16; 4:15 pm] BILLING CODE 6760-01-P
    FEDERAL TRADE COMMISSION Enforcement Policy Statement on Deceptively Formatted Advertisements AGENCY:

    Federal Trade Commission.

    ACTION:

    Commission policy statement.

    SUMMARY:

    The Federal Trade Commission has issued an Enforcement Policy Statement on Deceptively Formatted Advertisements. The Statement describes the underlying consumer protection principles that guide the Commission's enforcement actions, advisory opinions, and other guidance addressing various forms of deceptively formatted advertising, including advertising and promotional messages integrated into and presented as non-commercial content.

    DATES:

    The Commission announced the issuance of the Statement on December 22, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Laura Sullivan (202-326-3327) or Michael Ostheimer (202-326-2699), Bureau of Consumer Protection, 600 Pennsylvania Avenue NW., Washington, DC 20580.

    SUPPLEMENTARY INFORMATION: Enforcement Policy Statement on Deceptively Formatted Advertisements

    The Federal Trade Commission issues this enforcement policy statement regarding advertising and promotional messages integrated into and presented as non-commercial content.1 The statement summarizes the principles underlying the Commission's enforcement actions, advisory opinions, and other guidance over many decades addressing various forms of deceptively formatted advertising.

    1 The scope of this enforcement policy statement is restricted to commercial speech the Commission has authority to regulate. The Commission traditionally considers factors articulated in R.J. Reynolds Tobacco Co., 111 F.T.C. 539, 544-46 (1988), in evaluating whether speech is commercial. See, e.g., POM Wonderful LLC, 155 F.T.C. 1, 74-75 (2013), aff'd, 777 F.3d 478 (D.C. Cir. 2015).

    Section 5 of the FTC Act prohibits “unfair or deceptive acts or practices in or affecting commerce.” As the Commission set forth in its 1983 Policy Statement on Deception, a representation, omission, or practice is deceptive if it is likely to mislead consumers acting reasonably under the circumstances and is material to consumers—that is, it would likely affect the consumer's conduct or decisions with regard to a product or service.2 In determining whether an advertisement, including its format, misleads consumers, the Commission considers the overall “net impression” it conveys.3 Any qualifying information necessary to prevent deception must be disclosed prominently and unambiguously to overcome any misleading impression created.

    2FTC Statement on Deception, 103 F.T.C. 174, 175 (1984) (appended to Cliffdale Assocs., Inc., 103 F.T.C. 110 (1984)) (“Deception Policy Statement”).

    3Id. at 178.

    The Commission has long held the view that advertising and promotional messages that are not identifiable as advertising to consumers are deceptive if they mislead consumers into believing they are independent, impartial, or not from the sponsoring advertiser itself. Knowing the source of an advertisement or promotional message typically affects the weight or credibility consumers give it. Such knowledge also may influence whether and to what extent consumers choose to interact with content containing a promotional message. Over the years, the Commission has challenged as deceptive a wide variety of advertising and other commercial message formats, including “advertorials” that appeared as news stories or feature articles, direct-mail ads disguised as book reviews, infomercials presented as regular television or radio programming, in-person sales practices that misled consumers as to their true nature and purpose, mortgage relief ads designed to look like solicitations from a government agency, emails with deceptive headers that appeared to originate from a consumer's bank or mortgage company, and paid endorsements offered as the independent opinions of impartial consumers or experts.

    With the emergence of digital media and changes in the way publishers monetize content, online advertising known as “native advertising” or “sponsored content,” which is often indistinguishable from news, feature articles, product reviews, editorial, entertainment, and other regular content, has become more prevalent. In digital media, a publisher, or an authorized third party, can easily and inexpensively format an ad so it matches the style and layout of the content into which it is integrated in ways not previously available in traditional media. The effect is to mask the signals consumers customarily have relied upon to recognize an advertising or promotional message.

    At the same time, the business models of many publishers also have undergone significant change, as, increasingly, consumers are able to skip or block digital ads while watching digitized programming or browsing publisher content. Consequently, many publishers have begun to offer advertisers formats and techniques that are closely integrated with and less distinguishable from regular content so that they can capture the attention and clicks of ad-avoiding consumers.

    Regardless of the medium in which an advertising or promotional message is disseminated, deception occurs when consumers acting reasonably under the circumstances are misled about its nature or source, and such misleading impression is likely to affect their decisions or conduct regarding the advertised product or the advertising. This statement sets forth generally applicable standards on which the Commission relies in making such a determination.

    I. Deceptive Advertising Formats

    The principle that advertising and promotional messages should be identifiable as advertising is found in Commission and staff policy guidance,4 specific cases challenging deceptive advertising in a wide range of media,5 and Congressional policy with regard to telemarketing calls and commercial email.6 As set forth below, over the years, the Commission and staff have addressed the potential for consumers to be deceived by various categories of advertising formats, such as ads appearing in a news or feature story format, deceptive endorsements, undisclosed sponsorship of advertising and promotional messages, and ads in search results.

    4See, e.g., Advisory Opinion No. 191, Advertisements which appear in news format, 73 F.T.C. 1307 (1968) (hereinafter “Advisory Opinion on Ads in News Formats”).

    5See, e.g., Georgetown Publ'g House Ltd. P'ship, 122 F.T.C. 392 (1996) (consent); JS&A Grp., Inc., 111 F.T.C. 522 (1989) (consent).

    6See Controlling the Assault of Non-Solicited Pornography and Marketing Act of 2003, 15 U.S.C. 7701-7713 (hereinafter the “CAN-SPAM Act”); Telemarketing and Consumer Fraud and Abuse Prevention Act, 15 U.S.C. 6101-6108 (hereinafter the “Telemarketing Fraud Act”).

    A. Advertisements Appearing in a News Format or That Otherwise Misrepresent Their Source or Nature

    The Commission first addressed the issue of print advertisements appearing in a news format in a 1967 press release and subsequent 1968 advisory opinion.7 A newspaper column, advertising the cuisine of local restaurants, was written in narrative form, with each write-up discussing such details as how a meal was prepared, the name of the chef and/or head waiter, cocktail service offered, whether dancing was permitted, hours, and the price range of the meal.8 The Commission found that the column “use[d] the format and ha[d] the general appearance of a news feature and/or article for public information which purport[ed] to give an independent, impartial and unbiased view of the cuisine facilities of a particular restaurant.” The Commission also explained that the inclusion of the exact price of the meal advertised or listing a range of prices for other meals would not alter this impression. The Commission concluded that a clear and conspicuous disclosure that the column was an advertisement was necessary to prevent consumers from being deceived. Specifically, the Commission suggested placing “ADVERTISEMENT,” in clear type, sufficiently large to be readily noticed, in close proximity to the ad. The Commission, however, noted that in some instances, “the format of [an] advertisement may so exactly duplicate a news or feature article as to render the caption `ADVERTISEMENT' meaningless and incapable of curing the deception.” 9

    7Statement in Regard to Advertisements That Appear in Feature Article Format, FTC Release, (Nov. 28, 1967) (hereinafter “Statement on Ads in Feature Article Format”); Advisory Opinion on Ads in News Formats.

    8Advisory Opinion on Ads in News Formats, 73 F.T.C. at 1307.

    9Statement on Ads in Feature Article Format.

    Two decades later, in a case against a bookseller, the Commission applied this same analysis and concluded there was reason to believe that the bookseller violated the FTC Act through a deceptive direct-mail ad formatted to appear as if it were a book review torn out of a magazine, with a personalized note attached.10 The Commission alleged that the ad's format communicated a misleading claim that it was “a book review written by an independent journalist or reviewer, containing the independent opinions of the journalist or reviewer, and was disseminated in a magazine or other independent publication.” The Commission observed that the ad was printed on glossy stock and had a ripped, left edge, and included other elements, such as the header “REVIEW,” a byline, a publication date, and page numbers, and part of an unrelated article on the reverse side, which, taken together, made it look like a published review of the book advertised. In evaluating what the ad communicated to consumers, the Commission also considered that affixed to each ad was a small, stick-on note containing what appeared to be a personalized, handwritten message, with the recipient's first name and saying, “Try this. It works! J.”

    10Georgetown Publ'g House Ltd. P'ship, 122 F.T.C. at 393-96.

    During the 1980s, after the Federal Communications Commission removed its ban on program-length commercials, such advertisements, known as infomercials, began to air on television and radio.11 Concerned about the increasingly blurred line between advertising and non-promotional content, the Commission brought cases alleging that deception occurs when infomercials are presented as regular television or radio programming, such as a news report or talk show. In the Commission's first such case in 1989, the Commission challenged a television infomercial that opened with the statement, “Welcome to `Consumer Challenge,' hosted by Jonathan Goldsmith,” and went on to describe the program as one that “examines popular new products for you,” with the help of investigative reporters.12 It then announced that the day's program would investigate a particular brand of sunglasses, posing the question to viewers: “[N]ew Product innovation or consumer rip-off?” In evaluating the sunglass infomercial, the Commission asserted that its format was likely to mislead consumers into believing that it was “an independent consumer program . . . that conducts independent and objective investigations of consumer products,” including for the company's sunglasses. Since bringing that case, the FTC has charged that numerous other television and radio infomercials were deceptively formatted. In nearly every such case, the Commission has issued an order requiring a clear and prominent disclosure, at the beginning of an infomercial and again each time ordering instructions are given, informing consumers that the program is a “PAID ADVERTISEMENT” for the particular product or service advertised.13

    11See Deregulation of Radio, 84 F.C.C. 2d 968, 1007 (1981) (rescinding the FCC's policy banning program-length radio commercials); Revision of Programming and Commercialization, Policies, Ascertainment Requirements, and Program Log Requirements for Commercial Television Stations, 98 F.C.C. 2d 1075 (1984) (rescinding the FCC's policy banning program-length television commercials).

    12JS&A Grp., Inc., 111 F.T.C. at 523-24.

    13See, e.g., Vital Basics, Inc., 137 F.T.C. 254, 274, 340-41 (2004) (consent); Nutrivida, Inc., 126 F.T.C. 339, 342-43, 351-52 (1998) (consent); Bogdana Corp., 126 F.T.C. 37, 47, 100-01 (1998) (consent); Mega Sys. Int'l, Inc., 125 F.T.C. 973, 986, 1218-19 (1998) (consent); Olsen Labs., Inc., 119 F.T.C. 161, 167, 214 (1995) (consent); Wyatt Mktg. Corp., 118 F.T.C. 86, 94, 113-14 (1994) (consent); Del Dotto Enters., Inc., 117 F.T.C. 446, 452-53, 466 (1994) (consent); Synchronal Corp., 116 F.T.C. 989, 1002-03, 1045 (1993) (consent); Michael S. Levey, 116 F.T.C. 885, 900-01, 950-51 (1993) (consent); Nat'l Media Corp., 116 F.T.C. 549, 559, 582 (1993) (consent); CC Pollen Co., 116 F.T.C. 206, 209, 239-40 (1993) (consent); Nu-Day Enters., Inc., 115 F.T.C. 479, 483, 488-89 (1992) (consent); Twin Star Prods., Inc., 113 F.T.C. 847, 852-53, 862 (1990) (consent); TV Inc., 113 F.T.C. 677, 679, 693 (1990) (consent); see also FTC v. Direct Mktg. Concepts, Inc., 648 F. Supp. 2d 202, 209, 211 (D. Mass. 2009) (noting parties' stipulation to an injunctive provision addressing deceptive formats), aff'd, 624 F.3d 1 (1st Cir. 2010).

    More recently, the Commission has brought a series of cases concerning ads disguised to look like news reports on weight-loss pills and other products, where a purported journalist tested the advertised product and authored the story.14 The ads used devices such as news-related names and headlines suggestive of a local television station, trademarks of established news companies, reporter by-lines, and reader comment sections to create that false impression. In one case, the Commission alleged the format was deceptive despite the presence of a small-print disclaimer “Advertorial” in the top border of some Web sites.15 Consumers reached all these fake news Web sites by clicking on ads presented as attention-getting news headlines, which frequently appeared on legitimate news Web sites.

    14See, e.g., Complaint at 4-5, 8-9, FTC v. Circa Direct LLC, No. 11-cv-2172 (D.N.J. Apr. 18, 2011) (stipulated order); Complaint at 3-4, 6-7, FTC v. DLXM LLC, No. CV 11-1889 (E.D.N.Y. Apr. 18, 2011) (stipulated order); Complaint at 3-4, 6-7, FTC v. Coulomb Media, Inc., No. 211-cv-11618 (E.D. Mich. Apr. 15, 2011) (stipulated order).

    15See Complaint at 6, FTC v. Circa Direct LLC; see also Memorandum in Support of Plaintiff's Motion for a TRO at 14, FTC v. Circa Direct LLC (Apr. 18, 2011). Similarly, in a Securities and Exchange Commission case concerning paid promotions of stocks that appeared in a news format, a court held that, “[t]he `advertorial' label . . . simply does not convey to the reader that the articles, which appear in a news-item format, were indeed purchased by the subject companies; this label does not provide investors with the material information regarding the publishers' bias.” SEC v. Corp. Relations Grp., Inc., No. 6:99-cv-1222, 2003 U.S. Dist. LEXIS 24925, at *26-27 (M.D. Fla. Mar. 28, 2003).

    In another recent case, the Commission challenged as deceptive a Web site purported to originate from an independent scientific organization. The Commission alleged that dietary supplement marketers misrepresented that their Web site promoting the health benefits of their children's supplements was an independent, objective resource for scientific and other information on treating a specific health condition, and that they failed to disclose their relationship to the Web site.16

    16 Complaint at 3-4, 28-29, FTC v. NourishLife, LLC, No. 15-cv-00093 (N.D. Ill. Jan. 7, 2015) (stipulated order).

    The Commission also has challenged advertisements misrepresenting that a government agency endorsed or was affiliated with a product or service. For example, one such case against a seller of mortgage relief services concerned radio ads formatted to appear as public service announcements from the United States government, which began, “Please stay tuned for this important public announcement for those in danger of losing their home” and prominently featured the word “federal.” 17 A federal district court found these radio ads deceived consumers, observing that the defendants “intended to cause consumers to associate [those responsible for the ads] with the federal government so that consumers would be more likely to believe that [they] were credible and stable.”18 The Commission similarly has alleged that direct mail mortgage loan modification ads sent in official-looking brown envelopes with a window and a Washington, DC return address identifying the sender as the “NHMC Department of Financial Records” or “Nations Housing Modification Center” were deceptive.19

    17 Complaint at 6, 12, Fed. Loan Modification Law Ctr., LLP, No. SACV-09-401 (C.D. Cal. Apr. 3, 2009) (summary and default judgments). The Commission similarly has challenged sweepstakes prize promotion mailings misrepresenting a government affiliation. See, e.g., Complaint at 11-12, 15, FTC v. Nat'l Awards Serv. Advisory, LLC, No. CV-10-5418 (N.D. Cal. Nov. 30, 2010) (stipulated judgment) (some of the challenged mailings claimed a government affiliation using words such as “State of Illinois Commissioners of Regulation” or the “OFFICE OF THE PRESIDENT OFFICIAL NOTIFICATION,” and included language, symbols, and artwork evoking a government connection, such as “In God We Trust” or a bald eagle).

    18 Order Granting Plaintiff's Motion for Summary Judgment Against Boaz Minitzer at 7, Fed. Loan Modification Law Ctr., LLP, No. SACV-09-401 (C.D. Cal. Nov. 17, 2010).

    19 Complaint at 5, 13, Fed. Hous. Modification Dep't, Inc., No. 09-CV-01753 (D.D.C. Sept. 15, 2009) (stipulated orders).

    In 2002, when online search was a relatively new medium, FTC staff issued guidance concerning the potential for consumers to be deceived by paid ads formatted to appear as the regular search results that search engines return in response to consumers' queries.20 The Commission concurs with the staff's conclusion, as articulated in the 2002 guidance and updated guidance issued in 2013,21 that consumers ordinarily would expect a search engine to return results based on relevance to a search query, as determined by impartial criteria, not based on payment from a third party. Knowing when search results are included or ranked higher based on payment and not on impartial criteria likely would influence consumers' decisions with regard to a search engine and the results it delivers. Thus, failing to clearly and prominently disclose the paid nature of such advertising results is deceptive.

    20 Letter from Heather Hippsley, Acting Associate Director, Division of Advertising Practices, Federal Trade Commission to Gary Ruskin, Executive Director, Commercial Alert (June 27, 2002) (“Search Engine Guidance”), available at www.ftc.gov/sites/default/files/documents/closing_letters/commercial-alert-response-letter/commercialalertletter.pdf.

    21 Press Release, Federal Trade Commission, FTC Consumer Protection Staff Updates Agency's Guidance to Search Engine Industry on the Need to Distinguish Between Advertisements and Search Results (June 25, 2013), available at www.ftc.gov/news-events/press-releases/2013/06/ftc-consumer-protection-staff-updates-agencys-guidance-search; see also Exemplar letter from Mary K. Engle, Associate Director, Division of Advertising Practices, Federal Trade Commission to General Purpose Search Engines (June 24, 2013), available at www.ftc.gov/sites/default/files/attachments/press-releases/ftc-consumer-protection-staff-updates-agencys-guidance-search-engine-industryon-need-distinguish/130625searchenginegeneralletter.pdf (“Updated Search Engine Letter”).

    B. Misleading Door Openers

    Other formats that mislead consumers about a commercial message's nature or purpose also have been alleged or found to be deceptive, such as misleading sales visits and calls and emails with falsified sender information. An early example of such a challenge was a 1976 case against an encyclopedia seller.22 A salesperson would “disguise his role as a salesman and appear as a surveyor engaged in advertising research” or salespeople would “approach prospects' homes in the guise of delivering . . . gifts or prizes without identifying themselves as salesmen, or that the purpose of their visit is to sell encyclopedia.” 23 The Commission order required the respondents' sales representatives to present a card that clearly disclosed the purpose of the visit before entering a prospect's home.24 Subsequently, the Commission's Deception Policy Statement categorized this practice as a “misleading door opener,” citing it for the general proposition that, “when the first contact between the seller and a buyer occurs through a deceptive practice, the law may be violated, even if the truth is subsequently made known to the purchaser.” 25

    22Encyc. Britannica, Inc., 87 F.T.C. 421, 495-97, 531 (1976), aff'd, 605 F.2d 964 (7th Cir. 1979), as modified, 100 F.T.C. 500 (1982); see also Grolier, Inc., 99 F.T.C. 379, 383 (1982), aff'd, 699 F.2d 983 (9th Cir. 1983), as modified, 104 F.T.C. 639 (1984).

    23Encyc. Britannica, Inc., 87 F.T.C. at 496.

    24Id. at 524-26, 533-34.

    25Deception Policy Statement, 103 F.T.C. at 180 & n.37. A number of courts have stated or held, both before and after issuance of the Deception Policy Statement, that the FTC Act is violated if a consumer's first contact is induced through deception, even if the truth is clarified prior to purchase. FTC v. E.M.A. Nationwide, Inc., 767 F.3d 611, 632 (6th Cir. 2014); Resort Car Rental Sys., Inc. v. FTC, 518 F.2d 962, 964 (9th Cir. 1975); Exposition Press, Inc. v. FTC, 295 F.2d 869, 873 (2d Cir. 1961); Carter Prods., Inc. v. FTC, 186 F.2d 821, 824 (7th Cir. 1951); FTC v. LeanSpa, LLC, No. 3:11-cv-1715, 2015 U.S. Dist. LEXIS 26906, at *33-34 (D. Conn. Mar. 5, 2015); FTC v. Ivy Capital, Inc., No. 2:11-cv-00283, 2013 U.S. Dist. LEXIS 42369, at *23 (D. Nev. Mar. 26, 2013); FTC v. Commerce Planet, Inc., 878 F. Supp. 2d 1048, 1066 (C.D. Cal. 2012); FTC v. City West Advantage, Inc., No. 2:08-CV-00609, 2008 U.S. Dist. LEXIS 71608, at *7-9 (D. Nev. July 22, 2008); FTC v. Med. Billers Network, Inc., 543 F. Supp. 2d 283, 304 (S.D.N.Y. 2008); FTC v. Connelly, 2006 U.S. Dist. LEXIS 98263, at *49 (C.D. Cal. Dec. 20, 2006).

    In 1994, concerned about deception and abuse occurring in the telemarketing of goods and services, Congress enacted the Telemarketing Fraud Act,26 which prohibited the use of deceptive door-openers in telemarketing. That Act, among other things, outlawed as an abusive practice a telemarketer's failure to “promptly and clearly disclose . . . that the purpose of the call is to sell goods or services” when that is the case.27 The Commission implemented Congress's intent to prohibit this practice when it promulgated the Telemarketing Sales Rule.28 In enforcing that Rule, the Commission has brought cases against telemarketers who misrepresented that calls were from, or made on behalf of, companies with which consumers had done business, such as banks and credit card companies.29

    26 15 U.S.C. 6101-6108.

    27Id. at section 6102(a)(3)(C).

    28 16 CFR 310.4(d)(2).

    29See Complaint at 26, 28, FTC v. FTN Promotions, Inc., No. 807-cv-1279 (M.D. Fla. July 23, 2007) (stipulated orders); Complaint, Millennium Indus., Inc., No. 01-1932 (D. Ariz. Oct. 18, 2001) (stipulated order); Complaint, Creditmart Fin. Strategies Inc., No. C99-1461WD (W.D. Wash. Sept. 14, 1999) (stipulated order); Complaint, Liberty Direct, Inc., No. 299-cv-01637 (D. Ariz. Sept. 14, 1999) (stipulated order).

    When Congress passed the CAN-SPAM Act,30 among the practices the law was intended to address were emails that “mislead recipients as to the source or content of such mail.” 31 Specifically, Congress concluded that “[m]any senders of unsolicited commercial electronic mail purposefully disguise the source of such mail” and “include misleading information in the messages' subject lines in order to induce the recipients to view the messages,” and that the recipients of such mail “incur costs for the . . . time spent accessing, reviewing, and discarding such mail . . .” 32 The CAN-SPAM Act therefore effectively prohibited deceptive door-openers in commercial email. The Act outlawed the sending of emails containing falsified header information, including sender or subject information, and made doing so a violation of the FTC Act.33 Even prior to the law's passage, in a case against an email marketer, the Commission alleged it was deceptive to forge an email's header information so as to make recipients believe a well-known bank or mortgage company sent it.34

    30 15 U.S.C. 7701-7713.

    31Id. at section 7701(b)(2).

    32Id. at section 7701(a)(3), (7), and (8).

    33Id. at section 7704(a)(1) and (2). In certain circumstances, materially falsifying header information also can be a crime punishable by a fine, imprisonment, or both, and enforceable by the United States Department of Justice. See 18 U.S.C. 1037.

    34 Complaint, GM Funding, Inc., No. SACV 02-1026 (C.D. Cal. May 5, 2003) (stipulated order). The Commission has since brought a number of other cases challenging spam emails with deceptive sender and subject line information. See, e.g., Complaint at 21, FTC v. Sale Slash, LLC, No. CV15-03107 (C.D. Cal. Apr. 27, 2015); Complaint at 10-11, FTC v. Cleverlink Trading Ltd., No. 05C 2889 (N.D. Ill. May 16, 2005) (stipulated order); Complaint, Phoenix Avatar, LLC, No. 04C 2897 (N.D. Ill. Apr. 23, 2004).

    C. Deceptive Endorsements That Do Not Disclose a Sponsoring Advertiser

    Consumers may also be misled about an advertisement's nature or source as a result of an advertiser's use of consumer and other endorsements. As the Commission stated in the Endorsement Guides, “When there exists a connection between the endorser and the seller of the advertised product that might materially affect the weight or credibility of the endorsement (i.e., the connection is not reasonably expected by the audience), such connection must be fully disclosed. . . . clearly and conspicuously . . .” 35 In revising the Guides in 2009, the Commission specifically addressed paid endorsements in non-traditional forms of advertising, such as user-generated social media, personal blogs, online comment forums, or television talk show interviews.36 The Commission's advice was based on the principle that when the content in which an endorsement is disseminated is not identifiable by consumers as advertising, consumers would not ordinarily expect an endorser to be speaking on behalf of a sponsoring advertiser and such connection must be disclosed to avoid deceiving consumers.

    35 Guides Concerning Use of Endorsements and Testimonials in Advertising (hereinafter “Endorsement Guides”), 16 CFR 255.5 (Disclosure of material connections).

    36Id. Examples 3, 7, 8, 9.

    Since revising the Endorsement Guides, the Commission has brought a number of cases underscoring this principle.37 For example, in a case against an app developer, employees of a public relations firm hired by the developer posted reviews about its games in the iTunes app store, without disclosing their relationship to the company.38 The Commission asserted that the posted reviews were misrepresented as independent reviews reflecting the opinions of ordinary consumers, and that the failure to disclose the reviewers' material connection to the app company was deceptive. Another case concerned a home security firm's hiring of spokespersons who appeared on television and radio programs as impartial expert reviewers but failed to make known their connection to the company.39

    37See, e.g., Machinima, Inc., No. C-4569, 2016 FTC LEXIS 37, at *8-10 (Mar. 16, 2016) (consent); AmeriFreight, Inc., 159 F.T.C. 1627, 1629 (2015) (consent); Deutsch LA, Inc., 159 F.T.C. 1164, 1169 (2015) (consent); Complaint at 5, ADT LLC, No. C-4460 (June 18, 2014) (consent); Complaint at 10, United States v. Spokeo, Inc., No. CV12-05001 (C.D. Cal. June 19, 2012) (stipulated order for civil penalties); Legacy Learning Sys., Inc., 151 F.T.C. 383, 386-87 (2011) (consent); Reverb Commc'ns, Inc., 150 F.T.C. 782, 784 (2010) (consent).

    38Reverb Commc'ns, Inc., 150 F.T.C. 782, 783-84 (2010) (consent).

    39 Complaint at 1-5, ADT LLC.

    II. Commission Policy on Deceptively Formatted Advertising

    The recent proliferation of natively formatted advertising in digital media has raised questions about whether these advertising formats deceive consumers by blurring the distinction between advertising and non-commercial content. Natively formatted advertising encompasses a broad range of advertising and promotional messages that match the design, style, and behavior of the digital media in which it is disseminated. The ads can appear in a wide variety of forms, including written narratives, videos, infographics, images, animations, in-game modules, and playlists on streaming services. Often natively formatted ads are inserted into the stream of regular content a publisher offers,40 generally referred to in this statement as a “publisher site,” such as news and news aggregator sites and social media platforms.41 In some instances, publishers place these ads on their sites and, in other instances, advertising networks operating ad content-recommendation engines do so. Advertising and promotional messages also can be embedded into entertainment programming, including professionally produced and user-generated videos on social media.

    40 Commonly, when a natively formatted ad appears on a publisher site, it consists of headline text, a short description, and a thumbnail image, which, if clicked, lead to additional content.

    41 The term “publisher site” refers to any media platform on which consumers consume content and media creators and curators publish content. The content may be delivered by publishers through various means, including the web and mobile applications, and may be accessed by consumers on different devices, including computers, smartphones, tablets, and televisions.

    Regardless of an ad's format or medium of dissemination, certain principles undergird the Commission's deceptive format policy. Deception occurs when an advertisement misleads reasonable consumers as to its true nature or source, including that a party other than the sponsoring advertiser is the source of an advertising or promotional message, and such misleading representation is material. In this regard, a misleading representation is material if it is likely to affect consumers' choices or conduct regarding the advertised product or the advertisement, such as by leading consumers to give greater credence to advertising claims or to interact with advertising with which they otherwise would not have interacted.42 Such misleadingly formatted advertisements are deceptive even if the product claims communicated are truthful and non-misleading.43

    42 By product or advertising claims, the Commission generally means any representations about the benefits or attributes of a product, type of product, or category of products, including disparaging claims about a competitor's products.

    43 The Commission has challenged advertising formats as deceptive without challenging product claims made in advertisements. See, e.g., Complaint, ADT LLC; Georgetown Publ'g House Ltd. P'ship, 121 F.T.C. 392; JS&A Grp., Inc., 111 F.T.C. 522.

    Although the particular facts will determine whether an advertisement formatted like the material in which it appears is deceptive, this statement sets forth the factors the Commission will consider in making that determination.

    A. An Advertisement's Format Can Mislead Consumers as to Its Nature or Source

    In evaluating whether an ad's format is misleading, the Commission considers the net impression the advertisement conveys to reasonable consumers, not statements in isolation.44 Ads can convey claims by means other than, or in addition to, written or spoken words, such as visual or aural imagery and the interaction among all elements of the ad.

    44FTC v. Am. Home Prods. Corp., 695 F.2d 681, 687 (3d Cir. 1982), citing Beneficial Corp. v. FTC, 542 F.2d 611, 617 (3d Cir. 1976).

    Applying the net impression standard in its Advisory Opinion on Ads in a News Format, the Commission commented that inclusion of exact price information would not change the overall impression conveyed that a series of newspaper ads were feature articles giving independent and impartial restaurant reviews.45 In a case against a bookseller, the Commission's complaint noted a number of elements, including the challenged ad's printing on magazine-like paper, a ripped left edge, page numbering, inclusion of a publication date and byline, and an affixed personalized sticky note, in alleging that the overall impression created was that the ad was an independent book review.46 Thus, in evaluating whether an ad's format is misleading, the Commission will scrutinize the entire ad, examining such factors as its overall appearance, the similarity of its written, spoken, or visual style to non-advertising content offered on a publisher's site, and the degree to which it is distinguishable from such other content.

    45Advisory Opinion on Ads in News Formats, 73 F.T.C. at 1307-08.

    46Georgetown Publ'g House Ltd. P'ship, 122 F.T.C. at 393-96.

    Any determination of whether an advertisement's format misleads as to the ad's nature or source depends on how reasonable consumers would interpret the ad in a particular situation. To be reasonable, an interpretation or response of consumers to a particular ad need not be the only one nor be shared by a majority of consumers.47 Interpretations that advertisers intend to convey about an advertisement's nature or source are presumed reasonable.48

    47Deception Policy Statement, 103 F.T.C. at 177 n.20. “A material practice that misleads a significant minority of reasonable consumers is deceptive.” Id.

    48Id. at 178.

    In digital media, consumers can encounter natively formatted ads in a wide variety of situations, including in the news feed or main page of a publisher site, or through other means, such as posts in social media, in search results, and in email. In evaluating whether reasonable consumers would recognize ads as such, the Commission will consider the particular circumstances in which the ads are disseminated, including customary expectations based on consumers' prior experience with the media in which it appears and the impression communicated by the ad's format.49 For instance, if a natively formatted ad appearing as a news story is inserted into the content stream of a publisher site that customarily offers news and feature articles, reasonable consumers are unlikely to recognize it as an ad.

    49 For example, consumers' customary use of and prior experience with search engines are relevant to the need to distinguish paid from regular search results. See Updated Search Engine Letter, at note 2 and accompanying text.

    The target audience of an ad also may affect whether it is likely to mislead reasonable consumers about its nature or source. Increasingly, in digital media, advertisers can target natively formatted ads to individual consumers and even tailor the ads' messaging to appeal to the known preferences of those consumers.50 The propensity of an ad to mislead as to its nature or source may be different when considered from the perspective of its target audience. To the extent that an advertisement is targeted to a specific audience, the Commission will consider the effect of the ad's format on reasonable or ordinary members of that targeted group.51

    50 There may be a host of data collection and use activities associated with natively formatted ads disseminated programmatically in digital media, some of which may not be transparent to consumers. This enforcement policy statement is not intended to address the legal and policy implications of such practices. Existing Commission and staff guidance address the privacy issues raised by digital advertising and consistently recommend that companies provide truthful and prominent information and choices to consumers about their data collection, use, and sharing practices. See, e.g., FTC, Protecting Consumer Privacy in an Era of Rapid Change: Recommendations For Businesses and Policymakers (Mar. 2012), available at https://www.ftc.gov/sites/default/files/documents/reports/federal-trade-commission-report-protecting-consumer-privacy-era-rapid-change-recommendations/120326privacyreport.pdf (recommending a framework for addressing consumer privacy, including transparency and simplified choice regarding the online collection and use of consumer data for marketing purposes); FTC Staff Report: Self-Regulatory Principles For Online Behavioral Advertising: Tracking, Targeting, and Technology (Feb. 2009), available at www.ftc.gov/sites/default/files/documents/reports/federal-trade-commission-staff-report-self-regulatory-principles-online-behavioral-advertising/p085400behavadreport.pdf (setting forth proposed principles related to online behavioral advertising).

    51Deception Policy Statement, 103 F.T.C. at 177-78. For example, special considerations may be relevant in determining whether a natively formatted ad directed to children would be misleading. Id. at 177; cf. Commission Enforcement Policy Statement in Regard to Clear and Conspicuous Disclosure in Television Advertising, CCH Trade Regulation Reporter, ¶ 7569.09 (Oct. 21, 1970) available at www.ftc.gov/system/files/documents/public_statements/288851/701021tvad-pr.pdf (disclosures in television ads that are intended to qualify misleading claims communicated to children “must be written and presented in a manner that would be understood by them and have the capacity to attract their attention”).

    Certain ads that are formatted like the non-advertising content with which they are presented, however, may be unlikely to mislead consumers acting reasonably. Some ads by the very nature of their promotional message communicated may be inherently obvious as advertising to consumers. For instance, if a natively formatted ad with an image of a particular sports car and the headline “Come and Drive [X] today” were inserted into the news stream of a publisher site, that ad likely would be identifiable as an ad to consumers, even though it was presented in the same visual manner as news stories in the stream.

    Finally, in determining the overall impression communicated by an ad, the Commission also will consider any qualifying information contained in the ad.52 Advertisements may include disclosures to inform consumers of their commercial nature, including text labels, audio disclosures, or visual cues distinguishing the ad from other content into which it is integrated. Any disclosure used must be “sufficiently prominent and unambiguous to change the apparent meaning of the claims and to leave an accurate impression.” 53 A disclosure's adequacy ultimately will be measured by whether reasonable consumers perceive the ad as advertising.54

    52Deception Policy Statement, 103 F.T.C. at 181.

    53Removatron Int'l Corp. v. FTC, 884 F. 2d 1489, 1497 (1st Cir. 1989).

    54See supra note 47 and accompanying text.

    A disclosure must be made in “simple, unequivocal” language, so that consumers comprehend what it means.55 For example, in infomercial cases, the Commission has required the use of the words “Paid Advertisement.” 56 In its Advisory Opinion on Ads in a News Format, the Commission suggested use of the term “Advertisement” to prevent consumers from being deceived by those particular advertising formats.57 Disclosures also must be made in the same language as the predominant language in which ads are communicated.58

    55Thompson Medical Co., 104 F.T.C. 648, 783 (1984), aff'd, 791 F.2d 189 (D.C. Cir. 1986).

    56See, e.g., FTC v. Direct Mktg. Concepts, Inc., 648 F. Supp. 2d at 209, 211; Vital Basics, Inc., 137 F.T.C. at 340-41; Nutrivida, Inc., 126 F.T.C. at 351-52; Bogdana Corp., 126 F.T.C. at 100-01; Mega Sys. Int'l, Inc., 125 F.T.C. at 1218-19.

    57Advisory Opinion on Ads in News Formats, 73 F.T.C. at 1307-08; Statement on Ads in Feature Article Format.

    58See, e.g., Final Order and Judgment at 8, Direct Mktg. Concepts, Inc., No. 04-11136-GAO (D. Mass. Aug. 13, 2009) (as to Direct Marketing Concepts, Inc. and others); Free Annual Credit Disclosures, 16 CFR 610.4(a)(3)(ii) (general requirements for disclosures).

    The conspicuousness of the disclosure will depend on the method of delivery and placement within the ad. Depending on the circumstances, a disclosure in the text may not remedy a misleading impression created by the headline because reasonable consumers might glance only at the headline.59 In Commission cases and Rules addressing audio ads, the Commission has required audible disclosures to be delivered in a volume, cadence, and speed sufficient for ordinary consumers to hear and understand them.60

    59Deception Policy Statement, 103 F.T.C. at 180.

    60See, e.g., Final Order and Judgment at 8, Direct Mktg. Concepts, Inc. (radio disclosures must be “in a volume and cadence sufficient for an ordinary consumer to hear”); Carrot Neurotechnology, Inc., No. C-4567, 2016 FTC LEXIS 24, at *4 (Feb. 22, 2016) (consent) (necessary disclosures under the order must be “in a volume, speed, and cadence sufficient for ordinary consumers to easily hear and understand”); Free Annual Credit Disclosures, 16 CFR 610.4(a)(3)(iv) (“Audio disclosures shall be in a slow and deliberate manner and in a reasonably understandable volume and pitch.”).

    To be effective, a disclosure also generally must be made contemporaneously with the misleading claim it is intended to qualify. For example, disclosures that subsequently inform consumers of a natively formatted ad's commercial nature after they have clicked on and arrived at another page will not cure any misleading impression created when the ad is presented in the stream of a publisher site. This approach also reflects and is consistent with long-standing public policy, as codified in the CAN-SPAM Act 61 and Telemarketing Fraud Act 62 and found in Commission cases,63 that material misrepresentations as to the nature or source of a commercial communication are deceptive, even if the truth is subsequently made known to consumers.

    61 15 U.S.C. 7701-7713 at 7704(a)(2).

    62 15 U.S.C. 6101-6108 at 6102(a)(3)(C).

    63See, e.g., supra notes 22, 25, 34 and accompanying text.

    B. Misleading Claims About the Nature or Source of Advertising Are Likely Material

    Deception occurs when an ad misleads consumers about a material fact.64 Material facts are those that are important to consumers' choices or conduct regarding a product.65 Misleading representations or omissions about an advertisement's true nature or source, including that a party other than the sponsoring advertiser is the source of the advertising, are likely to affect consumers' behavior with regard to the advertised product or the advertisement.66 Consumers with such a misleading impression, for example, are likely to give added credence to advertising messages communicated and to interact with advertising content with which they otherwise would have decided not to interact.67

    64Deception Policy Statement, 103 F.T.C. at 182.

    65Kraft, Inc. v. FTC, 970 F.2d 311, 322 (7th Cir. 1992) (“a claim is considered material if it `involves information that is important to consumers and, hence, likely to affect their choice of, or conduct regarding a product'”) (quoting Cliffdale Assocs., Inc., 103 F.T.C. at 165). Material information may influence consumer behavior apart from the purchase of a product. Deception Policy Statement, 103 F.T.C. at 182 n.45. A material misrepresentation is one “the reasonable person would regard as important in deciding how to act, or one which the maker knows that the recipient, because of his or her own peculiarities, is likely to consider important.” Id. (citing Restatement (Second) of Torts, section 538(2) (1965)).

    66 There are some exceptions, where consumers might not act differently if they were to identify certain forms of advertising as such. For example, if a branded product is included in entertainment programming in exchange for payment or other consideration from an advertiser, unless this paid product placement communicates an objective claim about a product, the fact that such advertising was included because of payment is unlikely to affect consumers' decision-making. When no objective claims are made for the product advertised, there is no claim to which greater credence can be given; thus, whether an advertiser had paid for the placement or the product appeared because of the program writer's creative judgment would not likely be material to consumers. See generally Letter from Mary K. Engle, Associate Director, Division of Advertising Practices, Federal Trade Commission to Gary Ruskin, Executive Director, Commercial Alert (Feb. 10, 2005), available at www.ftc.gov/system/files/documents/advisory_opinions/letter-commercial-alert-applying-commission-policy-determine-case-case-basis-whether-particular/050210productplacemen.pdf (response to a petition from a consumer group to issue guidelines requiring the on-screen disclosure “ADVERTISEMENT,” whenever paid product placement occurred in television programming; FTC staff concluded that such a disclosure would not generally be necessary to prevent deception and that when particular instances of paid product placement or brand integration were deceptive, they could be adequately addressed on a case-by-case basis).

    67 In evaluating materiality, the Commission takes consumer preferences as given rather than considering whether they are objectively justified. Deception Policy Statement, 103 F.T.C. at 182 n.46.

    The Commission presumes that claims made expressly and claims the advertiser intended to make are material.68 The Commission also considers certain misleading formats to be presumptively material. Depending on the facts, false claims that advertising and promotional messages reflect the independent, impartial views, opinions, or experiences of ordinary consumers or experts are presumed material.69 Similarly, the Commission views as material any misrepresentations that advertising content is a news or feature article,70 independent product review,71 investigative report,72 or scientific research or other information from a scientific or other organization.73 Commercial communications that mislead consumers that they are from the government,74 a legitimate business, such as a well-known bank,75 or a marketing surveyor 76 also are presumed to be material.

    68Deception Policy Statement, 103 F.T.C. at 182.

    69See, e.g., supra notes 36, 37, 38, 39 and accompanying text. Regarding the specific issue of advertisers using spokespersons to promote products in programming without disclosing the spokesperson's financial ties to the advertiser, a connection between an advertiser and an endorser that is not reasonably expected by the audience must be fully disclosed. See, e.g., ADT LLC, No. C-4460, 2014 FTC LEXIS 142, at *3, 5-6 (June 18, 2014) (consent); Endorsement Guides, 16 CFR 255.5.

    70See, e.g., supra notes 7, 8, 13, 14 and accompanying text.

    71See, e.g., supra note 10 and accompanying text.

    72See, e.g., supra notes 12, 13 and accompanying text.

    73See, e.g., supra note 16 and accompanying text.

    74See, e.g., supra notes 17, 18, 19 and accompanying text.

    75See, e.g., supra notes 29, 34 and accompanying text.

    76See, e.g., supra note 23 and accompanying text.

    III. Conclusion

    Although digital media has expanded and changed the way marketers reach consumers, all advertisers, including digital advertisers, must comply with the same legal principles regarding deceptive conduct the Commission has long enforced. This statement sets forth principles of general applicability on which the Commission will rely in determining whether any particular advertising format is deceptive, in violation of Section 5 of the FTC Act. The Commission will find an advertisement deceptive if the ad misleads reasonable consumers as to its nature or source, including that a party other than the sponsoring advertiser is its source. Misleading representations of this kind are likely to affect consumers' decisions or conduct regarding the advertised product or the advertisement, including by causing consumers to give greater credence to advertising claims or to interact with advertising content with which they otherwise would not have interacted.

    By direction of the Commission.

    Donald S. Clark, Secretary.
    [FR Doc. 2016-08813 Filed 4-15-16; 8:45 am] BILLING CODE 6750-01-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000-0097; Docket 2016-0053; Sequence 6] Submission for OMB Review; Taxpayer Identification Number Information AGENCIES:

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

    ACTION:

    Notice of request for public comments regarding an extension to an existing OMB clearance.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning Taxpayer Identification Number Information. A notice was published in the Federal Register at 81 FR 6514 on February 8, 2016. No comments were received.

    DATES:

    Submit comments on or before May 18, 2016.

    ADDRESSES:

    Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Submit a Comment” that corresponds with “Information Collection 9000-0097, Taxpayer Identification Number Information”. Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 9000-0097, Taxpayer Identification Number Information” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 9000-0097, Taxpayer Identification Number Information.

    Instructions: Please submit comments only and cite Information Collection 9000-0097, Taxpayer Identification Number Information, in all correspondence related to this collection. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Mr. Curtis E. Glover, Sr., Procurement Analyst, Contract Policy Division, GSA, 202-501-1448 or email at [email protected]

    SUPPLEMENTARY INFORMATION: A. Purpose

    In accordance with 31 U.S.C. 7701(c), a contractor doing business with a Government agency is required to furnish its Tax Identification Number (TIN) to that agency. Also, 31 U.S.C. 3325(d) requires the Government to include, with each certified voucher prepared by the Government payment office and submitted to a disbursing official, the TIN of the contractor receiving payment under the voucher. 26 U.S.C. 6050M, as implemented in the Department of Treasury, Internal Revenue Service (IRS) regulations at Title 26 of the Code of Federal Regulations (CFR), requires heads of Federal executive agencies to report certain information to the IRS. 26 U.S.C. 6041 and 6041A, as implemented in 26 CFR, in part, requires payors, including Government agencies, to report to the IRS, on form 1099, payments made to certain contractors.

    To comply with the requirements of 31 U.S.C. 7701(c) and 3325(d), reporting requirements of 26 U.S.C. 6041, 6041A, and 6050M, and implementing regulations issued by the IRS in 26 CFR, FAR clause 52.204-3, Taxpayer Identification, requires a potential Government contractor to submit, among other information, its TIN. The TIN may be used by the Government to collect and report on any delinquent amounts arising out of the contractor's relationship with the Government. A contractor is not required to provide its TIN on each contract in accordance with FAR clause 52.204-3, Taxpayer Identification, when FAR clause 52.204-7, Central Contractor Registration, is inserted in contracts. FAR clause 52.204-7 requires a potential Federal contractor to provide its TIN in the Central Contractor Registration (CCR) system.

    B. Annual Reporting Burden

    Respondents: 39,428.

    Responses Per Respondent: 3.

    Total Responses: 118,284.

    Hours Per Response: 10.

    Total Burden Hours: 11,828.

    C. Public Comments

    Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulation (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0097, Taxpayer Identification Number Information, in all correspondence.

    Dated: April 13, 2016. Lorin S. Curit, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy.
    [FR Doc. 2016-08871 Filed 4-15-16; 8:45 am] BILLING CODE 6820-EP-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000-0175; Docket 2016-0053; Sequence 5] Submission for OMB Review; Use of Project Labor Agreements for Federal Construction Projects AGENCY:

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

    ACTION:

    Notice of request for public comments regarding an extension to an existing OMB clearance.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act of 1995, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve a new information collection requirement regarding Use of Project Labor Agreements for Federal Construction Projects. A notice published in the Federal Register at 81 FR 6516 on February 8, 2016. No comments were received.

    DATES:

    Submit comments on or before May 18, 2016.

    ADDRESSES:

    Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Submit a Comment” that corresponds with “Information Collection 9000-0175, Use of Project Labor Agreements for Federal Construction Projects”. Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 9000-0175, Use of Project Labor Agreements for Federal Construction Projects” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 9000-0175, Use of Project Labor Agreements for Federal Construction Projects.

    Instructions: Please submit comments only and cite Information Collection 9000-0175, Use of Project Labor Agreements for Federal Construction Projects, in all correspondence related to this collection. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Mr. Edward Loeb, Procurement Analyst, Office of Governmentwide Acquisition Policy, at telephone 202-501-0650 or via email to [email protected]

    SUPPLEMENTARY INFORMATION: A. Purpose

    FAR 22.501 prescribes policies and procedures to implement Executive Order 13502, February 6, 2009 which encourages Federal agencies to consider the use of a project labor agreement (PLA), as they may decide appropriate, on large-scale construction projects, where the total cost to the Government is more than $25 million, in order to promote economy and efficiency in Federal procurement. A PLA is a pre-hire collective bargaining agreement with one or more labor organizations that establishes the terms and conditions of employment for a specific construction project. FAR 22.503(b) provides that an agency may, if appropriate, require that every contractor and subcontractor engaged in construction on the project agree, for that project, to negotiate or become a party to a project labor agreement with one or more labor organizations if the agency decides that the use of project labor agreements will—

    (1) Advance the Federal Government's interest in achieving economy and efficiency in Federal procurement, producing labor-management stability, and ensuring compliance with laws and regulations governing safety and health, equal employment opportunity, labor and employment standards, and other matters; and,

    (2) Be consistent with law.

    B. Annual Reporting Burden

    Respondents: 70.

    Responses per Respondent: 1.

    Annual Responses: 70.

    Hours per Response: 1.

    Total Burden Hours: 70.

    C. Public Comments

    Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0175, Use of Project Labor Agreements for Federal Construction Projects, in all correspondence.

    Dated: April 13, 2016. Lorin S. Curit, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy.
    [FR Doc. 2016-08873 Filed 4-15-16; 8:45 am] BILLING CODE 6820-EP-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000-0060; Docket 2016-0053; Sequence 5] Submission for OMB Review; Accident Prevention Plans and Recordkeeping AGENCY:

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

    ACTION:

    Notice of request for an extension of an information collection requirement regarding an existing OMB clearance.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning Accident Prevention Plans and Recordkeeping. A notice published in the Federal Register at 81 FR 6517 on February 8, 2016. No comments were received.

    DATES:

    Submit comments on or before May 18, 2016.

    ADDRESSES:

    Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching for Information Collection 9000-0060, Accident Prevention Plans and Recordkeeping. Select the link “Comment Now” that corresponds with “Information Collection 9000-0060, Accident Prevention Plans and Recordkeeping”. Follow the instructions provided on the screen. Please include your name, company name (if any), and “Information Collection 9000-0060, Accident Prevention Plans and Recordkeeping” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 9000-0060, Accident Prevention Plans and Recordkeeping.

    Instructions: Please submit comments only and cite Information Collection 9000-0060, Accident Prevention Plans and Recordkeeping, in all correspondence related to this collection. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Mr. Curtis E. Glover, Sr., Procurement Analyst, Contract Policy Division, GSA, telephone 202-501-1448 or email at [email protected].

    SUPPLEMENTARY INFORMATION: A. Purpose

    The FAR clause at 52.236-13, Accident Prevention, requires Federal construction contractors to keep records of accidents incident to work performed under the contract that result in death, traumatic injury, occupational disease or damage to property, materials, supplies or equipment. Records of personal inquiries are required by the Department of Labor's (DOL) Occupational Safety and Health Administration regulations (OSHA). The records maintained by the contractor are used to evaluate compliance and may be used in workmen's compensation cases. The Federal Acquisition Regulation (FAR) requires records of damage to property, materials, supplies or equipment to provide background information when claims are brought against the Government.

    If the contract involves work of a long duration, or hazardous nature, the contracting officer shall insert the clause with its alternate that requires the contractor to submit a written proposed plan for implementing the clause. The plan shall include an analysis of the significant hazards to life, limb, and property inherent in performing the contract and a plan for controlling the hazards. The Accident Prevention Plan (APP) is analyzed by the contracting officer along with the agency safety representatives to determine if the proposed plan will meet the requirements of safety regulations and applicable statutes.

    B. Annual Reporting Burden

    Respondents: 215.

    Responses per Respondent: 1.

    Annual Responses: 215.

    Hours per Response: 22.

    Total Burden Hours: 4,730

    C. Public Comments

    Public comments are particularly invited on: Whether this collection of information is necessary; whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0060, Accident Prevention Plans and Recordkeeping, in all correspondence.

    Dated: April 13, 2016. Lorin S. Curit, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy.
    [FR Doc. 2016-08870 Filed 4-15-16; 8:45 am] BILLING CODE 6820-EP-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000-0159; Docket 2016-0053; Sequence 4] Submission for OMB Review; Central Contractor Registration AGENCY:

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

    ACTION:

    Notice of request for public comments regarding an extension to an existing OMB clearance.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning the Central Contractor Registration database. A notice was published in the Federal Register at 81 FR 6515 on February 8, 2016. No comments were received.

    DATES:

    Submit comments on or before May 18, 2016.

    ADDRESSES:

    Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching for the OMB control number. Select the link “Submit a Comment” that corresponds with “Information Collection 9000-0159, Central Contractor Registration.” Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 9000-0159, Central Contractor Registration” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 9000-0159, Central Contractor Registration.

    Instructions: Please submit comments only and cite Information Collection 9000-0159, Central Contractor Registration, in all correspondence related to this collection. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Mr. Curtis E. Glover, Sr., Procurement Analyst, Office of Governmentwide Policy, GSA, 202-501-1448, or via email at [email protected].

    SUPPLEMENTARY INFORMATION: A. Purpose

    The Federal Acquisition Regulation (FAR) Subpart 4.11 prescribes policies and procedures for requiring contractor registration in the Central Contractor Registration (CCR) database. The CCR is the primary vendor database for the U.S. Federal Government. CCR collects, validates, stores, and disseminates data in support of agency acquisition missions.

    Both current and potential Federal Government vendors are required to register in CCR in order to be awarded contracts by the Federal Government. Vendors are required to complete a one-time registration to provide basic information relevant to procurement and financial transactions. Vendors must update or renew their registration at least once per year to maintain an active status.

    The CCR validates the vendor information and electronically share the secure and encrypted data with Federal agency finance offices to facilitate paperless payments through electronic funds transfer. Additionally, CCR shares the data with Federal Government procurement and electronic business systems.

    B. Annual Reporting Burden

    Respondents: 110,350.

    Responses per Respondent: 1.

    Annual Responses: 110,350.

    Hours per Response: 1.7141.

    Total Burden Hours: 189,151.

    C. Public Comments

    Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulation (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control Number 9000-0159, Central Contractor Registration, in all correspondence.

    Dated: April 13, 2016. Lorin S. Curit, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy.
    [FR Doc. 2016-08872 Filed 4-15-16; 8:45 am] BILLING CODE 6820-EP-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Agency for Healthcare Research and Quality, HHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “Making It Easier for Patients to Understand Health Information and Navigate Health Care Systems: Developing Quality Improvement Measures.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

    This proposed information collection was previously published in the Federal Register on February 10, 2016 and allowed 60 days for public comment. AHRQ received no substantive comments of the public. The purpose of this notice is to allow an additional 30 days for public comment.

    DATES:

    Comments on this notice must be received by May 18, 2016.

    ADDRESSES:

    Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by email at [email protected] (attention: AHRQ's desk officer).

    FOR FURTHER INFORMATION CONTACT:

    Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]

    SUPPLEMENTARY INFORMATION: Proposed Project Making It Easier for Patients To Understand Health Information and Navigate Health Care Systems: Developing Quality Improvement Measures

    A goal of Healthy People 2020 is to increase Americans' health literacy, defined as “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.” 1 The effects of limited health literacy are numerous and serious, including medication non-adherence resulting from patients' inability to read and comprehend medication labels; underuse of preventive measures, such as vaccines; poor self-management of conditions such as asthma and diabetes; and higher utilization of inpatient and emergency department care. According to the 2003 National Assessment of Adult Literacy, 88% of US adults have significant difficulties understanding widely used health information. By adopting “health literacy universal precautions,” health care providers and organizations can create an environment in which all patients—regardless of health literacy level—can successfully (1) understand health information, (2) navigate the health care system, (3) engage in medical decision-making, and (4) manage their health.

    Numerous resources have been developed to support health care organizations in their attempts to address limitations in patient health literacy. However, little work has been done to establish valid quality improvement measures that organizations can use to monitor the impact of initiatives aimed at improving patient understanding, navigation, engagement, and self-management. Absent such measures, organizations may be unable to accurately assess whether their initiatives are effective.

    This research has the following goals:

    1. Identify existing quality improvement measures and gather proposals for additional measures (not generated from patient survey data) that organizations may use to monitor progress related to enhancing patient understanding, navigation, engagement, and self-management; and

    2. Identify a set of quality improvement measures that reflects patient priorities, has expert support, and can be recommended for more formal measure development and testing.

    This project is being conducted by AHRQ through its contractor, Board of Regents of the University of Colorado, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).

    Method of Collection

    Environmental Scan Interviews: Representatives from 25 health care organizations engaged in relevant quality improvement efforts will be interviewed to obtain information about the quality improvement measures they use in assessing their work to improve patient understanding, navigation, engagement, and self care.

    The planned environmental scan interviews will provide the information needed to:

    • Identify and document the characteristics of relevant quality improvement measures that are already in use; and

    • identify additional measures that would be useful to stakeholders in the field.

    The findings from these interviews will be used, along with the results from other activities (i.e., input from a Technical Expert Panel, literature review, a Request for Information published in the Federal Register, and focus groups with patients), to identify and document a set of quality improvement measures that can be recommended for rigorous testing and validation. Measures that are assessed to be valid and reliable will be eligible to be disseminated by AHRQ to support health care organizations in their efforts to improve patient understanding of health information, navigation of the health care system, engagement in medical decision making, and management of their health.

    Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in Environmental Scan Interviews. The Environmental Scan Interviews will be completed by 50 respondents (2 representatives from each of the 25 organizations targeted for participation).

    Exhibit 1—Estimated Annualized Burden Hours Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Hours per
  • response
  • Total burden hours
    Environmental Scan Interviews 50 1 2 100 Total 50 1 2 100

    Exhibit 2 shows the estimated annual cost burden associated with the respondents' time to participate in this information collection. The annual cost burden for the Environmental Scan Interviews is estimated to be $4,984.

    Exhibit 2—Estimated Annualized Cost Burden Form name Number of
  • respondents
  • Total burden hours Average
  • hourly wage
  • rate *
  • Total cost
  • burden
  • Environmental Scan Interviews 50 100 a $49.84 $4,984 Total 50 100 a 49.84 4,984 * National Compensation Survey: Occupational wages in the United States May 2014, “U.S. Department of Labor, Bureau of Labor Statistics.” a Based on the mean wages for Medical and Health Services Managers 11-9111.
    Request for Comments

    In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

    Sharon B. Arnold, Acting Director.

    1. U.S. Department of Health and Human Services. Healthy people 2010: Understanding and Improving Health. 2nd ed: U.S. Government Printing Office; 2000.

    [FR Doc. 2016-08856 Filed 4-15-16; 8:45 am] BILLING CODE 4160-90-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1110] Public Meeting on Patient-Focused Drug Development for Neuropathic Pain Associated With Peripheral Neuropathy AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public meeting; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for neuropathic pain associated with peripheral neuropathies. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of neuropathic pain associated with peripheral neuropathies, patient views on treatment approaches, and decision factors taken into account when selecting a treatment.

    DATES:

    The public meeting will be held on June 10, 2016, from 10 a.m. to 4 p.m. Registration to attend the meeting must be received by June 3, 2016 (see SUPPLEMENTARY INFORMATION for instructions). Submit electronic or written comments to the public docket by August 10, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2016-N-1110 for “Public Meeting on Patient-Focused Drug Development for Neuropathic Pain Associated with Peripheral Neuropathy.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FDA will post the agenda approximately 5 days before the meeting at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm.

    FOR FURTHER INFORMATION CONTACT:

    Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-402-6525, FAX: 301-847-8443, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background on Patient-Focused Drug Development

    FDA has selected neuropathic pain associated with peripheral neuropathy as the focus of a public meeting under Patient-Focused Drug Development, an initiative that involves obtaining a better understanding of patient perspectives on the severity of a disease and the available therapies for that condition. Patient-Focused Drug Development is being conducted to fulfill FDA performance commitments that are part of the reauthorization of the PDUFA under Title I of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144). The full set of performance commitments is available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.

    FDA committed to obtain the patient perspective on at least 20 disease areas during the course of PDUFA V. For each disease area, the Agency is conducting a public meeting to discuss the disease and its impact on patients' daily lives, the types of treatment benefit that matter most to patients, and patients' perspectives on the adequacy of the available therapies. These meetings will include participation of FDA review divisions, the relevant patient communities, and other interested stakeholders.

    On April 11, 2013, FDA published a notice in the Federal Register (78 FR 21613) announcing the disease areas for meetings in fiscal years (FYs) 2013-2015, the first 3 years of the 5-year PDUFA V time frame. The Agency used several criteria outlined in that notice to develop the list of disease areas. FDA obtained public comment on the Agency's proposed criteria and potential disease areas through a public docket and a public meeting that was convened on October 25, 2012. In selecting the set of disease areas, FDA carefully considered the public comments received and the perspectives of review divisions at FDA. FDA initiated a second public process for determining the disease areas for FY 2016-2017, and published a notice in the Federal Register on July 2, 2015 (80 FR 38216), announcing the selection of eight disease areas. More information, including the list of disease areas and a general schedule of meetings, is posted at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

    II. Public Meeting Information A. Purpose and Scope of the Meeting

    As part of Patient-Focused Drug Development, FDA will obtain patient and patient stakeholder input on the impacts of neuropathic pain associated with peripheral neuropathies. Peripheral neuropathy is a neurological disorder that develops as a result of damage to the peripheral nerves and is associated with both a physical and psychological burden. Nerve damage can be caused by diseases such as diabetes, physical injury, or exposure to drugs or toxins. The pain associated with neuropathies of sensory nerves may be characterized as a pins and needles sensation, as sharp, jabbing, or burning, or as an exaggeratedly intense or distorted pain response to typically nonpainful touch. While there is currently no cure, treatments for the pain associated with peripheral neuropathy include prescription medications and other approaches such as transcutaneous electrical nerve stimulation, braces, and behavioral therapies. FDA is interested in the perspectives of patients with peripheral neuropathy on specifically: (1) The impact of neuropathic pain associated with peripheral neuropathy and (2) treatment approaches for the neuropathic pain associated with peripheral neuropathy.

    The questions that will be asked of patients and patient stakeholders at the meeting are listed in this section, organized by topic. For each topic, a brief initial patient panel discussion will begin the dialogue. This will be followed by a facilitated discussion inviting comments from other patient and patient stakeholder participants. In addition to input generated through this public meeting, FDA is interested in receiving patient input addressing these questions through written comments, which can be submitted to the public docket (see ADDRESSES).

    Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients

    1. How would you describe your neuropathic pain associated with peripheral neuropathy? What terms would you use to describe the most bothersome aspects of pain? (Examples may include stabbing sensations, electric shocks, burning or tingling, etc.)

    2. Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your neuropathic pain? (Examples of activities may include sleeping through the night, daily hygiene, participation in sports or social activities, intimacy with a spouse or partner, etc.)

    3. How do your neuropathic pain and its negative impacts affect your daily life on the best days? On the worst days?

    4. How has your neuropathic pain changed over time?

    5. What worries you most about your condition?

    Topic 2: Patients' Perspectives on Current Approaches to Treatment

    1. What are you currently doing to help treat your neuropathic pain associated with peripheral neuropathy? (Examples may include prescription medicines, over-the-counter products, and other therapies including non-drug therapies). How has your treatment regimen changed over time, and why?

    2. How well does your current treatment regimen control your neuropathic pain?

    a. How well have these treatments worked for you as your condition has changed over time?

    b. Would you define your condition today as being well managed?

    3. What are the most significant downsides to your current treatments, and how do they affect your daily life? (Examples of downsides may include bothersome side effects, going to the hospital or clinic for treatment, time devoted to treatment, restrictions on driving, etc.)

    4. Assuming there is no complete cure for your neuropathic pain, what specific things would you look for in an ideal treatment for your neuropathic pain? What would you consider to be a meaningful improvement in your condition (for example, specific symptom improvements or functional improvements) that a treatment could provide?

    5. If you had the opportunity to consider participating in a clinical trial studying experimental treatments for neuropathic pain, what things would you consider when deciding whether or not to participate? (Examples may include how severe your neuropathic pain is, how well current treatments are working for you, your concern about risks, etc.)

    B. Meeting Attendance and Participation

    If you wish to attend this meeting, visit https://peripheralneuropathypfdd.eventbrite.com. Please register by June 3, 2016. If you are unable to attend the meeting in person, you can register to view a live Webcast of the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the Webcast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations because of a disability, please contact Meghana Chalasani (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting.

    Patients who are interested in presenting comments as part of the initial panel discussions will be asked to indicate in their registration which topic(s) they wish to address. These patients also must send to [email protected] a brief summary of responses to the topic questions by May 27, 2016. Panelists will be notified of their selection approximately 7 days before the public meeting. We will try to accommodate all patients and patient stakeholders who wish to speak, either through the panel discussion or audience participation; however, the duration of comments may be limited by time constraints.

    Docket Comments: Regardless of whether you attend the public meeting, you can submit electronic or written responses to the questions pertaining to topics 1 and 2 to the public docket (see ADDRESSES) by August 10, 2016. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Transcripts: As soon as a transcript is available, FDA will post it at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm.

    Dated: April 13, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08881 Filed 4-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1097] AbbVie Inc.; Withdrawal of Approval of New Drug Applications for ADVICOR and SIMCOR AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug applications (NDAs) for ADVICOR (niacin extended-release (ER) and lovastatin) tablets and SIMCOR (niacin ER and simvastatin) tablets. The holder of these two applications, AbbVie Inc., has requested that FDA withdraw approval of the applications and has waived its opportunity for a hearing. The Agency has also determined that ADVICOR and SIMCOR were withdrawn from sale for reasons of safety and effectiveness, and FDA will not accept or approve abbreviated new drug applications (ANDAs) that reference ADVICOR or SIMCOR.

    DATES:

    The effective date is April 18, 2016.

    ADDRESSES:

    For access to the docket to read background documents, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Jay Sitlani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6282, Silver Spring, MD 20993-0002, 301-796-5202.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA approved NDA 021249 for ADVICOR on December 17, 2001. ADVICOR is a fixed-combination drug product containing niacin ER and lovastatin in tablet form. The drug is approved in four strengths of niacin ER and lovastatin, respectively: (1) 500 milligrams (mg), 20 mg; (2) 750 mg, 20 mg; (3) 1 gram (g), 20 mg; and (4) 1 g, 40 mg. The approved indication reads as follows:

    ADVICOR is indicated for the treatment of primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb; Table 6) in:

    • Patients treated with lovastatin who require further TG-lowering or HDL-raising who may benefit from having niacin added to their regimen • Patients treated with niacin who require further LDL-lowering who may benefit from having lovastatin added to their regimen

    The indication was revised subsequent to the initial approval and currently states that ADVICOR is approved for the treatment of hypercholesterolemia when treatment with both Niaspan and lovastatin is appropriate.

    FDA approved NDA 022078 for SIMCOR on February 15, 2008. SIMCOR is a fixed-combination drug product containing niacin ER and simvastatin in tablet form. The drug is approved in five strengths of niacin ER and simvastatin, respectively: (1) 500 mg, 20 mg; (2) 500 mg, 40 mg; (3) 750 mg, 20 mg; (4) 1 g, 20 mg; and (5) 1 g, 40 mg. SIMCOR is approved for the following indications:

    • To reduce TC, LDL-C, apolipoprotein B, non-HDL-C, triglycerides (TG), or to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia when treatment with simvastatin monotherapy or niacin ER monotherapy is considered inadequate • To reduce TG in patients with hypertriglyceridemia when treatment with simvastatin monotherapy or niacin ER monotherapy is considered inadequate

    The labeling includes the following Limitation of Use in the Indications and Usage section of the labeling:

    • No incremental benefit of SIMCOR on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin monotherapy and niacin monotherapy has been established.

    II. Withdrawal Under Section 505(e) of the FD&C Act

    Based on the collective evidence from several large cardiovascular outcome trials (Refs. 1-3.), the Agency has concluded that the totality of the scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events. Consistent with this conclusion, FDA has determined that the benefits of ADVICOR and SIMCOR no longer outweigh the risks, and approval should be withdrawn.

    FDA requested that AbbVie Inc. voluntarily discontinue marketing of ADVICOR and SIMCOR, and AbbVie Inc. agreed to do so. AbbVie Inc. also has requested in writing that FDA withdraw approval of NDA 021249 and NDA 022078 and waived its opportunity for a hearing.

    Therefore, under section 505(e) of the FD&C Act and under authority delegated to the Director of the Center for Drug Evaluation and Research by the Commissioner of Food and Drugs, approval of ADVICOR and SIMCOR is withdrawn. Introduction or delivery for introduction of these products without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).

    The Agency is required to publish a list of all approved drugs (see section 505(j)(7) of the FD&C Act (21 U.S.C. 355(j)(7)). FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.161 and 314.162(a)(2)). For the reasons summarized in this document, the Agency has determined that ADVICOR and SIMCOR were voluntarily withdrawn from sale for reasons of safety or effectiveness. FDA will remove NDA 021249 for ADVICOR and NDA 022078 for SIMCOR from the list of products published in the Orange Book and will not accept or approve ANDAs that reference either drug product.

    III. References

    The following references are on display in the Division of Dockets Management (see ADDRESSES), and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    1. The ACCORD Study Group, “Effects of Combination Lipid Therapy in Type 2 Diabetes Mellitus,” New England Journal of Medicine, vol. 362, pp. 1563-1574, 2010 (http://www.nejm.org/doi/pdf/10.1056/NEJMoa1001282). 2. The AIM-HIGH Investigators, “Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy,” New England Journal of Medicine, vol. 365, pp. 2255-2267, 2011 (http://www.nejm.org/doi/pdf/10.1056/NEJMoa1107579). 3. The HPS2-THRIVE Collaborative Group, “Effects of Extended-Release Niacin with Laropiprant in High-Risk Patients,” New England Journal of Medicine, vol. 371(3), pp. 203-212, 2014 (http://www.nejm.org/doi/pdf/10.1056/NEJMoa1300955). Dated: April 13, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08894 Filed 4-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0271] Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act.” This guidance describes how FDA intends to apply the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to drugs compounded by licensed pharmacists or physicians in State-licensed hospital or health system pharmacies.

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work to finalize the guidance, submit either electronic or written comments on this draft guidance by July 18, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2016-D-0271 for “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability”. Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-3110.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act.” Pharmacies located within a hospital or standalone pharmacies that are part of a health system frequently provide compounded drug products for administration within the hospital or health system. Some of these compounders have registered with FDA as outsourcing facilities under section 503B of the FD&C Act (21 U.S.C. 353b) and others are State-licensed pharmacies subject to section 503A of the FD&C Act (21 U.S.C. 353a).

    Section 503A, added to the FD&C Act by the Food and Drug Administration Modernization Act of 1997, describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act:

    • Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice requirements);

    • section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and

    • section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)).

    The guidance describes how FDA intends to apply section 503A of the FD&C Act to drugs compounded by licensed pharmacists or physicians in State-licensed hospital or health system pharmacies.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 12, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08879 Filed 4-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0238] Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Section 503B defines an outsourcing facility, in part, as “a facility at one geographic location or address.” FDA has received questions from outsourcing facilities and other stakeholders about the meaning of this term, such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards. FDA is issuing this draft guidance to answer these questions.

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 18, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2016-D-0238 for “Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-3110.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.”

    Section 503B, added to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Drug Quality and Security Act in 2013, created a new category of compounders called outsourcing facilities. Section 503B describes the conditions that must be satisfied for human drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility to qualify for exemptions from three sections of the FD&C Act:

    • Section 502(f)(1) (concerning labeling requirements);

    • Section 505 (concerning drug approval requirements); and

    • Section 582 (concerning Drug Supply Chain Security Act requirements).

    Section 503B(d)(4) of the FD&C Act defines an outsourcing facility as a facility at one geographic location or address that: (1) Is engaged in the compounding of sterile drugs; (2) has elected to register as an outsourcing facility; and (3) complies with all of the requirements of this section. In addition, an outsourcing facility is not required to be a licensed pharmacy, and it may or may not obtain prescriptions for identified individual patients. Because drugs compounded by outsourcing facilities are not exempt from section 501(a)(2)(B) of the FD&C Act, outsourcing facilities are subject to current good manufacturing practice (CGMP) requirements.

    FDA has received questions from outsourcing facilities and other stakeholders about the meaning of the term “facility at one geographic location or address,” such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards. FDA is issuing this draft guidance to answer these questions.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the meaning of the term “facility at one geographic location or address” under section 503B of the FD&C Act. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 12, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08878 Filed 4-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1127] AbbVie Inc. et al; Withdrawal of Approval of Indications Related to the Coadministration With Statins in Applications for Niacin Extended-Release Tablets and Fenofibric Acid Delayed-Release Capsules AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is withdrawing approval of the indications related to the coadministration with a statin for niacin extended-release (ER) tablets and fenofibric acid delayed-release (DR) capsules. Affected applications include one new drug application (NDA) and seven abbreviated new drug applications (ANDAs) for niacin ER tablets, and one NDA and three ANDAs for fenofibric acid DR capsules. The holders of these applications have requested that FDA withdraw approval of the indications and have waived their opportunities for a hearing.

    DATES:

    The effective date is April 18, 2016.

    ADDRESSES:

    For access to the docket to read background documents, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Jay Sitlani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6282, Silver Spring, MD 20993-0002, 301-796-5202.

    SUPPLEMENTARY INFORMATION: I. Background A. Applications for Niacin ER Tablets

    FDA first approved NDA 020381 for Niaspan (niacin extended-release) tablets for several indications on July 28, 1997. On March 26, 2009, FDA approved a revised indication that read as follows:

    • Niaspan in combination with simvastatin or lovastatin is indicated for the treatment of primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb) when treatment with Niaspan, simvastatin, or lovastatin monotherapy is considered inadequate.

    In addition, the following Limitation of Use was added to the Indications and Usage section of the labeling:

    • No incremental benefit of Niaspan coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established. Niaspan has not been studied in Fredrickson Type I and III dyslipidemias.

    This indication was revised between March 26, 2009, and April 27, 2015, at which time it was removed from the approved labeling. The Limitation of Use currently reads:

    • Addition of Niaspan did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH).

    There are seven approved ANDAs that cited Niaspan as the reference listed drug (RLD) and that are approved for the same indications as Niaspan (see table 1).

    Table 1—Affected Niacin Products Application No. Drug Application holder NDA 020381 Niaspan (niacin extended-release) tablets AbbVie. ANDA 076250 Niacin extended-release tablets Barr. ANDA 076378 Niacin extended-release tablets Barr. ANDA 090446 Niacin extended-release tablets Lupin Ltd. ANDA 090860 Niacin extended-release tablets Lupin Ltd. ANDA 090892 Niacin extended-release tablets Lupin Ltd. ANDA 200484 Niacin extended-release tablets Sun Pharma Global. ANDA 201273 Niacin extended-release tablets Sun Pharma Global. B. Applications for Fenofibric Acid DR Capsules

    FDA approved NDA 022224 for Trilipix (fenofibric acid) DR capsules on December 15, 2008, for several indications, including the following:

    • Trilipix is indicated as an adjunct to diet in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD (coronary heart disease) or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal.

    CHD risk equivalents comprise:

    ○ Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);

    ○ Diabetes; and

    ○ Multiple risk factors that confer a 10-year risk for CHD >20 percent.

    The following Limitation of Use was included in the Indications and Usage section of the labeling:

    • No incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established.

    Both this indication and the Limitation of Use were removed from the labeling on April 27, 2015.

    There are three approved ANDAs that cited Trilipix as the RLD and that are approved for the same indications as Trilipix (see table 2).

    Table 2—Affected Fenofibric Acid Products Application No. Drug Application
  • holder
  • NDA 022224 Trilipix (fenofibric acid) delayed-release capsules AbbVie. ANDA 201573 Fenofibric acid delayed-release capsules Anchen Pharmaceuticals. ANDA 200750 Fenofibric acid delayed-release capsules Lupin Ltd. ANDA 200913 Fenofibric acid delayed-release capsules Mylan Pharmaceuticals Inc.
    II. Withdrawal Under Section 505(e) of the FD&C Act

    Based on the collective evidence from several large cardiovascular outcome trials (Refs. 1-3), the Agency has concluded that the totality of the scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events. Consistent with this conclusion, FDA has determined that the benefits of niacin ER tablets and fenofibric acid DR capsules for coadministration with statins no longer outweigh the risks, and the approvals for this indication should be withdrawn.

    FDA requested that the application holders voluntarily discontinue marketing of niacin ER tablets and fenofibric acid DR capsules for these indications. The NDA and ANDA holders identified above have requested in writing that FDA withdraw approval of these indications and waived their opportunity for a hearing.

    Therefore, under section 505(e) of the FD&C Act and under authority delegated to the Director of the Center for Drug Evaluation and Research by the Commissioner of Food and Drugs, the approvals of the indications related to coadministration with statins for the applications listed in tables 1 and 2 are withdrawn. Introduction or delivery for introduction of these products with these indications in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).

    III. References

    The following references are on display in the Division of Dockets Management (HFA 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    1. The ACCORD Study Group, “Effects of Combination Lipid Therapy in Type 2 Diabetes Mellitus,” New England Journal of Medicine, vol. 362, pp. 1563-1574, 2010 (http://www.nejm.org/doi/pdf/10.1056/NEJMoa1001282).

    2. The AIM-HIGH Investigators, “Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy,” New England Journal of Medicine, vol. 365, pp. 2255-2267, 2011 (http://www.nejm.org/doi/pdf/10.1056/NEJMoa1107579).

    3. The HPS2-THRIVE Collaborative Group, “Effects of Extended-Release Niacin with Laropiprant in High-Risk Patients,” New England Journal of Medicine, vol. 371(3), pp. 203-212, 2014 (http://www.nejm.org/doi/pdf/10.1056/NEJMoa1300955).

    Dated: April 13, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08887 Filed 4-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1112] Public Meeting on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public meeting; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting will take place on the FDA campus and also be broadcast on the Internet. The goal of this meeting is to provide information and receive comments on the ICH, as well as information related to the upcoming ICH meetings in Lisbon, Portugal, in June 2016. The topics to be discussed in the regional public meeting are the topics for discussion at the forthcoming ICH Assembly Meeting. The purpose of this regional public meeting is to solicit public input prior to the next Assembly and Expert Working Group meetings in Lisbon, Portugal, scheduled for June 11 through 16, 2016, at which the discussion of the topics underway and ICH reforms will continue to progress.

    DATES:

    The public meeting will be held on May 6, 2016, from 9 a.m. to 12 p.m., EST. Registration to attend the Webcast and requests for oral presentations must be received by May 4, 2016. Interested persons may submit either electronic or written comments to the public docket (see ADDRESSES) by June 6, 2016.

    ADDRESSES:

    The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2016-N-1112 for “The U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Amanda Roache, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring MD, 20993, 301-796-4548, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    The ICH, formerly known as the International Conference on Harmonisation, was established in 1990 as a joint regulatory/industry project to improve, through harmonization, the efficiency of the process for developing and registering new medicinal products in Europe, Japan, and the United States without compromising the regulatory obligations of safety and effectiveness. In 2015, the ICH was reformed to make the ICH a true global initiative that expands beyond the previous ICH members. More involvement from regulators around the world is expected, as they will join their counterparts from Europe, Japan, the United States, Canada, and Switzerland as ICH Regulatory Members. The reforms build on a 25-year track record of successful delivery of harmonized guidelines for global pharmaceutical development, and their regulation. Additionally, the reforms strengthen ICH as the leading platform for global pharmaceutical regulatory harmonization, and brings together in a transparent manner all key regulatory authorities and industry stakeholders.

    In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for medical product development among regulatory Agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. Members of the ICH Management Committee include the European Union; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labor, and Welfare; the Japanese Pharmaceutical Manufacturers Association; FDA; the Pharmaceutical Research and Manufacturers of America; Health Canada; Swissmedic; the World Health Organization; and International Federation of Pharmaceutical Manufacturers and Associations (as Observers). The ICH process has achieved significant harmonization of the technical requirements for the approval of pharmaceuticals for human use in the ICH regions over the past two decades. The current ICH process and structure can be found at the following Web site: http://www.ich.org. (FDA has verified the Web site addresses as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.)

    II. Webcast Attendance and Participation A. Registration

    If you wish to attend this meeting, visit http://ichpublicconsult2016.eventbrite.com. Please register by May 4, 2016. If you are unable to attend the meeting in person, you can register to view a live Webcast on the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the Webcast. Your registration must also contain your complete contact information, including name, title, affiliation, address, email address, and phone number. Registrations may be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, the number of participants from each organization may be limited based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations because of a disability, please contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the Webcast.

    B. Requests for Oral Presentations

    Interested persons may present data, information, or views orally or in writing on issues pending at the public Webcast. Public oral presentations will be scheduled between approximately 11:30 a.m. and 12 p.m. Time allotted for oral presentations may be limited to 5 minutes. Those desiring to make oral presentations should notify Amanda Roache (see FOR FURTHER INFORMATION CONTACT) by April 29, 2016, and submit a brief statement of the general nature of the evidence or arguments they wish to present; the names and addresses, telephone number, fax, and email of proposed participants; and an indication of the approximate time requested to make their presentation. The agenda for the public Webcast will be made available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm488618.htm.

    Dated: April 13, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08880 Filed 4-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-2065] Radiation Biodosimetry Medical Countermeasure Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled “Radiation Biodosimetry Medical Countermeasure Devices.” FDA has developed this guidance to provide industry and Agency staff with recommendations for the types of information that should be submitted to support marketing authorization for radiation biodosimetry medical countermeasure devices.

    DATES:

    Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2014-D-2065 for “Radiation Biodosimetry Medical Countermeasure Devices.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled “Radiation Biodosimetry Medical Countermeasure Devices” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Dickey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5648, Silver Spring, MD 20993-0002, 301-796-5028.

    SUPPLEMENTARY INFORMATION: I. Background

    This guidance provides recommendations for the types of information that should be submitted to support marketing authorization (e.g., the clearance or approval) for radiation biodosimetry medical countermeasure devices (referred to as “biodosimetry devices” or “biodosimeters” throughout this document).

    This guidance applies to premarket submissions for medical device systems intended to measure biological responses to unintended (non-therapeutic) radiation absorption. Biodosimetry devices are devices used for the purpose of reconstructing the ionizing radiation dose received by individuals or populations using physiological, chemical, or biological markers of exposure found in humans. Biodosimetry technologies may be used at various stages during triage, including both early mass casualty triage and subsequent clinical evaluation. Such exposures could be the result of intentional harm or as a consequence of a disaster. Devices may be designed to give quantitative outputs or qualitative information around a clinical decision making cut-point. Likewise, devices may be designed for use in field triage settings, at patient bedsides, or in Clinical Laboratory Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578) certified clinical laboratories. FDA considered both high-throughput and single-use devices in developing this guidance document.

    This guidance only applies to validation of diagnostic biodosimetry devices intended to be used to assess radiation absorption that occurs as a result of non-therapeutic or accidental exposures (e.g., a deliberate attack, such as use of an improvised nuclear device, or a natural disaster), and does not apply to medical devices intended to be used to measure doses delivered as a result of radiation therapy nor to devices that measure effects from long-term radiation exposure. In addition, dosimeters, which are devices that detect radiation exposure on a physical substrate rather than through a biological response and are worn by people who might be exposed to radiation during the course of their normal work (such as film badges), are not addressed in this guidance document. Finally, biological assays that might be used to detect the presence of ingested radioisotopes in sputum or urine are not considered in this guidance document.

    This guidance document does not provide specific study designs; it describes design principles for studies that may be used to establish a reasonable assurance of the safety and effectiveness of biodosimetry devices.

    In the Federal Register of December 30, 2014 (79 FR 78448), the Agency announced the issuance of the draft guidance entitled “Radiation Biodosimetry Devices; Draft Guidance for Industry and Food and Drug Administration Staff.” In the Federal Register of May 28, 2015 (80 FR 30466), FDA reopened and extended the comment period on the draft guidance. The Agency has considered the comments, as appropriate.

    II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Radiation Biodosimetry Medical Countermeasure Devices.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of “Radiation Biodosimetry Medical Countermeasure Devices” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1400045 to identify the guidance you are requesting.

    IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 58 have been approved under OMB control number 0910-0119; the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231; the collections of information in the guidance document entitled “Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable” have been approved under OMB control number 0910-0582; the collections of information in the guidance document entitled “Guidance for Industry and FDA Staff: Administrative Procedures for CLIA Categorization” have been approved under OMB control number 0910-0607; and the collections of information in the guidance document entitled “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” have been approved under OMB control number 0910-0756.

    Dated: April 12, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08899 Filed 4-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0269] Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled “Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” This guidance sets forth FDA's policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use.

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work to finalize the guidance, submit either electronic or written comments on this draft guidance by July 18, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by May 18, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

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

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

    Written/Paper Submissions

    Submit written/paper submissions as follows:

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

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

    Instructions: All submissions received must include the Docket No. FDA-2016-D-0269 for “Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    Submit comments on information collection issues to the Office of Management and Budget in the following ways:

    • Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to [email protected] All comments should be identified with the title, “Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Collection of Information.”

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Room 5197, Silver Spring, MD, 301-796-3110.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Section 503A (21 U.S.C. 353a), added to the FD&C Act by the Food and Drug Administration Modernization Act of 1997, describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act:

    • Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice requirements);

    • section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and

    • section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)).

    A compounded drug product may be eligible for the exemptions under section 503A of the FD&C Act only if it is, among other things, compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient. Among other conditions, to qualify for the exemptions under section 503A of the FD&C Act, the drug product must be compounded by a licensed pharmacist in a State-licensed pharmacy or a Federal facility, or by a licensed physician (section 503A(a)).

    This guidance sets forth FDA's policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the FD&C Act. It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the prescription requirement under section 503A of the FD&C Act. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information that they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the collection of information associated with this document, FDA invites comments on the following topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Under the draft guidance, if it is not obvious from a prescription order that the prescription is for a compounded drug product, a compounder may consult with the prescriber to determine whether the patient needs a compounded drug and make an appropriate notation on the prescription order. To serve as a basis for compounding under section 503A of the FD&C Act, a notation must document the prescriber's determination that a compounded drug is necessary for the identified patient. FDA recommends using the following statement:

    Per [type of communication] with [name of prescriber] on [date], [name of prescriber] has advised that compounded [name of drug] is necessary for the treatment of [name of patient].

    We estimate that annually a total of approximately 3,444 licensed pharmacists and licensed physicians (“number of respondents” in table 1) will make a notation with this statement on approximately 172,200 prescription orders (“total annual disclosures” in table 1). We estimate that the consultation between the compounder and the prescriber and adding the written statement to each prescription will take approximately 5 minutes per prescription order.

    In addition, the licensed pharmacist or licensed physician seeking to compound a drug product under section 503A should maintain records of valid prescription orders received for compounded drug products to demonstrate compliance with the prescription requirement in section 503A(a)(1) of the FD&C Act. For example, this includes records of valid prescription orders and of prescription orders bearing notations that the compounded drug product is necessary for the identified individual patient as described in section III.A of this guidance and section 503A(a) of the FD&C Act. Because the time, effort, and financial resources necessary to comply with this collection of information would be incurred by licensed pharmacists and licensed physicians in the normal course of their activities, it is excluded from the definition of “burden” under 5 CFR 1320.3(b)(2). FDA understands that maintaining records of prescriptions for compounded drug products is part of the usual course of the practice of compounding and selling drugs and is required by States' pharmacy laws and other State laws governing record keeping by health care professionals and health care facilities.

    Under the guidance, licensed pharmacists and licensed physicians should also maintain records of the calculations performed to determine the limited quantities of drug products compounded before the receipt of valid prescription orders under the enforcement policy described in section III.B.2 of this guidance and section 503A(a)(2) of the FD&C Act. These records should clearly reflect the quantity of a particular drug product compounded in advance of receiving prescription orders for identified individual patients that the compounder has kept on hand as stock for distribution, and the basis for the quantity the compounder kept in stock. Under the enforcement policy described in section III.B.2 of this guidance, this would include the quantity of the drug product distributed under prescription orders for identified individual patients during the reference period that the licensed pharmacist or licensed physician selected (i.e., a 30-day period within the last year).

    We estimate that annually a total of approximately 10,332 licensed pharmacists and licensed physicians (“number of recordkeepers” in table 2) will maintain approximately 103,320 records (“total annual records” in table 2). We estimate that maintaining the records will take approximately 5 minutes per record.

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

    Table 1—Estimated Annual Third-Party Disclosure Burden 1 Type of reporting Number of
  • respondents
  • Number of
  • disclosures per
  • respondent
  • Total annual disclosures Average
  • burden per disclosure
  • Total hours
    Consultation between the licensed pharmacist or licensed physician and the prescriber and adding a notation to document the prescriber's determination that a compounded drug is necessary for an identified patient 3,444 50 172,200 0.083 (5 minutes) 14,350 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 2—Estimated Annual Recordkeeping Burden 1 Type of reporting Number of
  • recordkeepers
  • Number of
  • records per
  • recordkeeper
  • Total annual records Average
  • burden per
  • recordkeeping
  • Total hours
    Records of calculations performed to determine “limited quantities” 10,332 10 103,320 0.083 (5 minutes) 8,610 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 12, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08877 Filed 4-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0427] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons Program AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by May 18, 2016.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-0510. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002—OMB Control Number 0910-0510—Extension

    The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250) was signed into law on October 26, 2002. Section 201 of MDUFMA added a new paragraph (g) to section 704 of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 374), directing FDA to accredit third parties (accredited persons) to conduct inspections of eligible manufacturers of class II or class III devices. FDA's guidance document entitled “Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria” provides information for those interested in participating in this voluntary program.

    In the Federal Register of October 21, 2015 (80 FR 63806), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

    Table 1—Estimated Annual Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    Request for accreditation 1 1 1 80 80 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Dated: April 12, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08893 Filed 4-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1109] Tobacco Farm Site Tours Program AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is announcing an invitation for participation in its voluntary Tobacco Farm Site Tours Program. This program is intended to give CTP staff an opportunity to visit farms that grow tobacco for sale to tobacco product manufacturers in order to gain a better understanding of tobacco farming and the processes involved in curing and preparing tobacco intended for sale to tobacco product manufacturers. This program is not an FDA regulatory inspection, and tobacco farms are not regulated entities unless they are also a tobacco product manufacturer or controlled by a tobacco product manufacturer. The purpose of this notice is to invite parties interested in participating in the Tobacco Farm Site Tours Program to submit requests to CTP.

    DATES:

    Submit either an electronic or written request for participation in this program by June 17, 2016. See section IV of this document for information on requests for participation.

    ADDRESSES:

    If your farm is interested in offering a site visit, please submit a request either electronically to http://www.regulations.gov or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Allison Hoffman, Office of Science, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 5426, Silver Spring, MD 20993-0002, 1-877-287-1373, email: [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) into law, amending the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and giving FDA authority to regulate tobacco product manufacturing, distribution, and marketing.

    CTP's Office of Science is conducting the Tobacco Farm Site Tours Program to provide its staff an opportunity to visit farms that grow tobacco for sale to tobacco product manufacturers (a “tobacco product manufacturer” is defined as any person, including any repacker or relabeler, who manufactures, fabricates, assembles, processes, or labels a tobacco product, or imports a finished tobacco product for sale or distribution in the United States (section 900(20) of the FD&C Act (21 U.S.C. 387(20))). Although farms that grow tobacco are not FDA-regulated entities unless they are also a tobacco product manufacturer or controlled by a tobacco product manufacturer (see section 901(c)(2) of the FD&C Act (21 U.S.C. 387a(c)(2))), tobacco farm site visits will aid the Agency in gaining a better understanding of tobacco farming and the processes involved in curing and preparing tobacco leaf intended for sale to tobacco product manufacturers. The goal for the Tobacco Farm Site Tours Program is for CTP staff to gain firsthand exposure to tobacco farming practices, including cultivation, harvesting, curing, and preparation for sale of tobacco leaf to tobacco product manufacturers.

    II. Description of Tobacco Farm Site Tours Program

    In the Tobacco Farm Site Tours Program, small groups of CTP staff plan to observe the operations of farms that grow tobacco for sale to tobacco product manufacturers. Please note that FDA does not regulate these farms and the Tobacco Farm Site Tours Program is not an inspection of facilities to determine compliance with the FD&C Act; rather, this program is meant to educate CTP staff and improve their understanding of tobacco farming. It is anticipated that the tobacco farm site tours will take place in the fall of 2016.

    III. Site Selection

    CTP hopes to be able to tour small, medium, and large farms, and farms that grow tobacco for different kinds of tobacco products. Final site selections will be based on the availability of funds and resources for the relevant fiscal year as well as the desire to visit a wide variety of types of tobacco farms. FDA plans on visiting nine or fewer farms. All FDA travel expenses associated with the farm site tours will be the responsibility of FDA.

    IV. Requests for Participation

    To aid in site selection, your request for participation should include the following information:

    • A description of your farm, including the size of the farm;

    • A list of the type(s) of tobacco grown and the kinds of tobacco product manufacturers to whom you sell tobacco;

    • The physical address(es) of the site(s) for which you are submitting a request; and

    • A proposed 1-day tour agenda.

    Identify requests for participation with the docket number found in brackets in the heading of this document. Received requests are available for public examination in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 12, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08900 Filed 4-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request AGENCY:

    Health Resources and Services Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

    DATES:

    Comments on this Information Collection Request must be received no later than June 17, 2016.

    ADDRESSES:

    Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, Room 14N-39, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984.

    SUPPLEMENTARY INFORMATION:

    When submitting comments or requesting information, please include the information request collection title for reference.

    Information Collection Request Title: Black Lung Clinics Program Performance Measures

    OMB No. 0915-0292—Extension.

    Abstract: The Federal Office of Rural Health Policy (FORHP), HRSA, conducts an annual data collection of user information for the Black Lung Clinics Program, which has been ongoing with OMB approval since 2004. The purpose of the Black Lung Clinics Program is to reduce the morbidity and mortality associated with occupationally related coal mine dust lung disease through the screening, diagnosis, and treatment of active, inactive, retired, and/or disabled coal miners. Collecting this data provides HRSA with information on how well each grantee is meeting the needs of these miners in their communities.

    Need and Proposed Use of the Information: Data from the annual report provides quantitative information about the clinics, specifically: (a) The characteristics of the patients they serve (gender, age, disability level, occupation type); (b) the characteristics of services provided (medical encounters, non-medical encounters, benefits counseling, and outreach); and, (c) the number of patients served. This assessment enables HRSA to provide data required by Congress under the Government Performance and Results Act of 1993. It also ensures that funds are effectively used to provide services that meet the target population needs. HRSA does not plan to make any changes to the performance measures at this time.

    Likely Respondents: Black Lung Clinics Program Grantees.

    Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below.

    Total Estimated Annualized Burden Hours Form name Number of
  • respondents
  • Number of
  • responses per respondent
  • Total
  • responses
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden hours
    Black Lung Clinics Program Measures 15 1 15 10 150 Total 15 1 15 10 150

    HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    Jackie Painter, Director, Division of the Executive Secretariat.
    [FR Doc. 2016-08802 Filed 4-15-16; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel, Household Air Pollution Health Outcomes Trial (UM1).

    Date: May 10, 2016.

    Time: 11:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Courtyard by Marriott, 5520 Wisconsin Avenue, Chevy Chase, MD 20815.

    Contact Person: Kristen Page, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7185, Bethesda, MD 20892, 301-496-2434, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: April 12, 2016. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-08801 Filed 4-15-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflicts and Continuous Submissions.

    Date: April 28, 2016.

    Time: 11:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Chee Lin, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive Room 4128, Bethesda, md 20892, 301-435-1850, [email protected]

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: April 12, 2016. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-08800 Filed 4-15-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request

    In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276-1243.

    Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

    Proposed Project: Monitoring of the National Suicide Prevention Lifeline (OMB No. 0930-0274) Revision

    The Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Mental Health Services (CMHS) is requesting approval for the revision of data collection associated with the previously-approved Monitoring of the National Suicide Prevention Lifeline (OMB No. 0930-0274; Expiration, July 31, 2016). The current request will continue previously-cleared efforts to evaluate process and impacts of follow-up services provided to suicidal individuals through the National Suicide Prevention Lifeline Crisis Center Follow-Up (NSPL Follow-Up) program.

    The NSPL, or Lifeline, is SAMHSA's 24-hour crisis hotline (1-800-273-TALK [8255]) that serves as a central switchboard, seamlessly connecting callers from anywhere in the U.S. to the closest of its 165 crisis centers within the Lifeline network. Since its inception, the Lifeline has helped more than 6 million people. In 2008, SAMHSA launched the NSPL Follow-up program and began awarding cooperative agreements to crisis centers in the Lifeline network to reconnect with suicidal callers to offer emotional support and ensure they followed up with referrals to treatment. In 2013, the program was expanded to include crisis center follow-up with any suicidal individual referred from a partnering emergency department (ED) or inpatient hospital.

    While previous evaluations of the NSPL demonstrated that suicidal callers experienced a reduction in hopelessness and suicidal intent after contacting the Lifeline, 43% of suicidal callers participating in follow-up assessments reported some recurrence of suicidality (e.g., ideation, plan, or attempt) since their crisis call (Gould et al., 2007). Even so, only about 35% of suicidal callers set up an appointment and even fewer had been seen by the behavioral health care system to which they were referred (Gould et al., 2007; Kalafat et al., 2007). Similarly, while several randomized, controlled trials have demonstrated that following up by telephone or letter with patients discharged from inpatient or ED settings can reduce rates of repeat suicide attempts (Vaiva et al., 2006), as well as completions (Fleischman et al., 2008; Motto & Bostrom, 2001), suicidal individuals discharged from EDs rarely link to ongoing care. As many as 70% of suicide attempters either never attend their first appointment or drop out of treatment after a few sessions (Knesper et al., 2010). Thus, it is imperative that EDs and inpatient settings link these individuals to follow-up care.

    SAMHSA is addressing this need through the NSPL Follow-Up program. The Monitoring of the NSPL will continue to assess whether the NSPL Follow-Up program achieves its intended goals. This revision of the Monitoring of the NSPL represents SAMHSA's desire to expand this process and impacts evaluation to assess follow-up with clients referred to the Lifeline from partnering inpatient hospitals and EDs and continue to improve the methods and standards of service delivery to suicidal individuals receiving crisis center services. This effort will build on information collected through previous and ongoing NSPL evaluations; expand our understanding of the outcomes associated with the NSPL Follow-Up program; and continue to contribute to the evidence base.

    This revision requests approval for the removal of one previously-approved instrument and the continuation and renaming of five previously-approved activities. Six crisis centers funded through the NSPL Follow-Up program in FY 2016 will participate in this effort.

    Instrument Removal

    Due to the completion of the motivational interviewing/safety planning (MI/SP) training and the fulfillment of data collection goals, the currently-approved MI/SP Counselor Attitudes Questionnaire and its associated burden will be removed.

    Instrument and Consent Revisions

    Each of the five instruments and consents associated with the Monitoring of the NSPL was previously approved by OMB (No. 0930-0274; Expiration, July 31, 2016). Revisions include the following: (1) The term “caller” will be replaced with “client” to reflect the change in respondent type to clients referred from partnering EDs and inpatient hospitals rather than callers, and (2) MI/SP will be removed from the titles of all instruments and consents. No other changes are being made.

    The MI/SP Caller Follow-up Interview will be renamed “Client Follow-up Interview.”

    The MI/SP Caller Initial Script will be renamed “Client Initial Script.”

    The MI/SP Caller Follow-up Consent Script will be renamed “Client Follow-up Consent Script.”

    The MI/SP Counselor Follow-up Questionnaire will be renamed “Counselor Follow-up Questionnaire.”

    The MI/SP Counselor Consent will be renamed “Counselor Consent.”

    The estimated response burden to collect this information associated with the Monitoring of the NSPL annualized over the requested 3-year approval period is presented below:

    Estimated Annualized Burden Activity Number of
  • respondents
  • Responses
  • per respondent
  • Total number
  • of responses
  • Burden per
  • response
  • (hours)
  • Annual burden
  • (hours) *
  • Client Initial Script 217 1 217 .08 17 Client Initial Script Refusals 53 1 53 .02 1 Client Follow-up Consent Script 161 1 161 .17 27 Client Follow-up Consent Script Refusals 10 1 10 .03 1 Client Follow-up Interview 160 1 160 .67 107 Client Follow-up Interview Refusals 1 1 1 .25 1 Counselor Consent 42 1 42 .08 3 Counselor Follow-up Questionnaire 42 15 630 .17 107 Total 685 1,274 264 * Rounded to the nearest whole number with 0 rounded to 1.

    Send comments to Summer King, SAMHSA Reports Clearance Officer, 5600 Fishers Lane, Room 15E57-B, Rockville, MD, 20857 OR email her a copy at s[email protected] Written comments should be received by June 17, 2016.

    Summer King, Statistician.
    [FR Doc. 2016-08864 Filed 4-15-16; 8:45 am] BILLING CODE 4162-20-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs And Border Protection Accreditation of Dixie Services Inc., as a Commercial Laboratory AGENCY:

    U.S. Customs and Border Protection, Department of Homeland Security.

    ACTION:

    Notice of accreditation of Dixie Services, Inc., as a commercial laboratory.

    SUMMARY:

    Notice is hereby given, pursuant to CBP regulations, that Dixie Services, Inc., has been accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of September 9, 2015.

    DATES:

    The accreditation of Dixie Services, Inc., as commercial laboratory became effective on September 9, 2015. The next triennial inspection date will be scheduled for September 2018.

    FOR FURTHER INFORMATION CONTACT:

    Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given pursuant to 19 CFR 151.12 that Dixie Services, Inc., 1706 First St., Galena Park, TX 77547, has been accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12.

    Dixie Services, Inc., is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):

    CBPL No. ASTM Title 27-04 D95 Standard Test Method for Water in Petroleum Products and Bituminous Materials by Distillation. 27-05 D4928 Standard Test Method for Water in Crude Oils by Coulometric Karl Fischer Titration. 27-06 D473 Standard Test Method for Sediment in Crude Oils and Fuel Oils by the Extraction Method. 27-07 D4807 Standard Test Method for Sediment in Crude Oil by Membrane Filtration. 27-08 D86 Standard Test Method for Distillation of Petroleum Products. 27-11 D445 Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids. 27-13 D4294 Standard Test Method for Sulfur in Petroleum and Petroleum Products by Energy-Dispersive X-ray Fluorescence Spectrometry. 27-14 D2622 Standard Test Method for Sulfur in Petroleum Products. 27-39 D721 Standard Test Method for Oil Content of Petroleum Waxes. 27-48 D4052 Standard Test Method for Density and Relative Density of Liquids by Digital Density Meter. 27-50 D93 Standard Test Methods for Flash-Point by Pensky-Martens Closed Cup Tester. 27-53 D2709 Standard Test Method for Water and Sediment in Middle Distillate Fuels by Centrifuge. 27-58 D5191 Standard Test Method For Vapor Pressure of Petroleum Products.

    Anyone wishing to employ this entity to conduct laboratory analyses should request and receive written assurances from the entity that it is accredited by the U.S. Customs and Border Protection to conduct the specific test requested. Alternatively, inquiries regarding the specific test this entity is accredited to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to [email protected] Please reference the Web site listed below for a complete listing of CBP approved gaugers and accredited laboratories.

    http://www.cbp.gov/about/labs-scientific/commercial-gaugers-and-laboratories Dated: April 11, 2016. Ira S. Reese, Executive Director, Laboratories and Scientific Services Directorate.
    [FR Doc. 2016-08930 Filed 4-15-16; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Accreditation and Approval of Oiltest, Inc., as a Commercial Gauger and Laboratory AGENCY:

    U.S. Customs and Border Protection, Department of Homeland Security.

    ACTION:

    Notice of accreditation and approval of Oiltest, Inc., as a commercial gauger and laboratory.

    SUMMARY:

    Notice is hereby given, pursuant to CBP regulations, that Oiltest, Inc., has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of December 11, 2014.

    DATES:

    Effective Dates: The accreditation and approval of Oiltest, Inc., as a commercial gauger and laboratory became effective on December 11, 2014. The next triennial inspection date will be scheduled for December 2017.

    FOR FURTHER INFORMATION CONTACT:

    Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1331 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that Oiltest, Inc., 109 Aldene Rd., Building #4, Roselle, NJ 07203, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Oiltest, Inc. is approved for the following gauging procedures for petroleum and certain petroleum products per the American Petroleum Institute (API) Measurement Standards:

    API chapters Title 3 Tank gauging. 7 Temperature determination. 8 Sampling. 11 Physical property. 12 Calculations. 17 Maritime measurement.

    Oiltest, Inc. is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):

    CBPL No. ASTM Title 27-03 ASTM D 4006 Standard test method for water in crude oil by distillation. 27-04 ASTM D 95 Standard test method for water in petroleum products and bituminous materials by distillation. 27-06 ASTM D 473 Standard Test Method for Sediment in Crude Oils and Fuel Oils by the Extraction Method. 27-08 ASTM D 86 Standard Test Method for Distillation of Petroleum Products at Atmospheric Pressure. 27-11 ASTM D 445 Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids (the Calculation of Dynamic Velocity). 27-13 ASTM D 4294 Standard test method for sulfur in petroleum and petroleum products by energy-dispersive x-ray fluorescence spectrometry. 27-46 ASTM D 5002 Standard test method for density and relative density of crude oils by digital density analyzer. 27-48 ASTM D 4052 Standard Test Method for Density and Relative Density of Liquids by Digital Density Meter. 27-50 ASTM D 93 Standard test methods for flash point by Pensky-Martens Closed Cup Tester.

    Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to [email protected] Please reference the Web site listed below for a complete listing of CBP approved gaugers and accredited laboratories.

    http://www.cbp.gov/about/labs-scientific/commercial-gaugers-and-laboratories. Dated: April 12, 2016. Ira S. Reese, Executive Director, Laboratories and Scientific Services Directorate.
    [FR Doc. 2016-08928 Filed 4-15-16; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection [1651-0074] Agency Information Collection Activities: Prior Disclosure AGENCY:

    U.S. Customs and Border Protection, Department of Homeland Security.

    ACTION:

    30-Day notice and request for comments; extension of an existing collection of information.

    SUMMARY:

    U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Prior Disclosure. This is a proposed extension of information collection requirements that were previously approved. CBP is proposing these requirements be extended with no change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.

    DATES:

    Written comments should be received on or before May 18, 2016 to be assured of consideration.

    ADDRESSES:

    Interested persons are invited to submit written comments on this proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to [email protected] or faxed to (202) 395-5806.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information should be directed to Tracey Denning, U.S. Customs and Border Protection, Regulations and Rulings, Office of International Trade, 90 K Street NE., 10th Floor, Washington, DC 20229-1177, at 202-325-0265.

    SUPPLEMENTARY INFORMATION:

    This proposed information collection was previously published in the Federal Register (81 FR 4326) on January 26, 2016, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.10. CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3507). The comments should address: (a) Whether the 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 estimates of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden, including the use of automated collection techniques or the use of other forms of information technology; and (e) the annual costs to respondents or record keepers from the collection of information (total capital/startup costs and operations and maintenance costs). The comments that are submitted will be summarized and included in the CBP request for OMB approval. All comments will become a matter of public record. In this document, CBP is soliciting comments concerning the following information collection:

    Abstract: The Prior Disclosure program establishes a method for a potential violator to disclose to CBP that they have committed an error or a violation with respect to the legal requirements of entering merchandise into the United States, such as underpaid tariffs or duties, or misclassified merchandise. The procedure for making a prior disclosure is set forth in 19 CFR 162.74 which requires that respondents submit information about the merchandise involved, a specification of the false statements or omissions, and what the true and accurate information should be. A valid prior disclosure will entitle the disclosing party to the reduced penalties pursuant to 19 U.S.C. 1592(c)(4).

    Current Actions: CBP proposes to extend the expiration date of this information collection with no change to the burden hours or to the information collected.

    Type of Review: Extension (without change).

    Affected Public: Businesses.

    Estimated Number of Respondents: 3,500.

    Estimated Number of Annual Responses: 3,500.

    Estimated Time per Response: 1 hour.

    Estimated Total Annual Burden Hours: 3,500.

    Dated: April 13, 2016. Tracey Denning, Agency Clearance Officer, U.S. Customs and Border Protection.
    [FR Doc. 2016-08910 Filed 4-15-16; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration Extension of Agency Information Collection Activity Under OMB Review: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY:

    Transportation Security Administration, DHS.

    ACTION:

    30-Day notice.

    SUMMARY:

    This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0058, abstracted below to OMB for review and approval of an extension of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. TSA published a Federal Register notice, with a 60-day comment period soliciting comments, of the following collection of information on February 10, 2016 (81 FR 7139). The information collection activity provides a means to gather qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery.

    DATES:

    Send your comments by May 18, 2016. A comment to OMB is most effective if OMB receives it within 30 days of publication.

    ADDRESSES:

    Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, OMB. Comments should be addressed to Desk Officer, Department of Homeland Security/TSA, and sent via electronic mail to [email protected] or faxed to (202) 395-6974.

    FOR FURTHER INFORMATION CONTACT:

    Christina A. Walsh, TSA PRA Officer, Office of Information Technology (OIT), TSA-11, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598-6011; telephone (571) 227-2062; email [email protected]

    SUPPLEMENTARY INFORMATION: Comments Invited

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The ICR documentation is available at http://www.reginfo.gov. Therefore, in preparation for OMB review and approval of the following information collection, TSA is soliciting comments to—

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

    (2) Evaluate the accuracy of the agency's estimate of the burden;

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

    (4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Information Collection Requirement

    Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.

    Type of Request: Extension.

    OMB Control Number: 1652-0058.

    Form(s): NA.

    Affected Public: Individuals, Households, Businesses, Organizations, and State, Local or Tribal Governments.

    Abstract: The information collection activity provides a means to gather qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery.

    From TSA's perspective, qualitative feedback from customers and stakeholders is information that provides useful insights on their perceptions, experiences, opinions, and expectations regarding TSA products or services, provides TSA with an early warning of issues with service, and focuses attention on areas where changes regarding communication, training, or operations might improve delivery of products or services. These collections will allow for ongoing, collaborative, and actionable communications between TSA and its customers and stakeholders. They will also allow feedback to contribute directly to the improvement of program management. The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered by TSA. If this information is not collected, vital feedback from customers and stakeholders on TSA's services will be unavailable.

    As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature. Information gathered is intended to be used only internally for general service improvement and program management purposes and is not intended for release outside of TSA (if released, TSA must indicate the qualitative nature of the information). Feedback collected under this generic clearance provides useful qualitative information, but it does not yield data that can be generalized to the overall population. Qualitative information is not designed or expected to yield statistically reliable or actionable results; it will not be used for quantitative information collections. Depending on the degree of influence the results are likely to have, there may be future information collection submissions for other generic mechanisms that are designed to yield quantitative results.

    Below we provide the Transportation Security Administration's projected average estimates for the next three years:

    Number of Respondents: 7,094,500.

    Estimated Annual Burden Hours: An estimated 3,547,250 hours annually.

    Dated: April 12, 2016. Christina A. Walsh, TSA Paperwork Reduction Act Officer, Office of Information Technology.
    [FR Doc. 2016-08835 Filed 4-15-16; 8:45 am] BILLING CODE 9110-05-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615—NEW] Agency Information Collection Activities: Application for Travel Document (Carrier Documentation), Form I-131A; New Collection AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    30-Day notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on October 2, 2015, at 80 FR 59805, allowing for a 60-day public comment period. USCIS did receive two comments in connection with the 60-day notice.

    DATES:

    The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until May 18, 2016. This process is conducted in accordance with 5 CFR 1320.10.

    ADDRESSES:

    Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB USCIS Desk Officer via email at [email protected] Comments may also be submitted via fax at (202) 395-5806 (This is not a toll-free number). All submissions received must include the agency name, the OMB Control Number 1615—NEW in the subject box and Docket ID USCIS-2015-0004.

    You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make. For additional information please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Acting Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, Telephone number (202) 272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at http://www.uscis.gov, or call the USCIS National Customer Service Center at (800) 375-5283; TTY (800) 767-1833.

    SUPPLEMENTARY INFORMATION: Comments

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2015-0004 in the search box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

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

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

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

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

    Overview of This Information Collection

    (1) Type of Information Collection Request: New Collection.

    (2) Title of the Form/Collection: Application for Travel Document (Carrier Documentation).

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: Form I-131A; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. Certain lawful permanent residents may file Form I-131A to obtain documentation that will allow a commercial carrier to board the lawful permanent resident on a vessel or aircraft destined for the United States without transportation carrier liability.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: 15,000 respondents submitting Form I-131A at .92 hours; 15,000 respondents providing biometrics at 1.17 hours.

    (6) An estimate of the total public burden (in hours) associated with the collection: 31,300 annual burden hours.

    (7) An estimate of the total public burden (in cost) associated with the collection: $7,350,000.

    Dated: April 12, 2016. Samantha Deshommes, Acting Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2016-08897 Filed 4-15-16; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5858-N-02] Housing Counseling Federal Advisory Committee; Charter Reestablishment AGENCY:

    Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.

    ACTION:

    Notice of Charter Reestablishment for Housing Counseling Federal Advisory Committee.

    SUMMARY:

    The Department of Housing and Urban Development announces the charter renewal of the Housing Counseling Federal Advisory Committee, a federal advisory committee established pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act and the Federal Advisory Committee Act. This charter renewal will take effect on May 1, 2016, and will expire after 2 years.

    FOR FURTHER INFORMATION CONTACT:

    Marjorie George, Housing Program Technical Specialist, Office of Housing Counseling, U.S. Department of Housing and Urban Development, 200 Jefferson Avenue, Suite 300, Memphis, TN 38103; telephone number 1-901-544-4228 (this is not a toll-free number); email [email protected] For hearing and speech-impaired persons, this number may be accessed via TTY by calling the Federal Relay Service at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION: Background and Authority

    Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), HUD is giving notice to reestablish the charter for the Housing Counseling Federal Advisory Committee (HCFAC). The HCFAC was established to advise HUD's Office of Housing Counseling (OHC) to meet its mission to provide individuals and families with the knowledge they need to obtain, sustain, and improve their housing through a strong national network of HUD-approved housing counseling agencies and HUD-certified counselors. The HCFAC, however, shall have no role in reviewing or awarding of OHC housing counseling grants and procurement contracts. See the HCFAC Web site for details at https://www.hudexchange.info/programs/housing-counseling/federal-advisory-committee/.

    Dated: April 12, 2016. Edward L. Golding, Principal Deputy Assistant Secretary for Housing.
    [FR Doc. 2016-08866 Filed 4-15-16; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLNVS00000 L58530000.E40000 241A; N-80613; 10-08807; MO# 4500090192; TAS:14X5232] Notice of Realty Action: Recreation and Public Purposes Act Classification, Clark County, NV (N-80613) AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The Bureau of Land Management (BLM) has examined and found suitable for classification under the Taylor Grazing Act, and for lease and conveyance under the provisions of the Recreation and Public Purposes (R&PP) Act, as amended, approximately 17.5 acres of public land in Clark County, Nevada. Clark County proposes to use the land for a community park. The 17.5-acre park will help meet future expanding needs in the southwestern part of Las Vegas Valley.

    DATES:

    Interested parties may submit written comments regarding the proposed classification for lease and conveyance of the land until June 2, 2016.

    ADDRESSES:

    Mail written comments to the BLM Field Manager, Las Vegas Field Office, 4701 N. Torrey Pines Drive, Las Vegas, Nevada 89130.

    FOR FURTHER INFORMATION CONTACT:

    Luis Rodriguez, 702-515-5069, email: [email protected] Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    Clark County submitted the parcel of land legally described as:

    Mount Diablo Meridian, Nevada T. 22 S., R. 60 E., Sec. 18, N1/2NE1/4NE1/4SW1/4, N1/2SW1/4NE1/4NE1/4SW1/4, N1/2SE1/4NE1/4NE1/4SW1/4,E1/2NW1/4NE1/4SW1/4, and E1/2SW1/4NE1/4SW1/4.

    The area described contains 17.5 acres, more or less, in Clark County.

    The parcel is located in the southwest part of the Las Vegas Valley.

    In accordance with the R&PP Act, Clark County has filed an application in which it proposes to develop the above-described land as a community park with children's playground area, perimeter walking path, picnic shade areas, restroom facilities, athletic facilities, and ancillary equipment. Additional detailed information pertaining to this application, plan of development, and site plan is located in case file N-80613, which is available for review at the BLM Las Vegas Field Office at the above address. Clark County is a political subdivision of the State of Nevada and is therefore a qualified applicant under the R&PP Act.

    Subject to limitations prescribed by law and regulation, prior to patent issuance, the holder of any right-of-way grant within the lease area may be given the opportunity to amend the right-of-way grant for conversion to a new term, including perpetuity, if applicable.

    The land identified is not needed for any Federal purpose. The lease and conveyance is consistent with the BLM Las Vegas Resource Management Plan dated October 5, 1998, and would be in the public interest. Clark County has not applied for more than the 640 acre limitation for public purpose uses in a year and has submitted a statement in compliance with the regulations at 43 CFR 2741.4(b).

    The lease and conveyance, when issued, will be subject to the provisions of the R&PP Act and applicable regulations of the Secretary of the Interior, and will contain the following reservations to the United States:

    1. A right-of-way thereon for ditches or canals constructed by the authority of the United States, Act of August 30, 1890 (43 U.S.C. 945); and

    2. All minerals shall be reserved to the United States, together with the right to prospect for, mine, and remove such deposits from the same under applicable law and such regulations as the Secretary of the Interior may prescribe.

    Any lease and/or conveyance will also be subject to valid existing rights, will contain any terms or conditions required by law (including, but not limited to, any terms or conditions required by 43 CFR 2741.4), and will contain an appropriate indemnification clause protecting the United States from claims arising out of the lessee's/patentee's use, occupancy, or operations on the leased/patented lands. It will also contain any other terms and conditions deemed necessary and appropriate by the Authorized Officer.

    Any lease and conveyance will also be subject to all valid and existing rights.

    Upon publication of this notice in the Federal Register, the land described above will be segregated from all other forms of appropriation under the public land laws, including the general mining laws, except for lease and conveyance under the R&PP Act, leasing under the mineral leasing laws and disposals under the mineral material disposal laws.

    Interested parties may submit written comments on the suitability of the land for a public park in the Enterprise area. Comments on the classification are restricted to whether the land is physically suited for the proposal, whether the use will maximize the future use or uses of the land, whether the use is consistent with local planning and zoning, or if the use is consistent with State and Federal programs. Interested parties may also submit written comments regarding the specific use proposed in the application and plan of development, and whether the BLM followed proper administrative procedures in reaching the decision to lease and convey under the R&PP Act.

    Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Only written comments submitted to the Field Manager, BLM Las Vegas Field Office, will be considered properly filed. Any adverse comments will be reviewed by the BLM Nevada State Director, who may sustain, vacate, or modify this realty action. In the absence of any adverse comments, the decision will become effective on June 17, 2016. The lands will not be available for lease and conveyance until after the decision becomes effective.

    Authority:

    43 CFR 2741.5.

    Vanessa L. Hice, Assistant Field Manager, Division of Lands.
    [FR Doc. 2016-08895 Filed 4-15-16; 8:45 am] BILLING CODE 4310-HC-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLWYD03000 16XL13100000.DM0000] Notice of Availability of the Final Environmental Impact Statement for the Continental Divide-Creston Natural Gas Development Project, Wyoming AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of availability.

    SUMMARY:

    In accordance with the National Environmental Policy Act of 1969 (NEPA), as amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) Rawlins Field Office has prepared a final environmental impact statement (EIS) for the proposed Continental Divide-Creston Natural Gas Development Project (CD-C) in Rawlins, Wyoming, and by this notice announces its availability.

    DATES:

    The BLM will not issue a final decision on the proposal for a minimum of 30 days of the date that the Environmental Protection Agency (EPA) publishes this notice in the Federal Register.

    ADDRESSES:

    The CD-C Final EIS is available for public review at the BLM Rawlins Field Office, 1300 North Third Street, Rawlins, Wyoming; the BLM High Desert District Office, 280 Highway 191 North, Rock Springs, Wyoming; and the BLM Wyoming State Office, 5353 Yellowstone Road, Cheyenne, Wyoming. The Final EIS may also be reviewed online at www.blm.gov/wy/st/en/info/NEPA/documents/rfo/cd_creston.html.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Fleuret, Project Manager, at (307) 328-4314; 1300 North Third Street, Rawlins, WY 82301; or [email protected] Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    BP America Production Company (BP) and 20 other companies propose to expand development of natural gas resources and condensate (oil) within the existing Continental Divide/Wamsutter II and Creston Blue Gap natural gas fields. More than 4,700 wells have been drilled in the project area since the 1950s under previous authorizations. Existing surface disturbance from natural gas and oil development in the project area is approximately 49,218 acres, including nearly 8,500 acres of long-term disturbance.

    The CD-C project would drill and develop up to 8,950 additional natural gas wells (some of which would also produce condensate (oil)), including 100 to 500 coalbed methane wells, using a combination of vertical and directional drilling techniques over an estimated 15-year period. The total estimated life of the project is 30 to 40 years and includes approximately 47,200 additional acres of disturbance. Planned facilities would include well pads, gas, condensate and water collection pipelines, compressor stations, water disposal systems, an access road network, and an electrical distribution system. All surface facilities would be removed when the project is completed and the land would be re-contoured to near pre-disturbance condition and re-vegetated with native plant communities.

    The project is located in the following area:

    Sixth Principal Meridian T. 14 N., R. 91 W., Secs. 6, 7, secs. 17 to 20, inclusive, and secs. 29 to 32, inclusive. T. 18 N., R. 91 W., Secs. 3 to 10, inclusive, secs. 15 to 21, inclusive, and secs. 28 to 32, inclusive. T. 19 N., R. 91 W., Secs. 1 to 23, inclusive, and secs. 26 to 34, inclusive. T. 20 N., R. 91 W., Secs. 6, 7, 18, 19, 30, and 31. T. 21 N., R. 91 W., Secs. 4 to 9, inclusive, secs. 16 to 21, inclusive, and secs. 28 to 33, inclusive. T. 22 N., R. 91 W., Secs. 4 to 9, inclusive, secs. 16 to 21, inclusive, and secs. 28 to 33, inclusive. T. 23 N., R. 91 W., Secs. 4 to 9, inclusive, secs. 16 to 21, inclusive, and secs. 28 to 33, inclusive. T. 14 N., R. 92 W., T. 15 N., R. 92 W., Secs. 3 to 10, inclusive, secs. 14 to 23, inclusive, and secs. 25 to 36, inclusive. T. 16 N., R. 92 W., Secs. 4 to 8, inclusive, secs. 18, 19, and secs. 29 to 33, inclusive. T. 17 N., R. 92 W., Secs. 1 to 23, inclusive, and secs. 27 to 34, inclusive. Tps. 18 to 23 N., R. 92 W. T. 14 N., R. 93 W., Secs. 1, 2, secs. 11 to 14, inclusive, secs. 23 to 26, inclusive, secs. 35 and 36. T. 15 N., R. 93 W., Secs. 1, 2, 3, secs. 10 to 15, inclusive, secs. 22 to 27, inclusive, secs. 34, 35, and 36. Tps. 16 to 23 N., R. 93 W. T. 16 N., R. 94 W., Secs. 1 to 14, inclusive, secs. 23 to 26, inclusive, secs. 35 and 36. Tps. 17 to 23 N., R. 94 W. T. 16 N., R 95. W., Secs. 1, 2, and 3. Sec. 4, E1/2. Secs. 10, 11, and 12. T. 17 N., R. 95 W., Secs. 1 to 15, inclusive, secs. 22 to 27, inclusive, secs. 34, 35, and 36. Tps. 18 to 24 N., R. 95 W. Tps. 18 to 24 N., R. 96 W. T. 19 N., R. 97 W., Secs. 1 to 4, inclusive, and secs. 9 to 16, inclusive; those portions of secs. 17, 19, and 20 lying south of the right-of-way granted to the Union Pacific Railroad Company by the United States, serial number WYE-05871; Secs. 21 to 36, inclusive. T. 20 N., R. 97 W., Secs. 1 to 4, inclusive, secs. 9 to 16, inclusive, secs. 21 to 28, inclusive, and secs. 33 to 36, inclusive. T. 22 N., R. 97 W., Secs. 1, 2, 3, and secs. 10 to 15, inclusive. T. 23 N., R. 97 W., Secs. 1 to 4, inclusive, secs. 9 to 16, inclusive, secs. 21 to 28 inclusive, and secs. 33 to 36, inclusive. T. 24 N., R. 97 W., Sec. 8, SE1/4; Sec. 9, S1/2; Sec. 10, S1/2; Sec. 11, S1/2; Sec. 12, S1/2; Secs. 13 to 16, inclusive; Sec. 17, E1/2; Sec. 20, E1/2; Secs. 21 to 28, inclusive; Sec. 29, E1/2; Secs. 33 to 36, inclusive. T. 19 N., R. 98 W.,

    Those portions of secs. 23 and 24 lying south of the right-of-way granted to the Union Pacific Railroad Company by the United States, serial number WYE-05871;

    Sec. 25;

    Those portions of secs. 26 to 31, inclusive, lying south of the right-of-way granted to the Union Pacific Railroad Company by the United States, serial number WYE-05871;

    Secs. 32 to 36, inclusive.

    The CD-C project area includes about 1.1 million acres, or 1,672 square miles, in Carbon and Sweetwater counties, Wyoming. Approximately 626,932 acres (58.6 percent) are administered by the BLM Rawlins Field Office, approximately 48,684 acres (4.5 percent) are State of Wyoming owned and approximately 394,470 acres (36.9 percent) are privately-owned. The project area is bisected by Interstate 80 and extends from 25 miles west of Rawlins, Wyoming, to 50 miles east of Rock Springs, Wyoming.

    Cooperating agencies for this EIS include the State of Wyoming, with active participation from many state agencies including the State Planning Office, Wyoming Game and Fish Department, State Historic Preservation Office, the Wyoming Department of Environmental Quality and the Wyoming Department of Agriculture. Regional cooperating agencies include Sweetwater and Carbon counties and the Little Snake River and Sweetwater County conservation districts.

    The Notice of Intent to prepare the EIS was published on September 8, 2005 (70 FR 53381), and again on March 3, 2006 (71 FR 10989). Public scoping meetings were held in Rawlins, Wyoming, on October 13, 2005, and on April 6, 2006. Fifty comment letters, faxes and emails were received during the extended scoping period. Key issues identified during scoping include:

    • Air quality: Potential project and cumulative impacts on air quality, including air quality-related values.

    • Cultural resources: The impact on the historical trails and historical travel routes in the project area.

    • Hydrology: Potential degradation of surface and/or groundwater quality by project construction and drilling activities.

    • Land ownership: The majority of the project area is in the checkerboard pattern of mixed public and private land ownership, complicating landscape scale mitigation on public lands where adjacent sections are nonpublic lands not subject to BLM regulations and requirements.

    • Non-native, invasive plant species: The effect of current and projected infestations of non-native, invasive species.

    • Rangeland management: Loss of livestock forage and the impact of project-associated hazardous conditions to area livestock operators.

    • Special-status species: The impact from project activities upon threatened and endangered and sensitive wildlife species.

    • Socioeconomics: The impact of the project on traditional socioeconomic indicators.

    • Surface disturbance/reclamation: The extent of existing and proposed surface disturbance and its effect on all resources in the project area; and

    • Wildlife habitat: The project's potential to further fragment wildlife habitats and diminish the value of those habitats for many species.

    In response, the BLM developed five alternatives to the Proposed Action, which were analyzed in the Draft EIS:

    • Alternative A, 100-Percent Vertical Drilling—This alternative assumes that all natural gas wells would be drilled from single-well pads, and that no directional drilling would occur;

    • Alternative B, Enhanced Resource Protection—This alternative identifies those resources that may be most at risk from mineral development, defines areas within the CD-C project area where those resource risks are likely to occur, and describes the enhanced protection and mitigations that could diminish those risks;

    • Alternative C, Surface Disturbance Cap, Core and Non-Core Areas—This alternative places a cap on unreclaimed surface disturbance caused by mineral development, a 60-acre cap in areas that have seen the greatest mineral development to date and a 30-acre cap in the rest of the project area. The cap is expressed in terms of acres per 640-acre section;

    • Alternative D, Directional Drilling—This alternative requires that all future natural gas wells on Federal mineral estate be drilled from multi-well pads, one new multi-well pad per section; and

    • Alternative E, No Action—NEPA regulations require that the EIS alternatives analysis “include the alternative of no action” (40 CFR 1502.14(d)). For the analysis in the Draft EIS, this means that the development activities on Federal lands proposed by the CD-C operators would not be approved or authorized. Lease rights on Federal lands or mineral estate granted by the BLM would remain in effect and other, additional or supplemental proposals to develop leased resources, such as oil and/or gas, could be received and would be considered by the BLM as appropriate.

    The Draft EIS Notice of Availability was published on December 7, 2012 (77 FR 73049), opening a 90-day public comment period. A public meeting was held on January 15, 2013, and the public comment period closed on March 7, 2013. Over 8,000 individual comment letters were received and identified issues such as the lack of a preferred alternative and concerns associated with each of the alternatives, including feasibility, sufficiency of the analysis and impacts to specific resources as a result of each alternative. Comments were considered and incorporated as appropriate into the Final EIS; however, the analysis of the alternatives and the identified impacts did not significantly change.

    The Final EIS differs from the Draft EIS by:

    • Dropping Alternative A, 100-Percent Vertical Drilling, from consideration due to public comments on feasibility and the magnitude of total disturbance;

    • Amending Alternative D, 100-Percent Directional Drilling, to recognize the impact the restrictions in that alternative would have on well density; as a result, this alternative now analyzes a 20-percent decrease in total wells drilled;

    • Redefining the No Action Alternative to include an analysis of impacts associated with development on state and private mineral estate in addition to potential development on Federal mineral estate; and

    • Including Alternative F, Agency-Preferred Alternative—This alternative responds to Draft EIS scoping concerns and comments by limiting development to eight wellpads per square mile section, requiring that wellpads be placed in the most environmentally suited areas, and creating a CD-C consultation and coordination group to response to evolving energy issues and concerns relating to the project. This alternative is a reconfiguration of elements of alternatives that were analyzed in the Draft EIS. The CD-C consultation and coordination group and protection measures of Alternative F were originally analyzed in the DEIS under Alternative B; and the emphasis on directional drilling was analyzed in Alternative D.

    The Final EIS includes potential landscape scale mitigation strategies. Consistent with Secretarial Order No. 3330 and the BLM's obligations under the Federal Land Policy and Management Act, BLM Wyoming drafted a landscape-scale mitigation appendix, Appendix S, for inclusion in the Final EIS. The appendix has been reviewed by the Washington Office and the cooperating agencies.

    Upon conclusion of the 30-day public availability period following the date the EPA publishes the NOA in the Federal Register, the BLM will prepare and sign the record of decision (ROD) to announce its final decision on the Continental Divide-Creston Natural Gas Development Project. Availability of the ROD will be announced to the local media and the project mailing list, and the ROD itself will be posted on the project Web page.

    Authority:

    40 CFR 1506.6, 40 CFR 1506.10.

    Mary Jo Rugwell, Acting BLM Wyoming State Director.
    [FR Doc. 2016-09010 Filed 4-15-16; 8:45 am] BILLING CODE 4310-22-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-PWR-PWRO-17327; PPPWLAKER6/PPMRSNR1Z.Y00000] Record of Decision for Development Concept Plans for Cottonwood Cove and Katherine Landing, Lake Mead National Recreation Area, Nevada and Arizona AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice of availability.

    SUMMARY:

    The National Park Service has prepared and approved a Record of Decision for the Final Environmental Impact Statement for the Development Concept Plans (DCP) for Katherine Landing and Cottonwood Cove. Approval of the DCP concludes an extensive conservation planning and environmental impact analysis effort that began during 2008.

    ADDRESSES:

    Those wishing to review the Record of Decision may obtain a copy by request to the Superintendent, Lake Mead National Recreation Area, 601 Nevada Way, Boulder City, Nevada 89005 or via telephone request at (702) 293-8978.

    FOR FURTHER INFORMATION CONTACT:

    Michael Boyles, Acting Chief, Resource Management and Visitor Services, (702) 293-8978.

    SUPPLEMENTARY INFORMATION:

    The National Park Service has prepared and approved a Record of Decision for the Final Environmental Impact Statement for the DCP for Cottonwood Cove and Katherine Land. This process was conducted pursuant to the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and the implementing regulations promulgated by the Council on Environmental Quality (40 CFR part 1505.2). The requisite no-action “wait period” was initiated on November 14, 2014, with the Environmental Protection Agency's Federal Register announcement of the filing of the Final EIS.

    Three alternatives, all including mitigation measures, were evaluated during the DCP process. The “agency preferred” Alternative 3 Enhance Visitor Experience and Park Operations has been selected as the approved DCP. All primary project components of the selected alternative will be implemented as staffing and funding allow. Key actions include the following:

    Cottonwood Cove

    • Develop new day-use areas (picnic and no-boat areas) in Ski Cove, and designate trail to Cottontail Cove; existing day-use areas in Cottonwood Cove remain.

    • Phase out trailer village near the end of the next concession contract pending an economic feasibility analysis. Redevelop site for RV use or concession operated overnight accommodations.

    • Expand motel as needed; additional structures double capacity and include meeting space (for hosting meetings and other events).

    • Maintain character of Mission 66 structures while responding to changing needs to the extent possible.

    • Construct engineered system of diversion dikes and concrete channels to convey the 500 year flood to better protect visitor areas. Maintain the Early Warning Detection System, install flood warning signs, and develop evacuation plan.

    Katherine Landing

    • Remove motel; redevelop site for expanded visitor parking near lake. Provide other forms of overnight accommodations (e.g., RV park with pull-through parking).

    • Phase out trailer village near the end of the next concession contract pending an economic feasibility analysis. The site would be redeveloped as part of an expanded, accessible campground that would be concessioner-run and would accommodate larger vehicles (larger sites with pull-through parking and hookups, etc.). Some portion of the campground would retain its current configuration for tent/car camping. Cabins may be part of the mix (exact mix of accommodations to be determined).

    • Develop new paved loop serving both north and south areas of the development (housing/administration area to campground loop D).

    • Consolidate NPS offices and operations (law enforcement/emergency, interpretation offices, etc.) in the vicinity of the NPS maintenance area; retain NPS maintenance area in same location.

    • Construct engineered system of diversion dikes, channels, and detention basin to convey predicted maximum flood flows through North and South Katherine Washes.

    • Install Early Warning Detection System for Katherine Landing; place flood warning signs and develop an evacuation plan for Katherine Landing and North and South Arizona Telephone Coves.

    Princess Cove, Cabinsite Point, and North and South Arizona Telephone Cove

    • Develop new picnic facilities at Cabinsite Point and provide additional parking and allow backcountry camping at some of the former cabin sites.

    • Develop picnic area at North Arizona Telephone Cove and design access roads to eliminate or greatly reduce exposure to flood hazards at both North and South Arizona Telephone Coves.

    • If launch capacity at Katherine Landing is reduced due to flood control, the park may consider paving and formalizing more of the overflow parking area at Princess Cove and improving the launch at North Arizona Telephone Cove or at Cabinsite Point, to align with established capacity levels set by the Lake Management Plan.

    The approved development concept plan/environmental impact statement is a programmatic document covering both Cottonwood Cove and Katherine Landing areas. More detailed information will be developed during the individual project design stage. Based on this further design information, additional natural and cultural resource surveys and further Section 106 and NEPA compliance will be tiered from this document.

    Dated: March 25, 2016. Patricia L. Neubacher, Acting Regional Director, Pacific West Region.
    [FR Doc. 2016-08837 Filed 4-15-16; 8:45 am] BILLING CODE 4312-FF-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-PWR-PWRO-19326; PXPD004214G001] Record of Decision for the Channel Islands National Park General Management Plan/Wilderness Study, Santa Barbara County, California AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice of availability.

    SUMMARY:

    The National Park Service (NPS) has prepared and approved a Record of Decision for the Final Environmental Impact Statement (EIS) and General Management Plan/Wilderness Study (GMP/WS) for Channel Islands National Park. Approval of the GMP/WS culminates an extensive public engagement and environmental impact analysis effort that began in 2001.

    ADDRESSES:

    Those wishing to review the Record of Decision may obtain a copy by submitting their request to the Superintendent, Channel Islands National Park, 1901 Spinnaker Drive, Ventura, CA 93001.

    FOR FURTHER INFORMATION CONTACT:

    Russell Galipeau, Superintendent, telephone (805) 508-5702 or email [email protected]

    SUPPLEMENTARY INFORMATION:

    This process was conducted pursuant to the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and the regulations promulgated by the Council on Environmental Quality (40 CFR part 1505.2). The original Notice of Intent (NOI) initiating the conservation planning and environmental impact analysis process appeared in the Federal Register on November 8, 2001 (66 FR 56575, column 1)—a revised NOI expanding GMP scope to include a wilderness study was published April 8, 2009 (74 FR 16006, column 2). Based on information obtained from extensive public outreach, three alternatives were developed. The NPS consulted with park partners; traditionally associated American Indian tribes and groups; the State Historic Preservation Officer; and other federal and state agencies. The Draft EIS was released on November 14, 2013 (78 FR 68469, column 2), for an extended 90-day review and comment period. Two public meetings were conducted to share information and gather feedback, one of which also included a public hearing on the wilderness study. Overall 1,620 pieces of correspondence were received during the public review period. The Final EIS was released on April 17, 2015. The legally required 30-day “wait period” was initiated on April 17, 2015, with the Environmental Protection Agency's Federal Register publication of filing of the Final EIS.

    The NPS evaluated the environmental consequences of two action alternatives and a no-action alternative. These alternatives described varying means to provide appropriate types and levels of access for visitors and authorized users, preserve wilderness character, protect cultural and natural resources, and adhere to legally required management and preservation objectives. Alternative 3 (agency-preferred) has been selected for implementation. This is also the environmentally-preferred course of action, which emphasizes resource stewardship and preservation while also placing more attention on expanding education and recreational opportunities and accommodations to provide diverse visitor experiences on the islands. Wilderness designation is proposed for 1,298 acres on Anacapa, Santa Barbara, Santa Cruz, and Santa Rosa Islands, and additionally on Santa Cruz and Santa Rosa Islands 65,278 acres are identified as potential wilderness.

    For a park that includes five remote islands spanning 2,228 square miles of land and sea, the new Channel Islands National Park GMP defines a clear direction for resource preservation and visitor experience over the next 20 to 40 years. The GMP provides a framework for proactive decision making, which will allow park managers to effectively address future opportunities and problems. The approved GMP will also serve as the basis for future detailed management documents, such as five-year strategic plans and project implementation plans.

    Dated: September 14, 2015. Martha J. Lee, Acting Regional Director, Pacific West Region.

    Editorial Note: This document was received for publication by the Office of the Federal Register on April 12, 2016.

    [FR Doc. 2016-08841 Filed 4-15-16; 8:45 am] BILLING CODE 4312-FF-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 731-TA-1070B (Second Review)] Certain Tissue Paper Products From China; Cancellation of Hearing for Full Five-Year Review AGENCY:

    United States International Trade Commission.

    ACTION:

    Notice.

    DATES:

    Effective Date: April 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Justin Enck ((202) 205-3363), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (http://www.usitc.gov). The public record for this review may be viewed on the Commission's electronic docket (EDIS) at http://edis.usitc.gov.

    SUPPLEMENTARY INFORMATION:

    Effective January 6, 2016, the Commission established a schedule for the conduct of this review (81 FR 1643, January 13, 2016). Subsequently, counsel for the domestic interested parties filed a request to appear at the hearing and for consideration of cancellation of the hearing. Counsel indicated a willingness to submit written testimony and responses to any Commission questions in lieu of an actual hearing. No other party has entered an appearance in this review. Consequently, the public hearing in connection with this review, scheduled to begin at 9:30 a.m. on Thursday, April 28, 2016, at the U.S. International Trade Commission Building, is cancelled. Parties to this review should respond to any written questions posed by the Commission in their posthearing briefs, which are due to be filed on May 5, 2016.

    For further information concerning this review see the Commission's notice cited above and the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).

    Authority:

    This review is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.62 of the Commission's rules.

    By order of the Commission.

    Issued: April 12, 2016. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2016-08797 Filed 4-15-16; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-930] Certain Laser Abraded Denim Garments; Commission Determination To Review Order No. 43, and on Review Vacating That Order as Moot; Termination of the Investigation AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission (“Commission”) has determined to review Order No. 43 issued by the presiding administrative law judge (“ALJ”). On review, the Commission has determined to vacate Order No. 43 because the law firm disqualification at issue has become moot. This investigation is terminated.

    FOR FURTHER INFORMATION CONTACT:

    Robert Needham, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-5468. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (http://www.usitc.gov). The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at http://edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.

    SUPPLEMENTARY INFORMATION:

    The Commission instituted this investigation on September 23, 2014, based on a complaint filed by RevoLaze, LLC and TechnoLines, LLC, both of Westlake, Ohio (collectively, “RevoLaze”). 79 Fed Reg. 56828 (Sept. 23, 2014). The complaint alleged violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, by reason of the importation into the United States, the sale for importation, and the sale within the United States after importation of certain laser abraded denim garments. The complaint alleged the infringement of seventy-one claims of six United States patents. The notice of institution named twenty respondents, including The Gap, Inc. of San Francisco, California (“Gap”), who, one-by-one were terminated from the investigation. On November 18, 2015, the Commission terminated the last remaining respondents from the investigation on the basis of settlement and withdrawal of the complaint. 80 FR Reg. 73209, 73210 (Nov. 24, 2015).

    However, previously in the investigation, the then-presiding ALJ disqualified complainants' counsel Dentons US LLP (“Dentons US”) in an order that was not an initial determination (“ID”). Order No. 43 (May 7, 2015). Subsequently, the ALJ granted (as an ID) Dentons US's motion to intervene regarding its disqualification, Order No. 82 (Aug. 7, 2013), but denied (as an order) its motion for reconsideration of Order No. 43 as well as its request for leave to seek interlocutory review before the Commission, Order No. 83 (Aug. 7, 2015); see 19 CFR 210.24 (interlocutory review by the Commission). The Commission determined not to review Order No. 82. Notice (Aug. 26, 2015).

    On October 27, 2015, in response to the issuance of an ID (Order No. 106), which terminated the investigation before the ALJ, Dentons US filed a petition for Commission review of Order Nos. 43 and 83. See 19 CFR 210.24 (rulings by the ALJ “on motions may not be appealed to the Commission prior to the administrative law judge's issuance of an initial determination”). On November 3, 2015, and November 9, 2015, the Office of Unfair Import Investigations and Gap, respectively, opposed Dentons' petition.

    The Commission has determined to review Order No. 43, and, on review, has determined to vacate the disqualification decision as moot. In view of the final disposition of the investigation as to all respondents, the issue of Dentons US's disqualification has no practical effect on this investigation.

    Although the Commission has the discretion to address issues that have become moot, it has determined not to do so here. The disqualification in this investigation turns on whether Dentons US and Dentons Canada LLP as members of Salans FMC Denton Group (“Dentons Verein”) should be treated as a single law firm under the American Bar Association's Model Rules of Professional Conduct (“Model Rules”) in this investigation. Answering that question would require further proceedings, and potentially additional factfinding. In particular, Comment 2 to Model Rule 1.0 sets forth several factors to consider in determining whether a group of lawyers constitute a law firm, including (1) how the lawyers present themselves to the public, (2) whether the lawyers conduct themselves as a law firm, (3) the terms of any formal agreement among the lawyers, and (4) whether the lawyers have mutual access to client information. Here, the record lacks sufficient evidence on these factors, especially as to the third factor, because the Dentons Verein organizational agreements have not been made part of the record of the investigation. The Commission has decided that the added delay, burdens, and expenses that would be incurred by the parties and the Commission in resolving these issues are unjustified given the termination of the investigation as to all respondents.

    Accordingly, the Commission has determined to review and vacate Order No. 43, without deciding whether the disqualification in this investigation was appropriate. The reasoning in support of the Commission's decision will be set forth more fully in a forthcoming opinion.

    In light of its determination above, the Commission has determined not to review Order No. 83, which denied as untimely a motion of Dentons US and Revolaze for reconsideration of Order No. 43 or for interlocutory review by the Commission.

    The Commission notes that in April 2016, it received several submissions from RevoLaze and Dentons US after the deadlines for submissions set forth in 19 CFR 210.43 had passed. The Commission rejects these submissions as untimely and procedurally improper, and did not consider them in making its determination.

    The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

    Issued: April 12, 2016.

    By order of the Commission.

    Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2016-08845 Filed 4-15-16; 8:45 am] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—IMS Global Learning Consortium, Inc.

    Notice is hereby given that, on March 18, 2016, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 et seq. (“the Act”), IMS Global Learning Consortium, Inc. (“IMS Global”) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, Baltimore County Public Schools, Baltimore, MD; Broward Community College, Fort Lauderdale, FL; explorance, Montreal, Quebec, CANADA; its learning, Bergen, NORWAY; Katy Independent School District, Katy, TX; and Purdue University, West Lafayette, IN, have been added as parties to this venture.

    Also, EUN Partnership AISBL, Brussels, BELGIUM; Open Universiteit Nederland, Heerlen, THE NETHERLANDS; D.E. Solution sprl, Brussels, BELGIUM; Poway Unified School District, Poway, CA; American Institutes for Research, Washington, DC; University of Bridgeport, Bridgeport, CT; and Gutenberg Technology, Cambridge, MA, have withdrawn as parties to this venture.

    No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and IMS Global intends to file additional written notifications disclosing all changes in membership.

    On April 7, 2000, IMS Global filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the Federal Register pursuant to section 6(b) of the Act on September 13, 2000 (65 FR 55283).

    The last notification was filed with the Department on December 29, 2015. A notice was published in the Federal Register pursuant to section 6(b) of the Act on January 22, 2016 (81 FR 3820).

    Patricia A. Brink, Director of Civil Enforcement, Antitrust Division.
    [FR Doc. 2016-08803 Filed 4-15-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—Advanced Media Workflow Association, Inc.

    Notice is hereby given that, on March 23, 2015, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 et seq. (“the Act”), Advanced Media Workflow Association, Inc. has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, Arista Networks, Santa Clara, CA; Cisco International Limited, Feltham, UNITED KINGDOM; Coveloz Technologies, Inc., Kanata, CANADA; Masstech Innovations, Markham, Ontario, CANADA; Iain Collins (individual member), London, UNITED KINGDOM; Gabor Forgacs (individual member), Budapest, HUNGARY; Laurance Hughes (individual member), Sydney, AUSTRALIA; Douglas McGee (individual member), Columbus, OH; and Nick Ryan (individual member), London, UNITED KINGDOM, have been added as parties to this venture.

    Also, Ad-ID, New York, NY; CNN/Turner Broadcasting System, Atlanta, GA; Masstech Group, Inc., Markham, Ontario, CANADA; Video Stream Networks (VSN), Barcelona, SPAIN; and SDVI Corporation, Menlo Park, CA, have withdrawn as parties to this venture.

    No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Advanced Media Workflow Association, Inc. intends to file additional written notifications disclosing all changes in membership.

    On March 28, 2000, Advanced Media Workflow Association, Inc. filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the Federal Register pursuant to section 6(b) of the Act on June 29, 2000 (65 FR 40127).

    The last notification was filed with the Department on December 23, 2015. A notice was published in the Federal Register pursuant to section 6(b) of the Act on January 22, 2016 (81 FR 3823).

    Patricia A. Brink, Director of Civil Enforcement, Antitrust Division.
    [FR Doc. 2016-08804 Filed 4-15-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Manufacturer of Controlled Substances Registration: Cody Laboratories, Inc. ACTION:

    Notice of registration.

    SUMMARY:

    Cody Laboratories, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cody Laboratories, Inc. registration as a manufacturer of those controlled substances.

    SUPPLEMENTARY INFORMATION:

    By notice dated December 4, 2015, and published in the Federal Register on December 10, 2015, 80 FR 76709, Cody Laboratories, Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice.

    The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Cody Laboratories, Inc. to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.

    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the following basic classes of controlled substances:

    Controlled substance Schedule Dihydromorphine (9145) I Amphetamine (1100) II Methamphetamine (1105) II Methylphenidate (1724) II Amobarbital (2125) II Pentobarbital (2270) II Secobarbital (2315) II 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333) II Phenylacetone (8501) II Cocaine (9041) II Codeine (9050) II Dihydrocodeine (9120) II Oxycodone (9143) II Hydromorphone (9150) II Diphenoxylate (9170) II Ecgonine (9180) II Hydrocodone (9193) II Meperidine (9230) II Methadone (9250) II Methadone intermediate (9254) II Morphine (9300) II Thebaine (9333) II Oxymorphone (9652) II Alfentanil (9737) II Remifentanil (9739) II Sufentanil (9740) II Tapentadol (9780) II Fentanyl (9801) II

    The company plans to manufacture the listed controlled substances in bulk for sale to its customers.

    Dated: April 11, 2016. Louis J. Milione, Deputy Assistant Administrator.
    [FR Doc. 2016-08843 Filed 4-15-16; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Registration: Research Triangle Institute ACTION:

    Notice of registration.

    SUMMARY:

    Research Triangle Institute applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Research Triangle Institute registration as an importer of those controlled substances.

    SUPPLEMENTARY INFORMATION:

    By notice dated July 29, 2015, and published in the Federal Register on August 4, 2015, 80 FR 46330, Research Triangle Institute, Kenneth S. Rehder, Hermann Building East Institute Drive, Room 106, Research Triangle Park, North Carolina 27709-2194 applied to be registered as an importer of certain basic classes of controlled substances. No comments or objections were submitted for this notice.

    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Research Triangle Institute to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.

    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of the following basic classes of controlled substances:

    Controlled substance Schedule AB-PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)1-pentyl-1H-indazole-3-carboxamide) (7023) I AB-CHMINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (7031) I AM-2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole) (7201) I AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole) (7694) I JWH-018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl) indole) (7118) I JWH-073 (1-Butyl-3-(1-naphthoyl)indole) (7173) I JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) (7200) I JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) (6250) I JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) (7019) I JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole) (7081) I JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole) (7122) I JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl) indole) (7203) I JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl) indole (7398) I THJ-2201 [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (7024) I 1-(1-Phenylcyclohexyl)pyrrolidine (7458) I 1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) I 1-[1-(2-Thienyl)cyclohexyl]pyrrolidine (7473) I 1-Methyl-4-phenyl-4-propionoxypiperidine (9661) I 1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine (9663) I 2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) (7348) I 2,5-Dimethoxy-4-ethylamphetamine (7399) I 2,5-Dimethoxyamphetamine (7396) I 2-(2,5-Dimethoxy-4-methylphenyl) ethanamine (2C-D) (7508) I 2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine (2C-E) (7509) I 2-(2,5-Dimethoxyphenyl) ethanamine (2C-H) (7517) I 2-(2,5-Dimethoxy-4-nitro-phenyl) ethanamine (2C-N) (7521) I 2-(2,5-Dimethoxy-4-(n)-propylphenyl) ethanamine (2C-P) (7524) I 2-(4-Isopropylthio)-2,5-dimethoxyphenyl) ethanamine (2C-T-4) (7532) I 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25B-NBOMe) (7536) I 2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) (7348) I 2-(4-Ethylthio-2,5-dimethoxyphenyl) ethanamine (2C-T-2) (7385) I 2-(4-Iodo-2,5-dimethoxyphenyl) ethanamine (2C-I) (7518) I 2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine (2C-C) (7519) I 3,4,5-Trimethoxyamphetamine (7390) I 3,4-Methylenedioxyamphetamine (7400) I 3,4-Methylenedioxy-N-ethylamphetamine (7404) I 3,4-Methylenedioxymethamphetamine (7405) I 3-Methylfentanyl (9813) I 3-Methylthiofentanyl (9833) I 4-Bromo-2,5-dimethoxyamphetamine (7391) I 4-Bromo-2,5-dimethoxyphenethylamine (7392) I 4-Methyl-2,5-dimethoxyamphetamine (7395) I 4-Methylaminorex (cis isomer) (1590) I 4-Methoxyamphetamine (7411) I 5-Methoxy-3,4-methylenedioxyamphetamine (7401) I 5-Methoxy-N,N-dimethyltryptamine (7431) I 5-Methoxy-N,N-diisopropyltryptamine (7439) I Acetorphine (9319) I Acetyl-alpha-methylfentanyl (9815) I Acetyldihydrocodeine (9051) I Acetylmethadol (9601) I Allylprodine (9602) I Alpha-ethyltryptamine (7249) I Alpha-methylfentanyl (9814) I Alpha-methylthiofentanyl (9832) I Alpha-methyltryptamine (7432) I Alphacetylmethadol except levo-alphacetylmethadol (9603) I Alphameprodine (9604) I Alphamethadol (9605) I Aminorex (1585) I Benzethidine (9606) I Benzylmorphine (9052) I Beta-hydroxy-3-methylfentanyl (9831) I Beta-hydroxyfentanyl (9830) I Betacetylmethadol (9607) I Betameprodine (9608) I Betamethadol (9609) I Betaprodine (9611) I Bufotenine (7433) I CP-47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol) (7297) I CP-47,497 C8 Homologue (5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol) (7298) I Cathinone (1235) I Clonitazene (9612) I Codeine methylbromide (9070) I Codeine-N-oxide (9053) I Cyprenorphine (9054) I Desomorphine (9055) I Dextromoramide (9613) I Diampromide (9615) I Diethylthiambutene (9616) I Diethyltryptamine (7434) I Difenoxin (9168) I Dihydromorphine (9145) I Dimenoxadol (9617) I Dimepheptanol (9618) I Dimethylthiambutene (9619) I Dimethyltryptamine (7435) I Dioxaphetyl butyrate (9621) I Dipipanone (9622) I Drotebanol (9335) I Ethylmethylthiambutene (9623) I Etonitazene (9624) I Etorphine (except HCl) (9056) I Etoxeridine (9625) I Fenethylline (1503) I Furethidine (9626) I Gamma Hydroxybutyric Acid (2010) I Heroin (9200) I Hydromorphinol (9301) I Hydroxypethidine (9627) I Ibogaine (7260) I Ketobemidone (9628) I Levomoramide (9629) I Levophenacylmorphan (9631) I Lysergic acid diethylamide (7315) I MDPV (3,4-Methylenedioxypyrovalerone) (7535) I Marihuana (7360) I Mecloqualone (2572) I Mephedrone (4-Methyl-N-methylcathinone) (1248) I Mescaline (7381) I Methaqualone (2565) I Methcathinone (1237) I Methyldesorphine (9302) I Methyldihydromorphine (9304) I Methylone (3,4-Methylenedioxy-N-methylcathinone) (7540) I Morpheridine (9632) I Morphine methylbromide (9305) I Morphine methylsulfonate (9306) I Morphine-N-oxide (9307) I Myrophine (9308) I N,N-Dimethylamphetamine (1480) I N-Benzylpiperazine (7493) I N-Ethyl-3-piperidyl benzilate (7482) I N-Ethylamphetamine (1475) I N-Ethyl-1-phenylcyclohexylamine (7455) I N-Hydroxy-3,4-methylenedioxyamphetamine (7402) I Nicocodeine (9309) I Nicomorphine (9312) I N-Methyl-3-piperidyl benzilate (7484) I Noracymethadol (9633) I Norlevorphanol (9634) I Normethadone (9635) I Normorphine (9313) I Norpipanone (9636) I Para-Fluorofentanyl (9812) I Parahexyl (7374) I Peyote (7415) I Phenadoxone (9637) I Phenampromide (9638) I Phenomorphan (9647) I Phenoperidine (9641) I Pholcodine (9314) I Piritramide (9642) I Proheptazine (9643) I Properidine (9644) I Propiram (9649) I Psilocybin (7437) I Psilocyn (7438) I Racemoramide (9645) I SR-18 (Also known as RCS-8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) (7008) I SR-19 (Also known as RCS-4) (1-Pentyl-3-[(4-methoxy)-benzoyl] indole (7104) I Tetrahydrocannabinols (7370) I Thebacon (9315) I Thiofentanyl (9835) I Tilidine (9750) I Trimeperidine (9646) I 1-Phenylcyclohexylamine (7460) II 1-Piperidinocyclohexanecarbonitrile (8603) II 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333) II Alfentanil (9737) II Alphaprodine (9010) II Amobarbital (2125) II Amphetamine (1100) II Anileridine (9020) II Bezitramide (9800) II Carfentanil (9743) II Coca Leaves (9040)